Last Updated on April 9, 2023 by The Health Master
The Supreme Court has held that a doctor’s act of storing small quantities of medicines will not amount to an offence of unauthorized stocking of medicines under Section 18(c) of the Drugs and Cosmetics Act 1940.
“When small quantity of medicine has been found in the premises of a registered medical practitioner, it would not amount to selling their medicines across the counter in an open shop“, observed a bench comprising Justices Krishan Murari and Sudhanshu Dhulia while quashing the criminal proceedings against a Tamil Nadu-based doctor under the Drugs and Cosmetics Act 1940.
The bench noted that the quantity of medicines which was allegedly seized from the premises of the petitioner was extremely small, a quantity which can be easily found in the house or a consultation room of a doctor.
The case in brief
The premises of appellant S. Athilakshmi, who is a registered medical practitioner carrying on her medical practice at premises in Chennai, was inspected in March 2016 by the Drugs Inspector, wherein a certain quantity of medicines, lotions, ointments, etc, were found.
Alleging that she stocked drugs for sale and sold the drugs without having a valid drug license, which is punishable under section 27(b)(ii) of the said Act, an application was moved by the inspector for obtaining a sanction for prosecution from the office of the Director of Drugs Control, Tamil Nadu.
The sanction was received in Jan 2018, after which, the Inspector filed a complaint before the 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.
She challenged the proceedings before the Madras High Court, however, her plea filed under Section 482 CrPC was dismissed, prompting her to file the instant SLP before the Supreme Court.
Supreme Court’s observations
The top Court noted that the Madras High Court lost sight of the fact that the appellant was a registered medical practitioner and her area of specialization being dermatology, it was possible that she was distributing these drugs to her patients for emergency uses and thus, she is protected by the Act itself.
In this regard, the Court referred to Schedule (K) 7 appended to the Drugs and Cosmetics Rules, 1945, which exempts certain drugs from the provisions of Chapter IV of the Act (which includes both Section 18 and Section 27 referred above, which are penal provisions).
The Schedule serves as an exception in favour of the medical practitioner where the drugs given in Schedule ‘K’ would be exempted from the purview of Chapter 4 of the Act.
It may be noted that Entry No. 5 under Schedule (K), which was applicable to the facts of the instant case, states thus:
“Drugs supplied by a registered medical practitioner to his own patient or any drug specified in Schedule C supplied by a registered medical practitioner at the request of another such practitioner if it is specially prepared with reference to the condition and for the use of an individual patient provided the registered medical practitioner is not (a) keeping an open shop or (b) selling across the counter or (c) engaged in the importation, manufacture, distribution or sale of drugs in India to a degree which render him liable to the provisions of Chapter IV of the Act and the rules thereunder.”
Against this backdrop, observing that she was protected under Entry 5 to Schedule K, the Court observed that the quantity of medicines seized from the appellant was extremely small, a quantity which can be easily found in the house or a consultation room of a doctor.
“The provisions of Section 18 and 27 are relevant provisions under the law, which have a social purpose, which is to protect ordinary citizens from being exploited inter alia, by unethical medical practitioners, and for this reason the punishment under Section 27 can extend up to 5 years under the law, and has a minimum punishment of 3 years. But given the facts and circumstances of the case and considering that the Appellant is a registered medical practitioner, along with the fact that the quantity of medicines which have been seized is extremely small, a quantity which can be easily found in the house or a consultation room of a doctor, in our considered view no offence is made out in the present case”, the Court observed.
“ In fact, an exception has been created under Schedule ‘K’ read with Rule 123 to the rules, the appellant ought to have been given the benefit of these provisions and such a registered medical practitioner should not have been allowed to face a trial where in all likelihood the prosecution would have failed to prove its case beyond reasonable doubt,” the Court further observed.
The Court further noted that the appellant had produced multiple invoices from pharmaceutical shops to show her bonafides and that drugs seized from her premises were admittedly of ‘standard quality’ which indicated that it was not a case where the Appellant was operating a shop to sell spurious medicines over the counter.
The Court also factored into account that no explanation was furnished in the instant case for a delay in getting the approval for prosecution.
“The sanction for prosecution given in the present case appears, prima facie, to suffer from the vice of nonapplication of mind. There is no reference to any of the documents, evidence or the submissions submitted by either of the parties, no reasons assigned or even an explanation pertaining to the delay which indicates it has been passed in a mechanical manner.”
The Court also found faults with the sanctioning authority for not examining whether a practicing doctor could be prosecuted under the facts of the case, considering the small quantity of the drugs and the exception created in favour of the medical practitioners under Rule 123, read with the Schedule ‘K’.
In view of this, the appeal was allowed and the order of the Madras High Court was set aside and the criminal proceedings on the file of X Metropolitan Magistrate, Egmore, Chennai were quashed.
Case Title: S. Athilakshmi vs. The State Rep. By The Drugs Inspector [SLP (Criminal) No. 9978 of 2022]
Citation: 2023 LiveLaw (SC) 194
Drugs and Cosmetics Act 1940- Supreme Court quashes criminal proceedings initiated against a doctor for stocking small quantities of medicine- Such stocking will not amount to the offence of unauthorized stocking of medicines as per Section 18(c)- When small quantity of medicine has been found in the premises of a registered medical practitioner, it would not amount to selling their medicines across the counter in an open shop -Para 9
Drugs and Cosmetics Act 1940– Sections 18 and 27- The provisions of Section 18 and 27 are relevant provisions under the law, which have a social purpose, which is to protect ordinary citizens from being exploited inter alia, by unethical medical practitioners, and for this reason the punishment under Section 27 can extend up to 5 years under the law, and has a minimum punishment of 3 years.
But given the facts and circumstances of the case and considering that the Appellant is a registered medical practitioner, along with the fact that the quantity of medicines which have been seized is extremely small, a quantity which can be easily found in the house or a consultation room of a doctor, in our considered view no offence is made out in the present case – Para 9
Drugs and Cosmetics Rules, 1940 – Rule 123- Schedule K- Drugs stored by a doctor exempted from offence of unauthorized stocking and selling under certain conditions – Para 8
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