What is Kiran Mazumdar-Shaw's proposal for India's drug regulation?

She proposes a dual-agency model where ICMR handles scientific review and CDSCO handles final approval and licensing.

How will ICMR and CDSCO work together under the new proposal?

ICMR will evaluate clinical trial protocols and issue a Scientific Determination and Ethics Concurrence, with CDSCO then granting final regulatory approval.

What is the main goal of Kiran Mazumdar-Shaw's regulatory reform plan?

The primary goal is to boost research and innovation of new drugs and emerging treatment modalities in India.

Home / Health / Biotech Chief Proposes Drug Approval Overhaul

Biotech Chief Proposes Drug Approval Overhaul

24 Nov

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Summary

Biocon chairperson suggests bifurcating drug approval process.
Proposal aims to speed up new drug research and innovation.
ICMR would handle scientific review, CDSCO final approval.

Biotech Chief Proposes Drug Approval Overhaul

Kiran Mazumdar-Shaw, executive chairperson of Biocon, has put forth a proposal to revamp India's drug regulatory processes, aiming to foster greater research and innovation.

Her suggestion to NITI Aayog outlines a dual-agency model, dividing the complex drug approval pathway. This model would assign the Indian Council of Medical Research (ICMR) the crucial role of conducting rigorous pre-licensing scientific reviews for safety and efficacy.

Subsequently, the Central Drugs Standard Control Organisation (CDSCO) would handle the final regulatory approval and licensing. This division of responsibilities, with ICMR focusing on scientific determination and CDSCO on regulatory oversight, is intended to bring enhanced speed, clarity, and accountability to the system.

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