MORE than 750 pharmaceutical companies operating in Pakistan are manufacturing export quality medicines. This industry hires mostly women and supports an entire chain of suppliers for its production operations.
Pakistan can increase pharmaceutical exports by around $10million to $20million every year by making policies that help these industries acquire export order.
What is needed is for the Drug Regulatory Authority of Pakistan to formulate policies that encourage generic medicines exports. At present DRAP’s policies are delaying the process of getting WHO Listed Agency (WLA) status.
To be able to export medicines, a pharmaceutical company needs to have three things; licence to manufacture, GMP compliance report and a product Bio Equivalency (BE) research study report. When all these documentations are completed only then will other countries allow registration of product for import.
Pakistani pharmaceutical firms fulfill the first two conditions but fail on the BE study report. Each BE study can cost up to $300,000 and our local pharmaceutical companies do not have the ability to fund such studies. This is the reason no Pakistani pharmaceutical company is exporting its products to EU countries, Japan, Australia or Russia.
Recently to promote new entrants in generic medicine exports, WHO drastically reduced the requirement of human trials on a few products, reducing its cost to $14,500.
Only two companies, one in Karachi and one in Peshawar, offer BE Research study service in Pakistan. A huge government fund has accumulated in the Central Research Fund which was created to help increase pharma sector exports. If the federal government allows these firms a loan from the CRF then within a year Pakistan pharma exports will increase.
The best thing is that it will not cost the government anything as the loans will be paid back from companies’ export profits. The plan is also sustainable as the pharma companies will continue new BE research studies on new products to increase their export portfolio.
Dr Rohail Baseer,
Published in Dawn, January 18th, 2020