Applicant’s Manual

for
License Management System

Directorate of Drugs Control

Department of Health & Family Welfare, Govt. of Odisha

Applicant’s Manual-LMS Page 1

Table of Contents
1. Introduction--------------------------------------------------------------------------------------- 3
2. Purpose of user manual-------------------------------------------------------------------------- 3
3. Login to the Website----------------------------------------------------------------------------- 3
4. LMS Registration process----------------------------------------------------------------------- 4
• Online Application For Grant of Retail Drug License---------------------------- - 7
• Online Application For Grant of Wholesaler--------------------------------------- 16
• Online Application For Grant of Manufacturer------------------------------------- 23
5. LMS Renewal Process----------------------------------------------------------------------------- 28
• Online Application For Renewal of Retailer/Wholesaler------------------------- 28
• Online Application For Renewal of Manufacturer--------------------------------- 34

Applicant’s Manual-LMS Page 2

Introduction

• Licensing Management System (LMS) is a web based application to track and trace the
licenses, grant and renewals at different licensing zones of Directorate of Drugs Control.
• This system enables citizen, interested in drug retailing, distributing and manufacturing, to
apply online for their drug licenses. The process of verification and recommendation by the
drug inspector and the approval of Licensing Authority are also being carried out online.
• The existing drug retailer, distributor and manufacturer can also renew/change their licenses
in the system.
• The system enables the existing workflow of different users to be managed and role access
has been provided to the stakeholders to help them in tracking of the work progress and status
report at any point of time.
• The system provides various analytical reports based on the MIS.
• Citizen can view the area wise valid list of drug retailers/ wholesalers/ manufacturers along
with their license number and other details.

Purpose of user manual

This Manual provides complete information about the usage of the system. The user can refer the
manual to understand the process and utilize the system effectively. This manual includes a
description of the system functions and features, contingencies and alternate modes of operation, and
step-by-step procedures for easy system access and use.

Login to the Website

The User has to perform following actions for logging into the Website.

i. Type the URL : http://dcodishaonline.nic.ininto the address bar.

( fig. Web Screen 1:Home Page)

The following details will be appeared in the home screen

 Login tab for new and existing applicants

Applicant’s Manual-LMS Page 3

  Login Panel for official users.
 Information on Retailers, Wholesalers, Manufacturers, Consumer Awareness and NSQ
Drugs
 Enforcement Module Tab

Registration/ Login process

The registration process for license of Pharmacist/Retailer/Wholesaler and Manufacturer can be

invoked through the login tab available for new and existing Applicants.

New Applicants Login- the Applicant, who is logging to the system for the first time, after which
the system will generate a User ID and Password for the Applicant.

Existing Applicants Login- the Applicant, who have already availed the User ID and Password
can login to the system directly.

(fig. Web Screen 2)

After logging in as new applicant, the following registration screen will appear.

Applicant’s Manual-LMS Page 4

 ( fig. Web Screen 3)

Applicant has to enter the following information

• Full Name
• Mobile No
• ID Proof (Driving License, PAN, Voter ID, Passport, Adhaar) Number
• Registered for- Retailer/Wholesaler/Manufacturer
• Apply for- New License/ Registration or Renew

( fig .Web Screen 4)

After clicking on the Submit Button, the applicant will get a confirmation Code on his/her mobile
number. Then the applicant has to put that received code in the Confirmation box and click on “Final
Submit” button, which will redirect him/her to the registration screen for
Retailer/Wholesaler/Manufacturer/ Pharmacist.

Applicant’s Manual-LMS Page 5

Applicant login page (Existing Applicant):

After successful registration all the applicant will be provided with an authenticated Login Id &
Password in there registered/given mobile number to access applicant dashboard panel.

Steps:

 Launch the Web Browser

 Enter the URL http://dcodishaonline.ic.inin the URL bar
 Then click on “Enter “ button from the keyboard, it will display the home page
as shown in the fig. Web Screen 1.
 Then click on “Existing” after clicking it click on “Click here to Login” as
shown below:

( fig. Web Screen 5)

Process: Click on “Click here to Login”, Applicant will get the following screen:

( fig. Web Screen 6)

In the above figure type your log in id & password then enter the Security code as shown and click on
log in Button, applicant will get the below screen.

