Government of India has recently notified the “New Drugs and Clinical Trials Rules, 2019”, which aims at promoting clinical research on pharmaceutical drugs in the country via transparent and faster approval process. The new rule will be applicable to all new drugs, ethics committee and investigational new drugs intended for human use, clinical trial, and bioequivalence study. Medical devices have also been referred to by the term “drug” in certain official documents. However, in this context, “drugs” refer to pharmaceutical entities.

In short, the Rules provide for disposal of clinical trial applications by way of approval or rejection or seeking further information within 90 days for drugs developed outside India by Central Licensing Authority (CLA). However, in case of an application for conducting clinical trial of a new drug or investigational new drug as part of discovery, research and manufacture in India, the application is to be disposed of within 30 days. In case of no communication from DCGI, the application will be deemed to have been approved. 

The Rules also aim to ensure patient safety in clinical trials via defining the process of informed consent, ethics committee, monitoring and compensation in cases of adverse events. The Rules mandate that in case of injury to the clinical trial subject, medical management will be provided as long as required as per the opinion of the investigator or till such time it is established that the injury is not related to the clinical trial. Compensation in cases of death and permanent disability or other injuries to a trial subject will be decided by the Drug Controller General of India (DGI).

Requirement of local clinical trial may be waived for approval of new drug if drug is approved and marketed in any of the countries to be specified by the DCG with approval of government from time to time and certain other conditions.  Local clinical trial may also be waived if the application is for import of a new drug for which the DCGI had already granted permission to conduct a global clinical trial which is ongoing in India and in the meantime the new drug has been approved for marketing in a country specified by the DCGI and certain other conditions. 

Furthermore, orphan drugs have been defined as a drug intended to treat conditions which affects not more than five lakh persons in India. It has been stated that no fee shall be chargeable in respect of application for conduct of clinical trial for orphan drugs for rare diseases in India. Moreover, the Rules exempt local clinical trials for orphan drugs permitted to be imported for sale or distribution.

With the introduction of these Rules, the rights, it is expected that safety and well-being of patients are protected, while ensuring a strong scientific base for the conduct of clinical trials.

New Drugs and Clinical Trials Rules, 2019