ABBVIE HEALTHCARE INDIA PRIVATE LIMITED vs APEX COMMITTEE FOR PHARMA MARKETING PRACTICES

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IN THE HIGH COURT OF KARNATAKA AT BENGALURU


TH
DATED THIS THE 5 DAY OF NOVEMBER, 2026

BEFORE

THE HON'BLE MR. JUSTICE SURAJ GOVINDARAJ

WRIT PETITION NO. 25995 OF 2026 (GM-RES)

BETWEEN

ABBVIE HEALTHCARE INDIA PRIVATE LIMITED
THROUGH ITS DIRECTOR,
KALYAN SATTARU
LEVEL 6 AND 7, PRESTIGE OBELISK,
NO. 3, KASTURBA ROAD, BENGALURU,
KARNATAKA, 560001, INDIA
COMPANY REGISTERED UNDER THE
COMPANIES ACT, 1956
... PETITIONER
(BY SRI. UDAYA HOLLA., SR. COUNSEL FOR
SMT. MAITREYI B. KANNUR., ADVOCATE)

AND











1. APEX COMMITTEE FOR PHARMA MARKETING PRACTICES

THROUGH ITS CHAIRMAN,
DEPARTMENT OF PHARMACEUTICALS
RD
ROOM NO. 340B, A-WING, 3 FLOOR,
SHASTRI BHAWAN, DR. RAJENDRA PRASAD ROAD,
NEW DELHI-110001


2. DEPARTMENT OF PHARMACEUTICALS

THROUGH ITS SECRETARY
RD
ROOM NO. 340B, A-WING, 3 FLOOR,
SHASTRI BHAWAN, DR. RAJENDRA PRASAD ROAD,
NEW DELHI-110001


3. DEPUTY DIRECTOR OF INCOME TAX (INVESTIGATION)
CENTRAL REVENUE BUILDING ANNEXE,
QUEEN'S ROAD, BENGALURU - 560001.

4. REGISTRAR OF COMPANIES, BENGALURU
Digitally Signed By:
SURAJ GOVINDA RAJ
05/11/2026, 17:29, Bengaluru
Verified

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ND
KENDRIYA SADAN, 2 FLOOR
'E' WING, KORAMANGALA,
BANGALORE - 560034

….RESPONDENTS
(V/O/D 19.08.2026;
SMT. NAYANATARA B.G., CGC FOR R1, R2 & R4;
SRI. Y.V. RAVIRAJ., ADVOCATE FOR R3)

THIS WRIT PETITION IS FILED UNDER ARTICLES 226 AND 227
OF THE CONSTITUTION OF INDIA PRAYING TO ISSUE A WRIT,
ORDER OR DIRECTION IN THE NATURE OF CERTIORARI OR ANY
OTHER APPROPRIATE WRIT, ORDER OR DIRECTION QUASHING AND
SETTING ASIDE THE ORDER DATED DECEMBER 23, 2024, BEARING
ACPMP NO. 01/2024 PASSED BY RESPONDENT NO. 1, THE APEX
COMMITTEE FOR PHARMA MARKETING PRACTICES (ANNEXURE A)
AND ETC.
THIS WRIT PETITION COMING ON FOR ORDERS AND HAVING
BEEN RESERVED FOR ORDERS ON 29.08.2026, THIS DAY, THE
COURT PRONOUNCED THE FOLLOWING:

CORAM: HON'BLE MR. JUSTICE SURAJ GOVINDARAJ

CAV ORDER


1. The Petitioner is before this Court seeking for the
following reliefs:
A. Issue a writ, order or direction in the nature
of certiorari or any other appropriate writ,
order or direction quashing and setting aside
the order dated December 23, 2024 bearing
ACPMP no. 01/2024 passed by Respondent
no. 1, the Apex Committee for Pharma
Marketing Practices (Annexure A)

B. Issue a writ, order or direction quashing and
setting aside all proceedings, references,
Digitally Signed By:
SURAJ GOVINDA RAJ
05/11/2026, 17:30, Bengaluru
Verified

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communications, notices, inquiries,
investigations, and actions initiated
pursuant to, in furtherance of, or on the
basis of the impugned order, including
proceedings initiated by Respondent nos. 3
and 4 vide summons dtd summons dtd
January 13,2026 ITBA/INV/S/131/25-26
/1084731119 (1) Annx-AA Summons Dtd
February 9, 2026 ITBA/INV/S/131/25-26
/1085748590(1) Annx-DD, Notice Dtd May
12, 2026 Bearing ROCB/206(4) / Inquiry/
Abbvie / IIOIOO596 (Annx-JJ) National or
State Medical Councils, or any other
authority;

C. Issue a writ, order or direction restraining
the Respondents, their officers, servants,
agents, and any authority acting pursuant to
or in furtherance of the impugned order
from taking any coercive or precipitative
steps against the Petitioner,

D. Pass such other and further orders as this
Honble court may deem fit in the facts and
circumstances of the present case.

2. When the petition was filed, the Petitioner had
sought a writ of certiorari to quash the order dated
23.12.2024 bearing ACPMP No.1 of 2024, passed by
Respondent No.1-the Apex Committee for Pharma
Marketing Practices and for interim relief staying the
operation of said order. An amendment application
was filed and allowed, pursuant to which the
Petitioner sought stay of consequential proceedings
initiated by Respondent No. 4, Registrar of
Companies (“ ROC ”), vide notice dated 12.05.2026 at
Digitally Signed By:
SURAJ GOVINDA RAJ
05/11/2026, 17:30, Bengaluru
Verified

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Annexure JJ, and summons by Respondent No.3,
dated 13.01.2026 and 09.02.2026 at Annexure-AA
and Annexure-DD, respectively.

3. It is after the said amendment that the petition was
to be taken up for consideration; since both the
counsels submitted that the matter could be taken
up for final hearing rather than consideration of
interim relief, this Court took up the matter for final
hearing.

4. Sri. Udaya Holla., learned Senior Counsel appearing
for the Petitioner, submits that;

4.1. On 12.12.2014, Respondent No. 2, Department
of Pharmaceuticals (hereinafter referred to, for
the sake of convenience, brevity, and
identification, as “ DOP ”), had issued the
Uniform Code for Pharmaceutical Marketing
Practices, 2014 (hereinafter referred to, for the
sake of convenience, brevity and identification,
as “ UCPMP 2014 ”), which governed
pharmaceutical marketing practices. It is
submitted that, subsequently, another Uniform
Code was issued in 2024 , known as “Uniform
Code for Pharmaceutical Marketing Practices,
2024 (hereinafter referred to, for the sake of
Digitally Signed By:
SURAJ GOVINDA RAJ
05/11/2026, 17:30, Bengaluru
Verified

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convenience, brevity and identification, as
“ UCPMP 2024 ”).

4.2. Learned Senior Counsel submits that both
UCPMP 2014 and UCPMP 2024 are voluntary
Codes governing the Marketing Practices of the
Indian pharmaceutical industry. UCPMP 2014
also refers to the Indian Medical Council
(Professional Conduct) Etiquette and Ethics
Regulations, 2002 (hereinafter referred to, for
the sake of convenience, brevity and
identification, as “ IMC Regulations 2002 ”).

4.3. Learned Senior Counsel submits that the code
of Conduct for Doctors and Professional
Association Doctors in relation to the
pharmaceutical and allied health sector would
be governed by both the UCPMP and the IMC
Regulations. The Petitioner had engaged certain
Healthcare Professionals (hereinafter referred
to, for the sake of convenience, brevity and
identification, as “ HCPs ”) under a Professional
Services Agreement. His submission is that
these agreements were for legitimate medical
knowledge dissemination and related
professional activities.
Digitally Signed By:
SURAJ GOVINDA RAJ
05/11/2026, 17:30, Bengaluru
Verified

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4.4. The Petitioner manufactures various medical
devices, which are imported and marketed in
India after obtaining appropriate regulatory
approvals. These devices fall under the Class C
medical devices category and require consistent
training and support to ensure better patient
outcomes . The manner in which the said
devices are used would have a direct bearing
on the success of the treatment. Therefore, the
skills of the HCP administering such injections
are of paramount importance. It is for that
reason that the Petitioner seeks to ensure that
the HCPs are trained in using such injectable
products in a proper manner as per the
product's directions for use.

4.5. Learned Senior Counsel’s submission is that, if
the HCP were not to administer the said
injections in a proper manner, there could be
rare but serious adverse events associated with
such intravascular injections of dermal fillers in
the face and tissue compression, including
temporary or permanent vision impairment or
cerebral ischemia.
Digitally Signed By:
SURAJ GOVINDA RAJ
05/11/2026, 17:30, Bengaluru
Verified

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4.6. It is for that reason, Learned Senior Counsel
submits that even the packaging of the said
products bears a disclaimer and/or a warning
that the product should only be used by
medical practitioners who have appropriate
training and experience in injection techniques,
and it is for that reason that only HCPs who are
trained by the Petitioner use the said products.
He submits that the HCPs not only trained
themselves, but after such training, trained
other doctors in India, ensuring that the
patients receive safe, competent and properly
administered treatment.

4.7. In this regard, Professional Services
Agreements (hereinafter referred to, for the
sake of convenience, brevity and identification,
as “ PSAs ”) are entered into with the HCPs and
some of the training is provided abroad at
various international conferences. Two of the
conferences which are the subject matter of the
present lis are the International Master Course
on Ageing Science, 2024 (hereinafter referred
to, for the sake of convenience, brevity and
identification, as “ IMCAS 2024 ”) held from
01.02.2024 to 03.02.2024 and the Aesthetic
Digitally Signed By:
SURAJ GOVINDA RAJ
05/11/2026, 17:30, Bengaluru
Verified

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and Anti-ageing Medicine World Congress, 2024
(hereinafter referred to, for the sake of
convenience, brevity and identification, as
“ AMWC 2024 ”) held from 26.03.2024 to
29.03.2024.

4.8. Learned Senior Counsel’s submission is that the
Petitioner therefore ensures that HCPs who
have entered into a PSA with the Petitioner
participate in conferences like the above and,
for that purpose, the Petitioner takes care of
the expenses of booking the flight tickets,
accommodation, etc.

4.9. Though UCPMP 2024 had come into force,
learned Senior Counsel submits that companies
such as the Petitioner were transitioning from
UCPMP 2014 and that some commitments had
been entered into before UCPMP 2024 came
into force. It is therefore contended that UCPMP
2014 applied to those commitments .

4.10. Learned Senior Counsel’s submission is that a
PSA is only for the purpose of training and is
not predicated or dependent on the HCP's
recommending, administering or prescribing the
Petitioner’s products; such factors do not have
Digitally Signed By:
SURAJ GOVINDA RAJ
05/11/2026, 17:30, Bengaluru
Verified

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any determinative effect on the HCPs to attend
such conferences. He further submits that the
PSAs do not influence the HCPs' decisions or
choices regarding the use of the Petitioner's
products or that of similar products by other
companies and therefore nothing to do with any
business promotion on the part of the
Petitioner.

4.11. Insofar as the IMCAS 2024 is concerned, six
HCPs attended the conference, which was
conducted by renowned independent
international association and attended by more
than 18,000 HCPs from across the world. He
submits that the Petitioner had not organised
the conference, nor did it have any role or
control in determining the location of the
conference. The Petitioner only provided the
logistics for booking tickets, stay in Paris, etc.

4.12. Learned Senior Counsel relies on Clause 9 of
the UCPMP 2014, which is reproduced
hereunder for easy reference:
9. Committee for Complaint Handling:
9.1 There will be a committee for handling the
complaints named as 'Ethics Committee for
Digitally Signed By:
SURAJ GOVINDA RAJ
05/11/2026, 17:30, Bengaluru
Verified

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Pharma Marketing Practices (ECPMP) in each of
the associations
9.2 The committee will have 3 members,
represented by the Executive Head of the
companies or a nominee from the Executive
Head, but not below the rank of Director in the
Board of Company
9.3 In case of conflict of interest, the Head of
the association will decide 3 members. who will
handle the complaint
9.4 There will be a review committee for
handling the review of the decisions of ECPMP, if
any of the parties (complainant or Respondent)
desire so. This committee will be named as
"Apex Ethics Committee for Pharmaceuticals
Marketing Practices (AECPMP) and will consist of
5 members, represented by the Executive Head
of the companies or a nominee from the
Executive Head, but not below the rank of
Director in the Board of Company. The members
of the committed will be nominated by the Head
of the Association.


