The medical device industry has recommended to the department of pharmaceuticals (DoP) to set up a centre of excellence to develop, scale up and validate technologies for quality assurance of medical devices in the country. This is very much required according to industry sources as the concept of quality assurance is the order of the day and the entire process needs to be validated in a way where products of consistently good quality are produced.

This will complement DoP recommendations to the government of India to have a national list of essential medical devices among others like setting up of medical device clusters and reduction of import duty as a part of the national medical device policy. However, a separate chapter on medical devices in the Drugs and Cosmetics Bill has also been accepted. This according to an industry source will not only boost medical device sector but will help come out with an effective medical device regulation. The industry has also been advocating for a separate medical devices bill since 2007 to attain self-sufficiency in the production of essential medical devices.

Meanwhile, there have been recommendations from certain quarters of the industry related to a separate Indian standard like CE mark with reference to the global harmonisation policy. The industry has also been advocating about a predetermined approach towards quality check of the product rather than a post quality check.

To which Sushobhan Dasgupta, president, NATHealth opines, "There are attempts from certain quarters to incorporate India marking for all medical devices distributed in the country. Imagine a situation where all countries mandated their own country marking; you would end up in a situation where there wouldn’t be enough space on the device packaging to incorporate the same. This will be a burden on both the local and foreign manufacturers."

He further explained that with regard to CE marking, the European Union (EU) has 28 member countries and only one mark has been considered as a passport for marketing the product in the EU. However in India, there exists a system of evaluation and approval by the Central Drugs Standard Control Organization (CDSCO) for regulated medical devices and in future the entire gamut of medical devices will get regulated. In such a condition, coming up with an Indian standard marking will be an additional control on the quality of the product which should be avoided especially when 75 per cent of the medical devices are imported.

Setting up centres of excellence to develop, scale up and validate technologies for quality assurance will complement the concept and agenda of setting up of medical device clusters to help boost the growth of medical device industry in India. "Ireland has adopted this concept and has become the hub of medical device production in the world. However, cluster locations should be carefully chosen based on the availability of the required infrastructure," Dasgupta suggested.

As for the issues related to the import duty, Dasgupta said that the Indian medical device industry is suffering due to the inverted duty structure. Finished medical devices attract a duty of approximately 10 per cent, whereas raw material import for the manufacturing of medical devices attracts 25 per cent to 30 per cent duty. This anomaly needs to be addressed and the duty for raw materials required for medical device production should be zero along with zero duty for finished medical devices."
 
Talking about indigenized production of medical devices, Dasgupta concluded that we should aim to attain self-sufficiency in the production of essential medical devices and then look at price control if needed.