Usha Sharma – Mumbai
Pharmaceuticals Export Promotion Council of India (Pharmexcil) has mooted the idea of a committee, constituted by the Drug Controller General (India) (DCGI), under the chairmanship of the joint secretary, Department of Commerce and Industry, Government of India to help the DCGI decide on issues related to the EU Directive on Falsified Medicines, due to come into effect from July this year. The committee will comprise of a representative each from both the DCGI and Pharmexcil.
Government of India had officially deputed the Drug Controller General (India) (DCGI) as the competent authority in India for issuing written certificates on API export consignments, as required by the EU Directive 2011/62/EU of June 8, 2011 with amended Directive 2001/83/EC. In line with this, DCGI had shared drafted guidelines for issuing written confirmation on EU Directive with Pharmexcil and Pharmexcil had requested Indian pharma companies to share their concerns and suggestions on the checklist issued by the DCGI before February 14, 2013.
Giving more details, Dr PV Appaji, Director General, Pharmexcil said, “We recently conducted a meeting with the DCGI and Additional Secretary, Department of Commerce and Industry, Government of India and discussed issues relating to the EU Directive on falsified medicines. We shared our comments and concerns over the draft guidelines prepared by DCGI and to a large extent, the DCGI agreed to the points we shared. We have suggested that DCGI should form a new committee which will mainly see to issues related to exports to the European Union. We expect to get a final confirmation by the end of this month for issuing written certificates to the exporters.”
He highlighted, “The committee may review all representations from the exporters from time to time and DCGI will act on the basis of the committee’s comments.”
In the same meeting, Pharmexcil also raised major issues related to the EU Directive and asked DCGI to consider simplifying the documents which need to be submitted to the DCGI. Like other regulatory agencies, inspections by DCGI officers can be carried out based on the site master plan to be submitted to DCGI. It has also suggested to consider critical data verification from the original documents which can be done at the site itself. Based on valid certificates held by individual companies issued by various regulatory agencies like US FDA, UK MHRA, EDQM, TGA or COPP under WHO-GMP, DCGI may consider the issue of confirmation certificates for a limited period.
Appaji said, “We have suggested that the DCGI should conduct inspection after issue of limited validity certificate. We want to ensure that all the issues related to the EU Directive will be resolved and the Government has also given us an assurance on this issue. Hopefully by the first week of March, we will receive the final confirmation from the DCGI.”
Pharmexcil has asked DCGI to upload all the government notifications and competent authority communication on the Central Drugs Standard Control Organization website. He was also asked to upload draft guidelines on the CDSCO website urgently and DCGI has assured that it will upload the guidelines very soon.