The Union Health Ministry may ban two drugs, Gatifloxacin and Tegaserod, soon. Gatifloxacin is an antibiotic and Tegaserod is meant to treat irritable bowel syndrome.
The move comes after international studies revealed that Gatifloxacin posed 17 times higher risk of developing serious hyperglycemia than other antibiotics in elderly patients. In the case of Tegaserod, there was a 10-fold increase in risk of heart attacks, studies have shown.
An expert committee is learnt to have recommended a prohibition on the production and use of these medicines in India due to such increased safety concerns.
The health ministry is expected to take a decision on the committee’s recommendations soon.
The expert committee — Drugs Technical Advisory Board — which consists of pharmacology experts is the highest technical authority when it comes to such decisions. The government notification is mostly a technical process, a medical expert said.
The two drugs under scanner are the latest among the series of medicines that were shortlisted by the Drugs Controller General of India (DCGI) for intense adverse drug reaction monitoring. Almost all these drugs were selected on the basis of ban or restriction announced in other countries.
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The ministry had notified ban of six such medicines last month. These include Nimesulide, Cisapride, Phenylpropanolamine, human placenta extract and Sibutramine, etc.
Rosiglitazone, Rimonabant and Diclofenac (for veterinary use) were also banned in the country during the last three years.