India’s role in global supply of COVID-19 drugs and vaccines remains crucial despite IPR waiver decision: GlobalData

Following the news that the US and EU have blocked India’s fight for intellectual property rights (IPR) waiver for COVID-19 drugs; Prashant Khadayate, Pharma Analyst at GlobalData, offers his view:

“India is already at the centre stage for the supply of repurposed COVID-19 drugs. Moreover, Indian vaccine players are gearing up to the potential vaccine launches’ manufacturing capacity. Therefore, India and South Africa’s proposal to the World Trade Organisation for the IPR temporary waiver will increase access and affordability, especially to the developing nations. WTO’s decision on IPR waiver is expected by the end of this year.

“Developing nations including China, Pakistan, Thailand, Indonesia and Turkey are in favour of the proposal, whereas developed nations like the US, the European Union, the UK and Switzerland are not in favour.

“According to GlobalData’s ‘Coronavirus Disease (COVID-19) Pharma Executive Briefing – October 13, 2020’, globally, there are a total of 62 COVID-19 vaccines in Phase I and the above stage and 447 COVID-19 pipeline candidates in Phase I and the above stage.

“The grant of an IPR waiver will be the icing on the cake for India. It is a well-established fact that pharma companies with intellectual rights may not be able to meet the supply requirements on their own and hence need to partner for the manufacturing and commercialisation of the patented drugs or vaccines.

“India has the highest number of FDA-approved manufacturing sites after the US and the world’s leading regulatory bodies approve India’s manufacturing sites. Hence, it is likely that most companies are happy to partner the Indian companies, which can supply therapies to other parts of the world.

“In addition, the compulsory license clause can help country-level governments override the intellectual property rights related to drugs or vaccines for the supply of the domestic markets in the absence of the IPR waiver as a way of circumventing intellectual property laws. However, the grant of IPR waiver will be an easy ride for all the developing nations with no further complications.”