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Date: 2021-06-11 Category: Not Applicable State: Union Government Country: India

BA-BE Study Centre Approval Under New Drugs and CT Rules 2019

Issued by Ministry of Health and Family Welfare · Central Drugs Standard Control Organization

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Executive Summary & Key Takeaways

What it means

  • The gazette notification provides an updated list of BA-BE (Bioavailability and Bioequivalence) study centers and bio-analytical laboratories approved under the New CT (Clinical Trial) Rules 2019.
  • The list includes the names and addresses of the firms, their registration numbers, dates of issue, and validity periods, which are generally 5 years from the date of issue.
  • The notification also includes a list of approved standalone bio-analytical labs with their addresses and validity dates.

Key Changes

  • The notification lists 73 BA-BE study centers and bio-analytical laboratories approved under the New CT Rules 2019.
  • Each listed facility has a registration number in the format BABE/2019/ or BABE/2020/ or BABE/2021/ followed by a sequential number.
  • The validity of the registrations is generally 5 years from the date of issue.
  • The notification also includes a separate list of approved standalone Bio-Analytical Labs, specifically mentioning M/s. Cliwis Lab Pvt Ltd, which was previously an approved BA-BE study center.
  • The list includes facilities located across various states in India, including Gujarat, Telangana, Maharashtra, Tamil Nadu, Karnataka, Uttar Pradesh, Haryana, and West Bengal.

Impact Analysis

Pharmaceutical Companies

  • Companies should verify the validity dates of the listed facilities to ensure continued compliance.

BA-BE Study Centers and Bio-analytical Laboratories

  • M/s. Cliwis Lab Pvt Ltd needs to ensure that it operates as a standalone Bio-Analytical Lab as per the new approval and adhere to all relevant guidelines.

Regulatory Authorities

  • The notification supports transparency and accountability in the BA-BE study process.

