DRUGS CONTROL DEPARTMENT
INTRODUCTION -
Drugs have a special
significance in human life. There may not be any need of a drug for a
healthy person in normal life. But in illness, accidents, epidemics and natural
disasters drugs are urgently required to combat the disease and it is there
that drug fights DEATH. DRUG is therefore the greatest weapon of
mankind to fight DISEASE and DEATH.
It is at this very point of death that the specific drug of highest
quality, purity and safety has to win the battle for life.
Therefore, one cannot compromise for anything less. Hence the need for DRUGS
CONTROL ADMINISTRATION.
Drugs Control
Department in KARNATAKA has its beginning in the year 1962. The Drugs and Cosmetics Act, 1940 and Rules,
1945 were implemented in KARNATAKA state with effect from 1-4-57. Drugs Control Department
in Karnataka is the premier law enforcement agency implementing the provisions
of Drugs & Cosmetics Act, 1940 and Rules 1945 and other drugs related
laws. Drugs Control Department in
Karnataka is functioning as an independent department since 1962 under the
Health and Family Welfare department, Government Of Karnataka with the Drugs
Controller as Head of the Department. It’s head office is located at
1)
Enforcement Wing
2) Drugs Testing Laboratory
3)
Enforcement
wing
deals with licensing of sales establishments manufacturing establishments,
inspections of sales and manufacturing establishments, drawl of samples for
test and analysis, investigation of complaints, launching of prosecution
against the defaulters etc.
The important aims and objectives of
the department are quality control of Drugs , consumer protection by exercising
strict control and vigilance on the drugs which are being manufactured and /or
marketed ,thereby ensuring drugs of standard quality, purity , strength, safety
are available to the public at controlled prices. The enforcement wing is
dealing with grant/renewal of manufacturing licenses, blood banks, sales
licences, inspections of manufacturing, blood banks, and sales establishments.
Investigation of complaints and launching prosecutions in case of breach of
law, drawing of drug/cosmetics samples for the purpose of Test or analysis to
ascertain its quality, purity and strength and safety.
Drugs Testing Laboratory is a statutory Laboratory that carries out testing and analysis of samples of Drugs & Cosmetics
drawn by enforcement officers and samples sent by a purchaser. It is
equipped to analyze all categories of drugs except Vaccines, Sera, Blood and
Blood components and Diagnostic Kits. The laboratory is having library and
animal house facilities. Drugs Testing Laboratory is situated in Drugs
Control Department,
Pharmacy
Education –
Government College of Pharmacy is situated at
The Board
of Examining Authority which is situated in the same campus is conducting the
examination and valuation of Diploma in Pharmacy Course. This authority is
entrusted with the responsibility of conducting Examination to students of
Diploma in Pharmacy as per the Education regulations of Pharmacy Council of
India, a statutory body to oversee the standard of education in Pharmacy in the
country. For this purpose, the Govt. has constituted Board of Examining
Authority with Principal ,Government
The Drugs Control Administration in
the State is implementing the following Central Legislations throughout the State.
1.
The
Drugs and Cosmetics Act, 1940 and Rules 1945.
An Act to regulate import, manufacture, distribution and sale of
Drugs and Cosmetics in the country. The
main object of the act is to prevent substandard in Drugs & Cosmetics. To ensure the quality of drugs manufactured
and sold in the state, drug samples are taken from manufacturing units,
hospitals and sales outlets and their quality is assessed after conducting
test/analysis in the Drugs Testing Laboratory of the Drugs Control
Administration.
2. Drugs
(Prices Control) Order, 1995 is issued by the Government of India under Section 3 of
the Essential Commodities Act 1955 (10 of 1955):
In this order, prices of 74 Bulk drugs and their formulations
are fixed by the Government of India (National Pharmaceutical Pricing Authority
under the Ministry of Chemicals and Fertilizers, Government of India) so as to
make these drugs available to the public at affordable prices. The enforcement wing of the Drug Control
Administration implements the provisions of the Drugs (Prices Control) Order
1995 in respect of the current prices of Bulk drugs and their formulations as
fixed by the National Pharmaceutical Pricing Authority. The drugs Control administration assists the
National pharmaceutical Pricing Authority in realization of the excess prices
charged by the errant manufacturers besides taking legal action against the
erring manufacturers and dealers.
3.
The
Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 & Rules
there under.
The above Act is an important piece
of legislation, enacted with a view to prevent objectionable and misleading
advertisement in order to discourage self medication and self treatment and to
control the advertisement of drugs in certain cases, to prohibit the
advertisements for certain purpose of remedies alleged to possess magic
qualities and to provide punishment for matters connected therewith. The enforcement wing of Drugs Control
Administration scrutinizes the labels, advertisements and other materials for
possible misleading and objectionable advertisements and the violators are
prosecuted in the Courts of law.
4. Narcotic Drugs and Psychotropic
Substances Act,1985 and Narcotic Drugs and Psychotropic Substances (Karnataka)
Rules 1985
The role of Drugs Control Department , Karnataka is to ensure
allocation of Narcotic Drugs and Psychotropic substances to the formulation
manufacturers in the state. Drugs Control Department , Karnataka under the
provisions of Narcotic Drugs and
Psychotropic Substances (Karnataka) Rules 1985, sanctions approval to
hospitals/ nursing homes as Recognised medical institution for the purpose of
possession, sale, import interstate, export interstate, or use of Oral Morphine
for the palliative care of cancer patients.
5 Poison Act, 1919 and
Karnataka Poisons Rule, 1966.
Under
Karnataka Poisons Rules 1966, license is granted for the stock and sale of
Poisons listed under the said rules. Inspections are also carried out to
ascertain whether the licensees are complying with the provisions of the above
statute are not.
Department’s
Enforce legislations to ensure quality
control of Drugs, by exercising strict control and vigilance on the drugs
manufactured and / or marketed, thereby ensuring drugs of standard quality,
purity, strength, safety available to the public at controlled prices.
