The document outlines the licensing requirements for the manufacture and sale of drugs, detailing various types of licenses needed for different categories of drugs, such as wholesale and retail sales. It describes the application process for obtaining manufacturing and selling licenses, including stages like layout plan approval, inspections, and required documentation. Additionally, the document covers penalties for offenses related to the manufacture and sale of adulterated or spurious drugs.

1. LICENCES (MANUFACTURING &
SALE)

2.  LICENCES:
 A licence is required for the manfacture and sale of drugs from the
licencing Authority and both have different identity .
 MANUFACTURING OF DRUGS:
 The term 'manufacture' means any drug which undergo any process or
part of a process for making, altering, ornamenting, finishing,
packing, labelling, breaking up or otherwise treating or adopting any
drug with a view to its sale or distribution. But it does not include the
compounding or dispensing of any drug or the packing of any drug in
the ordinary course of business.
 SALE OF DRUGS:
 1. Whole Sale: Sale of drugs from manufacturers or stockists to a
person or shopkeeper for the purpose of selling is known as
wholesale.
 2. Retail Sale: Sale of drugs from shopkeepers to the general public
for use or consumption is known as retail sale.

3.  THE FOLLOWING TYPES OF LICENCES ARE AVAILABLE
FOR THE MANUFACTURE OF DRUGS :
 1. Licence for the manufacture of Drugs other than those specified in
Schedules C, Cl and X.
 2. Licence for the manufacture of Schedule C & Cl Drugs.
 3. Licence for the manufacture of Schedule X Drugs.
 4. Licence for the Manufacture of LVP drugs.
 5. Licence for the Manufacture of Drugs meant for Examination, Test
or Analysis.
 6. Licence for the Manufacture of Homeopathic medicines.
 7. Licence to Manufacture Ayurvedic, Siddha or Unani Drugs.
 8. Loan licence.
 9. Repacking licence.
 10. Blood products.

4.  TYPES OF LICENCES ISSUED FOR SALE OF DRUGS:
 1. Licences for Whole sale.
 (1)Whole sale of Schedule C and Cl drugs
 (2) Whole sale of Schedule X drugs.
 (3) Whole sale of drugs other than Schedule C, Cl and X.
 2. Licences for Retail sale.
 (1) Retail sale of Schedule C & Cl Drugs.
 (2) Retail sale of Schedule X Drugs.
 (3) Retail sale of all drugs, other than Schedule C, Cl and X
 Drugs.
 (4) Restricted sale of drugs other than Schedule X. (v) Retail sale of
Homeopathic medicnes.

5.  PROCEDURE TO OBTAIN DRUG MANUFACTURING
LICENCE (FRESH)
 Stage 1: Approval of Layout Plan
 Stage 2: Application for grant of Own Manufacturing Licence
 Stage3: Inspection
 Stage 4: Grant of Licence

6.  Stage 1: Approval of Layout Plan :
 The Applicant has to submit 3 Blueprint copies of plan to the
concerned licensing Authority. (in case of Licenses for Blood Products
and Vaccines Sera 4 Blue print copies of plan to be submitted)
 The plan should be as per the requirements prescribed for
manufacturing premises in the Drugs and Cosmetics Act 1940.
 The plan is scrutinized by panel of officers as per the requirements of
the Drugs and Cosmetics Act 1940.
 If necessary the premises is inspected by the concerned Inspector
before plan Approval.
 Finally after scrutiny and compliance as per requirements of the Act
the layout plan is approved and a copy is given to the Applicant.

7.  Stage 2: Application for grant of Own Manufacturing Licence:
 The applicant has to make application in the requisite form (
24,24B,24C,27,27C,27D) and pay Necessary fees.
 The fee can be paid through challan at State Bank of India
 Stage3: Inspection:
 The application is scrutinized and premises inspected
 Stage 4: Grant of Licence:
 If all conditions as prescribed by the act are complied license is
granted

8.  DOCUMENTS TO BE ATTACHED ALONG WITH THE
APPLICATION FORM:
 Receipt for the fees paid, as the case may be or their attested copies.
 Copy of Approved layout plan of the manufacturing area.
 Documents viz. Rent receipt, purchase documents or its attested copies
showing lawful possession of the premises
 Documents relating to the constitution of the firm viz. Partnership-deed,
memorandum and article of association etc.
 List of machinery and equipments.
 Full particulars of the competent technical staff employed for manufacturing
and testing of drugs and cosmetics along with copies of their educational
qualifications and experience certificates approval letter as competent staff.
 In case, the application is for the products covered under Schedule C and C
(I) category, then the details of stability data is required.
 If the products are covered under ‘Patent and Proprietary’ definition, then
the two copies of methods of Analysis of the products be supplied.
 Full name of the proprietor or the partners, as the case may be shall be
provided in the application. In case of private or public limited concerns, full
name of the Directors who sign the application and the authorized signatory,
if any, shall be provided in the application .

