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CNBC TV18
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EU Pharma Ban = No Trade Talks?

Published on Thu, Aug 06,2015 | 19:40, Updated at Fri, Aug 07 at 11:21Source : CNBC-TV18 

Welcome to The Firm Audiocast. On August 5th the Indian Government took strong retaliatory action that raises questions about the future of India-EU trade talks. Disappointed by the EU ban on 700 pharmaceutical products, clinically tested at the GVK Biosciences lab, the Indian government has decided to defer proposed talks between chief negotiators on the India-EU Broad-based Investment and Trade Agreement. India’s Commerce Ministry said in its announcement ‘the Indian government has engaged on the issue with various EU regulators over past 8 months’ and that it ‘will examine all options in this regard’. The Commerce Ministry also said that ‘it is pertinent to mention that most of these drugs are already in EU market for many years without any adverse pharmaco-vigilance report from any member state.’

Is this retaliatory action by the Indian government justified? To talk us through the issue of the EU ban and subsequent events CNBC TV18’s Menaka Doshi talks to Murali Neelakantan, a well known lawyer with I-P expertise. Murali was the former Global General Counsel at Cipla and is now Founder & Principal at Amicus.





EU Order (Excerpts)
Overall summary of the scientific evaluation The French Agency on medicinal products (ANSM) conducted an inspection on 19-23 May 2014 (inspection reference GCP-141001-FR) at GVK Biosciences Private Limited, Swarna Jayanthi commercial complex, Ameerpet, Hyderabad 500 038, India. For the purpose of this report, GVK Biosciences Private Limited/Clinogent will be hereafter referred to as ‘GVK Bio’.

The following findings were reported in the French inspection report dated 02 July 2014, to which GVK Bio have responded on 18 July 2014 and in the final inspection report, which was issued on 21 July 2014: data manipulations of electrocardiograms (ECGs) were detected in each and every one of the 9 trials inspected by the ANSM. These data manipulations cast doubts on the authenticity of all other clinical records of these nine clinical trials. They were therefore considered by the ANSM as not compliant with Good Clinical Practice (GCP) and were considered not reliable to support marketing authorisation applications (MAAs). The data manipulations took place between at least July 2008 and 2013. The systematic nature of the data manipulations of ECGs, the extended period of time during which they took place and the number of members of staff involved highlight critical deficiencies in the quality system in place at GVK Bio's clinic in Hyderabad. They also show a lack of GCP training, awareness and understanding of members of GVK Bio staff, a lack of understanding by them of the importance of data integrity and of the possible consequences of their acts, as well as a lack of overview of clinical trial activities by the investigators. The seriousness of the deficiencies identified and the lack of GCP compliance at GVK Bio's clinic in Hyderabad raise questions as to the reliability of studies conducted between 2008 and 2014 at the site inspected, as well as the clinical part of all other bioequivalence trials performed prior to 2008.

Article 2
The Member States concerned shall suspend national marketing authorisations for the medicinal products referred to in Annex IB on the basis of the scientific conclusions set out in Annex II to this Decision.

The conditions for lifting the suspension are set out in Annex III. Member State may defer the suspension of the marketing authorisation for the medicinal products referred to in Annex IB, if it considers that a medicinal product is critical.

Member State shall, when it considers whether a medicinal product is critical, take into consideration the criticality criteria set out in Annex II.

This period of deferral shall not exceed twenty-four months from the date of the adoption of this Decision. If during this period a Member State considers a medicinal product not being critical anymore taking into consideration the criticality criteria set out in Annex II, the Member State shall suspend the concerned marketing authorisation.

The Member State shall for the medicinal products considered critical provide that the marketing authorisations holders shall submit a bioequivalence study within 12 months from the date of the adoption of this Decision.

 
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