Applicant’s Manual-LMS Page 6

Retail Drug License Apply Process

( fig. Web Screen 7)

In this page applicant starts the Registration (Retailer) process by filling up the form. The
Name and Mobile No. fields will be prefilled. The applicant needs to fill the following information.

• Name of the firm

• Applicant Type- Proprietor/Partner/Pvt. Ltd/ Limited
• If the Application Type is other than Proprietor, then the Add more tab will be visible
where, the multiple persons detail can be entered.
• Photo is to be uploaded (within 150 KB in jpg/jpeg format)
• ID proof need to be uploaded (within 100 KB in jpg/jpeg format)
• District/ Zone and Police Station need to choosen.
• Valid E-Mail to be provided
• A security captcha
After successfully entering of the above details and pressing the Apply Button, the applicant will get
his/her User ID & Password in the given Mobile number for the further registration process.

( fig. Web Screen 8)

The Applicant need to “Proceed”, By clicking it the applicant will Directly goes to the Login Page
for Further Registration

Applicant’s Manual-LMS Page 7

Click on the “Proceed”, Applicant will get the following screen (Applicant Login Page):

( fig. Web Screen 9)

In the above figure applicant need to type login id & password received in mobile and then enter the
Security captcha as shown and click on Login Button, Applicant will get the below screen.

( fig. Web Screen 10)

1. Click on My Profile as shown in the above figure Where applicant can view his/her details
(like Mobile Number, photo etc.).
2. Click on Status as shown In the above figure where applicant view his/her application
status details(Like Physical Verification date etc).As shown in below screen:

Applicant’s Manual-LMS Page 8

 ( fig. Web Screen 11)

3. Click on update My Photo applicant can update his/her own photo by browsing it from
save file.
4. Click on update My profile applicant can update his/her Profile (Where Applicant can
change the password).
5.In Compliance option Applicant can comply to the queries of DI or LA.
6. Clicking on “New Apply”, Applicant will be ready for new registration of retailer.

( fig. Web Screen 12)

In this page applicant has to choose the Apply for License (Retailers /Restricted Retailers/
Homeopathic Retailers).

If the Applicant choose Restricted Retailers, then applicant has 2 options in Apply For License
Category (Those are 1.Other than those specified in Schedule C, C(1) & X for dealers who do not
engage the services of a qualified Person, 2.Drugs specified in Schedule C & C(1) excluding those
specified In X for dealer who do not engage the services of a qualified person) what applicant has to
choose according to License category as shown in below screen.

Applicant’s Manual-LMS Page 9

 ( fig. Web Screen 13)

If the Applicant choose Homeopathic Retailers, then applicant has one option in Apply For License
Category (1.Application for selling Homeopathic medicine by Retail), after which the applicant will
get a box to update Competent person Details, as shown in below screen

( fig. Web Screen 14)

a. In this page applicant has to give or fill the Name of the competent person, competent
persons father’s name & browse and upload applicant photo copy. In Qualification field
applicant has to choose the qualification in the drop down list(Having options B.pharma,
D.pharm, M.pharm & others).After choosing one of it a text box will come out for
Registration No. where the applicant has to give the registration no. of the competent person
as shown in below screen:

( fig. Web Screen 15)

Applicant’s Manual-LMS Page 10

 b. If the applicant chooses other in Qualification Field then a text box will come to enter the
qualification details of the competent person. And also applicant can give more than one
competent persons details by clicking Add More button, as shown in below screen:

( fig. Web Screen 16)

If the Applicant choose Retailers option, then applicant has three options in Apply For License
Category (Those are 1.Other than those specified in Schedule C, C(1) & X, 2.As specified in
Schedule C, C(1) excluding those specified In Schedule X, 3.Schedule X) what applicant has to
choose according to License category as shown in below screen.

