An anti-obesity drug, banned in Europe and severely restricted in the US is being sold openly in India since 1999 under 20 different brand names.
The European Medicines Evaluation Agency has banned Sibutramine, which commands a Rs 24-lakh annual market in India.
In the US, the drug cannot be prescribed to people in the country with “high-risk diseases” such as depression, heart disease and diabetes.
“This severely restricts its use as almost all obese people have some risk factors for diabetes or heart disease,” said drug expert Dr C. M. Gulati, editor of Monthly Index of Medical Specialties.
Despite the restrictions worldwide, Sibutramine will continue to be sold in India till the Drugs Technical Advisory Board, which advises the Drugs Controller General of India (DCGI) on technical issues, studies and submits a report on its safety and effectiveness.
“The DCGI has directed the Pharmacovigilance Committee to independently assess the safety profile of Sibutramine in the Indian population. A decision will be taken as soon as it submits its report to the DTAB. It will take some months,” said a health ministry official unwilling to be named.
With this ban, the only anti-obesity drug available globally is orlistate.
Fenfluramine, dexfenfluramine and rimonabant have already been banned because the side effects outweighed the benefits.
In India, rimonabant was banned as recently as December 2009, over two years after the US Food and Drug Administration, the country’s federal drug regulatory authority, rejected its claims in July 2007.
Sibutramine works by acting on the hormones serotonin and noradrenaline to promote a feeling of satiety and fullness, prompting obese people to eat less. Along with a healthy diet and exercise, it is used to treat clinically obese adults with body mass index of over 30, which is calculated by dividing the weight (in kg) with height (in metres) squared (BMI = weight in kg / height in metres x height in metres).
It is not recommended for use in people younger than 18 years, people older than 65 years and people with a history of cardiovascular disease.
“The drug should never have been approved for use. The Sibutramine Cardiovascular OUTcomes (SCOUT) study of 10,000 people for six years in the US and found its use increased the risk of heart attacks and stroke by 16 per cent while the weight loss induced was just 2-4 kg,” said Gulati.