Regulatory amendment streamlines low‑quantity drug imports for R&D

The Ministry of Health and Family Welfare has proposed a revision to the Drugs Rules, 1945 that simplifies the approval process for importing small quantities of medicines intended for analytical testing or research and development.

The amendment introduces an acceptance‑based system that eliminates the need for a separate license when importing limited batches of drugs for non‑clinical testing. Under the new framework, applicants can obtain clearance through a streamlined procedure, reducing the administrative burden associated with Form 11 submissions.

Officials explained that the change will facilitate faster testing, encourage innovation, and support start‑ups and established firms alike in launching R&D activities. By removing licensing hurdles for low‑volume imports, the ministry aims to promote a more agile pharmaceutical ecosystem.

The revision is part of a larger governmental push to strengthen regulatory oversight while simultaneously improving the ease of doing business in the pharmaceutical sector.