Goals
and Objectives:
To strive for Pharmaceutical
excellence and health for all by ensuring the supply of safe, effective and
quality drugs at affordable prices to the people of Karnataka and endeavor to place
Karnataka Drugs Control Department on the global map as the best regulatory
agency.
Nature of work
a) Head quarters
·
Grant of fresh/renewal of manufacturing licences for Drugs &
Cosmetics. Grant/Renewal of approval of
approved laboratories. Grant/renewal of
poisons licence. Grant/Renewal of Blood
Banks and Blood components.
·
Inspections of manufacturing units and Blood banks.
·
Granting of permission to launch prosecutions
·
Scrutiny of reports sent by enforcement officers pertaining to
not of standard quality/adulterated/spurious/misbranded drugs. Investigation reports in respect of
complaints.
·
Issue of different certificates such as Good Manufacturing
Certificates (GMP certificate), Free Sale Certificate, Market Standing
Certificate, Export Registration Certificate etc., to the manufacturers for
export purpose.
·
Overall administration of the entire organization.
·
Accounts & Establishments section
·
Drawal of sample from the drugs/cosmetics manufacturing
establishments.
·
Launching of prosecution against the defaulters and follow up
court cases.
b) Blood Bank and Intelligence Wing:
·
Blood Bank Inspections in their respective jurisdiction.
·
Collection and dissemination of information
gathered during
intelligence work.
·
Inspection of drugs sales establishments
·
Drawl of sample from sales premises/hospitals for test and
analysis.
·
Launching of prosecution against the defaulters and follow up
court cases.
c)
Drugs Price Control Cell.
·
Inspection of drugs sales establishments
·
Detecting of price
control violation by manufacturers & dealers.
·
Drawl of samples from drugs sales premises/Hospitals for test
& analysis.
·
Launching of prosecution against the defaulters & follow up
court cases.
d)
Assistant Drugs Controllers / Drugs Inspectors at circles.
·
Grant / Renewal of licenses of sales establishments
·
Inspections of drugs sales establishment and government
hospitals
·
Investigation of complaints
·
Drawl of samples from sales/hospitals for test and analysis.
·
Launching of prosecution against the defaulters & follow up
court cases.
DRUGS CONTROL DEPARTMENT , MYSORE CIRCLE/MYSORE DIVISION
In
1) Office of the Deputy
Drugs Controller , Blood Bank and Intelligence Wing,
2) Office of the Assistant
Drugs Controller,
3) Office of the Assistant
Drugs Controller,
Office of the Deputy Drugs Controller , Blood Bank and
Intelligence Wing,
Address-
Deputy Drugs Controller, Blood Bank and
Intelligence Wing,
“ I” Block,
Phone no- 08212567180
Fax - 08212567180
e-mail: ddc__mys@yahoo.com
He is having jurisdiction
over the following Districts-
1) Mysore Dist.
2) Chamarajanagar Dist.
3) Kodagu Dist.
4) Udupi Dist.
5) Dakshina Kannada Dist
6) Chickkamagalore Dist.
7) Hassan Dist.
Organisation
Structure of the office of Deputy Drugs Controller, Blood Bank and Intelligence
Wing,
|
Sl. No |
Name of the officers/ official |
Designation |
No.of Posts |
Phone numbers |
|
1 |
Sri. H. Revanasiddappa |
Deputy Drugs Controller |
1 |
|
|
2 |
Sri.Nazeer Ahamed |
Drugs Inspector |
1 |
|
|
3 |
Smt. Mamatha. G |
Typist |
1 |
|
|
4 |
Sri. Mukthar Ahamed
Khan |
Driver |
1 |
|
|
5 |
Smt. Mangala Gouri |
Group-D |
1 |
|
Office of the Assistant Drugs Controller ,
Address-
Assistant Drugs Controller,
Complex,
“ I” Block,
Phone no- 0821-2568511
Fax – 0821-2568511
He is also a licensing
authority under the provisions of the Drugs and Cosmetics Act, 1940 and Rules
thereunder having jurisdiction over the following Areas.
|
Assistant Drugs
Controller, Mysore Circle-1 |
a. Entire K.R. Nagar Taluk b. Entire Hunsur Taluk c. Entire Periyapattana Taluk d. Entire Heggadavena Kote Taluk e. Postal Pincode of Comprising of 570001,570002, 570005 570007, 570009, 570012,
570020, 570021, 570022,
570024, 570025, 570026 |
Organisation
Structure of the office of Assistant Drugs Controller,
|
Sl. No |
Name of the officers/ official |
Designation |
No.of Posts |
Phone numbers |
|
1 |
Sri. V.L.Hambar |
Assistant Drugs Controller |
1 |
9945885442 |
|
2 |
Sri.M.Suresh |
Drugs Inspector |
1 |
9972573119 |
|
3 |
Vacant |
Office superintendent |
1 |
|
|
4 |
Smt. Indiramma. T.V |
Typist |
1 |
|
|
5 |
Vacant |
Group-D |
1 |
|
Office of the Assistant Drugs Controller , Mysore Circle-II
Address-
Assistant Drugs Controller, Mysore Circle-II, No. 186/B, Ist Floor,
Jwalamukhi Complex, “ I” Block,
Mysore-23.
Phone no- 08212568510
He is also a licensing
authority under the provisions of the Drugs and Cosmetics Act, 1940 and Rules
thereunder having jurisdiction over the following Areas.
|
Assistant Drugs
Controller, Mysore Circle-II |
a.Entire T.Narasipura Taluk b. Entire Nanjunagud
Taluk c. Entire d. Postal Pincode of Comprising of 570004,570006, 570008 570010, 570011, 570014,
570015, 570016, 570019,
570023, 570029, and Any pincode left over
in Area and also any
pincode newly forming in future. |
Organisation
Structure of the office of Assistant Drugs Controller, Mysore Circle-II
|
Sl. No |
Name of the officers/ official |
Designation |
No.of Posts |
Phone numbers |
|
1 |
Sri. Arun. B.P |
Assistant Drugs Controller |
1 |
9448407101 |
|
2 |
Sri.Babu. B.N |
Drugs Inspector |
1 |
9448205177 |
|
3 |
Vacant |
Office superintendent |
1 |
|
|
4 |
Vacant |
Typist |
1 |
|
|
5 |
Vacant |
Group-D |
1 |
|
HOME PAGE
1) Brief description of working of Drugs Control Department.
