Bangladesh has a well established pharma industry which is now gearing up for global audits.
Since India has the highest number of USFDA facilities at 584, Bangladesh is keen on partnership with India. It is wooing Indian companies for investments in Greenfield projects and also for tech-transfers which includes RL Fine Chem of Bengaluru.
Bangladesh is known for its industry-friendly environment and the government is pro-active in spurring indigenous production to cater to the domestic market needs. There is a competent drug regulatory system which is in a mode to ensure high quality manufacture and marketing of medicines.
Bangladesh which has a strong pool of scientific manpower with inherent strengths to drive growth of enterprises is a country to be watched closely. The concerns of political stability will be offset in the wake of the growth of the pharmaceutical industry in Bangladesh, aver experts.
In June 2016, at an Invest in Tripura meet, Bangladesh’s Industry Minister Alhaz Amir Hussain Amu said, ‘Bangladesh wants to be India's partner in the technology-based medium and large- scale industrial quest to make the country economically vibrant."
Calling upon the Indian entrepreneurs to invest in Bangladesh taking advantage of the congenial industrial climate there, Amu said "If SAFTA(South Asian Free Trade Area) comes into effect, then investors of Bangladesh will have a golden opportunity to harness the markets in India, European Union and Japan."
SAFTA or the South Asian Free Trade Area which was inked in 2004 to focus on customs union, common market and economic union.
"Bangladesh is importing around 3,000 items from India. Issues like customs surcharge, basic custom duty and addition duty must be addressed to create a win-win foreign trade," he said.
Co-operation via multilateral fora
India and Bangladesh are also engaged in regional cooperation through multilateral fora such as SAARC (South Asian Association for Regional Cooperation), BIMSTEC (Bay of Bengal Multi-Sectoral Technical and Economic Cooperation) and IORARC (Indian Ocean Rim Association for Regional Cooperation) etc. In pursuance of directions of the Prime Ministers of India and Bangladesh, both sides have also commenced implementation of sub-regional cooperation initiatives along with Nepal and Bhutan.
Bangladesh market
Providing an snapshot on the Bangladesh market earlier to Pharmabiz in his article titled ‘Bangladesh pharmaceutical sector: an overview,’, Muhammad Masud , Editor, The Pharma World, “There are 260 registered pharmaceutical companies in Bangladesh of which 191 are in operation. The manufactured products of these companies are meeting 97 per cent of the domestic requirement. Some vaccines, anti-cancer products, haematological products, biotech products are being imported. These 191 companies are marketing more than 1,350 molecules with 23,500 brands in the country. Bangladesh pharmaceutical industry is dominated by the local pharma companies, as 90 per cent of the market share is owned by the local companies. Top 20 companies are enjoying 82 per cent market share.
In June 2015, Beximco Pharmaceuticals Limited, a leading manufacturer of generic pharmaceutical formulations and APIs, announced that it became the first Bangladeshi pharmaceutical to be approved by the US Food and Drug Administration (FDA) following successful inspection of its oral solid dosage facility at Tongi, between January 19-22, 2015.
The company received the establishment inspection report (EIR) from the US drug regulatory authority stating that the audit is formally concluded. The company stated that it was a major milestone for the for it and for the entire industry as this is the first time a Bangladeshi company had received the prestigious FDA approval which was based on the comprehensive audit encompassing all the systems of drug manufacturing: quality; facilities and equipment; materials; production; packaging and labelling; and laboratory controls. Remarkably, there was no 483 observation issued by the US regulatory authority. A 483 form is issued when FDA has observations of non-compliance or deviation from Good Manufacturing Practices (GMP), stated Beximco in its communication.
Indian exporters
From the southern states of India , Biocon, RL Fine Chem, Bal Pharma, Aurobindo Pharma, MSN Labs and Hetero Drugs are key exporters to this region. India’s largest biotech industry Biocon also sees Bangladesh an important country for trade in South Asia. It exports insulin, immunologicals and statins.
