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.

Documents-required-for-obtaining-Lab-license

Procedure for obtaining license

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

Procedure-for-obtaining-Lab-license

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

Form-36

For Cosmetics

Form-Cos-22

For Medical Devices

Form-MD-39

Fee

Download the pdf file for the license fee structure for all licenses under the Drugs and Cosmetics Act 1940 and the Rule framed thereunder. Click below link

Licenses-fee-structure-for-all-licenses

Fees for various kinds of drugs Licenses under Drugs and Cosmetics Act 1940 & Rules 1945

Types of LicensesApplication on FormLicense on FormLicense FeeRenewal / Retention fee (after 5 years)Late fee Per monthFee for duplicate licenseAdditional Item (per item)Sale licensesWhole Sale1920-B 21-B3000/- (1500/- each)Retention fee after 5 years Rs. 3000/-2% (Rs 60/-)300/--Retail sale1920 & 21-do--do--do--do--Homeopathic (Wholesale)19-B20-D250/-20-E50/-150/--Homeopathic (Retail sale)19-B20-C250/-20-E50/-150/--Sch. X (Wholesale)19-C20-G500/-Retention2%150/--Sch. X (Retail Sale)19-C20-F500/-Retention2%150/--Manufacturing licensesManufacturing (Non-Biological)24257500/-Retention2%1000/-300/-Manufacturing (Biological)27287500/-Retention2%1000/-300/-Loan License (B)27-A28-B7500/-Retention2%-300/-Loan License (NB)24-A25-B7500/-Retention2%-300/-LVP27-D28-D7500/-Retention2%-300/-Homeopathic24-C25-C300/-26-C100/-50/-50/-CosmeticCOS 5COS 810,000/-Retention2% 500/-Repacking (NB)24-B25-B700/-Retention2%1000/-100/-Testing licensesLicense for Test / Analysis2930250/-Valid for 3 years and further renewal for 1 year---Cosmetic Testing LaboratoryCOS 22COS 231000/-----Commercial testing Laboratory36377500/-Retention2%--Blood CentreBlood Centre27-C28-C7500/-28-c1000/--300/-Medical Devices manufacturing licensesMedical Devices (Cat A& B)MD-3MD-55000/-Retention2%-500/-Medical Devices (Loan License) (Cat A& B)MD-4MD-65000/-Retention2%-500/-Medical Devices (Cat C& D)MD-7MD-850,000/-Retention2%-1,000/-Medical Devices Loan License (Cat C& D)MD-9MD-1050,000/-Retention2%-1,000/-Medical Devices RegistrationMedical Devices RegistrationMD-41MD-423,000/-Retention2%--

Click for all other application forms

Schedule L 1

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.

Requirements-and-Conditions-of-Commercial-Testing-Laboratory

License retention fee

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

Procedure-for-License-retention-fee

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

State-wise-List-of-Approved-testing-Laboratories-of-drugs-134-Labs

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

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 glasswareBalance (Analytical)MicroscopeSoxhlet ExtractorWater BathRefractometerOvenHot PlateTLC KitU.V. ChamberAny Other Specialized equipment

Mechanical Contraceptives (Schedule R)

Leakage testerBursting col.Pressure testerVernier CaliperMicrometerBalance (Analytical)Aging OvenEquipment’s for Package integrity test.

Surgical Dressing (Schedule FII)

U.V. CabinetSoxhlet extractorOvenScaleAbsorbency TesterBalance (Analytical)All equipment required for Sterility testing

Drug requiring Instrumental Analysis

UV/VIS SpectrophotometerI.R. SpectrophotometerPallet maker and holderKBR discs(for nuzole mull)Liquid Cell HolderHPLC (Isocratic & Quarternary)Type of detectorRequired ColumnsGas Chromatograph

Type of detectorRequired ColumnsAAS (Flame / Graphite furnace / Hydride generator)HPTLCTLCFluorimeterPoteniometric TitratorFlame PhotometerBalance (Analytical)MicroscopeKF Titrator

OvenFurnaceWater BathFridgeDissolution Test ApparatusBasket TypePaddle TypeDisintegration Test ApparatusMelting Point Apparatus

RefractometerPolarimeterGeneral GlasswareChemicalsStop watchWater Distillation PlantParticle Counter (Specially for LVP’s)710 micron Sieve for Uniformity of dispersion testPlatinum crucibleAny other instrument required for Specialized testing

Drugs requiring use of Microbiological Testing

GeneralClean roomLaminar FlowBiosafety CabinetAutoclave for sterilitypH MeterGas BurnerWater Bath

IncubatorFiltration unitVacuum PumpBOD IncubatorRefrigeratorBalance (Analytical)Glass waresCentrifugeMicroscopeOther general equipment required for general day to day activityCultures

Special requirements other than General for:

Disinfectants

Platinum loopProper CultureStop WatchOven up to 35oC

Antibiotics

SpectrophotometerVernier Caliper / Zone ReaderProper CultureBorerMedia

Vitamins (excluding electrophoresis)

SpectrophotometerVernier Caliper / Zone ReaderVortex MixerCultureMediaBorer

Sterility

Filtration UnitVacuum PumpMedia0.45m Pore Filter Paper SterileSterile forcepsScissorsBone cutterSurgical bladeAmpoule CutterSterile GlovesFace MasksCapsSterile garments

Endotoxins

LAL ReagentsHeating blockSterile test tubesVortex mixerSterile tipsPipettes tips (Pyrogen free)Stop watchLAL Water / Pyrogen free Sterile distilled water

Pyrogen

Animal HousePyrothermometer / Rectal thermometerSterile syringes, needlesPyrogen free glasswarePyrogen free Sodium Chloride Solution / WaterAnimal Holding Stands

Sterilized surgical Sutures and Ligatures

Sterility testing facilitiesTensile Strength Tester

Sera Vaccines

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

Pharmacological Testing

Operation TableKymographWater BathManometerCannulaOxygen CylinderOther equipments required for Pharmacological testing                          

Cosmetic Testing

Pay-off test apparatusBreak load apparatusFoam height apparatusScracth test apparatusDrying time apparatusPenetrometer for consistencyRotating Viscometer

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

List-of-Laboratory-Instruments
https://thehealthmaster.com/drugs/drug-testing-laboratories/commercial-testing-laboratories/