GOVERNMENT OF TELANGANA

ABSTRACT

T.S. – Drugs Control Administration, Hyderabad –Ease of Doing Business, 2017 –

Online Application process for Issue / Renewal of Licenses – Orders – Issued.
=================================================
HEALTH, MEDICAL & FAMILY WELFARE (C2) DEPARTMENT

G.O.Ms.No.103 Dated:21-6-2017
Read the following:

1) G.O.Rt. No. 233, HM&FW (C2) Dept, dt. 14-3-2017.

2) From the Director I/c, Drugs Control Administration, Hyd,
Lr. Rc. No. 17994/E/2015 -1 Dt. 06-6-2017.
***
O R D E R:

The Director, Drugs Control Administration, Hyderabad in his letter 2nd read
above, has stated that Telangana was ranked 1st in “Ease of Doing Business” in the
year 2016, our effort is to keep up the rank in 2017 also. Department of Industrial
Policy and Promotion (“DIPP”), Government of India has communicated the new
proposal on “Business Reform Action Plan 2017” and requested the following
initiatives to be taken up by Drug Control Administration to ease the process of
issuing/renewal of licenses for retail sale, wholesale and manufacturing of drugs:

1) Publish information about the procedure and a comprehensive list of

documents on the Department's website.

2) Define clear timelines mandated through the Public Service Delivery

Guarantee Act (or equivalent) legislation for approval of complete
application.
3) Design and implement a system that allows online application submission,
payment, tracking and monitoring without the need for a physical touch
point for document submission and verification and mandate that all
applications are submitted online.
4) Ensure that the system allows user to download the final signed approval
certificate from the online portal.
The system allows:

• Online submission of drug licenses application

• Online submission of documents and verification without the need for a
physical touch point
• Online payment of license fees, tracking and monitoring the progress of
application
• Allows the users to download the final signed approval certificate from the
online portal

2. It should be noted that online application for “Grant of Manufacturing

License” is accepted through the online “TS-iPASS portal” at
https://ipass.telangana.gov.in/.

3. In this connection, the Director, Drugs Control Administration, T.S.,

Hyderabad requested the Government to issue an order for the following:

1) Mandating all applications for issuing, renewals and amendments of

manufacturing & sales licenses to be submitted online from 1st July, 2017
onwards.
2) Defining clear timelines for the different online services offered by Drug
Control Administration as below:
*Maximum Response Time
S.No Item of Works Targeted
(In No. of Working Days)
Grant / Renewal of manufacturing licenses
1 (excluding LVP, Sera, Vaccines, r-DNA derived 14
drugs)
[P.T.O]
 :: 2 ::

Grant / Renewal of Sales (Retail/Wholesale)

2 14
Licenses
10
Grant / Renewal of Approval for Approved
3 (after joint inspection of the firm
Laboratories
with CDSCO)
4 Approval of Technical Staff 10
Recommending for Grant/Renewal of
Licenses to Central Licensing Authority, 10
5 Delhiwith respect to Vaccines and sera; Large (after joint inspection of the firm
VolumeParenterals, r-DNA Derived Drugs, and with CDSCO)
Blood Banks
6 Effecting Changes in Existing Licenses 10

4. The Director, Drugs Control Administration, T.S., Hyderabad has further

stated that, Final License will be issued by the licensing authority within the defined
working days of the application submission, provided all the documents, forms,
application are in order and after verifying the correctness of the statements made
by the applicant as per Rule 65A & Rule 84 AA of Drugs & Cosmetics act, 1940 and
rules made their under.

5. The Director, Drugs Control Administration, Hyderabad has also stated

that, a well-defined online application procedure (attached as Annexure I),
inspection procedure for sales and manufacturing licenses (attached as Annexure
II), comprehensive checklist (attached as Annexure III) and Fees Details (attached
as Annexure IV) for different applications are also uploaded on the Department’s
website. The applications shall be made through departmental online portal
www.dca.telangana.gov.in.

