Almost 3,00 drugs registered in 2015 – DRAP efforts to clear 7,500 pending cases by October 2016


By Our Staff Reporter 

KARACHI– Drug Regulatory Authority of Pakistan’s (Drap) chief executive officer (CEO) Dr Muhammad Aslam has vowed that all the 7,500 pending cases of drugs registration will be cleared during the current year.  The Drap has, however, registered 1,900 medicines during 2014 and 2,775 medicines in 2015, he added.

Giving details of the pending cases, Drap chief said that of the total 7,500 drug registration cases, 3,500 cases belonged to the period ranging between 2010 and 2015, while remaining 4,000 cases have been pending due to some technical reasons such as incomplete documents or non-payment of registration fees, etc.

According to a press release, the Drap had fixed the timeframe of 30 days to clear such cases and that all these cases would be registered by October this year. A mechanism had been evolved to maintain transparency in registration of drugs and two meetings will be convened every month to study the cases, the press release quoted Dr Aslam as saying.

“In fact, drugs registration cases kept on piling up as previously only few meetings used to be convened in a year,” he added.

He said that of the 700 pharmaceutical companies registered with Drap, 24 are multinationals.  He said that under the reforms transformation strategy, the authority had been focusing on four aspects which include registration, licensing, quality control and price control of medicines, besides an international standard of registration was being developed in the country to make it on par with the standard of WHO-specific format, called Committee on Trade and Development (CTD).

Under the Drap’s new reforms policy, senior-level officers such as chairman and secretary would be the signing authority for registration as against the past practice when a section officer used to be the signing authority, he said, adding that there would be an international standard accredited central drug-testing laboratory, while laboratories would also start working at provincial level.

He said these laboratories would be pre-qualified from the WHO in order to improve the credibility of these labs.

He said that a federal drug surveillance laboratory would soon start functioning under WHO assessment scheme and Drap would observe gaps and potentials, while its transparency would be checked by the WHO.

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) and the move would facilitate such companies to easily acquire registration in all the countries of the world.

Moreover, this step would also help increase figure of the country’s medicines’ export which, at present, stood at Rs167 million against India’s Rs20 billion and Bangladesh’s Rs1.8 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.
He said that under the 2015 drugs pricing policy, the government had strictly controlled the prices of drugs with 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 per cent to 6pc and up to 8pc in accordance with Consumer Price Index (CPI).

However, pharmaceutical companies, instead of waiting for government’s decision on their submitted submissions, moved to the court and got stay order, he deplored.


March 6, 2016

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