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Indian Medical Device Industry : Government Initiatives For Regulations, Safety & Competitiveness

The recent initiatives by government through various departments is expected to make the Indian Medical Device Manufacturing Sector grow faster in the next five years. The initiatives include the Bill to delineate Medical Devices from Drugs, removing Duty Anomalies, Materiovigilance Programme to monitor Safety of Medical Devices and many more.

Major challenges faced by Indian Medical Device Industry are lack of regulatory structure, harmonized standards, accreditation and adverse custom duties. Absence of any regulations for curbing imports of poor quality or substandard quality medical devices, lack of R&D capabilities with high reliance on outsourcing technology, are some of the leading factors affecting the competitiveness of Indian medical consumables.

The decision of the Department of Pharmaceuticals to come out with a draft National Medical Device Policy, 2015 is the first government initiative to give a proper direction to the growth of this sector in the country. The main objective of the policy is to set up National Medical Device Authority, an autonomous body for regulating the manufacture and sales. Such a national body should be able to strengthen the domestic base of this sector, reduce dependence on import and bring affordability and availability of these critical products.

Preference to local manufacturers in government purchases, institution of a regulatory framework around self-certification, and creation of a separate department for medical devices are some of the other suggestions put forth by AIMED.

Another move initiated by the health ministry is to come out with a Materio-Vigilance Programme of India (MvPI) intended to ensure safety of medical devices used in the country. There has been several complaints of malfunctioning of medical devices supplied by both Indian companies and MNCs from various parts of the country. Adverse events of even critical medical devices are not being monitored in the country. The basic objective of MvPI is to collect safety data in a systematic manner so that regulatory decisions and actions on the use of medical devices could be taken on time by the health authorities. These government initiatives should play a key role in developing this industry and ensure availability of quality medical devices at reasonable prices to the patient community in the country.

One more development is regarding inverted duty structure. It is expected that the Department of Pharmaceuticals will shortly recommend to rectify the inverted duty structure for the growing medical devices sector. An inverted duty structure impacts domestic industry adversely as manufacturers have to pay a higher price for raw materials in terms of duty, while imported finished products land at lower duty and cost lesser. The duty structure will have to be modified. For this, the Department of Industrial Policy and Promotion(DIPP) and Department of Pharmaceuticals will jointly finalise the recommendations.

Establishing an appropriate regulatory framework for medical devices will enable industry to better address the needs of Indian patients. The industry is encouraged that the government has taken cognizance of the fact that issues related to the pharmaceuticals sector are different from that of medical devices. The proposals for medical device parks, autonomous regulatory authority, 100 percent FDI, incentives for R&D, etc., will all foster the development of the industry. More details on each of the initiative is explained at length in the following press releases.

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