Over the last few years, if there is one adage that best describes the relationship between the Indian pharma and the government it is about one “who has never hoped can never despair’. But then, the pandemic changed it all. Healthcare is today occupying the mindspace of most policy makers and apparently all seem keen to convey an alignment of purpose and a willingness to change and accommodate. This was on display at the two day online ‘Global Innovation Summit 2021’ organized by the Indian Pharmaceutical Alliance, an association of many leading Indian pharmaceutical companies as its members.
Growth With Girth
It took off with Prime Minister Narendra Modi, health minister Mansukh Mandaviya, holding out hope. They talked the language of India not just being the pharmacy to the world but one that was also getting to ideate, innovate and could now harbour hopes of emerging as a $ 130 billion industry in India by 2030 – implying a good three-fold increase.
Senior policy makers and bureaucrats seemed all so willing to accept that there were fixes needed and that the process to bring them on was under way. This was quite clearly conveyed to industry leaders, with some of them rather open about the challenges and in voicing their serious concerns and worries even if couched in praise for a very receptive government.
Regulatory Reforms
It must have been music to many ears when Rajesh Bhushan, secretary, ministry of health and family welfare talked of a governance and regulatory environment that shuns territorial approach and embarks on a journey to a single window system.
The Drug Controller General of India V G Somani talked of the efforts on bring in new and strong regulatory reforms and one that would aim to create a suitable and enabling environment that leads to greater ease of doing business and at the same time able to spur innovation.
Also read| What to expect as India sets in motion drug regulatory changes
Describing the pandemic months and the efforts made to reduce redundant steps and the journey traversed on the drug and vaccine approvals, he said, “in last two years more than 180 subject expert committee meetings were held.” As also on how the established processes with long turnaround time were replaced by measures that were focused on handholding local FDAs (food and drug administrators), manufacturers and researchers. Giving an example of how it played out, he said, the country moved from a scenario when there was not a single covid testing kit to one where they all have proliferated today with many kits made within the country. The Indian drug regulator, he said, during this time also stayed in touch with many global regulatory authorities – UK’s MHRA or USFDA, WHO and others “and never diverted from international expectations.
Dialogue
Many seemed to agree with Biocon chairperson Kiran Mazumdar-Shaw that there was a constant need for dialogue and for a collaborative approach – be it to further an enabling environment for innovation or on drug pricing and especially affordable innovation.
Dilip Shanghvi, founder and managing director of India’s largest pharma company, Sun Pharmaceutical hailed the government proposal for research-linked incentives as one that was appropriate at a time when many in India after becoming successful in generics aim to do the same in drug innovation. The research-linked incentive scheme, he said, was a very good effort to recognize the challenges of the industry and to engage in a dialogue with all the stakeholders with a view to form a policy which would be a long-term policy, to incentivize and finance the industry. He however was still in favour of moving further ahead in fostering industry and academic collaboration, reach a situation where more Indian companies find it conducive and attractive to hold phase 1 and 2 clinical studies within India instead of the preference thus far to opt for locations abroad.
Dr Sanjay Singh, CEO, Gennova Biopharmaceuticals, which is enroute to bringing out India’s first mRNA vaccine, referred to a rather unique challenge that he still had to deal with in having to import 39 odd inputs that were needed.
Beyond Talent
Sanjay Murdeshwar, managing director, Novartis India, talked of the emerging strengths of India and the challenges. The company at one stage had toyed with the idea of investing in basic research out of India but finally opted to do so from China, and instead focused on late stage research out of India. Murdeshwar said it was time to look to India for its strengths in data and computing abilities because, as he felt drug discovery had today become more of a computing challenge. He still saw the need to building biomedical talent in the country and referred to how there were just about 1500 PhDs in biochemistry in India asd against around 15,000 in the US. Also, the fact that if the domestic market is big then it also adds a layer of attraction for investors and that is one reason why US and China have been able to attract investors. He may perhaps draw comfort from the hopes held out by the Indian leaders and policy-makers. As is apparent, everyone seems to be knowing where the challenges lie and many also clear about the solutions. Much then depends on how and in what timeframe these get to see the light of the day.
What is hard to miss at the moment is that the hopes have now been raised and in these teetering trying times sustaining an apparent optimism may be crucial.
