Islamabad - Drug Regulatory Authority of Pakistan (DRAP) directed all drugs manufacturers to recall the products of a Chinese company containing contaminated raw material which can cause cancer in patients. The decision was taken in a meeting held with pharmaceutical manufacturing companies’ representatives and DRAP officials.

Earlier, nine pharmaceutical companies were asked to recall medicines of high blood pressure, as the raw material used by these companies, manufactured by Chinese company Zheijiang Huahai could cause cancer. The name of the raw material used in these medicines was ‘valsartan’.  The directive was issued the European Medicating Agency (EMA) which pointed out that the raw material was contaminated. According to the statement, the meeting was chaired by CEO DRAP Sheikh Akhtar Hussain and the matter was discussed in depth, in light of the reviews by the European medicine agency (EMA), US-FDA.  All the manufacturers were again asked to ensure that products containing valsartan raw material sourced from M/s Zheijiang Huahai Pharmaceuticals, China are recalled as soon as possible.

The manufacturers informed that they have recalled all stocks and are putting all efforts to recall any remaining stock in the market.  Manufacturers were requested to re-start the manufacturing of valsartan products from alternate source of valsartan API after due testing to ensure availability. It was also directed by CEO, DRAP that manufacturers should build up their capacity to test the impurity NDMA to identify and quantify the API and finished products. It was also informed by the manufacturers that alternate source Zheijiang Tianyu , China has certified that their API is free from NDMA. CEO DRAP informed the participants that the objective of this meeting to verify the permissible levels of NDMA, its impact on public health and measures to mitigate the associated risks for the public health. The house unanimously made the following decisions. It was decided that DRAP should provide an update on the recalled products and inform the industry to hold the stock, as investigation is under process in coordination with global authorities like EMA, US-FDA and WHO.

Further, a questionnaire would be issued similar to EMA to confirm that NDMA is absent in other API manufacturers, once the EMA/ US-FDA/WHO completes their reviews. It was also decided in the meeting that the recalled finished product batches, on direction of DRAP containing valsartan manufactured by Zheijiang Huahai Pharmaceuticals, China must be segregated under lock/key until further notice. Furthermore, it was decided to initiate testing for the presence of NDMA. The possibility of testing random samples of API and finished products by WHO approved labs was also discussed.  The WHO labs will be identified by the manufacturers for testing of API, and for the testing of NDMA. The qualified APIs source could also be used by the other manufacturers.

Finished products that are manufactured by API source other than those mentioned above can be sold in the market by all manufacturers, but they should initiate testing to confirm the absence of the N-Nitrosodimethylamine (NDMA) impurity in the finished product and submit test reports within 3 months. Pharmaceutical manufacturer should comply with the pharmacopoeial requirements for the testing of impurities for all products in future.

A committee was constituted to prepare guidelines for the procurement of APIs as per pharmacopoeial specifications. CEO DRAP reiterated that DRAP’s prime most duty is to safeguard the public health and every effort shall be made to provide safe medicines to the general public.