2021 saw greater collaboration among pharma, govt, academia: Sudarshan Jain

'Diversified supply chain is a fundamental need', said Jain

This was a landmark year for the Indian pharma sector, which churned out new vaccines, collaborated for new drugs and ramped up supplies of key products. Sudarshan Jain, secretary general, Indian Pharmaceutical Alliance (IPA), speaks to Sohini Das about the trends that marked 2021 and what lies ahead for the Indian drug industry. Edited excerpts.

What were the key trends that dominated the Indian pharma industry in 2021?

Every adversity offers opportunity. The Covid-19 pandemic brought healthcare to the centre-stage. One big trend in 2021 was collaboration — among government, in­d­ustry and academia. Bureaucrats were most solution-oriented, (and focused on) what can be done, and done fast. Secondly, we realised the importance of self-reliance. In the initial days of Covid, we did not have enough PPE kits, testing kits, ventilators etc. We have had to create our own healthcare security. We also saw that regulatory processes got streamlined. Increased thrust on research and development was another key area that emerged in 2021. The Indian pharmaceutical industry also focused on the safety of employment and employees. Digitalisation and the speed at which it happened was a major change — we can connect with the USFDA (United States Food and Drug Administration) anytime and with stakeholders across the globe. Telemedicine and awareness about healthcare have grown in leaps and bounds. Imagine, a pulse oxi­m­eter has reached homes and people are now consci­o­usly monitoring their health.

How has the pandemic changed the way the pharma industry works?

There has been a fundamental change in the mindset; it is now more collaborative. In earlier times, if the sales team gave a forecast to the production team and it went wrong, the latter would most certainly get back and ask why a wrong forecast was given. But now we see things are quite different, more collaborative; there is more understanding of the broader uncertainties etc. Silos within the organisa­tions have broken. If demand for a particu­lar product suddenly shoots up, how quickly the production team can gear up to ramp up production — the focus is more on adapting to a more dynamic environment.

There has been an increased trend of voluntary licensing — remdesivir being a case in point. We should leverage this further in the future. Digitisation helped in quality control and assurance, supply chain operations, easing of clinical trials.

What kind of recommendations have you put forward to the government to streamline regulatory processes?

We have asked for streamlining things on the regulatory side and making processes simpler. For example, we have suggested that every proposal (from the industry for drug approval or clinical trials) should be treated like a project. A project management system needs to be brought in — once someone applies, someone at the regulator’s end has to monitor it; there have to be clear timelines. In the US, there are clear standard operating procedures (SoPs). We need to create such SoPs in India, too. We also need a single point of contact instead of multiple points, and also see that duplications are avoided. These will bring about fundamental changes for the benefit of the patient, while ensuring safety guidelines are maintained. All these recommendations have been made.

How long till we are no longer dependent on China for bulk drugs?

Diversified supply chain is a fundamental need. India lost that advantage in the 1980s. We have to revive that, but it won’t happen in a year’s time. China has already built that advantage, and their cost of production is already 25-30 per cent lower. This government has taken steps at a policy level. Still, it will take three to five years until we are self-reliant in active pharmaceutical ingredients (APIs). There will be price volatility in the meantime, and we have to be prepared for it.

It is not that we do not have a price ad­vantage at all. We have to go item by item, and build capacities to make fermentation-based APIs etc. We have to slowly build a diversified supply chain for APIs.

Any basic R&D by Indian pharma for Covid-19 drugs?

At present, it is only vaccines where we have done some original research — mRNA, DNA. There is nothing in the public domain so far on basic research for Covid-19 drugs by Indian pharma yet. There are talks of collaborations with global majors. We already have tie-ups for molnupiravir (antiviral medication used to treat Covid-19) in place.

2022 and beyond — what is the outlook?

There are a few focus areas. We know that 67 per cent of the world market for drugs co­mes from patented products. India’s pre­s­ence in that area is very less. We have to fo­cus on drug discovery — some compan­ies like Zydus Cadila, Sun Pharma, Lupin and Cipla are increasing their research ex­penditure. Last year, Indian pharmaceutical turnover (including exports) was about $44 billion, and we are targeting $130 billion in the next few years. We have to not only be at the top in terms of volume, but also be among the top five in terms of value. At the moment, we are 13th in terms of value. Unless we do basic research, come out with new molecules, we cannot reach that future.

As Ayush becomes more mainstream, does the allopathic industry see an opportunity here?

There is an opportunity in India's traditional healthcare system. For chronic diseases, Ayush can play a big role. Can we identify key areas; can we design more scientific clinical trials; and can we develop more manufacturing hubs – these will hold the key to how significant a role Ayush medicines can play. Critical drivers will be manufacturing at scale and bringing in credibility to the system.