In a move that would give end users more protection while using a medical device, the Drugs Technical Advisory Board (DTAB), India’s top drug advisory body, has recommended that the Health Ministry should notify all medical devices under the drug laws.
When enforced, this translates into medical devices being treated as drugs, more stringent tracking systems, mandatory reporting of all adverse reactions and registration of device before it is allowed into the market.
A decision to this effect was taken at a meeting earlier this month and the recommendations, when brought in for implementation by the Central Drugs Standard Control Organisation (CDSCO), would be introduced in a phased manner to help the manufactures/importers adhere to the new laws.
Currently of the 5,000-6,000 medical devices in the Indian market, there are only 23 notified medical devices under government control.
When enforced, medical devices will be recognised as drugs under Section 3 (b) (iv) of the Drugs and Cosmetics Act, 1940.
Call for separate law
The decision, however, has not gone down well with the Association of Indian Medical Device Industry (AIMED) which says that all medical devices need to be regulated under a separate medical devices-specific law.
Forum co-ordinator Rajiv Nath said the medical device industry wanted experts from within their industry to be part of the DTAB as special invitees.
In their release, AIMED noted: “The CDSCO should be strengthened with respect to manpower and infrastructure to regulate all medical devices and should include specialists like dentists and ophthalmologists in the category of experts to be recruited. Also manpower and infrastructure in all States should be strengthened and an advisory may be issued to all the States in this regard.”
AIMED has also asked the government to stick to the earlier assurance given to the industry by the Ministry in 2016, which included a four-step plan of starting with Medical Devices Rules (MDR), initially experimenting with a few electronic devices under MDR, amending MDR as per experience gained after six months of introduction and simultaneously drafting a Medical Device Patient Safety Bill to be reviewed and passed by Parliament.
“Also it’s imperative to have a separate law as devices are engineering items and not medicines — an X-Ray machine by no stretch of imagination can be called a drug. So continued attempts to regulate devices as drugs is illogical and incorrect. The Medical Devices Rules has risk proportionate controls correlating to risk classification of devices. Similarly the law and penal provisions need to be risk proportional as you can’t have the same penalty for the manufacturing failure of a spectacle and a contact lens or an intraocular lens,” said Mr. Nath.