Drug Regulatory Authority of Pakistan’s (DRAP) federal drug surveillance laboratory would soon start functioning in the country. According to an official of DRAP, 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 World Health Organisation (WHO) specific format called Committee on Trade and Development (CTD). 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 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 world. 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 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).