In a move to simplify and digitize the licensing process for pharmaceutical companies, the Central Drugs Standard Control Organization (CDSCO) has launched the Online National Drugs Licensing System (ONDLS). This online portal will now be used by small and medium pharma manufacturers to apply for an extension to implement the revised Schedule M guidelines.
This step comes in response to requests from manufacturers who need more time to upgrade their facilities and systems to meet the updated requirements of Schedule M—the key set of rules ensuring Good Manufacturing Practices (GMP) for pharmaceutical production in India.
🧾 What Is Schedule M and Why Was It Updated?
Schedule M is part of the Drugs and Cosmetics Rules, and it outlines the standards for:
- Manufacturing plant design
- Equipment and machinery
- HVAC systems and utilities
- Qualified technical staff
- Proper documentation practices
The updated Schedule M, notified on February 11, 2025, aims to strengthen drug quality and safety by aligning Indian manufacturing practices with global standards.
🏭 Who Can Apply for Extension and How?
As per the notification G.S.R. 127(E), small and medium pharmaceutical manufacturers with a turnover of less than ₹250 crores can seek an extension of the compliance timeline.
Key requirements to apply:
- Conduct a gap analysis – This includes reviewing current compliance levels in key areas like infrastructure, equipment, and documentation.
- Create a detailed upgrade plan – Manufacturers must explain how and when they will meet the revised Schedule M requirements.
- Submit Form A – This form must be submitted online to the Central Licence Approving Authority (CLAA) via the ONDLS portal.
🔗 Portal Link: www.statedrugs.gov.in
🗓️ The deadline to apply for an extension is within 3 months from the date of notification (i.e., by May 11, 2025).
📅 For approved applicants, the extended deadline to comply with Schedule M is December 31, 2025.
🚫 Important: Hard copy applications will NOT be accepted.
🌐 About ONDLS Portal
The Online National Drugs Licensing System (ONDLS) was developed by CDSCO to bring more transparency, efficiency, and speed to India’s pharmaceutical licensing system. The portal allows manufacturers to:
- Register digitally
- Submit applications for Schedule M Extension
- Upload necessary documents
- Track application status online
This eliminates paperwork and manual delays, offering a centralized and paperless process.
🧪 Why This Matters for the Healthcare Industry
While this update is focused on pharma manufacturers, it has a direct impact on doctors, hospitals, and patients. Here’s how:
- Ensures higher quality and safer medicines
- Aligns Indian manufacturing with global drug safety standards
- Encourages compliance and accountability in the pharma industry
- Strengthens trust in locally manufactured medications
✅ Are You a Doctor or Hospital Partnering with Local Pharma? Stay Informed!
If you prescribe or procure medicines from local manufacturers, it’s important to know whether your suppliers are working towards Schedule M compliance.
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