CDSCO Releases a List of “not of standard quality” Drugs

Syllabus: GS2/ Health

In News

• A recent quality control check by the Central Drugs Standard Control Organisation (CDSCO) has raised alarms over the safety and effectiveness of 53 medicines, including widely used drugs like Paracetamol and Pan D.

About

• Several medicines were found to be “not of standard quality” (NSQ), with some being declared spurious by drug testing labs.
• This raises serious public health concerns and it also highlights failure of several states in submitting data on quality of drugs. 
• Earlier, the drug regulator has actively banned risky fixed-dose drug combinations, further highlighting the need for stricter quality control measures in pharmaceuticals.

Drug Regulation in India

• Drug regulation in India is primarily governed by the Central Drugs Standard Control Organisation (CDSCO), operating under the Ministry of Health and Family Welfare. 
  • CDSCO acts as the National Regulatory Authority (NRA) of India. The Drug Controller General of India (DCGI) heads the CDSCO and is responsible for the approval of new drugs and clinical trials, along with setting standards for drugs.
  • Each state has its own regulatory authority to monitor the manufacturing, sale, and distribution of drugs within its jurisdiction.
• The regulation of drugs and pharmaceuticals in India is governed under the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945, which aim to ensure the safety, efficacy, and quality of drugs sold and consumed in India.

Issues Associated with Drug Regulation in India

• Quality Control Issues: Frequent reports of substandard and spurious drugs highlight the gaps in quality control. 
• Inadequate Monitoring and Enforcement: The capacity of both CDSCO and State Drug Control Authorities is limited in terms of resources and manpower. 
• Lack of Comprehensive Post-Market Surveillance: There is a lack of a robust post-marketing surveillance system to ensure that drugs continue to meet safety standards after they are marketed. 
• Fragmented Regulation: The division of regulatory responsibilities between the central and state governments often leads to coordination issues, inefficiencies, and variations in enforcement across states.
• Other issues like, lack of trained manpower, lack of transparency in clinical trials, pressure on the regulatory bodies for approval etc.
  • The Mashelkar Committee (2003) identified the lack of trained and adequate personnel as a significant issue in India’s drug regulatory framework. 

Way Ahead for Improvement

• Strengthening Regulatory Infrastructure: India needs to augment the capacities of both central and state drug regulatory authorities, with better resources, skilled personnel, and infrastructure to ensure robust drug regulation.
• Enhanced Coordination Between Central and State Agencies: Improved collaboration and sharing of information between CDSCO and State Drug Control Authorities is necessary to address issues like inconsistent regulation and enforcement.
• Focus on Quality Assurance: There should be a stringent focus on improving Good Manufacturing Practices (GMP), ensuring that manufacturers adhere to the highest quality standards.
• Robust Post-Marketing Surveillance: A comprehensive post-marketing surveillance system needs to be established to continuously monitor the safety, efficacy, and quality of drugs after they are approved and released in the market.
• Establishment of National Drug Authority: As recommended by the Mashelkar committee to revamp the structure of drug regulation. 

Source: TH