6. After careful consideration of the matter, the Government hereby agreed

the proposal of Director, DCA, T.S., Hyderabad and accordingly, permit the
Director, DCA, mandating all applications for issuing, renewals and amendments of
licenses to be submitted online from 1st July, 2017 onwards and for manufacturing
& sales defining clear timelines for the different online services offered by Drug
Control Administration as below:

*Maximum Response Time

S.No Item of Works Targeted
(In No. of Working Days)
Grant / Renewal of manufacturing licenses
1 (excluding LVP, Sera, Vaccines, r-DNA derived 14
drugs)
Grant / Renewal of Sales (Retail/Wholesale) 14
2
Licenses
10
Grant / Renewal of Approval for Approved
3 (after joint inspection of the firm
Laboratories
with CDSCO)
4 Approval of Technical Staff 10
Recommending for Grant/Renewal of
Licenses to Central Licensing Authority, Delhi 10
5 with respect to Vaccines and sera; Large (after joint inspection of the firm
Volume Parenterals, r-DNA Derived Drugs, and with CDSCO)
Blood Banks
6 Effecting Changes in Existing Licenses 10

7. The Director, Drugs Control Administration, T.S., Hyderabad shall take

further follow- up action in the matter.

(BY ORDER AND IN THE NAME OF THE GOVERNOR OF TELANGANA)

RAJESHWAR TIWARI
SPECIAL CHIEF SECRETARY TO GOVERNMENT
To
The Director (I/c), Drugs Control Administration, T.S., Hyderabad
 :: 3 ::
Copy to:
The Pay & Accounts Officer, Hyderabad.
The Principal Accountant General, T.S., Hyderabad.
The State Informatics Officer, NIC, BRK Bhawan, Hyderabad
The HM & FW (F) Department.
The Fin (EBS.V) Dept.
The OSD to C.M.
The OSD to Minister (M&H)
The P.S. to Spl. C.S. to Govt, HM&FW Dept.
SC/SF.

// FORWARDED :: BY ORDER //

SECTION OFFICER
 ANNEXURE TO G.O.MS. NO. 103, HM&FW (C2) DEPT,
DATED. 21-6-2017

Annexure I

(Online Application Procedure)

Online
Registration
Visit Drug Control Administration website "www.dca.telangana.gov.in" And select the tab
"Online Drug Licensing System"

Select "Apply Online" - First Time Applicants need to Register Under "New Users" by
filing in the details including the license information, and obtain a User ID and password
for login.

Confirmation to New Users/Applicants will be sent to their mail-id/ through SMS on the
registered mobile number. Onceregistered, Applicant can now Log-in to proceed with the
Filing online application.
Application
, Uploading
Documents Select the service category and type of License from the drop down list. For e.g - Under
Sales License - Retail or Wholesale, then the type i.e Grant / Renewal / Amendment
and Fees
Payment

Checklist / Documents to be submitted for each services are available under "How to
Apply" tab at home page. Checklist as per the License selected is also provided during the
application process. Applicant need to prepare the soft copies of all the documents required
for desired licences.

Applicant need to fill in the - firm details, constitution details, RP/CP and other required
information, and upload documents as per the checklist. (Application can be saved and
pages can be revisited to make any changes before submission)

License Fee to be Paid and Application Submitted (Acknowledgement of Fee Payment &
Application Submission Confirmation will be sent to the Applicant's registerd maid ID /
through SMS

Scrutiny of the application/documents by DCA Official, clarification / query (if any) will be
communicated to the applicant through mail or SMS alert. Alternatively, applicant can track
the status on their login dashboard. Applicant can reply to the queries online.
Application
Scrutiny & Inspection of the Unit / Premises by DCA Official (Applicant will be informed in advance).
Inspection Submission of Inspection Report to Senior Officials.
by DCA
Official Once approved, Applicant can download the Licnese from the Online Portal after
Signing-In. A copy of the License also be sent to the registered e-mail ID.

