IMA WHITE PAPER ON NON PRESCRIPTION DRUGS

The import, manufacture, distribution and sale of drugs and cosmetics in India is
regulated by the Drugs and Cosmetics Act, 1940 (hereinafter referred to as ―DCA‖)
and Drugs and Cosmetics Rules, 1945 (hereinafter referred to as ―DCR‖).

The profession and practice of pharmacy and constitution of pharmacy council is

being regulated by The Pharmacy Act, 1948.
DEFINITION OF DRUG
 The term ―drug‖ has been defined in Section 3(b) of the DCA which is an
inclusive definition. According to Section 3(b) of DCA ―drug‖ includes—
(i) 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;
(ii) such substances (other than food) intended to affect the
structure or any function of the human body or intended to be
used for the destruction of vermin or insects which cause
disease in human beings or animals, as may be specified from
time to time by the Central Government by notification in the
Official Gazette;
(iii) all substances intended for use as components of a drug
including empty gelatin capsules; and
(iv) such devices intended for internal or external use in the
diagnosis, treatment, mitigation or prevention of disease or
disorder in human beings or animals, as may be specified from
time to time by the Central Government by notification in the
Official Gazette, after consultation with the Board;

 According to Section 2 of the Pharmacy Act, the term drug means any
substance or mixture of substances manufactured, sold or represented for use
in-
(a) The diagnosis, treatment; mitigation or prevention of a-disease,
disorder, abnormal physical state or the symptoms thereof in man or
animal;
 (b) Restoring, correcting or modifying organic functions in man or.anima1;
(c) disinfection in premises in which food is manufactured, prepared,
preserved, packaged or stored for sale or sold or for the control of vermin
or insects in such premises;

 According to Section 2(b) of The Drugs And Magic Remedies

(Objectionable Advertisements) Act, 1954, the term drug‘ includes:

(i) A medicine for the internal or external use of human beings or

animals

(ii) Any substance intended to be used for or in the diagnosis, cure,

mitigation, treatment or prevention of disease in human beings or
animals

(iii) Any article, other than food, intended to affect or influence in any
way the structure or any organic function of the body of human beings
or animals;

(iv) Any article intended for use as a component of any medicine,

substance or article, referred to in sub-clauses (i), (ii) and (iii).

 According to Section 2(f) of Drugs (Prices Control) Order, 1995, the

definition of term drugs includes:
(i) 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
 (ii) such substances, intended to affect the structure or any function of the
human or animal body or intended to be used for the destruction of
vermin or insects which cause disease in human beings or animals, as
may be specified from time to time by the Government by notification
in the Official Gazette

(iii) bulk drugs and formulations

The definition of the term drug as mentioned above in various acts neither
classify / divide the drugs into allopathic drugs, ayurvedic, siddha or unani drug
or homeopathic drug nor does it discriminate between prescribed drugs or non
prescribed drugs. Further, the definition of drug does not define the term over the
counter drugs (OTC) as commonly known in USA which can be sold or purchased
by any person over the counter.
CLASSIFICATION OF DRUG EXCLUDING HOMEOPATHIC DRUGS

Allopathic Drugs / Medicines

 The provisions of Drugs & Cosmetics Act, does not define the term allopathic
drug or modern medicine.

 Indian Medical Council Act, 1956 (hereinafter referred to as IMC Act) is an

act to provide for the reconstitution of the Medical Council of India and the
maintenance of a Medical Register for India and for matters connected
therewith. According to Section 2 (g) of Indian Medical Council Act, 1956,
"medicine" means modern scientific medicine in all its branches and
includes surgery and obstetrics, but does not include veterinary medicine
and surgery.

 Indian Medical Degrees Act, 1916 was enacted to regulate the grant of titles
implying qualifications in Western medical science and the assumption and
use by unqualified persons of such titles.

According to Section 2 of the Indian Medical Degrees Act, 1916, ―Western

Medical Science‖ means the Western methods of Allopathic medicine,
Obstetrics and Surgery, but does not include the Homeoptahic or Ayurvedic
or Unani System of medicine. Thus, Indian Medical Degrees Act does not
grant degrees of Ayurvedic, Unani system of medicines.

