Tragic delay

Regulatory oversight of Johnson & Johnson case abysmal

The Central Drugs Standard Control Organization (CDSCO), which has been under attack for not being pro-active in seeking compensation for patients who got faulty hip implants manufactured by a subsidiary of Johnson & Johnson, posted a voluminous expert committee report on the subject late Tuesday night. The oversight of this case has proved abysmal so far. For example, while the report gives out detailed information linked to the implants that caused pain and agony to thousands of patients and their dependents, it’s quite strange that it has been put in the public domain more than six months after it was submitted. 

The CDSCO had given the expert committee report to the Union health ministry in February. The committee, set up by the health ministry in early 2017, categorically said in its report that it expects all its recommendations to be implemented in a time-bound framework in true letter and spirit. On compensation, the panel, comprising eminent people in the medical fraternity and the government, suggested that its recommendations need to be implemented immediately. According to the committee, although no amount of money would fill the void, patients should be given an opportunity to make the claim for “just and adequate’’ compensation. 

It reflects poorly on the government’s priorities that no concrete stand has been taken yet on offering relief to the aggrieved patients despite being engaged with the company for around eight years on the matter. While Johnson & Johnson has paid hefty compensation to patients in other parts of the world following a global recall of ASR hip implant device in 2010, India has been left out. In India, the Drugs and Cosmetics Act, 1940, which regulates medical devices as well, does not expressly provide for compensation in case of adverse or serious reactions. Even as the legal loophole has come in the way, the government and the regulators (both at the Centre and in the states) should have worked out a mechanism to seek compensation from the errant company and to make it liable for its faulty devices. In this case, all parties concerned, including doctors, hospitals, consumer groups and regulators, have failed in their responsibility to bring justice to suffering patients. While some state regulators such as Maharashtra Food and Drug Administration had raised their voice and advised CDSCO to take corrective action, nobody stepped up the act through a class action suit, for instance. Also, the Indian authorities were found lacking when they failed to challenge the company’s argument that aggrieved patients could not be traced. Johnson & Johnson told the regulator time and again that only hospitals and surgeons could have patient-related data and that it was confidential. 

The expert committee had consulted regulators of the US, UK, Japan, Australia, Canada, Brazil among others to come out with its detailed report that accused the firm of being evasive in providing information related to most issues including the design of the implant device and patients who had undergone the surgery. The committee, where a CDSCO top official was also a member, recommended amendment of the Drugs & Cosmetics Act to include the provision for compensation. Unfortunately, the execution of the report has been slow and tardy, to say the least, even as the government and regulators continue to drag their feet on the way forward.