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[🇧🇩] Pharmaceutical and Chemical Industry in Bangladesh

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[🇧🇩] Pharmaceutical and Chemical Industry in Bangladesh
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Renata to issue preferred stock in drive to slash finance costs​

FE REPORT
Published :​
Mar 15, 2024 00:53
Updated :​
Mar 15, 2024 00:53


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Renata plans to shed its loan burden further by issuing five-year preference shares, having witnessed profit erosion in FY23 and the first half of FY24 mainly due to a jump in its finance costs.

It received approval of the Bangladesh Securities and Exchange Commission (BSEC) on Thursday for issuing preference shares months after it had got permission to release bonds.

The leading drug maker will repay part of its bank loans with Tk 3.5 billion to be raised through preference shares against the backdrop of rising interest rates.

Dividends against the non-convertible and redeemable preference shares, which will be expected to be paid before common stock dividends, will be 9-10 per cent.

Md. Jubayer Alam, company secretary of Renata, said they were contemplating an offer of 10 per cent annual yield against zero coupon bonds and decided dividends against preference shares in sync with the bond yield.

He also said the company expected investors to invest in the shares and bonds given its reputation.

Renata's board of directors last year approved two proposals -- one to issue zero coupon bonds and another to float preference shares. Funds worth Tk 8.5 billion in total will be collected through bonds and preference shares.

The drug maker has taken the move at a time when many other companies have considered plans to cut down borrowing costs and have even revised proposals to issue corporate bonds with a higher interest rate to attract investors.

Rising interest rates of risk-free Treasury bonds has made it harder to draw investors to corporate debt securities. Return against T-bonds has already surpassed 11 per cent.

After replacement of the lending rate cap with a reference rate called SMART (six-month moving average rate of Treasury bills), the lending rate has been going up.
Renata has already been paying back loans at a higher interest rate.

The company's finance cost jumped 96 per cent year-on-year to Tk 851.87 million in FY23 as it had taken out fresh loans ahead of the withdrawal of the 9 per cent lending rate cap in June 2023.

Profit plunged 54 per cent to Tk 2.34 billion in FY23, compared to the previous fiscal year.

In the first half of FY24, the finance cost was Tk 571.12 million, up from Tk 567.64 million reported for the same period of the previous fiscal year.

Increased finance costs have been eroding the company's profits significantly.​
 
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Production at API Industrial Park to begin next month​


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Production of active pharmaceutical ingredients (APIs) at the API Industrial Park in Gazaria of Munshiganj will begin next month, with ACME Laboratories set to commission its manufacturing unit despite the lack of gas supply.

"Our factory is almost ready for operation," said Sheikh Maksudur Rahman, director of ACME Laboratories.​

The Bangladesh Small and Cottage Industries Corporation (BSCIC) has established the park on 200 acres of land and allocated 42 plots for 21 industrial facilities.

So far, four local manufacturers -- ACME Laboratories, Healthcare Pharmaceuticals, Ibn Sina Pharmaceuticals and Unimed-UniHealth Fine Chemicals -- have set up factories at the estate.

At present, Bangladesh depends on imports to meet around 85 percent of its requirement for both biological and non-biological small molecule APIs, costing the country about $1.3 billion each year.

Local companies cater to the remaining demand with at least six companies, including Square Pharmaceuticals and Incepta Pharmaceuticals, producing APIs worth more than Tk 2,000 crore annually.

Industry people say at least 50 percent of the country's demand for APIs could be met through local production if more big companies invest in the industry.

This means the remaining 50 percent would still need to be imported since it is now possible to manufacture only non-biological small molecule APIs locally.

Still, it is a venture worth making as the domestic market for non-biological small molecule APIs is currently worth around Tk 6,500 crore, according to Rahman.

He said regulatory bodies, including the Directorate General of Drug Administration, the Department of Inspection for Factories and Establishments and the Department of Narcotics Control, have already inspected their unit twice.

"Our investment in the facility has reached around Tk 500 crore as we imported sophisticated machinery from the US, Germany, Japan and India to ensure API production of global standard."

Rahman believes the unit will be able to produce APIs worth Tk 600 crore annually.

