New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has released a draft of revised Guidance for Industry document, in consultation with the stakeholders to align with the New Drugs and Clinical Trials (NDCT) Rules, 2019 and the Sugam application process.
The draft Guidance for Industry, Version 1.2, is related to submission of clinical trial application for evaluating safety and efficacy, requirements for permission of new drugs approval, and preparation of the quality information for drug submission for new drug approval of biotechnological and biological products.
The latest version of the guidance document has been developed in conformity with NDCT Rules 2019, under Drugs and Cosmetics Act 1940 and Good Clinical Practice Guidelines of India for the purpose of submission of Clinical Trial application.
Releasing the draft document, the Drugs Controller General (India) Dr Rajeev Singh Raghuvanshi solicited suggestions, comments or objections from the stakeholders with regard to the document, to be submitted to the regulator within 15 days from the date of issuance of the notice in an email address provided with the notice.
“The suggestions/comments/objections received on the email addresses within the period of 15 days shall be taken into consideration for finalisation of the draft Guidance document,” said the official while issuing notice on April 10, 2024.
According to the objectives elaborated in the document, the clinical trial sponsor is required to submit application (Form CT-04) for the purpose of conducting clinical trial in India and submit documents as per New Drugs and Clinical Trials Rules, 2019, through the Sugam or the National Single Window System (NSWS) portal.
The sponsor is also responsible for implementing and maintaining the Quality Assurance system to ensure that the clinical trial is conducted and data generated, documented and reported in compliance with the protocol and GCP guidelines issued by the CDSCO as well as all applicable statutory provisions of NDCT Rules. Standard operating procedures should be documented to ensure compliance with GCP and applicable regulations.
Sponsors are required to submit a status report on the clinical trial to the Licensing Authority at the prescribed periodicity. In case of studies prematurely discontinued for any reason including lack of commercial interest in pursuing the new drug application, a summary report should be submitted within 3 months, elaborates the document while discussing the objectives of the revised Guidance.
The summary report should provide a brief description of the study, the number of patients exposed to the drug, dose and duration of exposure, details of adverse drug reactions, if any, and the reason or discontinuation of the study or non-pursuit of the new drug application. Any expected serious adverse event (SAE) occurring during a clinical trial should be communicated promptly (within 14 calendar days) by the Sponsor to the Licensing Authority and to the other Investigator(s) participating in the study.
The manufacturer/sponsor has to submit an application in Form CT-04 for permission of Clinical Trial under the provisions of New Drugs and Clinical Trials Rules, 2019, under Drugs and Cosmetic Act 1940 and rules there under.
The requirements in respect of chemistry and pharmaceutical information has been elaborated for Biologicals in this document while requirement for conduct of clinical trial and other requirements remains the same as per New Drugs and Clinical Trials Rules, 2019.
Though the nomenclature of the sections mentioned in this guidance is specific to India, the content is aligned with ICH requirements. Whenever new rules are published, the new rules shall prevail over the guidance, it added.
