INOX AIR PRODUCTS LIMITED NOW KNOWN AS INOX AIR PRODUCTS PRIVATE LIMITED AND ANOTHERversusTHE STATE OF ANDHRA PRADESH
- Citation
- 2025 INSC 128
- Decided
- 30 January 2025
- Disposal
- Appeal(s) allowed
Holding
A sale of Nitrous Oxide I.P. between two entities each holding a Form 25 licence does not violate s.18(a)(vi) of the Drugs and Cosmetics Act, and therefore no offence under s.27(d) is made out.
Summary
The State of Andhra Pradesh alleged that INOX Air Products Ltd. (now INOX Air Products Private Ltd.) sold Nitrous Oxide I.P. to a third‑party firm that allegedly lacked a Form 20B licence, thereby violating s.18(a)(vi) of the Drugs and Cosmetics Act, 1940 and attracting punishment under s.27(d). The High Court dismissed the appellants' petition to quash the criminal proceedings, but the Supreme Court examined whether the sale constituted an offence given that both parties held licences under Form 25, which authorise manufacture and wholesale dealing. The Court held that the term “manufacture” under s.3(f) is broad and includes breaking up and repackaging, and that a Form 25 licence is not subordinate to Form 20B for the purpose of the alleged contravention. Consequently, no offence was made out and the High Court’s order, as well as the magistrate’s summoning order, were set aside. The appeal was allowed, quashing the criminal proceedings against the appellants.
Issues considered
- Whether the sale of Nitrous Oxide I.P. by the appellant to a firm holding only a Form 25 licence, and not a Form 20B licence, contravenes s.18(a)(vi) read with r.65(5)(1)(b) of the Drugs and Cosmetics Rules and is punishable under s.27(d) of the Drugs and Cosmetics Act.
- Whether a licence under Form 25 is subject to the conditions of Form 20B such that the absence of a Form 20B licence by the purchaser renders the sale illegal.
- Whether the magistrate’s order issuing process against the accused was valid in the absence of recorded reasons and an application of mind.
Legislation cited
- Code of Criminal Procedure, 1973s. 204, s. 482
- Drugs and Cosmetics Act, 1940s. 18(a)(vi), s. 18(c), s. 27(d), s. 3(f)
- Drugs and Cosmetics Rules, 1945s. 65(5)(1)(b), s. 70
Headnote
Issue for Consideration Whether selling of Nitrous Oxide I.P. by the appellant no. 1 company to the unlicensed accused No.3 firm which does not possess license under Form 20B of the Drugs and Cosmetics Act, 1940, was in contravention r.65(5)(1)(b) of the Rules, punishable u/s.27(d) of the said Act. Headnotes† Drugs and Cosmetics Act, 1940 – ss.3(f), 18(a)(vi), 27(d) – Drugs and Cosmetics Rules, 1945 – rr.65(5)(1)(b), 70, Form 20B, 25, 26 – Manufacture and sale of drugs – Condition of
Subjects
Judgment
[2025] 1 S.C.R. 1235 : 2025 INSC 128
INOX Air Products Limited now known as INOX
Air Products Private Limited and Another
v.
The State of Andhra Pradesh
(Criminal Appeal no. 486 of 2025)
30 January 2025
[B.R. Gavai* and Augustine George Masih, JJ.]
Issue for Consideration
Whether selling of Nitrous Oxide I.P. by the appellant no. 1 company
to the unlicensed accused No.3 firm which does not possess
license under Form 20B of the Drugs and Cosmetics Act, 1940,
was in contravention of s.18(a)(vi) read with r.65(5)(1)(b) of the
Rules, punishable u/s.27(d) of the said Act.
Headnotes†
Drugs and Cosmetics Act, 1940 – ss.3(f), 18(a)(vi), 27(d) –
Drugs and Cosmetics Rules, 1945 – rr.65(5)(1)(b), 70, Form
20B, 25, 26 – Manufacture and sale of drugs – Condition of
licences – Meaning of term “manufacture” – Appellant no. 1,
company engaged in the manufacture and sale of industrial
and medical gases in India – Complaint lodged by Drugs
Inspector that appellant no. 1 sold Nitrous Oxide I.P. to the
accused No.3 firm which did not have license for sale and
was in contravention of s.18(a)(vi) read with r.65(5)(1)(b) of
the Rules, punishable u/s.27(d) of the said Act – Trial court
took the complaint on its file and issued summons to accused
persons including the appellants – Appellants filed petition
before the High Court praying for calling of the records on
the file of the trial court and to quash the same against the
appellants – High Court dismissed the petition – Correctness:
Held: Both appellant no.1 and accused no.3 possessed licence
under Form 25 – Submission that the licence under Form 25 is
subject to Form 20B and since accused no.3 did not have licence
under Form 20B, sale to accused no.3 was in contravention of
s.18(a)(vi) is totally fallacious in nature – ‘Manufacture’ includes
any process or part of a process for making, altering, ornamenting,
* Author
1236 [2025] 1 S.C.R.
