Drug regulatory authority issues lincences to CBSCR


KARACHI – The Drug Regulatory Authority of Pakistan (DRAP) has issued licences to the Center for Bioequivalence Studies and Clinical Research (CBSCR), University of Karachi to conduct Bioequivalence and Bioavailability Studies and clinical research project.

The CBSCR, which works under Dr. Panjwani Center for Molecular Medicine and Drug Research (PCMD, University of Karachi, has also received licence from DRAP to act as a contract research organization (CRO) to conduct clinical trials for national and international market.

Prof. Dr. M. Iqbal Choudhary, Director, International Center for Chemical and Biological Sciences (ICCBS), University of Karachi expressed these views while speaking at a meeting held at the CBSCR on Thursday. Prof. Dr. Raza Shah, CBSCR in-charge, was also present on the occasion.

Prof. Choudhary congratulated the team of scientists working at the CBSR on this important development, and said that CBSCR was declared for the first time in Pakistan a Certified Reference Laboratory capable of conducting bioequivalence evaluation and development of generic pharmaceutical products in full compliance with the regulatory authorities in Europe, USA, and Japan.

CBSCR is providing services in the area of bioequivalence studies and clinical research to Pakistani pharmaceutical companies who can have a fairly good objective evaluation of their products, he said, adding that Pakistani pharmaceutical companies could avail this service to register their products in other countries where bioequivalence was mandatory.

He pointed out that this could, therefore, have a significant impact on the export potential of the Pakistani companies. The improved quality of products in Pakistan will add largely to reduced cost of treatment, improved health, and more affordable treatment of diseases, he said, adding that the Center was also offering a full range of analytical method development, certification of assays, dispute resolution between drug companies and the ministry of health. The Center is having the potential to become a premier teaching facility for analytical method development and documentation leading to good laboratory practices and generate revenues for the institute, Prof. Choudhary observed, saying that in an addition this was one of the greatest needs of the country to provide quality healthcare products.

The center is having testing facilities that include clinical monitoring of patients’ blood sample analysis statistical analysis, and evaluation of equivalence of products, he said, adding that traditional Chinese medicine (TCM), as a major component of complementary and alternative medicine remedies, has attracted increasing attention worldwide because of its satisfactory clinical efficacy. The CBSCR has conducted recently Phase II clinical trials for well-reputed Chinese pharmaceutical companies, he said.

The CBSCR has already signed an agreement with well-reputed foreign Pharma companies for the Phase II and Phase III clinical trials and in the process to initiate these trials, he informed the meeting participants. (Please send your news, article, pictorial on our email address <editor@enewspaper.com.pk & WhatsApp +923132434567 PLEASE SEND YOUR COMMENTS Thanks)