CIC directs RTI disclosure of crucial documents
NEW DELHI: 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 said.
Instead, he said, it sought the consent of Depuy Medical Private Limited applying the "third party" clause of the Act and the company rejected the request. The company claimed that the information sought attracts exemption clauses of the RTI Act related to commercial confidence.
Even exempted information can be furnished by a public authority if it finds that the disclosure is in larger public interest, according to the RTI Act.
When the matter came before the Central Information Commission, the top appellate authority on RTI matters in the country, the objections raised by Depuy were rejected by Information Commissioner Yashovardhan Azad, who heard the matter. Through his RTI application, Jain had sought documents submitted by Depuy Medical Private Limited Ltd, a subsidiary of Johnson and Johnson, for import and marketing clearance of "ASR XL Acetabular System" and "Depuy ASR Hip Resurfacing system" manufactured by Depuy International Ltd.
These replacements were marketed by Johnson and Johnson. When the matter was challenged by Jain, a pharmacist himself, before the CIC, the CDSCO tried to justify its stand, saying these medical implants manufactured by a foreign firms are imported and marketed by Johnson and Johnson Ltd. Accordingly, the manufacturer and marketing company Johnson and Johnson sign various agreements including the Power of Attorney by which the onus and responsibility of marketing the product and consequences thereof accrue on the marketing company, the CDSCO officials argued. Jain challenged the contention of the CDSCO, saying the matter pertains to large number of patients who had to suffer because of faulty products which were recalled by the United States. On being tested and found defective these implants have been banned from usage worldwide. But patients, mostly senior citizens in India, are being freely recommended and implanted with these allegedly cancercausing devices with far reaching complications, IC noted in the order.