( fig. Web Screen 17)

After choosing one of it/all of it a Pharmacist Details box will come where applicant has to Give or
Input the Pharmacist Details (Already registered Pharmacist).And after filling up all the Boxes
Applicant has to click Apply button for further Registration as shown in below screen:

( fig. Web Screen 18)

Applicant’s Manual-LMS Page 11

By Clicking on the “Apply”, Applicant will get the following screen:

( fig. Web Screen 27)

( fig. Web Screen 19)

In this page applicant has to fill all the text box fields(All the Fields are Mandatory) to go for
Further registration process .The Forms will Come According to the License Category on which the
applicant has choosen already at start. After filling all the fields the Applicant need to click the
“Save” Button, Then applicant goes to next form as shown in below screen:

Applicant’s Manual-LMS Page 12

 ( fig. Web Screen 20)

Here also applicant has to fill all the fields to go for further registration, after filling all the
field applicant has to click “Save” button. It goes to the Check list form as shown in below screen:

( fig. Web Screen 21)

Applicant’s Manual-LMS Page 13

 In this page Applicant has to Upload (Only pdf/jpg/jpeg files allowed) the photo copy of the
documents by Browsing it from save file. The Documents to be Upload by the applicant (All the
Fields are Mandatory) are the following (for Proprietor).

• Qualifying Exam Certificate

• Residence Certificate
• Id Proof
• Refrigerator Receipt
• Distributor Declaration
• Experience Certificate(If Any)
• Specimen Signature Of RP/CP
• Tenancy/House rent Agreement
• Khatian/Documentary evidence in support of Ownership of land
• Location and layout sketch map of premises
• Location and layout sketch map of premises
• Character Antecedent Verification Certificate
• Affidavit of RP/CP
• Declaration of RP/CP

After uploading all the Required Document Applicant has to Click/check the Button of Declaration
and have to click the “Save Button” to go for Further registration process as shown below.

( fig. Web Screen 22)

Applicant’s Manual-LMS Page 14

After clicking on “Save” Button a message will come, and in that page u can also Print the
application form with all the Details what the applicant has given already. As shown in below screen.

( fig. Web Screen 23)

The Applicant need to Print the Registration Form For further Registration process by clicking on
Print button. On clicking the Go To Home button Applicant goes to the Home page as shown in fig.
Web Screen 9.where Applicant can see his/her Status of registration & compliance message and the
applicant can give compliance, if any.

Applicant’s Manual-LMS Page 15

Wholesaler Drug License Apply Process

( fig. Web Screen 24)

The Process up to getting the User ID and Password is same as the process of retailer registration.
After Logging in, the applicant will get the following screen.

( fig. Web Screen 25)

i. Click on My Profile as shown in the above figure Where applicant can view his/her
details(like Mobile Number, photo etc.).

Applicant’s Manual-LMS Page 16

 ii. Click on Status as shown In the above figure where applicant view his/her application
status details(Like Physical Verification date etc).As shown in below screen:

( fig. Web Screen 26)

iii. Click on update My Photo applicant can update his/her own photo
iv. Click on update My profile applicant can update his/her Profile(Where Applicant can
change the password).
v. In Compliance option applicant can give the reply to the compliance asked for.
vi. Click on “New Apply” for New registration.

Click on the “New Apply”, Applicant will get the below screen:

( fig. Web Screen 27)

In this page applicant has to choose the Apply For License(Having options Wholesalers,
Wholesaler Motor Vehicle , Homeopathic Wholesalers).

If Applicant choose Wholesalers, then applicant will have three options in Apply For License
Category (Those are1.Other than those specified in Schedule C, C(1) & X, 2.As specified in
Schedule C, C(1) excluding those specified Schedule X, 3.Schedule X) from which the applicant can
choose according to License category as shown in below screen.

Applicant’s Manual-LMS Page 17

 ( fig. Web Screen 28)

If the Applicant will choose Wholesaler Motor Vehicle, then applicant has two options in Apply
For License Category (Those are 1.Applied for sell, store by wholesale, from a motor vehicle those
specified in Schedule(X), 2.Applied for sell , store by wholesale from a motor Vehicle in Schedule C,
C(1)) what applicant has to choose , as shown in below screen.

