The State Of Haryana vs. Krishan Kumar

REPORTABLE
2026 INSC 63
IN THE SUPREME COURT OF INDIA
CIVIL APPELLATE JURISDICTION
CIVIL APPEAL NOS. 1725-1731 OF 2023
THE STATE OF HARYANA APPELLANT(S)
VERSUS
KRISHAN KUMAR & ORS. RESPONDENT(S)
WITH
CIVIL APPEAL NOS. 1732-1738 OF 2023
CHETAN VERMA & ORS. APPELLANT(S)
VERSUS
STATE OF HARYANA & ORS. RESPONDENT(S)
WITH
CIVIL APPEAL NOS. OF 2026
(@ Special Leave Petition (C) Nos. 16490-16491 of 2023)
KIRAN KUMAR M. APPELLANT(S)
VERSUS
Signature Not Verified
THE KARNATAKA PUBLIC
SERVICE COMMISSION & ORS. RESPONDENT(S)
Digitally signed by
NIDHI AHUJA
Date: 2026.01.15
18:23:09 IST
Reason:
WITH
1


CIVIL APPEAL NO. OF 2026
(@ Special Leave Petition (C) No. )
[Diary No. 1909/2024]
PARVEEN KUMAR APPELLANT(S)
VERSUS
STATE OF HARYANA & ANR. RESPONDENT(S)
J U D G M E N T
J.K. MAHESHWARI
1. Leave granted.
2. The present batch of appeals concerns the challenge to the
power of the State Government to prescribe the essential
qualifications different from the qualification prescribed by the
1
Central Government under Rule 49 of the Drug Rules, 1945 (in
short, ‘ Drug Rules ’) framed in exercise of the power under Sections
2
6(2), 12, 33 and 33N of the Drugs and Cosmetics Act, 1940 (in
short, ‘ D&C Act ’) for appointment to the post of Drug Inspector (in
short, ‘ DI ’), or Drug Control Officer (in short, ‘ DCO ’).

1
As amended by (Amendment) Rules, 2025.
2
Chapter IVA – Provisions relating to [Ayurvedic, Siddha and Unani] Drugs.
2



3. These appeals arise from the proceedings in the State of
Haryana and Karnataka respectively. Since there is a commonality
of the facts and legal issues, they are being dealt with by this
common judgment. For the sake of brevity, we are first dealing with
the facts of the appeals from the State of Haryana, followed by

those from the State of Karnataka.
Civil Appeal Nos. 1725-1731 of 2023, Civil Appeal Nos. 1732-
1738 of 2023 and Diary No. 1909 of 2024
4. In Civil Appeal Nos. 1725-1731 of 2023 and Civil Appeal Nos.
1732-1738 of 2023, the State of Haryana and the participants,
both have challenged the final impugned judgement dated
09.09.2022 of the Full Bench of the High Court of Punjab and
Haryana at Chandigarh in the letters patent appeal and connected
civil writ petitions, whereby the High Court answered the reference
and quashed the advertisement, which was followed by the
corrigendum, for appointment to the post of DCO in the State of
Haryana. In Diary No. 1909 of 2024, the sole participant has
challenged the final impugned judgement dated 30.09.2022 of the
Single Judge of the High Court of Punjab and Haryana at
Chandigarh in the writ petition, whereby the High Court disposed
3


of the same in terms of the Full Bench judgement of the High Court
dated 09.09.2022.
5. The facts put in brief are that the Haryana Public Service
Commission (in short, ‘ HPSC ’) issued an advertisement on
07.09.2015, which was published on 10.09.2015, followed by the
corrigendum dated 04.06.2019 for appointment to the post of
DCO, prescribing qualification under the Haryana Food and Drugs
Administration Department, Subordinate Offices (Group B) Service
Rules, 2018 (in short, ‘ Rules of 2018 ’) framed in exercise of the
power under the proviso to Article 309 of the Constitution of India.
The essential qualification as specified was different from the
qualification prescribed by the Central Government under the
Drug Rules. Applying the Rules of 2018, the candidature of the
participants was rejected for want of possessing the essential
qualifications prescribed in the advertisement.
6. Being aggrieved, challenge was made before the High Court
inter-alia contending that under Section 33 of the D&C Act, only
the Central Government can make the rules for giving effect to the
provisions of Chapter IV [Manufacture, Sale and Distribution of
(Drugs and Cosmetics)] of D&C Act. Section 33(2)(b) of the D&C
Act specifies that the Central Government may prescribe the
4


qualification and duties of Government Analysts and the
qualifications of Inspectors by making such rules necessary for
giving effect to the provisions of the said Chapter. It may, under
Section 33(2)(n), prescribe the powers and duties of Inspectors and
specify the drugs or classes of drugs of cosmetics or classes of
cosmetics in relation to which and the conditions, limitations or
restrictions subject to which, such powers and duties can be
exercised. In exercise of such powers, the Drug Rules were
promulgated by the Centre, wherein Rule 49 prescribes the
qualifications of a person who may be appointed as DI/DCO under
the D&C Act. The proviso appended specifies that only those
‘Inspectors’ who possess experience in manufacture or testing or
inspection, as the case may be, shall be authorised to inspect the
manufacture of the substances as specified in Schedule C. Rules
51 and 52 of the Drug Rules prescribe the powers of Inspection.
7. The discord between the parties is that the State Government
under the proviso to Article 309 of the Constitution of India,
framed the Rules of 2018 which prescribed the qualification of
DI/DCO by adding the experience as essential for appointment,
akin to the proviso of Rule 49 of the Drug Rules, which was
prescribed only to inspect the manufacture of the substances
5


mentioned in Schedule ‘C’ of the D&C Act. Therefore, the concern
is whether addition of such qualification in Rules of 2018 is
justified in the matter of appointment of DI/DCO by the State
Government.
8. The High Court concluded that since Section 33 of the D&C
Act empowers the Central Government to make Rules on the
subject, as such, the field is occupied. Therefore, the State
Government cannot frame rules under the proviso to Article 309 of
the Constitution of India on the same subject for DI/DCO,
prescribing additional qualifications, i.e., experience in inspecting
Schedule C substance manufacturers under the Drug Rules. It
was contended that the experience prescribed under proviso to
Rule 49 of the Drug Rules cannot be made an essential
qualification for appointment to the post of DI/DCO, therefore, it
is illegal, arbitrary, discriminatory and also violative of Articles 14
and 16 of the Constitution of India.
9. When the matter travelled to the Division Bench of Punjab &
Haryana High Court at Chandigarh, it was referred to the Larger
Bench vide order dated 25.08.2021. For better understanding, the
said order is necessary hence, reproduced as under:-
6


“ The petitioner has filed this writ petition under Article 226
of the Constitution for quashing the essential qualification
as prescribed in advertisement dated 7.9.2015 (Annexure
P-1) for appointment to the post of Drug Inspector (Drug
Control Officer) further for quashing part of Serial No.11
Appendix B under Rule 7 of the Notification issued by Food
and Drugs Administration Department, Haryana
Government dated 13.11.2018 (Annexure P-10) (Haryana
Food and Drugs Administration Department, Subordinate
Office (Group-B) Service Rules, 2018) inter alia as the same
is contrary to Rule 49 of the Drugs and Cosmetics Rules,
1945.
The impugned notification dated 13.11.2018 (Annexure P-
10) was issued by Governor in exercise of the powers
conferred by the proviso to Article 309 of the Constitution of
India.
In A.B. Krishna v. State of Karnataka; (1998) 3 SCC 495,
Hon’ble Apex Court observed as follows:
“5. Rule-making power, so far as services under the Union
or any State, are concerned, are vested in the President or
the Governor, as the case may be, under Article 309 of the
Constitution which provides as under: -
“309. Recruitment and conditions of service of persons
serving the Union or a State – Subject to
the provisions of this Constitution, Acts of the
appropriate Legislature may regulate the recruitment,
and conditions of service of persons appointed, to
public services and posts in connection with the affairs
of the Union or of any State: Provided that it shall be
competent for the President or such person as he may
direct in the case of services and posts in connection
with the affairs of the Union, and for the Governor of a
State or such person as he may direct in the case of
services and posts in connection with the affairs of the
State, to make rules regulating the recruitment, and the
conditions of service of persons appointed, to such
services and posts until provision in that behalf is
made by or under an Act of the appropriate Legislature
under this article, and any rules so made shall have
effect subject to the provisions of any such Act.”
7


6. It is primarily the Legislature, namely, the
Parliament or the State Legislative Assembly, in whom
power to make law regulating the recruitment and
conditions of service of persons appointed to public
services and posts, in connection with the affairs of the
Union or the State, is vested. The legislative field
indicated in this Article is the same as is indicated in
Entry 71 of List I of the Seventh Schedule or Entry 41
of List II of that Schedule. The proviso, however, gives
power to the President or the Governor to make Service
Rules but this is only a transitional provision as the
power under the Proviso can be exercised only so long
as the Legislature does not make any Act whereby
recruitment to public posts as also other conditions of
service relating to that post are laid down.
7. The Rule-making function under the Proviso to
Article 309 is a legislative function. Since Article 309
has to operate subject to other provisions of the
Constitution, it is obvious that whether it is an Act
made by the Parliament or the State Legislature which
lays down the conditions of service or it is the Rule
made by the President or the Governor under the
Proviso to that Article, they have to be in conformity
with the other provisions of the Constitution specially
Articles 14, 16, 310 and 311.”
An intractable question has arisen in the present writ
petition in view of provisions of Drugs and Cosmetics Act,
1940 and Notification dated 13.10.2018, Annexure P-10,
issued by the State Government under Article 309 of the
Constitution of India in a matter relating to recruitment of
Drug Control Officers. Though, Section 21 of Drugs and
Cosmetics Act, 1940 clearly lays down that appointment
shall be made as per the qualifications prescribed, which
would normally indicate the qualifications prescribed in
Central statute. However, State Government invoked Article
309 of the Constitution of India and prescribed
qualifications different from that prescribed by the Central
Government. Though, undisputedly, the matter falls in the
realm of List III, the State Government never choose to enact
its legislation. Merely, for the purpose of laying down
qualification, it invoked Article 309 of the Constitution of
India. In such circumstances, it needs to be examined
8


whether invocation of such powers would be sustainable in
law; whether it would be hit by doctrine of eclipse; whether
notification needs to be examined in light of provisions of
Article 252 and 254 of Constitution of India. There is no
clear answer forthcoming in the judgments referred to by
the parties, particularly, ‘Priyanka and others versus UPSC
and others, passed in CWP-14287 of 2013. There is one
another judgment of this Court in LPA-1778-2016 Sachin
Saggar v. State of Punjab and others decided on 15.9.2016.
However, the rules framed by Punjab Government
regarding appointment of Drug Inspectors are in conformity
with Rule 49 of Drugs & Cosmetics Rules, 1945 framed by
Central Government, which is not so in State of Haryana. In
State of Haryana, the experience prescribed in proviso to
Rule 49 of Rules of 1945 framed by Central Government,
has been made one of the essential qualifications for
appointment as a Drug Inspector. There appears to be little
doubt that the Drugs and Cosmetics Act, 1940 enacted by
the Parliament under Central Statute is a complete
legislation on the subject. Section 21 thereof reads as
under:-
“21. Inspectors.—
(1) The Central Government or a State Government
may by notification in the Official Gazette, appoint such
persons as it thinks fit, having the prescribed
qualifications, to be Inspectors for such areas as may
be assigned to them by the Central Government or the
State Government, as the case may be.
(2) The powers which may be exercised by an
Inspector and the duties which may be performed by
him, the drugs or [classes of drugs or cosmetics or
classes of cosmetics] in relation to which and the
conditions, limitations or restrictions subject to which,
such powers and duties may be exercised or performed
shall be such as may be prescribed.
(3) No person who has any financial interest [in the
import, manufacture or sale of drugs or cosmetics] shall
be appointed to be an Inspector under this section.
(4) Every Inspector shall be deemed to be a public
servant within the meaning of section 21 of the Indian
9


