India Regulator Mandates Full Review of Unapproved Drugs

India's central drug regulator has announced that any new drug not yet approved anywhere in the world must undergo the full regulatory process in the country.

Background

This decision comes after a rise in applications from companies to import and market new drugs that are either still under review by foreign regulators or have completed phase III global clinical trials with Indian subjects participating. The Central Drugs Standard Control Organisation (CDSCO) examined the matter through its internal technical committee and determined that such investigational new drug applications require processing by the IND division of the CDSCO.

The regulator stated that these applications must be thoroughly evaluated for safety and efficacy before reaching the Indian market, rather than being approved based on trials conducted elsewhere. This means that companies cannot use the participation of Indian subjects in a global trial as a shortcut to market approval in India.

Regulatory Process

According to the regulator, all such applications will be examined and processed by the IND division under the New Drugs and Clinical Trials Rules, 2019. The drug will have to go through the full regulatory process, with the same scrutiny applied to any new drug seeking entry into the Indian market. This includes a comprehensive evaluation of non-clinical and clinical data in accordance with the provisions of the NDCT Rules, 2019.

Implications

This move sets a clear boundary for companies seeking to market new drugs in India. The regulator aims to ensure that any new drug cleared through this route is thoroughly evaluated for safety and efficacy before it reaches Indian shores. This decision is expected to impact the pharmaceutical industry, particularly companies that have been relying on global trials to fast-track market approval in India.

Compliance

Companies must now comply with the full regulatory process for new drugs not yet approved globally. This includes submitting detailed data on non-clinical and clinical trials, as well as undergoing rigorous evaluation by the IND division of the CDSCO. The regulator's decision is intended to protect Indian patients by ensuring that only safe and effective drugs are approved for marketing in the country.