Int’l drugs registration system to be made functional soon

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An international standard of drugs registration system was being developed in the country to make it at par with the standard of World Health Organisation’s (WHO) specific format of Committee on Trade and Development (CTD).
According to an official of Drug Regulatory Authority of Pakistan (DRAP), after achieving this international standard, Pakistani pharmaceutical companies would be able to get registration of their medicines from concerned authorities of major countries of the world.
He added that 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 easily register in every country of the globe.
This step would help increase 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 opportunities.
He said that PICS would endorse Pakistani pharma companies as reliable exporters of quality medicine. This would help improving the quality of local companies while country’s people would get quality medicines.
He said the federal drug surveillance laboratory would soon start functioning in the country. The laboratory would be international standard while labs would also start working at provincial level, he added.
He said under WHO assessment scheme, DRAP would observe gaps and potentials while its transparency would be checked by WHO. He said these laboratories would be pre-qualified from WHO in order to improve the credibility of these labs.
He said that taking cognizance of exercise of discretion in regard to drug pricing in the past, this government for the first time in the country’s history introduced a Drug Pricing Policy where discretion in fixing prices was altogether done away with and a Consumer Price Index based system was introduced.
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 per cent to 6 per cent and up to 8 per cent in accordance with Consumer Price Index (CPI).
He said that the government would take strict action against elements and companies resorting to illegal price hike, to safeguard the interests of the public. The action will serve as a determent and discourage the elements involved in illegal price hike of drugs. He added all out effort has been made to ensure that drugs are provided to the masses at affordable prices.

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