With a view to ensure quality in the medical devices industry, a largely unregulated segment, the central drug administration is planning to crack the whip against the manufacturers running business without licenses.
In order to act tough in this regard and amid reports of unlawful manufacturing of devices, the Drug Controller General of India (DCGI) has already slapped a public notice asking them to obtain licenses from the State licensing authorities and get them approved by the central authority.
"It is understood that certain manufacturers still continue to manufacture devices belonging to the listed categories without obtaining the requisite manufacturing licenses from the designated authorities. This activity is considered unlawful and would attract penalty under the Drugs and Cosmetics Act," the DCGI said in a notice.
Cardiac stents, drug eluting stents, catheters, intra-ocular lenses, IV cannulae, bone cements, heart valves, scalp vein set, orthopaedic implants, and internal prosthetic replacements had been brought under the purview of Drugs and Cosmetics Act, making it mandatory to get license to manufacture for sale and distribution in the year 2005.
"The manufacture, import, sale and distribution of the above said categories of medical devices (including accessories which are implanted with the devices e.g. screws etc) is prohibited under the Act without a requisite license for import or manufacture for sale of these devices issued under the said rules," the notice said.
Meanwhile, the efforts to streamline the sector still remained stuck as the health ministry opposing the Medical Devices and Regulation Bill 2005 prepared by the DST, which aimed at creating a regulatory authority among other things. The health ministry held that it had the jurisdiction over the devices that are treated as new drugs.
It is also learnt that a core group set up by the DCGI to look into the matter, met a couple of times, but could not make much progress. However, the CII forum for medical equipments which largely represented multinationals also has been roped in to be part of the effort.
On the other hand, indigenous manufacturers seeking adequate representation in the panel have moved the authorities again to demand separate regulatory agency to supervise and monitor the medical devices sector and extend incentives to the local players.