The Indian guidelines on similar biologics became effective on 15 September 2012. Prior to the introduction of the guidelines, such products were approved by the Review Committee on Genetic Manipulation (RCGM) and the Central Drugs Standard Control Organization (CDSCO – under the Ministry of Health and Family Welfare) using an abbreviated version of the pathway applicable to new drugs on a case-by-case basis [1]. The original guidelines offer a broad roadmap for laboratory tests, clinical trials and manufacturing processes, but are open to interpretation in some areas.

According to reports, officials say the new norms are expected to build further on the existing rules and will only be finalized after consultation with industry, academic institutions and stakeholders. A draft is expected to be published in the public domain and will be open to comments.

The revised guidelines are expected to increase requirements in areas such as comparability testing with the reference drug. In addition, issues such as pharmacovigilance and post-marketing surveillance for adverse events are also expected to be addressed. The revised guidelines may also set the threshold for the minimum number of patients needed for clinical trials depending on the drug. Finally, they will also address key issues that were not specified in the first guidelines in order to reduce the scope for interpretation.

The ministry expects to finalize the revision of the guidelines by the end of 2015.

Related article
‘Similar biologics’ approved and marketed in India 

Reference
1. GaBI Online - Generics and Biosimilars Initiative. Indian guidelines for ‘similar biologics’ [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Nov 20]. Available from: www.gabionline.net/Guidelines/Indian-guidelines-for-similar-biologics

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