Cos told to test drugs for cancer-causing impurities

Nagpur: Drug makers have been cautioned against having carcinogenic or cancer-causing nitrosamine impurities in their products beyond the permissible limit. It’s learnt, Vidarbha has some of the around 40 drug companies that have been told to get their products tested for nitrosamine impurities.
Some pharmaceutical products meant for heart burns, acid reflux, stomach ulcers, tuberculosis, angiotensin II receptor blockers for reducing blood pressure, blood sugar, anti-smoking drugs and some others are under scanner. While many medicines have been recalled from the market, production of others is being controlled to bring down the impurities in them within the safe limits.
The companies were told to send samples of their three batches to laboratories for screening of nitrosamine impurities like N-nitrosodimethylamine (NDMA) which may cause cancer if it’s above the permissible limits and consumed over a long period.
In 2018, the global pharmaceutical sector was taken by storm after the US Food and Drugs Administration raised the red flag following discovery of impurities in some drugs. US FDA had alerted about at least seven types of nitrosamine impurities like NDMA.
The Central Drug Standard Control Organization (CDSCO) and Indian Pharmacopoeia Commission (IPC) have taken the matter seriously. Last week, the Food and Drugs Administration (FDA) in Nagpur conducted an online webinar with around 40 pharmaceutical companies of Vidarbha to alert them on controlling the impurities and following good manufacturing practices as per the Drug and Cosmetics Act, 1940.
According to a FDA source, the equipment and the process for checking nitrosamine impurities are highly expensive. “There are limited laboratories which can test nitrosamine impurities. Most of them have huge testing loads and queues,” said an official adding that on their instruction, manufacturers from Vidarbha have already sent their samples and the results are awaited.
The officials also stated that the scientists across the globe are trying to find the source of nitrosamine impurities and how they are formed. “Whether it’s active pharmaceutical ingredients (API), reagents, solvents, excipients or other raw materials, or process of manufacturing and storing, the source behind the impurities is still being researched,” said an official.