Current progress and future challenges of pharmaceutical industry

Abdul Muktadir
The pharmaceutical sector in Bangladesh is a highly developed sector which is contributing substantially to its economy. After the promulgation of Drug Control Ordinance – 1982, the development of this sector was accelerated. The professional knowledge, thoughts and innovative ideas of the pharmacists working in this sector are the key factors for such developments.

Due to recent development of this sector, we are exporting medicines to global market including the European one. The local pharmaceutical manufacturers cater to about 97% of the internal demand. Leading pharmaceutical companies are also expanding their business with the aim to expand export market.

The annual per capita drug consumption in Bangladesh is one of the lowest in the world. However, the industry has been a key contributor to the Bangladesh economy since its independence. In Bangladesh, the pharmaceutical market has grown tremendously in the last few years. Bangladesh medicine sales reached Tk 40 billion (4,000 crore), in value terms, in 2007, which nearly doubled to Tk 70 billion (7,000 crore) in 2010. According to the experts, the growth trend would take the sales volume to Tk 90 billion (9,000 crore) in 2011.

The contributing factors in the growth of this market include the development of healthcare infrastructure, increase of health awareness, increased rural penetration of the manufacturers, increasing the purchasing capacity of people as well as the different government policies to ensure health services and facilities available even in the rural areas. This industry is expected to grow at a higher rate in the future. Healthy growth is likely to encourage the pharmaceutical companies to introducing newer drugs and newer research products, while at the same time maintaining a healthy competitiveness in respect of manufacturing quality pharmaceutical products and selling them at affordable prices. The latest addition in the Bangladesh pharmaceutical market is the launching of human vaccines for the first time in the country by local pharmaceutical companies which was earlier fully dependent on imported vaccine. Such Bangladeshi companies have the capability of producing and supplying the required quantity of vaccine for the whole nation. This will save a lot of foreign currency required to import vaccines by the government and also ensure the availability of the life-saving vaccines in Bangladesh. Moreover, a high-tech insulin manufacturing plant opened in Bangladesh which has the capability of providing world-class medicines to the country’s growing diabetic patients.

Pharmaceutical industry mulls to export drug items to all 120 destinations from the existing 83 countries by the next few years to give a big boost to the country’s export earnings. The pharmaceutical sector is the highest contributor to the national exchequer and the largest white collar labour intensive employment-giving sector of the country. Through exporting medicine Bangladesh earned Tk. 3.28 billion (328 crore), 3.48 billion (348 crore) and Taka 3.82 billion (382 crore) in 2008, 2009 and 2010 respectively and expects to earn much more in 2011.

There are 245 registered pharmaceutical manufacturing companies in Bangladesh. Today, Bangladesh pharmaceutical industry is successfully exporting APIs and a wide range of formulations covering all major therapeutic classes and dosage forms to 83 countries. Besides regular forms like tablets, capsules & syrups, Bangladesh is also exporting high-tech specialised products like HFA inhalers, suppositories, nasal sprays, injectables, IV infusions, etc., and have been well accepted by the medical practitioners, chemists, patients and the regulatory bodies of all the importing nations. The packaging and the presentation of the products of Bangladesh are comparable to any international standard.

The pharma industry of Bangladesh is now on the verge of entering highly regulated overseas markets like those in the USA and Europe. In this connection, several pharmaceutical manufacturers have already made huge investments in their new state-of-art manufacturing facilities. A number of companies have already obtained or in the process of obtaining UKMHRA, EU, TGA, AUSTRALIA and GCC certifications. The future of pharmaceutical exports from Bangladesh is, thus, bright.

After the inclusion of the Doha declaration in WTO / TRIPS Agreement, each and every country belonging to the least developed country (LDC) category has the option not to opt for pharmaceutical product patent until 2016. This means they can now legally reverse engineer patented products and sell in their markets as well as can export to other LDCs. This creates a huge export opportunities for Bangladesh, because, among all the 50 LDCs, Bangladesh has a strong base for the pharma manufacturing. Besides direct export operations, there is also a huge opportunity for the Bangladeshi companies to go for the contract manufacturing and compulsory licensing.

Challenges that work as constraints or limitations: The primary responsibility for drug quality control lies with the manufacturers. However, the government’s drug testing laboratories (DTL) and the Directorate General of Drug Administration (DGDA) have the monitoring and supervising role. Testing of drugs are required for evaluating pre-registration and post-marketed drugs and medicines quality. At present, there are two Govt. Drug Testing Laboratories in the country, one in Chittagong and another in Dhaka. The Directorate General of Drug Administration (DGDA) is the organisation entrusted with the responsibility of ensuring the quality, efficacy and safety of pharmaceutical products though the implementation of relevant legislation. The organisation is trying its best to fulfill the requirements of the pharmaceutical sector of the country and thereby meeting the needs of the people of the country by ensuring the safety, efficacy and quality of the medicines. Although with its present set-up and inadequate strength, the DGDA often finds it difficult to carry out its very large volume of assigned work but the positive sign is that the DGDA is continuously strengthening its infrastructure.

Restrictions on patent rights discourage foreign investors to come up actively in the pharmaceutical market in Bangladesh. Introduction of new research molecules is difficult due to slow registration process and restrictions on patent protection. Although the fixed mark-up system of pricing helped keep the prices of pharmaceutical products low, this made it difficult to cover costs of marketing and distribution. The fixed mark-up system also discourages some companies to invest for cGMP and assurance of high quality production.

Creation of the Active Pharmaceutical Ingredients (API) Industrial Park is the most significant requirement of the pharmaceutical industry. The government has already taken necessary steps to strengthening the pharma sector of Bangladesh by way of establishing API Industrial Park at Gazaria, Munshiganj and it is expected that THE API Industrial Park will be ready for operation within 2013. It will help increase the local pharmaceutical industry competitiveness to help boost exports. It would be a giant leap for the industry as most pharmaceutical raw materials could be produced locally.

In order to export a drug to a regulated market and to some moderately regulated market, it is mandatory to provide bioequivalence data. At present no bioequivalence laboratories exist in Bangladesh.

We have to conduct this experiment abroad at a high price. It is the need of time to establish full-fledged bioequivalence laboratories in Bangladesh within a short period of time to help boost the export and improve the quality of the products.

It is crystal clear that Bangladesh pharmaceutical market is growing at a high pace and has a very bright future. According to Business Monitor International’s latest report, Bangladesh has moved up one place to occupy the 14th position in 17 regional markets surveyed in BMIs Pharmaceutical & Healthcare Business Environment Ratings for the Asia region.

Still, Bangladesh has a long way to go. Bangladesh has a huge potential in pharmaceutical manufacturing and export as the supply of skilled manpower is adequate here. It has the potential to that of establish itself as a high volume export industry parallel to readymade garments (RMG) sector.

The writer is Secretary General, Bangladesh Aushad Shilpa Samity or Bangladesh Pharmaceutical Industry Association


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