Bombay High Court: Drug company not liable for non-compliance with standards notified after manufacture date
The Food and Drug Administration had complained that Shree Umiya Surgical Pvt Ltd had not complied with the prescribed
Bombay High Court: Drug company not liable for non-compliance with standards notified after manufacture date
The Food and Drug Administration had complained that Shree Umiya Surgical Pvt Ltd had not complied with the prescribed standards
The Aurangabad Bench of the Bombay High Court has recently held that a drug manufacturer cannot be held responsible for manufacturing the product for which the prescribed standard was notified after it was manufactured.
In the Kirti Kumar Jayantilal Patel v. State of Maharashtra case, a single judge bench of Justice Kishore C Sant quashed and set aside an order of the Chief Judicial Magistrate at Nanded, Maharashtra. The latter had summoned the directors of the manufacturing company Shree Umiya Surgical Pvt Ltd in a criminal complaint.
The complaint alleged that the Director and the Managing Director allegedly manufactured a surgical device, Mediplus Scalp, used for infusing liquids into the vein. The device did not comply with the standards prescribed by the Food and Drug Administration, (FDA).
However, Justice Sant noticed that when the device was manufactured, no standard had been notified.
The bench thus ruled, “The manufacturer cannot be faulted for not manufacturing the drug for which the standard is prescribed after the date of manufacture. The action initiated by the respondent itself is against the law. A person is expected to abide by the law as it exists on the date of the alleged act. The respondent has not come up with a case that on the date of manufacture the standard was prescribed.”
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 it did not comply with the IP requirements for sterility tests as given in the protocol.
Thereafter, FDA lodged a complaint against the directors of Shree Umiya Surgical with the magistrate. In 2006, the magistrate issued a process against the directors, who filed a petition challenging the order in the high court.
The directors pointed out that the sample had been drawn in 2004 and the standard of the FDA was notified by the State government in 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.
Accepting the contention, the court held, “No case is made out showing that there was a breach of any of the provisions of the Act by the petitioners. It is clearly demonstrated that when the drug was manufactured, there was no standard prescribed for the drug. The only case of the respondent is that even after prescribing the standard, the drug that was already circulated in the market was not withdrawn.”
The bench thus allowed the petition for quashing the order of the magistrate.