Supreme Court Reports
finishing, packing, labelling, breaking up or otherwise treating or
adopting any drug or cosmetic with a view to its sale or distribution –
Accused no.3, holding licence under Form 25, entitled to sell and
distribute the product received from appellant no.1 after altering,
breaking it up and packing it in smaller containers – Even if the
allegations made in the complaint are taken at its face value, no
case made out for offence punishable u/s. 18(a)(vi) rw s.27(d) –
Furthermore, in the order passed by the Magistrate while issuing
the process, except recording the submissions of the complainant,
no reasons recorded for issuing the process against accused
persons – Order of the Magistrate summoning the accused must
reflect that he has applied his mind to the facts of the case and
the law applicable thereto – No application of mind even for the
namesake by Magistrate while issuing process – Also, the High
Court totally misdirected itself – Interpretation by High Court
that since accused no.3 was given licence to manufacture, he
was not authorized to purchase it from appellant no.1, is without
considering the plain nature of s.3(f) and is totally unsustainable
in law – Impugned judgment quashed and set aside – Summoning
order also quashed and set aside – Code of Criminal Procedure,
1973 – s.482. [Paras 21-33, 35, 38-41]
Case Law Cited
Lalankumar Singh and Others v. State of Maharashtra, 2022
INSC 1059 : [2022] 14 SCR 573 : 2022 SCC OnLine SC 1383;
Pepsi Foods Ltd. and Another v. Special Judicial Magistrate and
Others, 1997 INSC 714 : [1997] Supp. 5 SCR 12 : (1998) 5
SCC 749; Sunil Bharti Mittal v. Central Bureau of Investigation,
2015 INSC 18 : [2015] 1 SCR 377 : (2015) 4 SCC 609; Mehmood Ul
Rehman v. Khazir Mohammad Tunda and Others, 2015 INSC 983 :
[2015] 4 SCR 841 : (2015) 12 SCC 420; Krishna Lal Chawla and
Others v. State of Uttar Pradesh and Another, 2021 INSC 160 :
[2021] 2 SCR 550 : (2021) 5 SCC 435 – referred to.
Books and Periodicals Cited
Black Law’s Dictionary, 5th Edition – referred to.
List of Acts
Drugs and Cosmetics Act, 1940; Drugs and Cosmetics Rules,
1945; Code of Criminal Procedure, 1973.
[2025] 1 S.C.R. 1237
INOX Air Products Limited now known as INOX Air Products Private
Limited and Another v. The State of Andhra Pradesh
List of Keywords
Nitrous Oxide I.P.; Industrial and medical gases; License for
manufacture of Nitrous Oxide I.P.; License for sale of Nitrous
Oxide I.P.; License under Form 20B of the Drugs and Cosmetics
Act, 1940; Meaning of term “manufacture”.
Case Arising From
CRIMINAL APPELLATE JURISDICTION: Criminal Appeal No.
486 of 2025
From the Judgment and Order dated 12.01.2024 of the High Court
of Andhra Pradesh at Amravati in CRLP No. 4148 of 2018
Appearances for Parties
Advs. for the Appellants:
Dr. Abhishek Manu Singhvi, S. Niranjan Reddy, Sr. Advs., R.
Bhatnagar, Ishan Khanna, Ishan Khanna, Agni Sen, Ms. Priyanka
Sharma, Ms. Akhila, Tejas Anand, M/s. Khaitan & Co.
Advs. for the Respondent:
Ms. Prerna Singh, Guntur Pramod Kumar, Dhruv Yadav.
Judgment / Order of the Supreme Court
Judgment
B.R. Gavai, J.
1. Leave granted.
2. The present appeal challenges the judgment and order dated 12th
January 2024 passed by the High Court of Judicature of Andhra
Pradesh at Amravati, whereby the High Court dismissed the Criminal
Petition No. 4148 of 2018 filed by the appellants herein under Section
482 of the Code of Criminal Procedure, 19731 thereby praying for
calling of the records pertaining to C.C. No. 71 of 2018 on the file of
the First Additional Judicial Magistrate of First Class, Kadapa2 and
1 “CrPC.” hereinafter
2 “Trial Court” hereinafter
1238 [2025] 1 S.C.R.
Supreme Court Reports
to quash the same against the appellants herein, who are arraigned
as Accused Nos. 5 and 6.
3. Shorn of details, the facts leading up to the present appeal are:
3.1. The first appellant herein - INOX Air Products Limited (Now
known as M/s. INOX Air Products Private Limited) is a company
incorporated in India having its registered office in Navi Mumbai,
Maharashtra and is engaged in the manufacture and sale of
industrial and medical gases in India. The second appellant -
Pavan Kumar Jain, is the Managing Director of the first appellant
company.
3.2. A complaint came to filed on 22nd December 2017 by the
Drugs Inspector, Kadapa before the Trial Court wherein the
appellants were made Accused Nos. 5 and 6. It was alleged
in the complaint that based on information received by the
complainant, on 3rd May 2016, the complainant along with 2
panch witnesses went to the RIMS General Hospital, Kadapa at
around 02:00 P.M. and met the Superintendent of the Hospital.