2) Organization structure
of the office of the Deputy Drugs
Controller, Blood bank
& Intelligence Wing,
3) Organization structure
of the office of the Assistant Drugs Controller,
Circle-I
4) Organization structure of the office of the Assistant Drugs Controller,
Circle-II
5) Details
of Licensing procedures
|
Sl no |
Licensing Particulars |
Application and other documents to be submitted as per
the Check list |
Licenses in forms To Be Granted |
|
1 |
Retail Licenses |
Application in Form 19 |
20 & 21 |
|
2 |
Wholesale Licenses |
Application in Form 19 |
20B & 21B |
|
3 |
Retail and Wholesale Licenses |
Application in Form 19 ( 2 Numbers) |
20, 21, 20B and 21B |
|
4 |
Restricted Licenses |
Application in Form 19A |
20A & 21A |
|
5 |
Motor Vehicle Licenses |
Application in Form 19AA |
20BB & 21BB |
6)
Other related links
Central Drugs Standard Control Organization - www.cdsco.nic.in
National Pharmaceutical Pricing Authority
– www. nppaindia. nic. in
CHECK LIST OF DOCUMENTS TO BE SUBMITTED WHILE APPLYING FOR THE GRANT OF FRESH LICENCES
IN FORMS 20, 21. (Retail )
1) Covering Letter (Application)
CªÀgÀt ¥ÀvÀæ
2).Form-19
Cfð £ÀªÀÄÆ£É -19
3).Additional Information Sheet
C¢üPÀ ªÀiÁ»w ºÁ¼É
4). Fees of Rs.3000/-
to be Paid in the following Head
of Account through Govt
challan at SBM,
±ÀÄ®Ì gÀÆ 3000 F PɼÀPÀAqÀ
¯ÉPÀÌ ²Ã¶ðPUÉ ¸ÀPÁðj ZÀ®£À ªÀÄÄSÁAvÀgÀ J¸ï © JªÀiï SeÁ£É ±ÁSÉ, C±ÉÆÃPÀ gÀ¸ÉÛ
ªÉÄʸÀÆj£À°è ¥ÁªÀw¸À vÀPÀÌzÀÄÝ
0210 Medical and Public Health
04 Public Health , 104 Fees etc,
201 Drugs and Cosmetics Act and
Rules Drugs Control Department
5).Photocopy of the Tax Paid
Receipt (latest)
EwÛÃa£À PÀAzÁAiÀÄ gÀ²Ã¢ ¥Àæw
6).Photocopy of the Rental
Agreement / lease deed (which is notarized) if the applicant is a legal tenant
¨ÁrUÉ PÀgÁgÀÄ ¥ÀvÀæ / °Ã¸ï rÃqï (£ÉÆÃlj
ªÀiÁqÀ¯ÁzÀ )
7) Proprietorship Declaration/ Partnership deed/
Articles of Association and Memorandum
ªÀiÁ°PÀvÀézÀ WÉÆõÀuÉ/¥Á®ÄzÁjPÉAiÀÄ PÀgÁgÀÄ
¥ÀvÀæ
8).Refrigerator Invoice / Declaration
²ÃvÀPÀAiÀÄAvÀæzÀ Rjâ ©®Äè/ WÉÆõÀuÉ ¥ÀvÀæ
9).Qualified Person Proforma in
respect of the Registered Pharmacist
CºÀðvÁ ªÀåQÛAiÀÄ £ÉêÀÄPÀ ¥ÀvÀæ
10).Photocopy and Original
Diploma in pharmacy certificate and
Pharmacy
Council Certificate
r ¥sÁªÀiÁð ªÀÄvÀÄÛ PÀ£ÁðlPÀ gÁdå OµÀzsÀ «eÁУÀ ¥ÀjµÀwÛ£À
£ÉÆÃAzÀt ¥ÀæªÀiÁt ¥ÀvÀæ (ªÀÄÆ®
ªÀÄvÀÄÛ eÉÃgÁPïì ¥ÀæwUÀ¼ÀÄ)
11).Affidavit of the Qualified
Person on a stamp paper of Rs. 20 /- which has to be
notarized (20.gÀÆ.¨ÁAqï ¥ÉÃ¥Àgï ªÉÄÃ¯É CºÀðvÀ ªÀåwÛAiÀÄ
±À¥ÀzsÀ ¥ÀvÀæ ( £ÉÆÃlj¬ÄAz zÀÈrüPÀÈvÀ
ªÁVgÀvÀPÀzÀÄÝ )
12) Plan /sketch of the proposed sales premises
showing the dimensions of the area. It
should contain the name and address of
the premises and duly signed by the
applicant.
DªÀgÀtzÀ
£ÀPÉë
13).Address Proof of the
applicant
CfðzÁgÀgÀ «¼Á¸À ªÀiÁ»w
14).Option and Approval Form in
duplicate.
C©üªÀÄvÀ ªÀÄvÀÄÛ C£ÀĪÉÆÃzÀ£ÉAiÀÄ
£ÀªÀÄÆ£É ¢é¥ÀæwUÀ¼ÀÀ°è
15).Photos (Qualified Person
:-Post card size I and Pass Port size 2;) and One passport
size photo of the Proprietor/
Partners/ Directors
J) CºÀðvÁ ªÀåQÛAiÀÄ ¨sÁªÀ avÀæ ¥ÉÆøï PÁqÀð-1, ¥Á¸ï ¥ÉÆÃlð ¸ÉÊdÄ
– 2,
©) ªÀiÁ°ÃPÀgÀÄ/ ¥Á®ÄzÁgÀgÀÄ/qÉÊgÉÃPÀÖgï
¨sÁªÀ avÀæ MAzÀÄ ¥Á¸ï ¥sÉÆÃlð ¸ÉÊeï
7) Area of the Premises for which application is made
shall not be less than
1) 10 sq. meters in case of
licence in forms 20.21.(Retail)
2) 15 sq. meters in case of licence in forms 20 ,21, and 20B, 21B.
