The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has called upon the industry to come forward with their issues relating to the issuance of Written Confirmation (WC) certificate by the DCGI for pharma products exported to the European Union (EU) for discussion with the commerce ministry.
The Council wants the industry to give their feed back on the issuance of WC or any other issues they are facing relating to it, so that they can take up this issue with the concerned authority. Pharmexcil informed that they want the stakeholders to pro-actively send in their representation at the earliest, as they are contemplating to have a meeting with the ministry along with the drug controller general of India by mid-July.
It is understood that apart from some minor issues faced by some exporters like the lack of clarity in classifying narcotics as per requirements, non clearance of some drugs that have not received approval from the Indian drug regulatory office etc. for exports, there are hardly any major issues that have come up for assistance. Dr P V Appaji, director general, Pharmexcil informed that with due representation from the industry in time, especially those relating to the pending application etc. they will be able to appraise the issues effectively to the authority.
He added, “We are happy to note that, the over all feedback from the industry on the procedural part relating to the issuance of WC from the DCGI has been positive, so far. However, all said and done, we want to make sure and assure all our stakeholders that all steps will be taken by the commerce ministry to ensure that exports do not suffer in any way due to this arrangement. We are constantly monitoring and looking at all the measures to ensure pro export environment for the industry.”
The Council stressed that even though some of the issues that have been highlighted target a very niche audience, steps will be taken to address their problems in time. “We are only waiting, so that we can present it all to the authority at single forum along with other glaring issues faced by the exporters rather than just presenting it randomly,” he informed.