The Hindu Business Line : Govt finalises norms to regulate medical devices

IN an attempt to check the sale of defective medical implants, the Health Ministry has finalised a notification amending the Drugs and Cosmetics Rules to include such devices.

It has also finalised regulations related to medical devices wherein companies manufacturing or importing stents, pacemakers, valves, catheters, and other such implants would have to seek prior approval from the regulator, according to top Government sources.

So far, medical devices were outside regulatory purview, which led to a surge in imports from countries such as Korea and China.

According to the officials, "We will be issuing a notification on regulating medical devices shortly."

Besides these, implants for hips and knee replacements would also be brought under the ambit of licensing. While in vivo devices (used for treatment inside the body) would be regulated initially, in vitro implants would later be added.

The Drug Controller General of India (DCGI), which gives clearances to medicines before they are introduced in the market, will be the nodal agency.

Special evaluation committees would be constituted to regulate the quality of the devices and ensure that the manufacturing facilities are GMP (Good Manufacturing Practices) compliant.

"While the regulator will set the parameters and will intensely monitor the manufacturing practices, companies importing medical devices would also have to seek licences," said sources.

The issue of regulation of medical devices came to the forefront after the Maharashtra Food and Drug Administration (MFDA) pointed out the absence of any guidelines.

The MFDA's contention was that drug-coated stents needed to get a licence from the DCGI.

This had resulted in the State Regulator banning Shruti Medi-Science from selling drug-coated stents it had imported from a Netherlands-based company.

Subsequently, the controversy took a legal turn. At a hearing early this week, the Bombay High Court directed the DCGI to come out with a notification regulating the segment in three weeks.

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