DRUGS CONTROL ORGANISATION

Medical & Health Department, Swasthya Bhawan, Tilak Marg Jaipur

Email address- drugcontrolraj@gmail.com Phone - 01412221760

Check List for documents to be submitted for

Grant of Manufacturing Licences.

(1) Application on prescribed form as per following table along with requisite fees given in
the same table , to be deposited in Bank through treasury challan duly attested by the
office in Head-
0210- Medical & public Health
04- Public Health
800- Other receipt
(02) Miscellaneous receipt
Application Type of License License & inspection Fee
Form 24 Drugs other than those specified in Rs 6000 +Rs 1500
Schedule C and C (1)
Form 27 Drugs those are specified in Schedule C Rs 6000 +Rs 1500
and C (1) excluding Part X-B and
Schedule X.

(2) Declaration of Proprietor/ Partners/ Director(s)/ Managing Director on Paper duly self
attested.
(3) List of all the Partners/ Directors with age & complete postal & residential address.
(4) Specific Power of attorney in favor of Authorised Signatory for submitting Application
on behalf of the Company on Rs 100/= Non-judicial Stamp paper duly attested by Notary
Public.
(5) Declaration of Manufacturing Chemist & Analytical Chemist and Quality Assurance
Personnel on paper duly self attested.
(6) Self attested Photostat Copies of qualification, experience and approval certificates of
Manufacturing Chemist.& Analytical Chemist and Quality Assurance Personnel
(7) Original & Attested copies of Registration issued by Pharmacy Council in the name of
Manufacturing Chemist &/or Analytical Chemists. ( If any)
(8) Site Master File duly signed.
(9) Section wise list of Plant and machineries, AHU’s, water system, analytical instruments,
apparatus for Quality Control.
(10) Registration from District Industries Center.
(11) Consent to establish & consent to operate from Rajasthan State Pollution Control Board.
(12) List of Reference books and literature provided.
(13) Document pertaining to ownership for the proposed site of the unit & documents in its
support.
(14) Attested copies of partnership deed / Memorandum & article of Association.
(15) Section wise blue print of location of plant and machineries & site plan.
(16) Consent letter from government approved laboratory for sophisticated tests
 FORM 24

[See Rule 69]

Application for the grant of or renewal of a licence to manufacture for sale 1[or for
distribution of] drugs other than those specified in 2[Schedule C, C(1) and X].

1. I/We ……………………………………, of ……………..… hereby apply for the

grant/renewal of a licence to manufacture on the premises situated at
………………… the following drugs being drugs other than those specified in
2
[Schedule C, C(1) and X] to the Drugs and Cosmetics Rules, 1945.

2. Names of drugs categorized according to Schedule M.

3. Names, qualifications and experience of technical staff employed for manufacture

and testing.

4. A fee of rupees ……………………... has been credited to the Government under

the head of account ………………………..

Date ………….. Signature ……………..

Note- The application should be accompanied by a plan of the premises.

 FORM 25
[See Rule 70]
13
Licence of manufacture for sale [or for distribution] of drugs other than those specified in
14
[Schedule C, C(1) and X].

Number of licence and date of issue …………………………

1. ……………………………………………..… is hereby licensed to manufacture
the following categories of drugs being drugs other than those specified in
14
[Schedule C, C(1) and X] to the Drugs and Cosmetics Rules, 1945, on the
premises situated at …………… under the direction and supervision of the
following 15[competent technical staff]:
(a) 15[Competent technical staff] (Names).
(b) Name of Drugs (each item to be separately specified) ……………
2. The licence authorizes the sale by way of wholesale dealing and storage for sale by
the licensee of the drugs manufactured under the licence, subject to the conditions
applicable to licence for sale.
3. The licence shall be in force from ………………. to …………….
4. The licence is subject to the conditions stated below and to such other conditions
as may be specified in the rules for the time being in force under the Drugs and
Cosmetics Act, 1940.

Date ………….. Signature ……….……..

