M/S Super Cardio Devices Pvt. Ltd. And Ors. vs State Of Haryana

CRM-M-11321-2015 (O&M) -1-


IN THE HIGH COURT FOR THE STATES OF PUNJAB AND
HARYANA AT CHANDIGARH


132

CRM-M-11321-2015 (O&M)
Date of decision : 14.09.2026

M/s Super Cardio Devices Private Limited and others ...Petitioners

Versus


State of Haryana ...Respondent
CORAM: HON'BLE MRS. JUSTICE MANISHA BATRA

Present:- Mr. Sushant Mahapatra, Advocate and
Mr. Sanjeev Kumar, Advocate
for the petitioners.

Mr. Ashok Kumar Khubbar, Addl. A.G., Haryana.

MANISHA BATRA, J. (Oral)

1. The present petition has been filed under Section 482 Cr.P.C.
(which corresponds to Section 528 of BNSS, 2023) seeking quashing of
complaint dated 16.07.2013 titled Haryana State through Drugs Control
Officer, Jhajjar v. M/s Super Cardio Devices Pvt. Ltd. and others , registered
as Complaint No.1231, filed under Sections 18(c) read with Sections 27(b)(ii),
28B, 28A and 27(d) of the Drugs and Cosmetics Act, 1940 (for short ‘the Act,
1940) and Rules 74 and 78 read with Schedules J, L-I and M of the Drugs and
Cosmetics Rules, 1945, pending before the Court of learned Chief Judicial
Magistrate, Jhajjar, along with the consequential proceedings, including the
summoning order dated 16.07.2013 and order dated 29.10.2014 passed by the
learned Sessions Judge, Jhajjar, whereby the revision petition preferred against
the summoning order was dismissed.
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2. The facts, as borne out from the complaint, are that petitioner
No.1-M/s Super Cardio Devices Pvt. Ltd. is a company having its premises at
105, MIE Part-A, Bahadurgarh, District Jhajjar, Haryana. Petitioner No.2 was
stated to be its Director-cum-Manufacturing Chemist and petitioner No.3 as its
Director. The complainant, i.e. the Drugs Control Officer, Jhajjar, received
information regarding manufacturing of Heart Lung Pack by petitioner No.1
without a valid drug manufacturing licence. An inspection of the premises was
carried out on 28.10.2010, where manufacturing activity relating to Heart Lung
Pack was found to be going on. The complainant took samples of the product
and completed the requisite proceedings under the Act and Rules. The State
subsequently treated the product as a drug and alleged that the petitioners were
manufacturing the same without the requisite manufacturing licence. As per the
further allegations, on a subsequent inspection conducted on 18.04.2012, three
pieces of Heart Lung Pack were taken as samples from the finished goods store
and the requisite forms were prepared. The complainant thereafter sought
permission from the State Drugs Controller, Haryana, for launching prosecution
against the petitioner, which was so granted. The complaint was accordingly
filed before the Court of learned Chief Judicial Magistrate, Jhajjar, who vide
order dated 16.07.2013 summoned the petitioners for the offences alleged in the
complaint. Aggrieved from the same, petitioner No. 2 filed a revision petition
against the impugned summoning order but the same was dismissed by the
Court of learned Sessions Judge, Jhajjar, vide order dated 29.10.2014. Hence,
the present petition.
3. It is argued by learned counsel for the petitioners that the
impugned complaint as well as the summoning order are not sustainable in the
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eyes of law. It is submitted that the entire prosecution is based on the
assumption that Heart Lung Pack is a “drug” within the meaning of Section
3(b)(iv) of the Act, 1940, whereas the statutory requirement for bringing a
medical device within the definition of drug has not been satisfied in the present
case. It is further argued that Section 3(b)(iv) requires the Central Government
to specify the concerned device by notification in the Official Gazette, after
consultation with the Drugs Technical Advisory Board. This requirement
assumes importance because the Heart Lung Pack was never specifically
notified as a drug in the Official Gazette. Learned counsel referred to the
notification dated 06.10.2005 issued by the Central Government under Section
3(b)(iv) to contend that the said notification specified ten categories of medical
devices, including “Catheters”, but did not mention Heart Lung Pack. The
relevant notification placed on record specifically mentions Cardiac Stents,
Drug Eluting Stents, Catheters, Intra Ocular Lenses, IV Cannulae, Bone
Cements, Heart Valves, Scalp Vein Sets, Orthopaedic Implants and Internal
Prosthetic Replacements. He further argued that Heart Lung Pack cannot
