banned drug
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 ache 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, the review by the expert committee, Drugs Technical Advisory Board (DTAB) and its sub-committee found that these drug combinations have no solid medical basis. Also, there is not enough scientific evidence available to prove their benefits.
The review process was going on since 2021
The testing process of these medicines started in the year 2021. During this period, available scientific studies and medical data were analyzed. Pharmaceutical companies and other concerned parties were also given a chance to present their views, but the expert committee was not satisfied with their arguments. After this, in December 2024, the sub-committee recommended banning all 16 drug combinations.
Most questions on antibiotics
The banned drugs include antibiotic combinations like Amoxicillin + Serratiopeptidase, Amoxicillin + Serratiopeptidase + Lactobacillus Sporogenes, Cefuroxime + Serratiopeptidase and Cefadroxyl + Probenecid. Experts say that no clear medical benefit was found in giving some elements together in these medicines.
Medicines for stomach ache and diabetes also included
The government has also banned medicines for stomach pain and cramps like Dicyclomine + Paracetamol + Clidinium Bromide. Apart from this, diabetes drug combination named 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’s emphasis on patient safety
The government says that medicines should be used only on scientific basis and as per medical need. Combinations that do not provide additional benefit to patients and may increase potential risks cannot be allowed to remain on the market. This decision of the government is being considered an important step towards safe and rational use of medicines.