4.13. Referring to Clause 9, Learned Senior Counsel
submits that a Committee for handling
complaints, namely, the Ethics Committee for
Pharma Marketing Practices (hereinafter
referred to, for the sake of convenience, brevity
and identification, as “ ECPMP ”) is to be
constituted in each Association, which would
have three members represented by the
Executive Head of the companies or a nominee
Digitally Signed By:
SURAJ GOVINDA RAJ
05/11/2026, 17:30, Bengaluru
Verified

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from the Executive Head, but not below the
rank of Director in the Board of the Company.

4.14. Learned Senior Counsel refers to Clause 10 of
the UCPMP 2014 and submits that the
procedure for lodging a complaint has been
detailed therein; the said Clause 10 is
reproduced hereunder for easy reference;
10. Lodging of Complaints
10.1 All complaints, related to the breach of the
Code should be addressed to the "Ethics
Committee for Pharma Marketing Practices
(ECPMP)", "Chief Executive Officer", "Name of
Association".
10.2 All complaints related to an activity of
breach of the Code should, to the extent
practicable, be made at one time. The complaint
must be made within six months of the alleged
breach of the Code, with a maximum of another
six months for reasonable delay that can be
explained in writing. Related complaints may be
clubbed together by the Ethics Committee to
save time and expedite disposal.
10.3 Complaints must be in writing and for each
case The Complainant should:
i. identify himself (whether a company, entity or
an individual) with a full mailing address (email
and mobile telephone no).
ii. identify the company, which is alleged to have
breached the Code, including the name of any
company personnel, product, or products, which
are specifically involved.
Digitally Signed By:
SURAJ GOVINDA RAJ
05/11/2026, 17:30, Bengaluru
Verified

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iii. give the details of the activity which is alleged
to be in breach of the Code, give the date of the
alleged breach, clauses of the Code which are
alleged to have been breached, and provide
supporting evidence of the alleged breach(es).
10.4 A non-refundable amount of Rs.1,000/ is to
be deposited by the complainant along with the
complaint. The respective association will
elaborate on their website how this payment is
to be made. No pseudonymous or anonymous
complaints or those made without the prescribed
fee will be entertained.
10.5 When the complaint is from a
pharmaceutical company, the complaint must be
signed or authorized in writing by the company's
managing director or chief executive officer or a
person at an equivalent level.
10.6 When it appears from media reports (other
than letters to the editor of a publication) that a
Company may have breached the Code, the
matter may be treated as a complaint, and the
committee may request the concerned
publication for further information, and the
source or the correspondent may be treated as
the complainant.
10.7. Any complaint received by the Department
of Pharmaceuticals may also be forwarded to the
concerned Association for necessary action. In
such cases, the concerned Association will take
up the matter further with the complainant
concerned. The Department may order a special
audit for the purpose.

4.15. By referring to Clause 10.3, Learned Senior
Counsel’s submission is that the complainant
should identify himself with full mailing address
and if the complaint is from a Pharmaceutical
Digitally Signed By:
SURAJ GOVINDA RAJ
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Company, the complaint must be signed or
authorised in writing by the Company's
Managing Director, Chief Executive or a person
of equivalent rank. The complaint must also the
clauses of the Code alleged to have been
breached.

4.16. Learned Senior Counsel refers to Clause 11 of
the UCPMP 2014 which is reproduced hereunder
for easy reference;
11. Handling of Complaints
11.1 Once a complaint is lodged, the process of
enquiry should be taken up and completed by
the ECPMP. The decision of the Committee will
be made by majority. In case of conflict of
interest, the member/s concerned should recuse
themselves from the proceedings.
11.2 When the Committee receives information
from which it appears that a company may have
contravened the Code, the managing director or
chief executive officer of the company concerned
will be asked to provide a complete response to
the matter.
11.3 To assist companies in ensuring that a
complete response is submitted, the Committee
may suggest to the Respondent company the
relevant supporting material to be supplied, and
it shall be the responsibility of the Respondent
company to ensure that a full response is
submitted within the stipulated timeframe.
11.4 Associations may engage the services of
professional auditors to facilitate better and
Digitally Signed By:
SURAJ GOVINDA RAJ
05/11/2026, 17:30, Bengaluru
Verified

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independent examination towards arriving at an
informed decision.
11.5 The Respondent company shall submit its
comments and supporting documents to the
Committee in not more than 30 days after
receipt of notice from the Committee.
11.6 The company against which the complaint
is made should provide supporting evidence
even if it thinks that the Code has not been
breached.
11.7 The Committee should render a decision
within 90 days of the receipt of complaint, and
having done so, it should promptly notify the
parties of its decision, the reasons thereof in
writing and send it by recorded mail.
11.8 Where the Committee decides there is no
breach of the Code, or that matter of complaint
is not within the scope of the Code, the
complainant will be so advised in writing,
including advice on the appropriate forum to
approach in such cases.
11.9 Where the Committee, after enquiry,
decides that there is a breach of the Code, the
complainant and the Respondent company will
be so advised in writing, including the remedial
steps that need to be taken in this regard
11.10 If no appeal is filed within the stipulated
period, the decision of the ECPMP shall be final
and binding, and adherence to such decision
shall be a condition of continued membership of
the Association. The decisions shall also be
uploaded on the website of the Association and
the Department of Pharmaceuticals.

4.17. Learned Senior Counsel submits that it is a
procedure under Clause 11 which is required to
be followed insofar as the handling of the
Digitally Signed By:
SURAJ GOVINDA RAJ
05/11/2026, 17:30, Bengaluru
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complaint is concerned. Once a committee
passes an order, it is required to be followed,
and it is final, subject to Clause 13.4, which
provides for an appeal. The review of decisions
is in terms of Clause 13, which is reproduced
hereunder for easy reference;
13. Appeal
13.1 If a party to the complaint is dissatisfied
with the decision of the ECPMP, it may file an
appeal before an Apex Committee for Pharma
Marketing Practices (ACPMP) headed by the
Secretary, Department of Pharmaceuticals,
having a Joint Secretary and a Finance Officer
dealing with the subject as its members.
Explanation: The expression 'party to the
complaint' means the complainant or the
Respondent entity, and the expression 'decision
of the ECPMP' includes a lack of decision thereof,
or inordinate delay in reaching such a decision.
13.2 The time limit for filing such an appeal will
ordinarily be 15 days, with an additional 15 days
of reasonable time delay permitted for reasons
to be recorded in writing.
13.3 The ACPMP will give a notice to both the
parties, and after giving a reasonable
opportunity of being heard, give a final decision
or ruling within six months.
13.4 The ACPMP may prescribe any penalties or
make a reference to an appropriate agency or an
authority of the Government in accordance with
para-12 above.
13.5 The decision in appeal shall be final and
binding on both the parties.
Digitally Signed By:
SURAJ GOVINDA RAJ
05/11/2026, 17:30, Bengaluru
Verified

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4.18. Learned Senior Counsel’s submission is that a
review of the decision can only be sought by
complying with Clause 13 and not otherwise.
Against this background, he submits that the
DOP received an anonymous complaint,
accompanied by documents, on 21.05.2024.
The complaint alleged unethical marketing
practices and a breach of the UCPMP by the
Petitioner, on the ground that it had provided
travel tickets and hotel accommodation for
extravagant pleasure trips under the guise of
conferences held in Paris and Monaco for 30
doctors connected with medical aesthetics and
anti-ageing products. Despite the anonymous
nature of the complaint, the DOP forwarded it
to the Ethics Committee for appropriate action.

4.19. Learned Senior Counsel submits that the OPPI
released its findings on 20.09.2024 and found
no irregularity in the Petitioner’s sponsorship.
However, the Apex Committee passed the
following order:
10. Upon perusal of the facts and after hearing
M/s. AbbVie at length, the Apex Committee is of
the opinion that M/s. AbbVie has violated the
Uniform Code for Pharmaceutical Marketing
Practices by sponsoring foreign vacations to
Digitally Signed By:
SURAJ GOVINDA RAJ
05/11/2026, 17:30, Bengaluru
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Monaco and Paris for 30 HCPs in violation of the
codal provisions. Therefore, in exercise of
powers conferred by the UCPMP 2024:
i. The Apex Committee reprimands M/s. AbbVie
Healthcare India Pvt Ltd for unethical marketing
practices. A copy of this order be published on
the website in accordance with the provisions
contained therein.
ii. The Central Board of Direct Taxes (CBDT) is
requested to evaluate the tax liability of M/s.
AbbVie Healthcare India Pvt Ltd along with 30
HCPS and take action in accordance with the
provisions of the Income Tax Act, 1961 read
with the subordinate circulars issued in this
regard.
iii. The National Medical Council (NMC) is
requested to take action against the 30
offending HCPs as per Indian Medical Council
(Professional Conduct, Etiquette and Ethics)
Regulations, 2002.

4.20. His submission is that, firstly, once the
reprimand had been issued, no further action
could be taken by any authority. Secondly, in
the present matter, notices have been issued by
the Registrar of Companies when there is no
direction by the Committee to the ROC to issue
any notices. Thirdly, that even that order could
not have been passed, since the complaint was
anonymous in nature.

4.21. By referring to Clause 10, Learned Senior
Counsel’s submission is that any complainant
Digitally Signed By:
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05/11/2026, 17:30, Bengaluru
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ought to identify himself and provide the
complete postal address; without such
identification and without such details being
furnished, the complaint could not have been
processed. The DOP could not have forwarded
the complaint to the Ethics Committee for
taking any action. The Ethics Committee should
also have considered this aspect and refrained
from taking any action on an anonymous
complaint, so the foundational requirement was
for the complainant to be identified and if the
complainant was a pharmaceutical company,
the complaint was required to comply with the
additional requirement of being signed or
authorised signed or authorised in writing by
the Company's Managing Director or Chief
Executive or a person of equivalent rank. In the
present case, admittedly, the complaint being
anonymous, neither DOP nor the Ethics
Committee could have proceeded on the same.

4.22. Lastly, Learned Senior Counsel’s submission is
that similar issues have been considered by the
Hon'ble Delhi High Court in Dr. Kiran Ninad
Hebbalkar & Ors. v. ACPMP [WP(C)
No.10370/2026 and CM. APPL No.48020/2026].
Digitally Signed By:
SURAJ GOVINDA RAJ
05/11/2026, 17:30, Bengaluru
Verified

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The Hon'ble Delhi High Court has, vide order
dated 04.08.2026, stayed the operation of the
impugned order dated 23.12.2024 insofar as it
directed the initiation of action against the
petitioners in that case.

4.23. Learned Senior Counsel also refers to the
decision of the Hon'ble High Court of Gujarat in
Dr Jagdish Jadavbhai Sakhiya v. Gujarat
Medical Council & Anr. [Spl. Civil Appl.
No.9821/2026 dt.27.07.2026] and submits that
the Hon'ble High Court of Gujarat also observed
that the company which organised the
conference had merely been reprimanded,
whereas the Petitioners, who were medical
practitioners, had been subjected to harsher
punishment. It therefore granted interim relief
in the proceedings against the doctors . His
submission is that the Hon'ble Delhi High Court
and the Hon'ble Gujarat High Court having
stayed the proceedings on those grounds would
also apply to the present matter.

4.24. Sri.Udaya Holla, learned Senior Counsel,
submits that the notice issued by the Ministry
of Corporate Affairs on 12.05.2026 is also
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based on the order passed by the Apex
Committee on 23.12.2024. In particular,
paragraph (ix) of the notice makes a clear and
categorical reference to the order passed by the
Apex Committee for Pharma Marketing
Practices in ACPMP No. 1 of 2024 , dated
23.12.2024, in the matter concerning the
Petitioner under UCPMP 2024.

