Drug Regulation

The Ministry of Health Is Yet to Communicate with J&J on the ASR Hip Implant Issue

For the last few months, the Indian media has been doggedly tracking the J&J hip implant scandal. To briefly recap the main facts, the company sold its new ASR hip implants to around 4,700 patients between 2006 and 2010. Around 2010, J&J decided to withdraw the implants from the market because of quality issues with the product that threatened patient safety. One of the issues debated in the press is the need to compensate the patients. After unprecedented patient activism lead by people like Vijay Vojhala, who was one of the recipients of the faulty implant, top officials at the Ministry of Health made promises in the media that the government would set up a committee to receive claims for compensation and that the government would direct J&J to pay the patients. As pointed out by Shamnad, in an editorial for the Hindustan Times there is no provision of law which requires J&J to submit to the diktats of a government appointed committee. At most, J&J can be sued before a consumer court and several patients have already filed individual lawsuits.

But what is more interesting is the response I received when I filed a RTI application with the Ministry requesting for a copy of all the communications between the Ministry and J&J with relation to the ASR hip implants. The reply from the Ministry states that there have been no communications between the Ministry and J&J on the issue and that my RTI application was being transferred to the Central Drug Standard Control Organization (CDSCO) which is the main drug regulator. The CDSCO is currently headed by a DCGI who does not even have a permanent job – the man has been receiving 3-month extensions from earlier this year and it is highly unlikely that J&J is taking him seriously.

Several media reports over the last month have given the impression that the Ministry of Health is at the forefront of the negotiations with J&J but how is that possible when the Ministry has not even communicated with J&J on the issue? It is time for the media to switch the spotlight to the Secretary of the Ministry of Health. Going after small fry like the DCGI isn’t going to yield any results. The buck stops with the Secretary for the Ministry of Health.

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Prashant Reddy

T. Prashant Reddy graduated from the National Law School of India University, Bangalore, with a B.A.LLB (Hons.) degree in 2008. He later graduated with a LLM degree (Law, Science & Technology) from the Stanford Law School in 2013. Prashant has worked with law firms in Delhi and in academia in India and Singapore. He is also co-author of the book Create, Copy, Disrupt: India's Intellectual Property Dilemmas (OUP).

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