simply be treated as a “catheter” merely because the word “Catheters” finds
mention in the 2005 notification. He referred to the material placed on record
explaining that the Heart Lung Pack is a customised tubing pack/extracorporeal
circuit which carries solutions during cardiac surgery and is not inserted into
the body. The cannulae and catheters which are inserted into the body are
distinct from the Heart Lung Pack.
4. While referring to the clarification dated 20.03.2009, on which the
prosecution principally relies, learned counsel for the petitioners has argued that
although Heart Lung Pack was mentioned at serial No.15 in the said
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clarification, yet, the clarification itself had no statutory force as it was not an
Official Gazette notification under Section 3(b)(iv). The document merely
listed 19 medical devices stated to be covered under the Drugs and Cosmetics
Act and Rules. More importantly, learned counsel argued that the said
clarification was immediately followed by the CDSCO circular dated
05.05.2009. The circular specifically stated that the matter had been referred to
the Ministry of Health for concurrence and approval and that the final decision
would be taken after such approval. In the meantime, the circular directed that
the practices prevailing prior to 20.03.2009 should continue until further orders
of the Ministry. It is, thus, argued that the clarification dated 20.03.2009 could
not be treated as a final or operative notification bringing Heart Lung Pack
within the definition of “drug”. Moreso, out of the 19 medical devices referred
to in the clarification dated 20.03.2009, 11 articles were subsequently
categorised under already notified medical devices, whereas Heart Lung Pack
was one of the eight devices which were left out. The subsequent letter dated
07.09.2012 issued by the Central Drugs Standard Control Organisation cannot
cure this defect. He pointed out that the said letter merely stated that Heart
Lung Packs are covered under the categories of “Catheter/Disposable Perfusion
Set” and that those categories were notified under Section 3(b)(iv). However,
the said letter was only an administrative communication and could not take the
place of a statutory notification in the Official Gazette.
5. Learned counsel for the petitioners, while referring to the
proceedings before the Expert Committee and the communication dated
20.05.2015 issued by the Director General of Health Services, has further
argued that the Expert Committee had opined that “Heart Lung Pack is not a
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drug but it is a medical device”. It is submitted that subsequent material is
relevant because it shows that even the Central authorities did not regard the
classification of Heart Lung Pack as an obvious or settled matter. The first
alleged offence relates to the inspection dated 28.10.2010. Therefore, the legal
position existing on that date would be relevant. A subsequent communication
issued in 2012 could not retrospectively make the manufacture of the product in
2010 an offence. The application made by the petitioners for a drug
manufacturing licence cannot be treated as an admission that Heart Lung Pack
was a drug. The application was made in the backdrop of the regulatory
uncertainty and in an attempt to comply with the directions of the authorities.
6. It is further argued that the learned Chief Judicial Magistrate had
passed the summoning order mechanically without considering the basic
question whether Heart Lung Pack was legally a drug at all. The learned
Sessions Judge also failed to consider the effect of the documents showing that
the product had not been notified as a drug. While submitting that the basic
ingredient of the alleged offences, i.e. manufacturing of a “drug” without a
licence, was absent and continuation of the criminal proceedings would amount
to abuse of the process of law, it is urged that the petition deserves to be
allowed and the impugned complaint and summoning order along with all the
subsequent proceedings having emanated therefrom are liable to be quashed.
7. Per contra , learned State counsel has opposed the petition and
argued that the prosecution has rightly been launched against the petitioners. He
argued that the Gazette Notification dated 06.10.2005 specifically notified
“Catheters” as drugs under Section 3(b)(iv) of the Act, 1940. The said article
falls within the category of catheter/disposable perfusion set and, therefore,
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CRM-M-11321-2015 (O&M) -6-

