Sale of Drugs – Wholesale, Retail sale and Restricted license. Offences and penalties Labeling & Packing of drugs- General labeling requirements and specimen labels for drugs and cosmetics, List of permitted colors. Offences and penalties.

1. THE DRUGS AND COSMETICS
ACT 1940 AND ITS RULES
1945
Miss. G. K. Bahatkar
M. Pharm
Assistant Professor,
P. R. Patil Institute of
Pharmacy, Talegaon

2. PROVISIONS APPLICABLE TO SALE OF DRUGS (OTHER THAN
HOMOEOPATHIC MEDICINE)
The Drugs and Cosmetics Act and Rules made thereunder provide
for sale of drugs only issue of license. State Government appoints
licensing authority for a specified area to issue licenses for the sale,
stock or exhibit for sale or distribute drugs. Applicant has to make
an application in a prescribed form (for sale of specified categories
of drugs) for grant of license. Granted license required to be
renewed within six months of its expiry.
Forms for application for the grant or renewal of license, to sell,
stock or exhibition for sale or distribution:
(a) For retail/wholesale of drugs other than those specified in
schedule X - Form - 19. (b) Restricted license (Applicants of a town
with population of 5000 or less than 5000 where services of
qualified person not required and itinerant vendors - Form - 19A.
(c) Wholesale/Distribution of drugs from a motor vehicle-Form -
19AA.

3. The application forms should be accompanied with prescribed fee. A
duplicate copy of a license can be issued on payment of prescribed fee if
original is defaced, damaged or lost.
Application for renewal of license should be made before expiry of license
but not later than six months of its expiry and should be accompanied
with prescribed fee plus additional late fee.
The licensing authority on satisfying that the conditions of license fulfilled
as per the provisions of the Act and Rules made thereunder issues license
in prescribed form.
Form of Licenses:
A license to sell, stock, exhibit for sale or distribute drugs issued in the
following forms:
1. Retail sale:
(1) For drugs other than those specified in Schedule C, C (1) and X: Form
20.

4. 2. Restricted license:
(i) For drugs other than those specified in schedule C, C (1) and X: Form 20-
A (i) For drugs specified in schedule C and C (1) Form 21-A valid for only
such drugs
3. Wholesale:
Specified in license. No license is issued for schedule X drugs.
• For drugs other than those specified in schedule C, C (1) and X: Form - 20
B
• For drugs specified in schedule C and C (1). Form – 21 8.
• For schedule X drugs – Form-20 G.
4. Sale of drugs by wholesale or distribute drugs by a motor vehicle:
• For drugs other than those specified in schedule C and C (1): Form – 20 –
BB.
• For drugs specified in schedule C and C (1): Form 21-88.
Such a license is not required where public carrier or hired vehicle is used for
Transportation or distribution of drugs.
For sale or stock of drugs at more than one places, a separate application
should be made for grant of license and separate license shall be issued for

5. Duration of license:
Original or renewed license unless suspended or cancelled, valid up to 31
December of The year following the year in which it is granted or renewed.
Certificate or renewal of a sale license issued in Form 21-C:
Forms in which licenses are issued for the sell, stock, exhibition for sale or
distribution of drugs.
License issued Forms
Drugs other
than C, C (1)
and X
Drugs
specified in
sch. C. C (1)
Drugs
specified in
sch. X
Retail 20 21 20-F
Restricted 20-A 21-A -
Wholesale 20-B 21-B 20-G
Wholesale or
distribution by motor
vehicle
20-BB 21-BB -

6. KINDS OF LICENSES FOR WHOLESALE
WHOLESALE
Form shop
Form motor
Vehicle
License for
wholesale of
C & C1
License for
Drugs other
than sch C &
C1
License for C
& C1 Drugs
Licenses for
drugs other
than Sch C &
C1

7. KINDS OF LICENSES FOR RETAIL SALE
Retail
Form Shop Vendors
Drug store Chemist &
Druggist
Pharmacy
Only specified
drugs in
specified area

8. Restricted Licenses:
Licenses for sale or distribution of drugs which can be sold without
supervision of a qualified person, issued at the discretion of licensing
authority.
In exceptional circumstances, such license may be issued to a
bonafide travelling agents of a firm dealing in drugs or a vendor who
purchases drugs from a licensed dealer for distribution in rural areas
where other channels of distribution of drugs are not available.
The restricted license in form 21-A may also be issued to a travelling
agent of a firm for drugs specified in Schedule C. Such a hence is not
needed for vendors for the specific purpose of distribution to medical
practitioner or dealers.
Such license is also not needed for travelling agents of licensed
manufacturer agents of such manufacturer or importers of drugs
engaged in free attribution of samples of medicine among members
of medical profession, hospitals, Dispensaries and the medical or
research institutions.

