Central Drug Testing Laboratories (2024)

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Central Drugs Standard Control Organization

Directorate General of Health Services
Ministry of Health & Family Welfare
Government of India

Central Drug Testing Laboratories (2)

Central Drug Testing Laboratories (3)

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Central Drug Testing Laboratories (4)Notice regarding Guidance for approval Covid-19 vaccine in India for restricted use in emergency situation which are already approved for restricted use by US FDA EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency use listing15th April,2021 DCGI Message 202101 Jan 2021For Medical devices which are under voluntary registrations, the file number generated is the registration number of firm.E-GOV cell at CDSCOCDSCO,HQ accredited with Quality Management Systems IS/ISO 9001:2015 by BIS

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Central Drug Testing Laboratories

Central Drugs Laboratory (CDL) Kolkata

The functions of the Laboratory include:

I. Statutory Functions:

  1. Analytical quality control of majority of the imported Drug available in Indian market.
  2. Analytical quality control of drug and cosmetics manufactured within the country on behalf of the Central and State Drug Controller Administrations.
  3. Acting as an Appellate authority in matters of disputes relating to quality of Drug.

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II. Other Functions:

  1. Collection, storage and distribution of International Standard International Reference Preparations of Drug and Pharmaceutical Substances.
  2. Preparation of National Reference Standards and maintenance of such Standards. Maintenance of microbial cultures useful in drug analysis Distribution of Standards and cultures to State Quality Control Laboratories and drug manufacturing establishments.
  3. Training of Drug Analysts deputed by State Drug Control Laboratories and other Institutions.
  4. Training of World Health Organization Fellows from abroad on modern methods of Drug Analysis.
  5. To advise the Central Drug Control Administration in respect of quality and toxicity of drug awaiting license.
  6. To work out analytical specifications for preparation of Monographs for the Indian Pharmacopoeia and the hom*oeopathic Pharmacopoeia of India.
  7. To undertake analytical research on standardisation and methodology of Drug and cosmetics.
  8. Analysis of Cosmetics received as survey samples from Central Drug Standard Control Organization.
  9. Quick analysis of life saving Drug on an All-India basis received under National Survey of Quality of Essential Drug Programme from Zonal Offices of Central Drug Standard Control Organization.

In addition to the above functions the Central Drug Laboratory also actively collaborates with the World Health Organisation in the preparation of International Standards and Specifications for International Pharmacopoeia. It also undertakes collaborative study on behalf of the Indian Pharmacopoeia Committee. The senior Officers of the Laboratory have been appointed as Government Analysts on behalf of most of the States of the Union for analysis of drug samples.

Director I/c:

Dr.Saroj Kumar Ghosh

Address:Director ,Central Drugs Laboratory, 3, Kyd Street, Kolkata, 700 016.

Email: cdlkol[at]cdsco[dot]nic[dot]in

Gram:
BIOSTAN LAB

Phone: 033 -22299541

Fax: 033-22299380

Under the National List Of Approved Testing Laboratories

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Certificate of Accreditation from National Accreditation Board for Testing and Calibration Laboratories(NABL)

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Suo Motu Disclosure under Section 4 under RTl Act 2005

Central Drug Testing Laboratories (5)

Central Drug Testing Laboratories (6)

Central Drugs Testing Laboratory (CDTL) Chennai , Tamil Nadu

Central Drug Testing Laboratory is one of the Seven National Laboratories in India engaged in the research and analysis of Drug and Cosmetics as per Drug and Cosmetics Act, 1940.

Director I/C (CDTL Chennai):

Smt.C Vijayalakshmi

Address:Central Drug Testing Laboratory, Govt. of India, 37, Naval Hospital Road, Periamet, Campus G.M.S.D., Chennai, 600 003

Phone:044-25610402/ 25610205

Gram:DRUGSLAB

Fax:044 -25610906

Email: cdtlchennai[at]cdsco[dot]nic[dot]in,cdtl-chennai[at]cdsco[dot]nic[dot]in

Suo Motu Disclosure under Section 4 under RTl Act 2005

Central Drug Testing Laboratories (7)

CENTRAL DRUGS TESTING LABORATORY HYDERABAD

Accredited By: NABL (ISO/IEC-17025:2017 in Chemical Testing)

The CDTL, Hyderabad is one of the National Statutory Laboratories of the Government of India, functioning under administrative control of the Drug Controller General (India), Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Ministry of Health and Family Welfare, New Delhi.