RAJESHWAR TIWARI
SPECIAL CHIEF SECRETARY TO GOVERNMENT

// FORWARDED :: BY ORDER//

SECTION OFFICER
 ANNEXURE TO G.O.MS. NO. 103, HM&FW (C2) DEPT,
DATED. 21-6-2017

Annexure II
(Inspection Procedure for Manufacturing & Sales License’s Application)

a) The inspector shall verify the following aspects at the time of inspection
of the facility for grant/ renewal of manufacturing licenses:
¾ Production area of the facility to verify the uni-flow of various
operations carried out in the respective modules.
¾ Design of the facility for proper segregation of areas meant for
various activities.
¾ Installation of the required equipment along with the qualification
status.
¾ Purified water generation and distribution system and the status of
validation.
¾ Air Handling Units validations along with the zoning classification
(air classification), pressure differentials in various areas of the
production modules.
¾ Material movement and men movement in the production areas to
ensure regarding the no chance of cross contamination/ mix up.
¾ Quality Control laboratory to verify the instruments & calibration
status (analytical capabilities of firm).
¾ Warehousing facilities of the firm for raw materials and finished
products.
¾ Required capabilities of Technical Staff for manufacturing and
testing.
¾ To verify the compliance of the facility with the provisions of Good
Manufacturing Practices as per Schedule M (general requirements
and specific requirements) and Good Laboratory Practices as per
Schedule L-1 of Drugs and Cosmetics Act 1940 and Rules made
thereunder.
b) The inspector shall verify the following aspects at the time of inspection
of the outlet/premises for grant/ renewal of sales licencesas per Rule
64& 65 of Drugs and Cosmetics Act 1940 and Rules made thereunder:
¾ Area of the outlet to verify the compliance with the statutory limits.
¾ Capabilities to provide good storage conditions for the drugs stocked
in the premises such as racks, refrigerator (for cold storage drugs)
etc.

RAJESHWAR TIWARI
SPECIAL CHIEF SECRETARY TO GOVERNMENT

// FORWARDED :: BY ORDER//

SECTION OFFICER
 ANNEXURE TO G.O.MS. NO. 103, HM&FW (C2) DEPT,
DATED. 21-6-2017

Annexure III
(CHECKLIST)
MANUFACTURING LICENSE
GRANT
FOR GRANT OF LICENCES IN FORM-25, 25-B (repacking), 28, 28D
(LVP, Sera, Vaccines, r-DNA derived drugs), 32
1. Application (statutory) in form-24/ 27/ 31/ 27D/ 24B
Duly signed by the Proprietor / Managing Partner / Managing Director/
Person declared as responsible under Sec.34 / Person Authorized by the
Board of Directors accompanied by Company Board Resolution.
2. Declaration of the Proprietor / Partners / Directors etc. in Affidavit (as
per format) & List of Directors downloaded from MCA website signed
by Company Secretary / Managing Director (In case of Company).
3. Partnership deed (In case of Partnership firms).
4. Self attested Copy of Aadhar card/Passport/Electoral card as proof of
residential address of the responsible person as mentioned in the
Affidavit at Sl.No. 2.
5. Rent / Lease deed in case of Rental premises.
6. Declaration of the ownership of the premises if premises owned by the
applicant firm or Company with the documentary evidence of ownership
like Registered sale deed etc and or proof of allotment of the site or
building along with latest property tax receipt.
7. Plan and layout of the premises showing the installation of Machinery
and Equipment, preferably a Blue Print approved by Licensed Engineer
and signed by the applicant who signed in the statutory form.
8. Detailed list of Manufacturing and Analytical Equipment.
9. Application for approval of Technical Staff in the prescribed format with
enclosures of consent letter, copies of qualification certificates,
experience certificates of proposed technical staff along with earlier
approvals, if any, appointment order of the Technical staff.
10. Permission obtained from the Municipal Authorities / Panchayat
authorities / Certificate in conformity with Factories Act for construction
and starting the Unit & Permission from T.S. Pollution Control Board
clearance of the area for setting up the manufacturing facility.
11. Form-46/ Form-46A from Drugs Controller General (India), New Delhi
in case of new drugs (Either Bulk drug or Formulation) – New Drugs as
defined under Rule 122 E of Drugs and Cosmetics Act and Rules made
there under.