( fig. Web Screen 29)

If the Applicant will choose Homeopathic Wholesalers, then applicant will have one option in
Apply For License Category (1.Application for Homeopathic medicine by wholesale) which the
applicant need to choose according to License category as shown in below screen.

( fig. Web Screen 30)

After choosing one of it, Applicant has to click Apply button for further Registration process

Applicant’s Manual-LMS Page 18

 ( fig. Web Screen 31)

In this page applicant has to fill all the text box fields(All the Fields are Mandatory) to go for
further registration process .The Forms will Come According to the License Category which the
applicant has already choosen. After filling all the fields Applicant has to click the “Save” Button,
Then applicant goes to next form as shown in below screen:

Applicant’s Manual-LMS Page 19

 ( fig. Web Screen 32)

After Form-C, the Check list will appear. (Same as Retailer Checklist)

( fig. Web Screen 33)

Applicant’s Manual-LMS Page 20

 In this page Applicant has to Upload (Only pdf/jpg/jpeg files allowed) the photo copy of the
documents by Browsing it from save file. The Documents to be Upload by the applicant (All the
Fields are Mandatory) are the following (for Proprietor).

• Qualifying Exam Certificate

• Residence Certificate
• Id Proof
• Refrigerator Receipt
• Distributor Declaration
• Experience Certificate(If Any)
• Specimen Signature Of RP/CP
• Tenancy/House rent Agreement
• Khatian/Documentary evidence in support of Ownership of land
• Location and layout sketch map of premises
• Location and layout sketch map of premises
• Character Antecedent Verification Certificate
• Affidavit of RP/CP
• Declaration of RP/CP

After uploading all the Required Document Applicant has to Click/check the Button of Declaration
and have to click the “Save Button” to go for Further registration process as shown below.

( fig. Web Screen 34)

After clicking on “Save” Button a message will come, and in that page u can also Print the
application form with all the Details what the applicant has given already. As shown in below screen.

Applicant’s Manual-LMS Page 21

 ( fig. Web Screen 35)

Applicant need to Print the Registration Form For further Registration process by clicking on Print
button. On clicking Go to Home button Applicant goes to the Home page as shown in fig. Web
Screen 14, where Applicant can see his/her Status of registration & compliance messages.

Applicant’s Manual-LMS Page 22

Manufacturer License Apply Process

The Process up to getting the User ID and Password is same as the process of retailer registration.
After Logging in, the applicant will get into the profile screen where the new license can be applied.
Click on the “New Apply”, Applicant will get the below screen:

( fig. Web Screen 36)

In this page applicant has to choose the Apply For License(Having options: Allopathy,
Homeopathy, Cosmetic, Blood Bank).

If the Applicant chooses Allopathy, then applicant will have eight options in Apply For License
Category (Those are 1.Other than those specified in Schedule C, C(1) & X(OWN), 2.Spcefied in
Schedule C, C(1) & X(other than LVP & Part XB)(OWN), 3.Spcefied in Schedule X and not spcefied
in Schedule C & C(1)(OWN), 4.Specified in Schedule C & C(1) and excluding those Spcefied in Part
XB & Schedule X(OWN), 5.Other than those specified in Schedule C, C(1) & X(LOAN), 6.Specified
in Schedule C & C(1) and excluding those specified in part XB & Schedule X(LOAN), 7.Other than
those specified in Schedule C, C(1) & excluding those specified in Schedule X(REPACKING),
8.LVP), on which the applicant can choose according to License category as shown in below screen.

( fig. Web Screen 37)

If the Applicant chooses Homeopathy, then applicant will have one option in Apply For License
Category (1.OWN) which the applicant can choose , as shown in below screen.

Applicant’s Manual-LMS Page 23

 ( fig. Web Screen 38)

If the Applicant chooses Cosmetic, then applicant will have two options in Apply For License
Category (1.own, 2.Loan) on which the applicant can choose according to License category as
shown in below screen.

