India drug ban; The central government has banned 16 fixed dose combination (FDC) drugs with immediate effect in view of concerns raised over safety and efficacy. Expert review found no solid medical basis for the use of these drugs. Keeping in mind the safety of the patients, the central government (…)
India drug ban; The central government has banned 16 fixed dose combination (FDC) drugs with immediate effect in view of concerns raised over safety and efficacy. Expert review found no solid medical basis for the use of these drugs.
Keeping in mind the safety of patients, the Central Government has banned the manufacture, sale and distribution of 16 fixed dose combination (FDC) medicines with immediate effect. These medicines include antibiotics, stomach pain medicines, diabetes medicines and some cosmetic and skin related products. The government has taken this action under Section 26A of the Drugs and Cosmetics Act, 1940.
According to government officials, a review by an expert committee, the Drugs Technical Advisory Board (DTAB) and its sub-committee, found that there is no solid medical basis for these drug combinations. Also, there is not enough scientific evidence to prove their benefits.
The review process was ongoing from 2021
The testing process of these medicines started in the year 2021. During this, available scientific studies and medical data were analyzed in detail. Drug companies and other concerned parties were also given an opportunity to present their case, but the expert committee was not satisfied with their arguments. Subsequently, in December 2024, the sub-committee recommended banning all 16 drug combinations.
Most frequently asked questions on antibiotic drugs
Banned drugs include antibiotic combinations like Amoxicillin + Serratiopeptidase, Amoxicillin + Serratiopeptidase + Lactobacillus Sporogenes, Cefuroxime + Serratiopeptidase and Cefadroxyl + Probenecid. Experts say that there is no clear medical benefit of giving some of the ingredients together in these medicines.
Including stomach pain and diabetes medicines
The government has also banned medicines used for stomach pain and cramps like Dicyclomine + Paracetamol + Clidinium Bromide. Apart from this, the combination of diabetes medicine called Gliclazide + Chromium Picolinate has also been banned. Experts say that the use of Chromium Picolinate in the treatment of diabetes is not recommended in any standard medical guideline.
Government emphasis on patient safety
The government says that drugs should be used only on scientific grounds and medical necessity. Combinations that offer no additional benefit to patients and may increase potential risks cannot be allowed to remain in the market. This decision of the government is being considered as an important step towards safe and rational use of medicines.
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