Drug Manufacturer Cannot Be Faulted With For Non-Compliance Of Standards Prescribed After The Date Of Manufacture: Bombay HC

The Bombay High Court has recently 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.

The Bench of Justice Kishore C Sant observed that “...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.”

Advocate Shailendra S. Gangakhedkar appeared for the petitioners and APP P.N. Kutti appeared for the respondent- State.

In this case, the Writ Petition was filed by the Director and Managing Director of Shree Umiya Surgical Pvt. Ltd., which manufactures Mediplus Scalp, a device used for infusing liquids into the vein.

In 2005, an officer of the Food and Drug Administration (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. The Magistrate issued process against the directors of the company. Thus, the director-petitioners approached the High Court.

The Counsel for the petitioners submitted that the sample had been drawn on October 1, 2004, whereas the standard of the FDA had been notified by the State government on October 6, 2005. It was also submitted that by the time notification was published, the drug had already been distributed in the market and the notification did not state that its application was retrospective.

The High Court accepted the submissions made by the petitioners 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.” said the Court.

Accordingly, the Writ Petition was allowed and the order of summoning the petitioner in the criminal complaint was set aside and quashed.

Cause Title- Kirti Kumar Jayantilal Patel & Ors. v. State of Maharashtra

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