OPPI seeks India-based start for regulatory data protection period

Industry body says it is open to a shorter regulatory data protection period if the clock starts from a drug's marketing approval in India rather than its first global approval

The Organisation of Pharmaceutical Producers of India (Oppi) is continuing discussions with the government on introducing Regulatory Data Protection (RDP), a mechanism that would prevent generic drugmakers from relying on the clinical trial and safety data submitted by innovators for a fixed period after a medicine is approved in India.

 

The industry body, which represents multinational research-based pharmaceutical companies, is seeking a 10-year protection period beginning from the date a drug receives marketing approval in India, instead of its first global approval as proposed in some quarters. However, Oppi said it is willing to accept a shorter protection period, provided the clock starts from Indian approval.

   

"Whether it is six, seven, eight, or 10 years, the first issue is the starting point," said Anil Matai, director general of Oppi. He argued that regulatory approvals in India can take anywhere between 18 months and four years, significantly reducing the effective protection period if calculated from the date of global approval.

 

Matai said consultations with the Department for Promotion of Industry and Internal Trade (DPIIT) have intensified since November, with multiple rounds of discussions involving the minister, secretary, and additional secretary. Oppi has also held separate discussions with the health ministry and the Central Drugs Standard Control Organisation (CDSCO). While no draft framework has been circulated and no timeline has been indicated, he said the proposal remains under active consideration.

 

The proposal has faced opposition from domestic generic drugmakers, who argue that RDP could delay the entry of lower-cost medicines and increase prices. Matai rejected the argument, saying generic companies would still be able to launch products during the protection period if they generate their own safety and efficacy data rather than relying on the innovator's regulatory dossier.

 

According to Matai, CDSCO had acknowledged a "lack of level-playing field" in an October communication and invited industry representations by early November. However, he said progress since then has been slow, with the proposal continuing to be discussed across the health ministry, DPIIT, and the commerce ministry.

 

Making the case for RDP, Matai said India risks falling behind in pharmaceutical innovation despite being one of the world's largest producers of medicines. Citing the World Intellectual Property Organisation's Global Innovation Index, he noted that India ranks 34th globally in innovation and has fallen significantly behind China in high-value drug research and biologics.

 

"We are the third-largest by volume, but that doesn't make us an innovator. We are a generic pharmacy to the world," Matai said, adding that India needs stronger innovation incentives if it wants to emerge as a global drug discovery hub.

 

He also dismissed concerns that RDP would reduce patient access, noting that patented medicines account for less than 5 per cent of India's pharmaceutical market even two decades after the country adopted a product patent regime in 2005. In more than 90 per cent of cases, he said, the proposed RDP period would fall within the existing patent term and would primarily prevent competitors from using the innovator's regulatory data rather than delaying generic competition itself.

 

To address what it describes as widespread misconceptions around RDP, Oppi is updating a public information document, explaining the distinction between patents and regulatory data protection, and the role of innovation in pharmaceutical research. The association said it will continue engaging with policymakers on its three key advocacy priorities: innovation, ease of doing business, and healthcare access.