The health ministry may delink the regulatory approval process of medical devices from that of the pharmaceutical sector. This was a long pending demand of the industry as common statute and regulations were allegedly curbing the growth of the medical device sector in the country.
The ministry is expected to issue a draft notification proposing changes in the Drugs and Cosmetic Rules soon.
Rajiv Nath, cordinator of the Association of Indian Medical Devices Industry (AIMED) calls it the first step to address a long pending ambiguity.
"Indian medical devices have for long been incorrectly and incompletely regulated. This has been confusing overseas and Indian investors. Medical device is an engineering industry", he says.
Globally, pharmaceutical and medical device sectors are governed by different set of rules as each sector is different in terms of research and development and technologies. The investment, production and taxation requirements are also not the same.
"This paradoxical situation also contributed to making India overwhelmingly import dependent and scaring away domestic and foreign investment. To rectify the situation, AIMED has been seeking changes in drug rules covering regulatory quality management framework and infrastructure requirements on the lines of the BIS and International ISO 13485 standards", Nath says.
The industry hopes that the distinction will result in India adopting a regulatory framework that is proportionate to the risk involved. Thus the regulatory approval requirements for a wheel chair will be different from that of a needle. High risk devices like orthopaedic implants or cardiac stents will be subjected to the highest level of regulatory compliance standards.
Almost 70 per cent of India's $10-billion medical device market is catered by imported products. Lack of internationally reputed regulatory framework has been a major stumbling block before the development of indigenous medical device manufacturing.
The amendments planned by the health ministry will only introduce a separate regulatory framework for the medical devices. It will still be within the regulatory purview of the Drugs Controller General of India. The industry has been calling for a separate authority to regulate medical devices.
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