4.25. Paragraph (x) of the notice further records, with
reference to the order dated 23.12.2024 passed
by the Apex Committee, that the company had
spent Rs. 1.91 crores on travel tickets and hotel
accommodation for what were described as
“extravagant pleasure trips under the guise of
conferences”. On this basis, he submits that the
action has been taken in pursuance of the Apex
Committee’s order and that the Ministry of
Corporate Affairs has no independent basis for
taking such action. It was merely because there
was a reprimand which had been issued that
the Petitioner did not challenge the order of the
Apex Committee, since it did not serve any
purpose. However, the MCA, now acting on the
order of the Apex Committee, having initiated
separate proceedings, the Petitioner has no
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option but to challenge the order of the Apex
Committee, as well as the notice issued by the
MCA.

4.26. Learned Senior Counsel reiterates that neither
the Ethics Committee nor the Apex Committee
could have taken up the matter when the
complaint was anonymous, there being a
specific embargo. In this regard, he relies
particularly on Clause 10 of UCPMP 2024, which
requires the complainant to be identified and to
provide full particulars. The UCPMP 2024, more
particularly Clause 10, is reproduced hereunder
for easy reference;
10. Lodging of Complaints
10.1 All complaints, related to the breach of the
Code should be addressed to the "Ethics
Committee for Pharma Marketing Practices
(ECPMP)", "Chief Executive Officer”, “Name of
Association"
10.2 All complaints related to an activity of
breach of the Code should, to the extent
practicable, be made at one time. The complaint
must be made within six months of the alleged
breach of the Code, with a maximum of another
six months for reasonable delay that can be
explained in writing. Related complaints may be
clubbed together by the Ethics Committee to
save time and expedite disposal.
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10.3 Complaints must be in writing and for each
case The Complainant should:
i. identify himself (whether a company, entity or
an individual) with a full mailing address (email
and mobile telephone no).
ii. identify the company, which is alleged to have
breached the Code, including the name of any
company personnel, product, or products, which
are specifically involved.
iii. give the details of the activity which is alleged
to be in breach of the Code, give the date of the
alleged breach, clauses of the Code which are
alleged to have been breached, and provide
supporting evidence of the alleged breaches).
10.4 A non-refundable amount of Rs.1,000/ is to
be deposited by the complainant along with the
complaint. The respective association will
elaborate on their website how this payment is
to be made. No pseudonymous or anonymous
complaints or those made without the prescribed
fee will be entertained.
10.5 When the complaint is from a
pharmaceutical company, the complaint must be
signed or authorized in writing by the company's
managing director or chief executive officer or a
person at an equivalent level.
10.6 When it appears from media reports (other
than letters to the editor of a publication) that a
company may have breached the Code, the
matter may be treated as complaint, and the
committee may request the concerned
publication for further information, and the
source or the correspondent may be treated as
the complainant.
10.7 Any complaint received by the Department
of Pharmaceuticals may also be forwarded to the
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concerned Association for necessary action. In
such cases, the concerned Association will take
up the matter further with the complainant
concerned. The Department may order a special
audit for the purpose.

4.27. By referring to Clause 10.4 of the UCPMP 2024,
Learned Senior Counsel’s submission is that no
pseudonymous or anonymous complaints or
those made without the prescribed fee will be
entertained. He submits that, since Clause 10.4
expressly prohibits the entertainment of
pseudonymous or anonymous complaints and
the complaint in the present case is admittedly
anonymous, neither the Ethics Committee nor
the Apex Committee nor the Ministry of
Corporate Affairs can initiate action on its basis .

4.28. Learned Senior Counsel refers to the decision of
the Ethics Committee, which is reproduced
hereunder for easy reference;
PRELIMINARY ISSUES TO BE DECIDED AT
THE THRESHOLD
Issue No. 1
Whether the two Conferences subject matter in
the instant Complaint will fall under the purview
of UCPMP 2024 and/or UCPMP 2014?
OPPI ECPMP Decision
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In our considered view, the allegations involving
the two Conferences, which are the subject
matter of the instant Complaint will be governed
by UCPMP 2014, and not UCPMP 2024, which
was notified on March 12,2024.
IMCAS 2024 which was held from February 1 to
3, 2024, will clearly fall within the purview of
UCPMP 2014.
As regards AMWC 2024, which was held between
March 26-29, 2024, the OPPI ECPMP is of the
opinion that it too comes under the purview of
UCPMP 2014 for the following reasons:

a. Immediately after the issuance of UCPMP
2024, the DoP convened consultations
with the pharmaceutical industry
associations (OPPI, IPA and IDMA)
wherein requests were made across-
board by all pharma associations for a
grace period for complying with UCPMP
2024. OPPI, vide its representation dated
April 17, 2024, requested the DoP to
inter alia provide for transition time till
June, 2024.

We understand that it is because of the
said requests that DoP Circular 1 of 2024
dated May 28, 2024 was issued. Circular
1 of 2024 provided for a separate and
stand-alone prospective self-declaration
format (to be signed by executive heads
of the Companies) for FY 2024-25 w.e.f.
April 1, 2024 through to March 31, 2025
which was to be submitted by June 30,
2024 to the respective associations i.e.,
OPPI, in this case. Therefore, it can be
stated that since the self-declaration to
be made by the Executive Heads
declaring/undertaking compliance of
UCPMP 2024 did not pertain to the period
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March 13-March 31, 2024 of the
Financial Year 2023-24, it is not
applicable for the said period during
which AMWC 2024 was held.

ISSUE No. 2
Whether the OPPI ECPMP can entertain an
anonymous complaint under UCPMP 2014?
OPPI ECPMP Decision
No. The instant Complaint being anonymous
cannot be entertained under the provisions of
UCPMP 2014.
Para 10.3 (i) of UCPMP 2014 requires the
complainant to identify himself (whether a
company or an individual) with a full
mailing address (fax number, if possible,
mobile telephone nos.).... Para 10.4 requires
deposit of a non-refundable amount of
Rs.1,000/-.
While UCPMP 2014 does not expressly prescribe
that an anonymous or pseudonymous complaint
without the same prescribed fee of INR 1000
cannot be entertained, it essentially does
expressly require disclosure of the complainant's
name and deposit of fee.

ISSUES DECIDED ON MERITS
ISSUE No. 3
Whether Allergan's engagement with HCPs
under PSAs is permissible under UCPMP
2014?
OPPI ECPMP Decision
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Yes. As per the interpretation of the Note to Para
7 of UCPMP 2014 read with Regulation 6.8.1 (g)
of the MCI Code, 2002, a pharmaceutical
company can have a relationship with HCPs
within the scope of Regulation 6.8.1 (g) of the
MCI Code.
Further, unlike Paras 6 and 6.2 (i) of UCPMP
2024, there were no express provision UCPMP
2014 in respect to CME or a provision prohibiting
such conferences to take place in foreign
locations.
Para 7.1 and Para 7.2 of UCPMP 2014 disallows
travel and hospitality to an HCP respectively,
unless such an HCP is a speaker at a CME/CPD.
However, a proviso to Para 7 provides that
"Where there is any item missing, the code of
MCI as per "Indian Medical Council (Professional
Conduct, etiquette and ethics) Regulation, 2002
as amended from time to time will prevail."
Regulation 6.8.1 (g) of the MCI Code does allow
a medical practitioner to work for pharmaceutical
companies in a wide variety of capacities-
advisory capacities, as consultants, as
researchers, as treating doctors, or in any other
professional capacity.
" Regulation 6.8.1 : In dealing with
Pharmaceutical and allied health sector
industry…
g) Affiliation : A medical practitioner may work
for pharmaceutical and allied healthcare
industries in advisory capacities, as consultants,
as researchers, as treating doctors or in any
other professional capacity. In doing so, a
medical practitioner shall always:
(i) Ensure that his professional integrity and
freedom are maintained.
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(ii) Ensure that patients' interests are not
compromised in any way.
(iii) Ensure that such affiliations are within the
law.
(iv) Ensure that such affiliations/employments
are fully transparent and disclosed."
To examine this issue further, OPPI ECPMP
sought for the copies of the PSAs signed with the
concerned 30 HCPs. The PSAs along with copies
of CV, Questionnaire on education, relevant
publication, research experience, scientific
knowledge etc. of HCPs were provided by
Allergan.
The OPPI ECPMP examined the PSAs and related
documents and found the following:
i. That selection of the HCPs met the selection
criteria. (see below under Issue No. 4)
ii. The PSAs were duly executed with individual
HCPs (in their professional capacity).
iii. All PSAs have categorical post-conference
commitment for the HCPs for a period of one
year from the effective date of the PSAs of
providing educational training Knowledge
Dissemination Activity as per the requirements
of Allergan, which in most cases is due by
January/March 2025.
iv. Further, all PSAs have defined "Services for
the HCPs, ie, to conduct Knowledge
Dissemination Activity.
v. Furthermore, the 'Compensation' clause states
that it includes payment of programme
participation fee, along HCPs travel, hotel
accommodation and legitimate meal expenses
and that no other fee or compensation shall be
payable to the HCPs to conduct the Knowledge
Dissemination Activity.
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OPPI ECPMP is of the considered view that in the
absence of any specific provision on industry
engagement with HCPs in their professional
capacity in UCPMP 2014, the provisions of the
MCI Code would become applicable, rendering
the said arrangements with the HCPs under the
PSAs legally valid.
However, the OPPI ECPMP directs Allergan to
furnish the information in respect of the
Knowledge Dissemination to be undertaken by
the 30 HCPs towards fulfilment of their obligation
under the said 30 PSAs prior to March 31, 2025,
within two months thereafter i.e., by May 31,
2025.

ISSUE No. 4
Whether the identification of HCPs for the
two Conferences was based on sales
generated for Allergan by the 30 HCPs
Sales in 2023?
OPPI ECPMP Decision
OPPI ECPMP examined the 'Sales & Expense
Tracker for AbbVie in India: 2024' (Annexure 3)
filed with the Complaint with details in respect of
2023 AbbVie business and the collated sales
data from its distributors titled 'HCP Sales data'
for the year 2023 provided by Allergan to the
OPPI ECPMP and find that the figures are similar
if not the same.
OPPI ECPMP sought further information from
Allergan on September 16, 2024 regarding
internal policy/SoP on maintenance of sales
records to HCPs.
Allergan provided the extracts of it's internal
policy in relation to interaction with HCPs, and
specifically in relation to PSAs with HCPs to the
OPPI ECPMP on September 18, 2024.
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Allergan has stated that its internal policy in
relation to interaction with HCPs, and specifically
in relation to professional services engagement
with HCPs is aligned with the Uniform Code of
Pharmaceutical Practice (UCPMP) 2014 and
UCPMP 2024, OPPI guidelines and directions
issued from time to time, and industry practices.
The OPPI ECPMP's considered view is that the
business generated by the HCPs in 2023 was not
the determining criteria for the selection of the
HCPs for attending the two conferences in 2024
for the following reasons:
i. The selection of HCPs was based on a defined
and objective selection process. Qualifications
were examined, vetted and approved by the
company's Medical Affairs team Annexure B to
Allergan’s response dated August 26, 2024. HCP
Selection Questionnaire on education, relevant
publication, research experience scientific
knowledge etc. based on speciality of the HCP's,
examination of detailed, curriculum vitae and
read with 'Levels and Tiers assigned to such
HCPs basis Experience and Skills, Medical
Approval for participation in the respective
conferences as shared by Allergan along with it's
response dated September 2, 2024
ii. All the PSAs have an express provision stating
that the PSA is not intended to influence HCP's
decisions or choices regarding the use of, or
prescription of Allergan's products; or the HCPs
are not required to demonstrate any preference
in prescribing or recommending AbbVie's
products as a consequence of the PSAs.
The relevant clause in the PSAs is reproduced
below:
1.2.1 "The Parties acknowledge that:
(a) the consideration provided by AbbVie in the
form of the compensation (including the
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payment of the monetary compensation, if any)

is not conditional upon Counterparty
recommending, administering or prescribing
AbbVie products and has not been determined in
any manner which takes into account the volume
or value of any referrals or business between
Counterparty and AbbVie; and
(b) nothing in this agreement is intended to (i)
influence Counterparty's medical decisions or
choices regarding the use of, or prescription of
AbbVie's products; or (ii) cause Counterparty to
demonstrate any preference in prescribing or
recommending AbbVie's products as a
consequence of AbbVie entering into this
Agreement.
iii. The criterion for Selection and Qualifications
outlined in the extracts of Allergan's Internal
Policy for engaging HCPs, as shared on
September 18, 2024 have the following specific
clauses:
•
Individuals contracted for Professional
Services must be selected based on
objective criteria and should be
chosen by personnel qualified to
assess the expertise and ability of the
individual to effectively provide the
requested Professional Services.

