UNIT II ADMINISTRATION OF THE ACT AND RULES......pptx

UNIT –II
ADMINISTRATION OF THE ACT
AND RULES

Classification of Administrative bodies
For the efficient administration of the act and the rules the following
agencies have been provided
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

1)Drugs Technical Advisory Board-DTAB
•DTAB Is constituted by the Central government to advise the
central and State governments on technical matters arising out of
the administration of this act.
•Functions-:
•1)It advise the central and state governments on technical
matters issues)of the administration of the act .
•2)It makes modifications and amendments in the act by
consulting the board.
•3)Other functions given by act.
•It consists of 18 members,of whom
• 8 are ex-officio,
• 5 are nominated and
• 5 are elected members,as follows.

I)Ex-officio members-:
(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 .
II)Nominated:
i)Two persons by the Central Government from among persons who are
incharge of drugs control in the States.
ii)One person by the Central Government from the pharmaceutical industry.
iii)Two government analysts, nominated by the central Government.

III)Elected:
1) One person, to be elected by the Executive Committee of the Pharmacy
Council of India, from among Teachers in pharmacy or pharmaceutical
chemistry or pharmacognosy on the staff of an Indian university or affilated
college .
2) One person, to be elected by the Executive Committee of the Medical Council
of India, from among Teachers in medicine or therapeutics on the staff of an Indian
university or an affilated college .
3) One pharmacologist to be elected by the Governing Body of the Indian Council
of Medical Research.
4) One person to be elected by the Central Council of the Indian Medical
Association.
5) One person to be elected by the Council of the Indian Pharmaceutical
Association

•The nominated and elected members of the Board shall hold office for three
years, but shall be eligible for re-nomination and re-election.
• The Central government shall appoint persons to be secretary of the board
and other staffs, if necessary.
•The person nominated or elected, shall hold office for so long as he holds the
appointment of the office by virtue of which he was nominated or elected to
the Board.
•The Board may constitute sub-committees and may appoint to such sub-
committees for such periods, not exceeding three years.
• As it may decide, or temporarily for the consideration of particular matters,
persons who are not members of the Board.

It is also an advisory body constituted by central government.
Constitution:
Two representatives of the Central Government
One representative of each State Government
Functions-:
1) This is also an advisory body constituted by the Central government for the
purpose of advising the Central government & the State government and
the DTAB, on any matter tending to secure uniformity throughout India in
the administration of this Act.
2)The Drugs Consultative Committee shall meet when required.
•3)The Central Government shall have power to regulate its own procedure.
2)Drug Consultative committee-:

Established in Calcutta, under the control of a director appointed by the Centr
Government.
Functions:
Analysis or test of samples of drugs/cosmetics sent by the custom collectors
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.
•Biological & microbiological Test/Analysis are not carried out by C.D.L, sent
Directore of central Research Institute-Kasauli.
•Biological for Veterinary use sent to the Director, Indian Veterinary Resear
Institute, Izatnagar.
Analytical
1) Central Drug Laboratory-:

PROCEDURE
1.All samples of drugs/cosmetics sent to C.D.L. for analysis by court under
registered post & sealed with copy of memorandum.
2.A copy of memorandum & specimen of impression of seal on packet sent
separately by registration post.
3.On receipt of the packet, director/officer should record the conditions of
seal on packet
4.On completion of test/analysis the director required to supply a report of the
analysis.

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
Analytical
2) Drug Control Laboratories in states-:
Function:
Testing of drug sample
Analysis of food sample
Analysis of exicse sample

• State government appoint persons as government analysts for the
purpose of analysis/testing of samples of drugs & cosmetics.
• The central government may also appoint such person as a
government analysts.
• Government analyst should have NO direct or indirect interest in
Import, Manufacture OR Sale of drugs & cosmetics.
Analytical
3) Government Drug Analyst

QUALIFICATION:-
A) For the analysis/testing of other than Biological(c/c1)
1.A graduate in Medicine OR Science OR Pharmacy OR Pharmaceutical
chemistry & with at least 5 year post graduate experience in testing OR
has completed two years training on testing of drugs, including in Sch.C
in CDL.
2.A postgraduate degree in Medicine OR Science OR Pharmacy OR
Pharmaceutical chemistry & with at least 3 year experience in testing OR
has completed two years training on testing of drugs, including in Sch.C
in CDL.
3.Holding associate ship Diploma of the Instiution of Chemists with
Analysis of drugs & Pharmaceuticals with at least 3 year experience in
testing.OR has completed two years training on testing of drugs,
including in Sch.C in CDL

