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Detail of Inspections for the year 2024
Sr. No	Date	Name of Expert	Inspection Name	Institutions/Firms Audited
1	8,9,10-01-2024	Mr. Devendra Barthwal(ATO)	Joint Inspection for issuance of NOC for import for export purpose: importing Bulk Drug Substance (Monovalent Oral Polio bulk (mOPV) virus Type 1 and Type 3) from Bilthoven Biologicals (BBio), The Netherlands, for manufacturing Poliomyelitis Vaccine (oral), Bivalent Type 1 and Type 3 Drug Product at SIIPL for export purpose only through UNICEF Supply	M/s Serum Institute of India, 212/2 Hadapsar, Pune 412208
2	14,15-01-2024	Mr. Jasvinder Singh (ATO)	Joint inspection to grant of permission in form CT-11 to manufacturer drug substance and drug product of various Antitoxin and Antiserum	M/s Biological E Limited,7-4-114, Gaganpahad, Rajendranagar Manda, Rangareddy, District - 500052
3	16-01-2024	Mr. Davinder Kumar (ATO)	Joint Inspection for grant of permission in From CT - 11 to manufacture “Varicella Zoster Virus (VZV) Vaccine (Recombinant) (50g/0.5 mL) for Clinical trial purpose	M/s Cadila Pharmaceuticals Ltd. 1389, Trasad Road, Dhokla – 382225, Ahmadabad
4	26-01-2024	Mr. Devendra Barthwal(ATO)	Joint Inspection for grant of permission in From CT - 11 to manufacture the drug product batches of Rabies Vaccine, Human I.P (Purified Chick Embryo Cell Culture Rabies Vaccine) in single dose vial (1.0 ml.) presentation For Examination, Test and Analysis purpose	M/s Zydus Life Sciences Limited, Zydus Corporate Park, Scheme No. 63, Sy. No. 536, Khoraj, Gandhinagar, Ahmedabad Gujrat - 382481
5	26,28-01-2024	Mr. Devendra Barthwal(ATO)	Joint Inspection for grant of permission in From CT - 11 to manufacture the drug product batches of Rabies Vaccine, Human I.P (Purified Chick Embryo Cell Culture Rabies Vaccine) in single dose vial (1.0 ml.) presentation For Examination, Test and Analysis purpose	M/s Zydus Life Sciences Limited, Zydus Corporate Park, Scheme No. 63, Sy. No. 536, Khoraj, Gandhinagar, Ahmedabad Gujrat - 382481
6	14,15-02-2024	Mr. Jasvinder Singh(ATO)	Joint inspection to grant of permission in form CT-11 to manufacturer drug substance and drug product of various Antitoxin and Antiserum	M/s Biological E Limited,7-4-114, Gaganpahad, Rajendranagar Manda, Rangareddy, District - 500052
7	16-02-2024	Mr. Davinder Kumar(ATO)	Joint Inspection for grant of permission in From CT - 11 to manufacture “Varicella Zoster Virus (VZV) Vaccine (Recombinant) (50g/0.5 mL) for Clinical trial purpose	M/s Cadila Pharmaceuticals Ltd. 1389, Trasad Road, Dhokla – 382225, Ahmadabad
8	16-02-2024	Mr. Davinder Kumar(ATO)	Joint Inspection for grant of permission in From CT - 11 to manufacture “Varicella Zoster Virus (VZV) Vaccine (Recombinant) (50g/0.5 mL) for Clinical trial purpose	M/s Cadila Pharmaceuticals Ltd. 1389, Trasad Road, Dhokla – 382225, Ahmadabad
9	26-02-2024	Mr. Davinder Barthwal(ATO)	Joint Inspection for grant of permission in From CT - 11 to manufacture the drug product batches of Rabies Vaccine, Human I.P (Purified Chick Embryo Cell Culture Rabies Vaccine) in single dose vial (1.0 ml.) presentation For Examination, Test and Analysis purpose	M/s Zydus Life Sciences Limited, Zydus Corporate Park, Scheme No. 63, Sy. No. 536, Khoraj, Gandhinagar, Ahmedabad Gujrat - 382481
10	27,28-03-2024	Mr. Sumir Rai Bhalla (TO)	Joint inspection for grant of approval of following additional products in Form 28D for export purpose.	M/s. VINS Bioproducts Limited, Sy. No.117, Thimmapur (V), Kothur (M), Mahaboobnagar -509325, Telangana, India
11	27,28-03-2024	Mr. Davinder Kumar (ATO)	Joint inspection for grant of manufacturing license in forms 28D for additional product i. e. Pneumococcal Polysaccharide Conjugate Vaccine (Absorbed).	M/s Biological E. Limited, Plot No. 1, Phase- II, Biotech Park, Kolthur Village, Shameerpet, Medchal-Malkajgiri (D)-500078 Telangana
12	22,23,24-04-2024	Ms. Suchita Sharma (ATO)	joint inspection for grant of permission in Form Ct-11	M/s. Biological E limited, kolthur village, Shameerpet, Medchal-Malkajgiri , Telangana
13	22-04-2024	Mr. Davinder Kumar (ATO)	Online joint Inspection for grant of permission to manufacture Yellow Fever Vaccine for examination, test and analysis purpose only.	M/s Chiron Behring Vaccines Pvt. Ltd., Plot No. 3502, Post Box No. 136, G.I. D. C. Estate, Ankleshwar, 393002 Gujrat India
14	24,26-04-2024	Mr. Davinder Kumar (ATO)	Online joint Inspection for to verify the compliance to the requirement of applicable GMP Guidelines.	M/s Gennova Pharmaceuticals Limited, Block No. 1, P-1 & P-2, ITBT Park, Phase –II, MIDC, Hinjawadi, Pune, Maharashtra
15	20,21-04-2024	Mr. Sushil Kumar Sahu(Director)	Online joint inspection of the premises for compliance verification of the facility.	M/s Yapan Bio Pvt., Limited, Suit no. 221 & 222, Building 450, MN Park, Synergy Surae-1 Genome Valley, Telangana-5000078
16	27,28,29-05-2024	Ms. Suchita Sharma (ATO)	Online joint Inspection for manufacturing of Cholera Vaccine in Form 28D	M/s Bharat Biotech International Limited, Genome Valley, Shameerpet, Hyderabad- 500078, Telangana
17	27,28,29-05-2024	Ms. Suchita Sharma (ATO)	Joint inspection for grant of permission in Form CT-11 to manufacture Haemophilus influenza type b conjugate (PRP-TT) BP for examination test and analysis .	M/s Panacea Biotec Limited, Ambala-Chandigarh Highway, Lalru, Distt. Mohali, Punjab
18	4,5,6-06-2024	Ms. Suchita Sharma (ATO)	Joint inspection for grant of permission in Form CT-11 to manufacture Haemophilus influenza type b conjugate (PRP-TT) BP for examination test and analysis .	M/s Panacea Biotec Limited, Ambala-Chandigarh Highway, Lalru, Distt. Mohali, Punjab
19	4,5,6-06-2024	Mr. Sumir Rai Bhalla Technical Officer	Joint inspection for grant of Permission to manufacture "BCG Vaccine" at new manufacturing facility -02	M/s, Greensignal Bio Pharma Pvt ltd,Chennai
Detail of Inspections for the year 2023
Sr. No	Date	Name of Expert	Inspection Name	Institutions/Firms Audited
1	5-01-2023 to 6-01-2023	Mr.Sumir Rai Bhalla(T.O) & Mr.Davinder Kumar (A.T.O)	Joint Inspection for Grant of manufacturing license in Form 28D to manufacture 1. Inactivated Hepatitis A Vaccine (Adsorbed) I.P (For Domestic & export) Pack size 0.5 mL and 1mL vial 2. Inactivated Hepatitis A Vaccine B.P (For export) 3. Hepatitis A Bulk Vaccine (For Domestic & Export).	M/s. Human Biological Institute ( A division of Indian Immunologicals Limited), Rakshapuram, Gachibowli,Hyderabad-500032
