The move by the Ministry of Health and Family Welfare to ‘suspend’ a diabetes treatment drug, pioglitazone, and its combinations has perplexed the pharmaceutical industry. The move follows reports of its suspected links to increased risk of cancer and heart failure.
While the drug is banned for sale in France, it sells in the U.S. and Europe with a cautionary note in the packing. The product has been sold in the U.S. since 2000, and in India since 2001.
Thiazolidinediones are referred to as glitazones, and are insulin-sensitizer drugs. The only Thiazolidinedione available is pioglitazone. Glitazones target insulin resistance, a core physiologic defect in those with Type 2 diabetes, and this improves glucose control for the patient.
“It is very perplexing,” said D.G. Shah, secretary-general, Indian Pharmaceutical Alliance (IPA), an industry body representing larger Indian pharmaceutical companies. “The decision has been taken to suspend the manufacture and sale of pioglitazone unilaterally without any consultation with industry and manufacturers. Industry should be given a chance and time to explain. What happens to patients?”
Based on volume sales compiled by IMS for May 2013, the number of patients in India using pioglitazone and its combinations was around 30 lakh, Mr. Shah said.
The market for this drug was around Rs. 700 crore, he added.
In India, it is made by several companies, including Lupin, USV and Sun Pharmaceuticals. A spokesperson from a leading manufacturer of the drug said, “most of the manufacturers have several anti-diabetes drugs in their portfolio. Manufacturers will comply but patients will be affected.”
A new family of anti-diabetes drugs known as gliptins are currently available with a unique action to decrease hepatic glucose output. They are DPP-4 inhibitors and available gliptins include sitagliptin, vildagliptin, saxagliptin and linagliptin. Gliptins were a relatively new, and were effective but cost five to six times more than pioglitazone, Mr. Shah said, adding that such unilateral action by the authorities put unnecessary pressure on the industry and patients.