New Delhi: The government will soon regulate the manufacture, import, sale and price of the all implantable medical devices and other high end equipment in the country to ensure their quality. The Drugs Technical Advisory Board (DTAB) has granted approval to a proposal to put them under the purview of section 3 (b) (iv) of the Drugs and Cosmetics Act, 1940 as medical devices.
DTAB in its meeting held on 16th may 2018 deliberated the matter and agreed for the proposal to include the following medical devices and other high end equipments under the purview of Section 3(b)(iv) of the Drugs and Cosmetics Act, 1940 :
- All implantable medical devices
- CT scan equipment
- MRI equipment
- Dialysis Machine
- PET equipment
- X-Ray Machine
Once these medical devices and other high-end equipments come under the purview of Section 3(b)(iv) of the Drugs and Cosmetics Act, 1940, it can be considered as drugs for the purpose of price control under the Drugs Price Control Order issued under the Essential Commodities Act, 1955.
A senior government official aware of the development told ET, “None of these devices is under regulation currently, once brought under the new regulation the government can regulate the licenses to manufacture, sell and import these products.”
Adding that this will help in promoting exports he further added that this will improve the quality of the products and could encourage the domestic industry because the benchmarks will be defined.
Speaking with ET, Malini Aisola of the All India Drug Action Network said, “This implies that the medical device rules will apply to these devices for approval and quality. It is positive that these will be regulated now.”
Talking about the approval to ET, Rajiv Nath, forum coordinator of the Association of Indian Medical Devices Industry said that the Central Drugs Standard Control Organisation will be able to audit these devices on its own or with the help of expert and third-party certification bodies.
Nath told ET, “The advantage is that now the concerns regarding patient safety will be addressed because there will be a regulator to look at these issues for addressing all of the risks associated with the devices.” He said it was not clear whether implants used in the body for less than 30 days would be regulated.
Expressing their view Nalinikanth Gollagunta, South Asia CEO of GE Healthcare said, “It’s a win-win situation for all. It will lead to a clear distinction between the compliant and noncompliant players.”
Gollagunta further told ET that the efforts must also be taken to ensure that the introduction of new products does not take a long time.
Both Nath and Gollagunta said a separate act was required for medical devices. As of now, these devices will be defined as “drugs” under the Drugs and Cosmetics Act and regulated using the Medical Devices Rules, 2017, reports the daily.