Effective from March 19, 2019, The New Drug and Clinical Trial Rules released by the Ministry of Health and Family Welfare have met with mixed reviews by the industry. These rules which apply to Investigational new drugs for humans, clinical trials, bioequivalence and bioavailability studies, except the chapter on ethics, were much awaited by the healthcare industry in order to bring a change in the clinical research sector in India.
These new rules have brought quite a few changes to the previously published Drugs and Cosmetics Rules, 1945, the name itself, being the first.
The drug approval regulatory body- the Central Drugs Standard Control Organisation (CDSCO) will have 30 days to respond to a clinical trial in India and 90 days for global trials with India as one of the site. Failing to respond within these timelines, the trials will be deemed as approved. Earlier, these approval timelines were a major challenge as these could take anywhere from six months to one year.
This, however, would add on to the pressure for CDSCO to approve trials within the stipulated timeline.
Hello phase IV
These rules state that the drugs and indications approved by the regulatory authorities like Food and Drug Administration, European Medicines Agency, etc, would not require a phase III to test the efficacy and safety in India and can directly skip these to a phase IV, to be promoted to the Indian population.
This rule would also apply to Orphan drugs which are used for treatment of rare diseases affecting less than five lakh Indians. With this rule, the accessibility of drugs for the Indian population is believed to increase and will help them in getting better treatment options. Whether these drugs be effective for the Indian population who differ from their counterparts, is still an unanswered question.
Free Post-trial drug access
Trial participants enrolled in clinical trials did not have access to the drugs under study until they were marketed after completing the necessary steps involved. This, however, has been revised in the new rules. Participants will have access to the trial drugs post-trial if and only if there is no other alternative available. Also, the trial participants would have to submit a written waiver to the sponsor, relieving them of the responsibility of any post-trial complications caused by the drug under study.
Clinical Trial Approval Validity
The approved clinical trials would have a validity of two years which is extendable by one year. This is aimed at fast-tracking the trials and in turn, would help patients to get faster access to drugs.
The New Drug and Clinical Trial Rules would now apply to bioequivalence and bioavailability studies and consider them at par with clinical trials. This would help in understanding these studies in terms of their conduct, analysis, and reporting. It has also been mentioned to acknowledge the centers conducting these studies.
It has been stated that the compensation for death or permanent disability of the trial participants would be decided by the Drug Controller General of India. Also, free compensation for trial-related disability or injury would be extended until the injury subsides or is no longer related to the trial or drug under study. There is, however, a catch in this clause. This extended compensation would be provided under the guidance of the trial investigator. So, if the investigator feels that the injury is not trial related or is no longer associated with the trial, his opinion would be deemed final. This does put the trial participant at a bit of disadvantage.
These rules aim to promote clinical trials and studies in India, which has a very high disease burden, yet only 1.2% of Global clinical trials are conducted here. Hopefully, these rules would help India be taken seriously as a country which supports ethical Clinical trials and studies, providing opportunities for various Global leaders to see India in a different light.
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