DRAP to clear 7,500 pending cases of drug registration soon-M. Aslam


 DRAP to clear 7,500 pending cases
of drug registration soon - M. Aslam

ISLAMABAD: Drug Regulatory Authority of Pakistan (DRAP) will clear all 7,500 pending cases of drugs registration in current year.  According to Chief Executive Officer (CEO) of DRAP, Dr Muhammad Aslam out of total registration cases, 3,500 were old pending cases from year 2010 to year 2015 while 4,000 cases were pending due to technical reasons like submission of incomplete documents or registration fees.

He further stated that the authority had fixed the time frame of 30 days to clear such cases and that all these cases would be decided by October this year. During the year 2014, as many as 1,900 medicines had been registered while in year 2015 total 2,775 medicines got registration.A mechanism had been developed to maintain transparency in registration of drugs, and it has been decided to hold two meetings every month to study the cases.In past there was trend of holding very few meetings throughout the year has resulted in piling up of the number of pending cases. At present a total 700 pharmaceutical companies which includes 24 multinationals were registered with DRAP.

Continuing Dr. Aslam said that under reforms transformation strategy, the authority had been focused on four aspects included registration, licensing, quality control and price control of medicines. An international standard of registration was being developed in the country to bring it at par with the standard of WHO specific format called Committee on Trade and Development (CTD). Under the new reforms senior level officers would be the signing authority for registration like chairman and secretary unlike past when a section officer was the signing authority.

An international standard accredited central drug testing laboratory is needed and good laboratories being established at provincial headquarters will also start functioning soon. These laboratories would be pre-qualified from WHO in order to improve the credibility of these labs. So far three levels had been achieved while pre-audit would start by end of this year.  A federal drug surveillance laboratory would soon start functioning. Under WHO assessment scheme, DRAP would observe gaps and potentials while its transparency would be checked by WHO, he added.

DRAP is working for the achievement of international standard after which Pakistani companies would be able to get membership of Pharmaceuticals Inspection Cooperation Scheme (PICS) that would help these companies for easily registration in every country in the world.

This step would help increasing country's medicines export which at present stands at the volume of Rs 167 million against India's figure of Rs 20 billion and Bangladesh Rs 1.8 billion. After joining PICS not only country's export would increase but local pharmaceutical exporters who were looking to export their products to less explored countries would be benefitted. PICS would endorse Pakistani Pharma companies as reliable exporters of quality medicine. This would help improving the quality of local companies and people would get quality medicines.  Under 2015 drugs pricing policy, the government had strictly controlled the prices of drugs in regard to hardship cases. (PR)

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