American Chambers of Commerce in India (AMCHAM) has called for formulating specific regulations for the medical device industry which, it said, had been operating in a largely unregulated environment in India unlike drugs and pharmaceuticals.

The few regulations that had been in place were unclear thereby hampering easy availability and access to quality products for patients. Since October 2005, the Government has sought to regulate manufacture, import and sale of ten classes of medical devices by bringing them under the ambit of Drugs and Cosmetics Act, 1945. The sector has, since then, been reeling from the application of pharmaceuticals specific regulatory provisions, a release from the Chambers said here.

``Because of the basic differences in the manufacturing process and mode of action between drugs and medical devices, many provisions of the Act are not relevant for the latter thereby causing considerable difficulties for manufacturers and imports in ensuring timely and adequate availability. The situation is further confounded by lack of adequate trained manpower with the office of the Drug Controller General of India (DCGI) who has been entrusted with the task of implementation. The current regulation is also not geared towards incorporating the frequent technological advancements that take place in this sector,'' the release said.

"Ideally, these regulations should be derived from regulatory standards developed by agencies in the developed markets such as US FDA and CE. In the short term, in the light of considerable work done by these agencies as well as the shortage of resources with the Indian Regulator, regulator should allow manufacturers (both Indian as well as Foreign) with registrations with regulatory bodies such as US FDA/CE/TGA to be registered automatically on filing proof of such registration. In the longer term, local Indian standards should incorporate GHTF standards for better harmonization," said AMCHAM chairman K N Memani.

According to AMCHAM, the estimated growth rate of medical device and technology industry is pegged at around 6 per cent per annum for the next 5 years.