New USFDA guidance to benefit Indian Pharma Companies

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Last Updated on December 25, 2020 by The Health Master

Indian pharma industry is of the view that the recent USFDA guidance on ANDA (abbreviated new drug application) submissions, amendments and requests for its final approval is expected to provide a big push for faster generic drug clearances.  

The new guidance is intended to assist applicants in preparing and submitting amendments to tentatively approved ANDAs, including requests for final approval.

The guidance provides recommendations on the timing and content of amendments to facilitate submission in a timely manner that can result in final approval on the earliest approval date. “Going forward, it is the ANDA approvals which would accelerate further growth of Indian pharma too,” said the pharma companies.

According to Umesh Baikunje, founder & director, Baikunje Consultancy, this guideline is very useful since it gives necessary recommendations to applicant avoid any further delays in getting the final approvals. India being very efficient in producing cost-effective or affordable quality product in shortest time, this will help to speed up and get more approvals. Only rider is any delay in submitting the amendments or updates will miss the bus.

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Picture: Pixabay

The regulatory note also stated that the process for obtaining approval to market a drug product approved under a new drug application (NDA) differs from that for obtaining approval to market a generic drug under an ANDA. A sponsor of an innovator drug must submit an NDA, which should contain among other things, a demonstration of the safety and effectiveness of the drug for the conditions of use for which approval is sought.

Commenting on the guidance, Prema Desai, pharma consultant noted that a request for final approval should clearly identify, in its cover letter, all changes to the ANDA that have been made.

The applicant also needs to monitor for updates related to the drug product like changes in bioequivalence recommendations, the RLD labelling changes and ensure that amendments are submitted on time and clearly identified before a request for final approval from the FDA.

In the last few years, Indian companies have been grabbing a fair share of the ANDA approvals from the global regulatory authority, estimated to be over 35 per cent and by far the largest by any country.  

An ANDA is submitted for the approval of a generic drug. It is only after US FDA’s consent, an applicant can manufacture and market the low cost generic product ensuring its safety and efficacy that is referenced with a branded version.

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Indian companies including Sun Pharma, Aurobindo, Alembic, Biocon , Cipla, Dr Reddys, Glenmark, Granules India, Ind-Swift Labs, Indoco Remedies, Jubilant Lifesciences, Strides Pharma and Zydus Cadila have been submitting ANDA applications and receiving the approvals.

It is reported that last year Indian pharma manufacturers secured 40 per cent of total final ANDA approvals and 49 per cent of total tentative approvals. In the last decade, alone, US FDA approved 5,768 ANDAs and 1,351 tentative approvals. Indian companies continued to hold leadership to garner over 35 per cent approvals.

However an ANDA applicant is not required to provide independent evidence of the safety and effectiveness of that generic drug. Instead, the applicant may rely on FDA’s finding that the reference listed drug (RLD) relied upon by the ANDA applicant is safe and effective. Therefore, an ANDA must also include sufficient information to demonstrate that the proposed product is bioequivalent to the RLD. It should also ensure the product’s identity, strength, quality, and purity.

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