The story so far

The Union Ministry of Health and Family Welfare recently banned the manufacture, sale, and distribution of 16 Fixed-Dose Combination (FDC) drugs nationwide. This restriction, targets therapeutically unjustified and potentially risky combinations of common antibiotics, painkillers, and skincare formulations, and is being strictly implemented with immediate effect across the country.

The nationwide ban imposed under Section 26A of the Drugs and Cosmetics Act, 1940 comes following a comprehensive review directed by the Supreme Court. An expert committee under the Drugs Technical Advisory Board (DTAB) noted that these formulations lacked clinical efficacy, provided no real therapeutic value, and posed risks of adverse side effects and antimicrobial resistance.

What are FDCs

An FDC is a pharmaceutical product that contains two or more active drugs combined in fixed proportions within a single dosage form, such as a tablet, capsule, syrup, or injection. FDCs are designed to improve patient compliance by reducing the number of medicines a patient needs to take and may enhance therapeutic effectiveness when the combined drugs have complementary actions. Common examples include combinations used for treating infections, diabetes, hypertension, and pain.

However, FDCs also have limitations, such as reduced flexibility in adjusting individual drug doses and a higher risk of adverse effects if the combination is irrational. Therefore, regulatory authorities evaluate FDCs for their safety, efficacy, and therapeutic justification, and may ban those that are considered unsafe, ineffective, or lacking scientific evidence.

Over the past decade, India has undertaken several major crackdowns on irrational FDCs. In March 2016, the Ministry of Health banned 344 FDCs. After legal challenges by pharmaceutical companies, the matter reached the Supreme Court of India, which, in 2017, directed a fresh scientific review by DTAB. Based on the DTAB’s recommendations, the government re-imposed bans on 328 FDCs and restricted six others in September 2018. Further reviews continued, and in 2024 the government banned 156 additional FDCs, including several commonly used cough, cold, fever, and pain medicines, describing them as irrational and lacking proven therapeutic benefit.

Why is the ban needed?

Welcoming the ban doctors said that ensuring patient safety and promoting evidence-based treatment is vital in treatment and care. Irrational drug combinations may increase the chances of adverse reactions, inappropriate antibiotic use, and antimicrobial resistance, making infections more difficult to treat over time. They have also advised that patients taking any of these medications should consult their doctor for suitable alternatives rather than discontinuing treatment on their own.

Sumit Aggarwal, director & head, internal medicine, Sarvodaya Hospital explained that several banned combinations, including those used to treat certain bacterial infections, such as amoxicillin + serratiopeptidase, cefuroxime + serratiopeptidase, and cefadroxil + probenecid, lacked adequate scientific justification and could pose risks when used indiscriminately.

Combinations that don’t work

Giving an example to explain doctors said that the Amoxicillin-Serratiopeptidase combination doesn’t make sense as Serratiopeptidase is an enzyme which decreases inflammation. Amoxicillin is essentially an antibiotic which will act on an infection. So combining these two is definitely an irrational combination.

Similarly, a combination of dicyclomine, paracetamol and clidinium bromide, could be considered irrational, as dicyclomine is an antispasmodic drug and adding a paracetamol to it d antispasmodic does not make sense; it creates a combination of drugs which is not required at all, said Neetu Jain senior consultant pulmonology critical care and sleep medicine, PSRI hospital. Another example she cited was dicyclomine with chlordiazepoxide, the latter being essentially a benzodiazepine, which induces sleep and is used for anxiety or it is used for depression. “So these are the kind of combinations banned by the government after a complete scientific review, and it is quite justified that these drugs should not be there in the market,’’ she said.

Manish Jangra, consultant dermatologist, Healing Hands, Multispeciality Clinic, noted that irrational combinations for skin care and treatment, sometimes combining traditional Indian systems with modern medicines is not recommended. There are no clinical studies proving the efficacy of mixing elements, such as Ayurvedic oils with Vitamin E , Vitamin A, glycerine etc. In fact some combinations could increase risk of irritant contact dermatitis and allergic contact dermatitis, he said.

Keeping up with developments

“Bans on FDCs when it comes to skin medications, especially steroids are important, but many times, companies change the FDC and re-launch. There is poor enforcement and patients avoiding proper treatment and care adds to the problem,’’ Dr. Jangra pointed out.

“When medicines are taken indiscriminately, they can expose patients to unnecessary side effects, increase the risk of adverse drug reactions and mask underlying illnesses,’’ said Vikram Jeet Singh, senior director (Unit -I) internal medicine, Aakash Healthcare. He added that most of the drug combinations which were banned by governments were Ayurvedic drug combination.

Doctors caution that not every drug combination available in the market necessarily translates into better treatment outcomes. Lakshman Ramachandran, consultant physician, Kailash Hospital noted that the latest move by the government will help ensure that patients receive therapies that are scientifically validated, safer, and more effective.