| Clinical research is the key towards discovery of | | | | clinical experts, set up an Expert Committee and |
| most current diagnostic strategies and to develop | | | | formulated their GCP guideline for generation of |
| current drugs for treatment of illnesses. | | | | clinical data on drugs. An endorsement of the |
| Good Clinical Practice (GCP) is an ethical and scientific | | | | adoption of this GCP guideline for streamlining the |
| high quality standard for developing, performing and | | | | clinical studies in India was made by the Drug |
| recording trials that involve the involvement of | | | | Technical Advisory Board, the highest technical body |
| individual clients. Complying with this standard of | | | | under D&C. |
| compliance offers peace of mind to the public that | | | | Investigation associations, investigators, institutional |
| their legal rights, safety and well-being of trial patients | | | | ethics committees and regulators will find that this |
| are safe, and steady with the principles encompassed | | | | confidence within their guideline will be profoundly |
| from the Declaration of Helsinki and guarantees that | | | | beneficial to in offering desired direction. Organizations |
| clinical trial information is credible. | | | | who may want to locate their clinical programme |
| It is commonly regarded that numerous nations | | | | within their country will also find the guideline |
| including those in Europe, United States and India | | | | beneficial. |
| offers distinctive opportunities for executing clinical | | | | Unless there is a comprehensive training program to |
| trials in view of their large patient pool, well-trained | | | | support these recommendations and polices then |
| and avid investigators and premiere medical | | | | people involved throughout performing the studies will |
| organizations readily available within these nations. | | | | only be paying lip service to the standards. This is |
| Additionally, India also has sizeable low per patient trial | | | | one fact that does not change no matter who |
| cost, when compared with developed countries. | | | | produces legislation or regulations to follow |
| To develop country specific recommendations within | | | | throughout clinical studies, and this should not |
| India, it was believed however that there was a | | | | neglected, For example, who takes ultimate |
| need to make certain uniform high quality of clinical | | | | responsibility for the training prerequisites within an |
| research throughout the country and to generate | | | | industry that could be considered to be |
| data for registration for new drugs before use in | | | | self-regulatory, and one of the issues surrounding this |
| their Indian population. The Central Drugs Standard | | | | is that there needs to be more regulation for the gcp |
| Control Organisation (CDSCO) in consultation with | | | | courses training programs. |