Drug Manufacturer Can’t Be Held Liable For Not Meeting Standards, Notified After Date Of Manufacture: Bombay HC

Bombay HC

Mumbai : The Bombay High Court recently held that the manufacturer of a drug cannot be prosecuted for manufacturing drugs which do not fulfil such standards that were notified by the government after the date of manufacture.

Justice Kishore C Sant of the Aurangabad bench set aside order of process against the manufacturer of Mediplus Scalp Vein Set, a device used for intravenous injections or taking blood samples observing –

“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 action initiated by the respondent itself is thus against the law.”

The court noted that the scalp vein set was notified as a “Drug” and standards were prescribed for it by the government in 2005 while the sample collected by the Drug Inspector was manufactured in 2004.

On June 3, 2005, the Drug Inspector drew a sample of medical Mediplus Scalp Vein set size 12 from the drugstore of Civil Hospital, Nanded. It was manufactured on October 1, 2004, and the expiry date was September 3, 2007. The analyst reported that the sample does not comply with IP requirements of sterility. The drug inspector sent the report and one sample to the manufacturer company and lodged a complaint against it on January 4, 2006.

The Chief Judicial Magistrate, Nanded issued process against the accused company under sections 27(c) (penalty for spurious drug) and 27(d) (penalty for any other drug in contravention of the Act) of the Drugs and Cosmetics Act, 1940.

Hence the Director and Managing Director of the accused company filed the present writ petition challenging the process.

Advocate Shailendra S Gangakhedkar for the petitioners argued that on the date of manufacture, the Mediplus Scalp Vein set was not included in the definition of “Drug” under section 3(b) of the Act and there was no standard prescribed for it. The state government prescribed the standard for the first time on October 6, 2005. By this time, the product was already in the market and hence there was no manufacturing violation, he argued.

APP PN Kutti for the State argued that while the drug was manufactured prior to notification prescribing standards, it was being sold even after the notification. Further, the manufacturer did not comply with the direction not to sell it and withdraw it from the market

He also submitted that the petitioner did not reply to the notice under Section 18-B requesting it to stop the sale and withdraw the balance stock available in the market.

The petitioners contended that they had a license to produce the drug till the end of 2007 and by the Food and Drug Control Administration, Gujarat and hence they could have manufactured it even after the date of notification by the State of Maharashtra.

The court opined that the trial court only passed the order of process after reading the complaint and documents but did not discuss or mention the reason to conclude that a prima facie case is made out against the accused company.

Though detailed reasons are not required during the issuing process, the trial court has to show that it has applied its mind to the facts of the case and concluded that a prima facie case exists, the court reiterated.

The Ministry of Health and Family Welfare included Scalp Vein Set as a “Drug” under sterile devices intended for internal and external human beings and prescribed the standards on October 6, 2005.

The court said that the notification does not have retrospective operation. Therefore, prosecuting the manufacturer for a drug manufactured in 2004 would be an abuse of process, the court held.

The prosecution submitted that the delay in filing the complaint was because the inspector had to gather information about the manufacturer of the product etc. However, the court noted that all necessary details are mandatorily printed on the sample itself and the inspector was aware of the manufacturer.

The court further said that the manufacturer is not liable for the notice under Section 18-B as the drug was already sent to the distributor in 2004 itself. The distributor had to act upon the notice and withdraw the drug from the market, it added.

“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 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 order stated.

Reference: Kirti Kumar Jayantilal Patel vs State of Maharashtra; Bench-Aurangabad , Mumbai High Court, Criminal Writ Petition No. 912 of 2022, D/j 31.3.2023


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