Central Drugs Laboratory, Kasauli
Inspections
| Detail of Inspections for the year 2020 | ||||
| Sr. No | Date | Name of Expert | Inspection Name | Institutions/Firms Audited |
|---|---|---|---|---|
| 1 | 3-1-2020 | Mr. Devender Kumar(A.T.O) | To attend the joint inspection for verification with respect to Rabies Vaccine (human)strain. | M/S Bharat Biotech International Ltd; |
| 2 | 7-01-2020,8-01-2020 | Mrs. Kiran Pandey (D.A.D) | To attend the joint Inspection | M/S Greensignal Biopharma Pvt.Ltd 49,Pappankuppam village,Chennai |
| 3 | 21-01-2020,22-01-2020 | Mrs. Seema Sood (A.T.O) | To attend the joint Inspection for revalidation of certificate of Pharmaceutical Products | M/S Panacea Biotec.Ltd.,Village Malpur,Baddi,Distt.Solan |
| 4 | 10-02-2020,11-02-2020 | Mrs. Sameera Rawat (A.T.O) | To attend the joint Inspection | M/S Panacea Biotec.Ltd.,Ambala,Chandigarh Highway,Lalru |
| 5 | 02-03-2020,06-03-2020 | Dr.Vivek Bansal (A.T.O) | To attend the joint Inspection | M/S Dano vaccine & Biologicals Pvt.Ltd 575,Sivareddyguda and M/S Bharat Biotech International Ltd.Hyderabad |
| 6 | 18-03-2020,20-03-2020 | Mr.Davinder Kumar (A.T.O) | To attend the joint Inspection | M/S Cadila Healthcare Lmt Ahmedabad |
| 7 | 19-03-2020,20-03-2020 | Mr.Davindra Barthwal (A.T.O) | To attend the joint Inspection | M/S Biomed Pvt.Ltd.Ghaziabad,Uttar Pradesh |
| 8 | 8-06-2020 | Mr.S.R.Bhalla (A.T.O) & Mr.Davinder Kumar (A.T.O) | To attend the online joint Inspection | M/S Cadila Healthcare.Ltd. |
| 9 | 27-07-2020 to 28.07.2020 | Mr.S.R.Bhalla (A.T.O) | To attend the online joint Inspection | M/S Cadila Healthcare.Ltd. |
| 10 | 13-08-2020 to 14.08.2020 | Mr.S.R.Bhalla (A.T.O) | To attend the online joint Inspection | M/S Serum Institute of India pune |
| 11 | 16-09-2020 to 18.09.2020 | Mr.S.R.Bhalla (A.T.O) | To attend the online joint Inspection | M/S Bharat Biotech Internationa Pvt.Ltd. |
| 12 | 28-09-2020 to 29.09.2020 | Mr.S.R.Bhalla(A.T.O) & Mr.Davinder kumar(A.T.O) & Mr.Jasvinder Singh(A.T.O) | To attend the online joint Inspection | M/S Premas Biotech Internationa Pvt.Ltd. |
| 13 | 14-10-2020 to 16.10.2020 | Dr. Vivek Bansal(A.T.O) | To attend the online joint Inspection | M/S Biological E Ltd. |
| 14 | 22-10-2020 to 23.10.2020 | Dr. Vivek Bansal(A.T.O) | To attend the online joint Inspection | M/S Biological E Ltd. |
| 15 | 23-10-2020 | Mr.Sushil Kumar sahu(D.A.D) | To attend the online joint Inspection | M/S Cadila Healthcare.Ltd.Ahmedabad |
| 16 | 11-11-2020 to 12.11.2020 | Mr.Sumir Rai Bhalla(A.T.O) | To attend the online joint Inspection | M/S Sri anantha Padmanabha Pharma pvt.Ltd.Telangana |
| 17 | 18-11-2020 to 20.11.2020 | Mr.Sumir Rai Bhalla(A.T.O) & Dr.Vivek Bansal(A.T.O) | To attend the online joint Inspection | M/S Bharat Biotech Internationational Ltd.Hyderabad |
| 18 | 24-11-2020 to 25-11-2020 | Mr. Devendra Barthwal(A.T.O) | To attend the online joint Inspection | M/S Cadila Healthcare.Ltd.,Ahmedabad |
| 19 | 24-11-2020 to 26-11-2020 | Mr.Sushil Kumar sahu(D.A.D) & Mr.Davinder kumar(A.T.O) | To attend the online joint Inspection | M/S Biological Evans Ltd.Hyderabad |
| 20 | 27-11-2020 to 28-11-2020 | Mr.Devendra Bharthwal(A.T.O) | To attend the joint Inspection | M/S Central Research Institute, Kasauli |
| 21 | 2-12-2020 | Mr.Seema Sood(A.T.O) | To attend the joint Inspection | M/S Panacea Biotech Ltd.,Ambala,Lalroo. |
| 22 | 07-12-2020 | Mr.Sumir Rai Bhalla(A.T.O) | To attend the joint Inspection | M/S Panacea Biotech Ltd.,Baddi(HP) |
| 23 | 17-12-2020 TO 18-12-2020 | Mr.Davinder Kumar(A.T.O) & Mr.Jaswinder Singh(A.T.O) | To attend the online joint Inspection | M/S Bharat Biotech International Ltd.,Hyderabad |
