Writing about drug policies in Bangladesh is easy and difficult at the same time. The easy part comes from reading through the policies and some of the information available on the country's drug regulatory authority's website. The difficult part comes when I talk to pharmaceutical company executives and visit their very impressive manufacturing facilities. They are very professional and the buildings and equipment are also impressive. So, it is hard not to believe their claims that the medicines produced at their facilities are safe, effective and of good quality. The other difficulties are due to lack of clear information from the government as well as from the industry.
The first Drug Policy of the country was adopted in 1982. Among several reasons, the primary one was to make World Health Organization (WHO) recommended essential drugs available to all within affordable prices and to provide incentives to local pharmaceutical industries to grow. Intentions were good, no doubt, and the country's local pharmaceutical industry has witnessed a significant, continual growth. Also, all essential drugs (initially 170 of them) were made available at or below the affordable price that the government has set. There were two other drug policies adopted in 2005 and 2016. The impact of these policies is visible and looks good. There are over 250 pharmaceutical manufacturers now in Bangladesh. That many companies in such a small country is unexpected and may not be comparable to that of any other developing countries of similar size. The incentives for growth of pharmaceutical companies in Bangladesh may be different than readymade garments industry. Cheaper labour cost has limited contribution to the growth of pharmaceutical companies in Bangladesh. Let's find out!
QUALITY AND SAFETY: The drug policy of a country should be based on the principles of securing, maintaining, and improving public health, and not just the health of the pharmaceutical industry, which is what it is currently. One may claim that the most essential drugs are affordable and available as a result of drug policy, hence they meet the principles of public health. I agree, and that was essential. Unfortunately, the devils are in the details. In order to make essential drugs affordable to all in Bangladesh, the government of Bangladesh sealed the upper limits of prices for active pharmaceutical ingredients (API), as well as the prices of finished drug products. Most of the APIs are imported from either India or China. This may potentially compromise the quality of the drugs. The pricing of the finished products plays a major role in penetrating and securing market share. Therefore, the incentive is to lower the cost of goods to maintain a reasonable margin, since the upper end of the price is sealed.
One may wonder if these drugs are safe for use. People should ask:
* Are the APIs imported at a cheaper price by the local pharmaceutical companies of good quality?
* Are these foreign API manufacturers exporting the same APIs at the same price to the companies in the regulated countries in the West?
* If not, how do they sell APIs to Bangladeshi pharmaceutical companies at a lower price?
* Whether quality aspects are being compromised?
* What are the health consequences of taking medicines made with poor quality APIs, especially when taken for a longer time ?
There are many more criteria to be examined to make a full assessment of the situation. Similar quality assessment should be done for inactive ingredients used to formulate finished medicines.
On the other hand, one can import quality APIs and other raw materials at a much higher price than the government-imposed price limits to produce better quality and expensive medicines to export to other countries.
SAFETY AND EFFICACY: Drugs produced in Bangladesh are "generic" versions of drugs approved in the regulated countries. Because Bangladesh enjoys the freedom from international intellectual proprietary regulations (patent) until 2032, local pharmaceutical companies can copy innovators' drugs almost immediately. With few exceptions, most of these drug formulations must be tested for bioequivalency with the innovators' drugs, to ensure that the locally produced drugs are absorbed by the patient's body in the same way as the innovator's drugs. This is a minimum requirement to ensure the safety and efficacy of local drugs. These bioequivalency studies are not required for registration by the Bangladesh Drug Administration. In the absence of any evidence of bioequivalency, there is no guarantee that the drugs produced are safe or effective.
DISPENSING DRUGS: After more than five decades of establishing pharmacy education in Bangladesh the country still has not defined the role of pharmacists. A pharmacist's primary role is to dispense drugs by filling prescriptions from physicians. This professional dispensing is a critical step in the overall healthcare system. In Bangladesh, pharmacies are run by B-grade pharmacists, with inadequate education and knowledge of drugs. They usually sell prescription drugs without prescriptions, including narcotics. This has been a dangerous practice in Bangladesh with significant health consequences, including fatalities. I could be wrong, but this benefits the pharmaceutical industry and hence there is no initiative to improve from that end.
CONCLUSION: Making medicine is a science and science is based on evidence. In the absence of evidence of safety, efficacy, and quality it cannot be science. This may sound harsh. But, when it is about the health, and life and death of people, there should not be any compromise.
People fully rely on the prescribing physicians to select the right medicines for them and on pharmaceutical companies to deliver safe, effective, and quality medicines. Physicians, pharmaceutical companies and dispensing pharmacists must maintain the highest ethical standards, because public health, life and death of patients depend on their honesty.
Common people should demand re-writing of drug policies and for their uncompromised implementation. There should be an expert committee to review and identify the flaws and limitations of the current policies, rules and regulations and develop a comprehensive policy that defends public health.
We also need to define the profession of pharmacists in Bangladesh. There should be another committee to develop a drug dispensing system where graduate pharmacists (B Pharm/Pharm D) will control dispensing. This is doable, and in my opinion graduate pharmacists will prefer to be a dispensing pharmacist instead of looking for a job in pharmaceutical industry. If there is a will, there is always a way!
It is important to make Bangladesh pharmaceutical industry a sustainable global business. Larger companies are probably trying to achieve this independently. But this is likely to take longer time unless regulatory infrastructure and governance become effective and the industry associations join hands to establish credibility globally-- most importantly in regulated countries. I believe that the Bangladeshi pharmaceutical industry could become even larger and play an important role in global drug business, if planned and executed carefully.
The writer is the Senior Vice President and Head of Global Regulatory Affairs at PTC Therapeutics, Inc, New Jersey, USA