Industry Must Bring In More Money Into Pharma R&D, Mindset Shift Is Necessary: DCGI

The Drug Controller General of India (DCGI) Rajeev Raghuvanshi on Thursday said that India has all the ingredients of a mature pharmaceutical market from infrastructure to fresh talent and that it's the right time for the industry to move from volume-led growth to a value-led one. 

India is ranked as the third largest pharmaceutical market in terms of volumes and 14th by value simply translating that the country produces more copycat drugs than the innovator medications. 

Delivering a keynote at an Organisation Of Pharmaceutical Producers Of India event in New Delhi, he said that India is designated as the world's pharmacy, as it produces 60 per cent of vaccines, 20 per cent of medicines globally and 25 per cent of US generics. “We also have the largest USFDA-compliant manufacturing plants outside the US, which is around 600,” he added.

Raghuvanshi said that the country’s total pharmaceutical trade is projected to be USD 130 billion in 2030 which will be an uphill task for industry to reach. 

“Whatever India has achieved is due to the generic drugs revolution which began in the early 1990s with Ranbaxy filing the first ANDA of Cefaclor and today we are world leaders in producing generics. But in the last thirty years, has the success of being leaders in the generic model stopped us from not moving up the value chain parallelly? Now that is required today more than any time in the past and I believe we are losing time,” the DCGI stated. 

He said that it would be difficult for India to maintain this leadership position if India does not shift the play from volume to value. 

This he further stated is also required for the value which we are giving to patients. Today, India has one of the largest pools of the population globally which has all kinds of diseases. India is also one of those countries which has the largest rare disease population, the DCGI informed. 

“The first and foremost need in India is the shift of the mindset. Owing to the successful generic model most of us are still stuck there - I do not know whether it is training or the mindset - people wait for some reference from the US or Europe to start working or developing a product and that is the biggest problem we need to come out from,” Raghuvanshi concurred. 

The DCGI said that there are a handful of people who are able to think that they can develop as an innovator, he said though there are some signals in the system and things are happening - this needs to be a mass movement in the country. 

“The industry has to bring in more money into research and development and there is no debate about that I hope pharma bodies like OPPI and IPA are already thinking about this and investments are increasing in R&D and I am sure that this will bring the induction effect on other companies also,” the DCGI noted.

Indian drugmakers spend around 6-8 per cent of their total revenues on R&D in India when compared with developed markets like the US which spent 19.1 per cent of its sales on research. 

Raghuvanshi highlighted that as a philosophy, the Indian government has recognised that there is a need to shift from volume to value which is a very big realisation and policies are framed around pushing this shift. 

For instance, he said the recent R&D policy by the Department of Pharmaceuticals was created to promote innovation and we have many Product Linked Incentive schemes (PLIs), and medical device parks working for the medical devices sector as well. 

“We have to flip this ratio of 80 per cent import and 20 per cent export of medical devices. The government is signalling that it's serious about this shift and in the regulatory framework a lot of streamlining has been happening right from Medical Devices Rules 2017, Clinical Trials Rules 2019 and the new Drugs and Cosmetics Bill which should be placed in the next parliament session which does complete streamlining of the medical devices regulations and law,” the Drug Controller General of India noted.

Beyond the money and mindset shift India also needs focused and outcome-based industry-academia partnerships, he added.