India to Renew Pending Bill on Medical Devices

India’s Ministry of Health (MOH) has renewed its effort to bring a long-pending bill on medical devices to Parliament.  The Ministry recently met with the Federation of Indian Chambers of Commerce and Industry (FICCI), the Association of Indian Manufacturers of Medical Devices and officials from the Central Drugs Standard Control Organization (CDSCO) to discuss the bill.  Despite long-standing resistance from some states, the Ministry has decided to continue securing the approval of all states.  The MOH hopes to present the bill to Parliament during the monsoon session in August and September, 2012.

The proposed bill is an amendment to the existing Drugs and Cosmetics Act (DCA).  Currently, medical devices are regarded as drugs.  As a result, thousands of medical devices are not regulated in India.  The amendment would add to the DCA a separate definition of medical devices.  In addition, the amendment would set up a new medical device regulatory body and provide details on risk-based classification, clinical trials and conformity assessment for medical devices.  The bill has been pending for more than four years.

A revised draft of the bill has been circulated among the states.  If the bill passes, more specific medical device regulations be implemented and more imported devices will require product registration.