An Indian export group has published what it claims are draft CDSCO guidelines setting out what API makers must do to comply with EU import rules that come into effect this summer.
The documents – which were made available by Pharmaceutical Export Promotion Council of India (Pharmexcil) and linked to by the Drug Regulations blog – apparently detail how manufacturers can obtain the written confirmations of quality that must accompany active pharmaceutical ingredients (APIs) shipped to the European Union (EU) from July.
The procedures for reporting non-compliant APIs and facilities to EU authorities are also set out as is - somewhat worryingly - an example of the ‘written confirmation’ letter that manufacturers must send with any shipments (in-Pharmatechnologist.com has decided not to include the link to this document).
in-Pharmatechnologist.com asked Pharmexcil and the Central Drugs Standards Control Organisation (CDSCO) to confirm the authenticity of the documents, but neither organisation responded to requests for information.
The CDSCO was first named as the body that will oversee the quality of APIs shipped to Europe last month according to Pharmexcil , although the role has not yet been confirmed by the Indian Government.
Confirmation of the CDSCO’s role and or the authenticity of guideline documents published by Pharmexcil would be welcome news for both manufacturers in India and drug companies and regulators in Europe.
The discovery of the documents comes a few days after authorities in China – another major source of the APIs used in Europe – started a survey of its manufacturers citing EU import laws as the motivation.
The initiative, unlike the Indian efforts, was announced officially by the State Food and Drug Administration (SFDA) on its website.