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

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The Aurangabad Bench of Bombay High Court last month held that a drug manufacturer cannot be held responsible for manufacturing a drug for which the prescribed standard was notified after the drug was manufactured. [Kirti Kumar Jayantilal Patel v. State of Maharashtra]
A single judge bench of Justice Kishore C Sant quashed and set aside an order of the Chief Judicial Magistrate at Nanded, Maharashtra which summoned the directors of a manufacturing company in a criminal complaint.

The complaint alleged that they had allegedly manufactured a surgical device which did not comply with the standards prescribed by the Food and Drug Administration, Maharashtra.

Justice Sant noticed 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,” the judge held.

The petition was filed by the Director and Managing Director of Shree Umiya Surgical Pvt Ltd., which manufactured Mediplus Scalp, a device used for infusing liquids into the vein.

In 2005, an officer of the FDA drew a sample of the vein set from a civil hospital in Nanded. The set was manufactured in 2004 with an expiry date in 2007.

The report of the sample stated that the sample did not comply with the IP requirements for sterility tests as given in the protocol.

The FDA received details about the product and lodged a complaint with the Magistrate.

On January 16, 2006, the Magistrate issued process against the directors of the company.

The directors, thus, filed the present petition in the High Court challenging the order.

The directors pointed out 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.

They argued that by the time the notification was published, the drug had already been distributed in the market. The notification also did not state that its application was retrospective.

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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