The Ministry of Health and Family Welfare has issued a draft amendment to the Drugs Rules, 1945 proposing mandatory authorization of a qualified person responsible for batch release of drug products. The proposal introduces recordkeeping requirements under Schedule U, mandates batch release certification, and requires manufacturers to maintain comprehensive batch release documentation to ensure compliance with GMP requirements.
The Ministry of Health and Family Welfare has published draft amendments to the Drugs Rules, 1945 aimed at strengthening pharmaceutical manufacturing oversight and product quality assurance. The proposal requires manufacturers seeking licenses under relevant provisions to designate an authorized person possessing appropriate qualifications and experience for batch release activities.
New Rule 68C and amendments to Rules 74, 74A, 74B, 78, 78A, and 122G introduce mandatory maintenance of batch release records in accordance with Schedule U. The draft further specifies detailed requirements for a Batch Release Certificate, including product details, manufacturing and testing site information, batch manufacturing and packaging records, environmental monitoring data, IPQC reports, Certificates of Analysis, and conformity certification.
These requirements are intended to enhance GMP compliance, traceability, accountability, and quality oversight of pharmaceutical products manufactured in India.