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The domestic medical devices industry is pressing for developing a regulatory framework and incorporate the best practices as per international standards at a time when it is getting increasingly difficult to compete with growing imports. The industry claims that India is increasingly becoming import dependent, nearly 70-75 per cent of all medical devices used in the country are imported.
According to Rajiv Nath, secretary of the Association of Indian Medical Device Industry (AIMED) the majority of India's $5 billion medical devices market is imported thanks to the low customs duty on imports. The AIMED has written to the Ministry of Health (MoH) in the Centre last month pointing out that the gross customs duty on medical devices have fallen in the last five years from 27 per cent to 10.77 per cent at the moment.
Nath explains, "Many Indian manufacturers have thus made a strategic shift and are now increasingly resorting to imports and trading rather than investing in factories and domestic production." Industry insiders claim that India is becoming increasingly import dependent for medical devices. "In the 80's and early 90's, the level of domestic production in overall medical devices industry was around 60 per cent. However, at the moment, more than 70 per cent is imported. We have become traders in place of manufacturers," he says.
There are around 1700 registered medical devices manufacturers in the country, and have a turnover of around $5-6 million. Ideally, the size of the medical devices industry should be double the size of the pharmaceuticals industry in any country, according to AIMED.
The AIMED is hence rooting for developing proper regulations to monitor the medical devices industry, so that the locally made medical devices could also compete with the imported ones owing to a standard certification. In its letter to the MoH, it has said that there is an urgent need to create a regulatory framework for medical devices and incorporate the best practices as per international standards.
"An ordinance may be passed to remove medical devices from the definition of drugs in the Drugs and Cosmetics Act. This would pave way for passing a bill on regulation of medical devices and patient safety by a national regulatory authority under the MoH. The current Central Drugs Standard Control Organisation's (CDSCO) role could be enlarged with more autonomy and could be renamed as the Indian Healthcare Products Regulatory Authority with de-centralised divisions for drugs, cosmetics,medical devices and diagnostics," the letter says.
The Centre, on its part, is planning to set up testing laboratories across the country wherever to test medical devices and hence smoothen the process of certification and, in turn, boost export prospects for Indian players. Ahmedabad, which is one of the medical devices and pharma machinery manufacturing hubs in the country, is likely to get a testing laboratory. Such laboratories can come up at multiple locations to help the local industry.
