Last Updated on November 29, 2024 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
List of Forms 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
For Cosmetics
For Medical Devices
Fee
License fee structure for all licenses
| Types of Licenses | Application Form | License on Form | Fee | Renewal / Retention fee | Late fee | Duplicate license | Fee per item |
| Drug Sale Licenses | |||||||
| Whole Sale | 19 | 20-B & 21-B | 3,000/- | 3,000/- | 2% | 300/- | – |
| Retail sale | 19 | 20 & 21 | 3,000/- | 3,000/- | 2% | 300/- | – |
| Homeopathic (WSDL) | 19-B | 20-D | 2,000/- | – | – | – | – |
| Homeopathic (RSDL) | 19-B | 20-C | 2,000/- | – | – | – | – |
| Sch. X (WSDL) | 19-C | 20-G | 500/- | 500/- | 2% | 150/- | – |
| Sch. X (RSDL) | 19-C | 20-F | 500/- | 500/- | 2% | 150/- | – |
| Drug Manufacturing Licenses | |||||||
| Manufacturing (Non- Biological) | 24 | 25 | 7,500/- | 7,500/- | 2% | 1,000/- | 300/- |
| Manufacturing (Biological) | 27 | 28 | 7,500/- | 7,500/- | 2% | 1,000/- | 300/- |
| Manufacturing Schedule X | 24 F | 25 F | 7,500/- | 7,500/- | 2% | 1,000/- | 300/- |
| License for Test / Analysis | 29 | 30 | 250/- | Valid for 3 years. Renewal for 1 year | – | – | – |
| Loan License (Biological) | 27-A | 28-B | 7,500/- | 7,500/- | 2% | No | 300/- |
| Loan License (Non- Biological) | 24-A | 25-B | 7,500/- | 7,500/- | 2% | No | 300/- |
| LVP | 27-D | 28-D | 7,500/- | 7,500/- | 2% | No | 300/- |
| Cosmetics Manufacturing Licenses | |||||||
| Manufacturing | COS 5 | COS 8 | 10,000/ | 10,000/- | 2% | – | 500/- |
| Loan License | COS 6 | COS 9 | 10,000/ | 10,000 | 2% | 500/- | |
| Laboratory | COS 22 | COS 23 | 1,000/- | 1,000/- | 2% | 100/- | – |
| Additional Section | – | – | 10,000/ | – | – | – | – |
| Free Sale | – | – | No fee | – | – | – | – |
| Medical Devices Manufacturing Licenses | |||||||
| Medical Devices (A& B) | MD-3 | MD-5 | 5,000/- | 5,000/- | 2% | – | 500/- |
| Medical Devices (Loan License) (A& B) | MD-4 | MD-6 | 5,000/- | 5,000/- | 2% | – | 500/- |
| Medical Devices (C& D) | MD-7 | MD-8 | 50,000/- | 50,000/- | 2% | – | 1,000/- |
| Medical Devices Loan License (C& D) | MD-9 | MD-10 | 50,000/- | 50,000/- | 2% | – | 1,000/- |
| Registration of Medical Devices Laboratory | MD-39 | MD-40 | 20,000/- | 20,000/- | 2% | – | – |
| Sale License | MD-41 | MD-42 | 3,000/- | 3,000/- | 2% | – | – |
| Free Sale certificate | 1,000/- for each category |
| Other Licenses | |||||||
| Blood Centre | 27-C | 28-C | 7,500/- | 26-G | 1,000/- | No | 300/- |
| Homeopathic Mfg License | 24-C | 25-C | 2,000/- For any no. of single ingredient | – | – | – | 200/- Per product of combination |
| Approval of Commercial testing Lab | 36 | 37 | 7,500/- | 7500/- | 2% | – | – |
| Repacking Non-Biological | 24-B | 25-B | 700/- | 700/- | 2% | 1,000/- | 100/- |
Compiled by:
Lalit Kr. Goel, DSDC, FDA Haryana
Rakesh Dahiya, SDCO, FDA Haryana
Download fee structure
Click below link to download the fee structure of all types of drug licenses
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
List of BA-BE Study centre & Bio Analytical Laboratory
DCGI dt 02-08-2021 – Updated list of BA-BE Study centre & Bio Analytical Laboratory under New CT RULE 2019
Also read about Govt Testing Laboratories, click here
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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