Despite the withdrawal of the suspension on manufacture and sale of pioglitazone by the Drug Controller General of India (DCGI) on August 1, the diabetic drug is not being sold by the retail chemists Maharashtra and Tamil Nadu. Until a few days ago, Orissa chemists were also not selling pioglitazone but pharmacy outlets have started selling the drug.
But most of the states including Karnataka, Kerala, Andhra Pradesh and Uttar Pradesh have been selling the drug soon after the suspension order was withdrawn.
Overt concern by the chemist fraternity is seen as one of the reasons for non-availability of the drug in two big major states. Some of the chemists are found to be advising patients to refrain from purchasing the drug in spite of being prescribed by reputed general practitioners and leading diabetologists in the country. This is biggest bane in drug marketing where chemists are engaged in impeding drug sales, when patients have demonstrated total faith in physicians who prescribe the drug after its suspension was revoked, said sources.
The challenge is now to handle the chemists’ fraternity. Therefore, there is need to create an awareness among the drug dispensers on the present status of the drug. State drugs controllers are convinced that box warning as a packaging insert and on promotional literature or visual aids are adhered to as per the suspension revoke order, stated sources.
Although pharma companies are relived that pioglitazone is back in the market, they are still sore about the government’s lackadaisical attitude in enforcing a suspension and revoking the same. There is still a lot of leg work for companies’ sales force who are approaching every physician, state regulatory authority and pharmacy distributor to ensure prescription and availability of the drug. However, there are still many chemists who are uninformed that the suspension of the pioglitazone has been lifted, stated sources.
Of the 60 million diabetics in the country, 50 lakh are on pioglitazone prescription. The government order to suspend the drug resulted in a sudden compromise of the patents glycemic status.
According to a panel of medical experts, the primary recommendation for diabetics in the country is diet-exercise. If the levels fail to come under control, then first line therapy is metformin. Due to secondary failure, combination of metformin with sulfonylureas which includes with glipizide, glimepiride, gliclacide among others are used to treat uncontrolled high blood sugar levels. However, pioglitazone is prescribed as a later option. But the efficacy of the drug cannot be ignored when it comes to glycemic control.