Representative body of research-based multinational pharmaceutical companies in Pakistan, Pharma Bureau, has urged the new government to make quality the cynosure of pharma policies in Pakistan.
Executive Director Pharma Bureau Ayesha T Haq said, "Multinational pharmaceutical companies, members of Pharma Bureau, in Pakistan are producing quality drugs in strict compliance with the international standards of current good manufacturing practices and selling them under the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) code of conduct. During the last seven years, the investment of MNCs in Pakistan was in excess of $0.5b towards maintaining good manufacturing practices standards as each MNC with a manufacturing facility invests average US$3.2 million per annum with some investing up to US$10 million per annum."
She added that in the past tragic incidents like PIC and Tyno syrup happened due to compromise on quality of drugs by some companies resulting from total failure of their suboptimal quality management systems. "Despite regulatory challenges, the multinational pharmaceutical companies are keeping up with the global quality standards and current good manufacturing practices."
It is pertinent to mention that recently European Medicines Agency (EMA) had issued an alert about a raw material, sourced from Shanghai and used to produce Valsartan, drug prescribed for high blood pressure, was found contaminated with an impurity - N-Nitrosodimethylamine (NDMA) in some areas of the European Union (EU). NDMA was classified as a probable carcinogenic (a substance that could cause cancer) based on results from laboratory tests.
Based on the alert, DRAP asked nine companies to recall the drug from markets. "We are proud to claim that none of the MNCs in Pakistan are using the affected raw material from the questionable sourcing companies," said Haq. She added that all multinational pharmaceutical companies operating in Pakistan are committed to maintaining the highest quality and ethical standards. "The government must develop and follow a comprehensive policy to ensure checks and balances for the provision of quality medicines to the patients," she demanded.
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