ISLAMABAD: Minister for National Health Services Saira Afzal Tarar Tuesday informed the Senate that pharmaceutical companies in the country were following local Good Manufacturing Practice (GMP) under Schedule B-II of Drugs Act, 1976.
Replying to a question, the minister said the GMP laws were based on the World Health Organization (WHO) guidelines, which were part of Drug Acts, 1976.
She said the Area Federal Inspector of Drugs, Drug Regulatory Authority Pakistan (DRAP), was responsible for the routine inspection of pharmaceutical facilities as well as implementation of WHO GMP guidelines by the industries.
Furthermore, the Central Licensing Board constituted a panel of experts for the grant of new license to the pharmaceutical industry and its renewal, the minister said.
She said the panel of experts conducted inspection of the pharmaceutical industry keeping in view Schedule B of Drugs (Licensing, Registration & Advertising) Rules, 1976 under Drugs Act, 1976.
Saira Afzal Tarar said that alternative medicines sector was unregulated before the promulgation of DRAP Act 2012.
She said the present Government notified Alternative Medicine and Health Products (Enlistment) Rules 2014, which also provided control of content of lead, mercury and arsenic in alternative medicines, including Ayurvedic medicines.
The minister said the DRAP had started enlistment of manufacturers, importers and their products. Major manufacturers and importers of this sector had been enlisted and granted enlistment certificates, which contained the condition that heavy metals in the finished product shall be within the prescribed limits as defined in the rules.
The Federal Government and the DRAP were well aware of their responsibilities and moving forward to regulate this sector, she said.
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