ºÉƸÀ ¥ÀgÀªÁzÀUÉ ¥ÀqÉAiÀÄ®Ä ªÀiÁgÁl CªÀgÀtzÀ «¹ÛÃtð F PɼÀPÀAqÀ
µÀgÀvÀÄÛUÀ½UÉ M¼À¥ÀnÖgÀÄvÉÛzÉ
1)
20-21-a®ègÉ OóµÀzsÀ ¥ÀgÀªÁ¤UÉ ªÀÄAdÆgÁwUÁV-10 ZÀzÀgÀ
«ÄÃlgïUÀ½VAvÀ PÀrªÉÄ EgÀ¨ÁgÀzÀÄ
2)
20-21/ 20©-21©-a®ègÉ ªÀÄvÀÄÛ ¸ÀUÀlÄ OµÀzsÀ ¥ÀgÀªÁ¤UÉUÁV 15
ZÀzÀgÀ «ÄÃlgï UÀ½VAvÀ PÀrªÉÄ
EgÀ¨ÁgÀzÀÄ
Note-1) Those who intends to possess license in form
20G to deal in Sch.X drugs by way
of wholesale
they shall submit the application in form 19C alongwith challan
of Rs. 500/- credited to the
same Head of Account mentioned above.
2)
Those who intends to
possess license in form 20F to deal in Sch.X drugs by way
of retail
they shall submit the application in form 19C alongwith challan
of Rs. 500/- credited to the
same Head of Account mentioned above.
µÀgÁ1 1) – C£ÀĸÀÆa JPÀì £À°è OµÀzsÀUÀ¼À£ÀÄß ¸ÀUÀlÄ ªÁå¥ÁgÀ ªÀiÁqÀ®Ä EaѸÀĪÀªÀgÀÄ
¸À°è¹gÀĪÀ zÁR¯ÁwUÀ¼À dÆvÉUÉ 19¹ Cfð £ÀªÀÄÆ£É ºÁUÀÆ gÀÆ 500 gÀ ZÀ®£ï£ÉÆA¢UÉ
ªÉÄîÍAqÀ ¯ÉPÀÌ ²Ã¶ðPÉ AiÀÄ°è ºÀt ¸ÀAzÁAiÀÄ ªÀiÁr, 20f ¥ÀgÀªÁ£ÀVAiÀÄ£ÀÄß
¥ÀqÉAiÀħºÀÄzÀÄ.
2) – C£ÀĸÀÆa JPÀì £À°è
OµÀzsÀUÀ¼À£ÀÄß a®ègÉ ªÁå¥ÁgÀ ªÀiÁqÀ®Ä EaÒ¸ÀĪÀªÀgÀÄ ¸À°è¹gÀĪÀ zÁR¯ÁwUÀ¼À
dÆvÉUÉ 19¹ Cfð £ÀªÀÄÆ£É ºÁUÀÆ gÀÆ 500 gÀ ZÀ®£ï£ÉÆA¢UÉ ªÉÄîÍAqÀ ¯ÉPÀÌ ²Ã¶ðPÉ
AiÀÄ°è ºÀt ¸ÀAzÁAiÀÄ ªÀiÁr, 20ZÁ¥À ¥ÀgÀªÁ£ÀVAiÀÄ£ÀÄß ¥ÀqÉAiÀħºÀÄzÀÄ.
.
CHECK LIST OF DOCUMENTS TO BE SUBMITTED WHILE APPLYING FOR THE GRANT OF FRESH LICENCES IN FORMS 20B & 21 B (Wholesale)
1) Covering Letter (Application)
CªÀgÀt ¥ÀvÀæ
2).Form-19
Cfð £ÀªÀÄÆ£É -19
3).Additional Information Sheet
C¢üPÀ ªÀiÁ»w ºÁ¼É
4). Fees of Rs.3000/-
to be Paid in the following Head
of Account through Govt
challan at SBM,
±ÀÄ®Ì gÀÆ 3000 F
PɼÀPÀAqÀ ¯ÉPÀÌ ²Ã¶ðPUÉ ¸ÀPÁðj ZÀ®£À
ªÀÄÄSÁAvÀgÀ J¸ï © JªÀiï ReÁ£É ±ÁSÉ, C±ÉÆÃPÀ gÀ¸,ÉÛ ªÉÄʸÀÆj£À°è ¥ÁªÀw¸À
vÀPÀÌzÀÄÝ
0210
Medical and Public Health
04 Public Health , 104 Fees etc,
201 Drugs and Cosmetics Act and
Rules Drugs Control Department
5).Photocopy of the Tax Paid
Receipt (latest)
EwÛÃa£À PÀAzÁAiÀÄ gÀ²Ã¢ ¥Àæw
6).Photocopy of the Rental
Agreement / lease deed (which is notarized) if the applicant is a legal tenant
¨ÁrUÉ PÀgÁgÀÄ ¥ÀvÀæ / °Ã¸ï rÃqï (£ÉÆÃlj ªÀiÁqÀ¯ÁzÀ )
7) Proprietorship Declaration/ Partnership deed/
Articles of Association and Memorandum
ªÀiÁ°PÀvÀézÀ WÉÆõÀuÉ/¥Á®ÄzÁjPÉAiÀÄ PÀgÁgÀÄ ¥ÀvÀæ
8).Refrigerator Invoice /
Declaration
²ÃvÀPÀAiÀÄAvÀæzÀ Rjâ ©®Äè/ WÉÆõÀuÉ ¥ÀvÀæ
9).Competent person Proforma
zÀPÀë ªÀåQÛ £ÉêÀÄPÀ ¥ÀvÀæ
10).Photocopy of qualification
certificate and experience certificate of the proposed
competent person
zÀPÀë ªÀåQÛAiÀÄ «zÁåºÀðvÁ ºÁUÀÆ C£ÀĨsÀªÀ
¥ÀævÀUÀ¼ÀÄ)
11).Affidavit of the
Competent Person on a stamp paper of Rs.
