Drug Manufacturer Can't Be Held Liable For Not Meeting Standards Prescribed After Date Of Manufacture: Bombay High Court
1 year, 11 months ago

Drug Manufacturer Can't Be Held Liable For Not Meeting Standards Prescribed After Date Of Manufacture: Bombay High Court

Live Law  

The Bombay High Court recently held that 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 action initiated by the respondent itself is thus against the law.” The court noted that 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. The Ministry of Health and Family Welfare included Scalp Vein Set as a “Drug” under sterile devices intended for internal and external in human beings and prescribed the standards on October 6, 2005.

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History of this topic

No arbitrariness in policy: HC rejects plea against categorising medical devices as ‘drugs’
1 year, 6 months ago

No arbitrariness in policy: HC rejects plea against categorising medical devices as ‘drugs’

The Hindu  

The Delhi High Court has upheld the Central government’s decision to include all medical devices within the ambit of the term ‘drug’ under the Drugs and Cosmetics Act. In an order on September 1, a Bench of Justice Rajiv Shakdher and Justice Tara Vitasta Ganju rejected a plea by the Surgical Manufacturers and Traders Association challenging the Centre’s 2018 and …

Implant Files: India fares poorly in probe into medical devices industry with low recall rate, non-existent regulations
6 years, 4 months ago

Implant Files: India fares poorly in probe into medical devices industry with low recall rate, non-existent regulations

Firstpost  

The ICIJ’s “Implant Files” report notes that India’s regulatory system “effectively doesn’t exist” and that there are “no specific rules or a law” that gives the government the authority to direct a manufacturer to compensate a victim of a faulty device. “Often following the trusted advice of their doctors, they have been injured, maimed and killed by poorly-tested implants.” While …

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