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Monday, December 16, 2019

J&J implants: Congress leader Anand Sharma seeks tougher norms for pharma majors

Speaking in the Rajya Sabha, Sharma noted that Johnson & Johnson had, in the US, agreed to pay over $1 billion as compensation and suggested that such firms were escaping responsibilities in India.

By: Express News Service | New Delhi | Updated: August 1, 2019 4:32:52 am
johnson and johnson, hip implants, faulty hip implants, implamt files, hip replacement surgeries, Anand Sharma, faulty hip implants, Johhson and Johson patients India, J&J implant files, J&J hip patients, J&J  patients in india Congress leader Anand Sharma. (Express Photo by Abhinav Saha)

Raising the issue of Johnson & Johnson selling faulty hip implants in the country, Congress leader Anand Sharma on Wednesday asked the Centre to tighten regulatory norms for pharmaceutical majors.

Speaking in the Rajya Sabha, Sharma noted that Johnson & Johnson had, in the US, agreed to pay over $1 billion as compensation and suggested that such firms were escaping responsibilities in India.

Read | Johnson & Johnson says no suffering patients in India. Meet some of them

He wondered how some of the implants banned globally were sold in India. “My submission is that once the products were withdrawn globally, how they (medical device firms) could enter the Indian market? Number two, we don’t have a joint registry because of which, these pharma companies which are selling medical devices in India — which has a market of implants of almost $500 million — are escaping and evading responsibility,” Sharma said.

He said the government had appointed an expert committee which had recommended Rs 20 lakh as compensation for 4,000 patients, but J&J said only 66 patients were identified and located in India. The company, in a submission in the Delhi High Court, agreed to pay Rs 25 lakh. The Congress leader stated that another committee had recommended a compensation of Rs 1.20 crore for each patient.

Read more from The Indian Express’ investigation series ‘Implant Files’

“The government ought to look at the regulatory law in our country, including the joint registry. The Ministry of Health and (Family) Welfare issued rules in 2017 on hip implants and other devices. My submission for the government is to bring a law to regulate medical devices in India,” he said.

Sharma said two implants, namely ASR and Pinnacle, were banned globally by the US FDA and Australian regulator way back in 2010. “But because of weak regulations in India and flawed presentations which were made, they were allowed to enter the Indian market and after that a large number of patients have suffered,” he said.

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