The need for effective drug regulation becomes imperative as drugs form an integral part of medical care. Drug regulation is essentially a public policy response to the demands of public health and the changing needs of pharmaceutical industry. Hence, the objective of all drug regulatory regimes is to ensure that safe, good quality and efficacious drugs reach the patients. And this objective of ...

This study is based on extensive literature survey and field research conducted in four states (Kerala, Tamil Nadu, Gujarat and Maharashtra) and four countries (USA, UK, China, Indonesia). Restricting ourselves to the realm of quality of drugs manufactured within the country, this study does not broach upon the issues that arise from drug approval processes and clinical trials, nor do we address the ...