DRAP gives another call for recall of Valsartan

Islamabad : The Drug Regulatory Authority of Pakistan (DRAP) Tuesday urged all manufacturers once again to ensure the recall of products containing Valsartan raw material sourced from M/s Zheijiang Huahai Pharmaceuticals, China, as soon as possible. Even though the manufacturers claimed having recalled all stocks, the reality is quite to the contrary.

“You are requested to restart manufacturing of Valsartan products from alternate source of Valsartan API after due testing to ensure availability,” manufacturers were told at a stakeholder meeting chaired by DRAP’s CEO. The meeting was convened to verify the permissible levels of NDMA, its impact on public health, and measures to mitigate associated risks for public health.

The DRAP chief asked manufacturers to build their capacity to test the impurity NDMA to identify and quantify the API and finished products. The manufacturers stated that alternate source Zheijiang Tianyu, China, has certified that their API is free from NDMA.

The house unanimously took the following decisions: DRAP should provide update on recalled products and inform the industry to hold the stocks as investigation is under process in coordination with global authorities like EMA, US-FDA and WHO; a questionnaire be issued to confirm NDMA is absent in other API manufacturers, once the EMA/US-FDA/WHO complete their reviews; recalled finished product batches containing Valsartan manufactured by Zheijiang Huahai Pharmaceuticals, China, must be segregated under lock/key until further notice; testing should be done for presence of NDMA. The possibility of testing of random samples of API and finished products by WHO approved labs was also discussed. The WHO labs will be identified by manufacturers for testing of API for the testing of NDMA. The qualified APIs source could also be used by the other manufacturers.

The meeting also decided that pharmaceutical manufacturers should comply with pharmacopoeial requirements for testing of impurities for all products in future.A committee was constituted to prepare guidelines for procurement of APIs as per pharmacopoeial specifications.