Bringing Harmony to Pharmaceutical industry in Pakistan


 Post Conference Workshop at Pakistan Pharma Summit-III

Bringing Harmony to Pharmaceutical
industry in Pakistan

FDA’s risk based inspection is based on Product type,
Potential Harm, Population size - Sarfraz Niazi

LAHORE: On the third day July 25th 2017 of the Pakistan Pharma Summit-III there was a post-conference Master class by Dr. Sarfraz K. Niazi on “Bringing Harmony to Pharmaceutical Industry in Pakistan”. This session was moderated by Mr. Arshad Rahim Managing Director of Obs Pakistan. In his introductory remarks Mr. Arshad Rahim introduced the guest speaker as a pioneer in Biosimilar, writer, teacher, author and founder of Therapeutics Proteins and Biosimilar Company.  In today’s workshop, Mr. Arshad Rahim said, we need to discuss as to what is the way forward and what we need to do now?  Stake holders are trying hard to push through their point of view and at times we do not even get acknowledgement. We do it all for the patient and patient safety remains our main concern. We continue our efforts to make the existing drugs safer for the patient. We need to identify important issues and find a solution but let us keep it short and simple. Recommendations for the Summit will be forward to the authorities to get it implemented. To have real benefit, leadership of the pharma industry has to work together.

Dr. Sarfraz K. Niazi

Some of the important issues which have been identified include lack of communication. There is a communication gap between the pharma industry, the regulators and the policy makers which are the three parties concerned.  We have to take this burden and put them together. Pharma industry, Mr. Arshad Rahim opined, has to take up its responsibility and they should know what is their duty and responsibilities. The building stands on the above three pillars and each one of them has to take some weight.

He emphasized the importance of frequent meetings between the pharma industry, regulators and policy makers to discuss important issues. We need to discuss what is the efficient way to communicate?  What are our responsibilities of as individuals and as an industry and how we have to work? Let us meet regularly and hold ourselves accountable, Mr. Arshad Rahim added.

Dr. Sarfraz Niazi started his presentation by reciting the following couplet which has lot of important meaning:

Nukta Cheen Ha, Gham-e-Dil Us KO Sunay Na Banay
Keya Banay Bat Jehan Bat Banay Na Banay

Dr. Sarfraz K. Niazi opined that we should have the ability to listen to other’s point of view. We should develop a communication system where people who are important in Pharma industry should be identified. The success of DRAP, he said, depends on its working.  FDA in United States has to go to the Congress every year. There should be periodic meetings with DRAP not to discuss problems but think how we can move forward in the interest of the country. In United States there is an Industry FDA Live Group. They discuss issues and deliberate how to resolve it? This is in addition to the regular meetings. This is a good idea and DRAP should be receptive to it as it will help them.

He then talked about the cGMP- a risk based approach by FDA and Pharmaceuticals cGMP for the 21st century. Emphasis on safety, he stated, comes from food first and drugs later. FDA’s risk based inspection is based on Product type, Potential Harm, Population size which is called as Matrixed approach. The onus lies on the drug manufacturers to prove that there is no erroneous contamination.  This drug can be made in this area without any contamination. Let them identify the drugs which cannot be made in the same area in the existing pharmaceutical plants because of the risk of contamination. This whole responsibility lies with the drug manufacturer. They must decide what is the risk,  how much damage they can cause with non-compliance? He then gave certain examples and said that while driving on roads, there is greater risk of accidents as compared to flying but the chances of dying were much more in case of Air crash as compared to road traffic accidents. Hence, you need to identify the risk and adopt a risk based assessment. Have you done your risk based analysis the FDA Inspector will ask while visiting the manufacturing plant? System based inspection consists of six systems i.e. Quality, Material, Laboratory control, Production, Packaging and Labelling, Facilities and equipment. It is quite likely that you know how to do it but you are not or may not be following it. You cannot repeat the test. He then briefly referred to the FDA Guidelines for the pharmaceutical industry as regards biological drugs development. How these drugs are approved and how they are evaluated?

Mr. Arshad Rahim

Moderating the session Mr. Arshad Rahim said that the question arises how do we start and maintain communication with DRAP? It has to be constructive, there has to be a change of mindset. We need understanding between ourselves instead of working as advisors. We know something but we lack the ability to express our feelings. We need to change our mindset from cannot do to Can Do. The key word remains patient safety, he added.

After the tea break, the participants had discussions among themselves in different groups who were facilitated by Mr. Arshad Rahim and Dr. Sarfraz K. Niazi and the discussion revolved around how we should initiate the dialogue, what are the simplest ways of doing it?