Penal Code (45 of 1860), and shall be officially
subordinate to such authority 4[having the prescribed
qualifications,] as the Government appointing him may
specify in this behalf.”
Section 33 of the Drugs and Cosmetic Act, 1940 empowers
the Central Government to frame Rules under the Act. In
exercise of the powers conferred by Section 33 of the Act,
the Central Government framed the Drugs and Cosmetics
Rules, 1945. Rule 49 of the said Rules prescribes the
qualification for appointment to the posts of Drug Inspectors.
Rule 51 authorises certain Drug Inspectors to inspect the
premises licensed for sale of drugs whereas Rule 52
authorises Drug Inspectors to inspect the manufacture of
drugs or cosmetics. However, there is not even a whisper in
the impugned advertisement dated 7.9.2015 as to whether
Drug Inspectors (Drug Control Officers) are being appointed
for the purpose of performing duties as prescribed under
Rule 51 or Rule 52. Further, in the present case, the State
invoked Article 309 of the Constitution prescribing essential
qualifications for such appointments, which are at variance
to those laid down in the Central Statute. Article 309 of the
Constitution was invoked for the limited purpose of
prescribing different qualifications. For all intents and
purposes if the Central Act prevails, the experience as laid
down in the proviso would not be essential qualification.
However, if notification issued by the State under Article
309 of the Constitution is given effect to then experience
become necessary and candidate not possessing the same
cannot be considered eligible.
An important question therefore arises (1) whether State
Government could have acted beyond the statutory
provisions contained in the Central Act i.e. Sections 21 and
33 of the Act and Rules framed thereunder, prescribing
qualifications and invoking Article 309 for this purpose.
While in the Rules of 1945, (2) whether the experience as
contained in the proviso to Rule 49 of the 1945 Rules,
whereas in the Rules framed by the State under Article 309
of the Constitution, the experience has been made as
essential qualification. Therefore, another question arises
(3) whether the Rules framed by the State under Article 309
of the Constitution would have overriding effect over the
10


rules framed under Central Statue, the primary legislation
governing the recruitment of Drug Inspectors.
A larger Bench needs to be constituted to decide these
questions. The application for vacation of stay be put up
before the said Bench.”
10. In the said reference, the larger Bench by majority vide
impugned order dated 09.09.2022 held that the State Government
could not have acted beyond the scheme of the D&C Act and the
Drug Rules prescribing experience as an essential qualification for
appointment of DI/DCO since the field was occupied by the Rules
of the Central government and hence, invoking power under the
proviso to Article 309 of the Constitution of India on the subject is
not proper. The primary legislation governing appointment of
DI/DCO is the D&C Act and the Drug Rules framed thereunder. In
its true sense, the State ought not to have framed separate rules
to override the effect of central legislations.

11. The minority view, while concurring with the operative
portion of the majority judgement inter-alia held that in the facts
of the present case, the State while exercising powers under
proviso to Article 309 of the Constitution of India did not act
beyond the scope of the D&C Act. It was opined that the power
under proviso to Article 309 of the Constitution of India could have
been exercised even if the field was occupied because the State
11


Rules prescribing qualification to the post of DI/DCO are not in
conflict with the Central Rules. It was noted that the experience
contained in proviso to Rule 49 of Drug Rules can be made
essential qualification looking at the duties of the Inspectors which
also include the inspection of the manufacture of substances
mentioned in Schedule C of Rule 52 of the Drug Rules. It was said,
prescribing qualification qua experience as an essential for initial
appointment of DI/DCO is not repugnant to the Drug Rules and
does not override the same. Additionally, the Constitutional power
under the proviso to Article 309 of the Constitution of India is to
regulate the recruitment and conditions of service, including
prescription of qualification which can be exercised by the State
clarifying the provision of Article 254 of the Constitution of India.
It was said that in the event of any conflict, the Drug Rules shall
prevail over the Rules of 2018.
SLP (C) Nos. 16490-16491 of 2023
12. Assailing the order dated 31.03.2023 passed by the Division
Bench of the High Court of Karnataka at Bengaluru, allowing the
3
writ petitions filed by the private respondents and setting aside

3
In Writ Petition No. 10575 of 2021 (S-KSAT) c/w Writ Petition No. 17163 of 2021 (S-KSAT).
12


the order dated 12.05.2021 passed by the Karnataka State
Administrative Tribunal (in short “ KSAT ”), the present appeal has
been filed.
13. The High Court was dealing with the similar controversy, in
4
particular, the vires of condition No. 2 in notification dated
23.03.2018 issued by the Karnataka Public Service Commission
(in short, ‘ KPSC ’) inviting applications for the post of Drug
Inspector. The dispute was set in motion when the interviews of
few amongst the eligible candidates as per list dated 07.11.2019
were postponed on the pretext of document verification and later,
their names were excluded vide the substituted select list dated
27.11.2020 without citing any reason, thereby altering the
procedure. In the substituted list, the departmental candidates
having experience in the manufacture and/or testing of the
substances mentioned in Schedule C and/or C1 drugs included in
the Drug Rules were brought in. Being aggrieved, original
5
applications were filed before KSAT, which came to be dismissed
vide common order dated 12.05.2021.

4
Must have put in a service of not less than eighteen months of experience in the
manufacturing and/or testing of schedule C and/or C1 drugs included in the Drugs and
Cosmetics Rules, 1945.
5
Original Application Nos. 5733-5786 of 2020 (Selection).
13



14. On assailing the same, the High Court considered the validity
of the judgment of KSAT and held that the rule-making power to
prescribe qualification for the post of Inspector is vested with the
Parliament alone and no ground is ceded to the State Legislature,
in line with the legislative backing of Section 38 of the D&C Act. It
was further held that the operation ceded to the State is only to
the extent of making appointment of Inspectors, but it in no way
reserves any power and authority with the State to frame any rule,
much less prescribe any criteria for eligibility of candidates for
such posts. The Court was of the opinion that once the State is
devoid of legislative competence to prescribe the qualification
under the proviso to Article 309 of the Constitution of India, adding
the qualification of experience by making rules, inconsistent with
the provisions of the D&C Act and Drug Rules, is arbitrary. In this
view, the judgment of KSAT was set-aside by the High Court
declaring that the qualification of experience for appointment of
Inspector is ultra vires to Section 33(2)(b) and 33(2)(n) of the D&C
Act read with Rule 49 of the Drug Rules. The High Court further
quashed all the endorsements and directed KPSC to re-do the
select list.

14


Arguments advanced on behalf of the parties
15. Mr. Vikramjeet Banerjee, learned Additional Solicitor General
representing the State of Haryana referring to Section 21 of the
D&C Act argued that the State Government also has the authority
to appoint such persons if it thinks fit having the qualification
prescribed for the post of Inspector in such areas, as may be
assigned to them, insofar as the power under Section 33 vested
with the Central Government is not absolute. The entry 19 of List
III under Schedule VII of the Constitution of India specifies ‘Drugs
and Poisons, subject to the provisions of entry 59 of List I with
respect to opium.’ Therefore, under proviso to Article 309 of the
Constitution of India, the State Government may prescribe the
qualification of persons who can be appointed as DI/DCO. In
exercise of such power, the Hon’ble Governor of the State of
Haryana promulgated the Rules of 2018 which were notified on
13.11.2018, bringing the experience within the ambit of essential
qualification and also the knowledge of Hindi or Sanskrit as one of
the subjects considering the demography of the State. Such
exercise of power cannot be said to be inconsistent with the D&C
Act and Drug Rules since they merely prescribe the qualification
for appointment of DI/DCO. The State, with intent to ensure
15


efficient discharge of duties by the Inspectors after their
appointment, is well within its domain to include ‘experience’ as
an essential qualification. It is further urged that the qualifications
prescribed in proviso to Rule 49 of the Drug Rules and the
qualifications prescribed in Appendix B is not repugnant,
therefore, the High Court was not justified in allowing the writ
petitions and setting aside the advertisement. In support, reliance
has been placed on the judgment of S. Satyapal Reddy Vs. Govt.
6
of A.P.
16. Mr. Anand Sanjay M. Nuli, learned Senior Counsel in civil
appeals concerning the State of Karnataka submits that the
Karnataka State Civil Services Act, 1978 (in short ‘ KSCSA ’) has
been enacted by the State Government. Section 3 specifies
‘Regulation of recruitment and the conditions of service.’ , and as per
clause (b), the State Government can make the rules for regulating
the recruitment and the conditions of service to the persons
appointed for the public service. Therefore, the State Government
was well within its domain and the powers vested, in promulgating
the ‘Health and Family Welfare Services (Drugs Control
Department Non-teaching staff) (Recruitment) Rules, 2013’

6
(1994) 4 SCC 391
16


(hereinafter referred to as ‘ Rules of 2013 ’). The powers have been
derived by the State Act to prescribe qualifications for the post of
Drug Inspector and therefore, the recruitment notification issued
on 23.03.2018 for filling 83 vacancies with condition no. 2 on the
post of DI/DCO is completely within the competence of the State
and consistent with the D&C Act and Drug Rules. He further
submitted that his case stands on a different footing as compared
to that of Haryana and urged that the findings of the High Court
qua condition no. 2 in the notification dated 23.03.2018,
prescribing “18 months experience in manufacturing/testing of
Schedule C and/or C1 drugs” as ultra vires Section 33(2)(b) and (n)
of the D&C Act and Rule 49 of the Drug Rules, is not correct. As
such, the direction issued to KPSC to re-do the select list may also
be set-aside.
17. Learned Counsel appearing on behalf of HPSC submits that
the advertisement was issued in the year 2015 under the Haryana
Drugs (Group B) Service Rules, 1989 (later repealed by the
Rules of 2018) prescribing the experience as essential
qualification. In such circumstances, the candidature of the
participants who did not possess the requisite experience in terms
of the Rules of 2018 and advertisement, was rightly rejected. It is
17


said, after participating in the process of selection, challenge as
made belatedly after declaring them unsuccessful, cannot be
maintained, hence, prayed for dismissal of the appeals on this
ground alone.
18. Per contra, Mr. Shoeb Alam, learned Senior Counsel
representing the participants in Civil Appeal Nos. 1725-1731 of
2023, has argued with vehemence that D&C Act was enacted in
the year 1940. The statements of object and reasons to bring such
Act makes it clear that for regulating the matters relating to control
of drugs, though the subject was within the Provincial Legislative
List, after the resolution was passed by Legislatures of all
Provinces, it fell within the domain of the Federal Legislature. At
the relevant point of time, Entry 19 of Part I of List III (Concurrent
Legislative List) of the Government of India Act, 1935 (in short ‘ GOI
Act ’) deals ‘ the poisons and dangerous drugs’ , while in List II
(Provincial Legislative List), Entry 14 deals with ‘public health and
sanitation ; hospitals and dispensaries; registration of births and
deaths . ’ Drugs and Cosmetics was part of public health and
sanitation in List II, and not a part of List III. Since the Provincial
Legislations relegated their powers to the Federal Legislature,
thus, in exercise of such power, D&C Act was enacted in 1940.
18


7

19. Article 372 of the Constitution of India, deals with the
continuity of the legislations as they existed pre-independence,
unless altered, repealed or amended by the competent Legislature
or authority. Since no amendment was brought in the D&C Act
either by State of Haryana or Karnataka, it carried forward post-
independence uninterruptedly between the Provinces (States) and
Federal (Centre). Once the Provinces (States) gave up their power
to Federal (Centre) to enact laws on the matters relating to control
of drugs, the Federal (Centre) occupied the field to frame rules on
the subject. Therefore, in absence of any amendment by the States
in the D&C Act altering the statutory framework prevailed pre-
independence, any encroachment by way of framing rules in the
said domain, is liable to be struck down. In the present case, the
State Government by exercising its power under proviso to Article
309 of the Constitution of India, and/or under the State Act
specifying the essential qualifications inconsistent with the
qualification as prescribed in Rule 49 of the Drug Rules cannot
operate in a field that is already occupied.
20. It is also his contention that Section 38 of the D&C Act
specifies a procedure to make rules under the Act, requiring

