Guideline for Grant of Different Licences Under Drugs and

NOTE

This booklet provides general guidelines for the grant of different licenses issued by the Drugs

Control Department, Govt. of N.C.T. of Delhi under the various provision of Drugs & Cosmetics

Rules, 1945. These guidelines are not exhaustive. In case of any controversy, relevant Rules must

always be referred to by the applicant/prospective licensee and the said rules, which are amended

from time to time, shall prevail over the general guidelines given in this booklet. Although every

effort has been made to provide accurate information in this booklet, for any particular clarification

the applicants are advised to contact personally the designated DUTY OFFICER of the department on

any working day during office hours.

Guidelines For Grant of Licences Under Drugs & Cosmetics

Act, 1940 and Rules thereunder

(Please refer to the NOTE printing on the front inside cover of this booklet)

INTRODUCTION

Drugs are essential for ensuring good health of a Nation. Drugs are different from other

commodities and because of that the Government has laid down stringent law. Regulation governing

manufacture & sale of drugs are given in the Drugs and Cosmetics Act, 1940 and Rules framed

thereunder. Control is exercised over drugs from the raw material stage during manufacture, sale,

distribution and upto the time it is passed-on to a patient or consumer by a Pharmacist in retail

Pharmacy, Hospital or a Dispensary.

Types of Licences issued by the Department for Manufacture of Drugs/Cosmetics:

(A) Different types of licences required for the manufacture of drugs ( The required application

form number for a particular licensce is mentioned in the bracket) are given hereunder :-

a) Licence on Form 25 is issued for the manufacture for sale/distribution of Allopathic drugs

other than those specified in schedule C, C(I) and X (Form 24)

b) Licence on Form 25-A is issued, for Loan Licence to manaufacture for sale distribution of

drugs in clause (a) above. (Form 24-A)

c) Licence on From 25-B, for re-packing for sale/ distribution of drugs mentioned in (a) above.

(Form 24-B)

d) Licence on Form 25-C is issued for manufacture for sale/distribution of Homoeopathic

Medicines (Form 24-C)

e) Licence on Form 25-F is issued for manufacture for sale/distribution of schedule X drugs

other than those specified in schedule C & C (1). (Form 24-F)

f) Licence on Form 28 is issued for manufacture for sale/distribution of Allopathic drugs

specified in schedule C & C (1) excluding those specified in schedule X (Form 27)

g) Licence on Form 28-A is issued for Loan Licence to Manufacture for sale/distribution of

drugs mentioned in clause (f) above. [Form 27-A]

h) Licence on Form 28-B is issued for manufacture for sale/distribution of drugs specified in

schedule C, C(1) & X, (Form 27-B.)

i) Licence on Form 28-C is issued to operate a Blood Bank for processing of Whole Human

Blood and / or Preparation of Blood Components (Form 27-C)

j) Licence of Form 28-D is issued to manufacture for sale or for distribution of Large Volume

Parenterals, Sera and Vaccines excluding those specified in schedule 'X' (Form 27-D)

k) Licence on Form 28-E is issued to manufacture for sale/distribution Blood products (Form

27-E)

(B) In addition to licences mentioned above, the following Licences are issued for the manufacture

of cosmetics.

a) Licence on Form 32 is issued for manufacture to sale/distribute of cosmetics. (Form No. 31)

b) Licence on Form 32-A is issued for Loan Licence for Manufacture to sale/distribute

cosmetics (Form No. 31-A)

(C) Laboratories which carry out tests on drugs, cosmetics and raw materials used in their

manufacture, on behalf of licensees for manufacture for sale of drugs/cosmetics, are granted

approval in Form 37, (Form No. 36)

(D) For the sake of convenience the details of the different types of licences, respective application

forms and fee etc. prescribed under the Drugs and Cosmetics Rules, 1945 are provided in a

tabular form at the end of these guidelines. In addition to application forms specified under

clause 'A' above, an entrepreneur, who desires to manufacture drugs, is required to submit the

below mentioned documents and fees.

