Panel to examine regulation, control of medical devices

Bp Apparatus, Medical Devices
Picture: Pixabay

New Delhi: A parliamentary panel has decided to examine regulation and control of medical devices in the country to ensure that they meet certain standards of quality and efficacy. The decision has come at a time when the government has proposed to regulate all the medical devices. 

The parliamentary standing committee on family health and welfare, headed by Samajwadi Party MP Ram Gopal Yadav, has decided to examine affordability of cancer treatment in the country, as per a bulletin issued by the Lok Sabha secretariat. 

The panel has decided to examine regulation and control of medical devices in the country. A gazette notification, issued by the Health Ministry on October 18, proposed to regulate all the medical devices. 

The ministry proposed to “notify” all such equipment used on human beings or animals as “drugs” so as to regulate them under the Drugs and Cosmetics Act. 

Once notified, the manufacture, import and sale of all the medical devices will need to be certified by the Central Drugs Standard Control Organisation (CDSCO). 

At present, only 23 medical devices are regulated under the law. 

The Drugs Technical Advisory Board (DTAB), the country’s highest advisory body on technical issues related to drugs and medical devices, had in April recommended that all the medical devices should be notified as drugs under the Drugs and Cosmetics Act. 

Besides, the panel has also decided to examine implementation of the Modi government’s flagship Ayushman Bharat scheme and promotion of generic drugs, among others.