Marketing Authorization (Form 44, Form 46)

Marketing Authorization (Form 44, Form 46)

Biopharmaceuticals are one of the elegant and sophisticated milestones of modern scientific research. The biopharmaceutical industry has been rapidly growing in India for last few years.It consists of both innovator Biologics and Biosimilars (similar biologics). Biosimilars are new versions of innovator biopharmaceutical products that are generally marketed after expiration of patents.The similar biologics are expected to become an important economic and therapeutic driver of the Indian pharmaceutical market.

Biologics include monoclonal antibodies, therapeutic proteins, DNA vaccines and fusion protein. An innovator biologic molecule follows regulatory procedure similar to any other new drug. The Central Drug Authority (Central Drug Standard Control Organization, CDSCO) prescribes information to be submitted for Market authorization of new biological drug in a predefined format to simplify submission requirements. The manufacturer/sponsor have to submit application on Form 44 for permission of new drug approval under the provisions of Drug and Cosmetics Act 1940 and Rules 1945. Form 44 is an application for grant of permission to import or manufacture a new drug. The requirements for Chemical and Pharmaceutical information are as per the International Submission requirements of Common Technical Document (CTD) and have five modules: Administrative/Legal Information, Summaries, Quality Information (Chemical, Biological and Pharmaceutical), Non-Clinical Information and Clinical Information.

In India similar biologics have unique guidelines for marketing authorization. A similar biologic product is that which is similar in terms of quality, safety and efficacy to an approved reference innovator biological product based on comparability. “Guidelines of similar biologic: Regulatory requirements for Marketing Authorization in India” has been updated in 2016.

Biosimilars have multistep process before obtaining market authorization involving several government agencies such as CDSCO, Review Committee on Genetic Manipulation (RCGM), Drug Controller General of India (DCGI), Institutional Biosafety Committee (IBSC), the Genetic Engineering Appraisal Committee (GEAC), the Food & Drugs Control Administration (FDCA) and the Institutional Animal Ethics Committee (IAEC). It can be developed in India only if the reference innovator is registered here. Otherwise it needs to be marketed for a minimum of 4 years in a well regulated market to gain marketing authorization. In order to gain approval, the company is first required to submit all product data to the authorities, including the manufacturing process, product characteristics, pre-clinical studies and basic clinical information. Pre-clinical trial approval is granted in the second step and the clinical trial in the third step. After this the company can apply for market authorization of the biosimilar to the DCGI. It is mandatory to submit post marketing surveillance data as well.

There are several challenges for filling up for approvals of biologics as they are extensive, exhaustive and at times excessive level of details required for description of a biological product.

CliniExperts, the leading global regulatory expert provides end to end regulatory solutions for Biologicals. These include multiple approvals for marketing authorization, manufacturing licence, import and registration and assist in post approval changes. Our services adhere to highest industry standards and subject to stringent quality checks.




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