Bangladesh, which has been constantly evolving in the past few years, has transformed itself into a robust pharmaceutical manufacturer in South Asia today. The country which was totally import dependent a few years ago for its domestic pharmaceutical needs, has grown into a strong exporter of generic medicines to the unregulated and European markets. Moreover as Bangladesh is considered to be among the Least Developed Countries (LDC) in the world, it has the advantage of reproducing the branded drugs.
Increasing export earnings
Currently Bangladeshi pharma companies are improving their export base. The industry now exports active pharmaceutical ingredients (APIs) and a wide range of pharmaceutical products, covering all major therapeutic classes and dosage forms, to more than 90 countries. The major destinations for Bangladeshi medicines are Myanmar, Sri Lanka and Kenya, while nearly 50 countries import Bangladeshi medicines regularly. The growth in exports has averaged over 10 per cent from 2010 to 2014. In 2015, the country’s pharma exports touched over $ 41.17 million. Pharmaceutical companies are trying to export to regulated, unregulated and moderately regulated markets.
For the first time in its history, Bangladesh has earned more than Takas (Tk) 3 billion by exporting medicines. According to analysts, in the first six months of 2015-16 fiscal, foreign exchange earnings from Bangladesh-made life saving drugs has reached the Tk 3 billion mark.
“No doubt, during the past few years, the Bangladeshi pharma industry has improved its ability to manufacture drugs for all kinds of needs. Though some manufacturers are already able to produce world class quality drugs, there are some other companies both in the public and private sectors which need to improve their manufacturing capabilities.
And in this endeavour, the Bangladeshi and Indian pharma companies can work together to help each other and grow their mutual businesses,” opined Dr. P.V. Appaji, Director General of Pharmexcil.
Future holds promise
The internal medicine market size of Bangladesh is more than Tk 120 billion and over 100,000 people are directly involved in the sector. Globe Pharmaceuticals Chairman Harunur Rashid thinks the country's pharmaceuticals sector is headed for better days. “We have a lot of expectations from the industry. Medicine export will hopefully increase 10 times in the next seven to eight years.”
Justifying the claim, he says people in the past used to buy medicines from China. Now that China is busy with its internal demand, consumers prefer India-made drugs and they would turn to Bangladesh-made drugs soon in a big way. “Nowhere in the world are medicines as cheap as in Bangladesh. This industry has the potential to earn more foreign currency than the garment sector”, opined Rashid.
The WTO has granted Least Developed Countries relaxation on intellectual property rights until 2033 and two Bangladesh companies have secured permission from the US Food and Drugs Administration (FDA). This has encouraged Bangladesh's pharmaceuticals industry to gear up for boosting exports with renewed enthusiasm. Exporters and analysts say if the US market opens up to Bangladesh-made drugs, export incomes would multiply several times. That would help drive the value of pharma stocks in Bangladesh's bourses despite an overall downward drop of other stocks.
“Bangladesh is a natural candidate to supplement or substitute other international manufacturers to the developing country markets of both finished drugs and APIs. In order to maximize growth, the pharmaceutical players need to set their sight in the global market and must improve both qualitatively and quantitatively,” observed S.V. Krishna Prasad, Managing Director of Cito Healthcare.
At present though the country exports medicines to more than 90 countries apart from meeting its own domestic demand, the country needs to do a lot more to get it qualified to supply the US markets. “It will be possible to export medicines worth $10 billion to the US market alone if the government provides better policy support and incentives,” observed Mohammed Farashuddin, former governor of Bangladesh Bank.
Among the leading pharma companies which have got approval from USFDA last year are Square Pharmaceuticals and Beximco Pharma. These two companies have been doing exceptional work in the pharmaceutical sector of Bangladesh and have gained the FDA approval last year. “Apart from these two companies, Incepta Pharmaceuticals is also expected to get the opportunity to supply medicines to US markets soon. The other companies will follow suit gradually,” opined Farashuddin.
Most of these USFDA approved companies are gearing up themselves to supply pharmaceutical products to the US markets in the next four to five months. Very soon the USFDA approved companies are expected to supply blood pressure medicine to the US markets. As part of this the Square pharmaceuticals and Incepta Pharma are preparing ground to being exports from next year.
According to the Export Promotion Bureau, Bangladesh’s export earnings in the first half of the current fiscal year stands at $16.8 billion, of which $37.9 million (about Tk 30 billion) was from medicine exports. The amount is 18 per cent higher than that of the same period in the previous year, and equal to the total earnings from medicine export in FY 2009-10. Bangladeshi medicine exporters brought home $72.6 million in the last fiscal year.
Increasing investments
To further boost the earnings, the manufacturers have increased investment. The import of capital machineries in the sector rose by 25 per cent between July and October in 2015-16.
Experts are of the view that Bangladesh may reap maximum benefit from the WTO’s relaxation. The country can manufacture and sell medicines for another 17 years without spending anything on intellectual property rights. The people will get usually expensive drugs for critical diseases including cancer, arthritis and asthma much cheaper. “An injection that costs Tk 300,000 abroad will be available in Bangladesh for Tk 60,000 only. If the opportunity is properly utilized, people from abroad will come to Bangladesh for treatment which will boost medical tourism in the country,” observed Abdul Muqtadir, leader of Bangladesh Association of Pharmaceutical Industries.
With pharma industry in Bangladesh incorporating new technology and adopting latest trends, the manufacturers are able to produce insulin, hormones, and cancer drugs of the highest quality. This sector provides 97 per cent of the total medicinal requirement of the local market. The industry also exports medicines to global markets, including Europe. Pharmaceutical companies are expanding their business with the aim to expand the export market.
There are five types of medicine manufacturing companies in Bangladesh. Among them about 200 companies manufacture Allopatheic drugs, about 170 companies manufacture Ayurvedic drugs, and around 270 companies manufacture Unani drugs. In addition to this, there are about 30 companies each who are involved in the manufacture of herbal and homeopathic & biochemical drugs.
Along with regular forms like tablets, capsules and syrups, Bangladesh also exports specialized products like HFA inhalers, CFC inhalers, suppositories, nasal sprays, injectables, IV infusions, etc. These products have been well accepted by medical practitioners, chemists, patients and the regulatory bodies of all of their importing nations. The packaging and the presentation of the products of Bangladesh are comparable to any international standard.
Regulatory authorities
The Directorate General of Drug Administration (DGDA) is the national drug regulatory authority which is under the Ministry of Health and Family Welfare. DGDA regulates all activities related to import and export of raw materials, packaging materials, production, sale, pricing, licensing, registration of all kinds of medicine including those of Ayurvedic, Unani, herbal and homoeopathic systems.
The Pharmacy Council of Bangladesh (PCB) was established under the Pharmacy Ordinance Act in 1976, to control the pharmacy practice in Bangladesh. The Bangladesh Pharmaceutical Society is affiliated with the International Pharmaceutical Federation and Commonwealth Pharmaceutical Association. The National Drug Policy (2005) states that the World Health Organization’s current Good Manufacturing Practices (GMP) should be strictly followed and that manufacturing units will be regularly inspected by the DDA. Other key regulatory features are restrictions on imported drugs, a ban on local production of around 1,700 drugs that are considered non-essential or harmful and strict price controls on some 117 principal medicines.