Amidst challenging times due to COVID-19, the Indian pharmaceutical industry emerged as an asset not only for India but the whole world and the collaboration and communication played a key role during this period when industry ensured the supply of essential medicines, says Sudarshan Jain, Secretary General, Indian Pharmaceutical Alliance.

Declaring pharmaceutical as an essential service, digitalization in government services such as Aarogyasetu app helped to accelerate vaccination. Overall, it was a great collaboration between industry, academia, policymakers and other key stakeholders, added Jain.

Jain spoke at the e-Conference on 'Indian Pharma Industry: Developing a conducive ecosystem' Jointly organized by Indian Pharma Post (IPP) and Indian Chemical News (ICN) yesterday. The well attended session was moderated by Pravin Prashant, Executive Editor, Indian Pharma Post & Editor, Indian Chemical News. 

Sharing his outlook for the industry, Jain said, "In the last three years we have been working on the vision document with McKinsey & Company. I believe R&D will become very important as it is fundamental to the future growth. Industry will have to focus on increasing geographical depth and go for quality dimension including implementing the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) standards. Achieving US $120-130 billion will not be a difficult task and soon we will be number one in terms of volume. Given the fact that India spends a meagre 0.7% of GDP on innovation as compared to other nations, the Finance Minister rightly labeled pharma as a sunrise sector. Now, we need to increase spending and develop innovation clusters here in India."

Jayaseelan J., National, Vice President (Industry Division), Indian Pharmaceutical Association, adds: "We have a great vision but it needs a lot of fine tuning. It is not just about pharmaceutical industry growth but saving trillions of people not just India but the world. We have commercially fixed a target for 2030 but for Vision 2030, we need to focus on research to develop more molecules. The acceptance of indigenous vaccines is a blessing in disguise. As an industry we should have a cost effective yet quality model as the other countries are benefiting. We can't lose out on opportunities. With skilled manpower, there should be a link between industry and institution. The pharma-biotech manpower should be industry friendly. During the Covid times, the interactions with regulators have increased multifolds and so has the speed and transparency due to adoption of digital technology. A lot of new concepts and initiatives have come to fore.”

Pointing out the challenges and way forward, Jayaseelan further adds, "Enough time is spent on clinical toxicity. Since we are talking about new NCEs, the regulatory department has to get technocrats on board. There should be specialists on the pattern of USFDA where they are handholding industry at each stage. More than 100 products are waiting for approval and ultimately we are losing. Therefore, the regulator must upgrade itself and so must the pharma industry."

Echoing the similar sentiment, Dr. Kommu Nagaiah, Chief Scientist & Head, CSIR-IICT, says that the Union Government has come up with a vision plan and there is a fine blueprint. “We must focus on building infrastructure for development of new molecules and a combined ecosystem for scientists and professors. There has to be srong group discovery work and scientists across various areas have to combine their efforts. We have to improve R&D efforts and aim to invest in research and scaling up manufacturing. Indian drug manufacturers and universities must increase their collaboration on all fronts, from basic chemicals to advanced chemicals. Collective efforts will yield the desired result. Another area where we can do better is phytopharma. India has a rich biodiversity but we haven't explored the full potential in the context of phytopharma. DBT, CSIR and other departments are doing their bit but they lack coordination," Nagaiah adds.

Spandan Mishra, Director - Sales, Customer Service & Logistics for Evonik India, Nepal & Sri Lanka region, says that the vaccines helped the country to get back to normalcy. “Going forward, Covid-19 will be the part of the vaccine chart as it will stay and we will need to ensure jabs for children. It has opened up a new industry altogether. The raw material providers and tech providers played a big role in completing the vaccine recipes. Going forward, there are 3 levers of growth including the biologics, vaccines, and NCEs. In fact, the pharmaceutical world will soon graduate to the biopharma world. The world's largest selling drug for the year 2020 is a monoclonal antibody which raked US $20 billion in sales globally, this will get off patented by next year. Till 2030, biologics worth US $100 billion will get off patented, so this is a huge opportunity which the Indian Pharma industry should focus on. Vaccines are another opportunity for the pharma industry and these have become a part of their portfolio. This is in the backdrop of market profitability of pharmaceutical generics not being a lucrative proposition anymore. Companies are also focusing on NCEs to keep their expansion plans on," Mishra informs.  

As Covid has been the biggest disruption in the last 100 years, industry does not know what will happen in future. “Besides lessons, changes during the pandemic are tremendous and now we are better prepared for future pandemics. For example, the adoption of tele-consultation has made the life of both doctors and patients comfortable except in case of surgeries. Again India is in control because of vaccine companies like Bharat Biotech and Serum Institute of India. AI and coordination have played a key role. While I never thought healthcare and the economy were interlinked, the pandemic has made us realize that the health of people is critical to the health of the economy. The challenge is that we do pharmaceutical imports worth US $3.8 billion and what is worrying is that we are dependent on one single nation, China. It is so high that we will not be able to manufacture 60% of our medicine. There is no riskier proposition than this. Covid-19 has highlighted this and accordingly the PLI scheme by the government has made a good start. With the identification of 68 APIs and approval to 16 manufacturers, hopefully manufacturing will begin in FY 23-24," says Govind K. Jaju, Partner, Suingora Consulting.

Dr. Mukund Chorghade, President & CSO, THINQ Pharma, informs that over-emphasis on cost effectiveness has led to lack of incorporation of many new technologies. “We need to immediately galvanize the research as we have the right talent, thinking, and resources. Companies must realize that R&D is not jugaad as somewhere the efforts are getting lost. Why not work on Indian traditional medicine as India has done well to position itself in API? India needs a winning partnership and time is right to give a huge fillip to Indian businesses. We need to put a new modular approach including continuous manufacturing, and flow chemistry. Initially there will be issues but we can benefit in the longer run. India should not be the dumping ground for toxic products. We have good science and intellectual minds for driving innovation and what we need is a collaboration between scientists, business development executives and other key stakeholders," Chorghade opines.