CDSCO declares certain blood grouping serums NOT OF STANDARD QUALITY

Written by Ruby Khatun Khatun Published On 2017-09-17T11:58:09+05:30 | Updated On 17 Sept 2017 11:58 AM IST

New Delhi: Through a recent notification, Central Drugs Standard Control Organisation, Directorate General of Health Services, Ministry of Health & Family Welfare (Diagnostics Division) , Government of India, has declared Mediclone D (Blood Grouping Sera Anti-D) B. No. 88BG022 and COMBIPACK ABD, Anti-A, B & D (B. No. 116160303) Not of Standard Quality under Drugs and Cosmetics Act 1940 and Rules.

Mediclone D (Blood Grouping Sera Anti-D) (B. No. 88BG022) is manufactured by M/s. Mediclone Biotech Pvt. Ltd. 29 Biopavilion, Velichai, Chennai-600048 whereas COMBIPACK ABD, Anti-A, B & D (B. No. 116160303) is manufactured by M/s Bhat Biotech India (P) Ltd. 11-A, 4^th Cross Road, Veerasandra Industrial Area, Electronic City, Bangalore -560100.

The sample of Mediclone D was collected by drugs Inspector, Jalgaon (Maharashtra) whereas the sample of COMBIPACK ABD was collected by drugs Inspector, Bijnor (U.P.) and both the samples are forwarded to NIB, Noida for Testing.

After the analysis of the samples, the government analyst at NIB (NOIDA) has now declared Mediclone D as Not of Standard Quality (NSQ) and COMBIPACK ABD as Not of Standard Quality (NSQ) & Spurious under the provisions of Drugs & Cosmetics Act 1940.

The details are given below:

SI. No	Name of Product / Batch / Lot No./ Mfg. date	Analytical report	Remark
1.	Mediclone —D (Blood Grouping sera, Anti D) B.No.:88BG022 Mfg. Date: 07-2016 Exp. Date: 06-2018	N/GA-03/2017-18/BRL/21 Dated 16-08-2017	Sample declared as Not of Standard Quality

SI. No	Name of Product / Batch / Lot No./ Mfg. date	Analytical report	Remark
1.	COMBIPACK ABD, Anti-A, B & D Anti-A (IgM) monoclonal, 10 ml; B.No.: 116160303 Mfg. Date: 03/2016 Exp. Date: 02/2018	N/GA-04/2017-18/BRL/31 Dated 11-09-2017	Sample declared as Not of Standard Quality & spurious
2.	COMBIPACK ABD, Anti-A, B & D Anti-B (IgM) monoclonal, 10 ml. B. No.: 116160303 Mfg. Date: 03/2016 Exp. Date: 02/2018	N/GA-05/2017-18/BRL/32 Dated 11-09-2017	Sample declared as Not of Standard Quality & spurious
3.	COMBIPACK ABD, Anti-A, B & D Anti-D (IgM) monoclonal, 10 ml B. No.: 116160303 Mfg. Date: 03/2016 Exp. Date: 02/2018	N/GA-06/2017-18/BRL/33 Dated 11-09-2017	Sample declared as Not of Standard Quality & spurious

The general public through the notice has been notified by the NPPA that above-mentioned products, Mediclone D (Blood Grouping Sera Anti-D) B. No. 88BG022 and COMBIPACK ABD (Anti-A, B & D) B. No. 116160303 should not be used in any form.

Find the attachments for the same.

http://www.cdsco.nic.in/writereaddata/Public Notice Mediclone-D.pdf

http://www.cdsco.nic.in/writereaddata/Public Notice Combipack ABD.pdf

Bhat Biotech India (P) Ltdblood grouping serumsCDSCOCentral Drugs Standard Control OrganisationCOMBIPACK ABDdeclaresDirectorate General of Health ServicesGovernment of IndiaMediclone Biotech Pvt LtdMediclone DMinistry of Health & Family WelfareNIBNoidaNot of Standard QualitySpurioussubstandardsubstandard quality

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Ruby Khatun Khatun