Research, clinical trials in Pakistan: Experts term DRAP biggest hurdle

KARACHI: The Drug Regulatory Authority of Pakistan (DRAP), which is supposed to give go-ahead for the clinical trials and research in the field of medicine, has emerged as the ‘biggest hurdle and road-block’ in approving research projects as it lacks enough qualified people to timely approve clinical trials and research projects, leading researchers and healthcare experts deplored on Monday.

They called for conducting clinical trials of medicines invented in the West on the people in Pakistan before they are given registration by local regulatory authorities, saying Pakistanis and other South Asians are ethnically and genetically different than Western people.

“People of Pakistan and other South Asians are different than people in the Europe and Americas and research has proven that we metabolise medicines differently than people in the West. There is a need to start local trials of medicines and collect indigenous data to come up with local solutions of different diseases and health conditions,” eminent physician and Director of Clinical Trials Unit at Aga Khan University told a research conference here at a local hotel.

Around 19 researchers and healthcare professionals from entire Pakistan were awarded research grants upto Rs300,000 each by the Pharmevo Research Forum for conducting research in the areas of paediatrics, diabetes, hypertension, cardiology, endocrinology, gynaecology, orthopaedics, infectious diseases and others areas with a timeline to complete their studies within 18 months for receiving the research grants.

Prof Saeed Hamid maintained that in India, no new drug is allowed to be produced locally until and unless local data on its safety, efficacy and dosage is submitted with the regulatory authorities and added that it has been proved through multiple studies that different doses of a medicine are required to produce the desired effects in the European and South Asian populations.

“Around 80-90 percent of Pakistani Hepatitis C patients are infected with Genotype-3 of the HCV, which is very difficult to treat but unfortunately, most of the data on this genotype comes from Western world as we don’t have enough data and research on this genotype because Pakistan is not a conducive place for clinical trials and research,” Prof Saeed Hamid deplored.

Congratulating the winners of research grants, Prof Saeed Hamid said these researchers should also strive for international research grants and also called for a consortium of clinical trials units working across the country to come up with quality research and data on local issues.

Editor-in-chief of Pakistan Journal of Medical Sciences Shaukat Ali Jawaid, who is overseeing the award of research grants to the researchers, said although local pharmaceutical firm Pharmevo was providing the research grants worth millions of rupees to healthcare professionals but no strings were attached to these financial grants and researchers were free to select the areas in which they wanted to conduct research.

“A team of advisors who are prominent healthcare professionals including Prof Anwar Siddiqui, Prof Badar Fayyaz Zuberi, Prof Feroz Memon and others have short-listed and approved the research projects for award of grants. It is heartening that pharmaceutical industry is supporting the research and others should follow this precedent,” he added.

Copyright Business Recorder, 2022