ISLAMABAD: The Drug Regulatory Authority of Pakistan (Drap) has said that the issue regarding the manufacturing of medicine for high blood pressure with contaminated material has been addressed. It says some manufacturers have started the production of their registered products containing Valsartan after the due procurement of the active pharmaceutical ingredient (API) from alternate sources.

The authority has also said that the recall process of batches of the anti-hypertensive medicine manufactured with API supplied by Zheijiang Huahai Pharmaceuticals, China, is near completion at the manufacturer level.

Last week, Drap had directed nine pharmaceutical companies to recall medicines prepared from Valsartan raw material, manufactured and supplied by Zhejiang Huahai Pharmaceuticals. The recall direction was made after an alert was issued by the European Medicine Agency (EMA) which detected N-nitrosodimethylamine (NDMA) in the raw material, which could cause cancer.

Pharma firms allowed to use raw material from other companies in their medicines

The Drap statement said pharmaceutical companies have submitted data of their recalled batches which is being scrutinised by Drap field officers.

Searle Company Lahore has said it is now manufacturing Valsartan from an alternate source, Zheijiang Tianyu Pharmaceuticals, China. The API supplying firm has said it has randomly sampled three batches. The results show that NDMA has not been detected in their Valsartan, ensures adequate safety and conforms to the regulatory requirement.

Searle Company has been allowed to manufacture its registered products from the said source.

Similarly, Tabros and Pharm Evo have changed their sources of API Valsartan and have marketed their products.

The Drap statement says it has already issued an advisory for healthcare professionals and patients that brands containing Valsartan from alternate sources can be prescribed and used by patients.

The authority is clarifying the confusion, saying that Valsartan containing medicines or its manufacturers have never been banned but the products manufactured by API supplied by Zheijiang Huahai Pharmaceuticals was recalled after the precautionary recall alert issued by EMA.

“The recall was based on the detection of an unexpected impurity NDMA which is classified as probable carcinogenic. Drap has 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,” the Drap statement says.

Published in Dawn, July 25th, 2018