India cuts stability data reqs for API firms seeking docs to ship to EU

By Gareth Macdonald

- Last updated on GMT

India says it needs less stability data for API exports
India says it needs less stability data for API exports
India has relaxed stability data requirements for API manufacturers seeking “written confirmation of quality” certificates needed to ship to the EU.

Since last Wednesday​, active pharmaceutical ingredient (API) manufacturing seeking CDSCO “written confirmation” need to submit six months of accelerated stability data (as well as six months of long term stability data for three drug batches.

The new data requirement contrasts with the 12 months stability data previously required and follows a recommendation from several CDSCO Zonal offices.

The revised rule comes with the caveat that no major changes are observed and that the firm provides details of its testing protocols within 30 days.

In addition, companies seeking written confirmation need to assign API batches with expiry dates as per International Conference on Harmonisation (ICH) guidelines.

International API firms wanting to ship to the EU have been required to provide "written confirmation" of the quality of their products from local regulators since July 2, 2013​. 

The CDSCO, which is the organisation responsible for conducting the assessments on which the confirmations are based, has previously set out guidance on the application​ and submission process and explained how ingredient manufacturers should prepare for facility inspections​.

It has also detailed the procedures for reporting non-compliant APIs and facilities to EU authorities​.

Related news

Show more

Related products

show more

Increasing the Bioavailability of Oncology Drugs

Increasing the Bioavailability of Oncology Drugs

Content provided by Lonza Small Molecules | 13-Nov-2023 | White Paper

Oral tyrosine kinase inhibitors (TKIs) are a class of cancer drugs that can be highly susceptible to issues with solubility in the gastrointestinal tract

Efficient Freezing & Storage of Biopharmaceuticals

Efficient Freezing & Storage of Biopharmaceuticals

Content provided by Single Use Support | 06-Nov-2023 | White Paper

Various options exist for freezing biopharmaceutical bulk material, but selecting the most effective and efficient approach for each cold chain can be...

Manufacturing Drugs with Highly Potent APIs

Manufacturing Drugs with Highly Potent APIs

Content provided by Altasciences | 28-Sep-2023 | White Paper

In this issue of The Altascientist, we examine the critical considerations for the safe and compliant manufacture of drugs with highly potent APIs (HPAPIs),...