The Drugs Controller General of India (DCGI) on Friday(24th November) ordered the “suspension” of the manufacture and import of anti-obesity drug Sibutramine after the medicine showed serious side effects, including heart attack, among some users. The DCGI also recommended to the Ministry of Health and Family Welfare a total ban on the sale of the drug.
It proposes the setting up of various committees to oversee the safety of drugs and also the feasibility of introducing new drugs in India.
The suspension order was issued under Section 26 (A) of Drugs and Cosmetic Act, with immediate effect, with the DCGI also seeking a total prohibition on its manufacture and sale in the open market. The ban has to be formally notified by the Health Ministry on the recommendation of the DCGI.
The decision was taken following recommendations of an expert committee comprising pharmacologist Y.K. Gupta (All-India Institute of Medical Sciences), endocrinologist A.C. Ammini (AIIMS) and S.D. Seth (Institute of Clinical Research) and Anoop Misra (Fortis Hospital).
Orlistate is now the only drug in the market for obesity-management and weight loss, though many new drugs are expected to be in the market shortly.
The decision to ban Sibutramine, sold under different brand names, was taken after studies found it increased the risk of heart attack, stroke and death. The drug has already been banned in the United States, Canada and Australia and was withdrawn in China on Tuesday. The European Medicine Agency (EMA) too has recommended complete withdrawal of this drug.
The preliminary reports of the “scout trials” on Sibutramine showed increase in heart rate and blood pressure among users. This was further confirmed in the final finding of the trial, promoting the government to take prohibitory action.
This is the third drug relating to diabetes and obesity that has been banned in India in the last one-and-half years.
Last month, the government banned the import and manufacture Rosiglitazone, an anti-diabetic drug. Rosiglitazone is already banned in Europe after users experienced serious side effects, including cardiovascular events and adverse effects on lipid profile.
Prior to that, anti-obesity pill Rimonabant was banned in March 2009 after it was found to cause depression and suicidal tendencies.
One of the most commonly prescribed medicines for weight loss and obesity management, Sibutramine has been available in India since 1999. It is manufactured and marketed by over 20 generic companies under various brand names.
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