Giving priority to 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 medications include antibiotics, stomach pain and diabetes medications, as well as some cosmetic and skin care products. The government has taken this step under Section 26A of the ‘Drugs and Cosmetics Act, 1940’. According to government officials, the review conducted by an expert committee, the Drugs Technical Advisory Board (DTAB) and its sub-committee, found that there is no solid therapeutic basis for these drug combinations. Additionally, there is not enough scientific evidence to support their benefits.
**Review process going on since 2021**
The investigation of these medicines started in 2021. During this time, available scientific studies and medical data were analyzed. Pharmaceutical companies and other concerned parties were given an opportunity to present their views, but the Expert Committee did not agree with their arguments. Subsequently, the sub-committee recommended banning all 16 drug combinations in December 2024.
**Antibiotics under review**
Banned drugs include antibiotic combinations, such as amoxicillin + serratiopeptidase, amoxicillin + serratiopeptidase + Lactobacillus sporogenes, cefuroxime + serratiopeptidase and cefadroxil + probenecid. Experts say that the combination of specific elements present in these medicines has not provided any clear medical benefit.
**Medicines for stomach ache and diabetes also included**
The government has also banned medicines used for stomach pain and cramps, such as dicyclomine + paracetamol + clidinium bromide. Apart from this, the diabetes drug combination Gliclazide + Chromium Picolinate has also been banned. Experts say that the use of chromium picolinate for the treatment of diabetes is not recommended in any standard medical guideline. The government’s focus is on the safety of patients.
The government believes that medicines should be used only on a scientific basis and based on medical need. Drug combinations that provide no additional benefit to patients and may increase potential risks cannot be allowed to remain on the market. This decision of the government is being seen as an important step towards the safe and correct use of medicines.
