Shaik Shameem*, B. Ranga Nayakulu1
*Department of Drug Regulatory Affairs, Srinivasa Institute of Pharmaceutical Sciences, Sri Chowdeswari Nagar, Peddasetty Palli, Proddatur-516361
1Associate Professor, Department of Pharmaceutics, Srinivasa Institute of Pharmaceutical Sciences, Sri Chowdeswari Nagar, Peddasetty Palli, Proddatur-516361
A b s t r a c t
Medicine is the science and art of healing. It encompasses a variety of health care practices evolved to maintain and restore health by the prevention and treatment of illness 1. Innovations in medical technology – starting from the ancients and till date – have produced numerous appliances and instruments that have been essential in diagnosis, treatment, prevention and rehabilitation, apart from pharmaceuticals. Modern medicine requires and utilizes numerous such instruments that can be used to uplift the health standards. Medical devices are evolved from medical technology. Medical devices need to be of adequate quality and safety to bring public health benefits without harming patients, health care workers or the community. Countries and jurisdictions have different policies and plans in relation to the personal and population-based health care goals within their societies. Major biopharmaceutical companies are required to determine the regulatory strategy that can speed up the drug approval process. India has issued new clinical trials rules to expedite new drug approvals. The clinical trial approval process was reformed to speed up the drug approval processes for prescription and orphan drugs. India’s regulatory authority, the CDSCO, has taken steps to improve transparency and accountability and promote ethical and scientific clinical research and development of new drugs. This resulted in high number of waivers for local phase 3 clinical trials and new conditional approval pathway for new drugs already approved and licensed by health authorities in the US, UK, Canada, and India.
Keywords: Medicine, biopharmaceutical companies, regulatory strategy, clinical trials, drug approval processes.