The Union Health Ministry has notified the Drugs and Clinical Trials Rules, 2019 with the government stating that the move is aimed at promoting clinical research in the country. The new Drugs and Clinical Trials Rules, 2019, has done away with the formality of conducting local trials so that the drugs can be introduced in Indian markets sooner.

Areas covered:

These rules will apply to clinical trial, bio-availability or bio-equivalence study, new drugs and regulation of ethics committee relating to clinical trial and biomedical health research.

Objective:

The aim is to promote clinical research in India, have predictable, transparent and effective regulations for such trials and also make faster accessibility of new drugs to the Indian population

Highlights:

• Reduction in time for approving applications, which has now come down to 30 days for drugs manufactured in India and 90 days for those developed outside the country.
• Also, in case of no communication from Drugs Controller General of India, the application will be deemed to have been approved
• As per the new rule the requirement of a local clinical trial may be waived for approval of a new drug if it is approved and marketed in any of the countries (EU, UK, Australia, Japan and US) specified by the Drugs Controller General with the approval of the government.
• The new rules will ensure patient safety and an ethics committee will monitor the trials and decide on the amount of compensation in cases of adverse events
• In case of injury to 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 injury to a trial subject will be decided by the Drug Controller General. 
• For the first time, Orphan Drugs have been defined as a drug intended to treat conditions which affects not more than five lakh persons in India. In addition, fee waivers for orphan drug trials will encourage more trials for rare diseases in India.

Conclusion:

The new rules protect the rights, safety and well-being of patients while ensuring a strong scientific base for the conduct of clinical trials. This will lead to more stability and growth in clinical research being done in India, which will ultimately ensure that patients have access to faster and more effective treatment. India has the second largest population in the world and the highest disease burden but does less than 1.2% of global clinical trials. The new rules will provide clarity to various applicants and help to smooth the application process.