Drug Regulatory Authority of Pakistan (DRAP) will clear all 7,500 pending cases of drugs registration in current year. Chief Executive officer (CEO) of DRAP, Dr Muhammad Aslam Sunday said that 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 said the authority had fixed the time frame of 30 days to clear such cases and that all these cases would be registered by October this year.
He said that during year 2014, as many as 1,900 medicines had been registered while in year 2015 total 2,775 medicines got registration, Dr Muhammad Aslam said while talking to APP.
He said that a mechanism had been developed to maintain transparency in registration of drugs, adding, it had 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 that resulted increase in number of pending cases, he added.
He said that total 700 pharmaceutical companies were registered with DRAP out of which 24 were multi-national companies.
Dr Muhammad 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. He said an international standard of registration was being developed in the country to make it at par with the standard of WHO specific format called Committee on Trade and Development (CTD).
He added under 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.
He said there would be international standard accredited central drug testing laboratory while labs would also start working at provincial level.
He said 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. He said that 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.
He said with this achievement of international standard on which the DRAP was working, 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 of the globe.
This step would help increasing figure of 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.
He said that after joining PICS not only country's export would touch the highest figure in export of medicines but local pharmaceutical exporters who were looking to export their products to less explored countries would get success. He said that 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. He said that under 2015 drugs pricing policy, the government had strictly controlled the prices of drugs in regard to hardship cases. Under the policy, it was the prerogative of the government to fix the prices of those medicines that fall under hardship regime.
He said there was a set procedure to increase prices like submission of request (certified data) with the government by pharmaceutical companies to raise prices as fixed at ratio of 4% to 6% and up to 8% in accordance with Consumer Price Index (CPI).
He however said that unfortunately pharmaceutical companies instead of waiting for government's any decision on their submitted submissions moved to the court and got stay order.
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