CDSCO asks MSME pharma firms to apply online for Schedule M extension

This comes after the health ministry had on February 11 formally extended the deadline for implementing the revised Schedule M by one year for pharma companies with an annual turnover below Rs 250 cr

The Central Drug Standards Control Organisation (CDSCO) has asked all small- and medium-sized pharmaceutical manufacturers to only submit online applications to seek extension for adhering to the revised ‘Schedule M’ norms.

 

In a circular dated March 20, the apex drug standards authority asked applicants to register on the Online National Drugs Licensing System (ONDLS) portal and submit applications there.

 

ONDLS is a single-window platform for processing applications such as issuance of manufacturing and sales licences and other certificates like good manufacturing practices (GMP), market standing certificate, and post-approval changes online.

 

This comes after the health ministry had on February 11 formally extended the deadline for implementing the revised ‘Schedule M’ by a year for pharmaceutical companies with an annual turnover of less than ₹250 crore.

 

The extension, however, is subject to these pharmaceutical companies submitting an application to the central licensing approval authority along with a plan for upgradation within three months from the date of the publication of notification.

 

The application, also called Form A, includes a gap analysis by manufacturers for key areas such as plant, lab equipment, heating, ventilation and air conditioning systems, and utilities. 

 

The companies would also have to provide an item-wise plan or strategy for compliance with the revised GMP, starting on or before March 31. 

 

The health ministry had earlier stated that it will conduct an audit of these facilities after three months, and action will be taken if the committed upgrade is not implemented.

 

Schedule M, which sets quality standards and GMP for pharmaceutical companies, was notified by the health ministry in December 2023 and came into effect on January 1, 2025.

 

However, the deadline was later extended to December 31, 2025 for small pharmaceutical companies after the ministry got representations from pharmaceutical bodies highlighting challenges faced by small- and medium-sized units in adhering to the revised GMP norms.

 

Currently, India has around 10,500 pharmaceutical units, of which 8,500 belong to the micro-, small- and medium-enterprises (MSME) sector. Of these, approximately 2,000 MSME units currently hold a World Health Organization-GMP certification.