The functions of the Laboratory include:

  • Analysis of Drugs and Pharmaceuticals, Cosmetics and Medical Devices manufactured in the country.
  • Analysis of Import drugs & Cosmetics samples entering through the port offices of CDSCO.
  • Analysis of Drugs & Pharmaceutical formulations received as Survey Samples from Central Drugs Standard Control Organization and its Zonal Offices.
  • Analysis of Drugs & Pharmaceuticals formulations received as national Survey samples from CDSCO or other offices under Ministry of Health & Family Welfare
  • Imparting Training to Drugs Analysts deputed by the Government laboratories from time to time.

Director I/c (CDTL Hyderabad):

Smt. C. Vijayalakshmi

Address: Central Drugs Testing Laboratory,

CDSCO Bhavan, S.R. Nagar, Metro Pillar No. A1013 S.R Nagar Hyderabad -500038

Telephone : 040 23811328/23811327

Email:cdtlhyd [at]cdsco[dot]nic[dot]in,

Suo Motu Disclosure under Section 4 under RTl Act 2005

CHECK LIST FOR SAMPLES RECEIVED OF COUGH SYRUP 17.01.2024

Central Drug Testing Laboratories (8)

Central Drugs Testing Laboratory (CDTL) Mumbai

Accredited By: NABL (ISO/IEC-17025:2017 in Chemical and Biological Testing)

Certified for: IMS (ISO-9001:2015, ISO-14001:2015, ISO-45001:2018)

The CDTL, Mumbai is one of the National Statutory Laboratories of the Government of India, functioning under administrative control of the Drug Controller General (India), Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Ministry of Health and Family Welfare, New Delhi.

The functions of the Laboratory include:

    • Analysis of Drugs and Pharmaceuticals, Cosmetics and Medical Devices manufactured in the country as per Drugs & Cosmetics Act. 1940 and rules thereunder.

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  • The Director, CDTL mumbai Acts as "Appellate Authority" as per Drugs & Cosmetics Act, 1940 for the testing of Copper T and Tubal Rings ( Intrauterine Contraceptive Devices.)
  • Analysis of Import drugs & Cosmetics samples entering through the port offices.
  • Analysis of Registration samples for approval of site registration as per GMP.
  • Analysis of New Drugs to get license for manufactring the same.
  • Analysis of Drugs & Pharmaceutical formulations received as Survey Samples from Central Drugs Standard Control Organization and its Zonal Offices.
  • Analysis of Drugs & Pharmaceuticals formulations received as national Survey samples from CDSCO or other offices under Ministry of Health & Family Welfare
  • Imparting Training to Drugs Analysts deputed by the Government laboratories form time to time.
  • To undertake anlytical research on standaridization and methodology of Drugs.
  • Participation in developing Standards and upgradation of Monographs of Indian Pharmacopoeia and suggesting modifications if any.
Director I/c (CDTL Mumbai):

Mrs. Sayali U. Warde

Address: Zonal FDA Bhawan, Bellasis Road, Governement Medical Stores Depot (GMSD) Compound, Mumbai Central, Mumbai-400 008

Phone:(Off.)022-2300 2309, 2300 2138

Fax:022-23099240

Email:cdtlmumbai[at]cdsco[dot]nic[dot]in

About Central Drugs Testing Laboratory Mumbai

SUO MOTO CDTL-Mumbai 2022 - 2023

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Annexure II

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Annexure IV

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Annexure V

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Annexure VI

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Annexure VII

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Annexure VIII

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Annexure IX

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Annexure X

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Annexure XI

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Regional Drugs Testing Laboratory (RDTL) Guwahati

The RDTL, Guwahati is one of the National Statutory Laboratories of the Government of India, functioning under administrative control of the Drug Controller General (India), Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Ministry of Health and Family Welfare, New Delhi.The RDTL Guwahati established in the year of 2002, at present having annual capacity of testing of about 2500 statutory samples of Drugs/Cosmetics/Medical Devices and is a NABL Accredited laboratory as per IS/ISO/IEC 17025:2017 in Chemical & Biological Testing since 13.03.2009.Presently laboratory is notified by the States of Arunachal Pradesh, Assam, Manipur, Meghalaya, Mizoram, Nagaland, Sikkim, Tripura, Bihar and Jharkhand for testing of samples of Drugs.

