Professional Documents
Culture Documents
Drugs and Cosmetic Act
Drugs and Cosmetic Act
2
History
British misrule-Providing poor healthcare system
to Indian citizens
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Definitions
Drugs :
All medicines for internal or external use of
human beings or animals and all substances
intended to be used for or in the diagnosis,
treatment, mitigation or prevention of any disease
or disorder in human beings or animals, including
preparations applied on human body for the
purpose of repelling insects like mosquitoes.
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Cosmetic :
Any article intended to be rubbed, poured,
sprinkled or sprayed on, or introduced into, or
otherwise applied to, the human body or any part
thereof for cleansing, beautifying, promoting
attractiveness, or altering the appearance, and
includes any article intended for use as a
component of cosmetic.
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Misbranded drugs :
(a) if it is so coloured, coated, powdered or
polished that damage is concealed or if it is made
to appear of better or greater therapeutic value
than it really is; or
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Adulterated drug :
(a) if it consists, in whole or in part, of any filthy,
putrid or decomposed substance; or
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Manufacture :
In relation to any drug or cosmetic, it includes
any process or part of a process for making,
altering, ornamenting, finishing, packing,
labelling, breaking up or otherwise treating or
adopting any drug or cosmetic with a view to its
sale or distribution but does not include the
compounding or dispensing of any drug, or the
packing of any drug or cosmetic, in the ordinary
course of retail business.
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Patent or Proprietary medicine :
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Administration of the act and rules
A) Advisory :
1)Drugs Technical Advisory Board-DTAB
2)Drugs Consultative Committee-D.C.C.
B) Analytical :
1)Central Drugs Laboratory - CDL
2)Drug Control Laboratory in states
3)Government Analysts
C) Executives :
1)Licensing authorities
2)Controlling authorities
3)Drug Inspectors
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Drugs Technical Advisory Board(DTAB)
Ex-Officio:
(i) Director General of Health Services (Chairman)
(ii) Drugs Controller, India
(iii)Director of the Central Drugs Laboratory, Calcutta
(iv) Director of the Central Research Institute, Kasauli
(v)Director of Indian Veterinary Research Institute,
Izatnagar
(vi) President of Medical Council of India
(vii) President of the Pharmacy Council of India
(viii)Director of Central Drug Research Institute,
Lucknow
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Nominated:
1) Two persons by the Central Government.
2) One person by the Central Government from
the pharmaceutical industry
3) Two persons holding the appointment of
Government Analyst under this Act,
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Elected:
1)one person, to be elected by the Executive Committee of the
Pharmacy Council of India,
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Drugs Consultative Committee(DCC)
It is also an advisory body constituted by central
government.
Constitution:
Two representatives of the Central
Government
One representative of each State
Government
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Functions:
To advise the Central Government, the State
Governments and the Drugs Technical Advisory
Board on any other matter tending to secure
uniformity throughout India in the
administration of this Act.
Functions:
Analysis or test of samples of drugs/cosmetics sent by the
custom collectors or courts.
Analytical Q.C. of the imported samples.
Collection, storage and distribution of internal standards.
Preparation of reference standards and their maintenance.
Maintenance of microbial cultures.
Any other duties entrusted by Central Government.
Acting as an appellate authority in matter of disputes.
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Drug control laboratories in state
In gujarat three laboratories established which collect, analysed
and report the various sample of the drugs and food.
1) Baroda: Established in 1959.
2) Bhuj: Established in 1979.
3) Rajkot: Established in 1983
The laboratory has the following devision:-
Pharmaceutical Chemistry Division
Immunology Division
Pharmacology Division
Pharmacognocy Division
Food Division
Ayurvedic Division
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Function:
Testing of drug sample
Analysis of food sample
Analysis of exicse sample
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Government analyst
These officers are appointed by the central or state
government and perform the duties.
Qualification of government analysist
1 Persons having qualification for appointment as
government as govermental Analysis for allopathic
drugs ;
2 having a degree in medicine, ayurved, sidha or
unani system and not less than three year post
graduate experience in the analysis of drugs in a
laboratory under control of a government analyst.
