Archive · 18 Jul 2025
Drugmakers Seek More Time for Export Compliance
Companies that make medicine in India have to follow new rules to sell their products to other countries.
They need to get a special certificate online that says their medicine is safe.
Right now, they get this certificate a different way, but now it's going online.
The companies need more time because it's a lot of work to put all the information into the system, and they're worried about how long it will take to get the certificates.
They export 45% of their medicine to the Rest of the World.
They need to be quick, so they don't lose business to other countries.
Drugmakers seek six more months to comply with new export regulations.
The new requirement involves uploading compliance certificates online.
Pharmexcil highlights the extensive data that needs to be uploaded.
The deadline for online submission has been extended by a month.
RoW regions account for 45% of India's pharmaceutical exports.
- Who
- Indian drug manufacturers, Pharmexcil, and the CDSCO.
- What
- Drugmakers seek time to transition to new online export regulations for pharmaceutical products.
- When
- The deadline was July 15 but extended for a month.
- Where
- India, regarding exports to the Rest of World (RoW) regions.
- Why
- To allow drugmakers sufficient time to upload data and ensure smooth functioning of the new online system for export certifications.
Industry Concerns
Regulatory Intent
Data Upload
Industry Concerns
Concerns about the humongous amount of data needed to be uploaded.
Regulatory Intent
The regulatory authority expects the online transition as a streamlined approach.
Turnaround Time
Industry Concerns
Query turnaround time may be slow.
Regulatory Intent
Regulatory authorities need to speed up the process.
- Industry Request
- Six months to comply
- Regulation
- Online submission of Certificate of Pharmaceutical Product (COPP)
- Deadline
- Extended by a month from July 15
- Export market share
- RoW regions account for 45% of India's pharma exports
- Centralized system
- Already in place for US and Europe markets