2	23-01-2023 to 24-01-2023	Ms. Suchita Sharma (A.T.O)	Joint Inspection for grant of permission to manufacture “ Pneumococcal Polysaccharide Conjugate Vaccine (adsorbed), I.P (15 Valent)” for sale or for distribution.	M/s. Tergene Biotech Private Limited, C/o Auro Vaccines Private Limited (formerly unit 18-Aurobindo Pharma Limited), Survey No. 69/A, 70/AA2, 70/AA5, 70/AA6, 70/AA&, 71/A5, 71/A6, 72/A6, 72, Indrakaran (V), Kandi (M), Sangareddy (D), Hyderabad, Telangana-502329
3	1-02-2023	Mr. Sushil Kumar Sahu(Director)	Joint Compliance Verification Inspection for Grant of CLAA approval of additional products namely Diphtheria and Tetanus Vaccine (Adsorbed) for Adults and Adolescents I.P. 0.5 mL single dose vial and Multi Dose (5 mL - 10 mL dose vial) in Form 28-D	M/s. Tergene Biotech Private Limited, C/o Auro Vaccines Private Limited (formerly unit 18-Aurobindo Pharma Limited), Survey No. 69/A, 70/AA2, 70/AA5, 70/AA6, 70/AA&, 71/A5, 71/A6, 72/A6, 72, Indrakaran (V), Kandi (M), Sangareddy (D), Hyderabad, Telangana-502329
4	2-02-2023 to 3-03-2023	Mr. Davinder Kumar(A.T.O)	Joint Inspection for verification of the product specific requirement and impact of the aforesaid change vis-à-vis applicable requirements and adequacy of data for proposed post approval change	M/s Green Signal Biopharma Limited, No. 49, Pappankuppam Village, Gummidipoondi, Chennai – 601201.
5	1,2,3-02-2023	Ms. Suchita Sharma(A.T.O)	Joint Compliance Verification Inspection for Grant of CLAA approval of additional products namely Diphtheria and Tetanus Vaccine (Adsorbed) for Adults and Adolescents I.P. 0.5 mL single dose vial and Multi Dose (5 mL - 10 mL dose vial) in Form 28-D	M/s Zydus Lifesciences Limited (formerly known as Cadila Healthcare Ltd.), Plot No. 23, 25/P, 37, 40/P, 42 to 47, Sarkhej - Bavla N. H. No. 8A, Opp. Ramdev Masala, Village: Changodar, Tal.: Sanand, Dist. Ahmedabad - 382 213, Gujarat
6	14,15,16-02-2023	Mr. Jaswinder Singh(A.T.O)	Joint Inspection for license of stock piling Lyophilized mRNA Vaccine for Injection (COVID-19).	M/s. Gennova Biopharmaceuticals Limited, Block 1, Plot No. P-1 & P-2, ITBT Park, Phase II, MIDC, Hinjawadi, Pune, Maharashtra-411057
7	15-02-2023	Mr. Sumir Rai Bhalla(T.O)	Joint Inspection to verify the tenets of GMP as per the applicable guidelines and adequacy of data for submitted Post Approval Changes as per CDSCO’s Guidance for Industry.	M/s Zydus Lifesciences Limited (formerly known as M/s Cadila Healthcare Limited), Vaccine Technology Centre, Plot Survey No. 23, 25/P, 37, 40/P, 42 to 47, Sarkhej - Bavla N. H. No. 8A, Opp. Ramdev Masala, Village: Changodar, Tal: Sanand Dist. Ahmedabad - 382213, Gujarat
8	16-02-2023	Mr. Sumir Rai Bhalla(T.O)	Joint Inspection for Grant of fresh manufacturing license to manufacture Human Vaccine Bulk Drug Substance.	M/s Hester Biosciences Limited, Village Merda - Ardaj, Taluka Kadi, Dist. Mehsana - 382 721, Gujarat
9	20,21-03-2023	Mr. Sumir Rai Bhalla(T.O)	Joint Inspection for grant of Permission in Form CT-22 to manufacture COVID-19 Vaccine (ChAd36-SARS-CoV-S (Recombinant)) Bulk Drug Substance for sale or for distribution.	M/s. Biovet Pvt Ltd, Survey No.27,Gat No.136, Manjari Khurd, Tal.Haveli, Dist. Pune
10	13-03-2023	Mr. Sumir Rai Bhalla(T.O)	Joint Inspection for Grant of permission to manufacture “Measles Single Harvest (Bulk) [Drug Substance] and Clarified & Concentrated Rubella Single Harvest (Bulk) [Drug Substance].	M/s Zydus Lifesciences Limited (formerly known as M/s Cadila Healthcare Limited), Plot Survey No. 23, 25/P, 37, 40/P, 42 to 47, Opp. Ramdev Masala, Sarkhej - Bavla N. H. No. 8A, Village: Changodar, Tal: Sanand Dist. Ahmedabad - 382213, Gujarat
11	3-05-2023 4-05-2023	Mr. Jaswinder Singh(A.T.O)	Joint Inspection to manufacture Inactivated Hepatitis A Vaccine (Adsorbed) I. P. under form CT-11 for test, examination and analysis purpose.	M/s Virchow Biotech Private Limited, Sr. No. 172 part, Gagillapur, Village Dundigal, Gandimaisamma, Mandal, Telangana State- 500043
12	11,12,15-05-2023	Mr. Devendra Barthwal(A.T.O)	Joint Inspection for grant of WHO-GMO/COPP for various products & For grant of permission in form CT-11 to manufacture Monovalent Inactivated Poliovirus Bulk (Type 1,2 &3) (Drug Substance) for conduct of clinical trial purpose	M/s Biological E. Limited, Plot No. – I, Phase – II, Biotech Park, Kolthur Village-500078, Shameerpet, Medchal-Malkajgiri (D) Telangana
13	18-05-2023	Mr. Davinder Kumar(A.T.O)	Joint Inspection for grant of permission to commence use of new Pneumococcal Polysaccharide Conjugate Vaccine (PPCV) DS facility	M/s Serum Institute of India Pvt. Ltd, 2012/2, Hadapsar, Pune - 411028
14	18-05-2023	Mr. Davinder Kumar(A.T.O)	Joint Inspection for grant of PAC to manufacture “Influenza Vaccine (Human, Live Attenuated) (Liquid), Seasonal Quadrivalent (NASOVAC-S4)” having formulation batch size 48.00 ± 5 % L and Filling batch size 70,588 ± 5 % vials	M/s Serum Institute of India Pvt. Ltd, 2012/2, Hadapsar, Pune - 411028
15	19-05-2023	Mr. Davinder Kumar(A.T.O)	Joint Inspection for grant of permission to commence use of newly created Prefilled Syringe facility (Blending Filling Capping area) & Vial Filling Facility (MMA-4 area)	M/s Serum Institute of India Pvt. Ltd, Sr. No. 105-110, Manjari BK, Hadapsar, Pune - 412307
16	20-05-2023	Mr. Davinder Kumar(A.T.O)	Joint Inspection for grant of permission to manufacture “Quadrivalent Human Papilloma Virus (Serotypes 6, 11, 16 & 18) Vaccine (Recombinant)” for examination, test and analysis in our M-SEZ-4/Third & Second Floor & Grant of permission to manufacture “Drug Substances of Diphtheria, Tetanus and Pertussis (Acellular component)” for examination, test and analysis in our M-SEZ-1/First Floor	M/s Serum Institute of India Pvt. Ltd, 2012/2, Hadapsar, Pune - 411028
16	1-06-2023 2-06-2023	Mr. Sumir Rai Bhalla(T.O)	Joint verification for grant of additional product manufacturing license in form 28 D to manufacture Snake Venom Antiserum (African) (Bulk) for export.	M/s Vins Bioproducts Limited, Sy. No. 117, Timmapur (V), Kothur (M), Rangareddy (D) – 5093025 T.S.
