Course abstract

As prescribed by the Drugs and Cosmetics Act 1940 and thereunder, it is pre-requisite for anyone to know about the current regulatory requirements prior to carrying out any clinical trial or before getting involved in new drug development or research for the purpose of seeking regulatory approval in India. In recent years there have been many changes/amendments in the clinical trial/new drug approval rules and regulations in India. It is important to know the right information as regulations can be misinterpreted. This knowledge when disseminated by the regulators themselves along with subject experts and experienced trainers, will have profound impact. Being an online course, it will address a larger section of public. Making it a ‘free course’ will allow many to acquire the knowledge at the comfort of their home without paying any money. Version 1.0 of this online course was launched in early 2019 with 12 lectures as a four-week course. This online course (version 1.0) was attended by 1047 participants (Jan - Mar 2019). The release of the New Drugs and Clinical Trials (NDCT) Rules, 2019 on March 19, 2019 has steered a need to revise this online course as version 2.0 so that it can be updated with the recent advancements in regulatory knowledge. A series of brainstorming sessions were conducted by CDSA with CDSCO for incorporating the new updates, the feedback received (version 1.0 participants). Also, the deliberations from various face-to-face programs that were conducted by CDSA and inputs from the interactive session on NDCT Rules conducted by CDSA with CDSCO were incorporated to decide upon the contents of version 2.0. This course now has 24 lectures spread over a period of 8 weeks. This course also involves 8 weekly assignments and a final exit assessment. The exit assessment and weekly assignments are optional in nature. Only those who are willing to take certification exam by paying fees, can opt for this. The course like version 1.0 is developed under the guidance of Shri A. B. Ramteke, Former Joint Drugs Controller (India) and presently Consultant, Regulatory Affairs at CDSA, THSTI, DBT along with CDSCO and subject experts. Few subject experts and trainers are invited to take 3-4 lectures to enrich the course. For example, CTRI lecture was taken by CTRI, ICMR. This course attempts to explain in simple language the fundamentals of current regulatory requirements for conducting clinical trials in India for investigational new drug (IND)/