Designation ……….…...
16
[*Licensing Authority
*Central Licence Approving Authority.
*Delete whichever is not applicable.]
Conditions of Licence
1. This licence and any certificate or renewal in force shall be kept on the approved
premises and shall be produced at the request of an Inspector appointed under the Drugs
and Cosmetics Act, 1940.
2. Any change in the [competent technical staff]17 named in the licence shall be forthwith
reported to the Licensing Authority.
3. If the licensee wants to manufacture for sale additional items of drugs not included above
he should apply to the Licensing Authority for the necessary endorsement as provided in
Rule 69(5). This licence will be deemed to extend to the categories so endorsed.
18
4. [* * *]
5. The licensee shall inform the Licensing Authority in writing in the event of any change in
the constitution of the firm operating under the licence. Where any change in the
constitution of the firm takes place, the current licence shall be deemed to be valid for a
miximum period of three months from the date on which the change takes place unless, in
the meantime, a fresh licence has been taken from the Licensing Authority in the name of
the firm with the changed constitution.
 FORM 27
[See Rule 75]
Application for grant or renewal of a licence to manufacture for sale 61[or for distribution of]
drugs specified in Schedule C and C(1) 62[excluding those specified in 63[Part XB and]
Schedule X].

1. I/We ………..…… hereby apply for the grant/renewal of a licence to

manufacture on the premises situated at ..……..…… the under mentioned
59
drugs, being drugs specified in Schedule C and C(1), [excluding those
specified in 60[Part XB and] Schedule X] to the Drugs and Cosmetics Rules,
1945.
Name(s) of drugs.
(each item to be separately specified).

2. The names, qualifications and experience of the expert staff responsible for the
manufacture and testing of the above-mentioned drugs:
a) Name(s) of staff responsible for test ………………………
b) Name(s) of staff responsible for manufacture …………..…

3. The premises and plan are ready for inspection/will be ready for inspection on ..
….
4. A fee of rupees ……………………... and an inspection fee of
rupees…………….. has been credited to the Government under the head of
Account …………………

Date ………….. Signature ……………..

Designation…………...
 FORM 28
[See Rule 76]
Licence to manufacture for sale 72[or for distribution of] drugs specified in Schedule C and
C(1) 73[excluding those specified in Schedule X].

Number of licence and date of issue …………………………

1. ……………………………………………..… is hereby licensed to manufacture at
the premises situated at the …………………. the following drugs, being drugs
specified in 70[excluding those specified in Schedule X] to the Drugs and
Cosmetics Rules, 1945.
Name of drugs ………………
2. Names of approved 74[competent technical staff] …………………..
3. The licence authorizes the sale by way of wholesale dealing and storage for sale by
the licensee of the drugs manufactured under the licence subject to the condition
applicable to licences for sale.
4. The licence will be in force from ……………… to ………………
5. The is subject to the conditions stated below and to such other conditions as may
be specified in the Rules for the time being in force under the Drugs and Cosmetics
Act, 1940.

Date of issue ………….. Signature ……….……..

Designation ……….…...
[*Licensing Authority
*Central Licence Approving Authority.
*Delete whichever is not applicable.]
Conditions of Licence
1. This licence and any certificate or renewal in force shall be kept on the approved
premises and shall be produced at the request of an Inspector appointed under the Drugs
and Cosmetics Act, 1940.
2. If the licensee wishes to undertake during the currency of the licence the manufacture of
any drug specified in Schedule C and C(1) [excluding those specified in Sch. X] not
included above, he should apply to the Licensing Authority for the necessary
endorsement as provided in Rule 75(3). This licence will be deemed to extend to the
categories so endorsed.
3. Any change in the [competent technical staff] shall be forthwith reported to the Licensing
Authority.
4. [* * *]
5. The licensee shall inform the Licensing Authority in writing in the event of any change in
the constitution of the firm operating under the licence. Where any change in the
constitution of the firm takes place, the current licence shall be deemed to be valid for a
miximum period of three months from the date on which the change takes place unless, in
the meantime, a fresh licence has been taken from the Licensing Authority in the name of
the firm with the changed constitution.
 Category wise applied Product Permissions details in no’s.
Licence Form Section Total Number of Number beyond 10
Products Applied products
Tablet
Capsule
Oral Liquid
Form-25
External Preparation
other than Schedule C
Powder
& C1 Category
Pessaries and
Suppositories
Inhalers and vitrallae
Tablet
Capsule
Oral Liquid
External Preparation
Form-28
Powder
Schedule C & C1
Parenteral Preparation
Category
Ophthalmic
Preparation
Pessartes and
Suppositories
 For Proprietor/Partner/Managing Director