The functions of the Laboratory include:

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I. Statutory Functions:
  1. Analysis of samples of Drugs, Cosmetics and Medical Devices.
  2. Analysis of samples entering through the port offices of CDSCO.
  3. Analysis of samples received from offices of Central Drugs Standard Control Organization, its Port Offices and Drugs Control Departments of North Eastern States, Sikkim, Bihar and Jharkhand.
The laboratory is committed to:
  1. Discharge duties with honesty, integrity, transparency, in a very impartial manner with high professionalism.
  2. Implement, maintain and constantly improve its effectiveness of the quality management system and adhere to the provision of Drugs & Cosmetics Act 1940, Drugs & Cosmetics Rules 1945 and Medical Devices Rules 2017 thereunder.
  3. Laboratory follows National, International Standards including Pharmacopoeias, Manufacturer’s methods of analysis etc. in testing of samples of Drugs, Cosmetics and Medical Devices.
  4. Maintain absolute impartiality and confidentiality.
Director I/c:

Mr. Dinesh Kumar

Address:Director-in-Charge Regional Drugs Testing Laboratory, Directorate General of Health Services, Guwahati-781 037 (Assam)

Phone:(Off.)0361-2338555/2330555
(Res.)0361-2337272/2330899

Fax:0361-2330555

Email:rdtlguwahati[at]cdsco[dot]nic[dot]in

Central Drug Testing Laboratories (9)

Central Drug Testing Laboratories (10)

Regional Drugs Testing Laboratory (RDTL) Chandigarh

The Regional Drugs Testing Laboratory (RDTL) - Chandigarh is one of the Seven National Drugs Testing Laboratories of Central Drugs Standard Control Organisation (CDSCO), set-up under the requirement for the testing of Drugs & Cosmetics products, working since November-2007. The Laboratory has been developed for the Quality Control of Drugs & Cosmetic products with respect to Infrastructure, Equipment and Manpower for the Chemical, Instrumentation and Microbiological analysis. The RDTL - Chandigarh is regularly testing number of Legal (Form-18), Survey and imported samples of Drugs & Cosmetics received from the Central Officers / Drugs Inspectors of CDSCO North Zone – Ghaziabad, Sub Zone - Baddi, Jammu, Varanasi and Assistant Drugs Controller (India), Indira Gandhi International Airport, New Delhi. Apart from this, laboratory is notified for the State of Haryana, Himachal Pradesh, Jammu & Kashmir, Union Territories of Chandigarh and Delhi for the analysis of Drugs & Cosmetic samples drawn by their Drug Officers. The laboratory is having testing capacity of about 5000 - Samples, per annum, and is NABL Accredited as per ISO / IEC 17025:2005, since 2016.

Director I/c : Dr. Debasis Maiti

Address :Regional Drugs Testing Laboratory, Sector 39-C, Chandigarh 160036

Phone:0172 - 2688239

Fax:0172-2636316

Email: rdtlchd[at]cdsco[dot]nic[dot]in

Suo Moto Disclosure as per Section 4 of RTI Act 2005

Certificate of Accreditation

Total Budget for the Public Authority

Details of CPIO and FAA

E Governance

Letter on uploading of document on the website of CDSCO

Notice for Hearing 2018-19 with Jugement

Organization and Function

Parliament Questions and Reply

Payment Details of Sample Testing Charges State wise

RTI Reply 2017-18

RTI Reply 2018-19

RTI Reply 2019-20

RTI Reply 2020-22

RTI Reply 2022-23

RTI Reply 2023-24

Central Drugs Laboratory, CDL Kasauli

Central Drugs Laboratory at Central Research Institute (CRI) Kasauli is a Central laboratory engaged in the testing of vaccines. It is a notified laboratory under the Drugs and Cosmetics Act, 1940 to function as Central Drugs Laboratory for testing of the following drugs or classes of drugs;

  1. Sera
  2. Solution of serum proteins intended for injection
  3. Vaccines
  4. Toxins
  5. Antigens
  6. Anti-toxins
  7. Sterilized surgical ligature and sterilized surgical suture
  8. Bacteriophages, including Oral Polio vaccine.

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Director(CDL Kasauli):

Sh. Sushil Kumar Sahu

Phone:01792-272046

Fax:01792 -272049

Email:cdlkasauli[at]cdsco[dot]nic[dot]in

Central Drug Testing Laboratories (11)

Central Drug Testing Laboratories (2024)
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