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EDITOR'S NOTE A BRAND Can India Achieve cGMP For Vaccines? Does It Matter? AUGUST 2013 EDITORIAL DIRECTOR: Dan Schell (814) 897-9000, Ext. 284 dan.schell@lifescienceleader.com CHIEF EDITOR: Rob Wright (814) 897-9000, Ext. 140 rob.wright@lifescienceconnect.com VP OF PUBLISHING: Jon Howland (814) 897-9000, Ext. 203 jon.howland@lifescienceleader.com PUBLISHER, CLINICAL & CONTRACT RESEARCH: Sean Hoffman (724) 940-7557, Ext. 165 sean.hoffman@lifescienceleader.com ASSOC. PUBLISHER/BIOPHARM & LAB: Shannon Primavere (814) 897-7700, Ext. 279 shannon.primavere@lifescienceleader.com PUBLISHER/OUTSOURCING: Cory Coleman (814) 897-7700, Ext. 108 cory.coleman@lifescienceleader.com GROUP PUBLISHER/OUTSOURCING: Ray Sherman (814) 897-7700, Ext. 335 ray.sherman@lifescienceleader.com BUSINESS DEV. MGR.: Mike Barbalaci (814) 897-7700, Ext. 218 mike.barbalaci@lifescienceleader.com SR. ACCOUNT EXECUTIVE: Scott Moren (814) 897-7700, Ext. 118 scott.moren@lifescienceleader.com PRODUCTION DIRECTOR: Lynn Netkowicz (814) 897-9000, Ext. 205 lynn.netkowicz@jamesonpublishing.com DIRECTOR OF AUDIENCE DEV.: Mindy Fadden (814) 897-9000, Ext. 208 mindy.fadden@jamesonpublishing.com Life Science Leader 5340 Fryling Rd., Suite 300 Erie, PA 16510-4672 Telephone: (814) 897-7700 ● Fax: (814) 899-4648 LIFE SCIENCE LEADER (ISSN: 21610800) Vol. 5, No. 8 is published monthly by VertMarkets at Knowledge Park, 5340 Fryling Road, Suite 300, Erie, PA 16510-4672. Phone (814) 897-9000, Fax (814) 899-5580. Periodical postage paid at Erie, PA 16510 and additional mailing offices. Copyright 2013 by Peterson Partnership. All rights reserved. Print PP. Printed in the USA. SUBSCRIPTION RATES for qualified readers in the U.S. $0. For non-qualified readers in the U.S. and all other countries $97 for one year. If your mailing address is outside the U.S. or Canada, you can receive the magazine digitally if you provide a valid email address. POSTMASTER: Send address corrections (Form 3579) to Life Science Leader, Knowledge Park, 5340 Fryling Road, Suite 300, Erie, PA 16510-4672. 6 LifeScienceLeader.com In May, amid much fanfare, the Indian government announced the development of a new low-cost vaccine proven effective against the diarrhea-causing rotavirus Ñ one of the leading causes of death across the developing world. According to reports, the Phase 3 clinical trial results of Rotovac, being developed by India-based Bharat Biotech, indicated it was safe and effective in the 6,799 infants who were injected with the vaccine. This news came just one week after GlaxoSmithKline (GSK) and Merck agreed to offer a 95 percent discount off the purchase price for their respective HPV vaccines (Cervarix and Gardasil) to the Global Alliance for Vaccines and Immunizations (GAVI Alliance), which delivers immunizations to the developing world. Interestingly, both GSK and Merck also make rotavirus vaccines (Rotarix and RotaTeq), which the GAVI Alliance is able to acquire for $2.50 a dose. If approved, Bharat Biotech has pledged to sell Rotovac for $1 a dose. Here are the problems I have with this news. First, in December 2011, WHO suspended Bharat Biotech from being able to supply the hepatitis B vaccine (Revac-B+) as a result of a failed site audit of the companyÕs Hyderabad, India, facility during a prequalification evaluation for possibly manufacturing two different vaccine types. Apparently the audit found deficiencies in the implementation of cGMP, as well as in the companyÕs quality management systems. The companyÕs website claims to have manufacturing, quality, and control procedures conforming to stringent standards set by national and international authorities, including the USFDA, and to be the first biopharma facility in India to be audited and approved by the Korean Food & Drugs Administration (KFDA). The company claims to have been audited by a number of other regulatory authorities but doesnÕt list the two most respected in the world, the European Medicines Agency (EMA) and the USFDA. So perhaps Bharat can make it cheaper, but can it make it safer? The second problem I have with this news revolves around a statement by IndiaÕs secretary of the Department of Biotechnology, Dr. K. Vijay Raghavan, quoted as saying, ÒThe clinical results indicate that the vaccine, if licensed, could save the lives of thousands of children each year in India.Ó I fully expect the Indian government will approve the license as it has shown favoritism towards Indian manufacturers for years under the guise of bringing cheaper drugs to the Indian people (e.g. see the Supreme Court of India denying Novartis patent protection for Gleevec). But itÕs that statement, Òsaving thousands of lives,Ó that really bothers me. ThatÕs because, no matter if the vaccine is approved and offered at $1.00 a dose, itÕs how the medicine is administered that really matters. A study by the International Clinical Epidemiology Network (INCLEN), an international network of healthcare professionals, found 62 percent of the injections administered in India to be unsafe. It is estimated that more than three billion injections are administered annually in India, meaning 1.89 billion are unsafe Ñ primarily the result of healthcare providers reusing needles and syringes intended to be single use. But whether it be hepatitis, the rotovirus, cervical cancer, or some other type of serious ailment, it seems Rob Wright to me that India should focus as much effort on safely administering drugs as it is on making rob.wright@lifescienceconnect.com drugs for less money. @RFWrightLSL August 2013