DRW Monthly
February 2008
Issue No. 15

Update on India's Medical Device Regulations

India has historically required only minimal regulatory requirements for the manufacture, approval, sale and import of medical devices. In 2005, the Ministry of Health issued a notification to regulate ten specific categories of medical devices as "drugs" as defined by the Drugs and Cosmetics Act, 1940. These include cardiac stents, drug eluting stents, catheters, intra ocular lenses, IV cannulae, bone cements, heart valves, scalp vein set, orthopedic implants, and internal prosthetic replacements.

In 2006, the Central Drug Standard Control Organization (CDSCO) within the Ministry of Health, the primary authority who regulates and oversees the import and manufacture of drugs, diagnostics, devices, and cosmetics, published a document entitled, Guidelines for Import and Manufacture of Medical Devices. These guidelines serve to clarify requirements surrounding the import, manufacture and sale of sterile devices in India. Both foreign and Indian companies must now apply for permission to import and sell medical devices in the country, and manufacturers and importers must register with the CDSCO.

In addition, in September 2007, the CDSCO produced an Additional Clarification to Guidelines for Import Registration and Manufacture of Medical Devices. This document covers several topics, ranging from regulating more categories of medical devices to setting new clinical trial requirements for specified medical devices.(1) The Ministry of Health also introduced a bill in the most recent Parliamentary session to amend the Drugs and Cosmetics Act, 1940. The bill lays down plans to establish a Central Drug Authority (CDA). The CDA would expand the powers of the country's drug quality regulator, the Drugs Controller General of India, and establish departments that would monitor clinical trials, medical devices, vaccines and other drug-related businesses.

In an effort to streamline the country's medical device regulatory process, the Department of Science and Technology within the Ministry of Science and Technology also drafted a bill in September 2007 to establish uniform medical device standards throughout the country. One of the main goals of the bill, which is currently being finalized, is to ensure that substandard devices are not exported, particularly to developing countries. The Department of Science and Technology also proposed that a Medical Device Regulatory Authority be created to establish and maintain a national system of certification relating to quality, safety, efficacy and availability of medical devices.(2)

Medical device companies in India have voiced concerns that the overlap between the provisions of these two bills could result in a period of extreme confusion for the industry once the legislation is passed. At this point, the industry is waiting to see which ministry will be taking the lead on implementing the key provisions of each of bill. Concerns have also been raised about amending the Drugs and Cosmetics Act, 1940 to include medical devices when the Act is primarily designed to regulate drugs and cosmetics. It is clear that many issues will need to be hashed out by all the stakeholders if a new regulatory system for medical devices is to be successfully implemented.

Related Resources