J&J implants: Ex-DGCI says prompt action was taken in patients’ interest
India’s drug regulatory agency took almost 2 years to cancel the product’s import and marketing permits
New Delhi: G.N. Singh, the former Drug Controller General of India (DGCI), who was at the helm of affairs when pharma giant Johnson and Johnson (J&J) recalled its metal-on-metal hip implants, said his office took “prompt action” in the “interest of patients” following the recall.
Singh’s role has come under scanner, with public health activists blaming him for taking a lackadaisical approach in cancelling the import licence of the company.
The firm recalled the product on 24 August 2010 and informed the Central Drug Standards Control Organization (CDSCO).
However, India’s drug regulatory agency took almost two years to cancel the product import and marketing permissions, according to the panel mandated to gather details about those suffering because of the implant and come out with the relief mechanism for them under the chairmanship of Dr Arun Agarwal, former dean of Maulana Azad Medical College (MAMC).
The implant, known as DePuy ASR (where ASR stands for acetabular surface replacement), was sold in India by DePuy International, a unit of J&J, and has come under severe scrutiny of government agencies after a Mint investigation published on 23 August exposed the sufferings of those who had to go through revision surgeries.
The “best course of action was taken within the statutory power”, Singh said, to allay fears of laxity. “The best possible steps were taken with regard to patient safety under the statute of Drugs and Cosmetics Act,” he said.
Singh was the drug controller from 2012 and relinquished the office this year on 20 February. He is now secretary-cum-scientific director at Indian Pharmacopoeia Commission in Ghaziabad. IPC is an autonomous body under the ministry of health and family welfare to deal with matters relating to timely publication of the Indian Pharmacopoeia, which is the official book of standards for drug included therein, and to specify the standards of identify, purity and strength of drugs imported, manufactured for sale, stocked or exhibited for sale or distributed in India.
Documents reveal CDSCO cancelled the product import and marketing permission on 11 July 2012. While the firm had informed CDSCO of their decision to voluntary recall on 24 August 2010 after they found revision rate for 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.
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.
On their part, DePuy Synthes, subsidiary of J&J Pvt. Ltd said they were “consistent” while recalling the product.
“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&J Medical India, and vice-president (orthopaedics) for Asia Pacific, DePuy Synthes.
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