CDSCO releases details of Not of Standard Quality samples for 2017-2023

Written By :  Dr. Divya Colin
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2024-09-19 12:30 GMT   |   Update On 2024-09-19 12:30 GMT
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New Delhi: The Central Drugs Standard Control Organization has published details of samples declared 'Not of Standard Quality' (NSQ) by Central Drugs Laboratory (CDL) along with regulatory action for the year 2017-2023.

The list includes various pharmaceutical products that have not met established quality standards. Notably, in 2017, the Tetanus Vaccine (adsorbed) from the Human Biological Institute was flagged due to physical quality failures linked to inadequate storage conditions.

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In 2018, a significant quality lapse was reported for Biological E's Diphtheria, Tetanus, Pertussis (Whole Cell), Hepatitis B (rDNA), and Haemophilus influenzae Type-b Conjugate vaccines, which failed physical tests. Following a joint investigation, conducted at manufacturing site on 09.04.2018 & 10.04.2018. The investigation team noted certain observations which was communicated to the firm for resposne. The firm had submitted the compliance report for the noted observations. The concerned Drugs Inspector completed the procedures as per the Drugs & Cosmetics Act.

Furthermore, in 2019,Biological E’s Diphtheria,Tetanus,Pertussis( Whole cell),Hepatitis B (rDNA) &Haemophilus influenzae Type-b Conjugate vaccine (Adsorbed) was also deemed to be of non-standard quality in 2019. Nonetheless, in keeping with the foregoing, a joint investigation was carried out at the manufacturing site on April 18, 2019, and the sample was marked as Standard Quality under Form -2 of Drugs Rules.

More alarmingly, a sample of the Covishield vaccine, claimed to be manufactured by SIIPL, was declared spurious in 2022, by CDL vide report no.: CDL/2022/3467 dated 16.06.2022. The police has investigated the matter and filed separate criminal case bearing no. 3087/2021 dated 04.12.2021 before Hon'ble XXII Judicial Magistrate F.C. Aurangabad. The matter is under trial.

Additionally, unlabelled vials of the ChAdoX1 nCoV19 and Novel Corona Virus - nCoV Vaccine (ZYCOVD) vaccines were found to be NSQ, failing multiple quality tests.

Detail of samples declared NOT OF STANDARD QUALITY (NSQ) by CDL along with regulatory action of year 2017

S.No

Name of Vaccine

Manufacturer

Batch No.

Mfg Date

Exp Date

Sub-Standard in

Type/ Source of Sample

Status

REGULATORY ACTION/

CONCLUSION (Including recall status)

1

Bio Typh (Vi Polysaccaride Typhoid Vaccine) I.P.

Spurious

1050411

Feb-15 Feb-16

Sep-17 Sep-18

Identity Test

Drug Inspectors

Not of Standard Quality (Spurious)

Joint investigation conducted at manufacturing site of Bio Med, Ghaziabad on 25.10.2017 and it was concluded that NSQ batch was not manufactured by firm.

Case filed before Hon'ble Court of District & Sessions Judge. The matter is under trial.

2

Tetanus Vaccine(adsorbed)

I.P (AbhayTox)

M/s Human Biological Institute, (A division of Indian Immunologicals Limited), Rakshapuram, Gachibowli Post, Hyderabad-

500032

Tox 23B/15

Apr-15

Mar-18

Physical aspect

Drug Inspectors

Not of Standard Quality

Joint investigation conducted at manufacturing site on 02.11.2017 and it was concluded that NSQ is due to improper storage condition of vials below recommended temperature.

This office has sent communication to SLA as per procedures.

Detail of samples declared NOT OF STANDARD QUALITY (NSQ) by CDL along with regulatory action of year 2018

S.No

Name of Vaccine

Manufacturer

Batch No.