7
Continuance in force of existing laws and their adaption.
19


approval of both the Houses of Parliament and modification, if any,
shall be only after approval by both the Houses of Parliament.
Therefore, the rules as enacted by the Central Government are
within legislative competence and under the domain of central law.
The said provisions shall have overriding effect over the rules
framed by the Governor of the State in exercise of powers under
proviso to Article 309 of the Constitution of India or under the
State enactment. As such, he prayed that the well-considered
judgments passed by the High Court of Punjab and Haryana and
the High Court of Karnataka do not warrant interference in these
appeals.
21. From the facts and arguments as advanced, it appears that
appointment to the post of DI/DCO, in the States of Haryana or
Karnataka is the subject of challenge in these appeals. In both
States, the eligibility as prescribed under the Central Rules has
been altered by making ‘experience’ an essential qualification for
appointment, as per State Rules, which have been assailed. The
challenge essentially is whether under the D&C Act, prescribing
qualification for appointment of DI/DCO is the domain of the
Centre or whether the States have power to prescribe qualification
for the said posts. In absence, since the field is occupied by the
20


Centre, the State Government can prescribe experience as an
essential qualification in addition to what has been prescribed in
the Drug Rules. In such circumstances, the following questions
arise for our consideration:-
(i) Whether on conferment of power under the
D&C Act to the Central Government to
prescribe qualification for the post of Inspector,
for which Rule 49 of the Drug Rules has been
framed and the field is occupied; the State
Government in exercise of power under the
proviso to Article 309 of the Constitution of
India may add ‘experience’ as an essential
qualification in the rules, on the same subject?
(ii) Whether the High Courts while allowing the
writ petitions and declaring the qualifications
added by the respective State Governments as
inconsistent to the Central Rules, have rightly
upheld the challenge before them?
(iii) In the facts of the respective cases what relief
can be allowed?
21


APPRECIATION OF THE QUESTIONS IN SERIATIM
22. We have heard learned counsel for the parties at length on
the conspectus of this case and on the questions posed
hereinabove. In that context, they are being appreciated in
succeeding paragraphs.
Question No. (i) and (ii)
23. Since the controversy involved in both these questions is
interlinked and the provisions of the Act and the Rules are similar,
to avoid repetition of facts both the issues are being dealt with and
answered collectively.
24. On tracing the history of introducing the D&C Act, 1940, it is
revealed that in 1937, a Bill was introduced in the Central
Legislative Assembly to give effect to the recommendations of the
Drugs Inquiry Committee to regulate the import, manufacture,
distribution and sale of drugs in the British India. This Bill was
referred to the Select Committee. The Select Committee expressed
its opinion that a more comprehensive measure for uniform control
of manufacture and distribution of drugs as well as of import was
desirable. The Government of India, accordingly, asked the
Provincial Legislatures to pass a resolution under Section 103 of
the GOI Act, empowering the Federal Legislature to pass an Act.
22


Accordingly, to provide the control of import of drugs into the
British India, control of manufacture, sale and distribution of
drugs and containing the provisions in this regard and prescribing
the manner of import, standards to be complied with drugs
manufactured, sold or distributed in British India, the Central
Government conferred the power to amend the first schedule while
the Provincial Governments conferred the power to amend the
second Schedule. As such, with an intent to maintain the
uniformity in the standards and in other important matters, the
Central Government considered it necessary and understood that
any authority within the Provincial Governments conferred by the
Bill in respect of the matters falling within the Provincial
Legislative field would be ultra vires to the Central Legislature. As
such, the Central Legislative Assembly after receiving the assent of
the Governor General on 10.04.1940 enacted the Drugs Act, 1940
(now the Drugs and Control Act, 1940) and brought it into force.
Section 103 of the GOI Act in respect of the above history is
relevant, and is reproduced as thus:-
“103 . If it appears to the Legislatures of two or more
Provinces to be desirable that any of the matters
enumerated in the Provincial Legislative List should be
regulated in those Provinces by Act of the Federal
Legislature, and if resolutions to that effect are passed by
all the Chambers of those Provincial Legislatures, it shall be
23


lawful for the Federal Legislature to pass an Act for
regulating that matter accordingly, but any Act so passed
may, as respects any Province to which it applies, be
amended or repealed by an Act of the Legislature of that
Province. ”
25. As per the GOI Act and from the above, it is clear that in the
pre-independence era, on passing of the resolution by all the
Chambers of Provincial Legislatures conferring power to the
Federal Legislature to pass an Act to regulate the matters
enumerated on the subject, the D&C Act has been brought into
force. The said provision further makes it clear that after passing
any enactment by Federal Legislature with respect to any Province
to which it applies, the same may be amended or repealed by an
act of the Legislature of that Province. Therefore, for amendment
and repealing, power was given to the Legislature of the Province
under the GOI Act.
26. Under the GOI Act, Entry 19 of List III (Concurrent Legislative
List) deals with ‘poisons and dangerous drugs while Entry 14 of
List II (Provincial Legislative List) deals with ‘public health and
sanitation; hospitals and dispensaries; registration of births and
deaths’. In the post-independence era, after coming into force of
the Constitution of India, Entry 19 of List III (Concurrent List)
deals with ‘drugs and poisons, subject to the provisions of Entry 59
24


of List I with respect to opium.’ Therefore, re-formation of the topics
and subjects was brought in the Seventh Schedule of the
Constitution of India. The consequence thereof was that, the
subject matter ‘drugs and poisons’ continued to be within the
concurrent jurisdiction of the Central as well as State Legislations,
maintaining the said subject at Entry 19 in the Concurrent List.
27. Article 372 of the Constitution of India deals with
“continuance in force of existing laws and their adaptation”. The
relevant part of the said Article is reproduced as under:-
“372. Continuance in force of existing laws and
their adaptation.—
(1) Notwithstanding the repeal by this Constitution of
the enactments referred to in article 395 but subject to the
other provisions of this Constitution, all the law in force in
the territory of India immediately before the commencement
of this Constitution shall continue in force therein until
altered or repealed or amended by a competent Legislature
or other competent authority.
(2) For the purpose of bringing the provisions of any
law in force in the territory of India into accord with the
provisions of this Constitution, the President may by order
make such adaptations and modifications of such law,
whether by way of repeal or amendment, as may be
necessary or expedient, and provide that the law shall, as
from such date as may be specified in the order, have effect
subject to the adaptations and modifications so made, and
any such adaptation or modification shall not be questioned
in any court of law.
(3) Nothing in clause (2) shall be deemed—
(a) to empower the President to make any
adaptation or modification of any law after
25


the expiration of three years from the
commencement of this Constitution; or
(b) to prevent any competent Legislature or
other competent authority from repealing or
amending any law adapted or modified by
the President under the said clause.
From the above, it can be safely observed that except as
8
provided under Article 395 of the Constitution of India, “repeals”
of the laws which were in force in the territory of India immediately
on the commencement of the Constitution of India, shall continue
to be in force until altered, repealed or amended by the Legislature
or other competent authority. In addition, it is further observed
that with an intent to bring the provisions of any law in force within
the territory of India as per the Constitution of India, the President
of India may, by order, make adaptation and modification of such
law, except by way of amendment or repeal, as may be necessary
or expedient. The President is restricted from making such
adaptation and modification after expiry of three years from the
commencement of the Constitution of India. Simultaneously, the
competent legislature or other authority is at liberty to repeal or

8
Repeals – The Indian Independence Act, 1947, and the Government of India Act, 1935,
together with all enactments amending or supplementing the latter Act, but not including the
Abolition of Privy Council Jurisdiction Act, 1949, are hereby repealed.
26


amend any law adopted or modified by the President, if such
legislature is competent in this regard.
28. As discussed, the D&C Act was enacted by the Federal
Legislature with the concurrence of the Provincial Legislatures,
therefore, it has become the ‘central law’ having force in all
territories, except as prescribed by the President of India while
exercising power under Article 372(2) of the Constitution of India,
and to that effect, passed the Adaptation of Laws Order, 1950
(C.O. 4) which reads as thus:-
“ xx xx xx
1. (1) This Order may be called the Adaptation of
Laws Order, 1950.
(2) It shall be come into force on the 26th day of
January, 1950.
2. In this order—
(c) “appointed day” means the 26th day of January,
1950;
(b) “existing Central law” means any law in force in
the territory of India immediately before the appointed day,
but does not include—
(i) an existing Provincial law;
(ii) an existing State law; or
(iii) an Act of Parliament of the United Kingdom
or any Order in Council, rule or other instrument
made under such an Act;
(e) “existing Provincial law” means—
27


(i) any Provincial Act or any Ordinance or
Regulation made by the Governor of a Province
under the Government of India Act, 1985; or
(ii) any rule, bye-law, regulation, order,
modification or other instrument made under any
such Provincial Act, Ordinance or Regulation;
which, immediately before the appointed day, was a law in
force in any Province or part thereof, and includes, with
respect to a merged territory, any law in force in such
territory immediately before the appointed day which was
made that territory or any part thereof by the Legislature or
other competent authority of the corresponding Indian State
or under the Extra-provincial Jurisdiction Act, 1947;
xx xx xx
(e) “existing law” means an existing Central law,
existing Provincial law or existing State law. ”
29. In view of the above, there cannot be any ambiguity that the
D&C Act and the Drug Rules thereunder were made pre-
independence. They were in existence in the territory of India
(within Provincial areas of the States) on the appointed day i.e.,
26.01.1950. Hence, the D&C Act is also subject to the amendment
or repeal by the respective State Governments. It may be noted
that in the facts of the case or during hearing, nothing has been
brought on record to indicate that the said D&C Act was amended
by the respective States, in so far as it relates to the power of
prescribing the qualifications of Inspectors by the Central
Government under Section 33(2)(b) and their powers under
Section 33(2)(n). Therefore, the D&C Act is still in force as a
28


“central law” as it existed on the appointed day in the same terms
and conditions, conferring power on the Central Government to
prescribe the qualification of Inspectors.
30. Learned Additional Solicitor General, Mr. Banerjee and
learned Senior Counsel, Mr. Nuli representing the appellants
heavily relied on Sections 21 and 22, which are part of Chapter IV
of the D&C Act, inter-alia contending that the power of the Central
Government to make rules is not alien to the power of the State
Governments to appoint such persons as DI/DCO, as it thinks fit.
The power to appoint DI/DCO would include the power to
prescribe qualifications as specified under Section 33 of the D&C
Act. In order to appreciate the said argument, Sections 21, 22 and
33 of the D&C Act are relevant, therefore reproduced as thus:-
“21. Inspectors. — (1) The Central Government or a
State Government may, by notification in the Official
Gazette, appoint such persons as it thinks fit, having the
prescribed qualifications, to be Inspectors for such areas as
may be assigned to them by the Central Government or the
State Government, as the case may be.
(2) The powers which may be exercised by an
Inspector and the duties which may be performed by him,
the drugs or [classes of drugs or cosmetics or classes of
cosmetics] in relation to which and the conditions,
limitations or restrictions subject to which, such powers and
duties may be exercised or performed shall be such as may
be prescribed.
29


(3) No person who has any financial interest [in the
import, manufacture or sale of drugs or cosmetics] shall be
appointed to be an Inspector under this section.
(4) Every Inspector shall be deemed to be a public
servant within the meaning of section 21 of the Indian Penal
Code (45 of 1860), and shall be officially subordinate to
such authority [having the prescribed qualifications,] as the
Government appointing him may specify in this behalf.]
22. Powers of Inspectors. — (1) Subject to the
provisions of section 23 and of any rules made by the
Central Government in this behalf, an Inspector may, within
the local limits of the area for which he is appointed,—
(a) inspect,—
(i) any premises wherein any drug or cosmetic
is being manufactured and the means
employed for standardising and testing the
drug or cosmetic;
(ii) any premises wherein any drug or cosmetic
is being sold, or stocked or exhibited or
offered for sale, or distributed;
(b) take samples of any drug or cosmetic, —
(i) which is being manufactured or being sold
or is stocked or exhibited or offered for sale,
or is being distributed;
(ii) from any person who is in the course of
conveying, delivering or preparing to deliver
such drug or cosmetic to a purchaser or a
consignee;
(c) at all reasonable times, with such assistance, if
any, as he considers necessary,—
(i) search any person, who, he has reason to
believe, has secreted about his person, any
drug or cosmetic in respect of which an
offence under this Chapter has been, or is
being, committed; or
30


