The sudden ban on diabetes drug pioglitazone by the union health ministry has caused chaos and confusion to one and all, including the state licensing authorities, patients, pharma companies, pharmacists and medical practitioners.
In Karnataka, there are two companies Biocon and Micro Labs which market this drug.
Pioglitazone has been reported to be safe with no adverse drug reactions reported so far. It is an important drugs in terms of regular revenues and many companies have been expanding their portfolio with this oral diabetic agent, according to a panel of pharma consultants who viewed the move to disallow pioglitazone as a pressure from a particular lobby.
Diabetologists from both government and corporate hospitals stated that pioglitazone is safe for type II diabetes and also reduces triglycerides and increase HDL levels.
However, there are reports from a couple of nursing homes where patients on pioglitazone reported to have developed lung congestion and required hospitalization. When patients were off the drug, there was relief. However, diabetologists said that this could be one in 1,000 cases reporting such a reaction and the drug was seen to be safe.
According to BR Srinath, senior vice president, Diabetes Task Force and Micro Critical Care, part of the Micro Labs Group, the US FDA has cleared pioglitazone. In fact, the global regulatory authority has gone a step ahead to allow a combination of pioglitazone with alogliptin. Now considering that the US does not allow combinations, this is to underscore the fact that pioglitazone is safe and is even being allowed to be in combination with another drug which no doubt proves its safety.
The manufacturers in India have to be given an opportunity to prove that the product is safe because it has been in the market for over a decade reporting no adverse drug reactions. Micro too has a formulation of pioglitazone known as ‘Tripride’ which was launched in 2004. The company will lose out its projected sales of Rs.60 crore for the fiscal 2013-14. In fact two divisions of Micro Labs : Caryson II and Diabetic Task Force were expected to generate Rs.12 crore and Rs.48 crore respectively for the year, said Srinath.
“This sudden ban without giving an opportunity to the companies will put nearly three million diabetics’ across the country into a serious problem. This may even cause a lot of deaths if patients have been forced to withdraw from this drug following the ban by the government. Pharma companies are now confused that when US has not banned the drug and approved combination of pioglitazone with alogliptin, the Indian government has banned it which comes as a surprise and shock. In India the market for pioglitazone is approx. Rs.700 crore which reinstates the importance of the drug for patients in the country,” Srinath stated.
Biocon manufactures pioglitazone in bulk and also has formulations: Piodart 15, Poiodart 30 and Piodart MF. “Pioglitazone is marketed globally and international regulators known to have high safety and compliance standards, continue to believe in the therapeutic advantages of this drug. But this decision is more critical for India as six per cent of the total diabetes patients here are on pioglitazone. With this decision, patients will now be compelled to use alternative therapy options which are eight to ten times times more expensive than pioglitazone and could reduce compliance rate in diabetes management. Our regulators need to review the decision and re-evaluate if the perceived risks of pioglitazone outweigh the pharmaco-economical benefits, especially in the socio-economic context of India,” said Rakesh Bamzai, president-marketing, Biocon.