Context: India safeguards its $25B generic drug industry by excluding data exclusivity from the India-UK FTA to ensure affordable drug access and faster generic launches. India’s stance upholds the TRIPS norms, protecting pharma exports and local manufacturers' interests.
Relevance of the Topic: Prelims: Concept of Data Exclusivity.
Data Exclusivity out of UK FTA:
- Recently, India and the UK have announced the conclusion of the free trade agreement (FTA) that will substantially liberalise trade between the two countries.
- The UK was pushing for inclusion of Data Exclusivity provisions in the FTA which would have prevented Indian generic drugs manufacturers from using the clinical trial data generated by the pharma patent holders.
- India has protected the interest of its generic pharma industry by keeping out data exclusivity provisions from the FTA with the UK. Earlier, India had also rejected a similar demand from the four-nation European Free Trade Association (EFTA) in their FTA signed in 2024.
What is Data Exclusivity?
- Data Exclusivity refers to the fixed period during which the non-clinical and clinical trial data submitted by the innovator pharmaceutical company to the regulatory body cannot be used by the generic manufacturers.
- Purpose: Protects data generated in the course of clinical trials of a drug. By gaining exclusive rights over this data, innovator companies can prevent their competitors from obtaining marketing licence for low-cost generic versions during the tenure of this exclusivity.
Lack of Data Exclusivity law in India:
- The Indian Drug and Cosmetic Act, 1940 and the Drug and Cosmetic Rules, 1945 do not provide for data exclusivity.
- Lack of Data Exclusivity law risks unfair commercial use of test data submitted to the Indian government during application for market approval of pharma or agro-chemical products.
- Indian laws allow the use of this data by companies to launch copies of the drugs that go off-patent. This reduces time and costs for generic manufacturers. If generic companies were to generate the same data independently, it would delay their generic launches.
India’s generic drug industry is estimated at about $25 billion and the country exports half of its output. Data exclusivity is beyond the provisions of the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement under the World Trade Organisation.