SM Shafiuzzaman, secretary general of the Bangladesh Association of Pharmaceutical Industries, which represents 265 local drug makers, said most of their members have not set up factories at the API park due to the long delay in getting gas connections.

He also said many companies in the pharmaceutical sector are currently under financial pressure. "So, they are taking time."

Monjurul Alam, chief executive officer of Beacon Medicare, said the pharmaceutical sector needs more research and development in regards to API manufacturing.

This is because local manufacturers will have to develop their own API formulas to avoid patent laws after Bangladesh graduates from the group of least-developed countries in 2026.

"We need API for our interest to take the pharmaceuticals sector to the next level."

Alam also said the pharmaceutical sector needs to develop biological drugs as it is dependent on non-biological medicine.

"We have realised in advance the need to make our own APIs. Therefore, we have taken the preparation to set up a factory in the park."

M Mohibuz Zaman, managing director of ACI HealthCare, said they will also start establishing their factory after gas connections are confirmed.

He informed that they delayed their plans to invest in the park amid the ongoing economic crisis and the appreciation of the US dollar as it would increase the amount of investment required.

Sanjay Kumar Bhowmik, chairman of the BSCIC, said that gas connections will reach the industrial park within a short time.

"We already spoke with Titas Gas Transmission and Distribution Company to provide gas connections while water and other utility supplies have already been ensured."

Bhowmik also said that they would work with pharmaceutical companies to quickly set up their units after ensuring gas supply.

He said large companies like Square and Beximco have obtained plots but are yet to start constructing their factories.

"We will sit soon with the companies that have not yet started setting up their factories. Gas supply will reach the facility next month."​
 
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Pharmaceutical sector on steady path to recovery​


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The pharmaceutical sector is eyeing a recovery from the difficulties brought on by the Covid-19 pandemic and Russia-Ukraine war as the opening of letters of credit (LCs) for raw materials imports is gaining pace, according to industry insiders.

The opening of LCs to import raw materials for the pharmaceutical sector increased by 14 percent to $636.26 million year-on-year during the July-January period of the current fiscal year, Bangladesh Bank data shows.

According to industry people, the dollar crisis in the country is gradually easing and the global supply chain is getting smoother, positively impacting the pharmaceutical sector.
"Opening of LCs for raw materials is increasing as the dollar crisis is lessening day by day," said Md Mahbubul Karim, executive director (supply chain management) at Incepta Pharmaceuticals Ltd.

According to him, the sector suffered a lot as the Russia-Ukraine war and dollar crisis disrupted the supply chain immensely.

"We could not even keep up with the lead times due to disruptions in the raw materials supply chain," he said.

He added that they had endured a tough time opening LCs despite managing 100 percent margin, but added that the current situation was much better.

He also alleged that pharmaceutical manufacturers would open LCs at the government rate but were later asked to settle them at higher rates.

He further said that the management teams of pharmaceutical companies had shown their efficiency during the difficult times. As a result, the sector tackled the crisis and there was no deficit of medicine.

"No visible impact was felt in the export of pharmaceutical products either," he claimed.

Pharmaceutical exports fetched $134.15 million during the July-February period of this fiscal year, a 13 percent increase compared to the same period in the last fiscal year.

Monjurul Alam, chief executive officer at Beacom Medicare Limited, a concern of Beacon Pharmaceuticals PLC, said opening LCs had become easier as the dollar crisis was gradually easing. Consequently, more LCs were being opened.

The situation will improve further in the second half of the year, he said.

"We were really worried about whether we could overcome the crisis or not," Alam said, adding that the sector was saved from a collapse by virtue of good management and government cooperation.

According to him, there was greater availability of the greenback in the second half of the current month. He also added that the price of dollars was decreasing.

"We opened LCs at Tk 118.50 per dollar last week while it was Tk 125 per dollar in February," he noted.

However, he said the local currency needed to strengthen further against the greenback for the economy to rebound strongly. He also believed the pharmaceuticals sector recovering rapidly would contribute to the country's economy.

Alam said the volume of sales in the domestic market increased slightly in the last fiscal year, but the margin declined due to increased costs of production.

Last year, drug sales grew two percent to Tk 30,059 crore, far lower than the four-year average growth of 8.5 percent in 2022, according to a report by IQVIA, a global provider of advanced analytics, technology solutions, and clinical research services.

