India’s drug regulator has clarified that pharmaceutical companies cannot use the participation of Indian patients in global clinical trials to bypass the country’s regulatory approval process.
The Central Drugs Standard Control Organisation (CDSCO) has directed that any new drug not approved anywhere in the world must undergo the complete domestic regulatory review before it can be marketed in India.
Comprehensive Safety and Efficacy Assessment
The clarification comes after a rise in applications seeking permission to import and market drugs that remain under review by foreign regulators or have completed Phase III global clinical trials involving Indian participants.
As per The Economic Times, CDSCO’s internal technical committee examined the issue and concluded that such applications must be processed by the regulator’s Investigational New Drug (IND) division.
Under the New Drugs and Clinical Trials Rules, 2019, companies must submit comprehensive non-clinical and clinical data for evaluation. Therefore, participation of Indian patients in an international trial alone will not qualify a drug for marketing approval in India.
Focus on Patient Safety
The regulator’s decision reinforces the need for an independent assessment of every new drug before it reaches Indian patients. CDSCO will evaluate the available evidence for safety and efficacy through the established regulatory process.
Consequently, the move is expected to strengthen oversight of innovative medicines and ensure that globally unapproved drugs meet India’s regulatory and safety requirements before entering the domestic market.