9. S.No
.
Category of drugs Applicatio
n
Form
Licen
c
form
Fees for
Grant/
Renewal
Renewal
Certificat
e
Form No.
Penalty after
expiry but
within
six months
Fees for
Duplicat
e
copy of
Org. Lic.
1 Drugs other than
those
specified in Schedule
C&C (1) & X
(i) Repacking of drugs
24-B 25-B Lic. fees of Rs.
500+ Insp. Fee
Of Rs. 200
26 Rs.500+Rs.250
p.m.
Rs.1000
(ii) Drugs specified in
Schedule X
24-F 25-B Lic. fees of Rs.
500+ Insp. fee
of
Rs.200
26-F Rs.6000+ Rs.
1000 p.m.
R.1000
(iii)Any other 24 25 Lic. fee of Rs.
6000+ Insp. fee
Of Rs. 1500
26 Rs.6000+Rs.
1000 p.m.
Rs.1000
(iv)Loan Licence 24-A upto
10
items for
Each
category
25-A Lic. fee of Rs.
6000+ Insp. fee
of
Rs. 1500
26-A Rs.6000+Rs.
1000
p.m.
Rs.1000

10. 2 Drugs specified
InScheduleC&
C(1) excluding
Those Pecified
in Sch. X
(i) Own unit
27up to 10
items for
each
category
28 Lic. fee of Rs.6000
+Insp. fee of Rs.
1500
26 Rs.6000+Rs.1000
p.m. or
Rs.100
(ii)Loan Licence 27-A p to 10
items
28-B Lic. fee of Rs.
6000+Insp.fee of
Rs.
1500
26-F Rs.6000+Rs.
1000 p.m.
Rs.1000
(iii)Drugsspecifi
ed in Schedule
C&C (1) &X
27-Bup to 10
items
28-D Lic. fee of Rs. 6000
+Insp. fee of Rs.
1500
26-F Rs.6000+Rs.
1000 p.m.
Rs.1000
(iv)Drugs
specified in
Sch. C
27-D p to 10
items
28-D Lic. fee of Rs. 6000
+ Insp. fee of
Rs. 1500
26-H Rs.6000+Rs.
1000 p.m.
Rs.1000
(v)Whol
Human Blood
& Components
27-C 28-C Lic. fee of Rs. 6000
+ Insp. fee of
Rs. 1500
26-G Rs.6000 + Rs.
1000 p.m.
Rs.1000
3. Mfg. of drugs for
purpose of
examination,
test / analysis
30 29 Rs.250 - - -

11.  PROCEDURE TO OBTAIN DRUG SELLING
LICENCE(FRESH):
 Stage 1 : Minimum carpet area
 Stage 2: Application for grant of Selling Licence
 Stage 3: Inspection
 Stage 4: Grant of Licence

12.  Stage 1: Minimum carpet area:
 For Retail sale - 10 square meter
 For Wholesale - 10 square meter
 For Retail - Wholesale - 15 square meter Storage facilities.
 Adequate storage facilities including cupboards with glass doors,
racks refrigerator and UPS is required.
 Stage 2: Application for grant of Selling Licence:
 The applicant has to make application in the requisite form viz 19,
19A,19B, 19AA details of Forms and pay necessary fees as given in
fee chart.
 The fee can be paid through challan at State Bank of India (Main
branch)

13.  Stage 3: Inspection:
 The application is scrutinized and premises inspected.
 Stage 4: Grant of Licence:
 If all conditions as prescribed by the act are complied license is
granted.

