IN THE HIGH COURT OF JUDICATURE AT ALLAHABAD
HARVIR SINGH, J.
M/s Marion Biotech Pvt. Ltd. and Others – Appellants
Versus
Union of India and Another – Respondents
Criminal Revision No. 4884 of 2024, Criminal Revision No. 5442, 5443, 5444 of 2025
Decided On : 14-01-2026
| Table of Content |
|---|
| 1. case background and allegations against the revisionists (Para 2 , 3) |
| 2. arguments regarding procedural irregularities and absence of liability (Para 4 , 5 , 6 , 7 , 8 , 9 , 10 , 11) |
| 3. court's evaluation of prima facie evidence and judicial discretion (Para 12 , 13 , 14 , 15 , 16 , 17 , 18) |
| 4. legal framework and responsibility under the drugs and cosmetics act (Para 21 , 22 , 23 , 24 , 25 , 26 , 27) |
| 5. final dismissal of revisions (Para 28 , 29) |
JUDGMENT :
HARVIR SINGH, J.
1. Heard Sri Niraj Kumar Singh, holding brief of Sri Saroj Kumar Yadav, learned counsel for the revisionists, and Sri R.P.S. Chauhan, learned counsel for the opposite party-Union of India, and perused the record.
2. This Criminal Revision is directed against the impugned cognizance and summoning order dated 19.01.2024 passed by the learned Chief Judicial Magistrate, Gautam Budh Nagar in Complaint Case No. 2462 of 2024 (Union of India vs. Ms Marion Biotech Pvt. Ltd. & Others), under Sections 18(a)(i), 16, 17-A, 17-B, 18-A, 18-B and punishable under Sections 27(a), 27(b)(i), 27(b)(ii), 27(c), 27(d), 28, 28-A, and 28-B of the Drugs and Cosmetics Act, 1940, Police Station Phase III, Noida, District Gautam Buddh Nagar.
3. The brief facts of the case, are that the revisionists, being directors and officials of M/s. Marion Biotech Pvt. Ltd., (hereinafter referred as Company) they were summoned, pursuant to a complaint filed by the Drugs Inspector, alleging various violations including manufacture/sale of drugs declared "not of standard quality" and further invoking sections related to adulterated and spurious drugs, procedural non-compliance, and liability of company officials. The case is primarily founded on a test analysis report declaring certain samples “not of standard quality,” resulting in proceedings under relevant penal Sections of the Drugs and Cosmetics Act, 1940 (hereinafter referred as “Act”).
4. Learned counsel for the revisionists submits, that the learned Magistrate has taken cognizance and issued summons without proper application of judicial mind. It is contended, that the complaint does not disclose any specific averment, showing that the directors or officers of the company were in charge of and responsible for the conduct of the business of the company at the relevant point of time, as required under Section 34 of the Drugs and Cosmetics Act, 1940. It is further argued, that the complaint has been filed without obtaining valid sanction, under Section 32 of the Act, and hence, the entire proceedings are vitiated by procedural irregularities.
5. The complaint, it is submitted, does not connect the alleged offences to specific acts of the revisionists; their roles, especially as Directors or functionaries, are not detailed with reference to the overt acts justifying prosecution under the Drugs and Cosmetics Act. The order is called a “manifestation of mechanical appreciation of facts” reflecting abdication of judicial duty in scrutinizing the record.
6. Learned counsel for the revisionists has submitted that the only finding by test analysis is that, the drug was “not of standard quality.” Nowhere has the sample been found “adulterated” or “spurious,” as defined in Sections 17A and 17B respectively. Thus, invocation of harsher sections (i.e., Sections 17A, 17B, 27a) is not permissible. Each section operates under different factual circumstances, and their criteria are exclusionary.
7. Learned counsel for the revisionists has, next submitted that the test analysis report, relied on, as the foundation of the complaint, lacks compliance with Rule 46 of the Drugs Rules, 1945, as much as, in that, it does not disclose the full protocol, methods, or results in detail. Further, the examination for Diethylene Glycol and Ethylene Glycol in this case was not mandated, but done only upon special request by the Drug Inspector, raising further questions about the standard procedure being adopted.
8. Learned counsel for the revisionists has further subm

Directors are liable under the Drugs and Cosmetics Act for the conduct of the company's business, and summoning orders require only a prima facie case without extensive procedural scrutiny.
Non-compliance with statutory provisions and resignation of the accused from the company absolved him of liability, leading to the quashing of the proceedings.
Directors of a company not involved in drug manufacturing cannot be held liable under the Drugs and Cosmetics Act absent specific evidence of their responsibility for the conduct of business.
Compliance with statutory provisions is essential for the validity of prosecution actions; failure to adhere to such requirements can lead to acquittal.
Non-compliance with inspection procedures under the Drugs and Cosmetics Act, 1940 is not fatal for prosecution in cases involving allegations of spurious drugs.
The main legal point established in the judgment is that the prosecution for manufacturing drugs not of standard quality may not be launched if the product is free from any foreign matter and the def....
Prosecution quashed for delay in sample testing beyond 60 days without extension under Rule 45 and failure to send sample to manufacturer under Section 23(4)(iii), depriving re-analysis right post sh....
Conviction under drug regulation provisions requires proving non-compliance, highlighting the importance of disclosing the manufacturer's details for legal protection.
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