Declaration

BEFORE THE DRUG CONTROL ORGANIZATION, MEDICAL & HEALTH, SWASTHYA

BHAWAN, TILAK MARG, JAIPUR (RAJASTHAN)

I ………………………….. declare solemnly on oath as under:-

1. That I am Proprietor/Partner/Managing Director of M/s ………………Address

…………….by whom an application for grant of Manufacturing licenses for category
……………….. has been made on Form No. 24 and 27 to the Licensing Authority and Drug
Controller, Rajasthan, Jaipur under the provision of Drug & Cosmetic Act, 1940 and Rules,
1945.
2. That following are the Partner/Directors of the firm:

Sr. No. Name & Father’s Name Age Residential Address

3. That the building in which manufacturing activities are proposed are own premises which are
adapted as per Schedule M of the said Rules.
4. That adequate qualified technical staff has already been appointed as per site master file &
other documents submitted along with application.
5. That i will be solely responsible for the conduct of day to day activities of the firm for the
purpose of section 34 of the said Act as well as other prevailing enactment established by
Law of Government of India & Shall abide by all the provision of Drug & Cosmetic Act
1945.

(Declarant)

Verification

I ………………………………. verify that the contents of this Declaration are true to the best of
my knowledge and belief. So GOD helps me. If any information given above found false or
wrong then I will be responsible for legal action and my services deemed to be forfeited.

Date: (Declarant)

Place: Name
 For Proprietor/Partner/Managing Director

Declaration

BEFORE THE DRUG CONTROL ORGANIZATION, MEDICAL & HEALTH, SWASTHYA

BHAWAN, TILAK MARG, JAIPUR (RAJASTHAN)

I ………………………….. declare solemnly on oath as under:-

1. That I am Proprietor/Partner/Managing Director of M/s ……………Address………….by

whom an application for grant of Manufacturing licenses for Manufacturing license for
category………….. has been made on Form No. 24 and 27 to the Licensing Authority and
Drug Controller, Rajasthan, Jaipur under the provision of Drug & Cosmetic Act, 1940 and
Rules, 1945.
2. That Shri/Smt. ……………………….. is authorized to sign and submit documents on behalf
of the firm to the Licensing Authority and Drug Controller, Rajasthan, Jaipur
3. That the signature of Shri/Smt. ……………………. are hereby attested as under:-

(Declarant)

Signature of ………………………

Verification

I ………………………………. verify that the contents of this Declaration are true to the best of
my knowledge and belief. So GOD helps me. If any information given above found false or
wrong then I will be responsible for legal action and my services deemed to be forfeited.

Date: (Declarant)

Place: Name
 For Authorized Signatory

Declaration

BEFORE THE DRUG CONTROL ORGANIZATION, MEDICAL & HEALTH, SWASTHYA

BHAWAN, TILAK MARG, JAIPUR (RAJASTHAN)

I ………………………….. declare solemnly on oath as under:-

1. That I am …………….(Post) of M/s……………Address……………….by whom an

application for grant of Manufacturing licenses for Manufacturing license for category
………. has been made on Form No. 24 and 27 to the Licensing Authority and Drug
Controller, Rajasthan, Jaipur under the provision of Drug & Cosmetic Act, 1940 and Rules,
1945.
2. That I am authorized to sign and submit documents on behalf of the firm to the Licensing
Authority and Drug Controller, Rajasthan, Jaipur.

(Declarant)

Signature of ………………………

Verification

I ………………………………. verify that the contents of this Declaration are true to the best of
my knowledge and belief. So GOD helps me. If any information given above found false or
wrong then I will be responsible for legal action and my services deemed to be forfeited.