Documents to be submitted at the time of inspection of the firm for

verification:
Site Master File as per Para 29 of Part I of Schedule M of Drugs and Cosmetics
Act, 1940 and rules made there under.
RENEWAL
FOR RENEWAL OF LICENCES IN FORM-25, 25-B (repacking), 28,28D
(LVP, Sera, Vaccines, r-DNA derived drugs), 32

1. Application (statutory) in form-24/ 27/ 31/ 27D/ 24B duly signed by the
Proprietor / Managing Partner / Managing Director/ Person declared as
responsible under Sec.34 / Person Authorized by the Board of Directors
accompanied by Company Board Resolution.
2. Copies of drug licences held by the firm.
3. Declaration of the Proprietor / Partners / Directors etc. in Affidavit (as
per format) and list of Directors downloaded from MCA website signed
by Company Secretary / Managing Director (In case of Company).
4. Consent letters of approved technical staff.
Documents to be submitted at the time of inspection of the firm for
verification:

Production particulars of the drugs manufactured during the previous

licensing period.

LOAN LICENSES
GRANT
FOR GRANT OF LOAN LICENCES IN FORM 25A, 28A, 28DA & 32A.

1. Application (statutory) in form-24A/ 27A / 31A/27DA.

Duly signed by the Proprietor / Managing Partner / Managing Director/
Person declared as responsible under Sec.34 / Person Authorized by the
Board of Directors accompanied by Company Board Resolution.
2. Partnership Deed in case of partnership firm.
3. Declaration of the Proprietor / Partners / Directors etc. in Affidavit (In
Prescribed Format) and List of Directors downloaded from MCA
website signed by Company Secretary / Managing Director (In case of
Company).
4. Self attested Copy of Aadhar card/Passport/Electoral card as proof of
residential address of the responsible person as mentioned in the
Affidavit at Sl.No. 2.
5. Letter addressed to the parent firm/Company requesting for consent for
availing the manufacturing facilities.

6. Consent letter from the parent firm/Company enclosed with statement of

spare capacity

7. Copy of licenses of the parent firm/Company with copy of approved list

of the products.( attested by the M.D. / Director of Parent unit/Company)

8. Consent letter of the Technical Staff ( Which contain the name of the
applicant Unit, and the products ) – (in prescribed Format)

9. Copy of the Drug licenses in Form 20B, 21B of the applicant.

 RENEWAL
FOR RENEWAL OF LOAN LICENCES IN FORM 25A, 28A 28DA &
32A.
1. Application (statutory) in form-24A/ 27A / 31A/27DA.
2. Duly signed by the Proprietor / Managing Partner / Managing Director/
Person declared as responsible under Sec.34 / Person Authorized by the
Board of Directors accompanied by Company Board Resolution.

3. Copies of drug licences held by the firm.

4. Declaration of the Proprietor / Partners / Directors etc. in Affidavit (In
prescribed format) and List of Directors downloaded from MCA website
signed by Company Secretary / Managing Director (In case of
Company).
5. Consent letters of approved technical staff of parent firm.
Documents to be submitted at the time of inspection of the firm for
verification:
Production particulars of the drugs manufactured during the previous
licensing period.

REQUIREMENTS FOR ISSUE OF DUPLICATE LIENCE

1. Covering letter indicating the reasons for application for duplicate
licence.
2. Copy of Manufacturing Licence.

DOCUMENTS FOR ISSUE OF CHANGE IN DIRECTORS OF THE FIRM

(INCLUSION OR DELETION OR CHANGE IN DESIGNATION)
1. Covering letter indicating the details of change.
2. Copy of Manufacturing Licence.
3. Revised list of Directors signed by the firm’s director.
4. List of Directors downloaded from MCA website signed by Company
Secretary / Managing Director (In case of Company).
5. Form 32/ Form DIR-12 for inclusion or deletion or change in designation
of the director.

