Vicarious liability under the Drugs and Cosmetics Act requires specific averments in the complaint to establish that individuals were in charge of and responsible for the conduct of the business at the time of the offence.

JUDGMENT :

Rakesh Kainthla, J.

1. The petitioners have filed the present petition for quashing of the complaint filed against them for the commission of offences punishable under Sections 16, 18 (a) (i), 18(a) (vi) read with Section 27(d) of the Drugs and Cosmetics Act, 1940 titled Union of India through Drugs Inspector (C.D.S.C.O.) Sub Zone Baddi vs. M/s VADSP Pharmaceuticals and others pending before learned Additional Chief Judicial Magistrate, Nalagarh, Baddi, H.P. (learned Trial Court). (The parties shall hereinafter be referred to in the same manner in which they are arrayed before the learned Trial Court for convenience.)

2. Briefly stated, the facts giving rise to the present petition are that the complainant filed a complaint before the learned Trial Court against the accused for the commission of offences punishable under Sections 16, 18(a)(i), 18(a)(vi) read with Section 27(d) of the Drugs and Cosmetics Act, 1940 and Rules 1945. It was asserted that the complainant drew a sample of Lycoyat manufactured by M/s Unison Pharmaceuticals, Plot No. 124, E.P.I.P. Industrial Area Phase-1, Jharmajri, Baddi, H.P. for test and analysis on 24.11.2017 in the presence of Mr. Premnath, Analytical Chemist of the Firm. The drug was divided into three portions and was sealed as per the procedure. A copy of Form No.17, along with a portion of a sealed sample, was handed over to Mr. Premnath, an Analytical Chemist. One sample of the drug was sent to the Government Analyst, i.e. Regional Drugs Testing Laboratory, Sector 39-C, Chandigarh-160036, after completing the codal formalities. As per the report, the drug was not found to be of standard quality, as it did not conform to claim as per Patent & Proprietary with respect to the uniformity of filled weight and the Assay of Vitamin D3, Calcium Pantothenate. The Drugs Inspector served a notice upon M/s Unison Pharmaceuticals. The necessary investigation was conducted, and it was found that the name of M/s Unison Pharmaceuticals was changed to M/s VADSP Pharmaceuticals. The Firm replied to the notice and requested retesting. The second sample was sent to the Central Drugs Testing Laboratory, Kolkata, which issued a report declaring that the sample was not of standard quality. Accused Nos. 1 to 3, being a manufacturing firm, had manufactured the drug, which was not of standard quality; hence, the complaint was filed against them for taking action as per the law.

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

4. Being aggrieved by the filing of the complaint and summoning order, the petitioners/accused have approached this Court for the quashing of the complaint. It was asserted that the petitioner had appointed Mr Premnath, an Analytical Chemist,as the In-charge and responsible for the business transactions of the Firm under Section 34 of the Drugs and Cosmetics Act. The sample handed over to Premnath was analysed by Shree Sai Test House Pvt. Ltd., who stated that ‘it complied with all the quality standards and parameters’. The report from the Central Drugs Laboratory was received after a gap of one year and two months. Petitioners Nos. 2 and 3 are neither in charge nor responsible for the Company. Mr Premnath, an Analytical Chemist, represented the Firm before various authorities. There are no specific averments regarding the essential requirements of the Act. The Government Analyst submitted a report after three months. He did not disclose the test protocol adopted by him. No case is made out against the petitioners. Therefore, it was prayed that the present petition be dismissed.

5. The petition is opposed by filing a reply admitting that samples were drawn by the Drugs Inspector. It was asserted that petitioners Nos. 2 and 3 are in charge of the Firm. The Firm was directed to furnish the details of the responsible person, but no response was received. Therefore, the plea that Mr Premnath, an Analytical Chemist,is the responsible person is not acceptable. The samples