( fig. Web Screen 39)

If the Applicant choose Blood Bank, then applicant will have two options in Apply For License
Category (Those are1.Blood Bank Without/with BCSU, 2.Sale/Distribution of Blood Product) on
which the applicant has to choose according to License category as shown in below screen.

( fig. Web Screen 40)

After choosing one of it, Applicant has to click Apply button for further Registration process

Applicant’s Manual-LMS Page 24

 ( fig. Web Screen 41)

In this page applicant has to fill all the text box fields(All the Fields are Mandatory) to go for
Further registration process .The Forms will Come According to the License Category which the
applicant has choosen . After filling all the fields the Applicant has to click the “Save” Button,after
which he/she gets a checklist.

Applicant’s Manual-LMS Page 25

 ( fig. Web Screen 42)

In this page Applicant has to Upload (Only pdf/jpg/jpeg files are allowed) the photo copies of the
documents. The Documents to be Uploading by the applicant (All the Fields are Mandatory) are the
following (For Proprietor).

• Application Form
• Additional Information with Treasury Challan towards License Fee, Inspection Fees &
additional Items
• Proof of Identity of the applicants(Copy of Passport/Residential Certificate/Voter ID)
• Constitution of Form(Proprietorship/partnership/Pvt. Ltd comp/Public Ltd. Company/
Registered Society/Govt. Agency)
• Documents Required/(Declaration regarding proprietorship of Registered Partnership
Deed/Registered under I.G.R, Odisha/Articles of Association(Registered with book)/
Memorandum of Association)as per company Act (1956)Registered Society (Bye laws)
• Resolution Copy passed by the Board of Directors for obtaining of License. If Govt. Agency,
(Legal Authorization from Competent Higher Authority)
• Power of Attorney/Letter of authorization(wherever applicable)
• List of Drugs/Cosmetics to be manufactured with formula (Category wise)/e.g: Tablets,
Capsules, Oral, Liquid, Ointment, injections, etc.
• List & No. of Equipments/machineries/instruments/instruments provided.
• Calibration Validation certificate of Equipments wherever necessary
• Draft Levels of their drugs or cosmetics for which application is made
• Layout plan of the premises(duly signed by Applicant & Owner of House)
• Documentary Evidence in support of Ownership & Building
• House Rent Agreement in Case of Tenancy or declaration of House Owner if same as applicant
for specific Purpose

Applicant’s Manual-LMS Page 26

 • Educational Certificate of the person in charge of Manufacturing, Testing and Quality
Assurance
• Consent Letter of Person In charge of Manufacturing, Testing & Quality Assurance for their
Specific Job.
• Experience Certificate of the person In charge of Manufacturing, Testing, Quality Assurance
from where respective X Employees.
• Declaration/Affidavit of their person In charge of Manufacturing, Testing, QA regarding their
Non-Engagement elsewhere & their previous engagements in the concerned Fields
• Line Diagram of AHU (Air Handling Unit)(ACD Humidifier/filtered Air/Purified Water
Supply/Portable Water Supply/Drainage/Return Air Vent etc.
• Fire Safety measures provided (No. of fire extinguishers) Provide with their validity & other
steps taken for safety.
• Provision made for disposal of Waste water Management.
• Pollution Control Certificate (Wherever applicable).
• Consent Letter Approved Institution to carry out Test & Analysis of Manufacturing Drugs prior
to release of the batch along with the copy of Valid License/thereof where the Applicant had not
provided own Testing facilities)
• Fire Safety Certificate obtained from Fire Officer.
• Compliance of Schedule M, MI, MII, MIII)as the case may be.
• Protocol for testing in case of Patent & Proprietary medicine whenever necessary.
• Undertaking for abiding the provision laid down under the D & C Rules.(As applicable from
Time to Time).

After uploading all the Required Document Applicant has to Click/check the Button of Declaration
and have to click the “Save Button” to go for Further registration process, After clicking on “Save”
Button A message will come, and in that page u can also Print the application form with all the
Details what the applicant has given already, as shown in Below screen.

