Joint responsibility

In dealing with the global recall of the artificial hip transplants of US-based Johnson and Johnson, India’s health regulators have been slow, negligent and non-transparent in their actions. Consider the facts, as pointed out by legal and public health experts: J&J secured an import licence under the Drugs and Cosmetics Act, 1940, for its articular surface replacement (ASR) implant in February 2010, barely two months after it was forced to recall its product in Australia. In August 2010, the company initiated a global recall of the device. In 2013, it agreed to pay $2.5 billion to over 8,000 US patients. But in India, it was business as usual. The Central Drugs Standards Control Organisation (CDSCO) revoked the licence only in July 2012, despite its Maharashtra branch raising concerns in May 2011. The CDSCO issued an alert only in December 2013, while the Union Health Ministry took another four years to set up a committee (in February 2017) to look into the issue. The panel came out with its report earlier this year, which came into the public domain last month. In all these years, 4,700 patients have received the implant, of which, 3,600 are not traceable. In the US, the FDA issues a public notice in consumer interest soon after any such episode. In contrast, the CDSCO has been utterly indifferent to the trauma of the patients concerned. While the committee has laid down certain ground rules — such as a baseline compensation of ₹20 lakh with State-level committees looking into the specifics — a lot of issues require to be explained. It is baffling that as many as 3,600 patients could have vanished into thin air, when obtaining medical records for a procedure like this does not seem like a tall order. How a figure of ₹20 lakh has been arrived at is not clear, when it is just a tenth of what a US patient has been promised in this case.

The CDSCO and State regulators could not have asked the company to compensate patients, as the D&C Act has no such provision on recalled products. The ₹20 lakh compensation benchmark has been arrived on the basis of clinical trials regulations. However, the Centre has done well to have brought into force the Medical Devices Rules, 2017, which seeks to classify them and create product standards. In view of these rules as well as the clinical trial regulations, the CDSCO can be said to have sufficient teeth to take the necessary steps. Compensation must be settled expediently and fairly, without discriminating between patient-consumers.

The Indian consumer is not new to product recalls. In the past, medicines like painkiller Vioxx (Rofecoxib) and diabetes drug Avandia (Rosiglitazone), for example, have seen global recalls, patient suits, litigation and payments. Abbott pulled out its reabsorbable stent Absorb, following a global recall. It’s time our regulatory response improved.

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