The Act, 1940 provides specific authorities authorized to initiate prosecution, excluding the police. The police cannot assume jurisdiction to investigate the case when the ingredients of the offences are not attracted.

1. The petitioner No. 1 M/s. Torque Pharmaceuticals Private Limited, is a company incorporated under the Indian Companies Act, 1956. It is engaged in manufacturing and supply of the bulk drugs. The petitioner No. 2 is the authorized signatory of the said company. They have been made accused in Agamkuan P.S. Case No. 332 of 2012 dated 31.12.2012 registered under Sections 406, 420, 273 read with 34 of the Indian Penal Code (for short the Code), 27(b)(ii) and 27(d) of the Drugs and Cosmetics Act, 1940 (for short the Act, 1940). The petitioners have made two prayers in the present application filed under Articles 226 and 227 of the Constitution of India. The first prayer of the petitioners is to quash the FIR of the aforesaid case and their second prayer is for issuance of a direction to the respondents to unlock the sealed premises/godowns and to release the drugs/medicines which belong to the petitioner No. 1.

Basic facts:

2. One Avinash Patel, Drug Inspector, Patna-7 submitted a written report to the officer-in-charge of Agamkuan Police Station on 31.12.2012 stating therein that in the light of the order as contained in memo No. 1429 (15) dated 20.12.2012 of the State Drug Controller, Bihar, Patna, after taking approval from the Principal Secretary, Department of Health, an inspecting team inspected the godown of M/s. Torque Pharmaceuticals Private Limited, Transport Nagar, Pahari, Patna. In course of inspection, it was found that the said firm had stored drugs in two other unauthorized godowns without obtaining license. As a result, the drugs stored in the two unauthorized godowns were seized in accordance with law in presence of the representative of the firm. The inspecting team conducted inspection from 24.12.2012 to 31.12.2012 and prepared its inspection report. In the written report submitted to the police, it has been stated as follows:-

(i) Methylergometrine Maleate Injection I.P. (ERGOMAC), which is to be stored in refrigerator, was found at a normal room temperature. The transportation of the said medicine had to be conducted maintaining cold chain. However, it was found that the said medicine was transported to the unauthorized godowns from the factory without maintaining the required cold chain. As per rule, the medicine was to be stored in a temperature not exceeding eight degree centigrade. The said medicine was not stored at the recommended temperature in the unauthorized godowns. Thus, it is alleged that the said act of the petitioners was in violation of Rule 65 (17) of the Drugs and Cosmetics Rules, 1945 (for short the Rules), which is punishable under section 27(b)(ii) of the Act, 1940.

(ii) Misbranded drugs were also found stored in unauthorized godowns. Outer carton of Methylergometrine Maleate Injection I.P. (ERGOMAC Injection) was bearing the words store between eight degree and twenty five degree centigrade. However, on the label of the ampoules it was written as store between two degree and eight degree centigrade. It is alleged that due to this misleading, contradictory and wrong information written on the label of the above said medicines, the same were misbranded drugs as per section 17 of the Act, 1940 and manufacture, sale, purchase, exhibition for sale and stocking of such medicines is prohibited under section 18(a)(i) of the Act, 1940 and contravention of the same is punishable under section 27(d) of the Act, 1940.

(iii) Expired drugs were found stored against the Rules. Few expired drugs were found stored separately in the corner of the room which is contravention of Rule 65(17) of the Rules, 1945. Such act is contrary to section 18(c) of the Act, 1940 which is punishable under section 27(b)(ii) of the Act, 1940.

3. On the basis of the aforesaid allegations a formal FIR was drawn and Agamkuan P.S. Case No. 332 of 2012 was registered against the petitioners and one Pramjeet Singh Chadhwal, the Managing Director of the company in question.

4. A number of documents including inspection repor