17	27-06-2023 28-06-2023	Mrs. Seema Sood	Joint Investigation for of Rabies Vaccine batches for release into the market.	M/s Chiron Behring Vaccines Pvt. Ltd, Ankleshwar, Gujrat
18	19-07-2023 20-07-2023	Mrs. Sameera Rawat	Joint Investigation for stoppage of further sale of Batch No.54A22001 A from the domestic market of Typhoid Polysaccharide Vaccine (TYPBAR)	M/s Bharat Biotech International Limited, Sy No. 230, 231 & 235, Genome valley, Turkapally, Shameerpet Mandal, Medchal-Malkajgiri District, Telangana 500 078
19	7 & 8 Aug 2023	Mr. Davinder Kumar	Joint Investigation for verify the tenets of GMP compliance as per applicable guidelines for issuance of license in Form 28D for “Quadrivalent Seasonal Influenza Virus-Llike Particle (VLP) Vaccine- 7 & 8	M/s Cadila Pharmaceuticals Limited,
20	21 & 22 Aug 2023	Ms. Suchita Sharma	Joint inspection for for grant of permission to manufacture "Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) (17-22 Valent)" for examination, test and analysis purpose. (USA)]	M/s Serum Institute of India Pvt. Ltd., 212/2, Hadapsar, Pune,
21	12-09-2023	Mr. Davinder Kumar	Joint Inspection Gujarat for grant of permission to manufacture of “Yellow Fever Vaccine” for examination, test and analysis purpose. 12 September, Mr. Davinder Kumar	M/s.Chiron Behring Vaccines Private Limited, Plot no. 3502, Post Box no. 136, G.I.D.C. Estate, Ankleshwar - 393001, Dist. Bharuch,
22	21-22-09-2023	Mr. Davinder Kumar	Joint Inspection Gujarat for grant of permission to manufacture of “Yellow Fever Vaccine” for examination, test and analysis purpose. 12 September, Mr. Davinder Kumar	M/s Serum Institute of India Pvt. Ltd., S. No. 105-110, Manjari BK., Pune, Maharashtra 412307.
23	20-21-09 2023	Mr. Davinder Kumar	Joint inspection for grant of manufacturing license in form 28 D to manufacture Chimpanzee Adenovirus Covid 19 vaccine bulk Drug substance and (ii to verify CAPA closure complete compliance made against observation (3c, 6c, 7 etc ) reporting during joint inspection dated 20 & 21 March 2023.	M/s. Biovet Pvt. Ltd., Manjari Khurd, Dist- Pune,
24	13,14-10-2023	Mr.Jasvinder Singh	Joint inspection under central inspection plan as per provisions of Drugs & Cosmetics Act, and WHO TRS Guidelines.	M/s Bharat Biotech International Limited, Genome valley, Turkapally, Shameerpet Mandal, Medchal-Malkajgiri District, Telangana 500 078
25	16,18-10-2023	Mr. Sumir Rai Bhalla	Joint inspection for grant of permission in Form CT-11 to manufacture Rotavirus Vaccine (Live Attenuated), Rabies Vaccine Human, Cholera Vaccine (Inactivated Cholera), Bivalent Poliomyelitis type 1 and type 3 live oral and Malaria vaccine RTS.	M/s. SapigenBiologix Private Limited, Plot no- B1/24 and ITBT 1/7, Daspur Road, Andharua, Bhubaneswar, Khordha, Orissa - 751003
26	16,10-2023	Mr. Davinder Kumar ATO	Joint Inspection for verification of submitted manufacturing stability and testing data for Conduct Phase I Clinical trial on “Varicella Zoster Virus Vaccine” of 50µg/ 0.5 ml	M/s. Cadila Healthcare Ltd., 1389, Trasad Road, Dholka - 382225, Ahmedabad, Gujarat
27	2,3-11-2023	Mr. Sumir Rai Bhalla (T.O)	Joint Inspection for grant of NOC nOPV 2 Vaccine for export purpose	M/s Biological E. Limited, SEZ unit, Sy. No. 549, 550, 552 to 556 Kolthur Village-500078, Shameerpet, Medchal-Malkajgiri (D) Telangana
28	8,9-11-2023	Mr. Davinder Kumar (ATO)	Joint inspection grant of permission in Form CT - 11 to manufacture of “ Mynflu001 - Tetravalent Recombinant Influenza Vaccine” (Drug Substances and Drug Products)” for examination, test and analysis purpose.	M/s. Mynvax Private Limited, Brigade MLR Centre, 4th Floor, No. 50/3, Vanivilas Road, Gandhi Bazaar, Basavanagudi, Bangalore, Karnataka 560 004
29	22-11-2023	Mr. Davinder Kumar (ATO)	Joint inspection grant of permission in Form CT - 11 to manufacture of “ Mynflu001 - Tetravalent Recombinant Influenza Vaccine” (Drug Substances and Drug Products)” for examination, test and analysis purpose.	M/s.Chiron Behring Vaccines Private Limited, Plot no. 3502, Post Box no. 136, G.I.D.C. Estate, Ankleshwar – 393001, Dist. Bharuch, Gujarat
30	21,22-11-2023	Mr. Davinder Kumar (ATO)	Joint inspection for grant of permission in Form CT – 11 to manufacture of:i. Hepatitis B Vaccine (rDNA) Drug Substance ii. Hepatitis B Vaccine (rDNA) Liquid, adsorbed iii. Inactivated, Purified Rabies Virus Vaccine Drug Substance iv. Rabies Vaccine, Human, (Purified Vero cell Rabies Vaccine) Liquid adsorbed and v. Rabies Vaccine, Human (Purified Vero cell Rabies Vaccine) Freeze dried For examination, test and analysis purpose	M/s Reliance Life Sciences Pvt. Ltd., Dhirubhai Ambani Life Sciences Centre Vaccine R&D, 2nd Floor, Building B4 R-282, TTC area of MIDC, Thane-Belapur Road, Rabale, Navi Mumbai 400701, Maharashtra