REQUIREMENTS FOR ISSUE OF CHANGE IN NAME OR STATUS OF

THE COMPANY/FIRM.
1. Covering letter indicating the details of change.
2. Copy of Manufacturing Licence.
3. Certificate issued by the Registrar of Companies.
TEST LICENSE
GRANT
FOR GRANT OFTEST LICENCE IN FORM-29

1. Application (Statutory) in Form - 30 (duly signed or counter signed by

the Head of the institution/ Director of the firm or Company)

2. Partnership deed / List of Directors downloaded from MCA website

signed by Company Secretary / Managing Director (In case of
Company). (only for the grant of first test licence on the applied
premises)

3. Rent / Lease deed in case of Rental premises. (only for the grant of first
test licence on the applied premises)
4. Declaration of the ownership of the premises if premises owned by the
applicant firm or Company with the documentary evidence of ownership
like Registered sale deed etc and or proof of allotment of the site or
building along with latest property tax receipt. (only for the grant of first
test licence on the applied premises).
5. Plan and layout of the premises showing the installation of Machinery
and Equipment preferably a Blue Print approved by Licensed Engineer
and signed by the applicant who signed in the statutory form. (only for
the grant of first test licence on the applied premises)
6. Self attested Photo copy of Aadhar card/Passport/Electoral card for
address Proof of Managing Director / Partners/ Proprietor. (only for the
grant of first test licence on the applied premises)

7. List of Manufacturing and analytical equipment. (only for the grant of

first test licence on the applied premises)

8. NOC from CDSCO for ‘New Drugs’ under Rule 122E of Drugs and
Cosmetics Act and Rules made thereunder

Bulk Drugs/Formulations
i. Brief Manufacturing procedure of each product
ii. Flow Chart with structural Formula of reactions (for bulk drugs) per
Master Formula record and specifications & analytical procedure of
applied products with in-house specification claim.
iii. Copies of monographs for drugs with pharmacopoeial specifications
other than IP.

RENEWAL
FOR RENEWAL OFTEST LICENCE IN FORM-29
1. Application (Statutory) in Form - 30 (duly signed or counter signed by
the Head of the institution/ Director of the firm or Company)
2. Copy of Form-29 issued earlier for the applied drugs.
3. Reconciliation particulars of the drugs manufactured during the previous
licensing period under earlier Form-29 issued.
 APPROVAL OF TESTING LABORATORY
GRANT
1. Application (statutory) in Form-36.duly signed by the Proprietor /
Managing Partner / Managing Director/ Person declared as responsible
under Sec.34 / Person Authorized by the Board of Directors
accompanied by Company Board Resolution with
2. Partnership Deed in case of partnership firm.

3. Declaration of the Proprietor / Partners / Directors etc. in Affidavit (as

per format) & List of Directors downloaded from MCA website signed
by Company Secretary / Managing Director (In case of Company).

4. Self attested Copy of Aadhar card/Passport/Electoral card as proof of

residential address of the responsible person as mentioned in the
Affidavit at Sl.No. 2.
5. Rent / Lease deed in case of Rental premises
6. Declaration of the ownership of the premises if premises owned by the
applicant firm or Company with the documentary evidence of ownership
like Registered sale deed etc and or proof of allotment of the site or
building along with latest property tax receipt.

7. Plan and layout of the premises showing the installation of Machinery

and Equipment, preferably a Blue Print approved by Licensed Engineer
and signed by the applicant who signed in the statutory form.
8. Detailed list of Analytical Equipment.
9. Application for approval of Technical Staff in the prescribed format with
enclosures of consent letter, copies of qualification certificates,
experience certificates of proposed technical staff along with earlier
approvals, if any, appointment order of the Technical staff.
RENEWAL
1. Application (statutory) in Form-36.
Duly signed by the Proprietor / Managing Partner / Managing Director/
Person declared as responsible under Sec.34 / Person Authorized by the
Board of Directors accompanied by Company Board Resolution with
2. Copies of drug licences held by the firm.

