India Bans 16 Drug Combinations Deemed Lacking Therapeutic Justification

16 popular drug combinations have been banned by the Indian government citing they lack "therapeutic justification" and their continued use was not considered beneficial in relation to the potential risks involved.

"In a significant step towards safeguarding public health and promoting the rational use of medicines, the Ministry of Health and Family Welfare has issued notifications under Section 26A of the Drugs and Cosmetics Act, 1940, prohibiting the manufacture for sale, sale and distribution for human use of 16 Fixed Dose Combinations (FDCs). The notifications have come into force with immediate effect," the government has said.

The prohibited formulations span a range of therapeutic categories, including certain dermatological preparations, analgesic (painkillers) and antispasmodic (muscle relaxants) medicines, and antibiotic-based combinations.

"Based on the scientific assessment and recommendations of the Expert Committee, the Government has taken action against 16 FDCs that were found to lack therapeutic justification and whose continued use was not considered beneficial in relation to the potential risks involved. The prohibited FDCs belong to various therapeutic categories, including certain dermatological preparations, analgesic and antispasmodic medicines, and antibiotic-based formulations," the Centre has said.

"The Ministry noted that this action is in line with the Government’s continuing efforts to ensure that only safe, effective and scientifically validated medicines are available to the public. In previous instances as well, several irrational FDCs were prohibited following detailed scientific review, reinforcing the commitment of the Government towards patient safety and evidence-based healthcare. Accordingly, the manufacture for sale, sale, distribution and supply of the identified 16 FDCs for human use shall stand prohibited with immediate effect across the country," it added.

Here's the complete list of banned drug combinations:

Acetyl Salicylic acid + Ethoheptazine

Aloe Extract + Allantoin + Alphatocopherol Acetate +D-Penthenol + Vitamin A

Aloe Extract +Vitamin E + Dimethicone + Glycerine

Aloe Vera +Jojoba Oil +Vitamin E

Aloe vera + Orange oil

Aloe vera + Jojoba oil + Wheat germ oil + Tea tree oil

Aloe vera + Vitamin E + Herbal

Dicyclomine + Paracetamol + Clidinium Bromide

Dicyclomine +Paracetamol + Clidinium Bromide + Chlordiazepoxide

Gliclazide + Chromium Picolinate

Paracetamol + Lignocaine

Amoxicillin + Serratiopeptidase+ Lactobacillus Sporogenes

Amoxicillin + Cloxacillin + Lactic acid bacillus + Serratiopeptidase

Amoxicillin + Serratiopeptidase

Cefadroxyl + Probenecid

Cefuroxime + Serratiopeptidase