Over 20 drug companies marketing anti-obesity drug sibutramine under a variety of brand names are likely to soon face a ban on selling the medicine.
The apex drug regulator, Drugs Controller General of India (DCGI), has initiated steps to ascertain the safety profile of the medicine. DCGI started the probe after an expert committee of its European counterpart, European Medicine Agency (EMA), recommended complete withdrawal of the drug from European markets due to serious side effects.
"We will ask members of our pharmacovigilance committee to take note of the EMA decision and explain their position over the continued marketing of sibutramine on Monday itself," DCGI Surinder Singh said.
The drug controller relies heavily on data approved by developed country regulators while clearing marketing applications in the country. It also follows overseas regulators in withdrawal of drugs. Last month, DCGI notified the ban of another anti-obesity medicine, rimonabant, 10 months after it was withdrawn from markets in developed countries.
Sibutramine, available in India since 1999, is one of the most commonly prescribed medicines sold in the Rs 200-crore (Rs 2 billion) anti-obesity market of the country. Leading firms like Cipla, Sun, Glenmark, Torrent, Mankind, Micro Labs and multinational firm Abbott have their own brands of sibutramine in the domestic market.
The EMA committee recommended the suspension of marketing approval across the European Union as its observations found that the heart attack risk associated with the medicine far outweighed its weight loss benefit.
"There are over two dozen firms that are marketing sibutramine in the country today. I hope the government will act fast and ban the medicine without waiting for 10 months till the companies exhaust their stocks in the market," CM Gulhati of Monthly Index of Medical Specialties (MIMS) said.
According to Gulhati, the actual sales volume could be much higher than market estimates as the drug was also being used by some "slimming centres" in their therapies. "No one knows to what extent such centres use these medicines. A sudden action is essential to protect the interest of the patient," Gulhati said.
Senior drug regulatory officials said the recommendations of the Indian Pharmacovigilance Committee would have to be vetted by the country's apex decision-making body on drug safety, the Drugs Technical Advisory Board, before a ban can be notified.
"If the expert committee recommends a ban, we will inform manufacturers to suspend production with immediate effect. Even if the notification takes time, the product will cease to be available much before that," a senior official said.
Based on international data, India has, in the past, banned two anti-obesity drugs - fenfluramine and dexfenfluramine. With sibutramine also coming under regulatory scanner, there is just one obesity drug, orlistate, left in the market.