"We are on the way to recovering fully from the crisis and maintaining the raw materials supply chain," said Shah Imran, head of procurement of Beximco Pharmaceuticals Ltd.

During the crisis, small manufacturers suffered a lot and failed to ensure smooth production, he said.

Fortunately, his company did not suffer severely due to their skilled management team, which helped facilitate the continuing supply of raw materials and production of lifesaving medicine, he noted.

He added that banks and the government also cooperated in opening LCs during the crisis, but added that banks charged a higher rate and 100 percent margin.

The situation has now improved and there is no possibility of a crisis regarding medicine supply in the future as the sector has already overcome the difficulties, he said.

"We have given serious effort to tackle the difficulties because of which we are enjoying a comfortable situation at this moment," said Imran.

Zahangir Alam, chief financial officer of Square Pharmaceuticals, said the dollar crisis did not impact his company as it had enough in-house income of dollars.

Although the dollar situation was tight, the supply of products to the drug market was not impacted, he said. As LC openings for medicine are rising, it will help the sector, he added.​
 
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Huge export market awaits pharma industry​

Vast manufacturing capacity to offer edge, say industry people

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Nazmul Hassan, president of the Bangladesh Association of Pharmaceutical Industries, Abdul Muktadir, senior vice-president of the association, Sharifa Khatun, secretary of the Economic Relations Division, and Rajarshi Dey Sarker, vice-president and general manager of Novo Nordisk Bangladesh, attend a session on the pharmaceutical and healthcare industry at the Bangladesh Business Summit at the Bangabandhu International Conference Centre yesterday. PHOTO: PRABIR DAS

Bangladesh is increasingly becoming a global hub for manufacturing quality and low-cost generic medicines since many countries don't have the facilities needed to produce drugs, industry people said yesterday.

Only two countries, China and India, along with the developed world have pharmaceutical manufacturing capabilities, highlighting the opportunity for Bangladesh to emerge as a hub for drugs for the global market.​

"None other than China and India and the western world is as good as Bangladesh in pharmaceuticals. So, Bangladesh has tremendous opportunity," said Abdul Muktadir, chairman and managing director of Incepta Pharmaceuticals Ltd.

"In fact, Bangladesh is becoming a major global hub for high quality, low-cost generic medicines."

He made the comments while presenting a paper on "Pharmaceutical and healthcare in Bangladesh: Investing for growth, global integration and post Least Developed Country (LDC) market opportunities" at the Bangladesh Business Summit.

The Federation of Bangladesh Chambers of Commerce and Industry organised the three-day summit at the Bangabandhu International Conference Centre to highlight the investment prospect in the country.

Also the senior vice-president of the Bangladesh Association of Pharmaceutical Industries (Bapi), Muktadir said China and India have big markets amounting to $220 billion and $40 billion, respectively, and they are growing.

"So, after meeting domestic requirements, India and China may not be enough capacity to meet such a huge global demand."

"Everyone is looking for an India Plus One, where Bangladesh has incredible opportunity," he said, at the discussion moderated by Economic Relations Division Secretary Sharifa Khatun.

Muktadir said China is mainly operating in the intermediary and chemical industries and supply from the country may face constraints in the current global geopolitical situation.

"All these geopolitical situations are creating huge opportunities for Bangladesh in the global export market," he said, adding that active pharmaceutical ingredients, pharmaceutical formulations, biosimilar, vaccine and medical device segments offer huge growth opportunities.

In Bangladesh, nine companies have already received regulatory approvals from highly regulated authorities in the US, the European Union and Australia as well as the World Health Organisation.

"The number will increase to 20 very soon," Muktadir added.

"This will make us a global supplier of medicines. There is a visible competitive advantage for Bangladesh in the global market."

In Bangladesh, 213 local companies are operational, meeting 97 per cent of the domestic requirements of medicine, clearly showing the manufacturing strength.

On the other hand, countries such as Singapore, Malaysia, the Philippines and Vietnam import between 60 per cent and 80 per cent of drugs.

Until the third quarter of 2022, the market size of pharmaceuticals in Bangladesh was $3.32 billion. The market has grown three times in the last decade and it is expected to grow to $6.68 billion by 2027.

