According to health ministry officials, the PMO, in a meeting of representatives from both the departments, decided in-principle that the health ministry would retain the reins of medical devices industry. The health ministry has been asked to consult and study the draft document prepared by the department of S&T and incorporate relevant inputs from the same in its own version of the draft Bill.
According to sources, the meeting was attended by the health secretary, science and technology secretary and the Drug Controller General of India where the secretary, S&T voiced his desire to withdraw from the race.
The PMO was concerned that two different sets of Bills, one drafted by the department of S&T called Draft Medical Device Regulation Bill proposing creation of Medical Devices Regulatory Authority and the othera Bill seeking amendments in the Drugs and Cosmetics Actto set up a Central Drugs Authority which seeks to regulate the medical devices industry along with pharma industry are parallely working towards the same goal. This was creating confusion in the international spheres on which body would get the final authority to regulate the medical devices industry. The US Ambassador to India is learnt to have sought clarification on the multiplicity of agencies trying to regulate the medical devices sector in India.
We are targeting notification by June 2010. We have started studying the department of S&T document already. Our aim is to prepare the final draft of bill by December-end so that we can place it before the Drug Technical Advisory Board for approval in February, said Surinder Singh, Drug Controller General of India.
The medical devices sector in the country at present is largely unregulated. Around 10-odd select devices have been put under regulation of over 14,000 prevailing devices since 2005. An attempt of the DCGI to increase the number of devices to 19 from 10 met with stiff resistance from the industry. The industry has a long-standing demand of creating a separate definition and guidelines for medical devices, which are currently being treated under the definition of drugs. The concerned bill of health ministry proposes to formulate a separate definition for medical devices as is the standard practice globally.
Also, the industry representatives met the minister of state for health and family welfare Dinesh Trivedi on Friday with their demands at a Ficci Round Table Conference, who has reassured them. Submit a concrete proposal to us and we would sort out the matter in two months from the time of submission. We are working towards a goal of having a diagnostic centre in every block of the country, Trivedi said.