Data exclusivity will kill the generics industry: Advocacy group

The government’s plans to introduce data exclusivity provisions in the country’s drug regulatory framework pose a risk to the generics market, and could likely create monopolies in the pharma sector, an advocacy group said on Wednesday.

The Working Group on Access to Medicines and Treatment (WGAMT) said that the Department of Promotion of Industry and Internal Trade (DPIIT) and the Central Drugs Standard Control Organisation (CDSCO) are considering to introduce data exclusivity (DE) provisions which could delay access to lifesaving generic medicines,