Usha Sharma – Mumbai
Government of India has 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 Directive 2011/62/EU of 8th June 2011 with amended Directive 2001/83/EC. In line with this, DCGI has shared drafted guidelines for issuing written confirmation on EU Directive with Pharmaceuticals Export Promotion Council of India (Pharmexcil). Pharmexcil has requested Indian pharma companies to share their concerns and suggestions on the checklist issued by the DCGI before February 14, 2013.
Speaking exclusively with Express Pharma, Dr PV Appaji, Director General, Pharmexcil said, “We are going to meet DCGI for discussing the final notification on the EU directive guidelines. Hence, I request all pharma companies to share their concerns and suggestions, which we can represent from Pharmexcil.”
Appaji continued, “Since we have limited time and as the implementation date is July 2, 2013, we shall try to finalise the final notification before February 21, 2013.”According to industry sources have stressed their concerns over the 90 day period for granting the approval. They pointed out that if the facility has been already approved by the World Health Organization -GMP – COPP) (by DCGI), then there is no need for conducting inspection again.
Forecasting the serious business of API, Appaji commented, “China has already joined hands with the European Union lobby concerning over APIs threat from India. I request any top five Indian pharma CEOs to come forward and we can organise a meeting with the Ministry of Commerce within a week to discuss the issues.”
EU ambassador has asked the Indian embassy whether DCGI has communicated or informed to the industry on EU directives mentioning DCGI as the competent authority. Pharmexcil informed that Government of India has already been informed about this.
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