IN MARCH 2009, Johnson & Johnson sought a registration certificate in India to import and market its ASR (articular surface replacement) hip implants with an undertaking that it would “withdraw the product from the market in 48 hours” if it faces action from “any regulatory authority of any country”. In December that year, these “faulty” implants were withdrawn in Australia following an intervention by that country’s medical regulator.
Despite this undertaking, J&J did not inform the Central Drugs Standard Control Organisation (CDSCO), the Indian regulator, of the action in Australia. And when it finally did so, on March 8, 2010, it took the CDSCO another three years to officially cancel the India licence of the ASR implants.
In fact, on January 11, 2010, the regulator granted a fresh import licence to J&J after receiving another undertaking that it would recall the product if found faulty by a regulator in any other country. The ASR implants were globally recalled on August 24, 2010.
Documents accessed by The Indian Express show that the first undertaking, dated March 12, 2009, is contained in a “Power of Attorney” submitted by J&J’s subsidiary, DePuy Orthopaedics, to CDSCO and is signed by Sally Hunter, the then worldwide vice president (regulatory affairs), DePuy Orthopaedics.
The three-page document contains a set of 10 commitments. “We shall from time to time report for any administrative action taken due to adverse reaction, viz. market withdrawal regulatory restrictions, or cancellation of the authorisation and/or ‘not of standard quality’ report of any medical device pertaining to the Registration Certificate declared by any regulatory authority of any country where the medical device is marketed/sold or distributed. The dispatch and marketing of the medical device in such cases shall be stopped immediately…,” it states.
“The licensing authority may direct any further modification to this course of action, including the withdrawing of the medical device from the Indian market within 48 hours time period,” it states.
In the second undertaking to CDSCO, dated April 24, 2009 — carrying the seal of DePuy International Ltd, St Anthony’s Road, Beeston, Leeds, UK – the company reiterated that it would “withdraw the product from Indian market within 48 hours” if the product is found to be “not of standard quality” by any regulatory authority.
“We shall from time to time report for any adverse action and ‘not of standard quality’ report of any medical device…declared by any regulatory authority…the marketing and use of the medical device in such cases, shall be discontinued forthwith and the drugs shall be withdrawn from the Indian market within 48 hours period,” states the undertaking submitted under the mandatory Schedule D(I) of the Drugs and Cosmetic rules.
Responding to queries from The Indian Express, a J&J spokesperson said the company has been “fully transparent and furnished full information known to us at the time of making the renewal application in May 2009 in India”.
“The ASR recall was voluntarily initiated by DePuy worldwide and in India simultaneously on August 24, 2010. DePuy Australia made the decision to discontinue sale of the ASR Hip System in Australia because of declining demand. There was no recall in Australia in 2009. We immediately informed the Drugs Controller General of India (DCGI) about the voluntary recall in August 2010 and have kept the DCGI informed of all key actions and worked to provide Indian patients and surgeons with the information and support they need, in line with government requirements,” the spokesperson said in a statement.
Dr S Eswara Reddy, DCGI, did not respond to requests for comment from The Indian Express.
As The Indian Express reported on August 24, the firm informed CDSCO only on March 8, 2010, about the adverse findings on the ASR implants by the Therapeutic Goods Administration (TGA) of Australia the previous year. Australia was the first country to take regulatory action to ensure the removal of DePuy’s ASR hip replacement implants from the market.
“The firm had applied for import licence on the basis of the registration certificate on 11 January, 2010. However, the fact the ASR was already recalled in Australia in December 2009, was not informed to the CDSCO even at the time of application for import licence. That the committee observes that there appears to be suppression of material facts by the firm to the CDSCO. This is construed as serious breach of a condition of approval,” states a report submitted by an expert committee set up by the Union Health Ministry.