The Government of India has recently notified the “New Drugs and Clinical Trials Rules, 2019”, which aim at promoting clinical research on pharmaceutical drugs in the country via transparent and faster approval process. The new rules will be applicable to all new drugs, the ethics committee and investigational new drugs intended for human use, clinical trials, and bioequivalence studies. 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 of India by the Central Licensing Authority (CLA). However, in case of an application for conducting a clinical trial of a new drug or investigational new drug as part of a discovery, researched and manufactured in India, the application is to be disposed of within 30 days. In case of no communication from the Drug Controller General of India (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 an injury to a clinical trial subject, medical management will be provided as long as required as per the opinion of the investigator, or until 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 DCGI.

Requirements of local clinical trials may be occasionally waived for approval of a new drug, if the drug is approved and marketed in any of the countries to be specified by the DCG with approval of the government and the fulfillment of certain other conditions. A 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. That is, if the global clinical trial is ongoing in India and in the meantime the new drug has been approved for marketing in a country specified by the DCGI, while certain other conditions also apply. 

Furthermore, orphan drugs have been defined as a drug intended to treat conditions which affect not more than five lakh (500.000) persons in India. It has been stated that no fee shall be chargeable in respect of applications for conduct of clinical trials 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 and 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 (Please note that the English content starts from Page 147)