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CDSCO amends guideline for post aproval changes in biological products:

As per the new amendment made by Central Drugs Standard Control Organisation (CDSCO) it is mandatory to file fresh new drug or manufacturing licenses for biological products in case of post approval changes. No provision for automatic approval of post approval changes.

According to a most recent guidance issued by the drug regulator, the applicants of the biological products who changes their product post approval should apply for new drug authorization, in case the change makes the product a new drug as per definition under rule 122E of the Drugs and Cosmetics Rules.

In case of change in manufacturing premises, the licensee would apply for the additional product permission to concerned state licensing authorities, zonal offices or sub-zonal offices and Central Licensing Approval Authority (CLAA) as per requirements of Drug & Cosmetics Act and Rules along with essential fees as per usual procedures.

Earlier, the applicants who reports the changes post approval of biologicals could have considered their application for change have been accepted by the Drug Controller General of India if the regulator has not opined otherwise within a period of 30 days from submission of application in case of major quality changes and 15 days for moderate quality changes.

According to the earlier guidance, the Level I - Supplements (major quality changes) are defined as changes that have a substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of a biological product as these factors may relate to the safety or effectiveness of the product even as the Level II - Notifiable Changes (moderate quality changes) are changes that have a moderate potential to have an adverse effect on the already mentioned characteristics of the biological product. The companies were to apply for change with support of extensive documentation, as per the earlier document too.

With the amendment brought in place has omitted the provision entirely, making it mandatory for the applicants to file a new drug application in case of major quality changes and for filings like an additional manufacturing license for moderate quality changes with clear statements of change about procedural, qualitative and quantitative changes in comparative table form.

Similarly, the applicants should submit clear statements and evidences about effect of change on quality, stability, validation, animal toxicity and clinical (safety and efficacy) status of the product. “If, any waiver is expected or assumed in physicochemical characterization studies, stability studies, validation studies, pre-clinical (animal toxicity) studies & clinical studies, it shall be justified precisely proving the equivalence,” clarifies the amended guideline.





Editorial Board

  • Professor Lilian M. Azzopardi
    Department of Pharmacy,
    University of Malta,

    Professor Karim A. Alkadhi
    Department of Pharmacological and Pharmaceutical Sciences,
    University of Houston,
    Houston, USA

    Dr. Poonam Singh
    Scientist, Division of Toxicology,
    Central Drug Research Institute,

    Dr. Jason Eriksen
    Department of Pharmacological and Pharmaceutical Sciences,
    University of Houston,
    Houston, USA

    Professor V. Kusum Devi
    Department of Pharmaceutics,
    Al-Ameen College of Pharmacy,
    Bangalore, India

    Associate Professor Bruce Charles
    Pharmacy Australia Centre of Excellence,
    School of Pharmacy, The University of Queensland,
    Brisbane, Australia

    Dr. Karem Alzoubi
    Assistant Dean, Faculty of Pharmacy,
    Jordan University of Science and Technology,

    Professor Nurten Özdemir
    Faculty of Pharmacy, Ankara University,
    Ankara, Turkey

    Dr. Veena S. Nukoolkarn
    Department of Pharmacognosy,
    Faculty of Pharmacy, Mahidol University,
    Phyathai, Bangkok

    Dr. Ajay Sharma
    Mason Eye Institute,
    University of Missouri,
    MO, United States

    Professor Olobayo O Kunle
    Director, Department of Pharmaceutical Technology and Raw Material Development,
    National Institute of Pharmaceutical Research and Development (NIPRD),
    Idu, Abuja, Nigeria

    Okoro Roland Nnaemeka
    Department of Clinical Pharmacy and Pharmacy Administration,
    University of Maiduguri,
    Maiduguri, Borno State, Nigeria

    Dr. Manoj Sharma
    Principal, Shri R N S College of Pharmacy,
    Gormi, Bhind, Madhya Pradesh, India

    Professor Dhrubo Jyoti Sen
    Department of Pharmaceutical Chemistry,
    Shri Sarvajanik Pharmacy
    Mehsana, Gujarat, India


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