Regulatory Guidelines-Present and Future Scenario


 Panel Discussions at Pakistan Pharma Summit-III

Regulatory Guidelines-Present and Future Scenario

Pharmaceuticals Export Council should be established consisting representatives from pharma industry, DRAP and TDAP - Dr. Aslam

LAHORE:Ms. Zeba Ahmed Shuja Director Technical at Schazoo Zaka moderated the panel discussion on regulatory guidelines: Present and Future Scenario during the Pakistan Pharma Summit-III organized by PPMA at Lahore from July 23-25, 2017. The panelists were Mr. Anis Shah CEO Merck, Dr. Ajmal Nasir Director Technical BFD Biosciences, Dr. Rizwan Mahmood Director Quality Operations at CCL Pharmaceuticals, Dr. Sarfraz K. Niazi Founder therapeutic Proteins Inc. from USA and Mr. Arshad Rahim Khan Managing Director OBS Pakistan.

Participating in the discussion Mr. Anis Shah said that it was all about us. We must work hand in hand. We need friendly environment. Pharma industry at present was facing some challenges. It needs Rs. 3 Million per line with this system of serialization. It also needs additional space which may not be available in many units to put it into practice. He suggested that the authorities should give some time. Pick and choose was the most suitable practice. Industry will not be able to comply with these regulations in the stipulated time. He gave some examples. If you change the name of the company, it is not accepted and the companies are asked to opt for complete new registration for all products despite the fact that it is the same company and same facilities. There may be a change of some technical staff. The authorities should make it simple instead of asking for new registration. His plea to the authorities was to make the system simple and the whole process smooth. Some companies have seven to eight lines and it may be very difficult for them. Let us not think about “Us” and “They,” and help the industry to grow. We can only move forward by working together. DRAP is building its capacity. Stability testing is good but if it has already been done in an environment much worse than us, it should be accepted. We have to follow some procedures which are dictated by DRAP. Define these procedures by sitting together in such a way that they are friendly both for the DRAP and the pharma industry. We have to spell out stability conditions we have to test. If some firm has already conducted stability testing in worst conditions than prevalent in Pakistan, DRAP should not hesitate to accept them, he added.

Dr. Rizwan Mahmood said that the industry can move forward by providing better services to the patients. Authorities intend to use CTD Form for regulations which is used in UK and USA. It has lengthy elaborate parts for API, true generics, new products, testing the material from the suppliers, Impurity in API and all this was extremely expensive. He urged the DRAP to establish some standards.

Mr. Furquan Kidwai CEO Dawaai. Pk talked about digital revolution in Pharmaceuticals and Healthcare. He highlighted the use of mobile phone in healthcare. Its use is helpful not only for the pharmacies but also for the patients to ensure compliance.

Pharmaceutical Exports: Current Trends
and Emerging Markets

Mr. Hamid Raza CEO of Neutro Pharma moderated the panel discussion on Drugs Exports. The panelists included Mr. Zahid Saeed Managing Director of Indus Pharma, Mr. Haroon Qassim Managing Director of PharmEvo, and Dr. Shahzad Khan CEO of CCL Pharmaceuticals, Ghuzzanfar Jawa Director Wilshire Laboratories and Mr. Nadeem from Herbion.

Initiating the panel discussion Mr. Nadeem said that even a small country like Jordan was much ahead of us as regards Drugs Exports. We need to develop business relations with European Union, USA and Australia. Pharma industry need to invest in herbal products. Aim at WHO and GMP certification. It requires lot of investment and standardization. If the pharma industry is given better prices, many of them will get these certification. Mr. Haroon Qassim opined that we need to have a long term vision. People are not prepared to take risk and accept the challenge. There are some risks in export market, he added.

Mr. Ghuzzanfar Jawa emphasized the importance of standardization of human resource and shared products. He suggested that let us do this together. Help small, medium size companies to grow so that we all grow together. Dr. Shahzad Khan suggested that we must develop a Vision which should include focus on exports. Balance short term and long term benefits. Now global giants are going into Generics. Those companies who are strong at home can go and succeed in export market as well.

Rana Sanaullah Punjab Law Minister presenting Mementoes to Mr. Ijaz Siddiqui, Mr. Arshad Rahim, Mian Asad 
Shuja Ur Rehman, Muhammad Tahir Azam, Kh. Shahzeb Akram and Mr. Haroon Qasim at Third Pakistan 
Pharma Summit held at Lahore from July 23-25, 2017.

