Poorly Manufactured Drugs

Published On:

Poorly manufactured drugs pose significant public health risks, requiring stricter regulation, better information sharing, and stronger enforcement mechanisms.

India faces challenges with substandard drugs, as incidents of non-standard quality (NSQ) drugs, including fatalities, highlight regulatory gaps. Pharmaceutical companies in West Bengal and other states can sell drugs nationwide due to central licensing under the Drugs and Cosmetics Act, 1940, limiting states’ regulatory power. Out of 894 drug samples tested in Karnataka, 601 failures were linked to manufacturers outside the state, showing the need for better oversight.

States currently rely on long prosecution processes, which are ineffective. Improved information sharing is crucial. A centralized database of drug testing reports and inspection details would help track manufacturers’ quality records and inform procurement agencies. This would assist drug inspectors in identifying high-risk manufacturers and prevent NSQ drugs from entering public healthcare systems.

The Union Ministry of Health must maintain a central register of blacklisted manufacturers to validate claims by companies and ensure safer procurement practices. Stronger legal powers should allow states to block manufacturers with unresolved NSQ cases from selling drugs. States must also prioritize drugs from regions with stringent regulatory practices to enhance public health safety.

Effective solutions, such as centralized reporting systems and stricter enforcement, require collaboration between state and central authorities. Central legislation must empower states to tackle manufacturing violations, ensuring accountability and improving the quality of medicines nationwide.