20 /- which has to be
notarized (20.gÀÆ.¨ÁAqï ¥ÉÃ¥Àgï ªÉÄï
zÀPÀë ªÀåwÛAiÀÄ ±À¥ÀzsÀ ¥ÀvÀæ ( £ÉÆÃlj¬ÄAz zÀÈrüPÀÈvÀ
ªÁVgÀvÀPÀzÀÄÝ )
12) Plan /sketch of the proposed sales premises
showing the dimensions of the area. It
should contain the name and address of
the premises and duly signed by the
applicant.
DªÀgÀtzÀ £ÀPÉë
13).Address Proof of the
applicant
CfðzÁgÀgÀ «¼Á¸À ªÀiÁ»w
14).Photos (Competent person:-
Post card size I and Pass Port size 2;) and One passport
size photo of the Proprietor/
Partners/ Directors
J) zÀPÀë
ªÀåQÛAiÀÄ ¨sÁªÀ avÀæ ¥ÉÆøï PÁqÀð-1, ¥Á¸ï ¥ÉÆÃlð ¸ÉÊdÄ – 2,
©) ªÀiÁ°ÃPÀgÀÄ/ ¥Á®ÄzÁgÀgÀÄ/qÉÊgÉÃPÀÖgï ¨sÁªÀ
avÀæ MAzÀÄ ¥Á¸ï ¥sÉÆÃlð ¸ÉÊeï
15) Documentary evidence from the concerned
Government agency that the proposed
premises for which the said application
is made is a commercial property.
¸ÀUÀlÄ OµÀzsÀ ¥ÀgÀªÁ£ÀV ¥ÀqÉAiÀÄ®Ä ¸ÀA§AzÀ¥ÀlÖ ¸ÀPÁðj E¯ÁSɬÄAzÀ
PÀl×qÀªÀÅ
ªÁå¥ÁgÀ GzÉÝñÀPÁÌV C£ÀĪÀÄwAiÀÄ£ÀÄß
¥ÀqÉ¢gÀĪÀ zÀÈrÃPÀÈvÀ ¥ÀvÀæªÀ£ÀÄß ¸À°è¸ÀĪÀÅzÀÄ.
15) Area of the Premises for which application is made
shall not be less than
1) 10 sq. meters in case
of licence in forms 20B & 21B
(wholesale)
ºÉƸÀ ¥ÀgÀªÁ¤UÉ ¥ÀqÉAiÀÄ®Ä ªÀiÁgÁl CªÀgÀtzÀ
«¹ÛÃtð F PɼÀPÀAqÉ µÀgÀvÀÄÛUÀ½UÉ M¼À¥ÀnÖgÀÄvÀÛzÉ.
1) 20©-21©-¸ÀUÀlÄ OµÀzsÀ ¥ÀgÀªÁ¤UÉ
ªÀÄAdÆgÁwUÁV -10 ZÀzÀgÀ «ÄÃlgïUÀ½VAvÀ PÀrªÉÄ
EgÀ¨ÁgÀzÀÄ
CHECK LIST OF DOCUMENTS TO BE SUBMITTED
WHILE APPLYING FOR THE GRANT OF FRESH LICENCES IN FORMS 20, 21, 20B and 21B
(Retail and Wholesale)
1) Covering Letter (Application)
CªÀgÀt ¥ÀvÀæ
2).Form-19 (Two ;numbers )
Cfð £ÀªÀÄÆ£É -19
3).Additional Information Sheet
C¢üPÀ ªÀiÁ»w ºÁ¼É
4). Fees of Rs.6000/-
to be Paid in the following Head
of Account through Govt
challan at SBM,
±ÀÄ®Ì
gÀÆ 6000 F PɼÀPÀAqÀ ¯ÉPÀÌ ²Ã¶ðPÀUÉ ¸ÀPÁðj ZÀ®£À ªÀÄÄSÁAvÀgÀ J¸ï © JªÀiï
SeÁ£É ±ÁSÉ C±ÉÆÃPÀ gÀ¸ÉÛ ªÉÄʸÀÆj£À°è
¥ÁªÀw¸À vÀPÀÌzÀÄÝ
0210 Medical and Public Health
04 Public Health , 104 Fees etc,
201 Drugs and Cosmetics Act and
Rules Drugs Control Department
5).Photocopy of the Tax Paid
Receipt (latest)
EwÛÃa£À PÀAzÁAiÀÄ gÀ²Ã¢ ¥Àæw
6).Photocopy of the Rental
Agreement / lease deed (which is notarized) if the applicant is a legal tenant
¨ÁrUÉ PÀgÁgÀÄ ¥ÀvÀæ / °Ã¸ï rÃqï (£ÉÆÃlj
ªÀiÁqÀ¯ÁzÀ )
7) Proprietorship Declaration/ Partnership deed/
Articles of Association and Memorandum
ªÀiÁ°PÀvÀézÀ WÉÆõÀuÉ/¥Á®ÄzÁjPÉAiÀÄ PÀgÁgÀÄ ¥ÀvÀæ
8).Refrigerator Invoice /
Declaration
²ÃvÀPÀAiÀÄAvÀæzÀ Rjâ ©®Äè/ WÉÆõÀuÉ ¥ÀvÀæ
9).Qualified Person Proforma in
respect of the Registered Pharmacist
CºÀðvÁÀ ªÀåQÛAiÀÄ £ÉêÀÄPÀ ¥ÀvÀæ
10).Photocopy and Original
Diploma in pharmacy certificate and
Pharmacy
Council Certificate
r ¥sÁªÀiÁð ªÀÄvÀÄÛ PÀ£ÁðlPÀ gÁdå OµÀzsÀ
«eÁУÀ ¥ÀjµÀwÛ£À £ÉÆÃAzÀt ¥ÀæªÀiÁt ¥ÀvÀæ (ªÀÄÆ®
ªÀÄvÀÄÛ eÉÃgÁPïì ¥ÀæwUÀ¼ÀÄ)
11).Affidavit of the Qualified
Person on a stamp paper of Rs. 20 /- which has to be
notarized (20.gÀÆ.¨ÁAqï ¥ÉÃ¥Àgï ªÉÄÃ¯É CºÀðvÀ ªÀåwÛAiÀÄ ±À¥ÀzsÀ ¥ÀvÀæ (
£ÉÆÃlj¬ÄAz zÀÈrüPÀÈvÀ
ªÁVgÀvÀPÀzÀÄÝ )
12) Plan /sketch of the proposed sales premises
showing the dimensions of the area. It
should contain the name and address of
the premises and duly signed by the
applicant.
