15 medical devices notified as drugs under price regulation: Government
The Ministry of Health has notified the Medical Devices Provisions, 2017, which will come into effect from January 2018. The government has also notified 15 devices, as the drugs automatically bring them under strict price control. In addition to catheters, stents and orthopedic implants, the list also includes heart valves, intraocular lenses, syringes, and needles.
The new rules will also require critical devices to be tested in India before they are approved for launch. The rules classify medical devices under four categories - A, B, C and D. The categories are based on the level of risk as low risk, medium risk and high risk. The rules for the regulations will be different according to the use and the risk factor. For example, implantable devices such as stents will be part of the high-risk category and monitored directly by the government regulator.
Medium and low risk devices will be regulated by state drug authorities and by quality monitoring agencies such as the Indian Bureau of Standards. At present, the quality controls of medical devices are weak in the absence of specific standards. While ensuring that medical devices sold in India meet standard quality parameters and are affordable, the new rules are also expected to provide players in the industry with a level playing field and ease of doing business.
"Devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of diseases or disorders in human beings or animals, which the central Government may from time to time specify through notification in the Official Gazette after consultation With the Board, fall under the definition of drug, "India's General Drug Controller (DCGI) GN Singh said in a statement, delivering a list of 15 medical devices reported so far.
The Center has brought medical devices such as stents, orthopedic implants and diagnostic equipment under strict regulation