falls within the notified category. Learned State counsel further relied upon the
clarification dated 20.03.2009 issued by the office of the DCGI, wherein Heart
Lung Pack was specifically mentioned at serial No.15 amongst the medical
devices covered under the Drugs and Cosmetics Act and Rules. He has also
referred to communication dated 07.09.2012 issued by the Central Drugs
Standard Control Organisation. Learned State counsel argued that the said
communication specifically records that Heart Lung Packs are covered under
the categories of Catheter/Disposable Perfusion Set, which are notified under
Section 3(b)(iv), and therefore the State authorities were justified in taking
action against the petitioners. It is further argued that the petitioners were found
manufacturing the product without a valid drug manufacturing licence. Samples
were taken during inspection and requisite proceedings were conducted under
the Act and Rules. The petitioners themselves subsequently applied for a drug
manufacturing licence, which also shows that they were aware of the regulatory
requirement. The question whether the particular Heart Lung Pack is a catheter
or a disposable perfusion set is a matter requiring evidence and technical
examination. Such a question, according to learned counsel, cannot be finally
decided by this Court in exercise of its inherent jurisdiction under Section 482
Cr.P.C. Hence, it is urged that the petition is liable to be dismissed.
8. This Court has heard the rival submissions of learned counsel for
the parties, besides going through the material placed on record.
9. The principal question which arises for consideration is whether,
on the date of the alleged manufacture, i.e. 28.10.2010, the Heart Lung Pack
manufactured by the petitioners could legally be treated as a “drug” within the
meaning of Section 3(b)(iv) of the Act, 1940, so as to attract the requirement of
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a manufacturing licence and the penal provisions of the Act, 1940? Section
3(b)(iv) of the Act brings within the definition of “drug” such devices intended
for internal or external use in the diagnosis, treatment, mitigation or prevention
of disease or disorder in human beings or animals as may be specified by the
Central Government by notification in the Official Gazette, after consultation
with the Board. Thus, in case of a medical device, mere use of the device for a
medical purpose does not, by itself, make it a “drug” within the meaning of the
Act. The statutory requirement of specification by the Central Government
through notification in the Official Gazette assumes significance before the
penal provisions of the Act can be invoked.
10. In the present case, the prosecution relies upon the notification
dated 06.10.2005 issued by the Central Government. A perusal of the said
notification shows that various medical devices were specified therein,
including “Catheters”. However, Heart Lung Pack is not specifically mentioned
in the said notification. The case of the petitioners, as emerging from the
material on record, is also that Heart Lung Pack is an extracorporeal
circuit/customized tubing pack which is used for carrying solutions during
surgery and is not itself inserted into the body, whereas a catheter is a distinct
device which is inserted into the body. The petitioners have accordingly sought
to distinguish Heart Lung Pack from the category of “Catheters”.
11. This distinction assumes importance because the prosecution
cannot proceed merely on the basis that Heart Lung Pack is a medical device.
What has to be shown is that the particular device was covered by the statutory
notification so as to fall within Section 3(b)(iv) of the Act, 1940 at the relevant
time. The requirement of a notification in the Official Gazette is, therefore, not
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a mere procedural formality, but is the statutory basis for bringing a particular
device within the definition of “drug”. Reference in this regard can be made to
Biogenetic Drugs (P) Ltd. v. State of Himachal Pradesh and others,
2025:HHC:20463 , wherein the Himachal High Court held that Section 3(b)(iv)
specifically requires a device to be specified by the Central Government by
notification in the Official Gazette. The Court further observed that regulatory
requirements could not be created merely through an administrative order or
office instruction in the absence of statutory authority. The respondents,
however, rely upon the clarification dated 20.03.2009 issued by the CDSCO,
wherein Heart Lung Pack finds mention at serial No.15 amongst the nineteen
