The Pharmaceuticals Export Promotion Council of India (Pharmexcil) is soon expected to meet the drug controller general of India (DCGI) to apprise him about the concerns of the industry over the renewal of the written confirmation (WC) certificates issued by the Centre to the API exporters, exporting to EU. This move comes in the wake of mounting pressure by the stakeholders over their fear over timely renewal of the WC certification, by the CDSCO due to dearth of manpower at the Centre and its zonal offices.
Industry fears that any delay in the renewal of these certificates will have a huge impact on their API exports, as there is a substantial value of API exports to EU. As per the directive on falsified medicines, which was implemented from July 2, 2013, all the APIs meant for medicinal products for human use would require written confirmation for each API unit by the DCGI's office confirming compliance with GMP standards or rules 'equivalent to the rules applied in the EU.
Following collaborative efforts between the commerce ministry and the DCGI’s office, India had started issuing WC since July 2013, which has a three-year validity. The industries fear stems from the fact that their WC validity is almost on the verge of expiry, while the CDSCO is ill equipped to address their demands due to shortage of manpower.
To ensure that exports do not suffer in the process of meeting the deadlines, Dr P V Appaji, director general of Pharmexcil informed that they have recommended the CDSCO to consider the possibility of issuing renewals of WC to exporters on the basis of their latest US FDA, MHRA, EDQM or CDSCO approvals for the time being. And later go for the inspection of the unit, as per the availability of the officials at the center and zonal offices, so that the companies do not suffer from the delay.
Pharmexcil has also recommended the Centre to put all the renewal details in the website so that it can be easily accessible to EU authorities or anyone seeking it, bringing more transparency into the system. “Our officials are in constant touch with the Centre to sort out this issue at the earliest, all steps are being taken by the commerce ministry with due diligence to follow up on this matter. We are positive that the DCGI will look into our suggestion and take requisite steps, as we want to ensure undisrupted export of APIs to EU,” he added.