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Central Information Commission

Mukesh vs Directorate Of General Of Health ... on 29 June, 2017

                    CENTRAL INFORMATION COMMISSION
                   August Kranti Bhawan, Bhikaji Cama Place,
                              New Delhi-110066

                                           F. No.CIC/YA/C/2015/900281



Date of Hearing                    :   27.06.2017
Date of Interim Decision           :   27.06.2017

Appellant/Complainant              :   Shri Mukesh

Respondent                         :   DGHS
                                       Central Drugs Standard Control
                                       Organisation
                                       Through: Sh. Gulshan Taneja, Sh.
                                       Mohan R, Sh. Sunil Kulshreshtha

Information Commissioner           :   Shri Yashovardhan Azad

Relevant facts emerging from appeal:

RTI application filed on           :   26.12.2014
PIO replied on                     :   -
First Appeal filed on              :   -
First Appellate Order on           :   -
2nd Appeal/complaint received on   :   25.05.2015

Information sought

and background of the case:

Vide RTI application dated 26.12.2014, the complainant sought documents submitted by M/s Johnson & Johnson Ltd in compliance documents related to licence no MD-132 and MD-132-83 for import of Medical Devices "ASR XL Acetabular System " & Depay ASR Hip Resurfacing system"Manufactured by Depay International Ltd. The CPIO/RTI, CDSCO West Zone Mumbai, transferred the RTI application to the CPIO/Technical Matter), CDSCO(HQ), New Delhi, for providing the information to the applicant directly. The CPIO, O/o DCG(I), New Delhi vide its letter dated 19.02.2015 followed the process as laid down under Section 11 of the RTI Act. The complainant did not avail the remedy of FAA. Feeling aggrieved as not received information, the complainant approached the Commission.

Relevant facts emerging during hearing:

Both parties are present during the hearing and the complainant narrates that he has raised this query in public interest because the faulty and defective devices imported are causing grave detriment to the health of the patients who undergo hip replacement surgeries. It is his case that on being tested and found defective these implants have been banned from usage worldwide, but patients, most senior citizens in our country are being freely recommended and implanted with these cancer causing devices with far reaching complications.
The Respondent stated that these medical implants manufactured by foreign manufacturer is imported and marketed by Johnson and Johnson Ltd. Accordingly, the manufacturer and marketing company viz. Johnson & 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 on the marketing company. The Respondent DGHS denies any role and responsibility in this entire transaction.
Interim Decision:
After hearing parties and perusal of record, it is evident that gravity of the issue at hand and exact role of the Respondent does not emerge clearly from the documents placed on record. Accordingly, the Commission grants time to the appellant to file an affidavit placing all relevant facts in a brief and concise synopsis not exceeding three pages highlighting the aspect of public interest involved in this case. The complainant shall file his affidavit by 10th July, 2017 with a copy marked to the Respondent. Respondent shall file their response by 24th July, 2017.
Order reserved.
(Yashovardhan Azad) Information Commissioner Authenticated true copy. Additional copies of orders shall be supplied against application and payment of the charges prescribed under the Act to the CPIO of this Commission.
(R.P.Grover) Designated Officer Copy to:-
MUKESH                            Deputy Director Admin. (Drugs)
MANAV NGO, SHOP                   & CPIO,
NO.-8, PANDHARE                   Directorate General of Health
BUILDING, 730, B.J. MARG,         Services, Central Drugs
BYCULLA WEST, MUMBAI-             Standard Control
400011                            Organisation, FDA Bhawan,
(Maharashtra).                    Opp. Mata Sundri
Maharashtra,Mumbai                College, Kotla Road, New
City,400011                       Delhi-110002.
First Appellate Authority under
RTI
Drugs Controller
General-(India), Directorate
General of Health
Services, Office of the DCG-I
(New Drugs Division), FDA
Bhawan, Opp. Mata Sundri
College, Kotla Road, New
Delhi-110002.