LAHORE

With a view to boost export of pharma products, the local pharmaceutical manufacturers have urged the government as well as the regulatory authority to harmonise laws and policies in accordance to the international standards. The association also demanded the Drug Regulatory Authority Pakistan to comply with World Health Organisation (WHO) guidelines for Global Manufacturing Practices (GMP) and Association of Southeast Asian Nations (ASEAN) Framework Agreement on mutual recognition arrangement which is beneficial for industry, government and patients, the main concern.

This was stated by Khawaja Shahzeb Akram, the former vice chairman of the Pakistan Pharmaceutical Manufacturers Association.  While sharing the growth and hurdles of pharmaceutical sector in Pakistan, he said few decades back, Pakistan-made drugs were exported to irregulated markets of the world. But regulators of the African countries are trained by WHO hence they demand standards and validations now.

Shahzeb Akram briefing about the facts of local pharmaceutical industry, stated that there are around 700 pharmaceutical companies having over 400 registered units including of 24 of multinational companies. Total pharmaceutical market size is Rs220 billion ($2.2 billion) and it is highly regulated industry having highly educated manpower. Pakistan is among the world’s 35 countries which are meeting 90 percent demand of their local drug market, he shared.

North America shares 42 percent export share of global drugs economy with $395 billions. Europe enjoys 31 percent with $295, Japan 9 percent with $89, Asia-Pacific-Africa 10 percent with $96 and Latin America have 8 percent market share with $75 in terms of money while Pakistani industry merely have share less than 0.1 percent of global export, he revealed. He stressed the need to tap international export potential and suggested local manufacturers to look for at least 2 percent of market share. Talking about the hurdles in export growth he informed that operating and infrastructure cost is growing and his manufacturing unit paid 17 percent extra cost of captive energy alone.

Khawaja Shahzeb, the Chief Executive Officer of Pharma Health Pakistan, observed that price policy is absent here and we got no price raise for last 12 years except of hardship cases. We will have to change our approach towards these issues. On many forums we have urged government to link drug prices with CPI or State Bank inflation statistics, he urged.

“There is need to harmonise and focus four areas including quality, efficacy, safety and administrative data with technical requirements on GMP. The WHO guidelines for GMP should be followed and Pharmaceutical Inspections Convention Scheme Membership (PIC/S) guide to GMP for medicinal products should be focused.”

“It is the responsibility of the government to formulate a policy that benefits the patients and also balances it with the viability of the industry.” He concluded that its time that government comes up with a swift formula in pursuit of reducing the medicine prices, it must not sacrifice safety, efficacy and quality of drugs and growth of Pakistan’s one vibrant industry that has tremendous export potential.