CDSCO waives local trials for drugs approved in major markets

Central Drugs Standard Control Organisation's (CDSCO) decision earlier this month to waive local clinical trials for selected drugs approved in select ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) markets, which offer significant therapeutic advances over the current standard of care, is welcome. This step will expedite access to cutting-edge therapies for Indian patients.

While New Drugs and Clinical Trials Rules, 2019 provided for the waiver of local clinical trials if a drug had been approved and marketed in certain countries, it remained unused due to a lack of clarity on eligible countries. The drugs regulator has now specified countries-the US, Britain, Japan, Australia, Canada and the EU-whose approved drugs will no longer require local clinical trials in India.

Local clinical trial requirements can lead to duplication of effort, increased costs and extended timelines for a drug developer to bring a new therapy to market. Breakthrough therapies often reach India several years after their global launch, leaving patients here at a disadvantage, especially those battling diseases with unmet medical needs. By eliminating this hurdle, CDSCO has reduced the time lag and alleviated the financial burden, making it feasible to introduce orphan drugs and advanced treatments like gene and cell therapies in India.


This policy shift benefits patients with rare diseases and conditions that progress rapidly. Swift access to proven treatments can be the difference between life and death. While some critics have voiced concerns about patient safety, these are mitigated by the stringent regulatory standards of the countries from which these drugs are being imported. Their rigorous approval processes ensure the safety and efficacy of drugs before they are approved for use in the general population.

Moreover, Indian clinical trial rules state that a waiver is contingent on specific conditions:

• A new drug must have no reported major adverse events
• There must be no evidence that enzymes or genes in the Indian population affect the drug's safety and efficacy
• The applicant must commit to conducting post-marketing Phase 4 trials.

To ensure tangible benefits reach patients, CDSCO should:

• Have oversight of real-world data and evidence generated in post-marketing trials
• If a drug fails to deliver the promised medical or financial benefits, regulatory interventions should be considered
• CDSCO shouldn't limit this waiver to new drugs but extend it to biosimilars, which offer cost-effective, high-quality alternatives to expensive biologics that can make advanced treatments for conditions, such as cancer, autoimmune diseases and diabetes more accessible to patients in India

The waiver's significance is underscored by past experiences, such as during the peak of the Covid. Though CDSCO had not approved Tocilizumab for treatment of Covid patients (and arthritis), it was included in India's guidelines in June 2020 as an investigational therapy for the disease.

CDSCO-approved drugs like favipiravir and paxlovid under emergency use authorisation (EUA) do not have to undergo standard phase-wise clinical trials. The rapid availability of these treatments and Covid vaccines proved critical in tackling the pandemic and underscored the need for agility during health crises.

India is not alone in taking such a step. Mexico, Indonesia, Panama and Taiwan have allowed the sale of new drugs approved in countries with stringent regulatory standards. Saudi Arabia and the UAE also prioritise access to innovative treatments through accelerated drug registration mechanisms.

CDSCO's decision balances patient safety with the imperative of timely access to lifesaving treatments while delivering on India's commitment to enhancing healthcare accessibility and offering the hope of a better life to countless patients.

The writer is chairperson, Biocon and Biocon Biologics