Recall of drugs made from Chinese Valsartan nearing completion: DRAP

ISLAMABAD: The exercise to recall batches of anti-hypertensive medicine, Valsartan, manufactured from the active pharmaceutical ingredient (API) supplied by Zheijiang Huahai Pharmaceuticals, China, is near completion at manufacturer’s level, said the Drug Regulatory Authority on Tuesday.

According to the drug regulator, the pharmaceutical companies have submitted the data of their recalled batches, which is under scrutiny by the DRAP field offices. "Some manufacturers have started production of their registered products containing valsartan after due procurement of API from alternate sources."

Recently, the Searle Company, Lahore, has informed the DRAP that it is now manufacturing their product valsartan from an alternate source, Zheijiang Tianyu Pharmaceuticals, China. The API supplier firm has said it has randomly sampled three batches and studied.

The results show that N-Nitrosodimethylamine (NNDMA) is not detected in their Valsartan ensures adequate safety and conforms to the regulatory requirement. The Searle Company has been allowed to manufacture its registered products from the said source. Similarly M/s. Tabros and Pharm Evo have changed their sources of API Valsartan and have marketed their products.

The DRAP has already issued advisory for healthcare professionals and patients that brands containing Valsartan from alternate sources can be prescribed and used by patients. Clearing a confusion regarding the usage of valsartan medicine, the DRAP said the Valsartan medicine or its manufacturers in Pakistan had never been banned but the products manufactured by API supplied by Zheijiang Huahai Pharmaceuticals, China, was recalled after the precautionary recall alert issued by the European Medicines Agency.

"This precautionary recall was based on the detection of an unexpected impurity N-NDMA which is classified as probable carcinogenic. We have issued instructions to manufacturers who are using API from alternate source to ensure the availability of their product in the market in best public interest and submit the compliance report," it said.