( fig. Web Screen 43)

Applicant need to Print the Registration Form For further Registration process by clicking on Print
button. On clicking Go to Home button Applicant goes to the Home page as shown in fig. Web
Screen 14, where Applicant can see his/her Status of registration & compliance messages.

Applicant’s Manual-LMS Page 27

LMS/PMIS Renewal process

In this section applicant fill up the form for the purpose of registration, and this section have four
types of registrations:

1. Online Application For Renewal of Retail Drug License

2. Online Application For Renewal of Wholesaler
3. Online Application For Renewal of Manufacturer

Online Application for Renewal of Retail/ Whole sale Drug License

After registration and submitting the OTP code, Applicant will get the following screen:

(Fig. Web Screen 44 )

The applicant need to choose the Zone and Range from the given Drop down list, after which he/she
needs to give the registration no. in the given drop down list and click on Go Button. The following
details will be extracted from database and be appeared.

(Fig. Web Screen 45 )

After proving the security code and clicking on verify button, the applicant will get the following
screen.

Applicant’s Manual-LMS Page 28

 (fig. Web Screen 46)
• The applicant need to upload his/her photo.
• Applicant need to choose the ID proof From the Drop down list having options(Driving
License, PAN card, Voter id, Passport, Adhaar Card), after choosing any of it applicant will
give the ID Proof No. following by uploading the document.
• Applicant need to fill up the ”Email” in provided text box.
• Applicant need to fill the security code given.
• The applicant will get his/her User ID & Password in the applicant given Mobile number for
the further registration process by clicking on the “Apply” button.
• By clicking on “Apply” Button, Applicant will get the following screen

( fig. Web Screen 47)

By clicking “Proceed” Button the applicant will go to the Login Page. After Logging in the profile
page will come, where the applicant can update and comply as before.(Pl refer the new registration
process). The status of Application will be shown as below.

Applicant’s Manual-LMS Page 29

 ( fig. Web Screen 48)

7. Click on update My Photo applicant can update his/her own photo by browsing it from save file.
8. Click on update My profile applicant can update his/her Profile(Where Applicant can change the
password).
9. In Compliance option applicant can reply the compliance asked for.;
10. Click on “Apply Process” Applicant has to click it For Renewal registration.

4.2.4 Click on the “Apply Process”, Applicant will get the below screen:

Applicant’s Manual-LMS Page 30

 ( fig. Web Screen 49)

By Clicking on Apply button Registration process Starts. In this page applicant has to fill all
the text box fields(All the Fields are Mandatory) to go for Further registration process .The Forms
will Come According to the License Category What the applicant has choosen already. After filling
all the fields Applicant has to click the “Save” Button, Then applicant goes to next form as shown in
below screen:

( fig. Web Screen 50)

Applicant’s Manual-LMS Page 31

 Here also applicant has to fill all the fields to go for further registration, after filling all the
field applicant has to click “Save” button. Like this when applicant fills all the Forms(According to
the License Category What the applicant has choosen) then it goes to the Check list form as shown in
below screen:

( fig. Web Screen 51)

In this page Applicant has to Upload ( Only pdf/jpg/jpeg Files allowed) the photo copy of the
documents by Browsing it from save file. The Documents to be Upload by the applicant(All the
Fields are Mandatory) are the following(For Proprietor).

• Qualifying Exam Certificate

• Residence Certificate
• Id Proof
• Refrigerator Receipt
• Distributor Declaration
• Experience Certificate(If Any)
• Specimen Signature Of RP/CP
• Tenancy/House rent Agreement
• Khatian/Documentary evidence in support of Ownership of land
• Location and layout sketch map of premises
• Location and layout sketch map of premises
• Character Antecedent Verification Certificate
• Affidavit of RP/CP
• Declaration of RP/CP

Applicant’s Manual-LMS Page 32

After uploading all the Required Document Applicant has to Click/check the Button of Declaration
and have to click the “Save Button” to go for Further registration process as shown below.:

( fig. Web Screen 52)

After clicking on “Save” Button A message will come, and in that page u can also Print the
application form with all the Details what the applicant has given already. As shown in below screen.

