Govt Bans 16 Fixed-Dose Drug Combinations Over Safety Concerns

At least 16 fixed-dose combination (FDC) drugs used across various therapeutic categories, including dermatological preparations, pain-relief medicines, antispasmodics and antibiotic formulations, will no longer be available in the market in the country.

The Union Health Ministry on Saturday announced that it has prohibited their manufacture, sale and distribution as they lack therapeutic justification and may pose risks to public health.

The ban came into force immediately following a notification issued on June 19.

The decision follows a detailed scientific review ordered in line with directions of the Supreme Court. It is aimed at removing irrational drug combinations from the market and promoting the rational use of medicines, a senior Health Ministry official said.

Fixed-dose combinations contain two or more active pharmaceutical ingredients in a single formulation. While many such products are clinically useful and improve patient compliance, experts have long expressed concern over combinations that offer little additional benefit and may increase the risk of adverse effects, irrational prescribing and antimicrobial resistance.

The latest action has been taken under Section 26A of the Drugs and Cosmetics Act, 1940, which empowers the Central government to prohibit drugs in public interest.

According to the official, the decision is based on recommendations of an Expert Committee constituted by the Drugs Technical Advisory Board (DTAB), the country's highest statutory body on technical matters relating to drugs.

The committee reviewed several FDCs available in the market and assessed whether they had a sound scientific rationale, therapeutic value and an acceptable safety profile.

After examining the evidence, it concluded that 16 combinations did not offer benefits that outweighed the potential risks and recommended their prohibition.

The banned formulations include combinations such as Acetyl Salicylic Acid with Ethoheptazine; Dicyclomine with Paracetamol and Clidinium Bromide; Dicyclomine, Paracetamol, Clidinium Bromide and Chlordiazepoxide; Gliclazide with Chromium Picolinate; and Paracetamol with Lignocaine.

Several antibiotic combinations have also been prohibited. These include Amoxicillin with Serratiopeptidase, Amoxicillin with Serratiopeptidase and Lactobacillus Sporogenes, Amoxicillin with Cloxacillin, Lactic Acid Bacillus and Serratiopeptidase, Cefadroxyl with Probenecid, and Cefuroxime with Serratiopeptidase.

The list also includes several dermatological and cosmetic preparations containing combinations of aloe vera extracts, vitamins, oils and herbal ingredients.

The move comes amid growing concern among public health experts over irrational prescribing practices and the continued availability of medicines that are not backed by adequate scientific evidence.

India is one of the world's largest markets for fixed-dose combination drugs. Over the years, concerns have repeatedly been raised about the safety and efficacy of several such products available in the country.

These concerns led to a series of scientific reviews, legal challenges and regulatory interventions aimed at identifying irrational combinations.

The government has previously banned several irrational FDCs after similar reviews. Such measures are intended to promote evidence-based prescribing and reduce unnecessary exposure to medicines whose clinical benefits remain unproven.

Particular attention has been given to antibiotic-containing combinations because inappropriate antibiotic use is a major driver of antimicrobial resistance, a growing global public health threat.

Dr. Sangeeta Sharma, Professor and Head of the Department of Neuropsychopharmacology at the Institute of Human Behaviour and Allied Sciences (IHBAS), Delhi, welcomed the decision, describing it as an important step towards promoting rational drug use. Dr. Sharma, who as the President of Delhi Society for Promotion of Rational Use of Drugs (DSPRUD), an organisation engaged in creating awareness on the misuse of antibiotics and antimicrobial resistance, said irrational fixed-dose combinations often encourage indiscriminate antibiotic use, increase treatment costs and contribute to the growing threat of drug-resistant infections.

The Ministry has directed all State Drug Controllers and enforcement agencies to ensure strict implementation of the notification.

Manufacturers, importers, distributors and retailers have been asked to take immediate corrective measures and comply with the ban.

With the notification now in force, the manufacture, sale, distribution and supply of the identified 16 fixed-dose combinations for human use will no longer be permitted anywhere in the country.