He was asked for the purchase bills and the person from
whom they had procured Oxygen I.P. and Nitrous Oxide I.P.
The Superintendent informed that they had purchased drugs
from M/s. Varasi Oxygen firm (Accused No. 1). On verification
of the purchase bills, it was discovered that the Accused No. 1
firm had the licenses for Oxygen I.P. only and not for Nitrous
Oxide I.P. The complainant asked for the purchase agreement
between the Hospital and the Accused No. 1 firm, and it was
revealed that the agreement had existed since 2009. The
complainant then seized the 72 purchase bills of the Nitrous
Oxide I.P. from the Superintendent and on verification it was
found that there was no physical stock of Nitrous Oxide I.P.
gas cylinders in the RIMS General Hospital.
3.3. The complainant addressed a letter to the Superintendent on
5th January for the name and address of the Accused No. 1 firm
and to produce the agreement between them. This was duly
submitted. Another letter was issued thereafter to Accused No.
1 firm on 6th January 2017 to produce the drug licenses for the
purchase and sale of the Nitrous Oxide I.P. and to produce the
purchase bills, sale bills, sale drugs and constitution particulars.
Accused No. 1 replied through its representative G. Raghunadha
[2025] 1 S.C.R. 1239
INOX Air Products Limited now known as INOX Air Products Private
Limited and Another v. The State of Andhra Pradesh
Reddy (Accused No. 2) that the Nitrous Oxide I.P. was purchased
from another firm - M/s. R.S. Gas Products (Accused No. 3)
and the purchase bills for the same were submitted.
3.4. The complainant issued a letter seeking similar submission
of licenses and purchase bills relating to Nitrous Oxide I.P. to
Accused No. 3 firm. Accused No. 3 firm submitted in its reply
that they had purchased the Nitrous Oxide I.P. from M/s INOX
Air Products (Accused No. 5), i.e. Appellant No. 1 herein.
However, no license for the purchase of Nitrous Oxide I.P. was
submitted by Accused No. 3 firm.
3.5. A similar letter was issued by the complainant to Appellant No.
1 firm on 19th May 2017 to produce and submit the drug license
to manufacture the drug Nitrous Oxide I.P. and to produce the
sale bills. A reply was received on 7th June 2017 from Appellant
No. 2 herein representing Appellant No.1. The drug licenses
for manufacturing and selling the drug Nitrous Oxide I.P were
submitted.
3.6. It was thus concluded by the Drug Inspector while submitting the
complaint that Appellant No. 1 firm (Accused No. 5) represented
by Appellant No. 2 (Accused No. 6) sold the drug Nitrous Oxide
I.P. to the unlicensed Accused No. 3 firm in contravention of
Section 18(a)(vi) of the Drugs and Cosmetics Act, 19403 read
with condition of the license in Form 26, point No. 03 read with
Rule 65(5)(1)(b) of the Drugs and Cosmetics Rules, 19454,
punishable under Section 27(d) of the said Act.
3.7. Based on the complaint, the Trial Court vide order dated 20th
January 2018 took the complaint on its file and issued summons
to all the Accused persons including the appellants herein.
3.8. The appellants filed the Criminal Petition No. 4148 of 2018 before
the High Court of Judicature of Andhra Pradesh at Amravati
under Section 482 of the CrPC praying for calling of the records
pertaining to C.C. No. 71 of 2018 on the file of the Trial Court
and to quash the same against the appellants herein, who are
arraigned as Accused Nos. 5 and 6.
3 “The said Act” hereinafter
4 “The said Rules” hereinafter
1240 [2025] 1 S.C.R.
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3.9. The High Court, vide the impugned judgment and final order
dated 12th January 2024 dismissed the criminal petition filed
by the appellants under Section 482 of the CrPC.
3.10. Being aggrieved thereby, the present appeal was filed.
4. We have heard Dr. A.M. Singhvi and Shri S. Niranjan Reddy,
learned Senior Counsel appearing on behalf of the Appellants, and
Smt. Prerna Singh, learned counsel appearing on behalf of the
Respondent-State.
5. Dr. Singhvi, learned Senior Counsel for the appellants submitted that
the term ‘manufacture’ as defined in Section 3(f) of the said Act is
wide enough and includes inter alia “making, altering, ornamenting,
finishing, packing, labelling etc.” It is submitted that the process of
manufacture adopted by accused No.3 was outlined in the application
form filed by accused No.3 with the Director General, Drugs Control
Administration, Andhra Pradesh for the grant of a manufacturing
license, as follows:
a. A3 would purchase NOIP in big cylinders from a licensed
manufacturer, which would be tested as per I.P. standards and
thereafter used for filling small cylinders.
b. A small sample of gas in the small cylinder is taken and tested
for its purity in the lab by lab methods.
6. Dr. Singhvi submitted that as such the procedure undertaken by
accused No.3 would come within the definition of ‘manufacture’ as
defined under Section 3(f) of the said Act.
