Efforts to streamline largely unregulated medical devices sector have hit a roadblock with the Health Ministry opposing the initiative launched by the Department of Science and Technology to frame a law and create a medical devices regulatory authority.

After the DST drafted the Medical Devices and Regulation Bill 2006, which was already circulated for public opinion, the health ministry has written to the DST, expressing its displeasure on the move. The health ministry said that the control of the sector should be left with it as medical devices were treated as new drugs and there are medicated and non-medicated devices, it is learnt.

However, in a positive move on the other hand, the health ministry has formed a core group, involving representatives from the industry and officials, to solve the contentious issues and give some guidance to the segment. The working group already met once and it would be meeting again soon to frame guidelines in a bid to put Indian industry on par with the global standards, sources said.

According to industry players, they were left with little options but to run from one ministry to another as there were no concrete guidelines to deal with devices. The DST, the health ministry and in some cases, the commerce ministry are involved and there was no uniformity among the State licensing authorities in the absence of clear-cut guidelines.

Assuming that the quality aspect of medical devices, coming under electronic devices broadly, the DST had prepared the Bill seeking to set up medical devices regulatory authority and impose strict standards. However, the fate of the bill now seems uncertain. DST sources, when contacted, remained non-committal on the future of the bill. It meant that the already aggrieved players in the sector will have to wait longer and cope with the continuing apathy and confusion.

In the absence of an administrative ministry to govern all aspects of the devices segment, the industry bodies were also at pains to seek some incentives to the indigenous players who are struggling hard against market power and lobbying clout of multinationals. The foreign players commanded 90 per cent of the Rs 12,000-crore market in the country at present, according to estimates.

Though the health minister, after represented by the associations like Association of Medical Devices and Suppliers of India, wrote to the Finance Ministry for some incentives in the budget, the sector got little. The association leaders claimed that they could not also follow up the matter as files and representations were sent from one ministry to another without any progress.