Supreme Court Quashes Criminal Proceedings Against Medical Practitioner Under Drugs and Cosmetics Act, 1940 Due to Exemption Under Schedule K of Drugs and Cosmetics Rules, 1945. Registered Medical Practitioner Found with Small Quantity of Medicines for Patient Treatment Was Not Stocking for Sale Under Section 18(c) of Drugs and Cosmetics Act, 1940.

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Case Note & Summary

The Supreme Court considered an appeal by a registered medical practitioner challenging criminal proceedings initiated against her under the Drugs and Cosmetics Act, 1940. The appellant, an Associate Professor and Head of Dermatology at a government medical college, also maintained a private practice at her premises. On 16 March 2016, a Drugs Inspector conducted an inspection and found various medicines at her premises. Based on this inspection and certain sale bills, the Drugs Inspector obtained sanction on 23 January 2018 and filed a complaint before the Metropolitan Magistrate, prosecuting the appellant under Section 18(c) of the Drugs and Cosmetics Act, 1940, punishable under Section 27(b)(ii). The appellant filed an application under Section 482 of the Code of Criminal Procedure, 1973 before the Madras High Court seeking quashing of the proceedings, which was dismissed by a Single Judge on 21 June 2022, leading to the present appeal. The core legal issue was whether the criminal proceedings should be quashed given the exemption available to registered medical practitioners under Schedule K of the Drugs and Cosmetics Rules, 1945. The appellant contended that as a registered medical practitioner, she was exempt under Schedule K when supplying drugs to her patients, provided she was not keeping an open shop or selling across the counter. The prosecution argued that she had stocked drugs for sale without a valid licence. The Court analyzed Section 18(c), which prohibits manufacturing, distribution, stocking, or exhibition of drugs for sale without a licence, and Section 27(b)(ii), which prescribes punishment. It then examined Rule 123 and Schedule K of the Drugs and Cosmetics Rules, 1945, which exempt drugs supplied by registered medical practitioners to their own patients under specified conditions, including not keeping an open shop or selling across counter. The Court noted that the appellant was a senior doctor engaged in government service and private practice, and the small quantity of medicines found were lotions and ointments typical for dermatology treatment. It held that such possession did not constitute 'stocked for sale' as envisaged under Section 18(c), and the appellant was protected by the Schedule K exemption. The Court emphasized that the allegations did not indicate she was running an open shop or selling drugs across the counter. Consequently, the Court allowed the appeal, quashed the criminal proceedings, and set aside the High Court's order, finding that continuing the prosecution would be an abuse of process.

Headnote

A) Criminal Law - Quashing of Proceedings - Section 482 Code of Criminal Procedure, 1973 - The appellant, a registered medical practitioner, sought quashing of criminal proceedings for alleged contravention of Section 18(c) of Drugs and Cosmetics Act, 1940 - The Supreme Court examined whether the allegations constituted an offence given the exemption under Schedule K of Drugs and Cosmetics Rules, 1945 - Held that the proceedings were liable to be quashed as the appellant was protected under the exemption for registered medical practitioners supplying drugs to patients (Paras 5-10).

B) Drugs and Cosmetics Law - Exemption for Medical Practitioners - Schedule K Drugs and Cosmetics Rules, 1945 - The appellant was charged with stocking drugs for sale without licence under Section 18(c) of Drugs and Cosmetics Act, 1940 - The Court analyzed Schedule K which exempts drugs supplied by registered medical practitioners to their own patients, provided they are not keeping an open shop or selling across counter - Held that the small quantity of medicines found in the appellant's premises did not constitute stocking for sale and she was entitled to exemption as a registered medical practitioner (Paras 7-10).

C) Drugs and Cosmetics Law - Interpretation of 'Stocked for Sale' - Section 18(c) Drugs and Cosmetics Act, 1940 - The prosecution alleged the appellant had stocked drugs for sale without valid licence - The Court interpreted that stocking for sale requires evidence of commercial activity beyond medical practice - Held that possession of small quantities of medicines by a registered medical practitioner for patient treatment does not amount to stocking for sale under the Act (Paras 6-9).