DªÀgÀtzÀ
£ÀPÉë
13).Address Proof of the
applicant
CfðzÁgÀgÀ «¼Á¸À ªÀiÁ»w,
14).Option and Approval Form in
duplicate.
C©üªÀÄvÀ ªÀÄvÀÄÛ C£ÀĪÉÆÃzÀ£ÉAiÀÄ £ÀªÀÄÆ£É ¢é¥ÀæwUÀ¼ÀÀ°è
15).Photos (Qualified Person
:-Post card size I and Pass Port size 2;) and One passport
size photo of the Proprietor/
Partners/ Directors
J) CºÀðvÁ ªÀåQÛAiÀÄ ¨sÁªÀ avÀæ ¥ÉÆøï
PÁqÀð-1, ¥Á¸ï ¥ÉÆÃlð ¸ÉÊdÄ – 2,
©) ªÀiÁ°ÃPÀgÀÄ/ ¥Á®ÄzÁgÀgÀÄ/qÉÊgÉÃPÀÖgï
¨sÁªÀ avÀæ MAzÀÄ ¥Á¸ï ¥sÉÆÃlð ¸ÉÊeï
7) Area of the Premises for which application is made
shall not be less than
1) 15 sq. meters in case of licence in forms 20 ,21, and 20B,
21B.
ºÉƸÀ ¥ÀgÀªÁ¤UÉ ¥ÀqÉAiÀÄ®Ä ªÀiÁgÁl CªÀgÀtzÀ
«¹ÛÃtð F PɼÀPÀAqÉ µÀgÀvÀÄÛUÀ½UÉ M¼À¥ÀnÖgÀÄvÀÛzÉ.
1)
20-21/ 20©-21©-a®ègÉ ªÀÄvÀÄÛ ¸ÀUÀlÄ OµÀzsÀ ¥ÀgÀªÁ¤UÉUÁV 15
ZÀzÀgÀ «ÄÃlgï UÀ½VAvÀ PÀrªÉÄ
EgÀ¨ÁgÀzÀÄ
CHECK LIST OF DOCUMENTS TO BE SUBMITTED
WHILE APPLYING FOR THE GRANT OF FRESH LICENCESS IN FORMS 20A and 21A
(Restricted licences )
1) Covering Letter (Application)
CªÀgÀt ¥ÀvÀæ
2).Form-19A
Cfð £ÀªÀÄÆ£É -19 J
3).Additional Information Sheet
C¢üPÀ ªÀiÁ»w ºÁ¼É
4). Fees of Rs.1000/-
to be Paid in the following Head
of Account through Govt
challan at SBM,
±ÀÄ®Ì
gÀÆ 1000 F PɼÀPÀAqÀ ¯ÉPÀÌ ²Ã¶ðPÀUÉ ¸ÀPÁðj ZÀ®£À ªÀÄÄSÁAvÀgÀ J¸ï © JªÀiï
SeÁ£É ±ÁSÉ, C±ÉÆÃPÀ gÀ¸ÉÛ ªÉÄʸÀÆj£À°è ¥ÁªÀw¸À vÀPÀÌzÀÄÝ
0210 Medical and Public Health
04 Public Health , 104 Fees etc,
201 Drugs and Cosmetics Act and
Rules Drugs Control Department
5).Photocopy of the Tax Paid
Receipt (latest)
EwÛÃa£À PÀAzÁAiÀÄ gÀ²Ã¢ ¥Àæw
6).Photocopy of the Rental
Agreement / lease deed (which is notarized) if the applicant is a legal tenant
¨ÁrUÉ PÀgÁgÀÄ ¥ÀvÀæ / °Ã¸ï rÃqï (£ÉÆÃlj ªÀiÁqÀ¯ÁzÀ )
7) Proprietorship Declaration/ Partnership deed/
Articles of Association and
Memorandum
ªÀiÁ°PÀvÀézÀ WÉÆõÀuÉ/¥Á®ÄzÁjPÉAiÀÄ PÀgÁgÀÄ ¥ÀvÀæ
8) Plan /sketch of the proposed sales premises
showing the dimensions of the area. It
should contain the name and address of
the premises and duly signed by the
applicant.
