(b) An application for grant of permission to import a new drug shall be made in Form 44 to the Licensing Authority, accompanied by a fee of fifty thousand. Form 44 is an application for grant of permission to import or manufacture a new involving several government agencies such as CDSCO, Review Committee. Dosage Form c. Proposed indication for the New Drug. 4 Application in Form 44 complete in all respect duly signed and stamped by authorized.

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Otherwise it needs to be marketed for a minimum of 4 years in a well regulated market to gain marketing authorization.

Marketing Authorization (Form 44, Form 46) For Manufacturers | CliniExperts

Marketing Authorization Form 44, Form 46 Biopharmaceuticals are one of the elegant and sophisticated milestones of cesco scientific research. 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. It consists of both innovator Biologics and Biosimilars similar biologics.


A similar biologic product is that which is similar in terms of quality, safety and efficacy to an approved reference innovator biological cdscoo based on comparability.

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.

It can be developed in India only if the reference innovator is registered here. These include multiple approvals for marketing authorization, manufacturing licence, import and registration and assist in post approval changes. Biologics include monoclonal antibodies, therapeutic proteins, DNA vaccines and fusion protein.

Marketing Authorization (Form 44, Form 46)

In India similar biologics have unique guidelines for marketing authorization. Pre-clinical trial approval is granted in the second step and the clinical trial in the third step. It is mandatory to submit post marketing surveillance data as well.

After this the company can apply for market authorization of the biosimilar to the DCGI. Biosimilars are new versions of innovator biopharmaceutical products that are generally marketed cdzco expiration of patents. CliniExperts, the leading global regulatory expert provides end to end regulatory solutions for Biologicals.


An innovator biologic molecule follows regulatory procedure similar to any other new drug. The biopharmaceutical industry has been rapidly growing in India for last few years.

The similar biologics are expected to become an important economic and therapeutic driver of the Indian pharmaceutical market.

Biopharmaceuticals are one of the elegant and sophisticated milestones of modern scientific research. Form 44 is an application for grant of permission to import or manufacture a new drug.

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