Introduction Central Drug Testing Laboratories & Responsibilities Role of Central Drugs Testing Laboratory No of laboratories in India, No of laboratories in each State Presented by J. Vinay Krishna Department of Industrial Pharmacy

1. Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
Central Drug Testing Laboratories
&
Responsibilities
A Seminar as a part of curricular requirement for
Master of Pharmacy, I Year - I semester
Presented by
J. Vinay Krishna
(20L81S0806)
Dept of. Industrial Pharmacy
Under the guidance/Mentorship of
Mr. E. Bhargav M. Pharm., (PhD)
Assistant Professor
Department of Industrial Pharmacy,

2. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
Contents:
2
 Introduction
 Role of Central Drugs Testing Laboratory
 No of laboratories in India
 No of laboratories in each State

3. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
Introduction
• CDL”- The Central Drugs Laboratory Established in Kolkata, CDL is the
national statutory laboratory of the Government of India. It is under the
control of a Director appointed by the Central Government. It is the
oldest quality control laboratory of the Drug Control Authorities in
India.
3

4. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
What is Drug Testing Laboratory ?
• Laboratory refers to a private or government facility that is capable
of testing a specimen to determine the presence of
dangerous drugs therein. NRL refers to the National
Reference Laboratory for Environmental and Occupational Health,
Toxicology and Micronutrient Assay designated by the Secretary of
Health.
4

5. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 5
Analytical quality control of drug and cosmetics manufactured within the
country on behalf of the Central and State Drug Controller
Administrations. Acting as an Appellate authority in matters of disputes
relating to quality of Drug.
Role of Central Drug Testing Laboratories CDTL

6. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
Central Drug Laboratory Kolkata
I. Statutory Functions:
 Analytical quality control of majority of the imported Drug available
in Indian market.
 Analytical quality control of drug and cosmetics manufactured within
the country on behalf of the Central and State Drug Controller
Administrations.
 Acting as an Appellate authority in matters of disputes relating to
quality of Drug.
6

7. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
II. Other Functions
 Collection, storage and distribution of International Standard
International Reference Preparations of Drug and Pharmaceutical
Substances.
 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.
 Training of Drug Analysts deputed by State Drug Control Laboratories
and other Institutions.
7

8. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
 Training of World Health Organization Fellows from abroad on
modern methods of Drug Analysis.
 To advise the Central Drug Control Administration in respect of
quality and toxicity of drug awaiting license.
 To work out analytical specifications for preparation of
Monographs for the Indian Pharmacopoeia and the
Homoeopathic Pharmacopoeia of India.
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9. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
 To undertake analytical research on standardisation and methodology
of Drug and cosmetics.
 Analysis of Cosmetics received as survey samples from Central Drug
Standard Control Organization.
 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.
9

10. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
 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.
10

11. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
Central Drugs Testing Laboratory Hyderabad
 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.
11

12. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
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.
12

13. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
• 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.
13

14. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
No of laboratories in India
Sl.No Name and area of the Drug testing Laboratories
1 Central Drugs Testing Laboratory, Mumbai, Maharashtra
2 Central Drugs Laboratory, Kolkata, West Bengal
3 Central Drugs Testing Laboratory, Chennai, Tamil Nadu
4 Central Drugs Testing Laboratory, Hyderabad, Andhra Pradesh
5 Central Drugs Laboratory, Central Research Institute, Kasauli,
Himachal Pradesh
6 Regional Drugs Testing Laboratory, Guwahati, Assam
7 Regional Drugs Testing Laboratory, Chandigarh
8 National Institute of Biologicals, Noida (U.P.)
14

15. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
No of laboratories in each State
15
Sl. No State No of Centres
01 Andhra Pradesh 2
02 Bihar 1
03 Chhattisgarh 1
04 Delhi 1
05 Goa 1
06 Gujarat 1
07 Haryana 1
08 Himachal Pradesh 1
09 Jammu & Kashmir 2

16. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 16
Sl.no State No of Centres
10 Jharkhand 1
11 Karnataka 3
12 Kerala 1
13 Madhya Pradesh 1
14 Maharashtra 2
15 Meghalaya 1
16 Orissa 1
17 Pondicherry 1
18 Punjab 1
19 Rajasthan 1
20 Tamil Nadu 2

17. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 17
Sl.no State No of Centres
21 Tripura 1
22 Uttar Pradesh 1
23 West Bengal 1
Total 29

18. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 18