•
Individuals may not be selected for
Professional Services as an incentive
to prescribe, purchase, use, or
recommend AbbVie Products.

•
The number of individuals contracted
must not be greater than the number
reasonably necessary to achieve the
legitimate business need

Further, under the section on 'Legitimate
Business Need', the internal policy also
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Prescribes that 'services may not be offered or
given with the intent to reward. induce, or in
exchange for, an explicit or implicit agreement
or understanding that AbbVie Products will be
used, purchased, leased, ordered, prescribed.
recommended, or arranged for or provided
formulary or other preferential or qualifying
status.
In this context, OPPI ECPMP also wishes to state
here that even Clause 7.4 of the OPPI Code 2019
permits engagement of services from HCPs and
inter alia states that the members can engage
HCPs as consultants and advisors for services
provided certain criteria are met. The criteria
inter alia include:
a) A written contract or agreement must be
agreed in advance of the commencement of the
services which specifies the nature of the
services to be provided and the basis for
payment of those services.
b) A legitimate need for the services must be
clearly identified and documented in advance.
c) The criteria for selecting consultants must be
directly related to the identified need and the
consultants must have the expertise necessary
to provide the service.
d) The hiring of the consultant to provide the
relevant service must not be an inducement to
prescribe, recommend, purchase, supply, and/or
administer any medicine.
ISSUE NO. 5
Whether the alleged tax evasion by Allergan by
claiming these expenses as marketing
promotional expenses is a violation of UCPMP
2014?
OPPI ECPMP Decision
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No. There are no Income Tax (IT) related
provisions in UCPMP 2014.
It is important to recognise that even under
UCPMP 2024, OPPI ECPMP understands that the
decision/s under the Income Tax Act, 1961 is to
be taken by the IT authorities and not by the
association ECPMP.
In the light of the above, Allergan should assess
its liability under the Income Tax (IT) Act. 1961
and applicable Circulars thereunder [Explanation
3 to Section 37(1) and Circular 12 of 2022 in
respect of Section 194 R (2) of the IT Act 1961,
if applicable] and it has time till October 31,
2024 to file its return for FY 23-24.
OPPI ECPMP decides and disposes off the
Anonymous Complaint dated May 21, 2024
accordingly.

4.29. Learned Senior Counsel submits that the Ethics
Committee while answering Issue No.1 had
come to a categorical finding that the complaint
will be governed by the UCPMP 2014 and not
UCPMP 2024. The UCPMP 2024 was notified on
12.03.2024, and the conferences were held
prior to that date. While answering Issue No.2,
the Ethics Committee has come to a categorical
conclusion that an anonymous complaint cannot
be entertained under the provisions of UCPMP
2014. While answering issue No.3, the Ethics
Committee has categorically held that the
Petitioner's engagement with HCPs under the
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PSA is permissible under UCPMP 2014. Insofar
as the purposes mentioned in Regulation No.6
are concerned, Clause 6 of the UCPMP 2014 is
reproduced hereunder for easy reference;
6. Gifts
6.1 No gifts, pecuniary advantages or benefits in
kind may be supplied, offered or promised to
persons qualified to prescribe or supply drugs,
by a pharmaceutical company or any of its
agents i.e. distributors, wholesalers, retailers
etc.
6.2 Gifts for the personal benefit of healthcare
professionals and family members(both
immediate and extended) such as tickets to
entertainment events) also are not be offered or
provided.

4.30. While answering Issue No.4, the Ethics
Committee came to a conclusion that the
business generated by the HCPs in 2023 was
not the determining criterion for the selecting
the HCPs to attend the two conferences, and
while answering Issue No.5, it categorically
came to a conclusion that there is no tax
evasion by the Petitioner in claiming the
expenses of marketing promotional expenses.

4.31. Learned Senior Counsel’s submission is that
once the Ethics Committee has passed the
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above order, neither the Petitioner nor the
anonymous complainant had sought review of
the said order. Learned Senior Counsel
therefore submits that the Apex Committee
could not have reviewed the ECPMP’s decision
as a suo motu appeal and passed the impugned
order.

4.32. Be that as it may, Learned Senior Counsel again
reiterates that the order of the Apex Committee
was not challenged by the Petitioner, since it
was only an order of reprimand and the
reprimand as such was accepted by the
Petitioner. Now that the MCA has issued a
notice in furtherance of the said order calling
upon the Petitioner to furnish various
documents and is proposing to conduct an
enquiry which is not envisaged or permitted by
the Ethics Committee or by the Apex
Committee, the Petitioner is challenging those
orders also.

4.33. He relies on the decision of the Hon’ble Apex
Court in Union of India and Ors. v Ram
Lakhan Sharma [(2018) 7 SCC 670],
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particularly paras 24 and 33, which have been
reproduced hereunder for easy reference:
24. The disciplinary proceedings are quasi-
judicial proceedings and the Enquiry Officer
is in the position of an independent
adjudicator and is obliged to act fairly,
impartially. The authority exercising quasi-
judicial power has to act in good faith without
bias, in a fair and impartial manner.
Xxx
33.The Division Bench after elaborately
considering the issue summarised the principles
in para 16 which is to the following effect:
“16. We may summarise the principles thus:
(16) The Enquiry Officer, who is in the
position of a Judge shall not act
as a Presenting Officer, who is in
the position of a prosecutor.
(ii) It is not necessary for the disciplinary
authority to appoint a Presenting Officer in each
and every inquiry. Non-appointment of a
Presenting Officer, by itself will not vitiate the
inquiry.
(iii) The Enquiry Officer, with a view to arrive at
the truth or to obtain clarifications, can put
questions to the prosecution witnesses and also
the defence witnesses. In the absence of a
Presenting Officer, if the Enquiry Officer puts any
questions to the prosecution witnesses to elicit
the facts, he should thereafter permit the
delinquent employee to cross-examine such
witnesses on those clarifications.
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(iv) If the Enquiry Officer conducts a regular
examination-in-chief by leading the prosecution
witnesses through the prosecution case, or puts
leading questions to the departmental witnesses
pregnant with answers, or cross-examines the
defence witnesses or puts suggestive questions
to establish the prosecution case against the
employee, the Enquiry Officer acts as prosecutor
thereby vitiating the inquiry.
(v) As absence of a Presenting Officer by itself
will not vitiate the inquiry and it is recognised
that the Enquiry Officer can put questions to any
or all witnesses to elicit the truth, the question
whether an Enquiry Officer acted as a Presenting
Officer, will have to be decided with reference to
the manner in which the evidence is let in and
recorded in the inquiry.
Whether an Enquiry Officer has merely acted
only as an Enquiry Officer or has also acted as a
Presenting Officer depends on the facts of each
case. To avoid any allegations of bias and
running the risk of inquiry being declared as
illegal and vitiated, the present trend appears to
be to invariably appoint Presenting Officers
except in simple cases. Be that as it may.”

4.34. By relying on Ram Lakhan Sharma, Learned
Senior Counsel submits that the Enquiry Officer,
being an independent adjudicator in quasi-
judicial disciplinary proceedings, is required to
act fairly and impartially and cannot assume
the role of a Presenting Officer.
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4.35. Learned Senior Counsel further submits that
Respondent No.4 has not acted independently
but has acted as per the instructions received.

4.36. He relies upon the decision of the Hon’ble Apex
Court in Union of India v Mahendra Singh
[2022 SCC OnLine SC 909], particularly para 15
and 16, which have been reproduced hereunder
for easy reference:
15. A three Judge Bench of this Court in a
judgment reported as Chandra Kishore Jha
v. Mahavir Prasad, held as under:

“17…............ It is a well-settled salutary
principle that if a statute provides for a
thing to be done in a particular manner,
then it has to be done in that manner
and in no other manner. (See with
advantage: Nazir Ahmad v. King Emperor
I(1935-36) 63 IA 372 : AIR 1936 PC 253
(2)), Rao Shiv Bahadur Singh v. State of
V.P. [AIR 1954 SC 322: 1954 SCR 1098],
State of U.P. v. Singhara Singh [AIR 1964
SC 358 : (1964) 1 SCWR 57].) An election
petition under the rules could only have
been presented in the open court up to 16-
5-1995 till 4.15 p.m. (working hours of the
Court) in the manner prescribed by Rule 6
(supra) either to the Judge or the Bench as
the case may be to save the period of
limitation. That, however, was not done…

16. The said principle has been followed by
this Court in Cherukuri Mani v. Chief
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Secretary, Government of Andhra
Pradesh11 wherein this Court held as under:

“14. Where the law prescribes a thing to
be done in a particular manner
following a particular procedure, it shall
be done in the same manner following
the provisions of law, without deviating
from the prescribed procedure …


4.37. By relying on Mahendra Singh , Learned
Senior Counsel submits that where the
applicable statutory provisions or rules
prescribe a particular procedure for undertaking
an action, the authority concerned is bound to
adhere to the procedure so prescribed and
cannot act in deviation therefrom. Applying the
aforesaid principle to the facts of the present
case, Learned Senior Counsel contends that the
impugned action, having been taken without
following the procedure mandatorily prescribed
under the applicable rules, is contrary to law
and cannot be sustained. It is, therefore,
submitted that the impugned action is liable to
be set aside for non-compliance with the
prescribed procedure.

4.38. He relies upon Sudarshan V. Biradar v. State
of Karnataka [2023 SCC OnLine Kar 178],
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particularly para 14, which has been
reproduced hereunder for easy reference:
14. As observed hereinabove, it is trite law
that the Rule making power conferred
upon by the parent Act cannot travel
beyond the mandate of the parent Act .
The view of mine in this regard is fortified by
the judgment of the Apex Court in the case of
1
UNION OF INDIA v. A. SRINIVASAN wherein
the Apex Court considers the entire spectrum
of the law rendered from time to time and
holds that a provision therein was contrary to
the provision contained in the enabling Act.
The Apex Court has held as follows:

“21. At this stage, it is apposite to state about
the rule-making powers of a delegating
authority. If a rule goes beyond the rule-
making power conferred by the statute, the
same has to be declared ultra vires. If a rule
supplants any provision for which power has
not been conferred, it becomes ultra vires. The
basic test is to determine and consider the
source of power which is relatable to the rule.
Similarly, a rule must be in accord with
the parent statute as it cannot travel
beyond it.

22. In this context, we may refer with profit to
the decision in General Officer Commanding-
in-Chief v. Subhash Chandra Yadav [(1988) 2
SCC 351 : 1988 SCC (L&S) 542 : (1988) 7 ATC
296 : AIR 1988 SC 876] wherein it has been
held as follows : (SCC p. 357, para 14)

“14. … before a rule can have the effect of a
statutory provision, two conditions must be
fulfilled, namely, (1) it must conform to the
provisions of the statute under which it is
framed; and (2) it must also come within
the scope and purview of the rule-making
power of the authority framing the rule. If
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either of these two conditions is not
fulfilled, the rule so framed would be
void.”

23. In Delhi Admn. v. Siri Ram [(2000) 5 SCC
451 : AIR 2000 SC 2143] it has been ruled
that it is a well-recognised principle that the
conferment of rule-making power by an
Act does not enable the rule-making
authority to make a rule which travels
beyond the scope of the enabling Act or
which is inconsistent therewith or
repugnant thereto.

24. In Sukhdev Singh v. Bhagatram Sardar
Singh Raghuvanshi [(1975) 1 SCC 421 : 1975
SCC (L&S) 101 : AIR 1975 SC 1331] the
Constitution Bench has held that : (SCC p.
433, para 18)

“18. … statutory bodies cannot use the
power to make rules and regulations to
enlarge the powers beyond the scope
intended by the legislature. Rules and
regulations made by reason of the specific
power conferred by the statute to make rules
and regulations establish the pattern of
conduct to be followed”.

25. In State of Karnataka v. H. Ganesh
Kamath [(1983) 2 SCC 402 : 1983 SCC (Cri)
514 : AIR 1983 SC 550] it has been stated
that : (SCC p. 410, para 7)

“7. … It is a well-settled principle of
interpretation of statutes that the conferment
of rule-making power by an Act does not
enable the rule-making authority to make
a rule which travels beyond the scope of
the enabling Act or which is inconsistent
therewith or repugnant thereto.”