sterile medical devices. The said document may certainly indicate the stand
taken by the department regarding the regulatory treatment of such devices.
However, the said clarification is admittedly not a notification issued in the
Official Gazette by the Central Government under Section 3(b)(iv) of the Act,
1940. The distinction between a statutory notification and an administrative
clarification cannot be lost sight of when the consequence sought to be imposed
is criminal in nature.
12. The aforesaid position becomes still more significant in view of
the subsequent circular dated 05.05.2009 issued by the CDSCO. The said
circular itself records that the clarification dated 20.03.2009 had been referred
to the Ministry of Health and Family Welfare for concurrence/approval and
that, till further orders, the prevailing practice before 20.03.2009 was to
continue. Thus, the material placed before the Court does not disclose a clear
and unequivocal statutory position regarding the inclusion of Heart Lung Pack
under the Act during the relevant period. The principle laid down in Kirti
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Kumar Jayantilal Patel and others v. State of Maharashtra,
MANU/MH/1218/2023 is relevant in this regard. In that case also, the Bombay
High Court was dealing with prosecution under the Drugs and Cosmetics Act
and held that a manufacturer could not be faulted for not complying with a
standard which had not been prescribed at the time when the drug was
manufactured. The Court ultimately quashed the criminal proceedings, holding
that the action initiated against the manufacturer was not in accordance with
law.
13. Coming to the letter dated 07.09.2012 relied upon by the
respondents, the said communication states that Heart Lung Packs are covered
under the categories of “Catheter/Disposable Perfusion Set”. The difficulty,
however, is that the said communication was issued much after the alleged
manufacture dated 28.10.2010. It is also an administrative communication and
not a notification in the Official Gazette issued under Section 3(b)(iv).
Consequently, the said letter may reflect the department's subsequent
understanding of the product, but it cannot by itself retrospectively create the
statutory foundation for criminal liability for an act allegedly committed in the
year 2010. The subsequent material placed on record also does not resolve the
issue in favour of the prosecution with the degree of certainty required in a
criminal case. In fact, the later consideration of the issue by the Expert
Committee and the departmental communications show that the precise
classification of Heart Lung Pack itself remained a matter requiring
examination. The material on record records the opinion that Heart Lung Pack
is a medical device, while the question of its classification under the notified
categories was still required to be considered by the competent authority. Thus,
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the subsequent material rather demonstrates that the precise statutory
classification of the product was not an entirely settled matter. It is, therefore,
necessary to keep in view the distinction between a medical device being
capable of being regulated and that device being brought within the definition
of “drug” under Section 3(b)(iv). The former, by itself, is not sufficient for
imposing criminal liability. In the present case, the prosecution has to
demonstrate that Heart Lung Pack was covered by a valid statutory notification
at the relevant point of time. The mere reference to Heart Lung Pack in a
subsequent departmental clarification or administrative communication cannot
substitute the requirement prescribed by the statute. The principle of strict
construction of penal provisions also assumes relevance. In Tolaram Relumal
v. State of Bombay, AIR 1954 SC 496 , the Hon'ble Supreme Court reiterated
that where a penal provision is capable of more than one reasonable
interpretation, a construction exposing a person to penal consequences cannot
be adopted unless the statutory requirement is clearly satisfied.
14. In the present case, therefore, the issue is not whether the
petitioners possessed a manufacturing facility, whether the product was used in
medical procedures, or whether the department subsequently considered such
product to be covered under the regulatory regime. Rather, the foundational
issue is whether the product manufactured by the petitioners on 28.10.2010
was, in law, a “drug” within Section 3(b)(iv) on that date. The 06.10.2005
notification does not specifically mention Heart Lung Pack; the clarification
