Vicarious liability under Drugs Act Section 34 requires specific averments that directors were in charge of and responsible for day-to-day business and supervision; mere directorship insufficient, but allegations of control over staff and overall activities held adequate for proceedings.

JUDGMENT :

Rakesh Kainthla, J.

The petitioners have filed the present petition for quashing of complaint No.3 of 2023, titled Union of India versus M/s Symbiosis Pharmaceuticals, summoning order dated 06.09.2025 and consequential proceedings pending before learned Additional Chief Judicial Magistrate, Nalagarh, District Solan, H.P (learned Trial Court). (Parties shall hereinafter be referred to in the same manner as they were arrayed before the learned Trial Court for convenience.)

2. Briefly stated, the facts giving rise to the present petition are that the complainant, Drugs Inspector, Central Drugs Standard Control Organization (CDSCO), Zonal Office, Baddi filed a complaint against the accused for violation of Sections, 16, 18(a)(i), 18 (a)(vi), 18 (B), 18(C), 32 & 34 of Drugs and Cosmetics Act, 1940 (in short, ‘Drugs Act’) read with Rule 84(E), Rules 69-A, 70-A and 74-B read with paragraph 16.10, and 26 of Schedule M of the Drugs Rules, 1945 punishable under Sections 28(A) and 27(d) of the Drugs Act. It was asserted that the complainant drew the samples of drugs including Vemifol Plus capsules manufactured by M/s Symbiosis Pharmaceuticals Pvt. Ltd. at Trilokpur Road, Kala Amb, Himachal Pradesh and marketed by M/s Vivex Pharmaceuticals, Pvt, Ltd, Mohali, from Mr. Sunil Kumar, Proprietor of the firm M/s Ranveer Medical Agency, Near Bus Stand, Baddi, Solan, for analysis. The samples were sent to the laboratory after completing the formalities. The report of analysis issued by the laboratory mentioned that the sample was not of standard quality, as the samples did not conform the claim as per the patent and proprietary in respect of the “Assay of Alpha Lipoic Acid” (result obtained as 59.91%, whereas the limit is not less than 90%). The reports of analysis were sent to Sunil Kumar, and he was asked to disclose the source of procurement of the drugs. He disclosed that he had procured the drugs from M/s Sahil Enterprises, Mohali and M/s Vivex Pharmaceuticals, Mohali. The reports were also sent to Sahil Enterprises and Vivex Enterprises. They were also asked to disclose the source of procurement of drugs. They disclosed that the drugs were procured from M/s Symbiosis Pharmaceuticals. The report was sent to M/s Symbiosis Pharmaceuticals. It was observed that the firm had not performed the process validation for the products and had not performed the stability study for Vemifol plus, and in this manner, violated the condition of the licence. The firm showed its willingness to challenge the sample, and the sample was sent to the Director, Central Drugs Testing Laboratory, Kolkata (CDTL). A report was issued by CDTL, Kolkata, that the sample did not conform to the manufacturer's specification with respect to “Assay of Alpha Lipoic Acid” (result reported as 74.081% of the claim while the limit is 90% to 110% of the claim). Hence, the complainant filed a complaint before the Court to take action against the accused.

3. The learned Trial Court found sufficient reasons to summon the accused.

4. Being aggrieved by the filing of the complaint and summoning the accused, the accused/petitioners have filed the present petition asserting that they were arrayed because of their designation as active Directors. There is no evidence that they were in charge or responsible for the conduct of the company at the relevant time, which is a requirement under Section 34 of the Drugs Act. No specific role, control, knowledge, supervision or respo