Blacklisted and Banned Medicines in India – Rules, Key Cases & Impact on Public Health

Published on: 8/12/2025

Medipectus Pharma brings you an in-depth guide to understanding banned medicines in India, blacklisted pharma companies, and how these rules impact PCD Pharma Franchise businesses. Our goal is to help patients, healthcare providers, and distributors stay informed and compliant.

Banned vs Blacklisted – What’s the Difference?

In India, the Central Drugs Standard Control Organization (CDSCO) regulates all medicines to ensure safety, quality, and effectiveness. There are two important terms to know:

  • Banned Medicines – These are drugs that cannot be manufactured, sold, or prescribed due to safety risks, poor effectiveness, or harmful compositions.
    Example: Painkillers, cough syrups, or antibiotics that cause serious side effects.
  • Blacklisted Pharma Companies – Companies added to a government blacklist for making poor-quality, fake, or substandard medicines. Blacklisted companies cannot sell medicines to government hospitals or participate in public tenders.

Who Controls Medicine Regulations in India?

The CDSCO is the apex body for drug regulation in India. Its key roles include:

  • Approving new medicines and clinical trials.
  • Setting quality control standards.
  • Inspecting manufacturing facilities.
  • Banning unsafe medicines under Section 26A of the Drugs and Cosmetics Act, 1940.
  • Coordinating with State Drug Authorities for local enforcement.

Key Laws Governing Medicines in India

  • Drugs and Cosmetics Act, 1940 & Rules, 1945 – Main legal framework for drug manufacturing, sale, and distribution.
  • WHO-GMP Guidelines – Good Manufacturing Practices for consistent quality.
  • Section 26A Power – Allows the government to ban any drug if it is unsafe or ineffective.

Types of Banned Medicines in India

  1. Fixed Dose Combinations (FDCs) – Multiple drugs in one pill that: Example: In 2016, 344 FDCs were banned, followed by 328 more in 2018, 14 in June 2023, and 156 in August 2024.
    • Have no proven medical benefit.
    • Cause more side effects.
    • Lead to overmedication.
  2. Single-Ingredient Drugs – Banned for safety concerns:
    • Rofecoxib – Painkiller linked to heart attacks.
    • Nimesulide (under 12 years) – Risk of liver damage in children.
    • Sibutramine – Weight-loss drug with heart risk.
    • Dextropropoxyphene – Painkiller linked to overdoses.

Why Medicines Get Banned

  • Safety Risks outweigh benefits.
  • No proven efficacy.
  • Misleading claims in marketing.
  • Harmful side effects or contamination.
  • Antibiotic resistance risks from misuse.

How Bans and Blacklisting Work

  • Expert Review: Drugs Technical Advisory Board (DTAB) studies drug safety.
  • Gazette Notification: Government officially announces bans.
  • Enforcement: CDSCO and State Authorities ensure compliance.
  • Blacklisting: Companies producing “Not of Standard Quality” drugs can be banned from government procurement.

Impact on PCD Pharma Franchise Businesses

All CDSCO rules apply to PCD Pharma Franchise companies, wholesalers, and distributors.
If a medicine is banned:

  1. Stop sales immediately.
  2. Check official CDSCO updates (not just news reports).
  3. Separate banned stock from other products.
  4. Inform all distributors & retailers.
  5. Coordinate recalls with manufacturers.
  6. Follow CDSCO recall timelines – 24 hours to stop sales, 72 hours to collect stock.
  7. Seek legal advice if there is pending court action.

Risks of Ignoring Ban Orders

  • Heavy fines and license cancellation.
  • Legal action and imprisonment.
  • Loss of brand reputation.
  • Customer safety risks and lawsuits.

Medipectus Pharma’s Commitment to Quality

At Medipectus Pharma, we strictly follow WHO-GMP manufacturing standards and CDSCO guidelines.
We do not deal in banned medicines and ensure our PCD Pharma Franchise partners are updated on every regulatory change.

We believe in:

  • Safe, effective, and high-quality medicines.
  • Transparent communication with our distributors.
  • Zero tolerance for substandard or counterfeit products.

Conclusion

India’s drug regulatory system plays a crucial role in protecting public health. By staying informed about banned drugs and blacklisted companies, PCD Pharma businesses can remain compliant and protect their customers.

Medipectus Pharma ensures every product meets the highest quality standards so that patients get safe and effective medicines they can trust.