Data Exclusivity India

Introducing data exclusivity in indian system is now hot topic. Data Exclusivity is a kind of protection granted for safety and efficacy data established during clinical trials, which is submitted by drug companies to regulatory agencies for evaluation and subsequently for approval.

Duration of Exclusivity varies from country to country, normally 5 to 10 years. During this exclusivity time no generic players dossier will be accepted by agency for approval. This exclusivity protects innovator companies' interest on investment made for clinical studies for particular drug/drug product regardless of patent protection. This protection is granted by regulatory agencies.

For more details on data exclusivity, please refer Link 1, Link 2

As of now, India does not provide any data exclusivity to innovator companies. Being a member country in WTO, this is the obligation for India to introduce such protection to protect interest of large/innovator companies as a part of TRIPS agreement.

Recently as per news articles on Economics time and business standard, WTO and Health ministry conducting questionnaire to introduce data exclusivity in Indian system of drug approval.

Indian pharmaceutical alliance (IPA) is a group of indian pharmaceutical companies, has raised objection on this issue.

To note, India has introduced product patent protection to chemical/pharmaceutical patents as a part of TRIPS agreement on 2005.

Economics times [Link] Business standard [Link]

News Update:

ipkat post on data exclusivity in EU [Link]