The Central government has moved forward with its plan to bring all implantable medical devices and other critical medical equipment under the purview of Section 3 (b) (iv) of the Drugs and Cosmetics (D&C) Act 1940 to ensure quality and reliability. The Central Drugs Standard Control Organisation (CDSCO), the national pharmaceutical regulatory body, has notified the list of devices to be regulated under the D&C Act and asked stakeholders to submit their suggestions by July 15.
Apart from all implantable medical devices, the list includes CT scan equipment, MRI equipment, Defibrillators, Dialysis machine, PET equipment, X-Ray machine and Bone marrow cell separator. The step, which is expected to address concerns regarding patient safety, was backed by the Drug Technical Advisory Board at its 79th meeting held on May 16, this year.
Once the decision takes effect, manufacturers and importers will have to get the national drug regulatory body’s nod to sell these products in the Indian market. As per the guideline, these devices will be defined as ‘drugs’ under the D&C Act for the purpose of price and quality control and regulated using the Medical Device Rules 2017.
While welcoming the step, the domestic industry representatives expressed disappointment over the delay in creating a separate act to regulate medical devices. A draft medical devices regulatory bill has been lying with the health ministry since 2016.
“The law to regulate medical devices needs to be passed and stakeholder consultation for the draft created by the health ministry needs to be expedited as clearly medical electronics are not drugs and a misfit in current legislation of D&C Act,” Rajiv Nath, Forum Coordinator of Association of Indian Medical Device Industry (AiMeD), told Pharmabiz.
Of late, the government has been adopting various measures to ensure the quality of medical devices sold in the country. Recently, an extensive set of safety and performance guidelines was formulated by the ministry. These norms are applicable to all medical devices including in vitro diagnostics. The new guidelines followed close on the heels of MD Rules 2017 that came into force at the beginning of the year. Five laboratories in the public sector have also been designated to test and evaluate medical devices to expedite the implementation of the new MD Rules.
As of now, India imports around 80 percent of its medical devices’ requirement and a fourth of that comes from the US.