Healthcare today occupies the minds of most policy makers and is apparently more inclined to express an all-purpose alignment and willingness to change and adjust.
Many agreed with Biocon chairperson Kiran Mazumdar-Shaw that there was a constant need for a dialogue and collaborative approach – whether to advance an enabling environment for innovation or on drug pricing. (representative image)
Over the years, if there is one saying that best describes the relationship between Indian pharma and the government, it is one about “one who has never hoped can never be disappointed”. But then, the pandemic changed all that. Healthcare today occupies the minds of most policy makers and is apparently more inclined to express an all-purpose alignment and willingness to change and adjust. This was showcased at the two-day online ‘Global Innovation Summit 2021’ organized by the Indian Pharmaceutical Alliance, a consortium of several leading Indian pharmaceutical companies.
development with girth
it left with the prime minister Narendra Modi, Health Minister Mansukh Mandaviya, expressing hope. He not only spoke of India being a pharmacy to the world, but also a language that can grow, innovate and develop, with the hopes of emerging as a $130 billion industry in India by 2030. and was now showing signs of a threefold increase.
Senior policy makers and bureaucrats were so inclined to accept that reforms were needed and the process of bringing them in was underway. This was clearly conveyed to industry leaders, some of them openly talking about the challenges and expressing their serious concerns and concerns, albeit praised for a very receptive government.
regulatory reform
It must have been music to many ears when Rajesh Bhushan, Secretary, Ministry of Health and Family Welfare, spoke of a governance and regulatory environment that abandons the regional approach and embarks on the journey of a single window system.
Drug Controller General of India VG Somani talked about the efforts to bring in new and stronger regulatory reforms and aimed at creating a conducive and enabling environment that is more ease of doing business and at the same time is capable of fostering innovation .
Read also| What to expect as India sets in motion drug regulatory changes
Describing the months of the pandemic and the efforts taken to mitigate unnecessary steps and the journey on drug and vaccine approval, he said, “Over 180 subject expert committee meetings were held in the last two years.” As well as how over time established procedures were replaced by measures focused on handling local FDAs (food and drug administrators), manufacturers and researchers. Giving an example of how this played out, he said, the country has moved from a scenario when there was not a single COVID test kit, to where they have all grown today with multiple kits made within the country. Indian drug regulators, he said, have been in touch with several global regulatory authorities – UK’s MHRA or USFDA, WHO and others – and never deviated from international expectations.
talks
Many agreed with Biocon chairperson Kiran Mazumdar-Shaw that there was a continued need for dialogue and for a collaborative approach – whether to advance an enabling environment for innovation or on drug pricing and affordable innovation in particular. .
Dilip Shanghvi, founder and managing director of India’s largest pharma company, Sun Pharmaceutical Appreciated the government’s proposal for research-linked incentives, which was appropriate at a time when many in India aim to do the same in drug innovation after succeeding in generics. The Research Linked Incentive Scheme, he said, was a great effort to identify the challenges of the industry and engage in dialogue with all the stakeholders to formulate a policy, which would be a long-term policy, to encourage and finance the industry. give. While they were still in favor of moving forward in fostering industry and academia collaboration, reach a position where more Indian companies find it favorable and attractive to conduct Phase 1 and 2 clinical studies within India, Instead choose locations far abroad. ,
Dr Sanjay Singh, CEO, Genoa Biopharmaceuticals, which is on its way to bring India’s first mRNA vaccine, mentioned a unique challenge that they still needed to import 39 odd inputs.
beyond talent
Sanjay Murdeshwar, Managing Director, Novartis India, which at one time toyed with the idea of investing in research outside India but eventually opted to do so from China, talked about India’s emerging strengths and challenges. He said that the time has come to look to India for its strength in data and computing capabilities, as he feels that drug discovery has become a computing challenge today. He still saw the need to build up the biomedical talent in the country and mentioned how India had about 1500 PhDs in biochemistry while the US had around 15,000. Also, the fact that if the domestic market is large it also adds a layer of attractiveness to investors and this is one of the reasons why the US and China have been successful in attracting investors. He may perhaps find rest in the hopes placed by Indian leaders and policy-makers. As is clear, everyone knows where the challenges lie and many are clueless about the solution as well. Much depends on how they see daylight and in what time frame.
What is difficult to remember at this time is that expectations have now risen and it can be important to maintain a clear optimism during this difficult time.
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