Firm resolve to support their cause

MAHESH ZAGADE was Commissioner of the Maharashtra Food and Drug Administration (FDA) from 2011 to 2015. It was on his watch that the controversy over Johnson & Johnson’s hip replacement device came to light. He was transferred from the FDA before the case was resolved. Zagade, who retired from service earlier this year, is firm in his resolve to support the cause of the patients. He recounts the case:

Given the fact that 4,700 patients across India have had J&J’s [Johnson & Johnson] hip replacement implant, it is very likely that other State FDAs to have received complaints. But the Maharashtra FDA was the first to act on a complaint. I joined the FDA in September 2011 and the first thing I did was to review all the pending cases, especially pending grievances. I came across this complaint against the hip implant and talked to my staff and asked them why they had not acted on it. They dismissed it as frivolous, but I was not convinced. I went to the Net, and it was a nightmare to read about patients’ experiences in Australia, Europe and America. I read about how the device had been recalled in these countries. Then I initiated an official investigation by the FDA. The company did not respond to my officers’ visits, so I summoned its officials to my office. After we talked, they said they would revert but they never did. So, I asked my officer to ask them what action they had taken. The company said it had its own policy and that it would appoint an agency to trace the patient.

I told the company that it was not necessary because it would take a long time and that it was possible under the present provisions of law that patients can be traced within a couple of days. To which the response was negative. All they had to do was contact doctors and dealers who maintained records, and in a matter of a few days all details would be known. But the company insisted that it had to do it in its own way; that it was its corporate policy.

The point in this whole thing is not the expense that the patients had been put through but what their expectations were. They expected that once they had this device it would improve the quality of their life, but this did not happen. Instead, they were in constant pain, with less mobility, and some even lost their lives. On investigation, we found violations by the company and we filed a first information report [FIR] with the Mahim police station.

In the meantime, J&J went to the High Court in Mumbai saying the FIR was frivolous. The court refused the company’s plea and allowed the investigation to continue. So it was like a High Court-certified investigation. The company withdrew its petition.

I realised that this was a pan-India matter so I wrote to the Additional Chief Secretary saying the case should be handled by the Central Bureau of Investigation (CBI). I also wrote to the Drug Controller General of India and I suggested to them that since they were the licensing authority for this product they should invoke all the provisions to give relief to the patients, like ordering statutory recall and taking action against the company. This would also help the FIR to become stronger. But the official recall was not done. In fact, to date there is no official recall of the devices.

In 2015, I was transferred from the FDA, and I do not know what happened thereafter. However, to my knowledge the FIR is still under investigation and the prosecution does not appear to have been launched, judging by media reports.

It is also revealed that a committee was appointed by the Government of India in 2017. Therefore, I assume that nothing was done between 2011 and 2017 to safeguard the interests of the patients, and it appears that the process was slowed down.

If the government wanted to act upon it, it could have constituted a committee in 2011-12. It is also not clear what is the legal basis for the committee. Most importantly, the Drugs and Cosmetics Act does not have any provision that empowers the government to give direction to the importer to give compensation to the patient. The correct thing would have been for the Drugs Controller General of India to call for an official recall and to insist that all patients be traced and appropriate action under the law, which would have strengthened the patients’ chances of getting proper compensation, taken.”

As told to Lyla Bavadam