Drug Regulators should work as facilitators, currently 5 Pakistani Pharma companies are investing overseas because our business environment is not friendly-Dr. Kaiser Waheed


 Pakistan Pharma Summit-III proceedings

Drug Regulators should work as facilitators,
currently 5 Pakistani Pharma companies are
investing overseas because our business
environment is not friendly - Dr. Kaiser Waheed

China and India have liberalized their drug pricing which among
other benefits has also accelerated their exports-Haroon Qassim

Educated patients are a challenge for doctors. In the past
it was quality but now safety of drugs was more
important - Dr. M. Aslam Afghani

From our correspondent

LAHORE: Pakistan Pharmaceutical Manufacturers Association (PPMA) organized its Third Pakistan Pharma Summit here from July 24-25, 2017. The theme of the Summit was “Expanding the Possibilities” and it attracted a large number of representatives from different sections of the pharmaceutical industry i.e., manufacturing, quality control, marketing besides drug regulators and government officials. Dr. Kaiser Waheed Chairman PPMA in his welcome address said that Pakistan was a developing country though the West considers us under-developed country. Bangladesh is also a developing country but in the field of pharmaceutical they are far ahead of us. We are trying hard to achieve the status of a developed country. A number of Pakistani Pharmaceutical companies are trying to achieve this status and meet the stringent regulatory standards of the developed countries. We are fighting price war in many countries.

Mian Mujtaba Shuja Ur Rehman Punjab Minister for Excise and Taxation presenting
a memento to Dr. Kaiser Waheed Chairman PPMA at Third Pakistan Pharma Summit
held at Lahore recently. Mr. Haroon Qasim, Mr. Javed Akhai, Mr. Ijaz Siddiqui
and Dr. M. Aslam are also seen in the picture.

Continuing Dr. Kaiser Waheed said that we should be proud of the fact that Pakistani Pharmaceutical industry is meeting almost 90% of the country’s demand of drugs and only 10% have to be imported. He also pointed out that as an industry they were also fearful of the impact of CPEC and we should be ready to face competition. The regulatory authorities wish the pharma industry to meet their regulatory requirements but the industry has its own limitations. In Pakistan the general population cannot afford expensive drugs, hence the price of drugs is so low that it is difficult for the Pakistani pharmaceutical industry to compete in the international market. We are here to provide safe and effective drugs and Pakistan was the only country where drugs are most economically priced. However, it is a pity that we as an industry have to pay taxes on packaging material as well while the importers just pay the 10% duty. This is a dilemma. Dr. Kaiser Waheed also disclosed that five Pakistani pharmaceutical companies are investing outside Pakistan. Why they are doing it because they do not find the business friendly environment in Pakistan. Further investment in Pakistan is restricted because of strict price control. We are in business and we wish to do business. Let us all learn something from the deliberations from the two days Pharma Summit.

Dr. Kaiser Waheed was of the view that let the regulators work as facilitators. Safety of medicines was a prime concern for all of us and the regulators. We have to make investment to improve our manufacturing facilities keeping in view our resources. We in the Pharmaceutical industry care for the patient who cannot get and afford drugs. Unfortunately the pharma industry does not enjoy good reputation despite the fact that it was working hard to make the country self-sufficient in drugs and medicines and we are determined to change this image for the better, he remarked.

Mr. Haroon Qassim Chairman of Pakistan Pharma Summit-III and Managing Director of PharmEvo in his speech stated that each moment in history is precious and unique. Sometimes these very moments set the shape for decades and centuries. Today’s event could be one such moment. Outlook for the Pakistani pharmaceutical industry has never been brighter but at the same time the lurking perils are dampening its luster. Some feel that the industry was now becoming a basket case due to tough regulatory challenges, poor healthcare policies by the governments along with technological revolution. Continuing Mr. Haroon Qassim said that if we look globally, all health economics are facing similar challenges and we in Pakistan were no exception. Some of the problems which the pharma industry in Pakistan faces he said were rising cost of doing business, changing demographics whereby the people were now living longer with chronic diseases.  At the same time, the patients were now more educated and all this put together are putting the pharma industry to the test and demands  so that the industry could answers their needs, fears as well as aspirations.

