The pharmaceutical industry in Bangladesh is preparing for a post-drugs patent waiver era -- likely to take effect after a decade -- so that the country can continue to produce a wide range of medicines at competitive costs.
"We are preparing ourselves to remain competitive even after the drug patent exemption for the poorest members of the World Trade Organisation is over," said Sharita Millat, an executive committee member of the Bangladesh Association of Pharmaceutical Industries.
Strengthening the backward linkage for self-sufficiency in Active Pharma Ingredients and registering more products and ingredients with the drug authorities is a part of that, said Sharita who is also the managing director of Veritas Pharmaceuticals Ltd.
"But this is not enough, as we are lagging far behind our competitors in terms of research, which is the backbone of the pharmaceutical industry," she expressed her concern while sharing her thoughts with The Business Standard about the burgeoning pharmaceutical industry in the country.
The story of pharmaceutical industry in Bangladesh
The emergence of the Pharmaceutical industry in Bangladesh is regarded as a unique case among least developed countries. This is the only least developed country where the local pharma industry is catering 98 percent of the home market demands, with a market size of around Tk20,000 crore.
Before the government formulated a prudent drugs policy in the 1980s, over two-third of the local market were import-dependent. Now pharmaceutical producers in Bangladesh are serving over 150 countries with affordable and of course reliable drugs, they are earning significant amount of foreign currency every year.
Some big firms are exporting to the most stringent drugs markets of the world too as they have introduced most modern technologies and adopted best practices in drugs manufacturing.
Apart from the local drugs policy and the emerging of a class of successful entrepreneurs, the least development status of the economy is credited by experts for Bangladeshi drug manufacturers being able to produce generic drugs with a waiver from complying patents of pharmaceuticals products.
To keep drugs affordable to the mass people, governments around the world are encouraging strengthening of generic drug manufacturing and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) at the World Trade Organisation in 2016 has extended the same waiver for the least developed countries till 2033.
But Bangladesh with its tremendous economic growth is set to upgrade its economic status from that of a least developed country to a developing one before 2027, said Sharita.
That means the country's drug manufacturers are going to miss the last few years of extended waiver period and they have to spend more for royalties to patent holders of pharmaceutical formulations and ingredients, she explains.
"To harvest from the potentials Bangladesh must act sharp against the challenges as things may get worse before it sees the best", she said.
As an active member of the pharmaceuticals association, she has also informed how the industry is preparing for a brighter and challenging tomorrow.
Preparation for the next decades
"We may enjoy a leeway of at least 2-3 years even after Bangladesh graduates from LDC status" she said with a call to get prepared even before that.
Bangladeshi pharmaceuticals entrepreneurs have nearly a decade to be fully competitive from every single aspect.
For that, the industry is heading for a strong backward linkage, registering local products and ingredients, more and more certification from the world's top drugs authorities and ensuring the best manufacturing practices in line with Current Good Manufacturing Practices (CGMP) guidelines of the US Foods and Drugs Administration.
The government is emphasising establishment of a strong backward linkage industry that will ensure self-dependency on active pharmaceuticals ingredient.
Most successful 50 companies are setting their facilities at the active pharmaceuticals ingredient industrial park that will help them producing patented and already opened active pharmaceuticals ingredients that need to be registered and even developing own ingredients to be patented.
It is a must for tomorrow's Pharmaceutical industry, said Sharita Millat.
Some top names at the local industry have already registered their generic products with the developed world's drugs regulators like the Food and Drug Administration of the United States.
Their strictest requirements costs at least $5 million for registering a generic product and the smaller companies with their talents and efforts need some support for that.
Some Bangladeshi pharmaceutical giants are planning to set up plants in the least developed countries of eastern Africa, which will find it hard to come out of least developed status in the coming couple of decades at least. This will help the firms enjoy patent waivers for more years and support the country's gross national income in coming days.
Opportunities in pharmaceutical sector
India and China - the biggest suppliers of raw materials to the Bangladeshi pharmaceutical firms - are now Bangladesh's export destinations too, said Sharita. This is because their costs against patents have increased in recent times as they no longer enjoy the patent waiver facility after becoming developing economies, she explained.
Sharita went on saying that less stringent export markets in the least developed countries are enjoying the reverse-engineered pharmaceutical products from Bangladesh and the markets are likely to lean to us even more, if we go further ahead.
The biggest prospect for the industry is in the developed markets as they pay good prices against tough compliances and the industry should focus more there.
The local market too is growing at a double-digit rate every year and shifts in consumers' economic status and health awareness will help the market grow more and more.
Bangladesh's success story in the pharmaceutical sector is a subject that other least developed nations can follow, Sharita said, adding if stays on track, the industry has all the potentials to be the top export earner for the country.
We just need to act properly and act in time in order to ensure proper development of competitiveness and branding so that we don't have to absorb any shock due to a changing scenario, suggested Sharita.
The new generation pharmaceutical manufacturers
Sharita's firm Veritas Pharmaceuticals Limited too is investing gradually to export generic drugs. The company came to commercial production in 2013 and it is registering more and more drugs with the local drugs administration to serve the home market.
She described the local market as something of an oligopoly of top 20 manufacturers who capture 87 percent of annual market turnover.
It is really a tough job to convince a doctor to prescribe your new drugs instead of already known names, no matter how good your drugs are.
However, by now Veritas Pharmaceuticals has managed to emerge with four-star products and Esover, the Esomeprazole capsule is the top-selling item of the company. It accounts for nearly 40 percent of the company's annual sales.
"I meet customers in drug stores and ask them why they selected the new name in gastric drugs," said Sharita.
Their answer proves that efforts for best drugs at an affordable price must win as many of the gastric patients responded with admiring the drug's fantastic efficacy.
However, Sharita expressed her concern over the fact that the number new investors in the local Pharmaceutical industry is not increasing much.
"We are one of the few entrants in last five-six years," she said.
Products with edge can help new investors grow, she suggested.
Cost vs quality
Good manufacturing practices engage an additional cost for the best sourcing of ingredients, compliant manufacturing process and storage.
Bangladeshi consumers are enjoying a remarkably reduced price of hundreds of drugs due to their localisation over the years.
For best drugs they need to pick the reliable products though that might cost a bit more.
On the other hand, from the industry perspective there is a challenge to control costs to keep drugs within everyone's reach.
A family of medical professionals
All the members of Sharita's family are healthcare personalities.
Her husband is a renowned doctor with international exposures, who is spending more time in politics nowadays with a dream to ensure better healthcare to the people.
Two of her children too are medical students.
Sharita, with her master's degree in economics from a US university and the entrepreneurial skills she has attained, is more focused into producing best drugs and exploring new markets.
She is confident about seeing a materialisation of her dream of a brighter healthcare scenario in coming days when services and drugs will be up-to-the mark and affordable not only in Bangladesh but also all over the world.