Government to Regulate Clinical Research Organisations | 07 Oct 2024

Source: LM

The government has established Standard Operating Procedures (SOPs) for clinical research organizations to ensure the safety of clinical trials. These updated regulations are part of the New Drugs and Clinical Trials (Amendment) Rules, 2024.

Under this the government has defined roles, duties and liabilities to monitor through registration, approval of licence and renewal, validity period, inspection, and suspension of license if found non-compliant.
The aim is to maintain product quality, expedite clinical trials of novel medications and vaccines, and bring in more transparency.
These have been framed after consultation with the Drugs and Technical Advisory Committee (DTAB).
Clinical Research Organization (CRO):
- A CRO is an entity that can be commercial, academic, individually owned, or an organization with legal status.
- It is appointed by the sponsor to manage specific tasks, duties, or obligations.
- These responsibilities relate to clinical trials, bioavailability, or bioequivalence studies.
- The delegation or transfer of responsibilities must be done in writing.
Drugs Technical Advisory Board:
- It is a statutory body constituted under the Drugs and Cosmetics Act, 1940.
- Its function is to advise the Central government and State government on technical matters related to drugs and cosmetics.