Litigation and Consulting

New drugs and clinical trial, 2019

The New Drugs and Clinical Trials Rules 2019 (New Rules) are now put into force by deleting Rules 122A to 122E from the Drugs and Cosmetics Rules 1945. The new rules provide for the constitution of the Ethics Committee, and such a committee is required to follow new rules. The controlling power is given to the central licensing authority. The rules clearly define the role of the ethics committee, and elaborate regulation has been provided for the constitution, registration, responsibility of the Ethics Committee, etc.

The rules further provide for the definition of orphan drugs, new drugs, pharmaceutical formulation, pharmacovigilance, placebo, serious adverse event, sponsor, and state licensing authority. Clinical trials of new drugs or investigational drugs are also provided in new sets of Rules. suspension and cancellation of registration of Ethic Committee, post-trial access of drugs, changes and clarity related to academic clinical trials and the role of ECs in compensation and medical management process are provided. Bioavailability or bioequivalence study of a new drug or investigational new drug is added separately in the Rules. Bioavailability study centres are approved by the CLA by way of registration. Engaging such centres necessarily requires a deep understanding of the law and the risks associated with it.

Mace assists the companies in drafting and vetting the agreement so that the engagement of study centres and work allotted to them is carried out smoothly. The clinical trial also requires entering into agreements and vetting of ethical committee guidelines. MACE, with its expertise in Pharmaceutical Laws, can make a difference in the management of Clinical Trials on the legal side.