The Union Health Ministry has banned 156 “irrational” fixed-dose combination (FDC) drugs with immediate effect, saying in a notice that an expert committee had found the combinations to have “no therapeutic justification” and could pose risks to patients.
Fixed-dose combination medicines contain more than one active ingredient. While these combinations may help patients with diseases such as tuberculosis or diabetes take less medicine, they also give patients ingredients they don’t need. For example, a patient may take a combination antibiotic when they only need paracetamol for a fever.
The 156 banned drugs include common combinations such as an anti-allergy medicine with a nasal decongestant, a mucus-dissolving syrup and paracetamol. Also on the list are antibiotics with acne creams and iodine solutions. Some of the banned combinations include a migraine medicine with an anti-nausea drug, a supplement such as menthol with aloe vera, the burn medicine silver sulfadiazine with an antiseptic, aloe extract and vitamins.
Also on the list is a combination of mefenamic acid, a drug usually taken for menstrual pain, and tranexamic acid, a common anti-fibrotic drug, as well as sildenafil, the active ingredient in Viagra, combined with a drug that relaxes blood vessels and muscles.
“These drugs are in addition to the 344 drugs that were banned earlier,” said a person familiar with the matter. This is the biggest crackdown on FDCs since the government banned 344 drugs in 2016, which was challenged by drug companies. On the court’s instructions, the matter was again referred to the Drugs Technical Advisory Committee, which decided that 328 were “unreasonable” and should be banned. Based on this recommendation, the government banned the 328 combination in 2018. The 15 FDCs manufactured before 1988 were exempt from the ban.
According to sources, the current list also includes pre-1988 medicines that were previously exempt from the ban. An industry expert on condition of anonymity said, “This notification has taken the industry by surprise as it bans the manufacture, sale and distribution of medicines with immediate effect. How will pharmaceutical companies recall products that are already in the market? Moreover, pre-1988 medicines are also banned under this notification, but why has such a decision been taken? These medicines have been in use for years and there is no evidence of any harm.”
A few days ago, the Ministry of Health banned the combination of paracetamol with painkillers and required the other two combinations to demonstrate efficacy on par with international innovative combination drugs.
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