e-Aushadhi Portal Guidelines for AYUSH Manufacturers: Key Requirements You Must Know

The e-Aushadhi Portal has been introduced to digitise the licensing process for manufacturers of Ayurveda, Siddha, Sowa-Rigpa and Unani (ASSU) medicines. These guidelines apply to manufacturers operating under Form 25D and Form 25E licences and aim to streamline licensing, improve transparency and simplify regulatory compliance.

Whether you are applying for a new manufacturing licence or already hold an ASSU manufacturing licence, understanding the latest e-Aushadhi Portal requirements can help you avoid various delays and ensure a smooth and hassle-free application process.

Quick Summary

Is Registration on the e-Aushadhi Portal Mandatory?

Yes. Registration on the e-Aushadhi Portal is mandatory for all applications related to ASSU manufacturing licences. Each manufacturing licence requires a separate portal registration. Therefore, businesses holding multiple licences must complete an individual registration for each licence before submitting applications through the portal. 

What Must Existing Licence Holders Do?

Manufacturers already operating under Form 25D or Form 25E must upload their previously approved records through the Legacy Module.

During the first phase of verification, applicants are required to submit: -

• Technical Expert details
• Perpetual licence details
• Licence issue and enforcement dates

Once the uploaded information is successfully verified by the concerned State Licensing Authority, manufacturers become eligible to apply for additional products, certificates and other services through the portal.

Who Can Be Appointed as a Technical Expert?

Technical Expert details must strictly comply with the provisions of the Drugs and Cosmetics Act, 1940 and the applicable Rules governing ASSU medicines. Providing accurate and proper information is essential for the purpose of smooth verification and regulatory compliance.

Can Manufacturers Use an External Testing Laboratory?

Yes. Manufacturers may use an outside testing laboratory. However, the laboratory must be registered on the e-Aushadhi Portal before it can be selected and linked with the manufacturing unit.

Can Existing Approved Products Be Added Later?

Yes. The Legacy Module allows manufacturers to add existing approved products for six months from the date the portal becomes mandatory. While adding products, applicants must provide the applicable shelf-life details as required under the relevant legal provisions. Manufacturers are also encouraged to upload at least one approved product for each dosage form along with the corresponding approval documents.

How Can You Avoid Delays in Approval?

Verification delays commonly occur due to incomplete licence information, incorrect Technical Expert details, missing supporting documents or failure to upload documents in the prescribed format.

Important: Manufacturers should regularly check and monitor the "Latest Updates" section of the e-Aushadhi Portal for new notifications, guidelines and instructions. For technical issues, applicants should contact the portal's IT support, while application-related queries should be addressed to the respective State Licensing Authority.

Final Thoughts

The e-Aushadhi Portal is an important initiative to modernise the licensing process for AYUSH medicine manufacturers. By understanding the registration requirements, the legacy data submission process and the documentation standards, manufacturers can ensure smoother compliance and minimise application delays.

Need assistance with AYUSH manufacturing licence compliance or the e-Aushadhi Portal? Remind Legal helps manufacturers with documentation, regulatory compliance, legacy data submission and licence-related applications to ensure a smooth and compliant filing process.

Frequently Asked Questions (FAQs)

1. Is registration on the e-Aushadhi Portal mandatory for AYUSH manufacturers?
   Yes. Registration is mandatory for all manufacturers applying for the licences or related services under the ASSU systems. Each manufacturing licence requires a separate portal registration.

2. Do existing Form 25D and Form 25E licence holders need to upload legacy data?
   Yes. Existing licence holders must upload their approved licence details and other required information through the Legacy Module before accessing additional online services.

3. Can I use an external laboratory for product testing?
   Yes. However, the external laboratory must first be registered on the e-Aushadhi Portal before it can be linked to your manufacturing unit.

4. What documents should I keep ready before using the e-Aushadhi Portal?
   Keep your perpetual licence details, licence issue and enforcement dates, Technical Expert information, approved product details (where applicable) and supporting documents in the prescribed format.

5. What happens after my Legacy Data is verified?
   After successful verification by the State Licensing Authority, you can apply online for additional products, certificates and other services available through the e-Aushadhi Portal.