Date: (Declarant)

Place: Name
 For Manufacturing Chemist

Declaration

BEFORE THE DRUG CONTROL ORGANIZATION, MEDICAL & HEALTH, SWASTHYA

BHAWAN, TILAK MARG, JAIPUR (RAJASTHAN)

I ………………………….. declare solemnly on oath as under:-

1. That i have following qualification :-

Sr. No. Qualification University

2. That I have following experience:-

Sr. No. Name and Address of the Firm Period of Working with Date

3. That I have approved in the following sections for analysis of Drugs.

Sr. No. Section in which Approving Authority Letter No. & Date
Approved

4. That I have joined M/s ………………Address………………………… on ………………

and will inform the Licensing Authority and Drug Controller, Rajasthan, Jaipur as soon as I
resign from this firm by registered post.
5. That I was working previously with M/s ……………Address……………….. and left on
dated ……. and informed the Licensing Authority ……………. regarding my Resignation
from this firm.
6. That I will be responsible for the Manufacturing activities of the Firm for the purpose of
Section 34 of the said act as well as other prevailing enactment by Law of Government of
India.

(Declarant)

Verification

I ………………………………. verify that the contents of this Declaration are true to the best of
my knowledge and belief. So GOD helps me. If any information given above found false or
wrong then I will be responsible for legal action and my services deemed to be forfeited.

Date: (Declarant)
Place: Name

For Analytical Chemist

Declaration

BEFORE THE DRUG CONTROL ORGANIZATION, MEDICAL & HEALTH, SWASTHYA

BHAWAN, TILAK MARG, JAIPUR (RAJASTHAN)

I ………………………….. declare solemnly on oath as under:-

1. That i have following qualification :-

Sr. No. Qualification University

2. That I have following experience:-

Sr. No. Name and Address of the Firm Period of Working with Date

3. That I have approved in the following sections for analysis of Drugs.

Sr. No. Section in which Approving Authority Letter No. & Date
Approved

4. That I have joined M/s ………………Address………………………… on ………………

and will inform the Licensing Authority and Drug Controller, Rajasthan, Jaipur as soon as I
resign from this firm by registered post.
5. That I was working previously with M/s ……………Address……………….. and left on
dated ……. and informed the Licensing Authority ……………. regarding my Resignation
from this firm.
6. That I will be responsible for the Manufacturing activities of the Firm for the purpose of
Section 34 of the said act as well as other prevailing enactment by Law of Government of
India.

(Declarant)

Verification

I ………………………………. verify that the contents of this Declaration are true to the best of
my knowledge and belief. So GOD helps me. If any information given above found false or
wrong then I will be responsible for legal action and my services deemed to be forfeited.
Date: (Declarant)

Place: Name
 For Quality Assurance Personnel

Declaration

BEFORE THE DRUG CONTROL ORGANIZATION, MEDICAL & HEALTH, SWASTHYA

BHAWAN, TILAK MARG, JAIPUR (RAJASTHAN)

I ………………………….. declare solemnly on oath as under:-

7. That i have following qualification :-

Sr. No. Qualification University

8. That I have following experience:-

Sr. No. Name and Address of the Firm Period of Working with Date

9. That I have approved in the following sections for analysis of Drugs.

Sr. No. Section in which Approving Authority Letter No. & Date
Approved

10. That I have joined M/s ………………Address………………………… on ………………

and will inform the Licensing Authority and Drug Controller, Rajasthan, Jaipur as soon as I
resign from this firm by registered post.
11. That I was working previously with M/s ……………Address……………….. and left on
dated ……. and informed the Licensing Authority ……………. regarding my Resignation
from this firm.
12. That I will be responsible for the Manufacturing activities of the Firm for the purpose of
Section 34 of the said act as well as other prevailing enactment by Law of Government of
India.

(Declarant)

Verification

I ………………………………. verify that the contents of this Declaration are true to the best of
my knowledge and belief. So GOD helps me. If any information given above found false or
wrong then I will be responsible for legal action and my services deemed to be forfeited.

Date: (Declarant)
Place: Name