Drug Act is major hurdle to boost pharma export: PPMA

KARACHI: Pakistan’s local pharmaceutical manufacturers have identified section 12 of Drug Act as a major hurdle in the boost and export of their products to other countries and have urged Government of Pakistan and Drug Regulatory Authority to harmonize laws & policies with accordance to international standards.

They also demanded Drug Regulatory Authority Pakistan DRAP to comply with World Health organization 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 Dr 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 Kaiser Waheed shared the growth and hurdles of pharmaceutical sector in Pakistan. He said few decades back, Pakistan made drugs were exported to unregulated 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 neighbouring 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. Our Drug Regulatory Authority DRA should be member of PIC/S as it is very beneficial for industry as well. We also need to come on same page with DRA and we have no competition with the authority, he asked.

Acting Chief Executive and Senior Director Drug Regulatory Authority Pakistan DRAP Ashraf Khan represented her in the event. In his speech, Arshad Khan said that drug is hope for patients and is ambassador of Pakistan in the world and no doubt there is need to make as many as ambassadors in the world. “Yes we need harmonization of the issues and scientific approaches towards issues,” he agreed.

Due to political scenario and image portrayed by media is also a great hurdle to increase our exports. He urged local manufacturers to establish their own brands and introduce the same in international market as well. Scientific approach should also be followed in amending laws and policies to bring them at par with needs and international standards. We have a policy board as well in DRAP. We are ready to accept suggestion from all stakeholders including manufacturers on it, he offered.

Secretary, Trade Development Authority of Pakistan Rabiya Javeri Agha appreciated the role of local pharmaceutical manufacturers and their issues are being addressed by her authority as well. We are supporting exports through delegation exchange program and exhibitions abroad, she informed. She told that four million people are provided employment by pharmaceutical sector. At present we are working on strategic partnership framework for next two years and suggestions of manufacturers will be appreciated, Rabiya Javeri Agha concluded.

Head, Department of MBA Health Management, Institute of Business Management IoBM Dr. Asima Faisal and Chairman Morgan Group Liaquat Jawaid were also among other speakers on the occasion. Event is following a three days exhibition participated by more than one hundred international and national companies.

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