dated 20.03.2009 is not an Official Gazette notification; the circular dated
05.05.2009 itself indicates that the matter was awaiting further consideration;
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and the letter dated 07.09.2012 is subsequent to the alleged offence and is only
an administrative communication.
15. It is true that the respondents seek to place Heart Lung Pack within
the notified categories of “Catheters” or “Disposable Perfusion Sets”. However,
whether the product actually falls within any such notified category cannot be
assumed merely from the nomenclature used in a subsequent departmental
letter, particularly when the petitioners have specifically asserted that Heart
Lung Pack is a distinct extracorporeal tubing system and the material on record
itself reflects that its precise classification was subsequently examined by the
authorities. No clear statutory notification which brought the particular product
within Section 3(b)(iv) on the relevant date has been produced before this
Court. The ratio of law laid down in Kirti Kumar Jayantilal Patel’s case
(supra) also assumes significance at this stage. The Court therein recognised
that criminal prosecution under the Drugs and Cosmetics Act cannot be
sustained on the basis of a requirement which was not legally applicable to the
manufacturer at the time of manufacture. The same principle applies here in the
limited sense that a subsequent administrative understanding cannot be used to
retrospectively fasten criminal liability upon the petitioners for manufacture
undertaken at a time when the statutory coverage of the product itself was not
clearly established.
16. It is also relevant that the entire prosecution in the present case
proceeds on the basic premise that Heart Lung Pack was a “drug” requiring a
licence for its manufacture. The allegation regarding manufacture without
licence and the consequential allegations under the provisions of the Drugs and
Cosmetics Act are dependent upon that foundational premise. If the product
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itself is not shown to have been brought within the definition of “drug” under
Section 3(b)(iv) in accordance with the statutory requirement, the very basis for
invoking the penal provisions of the Act against the petitioners becomes
unsustainable.
17. This Court is conscious that at the stage of considering a petition
under Section 482 Cr.P.C., it is ordinarily not required to undertake an
appreciation of evidence or conduct a mini-trial. However, the present case
does not require such an exercise. The issue arising for consideration is
essentially one concerning the legal applicability of the statutory regime to the
product in question and the documents relied upon by both sides are themselves
part of the record. Where the foundational requirement for attracting the penal
provision is absent or legally doubtful on the admitted material, continuation of
the criminal proceedings would serve no useful purpose.
18. Consequently, without expressing any opinion on the general
regulatory status of Heart Lung Pack as a medical device, this Court finds that
the prosecution has failed to establish the necessary statutory foundation for
treating the product manufactured by the petitioners on the relevant date as a
“drug” under Section 3(b)(iv) of the Act, 1940. The subsequent administrative
communications, including the letter dated 07.09.2012, cannot retrospectively
supply the requirement of a statutory notification so as to sustain criminal
liability for the alleged manufacture in the year 2010. In these circumstances,
permitting the criminal proceedings to continue against the petitioners would
amount to permitting a prosecution without the foundational ingredient
necessary to attract the penal provisions of the Act, 1940. The continuation of
such proceedings would, therefore, amount to an abuse of the process of law
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and calls for interference by this Court in exercise of its inherent jurisdiction
under Section 482 Cr.P.C.
19. Accordingly, the present petition is allowed and impugned
Complaint No.1231 dated 16.07.2013, the summoning order dated 16.07.2013
passed by the learned trial Court and the order dated 29.10.2014 passed by the
learned Additional Sessions Judge, Jhajjar, are hereby quashed, along with all
consequential proceedings arising therefrom.



14.09.2026 (MANISHA BATRA)
Waseem R. Ansari Waseem R. Ansari Waseem R. Ansari Waseem R. Ansari
JUDGE




Whether speaking/reasoned Yes/No


Whether reportable Yes/No

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