7. Dr. Singhvi further submitted that Form 20B and Rule 65(5) of the
said Rules are applicable to sale by way of wholesale. Rule 2(g) of
the said Rules defines “sale by way of wholesale dealing” to mean
“sale to a person for the purpose of selling again”. It is submitted
that wholesale dealing would not cover manufacture within its
scope and any drugs purchased in furtherance of a license under
Form 20B must be sold as it is, without any change and on as is
basis. It is submitted that the sale of Nitrous Oxide I.P. from the
first appellant – accused No.5 to accused No.3 is sale from one
manufacturer to another for further manufacturing. It is further
submitted that accused No.3 was granted a license to manufacture
in Form 25 by the Drugs Control Administration without requiring
[2025] 1 S.C.R. 1241
INOX Air Products Limited now known as INOX Air Products Private
Limited and Another v. The State of Andhra Pradesh
it to first obtain a license under Form 20B and/or any other Form
under the said Rules. It is therefore submitted that the prosecution
is totally untenable in law.
8. Dr. Singhvi further submitted that the order passed by the learned
Magistrate dated 20th January 2018 taking cognizance of the complaint
filed by the respondent and issuing process against all the accused
persons does not record any reasons and is a non-speaking one.
Relying on the judgment of this Court in the case of Lalankumar
Singh and Others v. State of Maharashtra5, it is submitted that
the order of the Magistrate issuing process/summons is liable to be
set aside on the said short ground.
9. Without prejudice to the aforesaid contention, it is submitted that
appellant No.1 had already nominated Mr. E.S.K. Sastry, who has
filed an affidavit undertaking that he was in charge of day-to-day
affairs and responsible for the business of appellant No.1 under
Section 34 of the said Act. It is submitted that appellant No.2 is a
73 years old person who resides in Mumbai and has no concern in
day-do-day affairs of the appellant No.1 Company. It is submitted
that there are no specific averments in the complaint with regard to
the role played by appellant No.2 and as such, in view of the law laid
down by this Court in the case of Pepsi Foods Ltd. and Another
v. Special Judicial Magistrate and Others6, the complaint is liable
to be quashed and set aside.
10. Ms. Prerna Singh, on the contrary, submitted that the license under
Form 25 is subject to the conditions as laid down in Form 20B. She
therefore submitted that since neither accused No.3 nor accused
No.5 possess a license under Form 20B, there was a contravention
of provisions of Section 18(c) of the said Act constituting an offence
punishable under Section 27(d) of the said Act.
11. Since in the present complaint, we are only concerned with the
appellants who are accused Nos. 5 and 6, we will refer to the
averments in the complaint insofar as the present appellants are
concerned. The only averment in the complaint pertaining to the
present appellants is as follows:
5 2022 SCC OnLine SC 1383 : 2022 INSC 1059
6 (1998) 5 SCC 749 : 1997 INSC 714
1242 [2025] 1 S.C.R.
Supreme Court Reports
“A5 represented by A6 sold the drug Nitrous Oxide I.P.
to the unlicensed A3 firm there by contravention of the
Sec 18(a)(vi) r/w condition of the license in Form 26 point
No.:03 r/w 65(5)(1)(b) of the Act, punishable under Section
27(d) of the Drugs & Cosmetics Act, 1940.”
12. It is thus clear that the only allegation against the present appellants
is that the appellants sold Nitrous Oxide I.P. to accused No.3 firm
which did not have license for sale and as such, there was a violation
of Rule 65(5)(1)(b) of the said Rules which is punishable under
Section 27(d) of the said Act.
13. For considering the rival submissions, it would be relevant to refer
to certain provisions of the said Act.
14. Section 3 of the said Act is a ‘Definitions’ section. Clause (f) thereof
reads thus:
“(f) “manufacture” in relation to any drug or cosmetic
includes any process or part of a process for making,
altering, ornamenting, finishing, packing, labelling,
breaking up or otherwise treating or adopting any drug or
cosmetic with a view to its sale or distribution but does
not include the compounding or dispensing of any drug,
or the packing of any drug or cosmetic, in the ordinary
course of retail business; and “to manufacture” shall be
construed accordingly;”
15. It could be seen that the term ‘manufacture’ as defined in the said Act
is firstly inclusive and secondly wide enough to include any process
or part of process from making, altering, ornamenting, finishing,
packing, labelling, breaking up or otherwise treating or adopting
any drug or cosmetic with a view to its sale or distribution. What is
excluded from the definition is the compounding or dispensing of
any drug, or the packing of any drug or cosmetic, in the ordinary
course of retail business.
16. It will also be apposite to refer to the relevant part of Section 18 of
the said Act which reads thus:
“18. Prohibition of manufacture and sale of certain
drugs and cosmetics.—From such date as may be fixed
by the State Government by notification in the Official
[2025] 1 S.C.R. 1243
INOX Air Products Limited now known as INOX Air Products Private
Limited and Another v. The State of Andhra Pradesh
Gazette in this behalf, no person shall himself or by any
other person on this behalf—
(a) manufacture for sale or for distribution, or sell, or stock
or exhibit or offer for sale, or distribute—
(i) ………..;
(ii) ………..
