The clinical use of the anti-diabetes drug, pioglitazone, is now going out of prescription choice among the medical practitioners in Kerala. The drug is currently under scrutiny because of certain suspected safety issues and availability of newer drugs, according to Dr K G Ravikumar, former director of clinical pharmacy, government medical college, Thiruvananthapuram.

In a research study conducted on the market sale of pioglitazone, Dr Ravikumar has found that the average sale of pioglitazone got reduced to 25 per cent in the community pharmacies in Kerala at the semi urban and urban centres in January 2014 as compared to the same month in last year.

He says that there is an urgent need to conduct scientific research studies on the drug in India. Pioglitazone belongs to the group of glitazones having thiazolidinedione structure, he said.

Out of the pioglitazone prescriptions that produced before the community pharmacies in January this year, 35 per cent were old ones originated before the notifications. Two northern districts of the state, Kasargode and Kannur have the highest number of prescriptions for the drug which is about 40 per cent compared to January 2013 situations. In districts like Wayanad and Alappuzha, the sale has reduced to about 10 per cent compared to pre-notification period.

In Kerala, the sale of the drug has reduced immensely. The situation is totally different in the hospitals in the state. When 28 hospitals of medium and large scale (private and government) covering five districts were studied, it was found that physicians in these hospitals have almost stopped prescribing pioglitazone for diabetic patients. The incidence of writing new prescriptions for pioglitazone was 4250 in January 2013 in Trivandrum which got reduced to a mere 24 in 2014 January. In Kozhikode 4350 (in 2013) became 38 while in Malappuram 2100 (in 2013) became 20 in 2014. Districts like Ernakulam and Thrissur have also shown same trend. If pioglitazone is prescribed anywhere in the state at present, it is mainly by the rural doctors and doctors who are not aware of the controversies going on, Dr Ravikumar said.

Pioglitazone was introduced in the Indian market in 2001 both as single and combination products with metformin, glimepiride and alogliptin. By 2012, it became one of the fast moving prescription drugs in the country and its sale exceeded to Rs.600 crore (6000 million). The Government of India suspended the manufacture, sale and distribution of pioglitazone with immediate effect through a gazette notification on 18th June 2013 because of its association with bladder cancer. On 31st July 2013, through another notification, the government revoked the suspension and allowed pioglitazone to be marketed in the country subject to certain conditions. By 2014 January, the sale of pioglitazone got reduced to 15- 20 per cent of the total quantity sold in January 2013 in India, says the study.

Pioglitazone was a favourite choice of anti-diabetic drugs to patients and physicians in India for over a decade. Now after the two notifications, the market of the drug got affected very much and the sales reduced to less than one fifth of its pre-withdrawal market share.