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26. In Kunj Behari Lal Butail v. State of H.P.
[(2000) 3 SCC 40 : AIR 2000 SC 1069] it has
been ruled thus : (SCC p. 46, para 13)

“13. It is very common for the legislature to
provide for a general rule-making power to
carry out the purpose of the Act. When such a
power is given, it may be permissible to
find out the object of the enactment and
then see if the rules framed satisfy the
test of having been so framed as to fall
within the scope of such general power
confirmed. If the rule-making power is
not expressed in such a usual general
form then it shall have to be seen if the
rules made are protected by the limits
prescribed by the parent Act.”

27. In St. Johns Teachers Training Institute v.
National Council for Teacher Education [(2003)
3 SCC 321 : AIR 2003 SC 1533] it has been
observed that : (SCC p. 331, para 10)

“10. A regulation is a rule or order prescribed
by a superior for the management of some
business and implies a rule for general course
of action. Rules and regulations are all
comprised in delegated legislations. The
power to make subordinate legislation is
derived from the enabling Act and it is
fundamental that the delegate on whom
such a power is conferred has to act
within the limits of authority conferred by
the Act. Rules cannot be made to supplant
the provisions of the enabling Act but to
supplement it. What is permitted is the
delegation of ancillary or subordinate
legislative functions, or, what is fictionally
called, a power to fill up details.”

28. In Global Energy Ltd. v. Central Electricity
Regulatory Commission [(2009) 15 SCC 570]
this Court was dealing with the validity of
clauses (b) and (f) of Regulation 6-A of the
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Central Electricity Regulatory Commission
(Procedure, Terms and Conditions for Grant of
Trading Licence and Other Related Matters)
Regulations, 2004. In that context, this Court
expressed thus : (SCC p. 579, para 25)

“25. It is now a well-settled principle of law
that the rule-making power ‘for carrying out
the purpose of the Act’ is a general delegation.
Such a general delegation may not be held to
be laying down any guidelines. Thus, by
reason of such a provision alone, the
regulation-making power cannot be exercised
so as to bring into existence substantive rights
or obligations or disabilities which are not
contemplated in terms of the provisions of the
said Act.”

29. In the said case, while discussing further
about the discretionary power, delegated
legislation and the requirement of law, the
Bench observed thus : (Global Energy Ltd.
case [(2009) 15 SCC 570], SCC p. 589, para
73)

“73. The image of law which flows from this
framework is its neutrality and objectivity : the
ability of law to put sphere of general decision-
making outside the discretionary power of those
wielding governmental power. Law has to provide a
basic level of ‘legal security’ by assuring that law is
knowable, dependable and shielded from excessive
manipulation. In the contest of rule-making,
delegated legislation should establish the structural
conditions within which those processes can
function effectively. The question which needs to be
asked is whether delegated legislation promotes
rational and accountable policy implementation.
While we say so, we are not oblivious of the
contours of the judicial review of the legislative
Acts. But, we have made all endeavours to keep
ourselves confined within the well-known
parameters.”

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30. In this context, it would be apposite to
refer to a passage from State of T.N. v. P.
Krishnamurthy [(2006) 4 SCC 517] wherein it
has been held thus : (SCC p. 529, para 16)

“16. The court considering the validity of a
subordinate legislation, will have to consider
the nature, object and scheme of the enabling
Act, and also the area over which power has
been delegated under the Act and then decide
whether the subordinate legislation conforms
to the parent statute. Where a rule is directly
inconsistent with a mandatory provision of the
statute, then, of course, the task of the court
is simple and easy. But where the
contention is that the inconsistency or
non-conformity of the rule is not with
reference to any specific provision of the
enabling Act, but with the object and
scheme of the parent Act, the court
should proceed with caution before
declaring invalidity.”

31. In Pratap Chandra Mehta v. State Bar Council
of M.P. [(2011) 9 SCC 573], while discussing about
the conferment of extensive meaning, it has been
opined that : (SCC p. 604, para 58)

“58. … The Court would be justified in giving
the provision a purposive construction to
perpetuate the object of the Act, while
ensuring that such rules framed are within the
field circumscribed by the parent Act. It is also
clear that it may not always be absolutely
necessary to spell out guidelines for delegated
legislation, when discretion is vested in such
delegatee bodies. In such cases, the language of
the rule framed as well as the purpose sought to be
achieved, would be the relevant factors to be
considered by the Court.”
(Emphasis supplied)
It is further germane to notice the judgment of the
Division Bench of Madhya Pradesh High Court in the
case of KALLU KHAN v. STATE OF MADHYA
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2
PRADESH , wherein the Division Bench considers
the very enactment, which reads as follows:

“15. For the regulation of registration of births and
deaths and matters connected therewith,
Parliament has enacted the Registration of Births
and Deaths Act, 1969. Different procedures were
prescribed under Chapter III-Registration of Births
and Deaths and section 13 deals with Delayed
Registration of Births and Deaths. Same is
reproduced hereinbelow for ready reference:—

“13. Delayed registration of births and deaths.
—
(1) Any birth of which information is given to the
Registrar after the expiry of the period specified
therefore, but within thirty days of its occurrence,
shall be registered on payment of such late fee as
may be prescribed.

(2) Any birth or death of which delayed information
is given to the Registrar after thirty days but within
one year of its occurrence shall be registered only
with the written permission of the prescribed
authority and on payment of the prescribed fee and
the production of an affidavit made before the
notary public or any other officer authorised in this
behalf by the State Government.

(3) Any birth or death which has not been
registered within one year of its occurrence,
shall be registered only on an order made by a
Magistrate of the first class or a Presidency
Magistrate after verifying the correctness of
the birth or death and on payment of the
prescribed fee.

(4) The provisions of this section shall without
prejudice to any action that may be taken against a
person for failure on his part to register any birth or
death within the time specified therefore and any
such birth or death may be registered during the
pendency of any such action.”

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16. Certain penalties have also been prescribed
under section 23 of the Act of 1969 to those
persons who may fail without any reasonable cause
to give information which it is his duty to give
under any of the provisions of sections 8 and 9. He
may face imposition of penalty as prescribed.
Similarly, power to prosecute (section 25) and
power to compound offences (section 24) are also
provided under the frame work of Act of 1969.
Therefore, it is clear that any noncompliance or
omission to give information attracts
penalties/penal provisions.

17. Act of 1969 gives power to the State
Government to make rules as per section 30 of the
Act of 1969. Same bears significance in the set of
factual set up of present case. For ready reference
section 30 of the Act of 1969 is reproduced
hereinbelow:—

“30. Power to make rules. — (1) The State
Government may, with the approval of the Central
Government, by notification in the Official Gazette,
make rules to carry out the purpose of this Act.
(2) In particular, and without prejudice to the
generality of the foregoing provision, such rules
may provide for—

(a) the forms of registers of births and deaths
required to be kept under this Act;

(b) the period within which and the form and the
manner in which information should be given to the
Registrar under section 8’

(c) the period within which and the manner in
which births and deaths shall be notified under
sub-section (1) of section 10;

(d) the person from whom and the form in
which a certificate as to cause of death shall be
obtained;

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(e) the particulars of which extracts may be
given under section 12;

(f) the authority which may grant
permission for registration of a birth or
death under sub-section (2) of section 13;

(g) the fees payable for registration made
under section 13;

(h) the submission of reports by the Chief
Registrar under subsection (4) of section 4;

(i) the search of birth and death registers and
the fees payable for such search and for the
grant of extracts from the registers;

(j) the forms in which and the intervals at
which the returns and the statistical report
under section 19 shall be furnished and
published;

(k) the custody, production and transfer of the
registers and other records kept by Registrars;

(1) The correction of errors and the
cancellation of entries in the register of births
and deaths;

(m) any other matter which has to be, or may
be, prescribed. (3) Every rule made under this
Act shall be laid, as soon as may be after it is
made, before the State Legislature.”

18. If section 13(3) and 30(f)(g) are seen
in juxtaposition then it makes the
legislative intent clear that by section
13(3) of the Act of 1969, Parliament has
given the authority to Judicial Magistrate
First Class (or Presidency Magistrate) to
verify the correctness of the birth or
death if not registered within one year of
its occurrence and understandably so
because after one year dispute and
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discrepancies may occur in respect of
date of birth or death of a person.

19. As per section 15 of Juvenile Justice
(Protection and Care of Children) Act, 2015;
wherein, person above 16 years but below 18
years if commits heinous offence then after
due procedure as prescribed may be tried in
Children's Court rather than before Juvenile
Justice Board. Age of prosecutrix assumes
importance in matters of POCSO Act and to
avoid all these complications, section 13 of Act
of 1969 provides mechanism for verification of
claim regarding correctness of birth or death
beyond one year of its occurrence, before the
Judicial Magistrate First Class only and not
before the Executive Magistrate.

20. Perusal of section 30 of Act of 1969
reveals that authority/power to make
rules to the State Government has been
given by the Parliament in respect of
section 13(2) and in respect of fees
payable for registration ismade under
section 13. But very specifically, section
13(3) is not under the purview of Rule
Making Authority of State Government. In
fact, sub-section (2) of section 30 starts
with following words:— “In particular,
and without prejudice to the generality of
the foregoing provision, such rules may
provide for”, therefore, State Government
can make rules as per the letter and spirit
of section 30 and 13(3) of Act of 1969
only and cannot go beyond that.

21. In the State of Madhya Pradesh, in
exercise of powers conferred by section 30 of
the act of 1969, State Government made rules
namely M.P. Registration of Births and Deaths
Rules, 1999. Earlier rules with the
nomenclature Registration of Births and
Deaths M.P. Rules, 1973 were repealed by the
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Rules of 1999, therefore, at present Rules of
1999 are in existence.

22. Here, Rule 9 is worth consideration
because it gives authority for delayed
registration and fee payable. Rule 9 of Rules of
1999 is reproduced hereinbelow for ready
reference:—

“9. Authority for delayed registration and
fee payable therefore. — (1) Any birth or
death of Which information is given to the
Registrar after the expiry of the period
specified in Rule 5 but within thirty days of its
occurrence, shall be registered on payment of
a late fee of rupees two.
(2) Any birth or death of which information is
given to the Registrar after thirty days but
within one year of its occurrence, shall be
registered only with the written permission of
the office authorised in this behalf and on
payment of a late fee of rupees five and on the
officer authorised in this behalf by the State
Government.

(3) Any birth or death which has not been
registered within one year of its
occurrence, shallbe registered only on an
order of a Magistrate of the first class or
an Executive Magistrate and on payment
of a late fee of rupees ten.”

23. Perusal of Rule 9(3) indicates that with
Magistrate of First Class (apparently JMFC),
the authority of Executive Magistrate has
also been inserted which if is read in
consonance with section 13(3) and
section 30(2)(f) and (g) of Act of 1969
then it gives an impression that Act no
where provides any authority to Executive
Magistrate to deal with delayed
registration, but Rules included him.

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28. Rule 13(3) in specific terms gives
authority to Magistrate of First Class (or a
Presidency Magistrate) to exercise
authority for delayed registration but
nowhere gives any authority to Executive
Magistrate. Even otherwise, spirit of
section 13(3) indicates that correctness
of birth or death is to be made after due
verification by JMFC and that verification
can only be made by way of a judicial
proceeding, may be it a summery
proceeding, but certainly as per
recognized principles of adjudication.

29. JMFC has all the necessary tools including
to call witnesses, requisition of record from
any public authority, compelling the
attendance of officers/witnesses and
appreciating the rival submissions and
evidence beside other tools of adjudication.
Executive Magistrate is not equipped with such
adjudicatory tools including the authority as
referred above. Therefore, understandably,
legislative intent under section 13(3) was to
confer jurisdiction over JMFC only and not
otherwise.

