Issues of Overlapping Medical Device Bills in India

Medical devices in India are largely unregulated at this point. To address this issue, the Department of Science and Technology (DST) had proposed a Medical Devices Regulations Bill, while the Health Ministry had proposed a similar bill to establish a Central Drugs Authority (CDA).

As reported in earlier newsletter issues, the Medical Devices Regulations Bill proposes setting up a centralized authority to establish standards and ensure compliance for medical devices in India.

The CDA would also be a completely centralized licensing system. It would be responsible for issuing manufacturing licenses for medical licenses, conducting standards and quality monitoring, ensuring compliance, etc.

With such overlap, the Ministry of Health and Family Welfare has asked the DST to not go ahead with its proposed Medical Devices Regulations Bill. As of now, DST has not stated if they will formally withdraw their bill. There have been discussions of making the two bills complementary and combining the two. DST officials have also stated that establishing accredited laboratories to test and certify medical devices could be included so that the new central authority is not overwhelmed.