Export-challenged pharma sector needs a wake-up pill

LAHORE: Regulation in developing economies can best be done by adopting those tried and tested procedures as benchmarks that have enabled any local company to earn acceptance in highly developed markets.

Pakistan can add billions of dollars to its exchequer if the regulators espouse acknowledged procedures.

Regulation, the world over, is exercised to facilitate the producers and protect the consumers. In Pakistan it is usually used to unnecessarily hamper growth and hurt both the producers and the consumers. Declaring pharmaceutical sector as the sunrise industry of Pakistan by McKinsey and Company, an American consultancy firm, is one such example. 

It has the potential to overshoot current textile exports but has no reach in any of the developed economy. Despite stringent regulations no Pakistani firm has been able to get US Food and Drug Administration (FDA) certification and only one pharma has just recently obtained accreditation from a British regulator.

Numerous Indian pharmaceutical concerns have been certified by the FDA and UK’s Medicines & Healthcare Products Regulatory Agency (MHRA). Today their pharmaceutical exports exceed $15 billion compared to less than $200 million from Pakistan. 

Developed economies like the United States, Canada, Britain, and European Union countries, Australia and New Zealand provide free or subsidised healthcare to their citizen. They do not buy branded products but prefer generic medicines that are many times cheaper than their branded counterparts.

To procure these generic medicines they float global tenders in which only FDA and MHPRA approved companies can participate. In most cases, Indian companies, approved as suppliers of specific medicines by these regulators, win the tenders after competitive bidding. 

Pacific Pharmaceuticals, which had recently been accredited by the MHRA, already holds a German certification, which is valid for European Union (EU). Pacific is the only Pakistani company that has competed against Indian pharmas and won many small orders. Now this company has got the British certification that is accepted by almost all markets where Britain had once ruled. So instead of only EU, it can market its products in Canada, Australia, New Zealand and even Bangladesh. This is a great achievement that should be celebrated nationally.

But more than that the Drug Regulatory Authority of Pakistan (DRAP) should analyse as to what Pacific has done in procedures, plant, and machinery that is missing in other around 600 pharmaceutical companies of Pakistan.

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.

Global pharmaceutical market is over $1.2 trillion. 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. 

One Pakistani company has got this certification; now is the time to replicate it success.

Dr Quratul Ain Irfan, vice president of Pacific Pharmaceuticals, said that her company wanted to get FDA certification as well but the US officials have indicated that currently Pakistan is not on their priority list. 

“Currently 28 of our generic medicines have been certified by the MHPRA and 20 more are in the process of approval,” said Ms Irfan and hoped to cross all export barriers by increasing the firms penetration in the MHPRA approved markets. 

She said obtaining approval from developed world regulators was possible with patience, dedication, and adherence to principles of best management practices. “I hope other Pakistan firms will follow the suit as the market is too big for one or two companies,” she added. It was found that after first FDA approval in India the Indian Pharmaceutical Regulator incorporated procedures, practices in its regulatory manual that facilitated scores of other Indian pharma concerns to get the certification from US regulator.