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Creation of US FDA like regulatory body required to boost Indian pharma industry: KPMG report
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Gireesh Babu, New Delhi
April 27 , 2022
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Creation of a single overarching regulator like the US Food and Drug Administration (FDA), the drug regulator having dedicated specialised teams to provide in-house regulatory guidance to pharma innovators and strengthening exchange of regulator best practices with international regulatory bodies could pave way for a conducive regulatory landscape to pave way for growth and innovation in the pharmaceutical sector in the country, say a latest report.
At present, the regulatory approvals for innovative pharmaceutical products take about 18-24 months and from an industry viewpoint, the current regulatory structure appears complicated with a web of entities at the central and state levels having the responsibility of monitoring the sector. The Sugam portal, which is currently operational, has certain limitations such as there is no provision of adding multiple files greater than 10 MB and no automated document management workflows.
“There can be an integrated portal enabling automated data transfer between different regulatory departments. Use of artificial intelligence (AI) and natural language processing (NLP) can ensure faster document review and deficiency identification leading to enhanced efficiency and reduction of human interface,” suggests a report, titled Impact of the pharma industry on the Indian economy in the post-Covid era, released by FICCI and KPMG.
“A single overarching regulator like the US FDA, if created, can jointly oversee the functioning of food, drugs and medical devices,” it added.
The future of the Indian pharma industry lies in moving up the value chain and innovating in complex generics, speciality drugs, new biological entities and new chemical entities and the country needs to build regulatory expertise in these domains. Towards this, the Central Drug Standard Control Organisation (CDSCO) can have dedicated and specialised teams to provide in-house regulatory guidance to pharma innovators working on these innovative segments.
Since it is important for the Indian industry to grow and expand in markets beyond the US and the EU, the country should strengthen the exchange of regulatory best practices with international regulatory bodies. The Pharmaceutical al Inspection Co-operation Scheme (PICS) has regulatory bodies from across the globe and Indian regulatory bodies can strive to be a part of this consortium.
Collaboration with global regulatory bodies helps the Indian counterparts enhance their exposure ties on the approval of new drugs and medical devices and ensures a globally consistent regulatory regime. The Indian regulator can work closely with the US FDA and other regulatory bodies to communicate issues faced by the Indian pharma companies and drive the requisite regulatory changes. They can also communicate the contributions of the Indian pharma products on shaping public health outcomes to the global healthcare and pharmaceutical markets and regulators, it opined.
The study also suggests creation of regulatory cells in academic institutes, to help them orient themselves with the regulatory aspects of pharmaceuticals, Collaborations with global regulatory institutes such as Centre for Innovation in Regulatory Sciences UK, DIA (US), Centre for Regulatory Excellence at the Duke-NUS Graduate Medical School (Singapore) etc.
“The Indian government along with the regulatory bodies have a bigger than ever role to play in driving the next wave of growth for the pharmaceutical industry in a post-Covid world. Enabling and supportive policies and stronger government support would help the industry achieve its vision of a truly global pharma leader,” said the report.
The government can also improve the ease of doing business, enabling building capacities in APIs and high-end specialised pharmaceutical products such as biologicals, complex generics and gene and cell therapy drugs. Setting up of pharma machinery and medical equipment manufacturing parks, and dedicated logistic clusters and primary warehousing hubs in different parts of the country would also be helpful. It should also import specific training programmes for pharma logistics as it involves specialised knowledge and skill to handle and deliver drugs.
It should also work towards strengthening the pharma higher education system and build industry-academia linkages by setting up some grants for funding research and innovation activities at academic institutes, it added.
Exports can be included in the PLI Scheme as India holds around $100 billion export potential. Some initiatives such as simplifying tendering, transparency in government tendering process can aid in attracting global firms to get R&D investments in India, as there is a gap existing to showcase potential business opportunities and return on investment to global MNCs for attracting investments in India, it said.
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