| 24 | 21-12-2020 to 23-12-2020 | Mr.Sumir Rai Bhalla(A.T.O) & Mr.Devendra Barthwal(A.T.O) | To attend the online joint Inspection | M/S Human Biological Institute, Tamilnadu |
| 25 | 28-12-2020 to 30-12-2020 | Dr.Vivek Bansal(A.T.O)& Ms.Suchita Sharma(A.T.O) | To attend the online joint Inspection | M/S BCG Vaccine Lab,Guindy,Chennai |
| Detail of Inspections for the year 2019 | ||||
| Sr. No | Date | Name of Expert | Inspection Name | Institutions/Firms Audited |
| 1 | 17-01-2019-19 Jan 2019 | Mr.S.R Bhalla (A.T.O) | joint inspection of WHO GMP certificate | M/S Haffkine Bio-pharmaceutical corp. Ltd.Pimpri Pune |
| 2 | 21 to 24-02-2019 | Dr.Vivek Bansal (A.T.O) | joint inspection of WHO GMP certificate | Premium Serum & Vaccine Pvt.Ltd. Narayan Pune |
| 3 | 12-02-2019 | Mrs. Kiran Pandey (D.A.D) | To attend Revision and fixatation of National Reference Standards of Vaccine and Immunosera | IPC Ghaziabad |
| 4 | 12-02-2019 | Mr.S.R Bhalla (A.T.O) | To attend Revision and fixatation of National Reference Standards of Vaccine and Immunosera | IPC Ghaziabad |
| 5 | 05-03-2019 to 6-03-2019 | Mr. Sushil Kumar Sahu (D.A.D) | To obtain manufacturing license in form 29 for the manufacture of BCG Vaccine IP/BP and BCG Immunotherapy IP/BP | M/s Serum institute of India Pvt. Ltd. Hadapsar, Pune |
| 6 | 18-04-2019 | Mrs. Kiran Pandey(D.A.D) | To attend first quarter follow up Inspection as per Central Inspection Plan 2019 | M/s Panecea Biotech Ltd., Baddi |
| 7 | 28-03-2019,29-03-2019 | Mrs. Kiran Pandey (D.A.D) | To attend pre audit of facility for estibishment of GMP Compliiant facility for the production of DPT group of vaccine | Pasteur Institute of India coonoor |
| 8 | 23,24-04-2019 | Dr.Vivek Bansal (A.T.O) | To attend joint inspection for grant of Licence to manufacture for sale or for distribution of Tetanus Vaccine(Abserbed) IP. | M/S Bio Vaccine India Indore |
| 9 | 24-25-04-2019 | Mr.S.R Bhalla (A.T.O) | To attend joint inspection for manufacture of Hyperimmunesera in Form 27-D | M/S Biological Pvt.Ltd Sangali Maharashtra |
| 10 | 22 to 27-04-2019 | Mr.Devendra Barthwal(A.T.O) | To attend joint inspection of manufacture Units | M/s Human Biological Institute Hyderabad & Bharat Bioteck Interation Ltd Hyderabad |
| 11 | 6,7-05-2019 | Ms. Sameera Rawat(A.T.O) | To attend joint inspection of 2nd quarter Annual Inspection as per Central Inspection plan 2019 | M/s Panecea Biotech Ltd., Baddi |
| 11 | 22,23-05-2019 | Mr.Dr.Vivek Bansal(A.T.O) | To attend joint inspection | M/s Bharat Immunological & Biologicals corporation Lmt Bulandshaher |
| 12 | 18-06-2019 | Mr.Devendra Barthwal(A.T.O) | To attend the joint inspection | M/s Bharat Immunological & Biologicals corporation Lmt Bulandshaher |
| 13 | 18-06-2019 | Mr. Devender kumar(A.T.O) | To attend the joint investigation for renewal and fresh manufacturing | M/s Chiron Behring vaccine Pvt.Lmt |
| 14 | 17-18-06-2019 | Dr.Vivek Bansal(A.T.O) | To attend joint inspection for Annual routine GMP inspection as per central inspection Plan,2019 | M/s Biological E Lmt.Hyderabad |
| 15 | 19-20,06-2019 | Dr.Vivek Bansal(A.T.O) | To attend joint inspection for Annual routine GMP inspection as per central inspection Plan,2019 | M/s Dano vaccine & Biologicals Pvt.Ltd. |
| 16 | 17 to 20-06-2019 | Mr.Devinder kumar(A.T.O) | To attend joint inspection for Annual routine GMP inspection as per central inspection Plan,2019 | M/s Shantha Biotechnics Ltd.Rangareddy |
| 17 | 14 to 19-07-2019 | Ms.Suchita Sharma(A.T.O) | To attend joint inspection | M/s Green Signal Biopharma Pvt.Ltd. Chennai |
| 18 | 17-18,07-2019 | Mr.Devender Bharthwal(A.T.O) | To attend 1st Quarter follow up inspection as [per central inspection plan 2019 | M/s Panecea Biotech Ltd., Ambala chandigarh |
