India: CDSCO Simplifies Schedule M Compliance Extension Process via ONDLS Portal (w.e.f. 25 March 2025)

The Department of Health and Family Welfare has taken a crucial step to support small and medium pharmaceutical manufacturers by granting an extension to comply with the revised Schedule M regulations. Per the recently published notifications on 11 February 2025, manufacturers can now apply for an extension of time for implementation. This move is expected to ease the transition for companies with a turnover of less than ₹250 crore, ensuring they effectively meet the new compliance standards.

Understanding the Compliance Extension

The government of India acknowledges the challenges faced by SMEs and has provided an option to apply for an extension until 31 December 2025.

To avail of this extension, manufacturers must:

• Submit an application to the Central License Approving Authority using Form A through the ONDLS Portal

• Apply within three months from the date of publication of the circular

• Provide a detailed plan of upgrading to align with the revised Schedule M norms

  
  

The Role of the ONDLS Portal

In a step towards digital transformation, the Central Drugs Standard Control Organization (CDSCO) has introduced an online system for extension requests. Manufacturers must register and submit their applications exclusively through the ONDLS portal. Hard copies of applications will not be accepted, reinforcing the shift toward a paperless regulatory process.

Conclusion

This extension provides valuable time for SMEs to upgrade their facilities without business disruption, ensuring global GMP standards compliance and access to financial assistance or partnerships to meet the revised requirements. Businesses must strategize their compliance efforts efficiently.

Source: Central Drugs Standard Control Organization (CDSCO)