Central Drugs Laboratory, Kasauli
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 22.10.20213. 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) | To verify the tenets of GMP as per the requirednents of Schedule M of Drugs & Cosmetics Rules 1945 and adequacy of data for grant of additional product permission to manufacture Quadrivalent Human Papill5tona Virus Vaccine(Recombinant) in form-28 D | M/S Serum Institute of India Pvt.Ltd.,Hadapsar,Pune |
| 29 | 4-08-2022 to 5-08-2022 | Ms.Suchita Sharma(A.T.O) | Joint Inspection for Grant of CLAA approval of additional product namely Diphtheria and Tetanus Vaccine(Adsorbed) for Adults and Adolescents I.P Multi Dose(5ml -10 ml dose vial) in Form 28D for domestic purpose. | M/S Cadila Healthcare Ltd.Plot No. Ahmadabad Gujrat |
| 30 | 4-08-2022 to 5-08-2022 | Mr.Davinder Kumar(A.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/s Biological E.limitd |
| 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 |
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