| 19 | 5-08-2019 | Mr.Jasvinder Singh(A.T.O) | To attend 1st Quarter follow up inspection as [per central inspection plan 2019 | M/s Panecea Biotech Ltd., Ambala chandigarh |
| 20 | 8-08-2019 | Mrs. Kiran Pandey (D.A.D) | To attend joint Inspection for grant of Licence to manufacturing mOPV Type-A | M/s Panecea Biotech Ltd.,Biotec Ltd.Malpur Baddi |
| 21 | 26-08-2019 to 28-08-2019 | Mrs. Kiran Pandey (D.A.D) | To attend the joint inspection. | M/s Biological E Lmt.Hyderabad |
| 22 | 29-08-2019 to 31-08-2019 | Mrs. Kiran Pandey (D.A.D) | To attend the joint inspection. | M/s Bharat Biotech International Limited |
| 23 | 26-08-2019 to 30-08-2019 | Mr. Sumir Rai Bhalla (A.T.O) | To attend the joint inspection. | M/S Human Biological Institute |
| 24 | 18-09-2019 to 19-09-2019 | Sh. Devender Barthwal (A.T.O) | To join the Joint Inspection for grant of Licence to Manufacturing mOPV Type-I (PT Biotech, Indonesia | M/S Panacea Biotec Ltd. Village malpur Baddi(H.P) |
| 25 | 14-10-2019 to 16-10-2019 | Mr. Sumir Rai Bhalla (A.T.O) | To attend the joint inspection. | M/S Cadila Healthcare Limited Ahmedabad Gujarat |
| 26 | 17-10-2019 to 18-10-2019 | Mr. Sumir Rai Bhalla (A.T.O) | To attend the joint inspection. | M/S Cadila Pharmaceutical Ltd. |
| 27 | 14-10-2019,15-10-2019 | Sh. Devender Barthwal, (A.T.O) | To attend the joint inspection. | M/S Pasteur Institute of India |
| 28 | 16-10-2019 to 18-10-2019 | Sh. Devender Barthwal, (A.T.O) | To attend the joint inspection. | M/S Human Biologicals Institute |
| 29 | 14-10-2019,15-10-2019 | Smt Seema Sood, (A.T.O) | To join the Joint Inspection for grant of inspection of permission under CT-11 to obatin Form-29 from State licensing Authority | M/S Vacxigen Lifescience Pvt. Ltd. |
| 30 | 04-11-2019 to 07-11-2019 | Sh. Devender Barthwal, (A.T.O) | To attend the joint inspection. | M/S Biological E Limited |
| 31 | 08-11-2019 to 09-11-2019 | Sh. Devender Barthwal, (A.T.O) | To attend the joint inspection. | M/S Shantha Biotechnics Ltd |
| 32 | 04-11-2019 to 06-11-2019 | Sh. Devender Kumar, (A.T.O) | To attend the joint inspection. | M/S Biological E Limited |
| 33 | 07-11-2019 to 09-11-2019 | Sh. Devender Kumar, (A.T.O) | To attend the joint inspection. | M/S Dano Vaccines & Biologicals Pvt.Ltd. |
| 34 | 20-11-2019 | Sh. Sumir Rai Bhalla (A.T.O) | To attend the joint inspection. | M/S Bio-Med Pvt Ltd C-96, Site-1, Bulandshahar Road, Indl Area Ghaziabad |
| 35 | 09-12-2019 to 13-12-2019 | Sh. Sushil Kumar Sahu(D.A.D) | To attend the joint inspection. | M/S Serum Institute of India Pvt.Ltd |
| 36 | 11-12-2019 to 12-12-2019 | Mrs. Kiran Pandey (D.A.D) | To attend the joint inspection. | M/S Green Signal Biopharma Ltd,Chennai |
| Detail of Inspections for the year 2018 | ||||
| Sr. No | Date | Name of Expert | Inspection Name | Institutions/Firms Audited |
| 12 | 18-06-2018 | Mrs seema Sood | To attend the 2nd quarter follow up inspection as per central inspection Plan 2018 | M/s Panecea Biotech Ltd., Baddi |
| 13 | 18-06-18 to 21-06-18 | Mr. Devendra Barthwal | To attend joint inspection of vaccine manufacturing units | M/s Cadila Pharmaceuticals Ltd. Ahemdabad |
| 14 | 4-06-2018to 9-06-2018 | Mr. Devendra Barthwal | To attend annual routine GMP inspection as per Central Inspection Plan 2018 based on RISK based approach | M/s Biological E Ltd., Hyderabad |
| 15 | 11,12,13-06-2018 | Mr.Vivek Bansal | To attend annual routine GMP inspection as per Central Inspection Plan 2018 based on RISK based approach | DANO Vaccine and Biological Ltd. Hyderabad |
| 16 | 14,15-06-2018 | Mr.Vivek Bansal | To attend annual routine GMP inspection as per Central Inspection Plan 2018 based on RISK based approach | M/s Biological E Ltd., Hyderabad |