DªÀgÀtzÀ £ÀPÉë
9.Address Proof of the applicant
CfðzÁgÀgÀ «¼Á¸À ªÀiÁ»w,
10).Photos ( One passport size
photo of the Proprietor/ Partners/ Directors )
ªÀiÁ°ÃPÀgÀÄ/ ¥Á®ÄzÁgÀgÀÄ/qÉÊgÉÃPÀÖgï ¨sÁªÀ avÀæ MAzÀÄ ¥Á¸ï
¥sÉÆÃlð ¸ÉÊeï
CHECK LIST OF DOCUMENTS TO BE SUBMITTED
WHILE APPLYING FOR THE GRANT OF FRESH LICENCESS IN FORMS 20BB and 21BB
(Motor Vehicle Licenses)
1) Covering Letter (Application)
CªÀgÀt ¥ÀvÀæ
2).Form-19AA
Cfð £ÀªÀÄÆ£É -19 J
3).Additional Information Sheet
C¢üPÀ ªÀiÁ»w ºÁ¼É
4). Fees of Rs.500 /-
per license to be Paid in the
following Head of Account through
Govt challan at SBM,
±ÀÄ®Ì
gÀÆ 500/ -F PɼÀPÀAqÀ ¯ÉPÀÌ ²Ã¶ðPUÉ ¸ÀPÁðj ZÀ®£À ªÀÄÄSÁAvÀgÀ J¸ï © JªÀiï
SeÁ£É ±ÁSÉ, C±ÉÆÃPÀ gÀ¸ÉÛ ªÉÄʸÀÆj£À°è ¥ÁªÀw¸À vÀPÀÌzÀÄÝ
0210
Medical and Public Health
04 Public Health , 104 Fees etc,
201 Drugs and Cosmetics Act and Rules
Drugs Control Department
5) Photocopy of the vehicle
registration certificate
ªÁºÀ£ÀzÀ £ÉÆÃAzÀt ¥ÀæªÀiÁt¥ÀvÀæzÀ
bÁAiÀiÁ¥Àæw.
6) Photo of the vehicle showing
the registration number.
ªÁºÀ£ÀzÀ
£ÉÆÃAzÀuÉAiÀÄ£ÀÄß ºÉÆA¢gÀĪÀ
ªÁºÀ£ÀzÀ ¨sÁªÀavÀæ
7) Proprietorship Declaration/ Partnership deed/
Articles of Association and
Memorandum
ªÀiÁ°PÀvÀézÀ WÉÆõÀuÉ/¥Á®ÄzÁjPÉAiÀÄ PÀgÁgÀÄ ¥ÀvÀæ
9.Address Proof of the applicant
CfðzÁgÀgÀ «¼Á¸À ªÀiÁ»w,
10).Photos ( One passport size
photo of the Proprietor/ Partners/ Directors )
ªÀiÁ°ÃPÀgÀÄ/ ¥Á®ÄzÁgÀgÀÄ/qÉÊgÉÃPÀÖgï ¨sÁªÀ avÀæ MAzÀÄ ¥Á¸ï
¥sÉÆÃlð ¸ÉÊeï
FORM-19
[see Rule 59 (2) ]
(Application for grant or renewal of a
licence to sell, stock or exhibit or
offer for
sale or distribute) drugs other than those
specified in Schedule X
1. I/We ……………………………of……………………………………….
hereby
apply for a licence to sell by Wholesale
/ Retail drugs specified in Schedules C and C(1) excluding those specified in
Schedyule X and /or drugs other than those specified in Schedules C and C (1) to the Drugs and Cosmetics Rules ,1945 and also to operate a Pharmacy on
the premises situated
at……………………………………………………………………………..
2.
The sale and dispensing of drug will be made under the personal
supervision of
qualified person
(Name)…………………………..(Qualifications)…………………………...
(Name)………………………….
(Qualifications)…………………………....
3.
Categories of drugs to be sold
…………………………………………
4.
Particulars of storage accommodation for Schedules C and C (I) drugs
in the Premises referred to above
…………………………………………………….
………………………………………………………………………………...
5. A
fee of rupees ………………………………………………………….
Has been
credited to Government under the Head
of account ………………..
………………………………………………………………………………..
Date
……………………
Signature
……………
FOR
OFFICE USE ONLY
Ref.No
DCD ADCD/BNG11/………../LS/9………9……issued fresh..........
Licence
(s) in form (s) …………….dated ……………..renewed vide……...
Certificares
in Form 21 C Nos………………dated …………………to the
Application
for categories of drugs ………………(Refrigerator Provided)
With
the Q.P/C.P ……………………………..
Asst,
Drugs Controller Licencing
Authority & Asst Drugs Controller
RECEIPT
Received application (s) for grant /renewal of licence
(s)
(contest not verified)
Licencing Authority &
Asst Drugs Controller
(FORM 19-A)
[See Rule 59 (2)]
[Application for grant or renewal of a restricted licence
to sell , stock or exhibit
(or offer) for sale, or distribute drugs by retail by dealers who do
not engage service of a qualified person ]
1.
I/We_________________________of______________hereby ___________apply
for a licence to sell by retail
(i) Drugs other than those specified in
schedules C and C (1) and X on the Premises
situated at____________
(ii) Drugs
specified in [schedule C (1) ] on the premises situated at ____________
____________________________________________________________________
Drugs
specified in [Schedule C (1) as vendor in the area
2. Sales
shall be restricted to such drugs as can be sold without the supervision of
a
qualified person under the Drugs
and Cosmetics Rules
3. Names or
classes of drugs proposed to be sold………………………..
4.
Particulars of the storage accommodation for the storage of [Schedules C (1)
drugs
on the
premises referred to above.
5.The drugs
for sale will be purchased from the following dealers and such other
dealers
as may be endorsed on the licence by the licensing authority from time to
time.
Name of
the dealers …………………licence No………………………….
6.Afee of
rupees___________has been credited to Government under the
head of
account …………………..
Date……………………
Inspector………………………
(FORM 19-C)
[See Rule 59 (2)]
Application for grant or renewal of a [licence to sell ,
stock , exhibit or offer for sale or
distribute] of drugs specified in Schedule X,
1.I/We………………of……………..here by apply
for a licence to sell by
wholesale/ retail drugs
specified in Schedule X to the Drugs and
Cosmetics
Rules, 1945 We operate a
Pharmacy on Premises sitanted at………….
2. The sale an dispensing of drugs
will be made under the personal supervision of
the qualified persons mentioned
below,
………….
(Name)………(Qualifications)
…………..(Name)………(
Qualifications)
3.Name of drugs to
be sold .