Key Entities Referenced

New CT Rules 2019: The regulatory framework governing clinical trials, including BA-BE studies, in India. BA-BE Study Centers: Facilities approved to conduct Bioavailability and Bioequivalence studies as per the New CT Rules 2019. Bio-analytical Laboratories: Laboratories approved to perform bio-analytical testing of samples generated during BA-BE studies as per the New CT Rules 2019. M/s. Cliwis Lab Pvt Ltd: An entity previously approved as a BA-BE study center, now listed as an approved standalone bio-analytical lab.
Official Source Record View Original Source →
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UPDATED LIST OF BA-BE STUDY CENTRE & BIO-ANALYTICAL LABORATORY dt. 10.06.2021 under New CT RULE 2019 Name & Address of the Firm Name & Address of the Bioanalytical S.No. Registration No. Date of Issue Valid Upto Clinical Facility Laboratory M/s. Citus Research LLP Office No. 401, 406, 407 & 408, M/s. Raptim Research Ltd. 1 BABE/2019/0001 Super mall 2, Infocity Campus, A-242, TTC Industrial Area, Near Mahape 20.06.2019 5 Years Near Gh Zero Circle, Gandhinagar, Depot, MIDC, Navi Mumbai -400710 Gujarat - 382009, India M/s. Admerus Biosciences Pvt Ltd Sy No. 480, Basuragadi Village, Gowdavalli Sy No. 480, Basuragadi Village, Grampanchayath, Medchal Mandal and 2 BABE/2019/0002 Gowdavalli Grampanchayath, 21.06.2019 5 Years District, Hyderabad-501401, Telangana, Medchal Mandal and District, India Hyderabad-501401, Telangana, India M/s. Veeda Clinical Research Private 1st, 2nd, 3rd and 4th floor, Nr. YMCA Club, Limited S.G. Highway, Vejalpur, Ahmedabad- 3 BABE/2019/0003 Office No. 9,10 & 11-1st, 2nd, and 3rd 380051 and Insignia, Opp. AUDA Garden, 08.07.2019 5 Years floor, Radhe Palladium, Panchot, Sindhu Bhavan, Bodakdev, Ahmedabad - Mehsana, Gujarat, India 54 M/s. Synergen Bio Private Limited M/s. Synergen Bio Private Limited Unit Nos. 101 to 104, Sai Chambers, Unit Nos. 101 to 104, Sai Chambers, 302 4 BABE/2019/0004 302 Old Mumbai-Pune Highway, 29.07.2019 5 Years Old Mumbai-Pune Highway, Wakadewadi, Wakadewadi, Shivajinagar, Pune, Shivajinagar, Pune, Maharashtra-411003 Maharashtra-411003 M/s. Mecleods Pharmaceuticals Ltd. M/s. Mecleods Pharmaceuticals Bioequivalence Department, R & D -IV, Ltd.Bioequivalence Department, R & D -III, 5 BABE/2019/0005 5th Floor , Empire Doctor House, 05.08.2019 5 Years Plot No. 18, Street No. 9, M.I.D.C Andheri Opposite Kargil Petrol Pump, Science (East) Mumbai -400093 City Road, Sola, Ahmedabad -380060 M/s. QPS Bioserve India Ltd M/s. QPS Bioserve India Ltd 6 BABE/2019/0006 Plot no. 47, IDA Balanagar, Hyderabad- Plot no. 47, IDA Balanagar, Hyderabad- 14.08.2019 5 Years 500037 500037 M/s. Axis Clinicals Limited, Atharva, Opp. Rajpath Club, S.G Highway, M/s. Axis Clinicals Limited, 1-121/1, 7 BABE/2019/0007 12.09.2019 5 Years Bodakdev, Ahmedabad-380015, Miyapur, Hyderabad. Gujarat M/s. Vimta Labs Limited, 141/2 & 142, M/s. Vimta Labs Limited, 141/2 & 142, IDA, 8 BABE/2019/0008 IDA, Phase-2, Cherlapally, Hyderabad- Phase-2, Cherlapally, Hyderabad-500 051, 04.11.2019 5 Years 500 051, Telangana State, India. Telangana State, India. M/s. Scitus Pharma Services Private M/s. Scitus Pharma Services Private Limited Limited 2/294, DRR Avenue, 2nd Street, 9 BABE/2019/0009 Module Nos. 34-37, 2nd Floor, SIDCO Multi- 31.10.2019 5 Years AUDCO Nagar, Kattupakkam, Storeyed Complex, SIDCO Industrial Poonamallee, Chennai -600056, Estate, Thirumazhisai, Chennai -600124 Tamilnadu M/s. Lotus Labs Private Limited M/s. Lotus Labs Private Limited #02, M.M. Towers, Survey No. 73/2, No. 07, Jasma Bhavan Road, Millers Tank 10 BABE/2019/0010 31.10.2019 5 Years Jakkur Plantation, Yelahanka Hobli, Bed Area, Vasanthanagar, Bangalore - Bangalore -560064, Karnataka 560052, Karnataka M/s. Spinos Life Science