ISLAMABAD: The Drug Regulatory Authority of Pakistan (DRAP) would clear all pending cases of licensing and registration of medicines in current year, an official said.
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
The official said the drug regulatory authority had fixed the timeframe 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 were registered while in year 2015 total 2,775 medicines got registration, the official said.
He said that a mechanism has been developed to maintain transparency in registration of drugs, adding that it has been decided to hold two meetings every month to study the cases.
He added in past there was trend of holding very few meetings throughout the year that resulted increase in number of pending cases.
He said that total 700 pharmaceutical companies were registered with DRAP out of which 24 were multi-national companies.
He said that under reforms transformation strategy, the authority has 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 the World Health Organisation 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.
The official 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. He added under WHO assessment scheme DRAP would observe gaps and potentials while its transparency would be checked by WHO.
He said that after achieving this international standard, Pakistani pharmaceutical companies would be able to get registration of their medicines from major countries’ authorities concerned.
He added 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 the 2015 drugs pricing policy, the government has 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 four per cent to six per cent and up to eight per cent in accordance with Consumer Price Index (CPI).
