The draft amendment to the New Drugs and Clinical Trials Rules, 2019 proposes a significant change in how ethics committees are registered in India, aiming to tighten oversight while reducing procedural delays. The amendment seeks to remove the provision for provisional certification and instead allow ethics committees to move directly to final registration after scrutiny by the regulatory authority.
Under the existing framework, ethics committees are granted a provisional registration that allows them to begin functioning while they undergo a more detailed evaluation for final approval. The draft amendment proposes to eliminate this interim step altogether. If implemented, committees would be permitted to operate only after clearing the full scrutiny process and securing final registration, effectively raising the entry bar for oversight bodies involved in clinical trials and biomedical research.
According to reports, the proposed change is positioned as a time-saving measure for compliant committees, as it removes an additional regulatory layer and shortens the overall registration timeline. By allowing committees that meet all requirements to directly obtain final registration, the regulator aims to streamline approvals and reduce administrative back-and-forth. At the same time, the amendment is designed to prevent non-compliant or inadequately prepared ethics committees from functioning even temporarily, closing a loophole that allowed them to operate during the provisional period.
From a regulatory standpoint, the move reflects a shift towards stricter upfront scrutiny rather than post-approval correction. Ethics committees play a critical role in safeguarding the rights, safety and well-being of clinical trial participants. Allowing committees that fail to meet standards to operate, even provisionally, has been a long-standing concern among regulators and policy experts. The draft amendment addresses this by ensuring that only committees that fully comply with prescribed norms can review and approve clinical trials.
However, the proposal also raises questions about capacity and transition. Smaller institutions and newly constituted ethics committees may face challenges in meeting all requirements in one go, potentially slowing down the establishment of new committees, especially in emerging research centres. There are also concerns about whether the regulatory authority has sufficient resources to conduct timely and thorough scrutiny, as delays at the registration stage could impact the start of clinical trials.
For the pharmaceutical and clinical research industry, the amendment signals a push for higher governance standards and greater accountability in trial oversight. While stricter controls may initially increase compliance costs and preparation time, industry experts note that a more robust and credible ethics review system could strengthen confidence in India’s clinical research ecosystem over the long term.
Overall, the draft amendment underscores the regulator’s intent to balance efficiency with integrity. By removing provisional certification, the government aims to speed up approvals for compliant ethics committees while ensuring that those failing scrutiny are kept out of the system entirely. The final impact will depend on how the amended rules are implemented and whether the regulatory process can deliver both speed and rigour in practice.