3. Declaration of the Proprietor / Partners / Directors etc. in Affidavit (as

per format)

4. List of Directors downloaded from MCA website signed by Company

Secretary / Managing Director (In case of Company).
5. Consent letters of approved technical staff.

APPROVAL/DELETION OF TECHNICAL STAFF

GRANT
1. List & details of the technical staff to be approved.
2. Details of the Technical Staff for approval in prescribed format
(application)
3. Consent of Technical Staff employed in the firm in the prescribed form.
4. Copies of self attested Educational Qualification Certificates &
Experience Certificates in the relevant field
5. Copy of Relieving Certificate from the previous employer, attested by
the applicant firm.
 6. Copy of Appointment and acceptance letters from the
employer/applicant firm.

7. *Copy of previous approval of the staff member proposed for deletion.

8. *Relieving letter issued by the firm to the staff member proposed for
deletion.

*Documents at Sl.No. 7 & 8 are for applications meant for deletion of technical
Staff.
SALES - RETAIL
GRANT
CHECKLIST FOR GRANT / CHANGE OF PREMISES OF RETAIL
LICENCE FROM-20, 21 (RETAIL)
1. Statutory form – 19 for licenses in form (20,21).
2. Declaration by the proprietor / Partner / Director / Competent Persons /
Regd. Pharmacist with proof of residential address (Present and
Permanent) for proof of residential address – Aadhar Card, Pass Port,
Driving License, Voter ID.

3. Partnership deed in case of partnership firm/ List of Directors

downloaded from MCA website signed by Company Secretary /
Managing Director (In case of Company).

4. In case of Company an Affidavit under Section 34 of Drugs and

Cosmetics Act, 1940 on Rs.20/- stamp paper along with copy of its board
resolution to this effect signed by one of the Directors of the
Company(In prescribed proforma).

5. Special declaration by Registered Pharmacist on Rs.20/- Non-Judicial

stamp paper(In prescribed proforma).

6. Self attested copy of Registered Pharmacist certificate (renewal up to

date) affixed with latest original photograph and signature of the
candidate / original to be produced to the Drugs Inspector at the time of
inspection for endorsement.

7. Plan of the premises indicating the carpet area (specifying length and
breadth in meters and area in Sq.m) by the Licensed Draftsman / Planner
along with the signature of Building owner and the applicant (Prop/
partners / Authorized signatory / Managing Director, etc,.) in a legal size.

8. Declaration of building owner(s) along with his/her/their Photograph(s)

(In prescribed proforma). Self attested photocopy of the document
showing the proof of ownership of the building owner for the premises to
be licensed (E.C / any other legal document showing the present
ownership.
SALES - WHOLESALE
GRANT
CHECKLIST FOR GRANT / CHANGE OF PREMISES OF
WHOLESALE
LICENCE
1. Statutory form – 19 for licenses in form (20B,21B).
2. Declaration by the proprietor / Partner / Director / Competent Persons /
Regd. Pharmacist with proof of residential address (Present and
Permanent) for proof of residential address – Aadhar Card, Pass Port,
Voter ID(In prescribed proforma).

3. Partnership deed in case of partnership firm / List of Directors

downloaded from MCA website signed by Company Secretary /
Managing Director (In case of Company).

4. In case of Company an Affidavit under Section 34 of Drugs and

Cosmetics Act, 1940 on Rs.20/- stamp paper along with copy of its board
resolution to this effect signed by one of the Directors of the Company
(In prescribed proforma).

5. Special declaration by Registered Pharmacist on Rs.20/- Non-Judicial

stamp paper (in case of Registered Pharmacist is appointed as C.P) (In
prescribed proforma).

