Valsartan recalled, not banned: DRAP
Says batches of drug made from particular raw material have been recalled
PHOTO: EXPRESS
ISLAMABAD:
The drug regulator has clarified that valsartan medicine made by Pakistani companies is not banned and only batches manufactured by using valsartan as a raw material, and supplied by Zhejiang Huahai Pharmaceuticals, China are being recalled.
In the wake of the recall issued by the Drug Regulatory Authority of Pakistan (DRAP) for valsartan by Zhejiang Huahai Pharmaceuticals, China and finished medicine made from it, certain misconceptions have a risen among the masses and prescribers and healthcare professionals, said a DRAP statement.
The recall of batches of valsartan medicine used to control blood pressure was issued by the European Medicine Agency (EMA) following detection of N-nitrosodimethylamine (NDMA), in the valsartan active substance.
EMA will ascertain the levels of NDMA in these valsartan medicines, its possible impact on patients who have been taking them and what measures can be taken to reduce or eliminate the impurity from future batches produced by the company, the DRAP statement said.
Patients and prescribers have been calling DRAP whether valsartan medicine manufactured by Pakistani companies produces cancer or are banned or should they stop taking medicine.
The authority, taking notice of misconception declares in clear terms that valsartan medicine made by Pakistani companies is not banned and only batches manufactured by the valsartan raw material manufactured using are being recalled.
The companies can manufacture and sale valsartan medicine made from valsartan raw material imported from other qualified sources, the statement said.
Published in The Express Tribune, July 18th, 2018.
The drug regulator has clarified that valsartan medicine made by Pakistani companies is not banned and only batches manufactured by using valsartan as a raw material, and supplied by Zhejiang Huahai Pharmaceuticals, China are being recalled.
In the wake of the recall issued by the Drug Regulatory Authority of Pakistan (DRAP) for valsartan by Zhejiang Huahai Pharmaceuticals, China and finished medicine made from it, certain misconceptions have a risen among the masses and prescribers and healthcare professionals, said a DRAP statement.
The recall of batches of valsartan medicine used to control blood pressure was issued by the European Medicine Agency (EMA) following detection of N-nitrosodimethylamine (NDMA), in the valsartan active substance.
EMA will ascertain the levels of NDMA in these valsartan medicines, its possible impact on patients who have been taking them and what measures can be taken to reduce or eliminate the impurity from future batches produced by the company, the DRAP statement said.
Patients and prescribers have been calling DRAP whether valsartan medicine manufactured by Pakistani companies produces cancer or are banned or should they stop taking medicine.
The authority, taking notice of misconception declares in clear terms that valsartan medicine made by Pakistani companies is not banned and only batches manufactured by the valsartan raw material manufactured using are being recalled.
The companies can manufacture and sale valsartan medicine made from valsartan raw material imported from other qualified sources, the statement said.
Published in The Express Tribune, July 18th, 2018.