30. Careful reading of section 30 of Act of
1969 if seen in juxtaposition to section 20
of the General Clauses Act, 1897, it makes
the case further clear that State
Government could not have framed Rules
contrary to the directions contained in
section 30 of Act of 1969. In other words,
the Attempt cannot exceed the Authority.
Section 20 of General Clauses Act, 1897 is
reproduced hereinbelow for ready reference:—

“Section 20. Construction of notifications
etc., issued under enactments. — Where,
by any Central Act or regulation, a power to
issue any notification, order, scheme, rule,
form or bye-law is conferred, then expressions
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used in the notification, order, scheme, rule,
form, or byelaw, if it is made after the
commencement of this act, shall unless there
is anything repugnant in the subject or
context, have the same respective meaning as
in the Act or Regulation conferring the power.”

(Emphasis supplied)

The Apex Court in a judgment rendered on
16.12.2022 in the case of KERALA STATE
3
ELECTRICITY BOARD v. THOMAS JOSEPH has
held as follows:

“66. At this stage, it is apposite to state about
the rule making powers of a delegating
authority. If a rule goes beyond the rule
making power conferred by the statute,
the same has to be declared invalid. If a
rule supplants any provision for which
power has not been conferred, it becomes
invalid. The basic test is to determine and
consider the source of power, which is
relatable to the rule. Similarly, a rule must be
in accord with the parent statute, as it cannot
travel beyond it.

67. Delegated legislation has come to stay as
a necessary component of the modern
administrative process. Therefore, the question
today is not whether there ought to be
delegated legislation or not, but that it should
operate under proper controls so that it may
be ensured that the power given to the
Administration is exercised properly; the
benefits of the institution may be utilised, but
its disadvantages minimised. The doctrine of
ultra vires envisages that a rule making
body must function within the purview of
the rule making authority conferred on it
by the parent Act. As the body making
rules or regulations has no inherent
power of its own to make rules, but
derives such power only from the statute,
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it has to necessarily function within the
purview of the statute. Delegated
legislation should not travel beyond the
purview of the parent Act. If it does, it is
ultra vires and cannot be given any effect.
Ultra vires may arise in several ways; there
may be simple excess of power over what is
conferred by the parent Act; delegated
legislation may be inconsistent with the
provisions of the parent Act or statute law or
the general law; there may be non-compliance
with the procedural requirement as laid down
in the parent Act. It is the function of the
courts to keep all authorities within the
confines of the law by supplying the doctrine of
ultra vires.

68. In this context, we may refer with profit to
the decision in General Officer Commanding-
in-Chief v. Dr. Subhash Chandra Yadav,
(1988) 2 SCC 351, wherein it has been held as
follows:—

“14. ….before a rule can have the effect of
a statutory provision, two conditions must
be fulfilled, namely, (1) it must conform
to the provisions of the statute under
which it is framed; and (2) it must also
come within the scope and purview of the
rule making power of the authority
framing the rule. If either of these two
conditions is not fulfilled, the rule so
framed would be void…..”

69. In Additional District Magistrate (Rev.)
Delhi Admn. v. Siri Ram, (2000) 5 SCC 451, it
has been ruled that it is a well recognised
principle that the conferment of rule-making
power by an Act does not enable the rule-
making authority to make a rule which travels
beyond the scope of the enabling Act or which
is inconsistent therewith or repugnant thereto.

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70. In Sukhdev Singh v. Bhagatram Sardar
Singh Raghuvanshi, (1975) 1 SCC 421, the
Constitution Bench has held that:
“ 18 .….These statutory bodies cannot use the
power to make rules and regulations to
enlarge the powers beyond the scope intended
by the Legislature. Rules and regulations made
by reason of the specific power conferred by
the statute to make rules and regulations
establish the pattern of conduct to be followed.
…”

71. In State of Karnataka v. H. Ganesh
Kamath, (1983) 2 SCC 402, it has been stated
that:

“ 7. …..It is a well-settled principle of
interpretation of statutes that the conferment
of rule-making power by an Act does not
enable the rule-making authority to make a
rule which travels beyond the scope of the
enabling Act or which is inconsistent therewith
or repugnant thereto.”

72. In Kunj Behari Lal Butail v. State of H.P.,
(2000) 3 SCC 40, it has been ruled thus:—

“ 13. It is very common for the legislature to
provide for a general rule-making power to
carry out the purpose of the Act. When such a
power is given, it may be permissible to find
out the object of the enactment and then see if
the rules framed satisfy the test of having
been so framed as to fall within the scope of
such general power confirmed. If the rule-
making power is not expressed in such a usual
general form then it shall have to be seen if
the rules made are protected by the limits
prescribed by the parent act…….”

73. In St. Johns Teachers Training Institute v.
Regional Director, National Council for Teacher
Education, (2003) 3 SCC 321, it has been
observed that:
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“ 10. A regulation is a rule or order prescribed
by a superior for the management of some
business and implies a rule for general course
of action. Rules and regulations are all
comprised in delegated legislation. The power
to make subordinate legislation is derived from
the enabling Act and it is fundamental that the
delegate on whom such a power is conferred
has to act within the limits of authority
conferred by the Act. Rules cannot be made to
supplant the provisions of the enabling Act but
to supplement it. What is permitted is the
delegation of ancillary or subordinate
legislative functions, or, what is fictionally
called, a power to fill up details…..”

74. In Global Energy Limited v. Central
Electricity Regulatory Commission, (2009) 15
SCC 570, this Court was dealing with the
validity of clauses (b) and (f) of Regulation 6-A
of the Central Electricity Regulatory
Commission (Procedure, Terms and Conditions
for Grant of Trading Licence and other Related
Matters) Regulations, 2004. In that context,
this Court expressed as under:—

“ 25. It is now a well-settled principle of law
that the rule-making power “for carrying out
the purpose of the Act” is a general delegation.
Such a general delegation may not be held to
be laying down any guidelines. Thus, by
reason of such a provision alone, the
regulation-making power cannot be exercised
so as to bring into existence substantive rights
or obligations or disabilities which are not
contemplated in terms of the provisions of the
said Act.

75. In the aforementioned case, while
discussing further about the discretionary
power, delegated legislation and the
requirement of law, the Bench observed thus:

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“ 73. The image of law which flows from this
framework is its neutrality and objectivity : the
ability of law to put sphere of general decision-
making outside the discretionary power of
those wielding governmental power. Law has
to provide a basic level of “legal security” by
assuring that law is knowable, dependable and
shielded from excessive manipulation. In the
contest of rule-making, delegated legislation
should establish the structural conditions
within which those processes can function
effectively. The question which needs to be
asked is whether delegated legislation
promotes rational and accountable policy
implementation. While we say so, we are not
oblivious of the contours of the judicial review
of the legislative Acts. But, we have made all
endeavours to keep ourselves confined within
the well-known parameters.”

76. In this context, it would be apposite to
refer to a passage from State of T.N. v. P.
Krishnamurthy, (2006) 4 SCC 517 wherein it
has been held thus:—

“ 16. The court considering the validity of a
subordinate legislation, will have to consider
the nature, object and scheme of the enabling
Act, and also the area over which power has
been delegated under the Act and then decide
whether the subordinate legislation conforms
to the parent statute. Where a rule is directly
inconsistent with a mandatory provision of the
statute, then, of course, the task of the court
is simple and easy. But where the contention is
that the inconsistency or nonconformity of the
rule is not with reference to any specific
provision of the enabling Act, but with the
object and scheme of the parent Act, the court
should proceed with caution before declaring
invalidity.”

77. In Pratap Chandra Mehta v. State Bar
Council of Madhya Pradesh, (2011) 9 SCC 573,
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while discussing about the conferment of
extensive meaning, it has been opined that:

“ 58. ….The Court would be justified in giving
the provision a purposive construction to
perpetuate the object of the Act, while
ensuring that such rules framed are within the
field circumscribed by the parent Act. It is also
clear that it may not always be absolutely
necessary to spell out guidelines for delegated
legislation, when discretion is vested in such
delegatee bodies. In such cases, the language
of the rule framed as well as the purpose
sought to be achieved, would be the relevant
factors to be considered by the Court.”

78. In Dr. Mahachandra Prasad Singh v.
Chairman, Bihar Legislative Council, (2004) 8
SCC 747, this Court explained the concept of
delegated legislation thus:

“ 13. …..Underlying the concept of delegated
legislation is the basic principle that the
legislature delegates because it cannot directly
exert its will in every detail. All it can in
practice do is to lay down the outline.

This means that the intention of the
legislature, as indicated in the outline (that is
the enabling Act), must be the prime guide to
the meaning of delegated legislation and the
extent of the power to make it. The true extent
of the power governs the legal meaning of the
delegated legislation. The delegate is not
intended to travel wider than the object of the
legislature. The delegate's function is to serve
and promote that object, while at all times
remaining true to it. That is the rule of primary
intention. Power delegated by an enactment
does not enable the authority by regulations to
extend the scope or general operation of the
enactment but is strictly ancillary. It will
authorise the provision of subsidiary means of
carrying into effect what is enacted in the
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statute itself and will cover what is incidental
to the execution of its specific provision. But
such a power will not support attempts to
widen the purposes of the Act, to add new and
different means of carrying them out or to
depart from or vary its ends. (See Section 59
in chapter “Delegated Legislation” in Francis
rd
Bennion's Statutory Interpretation, 3
Edn.)…….”

79. In McEldowney v. Forde, [1971] A.C. 632 :
[1969] 3 WLR 179, Lord Diplock explained the
role of the Courts in this area in the following
words:

“The division of functions between Parliament
and the courts as respects legislation is clear.
Parliament makes laws and can delegate part
of its power to do so to some subordinate
authority. The courts construe laws whether
made by Parliament directly or by a
subordinate authority acting under delegated
legislative powers. The view of the courts as to
whether particular statutory or subordinate
legislation promotes or hinders the common
weal is irrelevant. The decision of the courts as
to what the words used in the statutory or
subordinate legislation mean is decisive.
Where the validity of subordinate legislation
made pursuant to powers delegated by Act of
Parliament to a subordinate authority is
challenged, the court has a threefold task :
first, to determine the meaning of the words
used in the Act of Parliament itself to describe
the subordinate legislation which that authority
is authorised to make, secondly, to determine
the meaning of the subordinate legislation
itself and finally to decide whether the
subordinate legislation complies with that
description.”

80. A delegated power to legislate by
making rules or regulations ‘for carrying
out the purpose of the Act’, is a general
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delegation without laying down any
guidelines; it cannot be exercised so as to
bring into existence the substantive rights
or obligations or disabilities not
contemplated by the provisions of the Act,
2003 itself . The Court, considering the
validity of a subordinate legislation, will have
to consider the nature, object and scheme of
the enabling Act, and also the area over which
power as has been delegated under the Act
and then decide whether the subordinate
legislation conforms to the parent statute.

81. It is important to keep in mind that
where a rule or regulation is directly
inconsistent with a mandatory provision
of the statute, then, of course, the task of
the Court is simple and easy . But where the
contention is that the inconsistency or non-
conformity of the rule is not with reference to
any specific provision of the enabling Act, but
with the object and scheme of the parent Act,
the Court should proceed with caution before
declaring the same to be invalid.

82. Rules or regulation cannot be made to
supplant the provisions of the enabling
Act but to supplement it. What is
permitted is the delegation of ancillary or
subordinating legislative functions, or,
what is fictionally called, a power to fill up
details.

83. A Constitution Bench of this Court in the
case of Sukhdev Singh (supra), while
explaining the fine distinction between a rule
and regulation and also the power of the
delegate authority to frame such rules or
regulations has made few very important
observations which we must take notice of and
quote as under:

“11. The contentions on behalf of the
employees are these. Regulations are
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made under the statute. The origin and
source of the power to make regulations
is statutory. Regulations are self-binding
in character. Regulations have the force
of law inasmuch as the statutory
authorities have no right to make any
departure from the regulations.

12. Rules, regulations, schemes, bye-
laws, orders made under statutory
powers are all comprised in delegated
legislation. The need for delegated
legislation is that statutory rules are
framed with care and minuteness when
the statutory authority making the rules
is after the coming into force of the Act in
a better position to adapt the Act to
special circumstances. Delegated
legislation permits utilisation of
experience and consultation with
interests affected by the practical
operation of statutes.
xxxxxxxxx

14. Subordinate legislation is made by a
person or body by virtue of the powers
conferred by a statute. Bylaws are made in the
main by local authorities or similar bodies or
by statutory or other undertakings for
regulating the conduct of persons within their
areas or resorting to their undertakings.
Regulations may determine the class of cases
in which the exercise of the statutory power by
any such authority constitutes the making of
statutory rules.

