Usha Sharma & Viveka Roychowdhury – Mumbai
The Drug Controller General (India) will be the competent national authority to certify API exports to EU. As part of this role, the DCGI’s office will need to give a written qualification certifying that the exports meet EU GMP qualifications. It is expected that the Zonal offices of the Central Drugs Standard Control Organization (CDSCO) will also be part of this certifying process.
This new level of responsibility has been necessitated to prepare for a new regulation scheduled to go into force in the European Union (EU) from July 2, 2013. Called the Falsified Medicines Directive (2011/62/EU), it mandates that all active pharmaceutical ingredients (APIs) imported into the European Union will need to be certified by a designated national authority of the exporting nation that they meet EU GMPs. The Directive was proposed to address the menace of counterfeit medicines entering the EU market and protect patient safety.
Speaking on the sidelines of the ongoing industry meet, CPhI India, Rajeev Kher, Additional Secretary, Department of Commerce, indicated that he would be meeting the DCGI to iron out the details of how CDSCO will prepare for this certification process.
As it is expected that the Zonal officers of the CDSCO will have to be operationally in tune with the specifications of the EU GMP in order to certify that the export consignments meet these norms, Kher indicated that CDSCO would be putting together a set of guidelines for its Zonal officers to enable this certification.
Confirming his role, Dr GN Singh, DCGI, informed that his office would be drafting these guidelines in consultation with major industry players. These consultations are already underway and the DCGI indicated that the draft guidelines will be finalised by January 2013. This is to ensure that Indian pharma exporters as well as the Indian regulators are well prepared for the scheduled July 2013 roll out of the EU Falsified Medicines Directive.
Dr PV Appaji, Director General, Pharmexcil applauded this decision and pledged the support of the Council to DCGI/CDSCO. He revealed that Pharmexcil will be organising meetings in Mumbai and Hyderabad so that its members’ views can be channeled to the DCGI and incorporated into these guidelines as required. He expressed his hope that the drafting process will be completed within the next month. “Industry is anxiously awaiting these guidelines as they are crucial to pharma exports to the EU,” explained Appaji.
The Directive was initially seen as a trade barrier and pharma exporters from India had concerns that exports to the EU would suffer badly. Singh sought to ally these concerns saying, “We want to promote Indian pharma exports and to make this possible, the Centre and State regulators are working in close coordination with industry as well as with the Ministry of Commerce. My concern is that the regulator of the importing country should also be involved with the process to certify that the imported medicines do indeed meet their specifications.”
Singh’s concerns seem to be reflected by industry associations like the European Fine Chemicals Group (EFCG) who have recently called for mandatory inspections of all global API manufacturing sites via mutual recognition agreements. The EFCG has also gone on record to criticise the Directive, stating that the measures do not adequately address the API quality issues associated and that in reality it does little to improve upon the present Directive (2001/83/EC) with regard to patient safety.
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