Ayurvedic, Siddha And Unani Drug

 According to Section 3(a) of Drugs and Cosmetics Act, 1940, Ayurvedic,
Siddha or Unani drug‖ includes all medicines intended for internal or
external use for or in the diagnosis, treatment, mitigation or prevention of
disease or disorder in human beings or animals, and manufactured
exclusively in accordance with the formulae described in, the authoritative
 books of Ayurvedic, Siddha and Unani Tibb systems of medicine, specified in
the First Schedule.

 The Indian Medicine Central Council Act, 1970 (hereinafter referred to as

―IMCC Act) has been framed to provide for the constitution of a Central
Council of Indian Medicine and the maintenance of a Central Register of
Indian Medicine and for matters connected therewith.

According to Section 2(e) of the Indian Medicine Central Council Act,

"Indian Medicine" means the system of Indian medicine commonly known as
Ashtang Ayurveda, Siddha or Unani Tibb whether supplemented or not by
such modern advances as the Central Council may declare by notification
from time to time.
DEFINITION OF FOOD
The Food Safety and Standards Act, 2006 has been framed to consolidate the laws
relating to food and to establish the Food Safety and Standards Authority of India
for laying down science based standards for articles of food and to regulate their
manufacture, storage, distribution, sale and import, to ensure availability of safe and
wholesome food for human consumption and for matters connected therewith or
incidental thereto.

According to Section 3(j) of Food Safety and standards Act, 2006, ―Food‖ means
any substance, whether processed, partially processed or unprocessed, which is
intended for human consumption and includes primary food to the extent defined in
clause (zk), genetically modified or engineered food or food containing such
ingredients, infant food, packaged drinking water, alcoholic drink, chewing gum,
and any substance, including water used into the food during its manufacture,
preparation or treatment but does not include any animal feed, live animals unless
they are prepared or processed for placing on the market for human consumption,
plants, prior to harvesting, drugs and medicinal products, cosmetics, narcotic or
psychotropic substances :
Provided that the Central Government may declare, by notification in the Official
Gazette, any other article as food for the purposes of this Act having regards to its
use, nature, substance or quality
POISONOUS SUBSTANCES
According to Section 4 of DCA, any substance specified as poisonous by rule made
under Chapter III or Chapter IV or Chapter IVA shall be deemed to be a poisonous
substance for the purposes of Chapter III or Chapter IV or Chapter IVA, as the case
may be.
SCHEDULE DRUGS and NON SCHEDULE DRUGS
According to the provisions of Drugs & Cosmetics Act, 1940 and Drugs & Cosmetics
Rules, 1945 certain restriction has been imposed on the manufacture, sale,
advertisement, labeling, packing, etc. of certain drugs. Thus, the allopathic drugs
and ayurvedic, siddha and unani drgs can further be classified as

i) Schedule Drugs / Prescription Drugs: The List of schedule / prescription

drugs of allopathic and ayurvedic, siddha and unani drugs is mentioned in
Schedules appended to the Drugs and Cosmetics Rules, 1945. The drugs
mentioned in Schedule E1, G, H, H1 and X appended to the Drugs and
Cosmetics Rules, 1945 can be termed as Schedule Drugs / Prescription drugs.

ii) Non Schedule / Non Prescription Drugs: There are certain drugs as
mentioned in Schedule K of Drugs & Cosmetics Rules, 1945 which are
exempted from the various restrictions as imposed in case of schedule drugs.

iii) Non Schedule / Non Prescription Drugs not mentioned in Schedule K:

There are certain drugs other than those as mentioned in Schedule K which
are exempted from various restrictions as imposed in case of schedule drugs /
prescription drugs. These are those drugs which are not mentioned in any of
the Schedule appended to the Drugs and Cosmetics Rules, 1945. However,
there is no exhaustive list of non schedule drugs.
SCHEDULE / PRESCRIPTION DRUGS
The drugs mentioned in Schedule E1, G, H, H1 and X appended to the Drugs and
Cosmetics Rules, 1945 can be termed as Schedule Drugs / Prescription drugs. The
drugs mentioned in Schedule E1, G, H, H1 and X along with various restrictions as
imposed on these drugs are discussed hereinunder:

 SCHEDULE E(I) - List of poisonous substances under the ayurvedic

(including Siddha) and Unani Systems of Medicine

 Restriction on Labeling
According to Rule 161(2) of Drugs and Cosmetics Rules, 1945, the
container of medicines for internal use made up ready for the
treatment of human ailments shall, if it is made up from a substance
specified in Schedule E(1) be labeled conspicuously with the words:
Caution: To be taken under medical supervision‘ both in English and
Hindi language.

