ALCON LABORATORES INC, certified copy of all documents submitted
to DCGI / CDSCO by the sponsoring companies seeking permission to conduct clinical trials in
India ... DGHS, Mr. S. Kulshrestha, ADC (I) and Mr. R. K. Singh, CDSCO;
The Appellant / Complainant reiterated the contents of the RTI applications
(CIC/DTGHS
Complex
Meenambakkam, Chennai - 600027
2. CPIO
Office of Drugs Controller General (India)
CDSCO (HQ), RTI Cell, FDA Bhawan
Kotla Road, New Delhi - 110002
... ितवादीगण /Respondent ... certified
copy of documents available with / officially provided to port officials of CDSCO indicating
pack sizes i.e. 3 ml, 5 ml and physicians sample
certified copy of documents available with / officially provided to port officials of CDSCO
indicating pack sizes i.e. 3 ml, 5 ml and physicians sample ... authorizing actual import, certified copy of documents used by port officials of CDSCO that
indicate / provide pack sizes of the drug to be permitted / authorized
Delhi - 110002
2. CPIO (Administrative Matters)
O/o Dy. Director Administration (Drugs), CDSCO (HQ)
FDA Bhawan, Kotla Road
New Delhi - 110002
... ितवादीगण /Respondent
Date ... application sought information on 09 points regarding the copy of
CDSCO letter to CIC for registering CDSCO (HQ) / Delhi as a public authority for registration
CPIO
Director I/C, CDTL, Central Drugs Testing Laboratory
NABL Accredited Laboratory, CDSCO Bhawan
Ministry of Health & Family Welfare
Directorate General of Health Services ... drug samples declared not of standard quality were
displayed month-wise in CDSCO's website (www.cdsco.gov.in) under caption "Drug Alerts
inspect the file; copy of the
information provided by the PIO, CDSCO with respect to the RTI Application Number
MOHFW/R/2015/60406, copy ... DGHS,
Mr. S. Kulshrestha, ADC (I) and Mr. R. K. Singh, CDSCO;
The Complainant submitted that no satisfactory response was provided
public
domain. Accordingly, the report was uploaded on the website of CDSCO and the url as on date
was referred. The Appellant, if so desires ... import and marketing in the Country.
The firm informed the CDSCO of their decision to voluntarily recall ASR on 24.08.2010.
First recall was made
available with them. Furthermore, the CPIO, Assistant Drugs
Controller (I) & CDSCO (HQ), vide its letter dated 06.07.2017 retransferred the RTI application
to the Program ... application was transferred to the concerned department i.e. DCG(I),
CDSCO, New Delhi for further necessary action at their end. However, the information
regarding
were pending and
that the details were available on the website of CDSCO (www.cdsco.nic.in ) and for point no.
02, upheld the CPIO ... time lines prescribed for the purpose which is strictly adhered
to by CDSCO. It was reiterated that the license were approved by CLAA in compliance
Moto) the necessary details as per Section 4 of RTI Act on CDSCO website. The laboratory has
also participated in transparency audit conducted by Central