THIS is with reference to the advertisement supplement of Dawn regarding enactment of Drug Regulatory Authority of Pakistan (DRAP) Bill 2012. Nasir M. Shaikh, the Vice-Chairman of the Pakistan Pharmaceutical Merchants Association, has rightly indicated in his article two important points; establishment of research and development department in every pharmaceutical industry and proper utilisation of central research fund.
Regarding the first point, both quality assurance and quality control cannot be guaranteed in the absence of research and development.
Moreover, the bioequivalence, as highlighted by Mr Nasir, other aspects such as bioavailability, good manufacturing and laboratory practices should also be considered important tools of research and development.
This helps a prospective pharmaceutical industry not only to strengthen production and testing laboratory and update their analysts vis-a-vis the research filtering out from the research and development department, but also enhance the reputation in the countries where their pharmaceutical products are exported.
Regarding the second point, the DRAP Act 2012 has ensured it through proper collection and utilisation of this fund by all local manufacturers under the provision of Drug Act 1976.
Actually the central research fund is aimed at the establishment of research and development department but most of the local pharmaceutical industry has not followed it in letter and in spirit. Where does the central research fund go?
Mr Nasir’s idea of setting up a centre for pharmaceutical development and WHO-accredited laboratory to meet various challenges is commendable. It can be achieved by adopting the above two points.
Import of 90 per cent pharmaceutical raw material from India and China or elsewhere escalates the cost of finished products in Pakistan. If a condition be laid in DRAP clauses that every industry would make at least one such raw material, the cost of finished product can be minimised besides saving foreign exchange.
The policy board is requested to review the above mentioned two points with positive consideration making them compulsory.
It is also important to point out here that rush of molecular medicines are on the anvil. The pharmaceutical industry should be ready and equip itself with the production of such medicines and their quality control.
DR M QUDRAT-E-KHUDA Karachi