Saturday , 25 May 2024

A Study on Regulatory Guidelines for Product Development in Clinical Trial Research Studies in India, USA, AUSTRALIA

Eppalapalli Sree Rani1, K. Sunil Kumar*2
1Sun Institute of Pharmaceutical Education and Research, Kakupalli, Nellore, Andhra Pradesh, India.
2Associate Professor, Department of Pharmaceutics – Drug regulatory affairs, Sun Institute of Pharmaceutical Education and Research, Kakupalli, Nellore, Andhra Pradesh, India

A B S T R A C T
Drug discovery has a long history and dates back to the early days of human civilization. In those ancient times, treatments were often discovered by chance or resulted from observation of nature, typically but not exclusively, using ingredients extracted from plants/animals, and not just used for physical remedy but also for spiritual healing. The study aims to assess the regulatory guidelines for product development in clinical trial research studies in India, USA, and Australia. Drug development research, in particular, is long and arduous and bringing a single new drug costs on an average USD 1.78 billion and takes approximately 13.5 years from discovery to the market. Drug development research is primarily funded by the pharmaceutical industry including the process of human testing (Phase I-IV studies). These studies (called clinical trials or regulatory studies) are conducted with the academician as the principal investigator largely in academic centres. The pharmaceutical industry funds or ‘sponsors’ the studies and ensures compliance with the country’s regulatory requirements. It is the role of public regulatory authorities to ensure that pharmaceutical companies comply with regulations. There are legislations that require drugs to be developed, tested, trailed, and manufactured in accordance to the guidelines so that they are safe and patient’s well – being is protected. The government agencies should identify and promotes health campaigns regarding drug information services.

Keywords: Product development, Drug development research, Regulatory guidelines, pharmaceutical companies, Regulations.

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