(ii) enter and search any place in which he has
reason to believe that an offence under this
Chapter has been, or is being, committed; or
(iii) stop and search any vehicle, vessel or other
conveyance which, he has reason to believe,
is being used for carrying any drug or
cosmetic in respect of which an offence
under this Chapter has been, or is being,
committed,
and order in writing the person in possession of the drug or
cosmetic in respect of which the offence has been, or is being,
committed, not to dispose of any stock of such drug or cosmetic
for a specified period not exceeding twenty days, or, unless the
alleged offence is such that the defect may be removed by the
possessor of the drug or cosmetic, seize the stock of such drug
or cosmetic and any substance or article by means of which the
offence has been, or is being, committed or which may be
employed for the commission of such offence;]
(cc) examine any record, register, document or any other
material object found 2 [with any person, or in any place,
vehicle, vessel or other conveyance referred to in clause (c)], and
seize the same if he has reason to believe that it may furnish
evidence of the commission of an offence punishable under this
Act or the rules made thereunder;]
(cca) require any person to produce any record, register, or
other document relating to the manufacture for sale or for
distribution, stocking, exhibition for sale, offer for sale or
distribution of any drug or cosmetic in respect of which he has
reason to believe that an offence under this Chapter has been,
or is being, committed;]
(d) exercise such other powers as may be necessary for
carrying out the purposes of this Chapter or any rules made
thereunder.
(2) The provisions of 4 [the Code of Criminal Procedure, 1973
(2 of 1974)] shall, so far as may be, apply to any search or
seizure under this Chapter as they apply to any search or
seizure made under the authority of a warrant issued under
[section 94] of the said Code.
31


(2A) Every record, register or other document seized under
clause (cc) or produced under clause (cca) shall be returned to
the person, from whom they were seized or who produce the
same, within a period of twenty days of the date of such seizure
or production, as the case may be, after copies thereof or
extracts therefrom certified by that person, in such manner as
may be prescribed, have been taken.]
(3) If any person wilfully obstructs an Inspector in the
exercise of the powers conferred upon him by or under this
Chapter [or refuses to produce any record, register or other
document when so required under clause (cca) of sub-section
(1),] he shall be punishable with imprisonment which may
extend to three years, or with fine, or with both.]
33. Power of Central Government to make rules. —
(1) The Central Government may after consultation with, or

on the recommendation of, the Board and after previous
publication by notification in the Official Gazette, make rules for
the purposes of giving effect to the provisions of this Chapter:
Provided that consultation with the Board may be dispensed
with if the Central Government is of opinion that circumstances
have arisen which render it necessary to make rules without
such consultation, but in such a case the Board shall be
consulted within six months of the making of the rules and the
Central Government shall take into consideration any
suggestions which the Board may make in relation to the
amendment of the said rules.
(2) Without prejudice to the generality of the foregoing power,
such rules may—
(a) provide for the establishment of laboratories for
testing and analysing drugs or cosmetics;
(b) prescribe the qualifications and duties of
Government Analysts and the qualifications of
Inspectors;
(c) prescribe the methods of test or analysis to be
employed in determining whether a drug or
cosmetic is of standard quality;
32


(d) prescribe, in respect of biological and
organometallic compounds, the units or methods of
standardisation;
(dd) prescribe under clause (d) of section 17A the colour
or colours which a drug may bear or contain for
purposes of colouring;
(dda) prescribe under clause (d) of section 17E the colour
or colours which a cosmetic may bear or contain for
the purposes of colouring;
(e) prescribe the forms of licences for the manufacture
for sale or for distribution, for the sale and for the
distribution of drugs or any specified drug or class
of drugs or of cosmetics or any specified cosmetic
or class of cosmetics, the form of application for
such licences, the conditions subject to which such
licences may be issued, the authority empowered
to issue the same the qualifications of such
authority and the fees payable therefor; and
provide for the cancellation or suspension of such
licences in any case where any provision of this
Chapter or the rules made thereunder is
contravened or any of the conditions subject to
which they are issued is not complied
with;(ee)prescribe the records, registers or other
documents to be kept and maintained under
section 18B;
(eea) prescribe the fees for the inspection (for the
purposes of grant or renewal of licences) of
premises, wherein any drug or cosmetic is being or
is proposed to be manufactured;
(eeb) prescribe the manner in which copies are to be
certified under sub-section (2A) of section 22;
(f) specify the diseases or ailments which a drug may
not purport or claim to prevent, cure or mitigate and
such other effects which a drug may not purport or
claim to have;
(g) prescribe the conditions subject to which small
quantities of drugs may be manufactured for the
purpose of examination, test or analysis;
33


(h) require the date of manufacture and the date of
expiry of potency to be clearly and truly stated on
the label or container of any specified drug or class
of drugs, and prohibit the sale, stocking or
exhibition for sale, or distribution of the said drug
or class of drugs after the expiry of a specified
period from the date of manufacture or after the
expiry of the date of potency;
(i) prescribe the conditions to be observed in the
packing in bottles, packages, and other containers
of drugs or cosmetics, including the use of packing
material which comes into direct contact with the
drugs and prohibit the sale, stocking or exhibition
for sale, or distribution of drugs or cosmetics
packed in contravention of such conditions;
(j) regulate the mode of labelling packed drugs or
cosmetics, and prescribe the matters which shall
or shall not be included in such labels;
(k) prescribe the maximum proportion of any
poisonous substance which may be added to or
contained in any drug, prohibit the manufacture,
sale or stocking or exhibition for sale, or
distribution of any drug in which that proportion is
exceeded, and specify substances which shall be
deemed to be poisonous for the purposes of this
Chapter and the rules made thereunder;
(l) require that the accepted scientific name of any
specified drug shall be displayed in the prescribed
manner on the label or wrapper of any patent or
proprietary medicine containing such drug;
[] *
(n) prescribe the powers and duties of Inspectors and
the qualifications of the authority to which such
Inspectors shall be subordinate and specify the
drugs or classes of drugs or cosmetics or classes of
cosmetics in relation to which and the conditions,
limitations or restrictions subject to which, such
powers and duties may be exercised or performed;
34


(o) prescribe the forms of report to be given by
Government Analysts, and the manner of
application for test or analysis under section 26
and the fees payable therefor;
(p) specify the offences against this Chapter or any
rule made thereunder in relation to which an order
of confiscation may be made under section 31;
(q) provide for the exemption, conditionally or
otherwise, from all or any of the provisions of this
Chapter or the rules made thereunder, of any
specified drug or class of drugs or cosmetic or class
of cosmetics; and
(r) sum which may be specified by the Central
Government under section 32B.
31. After examining the contours of Section 21, indeed the power
to appoint such persons as they think fit as DI/DCO, on
possessing the prescribed qualification, for such area as may be
assigned, is co-extensive with the Centre as well as the State
Governments. In our view, the appointment of such persons ‘as it
thinks fit’ is the discretion to be exercise either by the Centre or by
the State Governments. But for the purpose of ‘having the
prescribed qualification’ for the post of DI/DCO, Section 33(2)(b)
of the D&C Act confers sole jurisdiction to Central Government and
the power to publish the notification in the official Gazette and to
give effect to the provisions of Chapter IV, which starts from
Section 16 and ends at Section 33A. Therefore, the State
Governments may have co-extensive powers to appoint DI/DCO
35


along with Central Government, but for the purpose of prescribing
qualification of DI/DCO as per Sections 33(1) and 33(2)(b), as well
as Section 33(2)(n), it is only the Central Government which has
the power. As such, by an express contextual language of the
enactment, the power to prescribe qualifications is with the
Central Government, without giving any solace to the State
Government. Therefore, to exercise the power for prescribing
qualification of Inspectors, the field is occupied by the Central
Legislature. In this regard, it can be clarified that the State
Governments, by way of amendment or repeal post-Independence
as specified in Article 372 of the Constitution of India, if exercise
the power to amend; they have to take the said recourse, otherwise
in the matter of prescribing the qualification of Inspectors, the field
is occupied by the Central Legislation as discussed. Under the said
power, Rule 49 of the Drug Rules prescribing ‘Qualification of
Inspectors’ cannot be permitted to be overridden by the Rules
framed in exercise of proviso to Article 309 of the Constitution of
India by the State or under the State statutes by the respective
State Governments. In this sequence, Rule 49 of the Drug Rules is
relevant, therefore, reproduced as thus:-
“49. Qualifications of Inspectors.
36


A person who is appointed as Inspector under the Act shall
be a person who has a degree in Pharmacy or
Pharmaceutical Sciences or Medicine with specialization in
Clinical Pharmacology or Microbiology from a University
established in India by law:
Provided that only those Inspectors-
(i) Who have not less than 18 months' experience in
the manufacture of at least one of the substances specified
in Schedule C, or
(ii) Who have not less than 18 months' experience in
testing of at least one of the substances in Schedule C in a
Laboratory approved for this purpose by the licensing
authority, or
(iii) Who have gained experience of not less than three
years in the inspection of firms manufacturing any of the
substances specified in Schedule C during the tenure of
their services as Drugs Inspectors, shall be authorized to
inspect the manufacture of the substances mentioned in
Schedule C:]
[Provided further that the requirement as to the academic
qualification shall not apply to persons appointed as
Inspectors on or before the 18th day of October, 1993.] ”
32. After going through the Drug Rules and the provisions as
quoted hereinabove, it is necessary to refer the rules of the
respective States whereby, in addition to the educational
qualification, experience of inspection under Rule 51 and 52 of the
Drug Rules was added and made part of essential qualification for
the candidates to participate in selection as DI/DCO. In this
context, the State of Haryana had framed the Haryana Drugs
(Group B) Service Rules, 1989. In the Rules of 1989, 1 ½ years’
experience was added with adequate knowledge of Hindi as an
37


essential qualification. The said Rules have been substituted by
the Rules of 2018. The only difference in those is that a candidate
must possess Hindi or Sanskrit up to matric or higher education,
otherwise the experience as was part of Rules of 1989 has been
maintained in the same terms. A comparison of Rule 49 of the
Drug Rules and the Rules of 2018, with remarks, specifying the
distinction in qualification for appointment to the post of DI/DCO
will be revealed from the following comparative table reproduced
as under:-

38

39

33. In the State of Karnataka, the Rules of 2013 have been
framed in exercise of the power under Section 3(1)(b) of KSCSA,
wherein also the experience has been made an essential
qualification for appointment to the post of DI/DCO. The same is
also reproduced, showing comparison through a table, for better
understanding, as under:-

40

41

34. It will not be out of place to observe that the Drug Rules have
been framed by the Central Government in exercise of the powers
under 6(2), 12, 33 and 33N of the D&C Act, while the Rules of 2018
were framed by the State of Haryana in exercise of power under
the proviso to Article 309 of the Constitution of India. In the State
of Karnataka, the Rules of 2013 have been framed under the
KSCSA. In the said context, the manner to frame the rules as
prescribed under the D&C Act assumes significance on the issue,
therefore, the said manner as specified in Section 38 is necessary
to be referred. A perusal of the same makes it is clear that after
making the rules, they were required to be approved by each House
42


of Parliament. Section 38 of the D&C Act as it exists by way of an
amendment with effect from 15.09.1964 is reproduced as under:-
“38. Rules to be laid before Parliament. — Every
rule made under this Act shall be laid as soon as may be
after it is made before each House of Parliament while it is
in session for a total period of thirty days which may be
comprised in one session or in two or more successive
sessions, and if, before the expiry of the session
immediately following the session or the successive
sessions aforesaid, both Houses agree in making any
modification in the rule or both Houses agree that the rule
should not be made, the rule shall thereafter have effect
only in such modified form or be of no effect, as the case
may be; so however that any such modification or
annulment shall be without prejudice to the validity of
anything previously done under that rule. ”
35. Similarly, the Rules of 2013 have been framed by the State of
Karnataka in exercise of the power under Section 3(1)(b) of KSCSA.
These powers are general in nature and are to be exercised by the
State Government to specify the different categories of posts in the
different branches of public services of the State, specifying the
total number, nature of posts in such categories and scale of pay
admissible to them. This power may also be exercised for
regulating the recruitment and conditions of service of persons
appointed to such public service within the State. Thus, it can very
well be inferred that the power of the State Government within the
said statute is general in nature for recruitment in public
43


employment in the state. However, the powers conferred under the
D&C Act by a central legislation and in particular, for the
appointment of DI/DCO, prescribing qualifications shall prevail
over the power exercised under the State enactment for public
employment in general within the state.