Participating in the discussion Syed Jamshed Ahmad Deputy Chief Executive PharmEvo remarked that we have been told about the validation of Quality Control on six standards but we must see are we following it or not? Where we want to go from here? Is it inward, let us identify the problems inside?  Manufacturing units should make safe drugs for the patients. Mr. Arshad Rahim remarked that we must say what we do and do what we say. Review and rewrite Standards Operating Procedures (SOPs) in Quality Management System.  Whatever is written, is it in place and in use? Syed Jamshed Ahmad said that we must discuss where do we stand now and where we wish to go in the next few weeks and months and years?

One of the practical questions which was put forward by one of the groups was that you import some raw material, it is tested, sample product is produced and it is passed. Now you place order for bulk import of raw material but find there are some impurities, black particles. You have identified it, you talk to the supplier who also agrees to replace it but it is not easy to re-export it and it may also take lot of time. In the meantime your competitors will take the advantage, you will be out of the market hence what to do in such a situation? Dr. Sarfraz K. Niazi remarked that first you need to do risk analysis. What is the risk if you go ahead and use that raw material instead of getting it replaced? What is the formulation in which you wish to use it, it certainly will not be advisable to use it in injectable, parenteral preparations. Talk to the regulators and take them into confidence and discuss with them how harmful these impurities or black particles could be? Is the raw material for a lifesaving drug? The decision will also depend on that. Dr. Sarfraz K. Niazi emphasized that every impurity should be identified. If you know and are convinced that using such a raw material does not cause harm, go ahead but take the regulator into confidence. Whatever decision you take, just take the DRAP into loop. An adhoc approach should be replaced with systematic approach. We as a company Dr. Sarfraz K. Niazi stated have chartered our SOPs based on the six systems of FDA.

Mr. Haroon Qassim 

During the discussion it was also pointed out that human resource is involved at every stage. We must look are we following the laid down SOPs? Dr. Obaid Ali from DRAP remarked that “Be Honest and be prepared to answer where you wish to go. Become a Scientist”.  It was also highlighted during the discussion that Trust deficit is there between the pharma industry, regulatory bodies and the policy makers. Efforts should be made to improve this Trust. Confidence is important for which we need to have frequent meetings. Mr. Haroon Qassim remarked that within the PPMA and the Industry there is no harmony, it should be improved. We need to put our own house in order. At present many companies are not taking interest in PPMA. Mr. Arshad Rahim remarked that Trust within the organization and institution is extremely important for success. He further suggested that let us categorize the industry by compliance with drug regulations instead of value in Billions. It is extremely important to build the image of the pharma industry.

Some of the participants stated that we should do risk assessment which should be documented and highlighted. We should have an Action Plan. It needs total disclosures.  What are the areas which need improvement and where investment is needed? Quality of communication was also important. There should be a Technical Committee of PPMA, it should discuss the issues, have regular meetings with the regulators so that the industry moves forward. Mr. Arshad Rahim laid emphasis on being transparent and sharing information. It was also suggested to have training workshops for industry and DRAP together. Let us discuss how many companies have to get PIC certification this year and then we can do it. Packing and labelling should be defined and qualifications of the personnel needed should also be defined.

Inspection should be to build capacity and not to get license. There was a need to look at the system and not the SOPs. All inspections should be based on capacity building. Another suggestion put forward was that the PPMA should be able to provide Continuing Professional Development courses and training workshops. Mr. Arshad Rahim said that PPMA should look at the standards of the companies when they apply for membership. Go and look at their Warehouse. Mr. Jawed Akhai opined that all pharmaceutical companies should be encouraged to become members of PPMA. Decisions in DRAP should not be based and dependent on one man. At present if one person says No, it is No and if he says Yes, it is Yes.

Dr. Sarfraz K. Niazi said that we need mutual respect. Do not expect any help from regulators to increase your exports. FDA is working very efficiently. When I send them a communication, I get feedback within twenty four hours. We need to open up and have instant communication and all this information should be available to the public. In USA industry do not depend on regulators, it follows the rules and laws. He reminded the participants that the Regulators are not responsible for your business.  In USA industry and FDA work in harmony. How to improve your business is your job, hence do not expect any help or assistance in business from DRAP. One of the participants remarked that we are not able to institutionalize changes. Policies change with the change of the Government. It creates problems for the industry which then starts looking for short cuts. Inclusion of Academia into the whole evolution process also came under discussion.

