The Bombay High Court allowed the petition filed against the order in which the issue process was given against the accused for the offence punishable u/s 27(c) and 27(d) r/w sect. 34 of the Drugs & Cosmetics Act, 1940 (“DC Act”). A single-judge bench of this Court comprising Hon’ble Justice Kishore C. Sant held that no person shall be made to face prosecution for manufacturing a drug prior to prescribing certain standards.
Brief Facts:
This petition was filed by the Director and Managing Director of Petitioner No. 3 – the company having a license to manufacture for sale (for distribution) drugs specified in Schedule C. A challenge in this petition is to an order of issuance of process dated 16.01.2006 passed by the learned Chief Judicial Magistrate.
The facts, in short, are that on 03.06.2005, the respondent drew a sample from drug store of the drug manufactured on 01.10.2004 expiry date of 30.09.2007. The report dated 08.09.2005 reported as “The Sample does not comply with I.P. requirements for tests for Sterility as given in the protocol”. The complainant sent a copy of the test report and one sealed counterpart of the sample to petitioner No.1 – company by communication dated 04.10.2005. After receiving the necessary information from the accused company and completing all the formalities, the complaint was lodged on 04.01.2006.
After receiving the order from the Court for the first time, the petitioner got knowledge of the case in April 2022 from accused No.1 i.e. distributor and it is thereafter, the petitioners approached this Court.
Contentions of the Petitioner:
The grounds on which the petitioners approached this Court were mainly that the Mediplus Scalp vein set was manufactured on 01.10.2004 and on the date of manufacture, the drug was complying with the standard or rather it was not included under section 3 (b) (iv) of the DC Act and there was no standard prescribed for the said item. The State of Maharashtra for the first time prescribed the standard in notification dated 06.10.2005. There cannot be a retrospective effect given to the notification prescribing standard.
Contentions of the Respondent:
The learned APP submitted that though the drug is manufactured prior to the notification prescribing standard, it was being sold even after notification under section 3, which is clearly an offence. He submitted that by order dated 04.10.2005, it was directed not to sell drug and to withdraw the sample from the market and the same is not done and therefore that is an offence.
Observations of the Court:
This Court observed that on the date of manufacture, there was no standard prescribed by Food and Drugs Administration, Maharashtra State. Vide notification dated 06.10.2005 the Ministry of Health and Family Welfare issued a prescribing notification standard for the sterile devices intended for external or internal use in human beings as drugs with immediate effect. Thus, at least when the drug was manufactured, there was no standard prescribed by the State of Maharashtra for the said drug and certainly, therefore manufacturer cannot be held responsible. Admittedly the drug is manufactured on 01.10.2004, and that fact is not disputed. Thus, in view of this Court, no person shall face prosecution for manufacturing a drug prior to prescribing a certain standard.
On the submission of the learned APP that prior to lodging the complaint, notice was given under section 18-B by the Government to withdraw the drug from the market, this Court finds that the petitioner cannot be made liable for such action as in 2004 itself the drug was sent to the distributor. It was for the distributor to act upon such notice.
The decision of the Court:
The Bombay High Court, allowing the petition, held that the manufacturer cannot be faulted for not manufacturing the drug for which the standard is prescribed after the date of manufacture.
Case Title: Kirti Kumar Jayantilal Patel and others vs State of Maharashtra
Coram: Hon’ble Justice Kishore C. Sant
Case no.: CRIMINAL WRIT PETITION NO. 912 OF 2022
Advocate for the Petitioner: Mr.Shailendra S. Gangakhedkar
Advocate for the Respondent: Mr.P.N. Kutti
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