Bangladesh’s drug policy needs major repair
Writing about drug policies in Bangladesh is both easy and difficult. The easy part comes from studying the policies plus some of the information on the country's drug regulatory authority's website. The difficult part comes when I speak to pharmaceutical company executives and visit their manufacturing facilities. They are professional, the buildings and equipment impressive. In fact it is hard never to believe their claims that the medicines produced at their facilities are safe, effective and of top quality. The other difficulties are due to too little clear information from the federal government and from the industry.
Bangladesh's first Drug Policy was adopted in 1982. Among several reasons, the primary one was to create World Health Organization (WHO) recommended essential drugs open to all in a affordable price and provide incentives to local pharmaceutical industries to grow. Intentions were good and the country's local pharmaceutical industry has witnessed a substantial, continual growth. Also, all essential drugs (initially 170 of these) were made available at or below the affordable price that the federal government has set. There have been two other drug policies adopted in 2005 and 2016. The impact of the policies is visible and looks good overall. There are over 250 pharmaceutical manufacturers now in Bangladesh. That lots of companies in such a tiny country is unexpected and may not be comparable to that of any other developing countries of similar size.
Quality and Safety
The drug policy of a country should be based on the principles of securing, maintaining, and bettering public health, and not only the health of the pharmaceutical industry. You can declare that the most essential drugs are affordable and available consequently of drug policy, hence met the principles of public health. I agree, and that was essential! Unfortunately, the devils are in the details. To make essential drugs affordable to all in Bangladesh, the federal government of Bangladesh sealed the upper limits of charges for active pharmaceutical ingredients (API), in addition to the prices of finished drug products. A lot of the APIs are imported from either India or China. This may potentially compromise the standard of the drugs. The pricing of the finished products plays a major role in penetrating and securing market share. Therefore, the incentive is to lessen the price of goods to maintain an acceptable margin, since the upper end of the price is sealed.
One may wonder if these drugs are safe for use. People should ask will be the APIs imported at a cheaper price by the neighborhood pharmaceutical companies of top quality? Are these foreign API manufacturers exporting the same APIs at the same price to the firms in the regulated countries in the west? If not, just how do they sell APIs to Bangladeshi pharmaceutical companies at less price? What quality aspects are being compromised? What exactly are medical consequences of taking medicines made out of poor quality APIs, in particular when taken chronically? There are various more conditions to be examined to create a full assessment of the situation. Similar quality assessment should be done for inactive ingredients used to formulate finished medicines.
On the other hand, you can import quality APIs and other recycleables at a much higher price compared to the government-imposed price limits to create better quality and expensive medicines to export abroad.
Safety and Efficacy
Drugs produced in Bangladesh are unproven "generic" versions of drugs approved in 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, almost all of these drug formulations should be tested for bio-equivalency with the innovators' drugs, to make certain that the locally produced drugs are absorbed and distributed inside body like the innovator's drugs. That is a minimum requirement to guarantee the safety and efficacy of local drugs. These bio-equivalency studies aren't necessary for registration by the Bangladesh Drug Administration. In absence of any evidence of bio-equivalency, there is absolutely no guarantee that the drugs produced in Bangladesh are safe or effective.
Dispensing Drugs
After a lot more than 5 decades of establishing pharmacy education in Bangladesh the united states still hasn't defined the role of pharmacists. A pharmacist's primary role is to dispense drugs by filling prescriptions from physicians. This professional dispensing is a crucial step in the entire healthcare system. In Bangladesh, pharmacies are run by B-grade pharmacists, with inadequate educations and understanding of drugs. They often sell prescription drugs without prescriptions, including narcotics. It has been a dangerous practice in Bangladesh with significant health consequences, including fatalities. I possibly could be wrong, but this benefits the pharmaceutical industry and therefore no initiatives to boost from that end.
Making medicine is a science based on evidence. In lack of proof safety, efficacy, and quality it can't be science and therefore they are not medicines.
This may sound harsh. But, when it's about medical, and life and death of individuals, there should not be any compromise.
General public fully depend on the prescribing physicians to select the right medicines for them and on pharmaceutical companies to provide safe, effective, and quality medicines. Physicians, pharmaceutical companies and dispensing pharmacists must keep up with the highest ethical standards, because public health is determined by their honesty.
General public should demand re-writing of drug policies and because of their uncompromised implementation. There must be an expert committee to examine and identify the flaws and limitations of the current policies, regulations and develop a comprehensive policy that defends public health.
We also need to define the profession of pharmacists in Bangladesh. There must be another committee to build up a drug dispensing system where graduate pharmacists (B. Pharm./Pharm. D.) will control dispensing. That is doable, and in my judgment graduate pharmacists will prefer to be a dispensing pharmacist rather than searching for a job in pharmaceutical industry.
It is important to help make the Bangladesh pharmaceutical industry a sustainable global business. Larger companies are most likely trying to do this independently. But that is more likely to take longer time unless regulatory infrastructure and governance become effective, and the industry associations join hands to determine credibility globally, most importantly in regulated countries. I assume that the Bangladeshi pharmaceutical industry could become even larger and play an important role in global drug business, if planned and executed carefully.