New Delhi: India’s drugs regulator is set to investigate anti-obesity drug sibutramine following its ban in Europe and a fresh warning against it by the US watchdog agency. Sibutramine is sold in India by close to 12 pharma companies, including Abbott India Ltd, Cipla Ltd, Glenmark Pharmaceuticals Ltd, Torrent Pharmaceuticals Ltd and Sun Pharmaceutical Industries Ltd.
On 21 January, the European Medicines Agency (EMA) issued a letter recommending the suspension of marketing authorizations for sibutramine after studies showed it increases the risk of cardiovascular events. The same day the US Food and Drug Administration requested the manufacturer of the drug to add a new contraindication to the existing warning for the sibutramine drug label.
Sibutramine, sold under the brand names such as Reductil, Meridia and Sibutrex globally, has a market value of Rs23.7 crore as per ORG IMS and was approved for marketing in India in December 1999 and is an “old drug” as per Indian law.
Thus, manufacturers of the drug in India do not need a licence from the Centre, but require one from the state drug authorities. However, the marketing approval authorization still remains with the Centre—the drug controller general of India (DCGI).
“On Monday I will write to members of our expert committee asking for a meeting within the next fortnight,” said DCGI Surinder Singh. “We will also invite one or two major manufacturers. Along with the experts we can then deliberate upon the data available now and then take a decision on whether we need to issue a warning or ban the drug in India.”
He added that manufacturers of the drug would also be given an opportunity to present their views.
“Since these decisions were taken outside India based on the active pharmacovigilance programme there, we need to have the industry on board as India doesn’t have a very strong pharmacovigilance system,” Singh said.
EMA’s decision came after the review of data from the sibutramine cardiovascular outcome trial (SCOUT) that was conducted on 10,000 patients. The trial showed an increased risk of serious, non-fatal cardiovascular events such as stroke or heart attack.
Based on the findings, EMA advised that doctors no longer issue any new prescriptions for sibutramine and review the treatment of those who are currently taking the medicine. It also advised that pharmacists should not dispense any prescriptions for sibutramine.
“The SCOUT trial showed some excess cardiovascular events in high-risk groups with previous history of heart attack and stroke,” said Dr Anoop Misra, director and head, department of diabetes and metabolic diseases at Fortis Hospitals. “There anyway it was doubtful if this drug will show benefit. However, in only obese people it remains to be proven if this drug will show similar effects. Certainly more evidence is required to ban this drug.”
The process of assessing the marketing of sibutramine in India will, however, be similar to that of anti-obesity drug rimonabant, which was banned in the country last year. Rimonabant’s marketing authorization was suspended in India in November 2008 after EMA recommended that member countries not allow it to be sold because it caused serious psychiatric side effects, including suicidal tendencies.
However, it took almost eight months to ban the drug in India following consultations with the industry and the Drug Technical Advisory Board, the highest such body related to pharmaceuticals.
“Although most of the patients enrolled within SCOUT are contraindicated from being treated with sibutramine under normal conditions of use, the (European) committee considered the cardiovascular risk to be relevant to normal clinical use because it is not always possible to identify underlying cardiovascular disease in patients who are obese or overweight,” said C.M. Gulhati, editor of medical journal, Monthly Index of Medical Specialities.
Apart from sibutramine, only one other anti-obesity drug, orlistate, remains in the global market.
Others such as rimonabant, fenfluramine and dexfenfluramine have already been banned for unacceptable side effects.
Other companies selling this drug in India are Intas Pharmaceuticals Ltd, Emcure Pharmaceuticals Ltd, Ind-Swift Laboratories Ltd, Mankind Pharma, Microlabs Ltd, Eris Lifesciences Pvt. Ltd and Ordain Health Care Pvt. Ltd.