| 17 | 4-6-2018 9-6-2018 | Mr.Devender kumar | GMP Inspection as per central inspection plan2018 based on RISK based approach & CAPA verification of previous inspection | M/s Biological E Ltd., Hyderabad |
| 18 | 18-06-2018 | Mr.Devender Bharthwal | Joint inspection for Manufactring Unit | M/s Cadila Pharmaceuticals Ltd. Ahemdabad |
| 19 | 21-06-2018 | Mr.Devender Bharthwal | Joint inspection for Manufactring Unit | M/s Cadila Pharmaceuticals Ltd. Dholka |
| 20 | 18,19-06-2018 | Mrs.Seema Sood | Joint inspection for Manufactring Unit | M/s Panecea Biotech Ltd., Baddi |
| 21 | 10-07-2018 | Mrs.Seema Sood | Joint inspection for Manufactring Unit | M/s Panecea Biotech Ltd., Baddi |
| 22 | 09-07-2018 10-07-2017 | Mrs.Seema Sood | To attend the 2nd quarter follow up inspectron as per Centyral Inspection Plan 2018 including verification of CAPA | M/s Panecea Biotech Ltd., Baddi |
| 23 | 26-09-2018 | Ms.Suchita Sharma (T.S) | To joint inspection for renewal of GMP certificate 2nd quarter follow up inspection and grant of COPP | M/s Panecea Biotech Ltd., Baddi |
| 24 | 24,25,26-09-2018 | Mr.Vivek Bansal | Verification of Post Approval change submitted under annual verication o/o DCGI | M/S Green signal |
| 25 | 27,28,29-09-2018 | Mr.Vivek Bansal | Joint Inspection Grant of Lince in Form 28 D. | M/S BCG Vaccine Laboratory |
| 26 | 4-09-2018 5-09-2018 | Mr. Sumir Rai Bhalla (A.T.O) | To attend joint inspection on NSQ Snake Venom Antiserum | M/S Vins Bioproducts Ltd Telangana(India) |
| 27 | 6-09-2018 7-09-2018 | Mr. Sumir Rai Bhalla (A.T.O) | To attend routine GMP Inspection as per Central Inspection Plan 2018 based on RISK Based approvel and CAPA verification of previous Inspection | HBI Telangana |
| 28 | 29-10-2018 3-11-2018 | Mr. Devendra Barthwal | joint inspection for verification of manufacturing activites | M/s Biological E Ltd.,Telangana India |
| 29 | 29-10-2018 30-10-2018 | Mr. Devendra Barthwal | CAPA Verifications of previous inspections of previous inspection from 29 Yellow fever | M/s Bharat Biotech International Ltd., Shameerpet Hyderabad,TS |
| 30 | 31-10-2018 1-11-2018 | Mr. Devendra Barthwal | CAPA Verifications of previous inspections & for grant of Form 29 NOC for thye manufacture(Lyophilization)of Antisera Products | M/s Biological E Ltd.,Telangana India |
| 31 | 3,4-10-18 4,5-10-18 | Mr.Sushil Kumar Sahu | Joint Inspection for grant of NOC to obtained manufacturing Linecience in form 28 D for Pneumococcal Polysaccharide Conjugate vaccine | M/s Serum institute of India Pvt. Ltd. Hadapsar, Pune |
| 32 | 21,22-2018 | Mr.S.R Bhalla | TO attend joint Inspection Risk based approach (Forth quarter annual) | M/S Haffkine Bio-pharmaceutical corpn.Ltd. Mumbai |
| 33 | 26-11-2018 27-11-2018 | Mr. Sumir Rai Bhalla (A.T.O) | joint inspection of WHO GMP certificate | M/s Cadila HealthCare Ltd.,Ahmedabad |
| 34 | 2-11-2018 3-11-2018 | Mr. Devendra Barthwal | CAPA Verification of previous inspections | M/S Human Biologicals Institute,Rakshapuram Gachibowli Hyderabad |
| 35 | 6-12-2018 7-12-2018 | Mr.Sushil Kumar Sahu | To attend joint Inspection grant of NOC | M/s Panecea Biotech Ltd., Baddi |
| 36 | 4,5-12-2018 | Seema Sood | To attend the 2nd quarter follow up inspection as per Central Inspection Plan 2018 | M/s Panera Biotech Pvt. Ltd.,Ambala Chandigarh Lalru |
| 37 | 26-12-2018 29-12-2018 | Dr.Vivek Bansal (T.S) | To attend joint inspection for annual routine GMP inspection | M/s Biological E Ltd.,Telangana India |
| 38 | 6-12-2018 7-12-2018 | Mr.Sushil Kumar Sahu | To attend 4th quarter annual inspection as per central Inspection plan 2018 | M/s Panera Biotech Pvt. Ltd., Lalru |
| 39 | 17,18-12-2018 | Mrs. Kiran Pandey | To attend Joint Inspection for Grant of No objection certificate (NOC) | Chambaghat Solan |
