New Delhi: In a major move aimed at protecting public health, the Union Ministry of Health and Family Welfare has banned the manufacture, sale, and distribution of 16 Fixed Dose Combinations (FDCs) across India with immediate effect. The decision comes after a scientific review found that these drug combinations lacked proper therapeutic justification and could pose risks to patients.
What Are Fixed Dose Combinations?
Fixed Dose Combinations (FDCs) are medicines that combine two or more active ingredients into a single product. While many FDCs offer benefits and convenience, health experts say some combinations may not provide additional medical advantages and could increase health risks.
Why Did the Government Ban Them?
The action follows directions from the Supreme Court, which ordered a detailed review of various FDCs available in the country.
Following the court’s directions, the Drugs Technical Advisory Board (DTAB) formed an Expert Committee to examine the safety, effectiveness, and medical value of several drug combinations.
After reviewing the available scientific evidence, the committee found that 16 FDCs lacked therapeutic justification. The committee also concluded that the potential risks outweighed the benefits of these medicines.
Based on these findings, the Health Ministry invoked Section 26A of the Drugs and Cosmetics Act, 1940, to prohibit the products.
Types of Medicines Affected
The banned combinations belong to different categories of medicines, including:
- Pain relief medicines
- Antispasmodic drugs
- Dermatological products
- Antibiotic-based formulations
- Diabetes-related medicines
Some of the prohibited combinations include:
- Acetyl Salicylic Acid + Ethoheptazine
- Dicyclomine + Paracetamol + Clidinium Bromide
- Gliclazide + Chromium Picolinate
- Paracetamol + Lignocaine
- Amoxicillin + Serratiopeptidase
- Cefuroxime + Serratiopeptidase
- Cefadroxyl + Probenecid
Immediate Nationwide Ban
The ministry has directed all State Drug Controllers, regulatory authorities, and enforcement agencies to ensure strict implementation of the ban. Manufacturers, distributors, importers, and retailers have also been instructed to stop the manufacture, sale, distribution, and supply of the identified products immediately.
Focus on Safe and Effective Medicines
The Health Ministry said the move reflects the government’s commitment to ensuring that only safe, effective, and scientifically validated medicines remain available to the public.
The ministry has previously banned several irrational drug combinations after expert reviews. Officials say these steps help improve patient safety and promote evidence-based healthcare practices.
With the latest notification now in force, the 16 prohibited Fixed Dose Combinations can no longer be manufactured, sold, or distributed anywhere in India.