and Research M/s. Spinos Life Science and Research Private Ltd Private Ltd Door No. 29 A, Krishna Madura Vanam, Door No. 29 A, Krishna Madura Vanam, 11 BABE/2019/0011 19.11.2019 5 Years Alankar Thottam, Vellakinar Pirivu, Alankar Thottam, Vellakinar Pirivu, Thudiyalur, Coimbatore - 641029, Thudiyalur, Coimbatore - 641029, Tamilnadu Tamilnadu M/s. Amaris Clinical (A Division of Caplin M/s. Amaris Clinical (A Division of Caplin Point Laboratories Ltd.) No.44, 8th Point Laboratories Ltd.) No.44, 8th Avenue, 12 BABE/2019/0012 Avenue, Domestic Tariff Area Mahindra 25.11.2019 5 Years Domestic Tariff Area Mahindra World City, World City, Chengalpattu – 603004, Chengalpattu – 603004, Tamil Nadu Tamil Nadu M/s. Ecron Acunova Limited M/s. Ecron Acunova Limited IV floor, Sri Shirdi Sai Baba Cancer IV floor, Sri Shirdi Sai Baba Cancer 13 BABE/2019/0013 28.11.2019 5 Years Hospital & Research Centre, Manipal - Hospital & Research Centre, Manipal - 576104, India 576104, India M/s. Apotex Research Private Ltd., M/s. Apotex Research Private Ltd., Site No 2, Bommasandra Industrial Site No 2, Bommasandra Industrial Area, 14 BABE/2019/0014 Area, 4th Phase Bommasandra 4th Phase Bommasandra Industrial Estate, 26.12.2019 5 Years Industrial Estate, PO-Bangalore-560099 PO-Bangalore-560099 M/s. Aizant Drug Research Solutions M/s. 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Ltd. 5th & 6th floor, Centaur House, 19 BABE/2020/0019 Ltd. 5th & 6th floor, Centaur House, Near 14.01.2020 5 Years Near Hotel Grant Hyatt, Vakola, Hotel Grant Hyatt, Vakola, Santacruz Santacruz (East), Mumbai-400055, (East), Mumbai-400055, Maharashtra,India Maharashtra,IndiaM/s Notrox Research Pvt Ltd (NRPL), M/s Notrox Research Pvt Ltd (NRPL), No. No. 19/3, 2nd Floor, Bikasipura Road, 19/3, 2nd Floor, Bikasipura Road, JC 20 BABE/2020/0020 JC Indusrial Layout, Off Kanakapura Indusrial Layout, Off Kanakapura Road 17.01.2020 5 Years Road (Behind Metro Cash & Carry), (Behind Metro Cash & Carry), Bangalore- Bangalore-560062, Karnataka, India 560062, Karnataka, India M/s. Sapthagiri Clintrac Private Limited, M/s. Sapthagiri Clintrac Private Limited, Sapthagiri Institute of Medical Sciences Sapthagiri Institute of Medical Sciences and 21 BABE/2020/0021 and Research Center Campus, #15, Research Center Campus, #15, 20.01.2020 5 Years Chikkasandra, Hesaraghatta Main Chikkasandra, Hesaraghatta Main Road, Road, Bangalore-560090 Bangalore-560090 M/s. Azidus Laborotories ltd., No. 23rd M/s. Azidus Laborotories ltd., No. 23rd 22 BABE/2020/0022 School Road, Rathinamangalam, School Road, Rathinamangalam, Vandalur, 07.02.2020 5 Years Vandalur, Chennai-600048 Chennai-600048 M/s Cliantha Research Limited,Property M/s.Cliantha Research Limited,opposite No 2A,Block –A, Sector-63,Gautam Pushparaj Towers,Nr.Judges 23 BABE/2020/0023 26.02.2020 5 Years Budh Nagar, Noida 201301 Uttar Bungalows,Bodakdev,Ahmedabad- Pradesh. 3800054,Gujarat,India M/s. Syngene International Limited, M/s. Syngene International Limited, Tower Tower 1, Semicon Park, Electronic City, 24 BABE/2020/0024 1, Semicon Park, Electronic City, Phase-2, 14.02.2020 5 Years Phase-2, Houser Road, Bangalore-560 Houser Road, Bangalore-560 100, India 100, India M/s. Anacipher Clinical Research M/s. Anacipher Clinical Research Organization, 3rd & 4th Floor, Mirra Organization, 3rd & 4th Floor, Mirra 25 BABE/2020/0025 18.02.2020 5 Years Kamshetty Mall, Ramanthapur, Medchal- Kamshetty Mall, Ramanthapur, Medchal- Malkajgiri Dist, Hyderabad Malkajgiri Dist, Hyderabad M/s. Enem Nostrum Pvt. Ltd., M/s. Enem Nostrum Pvt. Ltd., Plot No. 35, Ancilliary Industrial Plots, Plot No. 35, Ancilliary Industrial Plots, 26 BABE/2020/0026 20.02.2020 5 Years Govandi, Mumbai-400 043, India Govandi, Mumbai-400 043, India M/s Raptim Research Limited, A-213, A- M/s Raptim Research Limited, A-213, A- 226, A-242, TTC Industrial Area, 226, A-242, TTC Industrial Area, Mahape, 27 BABE/2020/0028 26.02.2020 5 Years Mahape, M.I.D.C. 