DRAP should come up with its Vision and Mission Statement besides short and long term plans

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DRAP should come up with its Vision and Mission
Statement besides short and long term plans

Incompetence and inefficiency of drug regulators are mainly
responsible for the country’s failure in the field of pharmaceuticals

The entire staff working in DRAP must undergo some evaluation
by an international agency to find out whether they are
capable of doing the job they have been entrusted

By Shaukat Ali Jawaid

KARACHI:At last the Drug Regulatory Authority of Pakistan (DRAP) has been able to get a Chief Executive and Dr. Mohammad Aslam an intelligent and sensible person who brings with him a rich experience of running an intravenous infusion production plant has been appointed as its Chief Executive Officer for a contract period of three years. The formal notification is also reported to have been issued in this regard. When the idea of DRAP was conceived a couple of years ago it was intended to be an independent and autonomous body manned by highly qualified people so that it can function just like the Food and Drug Administration (FDA) of USA and Committee on Safety of Medicine of UK. However, the people with the vested interested got active and slowly and gradually they managed to get the main objective diluted to a great extent. Those working in the Federal Health Ministry were later transferred to DRAP and they made sure that no competent and intelligent person from outside gets appointed.

This exercise of finding a Chief Executive Officer was done a few times, many people were interviewed but the terms and conditions were mentioned such or the whole process was carried forward in such a way to give the impression that no capable person is available in the country and the government should continue with the already available staff working in the ministry. As a matter of fact the incompetence and inefficiency of the drug regulators are mainly responsible for the country’s failure in the field of pharmaceuticals.  Someone must have done B. Pharm, D.Pharm or even Ph.D some years ago and got appointed in the Federal Health Ministry but then nobody bothered to keep themselves update with the latest developments in the field of pharmaceuticals. There has been no system in place to check and evaluate the competence and ability of these people through any international agency with proven accomplishments and credibility in this field, since they are entrusted such an important job of drug registration, visiting, inspecting and approving the drug manufacturing facilities to issue or renew their licenses. In the meantime, these officials just because of the fact that they were occupying important positions have been performing these duties. Many a times some of them are alleged to have misused, abused this authority and some even were alleged to have indulged in blackmailing the drug manufacturers. The story of a Federal Drug Inspector who was once arrested on charges of corruption and got tremendous publicity in the media is just one such example. These people starting from the Drug Inspectors to the top enjoy so many powers that in the absence of any monitoring, accountability, they are all the time tempted to take advantage of the situation.

We have miserably failed in the field of pharmaceuticals and let us have no shame to accept this fact.  Not only that it the incompetence and inefficiency of the drug regulators which is mainly responsible for our failure which is yet another fact.  It will not be advisable to invent the wheel, just take some lessons from a country like Bangladesh which was a part of Pakistan some years ago but after getting independence, their performance in the field of pharmaceuticals is much better.  Essential drugs are freely available at affordable prices and it has four FDA approved drug manufacturing facilities. Even a tiny country like Jordan has three FDA approved Plants. What was wrong with Pakistan that it has so far failed to have even a single FDA approved drug manufacturing facility needs to be looked into in detail. China has twenty two, Taiwan ten; Italy has forty FDA approved plants. Our neighboring country India has ninety FDA approved plants and has made major inroads in the international drug market earning precious foreign exchange through Drug Exports.  If we had some FDA approved drug manufacturing facilities, Pakistan too could have done much better but alas this dream could not be realized. Getz Pharma is reported to have made major investments in upgrading and setting up a new manufacturing plant and is trying to get FDA approval. The unrealistic drug pricing policy, lack of any incentives by the government to drug manufacturers to make investments coupled with the corrupt, incompetent and inefficient drug regulators have played havoc. Today even essential drugs are not available. The authorities are not prepared to allow an essential drug price increased from Rs. 25/- to 50/- but when local production stops being uneconomical, the same drug is smuggled into Pakistan  and is available at hundred rupees. That is exactly what is happening in case of many essential drugs like anti-epileptics etc., or their much more expensive substitutes are available which the patents are forced to buy and doctors have no other option but to prescribe these.  Tuberculosis remains a major public health problem in Pakistan. Just imagine the number of companies producing anti-TB drugs which are a few and even  one of the multinationals is reported to be under pressure from their parent offices to stop its production as it was no more economically viable. Thanks to our drug regulators and the incompetent political leadership which lacks vision and foresight.

