CDSCO has issued a revised edition of its guidance document pertaining to biologicals.
CDSCO has issued a revised edition of its guidance document pertaining to biologicals. The Central Drugs Standard Control Organisation (CDSCO) has recently released an updated edition of the Guidance for Industry for Biologicals, marking the first revision in 16 years since the previous version was introduced. This updated guidance aligns with the current regulations and online application procedures that have been implemented in recent years.
Within this new document, comprehensive guidance is provided for the submission of clinical trial applications aimed at assessing both safety and efficacy. Additionally, it outlines the prerequisites for obtaining permission for the approval of new drugs. Furthermore, the document offers detailed guidance on the preparation of quality information necessary for the submission of new drug approval applications, specifically focusing on biotechnological or biological products.
The Guidance for Industry (Biologicals) CDSCO
released the Guidance for Industry (Biologicals) version 1.1 back in 2008, which was crafted to adhere to international standards and in compliance with the Drugs and Cosmetics Rules, 1945, and Drugs and Cosmetics Act, 1940.
Now, Version 1.2 has been updated to synchronize with the New Drugs and Clinical Trials Rules, 2019, and the Sugam application process after extensive consultation with stakeholders. Dr. Rajeev Singh Raghuvanshi, Drugs Controller General (India), emphasized that this latest version incorporates feedback from the public, including suggestions, comments, or objections.
According to Dr. Raghuvanshi, “This Guidance aligns with the New Drugs and Clinical Trials Rules, 2019 under the Drugs and Cosmetics Act, 1940, and adheres to the GCP (Good Clinical Practices) Guidelines of India for the submission of Clinical Trial applications.”
The sponsor of a clinical trial must complete and submit an application (Form CT-04) to conduct clinical trials in India, adhering to the regulations outlined in the New Drugs and Clinical Trials Rules, 2019. Additionally, the sponsor bears the responsibility of establishing and upholding a Quality Assurance system to guarantee that the trial adheres to the protocol and Good Clinical Practice (GCP) Guidelines issued by CDSCO. Furthermore, they must ensure that all data generated during the trial is documented and reported in accordance with the relevant statutory provisions of the New Drugs and Clinical Trials Rules, 2019, as outlined in the Drugs and Cosmetics Act, 1940.
To ensure compliance with Good Clinical Practice (GCP) and relevant regulations, it is imperative to document standard operating procedures (SOPs). Sponsors are obligated to provide periodic status reports on clinical trials to the Licensing Authority as per specified intervals. If a study is terminated prematurely, for reasons such as lack of commercial interest in pursuing a new drug application, a summary report must be submitted within three months, as outlined in the guidance document.
This summary report should include a concise overview of the study, the number of patients who received the drug, dosage and duration of administration, any observed adverse drug reactions, and the rationale behind the study’s discontinuation or the decision not to pursue the new drug application. Any anticipated serious adverse events (SAEs) encountered during the clinical trial must be promptly communicated—within 14 calendar days—by the Sponsor to both the Licensing Authority and the other participating Investigators in the study.
The manufacturer or sponsor is required to submit an application using Form CT-04 to seek permission for a clinical trial under the provisions outlined in the New Drugs and Clinical Trials Rules of 2019, as per the Drugs and Cosmetic Act of 1940. The document provides detailed specifications regarding chemistry and pharmaceutical information for biologicals, while the requirements for conducting clinical trials and other aspects remain consistent with the New Drugs and Clinical Trials Rules of 2019.
Although the section titles referenced in the guidance are specific to India, the content adheres to the standards set by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
Applications must be submitted by the manufacturer or sponsor via Form CT-04 (online) using either the SUGAM platform or the newly introduced National Single Window System (NSWS) portal. It is noted in the guidance document that in the event of new rule publications, the updated rules will take precedence over the guidance provided.