The Wire: New Delhi: Friday, August 31, 2018.
The importer of
allegedly faulty hip replacement systems had objected to the disclosure of its
compliance documents submitted to the Central Drugs Standard Control
Organisation (CDSCO) for importing these medical devices, but this was
overruled by the Central Information Commission (CIC).
The matter came before
the CIC after Mukesh Jain of the 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 on if the information can
be disclosed or not.
The CDSCO had justified
the move citing the “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 are 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 thereof accrue to 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, the 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 the
UK, US, Australia and other countries.
Jain has clarified that
the imported drug has been detrimentally affecting 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 the
clause of commercial confidence, that can be withheld by it.