Commercial Testing Laboratories

Last Updated on July 11, 2021 by The Health Master

Commercial Testing Laboratories

Also read the article: Suggestion: G.S.R No. 223 (E) 18-03-2019, Form 39(A)

How to obtain License for Commercial Testing Laboratories

We have provided the procedure to obtain license for commercial testing laboratories, documents required, application form, fee required, conditions of licenses and procedure for retention fee etc.

Documents required

For obtaining license for Commercial Testing Laboratory, the list of documents required is provided below. Download the pdf file and prepare the documents accordingly.

Procedure for obtaining license

Procedure for obtaining license for Commercial Testing Laboratory. Download the pdf file for more detail and prepare the documents accordingly.

Application Form & Fee

List of Forms & Fee for obtaining the said license is provided below. Download the pdf file and prepare the Form accordingly and submit the required fee.

Form-36

Download the below pdf file

Schedule L 1

Submit your application (Online and / or hard copy) to State Drugs Controller / Licensing Authority of your area after completing all the required documents.

Note: Requirements of some of documents and procedure for submission of application may vary from State to State


Requirement and condition of license

Conditions of licenses is to be maintained after obtaining the required license for Commercial Testing Laboratory. Download the pdf file for ready reference.

License retention fee

Procedure for submission of license retention fee. Download the pdf file for more detail and prepare the documents accordingly.


List of approved MDTLs

List of approved Testing laboratories for Medical Devices, click below links:

List of MDTLs

CDSCO-dt-07-07-2021-List-of-14-Testing-Laboratories-for-Medical-Devices-MDTLs

CDSCO-dt-08-03-2021-List-of-11-Testing-Laboratories-for-Medical-Devices-MDTLs

CDSCO-dt-09-10-2020-List-of-10-Testing-Laboratories-for-Medical-Devices-MDTLs

CDSCO-dt-03-10-2019-List-of-4-Testing-Laboratories-for-Medical-Devices-MDTLs

State wise list of approved testing laboratories

List of approved Commercial Testing laboratories for drugs, click below link


Also read about Govt Testing Laboratories, click here


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Food testing laboratories

State wise list of food Analyst – Food testing Laboratories, click below link

State-wise-List-of-Food-Analyst-Food-testing-laboratory


Ayurvedic, Siddha & Unani testing laboratories

List of Ayurvedic, Siddha & Unani testing laboratories, click below links:

List-of-Approved-Testing-Laboratories-for-Ayurvedic-Siddha-and-Unani-Medicines-59

List-of-Assisted-State-Government-Drug-Testing-Laboratories-for-Unani-Medicine-27

List-of-Ayurvedic-Medicine-Testing-Laboratories-and-Government-Ayurvedic-Siddha-and-Unani-Pharmacies


Notifications:

For notifications of Testing Laboratories, click below link:

Notifications – Testing Laboratories


Laboratory Safety Manual

Laboratory Safety Manual – Revised July 2016, click below link

Laboratory-Safety-Manual-Revised-July-2016


List of Laboratory instruments

Here is the list of laboratory instruments for Pharmaceutical & Cosmetics units

Instruments required for testing of Drugs other than those specified in Schedule C & C1

Crude Vegetable Drugs

General glassware
Balance (Analytical)
Microscope
Soxhlet Extractor
Water Bath
Refractometer
Oven
Hot Plate
TLC Kit
U.V. Chamber
Any Other Specialized equipment

Mechanical Contraceptives (Schedule R)

Leakage tester
Bursting col.
Pressure tester
Vernier Caliper
Micrometer
Balance (Analytical)
Aging Oven
Equipment’s for Package integrity test.

Surgical Dressing (Schedule FII)

U.V. Cabinet
Soxhlet extractor
Oven
Scale
Absorbency Tester
Balance (Analytical)
All equipment required for Sterility testing

Drug requiring Instrumental Analysis

UV/VIS Spectrophotometer
I.R. Spectrophotometer
Pallet maker and holder
KBR discs(for nuzole mull)
Liquid Cell Holder
HPLC (Isocratic & Quarternary)
Type of detector
Required Columns
Gas Chromatograph

Type of detector
Required Columns
AAS (Flame / Graphite furnace / Hydride generator)
HPTLC
TLC
Fluorimeter
Poteniometric Titrator
Flame Photometer
Balance (Analytical)
Microscope
KF Titrator

Oven
Furnace
Water Bath
Fridge
Dissolution Test Apparatus
Basket Type
Paddle Type
Disintegration Test Apparatus
Melting Point Apparatus

Refractometer
Polarimeter
General Glassware
Chemicals
Stop watch
Water Distillation Plant
Particle Counter (Specially for LVP’s)
710 micron Sieve for Uniformity of dispersion test
Platinum crucible
Any other instrument required for Specialized testing

Drugs requiring use of Microbiological Testing

General
Clean room
Laminar Flow
Biosafety Cabinet
Autoclave for sterility
pH Meter
Gas Burner
Water Bath

Incubator
Filtration unit
Vacuum Pump
BOD Incubator
Refrigerator
Balance (Analytical)
Glass wares
Centrifuge
Microscope
Other general equipment required for general day to day activity
Cultures

Special requirements other than General for:

Disinfectants

Platinum loop
Proper Culture
Stop Watch
Oven up to 35oC

Antibiotics

Spectrophotometer
Vernier Caliper / Zone Reader
Proper Culture
Borer
Media

Vitamins (excluding electrophoresis)

Spectrophotometer
Vernier Caliper / Zone Reader
Vortex Mixer
Culture
Media
Borer

Sterility

Filtration Unit
Vacuum Pump
Media
0.45m Pore Filter Paper Sterile
Sterile forceps
Scissors
Bone cutter
Surgical blade
Ampoule Cutter
Sterile Gloves
Face Masks
Caps
Sterile garments

Endotoxins

LAL Reagents
Heating block
Sterile test tubes
Vortex mixer
Sterile tips
Pipettes tips (Pyrogen free)
Stop watch
LAL Water / Pyrogen free Sterile distilled water

Pyrogen

Animal House
Pyrothermometer / Rectal thermometer
Sterile syringes, needles
Pyrogen free glassware
Pyrogen free Sodium Chloride Solution / Water
Animal Holding Stands

Sterilized surgical Sutures and Ligatures

Sterility testing facilities
Tensile Strength Tester

Sera Vaccines

Sterility testing facilities and other specialized testing facilities required for Testing Sera vaccines

Pharmacological Testing

Operation Table
Kymograph
Water Bath
Manometer
Cannula
Oxygen Cylinder
Other equipments required for Pharmacological testing                          

Cosmetic Testing

Pay-off test apparatus
Break load apparatus
Foam height apparatus
Scracth test apparatus
Drying time apparatus
Penetrometer for consistency
Rotating Viscometer


Also download the above whole list of laboratory instruments, click below link:

List-of-Laboratory-Instruments

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