Mr. Zahid Saeed said that we need to go into the developed market but at the same time should not leave the developing market. India alone has drugs export worth two billion US$ to Nigeria. Neglecting the developing countries is not a solution. We must remember that one day it will be a value added market. If we become partner in drug development, the big companies from overseas will come to Pakistan. At present since we are not certified, foreign pharmaceutical companies do not wish to involve us. Mr. Jawed Akhai said that if you become owner of a plant overseas, you also get their supply chain and then bring their products to Pakistan. We should work on mergers and acquisitions. Once you are familiar with the overseas market, successfully completing the learning curve, you can start with just bringing one product manufacturing locally.

Responding to the question as to how the pharma industry can redefine its vision, Mr. Nadeem said that we can make more neutraceuticals for the developed market. You should be familiar with the local rules. There is a huge market for herbal products in USA and Canada. India is taking benefit of this market. We too have done much better in these countries. Even in Russia, we have a big market. Of course our first priority should be Pakistan and another option is to have joint ventures with China and then exports to the Chinese market will be possible. Mr. Haroon Qassim was of the view that we need to redefine what we need to do and come with our own model. PPMA should have its own export model, strategy and Vision. Let us define the export market at company level and industry level. Mr. Ghuzzanfar Jawa said that if we analyze the developing market, it will improve our vision. Dr. Shahzad remarked that is it not ironic that the No. 3 company in Pakistan has no presence outside. Mr. Zahid Saeed remarked that we need to think differently. Neutraceuticals are easier to enter. There are certain medical devices which are labeled as drugs. Certain lotions are defined as devices. Hence, we need to look at different categories. No Japanese company, he remarked, is founded without having a global vision.

Mr. Nadeem pointed out that India succeeded in drugs exports because they had a Vision and they got complete support of their government. In Pakistan we need DRAP support. Speedy local registration should be followed by exports. For product registration overseas, DRAP should help the industry. If the industry wishes to establish marketing offices overseas, even then DRAP should help them. Mr. Haroon Qassim suggested that the whole process including drug registration should be expedited. Mr. Ghuzzanfar Jawa said that the registration process in Pakistan is more stringent than FDA. Dr. Shahzad said that one can have more frequent and emergent meeting with Drug Registration Boards overseas as compared to the meetings with regulatory bodies in Pakistan. Government of Pakistan needs to put focus on Drugs Exports.

Mr. Zahid Saeed said that the pharmaceutical industry should be allowed to manufacture all those neutraceuticals in their existing plants which do not affect quality. Let the DRAP prepare a list which of these neutraceuticals can be manufactured in the existing plants which will be helpful. In Europe some of the companies have an additional room in the same facility to produce neutraceuticals. We should have a Pharmaceutical Export Cell. When Indian companies can export drugs to Pakistan, why we cannot export drugs to India, he asked? We should utilize the offices of Trade Development Authority of Pakistan (TDAP). Dr. Shahzad said that TDAP has a very negative role. It did lot of good things when it was headed by Mr. Tariq Ikram. Mr. Zahid Saeed remarked that instead of working on TDAP, let us work on our own companies.

Summarizing the deliberations Mr. Hamid Zeb said that we need to think globally. Make investment in human resource. Get our plants WHO, FDA approved, certified. Define our short term and long term goals, pool our resources. We should work individually as well as at association level, define role of the industry and have realistic goals. Pharma industry, DRAP and concerned ministries should work together to achieve our goals. Drug registration time should be reduced. Neutraceuticals should be made in the existing pharmaceutical plants and a Pharmaceuticals Export Council should be established. In response to a question from the audience that we need to develop a strategy for small and medium companies who do not have much finances and human resource, Mr. Haroon Qassim said that you need to have a Vision. There is no small or medium company. You have to Grow.

Dr. Muhammad Aslam Chief of DRAP said that the pharma industry need to plan for future. The companies should have a Vision and determination. There is no problem with the manufacture of neutraceuticals at the existing pharmaceutical plants. There should be no issue. He supported the idea of establishing the Pharmaceuticals Export Council which should have members from DRAP, Pharma industry and Trade Development Authority of Pakistan. You asked for registration of one product for those who export drugs worth one lac US$, we allowed you registration of one molecule which means quite a few products in different formulations. Similarly we can have some incentives for those units who get FDA, WHO certification. DRAP, he assured, will help you to enter more developed market. TDAP should help you in drug registration overseas. Hindrances should be identified, solutions should be identified and we will do the facilitation. It was also suggested to develop two centers at Karachi and Lahore for bioequivalence studies.