( fig. Web Screen 53)

Applicant need to Print the Registration Form For further Registration process by clicking on Print
button. On clicking on Go To Home button Applicant goes to the profile page.

Applicant’s Manual-LMS Page 33

Online Application for Renewal of MANUFACTURER

The Process of Applying renewal cases will be same as the process of wholesaler/retailer, up to
getting into the profile screen, after which the applicant will get the following screens in Apply
process.

( fig. Web Screen 54)

In this page applicant has to fill all the text box fields(All the Fields are Mandatory) to go for
Further registration process .The Forms will Come According to the License Category which the
applicant has chosen already. After filling all the fields Applicant need to click the “Save” Button,.
This will redirected to a checklist screen:

Applicant’s Manual-LMS Page 34

 ( fig. Web Screen 55)

In this page Applicant has to Upload (Only pdf/jpg/jpeg files allowed) the photo copy of the
documents by Browsing it from save file. The documents to be uploaded by the applicant (All the
Fields are Mandatory) are the following (For Proprietor).

• Application Form
• Additional Information with Treasury Challan towards License Fee, Inspection Fees &
additional Items
• Proof of Identity of the applicants(Copy of Passport/Residential Certificate/Voter ID)
• Constitution of Firm (Proprietorship/partnership/Pvt. Ltd comp/Public Ltd. Company/
Registered Society/Govt. Agency)
• Documents Required/(Declaration regarding proprietorship of Registered Partnership
Deed/Registered under I.G.R, Odisha/Articles of Association(Registered with book)/
Memorandum of Association)as per company Act (1956)Registered Society (Bye laws)
• Resolution Copy passed by the Board of Directors for obtaining of License. If Govt. Agency,
(Legal Authorization from Competent Higher Authority)
• Power of Attorney/Letter of authorization(wherever applicable)
• List of Drugs/Cosmetics to be manufactured with formula (Category wise)/For Ex:Tablet,
Capsules, Oral, Liquid, Ointment, lnjectable, etc.
• List & No. of Equipments/machineries/instruments/instruments provided.
• Calibration Validation certificate of Equipments wherever necessary
• Draft Levels of their drugs or cosmetics for which application is made
• Layout plan of the premises(duly signed by Applicant & Owner of House)
• Documentary Evidence in support of Ownership & Building

Applicant’s Manual-LMS Page 35

 • House Rent Agreement in Case of Tenancy or declaration of House Owner if same as
applicant for specific Purpose
• Educational Certificate of the person in charge of Manufacturing, Testing and Quality
Assurance
• Consent Letter of Person In charge of Manufacturing, Testing & Quality Assurance for their
Specific Job.
• Experience Certificate of the person In charge of Manufacturing, Testing, Quality Assurance
from where respective X Employees.
• Declaration/Affidavit of their person In charge of Manufacturing, Testing, QA regarding their
Non-Engagement elsewhere & their previous engagements in the concerned Fields
• Line Diagram of AHU (Air Handling Unit) (ACD Humidifier/filtered Air/Purified Water
Supply/Portable Water Supply/Drainage/Return Air Vent etc.
• Fire Safety measures provided (No. Of fire extinguishers) Provide with their validity & other
steps taken for safety.
• Provision made for disposal of Waste water Management.
• Pollution Control Certificate (Wherever applicable).
• Consent Letter Approved Institution to carry out Test & Analysis of Manufacturing Drugs
prior to release of the batch along with the copy of Valid License/thereof where the Applicant
had not provided own Testing facilities)
• Fire Safety Certificate obtained from Fire Officer.
• Compliance of Schedule M, MI, MII, MIII) as the case may be.
• Protocol for testing in case of Patent & Proprietary medicine whenever necessary.
• Copy of form 46 in case of new drug.

After uploading all the Required Document Applicant has to Click/check the Button of Declaration
and have to click the “Save Button” to go for further registration process. After clicking on “Save”
Button a message will come on registration of Application. It can be printed and kept. On clicking on
Go to Home button Applicant goes to the profile.

( fig. Web Screen 56 )

Applicant’s Manual-LMS Page 36