| 40 | 18,19-12-2018 | Mr.S.R Bhalla | To attend joint Inspection RISK based approach(forth quarter annual | M/s Serum institute of India Pvt. Ltd. Hadapsar, Pune |
| 41 | 21-05-2018 to 25-05-2018 | Mr.Sushil Kumar Sahu | Joint Inspection for Central Inspection plan using risk based approach and for investigation of AEFI cases. | M/s Serum institute of India Pvt. Ltd. Hadapsar, Pune |
| 42 | 18-06-2018 | Mr.Suresh kumar | Joint testing of Thymogam 250mg batch No.A05417006 | M/S Bharat Serium and Vaccine |
| 43 | 18-06-18 to 21-06-18 | Mr. Devendra Barthwal | To attend joint inspection of vaccine manufacturing units | M/s Cadila Pharmaceuticals Ltd. Ahemdabad |
| 44 | 4-06-2018to 9-06-2018 | Mr. Devendra Barthwal | To attend annual routine GMP inspection as per Central Inspection Plan 2018 based on RISK based approach | M/s Biological E Ltd., Hyderabad |
| 45 | 11,12,13-06-2018 | Mr.Vivek Bansal | To attend annual routine GMP inspection as per Central Inspection Plan 2018 based on RISK based approach | DANO Vaccine and Biological Ltd. Hyderabad |
| 46 | 14,15-06-2018 | Mr.Vivek Bansal/td> | To attend annual routine GMP inspection as per Central Inspection Plan 2018 based on RISK based approach | M/s Biological E Ltd., Hyderabad |
| 47 | 4-6-2018 9-6-2018 | Mr.Devender kumar | GMP Inspection as per central inspection plan2018 based on RISK based approach & CAPA verification of previous inspection | M/s Biological E Ltd., Hyderabad |
| 48 | 18-06-2018 | Mr.Devender kumar | Joint inspection for Manufactring Unit | M/s Cadila Pharmaceuticals Ltd. Ahemdabad |
| 49 | 21-06-2018 | Mr.Devender kumar | Joint inspection for Manufactring Unit | M/s Cadila Pharmaceuticals Ltd. Dholka |
| 50 | 18,19-06-2018 | Mrs.Seema Sood | Joint inspection for Manufactring Unit | M/s Panecea Biotech Ltd., Baddi |
| 51 | 10-07-2018 | Mrs.Seema Sood | Joint inspection for Manufactring Unit | M/s Panecea Biotech Ltd., Baddi |
| 52 | 09-07-2018 10-07-2017 | Mrs.Seema Sood | To attend the 2nd quarter follow up inspectron as per Centyral Inspection Plan 2018 including verification of CAPA | M/s Panecea Biotech Ltd., Baddi |
| 53 | 26-09-2018 | Ms.Suchita Sharma (T.S) | To joint inspection for renewal of GMP certificate 2nd quarter follow up inspection and grant of COPP | M/s Panecea Biotech Ltd., Baddi |
| 54 | 24,25,26-09-2018 | Mr.Vivek Bansal | Verification of Post Approval change submitted under annual verication o/o DCGI | M/S Green signal |
| 55 | 27,28,29-09-2018 | Mr.Vivek Bansal | Joint Inspection Grant of Lince in Form 28 D. | M/S BCG Vaccine Laboratory |
| 56 | 4-09-2018 5-09-2018 | Mr. Sumir Rai Bhalla (A.T.O) | To attend joint inspection on NSQ Snake Venom Antiserum | M/S Vins Bioproducts Ltd Telangana(India) |
| 57 | 6-09-2018 7-09-2018 | Mr. Sumir Rai Bhalla (A.T.O) | To attend joint inspection on NSQ Snake Venom Antiserum | M/S Vins Bioproducts Ltd Telangana(India) |
| 58 | 15-01-2018 till 16-01-2018 | Mrs Sameera Rawat(A.T.O) | To attend joint investigation(Surprise unannouced) | Bio-Med Pvt.Ltd.Ghaziabad |
| 59 | 16-01-2018 till 17-01-2018 | Dr.Vivek Bansal (T.S) | To attend joint investigation(Surprise unannounced) | DANO Vaccine and Biological Ltd. Hyderabad |
| 60 | 31-01-2018 till 02-02-2018 | Mr. Sumir Rai Bhalla (A.T.O) | To attend the Joint Investigation | M/S Vins Bioproducts Ltd Telangana(India) |
| 61 | 2018-02-05 | Mr.Devendra Barthwal(T.S) | To attend joint inspection | M/S Bharat Biotech International Ltd Hyderabad & M/S Dano Vaccine & Biologicals Hyderabad |
| 62 | 2018-02-05 | Dr.Vivek Bansal (T.S) | To attend joint inspection | M/S Shantha Biotech & M/s Bharat Serum Vaccine Ltd.Hyderabad |
