By Muhammad Luqman
With the grant of accreditation to a Lahore-based Pharmaceuticals company by British Medicines and Healthcare Products Regulatory Authority (MHRA), Pakistani Pharma sector now has access to European market.
MHRA certification will allow the company-Pacific Pharmaceuticals a greater access to not only in Europe but also in other developed countries like Australia and New Zealand where the UK certifications are accepted.
“If your plant is FDA- or MHRA-approved it helps you sell your products in the developed economies. But not every local firm can afford the exorbitant cost of handling documentation required for such accreditation,” says Dr. Quratul Ain Irfan, the Chief Executive Pacific Pharmaceuticals Company.
A number of Indian pharmaceutical concerns have already been certified by the FDA and UK’s Medicines and Healthcare Products Regulatory Agency (MHRA). Today their pharmaceutical exports exceed $15 billion compared to less than $200 million from Pakistan.
Pakistan has over 600 national and multinational pharmaceutical companies catering to the domestic needs while exports are mainly to Asian and African countries.
“ The accreditation of the British regulator will help Pakistani companies to participate in the global global tenders for generic medicines in which only FDA and MHPRA approved companies can participate,” says President Lahore Chamber of Commerce and Industry , Abdul Basit.
In the past , Indian companies, approved as suppliers of specific medicines by these regulators, win the tenders after competitive bidding. But now Pakistan will also be able to have share in global pharma market of over US $ 1.25 trillion.
Pakistani pharma companies plead that the Drug Regulatory Authority of Pakistan (DRAP) should analyse what is missing in the procedures adopted by around 600 pharmaceutical companies of Pakistan so that these could play their due role in the international pharma trade.
The drug regulator should concentrate on best manufacturing practices instead of devoting most of its energies on trivial matters like pricing, font size and color. Controlling prices without economic logic has resulted in the withdrawal of many essential drugs from the market paving way for smuggled and spurious drugs.
Although population is many times higher in Asia and Africa, more than 30 percent of overall pharma sales take place in Europe, 13 percent in Australia, New Zealand, Africa and Asia, 11 percent in Japan, and 37 percent in the US. Pakistan can have access to over $450 billion medicine market if the regulator starts facilitating the companies in attaining best management and manufacturing practices for regions that recognise British certification.