B) For the analysis/testing of Biological( Sch c/c1)
USED FOR HUMAN BEINGS
1.A graduate in Medicine OR Science OR Pharmacy OR Pharmaceutical
chemistry. And trained either in physiology or bacteriology, Serology,
pathology, pharmacology or Microbiology& with at least 5 year
experience in testing of biological products & have at least 6 months
training in Approvaled Laboratory.
2.A postgraduate degree in Medicine OR Science OR Pharmacy OR
Pharmaceutical chemistry or assosiate ship Diploma of the Institution of
Chemists with Analysis of drugs & Pharmaceuticals
3. And trained either in Physiology or bacteriology, Serology, pathology,
pharmacology or Microbiology& with at least 3 year experience in
testing of biological products & have at least 6 months training in
Approvaled Laboratory has completed two years training on testing of
drugs, including in Sch.C in CDL.

C) For the analysis/testing of Biological for veterinary use
1. A graduate in veterinary Science OR General Science OR medicine OR
Pharmacy.
And atleast 5 year experience of testing.
2. A postgraduate in veterinary Science OR General Science OR medicine OR
Pharmacy OR Pharmaceutical Chemistry.
And atleast 3 year experience of testing.
DUTIES:-
1)To analyze & test sample of drugs & cosmetics sent by inspector or other persons
& furnish reports.
2)To engage in any research work & forward the report to the government with a view
to publication.
PROCEDURE
2. On receipt of samples the analyst should record the condition or the seal &
compare it with the impression of the seal received separatly.
3. After completion of the analysis, a report in triplicate with full details should be
supplied.

FOR IMPORT:
The central government appoints licensing authorities to issue licences for the
import of drugs.
FOR MANUFACTURE & SALE:
The state governments appoint licensing authorities for respective territories to
issues licence for the sale of drugs, for the manufacture ,& ,for manufacture of
cosmetic.
The licensing authorities are designated differently in different states.
As
Drug controller
Director
Drug control Administration
Officer in charge, Drug control
Commissioner- FDCA
Executive
1) LICENSING AUTHORITIES

Qualification of licensing authority
(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.
(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 .
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.
(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;

All inspectors appointed shall be under the control of a controlling
authority.
QUALIFICATION:-
•A graduate in Medicine OR Pharmacy OR Pharmaceutical chemistry
(Clinical Pharmacology) OR Microbiology.
• And at least 5 year experience in the manufacture or testing of drugs or
enforcement of the Act.
Qualification
1 Persons having qualification for appointment as government as governmental
Analysis for allopathic drugs; or
2 Having a degree in ayurveda, siddha 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 examiner, or
(c) Head of an institution specially approved for this purpose.
2) CONTROLLING AUTHORITIES

3)DRUG INSPECTOR
State government appoint persons as drug inspectors to inspect
premises licensed for manufacture of drugs & cosmetics & sale of
drugs.
The central government may also appoint such persons.
Drug inspectors should have no any financial interest in the
import, manufacture or sale of drugs and cosmetics.
All drug inspectors are public servant within the meaning of
Indian Penal Code.
Inspectors are required to keep all information's confidential &
not to disclose

QUALIFICATION:-
1.A graduate in pharmacy or pharmaceutical sciences or medicines with
specialization in Clinical Pharmacology or microbiology from recognised
university .
Provided that for the purpse of Inspection of manufacture of substances specified
in schedule C, a person appointed as a Drug Inspector should have
A) Not less than 18 Months experience in manufacture of atleast one of the substances
specified in Sch.C
B) Not less than 18 Months experience in testing of at least one of the substances
specified in a schedule C in a approved laboratory.
C) Not less than 3 Years experience in the inspection of firms manufacturing any of
the the substsnces Specified in Sch.C during the course of their service as the
Drug Inspector.
Qualification
1 Persons having qualification for appointment as government as governmental Analysis for
allopathic drugs.
2 Having a degree in Ayurveda, Siddha 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 examiner, or
(c) Head of an institution specially approved for this purpose.