| 63 | 12-02-2018 till 16-02-2018 | Mr.Sushil Kumar Sahu | To attend the Joint inpection of the vaccine manufacturing unit for grant of form 29 NOC | M/S Human Biologicals Institute,Rakshapuram Gachibowli Hyderabad |
| 64 | 19-02-2018 till 24-02-2018 | Dr.Vivek Bansal (T.S) | To attend the Joint inpection of the vaccine manufacturing unit for grant of form 28 DA for Snake Venom Antiserum | M/S Bharat Serium and Vaccine M/S Shantha Bitechnics( Ltd.Athvelli,Ranga Reddy) M/S -Shantha Biotechnics Pvt.Ltd.Muppisedpally |
| 65 | 22-02-2018 till 23-02-2018 | Mr. Devendra Barthwal | To Joint Inspection for verification of CAPA | M/S Chiron Behring Vaccine Ltd.Ankleshwar |
| 66 | 09-02-2018 till 10-03-2018 | Mr.Sushil Kumar Sahu | To attend the inspection to access the readiness of the facilities of supply vaccine | Chengalpattu,Tamil Nadu |
| 67 | 26-03-2018-27-03-2018 | Dr.Vivek Bansal (T.S) Mr.Devendra Barthwal(T.S) |
To attend joint inspection | M/S Bio-med Pvt.Ltd.Bulandshahre road indl.area Ghaziabad |
| 68 | 02-05-2018 till 03-05-2018 | Mr.Sumeer Rai Bhalla (A.T.O) | To attend Joint Ispection for Renewal of License | M/S Haffkine Bio-Pharmaceutical corpn.Ltd Pimpri Pune |
| 69 | 04-05-2018 till 05-05-2018 | Mr. Sumir Rai Bhalla (A.T.O) | To attend Joint Ispection | M/S Haffkine Bio-Pharmaceutical corpn.Ltd Acharya Donde mrg,Parel,Mumbai |
| Detail of Inspections for the year 2017 | ||||
| Sr. No | Date | Name of Expert | Inspection Name | Institutions/Firms Audited |
| 1 | 03.01.2017 | Mr. Sushil Kumar Sahu (T.O) | Joint Inspection for grant of license for manufacture Rota Virus Vaccine(Live Attenuated,Oral) 1 pin for 28D under CLAA scheme. | M/s Serum institute of India Ltd. Hadapsar, Pune |
| 2 | 06.03.2017-08.03.2017 | Mr. Sushil Kumar Sahu (T.O) | Anual routine GMP inspection as per central inspection plan based on risk based approach | M/s Shantha Biotechnics Ltd., Hyderabad |
| 3 | 06.03.2017-08.03.2017 | Mr. Sumir Rai Bhalla (A.T.O) | Joint Inspection for grant of additional product and for annual audit inspection. | M/s Dano Vaccines & Biologicals Pvt. Ltd.Sivareddyguda, Ghatkesar, Hyderabad |
| 4 | 09.03.2017-11.03.2017 | Mr. Sushil Kumar Sahu (T.O) | Joint Inspection for grant of additional products and renewal of license | M/s Biological E Ltd., Hyderabad |
| 5 | 09.03.2017-11.03.2017 | Mr. Sumir Rai Bhalla (A.T.O) | Joint inspection for Renewal of license | M/s Bharat Biotech International Ltd., Hyderabad |
| 6 | 06.04.2017-07.04.2017 | Dr.Vivek Bansal (T.S) | To attend Joint Inspection | M/s Venky Parenterals Adavipolam, Yanam, A.P. |
| 7 | 10.04.2017-12.04.2017 | Mrs. Kiran Pandey (D.A.D) | Joint inspection of vaccine manufacturing unit | M/s Human Biologicals institute, Udhagamandalam (Ooty) |
| 8 | 10.04.2017-11.04.2017 | Mr. Jasvinder Singh (T.S) | Joint inspection for grant of certificate | M/s Panecea Biotech Ltd., Baddi |
| 9 | 17.04.2017-18.04.2017 | Mr. Sumir Rai Bhalla (A.T.O) | Joint inspection for grant of license for Typhoid vaccine | M/s Cadila HealthCare, Ahmedabad |
| 10 | 20.04.2017-21.04.2017 | Dr.Vivek Bansal (T.S) Mrs. Meena Chandel (T.S) |
Joint inspection for follow-up of first quarter as per central inspection plan | M/s Panera Biotech Pvt. Ltd., Lalru |
| 11 | 17.05.2017-18.05.2017 | Mr. Sumir Rai Bhalla (A.T.O) | Joint inspection for grant of license for typhoid vaccine | M/s Cadila HealthCare, Ahmedabad |
| 12 | 25.05.2017-26.05.2017 | Mr. Devender Kumar (T.S) | Joint inspection for Renewal of GMP certificate(vaccine division) | M/s Panecea Biotech Ltd., Baddi |
| 13 | 05.06.2017-10.06.2017 | Mrs. Kiran Pandey (D.A.D) | To attend Joint Inspection of vaccine manufacturing units | M/s Human Biological Institute Rakshapuram,Hyderabad |
