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BIOEMEDICAL CONSIDERATION IN THE MANUFACTURE, CLINICAL TRAIL AND 

BIOEQUIVALENCE STUDIES OF PHARMACEUTICALS 

 

A B M Faroque  

Professor and Dean,  

Faculty of Pharmacy, University of Dhaka, Bangladesh. 

 

 

ABSTRACT: Bangladesh pharmaceutical sector has been growing at a remarkable speed 

since 1982. From the meager 30% national market share, now it is supplying 97% of our 

annual demand. Around 1,100 generics are now available in a total of around 12,000 trade 

name products. The national market size has crossed 6,000 crore taka per annum, where 

the local multinational share is only 7%. Our industries are now exporting drugs to 72 

countries. But just because our pharmaceutical sector has developed its own backbone does 

not meant that our pharmaceutical industries have solved the relevant bioethical questions. 

There are complaints that some companies do not pursue necessary bioethical norm as at 

various levels of its manufacturing processes. Still a good number of small companies sell 

sub-standard and counterfeit drugs, and yet some are not following accepted GMP 

standards. Moreover, for capturing foreign markets we need clinical trials and bioequivalence 

study results. These study needs human subjects as volunteers. In a poverty-stricken 

country like us, if we do not establish these clinical trial and bioequivalence norms, 

everything becomes irrelevant. If we can establish theses norms, this could be the beginning 

of a new era for further growth of our pharmaceutical industries vis-à-vis our public health 

national economy.  

 

INTRODUCTION: Bangladesh has a severely war-torn economy, seriously disrupted 

infrastructure and a huge deficit in foreign currency when it earned independence in 1971. All 

these factors aggravated the overall health care situation of the country. At that time, 

country’s health care facilities, including the supply of medicines, were mostly depending on 

import. At that time more than 80% drugs of our annual demand were being imported. In 

1982, a National Drug Policy was announced that largely encouraged local production in our 

pharmaceutical sector. Under the umbrella of this drug policy, a large number of local 

companies invested in creating local pharmaceutical manufacturing facilities. This trend still 

continues. The present government is also encouraging these local investors and our hon’ble 



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Prime Minister Her Excellency Sheikh Hasina has also declared her policy to restrict import 

of drugs that are locally manufactured. This market protection stimulated the growth of our 

national pharmaceutical companies and has led to a national aspiration towards self-

sufficiency in pharmaceutical sectors.  

 

PHARMACEUTICAL SECTOR OF BANGLADESH: In today’s Bangladesh, the 

pharmaceutical sector has emerged as one of the fastest growing business sector, its current 

annual market size is about 6,000 crore taka, it is the second highest contributors to our 

national exchequer, and it is the largest white collar labor intensive employment sector. In 

1982, market share of the multinational pharmaceutical companies was 75%, only 25% was 

contributed by our national companies. But today our pharmaceutical market is dominated by 

local manufacturers and the top 10 pharmaceutical companies are mostly local companies. 

Today we are moving towards self-sufficiency in medicine by getting 97% our drugs that are 

consumed annually from local manufacturers and only 3% from import. These very meager 

imported items are vaccines, anticancer drugs, insulin etc. Whereas, drug import figures for 

Singapore is 75%, Myanmar 90% and Shri Lanka 85%.  

 

Another very import point regarding our pharmaceutical industries is that our pharma 

companies are heading towards self-sufficiency without compromising the quality. 

Bangladesh is now capable of producing high quality pharmaceutical products. This was 

possible because our industry now uses state-of-the-art manufacturing technology, very 

sophisticated QC equipment and apparatus, and highly skilled human resource. A good 

number of these plants have achieved MHRA, EU, GCC, TGA and ANVISA certifications. 

Now some of them are improving themselves further and trying to obtain the FDA 

certification too. Moreover, our pharmaceutical industries are achieving self-sufficiency 

without affecting the consumers’ affordability. Before Drug Policy in 1982, price of one 

Amoxicillin capsule was Tk. 7, now it is Tk. 3.60; Doxycycline capsule was Tk. 3.95, now it is 

Tk. 2 ; and Diclofenac tablet was Tk. 9, now it is Tk 0.50 only.  

