Ministry bans 156 ‘irrational’ fixed dose combination drugs with immediate effect

The Union Health Ministry has banned 156 “irrational” fixed dose combination (FDC) medicines with immediate effect, with the notification stating that an expert committee had found “no therapeutic justification” for these combinations and they may pose risk to the patients.

Fixed dose combination drugs contain more than one active ingredients. While such combinations may help patients with illnesses such as tuberculosis and diabetes consume fewer pills, they also end up delivering ingredients to patients that they may not need. For example, patients may end up taking an antibiotic combination for fever when they only require paracetamol.

The 156 banned drugs include popularly used combinations of anti-allergic medicines with nasal decongestant, syrups that break down mucus and paracetamol. The list also includes combinations of antibiotics with acne cream and iodine solution. Combination of migraine medicine with one to prevent nausea, combination of supplements such as menthol with aloe vera, and combination of burn medicine silver sulfadiazine with an antiseptic agent, aloe extract, and vitamin are among some of the combinations banned.

The combination of the drug mefenamic acid — usually taken for menstrual cramps — with the common anti-fibrotic medicine tranexamic acid is also on the list. So is the combination of the active ingredient in viagra sildenafil with a drug that relaxes blood vessels and muscles.

“These drugs are in addition to the 344 that were previously banned,” said people in the know of the matter. This is the biggest crackdown on FDCs since the government banned 344 drugs in 2016, which was then challenged by drug makers. As per the court directions, the matter was referred back to the Drugs Technical Advisory Board, which decided 328 were “irrational” and should be prohibited. On this recommendation, the government banned the 328 combinations in 2018. Fifteen FDCs manufactured prior to 1988 were kept out of the purview of the ban.

According to the sources, the current list also includes some of the pre-1988 medicines that were previously exempt from the ban. An industry expert on condition of anonymity said, “The notification has taken the industry by surprise as it has banned the manufacture, sale and distribution of the medicines with immediate effect. How will the drug companies withdraw products that are already in the market? In addition, pre-1988 drugs have also been banned by this notification, why was this decision taken? These medicines have been in use for years and there is no evidence of harm.”

A few days ago, the Health Ministry had also banned one combination of paracetamol with a pain medication and asked two other combinations to demonstrate equivalent efficacy to the international innovators combination drug.

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