Even as GlaxoSmithKline Plc.’s (GSK) diabetes drug Avandia got a reprieve from a US regulatory panel, it could be heading for a drug inquiry by the Indian drug regulator.
The office of Indian regulator is awaiting the final decision of US Food and Drug Administration (FDA) on GSK’s drug, but said it will start “pharmacovigilance” investigations in India.
India is home to 43 million diabetics of which 10 million are believed to be on this category of drugs, made by several generic drug companies here. The anti-diabetic market is pegged at Rs1,362 crore.
“We are waiting for US FDA’s stance on the issue,” said M. Venkateswarlu, drug controller general of India (DGCI), adding that the department will do its own pharmacovigilance inquiry into the health effects of the drug. He declined, however, to give any details as there is uncertainty over his continuing as the DCGI after Tuesday. Venkateswarlu was to relinquishing his post on 31 July, unless a government order extends his stay.
Pharmacovigilance, also called Phase IV or post-marketing studies, is a comprehensive analysis of a drug’s side effects. Drug makers are bound by law to undertake such surveillence and submit data, collected from their panel doctors, hospitals and patients, to the regulator though some experts are quite sceptical of its efficacy in India.
On Monday, a US FDA drug advisory committee voted 22-1 to keep the drug, which generated 2006 revenue of $3.38 billion (Rs13,655 crore), on the market. The panel did note increased risks of heart attacks in a 20-3 vote, and said the drug’s label should include a “black-box” warning, the most severe the FDA can require, to flag that risk.
Some panelists suggested the label caution against using the drug together with insulin because doing so may elevate heart risks. That joint use is currently FDA-approved. The experts also asked that the drug be studied further.
The FDA is yet to take a final call on the non-binding panel recommendation but has typically gone along with such panel recommendations.
“We welcome this decision as positive for patients,” said Ronald Krall, chief medical officer of GSK in a statement. “It was “important that Avandia remain a treatment option for patients.”
In May, the New England Journal of Medicine published a study that showed Avandia increased the risk of heart attacks by 43%.
GSK says the findings are inaccurate, but last week noted that sales of Avandia dropped by 22% to $710 million during the second quarter of 2007.
In India, the drug is sold as Windia by GSK Pharmaceuticals Ltd and under various brand names by nine other Indian companies including Sun Pharmaceuticals Ltd, Torrent Pharmaceuticals Ltd, Cipla Ltd and Glenmark Pharmaceuticals Ltd.
Brands of all these firms will be affected by the pharmacovigilance inquiry. “We are not concerned with brands. We look at the drug molecule,” said Venkateswarlu.
The Indian arm of GSK has been keeping the drug controller informed, said Sadhna Joglekar, vice-president, medical affairs and clinical research, GSK Pharmaceuticals India, who has personally briefed the regulator on the issue. “We report all unexpected adverse drug reactions anyway.”
Some doctors aren’t waiting for regulatory action. “We are shifting everybody who was on Avandia on to other drugs,” said Anoop Misra, endocrinologist and head of diabetes and metabolic diseases at Fortis Hospital here. Dr Misra says he has stopped the drug in about 50 patients and abstained from precribing it to some 70 others.
Anil Gomber, a diabeto-cardiologist at Max Hospital, is being extra diligent in keeping the drug off patients with heart diseases. He, too, has shifted over a dozen patients onto alternative medications.
Meanwhile, there are doubts about the Indian pharmacovigilance procedure as well.
C.J. Shishoo, a senior pharmacologist and director of Ahmedabad-based customer action group Consumer Education and Research Centre, claims that the system is not often very effective in India as drug firms do not update the regulator on the adverse reports. Dr Misra, who says there is hardly any pharmacovigilance in India, also points out that data collected by the regional centres of the National pharmacovigilance Committee aren’t disseminated to most doctors.
Drug enquiries in India are typically held only after there is sustained furore over a drug in the West. In 2004, the FDA had noted the alarming side effects of arthritis drug Vioxx from Merck. The Indian regulator had to compile a fresh market surveillance study to announce a restricted use of the drug in the country even as Merck withdrew Vioxx internationally.
Jane Wardell of AP, and AFP contributed to this story.