31	13,14-12-2023	Mr. Sachin Sood (ATO)	Joint inspection under Central Inspection Plan	M/s Serum Institute of India, 212/2 Hadapsar, Pune 412208
32	22-12-2023	Mr. Devendra Barthwal (ATO)	Joint Inspection under Central Inspection Plan	M/s Haffkine BioPharmaceutical Corporation Ltd., Acharya Donde Marg, Parel, Mumbai 411012
33	19,20-12-2023	Ms. Seema Sood (ATO)	Joint Inspection under Risk based Central Inspection Plan	M/s. Human Biologicals Institute ( A division of Indian Immunologicals Limited), Kozhipannai, Pudumund Post, Udhagmandalam-643007
Detail of Inspections for the year 2022
Sr. No	Date	Name of Expert	Inspection Name	Institutions/Firms Audited
1	01-01-2022	Mr. Sumir Rai Bhalla (T.O)& Mr. Jaswinder singh(A.T.O)	Joint inspection (Request for seeking export NOC (Tanzaia) to manufacture Sputnik light for commercial sale or distribution for export purpose only.	M/s Shilpa Biological Private Limited, Plot No. 532-A, Belur Industrial Area, Dharwad – 580011, Karnataka
2	04-01-2022 to 05-01-2022	Mr. Sumir Rai Bhalla (T.O)	Joint Inspection for the grant of permission in Form CT-11 to manufacture various drug substance and drug product (for examination, test and analysis purpose)	M/s Lupin Research Park, 46A/47A, Nande Village, MulshiTaluka, Pune, Maharashtra - 412115 India
3	05-01-2022 to 07-01-2022	Dr. Vivek Bansal (A.T.O)	For grant of permission to manufacture 1. Bordetella Pertussis (whole Cell inactivated) (bulk) I.P 2. Diptheria, Tetanus, Pertussis (whole Cell), Hepatitis B (rDNA), Haemophilus Influenza Type b Conjugate and Poliomyelitis (Inactivated) (adsorbed) Final Bulk Vaccine (RTF single dose)3. Diptheria, Tetanus, Pertussis (whole Cell), Hepatitis B (rDNA), Haemophilus Influenza Type b Conjugate and Poliomyelitis (Inactivated) (adsorbed) Final Bulk Vaccine (RTF Multi dose) 4. Diptheria, Tetanus, Pertussis (whole Cell), Hepatitis B (rDNA), HaemophilusInfluenza Type b Conjugate Final Bulk Vaccine (RTF) 5. Diptheria, Tetanus, Pertussis (whole Cell), Hepatitis B (rDNA), Haemophilus Influenza Type b Conjugate Vaccine (adsorbed) I.P under from 28D	M/s. Shantha Biotechnics Limited, Sy.No.274, Athvelli (V), Medchal (M), Rangareddy Dist. TS
4	14-01-2022	Mrs.Seema Sood (A.T.O)	Compliance verification for grant of manufacturing license to manufacture Gam COVID Vac Component I (Adenovirus Serotype 26) & Gam COVID Vac Component II (Adenovirus Serotype 5) Sputnik V Vaccine ready to fill for export at the manufacturing site	M/S Vacxigen Lifescience Pvt Ltd,chambaghat,Solan H.P
5	27-01-2022 to 28-01-2022	Mr.Davinder kumar(A.T.O) & Mr.Jasvinder Singh(A.T.O)	Joint inspection to verify the tenets of GMP as per Drugs and Cosmetics Rules for the new vaccine facility.	M/s Zydus VTEC Ltd. (Subsidiary of Cadila Healthcare Ltd.) Survey no. 23 Paiki, 25, Paili, 40/A/B, Opp. Ramdev Masala, Sarkhej-Bavla Highway, Vill-Changodar, Tal-Sanand, Dist-Ahmedabad-382213, Gujarat.
6	3-02-2022 to 04-02-2022	Mr.Sumir Rai Bhalla(T.O) & Mr.Davinder kumar(A.T.O)	joint Inspection for grant of Additionsl new manufacture facility to manufauture 1. COVOVAX(SARS-Cov-2 rs Protein Drug substance) 2. Sputnik light,rAd26-S-Cov2 Vector Vacine(Recombinant)(DRug Substance) 3. ChAdOx1,nCoV-19 Bulk Conc.Solution(Drug substance)-Reg.	M/S Serum Institute of INdia Pvt.Manjari BK Pune
7	14-02-2022 to 15-02-2022	Mr.Davinder kumar(A.T.O) & Mr.Jasvinder Singh(A.T.O)	Joint inspection to verify the tenets of GMP as per the requirement of schedule M of Drugs & Cosmetics Act, Rule 1945 and adequacy of data for change in the manufacturing process involving a non critical change in the manufacturing process of Rubella Virus Buld (use of HDCF-52 as production containers addition of neomycin in growth medium.	M/S Biologicals .E Limited,
8	15-02-2022 to 16-02-2022	Mr.Davinder kumar(A.T.O)	joint Inspection for Level I-Supplements under Post Approval Change for Sputnik Light Vaccine for addition of a drug product manufafacturing facility to manufacture new drug(Finished Formulation)for sale or distribution for Export to Russia-Reg.	M/S Stelis Biopharma Lmt.
9	24-02-2022	Mr.Davinder kumar(A.T.O)	APPLICATION FOR LICENSE IN FORM-28-D FOR NOVEL CORONA VIRUS 2019-NCoV-DRUG SUBSTANCE FOR MANUFACTURING	M/s. ZYDUS VTEC LIMITED, SURVEY NO: 23, PAIKI 25, 40/A/B, OPP. RAMDEV MASALA, VILLAGE: CHANGODAR, DIST: AHMEDABAD
10	24-02-2022 to 25-02-2022	Ms.Seema Sood(A.T.O)	1st quarter follow up inspection as per Central Inspection Plan 2022 for grant of manufacturing licenses of manufacture Gam-COVID-Vac	M/S Panacea Biotec Ltd,Village Malpur,Baddi,Distt.Solan,H.P reg.
