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September 3, 2018
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SC issues notices to health ministry, DRAP on plea for recalling substandard medicines

Karachi

September 3, 2018

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The Supreme Court has issued notices to the ministry of health, the drug regulatory authority and pharmaceutical companies on a petition for withdrawing from markets contaminated high blood pressure medicines that could cause cancer.

Mohammad Tariq Mansoor submitted in the petition that the Drug Regulatory Authority of Pakistan (DRAP) had directed nine pharmaceutical companies in June this year to recall medicines of high blood pressure, manufactured by them, as contaminated raw material used in those medicines could cause cancer.

He said directions to the effect were issued after getting an alert from the European Medicating Agency (EMA), which pointed out that the raw material used for producing the drugs was contaminated. He added that the EMA had detected an impurity — N-Nitrosodimethylamine (NDMA) — in the valsartan active ingredient which the company supplied to manufacturers in some areas of the European Union (EU) and in Pakistan as the NDMA was classified as a probable carcinogenic (a substance that could cause cancer) based on results from laboratory tests.

He said that drug inspectors and health departments had been informed that the recall directives would also be implemented on all medicines containing valsartan manufactured by the Chinese company whether locally manufactured or imported ones. Besides, healthcare professionals have been requested to take the necessary measures for the treatment of patients using valsartan products to protect patients from the complications of the NDMA.

He submitted that the DRAP and private pharmaceutical companies had failed to fulfil their obligations and they were not intimating the general public about the hazards and precautionary measures, including circulating a notice in the print and electronic media.

He said the DRAP had directed the nine pharmaceutical companies to not dispose of the medicines in the prescribed form in the public interest and prima facie the companies were trying to conceal the fact regarding the existing adverse drug reaction and vested interest of the companies.

He added that after the incident, the Punjab Institute of Cardiology where 200 persons died due to contaminated medicines, then chief justice of Pakistan Tassaduq Hussain Jillani had directed that the Adverse Drug Reaction reporting — which was done to analyse effects of medicines — be started, but the directive was not implemented.

Petitioner submitted that although Pakistan has more than 700 pharmaceutical companies but there was no proper arrangements to check the quality of the raw material impartially by the government and to properly keep the record of medicines. The court was requested to direct the DRAP and pharmaceutical companies to device a mechanism for recalling of product raw material testing where ADR should be carefully studied before and after import of active pharmaceutical ingredients either produced locally or from abroad and recall alleged contaminate drugs after proper record keeping and share such information with the public through notices. Chief Justice of Pakistan Justice Mian Saqib Nisar which took up the application while hearing human right cases issued notices to the ministry of health, DRAP and other respondents and called their comments.

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