POST TIME: 17 October, 2018 12:57:13 AM / LAST MODIFIED: 17 October, 2018 01:50:56 PM
20 medicines recalled for raw material impurities
Drug admin orders Incepta, ACME, Popular, Drug Int’l, Renata, Healthcare to withdraw blood pressure control medicines

20 medicines recalled for raw material impurities

The drug administration has asked six pharmaceutical companies to withdraw over 20 medicines used for blood pressure control after cancer creating compounds were found in raw materials. Directorate General of Drug Administration (DGDA), the drug regulatory authority of Bangladesh, in an order issued on Sunday asked Incepta Pharmaceuticals, ACME Laboratories Ltd , Popular Pharmaceuticals, Drug International, Renata Pharmaceuticals and Healthcare Pharmaceuticals to withdraw the medicines manufactured from the raw material ‘Valsartan’, which were produced by Zhuhai  Rundu Pharmaceutical Co Ltd and Zhejiang Tianyu Pharmaceutical Co Ltd of China.

Talking to The Independent, DGDA Director Ruhul Amin said the raw material named ‘Valsartan’ from two Chinese manufacturers contained traces of probable carcinogenic (cancer creating) compound NDMA (N-Nitrosodimethylamine). As the medicines made using this active ingredient from the two Chinese companies were withdrawn in European countries, the DGDA has also ordered the recall of such medicines from the Bangladesh market, added Amin.

The DGDA ordered its field officials to confiscate the medicines from the market within the next seven days. The recalled medicines include Amlosartan tablet of Incepta; Valtin, Co-Valtin tablets of ACME; Amlovas vs tablets of Popular; Tab,Av-5,10, 5/80 of Drug International; Valdipin FC of Renata; and Disys, Co-Disys tablets of Healthcare.  

Earlier in July, several heart drugs containing Valsartan were recalled in Europe and Asia after residues of a substance were found in its supplies that could cause cancer, according to international media. A Chinese company voluntarily informed the European Medicines Agency (EMA) that it had identified N-nitrosodimethylamine

(NDMA), a chemical that might lead to cancer, in its Valsartan provided to the European market.  As a result, medicines containing Valsartan made by the Chinese company were recalled. Valsartan, a drug first developed by Novartis to treat high blood pressure and heart failure, has already gone off patent and is used in many medicines made by several drugmakers. US Food and Drug Administration also joined European countries to recall it in July because of the health risk.