11	10-03-2022 to 11-03-2022	Dr.Vivek Bansal(A.T.O)	Grant of additional product- Diphtheria and Tetanus vaccine (Adsorbed) for adults and adolescent IP (Td vaccine), verification of approved post approval changes for scale up of batches size of Diphtheria, Tetanus and Pertussis vaccine (Adsorbed IP) from 150Lto 300L and 1st Quarter annual inspection as per Central Inspection Plan	M/S Central Research Institute Kasauli
12	10-03-2022 to 11-03-2022	Mr. Sumir Rai Bhalla(T.O)	Joint inspection for grant of permission to manufacture 1. Snake Venom Antiserum (Equine Plasma), 2. Rabies Antiserum (Equine Plasma), 3. Diptheria antitoxin (Equine Plasma), 4. Scorpion Venom Antiserum (Equine Plasma) 5. Tetanus Antitoxin (Equine Plasma) under CT-11	M/s.Serawinbiologicals, LLP,Sy.No.84,89,90 & 91, Mutpoor (V), Kondung (M), Ranga Reddy, Telangana-509207
13	14-03-2022 to 16-03-2022	Mr.Sumir Rai Bhalla(T.O)	1. Annual risk based Inspection. 2. Compliance verification for the observations reported during previous joint inspection from 20.10.2021 to 22.10.2021 3. Revalidation of COPP 4.CAPA	M/s Human Biologicals Institute,(A division of M/s, Indian Immunologicals Limited), Kozhipannai, Pudumund Post, Udhagamandalam-643 007, India
14	24-03-2022 to 25-03-2022	Mr. Devendra Barthwal(A.T.O)	Joint inspection for grant of permission for addition of facility: SEZ-4/GF for fill-finish of bOPV Vaccine	M/s Serum Institute of India Pvt. Ltd., Hadapsar, Pune
15	19-04-2022 to 20-04-2022	Mr. Sumir Rai Bhalla (T.O)	Joint inspection for grant of permission to manufacture Japanese Encephalitis Vaccine, Inactivated (adsorbed, Human) Rabies Vaccine (Human) and BCG Vaccine for examination, Test and analysis purpose.	M/s HLL Biotech Limited, Chengalpattu, Tamilnadu
16	09-05-2022 to 10-05-2022	Mr. Devendra Barthwal(A.T.O)	Joint inspection for Renewal of Manufacturing License in Form 28 D, bearing No. 5.	M/s Haffkine Bio-Pharmaceutical Corporation Ltd., AcharyaDondeMarg, Parel, Mumbai-400 012
17	10-05-2022 to 11-05-2022	Mr. Sumir Rai Bhalla (T.O)	Joint inspection to assess the capacity of laboratory w. r. t. infrastructure, facilities, technical manpower etc, w.r.t. evaluation of 10 vaccines (IPV, MR Vaccine live, Hep B Vaccine, Rotavirus Vaccine, Haemophilus Influenza Type b conjugate vaccine, Covid Vaccine (COVAXIN, COVISHIELD &ZCov-D) JE Vaccine and Vericella Vaccine)	National Institute of Biologicals (NIB) Noida
18	12-05-2022	Mr. Davinder Kumar (A.T.O)	Joint Check Compliance Inspection for Renewal of License No. G/Vac-1 in Form 28D	M/s Cadila Healthcare Limited, Survey No. 417, 419 & 420, Sarkhej – Bavla N. H. No. 8A, Moraiya, Tal. – Sanand, Dist. Ahmedabad – 382 210, Gujarat
19	06-06-2022 to 07-06-2022	Mr. Sumir Rai Bhalla(T.O) & Mr. Davinder Kumar (A.T.O)	Joint inspection for grant of permission to manufcture "Purified recombinant Triple Antigen SARS-CoV-2 Vaccine Bulk"for manufacture of recombinant Triple Antigen SARS- CoV-2 Vaccine Bulk"for clinical trial purpose	M/s Premass Biotech Pvt. Ltd., Plot No. 77, Sector-4, IMT Manesar, Gurgaon
20	22-06-2022 to 23-06-2022	Mr. Devendra Barthwal(A.T.O)	Joint Inspection for 1. Issuance of GMP/GLP certificate. 2. Compliance verification for the observation noted during the course of earlier joint inspection. 3. Annual inspection to verify tenets of GMP	M/s Bio-Med Pvt. Ltd., C-96, Site No.-1, Bulandshahr Road, Industrial Area, Ghaziabad, Uttar Pradesh
21	28-06-2022 to 29-06-2022	Ms. Seema Sood(A.T.O)	Inspection for renewal of GMP certificate for vaccine antigen bulk manufacturing facility and 2nd Quarter annual inspection as per Central Inspection Plan 2022	M/s Panacea Biotech Limited, Ambala Chandigarh Highway, Lalru, District Mohali, Punjab
22	04-07-2022	Mr. Jaswinder Singh(A.T.O)	Joint inspection for grant of permission to manufacture "C1-RBD COVID-19 Vaccine bulk & finished formulation" for the purpose of for examination, test and analysis	M/s Epygen Biotech Private Limited, PanvelRaigad (India)
23	04-07-2022 to 05-07-2022	Mr. Davinder Kumar(A.T.O)	Joint inspection for grant of permission to manufacture "Oral Cholera Vaccine" and Japanese Encephalitis Vaccine,Inactivated" for examination, test and analysis	M/s. Virchow Biotech Pvt.Ltd, Sy.No: 172 Part, Gagillapur (v), Dundigal-Gandimaisamma (M), Medchal-Mlkajgiri (D), T.S-500043
24	07-07-2022 to 08-07-2022	Mr. Devendra Barthwal(A.T.O)	Joint Inspection to verify the tenets of GMP as per the requirements of Schedule M of D&C Rules 1945 and adequacy of data for proposed change for manufacture “Rabies Vaccine, Human, IP.” Drug Substance.	M/s, Human Biologicals Institute, Udhagamandalam, Ooty, Tamilnadu
25	11-07-2022 to 12-07-2022	Mr. SumirRaiBhalla(T.O)	Joint Inspectionto verify the tenets of GMP as per the requirements of Schedule M of Drugs & Cosmetics Act 1940 & Rules 1945 and adequacy of data for additional manufacturing Block: B12 in Human Biologicals Institute for seed bank preparations including infrastructure like service section, hold room, media preparation room, decontamination, filling and lyophilization room .	M/s. Human Biological Institute,Rakshapuram,Hyderabad
26	11-07-2022 to 12-07-2022	Mrs. Sameera Rawat(T.O)	Inspection fsor grant of CLAA approval of additional products	M/s Panacea Biotec Ltd., VillageMalpur, Baddi, HP
27	19-07-2022 to 20-07-2022	Mr. Sumir Rai Bhalla(T.O)	Inspection for parallel samples for developing additional testing capabilities	National Centre for Cell Science, (NCCS) Pune
28	27-07-2022 to 28-07-2022	Mr.Davinder Kumar(A.T.O)	Joint Inspection for grant of additional product to manufacturer Quardivalent Human Papilloma Virus (serotype 6, 11, 16 & 18) recombinant in form 28-D	M/S Serum Institute of India Pvt.Ltd.,Hadapsar,Pune
