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Synopsis

The Aurangabad Bench of Bombay High Court recently quashed an order passed by the chief judicial magistrate at Nanded, Maharashtra against the manufacturer company of Mediplus Scalp Vein Set. The order summoned the directors of the manufacturing company in a criminal complaint matter.

A single judge bench of Justice Kishore C Sant observed that a drug manufacturer cannot be held liable for producing medicine for which the prescribed standard was notified after the date of manufacturing of the drug.

“It is clearly demonstrated that when the drug was manufactured, there was no standard prescribed for the said drug. The manufacturer cannot be faulted for not manufacturing the drug for which the standard is prescribed after the date of manufacture,” the court observed.

Background:

The present petition was filed by the Director and Managing Director of Shree Umiya Surgical Pvt Ltd which was the manufacturer of Mediplus scalp, a device used for infusing liquids into the vein or for taking blood samples from the body.

On June 03, 2005, the drug inspector had drawn a sample of Mediplus Scalp from Civil Hospital, Nanded whose manufacturing date was October 10, 2004, and whose expiry date was September 30, 2007. The inspector sent the sample to the analyst. In the report dated September 08, 2005, it was clearly mentioned that the sample of Mediplus scalp does not comply with IP requirements for tests for sterility as given in the protocol.

After getting all the necessary information, the drug inspector lodged a complaint on January 04, 2006.

The Chief Judicial Magistrate by order dated January 16, 2006, issued a process against the accused company under Sections 27(c), 27 (d) and 34 of the Drugs & Cosmetics Act, 1940.

Proceeding before the high court:

Counsel for petitioners submitted before the court that the Mediplus Scalp vein set was manufactured on October 10, 2004, and was to expire in September 2007. On the date of manufacturing, this drug was not included under Section 3 (b) (iv) of the Drugs & Cosmetics Act, 1940 and therefore there was no standard prescribed for this drug.

Further, it was stated that on October 6, 2005 state government prescribed the standard for the first time and by this time the product was already in the market with different sellers, retailers etc. Therefore during manufacturing, there was no violation of any provision of the act.

Counsel representing the state stated that while the drug was manufactured prior to notification, but it was being sold even after the notification. It was also submitted that by an order dated October 04, 2005, it was directed not to sell the drug and to withdraw the sample from the market, and the same was not done.

After hearing the contention of both parties, Justice Sant observed that there was no standard prescribed by the State of Maharashtra for the said drug and therefore manufacturer could not be held responsible.

“There cannot be retrospective effect given to the notification prescribing standard and no person shall be made to face prosecution for manufacturing a drug prior to prescribing certain standard. Section 18(a)(i) of the act clearly states that no person shall manufacture a drug which is not of standard quality from such date, which is fixed by the State Government by notification in the official gazette. In this case, the state government prescribed the standard for the first time on October 06, 2005. Thus, no person shall be made to face prosecution for manufacturing a drug prior to prescribing certain standards,” the bench said.

Accordingly, Justice Sant quashed the order of the chief judicial magistrate.

Case Title: Kirti Kumar Jayantilal Patel vs. State of Maharashtra

Statute: Drugs & Cosmetics Act, 1940