6. Self attested copy of Registered Pharmacist certificate (renewal up to

date) affixed with latest original photograph and signature of the
candidate (in case Registered Pharmacist is appointed as C.P) / SSC /
degree certificate (in case of candidate other than R.P).

7. Plan of the premises indicating the carpet area (specifying length and
breadth in meters and area in Sq.m) by the Licensed Draftsman / Planner
along with the signature of Building owner and the applicant (Prop/
partners / Authorized signatory / Managing Director, etc,.) in a legal size.

8. Declaration of building owner(s) along with his/her/their Photograph(s).

In prescribed proforma. Self attested photocopy of the document
showing the proof of ownership of the building owner for the premises to
be licensed (E.C / any other legal document showing the present
ownership.

9. Experience certificate of competent person.

SALES –RETAIL & WHOLESALE

RENEWAL
CHECKLIST FOR RENEWAL OF LICENSES (RETAIL /
WHOLESALE)

1. Statutory form – 19.

2. Declaration by the proprietor / Partner / Director / Competent Persons /
Regd. Pharmacist (In prescribed proforma).
3. Affidavit by R.P / C.P on Rs.20/- stamp paper. In prescribed proforma.
4. Self attested copy of Registered Pharmacist certificate (renewal up to
date) affixed with latest original photograph and signature of the
candidate.
5. Drug licence.
6. List of Directors downloaded from MCA website signed by Company
Secretary / Managing Director (In case of Company).

7. In case of Company an Affidavit under Section 34 of Drugs and

Cosmetics Act, 1940 on Rs.20/- stamp paper along with copy of its board
resolution to this effect signed one of the Directors of the Company (In
prescribed proforma).
HOUSE HOLD REMEDIES LICENSE (RESTRICTED LICENSE)
GRANT
1. Statutory form – 19A for licenses in form – 20A, 21A.
2. Declaration by the Proprietor / Partner / Director with proof of
residential address (Present and Permanent) (In prescribed proforma).
3. Partnership deed in case of partnership firm.
4. Plan of the premises indicating the carpet area (specifying length and
breadth in meters and area in Sq.m) by the Licensed Draftsman / Planner
along with the signature of Building owner and the applicant (Prop/
partners / Authorized signatory / Managing Director, etc,.) in a legal size.

5. Declaration of the building owner(s) (In prescribed proforma).

6. List of Directors downloaded from MCA website signed by Company
Secretary / Managing Director (In case of Company).

7. In case of Company an Affidavit under Section 34 of Drugs and

Cosmetics Act, 1940 on Rs.20/- stamp paper along with copy of its board
resolution to this effect signed by one of the Directors of the Company.
In prescribed proforma.

8. Details of the names of the dealers and their license numbers from whom
the applicant will purchase the drugs for sale.

9. Self attested photocopy of the document showing the proof of ownership

of the building owner for the premises to be licensed (E.C / any other
legal document showing the present ownership.

RENEWAL
1. Statutory form – 19A.
2. Declaration by the proprietor / Partner / Director / Competent Persons
/Regd. Pharmacist. In prescribed proforma.

3. Drug licence.
4. List of Directors downloaded from MCA website signed by Company
Secretary/ Managing Director (In case of company).

5. In case of company an Affidavit under Section 34 of Drugs and

Cosmetics Act, 1940 on Rs.20/- stamp paper along with copy of its board
resolution to this effect signed one of the Directors of the company. In
prescribed proforma.

6. Details of the names of the dealers and their license numbers from whom
the applicant will purchase the drugs for sale.

CHANGE OF CONSTITUTION
1. Statutory form – 19.
2. Declaration by the Partners with proof of residential address (Present and
Permanent)(In prescribed proforma).
3. Dissolution cum partnership deed in case of partnership firm.
4. Special declaration by Registered Pharmacist on Rs.20/- Non-Judicial
stamp paper, if being a part of the new constitution or otherwise(In
prescribed proforma).
 5. Self attested copy of Registered Pharmacist certificate (renewal up to
date) affixed with latest original photograph and signature of the
candidate.

