Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Why are Indian Drugmakers under scrutiny?


From UPSC perspective, the following things are important :

Prelims level: NA

Mains level: Drug standards control in India

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 and Independent Assessments

  • 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.

Punishment and Prosecution

  • 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.

Challenges in Drug Regulation

  • 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.

Also read:

[Sansad TV] Perspective: Common Drugs Standards

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