Thus, the ayurvedic, siddha and unani drugs enumerated in Schedule E1

have to be taken under medical supervision being poisonous substances.
Accordingly, these drugs under ayurvedic including siddha and unani
system of medicine enumerated in Schedule E1 can be termed as Scheduled
Drugs and all other drugs under ayurvedic, siddha and unani system of
medicine can be termed as Non Schedule Drugs.
 SCHEDULE G - Antihistaminic substances the following their salts, their
derivatives, salts of their derivatives.

 Restriction on Manufacture and sale of certain drugs

According to Section 18 of DCA prohibits manufacture and sale of
certain drugs and cosmetics without valid licence.

 Restriction on Labeling of Scheduled / Prescription Drugs

o According to Rule 96(1)(xi) of DCR, In addition to the other
particulars which are required to be printed or written under
these Rules, the label of innermost container of the following
categories of drugs and every other covering in which the
container is packed shall bear a conspicuous red vertical line
on the left side running throughout the body of the label
which should not be less than 1mm in width and without
disturbing the other conditions printed on the label under these
rules, namely: —

Narcotic analgestics, hypnotics, sedatives, tranquillisers,

corticosteroids, hormones, hypoglycemics, antimicrobials,
antiepileptics, antidepressants, anticoagulants, anti-cancer
drugs and all other drugs falling under Schedules ‗G‘, ‗H‘,
and ‗X‘ whether covered or not in the above list:

Provided that the provisions of this clause shall not apply to:

(a) Preparations intended for animal treatment;

(b) Preparations intended for external use;

(c) Ophthalmic preparations and ear drops; and

(d) Sterile preparations such as sutures, surgical

dressings and preparations intended for parenteral use.
 o According to Rule 97 of DCR, the container of a medicine for
internal use shall if it contains a substance specified in Schedule
G, be labeled with the words ‗Caution: it is dangerous to take
this preparation except under medical supervision‘—
conspicuously printed and surrounded by a line within which
there shall be no other words;

The drugs enumerated in Schedule G have to be specifically labeled as

dangerous to take this preparation except under medical supervision and
without the said label the drugs mentioned in Schedule G should not be sold
or purchased by any person. The drugs enumerated in Schedule G can be
termed as Scheduled Drugs.
 SCHEDULE H – Prescription Drugs
 Restriction on Manufacture and sale of drugs
According to Section 18 of DCA prohibits manufacture and sale of
certain drugs and cosmetics without valid licence.

 Restriction on sale / supply of schedules / prescription drugs

According to Rule 65 of CDR certain conditions are laid down w.r.t
sale and supply of drugs specified in Schedules of DCR.
o Rule 65(9) (a) Substances specified in Schedule H and Schedule
H1or Schedule X shall not be sold by retail except on and in
accordance with the prescription of a Registered Medical
Practitioner.
o Rule 65(9)(b) The supply of drugs specified in Schedule H and
Schedule H1or Schedule X to Registered Medical Practitioners,
Hospitals, Dispensaries and Nursing Homes shall be made only
against the signed order in writing which shall be preserved by
the licensee for a period of two years.
__
o Rule 65 (10) For the purposes of clause (9) a prescription shall
(a) Be in writing and be signed by the person giving it
with his usual signature and be dated by him;
(b) specify the name and address of the person for whose
treatment it is given, or the name and address of the
owner of the animal if the drug is meant for veterinary
use;
(c) Indicate the total amount of the medicine to be
supplied and the dose to be taken.
o Rule 65 (11) The person dispensing a prescription containing a
drug specified in Schedule H and Schedule H1and Schedule X
shall comply with the following requirements in addition to
____
other requirements of these Rules
 (a) The prescription must not be dispensed more than
once unless the prescriber has stated thereon that it may
be dispensed more than once;
(b) If the prescription contains a direction that it may be
dispensed a stated number of times or at stated intervals
it must not be dispensed otherwise than in accordance
with the directions;
(c) At the time of dispensing there must be noted on the
prescription above the signature of the prescriber the
name and address of the seller and the date on which the
prescription is dispensed.
o Rule 65(11-A) No person dispensing a prescription containing
substances specified in Schedule H and Schedule H1 or X, may
supply any other preparation, whether containing the same
substance or not, in lieu thereof.