(iii) ……….;
(iv) …………;
(v) ………….;
(vi) any drug or cosmetic in contravention of any of the
provisions of this Chapter or any rule made thereunder;
…………”
17. It will be relevant to refer to the relevant part of Section 27 of the
said Act which reads thus:
“27. Penalty for manufacture, sale, etc., of drugs in
contravention of this Chapter.—Whoever, himself or by
any other person on his behalf, manufactures for sale or
for distribution, or sells, or stocks or exhibits or offers for
sale or distributes,—
(a) …………
(b) ………..
(c) ………..
(d) any drug, other than a drug referred to in clause (a)
or clause (b) or clause (c), in contravention of any other
provision of this Chapter or any rule made thereunder,
shall be punishable with imprisonment for a term which
shall not be less than one year but which may extend to
two years and with fine which shall not be less than twenty
thousand rupees:
Provided that the Court may for any adequate and special
reasons to be recorded in the judgment impose a sentence
of imprisonment for a term of less than one year.”
1244 [2025] 1 S.C.R.
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18. It could be seen that for constituting an offence, what is necessary to
establish is that the accused manufactures for sale or for distribution,
or sells, or stocks or exhibits or offers for sale or distributes any drug
without a valid license required under clause (a)(vi) of Section 18 of
the said Act. As such, what the prosecution will have to establish is
that the appellants sold the drug to accused No.3 without accused
No.3 having the valid license for the further sale of the same. It will
be relevant to refer to the relevant part of Rule 65 of the said Rules
which reads thus:
“65. Condition of licences.—Licences in Forms 20,
20-A, 20-B, 20-F, 20-G, 21 and 21-B shall be subject
to the conditions stated therein and to the following
general conditions—
1. ……………….
2. ……………….
3. ……………….
4. ……………….
(5)(1) Subject to the other provisions of these rules the
supply of a drug by wholesale shall be made against a
cash or credit memo bearing the name and address of
the licensee and his licence number under the Drugs and
Cosmetics Act in which the following particulars shall be
entered—
(a) ……….,
(b) the name, address of the licensee to whom
sold and his sale licence number. In case
of sale to an authority purchasing on behalf
of Government, or to a hospital, medical,
educational or research institution or to a
Registered Medical Practitioner for the purpose
of supply to his patients the name and address
of the authority, institution or the Registered
Medical Practitioner as the case may be,
……..”
[2025] 1 S.C.R. 1245
INOX Air Products Limited now known as INOX Air Products Private
Limited and Another v. The State of Andhra Pradesh
19. Rule 65 of the said Rules deals with conditions of licences and Forms
20, 20A, 20B, 20F, 20G, 21 and 21B whereas Rule 70 thereof deals
with “Form of licence to repack or manufacture drugs other than
those specified in Schedules C and C(1)”.
20. It will be relevant to refer to Forms 20B and 25 of the said Rules,
which read thus:
“Form 20B
[See rule 61(1)]
Licence to sell, stock or exhibit or offer for sale, or
distribute by wholesale, drugs other than
those specified in Schedules C, C(1) and X
1,.………………………………………………………………
…………………………….is hereby licensed to sell, stock
or exhibit or offer for sale, or distribute by wholesale drugs
other than those specified in Schedules C, C(1) and X
on the premises situated at……………….. subject to the
conditions specified below and to the provisions of the
Drugs and Cosmetics Act, 1940, and the rules thereunder.
2. The licence unless sooner suspended or cancelled,
shall remain valid perpetually. However, the compliance
with the conditions of licence and the provisions of the
Drugs and Cosmetics Act, 1940 (23 of 1940) and the
Drugs and Cosmetics Rules, 1945 shall be assessed not
less than once in three years or as needed as per risk
based approach.
3. The sale shall be made under the personal supervision
of a competent person.
(Name of the competent person).] ………
4. Categories of drugs………..
Date ………………………………………… Licence No.
……………………………… Licensing Authority
Conditions of Licence
1. This licence shall be displayed in a prominent place in
a part of the premises open to the public.
1246 [2025] 1 S.C.R.
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2. The licensee shall comply with the provisions of the
Drugs and Cosmetics Act, 1940 and the Rules thereunder
for the time being in force.
3. (i) No drug shall be sold unless such drug is purchased
under a cash or credit memo from a duly licensed dealer
or a duly licensed manufacturer.
(ii) No sale of any drug shall be made to a person not
holding the requisite licence to sell, stock or exhibit for
sale or distribute the drug. Provided that the condition
shall not apply to the sale of any drug to —
(a) an officer or authority purchasing on behalf of
Government, or
(b) a hospital, medical, educational or research institution
or a registered medical practitioner for the purpose of
supply to his patients, or
(c) a manufacturer of beverages, confectionary biscuits
and other non-medicinal products, where such drugs are
required for processing these products.]
4. * * *
5. The licensee shall inform the Licensing Authority in
writing in the event of any change in the constitution of
the firm operating under the licence. Where any change in
the constitution of the firm takes place, the current licence
shall be deemed to be valid for a maximum period of three
months from the date on which the change takes place
unless, in the meantime, a fresh licence has been taken
from the Licensing Authority in the name of the firm with
the changed constitution.”