| 14 | 27.06.2017-28.06.2017 | Mr. Sumir Rai Bhalla (A.T.O) | To attend Joint Inspection | M/s Bharat Biotech International Ltd., Hyderabad |
| 15 | 29.06.2017-30.06.2017 | Mr.Devendra Barthwal ( T.S) | Joint inspection of manufacturing facility as per the central plan | M/s Zydus Cadila Ltd. VTC Bavala changodar (Ahmedabad) |
| 16 | 10.07.2017-11.07.2017 | Mr. Jasvinder Singh (T.S) | To attend Joint Inspection | M/s Bharat Biotech International Ltd., & Human Biological Hyderabad |
| 17 | 12.07.2017-13.07.2017 | Mr. Jasvinder Singh (T.S) | To attend Joint Inspection | M/s Biological E Ltd., Azamabad,Hyderabad & Human Biological Institute Medak |
| 18 | 14.07.2017-15.07.2017 | Mr. Jasvinder Singh (T.S) | To attend Joint Inspection | M/s Human Biological Institute Medak |
| 19 | 27.07.2017-28-07-2017 | Mr.Devendra Barthwal ( T.S) | Joint inspection of vaccine manufacturing facility(Rabies Vaccine) | M/s cadila HealthCare Ltd. Moraiya,Ahmedabad |
| 20 | 31.07.2017-04.08.2017 | Mrs. Kiran Pandey (D.A.D) | Joint inspection as per central inspection plan using risk based approach and investigation of AEFI cases | M/s Serum institute of India Pvt. Ltd. Hadapsar, Pune Gujarat |
| 21 | 24.08.2017-25.08.2017 | Mrs. Kiran Pandey (D.A.D) | To attend Joint Inspection for grant of NOC | M/s Panecea Biotech Ltd., Baddi |
| 22 | 30.10.2017-11.11.2017 | Dr.Vivek Bansal (T.S) | To attend the inspection of overseas drug manufacturing facilities | China GMP compliance |
| 23 | 09.11.2017-10.11.2017 | Ms.Suchita Sharma (T.S) | To attend Joint Inspection for Renewal of manufacturing license | M/s Venky Parenterals Adavipolam, Yanam, A.P. |
| 24 | 20.11.2017-21.11.2017 | Mrs. Kiran Pandey (D.A.D) | To attend Joint Inspection | M/s Biological E Ltd., Hyderabad |
| 25 | 22.11.2017-23.11.2017 | Mrs. Kiran Pandey (D.A.D) | To attend Joint Inspection | M/s Bharat Biotech International Ltd. |
| 26 | 24.11.2017-25.11.2017 | Mrs. Kiran Pandey (D.A.D) | To attend Joint Inspection | M/s Tergene Biotech Pvt.Ltd. |
| 27 | 27.11.2017-30.11.2017 | Mr. Sumir Rai Bhalla (A.T.O) | To attend Joint Inspection for investigation of AEFI cases | M/s Serum institute of India Pvt. Ltd. Hadapsar, Pune |
| 28 | 05.12.2017 | Mr. Sushil Kumar Sahu (T.O) | To attend the Joint inspection for Renewal of GMP certificate & Renewal of manufacturing license | M/s Panera Biotech Pvt. Ltd., Lalru |
| 29 | 07.12.2017- 08.12.2017 | Mr. Sushil Kumar Sahu (T.O) | To attend Joint Inspection | M/s Panecea Biotech Ltd., Baddi |
| 30 | 18.12.2017-20.12.2017 | Mr. Sumir Rai Bhalla (A.T.O) | Joint Inspection for additional products DTP Vaccine | M/s Cadila HealthCare Ltd.,Ahmedabad |
| 31 | 19.12.2017-21.12.2017 | Ms.Suchita Sharma (T.S) | To attend Joint Inspection | M/s Human Biological Institute Tamil Nadu |
| 32 | 21.12.2017-22.12.2017 | Dr.Vivek Bansal (T.S) | Routine Joint Inspection of vaccine manufacturing unit | M/s Cadila Pharmaceuticals Ltd. Ahemdabad |
| Detail of Inspections for the year 2016 | ||||
| Sr. No | Date | Name of Expert | Inspection Name | Institutions/Firms udited |
| 1 | 29.02.2016 | Mrs. Kiran Pande (Dy. Assistant Director) | Joint Inspection Of Manufacturing Unit | M/s Bharat Biotech International Ltd, Hyderabad |
| 2 | 03.03.2016-04.03.2016 | Mrs. Kiran Pande (Dy. Assistant Director) | Joint Inspection Of Manufacturing Unit | M/s Biological E. Ltd, Shameerpet |
| 3 | 04.03.2016-05.03.2016 | Mrs. Kiran Pande (Dy. Assistant Director) | Joint Inspection Of Manufacturing Unit | M/S Human Biological Institute, Karakaphatla. Medak |
| 4 | 29.03.2016-30.03.2016 | Mrs. Kiran Pande (Dy. Assistant Director) | Joint Inspection for grant of No objection certificate (NOC) Special permission to start manufacturing in new facility | BCG Vaccine Lab, Guindy, Tamilnadu |