(E) .

(i) Each application should be accompanied with a cash deposit receipt as proof that the fees

specified under the Rules has been deposited in the proper Head of Account.

(ii) A site plan giving the layout of the manufacturing premises with dimensions in meters and

details like position of doors, windows etc.

(iii) Key-plan, showing the location of the manufacturing unit giving important land marks so

that officers of the Department are able to locate the premises.

(iv) Documentary evidence of the constitution of the firm: Memorandum and articles of

association in case of company. Partnership deed, duly attested by Notary Public, in case of

partner-ship firm, an affidavit of the proprietor, attested by a Notary Public, in case of a

proprietorship firm.

(v) Power of Attorney in the name of one or more than one partner / Director /

Manager/Secretary or any person who is competent to correspond with the Drugs Control

Authorities with regard to grant/Renewal etc. of licence(s).

(vi) Detailed list of machinery and equipments installed for manufacture of drugs. The list should

give full details of each machine, its make, capacity, material of which it is made, whether it

is automatic or manual etc. duly signed by an authorised person of the firm.

(vii) Attested photo copies of certificates of qualifications, experience, letter of aproval (in case

where persons are already approved) Biodata, consent affidavit and joining report of the

whole time technical staff employed for the manufacturing and testing of drugs.

(viii) List of equipment, apparatus and reference books etc. with full details provided for quality

control and testing of drugs, signed by an authorised person of the firm.

(ix) List of items, with detailed formula, (including Pharmaceutical aids, excipients) intended to

be manufactured. For each item details are required to be given in the proforma prescribed

by the department each of which should be signed by an authorised person of the firm and

the manufacturing chemist.

(x) An affidavit/undertaking to the effect that neither the owner nor the firm had been

convicted under the Drugs & Cosmetics Act 1940.

(xi) Proof of ownership and proof of possession in respect of the premises.

(xii) All the photocopies of documents should be self attached.

In addition to what had been stated above, the prospective manufacturer is advised to refer :

(i) Schedule M of the Drugs & Cosmetics Rules, 1945 wherein minimum requirements in so far

as space, machinery and other details are prescribed.

(ii) Rule 71, 71-A, 71-B 76, 76-A, and 122-G, for different types of manufacturing licences.

(iii) Rules 96 to 105, regarding labelling etc.

It may be mentioned here that manufacture of drugs (bulk or formulations) without a valid

licence is an offence under the provisions of Drugs and Cosmetics Act, 1940 & Rules made

thereunder. Entrepreneurs can obtain licences on Form 25, 25-B, 28, 28-B at the same premises,

provided they fulfil the necessary requirements. It is also suggested that applications should be

submitted in the department as and when the premises are ready and the equipment is installed.

Types of Licences issued by the Department for sale of Drugs.

Different types of licence required for the sale of drugs (the required number of application form for

a particular licence is mentioned in the bracket) are given hereunder:-

(i) Licence on Form 20 is issued for the sale of Allopathic drugs by retail other than those

specified in Schedule C, C(1) and X. (Form-19)

(ii) Licence on Form 20-A is issued for the sale of restricted Allopathic drugs by retail other

than those specified in schedule C, C(1) and X. (Form-19A)

(iii) Licence on Form 20-B is issued for wholesale of Allopathic drugs other than those specified

in Sch C, C(1) and X. (Form-19)

(iv) Licence on form 20-C is issued for sale of Homoeopathic medicines by retail. (Form-19B)

(v) Licence on Form 20-D is issued for sale of Homoeopathic Medicines by wholesale.(Form -

19B)

(vi) Licence on Form 21 is issued for retail sale of Allopathic drugs specified in Sch C & C(1).

(Form-19)

(vii) Licence on Form 21-B is issued for wholesale of Allopathic drugs specified in Sch C & C(1).

