Even as the crucial date for the implementation of the 'EU Directive on Falsified Medicines' is approaching fast, the exporters have asked DCGI Dr G N Singh to takes up the issue with European Union (EU) for accepting Indian GMP as equivalent to that of EU CGMP to make export of active pharmaceutical ingredients (APIs) to EU hassle free.

The new law, which will be effective from July 2, 2013, is aimed at preventing falsified medicinal products from entering EU from other countries. As per the directive, the APIs meant for medicinal products for human use would require written confirmation for each API unit by the enforcement authorities of the exporting countries confirming compliance with GMP standards or rules 'equivalent to the rules applied in the EU', such as WHO GMP, 'International Conference for Harmonisation' Q7 (ICH Q7), etc.

However, this cumbersome requirement would not be necessary in case of exporting countries which are certified on the EU's list of countries having the standards of GMP which are equivalent to the standards of EU.

The EU has recently notified Switzerland as a country which is equivalent in the implementation of GMP requirements to that of EU GMP. Likewise, the requests from other countries like Brazil, Israel, Australia and Singapore are under examination by EU for equivalence assessment.

Exporters argue that inspections and other regulatory obligations being followed or enforced for Indian GMP for APls under the provisions of Schedule M of Drugs & Cosmetics (D&C) Act are also equivalent to that of EU CGMP. They further plead that the hassles of issuing written confirmations (certificates) to each company exporting the APls to EU can be avoided if the DCGI takes up the issue with EU for accepting Indian GMP as equivalent to EU CGMP.

Meanwhile, the Pharmaceuticals Export Promotion Council of India (Pharmexcil) has also written to the DCGI asking him to take up the issue with the EU to get Indian GMP as equivalent to EU CGMP.