9. Conditions to be satisfied to issue license in Form 20-A
and 21-A:
1. The licensing authority should satisfy that the premises in respect of which
license is to be granted are adequate and equipped with proper storage
accommodation for preserving the properties of drugs. This condition does
not apply in case of license granted to itinerant venders (who does not have
specified place for business).
2. Before granting a license, the licensing authority is empowered to consider:
• Number of licenses granted in a locality during one year of the preceding
year.
• The occupation, trade or business carried on by the applicant.
3. The licensing authority may refuse, grant or renew a license to any
applicant or licensee if offence is convicted under the Act and Rules made
thereunder and if licensing authority considers that he is not a fit person to
grant a license.
4. Any person aggrieved by the order passed by the licensing authority may
within 30 Days from the date of receipt of such order appeal to the State
Government and The state government after such enquiry into the matter as it
considers necessary And after giving the appellant an opportunity for

10. Conditions of license in Form 20-A 21-A, 20, 21, 20 B, 21 B, 20 F, 20
BB, 21 BB:
1. The license shall be displayed in a prominent place of the premises
open to the Public.
2 The licensee shall comply with the provisions of the Drugs and
Cosmetics Act 1940 and rules and thereunder.
3. No drug shall be sold unless such drug is purchased under cash or
credit memo from a duly licensed dealer or a duly licensed
manufacturer.
4. The licensee shall inform Licensing Authority in writing any change
in the constitution of firm operating under the license. From a date on
which such a change takes place, current license deemed to be valid
for a maximum period of three months. In the meantime, a fresh
license has to be taken from the licensing authority in the name of the
firm with changed constitution.
5. The licensee having a license in Form – 21 A, shall deal only in such

11. 6. The licensee shall report to the Licensing Authority any change in
the qualified staff in charge within one month of such change
(Applicable for License in Form No. 20, 21, 20 F).
7. No sale of any drug shall be made to a person not holding a
requisite license to sale, stock, or exhibit for sale or distribute the
drug, provided that the condition shall not apply to the sale of any
drug to
• An officer or authority purchasing on behalf and of Government or,
• A hospital, Medical educational or research institution, or a
Registered Medical Practitioner, for the purpose of supply to his
patients or
• A manufacturer of beverages, confectionery, biscuits and other
non-medical products where such drugs are required for processing
such products. (Applicable For licence in Form 20 B, 21 B, 20 BB, 21
BB).

12. Conditions to be satisfied by applicant to issue license in Form 20, 20-B, 20-F,
20-G, 21 or 21-8: (Under Rule 64 of D. and C. Rules):
1. The authority empowered to grant the license should lie satisfied that the
premises in respect of which the license is to be granted are adequate,
equipped with proper storage facilities for preserving the properties of drugs
and are in charge of a competent person to Supervise and control the sale,
distribution and preservation or drugs.
In case of “Pharmacy” license in Form 20 or 21 is granted only if licensing
authority is Satisfied that the requirements for a pharmacy in schedule N have
been complied. License in Form 20 F granted only to a pharmacy and if in a
specified area, pharmacy is not Operating, such license may be granted to a
“Chemist and Druggist”.
In granting such a license, authority empowered to grant, may have regard:
(I) Average numbers of licenses granted during the period of 3 years
immediately Proceeding.
(II) Occupation, trade or business carried on by the applicant.
2. In respect of a grant of a license for ‘wholesale’ of drugs other than those
specified In schedule C and C (1) and those specified in schedule C and C (1)

13. Premises in respect of which a wholesale license is to be granted, are of an
area not less than 10 square meters and in the charge of a competent person,
who is registered pharmacist or who has passed matriculation examination
with four years experience in dealing with drugs or who holds degree of a
recognized university with one year experience In dealing with drugs.
(1) In respect of application for the grant of a license in form 20 or 21 or both,
the Licensing authority shall satisfy itself that the premises are of an area of
not less than 10 square meters, and
(2) In respect of an application for the grant of a license,
(a) In form 20 or 21 or both and
(b) In form 20 B or 21 8 or both,
The licensing authority shall satisfy itself that the premises are of an area not
less than 15 meters.
3. Any person who is aggrieved by the licensing authority may within 30 days,
from the date of receipt of such order, appeal to the State Government and the
State Government may after such enquiry into the matter as it considers
necessary and after giving the appellant an opportunity for representing his
views in the matter, make such order in relation thereto as it thinks fit.

14. General conditions of a license: (Under Rule 65 of D. and C.
Rules):
The license in forms 20, 20-A, 20-B, 20-F, 20-G, 21, 21-A,
21-B.
Subject to the conditions stated therein and to the following
general conditions.
(a) Dispensing and compounding of drugs:
Any drug shall be compounded or made only by or under the
personal supervision of a registered pharmacist.
2. All drugs supplied on the prescription of a Registered
Medical Practitioner, shall be Supplied only by or under the
supervision of a registered pharmacist.
3. The supply of all drugs (except other than those specified in
schedule X) sold on a prescription of a RMP should be recorded
in a prescription register and serial number of entries in the
register should be entered on the prescription. The following
particulars should be entered in the register.