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Issue of Consideration

Whether the criminal proceedings against the appellant under Section 18(c) of Drugs and Cosmetics Act, 1940 punishable under Section 27(b)(ii) should be quashed considering the exemption available to registered medical practitioners under Schedule K of Drugs and Cosmetics Rules, 1945

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Final Decision

Supreme Court allowed the appeal, quashed the criminal proceedings, and set aside the High Court's order

Law Points

  • Exemption under Schedule K of Drugs and Cosmetics Rules
  • 1945 for drugs supplied by registered medical practitioners to their own patients
  • prohibition under Section 18(c) of Drugs and Cosmetics Act
  • 1940 on stocking drugs for sale without licence
  • interpretation of 'stocked for sale' in context of medical practice
  • quashing of criminal proceedings under Section 482 of Code of Criminal Procedure
  • 1973 when allegations do not constitute offence
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Case Details

2023 LawText (SC) (3) 100

CRIMINAL APPEAL NO. OF 2023 (@ SPECIAL LEAVE PETITION (CRL.) No.9978 OF 2022)

2023-03-15

Sudhanshu Dhulia

S. ATHILAKSHMI

THE STATE REP. BY THE DRUGS

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Nature of Litigation

Criminal proceedings under Drugs and Cosmetics Act, 1940 for alleged contravention of Section 18(c)

Remedy Sought

Appellant sought quashing of criminal proceedings under Section 482 of Code of Criminal Procedure, 1973

Filing Reason

Appellant aggrieved by dismissal of her quashing petition by High Court

Previous Decisions

High Court dismissed application under Section 482 CrPC on 21.06.2022

Issues

Whether criminal proceedings under Section 18(c) of Drugs and Cosmetics Act, 1940 should be quashed considering exemption under Schedule K of Drugs and Cosmetics Rules, 1945

Submissions/Arguments

Appellant contended she was exempt as registered medical practitioner under Schedule K Prosecution alleged she stocked drugs for sale without valid licence

Ratio Decidendi

Registered medical practitioners are exempt under Schedule K of Drugs and Cosmetics Rules, 1945 when supplying drugs to their own patients, provided they are not keeping an open shop or selling across counter; small quantity of medicines for patient treatment does not constitute 'stocked for sale' under Section 18(c) of Drugs and Cosmetics Act, 1940

Judgment Excerpts

The Appellant before this Court is a registered medical practitioner who is presently working as an Associate Professor and the Head of Dermatology Department An inspection was made on the above premises by the Drugs Inspector, Villivakkam Range on 16.03.2016 the Drugs Inspector filed a complaint before the Court of X Metropolitan Magistrate, Egmore, for prosecuting the Appellant under Section 18(c) of the Drugs and Cosmetics Act, 1940 punishable under Section 27(b)(ii) of the Act Her petition was dismissed by the Ld. Single Judge on 21.06.2022 Under Section 18 of Drugs and Cosmetics Act 1940, a prohibition has been imposed as to the manufacture, sale etc. of certain drugs and cosmetics Rule 123 of the rules exempts certain drugs from the provisions of Chapter IV of the Act Entry No. 5 under Schedule (K) are the drugs which are supplied by a registered medical practitioner Considering the small quantity of medicines, most of which are in the category of lotions and ointments, it cannot be said by any stretch of imagination that such medicines could be ‘stocked’ for sale

Procedural History

Inspection on 16.03.2016; sanction obtained on 23.01.2018; complaint filed before Metropolitan Magistrate; appellant filed Section 482 CrPC petition before High Court dismissed on 21.06.2022; appeal to Supreme Court

Acts & Sections

  • Drugs and Cosmetics Act, 1940: Section 18(c), Section 27(b)(ii), Section 33, Section 38
  • Code of Criminal Procedure, 1973: Section 482
  • Drugs and Cosmetics Rules, 1945: Rule 123, Schedule K
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