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Lambda Therapeutic Research Limited, 701, 7th Floor, The great Eastern M/s Lambda Therapeutic Research Ltd 43 BABE/2020/0044 Summit-‘A’, Plot No. 56, Sector 15, CBD Plot No. 38, Near Silver Oak Club, S.G. 04.08.2020 5 Years Belapur, Navi Mumbai-400 614, Highway, Gota, Ahmedabad -380061 Maharashtra, India M/s.Cliantha Research Ltd., 1st Floor, M/s.Cliantha Research Limited,opposite Sliver Arcade, Near Ashwamegh III, Pushparaj Towers,Nr.Judges 44 BABE/2020/0045 04.08.2020 5 Years Samrajya, Mujmahuda Road, Akota, Bungalows,Bodakdev,Ahmedabad- Vadodara-390020, Gujarat 3800054,Gujarat,India M/s Veeda Clinical Research Private Ltd., Rev. Sur. No. 12/1, Insignia, Corporate 2nd , 3rd, 4th floor-A, Near IIM, Shivalik House, Nr. Grand Bhagvati Hotel, Sindhu 45 BABE/2020/0046 07.08.2020 5 Years Plaza, Bhavan Road, S.G. Highway, Bodakdev, Ambawadi, Ahmedabad-380015 Ahmedabad-380054 M/s Lambda Therapeutic Research Ltd. 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Ltd., Ltd., P-1 Department, 201 & 301, 2nd 55 BABE/2020/0057 Synchrone House, behind Mondeal park, 24.12.2020 5 Years floor, Satva, Opp Bhavin School, Thaltej, nr. Gurudwara, S.G. Highway, Ahmedabad Ahmedabad - 380059, Gujarat, India M/s. Om Sai Clinical Research Pvt. Ltd., M/s. Om Sai Clinical Research Pvt. Ltd., C.S. No. 379/1-6, Peth Bagh, Near C.S. No. 379/1-6, Peth Bagh, Near Karnal 56 BABE/2020/0059 12.10.2020 5 Years Karnal ChoWky Police Station, Sangli - ChoWky Police Station, Sangli - 416416, 416416, Maharshtra Maharshtra M/s. Glenmark Research Centre, M/s. Glenmark Research Centre, Glenmark Glenmark Pharmaceuticals Ltd., 2nd Pharmaceuticals Ltd., 2nd Floor, M-4, 57 BABE/2020/0060 23.11.2020 5 Years Floor, M-4, MIDC Industrial Area, Taloja, MIDC Industrial Area, Taloja, Maharashtra - Maharashtra - 410208 410208 M/s. Glenmark Generics Ltd., Clinical M/s. Glenmark Generics Ltd., Clinical Research Unit, Plot D-508, T.T.C. Research Unit, Plot A-607, T.T.C. Industrial 58 BABE/2020/0061 23.11.2020 5 Years Industrial Area, Turbhe, Navi Mumbai - Area, MIDC,Mahape, Navi Mumbai - 400705 400705 M/s Taab Biostudy Services M/s Taab Biostudy Services 59 BABE/2020/0062 69, Ibrahimpur Road, jadavpur, Kolkata - 69, Ibrahimpur Road, jadavpur, Kolkata - 03.12.2020 5 Years 700032, India 700032, India M/s Cliantha Research Limited M/s Cliantha Research Limited Opposite Pushpraj Tower, Nr. Judge Opposite Pushpraj Tower, Nr. Judge 60 BABE/2020/0063 03.12.2020 5 Years Bungalows, Bodkdev, Ahmedabad- Bungalows, Bodkdev, Ahmedabad-380054, 380054, Gujarat Gujarat M/s. Actimus bio Sciences (P) Limited., M/s. Actimus bio Sciences (P) Limited., Plot 61 BABE/2020/0064 Plot no. D2, D-Block, Autonagar, no. D2, D-Block, Autonagar, Gajuwaka, 04.12.2020 5 Years Gajuwaka, Visakhapatnam - 530012 Visakhapatnam - 530012 M/s VerGo Pharma Research Pvt Ltd M/s VerGo Pharma Research Pvt Ltd (Division -VerGo Clinicals), Plot 24/1, D- (Division -VerGo Clinicals), Plot 24/1, D-1 62 BABE/2020/0065 09.12.2020 5 Years 1 Mologa de Orora, Corlim, Tiswadi, Mologa de Orora, Corlim, Tiswadi, Goa - Goa -403110, India 403110, IndiaM/s. Accutest Research Laboratories (I) M/s. Accutest Research Laboratories(I) Pvt. Pvt. Ltd., Ltd., Unit-II, Opp. Grand Bhagavati Hotel, 63 BABE/2020/0066 The Grand Monarch, 4th floor, Near 24.12.20 5 Years Sarkhej-Gandhinagar Highway, Bodakdev, Seema Hall, 100ft, Anand Nagar Road, Ahmedabad - 380059 Satellite, Ahmedabad - 380015 M/s. Accutest Research Laboratories(I) M/s. Accutest Research Laboratories(I) Pvt. Pvt. 