August 23,2024
The Health Ministry has banned 156 fixed dose combination (FDCs) medicines, which included commonly used antibiotics, painkillers and multivitamins. In a gazette notice published by the Health Ministry on August 21, the production, marketing, and distribution of medications is now outlawed after it was found that they pose health risks.
According to the notification, the list includes antibiotics, anti-allergic drugs, analgesics, multivitamins, and combination dosages for fever and hypertension are among the prohibited FDCs.
The decision comes following an expert group appointed by the central government as well as the Drug Technical Advisory Board (DTAB) made recommendations.
The Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Amylase + Protease + Glucoamylase + Pectinase + Alpha Galactosidase + Lactase + Beta-Gluconase + Cellulase + Lipase + Bromelain + Xylanase + Hemicellulase + Malt diastase + Invertase + Papain is likely to involve risk to human beings whereas safer alternatives to the said drug are available,” it stated.
The notification also stated that the matter was examined by an Expert Committee appointed by the Central Government and “the said Expert Committee considered this FDC as irrational.”
The Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended.”
The list of major FDC medicines includes a combination dose of Omeprazole Magnesium and Dicyclomine HCl which is used for treating stomach pain, as well as a combination of Mefenamic Acid and Paracetamol Injection for reducing pain and swelling in various diseases.
Additional FDCs include a combination of povidone iodine, metronidazole, and aloe used to prevent and cure skin infections, as well as ursodeoxycholic acid and metformin HCl used to treat fatty liver in diabetics.
“The DTAB did not find the claims of these combination medicines correct and took the decision considering that the harm to the patient is more than the benefit,” the gazette notification stated. “Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under Section 26A of Drugs and Cosmetics Act 1940,” the ministry stated in the notification.
The 156 banned drugs include popularly used combinations of anti-allergic medicines with nasal decongestant, syrups that break down mucus and paracetamol. The list also includes combinations of antibiotics with acne cream and iodine solution. Combination of migraine medicine with one to prevent nausea, combination of supplements such as menthol with aloe vera, and combination of burn medicine silver sulfadiazine with an antiseptic agent, aloe extract, and vitamin are among some of the combinations banned.
According to a report by Indian Express, this is the biggest crackdown on FDCs since the government banned 344 drugs in 2016, which was then challenged by drug makers. As per the court directions, the matter was referred back to the Drugs Technical Advisory Board, which decided 328 were “irrational” and should be prohibited. On this recommendation, the government banned the 328 combinations in 2018. Reportedly, 15 FDCs manufactured before 1988 were kept out of the purview of the ban.
Following the development, Sudarshan Jain, Secretary General, Indian Pharmaceutical Alliance told Financial Express.com: “The discussion on FDC is going on over a period of time with recommendation from Kokate committee and Nilima Kshirsagar committee. This is a right step in interest of patients and all aspects have been taken into consideration.”
Source: Financial Express