Following directions from the Supreme Court mandating a comprehensive review of Fixed Dose Combinations available in the country, the Union Ministry of Health and Family Welfare recently prohibited the manufacture, sale and distribution of 16 Fixed Dose Combinations (FDCs). These include certain antibiotic combinations, antispasmodic combinations, cosmetic and topical products, and also diabetes and pain-related combinations.
In its statement, the Ministry noted that after reviewing clinical data, the 16 specific combinations offered “no real therapeutic value” to patients.
According to the official press statement, the Drugs Technical Advisory Board (DTAB) constituted an Expert Committee to examine various FDCs and identify those that are “irrational, lack therapeutic justification, or may pose risks to human health“.
DISCLAIMER: This article is based on information from the public domain and/or the experts we spoke to. Always consult your health practitioner before starting any routine.
Here are the 16 FDC drugs banned by the Centre with immediate effect:
1 Acetyl Salicylic Acid + Ethoheptazine
2 Aloe Extract + Allantoin + Alpha Tocopherol Acetate + D-Panthenol + Vitamin A
3 Aloe Extract + Vitamin E + Dimethicone + Glycerine
4 Aloe Vera + Jojoba Oil + Vitamin E
5 Aloe Vera + Orange Oil
6 Aloe Vera + Jojoba Oil + Wheat Germ Oil + Tea Tree Oil
7 Aloe Vera + Vitamin E + Herbal Preparation
8 Dicyclomine + Paracetamol + Clidinium Bromide
9 Dicyclomine + Paracetamol + Clidinium Bromide + Chlordiazepoxide
10 Gliclazide + Chromium Picolinate
11 Paracetamol + Lignocaine
12 Amoxicillin + Serratiopeptidase + Lactobacillus Sporogenes
13 Amoxicillin + Cloxacillin + Lactic Acid Bacillus + Serratiopeptidase
14 Amoxicillin + Serratiopeptidase
15 Cefadroxyl + Probenecid
16 Cefuroxime + Serratiopeptidase
The notification issued under Section 26A of the Drugs and Cosmetics Act, 1940, have come into immediate effect.
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What do medical experts have to say?
Dr Aniket Mule, consultant, internal medicine, KIMS Hospitals, Thane, said that the government’s decision emphasises an important principle in modern medicine: each part of a drug combination should have a clear scientific purpose and proven benefit. “Over the years, some fixed-dose combinations were sold without strong evidence that they worked better than individual medicines. Unnecessary combinations can lead to more side effects, drug interactions, higher costs, and confusion about the cause of any negative reactions,” said Dr Mule.
Dr Shweta Nakhawa, consultant dermatologist, KIMS Hospitals, Thane, noted that several of the banned fixed-dose combinations are in the skincare and dermatology category, especially those with multiple ingredients like aloe vera extracts, vitamins, oils, and other additives. “While many of these ingredients are considered safe on their own, there is concern about whether combining them in one product actually offers a real benefit backed by scientific evidence,” Dr Nakhawa remarked.
Experts suggest that there is no need to panic (Photo: Getty Images/Thinkstock)
Dr Rajiv Kovil, diabetes and obesity specialist, Zandra Healthcare, appreciated the move and said that it’s an important “rational and evidence-based prescribing”. “As diabetologists, many of us may have prescribed some of these formulations when they were available in the market. The objective is not to question individual molecules, but to evaluate whether the combination itself offers additional efficacy, safety, pharmacokinetic advantage, or patient benefit,” said Dr Kovil.
However, regulatory science continuously evolves. “In the case of Gliclazide plus Chromium Picolinate, gliclazide remains a well-established and evidence-based antidiabetic drug with extensive outcome data. Chromium picolinate has shown inconsistent metabolic benefits, and robust randomised controlled trial evidence supporting its combination with gliclazide is limited. International guidelines do not endorse this combination. Therefore, the government’s emphasis on therapeutic justification and scientific validation is welcome,” continued Dr Kovil.
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Importantly, Dr Kovil noted that there is no clear “pharmacokinetic or pharmacodynamic advantage of combining these agents in a fixed-dose preparation”, indicating that prescribing two medications together in a single, combined pill offers no medical benefit compared to when they are taken as separate pills.
Dr Kovil reiterated that the objective is not to discredit individual molecules but to ensure that only combinations with proven efficacy, safety, and meaningful patient benefit remain available for clinical use.
For patients, experts only have one message: not to panic.
“Those taking any of the affected medicines should not stop treatment suddenly. Instead, they should talk to their doctor about suitable alternatives. The ban is part of a larger effort to encourage sensible prescribing practices and make sure patients receive treatments backed by solid clinical evidence and established safety data,” clarified Dr Mule.
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Dr Nakhawa concurred and that this regulatory action emphasises the need for scientifically validated formulations instead of relying on blends that may look helpful but lack enough clinical support. “Patients using skincare products affected by the ban should consult a dermatologist to find suitable alternatives instead of trying to replace treatments on their own,” Dr Nakhawa said.
DISCLAIMER: This article is based on information from the public domain and/or the experts we spoke to. Always consult your health practitioner before starting any routine.