29	3-08-2022 to 4-08-2022	Mr. Jaswinder Singh(A.T.O)	Joint Inspection to verify the tenants of GMP, manufacturing process and dossier documents w.r.t. additional of an identical filling (Fill-Finish) suite – filling line: 04 (ampoule) for Tetanus Vaccine (Adsorbed) IP – 0.5 ml Ampoules	M/s Biological E. Limited, 181 & 3, Azamabad, Hyderabad, Telangana - 500078
30	4-08-2022 to 5-08-2022	Mr.Davinder Kumar(A.T.O)	Joint Inspection to verify tenets of GMP under Drugs and Cosmetics Rule 1945 for the facility used for manufacturing of Measles Vaccine (Drug Substance) for clinical trial purpose	M/s Biological E. Limited, Plot No. 1, Phase II, Biotech Park, Kolthur Village, Shameerpet, Medchal-Malkajgiri (D), Telangana-500078
31	4-08-2022 to 5-08-2022	Ms. Suchita Sharma(A.T.O)	Joint Inspection for Grant of CLAA approval of additional products namely Diphtheria and Tetanus Vaccine (Adsorbed) for Adults and Adolescents I. P. 0.5 ml single dose vial and Diphtheria and Tetanus Vaccine (Adsorbed) for Adults and Adolescents I. P. 0.5 ml single dose vial in Form 28-D	M/s Cadila Healthcare Ltd. Plot No. 23, 25/P, 37, 40/P, 42 to 47 Sarkhej – Bavla N. H. No. 8A, Opp. Ramdev Masala, Village:Changodar, Tal.: Sanand, Dist. Ahmedabad -382213, Gujarat
31	10-08-2022 to 11-08-2022	Mrs Sameera Rawat(T.O) & Ms.Suchita Sharma (A.T.O)	Joint Inspection to verify manufacturing and quality control facility used for manufacturing of 4 vaccines 1.Pneumococal Polysaccharide Conjugate vaccine(Adsorbed)(14 Valent) (single & 5 Dose),2.Pentavalent vaccine (Diphtheria Tetanus, Pertusis(Whole Cell),Hepatitis B(rDNA) and Haemophililus influenza type b Conjugate vaccine(Single & 5 dose)3. Typhoid Vi Conjugate vaccine(Singlee,5 dose & 10 dose)4. SARS-CoV2(Covid -19)vaccine(Singl,10 doses & 20 dose)for examination,test and analysis purpose as per provision of New Drugs and Clinical Trials Rules,2019 under Drugs & Cosmetics Act,1940	M/s Biological E. Limited, Sy. No. 549, 550, 552 to 556, Kolthur Village, shameerpet, Medchal-Malkajgiri (D), Telangana-500078
32	16-08-2022 to 17-08-2022	Mr Sumir Rai Bhalla(T.O)	Joint inspection to assess the testing capability of the facility w.r.t. samples of Covaxin and Covishield	National Institute of Animal Biotechnology (NIAB), Survey No. 37, Gachibowli, Hyderabad-500032
33	16-08-2022 to 17-08-2022	Mr Sumir Rai Bhalla(T.O)	To verify tents of GMP under Drugs and cosmetics Rules 1945 for manufacture of Measles Vaccine(Drug Substance)for clinical trial purpose	M/sNational Institute of Animal Biotechnilogy(NIAB),Survey No.Gachibowli,Hyderabad-500032
34	13-09-2022	Mr Sumir Rai Bhalla(T.O)	Joint inspection to verify the impact of the changes mentioned under reference vis-à-vis applicable requirements and adequacy of data for post approval changes.	M/s Zydus Lifesciences Limited (formerly known as M/s Cadila Healthcare Limited), Vaccine Technology Centre, Plot Survey No. 23, 25/P, 37, 40/P, 42 to 47, Sarkhej - Bavla N. H. No. 8A, Opp. Ramdev Masala, Village: Changodar, Tal: Sanand Dist. Ahmedabad - 382213, Gujarat
35	21-09-2022	Ms. Suchita Sharma	To verify tents of GMP under Drugs and cosmetics Rules 1945 for manufacture of Measles Vaccine(Drug Substance)for clinical trial purpose	Joint inspection to verify the compliance of previous inspection observations and adequacy of data for proposed post approval changes.
36	26-09-2022 to 27-09-2022	Mr. Davinder Kumar(A.T.O)	Joint Inspection for Grant of additional Product manufacturing license in Form 28D to manufacture 1. Diphtheria and Tetanus Vaccine (Adsorbed) for Adults & Adolescents I.P (For Domestic & Export) 2. Diphtheria and Tetanus Vaccine (Adsorbed, Reduced Antigen(s) Content) (For export) and 3. Measles and Rubella Vaccine (Live) I.P for (For Domestic & Export) and 4. Measles and Rubella Vaccine (Live) for (For Export).	M/s. Human Biologicals Institute ( A division of Indian Immunologicals Limited), Rakshapuram, Gachibowli,Hyderabad-500032
37	6-10-2022 to 7-10-2022	Ms. Suchita Sharma(A.T.O)	Joint inspection for grant of Additional Product Permission-Hexavalent Vaccine for Sale or for distribution purpose.	M/s. Serum Institute of India Pvt. Ltd., Pune
38	6-10-2022	Mr. Jaswinder Singh (A.T.O)	Joint inspection for CLAA approval for Grant of additional product namely “Clarified & Concentrated Mumps (Bulk) - Drug Substance” for domestic purpose	M/s Zydus Lifesciences Limited (formerly known as M/s Cadila Healthcare Limited, Plot Survey No. 23, 25/P, 37, 40/P, 42 to 47, Sarkhej - Bavla N. H. No. 8A, Opp. Ramdev Masala, Village: Changodar, Tal: Sanand Dist. Ahmedabad - 382213, Gujarat
39	7-10-2022	Mr. Jaswinder Singh (A.T.O)	Joint inspection to verify the compliance status of GMP as per the requirements of Schedule M of Drugs & Cosmetics Rules, 1945 and adequacy of data for proposed changes for Purified Vi Polysaccharide S. Typhi Bulk (NP).	M/s Zydus Lifesciences Limited (formerly known as M/s Cadila Healthcare Limited, Plot Survey No. 23, 25/P, 37, 40/P, 42 to 47, Sarkhej - Bavla N. H. No. 8A, Opp. Ramdev Masala, Village: Changodar, Tal: Sanand Dist. Ahmedabad - 382213, Gujarat
40	9-10-2022 to 10-10-2022	Ms. Suchita Sharma(A.T.O)	Joint inspection for grant of permission to manufacture DTP Group of Vaccine for the purpose of examination, test and analysis.	M/s, Pasteur Institute of India, Coonoor - 643103
41	16-11-2022	Mr. Jaswinder Singh(A.T.O)	Joint inspection to verify the manufacturing facility as per the tenets of GMP.	M/s.Yapan Bio Private Limited, 221& 222, Building 450, MN Park, Synergy Square 1, Genome Valley, Shameerpet,Hyderabad-500078
