MNCs want easing of medical device imports

The Medical Technology Association of India (MTAI), representing multinational companies which market medical devices here,  has written to a number of foreign ambassadors for support to ease controls in the segment.

Its members — including US-headquartered Abbott Laboratories, Boston Scientific and UK-based Vygon — account for 70 per cent of medical devices imported into the country.

MTAI has written to the ambassadors/ high commissioners of America, Britian, Germany, France and Japan. It has asked for opportunities to discuss issues which it feels, are policy and regulatory hurdles to the growth of the medical technology sector.

In one such letter, reviewed by Business Standard, it has mentioned the government decision earlier this year to raise the customs duty on medical devices from 11 per cent to 18 per cent. And, been critical of the proposal to introduce labelling for medical devices marketed in India and high registration fees, among other issues.

The letters have been addressed to ambassadors of nations which are home to global headquarters of member-companies.  

MTAI says market access should be on the basis of the quality of medical devices. In the proposed Medical Devices Regulations, drug regulator CDSCO has said it would like to limit the shelf life of medical devices at five years. MTAI has been suggesting 10 years.

Regarding mandatory labelling for products, it has argued this will lead to significantly increasing the cost of devices.

This newly formed association says its products are superior to India-made ones. A recent example is a debate on the pricing of stents (for those with cardiac trouble).

While saying they had no knowledge of the MTAI move, senior commerce ministry officials said the customs duty increase is not set for a rollback.

The domestic industry, led by the Association of Indian Medical Device Industry (AIMED), claims MTAI members’ actions have led to prices of medical devices shooting up. And, that government tenders in the public health space should only go to domestic manufacturers.

“The domestic industry cannot grow when customs duty remains low and importers are given a free run,” says Rajeev Nath, forum coordinator at AIMED.

Product certification is another area of contention. AIMED collaborated with the Quality Council of India and other government agencies in a voluntary quality certification programme, called the Indian Certification for Medical Devices Scheme (ICMED).

The government has also been requested to make ICMED certification mandatory in all cases of public sector tenders, Nath added.