Abstract

LATEST TRENDS AND CHANGES IN REGULATORY ASPECTS OF CLINICAL TRIALS IN INDIA

Gangadhar Reddy Vadlatala*, Dr. Varada Bidargaddi, Dr. Shailendra Shettennavar

ABSTRACT

India has been a hub for conducting various multi centre trials. The current pressure and responsibility of sponsors and clinical research organizations (CROs) to execute clinical trials is increasing. It is clear that clinical trials bring the health and well being of our existence is being recognized and expectations from the public are high. The central Drugs Standard Control Organization (CDSCO) under Drug Controller General of India (DCGI) lays down the regulations for the conduct of Indian clinical trials. The conduct of clinical trials, regulations and quality of data generated in India may be the cause for out sourcing the clinical trials from India to china and Philippines. Updating our knowledge and understanding about our clinical trials scenario is the utmost importance in today’s clinical research industry in India. A few trends indicate that industry is searching to enhance their product development and quality. Procurement should be an integrated process within the overall clinical trial strategic planning. This review provides insight into the recent changes in regulatory aspects and the latest trends that are predicted in future.

Keywords: Electronic Storage, eSignatures, Logistics, drug regulatory, ethics committee, serious adverse event.