Mains Paper 2: Governance | Issues relating to development and management of Social Sector/Services relating to Health, Education, Human Resources
From UPSC perspective, the following things are important:
Prelims level: In-Vitro Diagnostics (IVD) Devices, DTAB, Medical Devices Rule
Mains level: New rules seek to remove regulatory bottlenecks to Make in India while ensuring availability of better medical devices.
Clinical Trials of Medical Devices
- Medical devices under local rules are classified based on associated risks, into Class A (low risk), Class B (low moderate risk), Class C (moderate high risk) and Class D (high risk).
- The manufacturers of medical devices are required to meet risk proportionate regulatory requirements that have been specified in the rules and are based on best international practices.
- As of now, all medical devices that fall under regulation have to undergo single or multiple clinical trials to prove their performance and quality in comparison to products currently available in the market.
- Conduct of clinical investigations while following the international practices is conducted in a manner that ensures objectives of patient safety and welfare and discovery of new medical devices.
Proposed Amendment in Medical Devices Rules
- IVDs include all blood testing techniques, tests that can detect diseases, conditions or infections for major conditions such as HIV, HBV (Hepatitis B), HCV (Hepatitis C).
- The government has proposed to do away with clinical trials for in-vitro diagnostic (IVD) devices with the aim of speeding up availability of such devices in India.
- The Union health ministry will now release a notification to this effect, after a meeting of the Drug Technical Advisory Board (DTAB) at which the board agreed to the proposal to amend the provisions of the Medical Devices Rules
What are the amendments?
- The board deliberated the matter and agreed to the proposal to amend the provisions in Rule 64 making it identical for waiver of clinical performance evaluation of in-vitro diagnostic medical devices.
- This is in line with a waiver given for medical devices under Rule 63 of the Medical Device Rules.
What are the benefits of doing so?
- The new rules seek to remove regulatory bottlenecks to make in India, facilitate ease of doing business while ensuring availability of better medical devices for patient care and safety.
- Medical device experts believe that the move will help importers to a large extent as the exemption of trials would also mean accelerating approval of state-of-the-art devices.
But it raises few questions as well
- The question is whether the US, Japan and EU (European Union) will give a similar reciprocal advantage to Indian exporters and waive off the need for clinical evaluation if such devices are sold in India.
- Regulation is not only about patient’s safety. It is also about parity.