(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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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.
Marketing Authorization (Form 44, Form 46) For Manufacturers | CliniExperts
An innovator biologic molecule follows regulatory procedure similar to any other new drug. Form 44 is an application for grant of permission to import or manufacture a new drug.
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 xdsco an approved reference innovator biological product based on comparability.
It can be developed in India only if the reference innovator is registered here. Otherwise it needs to be marketed for a forn 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.
CDSCO Registration services
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. Marketing Authorization Form 44, Form 46 Biopharmaceuticals are one of the elegant and sophisticated milestones of modern scientific research.