J&J implants: Ex-DGCI says prompt action was taken

03 Dec 2018 02:43
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<div class="img-responsive" readability="10 [[image https://www.livemint.com/rf/Image-621x414/LiveMint/Period2/2018/09/13/Photos/Processed/jj.jpg" alt="The implant, known as DePuy ASR was sold in India by DePuy International, a unit of J&amp;J. Photo: Reuters" title="The implant, known as DePuy ASR was sold in India by DePuy International, a unit of J&amp;J. Photo: Reuters"></div>
<p>The implant, known as DePuy ASR was sold in India by DePuy International, a unit of J&amp;J. Photo: Reuters</p>
<p xmlns:fn="http://www.w3.org/2005/xpath-functions" class="S3l &lt;b&gt;New Delhi:&lt;/b&gt; G.N. Singh, the former Drug Controller General of India (DGCI), who was at the helm of affairs when pharma giant &lt;a onclick=" return="" printpage('https:="" www.livemint.com="" ompanies="" 5jxj6ylfqlsuu8srtf2fo="" ot-all-hip-implants-faulty-everyone-wont-be-compensated.html')"="" href="https://www.livemint.com/Opinion/53NJm4aedr0pBAD9L5VeWO/JJ-implant-case-The-moral-hazard-of-multinationals.html ASR hip resurfacing] system at 13%. CDSCO asked the firm to submit the information pertaining to recall of ASR. On 28 September 2011 the firm was asked by CDSCO to give a presentation regarding recall procedure of the firm with protocol, reason for recall action taken by the manufacturer with investigation and compensation details and international regulatory status of ASR.&lt;/p&gt;&lt;p&gt;Interestingly, the joint commissioner the Food and Drugs Administration (FDA), Maharashtra, had urged corrective action in the matter on 21 October 2011 and again on 30 January 2012 recommended the CDSCO for cancellation of import licence. Mahesh Zagade, the former commissioner FDA, Maharastra said the regulator should have recalled the product on its own. “The recall should not have been left on the sweet will of manufacturer or trader. What was required at that time was to recall the product immediately. Nobody knows that from the time it was recalled by the company and the licence got cancelled, whether the product was still implanted. To my knowledge the product has still not been recalled by the government as it happens in the case of sub standard drugs,” he said.&lt;/p&gt;&lt;p&gt;On their part, DePuy Synthes, subsidiary of J&amp;J Pvt. Ltd said they were “consistent” while recalling the product.&lt;/p&gt;&lt;p&gt;“The product was there in India till 24 Aug 2010. We did a voluntary recall worldwide and India was no exception. Same day letters were sent to DCGI, surgeons, customers, sales organizations about the recall due to the reason of 13% revisions rates. The thing that is to be noted here that in Australia the product was not voluntary recalled in December 2009. In Australia too the product was voluntary recalled on Aug 24 2010 along with every other country in the world, so we were consistent. However, in Australia the product was product was stopped selling because of the declining sales,” said Sushobhan Dasgupta, managing director of J&amp;J Medical India, and vice-president (orthopaedics) for Asia Pacific, DePuy Synthes. &lt;/p&gt;&lt;div class=" gbnltrerm5cvod8gudjfj="" j-directed-to-trace-compensate-all-faulty-hip-implant-pat.html')"="" pinion="" 3njm4aedr0pbad9l5vewo="" j-implant-case-the-moral-hazard-of-multinationals.html')"="" story-meta="" <span="">First Published: <span class="s_meta" fdate="20180912164228 Wed, Sep 12 2018. 10 12 PM IST&lt;/span&gt;&lt;/div&gt;&lt;br/&gt;[[image http://www.clker.com/cliparts/N/G/s/m/Q/5/home-hi.png"></span>

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