36. In the appeals arising from the State of Haryana, the Full
Bench of the High Court of Punjab and Haryana at Chandigarh,
while dealing with the competence of rules framed by the Central
or State Government, observed that recruitment to the post of
DI/DCO is primarily governed by the D&C Act and the Drugs Rules
framed thereunder by the Central Government. The said
experience added in the proviso to Rule 49 of the Drug Rules is in
the context of the duties involving inspection of manufacture of
substances specified in Schedule C under Rule 52. Though, the
DI/DCO appointed on having qualification under Rule 49 also
exercise the duties of inspection under Rule 51, as such it can be
observed that the experience added to the proviso of Rule 49 of the
Drug Rules cannot be elevated as qualification essential for the
purpose of appointment, as envisaged by the Rules of 2018 framed
under proviso to Article 309 of the Constitution of India. It is thus
rightly concluded by the High Court that the power of the State
44


Government under proviso to Article 309 of Constitution of India
to regulate the recruitment and conditions of service, including the
prescription of qualification subject to the constitutional
limitations. Such rules framed by the State government must be
in consonance with the central statute or the Drug Rules framed
under the D&C Act in the present case. In case of conflict, the
Central Rules i.e., the Drug Rules shall prevail over the Rules of
2018.
37. In the appeals from the State of Karnataka, the High Court of
Karnataka at Bengaluru emphasised that the State Government
does not hold legislative competence to prescribe additional
experience for the post of DI/DCO, and by doing so, has attempted
to enter into the arena of competence occupied by the Central
Government in terms of the central law. It was held that by
Sections 12, 21, 33 and 33N of the D&C Act, the Parliament has,
in entirety, reserved the rule-making power for the Central
Government with the intent to ensure uniform standards for life
saving drugs. The High Court, in reference to Section 38 of the
D&C Act, held that the rules framed under the central law are
required to be laid before both Houses of the Parliament, therefore,
such rule-making power is exclusively vested with the Central
45


Government and the State Government is denuded of any
authority to legislate in such occupied field.
38. In view of the above, we have examined the scheme of the
D&C Act and the Drug Rules, whereby it is clear that power of
appointment may be co-extensive, but the person selected or
appointed must possess the qualifications as prescribed under the
D&C Act. The Central Government for the purpose of Chapter IV
of the D&C Act has prescribed the qualification of Inspectors i.e.,
DI/DCO by promulgating the Drug Rules. In the said context,
Section 3(i) lays relevant emphasis while defining ‘prescribed’ to
mean “prescribed by the rules made under this Act.” Therefore,
prescription of the qualification of Inspectors under the D&C Act
must be as prescribed by the rules made under the Act. Since such
qualification is prescribed under Rule 49 of the Drug Rules, which
have been framed under Section 6, 12, 33 and 33N of the D&C Act,
such qualification shall be the qualification prescribed for
appointment to the post of DI/DCO, and not otherwise.
39. On the said issue, the judgment of the Full Bench of the High
Court of Judicature at Allahabad in the case of Kuldeep
46


9
Singh Vs. State of U.P., can profitably be referred wherein
referring to provisions of D&C Act vis-à-vis Rule 49 of Drug Rules,
it was held as under:-
“16. Now, we proceed to interpret the provisions of Rule
49 of the Drugs and Cosmetics Rules, 1945. The substantive
part of Rule 49 specifies that in order to be appointed as an
Inspector under the Act, a person must have (i) a degree in
Pharmacy; or (ii) a degree in Pharmaceutical Sciences; or (iii)
a degree in Medicine with specialization in Clinical
Pharmacology or Microbiology from a University established
in India by law. The first proviso, however, specifies that
only those Inspectors who fulfill the experience referred to
in clause (i) or (ii) or (iii) shall be authorized to inspect the
manufacture of substances mentioned in Schedule C to the
Rules. When a Court interprets a statutory provision, or a
provision which is made by the delegate of the legislature
while framing subordinate legislation, it must give effect to
the plain, literal or grammatical meaning of the provision.
Under the substantive part of Rule 49, the qualifications
which are required to be held by an Inspector have been
specified. These are mandatory requirements and before a
person can be appointed as an Inspector, he must
necessarily hold the educational qualifications which are
prescribed in the substantive part. The proviso, however,
specifies that “only those Inspectors” shall “be authorized
to inspect the manufacture of substances mentioned in
Schedule C” who possess the experience as set out in one
of the three clauses thereto. In other words, the proviso
carves out an exception. A person who holds the
qualifications which are referred to in the substantive part
of Rule 49, is eligible to be appointed as an Inspector. Once
appointed as an Inspector, such a person would be
empowered to exercise the powers which are conferred
upon an Inspector under Section 21(2) and Section 22
together with Rules 51 and 52 of the Rules of 1945.
However, the effect of the proviso is that only those
Inspectors who fulfill the experience which is prescribed in
one of the three clauses of the first proviso to Rule 49 can

9
2014 SCC OnLine All 5119
47


be authorized to inspect the manufacture of substances
mentioned in Schedule C. But for the provisions contained
in the proviso to Rule 49, there would have been no embargo
on an Inspector being authorized to inspect the manufacture
of substances mentioned in Schedule C. The effect of the
proviso is that even though a person is appointed as an
Inspector, he can be authorized to inspect the manufacture
of Schedule C substances only upon fulfilling the experience
as prescribed in clauses (i) or (ii) or (iii) to the first proviso to
Rule 49. Hence, the proviso engrafts an exception by
entailing that before an Inspector can be authorized to
inspect the manufacture of substances mentioned in
Schedule C, he must fulfill the requisite experience as
prescribed in the proviso. Clause (i) of the proviso stipulates
an experience of 18 months in the manufacture of a
Schedule C substance. Clause (ii) of the proviso stipulates
18 months' experience in the testing of a Schedule C
substance in a laboratory approved by the licensing
authority. Clause (iii) of the proviso stipulates experience
which is gained of not less than three years in the inspection
of firms manufacturing any of the substances specified in
Schedule C during the tenure of their service as Drug
Inspectors. Ex facie, clause (iii) of the proviso specifies
experience which is gained during the tenure of service as
a Drug Inspector and not before appointment. The second
proviso to Rule 49 contains a stipulation that the
requirement of academic qualifications shall not apply to
those persons appointed as Inspectors on or before 18
October 1993. Rule 49 was substituted with effect from 19
October 1993. Hence, what the second proviso provides is
that it protects the services of those Inspectors who had
been appointed before the introduction of Rule 49 in its
present form on 19 October 1993. Rule 51 specifies the
duties of an Inspector to inspect premises licensed for the
sale of drugs. Rule 52 specifies the duty of an Inspector
“authorized to inspect the manufacture of drugs or
cosmetics”. Before an Inspector can be regarded as being
authorized to inspect the manufacture of a Schedule C drug,
he must possess the experience specified in the first proviso
to Rule 49 of 1945 Rules. Consequently, the experience
specified in the first proviso to Rule 49 is not a condition of
eligibility or a qualification for appointment as an Inspector
within the meaning of Rule 49. Undoubtedly and as a
48


matter of general principle, it is open to the appointing
authority to prescribe the conditions of eligibility for the
holding of a post. The conditions of eligibility may, in a given
case, legitimately include the possession of an academic
qualification and of experience even prior to appointment.
But, once the field is governed by a rule which has been
framed in exercise of a rule making power vested by statute,
the statutory rules must govern. Where, as in the present
case, the statutory rule does not incorporate a requirement
of experience as a condition of appointment, a requirement
of experience as a condition of eligibility can be introduced
only by way of an amendment to the statutory rules. Neither
the State in its administrative capacity nor, for that matter,
the Court would have the power to rewrite subordinate
legislation, in the present case Rule 49, by providing that
the provisions contained in the first proviso to Rule 49 are
an essential qualification or a condition of eligibility for
appointment to the post of Inspector. What Rule 49 plainly
postulates is that only those Inspectors who possess the
experience specified in the first proviso can be authorized to
inspect the manufacture of substances specified in
Schedule C. This is in the nature of an exception, as
explained earlier, since it permits only a certain category of
Inspectors holding the required experience to inspect the
manufacture of Schedule C substances. Plainly, the holding
of experience is not a condition of eligibility or a condition
for appointment.’

xxxx xxxx xxxx
24. The statutory provision which we are interpreting
in the present case has a different scheme altogether. The
main part of Rule 49 of the Rules of 1945 provides the
qualifications for appointment of an Inspector. The first
proviso carves out an exception by stipulating that only
certain categories of Inspectors would be authorized to
inspect the manufacture of Schedule C substances. But for
the proviso which places an embargo, a person who is
appointed as an Inspector upon possessing the
qualifications prescribed by the substantive part of Rule 49
would have been authorized to inspect the manufacture of
substances mentioned in Schedule C. What the first proviso
does is that it ensures that before an Inspector can be
authorized to inspect the manufacture of a Schedule C
49


substance, he or she must possess the experience
stipulated in the first proviso to Rule 49. What needs to be
noticed is that the proviso to Rule 49 of the Rules stipulates
that only those Inspectors, who satisfy condition (i) or (ii) or
(iii), shall be authorised to inspect the manufacture of the
substances mentioned in Schedule ‘C’. Schedule ‘C’ deals
with only sixteen types of biological and special products.
Schedule ‘C(i)’ deals with other special products. Schedule
‘D’ deals with certain other classes of drugs. For these
reasons, we have come to the conclusion that the first
proviso to Rule 49 does not provide an essential
qualification for appointment as a Drug Inspector and the
acquisition of the experience as set out in the first proviso
would operate to authorize a Drug Inspector to inspect the
manufacture of a Schedule C substance. ”
40. The judgment of the High Court of Judicature at Allahabad
has been relied upon by the High Court of Delhi on the same issue
10
in Union Public Service Commission Vs. Nidhi Pandey, . The
Delhi High Court in paragraphs 16 and 17 has held as under:-
“16. With the benefit of the above Full Bench judgment,
a careful reading of Rule 49 leaves no room for doubt that
as far as the eligibility criteria for appointment of an
Inspector is concerned, an Inspector must have (i) Degree in
Pharmacy or (ii) Degree in Pharmaceutical Science or (iii)
Degree in Medicine with specialization in Clinical
Pharmacology or Microbiology from a University established
in India by law. As far as the provisos are concerned, the
same relate to those inspectors who are to be allowed to test
substances and inspect establishments that manufacture
certain drugs. The requirement of experience as stipulated
in Rule 49 applies only after appointment and for the
purpose of deciding whether a Drug Inspector is authorized
to test specified substances and inspect the manufacturer
of substances specified in Schedule ‘C’. It is therefore
impermissible in law to amend Recruitment Rules 2010 to

