The draft bill seeking to introduce a regulatory system for medical devices used in clinical applications will be introduced in the parliament soon. The Bill with certain key provisions was discussed by the Drug Technical Advisory Board (DTAB) and is forwarded by the DCC subcommittee.

The Bill is learnt to have included standards and approval procedures for more than 1000 products available in the healthcare market.

The Bill is expected to be part of the Drugs & Cosmetics Act by including a specific definition for "medical devices". It has also proposed a separate Medical Devices Division in the office of Central Drug Standard Control Organisation (CDSCO) and the setting up of appropriate regulatory mechanism for certification, quality assurance and post-marketing surveillance of imported as well as locally made medical devices.

Broadly, the products included in the draft bill are electronic as well as mechanical devices made of plastic and metals, which are used within the body and externally for medical and therapeutic applications. Though there are standards set by the Bureau of Indian Standards (BIS) for almost all these products to ensure the manufacturing quality, the sources close to the technical committee, confirmed that since these devices are used in the clinical applications, the safety and therapeutic accuracy have to be tested and approved exclusively as it is followed in case of drugs.

"A lot of other factors have also to be considered and incorporated in the regulatory framework as the engineering (mechanical, electronic) and other scientific aspects are also to be looked after before evaluating the safety and manufacturing standards for these devices to be granted licence for manufacturing and marketing," the officials said.

Currently, there are no regulations for the manufacture, imports and marketing of these products in the country. The proposed regulatory framework will put all the medical devices including hearing aids, patches, straps, electronic massaging devises, inhalers, etc used for healing under regulatory mechanism. And none of these products are currently under regulatory monitoring for certification, quality assurance and post marketing surveillance. Also, many of these devices are sterilized using various techniques, efficiency of which need to be validated. In view of the emerging regulatory code for medical devises, the CDSCO has already initiated measures to build up capacities to have a separate division to deal with the new area, it is learnt.