Toxicity lab at DU to test efficacy of locally produced drugs

The Dhaka University (DU) yesterday proposed to set up a bioequivalence and toxicity lab at its pharmacy department in order to ensure quality of locally produced drugs and widen export market for Bangladesh’s pharmaceuticals abroad.
The proposal came at a regional seminar held at the Senate Bhaban of Dhaka University, amid growing concerns from local drug manufacturers, who have been facing ever increasing conditionality from importers to export drugs after clinical trial and toxicity tests.
Seminar sources said the drug manufacturers, who share a market of between Taka 5,000 crore and 7,000 crore in Bangladesh, currently do not require any clinical or toxicity tests as there is no legal and policy obligation to do so.
But in many countries, especially in developed world and even in emerging economy like India, companies can neither get registration nor market a medicine without bioequivalence, bio- availability and toxicity tests as well as clinical trials, said a pharmacist, Salem Azad Chowdhury, on the sidelines of the
event.
He said Bangladesh companies could not export medicines to many countries who ask for clinical trial and toxicity tests as import preconditions. Some of the companies, he said, have however met the demand through such trials and tests in high expenses in Europe, a process that leads to
higher production cost and loss of market competitiveness.
“Bio-equivalent studies are very important to protect the rights of local consumers as well as international buyers of medicines, but very few Bangladesh companies have done it,” added Professor Dr AK Azad Chowdhury, who spoke at the seminar as the chief guest.
Azad Chowdhury, also former vice chancellor of Dhaka University, said the country must have hospital unit for BE, BA, toxicity tests and clinical trials.
He suggested every local pharmaceutical company to do it, but reminded them to take ‘genomics’ into consideration during such studies.
“Some of the local companies who have already conducted the expensive bioequivalent, bio-availability and toxicity studies have got greater acceptability and market advantage in and outside Bangladesh,” said Pinkaki Bhattacharya of Popular Pharmaceuticals Ltd.
He, however, said the companies were reluctant to do BE, BA and toxicity tests due to high costs.
“The costs can be minimised through local initiatives,” responded Prof. Harun- Or Rashid, Pro-Vice Chancellor of Dhaka University. In this context, he suggested for establishing a BE- BA and Toxicity Study Centre at Dhaka University, which would cater all sorts of studies to protect quality of medicine from local producers.
Globally reputed oncologist Prof. Fazlul Karim asked an Indian pharmacologist that why do the cancer patients do get low efficacy from Indian drugs. He said cancer drugs from none of the Indian companies, excepting Sipla Pharma, were found effective.
Prof Dr TK Pal of Jadavpur University, India, presented the keynote paper in the seminar, where managing director of Jayson Pharma Mohammad Salimullah, vice president of Bangladesh Pharmaceuticals Association Khandoker Tariqul Islam, ex- Dean of Life Sciences Department of Jahangirnagar University Prof.  Shahabuddin Kabir, among others, spoke.
 
Courtesy of BSS via The Independent