DDA mulls recalling or banning Valsartan drugs

Published On: January 15, 2019 07:59 AM NPT By: Republica

KATHMANDU, Jan 15: The Department of Drug Administration (DDA), the apex drugs regulating body, has started discussing how to control the controversial Valsartan drugs, which are used by hypertension and heart patients. The authority is discussing whether to recall the drugs or ban them altogether.

During a meeting at the DDA on Monday, officials raised serious concerns over the possible negative impact of Valsartan drugs on patients and their presence in the Nepali market. “We held a serious discussion on the issue today,” said Santosh KC, senior drugs administrator at the DDA. 

KC said they will assess the supply and availability of the medicines in the market. “Then we will decide whether to recall or ban the controversial medicine,” said KC.

He further said that if the Valsartan medicines are still being sold in the market then the DDA can recall them. “But to ban the medicines, the decision has to be made by an advisory council headed by the health minister. We will take necessary decision within a couple of days,” he said. 

While several Valsartan drugs used by hypertension (high blood pressure) and heart patients have already been recalled in various countries including the US and Gulf countries because of some impurities in the key ingredient, they are still being sold in Nepal.

The US Food and Drug Administration (FDA) has classified some Valsartan medicines as “probably human carcinogen’’ after those medicines were found containing the chemical N-nitrosodiethylamine (NDMA), which can cause cancer in humans. NDMA may also cause damage to liver.

Even several months since an international ban, Valsartan medicines are still being produced and sold by Nepali pharmaceutical companies. Valzaar manufactured by the Indian Torrent Pharmaceuticals is registered with the DDA and is distributed by Pharmachem Pvt Ltd in Nepal, according to the details provided by the DDA. 

According to the DDA, 99 products of Amlodipine Valsartan, including 63 domestic and others mostly Indian, are registered with the DDA. Similarly, 23 items of Valsartan HCTZ including 21 domestic and two Indian are registered with the DDA.

However, the state-owned  National Medicines Laboratory (NML) under the DDA, the apex body for drugs management, is not quite up to the task of monitoring quality properly, according to officials. The government established NML in 2001 to examine the quality of medicines. Drug testing labs must be of at least BSL (bio-safety level) III standard. However, NML hardly meets the BSL I standard, according to DDA officials. 

“Our lab is not sophisticated enough to carry out extensive research on medicines,” KC said.

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