Bangladesh produces biologic drug in milestone achievement

A group of scientists and researchers have successfully produced the country’s first ever biologic drug, Erythropoietin, using genetic engineering and biotechnology. 

The physicians have already completed successful trials of the drug and it is now available in the market under a commercial name.

Medical experts and pharmaceutical scientists hoped that the new drug would enrich the local pharmaceutical industry further if there is necessary assistance. 

Cytologist Kakan Nag and genetic scientist Naznin Sultana, who previously produced a vaccine for coronavirus, have led the 10-member team of researchers that developed the biological drug. The initiative was supported by a local pharma company named Globe Biotech Limited.   Earlier, a research paper on the drug was published in Pharmaceutics, an international journal, on 22 June 2023. 

There are two types of drugs available in the market – chemical drugs and biologic drugs. For instance, paracetamol is a chemical drug and it requires some excipients alongside the main ingredient to give it the form of a pill. 

The excipients do not impair the effectiveness of paracetamol or cause any harm to the consumer’s body. A large number of chemical drugs are now available in the market. 

Biologic drugs are made from DNA. Insulin can be mentioned as an example of a biologic drug.

Erythropoietin is a protein hormone which produces red blood cells through a special process in the bone marrow. It is synthesised by the kidneys and liver. When the kidneys and livers get damaged, it disrupts or stops the production of red cells and leads to anemia and subsequent oxygen shortage in the human body. It may even lead to death in some cases.

There are chemical and biologic drugs in the market for the disease, but erythropoietin is the first ever locally produced biologic drug.  

Sitesh Chandra Bachar, a pharmacy department professor and pro-vice chancellor of Dhaka University, said Kakan Nag and his team have done an excellent job for the country’s pharmaceutical industry and medical sector. It proves that the scientists, researchers, and pharmaceutical companies in Bangladesh are capable of producing biological drugs. 

According to Kakan Nag and members of his research team, the gene that produces erythropoietin is first isolated from kidney cells in the production process. The erythropoietin-producing cells are then cloned and multiplied, while the best quality clones are stockpiled. 

The technology used to produce erythropoietin by preserving and utilising the clone stock is regarded as biotechnology. Thus, researchers are commercially producing erythropoietin for kidney and anemia patients in Bangladesh.

Noted researchers conducted clinical trials of erythropoietin with the approval of the directorate general of drug administration (DGDA) in 2021. They applied the drug on 42 people aged above 18 years and found it safe, effective and of good quality. 

Later in 2023, the DGDA authorised Globe Biotech for manufacture and marketing of the drug. In this regard, a research paper was published on 1 August 2023, in the international journal Archives of Clinical and Biomedical Research.

Alamgir Kabir, former chairman of the hematology department of Dhaka Medical College, has been prescribing his patients the locally produced drug. He told Prothom Alo, “I am giving the drug to the patients and am yet to hear anything about its side effects. It requires some more time to say how effective the medicine is.” 

It was learnt that the medicine is being used in Bangabandhu Sheikh Mujib Medical University (BSMMU) too. 

Bangladesh is almost self-sufficient in medicine, with around 97 per cent of demand being fulfilled by local producers. However, the biologic drugs are mostly imported from abroad. 

Bangladesh manufactures drugs invented in other countries, without making any payment for the intellectual property. Hence, it is possible to produce drugs locally at a low cost. 

But the privilege is set to over due to the country's graduation from the group of least developed countries (LDC) and it will need to spend huge sums on intellectual property rights from 2026. Then there will be a risk of drug prices going up. So, local production may cut the cost of drugs to a significant extent. 

While talking to Prothom Alo, Kakan Nag said, “We have proved our scientific knowledge and latest technical expertise by producing the biologic drug. We will be able to develop many biologic drugs, including monoclonal antibodies and insulin. All that is needed is a fair environment, policy, and support.”