Importer of alleged faulty hip replacement systems had objected to disclosure of its compliance documents submitted to the Central Drugs Standard Control Organisation (CDSCO) for importing these medical devices but was overruled by the CIC.



The matter came before the Central Information Commission after Mukesh Jain of Mumbai-based Manav Foundation had filed an RTI application seeking documents submitted by DePuy Medical Private Limited Ltd seeking clearance for import of medical devices "ASR XL Acetabular System" and "DePuy ASR Hip Resurfacing system" manufactured by DePuy International Ltd.

These replacements were marketed by Johnson and Johnson. Rather than disclosing information under the clause of "larger public interest", the mandarins of the CDSCO approached the company DePuy seeking their nod if information can be disclosed or not.

The CDSCO had justified the move citing "third party" clause of the RTI Act.  When the matter was challenged by Jain, a pharmacist himself, before the CIC, the CDSCO tried to justify its standing saying these medical implants manufactured by a foreign manufacturer is imported and marketed by Johnson and Johnson Ltd.

Accordingly, the manufacturer and marketing company Johnson and Johnson sign various levels of agreements including the Power of Attorney by which the onus and responsibility of marketing the product and consequences there of 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 cancer causing devices with far reaching complications, Information Commissioner noted in the order citing Jain's submissions.

Information Commissioner Yashovardhan Azad said none of the documents submitted by the CDSCO contain information of commercial confidence, trade secrets or intellectual property of the Drug manufacturer --DePuy International.

"Neither the company nor the respondent has made out a case as to which portion of these documents contain such information disclosure whereof is likely to adversely affect the competitive position of the company- the third party in question," he said.

Azad said Jain has successfully made out his case that he needs this information in larger public interest, on behalf of thousands of patients suffering in India waiting to get relief in the form of monetary compensation against the parent company in UK, USA, Australia and other countries.

Jain has clarified that the imported drug has been detrimentally affecting the senior citizens who have been administered such implants, he noted. The documents are required for proving the liability and onus of the companies in the case artificial hip implants imported by DePuy, Azad said.

"The exemption under Section 8(1)(d) (related to exemption of information pertaining to commercial confidence) of the RTI Act 2005 does not extend a blanket cover nor are such bald assertions legally tenable, unless tested on the touchstone of facts," he said.

Azad said the commission finds no impediment in directing disclosure of these compliance documents as submitted before the commission and sought by Jain. He, however, added a caveat that in case the CDSCO feels that any particular document attracts clause of commercial confidence that can be withheld by it.