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