The Organisation of Pharmaceutical Producers of India (OPPI) is advocating for a 10-year Regulatory Data Protection (RDP) period that begins from the date a drug receives marketing approval in India, rather than its first global approval. According to reports from Business Standard, OPPI director general Anil Matai emphasized that the starting point is the critical factor, stating that whether the protection period is 6, 7, 8, or 10 years, the first issue is the starting point. The industry body argues 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. As per the latest reports, OPPI is willing to accept a shorter protection period, provided the clock starts from Indian approval, with Matai noting that 'whether it is six, seven, eight, or 10 years, the first issue is the starting point'. The proposal represents 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.
OPPI has intensified consultations with the Department for Promotion of Industry and Internal Trade (DPIIT) since November, with multiple rounds of discussions involving the minister, secretary and additional secretary. As reported by Business Standard, the association 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, the proposal remains under active consideration. 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 noted that progress has been slow since then, with the proposal continuing to be discussed across the health ministry, DPIIT, and the commerce ministry. The latest reports confirm that discussions are ongoing with government officials at multiple levels.
The proposal has faced opposition from domestic generic drugmakers, who argue that RDP could delay the entry of lower-cost medicines and increase prices. However, OPPI rejects this argument, stating that 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 Business Standard, Matai noted that in more than 90% of cases, 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. The latest reports confirm that this remains the industry's position despite ongoing discussions, with Matai emphasizing that generic companies can still develop their own data during the protection period.
Matai argued that India risks falling behind in pharmaceutical innovation despite being one of the world's largest producers of medicines, citing the World Intellectual Property Organization's Global Innovation Index which shows India ranks 34th globally in innovation. As reported by Business Standard, he noted that India ranks third largest by volume, but that doesn't make it an innovator, stating the country is a 'generic pharmacy to the world'. He dismissed concerns that RDP would reduce patient access, noting that patented medicines account for less than 5% of India's pharmaceutical market even two decades after the country adopted a product patent regime in 2005. He also highlighted that India has fallen significantly behind China in high-value drug research and biologics, emphasizing that 'we are the third-largest by volume, but that doesn't make us an innovator. We are a generic pharmacy to the world'. He added that India needs stronger innovation incentives if it wants to emerge as a global drug discovery hub.
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. According to Business Standard, the association said it will continue engaging with policymakers on its three key advocacy priorities: innovation, ease of doing business, and healthcare access. The industry body is continuing discussions with the government on introducing 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. This comprehensive approach aims to clarify the regulatory framework and ensure that India maintains its position as a global pharmaceutical hub while protecting innovation incentives for research-based companies.
