A drugmaker cannot be held responsible for manufacturing a drug for which the prescribed standard was notified after it was manufactured, the Aurangabad bench of the Bombay High Court said on Wednesday.
Justice Kishore Sant quashed summons issued by the Chief Judicial Magistrate at Nanded to the directors of a manufacturing company in a criminal complaint.
Complaint was filed against surgical device not meeting standards
A complaint was registered alleging that they manufactured a surgical device that did not comply with the standards prescribed by the Food and Drug Administration (FDA).
However, the HC quashed the complaint noting that when the device was manufactured, no standard had been notified for it.
“The manufacturer cannot be faulted with for not manufacturing the drug for which the standard is prescribed after the date of manufacture. The action initiated by the respondent itself is thus against the law. A person is expected to abide the law as it exists on the date of alleged act. The respondent has not come up with a case that on the date of manufacture the standard was prescribed,” held justice Sant.
The HC was hearing a petition filed by Kirti Kumar Patel and Umaben Patel, Director and Managing Director of Shree Umiya Surgical Pvt Ltd, which manufactured Mediplus Scalp, a device used for infusing liquids into the vein.
Set was manufactured in 2004 with the expiry date in 2007
An officer of the FDA, in 2005, drew a sample of the vein set from a civil hospital in Nanded. The set was manufactured in 2004 with the expiry date in 2007. The sample’s report stated that it did not comply with the IP requirements for sterility tests as given in the protocol.
A complaint was subsequently lodged by the FDA with the magistrate. The magistrate issued process against the directors of the company on January 16, 2006.
Hence they approached the HC contending that the sample had been drawn on October 1, 2004, and the standard of the FDA had been notified by the state government on October 6, 2005. By the time the notification was published, the drug had already been distributed in the market. Besides, the notification did not state that its application was retrospective.
No case is made out: Court
Accepting the contention, the HC said 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 HC said.
