The Central Drugs Standard Control Organisation (CDSCO) has raised alarms over widespread drug quality issues in India. According to their latest alert, over 50 drugs, including common medications like paracetamol, Pan D, calcium, and vitamin D3 supplements, have been deemed “not of standard quality.” The report also highlights the failure of several states to submit necessary data on drug quality, raising concerns about the effectiveness of drug regulation in India.
Overview of Drug Regulation in India
India’s drug regulation is governed by the Drugs and Cosmetics Act, 1940, and its corresponding rules. The CDSCO, led by the Drugs Controller General of India (DCGI), is responsible for monitoring drug safety and quality. Each month, CDSCO releases a “Not of Standard Quality” (NSQ) list. Additionally, the National Pharmaceutical Pricing Authority (NPPA) monitors drug prices and availability.
While the central government plays a key role, drug regulation is also managed at the state level through State Drug Regulating Agencies (SDRAs), leading to uneven implementation.
Key Issues in Drug Regulation
Uneven Implementation: Fixed Dose Combinations banned at the central level may still be licensed by state units.
Officer Discretion: The Drugs and Cosmetics Act lacks clear metrics to guide drug regulation.
Lack of Resources: The Mashelkar Committee identified insufficient trained personnel and infrastructure.
Way Forward
Technology Integration: Encouraging the use of digital platforms like XLN to streamline services.
National Drug Authority: Revamping the regulatory structure as recommended by the Mashelkar Committee.
Recall Orders: Introducing a robust system to ensure implementation of drug recall orders.
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