15. 1. Serial number.
2. Date of supply.
3. The name and address of the prescriber.
4. The name and address of the patient/owner of animal if drugs supplied for
veterinary use.
5. The name of the drug or preparation and the quantity. (Name of ingredients
with their quantities if medicine is made by licensee).
6. Name of the manufacturer, Batch number and date of expiry if any, in case
of drug Specified in schedule C or H.
7. The signature of a registered pharmacist.
In case of drugs which are not compounded in the premises and which are
supplied from or in the original containers, the above particulars may be
entered in credit or cash memo book, serially numbered, and specially
maintained for this purpose.
If the medicine is supplied on prescription on which the medicine was supplied
previously and entries were made in prescription register, in such cases it is
sufficient, if new entry in the register includes a serial number, the date of
supply, the quantity supplied and reference number of previous entry in the

16. (b) Supply of Schedule 'C' drugs by retail (otherwise than on a prescription):
The supply of drugs specified in schedule C by retail should be recorded at
the time of supply in a register specially maintained for the purpose or in a
cash, or credit which includes the following particulars:
1. Serial number of the entry.
2. The date of supply.
3. The name and address of purchaser.
4. The name of the drug or preparation and quantity.
5. The name of manufacturer, batch number and date of expiry if any.
6. Signature of a person under whose supervision sale was affected.
The licensing authority may require records to be maintained in a register, if
entries in the carbon copies of the cash/credit memo book are not legible.

17. (c) Supply of other drugs:
The supply by retail of any drug shall be made against cash/credit memo
which contains following particulars:
I. Name, address and sale license number of a dealer.
II. Serial number of cash/credit memo.
III. The name and quantity of drug specified.
Carbon copies of cash and credit memos shall be maintained by the licenses
as records. All registers and records maintained should be preserved at least
for two years from the date of last entry therein.
(d) Sale of drugs specified in schedule H and schedule X:
(a) Substances specified in schedule H and X should not be sold by retail
except only in accordance with the prescription of RMP. In case of substances
specified in schedule X, the prescription should be in duplicate, one copy of
which retained by licensee and preserved at least for two years.
(b) Drugs from schedule H and schedule X, supplied to Registered Medical
Practitioner, Hospitals, Dispensaries and Nursing Homes, shall be supplied
only against signed written order and such order should be preserved at least
for two years.

18. A prescription of a RMP against which, drugs from schedule H or schedule X,
supplied should
I. Be in writing and signed by the person giving it, with his usual signatures
and be dated.
II. Specify the name and address of the patient or name and address of the
owner of the animal if drug is for veterinary use.
III. Indicate total amount of drug supplied and doses to be taken.
(e) Dispensing of schedule H and schedule X drugs:
A prescription containing schedule H or schedule X drugs:
Must not be dispensed more than once unless stated thereon by the
prescriber, That it may be dispensed more than once.
If it contains direction to dispense for a state number of times or at stated
intervals, it must be dispensed only in accordance with the direction.
At the time of dispensing such prescription, the name and address of the
dispenser, and the date of dispensing must be noted above the signature of
the prescriber on the prescription.
Person dispensing a preparation containing substances specified in schedule

19. (f) Storage of schedule X drugs:
Substances specified in schedule X kept in a retail shop or premises used in
connection Therewith shall be stored.
I. Under lock and key in a cup-board or drawer solely reserved for storage of
these substances.
II. If a part of the premises, separated from the remainder of the premises
and which Will have access to only by responsible persons.
(g) Records of purchase:
Records of purchase of a drug intended for sale or sold by retail should be
maintained by the licensee and such record should contain the following
particulars.
(i) The date of purchase.
(ii) The name and address of the person from whom purchased and his
license number.
(iii) The name of the drug, the quantity and batch number.
(iv) The name of the manufacturer.
(v) The purchase bills including cash or credit memos should be serially

20. (h) Wholesale supply of drugs:
The supply of a drug by a wholesaler shall be made against cash or
credit memo bearing name and address of license and his license
number under Drug and Cosmetics Act and should contain
following particulars:
(1) The date of sale.
(2) The name and address of the licensee to whom sold and his sale
license number.
(3) The name of the drug, quantity, and batch number.
(4) The name of the manufacturer.
Carbon copies of cash or credit memos shall be preserved as
records at least for three years from the date of the sale of the
drug.