42	22-11-2022 to 23-11-2023	Mr. Sumir Rai Bhalla(A.T.O)	M/s Stelis Biopharma Pvt. Ltd, (Unit-III), 68/a, 1st phase, Bommasandra Industerial Area, Bommasandra, Banglore – 560099, Karnataka	M/s Stelis Biopharma Pvt. Ltd, (Unit-III), 68/a, 1st phase, Bommasandra Industerial Area, Bommasandra, Banglore – 560099, Karnataka
43	24-11-2022 to 25-11-2022	Mr. Sumir Rai Bhalla(A.T.O)	Joint Inspection under Annual Central Inspection 2022	M/s M/s Stelis Biopharma Pvt. Ltd, (Unit-III), Plot No. 2-D 1, Obadenahalli, 3rd phase, Industrial Area, Doddaballapura, Karnataka - 561203
44	23-11-2022 to 24-11-2022	Mr. Devendra Barthwal(A.T.O)	Joint inspection for COPP under WHO-GMP certification scheme.	M/s. Haffkine Bio-Pharmaceutical Corporation Ltd., Acharya Donde Marg, Parel, Mumbai – 400 012
45	5-12-2022 to 6-12-2022	Sh. Davinder Kumar(A.T.O)	Joint Inspection for grant of permission to manufacture “Japanese encephalitis Vaccine Inactivated (Adsorbed), Human” for examination, test and analysis under CT-11..	M/s. Human Biologicals Institure, A division of Indian Immunologicals Limited, Sy.No. 281-284 and 321, Biotech Park, Phase III, Karkapatla (V), Markook (M), Siddipet (D), Telanagana-502281
46	13-12-2022 to 14-12-2022	Ms. Suchita Sharma(A.T.O)	Joint Inspection for grant of permission to manufacture Tetanus Vaccine (Adsorbed) I.P” for examination, test and analysis	M/s.Seasons Biologicals Pvt.Ltd,Plot No. 46/A, Biotech Park, Phase-III, Karkapatla (V), Markook (M), Siddipet (D),Telangana
47	14,15,16-12-2022	Mr. Sumir Rai Bhalla(A.T.O)	Joint Inspection for grant of COPP under WHO-GMP Certification Scheme and for renewal /retention of manufacturing license in form 28D.	M/s. Haffkine Bio-Pharmaceutical Corporation Ltd., (A Govt. of Maharashtra undertaking) Mumbai-Pune Road, Pimpri, Pune - 411 018
48	15-12-2022,16-12-2022	Mr. Sumir Rai Bhalla(A.T.O)	Joint Inspection to manufacture of Oral Cholera Vaccine & Japanese Encephalitis Vaccine, Inactivated for examination, test and analysis purpose.	M/s Virchow Biotech Pvt. Ltd
Detail of Inspections for the year 2021
Sr. No	Date	Name of Expert	Inspection Name	Institutions/Firms Audited
1	14-01-2021 to 15-01-2021	Mr.Sumir Rai Bhalla(T.O) & Mr.Davinder Kumar (A.T.O)	joint Inspection for grant of Permission to manufacture "mRNA Bulk for vaccine(COVID-19)"and mRNA vaccine for injection(COVID-19)35 ug 10.7ml for clinical trial reg.	M/S Gennova Biophamaceutical Ltd. Pune
2	2-02-2021 to 3-02-2021	Mr.Sumir Rai Bhalla(T.O) & Mr.Jaswinder Singh (A.T.O)	joint Inspection for grant of permission to obtain manufacturing license in form 28-D to manufacture additional product ChAd0x1 nCov-19 Corona Virus vaccine(Recombinant) COVISHIELD Reg.	M/S Serum Institute of India Pvt.Limited,Pune
3	9-02-2021,10-02-2021	Mr.Sumir Rai Bhalla(T.O) & Mr.Suresh Kumar (A.T.O)	joint Inspection for grant of retention of manufacturing License No.PC/Vacc/S in form 28 D	M/S Premium Serum & Vaccine Pvt.Limited,Pune
4	19-04-2021,20-04-2021	Mr.Sumir Rai Bhalla(T.O) & Mr.Davinder Kumar (A.T.O)	joint Inspection of manufactureing and quality control facilities used for manufacturing of Sputnik V Vaccine(Component I and Component II)reg.	M/S Hetro Biopharma Limited,Telangana
5	23-04-2021	Mr.Sushil kumar sahu(DAD)	joint Inspection of manufacturing and QC varification of drug product for COVID Vaccine.	M/S Panacea Biotech Limited Baddi (HP)
6	22-04-2021,23-04-2021	Mr.Davinder kumar (A.T.O)	Intimation of Joint Inspection	M/S Bharat Biotech International Limited,Hyderabad
7	3-05-2021 to 6-05-2021	Mr.Davinder kumar (A.T.O)	Intimation of joint Inspection	M/S Bharat Biotech International Limited,Hyderabad
8	4-05-2021	Mr.Sumir Rai Bhalla(T.O)	joint Inspection for grant of Fresh Loan License	M/S Bharat Biotech International Limited,Hyderabad
9	12-05-2021	Mr.Sumir Rai Bhalla(T.O)	joint Inspection	M/S National Institute of Animal Biotechnology,Hyderabad
10	17-05-2021 to 19-05-2021	Ms.Suchita Sharma(A.T.O)	Intimation of joint Inspection dates for Inspection	M/S Tergene Biotech Pvt.Ltd.Telangana
11	31-05-2021	Mr.Sumir Rai Bhalla(T.O)	joint Inspection for issues of additional facilities for upgraded filling Area-2 of Vaccine for Human use.	M/S Chiron Behring Vaccine Pvt. Ltd.Ankleshwar
12	2-06-2021 to 03-06-2021	Dr. Vivek Bansal(A.T.O)	Intimation of joint Inspection dates at the premises for verification of Block No.KAO8 facility used for manufacture of Teatnus Toxoid Vaccine"(Adsorbed)in ampoules and Rabies Vaccine,Human I.P Drug Product-Reg.	M/S Human Biologicals Institute,Karakapatla(V) Medak Dist.
13	8-06-2021 to 09-06-2021	Mr.Sumir Rai Bhalla(T.O)	joint Inspection	M/S Panacea Biotech Limited, Lalru,Punjab
14	10-06-2021	Mrs.Seema Sood(A.T.O)	joint Inspection for follow up of annual inspection and verification of Covid 19 Vaccine production	M/S Panacea Biotech Limited Baddi (HP)
15	26-06-2021	Dr. Vivek Bansal(A.T.O)	Joint Inspection to verify the principals of GMP as per schedule Mof D & C Act 1940 for the proposed additional fill finish facility SVP-3 for the applied drug product-Typhoid Polsaccharide Vaccine	M/S Cadila Healthcare Limited, Ahmedabad
16	01-07-2021 to 02-07-2021	Mr. Sumir Rai Bhalla (T.O) & Mr. Davinder Kumar(A.T.O)	Joint Inspection to verify the tenets of GMP as per the requirements of Schedule M of Drugs & Cosmetics Rules 1945 and adequancy of the data for additional new manufacturing facility in MSEZ-1/GF,SEZ-10/FF 7SEZ-6/GF facility for manufacture "Covishield Vaccine (ChAdOx1-nCov-19 Corona virus vaccine,(Recombinant) Drug Product(formulation and filling.)	M/S Serums Institute of India Pvt. Ltd. Pune
17	05-07-2021 to 06-07-2021	Mr. Davinder Kumar(A.T.O) & Mr. Jaswinder Singh (A.T.O)	Joint Inspection to verification of CAPA, PAC for addition of new presentation, to verify PB3 & PB4 (Bio-Process) facilities & CAPA against the audit dated 17-02-2020	M/S Bharat Biotech International Ltd. Hydrabad.