15. The words “rules” and “regulations” are
used in an Act to limit the power of the
statutory authority. The powers of statutory
bodies are derived, controlled and restricted by
the statutes which create them and the rules
and regulations framed thereunder. Any action
of such bodies in excess of their power or in
violation of the restrictions placed on their
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powers is ultra vires. The reason is that it goes
to the root of the power of such corporations
and the declaration of nullity is the only relief
that is granted to the aggrieved party.


18. The authority of a statutory body or public
administrative body or agency ordinarily
includes the power to make or adopt rules and
regulations with respect to matters within the
province of such body provided such rules and
regulations are not inconsistent with the
relevant law. In America a “public agency” has
been defined as an agency endowed with
governmental or public functions. It has been
held that the authority to act with the sanction
of Government behind it determines whether
or not a governmental agency exists. The rules
and regulations comprise those actions of the
statutory or public bodies in which the
legislative element predominates. These
statutory bodies cannot use the power to
make rules and regulations to enlarge the
powers beyond the scope intended by the
Legislature. Rules and regulations made
by reason of the specific power conferred
on the statute to make rules and
regulations establish the pattern of
conduct to be followed. Rules are duly
made relative to the subject-matter on
which the statutory bodies act
subordinate to the terms of the statute
under which they are promulgated.
Regulations are in aid of the enforcement
of the provisions of the statute. Rules and
regulations have been distinguished from
orders or determination of statutory
bodies in the sense that the orders or
determination are actions in which there
is more of the judicial function and which
deal with a particular present situation.
Rules and regulations on the other hand
are actions in which the legislative
element predominates.
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(Emphasis in original)

33. The Apex Court again considers the entire
spectrum of the law and lays down that
Statutory Bodies cannot use the power to
make rules to enlarge the powers beyond the
scope intended by the legislature. Any action
of the State in excess of their power would be
declared a nullity on the ground of it being
ultra vires the Act.


4.39. By relying on Sudarshan V. Biradar , Learned
Senior Counsel submits that, in the absence of
any recommendation or direction to Respondent
No. 4, the latter has exceeded its authority and
cannot conduct an inquiry . It is contended that
any action taken by the State authority in
exercise of a power not conferred by the parent
enactment, would be ultra vires and legally
unsustainable. Applying the aforesaid principle
to the notice issued by the Ministry of
Corporate Affairs on 12.05.2026, learned Senior
Counsel submits that the notice derives its
authority from the Apex Committee’s order
dated 23.12.2024 . Since there is a clear and
categorical reference made to the order passed
by the Apex Committee for Pharma Marketing
Practices in ACPMP No.1 of 2024 dated
23.12.2024 in the matter of the Petitioner
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under the UCPMP 2024 at para (ix), and since
the order merely reprimanded the Petitioner
and did not direct an inquiry, he submits that
the notice is without jurisdiction and liable to be
set aside.

4.40. Learned Senior Counsel’s submission therefore
is that the above petition is required to be
allowed and the reliefs sought for granted.

5. Smt.Nayanatara.B.G., learned counsel appearing for
Respondents No.1, 2 and 4 submits that:

5.1. The impugned order dated 23.12.2024 at
Annexure-A of the Apex Committee has neither
been passed in the Review jurisdiction nor in
the Appellate jurisdiction.

5.2. Learned Counsel for Respondents No.1, 2 and 4
submits that the entire manner in which the
matter was proceeded with is different. Her
contention is that a complaint was received by
the Department of Pharmaceuticals (DOP) and
not addressed to the Ethics Committee or the
UCPMP. The complaint was forwarded by the
DOP to the Ethics Committee as also the Apex
Committee to take action, and in that
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background, she submits that Clause 10 of
either the UCPMP of 2014 or UCPMP of 2024
would not be applicable to the present facts and
situation.

5.3. Learned Counsel for Respondents No.1, 2 and 4
also refers to Rule 9 of the UCPMP 2024, which
is reproduced hereunder for easy reference;
9. Ethics Committee for Pharma Marketing
Practices
9.1 All the Indian Pharmaceutical Associations
will upload the UCPMP on their website along
with the detailed procedure for lodging of
complaints which will be linked to the UCPMP
portal of the Department of Pharmaceuticals.
9.2 There will be a committee for handling
complaints named as "Ethics Committee for
Pharma Marketing Practices (ECPMP)" in each
Association, chaired by its Chief Executive
Officer. The Committee will have three to five
members, and its composition will be approved
by the Board of the Association and prominently
placed on its website.
9.3 If a complaint received in a particular
association is not concerned with its members,
the receiving association will input the abstract
of the complaint and will duly transfer the
complaint to such other association where the
Respondent company is a member of the other
association.
9.4 In case of companies, who are not members
of any Association, or member of more than one
Association, the complaint should ordinarily be
handled by the Pharma Industry Association to
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whom the complainant has addressed the
complaint; and where necessary, it will seek
guidance from the Department of
Pharmaceuticals.
9.5 All pharma associations will share on their
website the details of complaints received i.e.
the nature of complaint, the company against
whom the complaint has been made, the present
status of the complaint, including action taken
by the ECPMP, and such details should remain
uploaded for five years. Such details should also
be uploaded on the UCPMP portal of the
Department of Pharmaceuticals.


5.4. By relying on Rule 9, Learned Counsel for
Respondents No.1, 2 and 4 submits that it
relates to complaints received by the
Association and not the DOP, the ECPMP in
each Association, chaired by its Chief Executive
Officer, considers complaints received by that
Association .

5.5. Learned Counsel for Respondents No.1, 2 and 4
refers to Rule 10 of UCPMP 2024, which is
reproduced hereunder for easy reference:
10. Lodging of Complaints
10.1 All complaints, related to the breach of the
Code should be addressed to the "Ethics
Committee for Pharma Marketing Practices
(ECPMP)", "Chief Executive Officer". "Name of
Association".
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10.2 All complaints related to an activity of
breach of the Code should, to the extent
practicable, be made at one time. The complaint
must be made within six months of the alleged
breach of the Code, with a maximum of another
six months for reasonable delay can be
explained in writing. Related complaints may be
clubbed together by the Ethics Committee to
save time and expedite disposal.
10.3 Complaints must be in writing and for each
case The Complainant should:
i. identify himself (whether a company, entity or
an individual) with a full mailing address (email
and mobile telephone no).
ii. identify the company, which is alleged to have
breached the Code, including the name of any
company personnel, product, or products, which
are specifically involved.
iii. give the details of the activity which is alleged
to be in breach of the Code, give the date of the
alleged breach, clauses of the Code which are
alleged to have been breached, and provide
supporting evidence of the alleged breach(es).
10.4 A non-refundable amount of Rs.1,000/- is
to be deposited by the complainant along with
the complaint. The respective association will
elaborate on their website how the payment is to
be made. this. No pseudonymous or anonymous
complaints or those made without the prescribed
fee will be entertained.
10.5. When the complaint is from a
pharmaceutical company, the complaint must be
signed or authorized in writing by the company's
managing director or chief executive officer or a
person at an equivalent level.
10.6 When it appears from media reports (other
than letters to the editor of a publication) that a
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company may have breached the Code, the
matter may be treated as complaint, and the
committee may request the concerned
publication for further information, and the
source or the correspondent may be treated as
the complainant.
10.7 Any complaint received by the
Department of Pharmaceuticals may also be
forwarded to the concerned Association for
necessary action. In such cases, the
concerned Association will take up the
matter further with the complainant
concerned. The Department may order a
special audit for the purpose.


5.6. Relying on Rule 10, Learned Counsel for
Respondents No.1, 2 and 4 submits that this
Rule applies to complaints relating to breach of
the Code which are addressed to the Ethics
Committee and it is only with regard to those
complaints that the complainant is required to
be identified and to provide a full mailing
address, and Clause 10.4 expressly prohibits
the entertainment of pseudonymous or
anonymous complaints or complaints made
without the prescribed fee.

5.7. Learned Counsel for Respondent No.1, 2 and
4’s submission is that the procedure for lodging
of complaints under the UCPMP 2024 in terms
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of Rule 10 is for complaints lodged under the
UCPMP to the Ethics Committee and the same
cannot be extended to a complaint received by
the DOP under Clause 10.7.

5.8. Learned Counsel for Respondents No.1, 2 and 4
refers to the order dated 24.08.2024 passed by
the Section Officer (Policy) of the Department
of Pharmaceuticals, Ministry of Chemicals and
Fertilisers, Government of India, which clearly
mentions that the Department of
Pharmaceuticals vide OM dated 25.06.2024 had
referred a complaint to the OPPI against its
member, the Petitioner herein, as per para 10.7
of UCPMP 2024.

5.9. The OPPI had subsequently sought guidance on
the matter from the DOP, stating that the
complaint was anonymous. The DOP, vide its
letter dated 11.08.2024, invited the concerned
stakeholders, viz., the Ethics Committee of
OPPI and the Petitioner, to appear before the
Apex Committee under UCPMP 2024. On that
day, though the Director General of OPPI had
appeared with another member of the Ethics
Committee, the Managing Director of the
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Petitioner did not attend the meeting. The
Director General of OPPI had requested more
time to receive input from the Petitioner, and
the Apex Committee had also decided, in
accordance with para 10.7, to conduct a Special
Audit of the Petitioner, whose office is located
in Bangalore, and an Internal Audit Team of the
DOP was directed to conduct the Special Audit.

5.10. Learned Counsel for Respondent No.1, 2 and
4’s submission is that the aspect of anonymity
was considered by the DOP and the DOP,
having considered the seriousness of the issue,
had referred the matter to the Apex Committee
in terms of Clause 10.7, which has been
extracted above. Learned Counsel for
Respondents No.1, 2 and 4 submits that in
terms of Clause 10.7, any complaint received
by the DOP may also be forwarded to the
concerned Association for necessary action and
the Department may order a Special Audit for
the purpose.

5.11. Learned Counsel for Respondents No.1, 2 and 4
submits that apart from forwarding the
complaint to the concerned Association for
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necessary action, the DOP also ordered a
Special Audit on 02.09.2024 in terms of
Annexure-M, directing the Petitioner to furnish
the various documents indicated therein and
informed the Petitioner that an internal audit
team had been constituted by the DOP to
conduct the special audit of the Petitioner. The
audit team would be headed by Dr Ranjitha
from the Office of the Chief Controller of
Accounts, Department of Pharmaceuticals,
Ministry of Chemicals and Fertilisers. The
Petitioner was informed that some members of
the audit team would visit the Petitioner to
collect and verify the various documents as
stated therein.

5.12. Learned Counsel for Respondents No.1, 2 and 4
submits that the said letter of 02.09.2024 had
been received by the Petitioner, the Petitioner
had replied on 04.09.2024 stating that all the
necessary documents and information had been
supplied to the OPPI, the information sought in
the Special Audit Letter went beyond the initial
request received from the OPPI and the
allegations mentioned in the anonymous
complaint and on that basis it was contended
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that the Petitioner had indicated that it was
under no obligation to share the supporting
documents requested by the Special Audit
Team. Nevertheless, it furnished all the
requested documents and details. A clarification
was sought from DOP regarding the audit
process and its procedural aspects by
requesting a meeting with DOP.

5.13. Learned Counsel for Respondents No.1, 2 and 4
submits that thereafter various audit memos
have been issued viz., Audit Memos No.1, 2, 3,
4 and 5 on 05.09.2024. The said Audit Memos
No.1 to 5 were replied to by the Petitioner on
06.09.2024, placing its comments on record. By
way of letter dated 09.09.2024, the Senior
Accounts Officer had sought certain further
details from the Petitioner and also issued Audit
Memos No.6 and 7 on 09.09.2024. By way of
Audit Memo No.6, a specific query was raised to
provide the details of the deductions/rebates
claimed while calculating the applicable Income
Tax for the Financial Year 2022-23 to 2023-24,
and by way of Audit Memo No.7, a specific
query was raised regarding the list of medical
devices and drugs sold by the Petitioner,
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breakdown of sales expenses, categorization of
the medical devices, association of the
Petitioner with IMCAS 2024 and AMWC 2024,
the training imparted by the doctors who
attended IMCAS 2024 and AMWC 2024.