21. (i) Records of a purchase for wholesale supply:
Records of a purchase of a drug intended for resale or sold by wholesaler shall
be maintained by the licensee and such records shall show the following
particulars:
(i) The date of purchase.
(ii) The name, address and relevant license number of a person from whom
purchased.
(iii) The name of the drug, the quantity, and the batch number.
(iv) The name of the manufacturer.
(J) The description to be displayed on a premise:
(i) The description “Drug Store” shall be displayed by such licensee who do not
require services of a registered pharmacist.
(ii) “Chemist and Druggist” Licensees who employ the services of a registered
pharmacist but who do not maintain a “Pharmacy” for compounding against
prescription.
(iii)“Pharmacy”, “Pharmacists”, “Dispensing Chemist”, or “Pharmaceutical
Chemist”: displayed by licensees who employ the services of a registered

22. (o) Storage of drugs for veterinary use:
The medicines for treatment of animals kept in a retail shop and
labelled with the words "not for human use, for treatment of animals
only" and should be stored in a cupboard or a drawer reserved solely
for the storage of veterinary drugs or in a part of the premises
separated from the remainder of the premises to which customers
are not permitted to access.
(p) Supply of schedule X drugs:
The drugs specified in schedule X shall be supplied only on a
prescription of a Registered Medical Practitioner and such
prescription should be in duplicate, one copy of which retained by
licensee and preserved at least for two years. Unless otherwise
stated in the prescription by the prescriber, such drugs must not be
dispended more than once.
The supply of drugs specified in schedule X shall be recorded at the
time of supply in a bound and serially page numbered register,
specially maintained for the purpose and separate pages shall be
allotted for each drug and the following particulars shall be entered
in the register.

23. 1. Date of transaction.
2. Quantity received, if any, the name and address of the supplier and
relevant license number held by him.
3. Name of the drugs.
4. Quantity supplied.
5. Manufacturer’s name.
6. Batch number or lot number.
7. Name and address of the purchaser/patient.
8. Reference number of the prescription against which suppliers were made.
9. Bill number and date in respect of purchases and supplies made by him.
10.Signature of the person under whose supervision the drugs have been
supplied.

24. (q) Additional information to be furnished by an applicant for license to the
licensing Authority:
The applicant for the grant of a license or any person granted a license for the
sale of drugs shall on demand furnish to the licensing authority (before the
grant of the license or during the period of license in force), documentary
evidence in respect of the ownership of the occupation or rental or other basis
of the premises, specified in the application for license or in the license
granted, constitution of the firm, or any other relevant matter which may be
required for the purposes of verifying the correctness of the statements made
by the applicant or licensee.
Cancellation and Suspension of a license:
The licensing authority may, after giving the licensee an opportunity to show
cause why such an order should not be passed by an order in writing, stating
reasons therefore, cancel a license or suspend it for such a period as he thinks
fit either wholly or in respect of some of the substances to which it relates if in
his opinion, the licensee has failed to comply with any of the conditions of the
license or with any provision of the Act or rules thereunder.
A licensee whose license has been suspended or cancelled may within three
months of order, appeal against that order to the State Government which shall

25. (s) Procedure for disposal of drugs in the event of cancellation of
license:
If a licensee whose license has been cancelled, desires to dispose
drugs in respect of which license has been cancelled, he shall apply in
writing to the licensing authority for this purpose giving the following
particulars:
(a) The name and address of the person to whom the drugs are
proposed to be sold or supplied together with the number of the
license for the sale or manufacture, as the case may be, held by him.
(b) The name of the drugs together with their quantities, batch
numbers, the names and addresses of their manufactures, and date of
their expiry if any, proposed to be sold.
The licensing authority may , after examination of the particular refer
above and if Necessary, after inspection by an Inspector of the
premises where drugs are stocked, grant the necessary permission for
their disposal.

26. (t) Prohibition of manufacture and sale of certain drugs and cosmetics:
(Section 18)
No person shall manufacture or sell or stock or exhibit for sale or distribute,
(1) Any drug which is not of a standard quality or is misbranded, adulterated
or spurious.
(ii) Any patent proprietary medicine which label does not display true
formulae.
(iii) Any misbranded, spurious or sub-standard cosmetic.
(iv) Any drug which by means of any statement, design or device claims to
cure or mitigate any disease specified in schedule J (rule 106).
(v) Any cosmetic containing any ingredient which may render unsafe or
harmful for use.
(vi) Any drug in contravention to any provisions of the Act and rules
thereunder
Any drugs not intended for sale.
(viii) Any drug or cosmetic, imported or manufactured in contravention to any

27. 2.2 LABELLING AND PACKAGING OF DRUGS OTHER THAN
HOMOEOPATHIC MEDICINES
The rules made under Drugs and Cosmetics Act 1940, provide for the particulars
to be shown on containers of the drugs and manner in which particulars should
appear on the label. No person shall sell or distribute any drug (including a
patent or proprietary medicine) unless it is labelled in accordance with these
Rules.
1. Name of the drug :
The following preparations shall be labelled only with proper name:
(1) Preparations containing any new drug as a single active ingredient.
(ii) Preparations containing any drug specified in schedule W as the single active
ingredient.