18	26-07-2021 to 27-07-2021	Mr. Davinder Kumar(A.T.O)	Joint Inspection for grant of form 28D to manufacturing of whole inactivated Corona Virus Vaccine	M/S Bharat Biotech International Ltd. Hydrabad.
19	04-08-2021	Mr. Devendra Barthwal(A.T.O)	Joint Inspection for issue of Additional facility for upgraded filling Area-2 of Rabies Vaccine for Human use.	M/S Chiron Behring Vaccine Pvt. Ltd.
20	05-08-2021 to 06-08-2021	Mr. Jaswinder Singh(A.T.O)	Joint Inspection for Grant of permission to start use of Packing & Dispatch Area for Covishield(under existing Mfg.Lic. No. 10 in Form-28-D)in their SEZ-10/Ground Floor	M/S Serum Institute of India Pvt. Ltd. Pune
21	10-08-2021 to 11-08-2021	Mr. Davinder Kumar(A.T.O)	Joint Inspection for verification of CAPA submitted by the firm against the audit dated 20.11.2020 based on complaint received from WHO Geneva on Rotavirus Vaccine	M/S Bharat Biotech International Ltd. Hydrabad.
22	16-08-2021 to 17-08-2021	Mr. Davinder Kumar(A.T.O) & Mr.Jasvinder kumar(A.T.O)	Joint Inspection for grant of From 28D to manufacture "ÜB-612 CoVID-19 Vaccine(For export Purpose)	M/S Aurobindo Pharma Limited Telanagana
23	8-09-2021	Dr.Vivek Bansal(A.T.O)	Joint check compliance	M/S Cadila Healthcare Ltd,
24	16-09-2021 to 17-09-2021	Mr. Sumir Rai Bhalla(T.O) & Mr.Davinder kumar(A.T.O)	Joint inspection for grant of permission of Phase I clinical trail of combined Protain subunit vaccine against SARS Cov-2 virus reg.	M/S Reliance Life Science Pvt Mumbai
25	21-09-2021 to 22-09-2021	Mr. Davinder Kumar(A.T.O)	Joint Inspection for verify the compliance of New Drugs and clinical Trials Rules,2019.	M/S Reliance Life Science Pvt Ltd,Mumbai
26	4-10-2021 to 5-10-2021	Mr. Sumir Rai Bhalla(T.O) & Mr. Davinder Kumar(A.T.O)	Grant of aditional Product License in form 28D-SaRs-Cov-2 (Covid -19) vaccine	M/S Biological E Lmt. Azamabad,Hyderabad-Telangana India
27	5-10-2021 to 7-10-2021	Dr.Vivek Bansal(A.T.O)	Annual risk based joint inspection as per central inspection plan 2021.	M/S BCG Vaccine Lab,Guindy Chennai,Tamil nadu
28	8-11-2021 to 9-11-2021	Ms.Suchita Sharma(A.T.O)	Joint Inspection for grant of additional product permission to manufacture'Meningococcal polysaccharide conjugte vaccine	M/S Serum Institution of India Pvt.Ltd,Pune
29	17-11-2021 to 18-11-2021	Mrs. Seema Sood(A.T.O)	Joint Inspection for grant of manufacture Gam-Covid-Vac Component I (Adenovirus Serotype 26) & Gam-COVID-Vac Component II(Adenovirus Serotype 5) Sputnik V Vaccine ready to fill for Expert	M/S Vacxigen Lifescience Pvt. Ltd. Chambaghat, Solan(H.P)
30	22-11-2021 to 23-11-2021	Mr.Jasvinder Singh(A.T.O)	Joint Inspection for approval of license of stock biling of mRNA bulk for vaccine (COVID-19) and Lyophilized mRNA Vaccine for CT-11	M/S Dr.Reddy's Laboratories Ltd,
31	24-11-2021 to 26-11-2021	Mr. Sumir Rai Bhalla(T.O) & Mr. Davinder Kumar(A.T.O)	Intimation for Joint Inspection for grant of permissin to manufacture Gam-Covid-Vac combined vector vaccine for examination,test and analysis purpose under CT-11	M/S Dr.Reddy's Laboratories Ltd,
32	29-11-2021 to 1-12-2021	Mr. Sumir Rai Bhalla(T.O) & Mr. Davinder Kumar(A.T.O)	To verify the manufacturing and quality control facilities for manufacture of Gam-Covid-Vac combined vectore vaccine(Componenet-1 & Component-II)Spurhnik V Vaccine for examination test and analysis purpose	M/S Dr.Reddy's Laboratories Ltd,Telangana India
33	14-12-2021 to 15-12-2021	Mr. Sumir Rai Bhalla(T.O)	Joint Inspection for Grant of additiona Product Permission of manufauter Bulk Drug proposed vaccine i.e Sputnik Light and Sputnik V for export purpose	M/S Wockhardt Lmt Aurangabad.
34	14-12-2021 to 15-12-2021	Mrs Seema Sood(A.T.O)	Joint Inspection for Grant of NOC to expert"rAD26-S-CoV2 Viral Vector Vaccine (Recombinant)-Drug Substance & Drug Product to UAE.	M/S Serum Institute of India Pvt Ltd.Pune
35	16-12-2021 to 17-12-2021	Mr. Sumir Rai Bhalla(T.O)	Joint Inspection for Grant of additional product permission to manufature Formulation Drug proposed vaccine i.e Sputnik Light and Sputnik V. for export purposes.	M/S Wockhardt Lmt Aurangabad.
36	16-12-2021 to 17-12-2021	Mr.Jasvinder Singh(A.T.O)	Intimation of Joint inspection to verify the tenets of GMP,manufacturing process and dossier documents w.r.t grants of export NOC for Drugs substances and Drugs product of Sputnik Light Vaccine	M/S Gland Pharma Ltd.TSIIC Pashamylaram vill.Patancheru Mandal,Sangareddy M/S Gland Pharma Lmt,kolthur vill.shameerpet Mandal,Medchal-Malkajgiri Distt.T.S
37	22-12-2021 to 23-12-2021	Dr.Vivek Bansal(A.T.O)	Intimation of Joint inspection	M/S Sanofi Healthcare India Private Ltd Muppireddipalli Village,Medak district,Telangana
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