Lack of WHO prequalified vaccine lab a barrier to local production
Local pharmaceutical companies are pushing for the government to allow domestic production of generic Covid-19 vaccines.
Generic drugs contain the same active pharmaceutical ingredients as other drugs that are protected by chemical patents, though the manufacturing process may differ. The production of generic drugs is usually not allowed unless the patents have expired.
Experts said several technical and legal issues need to be resolved to ensure that local production of generic Covid-19 vaccines serves the public interest and not just pharmaceutical companies.
The Bangladesh Association of Pharmaceutical Industries (BAPI) has around 170 members, a handful of whom have initiated production of various vaccines for diseases other than Covid-19.
According to industry insiders, Incepta Pharmaceuticals and Popular Pharmaceuticals are currently producing several vaccines for humans. The two companies and F n F Pharmaceuticals Ltd also produce some veterinary vaccines.
No WHO prequalified vaccine testing lab
All the locally produced vaccines for humans are exported, but they cannot be sold to the World Health Organizations (WHO), GAVI or Unicef as there are no WHO prequalified vaccine testing labs in Bangladesh. The Bangladesh government also does not buy the locally produced vaccines and instead goes through the three international organizations.
Sources said vaccine samples currently need to be sent to India or Thailand for testing, which can take up to a month. A WHO prequalified lab in Bangladesh would cut down this time significantly.
Officials also said it was difficult to find skilled manpower for the labs, and they were considering recruiting from abroad.
It has been learned that at least four pharmaceutical companies are developing their labs to produce vaccines in the country. Beximco Pharmaceuticals Ltd is one of them.
Dhaka Tribune could not confirm the progress of Beximco’s vaccine production initiatives.
On Thursday, the Managing Director of Beximco Pharma and BAPI President, Nazmul Hassan Papon, said: “What Bangladesh could do next in terms of vaccinating all of its required people is to go for a production of Covid-19 vaccines in the country. We are exploring which vaccines we could bring to produce here.”
Hasneen Muktadir, vice president of Incepta Pharmaceuticals and BAPI representative for the company, agreed with Papon.
EH Arefin Ahmed, general manager of Incepta Vaccine Ltd, said Incepta was the first full-fledged biotech lab in Bangladesh that had received international recognition.
“Producing a vaccine is a time-consuming process. In the current situation, it is better to look into the possibility of producing generic Covid-19 vaccines,” he added.
“We are in constant contact with several vaccine developer organizations and if we get good feedback for Bangladesh in terms of price and demand, we will definitely go for it,” the Incepta official further said.
The chairman of the department of pharmacology of BSMMU, Professor Dr Sayedur Rahman, said the local production of generic Covid-19 vaccines would help the government cut down costs and potentially speed up the nationwide vaccination campaign.
“However, the government needs to take proper preparations to ensure that there is no corruption and no company ends up with a monopoly on vaccine production,” he added.
Bangladesh Ratifies IVI agreement to facilitate vaccine production in the country
Meanwhile, the government has approved a proposal to ratify the agreement to establish the International Vaccine Institute (IVI) to facilitate the production of new vaccines in the country through the transfer of newly invented vaccine technology.
The decision came at a weekly virtual meeting of the Cabinet Division chaired by Prime Minister Sheikh Hasina.
The Cabinet Secretary Khandker Anwarul Islam said the proposal was placed in the meeting to become a full member of the institute.
Initiated in 1996, IVI was established officially under the Vienna Convention as an independent and autonomous international organization in 1997. Bangladesh was one of the signatories when the institute was established.
The secretary said it would ease the process of the transfer of newly invented vaccine technology and its production in the country that would allow the country to get vaccines at much lower costs.
It will also open up a vast opportunity in the case of vaccine exports, easing the way for the country to qualify for World Health Organization standards, he added.
The vaccine manufacturers would get training and technical assistance in vaccine production and its research in Bangladesh. Their capacity would be increased and production, application and quality control measures would be more up-to-date, Khandker Anwarul said.
“We are hoping that we will achieve the qualification soon and in this current situation it is more needed,” the secretary added.