28. 2. Statement of net content:
In terms of weight, volume, number of units of contents, number of units of activity etc.
as the case may be.
(3) The content of active ingredients:
This shall be expressed in terms of:
1. For oral liquids: Content per single, dose as per 5 ml or per ml etc.
2. For liquid parenteral – Content per mellite or percentage by volume or content per
dose.
3. For drugs in solid form for parenteral use, units or weight per gram or milligram.
4. For tablets, capsules, pills etc: content per tablet/capsule/pill etc.
5. For other preparations: Contents in terms of percentage by weight or volume as
Unitage per gram or per milliliter.
4. The name and address of the manufacturer:
5. Distinctive batch number:
Figures representing batch number preceded by the words ‘Batch No.’ or ‘B. No', or
'Batch' or ’Lot No.’ or ‘Lot’.(Same batch number shall be assigned to a product
manufactured from one Homogenous mix, homogenous bulk etc.)

29. 6. Manufacturing license number: Every drug
manufactured in India shall bear on its label the
number of license under which drug is
manufactured. Figure representing the
manufacturing license number preceded by words
‘Manufacturing License Number’ or, Manufacturing
License No., or M.L.
5. Date of manufacture: Every drug manufactured
for sale bear on its label date of Manufacture.
6. Date of expiry of potency: Drugs specified in
schedule P including combinations with other
drugs shall bear an label 'expiry date’.
7. Every drug distributed as a free sample to the
medical profession, while complying with above
provisions, shall further bear on the label, the
words “physician’s sample – Not to be sold’ which
shall be overprinted.
8. Alcoholic preparations containing more than
three per cent by volume of alcohol, shall bear on
the label statement showing the quantity of
alcohol in terms of average percentage by volume
in the finished product.

30. In addition to other particulars the label of innermost container of
the following categories of drugs and every other covering in which
container is packed shall bear a conspicuous vertical line on the left
side running throughout the body of the label which should not be
less than 1 mm in width and without disturbing the other
conditions printed on the label under these rules, namely Narcotic
analgesics, hypnotics, sedatives, tranquilizers corticosteroids,
hormones, hypoglycemics, antimicrobials, antiepileptics,
antidepressants, anticoagulants, anticancer drugs and all drugs
falling under schedule G, H and X whether covered or not in the
above list.
Provided that provisions of these clause shall not apply to:
(i) Preparations intended for animal treatment.
(ii) Preparations intended for external use.
(iii) Ophthalmic preparation and ear drops.
(iv) Sterile preparations such as sutures, surgical dressings and
preparations intended for parenteral use.

31. 2.3 LABELLING OF MECHANICAL CONTRACEPTIVES
The particulars printed on the label of
mechanical contraceptives are as
specified in schedule R and following
additional particulars:
(i) The date of manufacture.
(ii) The date unto which it is expected
to retain its properties.
(iii) The storage conditions necessary
for preserving the properties or
contraceptive. For oral contraceptive:
Date of manufacture only.

32. 2.4 LABELLING OF MEDICINES
Medicines for internal use:
(a) If it contains substance specified in schedule G
the words of caution - 'It is dangerous to take this
preparation except under medical supervision'
should be conspicuously printed and surrounded by
a line.
(b) If it contains a substance specified in schedule H:
(i) Symbol Rx conspicuously displayed on the left top
corner of the label.
(ii) The words schedule H drug, warning: To be sold
by a retail on the prescription of a Registered
Medical Practitioner only.
(c) It contains a drug specified in schedule H and
comes within purview of the Narcotic and
Psychotropic Substances Act 1985.
(i) Symbol NRx, conspicuously displayed on the left
top corner of the label in Red ink.
(ii) Schedule H drug, warning: To be sold by retail on

33. (d) If it contains a substance specified in
schedule X:
Symbol XRx in red conspicuously displayed
on the left top corner of the label.
The words: Schedule X drugs’ warning: To
be sold by retail on the Prescription of a
Registered Medical Practitioner only.
2. The container of a lotion, liniment,
liquid antiseptic or other liquid medicine
for External application – the words in
capital ‘FOR EXTERNAL USE ONLY.
3. Medicines for treatment of human
ailments containing industrial methylated
spirit shall indicate the fact on label and
labelled with words: ‘For external use only
4. Substance specified in schedule X in bulk

34. 5. Patent and proprietary medicines containing vitamins: the words indicating
whether for,
For therapeutic use!
For prophylactic use
(a) ‘For pediatric use as the case may be
(b) Age of the child/infant for whose use it is meant.
6. Non-sterile surgical ligature and sutures the words in a conspicuous manner
and in indelible red ink. “Non-sterile surgical ligature (suture), not to be used for
operations upon the human body unless efficiently sterilized”.
7. Patent and proprietary medicine:
Name and address of the manufacturer.
True formula or list of ingredients printed in indelible ink on outer label of every
package.
8. Pharmacopoeia and other official drugs: Name or synonym as specified in the
pharmacopoeia followed by the abbreviations recognized, I.P., B.P., B.P.C. etc. as
the case may be indicating that the drug is in accordance with standards set out
in such Pharmacopoeia.

