guidelines for differenet licences under drug and cosmetic act

8/18/2019 Guidelines for Differenet Licences Under Drug and Cosmetic Act

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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.


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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 ofdrugs 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)


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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 feesspecified 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 tobe 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.


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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:-

A. 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 thosespecified 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)

(B) (i) Each application should be accompained with a cash deposit receipts as proof that the fees

specified under the Rules has been deposited in the proper head of account.

(ii) The site plan and key plan of the premises showing the location of the premises giving

important land marks so that officer of the Department are able to locate the same.

(iii)

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

(iv) Power of Attornery in the name of one or more than one

Partner/Director/Manager/Secretary or any other person who is competent to correspond

with the Drugs Control Authorities with regard to licence(s).


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(v) Affidavit/undertaking regarding non-conviction of Prop./Partner/Director as well as the

firm under Drugs & Cosmetics Act, 1940.

(vi) An affidavit/undertaking from the Regd. pharmacist/competent person, as the case may

be, about his joining the firm on full time basis.

(vii) Proof of qualification, registration and experience, bio-data of the Registered

Pharmacist/Competent person, as the case may be, employed by the firm, to supervise and

control the sale and distribution of drugs.

(viii) The applicant has to provide an independent shop with the adequate area for grant of

retail/wholesale licences as per details given below:

a) For grant of a licence in Form 20 or Form 21 or both, the premises are of an area of not

less than 10 square metres.

b) For grant of a licence in form 20-B or form 21-B or both, the premises are of an area of

not less than 10 square metres and

c)

For grant of licences

(i) In Form 20 or Form 21 or both, and

(ii)

In Form 20-B or Form 21-B or both, the premises should be of an area of not less

than 15 square metres.

The clear height of the sales premises should be in accordance with the National Building Code of

India, 2005 as amended from Time to Time.

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

(x) All the affidavits shall be typed & duly attested by Notary Public.

(xi) No drug licence is granted in a premises situated on a DDA alloted residential plot/land or

flat unless it meets with the requirements of MPD-2021.

(xii) For the sake of authenticity and to ensure confirmation of having submitted the same, all

the documents are required to be self-attested by the applicant/authorized person.

(xiii)

The application for Retail/Wholesale licences should be accompanied with two recentpassport size photographs showing the frontal view of full face of the

Pharmacist/Competent Person. One additional photograph is required to be pasted on the

Bio-data proforma and should be cross signed by Pharmacist/Competent Person. The

photographs should have a light background preferably white.


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AFFIDAVIT

I ........................................................ S/o Sh. ............................................ R/o

............................................................................................. do hereby Solemnly Affirm and declare as

under :-

*1. That the Deponent is the sole Proprietor / Partner / Director of M/s

......................................................................................... situated at

.............................................................................................................

*2. That neither the firm nor the Proprietor / Partner / any Director of the firm has ever been

convicted under the Drugs and Cosmetics Act, 1940.

3. That the premises situated at ..............................................................

................................. are in physical and legal possession of the firm.

*4. That the premises are not situated on DDA Residential Plot/Land/Flat.

or

That the premises are situated on DDA Residential Plot/Land/Flat

5. That in case any statement / document accompanying my application is found to be false /

misleading at any stage, my approval / permission / licence so obtained would be liable to be

cancelled by the licensing authority without any notice.

DEPONENT

VERIFICATION

Verified at Delhi on this ................................. day of .................................

that the contents of the above affidavit are true and correct to the best of my knowledge and belief

DEPONENT

*Delete whatever is not applicable

(To be Submitted on Rs. 10/- Non Judicial Stamp Paper duly attested by Notary Public.)


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AFFIDAVIT

I ........................................................ S/o Sh. ............................................ R/o

............................................................................................. do hereby Solemnly Affirm and declare as

under :-

1. That the Deponent is the a Registered Pharmacist from Delhi Pharmacy Council with Regn.

No. ........................... dated .................

2. That the deponent has passed …………..................... in the year ...................... from

.................................... Board/University.

3. That the Deponent has joined M/s. ......................................................

situated at .......................................................................... with effect from ..................................... as

a full-time Registered Pharmacist / Competent Person for retail sale/wholesale of drugs.

4. That previously the Deponent was working as Regd pharmacist / Competent Person with

M/s. ...............................................................

situated at ............................... holding licence no. (s) ........................ on Forms ......................... which

job I have left w.e.f. ......................... and intimated to the Drugs Control Office on -------------

or

That previously the Deponent was not working anywhere.

