Procedure to obtain license for Commercial Testing Laboratories

How to obtain License for Commercial Testing Laboratories

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Rakesh Dahiya

Procedure to obtain license for 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 & 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

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


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

Types of LicensesApplication Form License on Form FeeRenewal / Retention fee Late fee Duplicate licenseFee per item
Drug Sale Licenses
Whole Sale1920-B & 21-B3000/-  3000/-2%  300/-
Retail sale1920 & 21-do--do--do--do-
Homeopathic (WSDL)19-B20-D250/-20-E50/-150/-
Homeopathic (RSDL)19-B20-C250/-20-E50/-150/-
Sch. X (WSDL)19-C20-G500/-500/-2%  150/-
Sch. X (RSDL)19-C20-F500/-500/-2%150/-
Drug Manufacturing Licenses
Manufacturing (Non- Biological)24257500/-7500/-2%  1000/-300/-
Manufacturing (Biological)27287500/-7500/-2%  1000/-300/-
Manufacturing Schedule X24 F25 F7500/-7500/-2%1000/-300/-
License for Test / Analysis2930250/-Valid for 3 years. Renewal for 1 year
Loan License (Biological)27-A28-B7500/-7500/-2%  No300/-
Loan License (Non- Biological)24-A25-B7500/-7500/-2%  No300/-
LVP27-D28-D7500/-7500/-2%  No300/-
Cosmetics Manufacturing Licenses
ManufacturingCOS 5COS 810,000/10,000/-  2%500/-
Loan LicenseCOS 6COS 910,000/10,0002% 500/-
LaboratoryCOS 22COS 231,000/-1,000/-2%100/-
Additional Section10,000/
Free SaleNo fee
Medical Devices Manufacturing Licenses
Medical Devices (A& B)MD-3MD-55000/-5000/-2%500/-
Medical Devices (Loan License) (A& B)MD-4MD-65000/-5000/-2%500/-
Medical Devices (C& D)MD-7MD-850,000/-50,000/-2%1,000/-
Medical Devices Loan License (C& D)MD-9MD-1050,000/-50,000/-2%  1,000/-
Registration of Medical Devices LaboratoryMD-39MD-4020,000/-20,000/-2%
Sale LicenseMD-41MD-423,000/-3,000/-2%
Free Sale certificate  1,000/- for each category    
Other Licenses
Blood Centre27-C28-C7500/-26-G1000/-No300/-
Homeopathic Mfg License24-C25-C300/-26-C100/-50/-50/-
Approval of Commercial testing Lab36377500/-7500/-2%
Repacking Non-Biological24-B25-B700/-700/-2%1000/-100/-

Area required

Area required for manufacturing of Drugs, Cosmetics, Homoeopathic and Blood Centre

Manufacturing area / sectionArea prescribed for basic installations (Square Metre)Ancillary Area prescribed (Square Metre)Total Area required (Square Metre)
Allopathic drugs   
External Preparations301040
Oral Liquid Preparations301040
Tablets (uncoated) Non-Beta Lactum (Granulation + compression + packaging etc)602080
Coating (Non-Beta Lactum)30 1040
Tablets (uncoated) Beta Lactum (Granulation + compression + packaging etc)602080
Coating (Beta Lactum)30 1040
Powders (oral)3030
Hard Gelatin Capsules (Beta-lactam)251035
Hard Gelatin Capsules (Non Beta-lactam)251035
Ophthalmic Preparation251035
Eye ointment, Eye lotion2525
Pessaries2020
Inhalers & Vitrallae2020
Re-packing of drugs3030
Parenteral (Small Volume Parenteral)150100250
Parenteral (Large Volume Parenteral)150150300
Plastic (LVP) by Form-Fill-Seal / Blow, Fill –Seal technology250150400
Homoeopathic   
Mother tincture and
mother solutions
5555
Potentization section2020
Trituration, Tableting,
Pills and Globules section
5555
Syrups & other oral liquids2020
Ointments & lotions section2020
Ophthalmic Preparations2020
Packing & labelling5050
Cosmetics   
A. Powders1515
B. Skin powder for infants1515
C. Creams, Lotions, Shampoo, Shaving Creams, Hair Oils, Emulsions, Pastes, Cleansing Milk, Pomade2525
D. Nail Polish and Nail Lacquers1515
E. Lipsticks and Lipgloss1515
F. Depilatories used for eyes1010
G.
1. Eyebrows, Eyelashes, Eyeliners
2. Kajal and Surma

10 10



5 For base sterilization

10 15
H. Aerosols1515
I. Alcoholic Fragrance Solutions1515
J. Hair Dyes1515
K. Tooth powders general1515
L. Toilet Soaps100100
Blood Bank / Centre   
Blood Bank / Centre
(only for Whole Human Blood)
100100
Blood Component5050
Blood Bank / Centre
including Blood Components
150150
Apheresis1010
Medical Devices
Area not prescribed in MDR 2017 for manufacturing of Medical Devices
Medicinal Gas
Area not prescribed for manufacturing of Medicinal gases
Disinfectant
Area not prescribed for manufacturing of Disinfectants
API (Bulk drug)
Area not prescribed for manufacturing of API (Bulk drugs)
Empty Capsule Shell
Area not prescribed for manufacturing of Empty gelatin Shell
Soft Gelatin Capsules
Area not prescribed for manufacturing of Soft Gelatin Capsules
Cytotoxic substances / Sex hormones
Same area required as defined for tablet section
Laboratory
Area for Commercial Laboratory or Laboratory for manufacturing units not prescribed

Note: Requirement of ancillary area shall not apply to the units registered before 30-06-2005


Compiled by:

Lalit Kr. Goel, DSDC, FDA Haryana

Rakesh Dahiya, SDCO, FDA Haryana


Download area requirement

Click below link to download the requirement for the manufacturing of Drugs, Cosmetics, Homoeopathic and Blood Centre


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

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


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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


Download the whole list of laboratory instruments, click below link:

List-of-Laboratory-Instruments



Compiled by:
Rakesh DahiyaSDCO cum Licensing Authority, FDA Haryana


Commercial Testing Laboratories

Govt Laboratories

List of Laboratory instruments

NABL

Latest Notifications: Testing Laboratories

NABL 164 released : Guidelines for Inter-laboratory comparison

NABL releases NABL 136: specific criteria for X-Ray equipment

NABL: List of NABL Accredited Testing Laboratories

NABL 126: Specific criteria for calibration of Medical Devices

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