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Duties:
1) The Government Analyst shall cause to be
analysed or tested such samples or drugs
and cosmetics as may be sent to him by
Inspectors.
2)A Government Analyst shall from time to
time forward reports to the Government
giving the result of analytical work and
research with a view to their publication.
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Licensing authority
Qualification:
(i) Graduate in Pharmacy on Pharmaceutical
Chemistry or in Medicine with specialization in
clinical pharmacology or microbiology from a
University established in India by law; and
(ii)Experience in the manufacture or testing of drugs
a minimum period of five years, Provided that the
requirements as to the academic qualification shall
not apply to those inspectors .
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Duties:
(1) to inspect all establishments licensed
for the sale of drugs within the area
assigned to him;
(2) to satisfy himself that the conditions of
the licences are being observed;
(3) to procure and send for test or analysis,
if necessary, imported packages.
(4) to investigate any complaint.
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(5) to maintain a record of all inspections made and
action taken by him in the performance of his
duties,
(6) to make such enquiries and inspections as may be
necessary to detect the sale of drugs in
contravention to the Act;
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Controlling authority
DRUG INSPECTOR
Qualification:
graduate in Pharmacy or Pharmaceutical Chemistry
or in Medicine with specialization in clinical
Pharmacology or microbiology from a University
established in India by law and
experience in the manufacture or testing of drugs or
enforcement of the provisions of the Act for a
minimum period of five years:
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Drug Inspector
Qualification
1 Persons having qualification for appointment as
government as govermental Analysis for allopathic
drugs ; or
2 having a degree in ayurved, sidha or unani system
and not less than three year post graduate experience
in the analysis of drugs in a laboratory under control
of (a) a government analyst, or (b) a chemical
examinar, or (c) head of an institution specially
approved for this purpose.
3 Degree in Pharmacy 0r Pharmaceutical Sciences
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Power: Duties of Drug Inspector
a) Inspect, --
(i) any premises where in any drug or cosmetic is being manufactured.
(ii) any premises where in any drug or cosmetic is being sold, or
stocked or exhibited or offered for sale, or distributed ;
(b) Take samples of any drug or cosmetic,--
(i) which is being manufactured or being sold or is stocked or
exhibited or offered for sale, or is being distributed;
(ii) from any person who is in the course of conveying, delivering or
preparing to deliver such drug or cosmetic to a purchaser or a
consignee.
C) Other Duties
Search in places, Persons, vechicles, etc
Verification of stock registers
Seizing of medical shops any offences under this act
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Provision
of Act
Manufacturi Labeling
Import Sales
ng &
Packaging
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IMPORT
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IMPORT of drugs
Classes of drugs prohibited to import
Import of drug under license
1)Specified in Schedule-C/C1
2)Specified in Schedule-X
3)Imported for Test/Analysis
4)Imported for personal use
5)Any new drugs
Drugs exempted from provisions of import
Offences and Penalties
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Classes of drugs prohibited to
import
Misbranded drugs
Drugs of substandard quality
Drugs claiming to cure diseases specified in Sch-J
Adulterated drugs
Spurious drugs
Drugs whose manufacture, sale/distribution are
prohibited in original country, except for the purpose
of test, examination and analysis.
Patent/Proprietary medicines whose true formula is not
disclosed.
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Import of the biological drugs(C/C1)
Conditions to be fulfilled:
Licensee must have adequate facility for the storage.
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Penalties related to Import
OFFENCES PENALTIES
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Cosmetics prohibited to import
Misbranded cosmetics
Spurious cosmetics
Cosmetic containing harmful ingredients
Cosmetics not of standard quality
which contains more than-2 ppm Arsenic, 20 ppm
lead, 100 ppm heavy metals
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MANUFACTURE
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Manufacture
Prohibition of manufacture
Manufacture of other than in Sch-C/C1
Manufacture of those in Sch-C/C1
Manufacture of Sch-X drugs
Loan license
Repackaging license
Offences & Penalties
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Prohibition of manufacture
Drug not of standard quality or misbranded,
adulterated or spurious.
