In what would translate into streamlining and tightening of regulations of manufacture, sale and distribution of the $2.12-billion medical devices market, the category will get a separate definition from the umbrella definition of ‘Drugs’ in probably four to six months time from now, by when the health ministry would have readied the first draft of the revised Drugs and Cosmetics Act.
Currently the medical devices with a few exceptions that have been listed out on the Drug Controller General India (DCGI) website, falls under the broad definition of ‘Drugs’ as envisaged in Drugs and Cosmetics Act, 1940. The few exceptions that have been notified by the central drug authority to obtain a separate licence from the Central Licensing Approving Authority, include manufacture, import, sale and distribution of cardiac stents, drug eluting stent, catheters, intra ocular lenses, heart valves, orthopaedic implants. The manufacturers and distributors of such equipments need to submit an application for grant of licence to state licensing authorities (state drug controller general). Such licence would then have to be approved by the DCGI before being granted.
The ministry is working on a separate section of guidelines for medical devices and clinical trials within the purview of the Drugs and Cosmetics Act. The section on medical devices will include the need to conform to quality standards, the apex body to supervise quality standard, frequency of inspection, procedure of auditing, reporting requirements, and post marketing surveillance. Once the draft is ready and even during the process of preparation, inter-ministerial consultation will be held with relevant inputs, which then would be incorporated by the ministry of chemical and fertilizers. The draft will also be put out for a 60-days public debate before being finalized, according to sources in the ministry.
Since forming guidelines for medical devices would require amendments in the Drugs and Cosmetics Act, 1940, it would have to be approved by the houses of Parliament before getting implemented.
The issue of not regulating medical devices separately, flared up in 2005 when the Mumbai High Court asked the central government to fix standards for drug-eluting cardiac stents. The High Court decision followed press reports that the Maharashtra state government’s JJ hospital had been using untested and unapproved cardiac stents on its patients. It involved drug-eluting stents manufactured by a Netherlands-based company, which was not even approved for use in the Netherlands, but were being marketed in India.
In a related development DCGI, Surinder Singh, in his special address to the Asian Harmonization Working Party meeting on Wednesday said that the government is already working on aligning its ‘regulations for medical device’ with the help of Global Harmonization Task Force while balancing the special needs of emerging Indian medical devices industry.