Health Sector – UHC, National Health Policy, Family Planning, Health Insurance, etc.

Govt may scrap trials for some IVD devices


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

  1. 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).
  2. 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.
  3. 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.
  4. 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

  1. 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).
  2. 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.
  3. 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?

  1. 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.
  2. 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?

  1. 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.
  2. 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

  1. 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.
  2. Regulation is not only about patient’s safety. It is also about parity.
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