5.14. Learned Counsel for Respondent Nos. 1, 2 and
4 submits that the Petitioner replied to these
details and audit memos on 10.09.2024;
thereafter, a corrigendum to Audit Memo No. 7
and Audit Memo No. 8 was issued on
10.09.2024, which the Petitioner replied to on
12.09.2024. She submits that along with the
said reply, various documents and emails were
enclosed with the reply.

5.15. Learned Counsel for Respondents No.1, 2 and 4
draws a distinction between the order of the
Ethics Committee and the Special Audit Report.
Though these aspects were going on in parallel,
the Special Audit was being conducted by the
audit team appointed by the DOP. The Ethics
Committee was hearing the matter in respect of
the complaint, in furtherance of which the
Ethics Committee passed its order on
20.09.2024. The Special Audit Committee also
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submitted a separate report on 20.09.2024 to
the Secretary, DOP.

5.16. By referring to the Special Audit Report,
Learned Counsel for Respondents No.1, 2 and 4
submits that the main objective of the Special
Audit was to fact-check and scrutinize the
veracity of the allegations made against the
Petitioner in the complaint received by the DO
and referred to the OPPI under para 10.7 of the
UCPMP 2024.

5.17. Learned Counsel for Respondents No.1, 2 and 4
submits that the report considered the
contravention of the Guidelines of the UCPMP
by sending 30 doctors to luxury destinations
like Paris and Monaco in early 2024 by Business
Class, involving stays in 5-star hotels, even
though they were not speakers at the
conferences. The Petitioner claimed these
expenses as marketing costs, and the doctors
received untaxed benefits, which were passed
on to the patients who face higher treatment
costs.

5.18. Learned Counsel for Respondents No.1, 2 and 4
submitted that the audit report is a detailed
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report of nearly 20 pages by virtue of which all
the data was fact-checked, and the final the
report concluded that the Petitioner had
included the expenditure on Continuing Medical
Education (CME)/Continuing Professional
Development (CPD) for income-tax purposes
for FY 2022-23, and that no HCP had served as
a speaker at IMCAS Paris 2024 or AMWC
Monaco 2024 . Learned Counsel for Respondents
No.1, 2 and 4 therefore submits that there
being a violation of the UCPMP and the IMC
regulations, action was required to be taken.

5.19. This Special Audit Report had been forwarded
to the Petitioner, who responded to it on
12.10.2024. In the reply, it was again
reiterated by the Petitioner that an anonymous
complaint could not be looked into by the DOP.
The UCPMP 2024 was not applicable to IMCAS
Paris, which was held from 01.02.2024 to
03.02.2024, before UCPMP 2024 was notified
on 12.03.2024. AMWC, Monaco was held from
26.03.2024 to 29.03.2024, shortly after the
notification. Hence, the Petitioner had
contended that there ought to be a transitional
grace period up to 30.06.2024 since all the
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bookings, etc. had been made prior to UCPMP
2024 coming into force. It was denied that
there was any contravention of the UCPMP
2014, etc.

5.20. In furtherance of the said reply, the Apex
Committee convened a meeting on 21.10.2024,
at which representatives of the Petitioner, the
Director General of OPPI and officials of the
Department of Pharmaceuticals were present.
Upon examination of the documents and the
submissions made, the Committee issued its
order dated 07.11.2024 . Upon examining the
documents, the Apex Committee formed the
opinion that there were apparent breaches of
para 7.1 and 7.2 of UCPMP 2014, para 6.2.1,
8.2 and 8.3 of UCPMP 2024 and para 6.8.1 (b)
and (c) of the IMC Regulations, 2002 and
directed the Petitioner to offer comprehensive
assistance to underprivileged patients who were
receiving treatment at Central Army Hospitals
(including life-saving medications or surgeries)
for an amount equivalent to the violations
confirmed by the Special Audit Team within 12
months from the date of the order.
Digitally Signed By:
SURAJ GOVINDA RAJ
05/11/2026, 17:30, Bengaluru
Verified

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5.21. Learned Counsel for Respondents No.1, 2 and 4
submits that the Petitioner responded to the
said order on 10.12.2024, denying any violation
and rejecting the proposed remedial action. Her
submission, therefore, is that it is not only the
order of the Ethics Committee; the order of the
Apex Committee is also relevant .

5.22. Insofar as the Apex Committee is concerned,
Learned Counsel for Respondents No.1, 2 and 4
submits that in terms of Clause 10.7 of UCPMP
2024, any complaint received by the DOP could
be forwarded to the concerned association for
necessary action and in such cases, the
concerned association would take up the matter
further with the complainant concerned.
However, Learned Counsel for Respondents
No.1, 2 and 4 submits that Clause 10.7 also
provides for the department to order a Special
Audit for the purpose, which is what was
ordered and on the basis of the report of the
Special Audit Committee, the matter was taken
up by the Apex Committee. Learned Counsel for
Respondents No.1, 2 and 4 refers to Section
206 of the Companies Act 2013, which is
reproduced hereunder for easy reference:
Digitally Signed By:
SURAJ GOVINDA RAJ
05/11/2026, 17:30, Bengaluru
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206. Power to call for information,
inspect books and conduct inquiries.—
(1) Where on a scrutiny of any document
filed by a company or on any information
received by him, the Registrar is of the
opinion that any further information or
explanation or any further documents
relating to the company is necessary, he
may by a written notice require the
company—
(a) to furnish in writing such information or
explanation; or
(b) to produce such documents, within such
reasonable time, as may be specified in the
notice.
(2) On the receipt of a notice under sub-
section (1), it shall be the duty of the
company and of its officers concerned to
furnish such information or explanation to
the best of their knowledge and power and
to produce the documents to the Registrar
within the time specified or extended by
the Registrar:
Provided that where such information or
explanation relates to any past period, the
officers who had been in the employment
of the company for such period, if so called
upon by the Registrar through a notice
served on them in writing, shall also
furnish such information or explanation to
the best of their knowledge.
(3) If no information or explanation is
furnished to the Registrar within the time
specified under subsection (1) or if the
Registrar on an examination of the
documents furnished is of the opinion that
the information or explanation furnished is
inadequate or if the Registrar is satisfied
Digitally Signed By:
SURAJ GOVINDA RAJ
05/11/2026, 17:30, Bengaluru
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on a scrutiny of the documents furnished
that an unsatisfactory state of affairs exists
in the company and does not disclose a full
and fair statement of the information
required, he may, by another written
notice, call on the company to produce for
his inspection such further books of
account, books, papers and explanations
as he may require at such place and at
such time as he may specify in the notice:
Provided that before any notice is served
under this sub-section, the Registrar shall
record his reasons in writing for issuing
such notice.
(4) If the Registrar is satisfied on the basis
of information available with or furnished
to him or on a representation made to him
by any person that the business of a
company is being carried on for a
fraudulent or unlawful purpose or not in
compliance with the provisions of this Act
or if the grievances of investors are not
being addressed, the Registrar may, after
informing the company of the allegations
made against it by a written order, call on
the company to furnish in writing any
information or explanation on matters
specified in the order within such time as
he may specify therein and carry out such
inquiry as he deems fit after providing the
company a reasonable opportunity of being
heard:
Provided that the Central Government
may, if it is satisfied that the circumstances
so warrant, direct the Registrar or an
inspector appointed by it for the purpose to
carry out the inquiry under this sub-
section:
Digitally Signed By:
SURAJ GOVINDA RAJ
05/11/2026, 17:30, Bengaluru
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Provided further that where business of a
company has been or is being carried on
for a fraudulent or unlawful purpose, every
officer of the company who is in default
shall be punishable for fraud in the manner
as provided in section 447.
(5) Without prejudice to the foregoing
provisions of this section, the Central
Government may, if it is satisfied that the
circumstances so warrant, direct inspection
of books and papers of a company by an
inspector appointed by it for the purpose.
(6) The Central Government may, having
regard to the circumstances by general or
special order, authorise any statutory
authority to carry out the inspection of
books of account of a company or class of
companies.
(7) If a company fails to furnish any
information or explanation or produce any
document required under this section, the
company and every officer of the company,
who is in default shall be punishable with a
fine which may extend to one lakh rupees
and in the case of a continuing failure, with
an additional fine which may extend to five
hundred rupees for every day after the first
during which the failure continues


5.23. Learned Counsel for Respondents No.1, 2 and 4
submits that independent of those proceedings
before the Ethics Committee or OPPI and/or the
Apex Committee, the Registrar has the power
under Section 206 to call for information,
Digitally Signed By:
SURAJ GOVINDA RAJ
05/11/2026, 17:30, Bengaluru
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inspect books and conduct enquiries by way of
a written notice.

5.24. Learned Counsel for Respondent No.1, 2 and
4’s submission is that, irrespective of the Ethics
Committee reprimanding the Petitioner and the
Apex Committee imposing a penalty of the like
amount as spent on the HCPs, the conduct of
the business and the affairs of the company
require a further enquiry by the ROC since
there are other issues relating to the operation
of the company which the ROC can look into
and in that background, she submits that the
notice issued by the ROC on 12.05.2026 at
Annexure-JJ is proper and correct. What is only
sought for are the balance sheets, financial
reports, audit reports, minutes of the meetings,
etc., which could easily be provided by the
Petitioner. There is no need for the Petitioner to
refrain from or object to such providing of the
documents. If the Petitioner had nothing to
hide, then the documents, if in favour of the
Petitioner, would enure to the benefit of the
Petitioner.
Digitally Signed By:
SURAJ GOVINDA RAJ
05/11/2026, 17:30, Bengaluru
Verified

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5.25. Learned Counsel for Respondents No.1, 2 and 4
submits that the due procedure in respect of
the said enquiry under Chapter XIV of the
Companies Act 2013 would be followed and
complied with.

5.26. Her submission is that no doctor can avail of
free travel and accommodation under the
Indian Medical Council (Professional Conduct,
Etiquette and Ethics) Regulation 2002 and in
this regard, Learned Counsel for Respondents
No.1, 2 and 4 relies on Regulation 6.8, which is
reproduced hereunder for easy reference:
6.8 Code of conduct for doctors in their
relationship with pharmaceutical and allied
health sector industry"
The Section 6.8.1(b) shall be substituted in
terms of Notification published on 01.02.2016 in
Gazette of India, as under:-
(b) Travel Facilities A medical practitioner shall
not accept any travel Facility inside the country
or outside, including rail, road, air, ship, cruise
tickets, paid vacation, etc. from any
pharmaceutical or allied healthcare industry or
their representatives for self and family
members for vacation or for attending
conferences, seminars, workshops, CME
Programme. etc. as a delegate.
(iii) Action to be taken by the Council for
violation of Section 6.8, as amended vide
notification dated 10/12/2009, shall be
Digitally Signed By:
SURAJ GOVINDA RAJ
05/11/2026, 17:30, Bengaluru
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prescribed by further amending the Section
6.8.1 as under:-

SECTION ACTION
6.8.1 In dealing with
Pharmaceutical and allied
health sector industry, a
medical practitioner shall follow
and adhere to the stipulations
given below:-


Gifts more than Rs. 1,000/-
upto Rs 5,000/-
a) Gifts. A medical practitioner
shall not receive any gift from
any pharmaceutical or allied
health care industry and their
sales people or representatives
Censure


Gifts more than Rs. 5,000/-
upto Rs 10.000/ Removal
from Indian Medical Register
or State Medical Register for 3
(three) months
Gifts more than Rs 10.000 Rs
50.000 Removal from Indian
Medical Register State Medical
Register for six months
Gifts more than Rs 50,000/-
Rs 1,00,000/ Removal from
Indian Medical Register of
State Medical Register for
(one) year
Gifts more than Rs 100,000/-
Removal for a period of more
than (one) year from Indian
Medical Register or State
Medical Register
b) Travel facilities A medical
practitioner shall not accept
any travel facility inside the
country or outside, including
rail. road, air, ship, cruise
Expenses for travel facilities
more than Fis 1.000/ upto Rs
5.000/- Censure
Expenses for travel facilities
Digitally Signed By:
SURAJ GOVINDA RAJ
05/11/2026, 17:30, Bengaluru
Verified