The issue of drug prices is often highlighted when we talk about regulatory challenges. China and India have liberalized their drug pricing which among other benefits has also accelerated their exports. In case we in Pakistan manage to address this issue, we have great potential to reach up to the next level. Continuing Mr. Haroon Qassim said that  may be it the precision medicine that provides the biological basis of disease to health sensors targeting Parkinson’s disease, diabetes, cardiovascular disease, asthma an breast cancer in addition to the recently FDA approved  drug for epilepsy, the jump was unbelievable. Sophisticated and organized counterfeiters were the pharma industry’s biggest migraine as they also put millions of lives at risk every year. We need to tighten the supply chain to eliminate the illicit drugs.

Speaking about the regulatory bodies across the globe Mr. Haroon Qassim said that   they are planning to implement the process of serialization in their systems by the year 2020. This was being done to protect the patients from the menace of counterfeit drugs. In Pakistan DRAP also has plans to serialization process a bit quicker as compared to USA and Europe which was very encouraging. However, Mr. Haroon Qassim hasted to add that there is a word of caution. We in the pharma industry believe that an entire ecosystem has to be built before venturing into the complexities of this magnificent tool as being over ambitious sometimes has some undesirable consequences. Pharma industry appreciates the DRAP for its futuristic approach but he suggested that let the DRAP work as a partner with the industry rather than confronting and issuing SROs.

Mian Mujtaba Shuja Ur Rehman presenting mementoes to Mr. Jawed Akhai, Mr. Haroon Qasim,
Mr. Arshad Rahim, Mr. Nadeem Ahmad and Mian Asad Shuja Ur Rehman at the Third Pakistan
Pharma Summit held
at Lahore from July 23-25, 2017.

According to reports by 2020 or 2021, it is expected that almost 75% of the World’s pharmaceutical supply chain will be covered under various regulatory mandates. Compliance with these regulations will require the pharmaceutical companies to invest in new technology, make major process changes besides restructuring their supply chains. No doubt this was a tall order and as industry, are we ready for that, he asked? He hoped that this Summit will result in some practical and concrete results. This is a historic opportunity to widen and reassess our capabilities to tackle the challenges we in the pharma industry are facing today. We must keep the promises we make today, he added. His passionate plea to the pharma industry and the regulatory agencies was that we must work together to ensure maximum benefit to the patient while minimizing the risks. He stressed the importance of objective dialogue between the industry and the regulatory bodies on regular basis. This will go a long way in resolving and dissolving all emerging challenges and issues which will provide a win-win scenario for all of us.

Mr. Haroon Qassim, thanked Dr. Sarfraz Niazi from USA, an authority in this field who has contributed a great deal to the scientific literature as well and Dr.Rene Roth Ehrang from Germany to come to Pakistan to participate in the Summit and enrich the participants with their valuable views. The organizers have put in lot of efforts to organize this Summit and I hope our objectives will be achieved at the end of the two days deliberations. He also thanked his colleagues in the PPMA who extended their valuable help and assistance to organize this event.

Dr. M. Aslam Chief Executive of Drug Regulatory Authority of Pakistan (DRAP) in his speech commended the Pakistani Pharmaceutical industry for making available quality drugs at affordable prices. Our concern about quality and safety is common and important. It is our duty to make available quality drugs and ensure compliance with regulatory mechanism. It will support the business as well and earn the industry lot of goodwill and also help boost our drugs exports. He congratulated the PPMA leadership for organizing such an important event. He then read a message from the Federal Minister of State for Health Ms Saira Afzal Tarrar which stated that “Health is right of people. Government of Pakistan was determined to provide health cover to the entire population by 2025. Through DRAP we are helping the pharma industry which is our supply chain partner. Technology is developing fast and it depends upon us how quickly we can adopt it as we have the capabilities”.

Dr. Aslam was of the view that with ever increasing knowledge, concerns were also increasing. Now people have been empowered to have knowledge in their own hand in the shape of smart mobiles. Today patients are more educated, they know the risk factors. Educated patients are a challenge for the doctors. Drug manufactures and other institutions know about it. Concerns are becoming more and more. Safety of the drugs was the highest concern. In the past it used to be quality but now it is safety which is more important. There are three things which are most important for successful running of the business i.e.  Work carefully for continuous sustainability of your business. Second is the management and leadership, keeping in mind the technological and society needs. Thirdly lack of regulatory compliance was a risk for failure. Many plants had to be closed which did not take care of these issues. Industry must know what it wish to do in future. You need to develop a strategic plan for the pharma industry where it wishes to go in the next five, ten and twenty years. He reiterated the government’s determination to ensure supply of safe, effective, quality drugs. We must plan so that we are able to maintain, sustain growth in future, Dr. Aslam remarked. 

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