Even as the majority opinion in the endocrinology fraternity seems to be critical of the decision ' to defend which the ministry has little more to show than a letter from a Chennai diabetologist professing a urinary bladder link to the drug and a ban in France ' the drug regulator continues to tie itself in knots to rationalise it. Drug Controller General of India Dr G N Singh said that patient safety is paramount. "It doesn't matter one person wrote to us. A whistleblower is always one," he said.
Interestingly, the man he is trying to defend, Dr V Mohan of Dr Mohan's Diabetes Specialities Centre, whose letter seems to have triggered the sudden antipathy in the ministry to the drug that is in use in the US, UK, Canada, Australia, is up in arms against the lack of a pharmacovigilance programme in India. "I had written that letter in good faith, in the interest of my patients and not to benefit some drug company. It is the duty of the DCGI to commission a study. But the DCGI does not know how it operates. They should have called the expert committee meeting earlier," he said.
His centre, along with the Public Health Foundation of India, had received an unrestricted educational grant from MSD pharmaceuticals, the Indian subsidiary of US drug company Merck whose product Sitagliptin would be the biggest gainer from the pioglitazone ban. He conceded that he could have called for a study rather than gunning for a ban.