The Ministry of Health and Family Welfare government of India has decided to ban the manufacture, sale, and distribution of 156 fixed dose combinations. These include treatments for common ailments like colds and fevers. An Expert Committee and the Drugs Technical Advisory Board found no therapeutic justification for these combinations and identified potential health risks, leading to the prohibition.
The government banned 156 fixed dose combination (FDCs) medicines, which included antibiotics, painkillers and multivitamins, after a review found that they posed health risks.The Union Ministry of Health and Family Welfare issued a gazette notification, prohibiting the manufacture, sale and distribution of these medicines.Click here to connect with us on WhatsAppThe banned FDCs include antibiotics, anti-allergics, painkillers, multivitamins and combination doses for fever and hypertension among others. According to the notification, this decision was taken after the recommendations of the Drug Technical Advisory Board (DTAB) and an expert committee formed by the central government. “The matter was examined by an expert committee appointed by the central government and the DTAB, with both bodies recommending that there is no therapeutic justification for the ingredients contained in the said FDCs,” the notification stated.
Impact on Pharmaceutical Industry
The banned FDCs include popular combinations such as mefenamic acid and paracetamol injections, commonly used for pain relief and fever, and omeprazole magnesium with dicyclomine HCl, used to treat abdominal pain. The ban is expected to impact major pharmaceutical companies, including Sun Pharmaceuticals, Cipla, Dr. Reddy’s Laboratories, Torrent Pharmaceuticals, and Alkem Laboratories.
FDCs on the ban list
The ban list includes “Aceclofenac 50mg + Paracetamol 125mg tablet.” This is one of the popular combinations of pain-relieving medicines manufactured by top pharmaceutical companies.
The list also includes Mefenamic Acid Paracetamol Injection, Cetirizine HCl Paracetamol Phenylephrine HCl, Levocetirizine Phenylephrine HCl Paracetamol, Paracetamol Chlorpheniramine Maleate Phenyl Propanolamine and Camylofin Dihydrochloride 25 mg Paracetamol 300mg.
The government also banned the combination of Paracetamol, Tramadol, Taurine and Caffeine. Tramadol is an opioid-based painkiller.