5-year cap on shelf-life of medical devices likely, rules by year-end

Final regulations may not change from the draft despite industry protests

The government is expected to notify regulations for the medical devices sector by the end of this month, without changing much from the earlier draft. The final notification will follow years of lobbying by medical devices manufacturers — both international and domestic players — who have been asking for separate regulations for the sector. 

“After taking into consideration industry opinions, the final set of regulations will be notified by the end of this month”, a senior government official told Business Standard. The domestic and multi-national manufacturers of medical devices had raised objections to a number of clauses in the draft gazette notification earlier. But officials pointed out that the government stand on critical issues including the cap on shelf life of devices, compliance with unique identification norms and allowing contracting manufacturing will remain unchanged. 

Indications are that the central drug regulator plans to limit the shelf life up to five years for all medical devices in the final gazette notification, without changing the norm laid out in the earlier draft regulations.  The official told Business Standard, “Whether an extension should be given to a particular company for any product will be decided on a case-to-case basis.” 

Among other things, the Central Drugs Standard Control Organisation (CDSCO) is of the opinion that the packaging of any the device is also part of the quality check. One such category the CDSCO has identified is that of orthopaedic implants.

The draft gazette notification noted that the shelf life of medical devices would be five years which some industry bodies had objected to, one being Medical Technology Association of India (MTaI) which represents MNCs.   

The government plans to give the industry four to five years to comply with unique identification norms for all medical devices in the country. 

While domestic medical devices manufacturers were critical of the draft allowing contract manufacturing in the country, an official told Business Standard that the same norms will stay as it was a global practice. He explained that by encouraging contract manufacturing in the country, the Make in India campaign would get a push.

A draft gazette notification was released by the government in October, after taking stakeholders’ consultations.