ISLAMABAD, March 10: The Central Development Working Party of the Planning Commission has approved a project submitted by the Higher Education Commission for setting up the Centre for Bioequivalence Studies and Bioassay Research at the HEJ Research Institute of Chemistry, University of Karachi.
The proposed CBSBR will offer, for the first time in Pakistan, a Certified Reference Laboratory that would conduct bioequivalence evaluation and development of generic pharmaceutical products in full compliance with the regulatory authorities in Europe, USA, and Japan. It will function on a fee basis for the services offered.
The aim of the project is to provide availability of this service to Pakistani pharmaceutical companies in obtaining an objective evaluation of their products. The companies will be able to use this service to register their products in other countries where demonstration of bioequivalence is a requirement. This will, therefore, have a significant impact on the export potential of the Pakistani companies. The improved quality of products in Pakistan will add largely to a reduced cost of treatment, improved health, and more affordable treatment of diseases.
The ministry of health has been made responsible for all new applications in compliance with the law. The centre will also offer a full line of analytical method development, certification of assays and dispute resolution between drug companies and ministry of health.
The centre will be a premier teaching facility for analytical method development and documentation leading to good laboratory practices and will generate revenues for the institute. It is expected that this project will result in casting a considerable economic impact on the development of the country.
The centre will also offer contract research services to the pharmaceutical industry and academic researchers, a state-of-the-art bioassay development facility that will assist in the development of new drugs, better application of existing molecules and creating a justification of many drugs, particularly those derived from natural sources.
Bioassays are historically highly variable and require a very high degree of analytical and pharmacological sophistication in making an objective evaluation. The centre will offer this service to academia and the industry and thus fulfil a long-felt need for expertise in this area.
