Affordable solutions needed to intensify innovations in Indian pharma sector: DGHS

Advanced, affordable and accessible solutions is the only way forward towards intensifying the innovations in Indian pharma sector, a top Union Health Ministry official said at an ASSOCHAM event.

We need to build and develop an enabling ecosystem that unleashes the country's entrepreneurial energy so that it creates a vast and vibrant marketplace for small, medium and large enterprises which are symbiotically interconnected to deliver superior and sustainable solutions, said Dr Promila Gupta, Director General of Health Services (DGHS) .

She rued the fact that despite having technical capacity together with vast talent pool and potential, India's role in new drug discoveries, be it bio-pharmaceuticals or bio-similar, even for country's own health priorities is quite limited.

There are other factors like changing burden of disease owing to emergence of non-communicable diseases, more chronic diseases, cancerous conditions, lifestyle diseases and India is now said to be on threshold of diabetes capital of the world.

All these require us to find advanced but affordable and accessible solutions and steer our efforts towards intensifying the innovations in pharma sector, added Dr Gupta.

She urged the Indian pharmaceutical industry to take advantage of opportunities that have come up owing to recent revolutions at molecular level, genomics, proteomics, metabolomics, bioinformatics and imaging technology which has led to advanced research in terms of understanding the underlined mechanism of several diseases.

I feel that academic institutions, research laboratories and pharmaceutical industry involved in healthcare research, should utilise these opportunities properly and come up in a big way for discovery and development of new medical products and services in the country, further said Dr Gupta.

She also lauded the domestic pharmaceutical industry for playing a crucial role in manufacturing generic drugs which are being exported to about 200 countries as India takes care of about 20 per cent of global needs of generic drugs.

The DGHS, however strongly suggested the industry to shift its approach and put more focus on research and development (R&D) of innovative medical products and services for sustainable growth considering the significant changes in global pharma markets in terms of trade practices, competitiveness, market demands and many other factors.

She said that although during the last decade many Indian pharmaceutical companies have started investing in R&D for innovation of newer molecular entities, the success in terms of translating the innovation from laboratories to markets in India is limited.

This requires effective co-ordination and exchange of information and collaboration between academic institutions, universities and industry and a very clear understanding of regulatory pathways which is the need of the hour for these innovations, said Dr Gupta.

Highlighting the steps taken by the Union Government, she said that draft new Drugs and Clinical Trial Rules notified in February 2018 contain various provisions for encouraging research and development of drugs - reducing time in disposal of application given for conducting clinical trial for a new drug or investigational new drug as part of discovery, research and manufacture in India; waving off local clinical trial requirement if the new drug is approved and marketed in any of the countries identified by the DCGI (Drug Controller General of India) and special mechanism incorporated to expedite development of new drugs and approval processes intended to be used in life threatening or serious disease conditions or rare diseases and for drugs intended to be used in diseases of special relevance to Indian scenario or unmet medical needs in India or for disaster or for specific defence use.

Realising the importance of clinical trials for innovation of new drugs to cope up with challenges of disease burden in public health, the CDSCO (Central Drugs Standard Control Organization) and the Ministry of Health and Family Welfare have taken various measures to promote the scientific and ethical clinical trials in the country, she added.

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