THIS is with reference to a news item (Feb 19) that the federal government intends to review licences of all the drug companies in the country issued during the last two decades. This is a commendable decision taken with the establishment of the Drug Regulatory Agency of Pakistan (DRAP) in the wake of deaths that occurred due to adverse drug reaction in Lahore.
Many more steps have been highlighted regarding quality and purity of drugs. I wonder how one can determine standards of manufacturing and testing as well as Current Goods Manufacturing Practices (CGMPs) in the absence of research and development activities in any pharmaceutical company. Why has this aspect not been included?
It is suggested to the DRAP members that while reviewing the licences they should also take serious notice that each and every company should have research and development facilities and the products coming out for marketing should have also been verified and certified by research and development. There can be serious errors in manufacturing which can be rectified by research and development department. DRAP members should also take notice that testing of non-pharmacopoeal drugs should require extra qualifications and experience of analysts and quality control managers’ skill.
The standard operating procedures of both manufacturing and testing should be prepared after the drug has passed through the research and development department.
DR M. QUDRAT-E-KHUDA Karachi
