New Delhi: The central government has prohibited 156 combination drugs commonly used as painkillers, multivitamins, and antibiotics for fever, colds, and other ailments.
In a gazette notification dated August 21, the government stated that the Fixed Dose Combination (FDC) of Amylase, Protease, Glucoamylase, Pectinase, Alpha Galactosidase, Lactase, Beta-Glucanase, Cellulase, Lipase, Bromelain, Xylanase, Hemicellulase, Malt Diastase, Invertase, and Papain poses risks to human health, and safer alternatives are available.
Based on the recommendations of the Drugs Technical Advisory Board (DTAB), the central government has, in the greater public interest, prohibited the manufacture, sale, and distribution of these drugs for human use across the country with immediate effect.
This decision follows an examination by an expert committee appointed by the central government, which deemed the administration of this FDC as "irrational."
The DTAB also reviewed this FDC and concluded that "there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risks 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. In view of this, 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, antiparasitic purposes, skincare, and anti-allergic treatments. FDCs, or Fixed Dose Combination drugs, are medicines that combine more than one drug in a single pill; these are also known as cocktail drugs.
34 more multivitamins under review
The government is also considering banning 34 additional multivitamins, according to sources. "Thirty-four multivitamins are under evaluation based on reviews," sources said.
The sources further mentioned that under new regulations, states can no longer approve drug combinations.
"Based on the recommendations of the DTAB sub-committee, the central government recently prohibited 156 FDCs," sources added.
"As per the first assessment report of the Professor Kokate committee, constituted by the central 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 were 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."
