The Bombay High Court has recently passed an order where it has held that drug manufacturers cannot be prosecuted for non-compliance with standards which are notified after the manufacturing of a drug.
A single-judge bench of Justice Kishor C Sant of the Aurangabad bench quashed the order given before by the Chief Judicial Magistrate at Nanded which had summoned the directors of a manufacturing company in a criminal complaint.
According to the complaint, it was alleged that the accused in the case who were managing directors of a firm manufacturing Mediplus Scalp Vein Set which is used for taking blood samples and infusing a liquid into veins had allegedly manufactured the said device which did not comply with the standards prescribed by the Food and Drug Administration, Maharashtra.
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In 2005, an FDA official took a sample from the vein set which was manufactured in 2004 with an expiry date in 2007.
The sample did not comply with the IP requirements for sterility tests as per protocol following which a complaint was lodged and manufacturers of the medical set were summoned and Chief Judicial Magistrate, Nanded issued a process against them under sections 27 (c) and 27(d) of the Drugs and Cosmetics Act, 1940.
The directors challenged this action and filed a writ petition in which they claimed 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.
Accepting the contention, the HC observed in its order "No case is made out showing that there was a 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respondent is that even after prescribing of the standard, the drug that was already circulated in the market was not withdrawn from the market.”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 petitioner is right in submitting that after manufacturing of the drug, it went through a chain of distributor, whole-seller, retailer etc. The respondent has not come up with a case that the petitioner had any control over the drugs after it was circulated in the market," the court order stated.
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