Following the recent ban on 156 drugs, the Government of India is now considering banning 34 additional multivitamins, according to sources. “34 multivitamins are under evaluation based on reviews,” sources said.
The sources also mentioned that under new regulations, states can no longer approve drug combinations.
“Based on the recommendations of the DTAB sub-committee, the Union Government recently prohibited 156 Fixed-Dose Combinations (FDCs),” sources added.
“As per the first assessment report of the Professor Kokate committee, constituted by the Union Government to examine FDCs licensed by state authorities without the permission of the Drug Controller General of India (DCGI), several FDCs were declared irrational. However, these notifications were challenged in court, and the matter was referred to the DTAB,” sources said.
Sources indicated that these drugs are banned based on concerns about safety and efficacy.
The Indian Pharmaceutical Alliance (IPA) has endorsed the government’s decision. Sudarshan Jain, Secretary General of the IPA, told ANI, “This has been ongoing for many years, with committees such as the Kokate Committee and the Nilima Kshirsagar Committee reviewing the matter extensively. This is a right step taken in the interest of patients, considering all aspects.”
When asked about the impact on pharmaceutical companies, Jain said, “They have been given the opportunity to provide data supporting their products. Those with adequate supporting data will continue, while companies lacking such data will have to withdraw their products.”
The list of banned drugs includes medications used for hair treatments, antiparasitic purposes, skincare, and anti-allergic treatments. These medicines are fixed-dose combination (FDC) drugs, also known as cocktail drugs, which combine more than one drug into a single pill.
According to a Gazette notification issued by the government announcing the ban, “The matter was examined by an Expert Committee appointed by the Union Government, which reviewed the entire issue thoroughly and deemed these FDCs irrational. The Drugs Technical Advisory Board also examined these FDCs and recommended that there is no therapeutic justification for the ingredients contained in them, and they may pose risks to human beings.”
The notification further stated, “In the larger public interest, it is necessary to prohibit the manufacture, sale, or distribution of these FDCs under Section 26A of the Drugs and Cosmetics Act, 1940. Based on the recommendations of the Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in the public interest to prohibit the manufacture for sale, sale, and distribution for human use of the said drugs in the country.”
Among the banned combinations is the FDC of Amylase + Protease + Glucoamylase + Pectinase + Alpha Galactosidase + Lactase + Beta-Gluconase + Cellulase + Lipase + Bromelain + Xylanase + Hemicellulase + Malt diastase + Invertase + Papain, which has been prohibited with immediate effect. Mefenamic Acid + Paracetamol Injection is likely to pose a risk to human beings and is also prohibited.
Additionally, Ergotamine tartrate + Caffeine + Paracetamol + Prochlorperazine maleate has also been prohibited with immediate effect.
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