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CDSCO releases updated version of guidance document for biologicals
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Gireesh Babu, New Delhi
May 29 , 2024
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The Central Drugs Standard Control Organisation (CDSCO) has issued an updated version of the Guidance for Industry for Biologicals after 16 years from the introduction of the previous version, in tune with the regulations and online application processes introduced in recent times.
The new document includes guidance for submission of clinical trial applications for evaluating safety and efficacy, requirements for permission for new drugs approval, and guidance for preparation of the quality information for drug submission for new drug approval on biotechnological or biological products.
The CDSCO had published the Guidance for Industry (Biologicals) version 1.1 in the year 2008, which was prepared in line with the international guidelines and in accordance with the Drugs and Cosmetics Rules, 1945 and Drugs and Cosmetics Act, 1940.
Now, the Version 1.2 is updated to align with New Drugs and Clinical Trials Rules, 2019 and Sugam application process after consultation with the stakeholders and it is published after considering the public suggestions, comments or objections, said Dr Rajeev Singh Raghuvanshi, Drugs Controller General (India) while introducing the latest version.
"This Guidance has been developed in conformity with New Drugs and Clinical Trials Rules, 2019 under Drugs and Cosmetics Act 1940 and GCP (Good Clinical Practices) Guidelines of India for the purpose of submission of Clinical Trial application," says the document.
The clinical trial sponsor is required to submit an application (Form CT-04) for the purpose of conducting clinical trials in India and submit documents as per New Drugs and Clinical Trials Rules, 2019 there in. The sponsor is also responsible for implementing and maintaining 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 CDSCO as well as all applicable statutory provisions of New Drugs and Clinical Trials Rules, 2019 under Drugs and Cosmetics Act, 1940.
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, says the Guidance document.
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 for 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 or 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. The requirements in respect of chemistry and pharmaceutical information have been elaborated for biologicals in the document while requirement for conduction 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 the guidance is specific to India, the content is aligned with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) requirements, it added.
The manufacturer or sponsor shall submit the application in Form CT-04 (online) through SUGAM or the recently launched National Single Window System (NSWS) portal. Whenever new rules are published, the new Rules will prevail over this guidance, says the guidance document.
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