Drugs in Sch-J
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Manuf. of drugs those in Schedule-
C/C1(Biological)
Conditions:
Drugs must be issued in previously sterilized sealed
glass or suitable container
Containers should comply with Sch-F
Some classes tested for aerobic & anaerobic micro-
organism.eg. Sera ,Insulin, Pituitary hormones.
Serum tested for abnormal toxicity
Parentral in doses of 10 ml or more should be tested for
freedom from Pyrogens
Separate lab. for culture & manipulation of spore
bearing Pathogens
Test for sterility should be carried out.
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Manufacture Of Sch-X drugs
Conditions:
Accounts of all transactions regarding manuf. should
be maintained in serially.(Preserved for 5 years)
Have to sent invoice of sale to licensing authority
every 3 months
Store drugs in direct custody of responsible person.
Preparation must be labeled with XRx
Marketed in packings not exceeding
100 unit dose –Tablets/Capsules
300 ml- Oral liquid
5 ml - Injection
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Loan License
Definition:
A person(applicant) who does not have his
own arrangements(factory) for manufacture but
who wish to manufacturing facilities owned by
another licensee. Such licenses are called Loan
licenses.
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Repackaging license
Definition:
Process of breaking up any drug from a bulk
container into small packages and labeling with a
view to their sale and distribution.
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Penalties related to
Manufacture PENALTIES
OFFENCES
Manufacture of any spurious drugs a) 1-3 years imprisonment and
Rs.5000 fine
b) 2-6 years imprisonment &
Rs.10000 fine on subsequent
conviction
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Manufacture of cosmetics
Prohibited for the following classes of drug:
Misbranded or spurious cosmetics and of substandard
quality
Cosmetics containing hexachlorophene or mercury
compounds
Cosmetics containing color which contain more than-
- 2 ppm of arsenic
- 20 ppm of lead
- 100 ppm of heavy metals
Eye preparations containing coal-tar color
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SALE
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TYPES OF SALES LICENCES
Allopathic Drugs
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Class of drug prohibited to sale
Misbranded, spurious, adulterated and drugs not
of standard quality
Patent/Proprietary drugs with undisclosed
formula
Sch-J drugs
Expired drugs.
Drugs used for consumption by government
schemes such as, Armed force.
Physician’s samples
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Forms Renewal Fee+ Penalty after
Fees for
Application Fees for duplicate
S.No. Category Type Sale Licence Form Certificate Form expiry but within six
Form Grant/Renewal copy of Org.
No. months
Lic.
Rs.1500+Rs.500 p.m.
Whole Sale 19 20-B Rs.1500 21 -C Rs.150
or part there of
Drugs other than
Rs.1500+Rs.500 p.m.
1 those specified in Retail Sale 19 20 Rs.1500 21 -C Rs.150
or part there of
Schedule C&C (1)&X
Rs.500+Rs.250 p.m. or Rs.150 R- 59
Restricted(Gen.Store) 19-A 20-A R-61 (1) Rs.500 R-59 (2) 21 -C
part thereof R-59 (4) (3)
Rs.1500+Rs.500 p.m.
Drugs specified in Whole Sale 19 21B Rs.1500 21 -C Rs.150
or part there of
Schedule C&C (1)
Rs.1500+Rs.500 p.m.
2 but excluding those Retail Sale 19 21 Rs.1500 21 -C Rs.150
or part there of
specified in Schedule
Rs.500+Rs.250 p.m. or Rs.150 R- 59
‘X’ Restricted(Gen.Store) 19-A 21-A R-61 (1) Rs.500 R-59 (2) 21 -C
part thereof R-59 (4) (3)
Rs.500+Rs.250 p.m. or
Whole Sale 19-C 20-G Rs.500 21-C Rs.150
Drugs specified in part there of
3
Schedule ‘X’ Rs.500+Rs.250 p.m. or Rs.150 R- 59
Retail Sale 19-C 20-F R-61(1) Rs.500 R-59(2) 21-C
part there of R-59(4) (3)
Sale of Drugs from
motor vehicles (1)
Rs.500+Rs.250 p.m. or
Drugs other than Whole Sale 19-AA 20-BB Rs.500 21-CC Rs.150
part there of
4 those specified in
Schedule C&C (1)
(2) Drugs specified in Rs.500+Rs.250 p.m. or
Whole Sale 19-AA 21-BB R-62-D Rs.500 21-CC Rs.150
Schedule C&C (1) part there of
Rs.250+Rs.50p.m. or
Whole Sale 19-B 20-D Rs.250 20-E Rs. 50
part there of
Homoeopathic Rs. 50
5 R-67-A(2)
Medicines 20-C Rs. 250 Rs.250+Rs.50p.m. or
Retail Sale 19-B 20-E *GSR No. 421
R-67-C R-67-A(2) part there of R-67-A(2)
dated
24/08/2001
4/2/2012 55
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} drugs specified in Schedule X
