ISLAMABAD: Manufacturers have been allowed by the drug regulator to restart manufacturing of valsartan products from an alternate source of valsartan Active Pharmaceutical Ingredient (API) after due testing to ensure availability of the drug for the patients.
A meeting of stakeholders with the Drug Regulatory Authority of Pakistan (DRAP) senior officers took place on Tuesday to discuss the issue of medicines containing valsartan raw material manufactured by Zheijiang Huahai China. The matter was discussed in depth in the light of reviews by the European Medicine Agency (EMA) and the US-FDA.
Drugs used to treat high blood pressure having raw material from a Chinese company were recalled because some products contained cancer causing chemicals.
DRAP CEO Dr Sheikh Akhter Hussain who chaired the meeting reiterated that DRAP’s primary duty is to safeguard public health and every effort shall be made to provide safe medicines to the general public. All the manufacturers were again asked to ensure the recall products containing valsartan raw material sourced from Zheijiang Huahai Pharmaceuticals as soon as possible.
The manufacturers informed that they have recalled all stocks and are putting all efforts to recall any remaining stocks in the market.
DRAP CEO also directed manufacturers to build up their capacity to test the impurity of the chemical N-nitrosodimethylamine (NDMA) so the regulators can identify and quantify the API and finished products. It was also informed by the manufacturers that alternative source Zheijiang Tianyu, China has certified that their API is free from NDMA. DRAP CEO informed the participants that the objective of this meeting was to verify the permissible levels of NDMA, its impact on public health and measures to mitigate the associated risks for the public health.
Published in The Express Tribune, August 8th, 2018.