Affordable Solutions Needed in Pharma Sector: DGHS

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

“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) while inaugurating ‘Pharma Conclave 2018’ organised by ASSOCHAM in New Delhi recently.

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 biosimilars, even for the country’s own health priorities is quite limited.

The emergence of non-communicable diseases, more chronic diseases, cancerous conditions, lifestyle diseases and diabetes requires the industry to find advanced but affordable and accessible solutions, 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 improved understanding of the underlying 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,” she added.

Dr. Gupta lauded the domestic pharmaceutical industry for playing a crucial role in manufacturing generic drugs, which are being exported to about 200 countries. She strongly urged 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 and market demands. 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.”

Provisions for encouraging R&D

Highlighting the steps taken by the Union Government, she said that draft new Drugs and Clinical Trial Rules notified in February 2018 contain several provisions for encouraging R&D:

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;

Waiving 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 to expedite development of new drugs intended to be used in life threatening or serious disease conditions, rare diseases, unmet medical needs, for disasters, 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 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.