(Form-19)

(viii) Licence on form 21-A is issued for retail sale of restricted Allopathic drugs specified in

Schedule C (I). (Form-19A)

(ix) Licence on Form 20-F is issued for retail sale of drugs specified in Sch. 'X'. (Form-19-C)

(x)Licence on Form 20-G is issued for wholesale of drugs Specified in Sch. 'X'. (Form-19-C)

(w.e.f. 1/12/2015 Licences are being granted online through website http://xlnindia.gov.in )

Subsequently other services like processing of applicantion for renewal of Licences &

approval/deletion name of Registered Pharmacist/ Competent Person are also being processed

Online through website http://xlnindia.gov.in

http://xlnindia.gov.in/

http://xlnindia.gov.in/

FORMS AND FEES

A: SALE APPLICATIONS, LICENCES, FEES AND PENALTY

S.No. Category Type Sale Application

Form

Licence

Form

Fees for

Grant/

Renewal

Renewal

Certificate

Form No.

Penalty after expiry

but within six

months

Fees for

duplicate

copy of Org.

Lic.

1 Drugs other than

those specified in

Schedule C&C

(1)&X

Whole Sale 19 20-B Rs.1500 21 -C Rs.1500+Rs.500

p.m. or part thereof

Rs.150

Retail Sale 19 20 Rs.1500 21 -C Rs.1500+Rs.500


Rs.150

Restricted

(Gen. Store)

19-A 20-A

R-61

(1)

Rs.500

R-59

(2)

21 -C Rs.500+Rs.250


R-59 (4)

Rs.150

R- 59 (3)

2 Drugs specified in

Schedule C&C (1)

but excluding those

specified in

Schedule ‘X’

Whole Sale 19 21B Rs.1500 21 -C Rs.1500+Rs.500


Rs.150

Retail Sale 19 21 Rs.1500 21 -C Rs.1500+Rs.500


Rs.150

Restricted

(Gen.Store)

19-A 21-A

R-

61 (1)

Rs.500

R-59

(2)

21 -C Rs.500+Rs.250


R-59 (4)

Rs.150

R- 59 (3)

3 Drugs specified in

Schedule ‘X’

Whole Sale 19-C 20-G Rs.500 21-C Rs.500+Rs.250


Rs.150

Retail Sale 19-C 20-F

R-

61(1)

Rs.500

R-59(2)

21-C Rs.500+ Rs.250

p.m. or part

thereof R-59(4)

Rs.150

R- 59 (3)

4 Sale of Drugs from

motor vehicles (1)

Drugs other than

those specified in

Schedule C&C (1)

(2) Drugs specified

in Schedule C&C

(1)

Whole Sale 19-AA 20-BB Rs.500 21-CC Rs.500+Rs.250


Rs.150

Whole Sale 19-AA 21-BB

R-62-

D

Rs.500

R-62-C

21-CC Rs.500+Rs.250


R-62-C

Rs.150

R-62-C

5 Homoeopathic

Medicines

Whole Sale 19-B 20-D Rs.250 20-E Rs.250+Rs.50p.m.

or part thereof

Rs. 50

Retail Sale 19-B 20-C

R-67-

C

Rs. 250

R-67-

A(2)

20-E Rs.250+Rs.50p.m.

or part thereof

R-67-A(2)

Rs. 50

R-67-A(2)

*GSR No. 421 dated 24/08/2001

B : MANUFACTURING APPLICATIONS, LICENCES, FEES AND PENALTY*

I. ALLOPATHIC DRUGS

S.No. Category of drugs Application

Form No.

Licence

Form

No.

Fees for Grant / Renewal Renewal

Certificate

Form No.


but within six months

Fees for

duplicate

copy of Org.

Lic.

Fee for addl.

Item for

more than 10

item for each

category

1. Drugs other than those

specified in Schedule

C&C (1)&X

(i)Repacking of drugs

24-B upto 10

items for each

category

R: 69(1)(a)

25-B

R:70

Lic. Fees of Rs.500+Insp. Fee of

Rs. 200 for every inspection or for

renewal of licence R-69(2)(a)

26-B

R: 73-B

Rs.500+Rs.250p.m. or

part thereof in addition

to an inspection fee of

Rs. 200

R-69(3)(i)

Rs. 1000

R:69(4)

Rs.100 for

each addl.

item,

R: 69(5)

(ii)Drugs specified in

Schedule ‘X’

24-F upto 10

items for each

category

R: 69(1)(b)

25-F

R:70

Lic. Fee of Rs. 6000+ Insp. Fee of

Rs.1500 for every inspection or for

renewal of licence.

