The Drug Controller General of India (DCGI) issued notices to all state drug controllers directing them to suspend licenses granted to manufacturers for sales, manufacturing and distribution of sibutramine, R-sibutramine and their formulations with immediate effect. The decision to stop manufacturing of the drug comes in the wake of the latest studies suggesting higher risk of heart diseases from the use of this drug. The drug is already banned in Europe, Australia, Canada and US whereas India decided to ban only on November 12.
In view of latest studies suggesting higher risk of heart diseases, an expert committee was constituted to examine the safety issue and to recommend regulatory action to be taken in the country in respect of the continued marketing of sibutramine, R-sibutramine and their formulations.
The decision to ban the drug comes after the pharmacovigilance committee who independently conducted the safety profile of sibutramine in Indian population found higher risk of heart-related problems in patients taking sibutramine, R-sibutramine and their formulations. It was supported by the fact that even the originator of the drug Abbott had stopped the marketing and distribution of the drug in India based on the results of Sibutramine Cardiovascular Outcome Study (SCOUT).
The drug is banned under section 26A of Drugs & Cosmetic Act, following the studies revealed the potential of serious side effects like heart attacks, strokes and cardiac arrest. Following this notice the state FDA's have already issued the order to manufacturing companies to stop the production of the drug.
The Gujarat Food and Drug Control Administration (FDCA) has sent the notices to the companies manufacturing sibutramine, R-sibutramine and their formulations. According to Hemant Koshia, commissioner, FDCA, “On receiving the notice from the DCGI's office to stop manufacturing of this anti obesity drug from the market, we have directed all the manufacturers in the state to immediately stop the manufacturing of the drugs from the market.”
Koshia, informed that in Gujarat almost 88 product license were given to 20 manufacturers with different strengths and names to manufacture sibutramine and its formulations. He informed, “We have sent the order to all the manufacturers in the state to immediately suspend the manufacturing of this drug.”
Sibutramine is a medication that assists with weight-loss by altering neurotransmitters within the brain. Neurotransmitters are chemicals that are produced and released by nerves in order to communicate with other nerves. However numerous studies point out that sibutramine should not be used in patients with a history of coronary artery disease, stroke or transient ischemic attack (TIA), arrhythmias, congestive heart failure, peripheral arterial disease, and/or uncontrolled hypertension.
In India sibutramine is manufactured and marketed by two dozen generic companies under various brand names. Apart from Abbot, Cipla (brand name Obestat), Sun Pharma, Glenmark, Torrent, Mankind and Micro Labs sell sibutramine preparations.