International standards: ‘To prosper, quality management in pharmaceutical industry is necessary’

A conference on Pakistan's pharmaceutical industry was held to highlight needed changes


Our Correspondent September 07, 2015
A conference on Pakistan's pharmaceutical industry was held to highlight needed changes. PHOTO: REUTERS

KARACHI: In light of the three-day-long 11th Health Asia International Exhibitions and Conferences, a pre-event conference on compliance issues in the pharmaceutical industry was organised on Monday.

The conference was organised to educate and inform the regulatory authorities and pharmaceutical companies to meet international standards. The three-day exhibition started at Karachi Expo Centre on Monday when more than 300 foreign delegates arrived from Germany, Italy and Spain. Health Asia, in the next three days, will consist of 13 CME accredited seminars and workshops on different medical subjects and specialties.

The chief guest at the occasion, Dr Muhammad Aslam, chief operating officer for the Drug Regulatory Authority of Pakistan, said that raising the compliance standards in our industry will help it grow exponentially.

The conference mainly focused on the facilities designed under international standards, quality risk management and the sterilisation process of equipment. Speaking about the quality risk management, general and quality assurance manager at CCL Pharma, Muhammad Naeem, emphasised on the assessment process of risks. "We should analyse before evaluating the risk factor in our industry," he pointed out while giving a power point presentation.



Speaking about internal regulation and how Pakistan's inspection authority is facing a convergence, the managing director of Indus Pharma, Zahid Saeed, stressed that students who are graduating from universities and colleges in pharmacy do not have exposure to regulatory authorities and do not know how to work.

He also urged all educational institutions to revise their curriculum and subjects because fresh graduates are the best to work with if they have proper knowledge of the industry. "Special courses should also be introduced for those pharmacists who have already graduated so that they can also play their part in meeting international standards," Saeed said.

Another panelist, Sultan Ghani, said that the quality management system in companies should be handed over to professionals but not the owners of the companies, who are not professionals. "Owners can be the holders and should make decisions and guidelines but, to prosper as a healthy nation, quality management should be taken care of by professionals," he added.

Seconding Ghani's view, managing director for PharmaEvo, Haroon Qasim, mentioned that Pakistan, as a pharmaceutical industry, needs to understand its dimensions and should realise where it is lacking as an industry. "We still need to understand where we want to see ourselves in the world in terms of the pharmaceutical industry," he said.

Published in The Express Tribune, September 8th,  2015.

COMMENTS (1)

Abbassin | 9 years ago | Reply A good piece for the lay man, but for one in the know and many others around the globe, the reality is that in spite of conferences after conferences such as this over the years, nothing practical has been done to meet international regulatory compliance. The fact is that the two stakeholders-the government and the industry have never been on the same page when it comes to quality regulations, which is evident by years of neglect on the part of the government to establish a national drug regulatory authority, with mandate to regulate and monitor compliance, and the powers to take action against non-compliance. As for industry, since they have operated in the dark, they took advantage of the vacuum and looked more at their immediate bottom line than long term future, which can only come with international compliance. The result is that a country with a long history of a large robust, national and international pharmaceutical industry does not have one single company which has the quality standards to penetrate any of the regulated markets. For comparative purposes, Bangladesh a new kid on the block has something like four or five companies, which are approved suppliers of pharmaceutical products to the regulated markets. Where do we go from here? The answers may be complex and tedious, but for starters, the above mentioned two stake holders must learn, teach, and practice “quality” at all times-remember quality is a state of mind-and taking care of the health of a nation is a sacred trust. Hence they must get together, forge a partnership to move forward, as is the norm internationally.
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