Mfg Date

Exp Date

Sub-Standard

in

Type/ Source

of Sample

Status

REGULATORY ACTION/

CONCLUSION (Including recall status)

1

Diphtheria,Tetanus,Pertus sis (Whole cell) ,Hepatitis B (rDNA) & Haemophilus influenzae Type-b Conjugate

vaccine (Adsorbed)

M/s Biological E Ltd, Plot no. 1, SP Biotech Park, Phase II, Kolthur (Village), Shameerpet (mandal), Ranga Reddy (District), Telangana - 500078

220103715A

Feb-16

Jan-18

Physical aspect

Drugs Inspector

Not of Standard Quality

Joint investigation conducted at manufacturing site on 09.04.2018 & 10.04.2018. The investigation team noted certain observations which was communicated to the firm for resposne. The firm had submitted the compliance report for the noted observations.

The concenrned Drugs Inspector completed the procedures as per the Drugs & Cosmetics Act.

2

Peda Typh (Vi-Conjugate Typhoid Vaccine)

M/s Bio med., C-96, Bulandshar Road, Industrial Area, Ghaziabad-201009,

U.P- 201009

TC010915

Sep-15

Aug-18

VI Polysaccride content

Drug Inspectors

Not of Standard Quality

The sample was declared as Standard Quality

under Form -2 of Drugs Rules.

3

Peda Typh (Typhoid Vi- Conjugate Vaccine)

M/s Bio med., C-96, Bulandshar Road, Industrial Area, Ghaziabad-201009,

U.P- 201009

TC010417

Apr-17

Mar-20

VI Polysaccride content

Drug Inspectors

Not of Standard Quality

The sample was declared as Standard Quality under Form -2 of Drugs Rules.

4

Tetanus Vaccine(adsorbed) I.P

Vials Received Without Label

--

--

--

Container Closer Integrity

Drug Inspectors

Not of Standard Quality

Case filed before Hon'ble Court. Judgement was passed wherein the accused were sentenced and fined.

5

Poliomyelitis Vaccine live oral I.P. Divalent (Bivalent/bOPV)

M/s Bio med., C-96, Bulandshar Road, Industrial Area, Ghaziabad-201009, U.P- 201009

B100318

Mar-18

Feb-20

Identity: Type-2 detected

Drug Inspectors

Not of Standard Quality

Joint investigation conducted at manufacturing site on 03.10.2018 to 06.10.2018 & 08.10.2018.

The sample was also declared as Not Standard Quality in Form -2 under Drugs Rules.

Case filed before Honble Court. The matter is under trial.

6

Poliomyelitis Vaccine live oral I.P. Divalent (Bivalent/bOPV)

M/s Bio med., C-96, Bulandshar Road, Industrial Area, Ghaziabad-201009, U.P- 201009

B100318

Mar-18

Feb-20

Identity Type-2 detected

Drug Inspectors

Not of Standard Quality

Joint investigation conducted at manufacturing site on 03.10.2018 to 06.10.2018 & 08.10.2018.

The sample was also declared as Not Standard Quality in Form -2 under Drugs Rules.

Case filed before Honble Court. The matter is under trial.

Detail of samples declared NOT OF STANDARD QUALITY (NSQ) by CDL along with regulatory action of year 2019

S.No

Name of Vaccine

Manufacturer

Batch No.

Mfg Date

Exp Date

Sub- Standard in

Type/ Source of Sample

Status

REGULATORY ACTION/

CONCLUSION (Including recall status)

1

Diphtheria,Tetanus,Pertu ssis( Whole cell)

,Hepatitis B (rDNA) & Haemophilus influenzae Type-b Conjugate

vaccine (Adsorbed)

M/s Biological E Ltd, Plot no. 1, SP Biotech Park, Phase II, Kolthur (Village), Shameerpet (mandal), Ranga Reddy (District),

Telangana - 500078

220106717A

Oct-17

Mar-20

Physical aspect

Drug Inspectors

Not of Standard Quality

Joint investigation conducted at manufacturing site on 18.04.2019. The sample was declared as Standard Quality under Form -2 of Drugs Rules.