 Restriction on Advertisement of Scheduled / Prescription Drugs

According to Rule 74(p), Rule 74A(i), Rule 74B(7), Rule 78(q) and
Rule 78A(8) of DCR, no advertisement of the drugs specified in
Schedule H, Schedule H1 and Schedule X shall be made except with
the previous sanction of the Central Government.

 Restriction on Labeling of scheduled / prescription drugs

o According to Rule 94(2) of DCR, the provisions of Rules 96 to
101 inclusive, shall not apply to a medicine made up ready for
treatment, whether after or without dilution, which is supplied
on the prescription of a registered practitioner provided that:

(i) the medicine is labelled with the following particulars :

(a) the name and address of the supplier;

 (b) the name of the patient and the quantity of the
medicine;

(c) the number representing serial number of the

entry in the prescription register

(d) the dose, if the medicine is for internal use;

(e) the words ―FOR EXTERNEL USE ONLY‖ shall

be printed on the label if the medicine is for
external application.

(ii) Condition (3) of the conditions in Rule 65 is satisfied.

o According to Rule 95 of DCR , Subject to the other provisions of

these Rules, no person shall sell or distribute any drug
(including a patent or proprietary medicine) unless it is labelled
in accordance with these Rules.

o According to Rule 96(1)(xi) of DCR, In addition to the other

particulars which are required to be printed or written under
these Rules, the label of innermost container of the following
categories of drugs and every other covering in which the
container is packed shall bear a conspicuous red vertical line
on the left side running throughout the body of the label
which should not be less than 1mm in width and without
disturbing the other conditions printed on the label under these
rules, namely: —

Narcotic analgestics, hypnotics, sedatives, tranquillisers,

corticosteroids, hormones, hypoglycemics, antimicrobials,
antiepileptics, antidepressants, anticoagulants, anti-cancer drugs
and all other drugs falling under Schedules ‗G‘, ‗H‘, and ‗X‘
whether covered or not in the above list:

Provided that the provisions of this clause shall not apply to: −

(a) preparations intended for animal treatment;

 (b) preparations intended for external use;

(c) ophthalmic preparations and ear drops; and

(d) sterile preparations such as sutures, surgical dressings and

preparations intended for parenteral use.

o Rule 97 of DCR deals with the Labelling of Medicines which is

reproduce hereunder:

(1) The container of a medicine for internal use shall—

(b) if it contains a substance specified in Schedule H be labelled

with the symbol Rx and conspicuously displayed on the left top
corner of the label and be also labelled with the following
words:—

‗Schedule H drug—Warning: To be sold by retail on the

prescription of a Registered Medical Practitioner only‘;

(c) if it contains a substance specified in Schedule H and comes

within the purview of the Narcotic Drugs and Psychotropic
Substances Act, 1985 (61 of 1985) be labelled with the symbols
NRx which shall be in red and conspicuously displayed on the
left top corner of the label, and be also labelled with the
following words:—

‗Schedule H drug — Warning: To be sold by retail on the

prescription of a Registered Medical Practitioner only‘;

The drugs mentioned in Schedule H as prescription drugs cannot be

manufactured, sold without a valid licence. Further, the drugs mentioned in
Schedule H can be sold only on and in accordance of the prescription of a
registered medical practitioner and all the drugs mentioned in Schedule H
bears a label mentioning the same. Also, the drugs mentioned in Schedule H
cannot be advertised. Thus, drugs mentioned in Schedule H are Prescription
drugs / Scheduled Drugs as a person has to produce the registered medical
prescription at the Chemist counter for dispensing any prescription drugs
Therefore, the drugs mentioned in Schedule H cannot be sold / purchased
without a prescription from the registered medical practitioner.
 SCHEDULE H1 – Prescription drugs
 Restriction on Manufacture and sale of certain drugs
According to Section 18 of DCA prohibits manufacture and sale of
certain drugs and cosmetics without valid licence.