14.  DOCUMENTS TO BE ATTACHED ALONG WITH THE
APPLICATION FORM:
 Requisite Application Form. Receipt for the fees paid or challan, as
the case may be or their attested copies.
 Layout plan of selling premises in 3 copies.
 Documents viz. rent receipt, purchase documents or its attested copies
showing lawful possession of the premises.
 Documents relating to the constitution of the firm viz. Partnership-
deed, memorandum and article of association etc.
 Full particulars of the competent technical staff /registered persons
along with copies of their educational qualification, experience and
registration certificates.
 Full name of the proprietor or the partners, as the case may be shall be
provided in the application. In case of private or public limited
concerns, full name of the Directors who sign the application and the
authorised signatory, if any , shall be provided in the application.
 Documents for the purchase of Refrigerator/Deep freezer (For
Vaccines / Sera).

15. S.
No.
Category Type Sale Applic
ation
Form
Licence
Form
Fees for
Grant/
Renewal
Renewal
Certificate
Form No.
Penalty after expiry but
within six months
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
Retail Sale 19 20 Rs.1500 21-C
Restricted
(Gen.Store)
19-A 20 Rs.1500 21-C Rs.500+250 p.m. or part
thereof
2 Drugs specified
in Schedule C&C
(1) but excluding
those specified in
Schedule ‘X’
Whole Sale 19 21-B Rs.1500 21-C Rs.1500+Rs.500 p.m. or part
thereof
Retail Sale 19 21 Rs.1500 21-C
Restricted
(Gen.Store)
19-A 21-A Rs.1500 21-C Rs.500+Rs.250 p.m. or part
thereof
3 Drugs specified
in Schedule ‘X’
Whole Sale 19-C 20-G Rs.1500 21-C Rs.500+Rs.250 p.m. or part
thereof
Retail Sale 19-C 20-F Rs.1500 21-C
4 Sale of Drugs
from motor
vehicles
(1) Drugs other
than those
specified in
Schedule C&C
(1)
Whole Sale 19-AA 21-BB Rs.500 21-CC
Retail Sale 19-AA 21-BB Rs.500 21-CC Rs.500+Rs.250 p.m. or part
thereof
(2) Drugs
specified in
Schedule C&C
(1)
Whole Sale 19-B 21-D Rs.250 21-CC Rs.250+Rs.50p.m. or part
thereof
Retail Sale 19-B 21-C Rs.250 21-E

16. TIME FRAME FOR DISPOSAL OF APPLICATION FOR
LICENCES:
For Manufacturing
licences
For sale licences
(a). Time for scrutiny of the
application and the
documents and
communication of
shortcomings, if any
within 15 days of receipt of
application
within 15 days of receipt
of application
b)Time for inspection of the
premises of the applicant
firm
within 30 days of receipt of
complete documents
within 15 days of receipt of
complete documents
(c) Time for grant of
licences, if the conditions
are satisfies.
within 45 days of
inspection
within 15 days of
inspection
d). Final disposal of
application when additional
documents / clarification
are required after
inspection.
within 15 days of
inspection
within 90 days of
inspection

17.  OFFENCES AND PENALTIES:
 1. Whoever, himself or by any other person on his behalf, manufactures for sale or for
distribution or sells or stocks or exhibits or offers for sale or distributes :
 (i) any drug deemed to be adulterated or spurious and which is likely to cause deat.h shall be
punishable with imprisonment for 5 years along with fine of Rs. 10,000
 (ii) any drug deemed to be adulterated (but not cause death) or without a valid licence shall be
punishable with imprisonment of 1 to 3 years and with fine of Rs. 5,000/-on first offence,
imprisonment of 2 to 6 years and fine of Rs. 10,000/- for similar subsequent offence.
 (iii) any drug to be spurious (but not cause death) shall be punishable with imprisonment of 3
to 5 years and with fine of Rs. 5,000/- for first offence. Imprisonment of 6 to 10 years and
fine of Rs. 10,000/- for subsequent offence.
 (iv) any drug contravening other provisions of Act and Rules shall be punishable with
imprisonment of 1 to 2 years and fine for first offense. Imprisonment of 2 to 4 years with fine
of Rs. 5000/- for subsequent offence.
 In addition to the above, in all cases, the drugs, containers, machineries, packages,
vehicles used in carrying such adulterated or spurious drugs shall be liable for
confiscation.
 2. For refusing to give the details of purchase or for giving false information regarding the
purchase of drug shall be imprisoned for one year or with fine up to Rs. 1,000/-.
 3. For utilising any analytical test report given by a Government Analyst, for advertising
purpose,shall be punishable with fine ofRs. 500/- on first conviction and imprisonment up to
10 years with fine on subsequent offence. In general, any offence has been committed by
stocking adulterated or spurious drugs, such stocks of drugs are liable for confiscation.