35. 9. Ophthalmic preparations:
(a) Ophthalmic solutions and suspensions: The
following additional particulars shall be shown on the
label of container.
 The statement ‘use the solution within one month
after opening the container”.
 Name and concentration of the preservative if used.
 The words ‘NOT FOR INJECTION’.
 Special instructions regarding storage, wherever
applicable.
A cautionary legend reading as:
Warning:
(i) If irritation persists or increases, discontinue the
use and consult physician.
(ii) Do not touch the dropper tip or the other
dispensing tip to any surface since This may

36. (c) Ophthalmic ointments:
 Special instructions regarding storage wherever
applicable.
 ‘WARNING: If irritation persists or increases,
discontinue and consult physician.
10. Medicines made up ready for the treatment of
animals:
 The words ‘Not for human use. For animal
treatment only.
 Symbol depicting the head of a domestic animal.
11. Disinfectants
 Name of the product and name and address of
the manufacturer
 Grade, type and R.W. coefficient of the product.
Date of manufacture and date before which it
should be used.

37. 12. Coloured Medicines:
Common name of the colour used shall be displayed on
the label.
13. Labelling of vaccines:
(a) The label on the container shall display:
(i) The name of vaccine (international name or proper
name).
(ii) The principal place of manufacture.
(iii) The batch number or lot number.
(iv) The total number of doses in the container.
(b) In addition to above information, the label on the
package shall show:
 The name and address of the manufacture.
 The manufacturing license number, if manufactured in
India.
 The date of manufacturing and date of expiry.
 The precautions necessary for preserving the
properties of the vaccine.
The nature and percentage of preservative used if any.

38. (c) The following additional information shall be given in leaflet accompanying
the package.
(i) Conditions of storage.
(ii) Instructions for use.
(iii) The method of reconstitution of the vaccine.
(iv)A statement that, after rehydration, of the dried vaccine, the vaccine should
be used within six hours.
2.5 LABELLING OF MEDICINES MEANT FOR EXPORT
The following particulars shall appear on the label of container of medicine
meant for export:
Name of the drugs.
The name, address of the manufacturer, and the manufacturing license
number.
Batch or lot number.
Date of expiry if any.
If such particulars are not required by the importer, the labels on packages or
content shall bear a code ‘Not approved by licensing authority’.

39. 2.6 LABELLING OF MEDICINES DISPENSED ON PRESCRIPTION OF REGISTERED
MEDICAL PRACTITIONER
Medicines supplied against prescriptions of Registered Medical Practitioner shall
be Labelled with the following particulars:
Name and address of the supplier.
Name of the patient and quantity of medicine.
Serial number of an entry in the prescription register.
Dose if the medicine is for internal use.
The words ‘For External Use only’, if the medicine is for external application.
(Rule 104-A) Prohibition against altering inscriptions on containers, labels or
Wrappers or drug.
No person shall alter, obliterate or deface any inscription or mark made or
recorded by the manufacturer on the container, label or wrapper of any drug.
Provided that nothing in this rule shall apply to any alteration, any inscription or
mark made on the container, label or wrapper of any drug at the instance or
direction of with the permission of the Licensing Authority.

40. Packing of drugs:
The pack sizes of drugs meant for retail sale shall be as prescribed in
Schedule P-1 to these rules.
The pack sizes of drugs not covered by the Schedule P-1 shall be as given
below: Unless specified otherwise in Schedule P-1.
The pack sizes for Tablets/Capsules shall be: Where the number of Tablets
(coated or uncoated)/Capsules (hard or soft gelatine) is less than 10, such
packing shall be made by the integral number. For numbers above 10, the
pack sizes of Tablets/Capsules shall contain multiples of 5.
The pack sizes for liquid Oral preparations shall be 30 ml (pediatric only) 60
ml/ 100 ml/200 ml /450 ml.
The pack sizes for Pediatric Oral Drops shall be 5 ml/10 ml/15 ml. (iv) The
pack sizes for Eye/Ear/Nasal drops shall be 3 ml/5ml/10 ml.
The pack sizes for Eye Ointment shall be 3 gm/5 gm/10 gm.

41. The imported formulations in finished form.
Preparations intended for Veterinary use.
Preparations intended for export.
Vitamins / Tonics / Cough Preparations / Antacids / Laxatives in Liquid Oral
forms, Unit dose.
Pack sizes of dosage forms meant for retail sale to Hospitals, Registered
Medical Practitioner, Nursing Homes.
Physician’s Samples.
Pack sizes of Large Volume intravenous Fluids.
Provided also that pack sizes of any of the new drug as and when approved by
the Licensing Authority appointed under Rule 21
Packing of drugs specified in Schedule X:
The drugs specified in Schedule X shall be marketed in packings not exceeding
:
100 unit doses in the cases of tablets/capsules; and
300 ml in the case of oral liquid preparation;
5 ml in the case of injections:

42. Provided that nothing in this rule shall apply to packing meant for use of a
hospital or a dispensary subject to the conditions that:
(1) Such supplies are made by the manufacturers or distributors direct to the
Hospitals/dispensaries; and
(2) Hospital packs shall not be supplied to a retail dealer or to a Registered
Medical Practitioner.
(Rule 106) Diseases which a drug may not purport to prevent or cure:
(i) No drug may purport or claim to prevent or cure or may convey to the
intending user thereof any idea that it may prevent or cure, one or more of
the diseases or ailments specified in Schedule J.
(ii) No drug may purport or claim to procure or assist to procure, or convey
to the intending user thereof any idea that it may procure or assist to
procure, miscarriage in women.

