MoHFW proposes amendment to Drugs Act, 1945 to mandate authorisation of qualified personnel for drug batch release
Summary
- The Union Health Ministry has drafted a proposal to amend the Drugs (Regulation) Act, 1945.
- The amendment seeks to make it mandatory for drug batches to be released only after authorisation by qualified personnel.
- The move aims to tighten quality control, curb sub‑standard medicines and ensure compliance with Good Manufacturing Practices (GMP).
- The proposal will be placed before the Union Cabinet for approval before being introduced in Parliament.
- Implementation is expected to strengthen the regulatory oversight of pharmaceutical manufacturers across India.
Key Facts
- · Act concerned: Drugs (Regulation) Act, 1945
- · Proposed change: compulsory authorisation by qualified persons for drug batch release
- · Authority proposing amendment: Ministry of Health and Family Welfare
- · Objective: improve drug safety and compliance with GMP standards
- · Process: amendment to be cleared by Cabinet and then tabled in Parliament
Why it matters
Ensuring that only qualified professionals can approve drug batches will reduce the circulation of sub‑standard medicines, protect public health, and align India's pharmaceutical regulatory framework with international best practices, thereby boosting confidence in Indian drugs domestically and abroad.
#Health Ministry#Drugs Act#pharmaceutical regulation#quality control#public health#legislative amendment