Promoting Clinical Research in Pakistan: Ideas for Authorities
As medical technology advances day by day, we see new inventions around us in the field of medicine to give the best possible treatment to the patients. But the major concerns in all the advancement in medicine are safety and quality. Inarguably, safety comes first.
DRAP (Drug Regulatory Authority of Pakistan) which was recently formed on November 12, 2012 is directly related to the maintenance of public health and safety. In my opinion DRAP should take some major initiatives to promote clinical research in Pakistan, support Pakistan’s pharmaceutical manufacturing and exports and make Pakistan’s economy strong.
I think DRAP should take the following steps to give safe & qualitative medicines to the public and for better growth of Pakistan’s pharmaceutical manufacturing and exports and hence support of the country’s economy:
1. Clinical research/bioequivalence studies should be promoted and facilitated by the government so that small-scale pharmaceutical firms can easily get their products’ clinical research data and support Pakistan’s economy.
2. DRAP should make proper guidelines through ICH-GCP (International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use and Good Clinical Practice) protocols and ethical committees should be established. All pharmaceutical manufacturing and exports should be bound to follow these set guidelines otherwise strict action should be taken against them.
3. At least each province and major city should have government based clinical research centers so that research becomes more convenient and cost effective for pharmaceutical manufacturing.
4. Clinical trials/bioequivalence studies costs should be low so that pharmaceutical firms can easily get their product clinically approved. Hence the people of Pakistan as well as other countries get safe and quality products and Pakistan comes in the list of those countries that are generating clinical trials data itself.
5. Clinical trials/bioequivalence studies data collection centers should have websites established under the regulation of government. This would mean that it would be very easy to get the clinical data from the website which is regularly updated on completion of trials conducted by different clinical trials/bioequivalence centers in Pakistan.
6. Qualified staff should be appointed to conduct clinical trials/bioequivalence studies who have complete knowledge and can make sure that the data which is going to be generated is original and follows all the guidelines and protocols.
7. Clinical trials/bioequivalence studies should be implemented on medicines intended for local market as well as for export. If clinical trials/bioequivalence studies are done by every pharmaceutical company, the chances of SAE (serious adverse events) should be low and it would be beneficial for pharmaceutical exporters as Pakistan’s pharmaceutical manufacturing reputation would improve in the international market. Hence Pakistan’s economy would benefit.
8. Clinical trials/bioequivalence studies should not only be done just to improve the market value of medicines – the first objective should be providing safe, secure and beneficial medicines to the public.
9. Only registered and approved clinical trials/bioequivalence centers which have complete facilities, qualified staff and are willing to serve should be allowed to conduct studies.
10. Awareness sessions and programs should be organized on different platforms regarding Clinical trials/bioequivalence studies. Information sessions for pharmaceutical companies, hospital pharmacies, and universities should be organized. Training programs and general public awareness sessions should also be arranged.
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