The pharmaceutical exporters, who are exporting their Active Pharmaceutical Ingredients (APIs) to the 27-nation European Union (EU), are annoyed over the lackadaisical attitude of the authorities over their demand to take up the issue with EU for accepting Indian GMP as equivalent to that of EU CGMP, to make export of APIs to EU hassle free once the 'EU Directive on Falsified Medicines' comes into force on July 2, 2013.

According sources, even though the exporters have been crying coarse over the issue for quite some time, their representations to the authorities are yet to make any impact.

Drug controller general of India (DCGI) Dr GN Singh admitted that even though he has received memorandum from the stakeholders in this regard he is yet to take any concrete action on the issue. “I will soon hold discussions with the stakeholders to understand the issue fully before taking any step on this matter,” Dr Singh said.

Meanwhile, senior officials in the union commerce ministry said that the ministry so far has not taken any step on this issue as it did not receive any demand in this regard from the exporters or from any other quarters. “Nobody has contacted us with this demand so far and we are not aware of such demands,” said a senior official in the commerce ministry.

It may be recalled that the Pharmaceuticals Export Promotion Council of India (Pharmexcil), an arm of the union commerce ministry, had recently written to the DCGI asking him to take up the issue with the EU to get Indian GMP as equivalent to EU CGMP.

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

Under the new EU 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 Harmonization' 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.

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 Act (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.