Valsartan recall process nearly complete

Antihypertensive medicine from Zheijiang Huahai Pharmaceuticals was suspected of containing cancer causing agent

The Drug Regulatory Authority (DRAP) said on Tuesday that the recall process of batches of antihypertensive medicine valsartan manufactured from the active pharmaceutical ingredient (API) supplied by Zheijiang Huahai Pharmaceuticals, China was near to completion at manufacturer’s level.

The drug was recalled due to presence of N-Nitrosodimethylamine (NNDMA) a probable carcinogenic compound.

The pharmaceutical companies have submitted the data of their recalled batches which was under scrutiny by DRAP field offices, said a press release of the regulator.

Some of the manufacturers have started production of their registered products containing valsartan after due procurement of API from alternate sources.

DRAP said that recently Searle Company had informed that they were now manufacturing their valsartan from an alternative source. API supplier firm has informed that they have randomly sampled three batches and studied. The results show that N-Nitrosodimethylamine (NNDMA) is not detected in their valsartan, which ensures adequate safety and conforms to the regulatory requirement.

DRAP said that Searle has been allowed to manufacture its registered products from the said source. Similarly, Tabros and Pharm Evo have changed their sources of API valsartan and have marketed their products.



The drug regulator has already issued advisory for the healthcare professionals and patients that brands containing valsartan from alternative sources can be prescribed and used by patients.

Confusion regarding the usage of valsartan medicine is being clarified by DRAP that the valsartan medicine or its manufacturers in Pakistan have never been banned but the products manufactured by API supplied by Zheijiang Huahai Pharmaceuticals was recalled after the precautionary recall alert issued by EMA. This precautionary recall was based on the detection of an unexpected impurity N-NDMA which is classified as probable carcinogenic.

DRAP has issued instructions to manufacturers who are using API from alternative source to ensure the availability of their product in the market in best public interest and submit the compliance report.

Published in The Express Tribune, July 25^th, 2018.