Power:
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) Search-:
Any person in connection with the offence under this chapter at all reasonable times.
D) Enter and search-: Any place in which he has reason to believe an offence relating to
manufacture, sale or distribution of drugs or cosmetics has been, or is being committed.
E)Stop & Search-: Vehicle, Vessel, or other conveyance which, he has reason to believe, is
being used for carrying any drug or cosmetic in respect of which an offence has been, or is
being, committed and order in writing the person in possession of not to dispose of any
stock that of for a specified period not exceeding 20 days.
F)Examine Data-: Examine any record, register, document or any other material object
with any person or in any place mentioned above and seize the same if it is likely to furnish
the evidence as an offence

 Inspect NLT twice an year all establishments licensed for sale of drugs within the
area assigned to him.
 Procure and send for tests or analysis, if he has reason to think that the drugs are
sold in contravention of provisions of Acts or Rules.
To investigate any complaints made to him in writing & to institute prosecutions
in respect to the breaches of the act.
 To maintain all records of inspections made & actions taken by him including
taking of samples and seizure of stocks & to submit copies of such records to the CA.
 Make enquiries such inspections as may be necessary to detect sale of drugs in
contravention to the Act.
 When so authorized by State Governments to detain imported packages which he
has reason to suspect to contain drugs whose import is prohibited.
DUTIES OF INSPECTORS

• Inspect NLT twice a year all premises licensed for the manufacture of drugs within
the area allotted to him and satisfy himself that the condition of license and provisions
of Acts and Rules are observed.
• In establishments licensed to manufacture products specifies in Schedule C and C1
inspect the process of manufacture, means employed for standardizing and testing of
drugs, methods & place of storage, technical qualifications of staff employed & all
details of location, construction & administration of establishment likely to affect the
potency or purity of drug.
•To send controlling authority after each inspection a detailed report indicating
conditions of license & provisions of Acts & Rules which are being observed & which
are being not observed.
• To take samples of drugs manufactured on premises & send them for test or
analysis.

Procedure :-
Collection of sample and pay its fair price, if refused then issue the
receipt(form 19) and inform the concern (Form 17)
*Each portion is then sealed & suitably marked.
Government
analyst
Warrantor Presenting
before the court
Restored by
person
Inspector should sent sample to Government Analyst by registered post or by hand in sealed packet
enclosed together with memorandum in( Form 18)

Case 1
If the confiscated drug is not of standard quality, it should be
reported to court accordingly & court may order destruction of
drug under the supervision of Inspector in presence of such
authority that the court may prescribe.
Case 2
If confiscated drug is of standard quality, Inspector may
report court accordingly and court may order sale of drugs by
public auction to any party holding a requisite license and
documents or records should be registered within 20 days.

Penalty for obstructing inspector.
If any persons willfully obstruct an inspector in the exercise
of the powers conformed upon him or refuse to produce
any record,register or any other documents when required
or any document when required ,he shall be punishable
with imprisonment (jail)up to 3 year or with fine or both.

Reference
The drugs and cosmetics act and rules, Textbook of Forensic
Pharmacy. Author, N. K. Jain. Edition, 6. Publisher, Vallabh
Prakashan, 2003. ISBN, 8185731152, 9788185731155 ; pg no 148-157

Sale of drugs
•Definition-:
• The process of passing drugs from manufactures to consumers is termed
sale.
•Before 1940 ,there was no restriction /prohibition of selling ,compounding, and
despensing of drugs.
•But after implementation of D &C 1940 ,selling compounding ,dispensing of
drugs became a prohibited work , and only licensed persons can involve in these
works ,and under there guidance can be performed.
•Types of sale-:
1)Wholesale of drugs-: Issued to wholesalers for drug distribution.From
stockists to shopkeepers
2)Retail sale of drugs-:Issued for retail sale to patients.From shopkeepers
(chemists, druggists) to patients.
3)Restricted sale of drugs-: Restricted License means any license that is issued
subject to a definite period of suspension or terms of probation.

Classes of drugs prohibited to be sold
Misbranded,
spurious,
adulterated and drugs not of standard quality
Patent/Proprietary drugs with undisclosed formula
Sch-J drugs
Expired drugs.

31
TYPES OF SALES LICENCES
Allopathic Drugs
Whole Sale Retail Sale Sales From
Motor Vehicle
( Vender)
General Licence Restricted
Licence
Drugs other
than sch.-
C/C1 & X
Drugs in
Sch.- C/C1
Drugs in
Sch.- X
For
Sch.- C/C1

