Central Drugs Laboratory, Kasauli

Central Drugs Standard Control Organisation
Ministry of Health & Family Welfare
Government of India

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
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