Pharmaceutical quality

                                       -         Ganadhish Kamat   Current Drugs & Cosmetics Act 1940 & Rules 1945 there under were enacted prior to independence when the drug development and manufacturing in India was in its infancy. Import was the main source of modern medicines and export was non-existent. Knowledge about Pharmaceutical science was also limited in pre independence days. The act and the rules are largely focused on administrative controls through licensing and surveillance through inspections, sampling, and testing. Many of the regulations have become outdated in light of new developments in the pharmaceutical science and some create hindrance in innovation and drug development. This the time for complete overhaul of the D&C Act and the Rules to make it more efficient and effective in ensuring quality and safety of the drugs in India and removing unnecessary burden on manufacturers and the enforcement agency. During past one decade, India has become