When the idea of DRAP was conceived, the job description and requirements of a Chief Executive Officer was discussed in detail. The incumbent was supposed to have not only the knowledge of drug manufacturing; he was also supposed to have many other qualities which are essential requirements for this position.  It included good inter personal communication, good communication skills, vision and foresight, thoroughly professional and a team leader with proven accomplishments. He not only has to keep an eye on the drug manufacturing facilities with the help of a team which should be knowledgeable and competent but he is also supposed to interact with chief executives of multinational pharmaceutical giants on one hand, international drug regulatory agencies like FDA. Committee on Safety of Medicine, World Health Organizations etc., on the other. He is also supposed to keep himself fully abreast of latest developments in different areas related to drugs safety, drug manufacturing, patient’s safety,successfully interact with the government officials and convince them of the need to have some long term plans. How Dr. Aslam is going to come up to these expectations only time will tell.

Current Good Manufacturing Practices (cGMP) have gone much beyond the capacity of our drug regulators. It is a fact and one of the DRAP representatives did admit it while speaking at the Clinical Trials symposium held at the Aga Khan University last years. He even admitted that they are dependent for carrying out many of the tests on the expertise of people working in various pharmaceutical companies. They do not have the requisite equipment, instruments as well as the expertise.

What DRAP immediately needs to do is to come up with its Vision and Mission statements and what it wishes to achieve in the next few years. It must set some targets and plan how to get them implemented.  For example let us plan to have a couple of FDA approved plants in the country in the next few years. What incentives it requires, what are the hindrances, hurdles and how they will be overcome must be put in black and white. Take the leaders of the Pharma industry in confidence and come up with some joint strategies to accomplish this. Unfortunately, people working in the Federal Health Ministry all these years and now in DRAP think as if everyone in the pharmaceutical industry is a criminal and busy in making money which is far from the ground realities. Had it been so, many of the multinationals would not have packed up and a few left so far are also not at all happy. The attitude of the drug regulators has most of the time remained as of controllers who were bent upon punishing and creating hurdles in the growth and development of the pharmaceutical industry rather than adopting the role of facilitators.  The total drug production of one drug manufacturing facility in Turkey is reported to be worth more than the total pharmaceutical market of Pakistan. They are exporting drugs to the entire European well developed and the most competitive market and many other countries even in North America. How they were able to achieve that and why we have failed needs a critical analysis by the political leadership of the country.

 To begin with let us have a liaison with the regional bodies and ask them to come and help us out. There are approved regional guidelines and let us implement them. So far we have had no system to upgrade and ensure the competence of our drug regulators and validate that through some certification from an international organization with known credibility and credentials.  Let us go for a major surgical procedure and chop of painlessly all those from the drug regulatory affairs by shifting them to some other departments and inducting new fresh blood which is competent, energetic and certified by international agencies, pay them well which only a totally independent and an autonomous DRAP can do. They alone can guide and help us rather than those with drug inspector’s mentality even if they are occupying some higher position and authority. Government in general and DRAP in particular have to first of all set its own house in order. It will demand taking some unpleasant decisions but they have become a must if we have to make progress and compete with the world. Somebody who is selected and appointed as Chief of the Central Drug Laboratory or to the office of Drugs Controller, or who is heading the Quality Assurance Division and looking after other important issues, must inspire confidence in them that they are competent and intelligent to occupy that position. Only then if they visit, inspect and approve a drug manufacturing facility, people will have confidence that the drugs being produced in these facilities are safe.

