**Summary:**
This Office Memorandum, issued by the Drugs Controller General of India, alerts relevant authorities to the substandard quality of Human Albumin IPEP Albiomin 20% (200g/l) solution for infusion, Batch Nos. B236434 and B236444, manufactured by Biotest Pharma GmbH, Germany, and imported by Paviour Pharmaceuticals P Ltd., New Delhi. The batches were declared substandard by NIB, Noida. The memorandum directs concerned parties to recall the specified batches, monitor the quality of future imports by Paviour Pharmaceuticals, and report any non-compliance. It also requests Paviour Pharmaceuticals to provide details of the distribution of these batches in the market.
Key Entities Referenced
Directorate General of Health Services: An organization, likely a department within the Indian government, responsible for health services.
Drugs Controller General: Position held by Dr. G N. Singh, responsible for drug regulation in India.
Human Albumin IPEP Albiomin 20 200 g1: A specific pharmaceutical product (solution for infusion) that is the subject of the alert due to substandard quality.
Biotest Pharma GmbH, Germany: The manufacturer of the Human Albumin IPEP Albiomin product, located in Germany.
Paviour Pharmaceuticals P Ltd., New Delhi: The importer of the Human Albumin IPEP Albiomin product, located in New Delhi.
NIB, Noida: National Institute of Biologicals, Noida. The laboratory that declared the Human Albumin product as substandard.
Dr. G N. Singh: The Drugs Controller General of India.
CDSCO: Central Drugs Standard Control Organisation (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices.
File No, X11026/67/15-BD Top Priority
Directorate General of Health Services Alert Notice :
O/o Drugs Controller General (1)
(Biological Division)
FDA Bhawan, Kotla Road,
New Delhi
Dated: 4 g way 26(6
Office Memorandum
Sub: Sub-standard quality of Human Albumin IP/EP (Albiomin 20%) 200 g/1,
solution for infusion, Batch No. B236434, Mfd. Dt. 30/07/2014 and Exp.
Dt. 30/06/2017 and Batch No. B236444, Mfd. Dt. 16/08/2014 and Exp.
Dt. 31/07/2017, imported by Paviour Pharmaceuticals (P) Ltd., New Delhi -
regarding.
Ref: Letter No. ADC/Deihi/Imp/NSQD-Paviour/14-15/119
dated 28/04/2015
from ADC(I), IGI Cargo Complex, New Delhi Vide FTS No. 22578/2015 dated
29/04/2015.
This is with reference to the Human Albumin IP/EP (Albiomin 20%)
200 g/1, solution for infusion, Batch No. B236434, Mfd. Dt. 30/07/2014
and Exp. Dt. 30/06/2017 and Batch No, B236444, Mfd, Dt. 16/08/2014
and Exp. Dt. 31/07/2017, manufactured by Biotest Pharma GmbH,
Germany, imported by Paviour Pharmaceuticals (P) Ltd., New Delhi and
declared as sub-standard by NIB, Noida.
In view of above, you are requested to recall the subject batches and
keep vigil over quality of next batches imported by the firm and inform this
Directorate in case of any non-compliance reported.
(Dr. G} N. Singh)
Drugs Controller Gengral (India)
Enclosure: A test reports received from NIB, Noida.
To,
Asst. Drugs Controller (1),
Customs House, Indira Gandhi International Airport,
New Delhi)
Copy toa:
1, All Zonal/ Sub-Zonal/ Port Offices of CDSCO - with the Direction to submit the action
taken report to this office
2. M/s Paviour Pharmaceutical (P) Ltd., 311-312, Suneja Tower-I, District Centre, Janak Puri,
New Delhi-110058- with the direction to submit the details of these batches in the market.