India issues Guidelines for Certification of API Exports to EU - can the EU accept this Certification?

After the announcement from India that the Central Drugs Standards Control Organization (CDSCO) would be the competent authority to issue written confirmations as required by the Falsified Medicines Directive for importing APIs into the European Union, all eyes were on the Indian Regulator to announce the procedure for issuance of such certification.

The Indian regulator has now published documents on its website. These documents give administrative procedure to be followed by manufacturers and the CDSCO.

However it is surprising that both the Indian "Drugs and Cosmetics Act" and the Indian "Drugs and Cosmetics Rules" do not have any provision for issuance of a guidance document. But these documents have been published as guidelines and SOPs. So some questions might be asked: how do these documents become a statute or a regulation or a standard? And are they an enforcement tool or do they have any legislative sanction and legal status? The standard for GMPs has remained unchanged and this standard is not equivalent to ICH Q7 or Part 2 of the EU-GMP Guide.

India has a federal structure with each state having its own local Food and Drugs administration who issue the manufacturing license for the manufacture of an API. The inspectors of these local offices have the legal authority to inspect the manufacturing premises and not the CDSCO, which is a Central Authority. So now there is a somehow paradox situation where the standards for GMP are national Indian Standards enforced by the state/provincial Indian FDA and there is a Written Confirmation issued by CDSCO as a central agency with no enforcement authority and no oversight of GMP implementation.

Uday Shetty points out that India first needs to have a Regulatory Standard in place which is equivalent to the EU standard and than have an effective enforcement practice in place. Once this is realised, a Written Confirmation can be issued. He thinks that Written Confirmations can not be given until GMP standards and enforcement are really equivalent to those in the EU. For this India needs to change its statutes, modify the GMP regulations in the Indian Drugs and Cosmetics Act and rules to incorporate the GMP requirements of ICH Q7 and introduce regulatory and/or legislative measures for effective  enforcement of GMPs before a legally valid certification required by EU Directive can be issued.

Here you can find Uday Shetty's original blog

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