Dear Colleagues! This is Asrar Qureshi’s Blog Post #798 for Pharma Veterans. Pharma Veterans welcome sharing of knowledge and wisdom by Veterans for the benefit of Community at large. Pharma Veterans Blog is published by Asrar Qureshi on WordPress, the top blog site. Please email to email@example.com for publishing your contributions here.
Several posts were published under this topic, but each post was complete in itself. This is the last post.
Let us start with a question.
Pharmaceutical business is like any other business, why should there be so much emphasis on ethics here?
There are two responses to this.
One, two businesses touch lives life like no other business; food and drugs. Food gives health and bad food can give disease, which may require treatment. Generally, an imminent threat to life may not be there. Drugs treat illnesses and diseases and may help save lives; wrong drugs may take lives. While effect of food may take some time, drugs’ effect is seen immediately. Both food and drugs should be regulated, and this is being done everywhere. The mechanisms vary, for example USFDA is United States Food and Drug Authority. Most other countries have separate regulatory bodies for food and drugs, but they usually include cosmetics with drugs.
Two, ethics are now being pushed into every business, and every business must show social responsibility. Old cases are being pulled out to fix responsibility for climate disaster on the corporates and heavy fines have been imposed. The extent of regulatory coverage is wider and deeper for Pharma.
As elaborated earlier, ethics did not come into pharma business overnight, these have evolved over many decades. The regulators learned from every mishap and added regulation to prevent its recurrence. The process still goes on.
I would like to examine the situation in Pakistan in some detail.
Pakistan has a highly developed pharmaceutical industry which has made a name for it at home and abroad. I had the opportunity to travel to many countries for international business development, and the sentiment that Pakistani products had good quality (also better than Indian products) was echoed almost everywhere. The companies who forayed into international business many years ago were particularly conscious about quality, hence the good impression.
At home, the quality of pharmaceutical products is generally quite good. I have pointed out in several posts, including the last one on Marketing, that around 90% market share is held by only fifty companies. These are all developed enterprises in all aspects; their manufacturing facilities are upgraded, they are quality conscious, and they comply with regulations by and large.
Then there are over six hundred manufacturers and a large number of marketers who take products from small manufacturers. In this segment of the industry, survival is the most urgent requirement. We know that survival instinct may lead to legitimizing the wrongdoings. Their manufacturing units do not comply with the GMP requirements, and their quality parameters are often ignored in procurement and production, even then, the final product is more or less okay. It is due to the fact that quality specifications have a range which in some cases is quite wide. The products will still pass quality testing, but their efficacy/safety may not be exactly the same as that of a better product. You will find these products selling more aggressively in suburban and rural areas where prescription is not issued by the doctor, rather the medicine is given by him to patient through his own pharmacy. More discounts and free goods offerings are very welcome here. I would again emphasize that their quality is not bad, but at the lower end of the spectrum.
There is a third category of manufacturers who would do anything to maximize profit. They are fewer in number fortunately, but they do impact the market. It should be understood that the drugs of today cannot be manufactured in the backyard of a home, or a garage; these need a proper manufacturing unit. Counterfeiting is the easiest way to make quick money; make replica of a fast-selling product and sell it quickly at good price. Selling own brands will take years to consolidate, but counterfeit can bring money immediately, as long as it is not caught. Counterfeiting is not new in the market. Senior people say that it had been happening selectively since long and was not detected for a number of reasons. They give us to understand that the quality of counterfeit product was almost the same as that of the original and the prescribers/ users did not see the finer differences. At the lower end of this bracket, there are some unscrupulous people who are involved in the criminal activity of spurious drugs. There are other areas also where profit making activities are done, but these can only be understood by the industry insiders. The only thing to mention is that these are not related to product quality.
What should be done to ensure compliance to regulations, ensuring quality standards, and curbing undesirable practices?
The answer is the same: Improve and strengthen regulatory function. DRAP is the custodian of regulatory function. Before DRAP was formed, the Ministry of Health had this responsibility. MoH had more laid-back approach, conventional methods, and a favorable tilt towards local industry. DRAP is designed to be more focused, upgraded, and more resourceful, however, since its establishment, it has been mired into the fight between the old guard and the new corps, which has seriously debilitated it performance. Another serious issue with DRAP is their ever-increasing effort to earn more money through increasing fees manifold. The quality of people, working, time to close matters at hand, upgrading of policies, and other developmental work is either slow or stalled.
To get ethics implemented and complied with, the writ of DRAP must be established through better quality tools and people; sermons, seminars, conferences, and rhetoric shall not achieve much.
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