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- Title
Scenarios in medical ethics-3: New drugs and clinical trials rules 2019.
- Authors
Mathaiyan, Jayanthi; Ganesan, Prasanth; Kadhiravan, Tamilarasu; Anandabaskar, Nishanthi
- Abstract
The new drugs and clinical trial (NDCT) rules 2019 was released on March 19, 2019, by the Central Drugs Standard Control Organization (CDSCO).[[1]] This was a step toward updating the information about the conduct of clinical trials with new investigational medicinal products in India and the associated regulations surrounding this exercise. Who should be covered by the negligence insurance-the PI/PI and institute,/PI and trial team members/PI, Ethics committee and Institute? In fact, the CDSCO can inform the MCI about the negligence and the MCI can decide to penalize the PI for negligenceSince the trial insurance may not cover PI negligence, it is the responsibility of the PI/Institution to obtain insurance cover for legal issues arising over alleged PI/trial team negligence.
- Subjects
CLINICAL drug trials; MEDICAL ethics; PROTEIN-tyrosine kinase inhibitors; INSURANCE; PUBLIC health research; PUBLIC health ethics
- Publication
Journal of Pharmacology & Pharmacotherapeutics, 2020, Vol 11, Issue 4, p148
- ISSN
0976-500X
- Publication type
Article
- DOI
10.4103/jpp.jpp_173_20