FACTS
2. The Appellant before this Court is a registered medical practitioner who is presently working as an Associate Professor and the Head of Dermatology Department, in the Government Omandurar Medical College, Chennai. In the past, she has held the post of Assistant Professor and Civil Surgeon at Royapettah Medical College. It is permissible for her under the law to practice medicine when she is not performing her official duties. The Appellant, in her individual and independent capacity was carrying on her medical practice at a premises which is No. 87, Red Hills Road (North), Villivakkam, at Chennai. It is here that she could be consulted and where she meets and examines her patients.
3. An inspection was made on the above premises by the Drugs Inspector, Villivakkam Range on 16.03.2016. As per inspection report, the Drugs Inspector found some medicines in the inner room of her premises.
4. The Drugs Inspector thereafter moved an application for obtaining sanction from the office of the Director of Drugs Control, Tamil Nadu, Chennai on 22.09.2016 which was given to him on 23.01.2018. Consequently, 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.
5. Aggrieved by these proceedings, the Appellant filed an application under Section 482 of the Code of Criminal Procedure, 1973 before the High Court of Madras for quashing the criminal proceedings. Her petition was dismissed by the Ld. Single Judge on 21.06.2022. Aggrieved by this, the Appellant has filed Special Leave Petition before this Court against the order of the Single Judge.
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SECTION 18 (C) OF DRUGS AND COSMETICS ACT 1940
7. As we can see the prohibition under Section 18(c) is on the manufacturing, distribution, stocking or exhibition of medicines for the purposes of sale. The charge in the present case is that the Appellant had “stocked” medicines for “sale”. The entire emphasis is on “sale” of these medicines. This is evident from the sanction being sought by the Drug Inspector from the office of the Director, Drugs Control, Tamil Nadu wherein as per the sanction letter dated 23.01.2018, he had said that the Appellant be prosecuted for the contravention of:
“Section 18(c) of Drugs and Cosmetics Act 1940 for having ∙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”.
Thus, as per the prosecution she had stocked the drugs and sold them. What the Director of Drugs Control and the High Court lost sight of is the fact that the Appellant is a registered medical practitioner, her area of specialization being dermatology. She has an M.D. (DVL) degree in this specialisation. It is not a case that she had opened a shop in her premises from where she was selling drugs and cosmetics across the counter! It is possible that she was distributing these drugs to her patients for emergency uses and thus she is protected by the Act itself. Schedule (K) which is a part of the Drugs and Cosmetics Rules, 1945 provides an exemption which we shall examine hereafter.
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8. Under Section 33 of the Act, the Central Government can make rules which have to be laid before the Parliament for its ratification under Section 38 of the Act. These rules have been framed which is known as Drugs and Cosmetics Rules, 1940. Rule 123 of the rules 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), under certain conditions Rule 123 reads as under:
“123. The drugs specified in Schedule K shall be exempted from the provisions of Chapter IV of the Act and the rules made thereunder to the extent and subject to the conditions specified in that Schedule.”
Entry No. 5 under Schedule (K) are the drugs which are supplied by a registered medical practitioner with which we are presently concerned.
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It is not the case of the prosecution that the Appellant was selling drugs from an open shop across the counter. She is a senior doctor who is engaged as an Associate Professor and Head of Department, Dermatology in a Government Medical College, and being a medical practitioner, under certain conditions, she is also protected under the law which has been referred to above.
9. 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 and would come in the category of stocking of medicines for the purpose of sale. 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. In fact, this is not even the allegation against the Appellant. Undoubtedly, 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. 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.
10. But what the High Court failed to consider, however, is the provisions contained in Rule 123 read with Schedule ‘K’ to the 1945 Rules and when admittedly it is not the case of the prosecution that the drugs which were seized were being sold in an open shop across the counter. Since this was not being done as visualized above, and an exception is created under the law 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, we are of the considered view that prosecution against the Appellant is unwarranted.
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SANCTION
13. Another factor which must be considered is that the search was carried out on 16.03.2016 and sanction for prosecution was sought on 22.09.2016 and the sanction ultimately was given on 23.01.2018. There is no explanation which has been given for this delay in getting the approval. In the recently decided case of Hasmukhlal D. Vohra and Anr. v. State of Tamil Nadu [2022 SCC OnLine SC 1732], criminal proceedings were quashed against a Petitioner on the grounds that the substance in question was not a drug under Indian Pharmacopoeia.
14. 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. This Court in the case of Mansukhlal Vithaldas Chauhan v. State of Gujarat [(1997) 7 SCC 622], highlighted the importance of a prior sanction granted under Section 197 of the Code of Criminal Procedure, 1973 while quashing the criminal proceedings instituted against a Divisional Accountant engaged with the Medium Irrigation Project Division, Gujarat.
15. The possession of the drugs is not disputed in this case by either side. However, this Court in the case of Mohd. Shabir v. State of Maharashtra[(1979) 1 SCC 568] while allowing an appeal in part and directing the release of an Appellant who had been prosecuted under the provision 18(c) of the 1940 Act, this Court observed that possession simpliciter would not itself be an offence but the prosecution had to prove the essential ingredient under Section 27 which was that even a ‘stock’ of the medicine was for sale. It was observed as follows:
‘4. …We, therefore, hold that before a person can be liable for prosecution or conviction under Section 27(a)(i)(ii) read with Section 18(c) of the Act, it must be proved by the prosecution affirmatively that he was manufacturing the drugs for sale or was selling the same or had stocked them or exhibited the articles for sale. The possession simpliciter of the articles does not appear to be punishable under any of the provisions of the Act. If, therefore, the essential ingredients of Section 27 are not satisfied the plea of guilty cannot lead the Court to convict the appellant.’
16. The sanctioning authority had not examined at all whether a practising doctor could be prosecuted under the facts of the case, considering the small quantity of the drugs and the exception created in favour of medical practitioner under Rule 123, read with the Schedule “K”. All these factors ought to have been considered by the sanctioning authority. Under these circumstances we allow this appeal and set aside the order of the learned Single Judge of the Madras High Court and quash the criminal proceedings in Criminal Case No. 7135 of 2018 on the file of X Metropolitan Magistrate, Egmore, Chennai.
PARTY: S. ATHILAKSHMI vs THE STATE REP. BY THE DRUGS INSPECTOR – CRIMINAL APPEAL NO. OF 2023 (@ SPECIAL LEAVE PETITION (CRL.) No.9978 OF 2022) -March 15, 2023.
https://main.sci.gov.in/supremecourt/2022/29229/29229_2022_11_1501_42840_Judgement_15-Mar-2023.pdf
