The Central Drugs Standard Control Organization (CDSCO) has announced amendments to the New Drugs and Clinical Trials Rules, 2019. These amendments aim to strengthen the regulatory framework for clinical research organizations (CROs) in India.
What is a Clinical Research Organization (CRO)?
The rules now define a CRO as a body that can conduct clinical trials on behalf of a sponsor. Such a body may be commercial or academic or of other category and may be owned by an individual or an organisation having status of legal entity. The sponsor may, delegate or transfer in writing, some or all of the tasks, duties or obligations regarding clinical trial or bioavailability or bioequivalence study to such a CRO.
Registration of CROs
CROs are now required to register with the Central Licensing Authority before conducting clinical trials or bioavailability or bioequivalence studies of new drugs or investigational new drugs in human subjects.
The registration process involves submitting an application, paying a fee, and providing necessary documents. CRO registration is valid for five years and can be renewed.
The Central Licensing Authority has the power to inspect CROs, suspend or cancel their registration, and take other necessary actions.
These amendments are expected to bring more transparency and accountability to the clinical research industry in India. They will also help ensure that CROs adhere to ethical standards and conduct clinical trials in a safe and responsible manner.