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M/s ZenRise Clinical Research Pvt ltd, M/s ZenRise Clinical Research Pvt ltd, Plot 67 BABE/2021/0070 Plot No. 201, MythriNagar, Madinaguda, No. 201, MythriNagar, Madinaguda, 15.02.2021 5 Years Miyapur, Hyderabad, India Miyapur, Hyderabad, India M/s Cliantha Reseach Limted M/s Cliantha Reseach Limted Cliantha Corporate, TP 86, FP 28/1, Off. Cliantha Corporate, TP 86, FP 28/1, Off. 68 BABE/2021/0071 26.02.2021 5 Years S.P Ring Road, Sarkhej, Ahemdabad- S.P Ring Road, Sarkhej, Ahemdabad- 382210, Gujarat, India 382210, Gujarat, India M/s AnaZeal Analyticals & Research Pvt M/s AnaZeal Analyticals & Research Pvt Ltd, D-334, TTC Industrial Area, MIDC, Ltd, D-334, TTC Industrial Area, MIDC, 69 BABE/2021/0072 01.04.2021 5 Years Turbhe, Navi Mumbai-400705, Turbhe, Navi Mumbai-400705, Maharashtra, India Maharashtra, India M/s Clians Labs Private Limited M/s Clians Labs Private Limited #4th Flooor, Plot No. 38/A, Vibrant #4th Flooor, Plot No. 38/A, Vibrant Center, 70 BABE/2021/0073 08.04.2021 5 Years Center, IDA-Balanagar, Hyderabad- IDA-Balanagar, Hyderabad-500037, 500037, Telangana, India Telangana, India M/s Vayam Research Solutions Limited M/s Vayam Research Solutions Limited Near Zodiac Farm, Opp. AUDA Garden, Near Zodiac Farm, Opp. AUDA Garden, 71 BABE/2021/0074 B/h Vaishno Devi Temple, Off S.P. Ring B/h Vaishno Devi Temple, Off S.P. Ring 09.04.2021 5 Years Road, Khoraj, Gandhinagar, Gujarat- Road, Khoraj, Gandhinagar, Gujarat- 38242, India 38242, India M/s. Micro Therapeutics Research Labs M/s. Micro Therapeutics Research Labs Limited, Plot no. 46 (Part), Ground and Limited, Plot no. 46 (Part), 2nd floor, 72 BABE/2021/0075 15.04.2021 5 Years First floor, Rangasamy Street, Rangasamy Street, Chrompet, Chennai - Chrompet, Chennai - 600044 600044 M/s Reliance Clinical Reseach Services M/s Reliance Clinical Reseach Services A division of Reliance Life Sciences Pvt. A division of Reliance Life Sciences Pvt. Ltd., Dhirubhai Ambani Life Sciences Ltd., Dhirubhai Ambani Life Sciences 73 BABE/2021/0076 06.05.2021 5 Years Centre (DALC), R-282, B-22 Building, Centre (DALC), R-282, South Block, !st Thane-Belapur Road, Rabale, Navi Floor, Thane-Belapur Road, Rabale, Navi Mumbai, Maharashtra, (India) -400701 Mumbai, Maharashtra, (India) -400701 M/s. Micro Labs Ltd, (CPU) Nos 9 to 14, Katha Nos. 390/395, M/s. Micro Labs Ltd, Situated at Kudlu, Near Grama 74 NIL 58/3, Singasandra Post, Sarjapura Hobli, 30.12.2018 30.12.2021 Panchayath Office, Singasandra Post, Anekal Taluk, Bengaluru - 560068 Sarjapura Hobli, Anekal Taluk, Bengaluru - 560068 M/s. Wockhardt CPB, M/s. Wockhardt CPB, Clinical Pharmacokinetic and Bio Clinical Pharmacokinetic and Bio Pharmaceutical Dept., Wockhardt Pharmaceutical Dept., Wockhardt 75 NIL 23.10.2018 23.10.2021 Research Centre, Wockhardt Ltd, D-4, Research Centre, Wockhardt Ltd, D-4, M.I.d.C., Area, Chikalthana, Aurangabad M.I.d.C., Area, Chikalthana, Aurangabad - - 431006 431006 M/s. CBCC Global Research LLP, M/s. CBCC Global Research LLP, Skoda 76 NIL Skoda House, Opp. L.J Campus, S.G. House, Opp. L.J Campus, S.G. Highway, 01.11.2018 01.11.2021 Highway, Sarkhej, Ahmedabad - 382210 Sarkhej, Ahmedabad - 382210 M/s. ClinSync Clinical Research Pvt. M/s. ClinSync Clinical Research Pvt. Ltd., Ltd., JSR Mall, Plot No. 7 to 18, JSR Mall, Plot No. 7 to 18, Madinaguda 77 NIL 07.12.2018 07.12.2021 Madinaguda Village, Serilingampally Village, Serilingampally Mandal, Hyderabad Mandal, Hyderabad - 500050 - 500050 NAME OF APPROVED STAND ALONE - Bio - Analytical Labs ADDRESS OF BIO ANALYTICAL S.NO. File No. VALID UPTO CENTRE M/s. Cliwis Lab Pvt Ltd, 3rd floor, 11-6- 29/B, Plot No. 32, Venkateswara co-op 1 4-14/2018/BA-BE/05 03.12.2021 Industrial Estate, Balanagar, Hyderabad - 500037, Telangana*old approved ba-be study centre.

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