Form 25
[See Rule 70]
Licence of manufacture for sale or for
distribution of drugs other than those specified
in Schedules C, C(1) and X
[2025] 1 S.C.R. 1247
INOX Air Products Limited now known as INOX Air Products Private
Limited and Another v. The State of Andhra Pradesh
Number of licence and date of issue ……………………….
1. ………………………… is hereby licensed to manufacture
the following categories of drugs being drugs other than
those specified in Schedules C, C(1), and X to the Drugs
and Cosmetics Rules, 1945, on the premises situated
at ………… under the direction and supervision of the
following competent technical staff:
(a) Competent technical staff (Names)…………..
(b) Names of Drugs (each item to be separately specified)
………..
2. The licence authorises the sale by way of wholesale
dealing and storage for sale by the licensee of the drugs
manufactured under the licence, subject to the conditions
applicable to licence for sale.
3. The licence unless sooner suspended or cancelled shall
remain valid perpetually. However, the compliance with
the conditions of licence and the provisions of the Drugs
and Cosmetics Act, 1940 (23 of 1940) and the Drugs
and Cosmetics Rules, 1945 shall be assessed not less
than once in three years or as needed as per risk based
approach.
4. The licence is subject to the conditions stated below
and to such other conditions as may be specified in the
rules for the time being in force under the Drugs and
Cosmetics Act, 1940.
Date…………..
Signature ……………
Designation ……………..
*Licensing Authority
*Central Licence Approving Authority
*Delete whichever is not applicable.]
Conditions of Licence
1248 [2025] 1 S.C.R.
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1. This licence shall be kept on the approved premises and
shall be produced at the request of an Inspector appointed
under the Drugs and Cosmetics Act, 1940.
2. Any change in the competent technical staff named in
the licence shall be forthwith reported to the Licensing
Authority.
3. If the licensee wants to manufacture for sale additional
items of drugs not included above he should apply to the
Licensing Authority for the necessary endorsement as
provided in Rule 69(5). This licence will be deemed to
extend to the categories so endorsed.
4.* * *
5. The licensee shall inform the Licensing Authority in
writing in the event of any change in the constitution of
the firm operating under the licence. Where any change in
the constitution of the firm takes place, the current licence
shall be deemed to be valid for a maximum period of three
months from the date on which the change takes place
unless, in the meantime, a fresh licence has been taken
from the Licensing Authority in the name of the firm with
the changed constitution.”
21. A perusal of clause 2 of Form 25 which is a licence issued under
Rule 70 of the said Rules would reveal that it authorizes the sale
by way of wholesale dealing and storage for sale by the licensee of
the drugs manufactured under the licence, subject to the conditions
applicable to licence for sale. It is the contention of the respondent
that the licence under Form 25 is subject to Form 20B and since
accused No.3 did not have a licence under Form 20B, the sale to
accused No.3 by the appellants was in contravention of Section 18
(a)(vi) of the said Act.
22. It is undisputed that both the accused i.e. appellant No.1 and accused
No.3 possessed licence under Form 25. The allegation is that since
accused No.3 did not possess a licence under Form 20B, appellant
No.1 could not have sold the drugs to accused No.3 for further sale
thereof.
[2025] 1 S.C.R. 1249
INOX Air Products Limited now known as INOX Air Products Private
Limited and Another v. The State of Andhra Pradesh
23. We find the said argument to be totally fallacious in nature. As
discussed hereinabove, the term ‘manufacture’ is an inclusive term
and has a wide scope. It includes any process or part of a process for
making, altering, ornamenting, finishing, packing, labelling, breaking
up or otherwise treating or adopting any drug or cosmetic with a
view to its sale or distribution.
24. For appreciating the rival contention, it will be apposite to explain
the nature of processes that are undertaken by appellant No.1 and
accused No.3. Appellant No.1 purchases Nitrous Oxide I.P. in bulk
and after storing them in bulk containers sells them for further sale.
Accused No.3 purchases the large containers from appellant No.1,
opens the seal and stores them in smaller containers and reseals
them for further distribution and sale.
25. Since both accused No.3 and appellant No.1 are holding the licence
for manufacture, they will be entitled to carry out any process or part
of process which includes altering or breaking up with a view to its
further sale or distribution.
26. Since accused No.3 also possesses licence under Form 25 for
manufacture it is not only entitled to alter, break up, repack and
relabel the product received from appellant No.1, it is also entitled
to do it with a view for further sale or distribution. Since accused
No.3 is also holding the licence under Form 25, it is entitled to sell
and distribute the product received from appellant No.1 after altering,
breaking it up and packing it in smaller containers. On a plain and
literal interpretation of the term ‘manufacture’ as defined in the said
Act, we find that the contention of the State is totally untenable. It
would have been a different matter if accused No.3 did not have a
licence under Form 25 which apart from permitting accused No.3
from altering, breaking it up and packing the product received from
appellant No.1 in a smaller container also authorizes it to further sell
the same by wholesale dealings. Only in the absence of any licence
with accused No.3 which permitted it to further sell and distribute
the product received from appellant No.1, sale of the product by
appellant No.1 to it would have contravened the provisions of Section
18(a)(vi) and constituted an offence punishable under Section 27(d)
of the said Act.