10
2020 SCC OnLine Del 1974
50


make the requirement of experience an essential
qualification for the purpose of recruitment and
appointment, when such experience is not an essential
qualification stipulated in Rule 49 of the Drugs and
Cosmetics Rules, 1945. The inclusion of requirement of
experience in the advertisement, on the strength of the
Recruitment Rules, 2010 is therefore equally untenable. It
would appear that by amending its Recruitment Rules, the
petitioner has in a sense, amended Rule 49 which is a
statutory rule. This is clearly impermissible in law.
17. In our view therefore, the Tribunal has correctly
analysed the position based upon the interpretation given
in the judgment of the Full Bench of the Allahabad High
court and has correctly addressed the matter. ”
41. Both the judgments relate to the same post of DI/DCO,
interpreting the provisions of the D&C Act and the Drugs Rules,
and in our view, both these judgments and their ratio are rightly
on the subject. We are in agreement with the view taken by the
Full Bench of the High Court of Judicature at Allahabad and the
High Court of Delhi with respect to interpretation of Sections 21
and 33 of the D&C Act, as well as Rule 49 of the Drug Rules and
its proviso.
Doctrine of Occupied Field vis-à-vis Article 309 of the
Constitution of India
42. The question of applicability of Article 309 of the Constitution
of India in the context of promotional rules arose in A.B. Krishna
51


11
and Others Vs. State of Karnataka and Others , . In this case,
the Mysore Fire Force (Cadre Recruitment) Rules, 1971 were
framed by the State of Karnataka under Section 39 of the Fire
Force Act, 1964, being a State Act. The 1971 Rules required
qualifying an examination for the purpose of promotion. This Court
upheld the applicability of the 1971 Rules over an amendment
made by the Governor of Karnataka to the Karnataka Civil Services
(General Recruitment) Rules, 1977 in exercise of powers under
Article 309 of the Constitution of India. The observations made in
this regard are necessary below for ready reference:-
“8 . The Fire Services under the State Government
were created and established under the Fire Force Act,
1964 made by the State Legislature. It was in exercise of
the power conferred under Section 39 of the Act that the
State Government made Service Rules regulating the
conditions of the Fire Services. Since the Fire Services had
been specially established under an Act of the legislature
and the Government, in pursuance of the power conferred
upon it under that Act, has already made Service Rules, any
amendment in the Karnataka Civil Services (General
Recruitment) Rules, 1977 would not affect the special
provisions Validly made for the Fire Services. As a matter of
fact, under the scheme of Article 309 of the Constitution,
once a legislature intervenes to enact a law regulating the
conditions of service, the power of the Executive, including
the President or the Governor, as the case may be, is totally
displaced on the principle of “doctrine of occupied field”. If,
however, any matter is not touched by that enactment, it
will be competent for the Executive to either issue executive

11
(1998) 3 SCC 495
52


instructions or to make a rule under Article 309 in respect of
that matter.
9 . It is no doubt true that the rule-making authority under
Article 309 of the Constitution and Section 39 of the Act is
the same, namely, the Government (to be precise, the
Governor, under Article 309 and the Government under
Section 39), but the two jurisdictions are different. As has
been seen above, power under Article 309 cannot be
exercised by the Governor, if the legislature has already
made a law and the field is occupied. In that situation, rules
can be made under the law so made by the legislature and
not under Article 309. It has also to be noticed that rules
made in exercise of the rule-making power given under an
Act constitute delegated or subordinate legislation, but the
rules under Article 309 cannot be treated to fall in that
category and, therefore, on the principle of “occupied field”,
the rules under Article 309 cannot supersede the rules made
by the legislature. ”
43. In light of the facts of the present appeals and the judgment
of this Court in A.B Krishna (Supra), we are of the considered
opinion that the Doctrine of Occupied Field is applicable. The D&C
Act being a central law confers power to the Central Government
to prescribe the qualification for appointment of Inspectors, which
has been exercised by framing the Drug Rules. Thus, it is the
primary legislation on the subject and occupies the field. The Drug
Rules, were framed by the Central Government in exercise of
powers conferred by the D&C Act. The Rules of 2018 framed by
the State of Haryana under the proviso to Article 309 of the
Constitution of India cannot override the Drug Rules in so far as it
relates to prescription of qualification for appointment of
53


Inspector. Similar is the case in the State of Karnataka where the
Rules of 2013 were framed in exercise of powers under Section
3(1)(b) of the KSCSA.
44. It is therefore apposite to underscore the material distinction
in the manner of framing of the two sets of Rules. While the Rules
of 2013 trace their authority to a State enactment, the Drug Rules
emanate from a central legislation enacted under the Concurrent
List, wherein the central law, along with the Rules framed
thereunder, constitutes the primary and dominant regulatory
framework. Consequently, the Rules of 2013 cannot be construed
so as to invalidate or prevail over the central Drug Rules.
45. Additionally, Section 33(2)(b) read with Section 33(2)(n) of the
D&C Act confer exclusive jurisdiction upon the Central
Government to frame rules for the purpose of appointment of
Inspector. ‘ Expressio unius est exclusio alterius ’ means the
“express mention of one thing excludes others.” This internal aid to
statutory interpretation further reinforces the legislative intent
that the power to prescribe qualifications and conditions for
appointment of Inspectors vests exclusively with the Central
Government under the D&C Act. Once the Centre has consciously
and expressly occupied the field by placing the Drug Rules framed
54


under the D&C Act before both Houses of the Parliament as
provided under Section 38, any inconsistent exercise of power by
the State, even under the proviso to Article 309 of the Constitution
of India, stands impliedly excluded.
46. Reverting to the issue as raised regarding inconsistency
between the laws made by the Parliament and the laws made by
legislature of the State is also a point which requires consideration.
As discussed, the power for appointment to the post of DI/DCO is
co-extensive with the Central and State Governments, and they
may assign the duties as they think fit. As analysed above, under
the D&C Act, the power to prescribe the qualification of Inspectors
is the domain of the Central Government. In the previous
paragraphs, it is also said that the provisions of the D&C Act
regarding power of the Central Government to prescribe the
qualification has not been amended by the respective States. Since
the subject matter is under Entry No. 19 by Concurrent List of List
III, therefore, on the subject occupied by the Central Legislation,
the power of State legislation does not flow to the State on the
subject so occupied.
47. Learned Additional Solicitor General, Mr. Vikramjeet
Banerjee appearing on behalf of the State of Haryana has heavily
55


placed reliance on the judgment of S. Satyapal Reddy (Supra)
wherein the qualification for appointment on the post of Assistant
Motor Vehicles Inspector in the State of Andhra Pradesh as per
State rules was an issue. In the facts of the said case, the Central
Government framed the rules in exercise of power under Section
213(4) of the Motor Vehicles Act, 1988 vide S.O.443(E) dated
12.06.1989 prescribed a diploma in Mechanical Engineering as the
‘minimum qualification’ for appointment to the said post. The
Government of Andhra Pradesh in exercise of powers under
proviso to Article 309 of the Constitution of India, framed the
Andhra Pradesh Transport Subordinate Service Rules, 1984 and
enhanced the qualification of diploma into degree as qualification
for appointment. In the said context, this Court held as under: -
“5. …It is seen that marginal note in Section 213 for
“appointment of Motor Vehicles Officers” indicates the
subject-matter of the section. Sub-section (1) says that the
State Government may, for the purpose of carrying into
effect the provisions of this Act, establish Motor Vehicles
Department and “appoint as officers thereof such persons
as it thinks fit”. The power of appointment includes the
power to select a fit and competent person who it thinks fit
to hold the post and would discharge efficiently the
functions assigned under the Act. It includes the power
to prescribe qualifications to select suitable officers.
The Parliament preserved that power to the State
Government under Section 213(1) itself by allowing it to
appoint the officers whom it finds fit to carry into effect the
provisions of the Act. Sub-section (4) gives power to the
Central Government, having regard to the object of the Act,
56


by a notification in the Official Gazette “to prescribe
minimum qualification” which the officers or class of officers
thereof shall possess for being appointed as such officer or
to the cadre belonging to the State Government. Under Entry
41 of List II (State List) of VIIth Schedule to the Constitution,
the public service includes the services of the officers to be
appointed under sub-section (1) of Section 213 of the Act. No
doubt, as contended by the learned counsel for the
appellants that the Act receives paramountcy, since under
Entry 35, the subject under the Act covers the concurrent
field. Sub-section (4) of Section 213 also preserves the
power to prescribe qualifications higher than that
“minimum qualification” prescribed by the Central
Government to appoint the “said officers or any class
thereof shall possess for being appointed as such . ”
48. In light of the said observations, if we examine the scheme of
the Mother Vehicle Act, 1988, Section 213 deals with the
appointment of Assistant Motor Vehicle Inspectors. Sub-section
(iv) therein confers power on the Central Government to prescribe
the ‘minimum qualification’ which the said officers or any class
thereof shall possess for being appointed as such. However,
prescribing the ‘minimum qualification’ i.e., holding a diploma in
Mechanical Engineering was ‘minimum’. Section 213(iii) of the
Motor Vehicles Act, 1988 also confers powers on the State
Government to make rules for regulating the discharge of functions
by officers of the motor vehicle department and in particular, and
without prejudice to the generality of forgoing power, prescribe the
uniform to be worn by them, the authorities to which they shall be
57


sub-ordinate, the duties to be performed by them, the powers
(including the powers exercisable by police officers under this Act)
to be exercised by them and the conditions governing the exercise
of such power. Therefore, to sustain the discharge of the duties of
the powers were given to the State Government. In the said case,
the State Government by its rules under the proviso to Article 309
of the Constitution of India prescribed the educational
qualification as a degree in Mechanical Engineering for the post of
Assistant Motor Vehicle Inspector. However, the said qualification
was above that prescribed by the Central Government i.e., a
diploma in Mechanical Engineering which was the minimum
qualification. This Court while dealing with the issue has observed
as under: -
“7. It is thus settled law that Parliament has exclusive
power to make law with respect to any of the matters
enumerated in List I or concurrent power with the State
Legislature in List III of the VIIth Schedule to the Constitution
which shall prevail over the State law made by the State
Legislature exercising the power on any of the entries in List
III. If the said law is inconsistent with or incompatible to
occupy the same field, to that extent the State law stands
superseded or becomes void . It is settled law that when
Parliament and the Legislature derive that power
under Article 246(2) and the entry in the Concurrent
List, whether prior or later to the law made by the
State Legislature, Article 246(2) gives power, to
legislate upon any subject enumerated in the
Concurrent List, the law made by Parliament gets
paramountcy over the law made by the State
58


