Central Idea

The Indian pharmaceutical industry has faced international scrutiny for exporting allegedly contaminated drugs, leading to adverse health outcomes and deaths in several countries.
Instances of sub-standard drugs, including cough syrups and anaesthetic medications, have raised concerns about the quality and safety of Indian pharmaceutical products.

Lack of Regulatory Action

Probing Contamination: Despite reports of deaths and adverse reactions linked to contaminated drugs, the Ministry of Health and Family Welfare has not provided information on the investigations launched.
Regulatory Responsibility: The Central Drugs Standard Control Organisation (CDSCO) is responsible for licensing and prosecuting pharma companies, while State governments handle regulatory enforcement.

Loss of Confidence: Countries like Gambia, Nigeria, Sri Lanka, and Cameroon have raised red flags on drugs manufactured in India due to safety concerns and sub-standard quality.
Independent Assessments: Some countries, such as Mozambique, have established independent systems to check drug samples before export, highlighting the need for rigorous inspections.

Inadequate Punitive Measures: Merely suspending or cancelling manufacturing licenses is deemed insufficient to deter pharmaceutical companies from non-compliance.
Legal Provisions: The Drugs and Cosmetics Act allows for imprisonment for life for manufacturers violating good manufacturing practices, but prosecutions are often delayed and convictions are rare.

Shortage of Drug Inspectors: The CDSCO faces a shortage of drug inspectors, hindering effective oversight and inspections.
Administrative Errors: Errors committed by drug inspectors, such as incomplete testing processes and improper documentation, contribute to poor conviction rates.

To restore its reputation and ensure the safety of pharmaceutical products, India needs to strengthen its regulatory framework and inspection processes.
Robust inspections, timely reporting of non-compliance, and effective prosecution of offenders are necessary to address the concerns regarding contaminated drugs.
Adequate allocation of resources and addressing the shortage of drug inspectors will play a crucial role in enhancing the effectiveness of drug regulation in India.

[Sansad TV] Perspective: Common Drugs Standards