Products explicitly labeled 'not for medicinal use' are exempt from mandatory manufacturing licensing under relevant drug regulations. Prosecution initiated in defiance of such statutory exemptions fails to disclose an offence and constitutes an abuse of process, warranting the quashing of criminal proceedings.

JUDGMENT :

ANIL KUMAR CHOUDHARY, J.

By the Court:- Heard the parties.

2. This Cr.M.P. has been filed invoking the jurisdiction of this Court under Section 482 of the Code of Criminal Procedure with the prayer to quash the entire criminal proceeding including the order taking cognizance dated 16.05.2020 passed by learned Additional Judicial Commissioner-II, Ranchi in connection with Drugs & Cosmetics Case No.01 of 2020 in which cognizance of the offence punishable under Sections 27 (b) (ii) and 27 (d) of the Drugs and Cosmetics Act, 1940 was taken, which is now pending in the court of learned Additional Judicial Commissioner-II, Ranchi.

3. Learned counsel for the petitioner submits that the allegation against the petitioner is that the petitioner is a manufacturer of Fit Eye Plus Capsule but the petitioner does not have the license for manufacturing of the said drugs which were subsequently sold by the co-accused persons. Hence, it is alleged that the petitioner has inter alia committed the offences punishable under Sections 27 (b) (ii) and 27 (d) of the Drugs and Cosmetics Act, 1940 and the learned Additional Judicial Commissioner-II, Ranchi has taken cognizance of the said offences inter alia against the petitioner- company vide its order dated 16.05.2020 in Drugs & Cosmetics Case No.01 of 2020. It is next submitted that the petitioner-company has license under the Drugs and Cosmetics Act, 1940 vide the copy of the license kept at Annexure- 1 and Annexure-1/1 and also the FSSAI License, the copy of which has been kept at Annexure-1/2 of this criminal miscellaneous petition. It is next submitted that even assuming for the sake of arguments that the petitioner does not have the license for manufacturing the said drugs but as in the strips of the medicines which has allegedly been produced by the petitioner-company, it has been conspicuously labelled with the words “not for medicinal use”, hence, assuming for the sake of arguments that the said medicines manufactured by the petitioner- company are drugs falling under Clause (b) (i) of Section 3 of the Drugs and Cosmetics Act, 1940, those medicines would fall under the exemption specified in “Schedule K” of the Drugs and Cosmetics Rule, 1945, since the same is not intended for medicinal use, hence, the same is exempted from the provisions of Chapter IV of the Drugs and Cosmetics Act, 1940. It is next submitted that the complainant- Drug Inspector has committed an illegality by not seizing the alleged medicines produced by the petitioner- company physically, hence, has not complied with the statutory requirement as mandated under Section 23 and 25 of the Drugs and Cosmetics Act, 1940. Hence, the complaint suffers from manifest error. In this respect, the learned counsel for the petitioner relies upon the judgment of the Hon’ble Supreme Court of the India in the case of Medicamen Biotech Limited & Another vs. Rubina Bose, Drug Inspector reported in (2008) 7 SCC 196 paragraph-13 of which reads as under:-

“13. As would be evident, the matter would turn on an examination of the legal provisions. Section 23 of the Act provides the procedure for taking of samples and sub-section (4) thereof, as already mentioned above, provides that the sample shall be divided into four portions and be kept/disposed of in the manner laid therein including one sample to be produced before the Magistrate. Section 25 is reproduced below:

“25. Reports of Government Analysts.—

(1) The Government Analyst to whom a sample of any drug or cosmetic has been