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Indian authorities have prohibited as many as 156 combination drugs that are often administered as painkillers, multivitamins, antibiotics, and those taken for fever and cold, among others.
In a gazette notification dated August 21, India's central government said the use of drugs with 'fixed-dose combination' 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 are available.
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Upon recommendations of the Drugs Technical Advisory Board, the central government has banned the manufacture, sale, and distribution of these drugs across the country with immediate effect.
The move comes after the matter was examined by an expert committee, which concluded that the the administration of such fixed-dose combination drugs as "irrational".
The Drugs Technical Advisory Board also examined the FDC and said: "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 the 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," the notification read.
The list of banned drugs also includes those used for hair treatments, skincare, and antiparasitic and anti-allergic medications.
FDC drugs refer to two or more medicines combined in a single pill. These are also known as cocktail drugs.
The Indian Pharmaceutical Alliance (IPA) supports the decision of the government. Sudarshan Jain, secretary-general of the IPA told ANI that "this has been going for many years and there was a committee which reviewed the whole thing.... This is the right step in the interest of patients, and all aspects have been taken into consideration".
"They have given the opportunity to give the data to support their products, so the right products will continue and when there is no data to support then companies have to withdraw it," Jain added.
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