Speaking about collaboration and passion Dr. Sarfraz Niazi mentioned the following:

  1. Safety of drugs
  2. Education
  3. Institutional Inspection Model
  4. Shared Vendor qualifications
  5. Commonly owned API
  6. Risk based cGMP with DRAP

Continuing Dr. Sarfraz K Niazi said that in India, there are lot of control but even then pharmaceutical industry of India was doing lot of business. You have to provide drugs to every patient and you have to make some money to survive and sustain. Some of the Drug Inspectors are good and some are not so good. Some young ones are harsh and they wish to show off. While dealing with these Drug Inspectors do not talk more than you are asked. Just answer questions from the Drug Inspectors when they come for inspection. Do not try to impress them. Do not cheat intentionally. The moment you start trying to hide, become defensive, you are in trouble and face problems, he added.

Some of the participants complained that they cannot make the desired changes with the present price structure. The regulators expect us to do that but we cannot afford. We need to use the media to educate the public. We have many constraints.  Dr. Sarfraz Niazi said that we hear lot of political slogans about the drug prices being higher in Pakistan as compared to many countries which was not at all based on facts. In developing countries we do not value Life. Government should have some plan to provide drugs to those who cannot afford it. Mr. Arshad Rahim said that it has been rightly pointed out that let us set our own house in order, let us adopt safety mindset from this moment onward and the rest will follow. We should know that something was going wrong and do not wait for the Inspection report. We all need to promote safety culture in our organizations. Training of human resource, bringing harmony is a circular and not straight line. We need to have a re-look at that.

Dr. Sarfraz Niazi said that safety is above economics in pharma industry. Economics plays an important role in change. To do that do global business.  You cannot spit while in Aga Khan University Hospital because someone will get hold of you immediately and you will have to clean that but look at other buildings in Karachi where people are in the habit of spitting in every corner.  Why the same rules cannot be implemented at other places. You can either change or fail in companies but to take some of these steps may be difficult. One of the participants suggested using research funds with the government to bring harmony within the organization. Let us give new molecules to the world market which is possible if we have effective linkage with the academia. Another participant remarked that Higher Education Commissions has given lot of research funds to various academic institutions but no worthwhile research came out of it. Unfortunately everyone is interested in basic research.

In order to improve the image of the Pakistani pharma industry it will have to go to the global market. This is the only way to succeed. Drug regulators job is to approve drugs, where you make it and when does not matter. One of the participant referred to the price difference in the same product by different companies and asked how we can harmonize in such a situation. We have to be realistic, he stated.

Mr. Haroon Qassim remarked that DRAP and the Pharma industry, both have to put their house in order. Things should not be personal dependent. We must accept our deficiencies. Industry has to go to a certain level and it all depends on Vision, your own vision and company vision. Our communication with DRAP has to be in our charter. Let us be honest. Leadership of the industry and DRAP has to play an important role to resolve our issues. Top leadership of DRAP has to keep its door open and accessible.  Mr. Hamid Raza said that the Regulators should have the decision making powers. At present even the DRAP decisions have to be taken by the Minister or the Prime Minister. There are barriers with Drug Registration and Pricing Board meetings which adversely affect the smooth functioning and development, progress of the pharma industry. Drug registration and Licensing should be quick. Once you get a license, drug registration should be expedited immediately. The regulators should control drugs but not the business of the companies.

Dr. Kaiser Waheed

Chairman PPMA Dr. Kaiser Waheed remarked that unfortunately the regulators are not regulators but controllers perhaps because for a long time, the name was Drug controller. If the working environment is good and conducive, it will benefit the patient more than the industry or the regulators. We need to provide enabling environment for the industry. Look at the orphan drugs, many of them are not available as it is not economically viable. The issue of orphan drugs has to be solved. We in the PPMA have been highlighting the issues and also offer solutions.  We have suffered a lot but we are doing all this for the pharma industry. During the presentation by Dr. Sarfraz K. Niazi there were many things which were eye opener for us. We wish to change ourselves. We provide a platform to the industry where they should learn and share.

He was of the view that the regulators should work in business environment for some time only then they will know the challenges. He reiterated that none including those in the DRAP should consider themselves as “Akle Qull” and “Know All”. Sometimes the attitude of some drug regulators is very disappointing and they do not give due respect to the drug manufacturers. We in the industry are trying our best to ensure that our drugs should be safe for the patient. He was of the view that the pharma industry has to change itself and it should not look towards DRAP. Use latest technology and make safe drugs.

Mr. Arshad Rahim winding up the session said that the main objective of today’s workshop was interactive discussion.  Let us from today resolve to change from “I will do it and I want to do it to I must do it.”