Sunday, September 9, 2018

J&J faulty hip transplant: CIC directs RTI disclosure of crucial documents

A Johnson & Johnson subsidiary caught in a controversy over faulty hip replacement systems has opposed RTI disclosure of crucial documents it submitted to the country's drug regulator for seeking import clearance for these devices, the CIC has said. The commission, however, said it has found no impediment in directing disclosure of these compliance documents. Among the records whose disclosure the DePuy Medical Private Limited, the Johnson and Johnson subsidiary, has opposed was an indemnity clause, said Mukesh Jain, the RTI applicant who had sought the information from Central Drugs Standard Control Organisation (CDSCO). The indemnity clause makes companies liable for compensation to patients globally in case equipment are found faulty. The CDSCO, the drug regulator, did not apply the RTI clause of "larger public interest" to provide the documents, Jain told PTI. Instead, he said, it sought the consent of DePuy Medical Private Limited applying the "third party" clause of the Act

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