Drug manufacturer not liable for non-compliance with standards notified after manufacture date : Bombay High Court


The Bombay High Court passed a order on 31 March, 2023.This was seen in the case of Kirti Kumar Jayantilal Patel v. State of Maharashtra 912 OF 2022 and the case was presided over by Hon’ble Justice KISHORE C.SANT. 


In this case the respondent drawn sample from drug store of Civil Hospital. Said sample was sent to analyst.  Wherein it was reported as “The Sample Does Not Comply with I.P. requirements for tests for Sterility as given in the protocol.” The complainant after getting the report, gave one copy of the test report with notice under section 18-A of the Drugs and Cosmetics Act, 1940 to disclose the name of supplier


The High Court accepted the contention and held that the order issuing process was without application of mind.“No case is made out showing that there was breach of any of the provisions of the Act by the present petitioners. It is clearly demonstrated that when the drug was manufactured, there was no standard prescribed for the said drug. The only case of the respondent is that even after prescribing of the standard, the drug that was already circulated in the market was not withdrawn from the market,” the Court concluded. The Court was satisfied that it was a fit case to intervene and allowed the petition for quashing the summoning order.


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