By Ames Gross India’s medical device market is estimated to be worth close to $3 billion th

By Ames Gross

India’s medical device market is estimated to be worth close to $3 billion this year, making it the fourth largest medical device market in Asia after Japan, China and South Korea. The country’s device market currently comprises about 5 percent of India’s $65 billion healthcare market and is expected to grow about 15 percent each year, reaching an estimated $5 billion by 2015.

About 75 percent of India’s medical devices are imported. Despite this high percentage, the country has not established comprehensive guidelines to regulate the standards and use of medical devices. Certain medical devices are classified as drugs under India’s Drugs & Cosmetics Act 1940 (DCA). These include cardiac stents, drug-eluting stents, catheters, intraocular lenses, bone cements, heart valves and scalp vein sets, among others. There still are thousands of other medical devices that are outside the purview of the DCA.

The Central Drugs Standard Control Organization (CDSCO) is the regulatory organization that implements and enforces the DCA. The CDSCO works with the Federation of Indian Chambers of Commerce and Industry (FICCI), which highlights industry issues faced by India’s device firms. The CDSCO and FICCI also work with other Indian healthcare regulators to promote the manufacturing of medical devices and to streamline regulatory processes toward global harmonization.

Recently, there has been talk of India reintroducing the Medical Device Regulation bill to Parliament. The legislation previously was introduced in 2006 to consolidate laws for medical devices and establish a regulatory body to implement and maintain the quality and safety standards of India’s medical products. However, the bill was not passed by India’s Council of States (Rajya Sabha) and it subsequently was abolished. If the proposal is reintroduced this year and passed during the July/August monsoon session in Parliament (scheduled for July 26-Aug. 27), lawmakers then would have to establish the Medical Device Regulation Act, which eventually would provide a more structured and comprehensive legal framework for medical device companies in India.

New medical regulations still are evolving in India. Over the last few months, the government implemented new regulations that may affect medical device companies, including updated technical specifications on medical equipment procured in hospitals as well as new requirements for clinical trials conducted in India.