4.Particulars of storage accomdation
5.A fee……........has been credited to Government account under the head
of account ………………
……………………………………………………………………………….
Date……………………………. Signature ……………………....
(FORM -19 AA)
[ See Rule 62-C]
Application for grant or renewal of a [licence to sell, stock
or exhibit or offer for sale by wholesale or distribute] drugs from a
motor vehicle
1.
I/we …………of………………………..here by apply for [licence to sell, stock or exhibit or offer for sale by wholesale or
distribute] drugs specified in Schedule C
and C (1) and /or drugs other than
those specified in Schedule C and
Schedule C (1) from the vehicle bearing registration No……………assigned under the Motor Vehicle Act, 1939.
2. Categories of drugs to be sold /distributed___
…………………………………………….
…………………………………………….
…………………………………………….
3.A Fee of rupees …………………………………has been
credited to Government
under
the head of account ……………………………………………
4.Particulars of the storage accommodation
for the storage of drugs specified in
schedule C & C (1) on the vehicle
referred to above.
Signature……………………….
Date …………………….
ADDITIONAL
INFORMATION TO BE SUPPLIED WITH THE APPLICATION
IN
FORM 19/ 19-A/19AA/19-C
1.(a) The Constitution of the
firm : Proprietor
ship /Partnership/Company
/Private Limited /
Public Limited /Cooperative
Society /Registered/
Unregistered. Necessary
Documentary evidence like
Partnership deed, Memorandum of
Articles etc. should be
submitted
(b) Names of all the partners ,
Directors ,Proprietor
etc. and their full residential
address of each:-
(1)
………………………………………………………
……………………………………………………….
(2)
……………………………………………………….
……………………………………………………….
(3)
……………………………………………………….
……………………………………………………….
(4)
……………………………………………………….
……………………………………………………….
(5)
……………………………………………………….
……………………………………………………….
2.What are the educational
qualifications of____
(a)
The applicant
or/and ……
(b)
Person in charge of the premises for which licence
is applied for.
3. Has the applicant ever
engaged himself or on behalf of
any other person in selling drugs any time prior to this
application ? If so, the dates
together with necessary
documentary evidence may be
supplied (enclosed) ……
4.What other business is carried
on by the applicant at present ?
5.Is the application for fresh
licence or renewal ? …….
6.Year in which licence was
first granted …….
7.Particulars of licences
granted under Drugs Rules.
Form licence No. Date of Issue
20
21
20B
21B
20G
20F
20A
21A
20BB
21BB
8. Was the application ever rejected or licence
previously cancelled or suspended or
surrendered ?
If so, for what reason ?
9 .Was the applicant ever warned for selling drugs
which were not of standard quality ?
10.Was the application or any
person at present
employed by him on this premises ever Convicted
and sentenced under _____
(a) Drugs and Cosmetics Act,
1940 ……
(b) Drugs (Prices Control) Order, 1995 …….
(c) The Poisons Act, 1919
……..
(d) The Pharmacy Act,1948.
(e) Any other Act.
…….. Date of
issue
11.(a) The Karnataka Poisons
Rules, 1966 . Licence No. Date of issue
12. Sale of Intoxicants Taxation
Act .
Licence No. Date of issue
13. Spirituous Medicinal
Preparations Rules
Licence No. Date of issue
14.Sales Tax Registration
No.
Licence No. Date of issue
15.Shops and Establishments
Act.
Licence No. Date of issue
16.Application fee:
Amount Challan No Date of challan
17.Is the applicant an agent or
Distributor of any
drug
manufacturing concern ? If so the area of
distribution
and date of appointment should be
stated with
full particulars .
The applicant shall inform the licensing Authority
if the agency is terminated any
time during which the
licence is in force.
18.Is the Firm or Company
(a) Restaurant ?
……..
(b) Provision stores ? …….
(c) Petty Shop ?
……..
(d) General Merchant ? ……..
(e) Drugs stores ? ……..
(f) Chemist
and Druggist ? ……..
(g) Dispensing Chemist ? ………
(h) Distributing Agency
? ……..
(I) Stockiest
?
……..
(j) Wholesaler ? ……..
19.The applicant has in all
_____rooms for storage
and sale of drugs, The floor
area square feet of each
room must be given with a sketch . ……….
Whether the applicant is a legal
tenant or the owner
of the premises ? Necessary
documentary evidence
should be enclosed …………
20.The applicant does /does not
stock or sell drugs at
any other premises nor he has the office
except at the premises
for which this application is made -.
OR
The address of other premises are
1.
2.
21.What class of drugs and
cosmetics are stocked
sold or distributed:
(a) Poisons .
……..
(b) Injections. ……..
(c) Oral Vitamin Products. ……..
(d) House-hold remedies. …….
(e)
Tinctures and other
Spirituous Preparation . ………
(f) Ayurvedic and Unani Medicines ? ……….
(g) Homoeopathic medicines ……….
(h) Cosmetics
……….
(i) Veterinary Drugs ……….
22.The applicant deals in the
following class of commodities
only, besides drugs on these
premises viz,
1.
2.
3.
23.Storage facilities.
1.Racks. ………..
2.Locked cupboards ………..
3. Refrigerator. ……….
4. Cold room. ……….
24. Hours of business and
working days.
… …………
25. Name of the trade or
professional Association of which
the applicant is a member and
the date of commencement of
membership.
………..
26. Name / Categories of drugs /
proposed to be / are
being sold should
be furnished in detail in a list in
triplicate
…………
I certify that all the above
information is true and I understand that my application is liable to be
rejected summarily or the licence liable to be cancelled forth with if the
above information is proved to be false in any particular .
Signature
of the Applicant
Name in block letters ………….........................
Place ………………………………….
Designation …………………………………..
Date…………………………………..
Seal ……………………………………………
________________________________________________________________________
Note: Whatever not applicable should be
struck off.
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¥Àj¥ÀvÀ
___________________________________________
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