After almost 10 months since the Drugs Technical Advisory Board (DTAB) recommended its prohibition following reports of various side effects, the Union health ministry has banned manufacturing, marketing and imports of the anti-obesity drug rimonabant in the country.
The Ministry of Health and Family Welfare, through two notifications - GSR 884(E) and GSR 885 (E) dated December 11, announced that the Central Government is satisfied that it is necessary and expedient to prohibit the manufacture, sale and distribution of rimonabant in the public interest. The action is taken under Section 10-A and Section 26-A of the Drugs and Cosmetics Act, 1940.
Section 10-A confers power to the central government to prohibit import of drugs and cosmetics in public interest whereas Section 26-A provides the government the power to prohibit manufacture, sales and distribution of drug and cosmetic in public interest.
The drug, which once considered as an effective weight losing medication, is found to create psychiatric side effects including suicidal tendencies in those who consume it and has been banned in several developed countries. The issue was raised in India last year and the DTAB has advised the government to withdraw the drug from market in March this year.
Several Indian majors including Ranbaxy, Sun Pharma, Cadila Healthcare (Zydus) and Torrent Pharma were manufacturing and selling the drug in India. The DCGI, following the controversy, asked the companies to stop manufacturing and supply of the medicine. The state regulatory officials has already conveyed the orders with the companies and many of the major companies responded with ceasing manufacturing activities, informs top drug regulatory officials from Gujarat and Maharashtra. Sanofi-aventis under the brand name Acomplia, has lately been found responsible for causing serious depression, anxiety and stress disorders in patients using it. The US Food and Drug Administration (US FDA) study indicated an increased risk of suicidal ideation in patients. The originator company stopped promoting the pill to other countries after it failed to secure marketing approval from US FDA in 2007.
The FDA has also expressed its concerns about an increased risk of other psychiatric adverse events and adverse neurological events including seizure with rimonabant 20 mg, while noting the high numbers of patients who withdrew prematurely from the RIO trials during the first year of treatment. The European drug regulatory body has also taken a similar view, and the DTAB has followed suit lately.
The ban on a product under Section 10-A is imposed in India for the first time after almost 11 years. In 1998, the government had prohibited imports of two anti obesity drugs – fenfluramine and dexfenfluramine – which was the last time when government imposed the Section 10-A before ban of rimonabant. The government has banned fixed dose combination of diazepam and diphenhydramine hydrochloride in India by exercising the powers conferred under Section 26-A in April 2008, according to official sources.