Regulator looks to make drug approval process fairer to first applicant

In a move to spur drug innovation and to restore fairness in the regulatory ecosystem, India’s top drug authority plans to overhaul a rule that puts early applicants for new medicines at a disadvantage, according to official documents and people familiar with the matter.

- Priyanka Sharma [e-mail]

The change is aimed at easing delays and encouraging greater investment in clinical research.

(MINT)

The change is aimed at easing delays and encouraging greater investment in clinical research, a crucial step as India seeks to reinforce its role as the “pharmacy of the world” and expand its $50 billion pharmaceutical market.

Under the existing framework, the first company seeking approval for a new drug must conduct clinical trials and bioequivalence studies, an expensive and time-consuming process. Subsequent applicants can get nod for the same drug by giving only bioequivalence data, effectively benefiting from the groundwork laid by the initial applicant.