Drug Act a major hurdle to boost export, says PPMA

Pakistan’s local pharmaceutical manufacturers have identified section 12 of Drug Act as a major haurdle in the boost and export of their products to other countries and have urged Government of Pakistan and Drug Regulatory Authority to harmonize laws and policies with accordance to international standards. They also demanded Drug Regulatory Authority Pakistan (DRAP) to comply with World Health aOrganization (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 Shaikh Kaiser Waheed and Zahid Saeed, both the former chairmen of Pakistan Pharmaceutical Manufacturers Association (PPMA) during the 9th Health Asia Seminar on “Exploring the untapped potential of export of pharmaceutical products from Pakistan” held here in expo center, Karachi by Pakistan Pharmaceutical Manufacturers Association (PPMA) and Ecommerce Gateway.
Former Chairman PPMA Dr. Shaikh Kaiser Waheed shared the growth and hurdles of pharmaceutical sector in Pakistan. He said few decades back, Pakistan made drugs were exported to un-regulated markets of the world which later on expanded to low regulated countries. Regulators of the few African countries are trained by WHO hence they have good knowledge of inspecting the standards, validations, processes of pharmaceutical products. PPMA urged the DRAP that uniform standard of inspection by the regulators of Pakistan should be adopted.
Pharmaceutical industry have grown at fast pace but we have no share on share in world export market of drugs. Law like Section 12 of Drug Act is not enforced in any country even in our neighboring India. This act should be amended in accordance with international standards, he demanded.
Dr. Shaikh Kaiser Waheed deplored that there is no dedicated institution in the country to produce human resource for pharmaceutical industry. Our universities are producing pharmacists who only spend two weeks internship in manufacturing units and award them degrees. Can they promote pharmaceutical industry? I have doubts about it, he was of the view. We have many other issues related to foreign exchange etc. Today’s seminar is a landmark event resulted in discussion on these issues at least. This is the most important question of today that how can we tap regulated pharmaceutical market of regulated countries like Europe and USA? he underlined. He urged DRAP to establish a separate directorate or desk for one window operation to address export related issues. DRAP has received rupees 400 million from pharmaceutical industry but failed to facilitate us. There is dearth of officers in the authority which is hampering pharmaceutical industry, he noted. Former Chairman PPMA Zahid Saeed briefed the audience about the facts of local pharmaceutical industry in Pakistan. There are 688 pharmaceutical companies having 405 registered units including of 24 of multinational companies. Total pharmaceutical market size is rupees 220 billion (US$ 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 US$395 billions. Europe enjoys 31 percent with US$295, Japan 9 percent with US$89, Asia-Pacific-Africa 10 percent with US$96 and Latin America have 8 percent market share with US$75 in terms of money while Pakistani industry merely have share less than 0.1 percent of global export, he told. He stressed on 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. Almost 75 percent of drugs are sold at the most cheapest rates as compared with India although our cost is increased 35 percent of those manufacturing units in India, he informed.
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 harmonize 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.