The Indian regulator said the contaminated batches did not enter the domestic market.
New Delhi: An Indian firm is among three drug-makers hit by global recalls of a China-manufactured ingredient for hypertension and heart medicines that was found to possess a suspected carcinogen.
The crackdown by US, Canadian, European and a few Asian regulators began in July after the discovery of the potentially cancer-causing substance N-nitrosodimethylamine (NDMA) in valsartan manufactured by Chinese firm Zhejiang Huahai Pharmaceuticals, a listed firm on Shanghai’s stock exchange.
Medicines made by two of its customers, China’s Zhejiang Tianyu Pharmaceutical and India’s Hetero Labs, have also been found to contain NDMA, which is reportedly used by scientists to induce cancer in lab rats.
NDMA can also be unintentionally produced through certain chemical reactions, among the lines being investigated to get to the root of the contamination. Zhejiang Huahai Pharmaceuticals has reportedly stopped the supply of valsartan following the discovery.
Last week, the US drug regulator, the Food and Drug Administration (FDA), announced recalls of some valsartan-containing products manufactured by Hetero Labs Limited.
Amid the widening crackdown, India’s apex drug regulatory body, the Central Drug Standard Control Organisation (CDSCO), banned the import of valsartan from the Chinese firm.
“We have issued an import alert on the supplies of the ingredient Valsartan from the Chinese company. We have alerted all port offices across India,” S. Eswara Reddy, the drugs controller general of India (DCGI), told ThePrint.
The government also issued a showcause notice to the Mumbai-based importer of the valsartan, which supplies the active pharmaceutical ingredient (API) to Indian firms.
“The company, Ethachem, was legally obligated to inform the Indian government about the global recalls of the product, its clients, and quantity of usage in India. It failed to inform us,” Reddy added.
“Hetero Labs was using the imported Chinese API through the same agent, Ethachem. The company was importing API from China and then exporting the finished medicine to the US,” Reddy said.
While tests on the samples from Hetero Labs showed lower amounts of NDMA than those from Zhejiang, the episode might dent India’s reputation of India as a prime drug exporter acknowledged as the ‘pharmacy to the world’.
The DCGI, however, said Indian patients had nothing to worry about. “The impacted products are not marketed in India but were used for exports,” he added, “Drugs in India are completely safe for consumption.”
The regulator has been conducting surprise inspections on other firms importing the tainted API from China to ensure no more contaminated stocks find their way to the markets, domestic and international.
Even globally, regulators have said patients have no cause of immediate concern.
According to a report in USA Today, FDA scientists estimate that one additional case of cancer would develop over the lifetime of 8,000 patients — if they had all taken the highest valsartan dose (320 mg) from the recalled batches daily for four years.
The FDA’s counterpart from across the Atlantic, the European Medicines Agency, is working with international partners to understand the impact of NDMA, but said “there is no immediate risk to patients”.
The crackdown is the second biggest blow for China’s growing pharmaceutical industry in the space of a few weeks. Just recently, parents in the country were up in arms following reports that hundreds of thousands of children had been vaccinated with ineffective medicine, rendering them vulnerable to avoidable diseases.