India Considers Banning 34 More Multivitamins After Recent Drug Ban
The Government of India is evaluating a ban on 34 additional multivitamins following the recent prohibition of 156 Fixed-Dose Combinations (FDCs). According to sources, these multivitamins are under review based on safety and efficacy concerns.
New Regulations and Committees
Under new regulations, states can no longer approve drug combinations. The Central Government recently banned 156 FDCs based on recommendations from the DTAB sub-committee. The Professor Kokate committee, formed to examine FDCs licensed without the Drug Controller General of India’s (DCGI) permission, declared several FDCs irrational. These notifications were challenged in court and referred to the DTAB.
Support from the Indian Pharmaceutical Alliance
The Indian Pharmaceutical Alliance (IPA) has endorsed the government’s decision. Sudarshan Jain, Secretary General of the IPA, stated, “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.”
Jain also mentioned that pharmaceutical companies have the opportunity to provide data supporting their products. Those with adequate data will continue, while others will have to withdraw their products.
Details of the Ban
The banned drugs include treatments for hair, skin, and allergies. These FDCs, also known as cocktail drugs, combine more than one drug into a single pill. An Expert Committee appointed by the Central Government reviewed these FDCs and deemed them irrational. The Drugs Technical Advisory Board also found no therapeutic justification for the ingredients and recommended the ban.
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 and Ergotamine tartrate + Caffeine + Paracetamol + Prochlorperazine maleate have also been banned.
Doubts Revealed
Multivitamins -: Multivitamins are pills or tablets that contain many different vitamins and minerals that people take to stay healthy.
Drug Ban -: A drug ban means that the government has decided that certain medicines cannot be sold or used because they might not be safe or effective.
Fixed-Dose Combinations (FDCs) -: FDCs are medicines that combine two or more drugs in a single pill. They are used to treat various conditions but can be banned if they are not safe or useful.
Indian Pharmaceutical Alliance -: The Indian Pharmaceutical Alliance is a group of big medicine-making companies in India that work together to make sure medicines are safe and effective.
Pharmaceutical companies -: Pharmaceutical companies are businesses that make and sell medicines to help people get better when they are sick.
Efficacy -: Efficacy means how well a medicine works to make people feel better or cure their illness.
Irrational -: In this context, irrational means that the medicines do not make sense to use because they might not work well or could be harmful.
