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