New Delhi: Advanced, affordable and accessible solutions are the only way forward towards intensifying the innovations in the Indian pharmaceutical sector, a top Union Health Ministry official said at an ASSOCHAM event in the national capital.
“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 an ASSOCHAM Pharma Conclave 2018.
Despite having the technical capacity and vast talent pool and potential, Gupta said India’s role in new drug discoveries, be it bio-pharmaceuticals or bio-similar, even for country’s own health priorities, is quite limited. Furthermore, other factors like changing the burden of disease owing to the emergence of non-communicable diseases, more chronic diseases, cancerous conditions, lifestyle diseases and India is now said to be on the threshold of diabetes capital of the world.
All these, as per Gupta, give rise to the need to find advanced but affordable and accessible solutions and steer efforts towards intensifying the innovations in the pharma sector. She also urged the Indian pharmaceutical industry to take advantage of opportunities that have come up owing to recent revolutions at the 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,” said 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 percent 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.
“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 coordination 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,” she added.
Highlighting the steps taken by the Union Government, Gupta noted that the new draft 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, waving off local clinical trial requirement if the new drug is approved and marketed in any of the countries identified by the DGCI 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.