R: 69(2)(b)

26-F

R-73

Rs.6000+Rs.1000 p.m.

or part thereof in

addition to insp. Fee of

Rs. 1000.

R:69(3)(ii)

Rs.1000

R-69 (4)

Rs.300 per

item

R-69 (5)

(iii) Any other drugs 24 upto 10

items for each

category

R: 69(1)(c)

25

R:70



renewal of licence.

R: 69(2)(c)

26

R-73

Rs.6000+Rs.1000 p.m.

or part thereof in


Rs. 1500.

R:69-A(1)

Rs.1000

R-69 (4)

Rs.300 per

item

R-69 (5)

(iv) Loan Licence 24-A upto 10

items for each

category

R: 69-A(1)

25-A

R:70-A



renewal of licence.

R: 69A(1)

26-A

R-73A

Rs.6000+Rs.1000 p.m.

or part thereof in


Rs. 1500.

R:69-A(1)

Rs.1000

R-69-A (4)

Rs.300 per

item

R-69-A(3)

*GSR No. 421 dated 24/08/2001

¤ Fee for further application after rejection Rs.250(R:82)

ø Fee for further application after rejection Rs. 250(R:122K)

2. Drugs specified in

Schedule C&C (1)

excluding those specified

in Sch.X (i) Own unit

27 upto 10

items for each

category R:

75(1)

28

R:76



renewal of licence. R: 75(1)

26

R: 77

Rs.6000+Rs.1000 p.m.

or part thereof in


Rs. 1500. R:75(1)

Rs. 1000

R:75(4)

Rs.300 per

item,

R: 75(5)

(ii) Loan Licence 27-A upto 10

items for each

category

R: 75A(1)

28-A

R:76-A



renewal of licence.

R: 75A(1)

26-A

R-83-A

Rs.6000+Rs.1000 p.m.

or part thereof in


Rs. 1500.

R:75(1)

Rs.1000

R-75A (4)

Rs.300 per

item

R-75(5)

(iii)¤ Drugs specified in

Schedule C&C(1) &X

27-B upto 10

items for each

category

R: 75(2)

28-B

R:76



renewal of licence.

R: 75(2)

26-F

R-77

Rs.6000+Rs.1000 p.m.

or part thereof in


Rs. 1500.

R:75(2)

Rs.1000

R-75(4)

Rs.300 per

item

R-75(5)

(iv) ø Drugs specified in

Sch.C, viz. LVP and

Sera & Vaccines

27-D upto 10

items for each

category

R: 75(3)

28-D

R:76



renewal of licence.

R: 75(3)

26-H

R-77

Rs.6000+Rs.1000 p.m.

or part thereof in


Rs. 1500.

R:75(3)

Rs.1000

R-75(4)

Rs.300 per

item

R-75(5)

(v) Whole Human Blood

& Components

27-C

R: 122F(1)

28-C

R:122G



renewal of licence.

R: 122F(1)

26-G

R122-H

Rs.6000+Rs.1000 p.m.

or part thereof in


Rs. 1500.

R:122F(1)

Rs.1000

R:122F(1)

Rs.300 per

item

R-75(5)

3. Mfg. of drugs for

purpose of examination,

test/analysis

30

R: 90

29

R:89

Rs. 250

R:90(2)

-- -- -- --

III- COSMETICS

Note: Fee for further application after rejection Rs. 250 (R:139 AD)

S.No. Category of

drugs

Application

Form No.

Licence

Form

No.

Fees for Grant /

Renewal

Renewal

Certificate

Form No.



Fees for

duplicate

copy of Org.

Lic.

