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 The Indian pharmaceutical industry is of the view that the US FDA’s draft on Advanced Manufacturing Technologies (AMT) Designation Programme will propel Industry 4.0. It will also bring in transparency and accountability. The global regulator is seeking industry comments and suggestions before March end.
Advanced manufacturing, according to the US FDA, is an approach that has the potential to improve the reliability and robustness of the manufacturing process, supply chain and increase timely access to quality medicines. Even as India accounts for the largest approval of US FDA facilities pegged at 607 production plants, the country stands as a key supplier of medicines and with every third of its formulation is a prescription of choice in the US.
It is here the global regulator encourages early adoption of AMT that has the potential to benefit patients by improving manufacturing and supply dependability besides optimize development time of biological products.
Kaushik Desai, pharma consultant, said that it is an excellent initiative by US FDA. It will pave the way for companies to change their legacy processes to better practises with novel techniques. There will be time saving in delivery of pharmaceuticals. Automation and digitalisation will get a further push with this initiative.
This Advanced Manufacturing Technologies Designation Programme is currently brief in content and needs more clarity on what qualifies a novel process. The statements are very general and open-ended which can be interpreted differently, pointed out Desai.
Indian companies with US FDA approved sites should take advantage of this programme for their existing approved ANDAs in improving processes and expedite development. Hence it is key for Indian pharma to go through this draft document and comment suitably, added Desai.
In its draft US FDA noted that AMT is integral to ensuring quality and supporting a robust supply of drugs that are life-supporting to providing healthcare otherwise or during a medicine shortage. Advanced manufacturing can directly improve product quality through better production controls and fewer human interventions.
The draft guidance specifically, indicates process for submitting an AMT designation request, including a description of eligibility criteria and the data among other information to be included. It also details when and how FDA will communicate receipt of and provide advice on an AMT designation request.
Potential benefits related to drug development and application assessment with the new draft guidance on Advanced Manufacturing Technologies Designation Programme, are that it offers a framework for applicants including contract manufacturers and technology developers. US FDA said it will expedite assessment of applications for drugs that are manufactured using a designated AMT. This is because the global regulator views that use of designated AMTs can provide greater assurance of quality and shorten drug development time. It will assist stakeholders in efficiently meeting regulatory requirements for commercial manufacturing, and strengthen regulatory predictability.
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