27. Ms. Prerna, learned counsel for the State vehemently argued that
since the licence under Form 25 is ‘subject to’ the licence for sale i.e.
1250 [2025] 1 S.C.R.
Supreme Court Reports
Form 20B, there was a violation of Section 18(a)(vi) of the said Act.
28. Even if the contention of the learned counsel for the State is to be
accepted, still an offence would not be made out.
29. The term ‘subject to’ has been defined in the Black Law’s Dictionary,
5th Edition at Page 1278, which reads thus:
“Liable, subordinate, subservient, inferior, obedient
to; governed or affected by; provided that; provided;
answerable for.”
30. As such, the licence under Form 25 would be liable, subordinate,
subservient, inferior, obedient to; governed or affected by the licence
under Form 20B. However, for that, the prosecution will have to
show that appellant No.1 who possesses the licence under Form 25
has violated any of the provisions under licence in Form 20B. The
learned counsel for the State has not been in a position to point out
violation of any of the conditions as stipulated in Form 20B.
31. In that view of the matter, we find that even if the allegations made
in the complaint are taken at its face value, no case is made out for
an offence punishable under Section 18(a)(vi) read with Section 27
(d) of the said Act.
32. There is another ground on which the impugned judgment and order
is liable to be quashed and set aside. It will be relevant to refer to
the order passed by the learned Magistrate while issuing the process
which reads thus:
“The Drugs Inspector Kadapa filed complaint against A1
and A2 U/s 32 of Drugs and Cosmetics Act 1940 and
1945 for the contravention of the sec 18(c) Punishable
under section 27(b)(ii) on A1 to A4 and contravention of
section 18(a)(vi) r/w condition of the license in form 25
point No. 03 r/w Rule 65(5)(1)(b) of the Act, punishable
under section 27(d) on A5 and A6.
It is submitted that all the concerned records i.e., document
number 1 to 6, 7 (72 pages of carbon copy bills on which
the payment order passed by Superintendent, RIMS
General Hospital, Kadapa) Serial No.8 to 19 and Serial
No. 20 containing (pages 1 to 15 along with cover) shown
[2025] 1 S.C.R. 1251
INOX Air Products Limited now known as INOX Air Products Private
Limited and Another v. The State of Andhra Pradesh
and filed along with the complaint and other connected
records are verified and found it on correct lines.
It is further submitted in this case No property seized in
this case except the above said documents.
Hence, if your honour pleases the case may be taken on
file against A1 and A6 and may be pass orders for issue
of C.C. No. and also summons to A1 to A6.
Submitted
Taken on file U/Secs.32 of Drugs and Cosmetics Act 1940
and 1945 for the contravention of the sec 13(c) Punishable
under section 27(b)(ii) on A1 to A4 and Contravention of
section 18(a)(vi) r/w condition of the
license in form 25 point No. 03 r/ow Rule 65(5)(1)(b) of
the Act, punishable under section 27 (d) on A5 and A6
of the said Act.
Issue summons to A1 to A6.
Call on 5/3/18.”
33. It could be seen from the aforesaid order that except recording the
submissions of the complainant, no reasons are recorded for issuing
the process against the accused persons.
34. In this respect, it will be relevant to refer to the following observations
of this Court in the case of Pepsi Foods Ltd. (supra):
“28. Summoning of an accused in a criminal case is a
serious matter. Criminal law cannot be set into motion as
a matter of course. It is not that the complainant has to
bring only two witnesses to support his allegations in the
complaint to have the criminal law set into motion. The
order of the Magistrate summoning the accused must
reflect that he has applied his mind to the facts of the
case and the law applicable thereto. He has to examine
the nature of allegations made in the complaint and the
evidence both oral and documentary in support thereof
and would that be sufficient for the complainant to succeed
in bringing charge home to the accused. It is not that the
Magistrate is a silent spectator at the time of recording of
1252 [2025] 1 S.C.R.
Supreme Court Reports
preliminary evidence before summoning of the accused.
The Magistrate has to carefully scrutinise the evidence
brought on record and may even himself put questions
to the complainant and his witnesses to elicit answers to
find out the truthfulness of the allegations or otherwise and
then examine if any offence is prima facie committed by
all or any of the accused.”
35. This Court has clearly held that summoning of an accused in a
criminal case is a serious matter. It has been held that the order
of the Magistrate summoning the accused must reflect that he has
applied his mind to the facts of the case and the law applicable
thereto. This Court held that the Magistrate is required to examine
the nature of allegations made in the complaint and the evidence,
both oral and documentary in support thereof and as to whether
that would be sufficient for proceeding against the accused. It has
been held that the Magistrate is not a silent spectator at the time of
recording of preliminary evidence before summoning the accused.
36. The said law would be consistently following by this Court in a
catena of judgments including in the cases of Sunil Bharti Mittal
v. Central Bureau of Investigation7, Mehmood Ul Rehman v.
Khazir Mohammad Tunda and Others8 and Krishna Lal Chawla
and Others v. State of Uttar Pradesh and Another9.