4/2/2012 32
S.No. Category Type Sale
Application
Form
Licence Form
Fees for
Grant/Renewal
Renewal
Certificate Form
No.
Fee+ Penalty after
expiry but within six
months
Fees for
duplicate
copy of Org.
Lic.
1
Drugs other than
those specified in
Schedule C&C (1)&X
Whole Sale 19 20-B Rs.1500 21 -C
Rs.1500+Rs.500 p.m.
or part there of
Rs.150
Retail Sale 19 20 Rs.1500 21 -C
Rs.1500+Rs.500 p.m.
or part there of
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 in
Schedule C&C (1)
but excluding those
specified in Schedule
‘X’
Whole Sale 19 21B Rs.1500 21 -C
Rs.1500+Rs.500 p.m.
or part there of
Rs.150
Retail Sale 19 21 Rs.1500 21 -C
Rs.1500+Rs.500 p.m.
or part there of
Rs.150
Restricted(Gen.Store) 19-A 21-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)
3
Drugs specified in
Schedule ‘X’
Whole Sale 19-C 20-G Rs.500 21-C
Rs.500+Rs.250 p.m. or
part there of
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 there of R-59(4)
Rs.150 R- 59
(3)
4
Sale of Drugs from
motor vehicles (1)
Drugs other than
those specified in
Schedule C&C (1)
Whole Sale 19-AA 20-BB Rs.500 21-CC
Rs.500+Rs.250 p.m. or
part there of
Rs.150
(2) Drugs specified in
Schedule C&C (1)
Whole Sale 19-AA 21-BB R-62-D Rs.500 21-CC
Rs.500+Rs.250 p.m. or
part there of
Rs.150
5
Homoeopathic
Medicines
Whole Sale 19-B 20-D Rs.250 20-E
Rs.250+Rs.50p.m. or
part there of
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 there of R-67-A(2)
Rs. 50
R-67-A(2)
*GSR No. 421
dated
24/08/2001
Forms

33
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……………………

Wholesale License Conditions
Minimum area: 10 sq. m.
Storage: Refrigerator & air conditioner.
Competent Staff: Pharmacist or qualified person.
Display license prominently.
Purchase from a licensed dealer/manufacturer.
Maintain purchase records for 3 years.
Maintain records for 2 years.
Maintain Inspection book (Form 35).
Do not stock/sell expired or physician's sample drugs.
A separate record for Schedule X drugs.
34

Conditions of Whole Sale License:
1. Area: Shall not be less than 10 sq. m. 2. Storage:
It is necessary to have a refrigerator and air conditioner on the premises because certain
drugs such as vaccines, insulin injections etc. are needed to be stored in the fridge.
3. Competent Staff: The sale can be made either by a registered pharmacist or another
competent person who must be a graduate with one year experience in drugs or in the
presence of any one who has passed S.S.L.C having experience of four years in drugs,
specially approved by drug control department.
4. License shall be displayed in a prominent place.
5. The drugs shall be purchased from a duly licensed dealer or a manufacturer.
6. Supply of drugs shall be made against a cash memo. Carbon copies of the same shall
be preserved for 3 years from the date of last entry.
7. Shall maintain the records of purchase, and produce all the registers and records
during inspection. Records must be preserved for 2 years from the last entry.
8. An Inspection book shall be maintained in Form 35.
9. The drugs after expiry, Physician’s sample and the drugs meant for Government
supply, shall not be stocked or sold.
10. A separate record shall be maintained for the supply of Schedule X drugs, the copies
of invoices of sale of such drugs to the retailer, shall be forwarded to the Licensing
authority.
11. No sale of any drug should be made for the purpose of resale to a person not
holding the license to sell or distribute the drugs.

Retail sale-: Issued for retail sale to patients.From shopkeepers
(chemists, druggists) to patients.
For retail sale, two types of licenses are issued:
i) General licenses
ii) Restricted licenses
•Conditions for retail sale-:
•Facility according to schedule N.
•Purchased only from licensed wholesalers.
•Separate license for schedule C/C1drugs,Schedule X and for the drugs
other than schedule C and C1 and X.
•Schedule H and X drugs will not be sold without valid prescription .
•All the registers and records should be maintained for at least 2 years
from the date of the last entry.
•The licensee should allow the inspectors for inspection of
permises,register and records. 36

Restricted license:
Restricted License Conditions
Retail sale of specific drugs.
Forms 20A and 21A.
(a) For drugs not needing qualified supervision.
(b) Licenses for itinerant vendors in exceptional cases.
(c) License for travelling agents for specific distribution purposes.
(d) Adequate premises with storage facilities.
(e) Display license in public area or on demand.
(f) Comply with Drugs and Cosmetics Act.
(g) Purchase from licensed dealers/manufacturers.
(h) Deal with drugs not requiring qualified supervision.
(i) Sell drugs in original containers.