Local companies are capable of producing all types of dosage forms such as tablets, capsules, liquid preparations, dry suspension, injections, nasal spray, and granules in sachets.

Now, drug-makers are focusing on making APIs, the raw materials of drugs, in order to enhance competitive strength.

At present, 15 companies are producing APIs and 27 more firms will set up facilities at the API Park in Munshiganj, about 40 kilometres from the capital.

The Bapi aims to produce 800 to 1,000 generic bulk drugs, Muktadir said.

Local companies export products to 157 countries in Asia, Africa, North America, South America and Europe. Export receipts grew almost three times in the past seven years.

Medicines exports rose more than 11 per cent year-on-year to $188 million in 2021-22, data from the Export Promotion Bureau showed.

"The shipment will increase to $450 million by 2025," said Muktadir, citing the research of Dublin-based Research and Markets.

The global generic market is about $400 billion and if Bangladesh can raise its share to 1 per cent, the pharma export will reach $4 billion.

"This is highly achievable as per a majority of experts," Muktadir said. "And if we can elevate it to 10 per cent, it will be $40 billion."

The sector faces challenges as well.

Since Bangladesh is set to graduate from the grouping of the least-developed countries to a developing country in 2026, the country will lose waivers on making patented drugs as per international rules.

"The prices of patented products will be expensive and some complex biologics may not be available in the country," said Muktadir.

He said there should be a waiver from patented medicines that are already in the market.

Muktadir urged the government to negotiate with the World Trade Organisation for having the TRIPS waiver extended for pharmaceutical products even if the country graduates from the LDC group.

"In the meantime, companies will develop their finished formulation manufacturing capacity. The production of the selective items that are currently patented will provide us valuable data," he said.

Muktadir said Bangladesh should focus on potential API markets such as Latin America, Indonesia, Pakistan, Egypt and Kenya.

"These items will be available from Bangladesh at competitive prices."

Bapi President Nazmul Hasan said: "Bangladesh is the cheapest source of pharmaceuticals in the world. It is proven that we can produce quality medicines."

Access to many essential medicines will be affected as prices would go up after Bangladesh becomes a developing country. But Hasan thinks there are opportunities too.

"Drugs worth $150 billion will be off-patented by 2030. It is possible for Bangladesh to gain from this," said Hasan, also the chief executive officer of Beximco Pharmaceuticals.

He called upon multinationals to establish facilities here and suggested local manufacturers maintain relations with global firms and strengthen research and development capabilities.

Rajarshi Dey Sarker, vice-president and general manager of Novo Nordisk Bangladesh, recommended local companies form partnerships.

Novo Nordisk has collaborated and partnered with Eskayef Pharmaceuticals and set up a manufacturing facility to produce Novo Nordisk's insulin cartridges used by diabetic patients.

"The partnership will ensure the supply of insulins in Bangladesh and export to other countries," Sarker said.
 
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Renata starts directly exporting medicines to US


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Renata PLC has begun exporting medicines to the US market, becoming the sixth pharmaceutical manufacturer from Bangladesh to directly ship products to the world's largest market.


In its first shipment, Renata dispatched 12.8 million Metoprolol Tartrate tablets for the US market today, according to a press release of the company. The drugs were produced at its Rajendrapur facility.

Metoprolol Tartrate is used for treating hypertension, angina, heart failure, and other cardiovascular conditions.

Before this, five Bangladeshi pharmaceutical manufacturers - Eskayef Pharmaceuticals Ltd, Square Pharmaceuticals Ltd, Beximco Pharmaceuticals Ltd, Incepta Pharmaceuticals Ltd, and ACI Limited - began exporting medicines to the US market.

Renata has also shipped Frovatriptan and Metolazone to the US under a contract manufacturing agreement.

According to Renata, the US market for Metoprolol Tartrate is substantial and expanding, with over 65.5 million prescriptions recorded in 2021.

The company operates 14 factories in Mirpur, Rajendrapur, and Bhaluka. The Rajendrapur facility received the approval from the US Food and Drug Administration in November 2022.​

Renata exports its products in 40 countries, the press release said.
 
