“The R&D Paradox!” Why Pharma MNCs/ Biotech Behemoths Of The World Are Resisting In Setting Up R&D Innovation Center’s In India. What It Takes To Break The Inertia.

Predominantly, MNC, Pharma, and Biotech companies in the USA and Europe, from the so-called advanced high-income countries set up shop in other countries, avoiding developing LMIC countries except China. India is no exception to this, and there are no major Pharma, MNC, or US or EU-based Biotech companies that do R&D here. Why is there such reluctance in setting up Innovation Excellence centers in India while the talent pool and infrastructure are conducive now?

Scores of scientists trained in the USA and EU are returning home to do research, and the government, with the Atmanirbhar projects and SOPs, is laying red carpets for MNCs. While I should mention, in the past, AstraZeneca in our memory, and Hoechst (Now Sanofi), and recently Pfizer, before exiting the Biosimilar business in Chennai, earlier times in the 70s were exceptions to this rule. Even they left the country abruptly, abandoning R&D drug discovery and development.

We have to go back to looking at the origin of the Indian industry. India’s pharma was trading and was, and is, a reengineering industry, while Biotech is a sunrise service and the Biosimilar industry is a generic sector. Neither can invest 2 to 3 Bn USD required for the drug discovery and development of either small or large molecules, which is required. Our industry is at a crossroads for some time, inventions and innovations are required to take the industry to the next stage considering the US is fast developing cell and gene therapies and CRISPR DNA and RNA editing technologies. However, due to constraints in the availability of risk funds, Pharma has not been investing heavily in Drug Discovery.

Biotech is purely a discovery-based science – a deep science and tech. Our industry concentrating on services Genomics and services clinical diagnostics and generic Biosimilars is the tip of the iceberg to the R&D innovation cry in India. What would it take at this stage for Amgen or Genentech or Regeneron or Biogen to open an R&D shop in India? Moreover, MNC pharmaceutical companies such as Merck, Pfizer, and JnJ can initiate small molecule discovery or large molecule discovery from scratch in India. Our Intellectual property regimes have to be tightened, and if someone does risk research, their IP should be protected. If MNCs invest billions, they will not tolerate anyone copying their drugs, saying they need at least market accessibility and protection. In turn, MNCs pharma can work out licensing agreements with local Pharma companies as already done with Molnupiravir during the COVID pandemic. If MNCs see value in markets and low cost in developing drugs in LMIC Countries like India, then Chinese drug development centers will relocate to India. It will not be China plus 1 but India all the way.

While the Pharma industry in the US and EU & Japan are moving ahead with Discovery Genomics, Multi-Omics, Multi-Scale Biology, and Integrated OMICS- we are saddled with old-fashioned small molecule re-engineering here in India. Still repurposing old drugs to new indications and working on a class of known targets seems to be the age-old practice. What could be said new of them is they have invested around 3 to 5 or max 8 to 10 percent barring alembic 17 percent of their revenue in R&D in this fashion in synthetic organic chemistry and some low-key Biology to help in target validation. However, all of the pharma companies in India, except Glenmark, DRL, and Ranbaxy, does not have a track of doing R&D over the years, and they still have not brought a molecule into the market. Though it is a herculean challenge for Indian Pharma majors and MNCs which are still into high-value generics, API, and bulk drugs to move into value-based discovery based on modern biology, at least the chemistry innovations, say process-level incremental innovations, are intact.

Is invisible innovation, as suggested by Prof. Nirmalya Kumar, a way forward? Or, as Prof. Gary Pisano says, “he had not found more brilliant people on earth than biologists in this advanced world”? Considering these statements, is it time for India to move and march ahead in Discovery R&D of at least chemistry-based small molecules to bring out a new molecule in 10 years of time by 2035?

Biology is a context-dependent knowledge, and deep science and deep tech, with genomics as informatics. India is yet to make a mark in Genomics as our industry is genome diagnostics service providers and R&D service providers. The need of the hour is Discovery Genomics integrated into drug discovery in Biopharmaceuticals, Cell and Gene Therapy, Genome-Guided Therapy, Pre-Clinical organoid, humanoid, spheroid models, and Genome-based patient recruitment for clinical trials to delineate responders vs. non-responders in Precision medicine.

I am recommending an overhaul of the R&D culture in Biotech and Indian MNC Pharma to include DNA editing, Shooting the messenger by RNA editing, Cell Therapy, Genome Medicines, and Multi-Omics approaches to Polygenic diseases, and Integrative Biology, including systems and Synthetic biology. Jai Hind.