April 30, 2022

 

Central Drugs Standard Control Organization (CDSCO) under the aegis of Ministry of Health and Family Welfare, Government of India has been taking many steps to control the menace of unapproved and irrational Fixed Dose Combinations (FDCs). In this process, government has banned many FDCs due to lack of safety and efficacy data. CDSCO vide their letter date 27.08.2021 has suggested various pathways for the regularization of these FDCs. For the complete update on these pathways and copies of original orders please visit our article Pathway for regularization of FDCs declared as rational.

 

CDSCO in their letter dated 27.08.2021 had provided a timeline of 180 days for filing of the applications. However, in the wake of COVID 19, CDSCO received various representations from stakeholders for extension of timeline for filing of the applications. Accordingly, CDSCO has now extended the timeline for regularization of FDCs till 31.10.2022.

 

Note: We at Vaayath, provides all the support for all types of DCGI/CDSCO permissions. Please feel free to contact us on vaayath@gmail.com for any clarification or support in filing of applications. 

 

 Reference:

  1. CDSCO order no. 04-146/2007-DC(Part-I) regarding extension of timelines for regularization of FDC