 Restriction on sale / supply of schedules / prescription drugs

According to Rule 65 of CDR certain conditions are laid down w.r.t
sale and supply of drugs specified in Schedules of DCR.
o Rule 65(9) (a) Substances specified in Schedule H and Schedule
H1or Schedule X shall not be sold by retail except on and in
accordance with the prescription of a Registered Medical
Practitioner and in the case of substances specified in Schedule
X, the prescriptions shall be in duplicate, one copy of which
shall be retained by the licensee for a period of two years.
o Rule 65(9)(b) The supply of drugs specified in Schedule H and
Schedule H1 or Schedule X to Registered Medical Practitioners,
Hospitals, Dispensaries and Nursing Homes shall be made only
against the signed order in writing which shall be preserved by
the licensee for a period of two years.
__
o Rule 65 (10) For the purposes of clause (9) a prescription shall
(a) be in writing and be signed by the person giving it
with his usual signature and be dated by him;
(b) specify the name and address of the person for whose
treatment it is given, or the name and address of the
owner of the animal if the drug is meant for veterinary
use;
(c) indicate the total amount of the medicine to be
supplied and the dose to be taken.
o Rule 65 (11) The person dispensing a prescription containing a
drug specified in Schedule H and Schedule H1 and Schedule X
 shall comply with the following requirements in addition to
__
other requirements of these Rules
(a) the prescription must not be dispensed more than
once unless the prescriber has stated thereon that it may
be dispensed more than once;
(b) if the prescription contains a direction that it may be
dispensed a stated number of times or at stated intervals
it must not be dispensed otherwise than in accordance
with the directions;
(c) at the time of dispensing there must be noted on the
prescription above the signature of the prescriber the
name and address of the seller and the date on which the
prescription is dispensed.
o Rule 65(11-A) No person dispensing a prescription containing
substances specified in Schedule H and Schedule H1 or X, may
supply any other preparation, whether containing the same
substance or not, in lieu thereof.

 Restriction on Advertisement of Scheduled / Prescription Drugs

According to Rule 74(p), Rule 74A(i), Rule 74B(7), Rule 78(q) and
Rule 78A(8) of DCR, no advertisement of the drugs specified in
Schedule H, Schedule H1 and Schedule X shall be made except with
the previous sanction of the Central Government.

 Restriction on Labeling of scheduled / prescription drugs

o Rule 97 of DCR deals with the Labelling of Medicines which is

reproduce hereunder:

(1) The container of a medicine for internal use shall—

(e) if it contains a drug substance specified in Schedule H1, the

drug formulation shall be labelled with the symbol Rx which
 shall be in red and conspicuously displayed on the left top
corner of the label, and shall also be labelled with the following
words in a box with red border:

―SCHEDULE H1 DRUG – WARNING:

- It is dangerous to take this preparation except
in accordance with the medical advice.
- Not to be sold by retail without the
prescription of a Registered Medical
Practitioner.

The drugs mentioned in Schedule H1 as prescription drugs cannot be

manufactured, sold without a valid licence. Further, the drugs mentioned in
Schedule H1 can be sold only on and in accordance of the prescription of a
registered medical practitioner and all the drugs mentioned in Schedule H1
bears a label mentioning the same. Also, the drugs mentioned in Schedule H1
cannot be advertised. Thus, drugs mentioned in Schedule H1 are Prescription
drugs / Scheduled Drugs as a person has to produce the registered medical
prescription at the Chemist counter for dispensing any prescription drugs
Therefore, the drugs mentioned in Schedule H1 cannot be sold / purchased
without a prescription from the registered medical practitioner.
 SCHEDULE X – Special drugs for import licences

 Restriction on Manufacture and sale of certain drugs

According to Section 18 of DCA prohibits manufacture and sale of
certain drugs and cosmetics without valid licence.

