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Centre bans 156 combination drugs administered as painkillers, antibiotics; more multivitamins under review
In a gazette notification, the government said these drugs are likely to involve risk to human beings and safer alternatives are available
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The Central Government has prohibited as many as 156 combination drugs that are often administered as painkillers, multivitamins and antibiotics, for fever and cold, among others.
In a gazette notification dated August 21, 2024, the government said the use of the drug Fixed Dose Combination (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 drugs are available.
The medicines combined in more than one drug in a single pill are FDC drugs, which are also known as cocktail drugs.
Government bans 14 combination drugs used to treat common ailments
The move from the government comes after the matter was examined by an expert committee appointed by the Central Government, and the said expert committee considered the administration of 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 26A of the Drugs and Cosmetics Act 1940,” it said.
In view of the above, any kind of regulation or restriction to allow for any use in patients is not justifiable,” the notification read.
The list of banned drugs also includes drugs used for hair treatments, anti-parasitic, skincare, anti-allergic.
IPA supports government ban on drugs
The Indian Pharmaceutical Alliance (IPA) has endorsed the decision of the government. Sudarshan Jain, Secretary General, IPA, told ANI: “This has been going for many years and 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, Mr. 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.”
An official comment from the Union Health Ministry is awaited.
India’s alarming ‘fixed dose combination’ problem
“More multivitamins under reviews”
“A total of 34 multivitamins are under evaluation based on reviews,” sources said. They mentioned that under new regulations, States can no longer approve drug combinations.
“Mefenamic Acid and Paracetamol Injection is likely to pose a risk to human beings and is also prohibited. Additionally, Ergotamine tartrate, Paracetamol, Prochlorperazine maleate has also been prohibited with immediate effect.”
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