Since 2019, after implementation of New Drugs and Clinical Trial (NDCT) Rules, the regulatory landscape in India is continuously evolving, striving for alignment with global standards, while ensuring affordability and accessibility for its vast population. In 2023, significant changes have occurred in the regulatory landscape strengthening the clinical trials in India. The Secretary and Scientific Director of The Indian Pharmacopeia Commission was appointed as new Drugs Controller General of India (DCGI) at least till February 28, 2025. This appointment was crucial, given that the DCGI holds the final authority in regulatory approvals for drugs, devices, and vaccines trials in India.
Under the Ministry of Health and Family Welfare, Govt. of India, the Central Drugs Standard Control Organization (CDSCO), headquartered in New Delhi, is the National Regulatory Authority in India. The Drugs Controller General of India (DCGI), an official of the CDSCO, is the final regulatory authority for the approval of clinical trials in the country. The Indian regulatory framework allows concurrent submission of applications for regulatory and institutional ethics committee (IEC) approval. Clinical trials for a new drug can only be initiated after DCGI has issued CT-NOC and Test License, and the approval has been obtained from the registered Institutional ethics committee of the site and the trial is registered with clinical trial registry (CTRI) in India.
A single regulatory dossier is prepared containing application for permission to undertake clinical trials, Clinical Trial – No Objection Certificate (CT-NOC), for importation of new drugs (Test License) in the prescribed formats. The regulatory dossier is uploaded through SUGAM, an e-Governance system (https://cdscoonline.gov.in) under CDSCO for online submission of clinical trial application and obtaining (CT-NOC) and Test Licenses and approvals. Subject Expert Committee (SEC) reviews clinical trial application. If SEC reviews and accepts the application without any query, DCGI issues NOCs for the conduct clinical trial. This process previously took 12-16 weeks in total. Considering all those regulatory changes in recent years, the current approval timeline stands at 10-12 weeks.
GCT has consistently demonstrated efficiency in obtaining approvals in India, surpassing the official timeline. A noteworthy example of GCT’s commendable performance is the approval of a Phase II rare disease study in India. This process, from the initial query to approval, took less than 100 days. The success is attributed to the dedicated efforts of GCT’s team in India and effective communication with the Sponsor and the efficiency at the office of the regulatory authorities.
Having established its presence in India since 2017, GCT has recently relocated to a new office to accommodate the increasing demand for clinical drug development programs in the region.