DGFT Gives up on Pharma
TRACK AND TRACE after 14 years of trying, Hands over the baton to Ministry of
Health (CDSCO) even as Drugs are under Dept of Chemicals
·
India should Limit Regulation only till Port
of Export, Importing Country and Importer should take over Subsequently
The
Directorate General of Foreign Trade (DGFT) has decided to streamline export regulations
by aligning with the evolving regulatory framework of the Ministry of Health &
Family Welfare (MoH&FW). Accordingly, the provisions
related to the Track and Trace System for pharmaceutical exports under the Foreign
Trade Policy (FTP) are being withdrawn.
The
Track and Trace System, introduced via Public Notice dated 10th January 2011, mandated
barcoding at various packaging levels. While tertiary and secondary packaging requirements
were successfully implemented in 2011 and 2013, primary-level barcoding and parent-child
data uploading faced operational challenges and were repeatedly deferred, with the
last extension valid until 1st February 2025.
The
decision to withdraw these provisions is based on the following key considerations:
MoH&FW has already implemented barcode/QR code
requirements for 300 drug brands under the Drugs Rules, 1945, effective 1st August
2023, with plans for further expansion.
Most
export destinations have their own serialization requirements, ensuring product
traceability without additional domestic regulations.
MoH&FW, as the primary regulatory authority, provides
a unified framework through the Central Drugs Standard Control Organization (CDSCO),
ensuring consistency and eliminating duplication.
With
this step, DGFT is enhancing ease of doing business for pharmaceutical exporters
while ensuring regulatory coherence. Accordingly, the provisions under Para 2.76
of the Handbook of Procedures (HBP) 2023 have been withdrawn.