In the wake of DCGI's warning of strict action against the medical devices manufacturers, who run their business without licenses, the CII is making efforts to bring the regulators and the industry on a single platform to instill awareness on the issue of regulation on medical devices.
Even though the government has brought 10 more medical devices under government regulation through a notification dated way back on October 6, 2005, there has been little impact on the industry and the medical devices industry remained by and large an unregulated segment. The major reason for this situation is that the regulation looked optional and there was no motivation for the domestic industry to comply with the government order, sources said adding there was lack of clarity about the regulation.
To bring clarity and also to help domestic medical devices industry to understand the regulation better, the CII in association with the CDSCO is planning to organize a series of awareness seminars on the issue in different cities of the country. The first such seminar is proposed to be held in Mumbai in the end of September or early October this year, which will be followed by seminars in other major cities to shed more light on the issue of regulation on manufacturers of medical devices.
As per data available with the union health ministry, only a handful of medical devices manufacturers have come forward to register with the concerned state licensing authorities for permission to manufacture the medical devices. Majority of the manufacturers are still doing this thriving business without proper license, sources said.
The 10 medical devices, which were brought under the purview of Drugs and Cosmetics Act, making it mandatory to get license for manufacture for sale and distribution are Cardiac stents, drug eluting stents, catheters, intra ocular lenses, IV cannulae, bone cements, heart valves, scalp vein set, orthopaedic implants and internal prosthetic replacements.
The DCGI Dr Surinder Singh had recently warned the medical devices industry of action if it failed to obtain licences from the State licencing authorities and get them approved by the central authority. The DCGI's action in this regard is to ensure quality in the medical devices industry.