Regulatory data protection for pharmaceuticals in India

14 Oct

How implementing RDP in India could benefit society, industry, and the economy

Regulatory Data Protection (RDP) protects the data generated through clinical trials for regulatory approval and incentivises pharmaceutical R&D

Innovator companies make significant investments to produce safety and efficacy data necessary for marketing approvals. In addition to ensuring that this confidential data is not disclosed to competitors, many markets protect this data with RDP for a limited period, during which other parties cannot rely on the data to obtain marketing authorisation. Once the RDP term expires, third parties can rely on that data for generic or biosimilar approvals. In this manner, RDP facilitates a level playing field between innovators and generics.

In the past, India debated proposals to introduce RDP and recently observed that the lack of an RDP policy is a “missing link” to support a level playing field between innovators and generics.

To assess the potential impact of RDP, we isolated the effect of RDP from other important factors that may differ between RDP and non-RDP markets, including population size, income levels, and healthcare spending. Our analysis draws on 15 years of data from 53 developed and developing markets, complemented by India-specific data.

Implementing RDP could increase the availability of innovative medicines in India

The availability of innovative medicines in India is below the average non-RDP market. With RDP, the availability of innovative medicines in India could increase by up to 156%. In practice, this means that with RDP, 25 more of the innovative medicines launched globally between 2017 and 2021 would have been available in India in 2021.

Implementing RDP could also create significant opportunities for the generic and biosimilar industry in India

RDP complements follow-on competition by increasing the availability of innovative medicines. On average, 41 generics or biosimilars are available in India for every innovative medicine, highlighting the significant opportunity for the generic industry to build on the greater availability of innovative medicines.

Implementing RDP could unlock an estimated USD 12.7 billion in additional pharmaceutical R&D investments and substantially increase clinical trial activity

Effective RDP policies in India are expected to increase clinical trial activity from 1,619 to 5,827 clinical trials per year in the long run. This would move India’s global ranking from 90th to 56th in annual trials per million people.

Assuming that the investments required to conduct a clinical trial remain constant, this could drive an additional USD 12.7 billion annually in pharmaceutical R&D investments in India.

The study was commissioned by PhRMA.

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