5. That the Deponent shall inform the the Drugs Control Department Govt. of N.C.T. of Delhi,

F-17, Karkardooma Delhi-32 as and when he shall leave the present firmM/s....................................................................................

6. That the Deponent is not employed anywhere else except with M/s …………………………............

DEPONENT

VERIFICATION:

Verified at Delhi on this ................................. day of .............................. that the contents of the

above affidavit are true and correct to the best of my knowledge and belief.

DEPONENT

Note Strike out which is not applicable.



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AFFIDAVIT

(To be submitted in cases where the premises are located on DDA residential plot/flat/building)

I ................................ S/o Sh. ............................................ R/o ..................... do hereby Solemnly

Affirm and declare as under :-

1.

That I am the sole proprietor / one of the partner/Director of

M/s. ___________________ situated at __________________________

2. That I have applied for grant of licence for retail sale of drugs / chemist shop at the premises

situated at ________________________________

3.

That the premises where licence has been applied qualify for use as Small Shops under mixed land

use regulations, clause 15.6.3, of Master Plan for Delhi 2021(MPD-2021).

4. That the conversion charges towards the mixed land use, as applicable in respect of the premises

under reference,have been deposited vide receipt no. _________________________ dated

_______________________ to Municipal Corporation of Delhi for the period ------------- and I

further undertake to pay mixed land use charges from time to time as applicable.

5. That in future if it is found that the premises of my firm do not qualify for use as small shops for

mixed land use regulations, under clause 15.6.3, of Master Plan for Delhi, Drugs Control

Department may cancel licences of my firm without any prior notice.

6. That in future if it is found that I have violated any provision of the Drugs and Cosmetics Act,1940

and Rules thereunder, and/or MPD-2021, Drugs Control Department may cancel licences of my firm

without any prior notice.

7. That if any misrepresentation is observed in this affidavit, or in any of the documents submitted by

me alongwith my application for the grant of Licences referred to above, Drugs Control Department

may cancel licences of my firm without any prior notice.

(DEPONENT)

VERIFICATION:

Verified at Delhi on this ................................. day of .............................. that the contents of the

above affidavit are true and correct to the best of my knowledge and belief.

(DEPONENT)



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Check List of documents required to be submitted by the applicant for

grant of retail/wholesale drugs licences.

1. Application Form

2.

Fee deposit Receipt

3. Declaration form

4. Key Plan

5.

Site Plan

6. Basis of possession of the premises

7. Proof of ownership of the premises, if rented

8.

Proof of constitution of the firm

9. Affidavit of non-conviction of Directors/Proprietor/Partner under Drugs & Cosmetic Act, 1940.

10.

Certified copy of Qualification certificates of the competent person.

11.

Experience certificate of the competent persons.

12. Biodata on Proforma

13. Affidavit of competent person Registered Pharmacist regarding fulltime working with the firm

duly attested by Notary.

14. Photo identification proof of proprietor/partner/Director.

15.

Certified copies of Qualification, Registration with Delhi Pharmacy Council and valid photo (I.D.

in respect of Registered Pharmacist.

16. All the photocopies of documents should be self attested.


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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 inSchedule 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 p.m. or part thereof

Rs.150

Restricted(Gen. Store)

19-A 20-A

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)

2 Drugs specified inSchedule C&C (1)

but excluding thosespecified in

Schedule ‘X’

Whole Sale 19 21B Rs.1500 21 -C Rs.1500+Rs.500 p.m. or part thereof

Rs.150

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


Rs.150

Restricted(Gen.Store)

19-A 21-AR-

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)

3 Drugs specified inSchedule ‘X’

Whole Sale 19-C 20-G Rs.500 21-C Rs.500+Rs.250 p.m. or part thereof

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 frommotor vehicles (1)

Drugs other thanthose 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 p.m. or part thereof

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 HomoeopathicMedicines

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


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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 fo

Item

more t

item fo

cate

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

each ad

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

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

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

item

R-69-A

*GSR No. 421 dated 24/08/2001


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¤ 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

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

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

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

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

addition to insp. Fee ofRs. 1500.

R:122F(1)

Rs.1000

R:122F(1)

Rs.300

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)

-- -- -- --


14/17

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 category1. 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)


15/17

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)


16/17

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 sellHomoeopathic Medicines

by retail

24-C

R: 85-B(2)

25-C

R:85-(b)

Rs.200 + Rs. 100 for 1st



licenceR-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)


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guidelines for differenet licences under drug and cosmetic act

Documents