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The Drugs Controller General of India (DCGI) has recently taken a significant decision under which the Central Drugs Standard Control Organisation (CDSCO) has waived off local clinical trials for certain categories of new drugs that have already been approved in countries like the United States, United Kingdom, Japan, Australia, Canada and the European Union. Besides, clinical trial waiver will also be considered for new drugs for rare diseases, drugs used in pandemic situations or for special defense purposes, new drugs having significant advances over the existing standard of care and gene and cellular therapy products that are approved in these developed markets. Similar condition will be applicable for import of a new drug for which the CDSCO has already granted permission to conduct a global clinical trial, which is ongoing in India and in the meantime has been approved for marketing in a country specified under Rule 101, subject to conditions. The DCGI has taken the new policy under Rule 101 of the New Drugs and Clinical Trials Rules, 2019. As per the Rule 101 of NDCT Rules, 2019, the CDSCO can specify the name of the countries, from time to time, for considering waiver of local clinical trial for approval of new drugs under Chapter X and for grant of permission for conduct of clinical trial under Chapter V. Chapter X deals with the import or manufacture of new drugs for sale or for distribution, while Chapter V deals with the norms for clinical trial, bioavailability and bioequivalence study of new drugs and investigational new drugs. No doubt, the notification of the six countries under Rule 101 will help faster decisions on the waiver of the requirement of local clinical trials, with consistency and predictability.
Of course, this is a progressive move by the DCGI which will significantly benefit both domestic and multinational drug manufacturers by expediting the approval process and facilitating faster access to essential medications for Indian patients. The inclusion of specific categories like orphan drugs for rare diseases, gene and cellular therapy products, new drugs used in pandemic situations, those for special defense purposes and new drugs with significant therapeutic advance over the current standard care would address critical and unmet medical needs. This strategic alignment is particularly crucial for accelerating access to innovative therapies to the patients in the country. Certainly, this policy shift promises faster access to advanced therapies, offering a ray of hope to millions of Indian patients, particularly those in urgent need of lifesaving treatments. At present, the requirement for local clinical trials is delaying the introduction of breakthrough treatments in India by several years. This often leaves patients, especially with rare diseases and conditions with unmet medical needs, at a disadvantage. As conducting local clinical trials is both time-consuming and expensive, the new policy will reduce the development cost and can launch these therapies in India. For globally approved drugs, Phase-4 study, as recommended by the CDSCO, will bring necessary checks and balances. While this local clinical trial waiver offers significant benefits, it also comes with responsibilities as solely relying on foreign clinical trial data might not align with India’s ethical and safety standards. So, both the industry and the drug regulatory authorities need to ensure robust post-marketing surveillance to monitor the safety and efficacy of these drugs.
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