The Union Health Ministry has issued a draft notification which intends to regulate all the medical devices used on human beings and animals in the country. The draft also makes it mandatory for all the devices to get certified by India’s drug regulatory authority, Central Drugs Standard Control Organisation (CDSCO). 

At present only 23 medical devices are regulated under the Drugs and Cosmetics act 1940. In the new draft, almost 36 devices including instruments, apparatus, appliances and implants, whether used alone or in combination for various purposes like diagnosis, prevention, monitoring, treatment, alleviation of any disease, investigation, replacement or modification or support of the anatomy among others are included. 

For now, the health ministry has decided to bring all medical devices under the Drugs and Cosmetics Act until separate legislation is enacted. “In pursuance of sub-clause (iv) of clause (b) of Section 3 of the Drugs and Cosmetics Act, 1940, the Central Government, after consultation with the Drugs Technical Advisory Board, hereby specifies the following devices intended for use in human beings or animals as drugs with effect from the 1st day of December 2019,” reads the draft notification dated Oct 18. 

Once notification comes into effect, the Central Drugs Standard Control Organisation (CDSCO) will be the nodal authority to investigate the quality, safety-related failure, complaints and can suspend the registration based on the outcome of the investigation. 

“The Health Ministry’s proposal to regulate all medical devices will allow Indian patients access to quality medical devices, and also put a check on garage manufacturing. Bringing all medical devices under regulation has been a long-pending demand from the industry and it is encouraging to see the government taking cognizance of industry concerns,” said Pavan Choudary, director-general and chairman, Medical Technology Association of India (MTaI).

Source: Economic Times, Hindustan Times. 

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