43. VARIOUS OFFENSES AND CORRESPONDING
PENALTIES: (SECTION 27, 27A)
Offences Penalties
Any Adulterated or spurious
drug when used by any person,
is likely to cause his death or
cause grievous hurt within the
meaning of Section 320 of the
LP.C
Imprisonment for 5 years but which may extend to life
imprisonment and with fine not less than 10,000/-.
Any Drug deemed to be
adulterated without valid license
Imprisonment 1 year + extend to 3 years + 5,000 on first
conviction and imprisonment not less than two years +
extend to 6 years + fine not less than 10,000/- on any
subsequent conviction.
Any drug deemed to be spurious Imprisonment not less than 3 years + extend to 5 years +
fine 5000/- provided that for any adequate and special
reason court may impose imprisonment less than three
years on first conviction and with imprisonment not less
than six years + extend to ten years + with fine 10,000/- on
any subsequent conviction.
Drug in contravention Imprisonment upto one year + extend to 2 years and with
fine. Provided that for any adequate and special reasons
court may impose imprisonment less than 1 year. For any

44. Offences Penalties
Spurious cosmetic Punishable with imprisonment up to 3
years and fine.
Any cosmetic in
contravention
Punishable with imprisonment up to one
year, or with fine up to 1,000 or with both,
on first conviction and with imprisonment
up to 2 years and with fine up to 2000
rupees or with both on any subsequent
conviction.
• Penalty for non-disclosure of the name of the manufacturer: (Section 28):
Any one who does not disclose, the name of the manufacturer or his agent
from Whom he acquired the drug, if required by the Inspector, shall be
punishable with The imprisonment for a term which may extend to
1,000/- or with both.
• Penalty for not-keeping documents etc. and for non-disclosure of
information: Whoever without reasonable cause or excuse does not
maintain records, registers and documents as prescribed (Section 18),
does not furnishes information to the authorized officers under Drugs and
Cosmetics Act, shall b Punishable with imprisonment upto 1 year or with

45. Penalty for manufacture etc. of drugs or cosmetics, whose
manufacture, sale etc. prohibited in the public interest: (Section 28
B): Whoever himself or by any other person manufacture, sells or
distributes any drug or cosmetic, whose manufacture, sale etc. is
prohibited in the public interest by notification in the official gazette,
shall be punishable with imprisonment up to three years and fine up
to * 5,000/-.
Penalty for use of Government Analyst report for advertising:
Whoever uses any report of a test or analysis made by CDL or
Government Analyst or extract from such report for the purpose of
advertising any drug or cosmetic shall be punishable with fine upto
500/- on first conviction and with imprisonment upto ten years or
with fine or with both on any subsequent conviction.

46. PROVISIONS APPLICABLE TO MANUFACTURE
AND SALE OF AYURVEDIC AND UNANI DRUGS
Ayurvedic (including Siddha) and Unani drugs are required to be
manufactured according to the formulae prescribed under
second schedule. A license is required for manufacture of these
drugs. A separate license is required to carry out manufacturing
at different premises. Application for the grant of license shall
be made in form 24-D and on satisfying by licensing authority,
license is issued in Form 25-D, loan license for manufacture of
such drugs granted in Form 25-E, for the grant of which
application shall be made in Form 24-E. Applications shall be
accompanied with prescribed fees. Granted license valid for a
period up to 31 December following the year in which license is
granted or renewed.
Conditions for Grant or Renewal of a License:
Following conditions shall be complied with by the applicant
before grant of a licence:
(i) Manufacturing of Ayurvedic (including Siddha) and Unani
drugs shall be carried out In such premises and under such
hygienic conditions as specified in schedule T.

47. (ii) Manufacturing shall be carried out under the direction and supervision of
a Qualified technical staff, who possesses:
A degree in Ayurveda, Ayurvedic Pharmacy, Siddha or Unani Systems of
medicine as the case may be.
A diploma in Ayurveda, Siddha or Unani System of medicine, recognized by
Central Government.
Graduate in Pharmacy or pharmaceutical chemistry or chemistry or Botany
with at least two years post-graduate experience in the manufacturing of
Ayurvedic, Siddha or Unani drugs.
Vaidya or Hakim registered in a State Register of practitioners of
indigenous systems of medicine with at least four years experience in the
manufacturing of Siddha or Unani drugs.
Pharmacist in Ayurvedic, Siddha or Unani Systems of medicine with not less
than eight years of experience in the manufacture of Ayurvedic or Siddha e
Unani drugs.
The competent technical staff to direct and supervise manufacturing of
Ayurvedic or Siddha or Unani drugs shall have qualifications in the