38
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……………………….

Sr.
No.
Offence Penalties
First conviction Subsequent conviction
1. Sale or distribution of:
(i) Any adulterated or
spurious drugs or drug
not of standard quality
(ii)Any adulterated but not
containing toxic or
harmful substances injurious
to health
(iii)Without a license
iv)Spurious drugs but not
manufactured under the
name of any other drug
(iv)Any otherContravention of
this act
Imprisonment upto 5 years and
extending upto lifetime and fine of
not less than` 10,000.
Imprisonment from 1-3 years and
fine of not less than ` 5,000
Imprisonment of less than a year and
a lesser fine.
Imprisonment for 3-5 years and fine
of not less than` 5,000.
Imprisonment for 1 year.
Imprisonmentfrom 1-2 years and fine.
Imprisonment upto 10 years
or fine upto
` 20,000 or both.
Imprisonment for 2-4 years or
fine upto` 10,000.
Imprisonment for not less than
2 years or fine upto ` 10,000.
Imprisonment for not less than
6-10 years or fine upto ` 10,000.
Imprisonment for 2-4 years or
fine upto` 5,000 or both.
2. Not keeping records of sale in the
specified manner.
Imprisonment upto 3 years or fine
upto ` 1000 or both.
Same
conviction
as first
OFFENCES AND PENALTIES OF SALE OF DRUG

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.
•The rules under this act provides for the particulars to be shown on the
containers of the drugs.
•No person shall sell or distribute any drug unless it is labelled according
to the rules.
MANNER OF LABELLING (General labelling )
•1)Identifying particulars such as name of drug,batch
number,manufacturer’s name etc.
•2)Date of expiry of potency(expiry date)
•3)Particulars related to potency,official standard.etc
•4)Precautionary information related to care in
handling,use,distribution.etc
•5)Particular’s related to storage,manner of use,etc
•6)Genearal information such as physicians sample,not to be sold,etc
40

•General requirements of labelling
•Name of the drug
•Statement of net content
•The content of active ingredients expressed in terms of
•Oral liquids
•Liquid parenterals
•Drugs in solid form
•For tablets ,capsules,pills
•For other preparations
•The name and address of the manufacturer
•Distinctive batch number
•Manufacturing license number
•Date of expiry of potency
•labeling of mechanical contraceptive
•Distributed as free sample to medical practioners bearing the
lable ‘not to be sold’

PACKAGING
•The pack size of drugs for retail sale shall be as prescribed in
Schedule P 1
•If no of capsules, tablets is less than 10,the pack size should be
integral
•For no above 10 size be multiple of 5
•liguid oral preparations-30 ml for pediatric preparations
•Paediatric oral drops-5ml/10ml/15 ml
•Eye/ear/nasal drops-3ml/5ml/10ml
•Eye ointment-3 gm/5 gm/10 gm

LIST OF PERMITTED COLOURS
No drug shall contain a color other than that specified below:
(1) Natural Colours: Annatto, Carotene, Chlorophyll, Cochineal, Curcumin,
Red oxide of iron, Yellow oxide of iron, Titanium dioxide, Black oxide of
iron.
(2) Artificial Colours: Caramel, Riboflavin.
(3) Coal Tar Colours: Quinazarine Green SS, Alizarin Cyanine Green F, Fast
Green FCF, Tartrazine, RED (Erythrosine), Eosin YS or Eosine G, Toney
Red or Sudan III, Indigo Carmine, Brilliant Blue FCF, Orange G, Resorcin
Brown, Naphthol Blue-Black.
(4) Lakes the aluminum or calcium salts (lakes) of any of the water-soluble
colors listed above.
(5) The label on the container of a drug containing a permitted color shall
indicate the common name of the colour

Offences and Penalties of labelling
and packing of drugs
Same as to sale of drug…..

References
Available on www.cdsco.nic.in
“Pharmaceutical Jurisprudence” by Dr.S.P. Agarwal; Rajesh Khanna; Pg: 40-109.
Forensic Pharmacy by C.K. Kokate and S.B. Gokhle; Published by Pharma Book Syndicate; Pg: 47-121.
Reference
The drugs and cosmetics act and rules, Textbook of Forensic Pharmacy. Author, N. K. Jain.
Edition, 6. Publisher, Vallabh Prakashan, 2003. ISBN, 8185731152, 9788185731155 ; pg no 148-157
48

UNIT II ADMINISTRATION OF THE ACT AND RULES......pptx

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