37. Recently, a Bench of this Court to which one of us (Gavai, J.) was
a Member, in the case of Lalankumar Singh (supra), has observed
thus:
“38. The order of issuance of process is not an empty
formality. The Magistrate is required to apply his mind as
to whether sufficient ground for proceeding exists in the
case or not. The formation of such an opinion is required
to be stated in the order itself. The order is liable to be
set aside if no reasons are given therein while coming to
the conclusion that there is a prima facie case against
the accused. No doubt, that the order need not contain
7 (2015) 4 SCC 609 : 2015 INSC 18
8 (2015) 12 SCC 420 : 2015 INSC 983
9 (2021) 5 SCC 435 : 2021 INSC 160
[2025] 1 S.C.R. 1253
INOX Air Products Limited now known as INOX Air Products Private
Limited and Another v. The State of Andhra Pradesh
detailed reasons. A reference in this respect could be made
to the judgment of this Court in the case of Sunil Bharti
Mittal v. Central Bureau of Investigation9, which reads thus:
“51. On the other hand, Section 204 of the
Code deals with the issue of process, if in the
opinion of the Magistrate taking cognizance of an
offence, there is sufficient ground for proceeding.
This section relates to commencement of a
criminal proceeding. If the Magistrate taking
cognizance of a case (it may be the Magistrate
receiving the complaint or to whom it has
been transferred under Section 192), upon a
consideration of the materials before him (i.e.
the complaint, examination of the complainant
and his witnesses, if present, or report of inquiry,
if any), thinks that there is a prima facie case
for proceeding in respect of an offence, he shall
issue process against the accused.
52. A wide discretion has been given as to grant
or refusal of process and it must be judicially
exercised. A person ought not to be dragged
into court merely because a complaint has been
filed. If a prima facie case has been made out,
the Magistrate ought to issue process and it
cannot be refused merely because he thinks
that it is unlikely to result in a conviction.
53. However, the words “sufficient ground for
proceeding” appearing in Section 204 are of
immense importance. It is these words which
amply suggest that an opinion is to be formed
only after due application of mind that there is
sufficient basis for proceeding against the said
accused and formation of such an opinion is to
be stated in the order itself. The order is liable
to be set aside if no reason is given therein
while coming to the conclusion that there is
prima facie case against the accused, though
the order need not contain detailed reasons.
1254 [2025] 1 S.C.R.
Supreme Court Reports
A fortiori, the order would be bad in law if the
reason given turns out to be ex facie incorrect.”
39. A similar view has been taken by this Court in the case
of Ashoke Mal Bafna (supra).
40. In the present case, leaving aside there being no
reasons in support of the order of the issuance of process,
as a matter of fact, it is clear from the order of the learned
Single Judge of the High Court, that there was no such
order passed at all. The learned Single Judge of the High
Court, based on the record, has presumed that there was
an order of issuance of process. We find that such an
approach is unsustainable in law. The appeal therefore
deserves to be allowed.”
38. In the present case also, we find that there is no application of mind
even for the namesake by the learned Magistrate while issuing the
process. On this ground also, the impugned judgment and order is
liable to be quashed and set aside.
39. We also find that the High Court has totally misdirected itself in the
present matter. It will be relevant to refer to the following observations
of the High Court:
"24. Admittedly, petitioners/accused have sold the nitrous
oxide to Accused 3 & 4 without producing the license.
Accused No.3 firm was given permission for manufacturing
of nitrous oxide.
25. On repetition, as discussed supra, the 3rd accused
has given licence to manufacture the Nitrous Oxide and
Oxygen and the petitioner/A5 firm is also given licence to
manufacture Nitrous Oxide.
26. In the instant case, the petitioners/accused have
sold the drug in contravention of the Act and Rules and,
therefore, in view of the provisions under Section 18(a)(vi)
r/w Section 27 of the Act, 1940 is liable to be prosecuted.”
40. Having observed all this, the learned Single Judge of the High Court
goes on to observe that the definition of ‘manufacture’ as defined
under Section 3(f) of the said Act was not relevant for deciding
the present issue. It goes on to say that since accused No.3 was
[2025] 1 S.C.R. 1255
INOX Air Products Limited now known as INOX Air Products Private
Limited and Another v. The State of Andhra Pradesh
given licence to manufacture, he was not authorized to purchase it
from accused No.5. We find that the said interpretation is without
considering the plain nature of Section 3(f) of the said Act and is
totally unsustainable in law.
41. In view of the detailed elaborations made by us hereinabove, we
pass the following order:
(i) The appeal is allowed;
(ii) The impugned judgment and order 12th January 2024 passed by
the High Court of Judicature of Andhra Pradesh at Amravati in
Criminal Petition No. 4148 of 2018 is quashed and set aside; and
(iii) The summoning order dated 20th January 2018 passed by the
Trial Court in C.C. No. 71 of 2018 and the proceedings arising
therefrom are also quashed and set aside.
42. Pending application(s), if any, shall stand disposed of.
Result of the case: Appeal allowed.
†
Headnotes prepared by: Nidhi Jain
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