Legislature unless the State law is reserved for
consideration of the President and receives his
assent. Whether there is an apparent repugnance or conflict
between Central and State laws occupying the same field
and cannot operate harmoniously in each case the court has
to examine whether the provisions occupy the same field
with respect to one of the matters enumerated in the
Concurrent List and whether there exists repugnancy
between the two laws. Article 254 lays emphasis on the
words “with respect to that matter”. Repugnancy arises
when both the laws are fully inconsistent or are absolutely
irreconcilable and when it is impossible to obey one without
disobeying the other. The repugnancy would arise when
conflicting results are produced when both the statutes
covering the same field are applied to a given set of facts.
But the court has to make every attempt to reconcile the
provisions of the apparently conflicting laws and the court
would endeavour to give harmonious construction. The
purpose to determine inconsistency is to ascertain the
intention of Parliament which would be gathered from a
consideration of the entire field occupied by the law. The
proper test would be whether effect can be given to the
provisions of both the laws or whether both the laws can
stand together. Section 213 itself made the distinction of the
powers exercisable by the State Government and the
Central Government in working the provisions of the Act. It
is the State Government that operates the provisions of the
Act through its officers. Therefore, sub-section (1) of Section
213 gives power to the State Government to create
Transport Department and to appoint officers, as it thinks
fit. Sub-section (4) thereof also preserves the power. By
necessary implication, it also preserves the power to
prescribe higher qualification for appointment of
officers of the State Government to man the Motor
Vehicles Department. What was done by the Central
Government was only the prescription of minimum
qualifications, leaving the field open to the State
Government concerned to prescribe if it finds
necessary, higher qualifications. The Governor has
been given power under proviso to Article 309 of the
Constitution, subject to any law made by the State
Legislature, to make rules regulating the recruitment which
includes prescription of qualifications for appointment to an
59


office or post under the State. Since the Transport
Department under the Act is constituted by the State
Government and the officers appointed to those posts
belong to the State service, while appointing its own officers,
the State Government as a necessary adjunct is entitled to
prescribe qualifications for recruitment or conditions of
service. But while so prescribing, the State Government may
accept the qualifications or prescribe higher qualification but
in no case prescribe any qualification less than the
qualifications prescribed by the Central Government under
sub-section (4) of Section 213 of the Act. In the latter event,
i.e., prescribing lesser qualifications, both the rules cannot
operate without colliding with each other. When the rules
made by the Central Government under Section 213(4) and
the statutory rules made under proviso to Article 309 of the
Constitution are construed harmoniously, there is no
incompatibility or inconsistency in the operation of both the
rules to appoint fit persons to the posts or class of officers of
the State Government vis-a-vis the qualifications prescribed
by the Central Government under sub-section (4) of Section
213 of the Act. ”
49. In the facts of the case at hand, the judgment in S. Satyapal
Reddy (Supra) is completely distinguishable and the ratio does not
have any relevance herein. The said judgment dealt with the
provisions of the Motor Vehicle Act, 1988 wherein the power of the
Central Government under Section 213(4) was to prescribe
‘minimum qualification.’ As discussed, the State Government also
has powers to regulate the functioning, therefore, the field was
open for the State Government to prescribe the higher educational
qualification, if it deems it necessary. As such, the words
‘minimum qualification’ do not have any necessary implication on
60


the State, which cannot prescribe the higher educational
qualification for the post of Motor Vehicle Inspector. In the said
context, this Court found that when the ‘minimum’ prescribed
qualification by the Central Government i.e., the diploma in the
Mechanical Engineering and the qualification prescribed by the
State Government i.e., degree in Mechanical Engineering is merely
a degree in the same subject, it does not have any repugnancy on
the issue. Therefore, the said judgment is of no help to the
appellants.
50. In our view, the findings recorded by the High Court, inter-
alia observing that in the context of the D&C Act for the purpose
of prescribing the qualification for the Inspectors i.e., DI/DCO, the
field is occupied by the Drugs Rules. The rules framed by the State
Government under the proviso to Article 309 of the Constitution of
India by adding experience in addition to the qualification
prescribed by the Drugs Rules cannot be made applicable for their
appointment as Inspectors. Similar analogy shall follow in the case
of State of Karnataka, therefore, we are not impressed by the
arguments as advanced on behalf of the State of Haryana as well
as the State of Karnataka. As such, the arguments stand repealed,
upholding the reasoning arraigned by both the High Courts.
61



51. Yet another point for consideration is based on the minority
view of Hon’ble Judge of the High Court of Punjab and Haryana at
Chandigarh, which refers to Rules 51 and 52 of the Drug Rules,
corresponding to the qualifications specified in Rules of 2018 and
the same requires emphasis. In the said context, it is necessary to
reproduce Rule 51 which deals with ‘duties of Inspectors of
premises licensed for sale’ and Rule 52 which deals with ‘duties of
Inspectors specially authorised to inspect the manufacture of drugs’
as specified by the Drugs Rules. Both the rules refer to schedule C
and C1 of the D&C Act, therefore, the same are reproduced as
thus:-
“51. Duties of Inspectors of premises licensed for
sale.
Subject to the instructions of the controlling authority, it
shall be the duty of an Inspector authorized to inspect
premises licensed for the sale of drugs-
(1) to inspect [not less than once a year] all
establishments licensed for the sale of drugs within the area
assigned to him;
(2) to satisfy himself that the conditions of the licenses
are being observed;
(3) to procure and send for test or analysis, if
necessary, imported packages which he has reason to
suspect contain drugs being sold or stocked or exhibited for
sale in contravention of the provisions of the Act or rules
thereunder;
(4) to investigate any complaint in writing which may
be made to him;
62


(5) to institute prosecutions in respect of breaches of
the Act and rules thereunder;
(6) to maintain a record of all inspections made and
action taken by him in the performance of his duties,
including the taking of samples and the seizure of stocks,
and to submit copies of such record to the controlling
authority;
(7) to make such enquiries and inspections as may be
necessary to detect the sale of drugs in contravention of the
Act;
(8) when so authorized by the State Government, to
detain imported packages which he has reason to suspect
contain drugs, the import of which is prohibited.
52. Duties of Inspectors specially authorized to
inspect the manufacture of [drugs]
Subject to the instructions of the controlling authority it shall
be the duty of an Inspector authorized to inspect the
manufacture of [drugs]
(1) to inspect [not less than once a year], all premises
licensed for manufacture of [drugs or cosmetics] within the
area allotted to him to satisfy himself that the conditions of
the license and provisions of the Act and rules thereunder
are being observed;
(2) in the case of establishments licensed to
manufacture products specified in Schedules C and C (1) to
inspect the plant and the process of manufacture, the
means employed for standardizing and testing the [drugs or
cosmetics], the methods and place of storage, the technical
qualifications of the staff employed and all details of
location, construction and administration of the
establishment likely to affect the potency or purity of the
product;
(3) to send forthwith to the controlling authority after
each inspection a detailed report indicating the conditions
of the license and provisions of the Act and rules thereunder
which are being observed and the conditions and
provisions, if any, which are not being observed;
63


(4) to take samples of the [drugs or
cosmetics] manufactured on the premises and send them
for test or analysis in accordance with these rules;
(5) to institute prosecutions in respect of breaches of
the Act and rules thereunder.
[SCHEDULE C
(See rules 23, 61 and 76 and Part X)
BIOLOGICAL AND SPECIAL PRODUCTS
1. Sera.
2. Solution of serum proteins intended for injection.
[3. Vaccines for parenteral injections.]
4. Toxins.
5. Antigen.
6. Antitoxins.
7. Neo-arsphenamine and analogous substances
used for the specific treatment of infective diseases.
8. Insulin.
9. Pituitary (Posterior Lobe) Extract.
10. Adrenaline and Solutions of Salts of Adrenaline.
[11. Antibiotics and preparations thereof in a form to be
administered parenterally.]
[12. Any other preparation which is meant for
parenteral administration as such or after being made up
with a solvent or medium or any other sterile product and
which-
(a) requires to be stored in a refrigerator; or
(b) does not require to be stored in a
refrigerator.]
13. Sterilized surgical ligature and sterilized surgical
suture.
[14. Bacteriophages.]
[15. Ophthalmic preparations.]
[16. Sterile Disposable Devices for single use only.]

[SCHEDULE C (1)
(See Rule 23, 61 and 76)
OTHER SPECIAL PRODUCTS
64


1. Drugs belonging to the Digitalis group and
preparations containing drugs belonging to the Digitals
group not in a form to be administered parenterally.
2. Ergot and preparations containing Ergot not in a
form to be administered parenterally.
3. Adrenaline and preparations containing
Adrenaline not in a form to be administered parenterally.
4. Fish Liver Oil and preparations containing Fish
Liver Oil.
5. Vitamins and preparations containing any
vitamins not in a form to be administered parenterally.
6. Liver extract and preparations containing liver
extract not in a form to be administered parenterally.
7. Hormones and preparations containing Hormones
not in a form to be administered parenterally.
8. Vaccine not in a form to be administered
parenterally.
[9. Antibiotics and preparations thereof not in a form
to be administered parenterally.]
[10. In-vitro Blood Grouping Sera.
11. In-vitro Diagnostic Devices for HIV, HbsAg and
HCV.]

52. After reading the above provisions, the duties in brief
specified for the Inspectors under Rules 51 and 52 of the Drug
Rules are reproduced in tabular form as under:-

65

53. In reference to the above, and on reading Rule 49 of the Drugs
Rules, it is luculent that a person who has a degree in Pharmacy
or Pharmaceutical Sciences or Medicine with specialization in
Clinical Pharmacology or Microbiology from a University as
prescribed can be appointed as Inspector under the D&C Act. Such
Inspector shall exercise all duties as specified in Rule 51 of the
Drugs Rules. The proviso to Rule 49 makes a distinction in the
discharge of the duties of the Inspectors, whereby an Inspector
having not less than 18 months of experience in the manufacture
of at least of one of the substances specified in Schedule C; or has
experience in testing of at least one of the substances in Schedule
C in a laboratory approved for this purpose by the licensing
66


authority; or who has gained experience of not less than three
years in the inspection of firms manufacturing any of the
substances specified in Schedule C during the tenure of their
services as Drugs Inspector shall be authorised to inspect the
manufacture of the substances mentioned in Schedule C.
Therefore, the intent of the central law and the rules thereunder is
clear. Possessing an experience of a specific nature shall not be
included within the qualification prescribed for initial appointment
as Inspector. It carves out a distinction between the Inspector
appointed at the initial stage and the Inspectors who have gained
experience as prescribed, enabling them to discharge a higher
degree of responsibility by virtue of their experience.
54. In the said context, in our view, the minority opinion in
reference to Rules 51 and 52 of the Drug Rules, by giving a distinct
analogy, does not appear to be plausible or acceptable to this
Court. Therefore, under the D&C Act, as apparent from the history
and discussion appreciated by us hereinabove, the power to
prescribe the qualification for Inspectors is with the Central
Government. By virtue of the Drug Rules, the qualification for
appointment of Inspector has been prescribed, with further
distinction in the duties to be discharged by the Inspectors
67


appointed initially and by those after gaining experience.
Therefore, the proviso to Rule 49 only deals with such distinction
of the duties and does not say anything on the qualification
required for appointment to the post of Inspector. Thus, Rules
framed in exercise of the power under proviso to Article 309 of the
Constitution of India by the State Government, or under a State
statute which applies in general, prescribing distinct qualifications
under the enactment, cannot override the provisions of the Drug
Rules.
55. After perusal of the contents of the advertisement issued by
the State of Haryana, it reveals that in addition to the educational
qualification prescribed under Rule 49 of the Drugs Rules which
is similarly specified in the Rules of 2018, it is contended that the
candidates who applied for the post of DI/DCO may not be eligible
unless they possess the experience as enumerated in the Rules of
2018. If we look into the advertisement issued by the State of
Karnataka whereby, they have added experience in the nature of
‘minimum’ qualification. Therefore, by virtue of the Rules of 2018
or the Rules of 2013, the States of Haryana and Karnataka have
made the qualification of experience a ‘minimum qualification’,
which under Drug Rules, was prescribed only for Inspectors for the
68


purpose of inspection under Rule 52. In our view, such recourse is
contrary to the central law i.e., the D&C Act which is primary in
nature. It is further required to be observed that on conjoint
reading of Section 103 of the GOI Act and Article 372 of the
Constitution of India, if the respective States wish to derive power
for prescribing the qualification for appointment of Inspector, they
may take the recourse as permissible by way of making an
amendment in the D&C Act, as made by the State of Maharashtra
for certain provisions. In absence of such amendment or repeal,
adding experience as prescribed in the respective State Rules as
‘minimum qualification’ for appointment to the post of DI/DCO is
completely inconsistent with the recourse permissible. Further,
when the subject was already occupied by the primary legislation,
therefore, such recourse may not be countenanced under the law.
56. In view of the above, it is concluded that the powers so
exercised either by the State of Haryana or Karnataka to prescribe
such qualifications for appointment of Inspector, over and above
the provisions of the Drug Rules, is completely alien, in particular
when the subject was already occupied by the Central Government
and the rules have been framed by it. Once it has been held that
State Governments do not have the power to legislate on the issue
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in the manner as done, and the recourse as permissible has not
been taken, the question of repugnancy is not required to be dealt
with. In such view of the matter, we are of the considered opinion
that the High Court of Punjab and Haryana at Chandigarh or the
High Court of Karnataka at Bengaluru have interpreted the
provisions in right earnest and rightly allowed the writ petitions
filed by the participants, assailing the addition of experience as an
essential qualification to participate in the process of selection.
Therefore, the question nos. (i) and (ii) are answered accordingly.
Question No. (iii)
The relevant challenge, reliefs, events with respect to the appeals
arising from the State of Haryana
57. Referring to the facts in the appeals from the State of
Haryana, the HPSC issued an advertisement for appointment of 4
posts of DCO, which was later increased to 26 vide corrigendum
dated 04.06.2019. The essential qualification prescribed in the
advertisement was in terms of the Rules of 1989, as substituted
by the Rules of 2018, wherein experience was added within the
essential qualification.
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58. The recruitment test was conducted and the result was
announced on 12.12.2019, however since the number of qualified
candidates was less than three times the posts advertised, a
second result was declared on 04.06.2020. Thereafter, the
screening and process for verification of documents of the
candidates was done. It may be noted that neither list included the
12
names of the private Respondents herein nor Parveen Kumar in
due to lack of experience which was prescribed as an essential
qualification.
59. On 07.07.2020, the HPSC vide an announcement rejected the
candidature of participants in both lists, including the private
Respondents, for non-submission of hard copy of the online
application and various other reasons. Challenging the same, one
Krishan Kumar, private Respondent herein, filed a representation
which came to be rejected by the HPSC on 14.07.2020. In the
interregnum, various private Respondents filed different writ
petitions before the High Court alleging that the qualifications
mentioned in the advertisement were in contravention to those
prescribed under the Drug Rules, and all such connected matters
were finally decided in terms of the impugned judgment herein.

