Clarification on Import and Marketing of New Drugs Undergoing Global Clinical Trials in India

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Dated: 13.08.2026

Clarification on Import and Marketing of New Drugs Undergoing Global Clinical Trials in India

The Central Drugs Standard Control Organization (CDSCO) has issued a circular to clarify the process for submitting applications to import and market new drugs in India that are not yet approved anywhere in the world but are undergoing or have completed Phase III Global Clinical Trials (GCTs) with Indian participation. This guidance is crucial for pharmaceutical companies, clinical research organizations, and other stakeholders involved in drug development and regulatory affairs.

Background

With the increasing participation of Indian subjects in global clinical trials, there has been a rise in applications seeking permission to import and market new drugs in India based on data from these trials. However, many of these drugs are still under review by foreign regulatory authorities and have not received approval in any country.

Key Clarifications from the Circular

Scope of Applications
- The circular addresses applications for new drugs that are not approved anywhere in the world but have Phase III GCTs ongoing or completed with Indian subjects.
Regulatory Review Process
- Such applications require a comprehensive evaluation of both non-clinical and clinical data.
- The review must be conducted in accordance with the New Drugs and Clinical Trials (NDCT) Rules, 2019.
Role of the IND Division
- The Investigational New Drug (IND) Division within CDSCO is designated to process these applications.
- The IND Division will ensure that all regulatory requirements under the NDCT Rules, 2019 are met.
Submission Guidelines
- Applicants must submit their applications directly to the IND Division at CDSCO Headquarters in New Delhi.
- All stakeholders are informed of this requirement through the official CDSCO website.

Implications for Stakeholders

Pharmaceutical Companies: Must ensure that their applications for unapproved new drugs with Indian GCT participation are routed through the IND Division and comply with the NDCT Rules, 2019.
Clinical Research Organizations: Should align their documentation and data submission practices with the clarified regulatory pathway.
Regulatory Affairs Professionals: Need to stay updated on these procedural changes to avoid delays or rejections in the application process.

Conclusion

This clarification streamlines the regulatory process for new drugs undergoing global clinical trials with Indian participation. By centralizing the review under the IND Division and adhering to the NDCT Rules, 2019, CDSCO aims to ensure a thorough and consistent evaluation of new drug applications, ultimately safeguarding public health while supporting innovation in drug development.

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Source: CDSCO

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