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Drug market regulation must be a policy priority
01 May, 2024, 00:00

THE High Court, in a commendable move on April 29, asked the Directorate General of Health Services to take effective steps against the arbitrary price hike of essential drugs. The court gave the directive while hearing a writ petition from the Consumers Association of Bangladesh seeking redress for the incessant increase in drug prices in recent months. The consumer association's petition is based on a media report that said that drug prices have increased by 7–140 per cent in recent weeks. The prices of commonly prescribed drugs, including antibiotic tablets, insulin, and injections for diabetics, have increased the most. Drugs to treat chronic diseases such as heart disease, high blood pressure, and asthma also saw a significant increase. Meanwhile, the profits of the drug companies have inflated by as much as 60 per cent. The drug companies tried to justify the increase, saying that the raw material for drug production has increased in the international market. However, the price increase appears arbitrary, as the rising price of raw materials for drugs has not resulted in similar price hikes in other countries. The fact that the pharmaceutical industries are arbitrarily increasing prices is, therefore, a case of regulatory failure and proves that the directorate general of drug control has failed to perform its mandated role.

What, however, is worrying is that drug manufacturers often increase the prices of medicines without the approval of the agency and often violate the prices that the agency sets. There are also allegations that manufacturers often create an artificial supply shortage to increase prices. A supply shortage of normal and DNS saline, a medicine prescribed for blood and fluid loss in dengue cases, was reported in June 2023, when the drug administration authorities requested saline producers to increase production. Yet, supply shortages continued to jeopardise dengue treatment. Health rights activists consider the failure of the government to control the drug market a primary problem and say that drug producers cannot set prices for life-saving medicines. The drug administration has also failed to regulate sales of drugs and to control the quality of drugs manufactured, resulting in a high prevalence of counterfeit medicines on the market. On a number of occasions, the drug administration decided to increase the price of essential drugs, entertaining the profit-seeking interests of the drug companies. In July 2022, the government decided to increase the prices of 19 generic drugs from 53 brands, as the producers had threatened to stop production unless the prices were increased. In this context, the allegation that the public health activists made against the government that it has left the drug administration in the hands of pharmaceutical companies does not seem far from the truth.

Making safe drugs available for citizens at affordable prices is a fundamental requisite for any public health system, but the government has been negligent in drug market regulation. The government must, therefore, take action to control drug prices as directed by the High Court and immediately review the role of the drug administration in price control, quality control, and regulation of drug sales, as it is glaringly evident that it has failed to serve the interests of people.​
 
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Renata ships first drug registered in Australia
The contraceptive pill named Levonorgestrel 1.5 mg is known by its brand name of Novella-1

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Renata has shipped the initial consignment of Levonorgestrel 1.5 mg, which is the first registered product of the leading Bangladeshi pharma company in Australia.

The distribution and commercialisation of Levonorgestrel, known by its brand name of Novella-1, will be done in Australia through Renata's partner Nova Pharmaceuticals Australasia Pty Ltd, according to a statement of Renata PLC.

Levonorgestrel is approved by the World Health Organisation, amongst other regulatory authority bodies such as the US FDA and Therapeutic Goods Administration (TGA), as a first line oral emergency contraceptive pill.

Being a potent product, it is manufactured and supplied from Renata's TGA approved potent product facility, the statement read.

The commercial launch of Levonorgestrel, with two other products in queue for registration in Australia, would further bolster Renata's growing market access worldwide, Renata said.

"This event hallmarks Renata's expansion into yet another stringent regulated market, attributing to the quality assured global standards of its products."

Nova Pharmaceuticals has been a leader in market supply of pharmaceutical products to all pharmacies and supermarkets in Australia for the last 18 years.​
 
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Local pharma lights up hope in cancer treatment

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Photo: Anisur Rahman

The pharmaceutical sector of Bangladesh has achieved many milestones over the past 14 years. Not only do local companies now meet 90 percent of the country's demand for medicines, but the products are also exported to around 150 countries, fetching hundreds of millions of dollars.

However, among the most significant strides the sector has made is its advancement in the manufacture of life-saving cancer medication.

In the last 14 years, pharmaceutical companies like Beacon, Eskayef, Renata, Incepta, Healthcare, and Techno Pharma produced more than 110 varieties of oncological drugs.

Around 17 local companies are manufacturing anti-cancer drug products. Thanks to their bold initiatives, patients in Bangladesh can now access cancer drugs at affordable prices, which have brought down the cost of treatment.

