India :New Form 40 draft guidance for API importers

India’s CDSCO has issued draft guidance designed to help active pharmaceutical ingredient (API) importers streamline the submission and registration process.

The document provides advice on the Central Drugs Standard Control Organization’s (CDSCO) ‘Form 40’ registration form, which is used by firms wishing to bring APIs and finished drugs into the country.

Under the new proposal importers would be required to provide details of the overseas production sites, including audit reports, where the APIs, drugs and intermediates they bring into India are manufactured and tested.

The draft guidance also sets out the quality testing processes required for imported batches as well as the various legal obligations importers undertake and the CDSCO’s registration fees - $1,500 for each manufacturing site and $1,000 for each compound imported.

The organisation has invited stakeholders that will be affected by the new guidance, primarily local manufacturers, wholesalers and local distribution agents, to provide comments and feedback over the next 20 days.

The Indian regulator, which maintains a list of registered finished formulation and bulk drug s imports, has been trying to tighten up its oversight of pharmaceuticals brought into the country over the last few years.

This process began in 2009 when the organisation revised its rules on APIs for trials and began asking drugmakers seeking to bring ‘appreciably large’ quantities of a test compound into India to provide justification for doing so.

CDSO GUIDANCE.pdf (921.2 KB)