6. Declaration of competent person if being the part of the new constitution

or otherwise (In prescribed proforma).

7. Plan of the premises indicating the carpet area (specifying length and
breadth in meters and area in Sq.m) by the licensed draftman / planner
along with the signature of Building owner and the applicant (Partners).

8. Declaration of building owner(s) along with his/her/their Photograph(s).

In prescribed proforma.

9. Self attested photo copy of the document showing the proof of

ownership of the building owner for the premises to be licensed (EC/any
other legal document showing the present ownership of the building
premises).

10. Original drug license.

11. List of Directors downloaded from MCA website signed by Company
Secretary / Managing Director (In case of Company).

12. In case of Company an Affidavit under Section 34 of Drugs and

Cosmetics Act, 1940 on Rs.20/- stamp paper along with copy of its board
resolution to this effect signed by one of the Directors of the
Company(In prescribed proforma).

CHANGE OF PHARMACIST
1. Statutory form – 19.
2. Declaration by the Registered Pharmacist with proof of residential
address (Present and Permanent)(In prescribed proforma).
3. Special declaration by Registered Pharmacist on Rs.20/- Non-Judicial
stamp paper (In prescribed proforma).

4. Self attested copy of Registered Pharmacist certificate (renewal up to

date) affixed with latest original photograph and signature of the
candidate, original certificate shall be produced before Drugs Inspector
for endorsement.
5. Drug licence.

6. List of Directors downloaded from MCA website signed by Company

Secretary / Managing Director (In case of Company).

7. In case of Company an Affidavit under Section 34 of Drugs and

Cosmetics Act, 1940 on Rs.20/- stamp paper along with copy of its board
resolution to this effect signed by one of the Directors of the
Company(In prescribed proforma).

ISSUE OF DUPLICATE LICENSE

1. Covering letter indicating the reasons for application for duplicate
licence.
2. Copy of sales licence
// FORWARDED :: BY ORDER //

SECTION OFFICER
 ANNEXURE TO G.O.MS. NO. 103, HM&FW (C2) DEPT,
DATED. 21-6-2017

Annexure IV
(FEE Details in Rs)
APPLICATION FEES STRUCTURE – MANUFACTURING LICENCES

Grant Application Renewal Application Late fee Duplicate

Application Licence
Licence Inspection Licence Inspection per Licence
Form Form
Fees Fees Fees Fees month fee
24 25 6000 1500 6000 1500 1000 1000
24A 25A 6000 1500 6000 1500 1000 1000
24B 25B 500 200 500 200 250 1000
24F 25F 6000 1500 6000 1500 1500 1000
27 28 6000 1500 6000 1500 1000 1000
27A 28A 6000 1500 6000 1500 1000 1000
27C 28C 6000 1500 6000 1500 1000 1000
27D 28D 6000 1500 6000 1500 1000 1000
27DA 28DA 6000 1500 6000 1500 1000 1000
27F 28F 6000 1500 6000 1500 1000 1000
30 29 250

31 32 2500 1000 2500 1000 400 250

31A 32A 2500 1000 2500 1000 400 250

37(Sch
36 - 6000 - 6000 1000 -
C& C1)
37(Other
36 than - 1500 - 1500 1000 -
C&C1)

APPLICATION FEES STRUCTURE – SALES LICENCE

Renewal
Application Licence Grant Application Late fee per Duplicate
Application
Form Form month Licence fee
Licence Fees Licence Fees
19 20B 1500 1500 500 150
19 21B 1500 1500 500 150
19 20 1500 1500 500 150
19 21 1500 1500 500 150
19C 20F 500 500 250 150
19C 20G 500 500 250 150
20BB,
19AA 500 500 250 150
21BB
19A 20A 500 500 200 150

// FORWARDED :: BY ORDER //

SECTION OFFICER