Monjural Alam, chief executive officer of Beacon Medicare, said the prices of such drugs in Europe and the US are beyond the purchasing capacity of many patients.

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"There is a scarcity of life-saving drugs worldwide. When the drugs are available, they are usually beyond the reach of common people. To this end, we have established a facility within our company to serve global patients," he said.

Before 2009, there was scepticism regarding Beacon's ability to manufacture sophisticated cancer drugs. However, the plant has become successful, and patients can buy life-saving drugs at reasonable prices.

Claiming that Beacon pioneered the manufacturing of cancer drugs in Bangladesh, he said it now meets around half of the local demand for cancer drugs.

Before 2010, Bangladesh relied entirely on imports for oncology drugs. This means only patients from financially solvent families could afford cancer treatment due to the exorbitant cost of medicines. Today, it not only meets domestic consumption but also serves as an exporter in the global market.

"This achievement was made possible by the dedication of local pharmaceutical companies and the trust placed by doctors and patients in local products," Alam said.

According to manufacturers, local companies produce around 99 percent of oncology drugs, yet some patients still resort to imported drugs or unofficial imports.

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Recently, pharmaceutical companies have been affected immensely due to the supply chain disruptions and the dollar crisis against the backdrop of the Russia-Ukraine war. The situation is improving following the collaborative efforts of the government and drug manufacturers.

It provides medicines worth Tk 3 crore to poor patients annually.

Beacon plans to establish a second oncology plant to meet the increasing global demand for cancer drugs. The company is also considering setting up a palliative care centre to alleviate the suffering of patients.

A relative newcomer to the scene is Eskayef Oncology, which commenced its journey in 2018. However, the company, which boasts advanced technologies, has expanded its footprint beyond Bangladesh in no time.

It is one of the few Asian companies to have secured approval from the European Union Good Manufacturing Practice (EU GMP) to produce anti-cancer medicines. This is recognised by 27 nations of the EU and is considered a passport for entry into the global market.

"This recognition facilitated the entry of our drugs into the EU market and various other countries," said Mohammad Mujahidul Islam, executive director (marketing and sales) of Eskayef.

Eskayef is currently exporting products to over 60 countries.

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"Thanks to modern technologies, facilities, and unwavering dedication, Eskayef Oncology is committed to delivering affordable and globally standard anti-cancer products to patients both at home and abroad," he said.

Prof Golam Mohiuddin Faruque, president of the Bangladesh Cancer Society, said Bangladesh has achieved tremendous improvement in cancer treatment and anti-cancer drug manufacturing.

Bangladesh exported cancer drugs worth Tk 1,000 crore in 2023. The amount was around Tk 500 crore in 2019. Local sales of cancer drugs have reached Tk 800 crore to Tk 1,000 crore as demand is increasing by an average of 15 percent each year, according to the manufacturers.

Prof SM Abdur Rahman, chairman of the pharmacy department at the University of Dhaka, said Bangladesh's pharmaceutical companies have set up world-class manufacturing plants equipped with sophisticated machinery, enabling them to produce top-class drugs.

He thinks there is no doubt that Bangladesh's oncology products will dominate the world market, meeting global standards, quality, and cost-effectiveness.

There are areas of concern.

After 2026, when Bangladesh graduates from the group of least-developed countries, local pharmaceutical companies will have to follow patent guidelines while manufacturing drugs, including oncology products. If medicines are produced following the patent rights, the drugs will be costlier in the local market.

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To avert the situation, Bangladesh initially tried to extend its Trade-Related Aspects of Intellectual Property Rights (TRIPS) waiver by six to nine years and then up to January 1, 2033. However, at the 12th Ministerial Conference of the World Trade Organisation (WTO) in Geneva in June 2022, global leaders did not extend the TRIPS deadline for graduating LDCs.

Under the current agreement, drug-makers in LDCs can produce any generic medicine without having to follow patent guidelines until January 1, 2033. But the benefit is not applicable to graduating LDCs such as Bangladesh.

Beacon's Alam, however, said it would be applicable for only new molecules, which comprise few drugs. "So, the pharmaceuticals sector will not face significant challenges after graduation."​
 
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