12
Appellant in Diary No 1909 of 2024.
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60. Ultimately, on 18.09.2020, the HPSC declared the result for
the posts as advertised, which was subject to the final outcome of
the writ petitions pending before the High Court. In furtherance of
the same, a letter was issued to the Additional Chief Secretary,
Health Department, Government of Haryana recommending
issuance of appointment orders to the successful candidates,
subject to final outcome of the pending writ petitions. On
22.09.2020, the High Court in CWP No. 15067 of 2020 filed by one
of the private Respondents i.e., unsuccessful candidates, granted
a stay on the further recruitment process, and as such,
appointment orders were not issued.
61. It may be noted here that one of the candidates filed CWP No.
16961 of 2019, which was dismissed by the Single Bench of the
High Court on 04.03.2020 observing that the nomenclature of the
post was changed from Drug Inspector to Drug Control Officer,
with the qualification remaining as was prescribed. Challenging
this order, multiple LPAs and Writ Petitions were filed before the
Division Bench of the High Court, which were decided collectively
vide the judgement dated 09.09.2022 impugned herein.
62. The High Court, by a larger Bench, upon consideration of the
matter in the impugned judgment dated 09.09.2022, examined the
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extent of the State Government’s power to prescribe qualifications
for appointment to the post of DCO in exercise of powers under the
proviso to Article 309 of the Constitution of India. It proceeded on
the premise that recruitment to the post is primarily governed by
the D&C Act and the Drug Rules framed thereunder by the Central
Government. While it was noted that the experience referred to in
the proviso to Rule 49 of the Drugs Rules is relevant in the context
of duties involving inspection of manufacture of substances
specified in Schedule C under Rule 52. The conjoint reading of the
majority and minority opinion ultimately concludes that such
experience could not be elevated to be an essential qualification for
initial appointment by the State in rules framed under Article 309
of the Constitution of India. It was observed that the State’s power
under the proviso to Article 309 of the Constitution of India
extends to regulation of recruitment and conditions of service,
including prescription of qualifications, subject to the
constitutional limitation that such rules must not be inconsistent
with the Central statute and the Rules framed thereunder, and
that in the event of any conflict, the Drugs Rules would prevail over
the State Rules of 2018.
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63. Ultimately, the advertisement in question, and selection
made pursuant to the same, was set aside by the High Court. The
writ petition filed by the sole appellant Parveen Kumar was also
disposed of by the Single Judge of the High Court vide judgement
dated 30.09.2022, in terms of the judgement dated 09.09.2022 of
the Full Bench of the High Court. When the matter travelled up to
this Court, leave was granted on 13.03.2023, and on 17.07.2023,
it was directed that on consideration of shortage of persons for the
post in question, the HPSC may allow conditional appointment of
persons selected, for the 26 posts as per the advertisement, but it
shall be subject to final outcome of the present appeals.
The relevant challenge, reliefs, events with respect to the appeal
arising from the State of Karnataka
64. Reverting to the facts in the appeal arising from Karnataka,
admittedly KPSC issued the recruitment notification dated
23.03.2018 inviting applications for 83 posts of Drugs Inspectors.
The eligibility criteria were prescribed in terms of KSCSA and rules
framed thereunder. Written examinations were conducted and all
the appellants as well as private respondents participated in the
examination. On the basis of marks obtained in the written
examination, first list dated 07.11.2019 of 232 eligible candidates
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for interview was issued by KPSC, followed by list dated
13.11.2019 of candidates for document verification.
65. The document verification commenced from 16.11.2019,
however, as contested by KPSC, they faced certain difficulties in
verifying the experience certificate of certain candidates who
possessed certificates from other States. To remedy the same, the
interview was postponed and a Technical Committee comprising of
two Assistant Drug Inspectors and one Assistant Drugs Controller
was constituted to verify the experience certificates. The
Committee submitted a report dated 12.11.2020, on the basis of
which, only 43 candidates in addition to those already interviewed
were called for interview on 27.11.2020, while excluding others on
the pretext that they did not possess requisite experience,
including private respondents herein.
66. Aggrieved, the private respondents (32 in total) along with
unsuccessful candidates (34 in total) approached KSAT in a bunch
of original applications inter-alia seeking to quash the list dated
27.11.2020 and praying to induct their name in the new list of
candidates for interview. Pending original applications, provisional
list of 66 selected candidates was published by KPSC on
15.12.2020, which was stayed by KSAT on 19.01.2021. However,
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KSAT vide common order dated 12.05.2021 dismissed all the
original applications, while granting limited relief to 5 candidates
to get their documents re-verified and in case found eligible, they
be considered for interview.
67. Dissatisfied, 18 unsuccessful candidates assailed the order
of KSAT before High Court in the writ petition bearing No.
10575/2021. During pendency of which, KPSC in compliance of
order passed by KSAT conducted interview of one candidate and
thereafter published final list dated 22.06.2021 of 67 successful
candidates. The recruitment process was stayed by High Court
vide order dated 24.06.2021, however, the final list was published
in the gazette on 13.07.2021. Be that as it may, concerned with
the litigation, the successful candidates (appellants herein) got
themselves impleaded before the High Court, whereafter, the
impugned order was passed on 31.03.2023 allowing the writ
petition, setting aside the common order passed by KSAT and
declaring the qualification of prescribed experience in terms of
KCSCA as ultra vires Section 33(2)(b) of the D&C Act read with
Rule 49 of the Drug Rules. The KPSC was directed to re-do the
select list within a span of three months. The High Court
concluded that the State does not hold legislative competence to
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prescribe an additional experience criterion for the statutory post
of Drug Inspector, which is exclusively occupied by Central
legislation.
68. After perusal of the proceedings of this case, it is vividly clear
that vide order dated 17.07.2023, this Court allowed the
conditional appointment of those who have been selected by the
Haryana Public Service Commission on 26 posts, subject to final
outcome of the present appeals. It was clarified that such condition
should be incorporated in the appointment orders to be issued by
the State Government, and in furtherance to such order,
appointments were made but details of the same are not available
on record. While in the State of Karnataka, the appointments have
not been made because of the order granting stay by the High
Court, and finally allowing the writ petitions. It is relevant to note
that vide order dated 26.02.2024 in the proceedings related to
13
Karnataka, the interim relief granted on 24.07.2023 was
modified to the extent that as per the directions issued in para
82(vi) of the impugned order, the respondents are permitted to redo
the select list, however it shall not be finalized without leave of this
Court. On the same day, the matters pertaining to the State of

13
Notice and stay on Para 82(vi) of the impugned order.
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Karnataka was tagged with the batch of appeals arising from the
State of Haryana.
69. In view of the appreciation of the facts and law, as made on
issue Nos. (i) and (ii), it is apparent that the State Governments do
not have power to legislate on the field except in the manner so
prescribed, hence, the judgments passed by both the High Courts
are upheld. At this stage, it is to be noted that the High Court of
Punjab and Haryana at Chandigarh vide the impugned judgement
dated 09.09.2022 has set-aside the advertisement and the entire
process of selection and appointment to the post of Drug Inspector,
whereas vide the impugned order, the High Court of Karnataka at
Bengaluru has set-aside the order of KSAT and declared the
condition prescribing experience as an essential qualification as
ultra vires , with direction to KPSC to re-do the selection list.
70. On the insistence of the State of Haryana, this Court vide
order dated 17.07.2023 allowed conditional appointment of the
persons selected by HPSC, subject to outcome of these appeals. In
furtherance, some persons have been appointed in the State of
Haryana in view of liberty granted, and hence it is prayed that
discretion under Article 142 of the Constitution of India be
exercised in favour of those appointees. Considering the aforesaid
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and the fact that the issue of adding the experience as an essential
qualification before both the High Courts and in both the appeals
is the same, therefore, in order to maintain consistency of the
directions, we are inclined to mould the relief.
71. Accordingly, the appeals filed by the State of Haryana and
arising from State of Karnataka fail, and are hereby dismissed. The
appeal bearing Diary No. 1909 of 2024 filed by the sole appellant
Parveen Kumar succeeds, and is hereby allowed. Accordingly,
these appeals are disposed of in terms of the following directions:-
(i) The Public Service Commission of the respective States are
directed to complete process of selection by taking
qualification as prescribed in Drug Rules as essential,
ignoring the requirement of experience as prescribed in terms
of State Rules. Thus, the qualifications specified in the
respective advertisements, as an essential
requirement/experience for appointment by way of additional
qualification stand quashed as ultra vires to D&C Act.
(ii) The Haryana Public Service Commission (HPSC) and the
Karnataka Public Service Commission (KPSC) are directed to
re-draw the selection list of all those candidates who possess
the qualification as directed hereinabove in direction (i) and
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prepare the final selection list, following the Rule 49 of the
Drug Rules.
(iii) We make it clear that if the persons appointed in the State of
Haryana fall within the merit of the said newly drawn
selection list, which would consequently be prepared by
HPSC and KPSC respectively, in compliance with the
directions hereinabove, they be continued in service without
any hindrance and shall be entitled to all consequential
benefits similar to the other selected candidates who find
place in the newly drawn selection list.
(iv) With respect to persons appointed in the State of Haryana,
despite the selection itself being quashed; it is clarified that
such appointees who do not fall within the merit of the said
newly drawn selection list, the State Government shall be at
discretion to continue them in employment, however only
upon creation of supernumerary posts for them and not
against the advertised vacancies. Simultaneously, their
seniority and other benefits be decided by putting them in
bottom of the select list or by taking the recourse as
permissible under law.
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(v) In consequence of dismissal of the Civil Appeal Nos. 1725-
1731 of 2023, 1732-1738 of 2023; and Special Leave Petition
(C) Nos. 16490-16491 of 2023, and further, appeal bearing
Diary No. 1909 of 2024 filed by sole appellant being allowed
in terms of the directions as issued hereinabove; the HPSC
and KPSC are directed to prepare the final merit lists of
selected candidates for the respective States within a period
of eight weeks and the same be sent to the States. The
respective State Government, after completing necessary
formalities, shall take steps for appointment of the selected
candidates within a period of eight weeks thereafter.
72. Pending application, if any, shall stand disposed of.

….…………………………J.
[J.K. MAHESHWARI]
….…………………………J.
[VIJAY BISHNOI]

New Delhi;
th
13 January, 2026.
81