If you’re part of India’s pharmaceutical manufacturing world, it’s crucial that you align your practices with CDSCO guidelines for BMR and eBMR. The Central Drugs Standard Control Organization (CDSCO) plays a key role in regulating how batch records are created, maintained, and audited across the country.
Let’s break it down so you can understand what’s expected — and how you can stay ahead.
What is the CDSCO’s Role in BMR?
CDSCO ensures that every drug manufactured in India meets GMP (Good Manufacturing Practice) standards, including proper Batch Manufacturing Record (BMR) documentation. Whether you’re handling paper-based BMRs or transitioning to electronic systems (eBMR), your records must be complete, legible, accurate, and traceable.
You can check out CDSCO’s official GMP guidelines for more information.
Key Expectations for BMRs in India
Here’s what you need to make sure your BMR covers:
✅ Comprehensive Process Documentation
Every single step — from raw material issue to final packaging — must be recorded. This includes equipment used, process parameters, personnel involved, and time stamps.
✅ Real-Time Entry
Entries should be made at the time of operation, not after. Backdated entries are considered a serious GMP violation.
✅ Cross-Verification and Approvals
Signatures from the production team and QA are mandatory. CDSCO expects clear segregation of duties and accountability.
Moving Toward eBMR in Indian Pharma
India’s pharma sector is quickly embracing digital documentation to improve accuracy and regulatory compliance. But the transition from BMR to eBMR requires validation, training, and audit-readiness.
Here’s what CDSCO looks for in eBMR systems:
- 21 CFR Part 11 or equivalent compliance (electronic records & signatures)
- Tamper-proof audit trails
- System validation reports
- Proper backup & data recovery measures
- Controlled access and role-based user permissions
Some Indian pharma plants have already implemented systems that meet both CDSCO and global regulatory standards like WHO-GMP.
Switching to eBMR is a smart move — but only if it’s done correctly. Make sure your solution is fully validated, your team is well-trained, and your SOPs reflect the digital shift.
Being proactive with compliance isn’t just about avoiding audits — it’s about building quality into your process from day one.