Dr Kaiser Waheed is President and Chief Executive of Medisure Pharma International, Karachi and Chairman of Pakistan Pharmaceutical Manufacturers Association (PPMA). In an e-mail interview Waheed shared in detail the changing regulatory policies, current trends, status and nature of pharmaceutical industry in Pakistan. Experts:
The Pakistan Health Ministry has issued the draft for data exclusivity recently. What is the response of the pharma industry in the country?
Data exclusivity is already covered under the Drug Act 1976. There is no reason to have a new law. As far as Article TRIPS 39.3 is concerned, there is no need for national laws to be more stringent than TRIPS.
Could you explain the impacts of the latest 'good manufacturing practices' in the pharma industry? How soon, do you think, the Pakistan pharma industry will comply the new norms?
The national industry is gearing up to be complaint with cGMP guidelines. Many units are already cGMP complaint units. In fact now industry is looking towards to be WHO and other international regulatory compliant.
Could you brief us on the status of intellectual property protection and data exclusivity records in Pakistan since 01/01/2005 --the day the country became TRIPs-complaint?
Pakistan respects WTO and TRIPS responsibilities and is fully compliant with IPR obligations.
Recently, PPMA commented that the share of multinationals in the Pakistani market had decreased from 80 per cent to 51 per cent within the last 25 years. Could you explain the factors that helped the domestic companies to grow higher in the recent past?
Good quality with affordability was instrumental in claiming the market share and of course the ever increasing confidence of people and medical community at large helped the industry flourish in the region.
What are the latest trends in Pakistan pharmaceutical export industry?
Pakistan is gearing up to capture the regional markets and the local pharma industry is aggressively working in building up technical capacity and developing highly qualified and skilled HR.
Could you elaborate the current status of pharma industry in Pakistan, its export prospects and expectations in future?
I anticipate the pharma industry to play a major role in the supply of world class products manufactured in Pakistan to the region and other competitive markets globally
Pakistan is reportedly coming up with a Drug Regulatory Agency for monitoring and regulating the medicines sold in the country. How do the manufacturing industry prepare itself for the new, more stringent regulatory mechanism?
We are working closely with Fed Govt on the important subject of DRA and will make sure that it accommodates the expectations and objectives of the local pharma industry without compromising on good standards.
Do you think Pak pharma will become self-sufficient in terms of manufacturing soon? How?
Not only self sufficient but also excel in quality and supply to regional and other global markets.