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, the government said that the use of the drug 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 to the said drug are available.
Upon recommendations of the Drugs Technical Advisory Board, the central government, in the greater interest of the public, has prohibited the manufacture for sale, sale, and distribution for human use of those drugs across the country with immediate effect.
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 this Fixed Dose Combination 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 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 drugs used for hair treatments, antiparasitic, skincare, anti-allergic. The medicines combined in more than one drug in a single pill are Fixed dose combination drugs FDC, these drugs are also known as cocktail drugs.
The Indian Pharmaceutical Alliance supports the decision of the government. Sudarshan Jain, Secretary General, IPA told ANI that, “this has been going for many years and there was a committee which reviewed the whole thing… This is a 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.