According to GG Gurudatta, President and Executive Director- Business, Nuwill Research and Innovations Pvt. Ltd. Bangladesh has strong presence in pharmaceutical manufacture. Therefore exports from India is not an important focus for companies here except for a handful of vaccine and oncology formulations. However the active pharmaceutical ingredient manufacturers still consider it as a market of opportunity which cannot be ignored.
Bangladesh government has promoted special economic zones and is viewing Indian pharma to invest in Greenfield projects here. The local companies in the region are gearing up for audits from global regulators like USFDA and EMA, stated Gurudatta adding that India is not on their radar for generic drug imports.
However for oncology and vaccines, India is much sought after for formulations. This is where Biocon chips in its cancer drug exports too, stated an industry observer.
The trend in Bangladesh pharma sector is an aggressive move for international presence and getting global audits successfully on track. Other than Beximco Pharmaceuticals which is the largest player in the region, Star Drugs is also now working towards EMA audit.
In the area of APIs, there is a huge dependence is on India. This is because globally key API players are in China, India and Europe. Going by the accessibility, Indian pharma companies are much preferred source for supplies, Gurudatta noted.
The challenge is therefore for the formulations companies as these will find it tough to make an entry into the region. But API sector is seen to have favourable customers, said Gurudatta.
A UK Trade and Investment report indicated that Life sciences is one of the fastest growing sectors in Bangladesh. In 2013, the domestic market grew by 24.3 per cent to US$ 1.136 billion. Many companies are looking to partner foreign investors. Products still being imported include: vaccines, oncology, haematological products and biotech drugs.
New phase of transition
“There are imminent signs of large scale manufacturing infrastructure for pharmaceuticals in Bangladesh. This is a sign of a new phase of transition. It is a fact that Indian players in the API sector have been approached for co-product development and manufacture,” said Anjan K Roy, managing director, RL Fine Chem, a company which exports to the region and also having companies from Bangladesh seeking collaborative pacts for manufacture.
Efforts to get compliant to global regulatory standards are underway and in a couple of years, we will see the pharma industry in Bangladesh being preferred for supplying to regulated markets of the US, EU and Japan.
The access to South East Asia will see several contract manufacturing assignments to take off from here going by quality-competent workforce at affordable rates, noted Roy.
In the South Asian region, India and Bangladesh have the pharmaceutical prowess. While India has proved its capability across research, manufacture, marketing, clinical trials and as a key outsourcing partner, Bangladesh is demonstrating its mettle in formulation manufacture. In the case of APIs, China and India are its two sources of Bangladesh bulk drug imports. Now it could take a while for Indian pharma to be a major supplier to Bangladesh over China because the former is a price sensitive market, said Roy.
However China is strong in APIs for antibiotics and India is known for its strengths in oncology and central nervous system products in this space. The increase in chronic diseases in Bangladesh will see only exports for bulk drugs growing. At least in the long-term, we do not see much of API production for high value and low volume drugs, said Roy adding that Indian pharma will continue to exports these medicines.
Consolidating presence in Bangladesh
For Bal Pharma too, Bangladesh is a key market for growth. We are registering 20 per cent annual growth from this region. The company has been trading with six APIs including anti- diabetic and anti-histamine. Efforts to increase its API product range is on the cards said Archana Dubey, vice president, international marketing, Bal Pharma.
“Despite the cut throat competition from China and companies within India, we are able to succeed in the region. This clearly indicates the dependence of APIs for the local manufacturers in Bangladesh. These local manufacturers are suppliers to the US and EU region where customers mandate high quality of APIs supported with dossier submission. We stand to gain here and have an edge. We are witnessing growth in our APIs, informed Dubey.
“Long-term, diligent planning and investment to sustain labour intensive sectors like pharmaceuticals are being recognized by countries in the South Asia, South East Asia and Asia-Pacific region for its infrastructure, compliances, supplier performances and quality workforce, pointed out the RL Fine Chem chief who intends to further consolidate his presence in Bangladesh.
The painstaking negotiations on pricing is a survival strategy in the region, pointed out the Bal Pharma VP in international marketing who feels that the Indian government should ensure that its industry can maximize on SAFTA and ASEAN pacts to boost international trade ties.