Inspections

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
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