TaxTMI 
TaxTMI 
2023 (3) TMI 1397
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....ine 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 the following medicines in the inner room of her premises. S No. Name of Drug Quantity M.R.P (Rs.) 1. Denidol Lotion 50ml 1 No. 198.50 2. Salico Lotion 30ml 4 Nos. 75/30 ml. 3. A­CN Gel 20 gms 1 No. 98/20gms 4. Tebir Gel 10 gms 9 Nos. 47.90/10gms 5. Soltop­S.6% Lotion (30ml) 4 Nos. 125/30ml 6. Mycotin Cream 15 gms 3 Nos. 115/15gms 7. Mopry 2% Ointment 4 Nos. 75.60/5gms 8. Momtop­S Ointment (10gms) 1 No. 145/10gms 9. ESM Cream (10gms) 4 Nos. 76/10gms 10. Nu­Whitified Ointment (20gms) 7 Nos. 40/20gms 11. Momesone Cream (15gms) 3 Nos. 82/15gms 12. Sudif Crea....
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....- (a) ......................................... (b) [sell or stock or exhibit or offer for sale,] or distribute any drug [or cosmetic] which has been imported or manufactured in contravention of any of the provisions of this Act or any Rule made thereunder; (c) [manufacture for sale or for distribution, or sell, or stock or exhibit or offer for sale,] or distribute any drug [or cosmetic], except under, and in accordance with the conditions of, a licence issued for such purpose under this Chapter: Provided that nothing in this Section shall apply to the manufacture, subject to prescribed conditions, of small quantities of any drug for the purpose of examination, test or analysis: Provided further that the [Central Government] may, after consultation with the Board, by notification in the Official Gazette, permit, subject to any conditions specified in the notification, the [manufacture for sale or for distribution, sale, stocking or exhibiting or offering for sale] or distribution of any drug or class of drugs not being of standard quality. The punishment for contravention of Section 18(c) is provided Under Section 27(b)(ii) which read....
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....he 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. The relevant provision of Schedule (K) reads as under: Schedule K (See Rule 123) Class of Drugs Extent and Conditions of Exemptions 1.xxxxxxxxxxxx xxxxxxxxxxxxxxxxx 2. xxxxxxxxxxx xxxxxxxxxxxxxxxxx 3. xxxxxxxxxxx xxxxxxxxxxxxxxxxx 4. xxxxxxxxxxx xxxxxxxxxxxxxxxxx 5. Drugs supplied  ....
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....p; substance specified in [Schedule G, H or X] of the following additional conditions shall be complied with:­ a. the medicine shall be labelled with the name and address of the registered medical practitioner by whom it is supplied; b. if the medicine is for external application, it shall be labelled with the words [***] "For external use only" ― or, if it is for internal use with the dose; c. the name of the medicine or ingredients of the preparation and the quantities thereof, the dose prescribed, the name of the patient & the date of supply and the name of the person who gave the prescription shall be entered at the time of supply in register t....
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....s 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. The learned single judge while dismissing the application Under Section 482 Code of Criminal Procedure of the Appellant has relied upon a decision of this Court: "9. It is too late in the day to seek reference to any authority for the proposition that while invoking the power Under Section 482 Code of Criminal Procedure for quashing a complaint or a charge, the Court should not embark upon an enquiry ....
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....over the counter. 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. One of the considerations was the delay in the proceedings against which the following observations were made, "25. In the present case, the Respondent has provided no explanation for the extraordinary delay of more than four years between the initial site inspection, the show cause notice, and the complaint. In fact, the absence of such an explanation only prompts the Court to infer some sinister motive behind initiating the criminal proceedings. 26. While inordinate delay in itself may not be ground for quashing of a criminal complaint, in such cases, unexplained inordinate delay of such length must be taken into ....