48. Conditions of License:
Stated therein and the following further conditions:
The licensee shall maintain proper records of details of
manufacture and tests if any carried out by him, of the raw materials
and finished products.
The licensee shall allow an Inspector to enter and inspect premises,
to take samples of raw materials and finished products and to
inspect records maintained under the Rules.
The licensee shall maintain Inspection Book in form 35.
Cancellation and Suspension of License:
The granted or renewed license may be suspended or cancelled at
the desecration of licensing authority. A licensee whose license has
been suspended or cancelled may appeal to the State Government
within three months from the date of receipt of such order. The
decision of the Government is final.

49. Identification of Raw Materials:
Raw materials used in manufacture of such drugs shall be identified and
tested, wherever tests are available for their genuineness, and records of
such tests and methods shall be maintained.
Prohibition of Manufacture and Sale of certain Ayurvedic, Siddha and Unani
Drugs:
(A) No person shall manufacture for sale:
Any misbranded adulterated or spurious Ayurvedic, Siddha or Unani drugs.
Any patent or proprietary medicine the true list of ingredients is not
displayed on the label or container in a prescribed manner.
Any Ayurvedic, Siddha or Unani drug in contravention of any of the
provisions of the Act and Rule thereunder, related to such drugs.
(B) Sale, stock, or distribute any drug manufactured in contravention of any
of the Provisions of the Act and Rules thereunder.
(c) Any drug not manufactured in accordance with the conditions of a license.
Nothing from this apply to the Vaidyas and Hakims who manufactures drugs

50. Sale of Ayurvedic and Unani Drugs:
No license is necessary for sale of Ayurvedic, Siddha or Unani drugs, but dealers of
such drugs can sell only such products which are manufactured by a person licensed t
manufacture Penalty for manufacture, sale etc. of Ayurvedic, Siddha or Unani drug in
contravention Of provisions related to manufacture of such drug:
(a) Manufacture of a drug deemed to be adulterated or, Manufacture of a drug without
a valid license, shall be punishable with imprisonment upto one year and with fine not
less than two thousand rupees.
(d) Manufacture of any Ayurvedic, Siddha or Unani drug deemed to be spurious,
punishable with imprisonment not less than one year which may extend upto three
years and with fine not less than five thousand rupees.
(c)Contravention of any other provisions related to Ayurvedic, Siddha or Unani drugs
Punishable with imprisonment up to three months and with fine not less than five
Hundred rupees.
For any subsequent offence under
(a) Will be punishable with imprisonment up to two years and fine not less than two
thousand rupees and under
(b) With imprisonment not less than two years which may extend up to six years and
with fine not less than five thousand rupees and under with imprisonment up to six
months and with fine not less than one thousand rupees.

51. Confiscation:
Any stock of drug in respect of which the contravention has been made shall be liable
For confiscation.
Labelling and Packing of Ayurvedic (including Siddha) or Unani Drugs:
Manner of Labelling: Following shall be displayed on the label of the container or
carton of Ayurvedic, Siddha or Unani drug:
1 List of all ingredients, together with their quantities and reference to method of
preparation as detailed in Standard text, shall be displayed on the label of the
container or package. If list is too large it may be required separately and enclosed
with packing.
2. If medicine is for internal use and contains substance from schedule E (1), be
conspicuously labelled with the words “caution To be taken under medical supervision”
both in English and Hindi.
3. Following particulars shall be written or printed in indelible ink, and appear in a
conspicuous manner on the label of innermost container and other coverings:
Name of the drug, as mentioned in the authorities books, included in First schedule.
Net content, in terms of weight, measure, number etc.

52. Licence number under which manufacturing is carried out, preceded by words
“Manufacturing licence number’, or Mfg. Lic. No, or M.L.”.
A distinctive batch number, proceeded by words, ‘Batch No.’, or ‘Batch’ or ‘Lot
Number’ or ‘Lot’ or any distinguishing prefix.
Date of manufacture, means the date of completion of the final product or date
of Bottling or packing for issue.
The words, “Ayurvedic Medicine” or “Siddha Medicine” or “Unani Medicine” as
the case may be.
The words “FOR EXTERNAL USE ONLY”, if the medicine is for external
application.
Every drug intended for free distribution to the Medical Profession, besides
complying with above provisions, shall bear on the label, the words ”Physicians,
Sample – Not to be sold” and shall be overprinted.

53. Packing of Asavas with high content of alcohol as base.
Name of drug Maximum size of packing
Kapur Asava 15 ml
Ahiphenasava 15 ml
Mrigamadasava 15 ml
Name of the drug Max. content of
alcohol
(Ethyl alcohol v/v)
Max. size of packing
Mritsanjivani Sura 16 per cent 30 ml
Mahadrakshasav 16 per cent 120 ml

54. THANK
YOU