 

In this way another national aspiration has developed in our pharmaceutical sector i.e. 

turning an import-based pharmaceutical industry into an exporter of quality medicines. 

Today, Bangladesh is successfully exporting its quality products to 87 countries in Asia, 

Africa, Latin America and Europe. The drugs we are exporting are a wide range of 

pharmaceutical products covering all major therapeutic classes and doses forms. Besides 



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conventional products we are exporting high-tech specialized products like inhalers, nasal 

spray, infusions etc. The quality and efficacy of the products being exported from 

Bangladesh have been highly appreciated in all the countries we are exporting.  Bangladesh 

now has become one of the cheapest sources of quality medicines in the world. So the 

generic pharmaceutical market of the world is now open for Bangladesh. 

 

BIOETHICS: But just because our pharmaceutical sector has developed its own backbone 

does not mean that all our pharmaceutical industries have solved the relevant bioethical 

questions.  Though we are proud of many of our pharmaceutical companies; still there are 

complaints that some other companies do not pursue necessary bioethical norms at various 

levels of their manufacturing processes. Still a good number of companies sell sub-standard 

and counterfeit drugs, and yet some are not following the accepted GMP standards. This is 

very much unfortunate and need to be addressed properly both for the sake of public health 

and for the interest of the pharmaceutical companies. 

 

The deviations that some companies of our country are showing in general are : not 

employing enough qualified pharmacists, absence of  regular health check-up of the 

personnel directly in contact with  the manufacturing process, not having formal GMP  

training for all personnel of vital departments, not following proper in-process quality control 

measures, not having proper QC instruments, not using appropriate reference standards, not 

having any authorized vendor list for procurement of raw materials, not performing 100% 

sampling for identification of APIs and excipients, not having standard cleaning schedules for 

production machineries and surroundings , not rotating the disinfectants for cleaning of 

floors, not validating the production equipment and processes properly, not having 

acceptable waste disposal system etc. These variations are neither acceptable nor good for 

developing a positive image of our overall pharmaceutical manufacturers. Ethical self-

regulation could be a means to minimize such deviations. Though these companies are not 

competing in the export market but their products are being sold in the local market. This is 

an important concern for us because these companies are not GMP-compliant. Fortunately 

market share of these companies is negligible. 

 

If we consider exporting our medicine to the world market, it needs clinical trial and 

bioequivalence studies. As clinical trials and bioequivalence studies are experiments on 

human subjects, this means that ethical issues are always to be considered. These 



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experimental subjects are assigned either to receive the experimental intervention, or to 

receive an already established treatment product. WHO’s approach to bring all clinical trial 

data including trial conducted by private pharmaceutical companies, into a clinical trial 

registry is an excellent idea. Poor counties like Bangladesh will be benefited from this 

approach because we have a very large poor population that might be used as guinea pigs if 

appropriate national bioethical principles are not there. Right to informed consent and getting 

unbiased scientific health information about any experimental product is most important. It is 

an issue if global justice too.   

 

CONCLUSION: In a poverty stricken country like Bangladesh, if we do not establish these 

clinical trial and bioequivalence study norms nationally, everything else becomes irrelevant. 

Growth of our national pharmaceutical industry or earning a huge foreign currency without 

bioethical considerations is absolutely impossible and unacceptable. If we can establish 

these national bioethical norms, this could be the beginning of a new era for future growth of 

our pharmaceutical industries vis-á-vis our public health and national economy. 

 

We want to keep it in mind that ethical behavior is essential if a business is to function 

effectively. Policing through self-regulation is a good idea where bioethics can play a vital 

role. We need proper national ethical guidelines and this ultimately will be a right step in the 

right direction for further advance of our pharmaceutical industries, for better health care 

coverage of our poor people and for a potentially remarkable growth of our national 

economy.   

 

 

 

 

 