2

Tetanus Vaccine (Adsorbed) I.P.

M/s DANO Vaccines & Biologicals Pvt Ltd., Factory- 575, Sivaredyguda, Ghatkesar-501301, (T.S.)

1641V

Nov-16

Oct-19

Physical aspect

Drug Inspectors

Not of Standard Quality

Administrative action recommended.

Detail of samples declared NOT OF STANDARD QUALITY (NSQ) by CDL along with regulatory action of year 2022

S.No

Name of Vaccine

Manufacturer

Batch No.

Mfg Date

Exp Date

Sub-Standard in

Type/ Source of Sample

Status

REGULATORY ACTION/

CONCLUSION (Including recall status)

1

Covishield Vaccine

Spurious

4121MC040

07.07.2021

06.04.2022

Spurious

Drug Inspectors

Not of Standard Quality (Spurious)

The survey sample of corona virus vaccine purported to be manufactured by SIIPL was declared Spurious by CDL vide report no.: CDL/2022/3459 dated 16.06.2022.

The police investigated the matter and filed criminal case bearing no. 3087/2021 dated 04.12.2021 before Hon'ble XXII Judicial Magistrate F.C. Aurangabad.

The matter is under trial.

2

Covishield Vaccine

Spurious

4121MC019

14.06.2021

13.03.2022

Spurious

Drug Inspectors

Not of Standard Quality (Spurious)

The survey sample of corona virus vaccine purported to be manufactured by SIIPL was declared Spurious by CDL vide report no.: CDL/2022/3467 dated 16.06.2022..

The police has investigated the matter and filed separate criminal case bearing no.

3087/2021 dated 04.12.2021 before Hon'ble XXII Judicial Magistrate F.C. Aurangabad.

The matter is under trial.

3

Unlabelled filled transparent fluid vial purported to be ChAdoX1 nCoV19 corona virus

vaccine

Spurious

--

--

--

Identity, Assay, Biochemical test, Sterility Test, Physical aspect and Label review

Drug Inspectors

Not of Standard Quality (Spurious)

The sample was declared as NSQ (Spurious).

Case filed before CJM Court & the matter is under trial.

4

ChAdoX1 nCoV19 corona virus vaccine (Covishiled

vaccine)

Spurious

4121MC034

01.07.2021

31.03.2022

Identity, Assay, Biochemical test, Sterility Test, Physical aspect and

Label review

Drug Inspectors

Not of Standard Quality (Spurious)

The sample was declared as NSQ (Spurious).

Case filed before CJM Court & the matter is under trial.

5

Novel Corona Virus - nCoV Vaccine (ZYCOV- D)

Spurious

I457BH110

29.09.2021

28.06.2022

Identity, Assay, Biochemical test, Sterility Test, Physical aspect and

Label review

Drug Inspectors

Not of Standard Quality (Spurious)

The sample was declared as NSQ (Spurious).

Case filed before CJM Court & the matter is under trial.

Detail of samples declared NOT OF STANDARD QUALITY (NSQ) by CDL along with regulatory action of year 2023

S.No

Name of Vaccine

Manufacturer

Batch No.

Mfg Date

Exp Date

Sub-Standard in

Type/ Source of

Sample

Status

REGULATORY ACTION/

CONCLUSION (Including recall status)

1

Typhoid Polysaccharide Vaccine I.P. (TYPBAR)

M/s Bharat Biotech,Genome Valley Shameerpet, Hyderabad – 500

078 Telangana INDIA

54A22001A

Apr-22

Mar-25

O-acetyl Content

Drug Inspectors

Not of Standard Quality

Joint investigation conducted at manufacturing site on 19.07.2023 & 20.07.2023.

The SLA suspended the product permission of Typhoid vaccine for 15 days.

Also Read:NPPA Revises and Fixes Ceiling Price of Chloroquine Tablet 150 mg

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