New Delhi: India's health ministry has for over six years failed to move against the drugs and devices company Johnson & Johnson, accused of misleading the government and failing to take adequate remedial measures for patients in India who received its allegedly faulty hip implants.

A government panel had observed in January that the company appeared to have suppressed from Indian regulators certain facts about the implants, recalled worldwide in August 2010 after being found to carry a high risk of repeat surgery.

The company has denied suppression of facts or any wrongdoing.

In its report to the health ministry, the panel had also corroborated concerns, first conveyed by Maharashtra state regulators in January 2012, that the company had not done enough to reach out to all patients in India who had received the implants.

The panel has recommended that eligible patients should receive a "base amount" of Rs 20 lakh as compensation, and proposed mechanisms to identify eligible patients. The health ministry has not yet indicated how it would respond to the recommendations.

Health minister J.P. Nadda said on Monday that the ministry was "deliberating" on the panel's report. A senior ministry official, who requested anonymity, told The Telegraph the discussions were centred on how to proceed on the report's recommendations.

Patients' rights advocates say the chronology of events since the August 2010 global recall of the implants by DePuy, a Johnson & Johnson subsidiary, suggests that the Centre's drug regulators responded with significant delays to alerts from their Maharashtra counterparts and pleas for intervention from patients.

A former Maharashtra state regulator said the chronology reeked of regulatory delays and inaction.

"We're seeing what happens when regulators of health do not do what they're expected to do," said Mahesh Zagade, former commissioner with Maharashtra's food and drug administration.

Zagade had written to the Central Drugs Standard Control Organisation (CDSCO) on January 30, 2012 that the company had not taken proper remedial measures for all patients.

About 4,700 patients in India -- among 93,000 worldwide -- had received DePuy's implants between June 2004 and August 2010. The global recall came amid concerns that the metallic implants could leak potentially toxic cobalt and chromium into patents' bodies and pose a risk to their health.

Johnson & Johnson has since then tracked 1,080 Indian patients. It has reimbursed the costs of revision surgery and related medical expenses to 275 eligible patients, and the costs for testing and monitoring to all 1,080 patients.

A Johnson & Johnson spokesperson said the company had no access to patient data and had to rely on surgeons, hospitals, helplines and public advertisements to find as many patients as it could who had received the implants.

"Not all patients will require revision surgery, as a number of patients continue to do well with the implants," the spokesperson said.

Australia's regulatory body, Therapeutic Goods Administration, was the first to order a recall of the implants in December 2009 after its national joint replacement registry noted an "unacceptably high need" for repeat joint replacement in patients who had received the DePuy implants.

The panel probing the matter in India has noted that the company should have, under the rules, informed Indian drug regulators about the recall in Australia.

"There appears to have been suppression of material facts by the firm to the CDSCO," the panel's report says.

The Johnson & Johnson spokesperson told this newspaper that the December 2009 recall in Australia was a company decision and a "solely commercial decision based on declining sales".

But a document on the Therapeutic Goods Administration website says: "Australia was the first country in the world to take regulatory action to ensure the removal of the DePuy ... hip replacements from the market."

A senior government official who is familiar with the panel's report and spoke on condition of anonymity, when asked about the panel's observations about the suppression of facts, said this may be viewed as "minor non-compliance" with rules and not "major" or "critical" non-compliance.

After the alerts from Maharashtra in 2012, government documents show that the CDSCO itself issued a "medical device alert" on December 9, 2013 -- more than three years after DePuy's worldwide recall. The CDSCO alert called on patients and doctors to report any adverse events suspected to be associated with the implants. A CDSCO official said the 2013 alert was aimed at reaching out to as many patients and doctors as possible.

In contrast, the UK Medicines and Healthcare products Regulatory Agency had issued a medical device alert on September 7, 2010, less than three weeks after the August recall. 

Patients' rights advocates say the three-year delay by the CDSCO in issuing the alert is baffling.

"It is hard to explain such a delay as incompetence," Malini Aisola, a coordinator with the All India Drug Action Network, a consortium of doctors and health experts campaigning for patients' rights, said. "Regulators need to be aware of what's going on around the world."

The CDSCO sent a letter to the Indian Orthopaedic Association only on February 5 2014 requesting it to circulate the medical device alert to all its members to identify patients who had received the implants and might require revision surgery.

Zagade said: "Our regulators should have taken note of developments elsewhere and acted much faster."

The company has claimed that all its actions on the implants were appropriate and responsible.

"We immediately informed the DCGI (Drug Controller-General of India) about the voluntary recall. Since then, we have kept the DCGI informed on all key actions and worked diligently to provide Indian patients and surgeons with the information and the support they need, in line with government requirements," the spokesperson said.

More than 19,000 people worldwide have filed lawsuits over the DePuy implants, according to an August 6, 2018, post on Drugwatch, a US-based website that seeks to provide the public with information about the risks associated with medicines and devices.

DePuy and Johnson & Johnson have between 2013 and 2015 settled more than 9,000 lawsuits over the implants for $4.4 billion, the post said.

Patients and their families in India, learning about the settlements, began to seek compensation in 2014.

Among them was Mumbai-based Vijay Vojhala, himself a product manager for a medical equipment-maker, who had undergone a revision surgery in mid-2012 after receiving the implant in mid-2008 and suffering from the metal toxicity.

Since 2014, Vojhala has sent multiple letters to the CDSCO, the health ministry, and the Prime Minister's Office, seeking government intervention to help patients receive compensation.

Faced with such complaints from patients, the health ministry set up the panel of experts to examine DePuy's actions and help address patients' grievances.

A senior government official who asked not to be named said the panel's formation should be credited "entirely" to Vojhala's persistent pleas.

But even a panel member was puzzled that the health ministry had not yet made public the panel's report, submitted in January this year.

"I see no reason why the government has not made our report public," Bejon Misra, a panel member and consumer rights activist and founder of the non-government Safe Medicines and Access Initiative, said. "We need to bring about a change in the way our regulatory system functions."