From LDC to Global Player: Reinforcing Pharma Regulations and Capabilities

Pharma sector is one of our prouds as it takes care of 98% of local demand and thus saving about USD 7-8 billion of foreign currencies as per industry leaders. The domestic pharmaceutical market is about to reach USD 6 billion by 2025. The sector contributes around 1.83% of GDP. The forcast for attracting FDI is nearby USD 23 billion by 2030. However the sector is heavily import dependent, annual otflow of approximately USD 1.3 billion for Activated Pharmaceuticals Ingriedients(API) import. Export of pharma products is close to USD 200 million to 150+ countries. The sector created a huge number of white colour jobs from different Universities of Bangladesh.

At the stage of post LDC era, TRIPS waiver which is being enjoyed by the country will be lost, at the moment, Bangladesh can use generic medicine without royalties, after graduation, MNC dominance risks will be increased, price surge will intensify out of the pocket expenditures, affecting the marginal people most. Bangladesh at the moment has a very limited R&D, mostly being pursued by the industry stake holders themselves, there is even no established large, strong government supported laboratories with in the country, while the pharma products and process needs tests in each and every stages to pass through the whole life of a molucule and dosses.

The revisited Patent Act 2023 has been a policy tool to support industries, extended support for compulsory licenses( Art 31 of TRIPS), Bangladesh needs to institutionalize the benefits to enable swift use of it in the public health crises. For utilizing bolar provisions( Article 30), we need to enact permission for pre-expiry preparation of generics, parellel imports( Art 6) will allow us to import lower-cost medicines from global markets. However for utilizing these benefits strong institutions with required legal and TRIPS related information will be needed. The study by BIDA rightly identified that there is a lack of advanced API systhesis facilities, insufficient bio-equivalence testing labs, outdated formulated technology, weak IP management system and limited cold chain infrastructure for biologics. The Bio-equivalence lab should be WHO-standard, biotech and bioformatics research centres, animal testing facilities, GMP compliant pilot plants, dedicated vaccine research units etc are some of other prescriptions.

At the post LDC era, to keep hold of the markets, Bangladesh needs to get involved in contract manufacturing, put stronger attention for concentrating on biosimilars potentials, API export growth etc. The challenges for all these issues are aware by the industry stakeholders, however they need support for institutional, financial, technical and regulatory supports. For biosimilar, complex regulations hinder market entry in developed nations, so industry alone is not enough to sustain.

In order to complement the existing framework and smoothen the post-LDC challenges, there were some agreement that the enterprises will go for registering as much as possible new medicine until graduation, however, in a recent seminar it was highlighted that there is delay of completion of 600 new medicine registration and 15 high value biologic drugs, which is a primary task to face immediate situation after graduation, but because of regulatory hassles these steps slowed. It seems that government is also sincere to resolve these issues to face post LDC situation.

The study conducted by BIDA informed that about 66% of the export items belong to a single HS code (HS 300490) showing low diversification of products. At the stage of present global trade dynamics, showing high export concentration in limited product segments such as HS 300490, 300215, and 300220 (ITC Trade Data 2021) is risky. Bangladesh needs to work for product diversification to increase its export.

The transition of the sector from LDC to a global player needs full utilization of TRIPS flexibilities for existing generics and operationalizing the API park. The country needs to chanelizing enough resources to avoid risks in changed markets shaped by biologics, advanced therapies and costly R&D. A policy note prepared by the International Trade, Investment & Technology Wing, Ministry of Foreign Affairs highlighted the needs for a national strategy for contract research organizations(CROs), more focus on Biosimilar and Biologics and Ethnopharcology. For all these changeover and sustain the challenges, it needs skill manpower and regulatory back-up for revamping the sector.

Industry leaders believe that if required utilities, raw material import facilities along with skilled manpower are available, it would be possible for them to be self sustained. Private sector leaders informed that the sector can provide 100% drugs for local consumption and can contribute for exports. Bierfed that for registering doses in a regualted market, the enterprises has to go thorugh a number of process and steps, claimed to dissiminate a signal to the global community that we are not violating the IPR, and for this they need a number of capable patent lawyer to support the industry and an establishment of an IPR centre. Bangladesh needs to be ready to register more doses which is costly, time bound and process oriented, so continuous efforts needs to be lended. Similar is the case of API, getting a global leadership for a single molucule, it takes years after years. API park was not ready so far, but now getting momentum as the time for graduation is coming closer, a coordinated effort, need based R&D can give some gradual improvements.

They have given some examples of R&D which has supported them to be a global leader, if at least 20,000 doses can be established in the country and if a single company at least can attain a global leadership in a single product, it will be a huge benefit for the country. A concerted action and collective work of government private sector could generate at least twenty molucules, can lead Bangladesh to get a global leadership. In regard to a success of developing API, utility support is a must, as Bangladesh is having deficiencies in gas, clean coal could be a substitute, as the diesel based operation would increase costs significantly making them uncompetitive.

In regard to the API systhesis facilities Bangldesh too some extent moving forward. Ibn Sina API industry limited in the BSCIC API industrial park and Square pharamaceuticals, Acme Laboratories, Globe pharma have some how progressing with API production. The Sydney based company HA Tech has established a large scale API manufacturing facility aiming to meet country’s growing demand. India and China two Asian countries are lead in API supplies in the world. There are countries across EU such as Germany and the UK, Italy have some footing in the API sector. As Bangladesh is dependent on importing raw materials from other countries for API, industry expertise has to be exploited with enabling environment created by the government.

LDC graduationhas been protested by the private sector but government is determined. STS has been prepared and floated only, the action plan identified for the specific Ministries have not yet started implementing these issues, because for these agenda items, it needs financing supports. The R&D supprt facilities by the government is very meagre in the country, as there may not be any immediate benefits from these investment, however in order to sustain competitiveness of Pharma sector in the post LDC era, government has to invest hugely to support capacity building, knowledge build up, university graduates, lawyers, research centres also with a clear road map is prioritizing the areas.

So far, whatever strength is available within the country, technology-transfer through industry-academia collaboration have not happened. Our scientists, engineers are doing excellent jobs and contributing abroad because of proper support, a strong diaspora of Bangladesh is also acknowledged everywhere, they can be engaged to help the country for technology transfer. Data management and digitizatization for regulatory compliance, limited mRNA/LNP delivery system expertize is absent. Lipid Nanoparticles(LNP) are tiny fatty droplets that carry mRNA safety to cells, needed to bring changes in the medicines.

Biologis drugs are getting momentum made of living sources and are more complex than small-molucule drugs, it is said that biosimilars can not be copied exactly, but have proven by this time as safe and effective. Biosimilars offer more treatment choices, may lead to lower healthcare costs. Bangladesh is behind in this respect as well. EU is the lead in biosimilar development while US is another example, but China is advancing rapidly in the respect. Bangladesh may extend collaboration with China to have an access to these biosimilar products with the support from the Universities in Bangladesh, who claim that they have got trained manpower, can be utilized by the industries.

Pharmaceutical stakeholders suggested that fast tracking drug registration and approval process should be enhanced. Capacities of DGDA and Drug Control Committee are an urgent need. Bangladesh has established a large pharma sector, government also own these issues, strong political support is a must to keep hold the continued journey of the sector. The technicalities, technology support, skill development following peer countries and neighbouring countries is possible to be built if a combined efforts are sustained.

Ferdous Ara Begum: Economist and chief executive, Business Initiative Leading Development