NEW DELHI: Pharmaceutical giant Johnson & Johnson applied for import licence in India in January 2010 for its hip implants even as the product had already been recalled from Australia in December 2009 because of “adverse” events, says the report of the committee constituted by the health ministry. This has been construed as a “serious breach” of conditions for approval by the committee because the firm allegedly "suppressed" these material facts from the regulator while seeking the nod.

The Central Drugs Standard Control Organisation – the pharmaceutical regulatory arm under the health ministry – made the report public on Tuesday after patients affected by “faulty” implants wrote to health minister JP Nadda. The committee, headed by former dean of Maulana Azad Medical College Dr Arun K. Agarwal, has recommended a basic compensation of at least Rs 20 lakh, while suggesting that individual cases be evaluated. The report was submitted to the health ministry in February this year.

While the government is yet to take any action against J&J, patients who have suffered disability due to the implant have demanded a CBI investigation and criminal charges against the American company, apart from compensation.

“The situation is very confusing for us. The compensation recommended by the committee is not justified. Moreover, it has recommended further testing for patients to prove their disability. This is unfair. We are studying the report in detail and will again approach the health ministry to take strong action including criminal charges and CBI inquiry against the company,” Vijay Vojhala, one of the patients who suffered disability due to faulty implants, told TOI.

The committee report also observed that there was something that the firm “intended to hide” and which reflects its “non-cooperative intent”.

According to the report, the company reported 35% revision surgeries in 2014 – much higher than usual- which the committee feels is under-reporting as majority of patients are yet to be traced. The company informed the regulator that faulty implants were placed in around 4700 patients in India but over 3600 patients are yet to be traced.

Public health groups, which have taken up the cause of the patients, have also raised concerns about the silence of the regulator and the government on penalising and punishing the company for allegedly hiding facts in India and not identifying patients.

However, according to a senior health ministry official, there is no provision in the Drugs & Cosmetics Act to penalise the company.

“The DCGI (Drugs Controller General of India) should take responsibility for the lack of timely action. His stand that the company did not commit any offence is not in consonance with the committee findings. The government must act swiftly to prosecute the company,” said Malini Aisola of All India Drug Action Network, a public health group that advocates patients rights.

Former Maharashtra Food & Drug Administration Commissioner Mahesh Zagade, who first initiated investigations into J&J’s faulty hip implants in 2011, has accused the office of the Drug Controller General of India (DCGI) of delay in taking action against the company despite enough evidence.

While the company ordered a global recall in 2010, the DCGI’s office issued a recall notice in India in December 2013, three years after the official withdrawal by the company.