| 5 | 27.05.2016 | Mr. Sumir Rai Bhalla (A.T.O.) | Joint Inspection | M/s PANERA Biotech Pvt. Ltd. Lalaru (Punjab) Panacea Biotech Ltd., Baddi, H.P. |
| 6 | 21.06.2016-23.06.2016 | Ms. Suchita Sharma (T.S.) | Observed Audit as a part of NRA Assessment | Panacea Biotech Ltd., Baddi, H.P. |
| 7 | 22.06.2016-24.06.2016 | Dr. Vivek Bansal (T.S.) | Observed Audit | Green Signal Biopharma Pvt. Ltd., Chennai |
| 8 | 29.06.2016-01.07.2016 | Mr. Devendra Barthwal (T.S.) | Observed Audit | M/s Haffkine biopharmaceutical Ltd. Mumbai. |
| 9 | 22.07.2016-23.07.2016 | Mr. Devendra Barthwal (T.S) | Joint Inspection for grant of additional products permission for Rabies Vaccine. Human IP (Freeze- Dried). | M/s Serum Institute of India Ltd. |
| 10 | 11.8.2016 to 13.8.2016 | Mr. Sushil Kumar Sahu (T.O.) | Inspection for grant of License to manufacturing in form 28-D under CLAA Scheme for onsite evaluation and to verify the requirements of GMP as per Schedule M of D & C Act and rules. | M/S Cadila Healthcare Ltd. Ahmedabad. |
| 11 | 16.8.2016 to 20.8.2016 | Mrs. Kiran Pande (Dy. Assistant Director) | Joint inspection | Biological E Ltd., & M/s Human Biological Institute Hyderabad. |
| 12 | 17.8.2016 to 19.8.2016 | Mr. Sushil Kumar Sahu (T.O) | WHO observed Audit including Annual Audit Inspection based on Risk Based Approach. | Bharat Biotech International Ltd, Hyderabad. |
| 13 | 6.9.2016 to 9.9.2016 | Mr. Sumir Rai Bhalla (A.T.O.) | Inspection proposed for Risk based approach | Human Biological Institute & Biological E Ltd.Hyderabad. |
| 14 | 27.09.2016 to 28.9.2016 | Mr. Davinder Kumar, (T.S.) | Joint Inspection for follow -up earlier inspection conducted on 14/12/15 to 15/12/2015 and 26 to 27/5/2016 | M/s Pan Era Biotech Pvt. Ltd. Lalru. |
| 15 | 29.09.2016-30.092016 | Mrs. Seema Sood (T.S.) | Joint inspection for follow up of earlier inspection conducted on 23rd to 25th May'2016 for 3rd quarter central inspection plan, 2016 | M/s Panacea Biotech. Ltd., Village- Malpur Baddi |
| 16 | 29.09.2016-30.09.2016 | Miss. Suchita Sharma (T.S.) | Joint inspection for follow up of earlier inspection conducted on 23rd to 25th May'2016 for 3rd quarter central inspection plan, 2016 | M/s Panacea Biotech. Ltd., Village- Malpur Baddi |
| 17 | 4.10.2016 to 10.5.2016 | Mr. Sushil Kumar Sahu, (T.O) | Joint inspection | M/s Chiron Behring Vaccines Pvt. Ltd., Gujarat. |
| 18 | 17.10.2016 to 21.10.2016 | Mr. Sushil Kumar Sahu, (T.O) | WHO Audit of vaccine | Haffkine Bio- Pharmaceutical Corporation Ltd.Mumbai. |
| 19 | 21.11.2016 to 23.11.2016 | Mr. Davinder Kumar (T. S.) | Attended Inspection as per Central Inspection Plan-2016. | M/s Bharat Immunological & Biological Corporation Bulandshahar. (UP) |
| 20 | 25.11.2016 | Dr. Vivek Bansal, (T.S.) Mrs. Meena Chandel (T.S) |
Joint Investigation of the facility to verify the factual status of Batch manufactured | M/s Panacea Biotech Ltd. (Unit-II), Baddi. |
| 21 | 25.11.2016 to 26.11.2016 | Mrs. Meena Chandel (T.S) | Joint Inspection for grant of additional product | M/s Panacea Biotech Ltd. (Unit-II), Baddi. |
| 22 | 1.12.2016 to 12.3.2016 | Mr. Sushil Kumar Sahu (T.O) | Joint Inspection for grant of renewal of license in Form 26-H for the period of 1/1/2017 to 31/12/2021 | M/s Serum Institute Pune. |
| 23 | 27.12.2016to 28.12.2016 | Miss. Suchita Sharma, (T.S) | Follow-up of 4th quarter as per central inspection plan (CIP) 2016 and renewal of manufacturing license | M/s Central Research Institute, Kasauli |
| 24 | 27.12.2016 to 28.12.2016 | Mr. Sumir Rai Bhalla (A.T.O) | Follow-up of 4th quarter as per central inspection plan (CIP) 2016 and renewal of manufacturing license | M/s Central Research Institute, Kasauli |
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