India's CDSCO Mandates IND Division Review for New Drugs Not Yet Approved Anywhere Globally
核心洞察
India's DCGI has directed that all applications to import and market new drugs not approved anywhere in the world must be submitted to the IND division of CDSCO (搜索).
The directive follows an internal technical committee review which concluded such drugs require comprehensive evaluation of non-clinical and clinical data under NDCT Rules, 2019.
These investigational new drugs, even those with completed or ongoing Phase III global trials involving Indian subjects, will be treated as independent new drugs in India.
India's apex drug regulatory authority has issued a significant clarification that reshapes the regulatory pathway for novel pharmaceutical products entering the country. In a circular issued earlier this week, Dr. Rajeev Singh Raghuvanshi (搜索), Drugs Controller General (India), directed that all applications seeking permission to import and market new drugs that are not approved anywhere in the world must be routed through the Investigational New Drugs (IND) division of the Central Drugs Standard Control Organisation (CDSCO (搜索)).
The directive comes after the central drug regulator observed a growing number of applications seeking marketing approval for drugs based on Phase III global clinical trials (GCTs) that are either ongoing or have been completed with the participation of Indian subjects, despite these drugs lacking regulatory approval in any other country.
Internal Technical Committee Deliberations
The matter was examined through an internal technical committee within CDSCO (搜索). After detailed deliberations, the committee opined that such investigational new drug applications, which remain under review by foreign regulatory authorities, require processing by the IND division. The rationale centers on the need for a comprehensive evaluation of non-clinical and clinical data in accordance with the provisions of the New Drugs and Clinical Trials (NDCT) Rules, 2019.
"Such investigational new drug (IND) applications, which are under review by foreign regulatory authorities, is required to be processed by the IND division, as these applications require a comprehensive evaluation of non-clinical and clinical data in accordance with the provisions of the NDCT Rules, 2019," stated the DCGI in the communication.
Regulatory Implications for Drug Developers
Under the NDCT Rules, 2019, an investigational new drug is defined as a new chemical or biological entity or substance that has not been approved for marketing as a drug in any country. The IND division deals specifically with such entities and plays a crucial role in India's regulatory framework, ensuring that new drugs meet established safety, efficacy, and quality standards.
The IND application represents a critical step in the drug development process in India. Applicants must submit their application for permission to conduct clinical trials and to import and manufacture the IND along with requisite documentation and fees as prescribed under NDCT Rules 2019 through the online Sugam portal. This application is necessary before any human subject is exposed to an investigational new drug, ensuring that clinical research is conducted under rigorous scientific and ethical standards.
Distinction from Marketing Approval Pathways
The clarification draws an important distinction between drugs seeking marketing approval based on global trials—which may allow companies to seek waivers for costly and time-consuming local studies—and drugs that have not yet been assessed and validated by any regulatory authority. For the latter category, companies are still required to obtain prior regulatory approval through the IND pathway.
On a case-by-case basis, the Central Licensing Authority has previously allowed waivers for capital-intensive Phase III trials and has also embraced non-animal methods to reduce the time and investment required for preclinical toxicology studies. However, the new directive makes clear that drugs without any global regulatory approval will be treated as independent new drugs in India and require comprehensive review spanning all applicable stages of clinical evaluation.
Submission Process
Accordingly, all such applications shall now be submitted to the IND division at CDSCO (搜索) headquarters in New Delhi, where they will be examined and processed as per the applicable regulatory requirements under the NDCT Rules, 2019. The IND review involves a comprehensive assessment of the drug's safety and quality—through animal pharmacology and toxicology data—before it can proceed to human trial stages.
This regulatory clarification is expected to impact pharmaceutical companies developing novel therapeutic candidates who seek to leverage Indian clinical trial data for market access while the drug remains unapproved in other jurisdictions.