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India pharma needs to enter into research and manufacture of innovative dosage forms as a viable profitable model. This is the only way to succeed and make a positive impact in the international arena, said Harish Jain, president, Karnataka Drugs and Pharmaceutical Manufacturers Association and director, Embiotic Labs.
In order to help the pharmaceutical industry, this year Union Budget too highlighted new programme to promote research and innovation in pharmaceuticals through centres of excellence. Now the government is firming up guidelines to catalyse R&D and innovation in pharma and med-tech sectors. We see this as a platform for take-off to strengthen drug research and development. India has the adequate scientific acumen to pursue this, he added.
At the international conference hosted by Sri Adichunchunagiri College of Pharmacy titled Innovation and Advances in Pharmaceutical Sciences: Current scene and Future prospects, Jain lauded the prowess of Indian pharma as the pharmacy of the world, with the highest US FDA approved production units of 615 outside of the US and also having a significant number of successfully audited plants by stringent global regulatory authorities like EMA, UK MHRA, PMDA, Japan, etc.
If Indian pharma has to reach the target of US$ 130 billion, then there is no substitute for innovation. The sector needs to pace up devise strategies to look at development of innovative dosage forms in an aggressive manner. This is because drug development is a lengthy, complex, and an expensive process, ridden with a high level of uncertainty that a drug will actually get ahead. Moreover, it is not the time for Indian pharma to pursue drug discovery. There is need for rapid development in this space. The Covid vaccine is a classic example where technology transfer of research from University of Oxford to Serum Institute for Covishield and ICMR tech transfer to Bharat Biotech are the proven success stories.
The industry must take a cue from these pandemic vaccine development learnings and look for tech-transfers in drug development. Moreover the country is the hub for contract research. Several oncology, neurology, psychiatry drugs and delivery devices are outsourced to India. Our qualified scientific –engineering workforce and sound knowledge of organic chemistry are factors that will bolster Indian pharma towards developing innovative dosage forms.
Supporting this is digital technology implementation for developing innovative dosage forms. From AI, ML, data analytics to AR-VR, IoT and digital twins, the sector is deeply entrenched into to maximize the know-how. In fact these technologies will enable easing expensive research into innovative dosage form easily understanding which drug compositions would be best suited for treating different diseases.
For innovation and research, Indian pharma requires an ideal ecosystem and funding. There is need to identify high ranking universities and tap right sources of funding from an industry perspective, the government needs to encourage research services, said Jain.
Quoting the IBEF report, Jain said in the last five years, the pharma export increased at a CAGR of 7% from US$ 17.3 billion in 2018 to US$ 24.6 billion in 2022. Intense price competitiveness and good quality services have helped to dominate the export market.
The strengthening of pharmacovigilance with our pool of pharmacy diploma , graduate and post graduates will ensure only high quality innovative dosage forms are in the supply chain. There is no viability for Indian pharma in new drug discovery as innovative dosage form is the only successful business model to pursue, asserted Jain.
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