Pioglitazone is now seen to be the bitter pill for not just diabetics but diabetologists and pharma companies who are at the receiving end as they expect that the suspended drug will now be back in the market. Currently, pioglitazone is under scrutiny by the Drug Technical Advisory Board (DTAB) which will come out with its final decision on July 19.

If pioglitazone is back in the market, it would take us a lot of efforts to convince the patients about the safety of the drug as there has been a lot of unwarranted negative publicity against the drug ever since it was banned by the government last month, said a section of doctors representing leading medical centres like Manipal, Apollo, Philomena’s and Victoria Hospital.

From a pharma company perspective, officials have categorically stated that the whole exercise to suspend Pioglitazone, which has a market size of Rs. 700 crore, is driven by the global pharma majors who have a track record to vilify good generic molecules by sponsoring misleading health impact reports. Such strategies are meant to ensure that medical practitioners are forced to prescribe alternate molecules or therapies of big pharma’s choice, which are usually patented and very expensive.

This fiasco about the pioglitazone ban has been the result of managing doctors and influencing regulators, which has taken deep roots in Indian healthcare system. Traditionally, the Indian pharma regulatory system was quiet simple and conducive which has led to phenomenal growth of domestic industry over the past decade.

However, in the recent past, the Indian regulatory system has become quite complex, making it difficult for the domestic pharma companies to grow and operate. Many of the recent rules and guidelines seem to be designed to disadvantage the domestic industry.

Some global big pharma in the international arena have a reputation in ensuring the ban on competitive molecules and recommending drugs from their stables. These companies are known to create a fear wave with global health authorities that only a particular drug was safe and efficacious and controlling the disease or disorder, stated a pharma analyst.

“The recent example of press reports about GSK influencing doctors in  China to prescribe their product at the expense of other products is a testimony of how some big pharma influences the decision makers. Pioglitazone ban has similar overtones where a renowned ‘Dr Mohan’  wrote a recommendation to regulators to ban the drug for reasons which were unsubstantiated. It was conveniently ignored as per press reports that his diabetes centre was getting financial and other support of unknown value from MSD, which is getting benefitted with this ban,” said sources.