1. I/We ……………………….. of …………..hereby 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 the premises, situated at………….
2. The sale and dispensing of drugs will be made under the personal supervision of the
qualified persons mentioned below:-
Name………………….(Qualification)
Name………………….(Qualification)
3. Name of drugs to be sold .
4. Particulars of storage accommodation.
5. A fee of rupees…………………….. has been credited to Government account under
the head of account………………………………….
Date………………………….
Signature……………………
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Wholesale of biological (C/C1)
Adequate premises, with greater than 10 M2
area, with proper storage facility
Drugs sold only to retailer having license
Premises should be in charge of competent
person who is Reg. Pharmacist.
Records of purchase & sale
Records preserved for 3 years from date of sale
License should displayed on premises
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whole sale from other than specified in c/c1 and x
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Retail sale
For retail sale, two types of licenses are issued:
i) General licenses
ii) Restricted licenses
Restricted license:
Granted to those dealers who do not engage the services of a qualified
person and only deal with such classes of drugs whose sales can be effected
without qualified person and vendors who do not have fixed premises.
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FORM 19-A
{(See Rule 59(2)}
Application for the 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 the 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 Schedule C, C(1) and X on the premises situated at
……………………….or (ii) Drugs specified in {Schedule C(1) on the premises situated
drugs specified in {Schedule C(1) as vendor in the at……………………..
are………………………………..
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 {Schedule 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.
6. A fee of rupees __________ has been credited to Government under the head of account
………………………
Date……………………..
Signature……………………….
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Labeling & Packaging
All the general and specific
labeling and packaging
specified to all classes of drugs
and cosmetics should be as per
the provisions made under the
act.
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TYPE
Schedules to the rules CONTENT
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Schedules to the rules
TYPE CONTENT
“J” List of diseases and ailments that drug should not claim to cure
“K” List of drugs that are exempted from certain provisions regarding
manufacture
“M” Requirements of manufacturing premises, GMP requirements of factory
premises, plants and equipments
“M1” Requirements of factory premises for manufacture of Homeopathic
medicines
“M2” Requirements of factory premises for manufacture of cosmetics
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Schedules to the rules
TYPE CONTENT
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Drugs and Cosmetics (Amendment) Act,
2008
Salient features of the Act:-
Substantial enhancement in punishment
Life imprisonment for offenders involved in
manufacture, sale and distribution of spurious
and adulterated drug likely to cause grievous
hurt
Minimum punishment of seven years which
may extend to life imprisonment
Provision for compensation to affected person
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QUESTIONS
Describe the functions of Central Drug Laboratory.
Sale of drugs according to Drugs and Cosmetic Act.
Describe the administration of Drug and cosmetics
act
Manufacture of drugs according to Drugs and
Cosmetics Act.
Describe the Administration of DTAB
Define the fallowing Terms
A) Misbranded Drugs
B) Adulterated Drugs
C)Spurious Drugs
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References
www.cdsco.nic.in
“Pharmaceutical Jurisprudence”, Jani GK, Atul
prakashan; Fifth edition(2005-06); 28.
“Forensic Pharmacy”, Kokate CK and Gokhle SB,
Pharma Book Syndicate; 152
“Laboratories”
http://www.gujhealth.gov.in/fdc-laboratory.htm
A text book of Forensic Pharmacy, B.M.Mithal
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