From pharmacy to laboratory: India's leap into drug discovery

When Prime Minister Narendra Modiji in his Independence Day address this year called for greater global pharma ambition and said that one or two Indian pharmaceutical companies should make their mark among the world’s top five pharmaceutical companies, he was not only appreciating the significant work accomplished in the pharmaceutical sector but was also indicating the potential of the sector.As India advances toward Viksit Bharat@2047, a robust Drug Discovery and Development ecosystem will play a decisive role for the pharma industry’s growth, scientific advancement along with development of life-saving medical treatments.WHERE DOES INDIA PHARMA SECTOR STAND NOW?India currently ranks 3rd globally by volume and 11th by value, comprising over 3,000 companies and 10,500 manufacturing units. Global pharma market is around $1.7 trillion. Biologics segment of the sector itself is projected to expand to $1 trillion in the next decade globally. Presently valued at $ 60 billion, predominantly due to its prowess in generic medicines, India Medpharma has the opportunity to capture a fair share of the global market.Over the past decade, the pharma scenario in the country is changing. The industry has expanded beyond chemical comfort zone into capital-intensive, large-molecule frontiers. I visited a number of pharmaceutical laboratories/ companies on both institutional and industry side across the country during last few months. I also interacted with young brains trained on mathematics, AI and computing, working alongside biologists and chemists. The unmistakeable buzz everywhere is about novel drug discovery. Hundreds of researchers in AI labs, molecular biology labs, quality control labs, across the country deep into experiments are quietly leading a change with patience and perseverance. India is no longer contented with conventional generic drug business models. The story now is not about Indian companies making an existing drug/therapy cheaper, but increasingly, about them building a discovery ecosystem for novel therapeutics.DRUG DISCOVERY AND DEVELOPMENT ECOSYSTEMMost of the new discoveries in pharma are now in biological drugs and the pace of discovery has gone up due to multiple reasons. Universities are doing fundamental research and developing platforms in cell and gene therapy, CAR Ts, antibody drug conjugates, peptide drug conjugates etc. New drugs that are coming up using these platform technologies are very effective, completely treating cancer with a single/ limited doses, completely treating immune diseases like thalassemia. They are also expensive, cost of development and the cost of manufacturing is far more.In this drug discovery journey for next generation therapies, start-ups are marking their distinct presence. Start-ups in biotech and Lifesciences segment are mushrooming, not just in Benglauru and Hyderabad but also in cities like Kochi, Thiruvananthapuram, Bhopal, Sambaji Nagar, Ahmedabad etc. While Start-ups like Peptris Technologies, ImmunitoAI, Sravathi AI are working with AI driven models to speed up the drug discovery process, there are others who are developing capabilities to make advanced therapeutics more accessible and affordable for Indian patients.With the increased use of AI for drug discovery, the time taken to identify which protein will work in which tumor target has been reduced considerably. Out of 10,000 possible proteins, it is possible to shortlist 10 or 15 using AI. The shortlisting and testing time has reduced from, say, years to months. In a year, far more new drugs are coming out, which are effective. Particularly post covid, the pace of drug discovery and the development of new drugs has become very fast.Using AI, startups are able to do the shortlisting of molecules at lower cost compared to large companies. Testing /Characterisation of the shortlisted molecules is done in the wet labs by using CRDMOs or government lab infrastructure. Once they reach the proof- of-concept stage, they try to out-license these drugs. To go beyond Phase 1 trial is an expensive proposition for start-ups. Large companies have found a niche in licensing the product, doing clinical trials and selling the product.There are some problem areas though. For deep-tech biological drug discovery, there are not enough venture funds in India. Our university-industry collaboration is also relatively limited. Regulatory system needs to be faster. These are being addressed partly through the Biopharma Shakti Mission and PRIP. A number of startups have already made a good beginning.Immunoadoptive Cell Therapy Pvt. Ltd developed second-generation CD19 CAR-T therapy for non-Hodgkin lymphoma and acute lymphoblastic leukemia, which is a manufacturing success and has substantially improved local affordability. Funding- Approx $15.9 - $17.18 millionImmuneel Therapeutics’ Qartemi is an approved second-generation CD19-directed CAR-T cell therapy used for treating relapsed or refractory B-cell non-Hodgkin lymphoma. Funding - Approx US$49.8 millionBugworks Research India Pvt. Ltd has a pipeline of anti-infective, oncology drugs. Lead asset is a novel antibiotic for multidrug-resistant bacterial infections. Funding -Approx US$43-45 million.Eyecyte-RPE from Eyestem Research Pvt. Ltd. is an investigational allogeneic cell-replacement therapy currently in Phase 2 development. Funding- Approx US$16.4 millionNKure Therapeutics and Zumutor Biologics, prominent start-ups in Natural Killer (NK) cell therapies for treatment of leukemia, lymphoma, multiple myeloma, solid tumors and potentially infectious, autoimmune and neurodegenerative diseases. Funding- Approx US$2.15-2.36 million and Approx US$27.9 million respectively.Our objective is to strengthen the entire ecosystem, venture funding, university-industry collaboration, CRDMOs and a faster regulatory system, so that the pace of drug discovery and development can be further accelerated.For the Government of India, affordable, accessible and universal health care is a key priority and remains the cornerstone of all conversations. Pharmaceutical sector is not only important for ensuring quality health care to all citizens but also as a strategic industry for realising Viksit Bharat@2047. The Government is extending support for biologics and actively working to secure resilient supply chain for generics. In this context, Pharma sector’s ambition to discover 100 new molecules does not look like an outlandish dream. Driven by a powerful combination of artificial intelligence, a dominant CRDMO infrastructure and aggressive state backing, India will continue to be the pharmacy of the world, but it will also emerge as one of the world's biggest laboratories for pharmaceutical innovation for affordable & advanced therapeutics.- Ends