Fee for addl.

Item for more

than 10 item for

each category

1. Own

manufacturing

31 upto 10

items for each

category

R: 138(1)

32

R:139-A

Lic. Fee of Rs.2500 +

insp. Fee of Rs. 1000

for every inspection or

for renewal of licence

R-138(2)

33

R: 141

Rs.2500+Rs.400 p.m.

or part thereof in

addition to insp. fee of

Rs. 1000

R-138(2)

Rs. 250

R:138(4)

Rs.100 for each

additional item

subject to a

maximum of

Rs.3000 R: 138(3)

2. Loan Licence 31-A upto 10

items for each

category

R:138-A(1)

32-A

R:139-B

Lic. Fee of Rs.2500 +

insp. Fee of Rs. 1000

for every inspection or

for renewal of licence

R-138-A(1)

33-A

R:141-A

Rs.2500+Rs.400 p.m.

or part thereof in

addition to insp. fee of

Rs. 1000

R-138A(2)

Rs. 250

R:138-A (6)

Rs.100 for each

additional item

subject to a

maximum of

Rs.3000

R: 138-A (5)

IV-APPROVAL OF PRIVATE TESTING LABORATORIES

Note: Fee for further application after rejection Rs. 250 (R:139 AD)


Form No.

Licence

Form

No.

Fees for Grant /

Renewal

Renewal

Certificate

Form No.

Penalty after

expiry but within

six months

Fees for

duplicate

copy of

Org. Lic.

Fee for addl.

Item for more

than 10 item

for each

category

1. Testing of drugs

specified in Sch. C &

C(1)

36

R: 150-B

37

R:150-C

Inspection fee of Rs.

6000

R:150-B(1)

38

R: 150-J

Rs.6000+Rs.1000


R:150-B(1)

-

Rs.1500 per

category

R: 150 B (2)

2. Testing of drugs other

than those specified in

Sch. C & C(1) &

Homeopathic

Medicines &

Cosmetics

36

R: 150-B

37

R:150-C

Inspection fee of Rs.

1500

R:150-B(1)

38

R: 150-J

Rs.1500+Rs.1000


R:150-B(1)

-

Rs.1000 per

category

R: 150 B (2)

II - HOMEOPATHIC MEDICINES

Note : Fee for further application after rejection Rs. 250 (R-85 ED) Additional item : Cosmetics – Rs. 100/- per item subject to max. of Rs. 3000/- Allopathic Drugs – Rs. 300/- per item Homoeopathic Medicines – Rs. 50/- Per item.


Form No.

Licence

Form

No.

Fees for Grant / Renewal Renewal

Certificate

Form No.

Fee+ Penalty after expiry


Fees for

duplicate copy

of Org. Lic.

1. Mother Tinctures &

Potentised Preparations

24-C

R: 85-B(2)

25-C

R:85-D

Rs.200 + Rs. 100 for 1st

inspection or Rs. 50 in case

of inspection for renewal of

licence

R-85-B(2)(a)

26-C

R: 85-G

Rs.200+Rs.100p.m. or part

thereof and inspection fee of

Rs. 50

R-85-B(3)(a)

Rs. 50

R:85-B(4)

2. Potentised Preparation 24-C

R: 85-B(2)

25-C

R:85-(b)

Rs.200 + Rs. 100 for 1st



licence

R-85-B(2)(b)

26-C

R: 85-G



Rs. 50

R-85-B(3)(b)

Rs. 50

R:85-B(4)

3. Potentised Preparations

from back potencies by

Pharmacy which are

licensed to sell

Homoeopathic Medicines

by retail

24-C

R: 85-B(2)

25-C

R:85-(b)

Rs.200 + Rs. 100 for 1st



licence

R-85-B(2)(c)

26-C

R: 85-G



Rs. 50

R-85-B(3)(c)

Rs. 50

R:85-B(4)

4. Additional item Rs. 50 for each additional

item

R: 85-B(5)

Documents

Guideline for Grant of Different Licences Under Drugs and