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CDSCO declares certain blood grouping serums NOT OF STANDARD QUALITY


CDSCO declares certain blood grouping serums NOT OF STANDARD QUALITY

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, 4th 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%20Notice%20Mediclone-D.pdf

http://www.cdsco.nic.in/writereaddata/Public%20Notice%20Combipack%20ABD.pdf



Source: self
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