Coming to the pharmaceutical industry, it cannot escape to share some of the blame. First we had the Pakistan Pharmaceutical Manufacturers Association (PPMA) and later the Multinationals formed their own body the Pharma Bureau. Hence, the Pharma industry is a house divided. They have been pursuing their own agenda keeping in view their vested interests. Most of the time PPMA has remained a dead horse and worked just as a post office disseminating the information among its members received from the Federal Health Ministry and passing on their member’s requests, complaints and representations to the government. Pharma industry failed to present its case as one entity after having done some home work so that their arguments are based on some scientific facts so that it can contest the drug regulators and other government functionaries. The press conference addressed by Mr.Saeed Allawala newly elected Chairman of PPMA along with few other PPMA members on January 21stwas perhaps for the first time that some one representing Pharma industry came up with comparative  facts and figures as regards prices of drugs  in Pakistan, India and Bangladesh. They not only demanded rationalization of the drug pricing policy to ensure availability of all the essential drugs but also urged the government to give some incentives to the industry to make investment in the drug manufacturing facilities to get FDA recognition which will help us increase our drug exports manifold. In the past a few conscientious people in the industry when they got an opportunity to head the PPMA did try to make some progress and interact with the authorities on behalf of the industry but their efforts were also thwarted by people with vested interests.

What has been happening so far most of the time is that , people in the industry have had individualistic approach? Whosoever could find some connection in the political powercorridor got price increase, some adopted other well known ways to get their jobs done and they were thus content with it. “Our job is done and why should we worry about others”. This thinking has eventually hurt the interests of the pharmaceutical industry as a whole in which each and every onehas suffered in the long run. Pharma industry also needs to learn some lessons from its past failures and do some serious homework and present its case on rationalization of drug prices, new drug policy based on scientific facts.

The task ahead of the newly appointed DRAP Chief Executive is not an easy one and to overcome all the likely hurdles coming in his way, he should not hesitate to consult and get advice from professionals in these fields which are available within the country and in the region. National Bioethics Committee (NBC) formed by the federal government has prepared Guidelines on Physicians interaction with the pharmaceutical trade and industry. They have already been approved by the Federal Government. DRAP can play an important role in its implementation which will also save the pharmaceutical industry from the coercion and blackmail of the medical conference organizers. Genuine academic activities and CME is supported by the Pharma industry all over the world but in Pakistan, things have gone too far and for some in the medical profession, it has become a money making business by holding these conferences at Five Star Hotels.  The first and foremost important thing is to ensure the change of mindset and thinking of all those working in the DRAP that all those in the pharmaceutical industry are not criminals. Many of them have done a commendable job even in the worst circumstances. Let us not forget that they are of course in business and making reasonable profits to ensure their sustainability, development, up gradation of their facilities is their right as they are not working as Charities. However, those found indulging in unethical practices needs to be taken to task and no one even the PPMA or Pharma Bureau will have any sympathy or soft corner for such criminal elements.Pharmaceuticals are a different field as compared to other businesses as here one deals with the life of the people. Hence, patient safety and safe medications get preference. That is why pharmaceutical business has its own calling, norms and requirements which those entering this field must follow.

As regards drug pricing, what is more surprising is the fact that at the various meetings of the Drug Policy Board this issue has been discussed in detail including the various options available to fix drug prices. It had become evident that there was an urgent need to rationalize the drug prices otherwise the availability of essential drugs will remain a problem. Not only that it was thought to be essential for the growth and development of the Pharma industry. But even knowing all this, the hardships of the industry, why those at the helm of affairs are reluctant to take some positive decisions is quite intriguing.  May be it has something to do at the top where there is a need to change the mind set and the bureaucrats do not find the courage to put forward their viewpoints  fearing they might face the same fate which some of their colleagues had to face in the recent past. Whatever may be the reasons; all what is going on at present in the pharmaceutical sector is not at all in the long term national interest.

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