New Delhi: A European health regulator has urged Indian drug-maker Hetero Labs Limited, which manufactures diabetes medicine pioglitazone, to test the pills after finding cancer-causing substance in them.
The European Medicines Agency (EMA) has found “low levels” of cancer-causing substance in some pioglitazone pills manufactured by the Hyderabad-based company.
The EMA had last month urged all companies using certain reagents to manufacture pioglitazone “to test their products” and “check their (manufacturing) processes to rule out the presence of nitrosamine impurities, in particular, nitrosodimethylamine (NDMA)”.
NDMA is a cancer-causing substance, while reagent is a substance for use in chemical analysis.
“The request follows the detection of low levels of NDMA in a few batches of pioglitazone manufactured by Hetero Labs in India,” the EMA had said in its safety reviews published on 26 April.
When contacted by ThePrint, Hetero Labs did not respond to queries.
Hetero Labs — which claims to be the world’s largest producer of anti-retroviral drugs for the treatment of HIV/AIDS — sells generic medicines in over 126 countries across the globe, including the United States, Australia, South Africa, and European Union member countries.
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What is NDMA?
The EMA said NDMAs were classified as probable human carcinogens, substances that could cause cancer.
“They are present in foods and water, and most people are exposed to them daily in small amounts. However, their presence in medicines is largely avoidable and the relatively low risk they pose to patients does not make them acceptable,” it said.
According to the World Health Organisation (WHO), there is conclusive evidence that NDMA is a potent carcinogen in experimental animals by several routes of exposure, including through ingestion of drinking water.
“The mechanism by which NDMA produces cancer is well understood to involve biotransformation by liver microsomal enzymes, generating the methyldiazonium ion,” it said.
Indian regulator seeks detail from Hetero Labs
Following the EMA’s advisory, Indian drug regulator Central Drugs Standard Control Organisation (CDSCO) has also written to Hetero Labs, asking the details of the reagents used by the company to manufacture pioglitazone pills.
Pioglitazone is used to improve blood sugar level in adults suffering from type 2 diabetes. The medicine works by increasing the body’s sensitivity to insulin, which is a natural hormone that controls the blood sugar level.
“Our tests will not reveal what reagent they are using, which has introduced the impurities in their medicines,” said a senior CDSCO official.
“We have asked the company to furnish the details and after analysing those details, we will ascertain if there is a need to change agents for domestic market products as well or not,” he said.
Notably, usage of pioglitazone was suspended in India in 2013 over safety concerns, but the suspension was revoked a month later.
“Today, around 10 per cent of total type 2 (diabetic) patients are administered the drug, which is available in several brand names in India,” said Dr Anoop Misra, chairman, Fortis-C-DOC Centre of Excellence for Diabetes.
FDA intervention
Last year in August, the US health regulator, the Food and Drug Administration (FDA), had announced a recall of commonly used hypertension medicines — known as valsartan drugs — manufactured by Hetero Labs for containing the NDMA.
“FDA has updated the list of valsartan products under recall and the list of valsartan products not under recall to incorporate recalls of valsartan-containing products manufactured by Hetero Labs Limited, in India, labeled as Camber Pharmaceuticals Inc,” FDA had said.
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