 Restriction on sale / supply of schedules / prescription drugs

According to Rule 65 of CDR certain conditions are laid down w.r.t
sale and supply of drugs specified in Schedules of DCR.
o Rule 65(9) (a) Substances specified in Schedule H and Schedule
H1 or Schedule X shall not be sold by retail except on and in
accordance with the prescription of a Registered Medical
Practitioner and in the case of substances specified in Schedule
X, the prescriptions shall be in duplicate, one copy of which
shall be retained by the licensee for a period of two years.
o Rule 65(9)(b) The supply of drugs specified in Schedule H and
Schedule H1 or Schedule X to Registered Medical Practitioners,
Hospitals, Dispensaries and Nursing Homes shall be made only
against the signed order in writing which shall be preserved by
the licensee for a period of two years.
___
o Rule 65 (10) For the purposes of clause (9) a prescription shall
(a) be in writing and be signed by the person giving it
with his usual signature and be dated by him;
(b) specify the name and address of the person for whose
treatment it is given, or the name and address of the
owner of the animal if the drug is meant for veterinary
use;
(c) indicate the total amount of the medicine to be
supplied and the dose to be taken.
o Rule 65 (11) The person dispensing a prescription containing a
drug specified in Schedule H and Schedule H1 and Schedule X
 shall comply with the following requirements in addition to
____
other requirements of these Rules
(a) the prescription must not be dispensed more than
once unless the prescriber has stated thereon that it may
be dispensed more than once;
(b) if the prescription contains a direction that it may be
dispensed a stated number of times or at stated intervals
it must not be dispensed otherwise than in accordance
with the directions;
(c) at the time of dispensing there must be noted on the
prescription above the signature of the prescriber the
name and address of the seller and the date on which the
prescription is dispensed.
o Rule 65(11-A) No person dispensing a prescription containing
substances specified in Schedule H and Schedule H1 or
Schedule X, may supply any other preparation, whether
containing the same substance or not, in lieu thereof.

 Restriction on Storage of Schedule / Prescription Drugs

Rule 65 (12) Substances specified in Schedule X kept in retail shop or
premises used in connection therewith shall be stored—
(a) under lock and key in cupboard or drawer reserved solely
for the storage of these substances; or
(b) in a part of the premises separated from the remainder of the
premises and to which only responsible persons have access;

 Restriction on Advertisement of Scheduled / Prescription Drugs

According to Rule 74(p), Rule 74A(i), Rule 74B(7), Rule 78(q) and
Rule 78A(8) of DCR, no advertisement of the drugs specified in
Schedule H, Schedule H1 and Schedule X shall be made except with
the previous sanction of the Central Government.
 Restriction on Labeling of scheduled / prescription drugs

o According to Rule 96(1)(xi) of DCR, In addition to the other

particulars which are required to be printed or written under
these Rules, the label of innermost container of the following
categories of drugs and every other covering in which the
container is packed shall bear a conspicuous red vertical line
on the left side running throughout the body of the label
which should not be less than 1mm in width and without
disturbing the other conditions printed on the label under these
rules, namely: —

Narcotic analgestics, hypnotics, sedatives, tranquillisers,

corticosteroids, hormones, hypoglycemics, antimicrobials,
antiepileptics, antidepressants, anticoagulants, anti-cancer drugs
and all other drugs falling under Schedules ‗G‘, ‗H‘, and
Schedule ‗X‘ whether covered or not in the above list:

Provided that the provisions of this clause shall not apply to: −
(a) Preparations intended for animal treatment;
(b) Preparations intended for external use;
(c) Ophthalmic preparations and ear drops; and
(d) Sterile preparations such as sutures, surgical dressings and
preparations intended for parenteral use.

o Rule 97 of DCR deals with the Labelling of Medicines which is

reproduce hereunder:

(1) The container of a medicine for internal use shall—

(d) if it contains a substance specified in Schedule X, be labelled

with the symbol XRx which shall be in red conspicuously
displayed on the left top corner of the label, and be also labelled
with the following words:—
 ‗Schedule X drug — Warning: To be sold by retail on the
prescription of a Registered Medical Practitioner only‘;

(5) Substances specified in Schedule X in bulk form shall bear a label

wherein the symbol as specified in sub-rule (1) shall be given
conspicuously in red letters

 Restriction on Packing of scheduled / prescription drugs

According to Rule 105A of DCR deals with Packing of drugs specified in
Schedule X: The drugs specified in Schedule X shall be marketed in packings
not exceeding-
(i) 100 unit doses in the case of tablets/capsules;
(ii) 300 ml in the case of oral liquid preparations; and
(iii) 5 ml in the case of injections:

Provided that nothing in this rule shall apply to packing meant for use
of a hospital or a dispensary subject to the conditions that–

(i) such supplies are made by the manufacturers or

distributors direct to the hospital/dispensaries; and
(ii) hospital packs shall not be supplied to a retail dealer or to
a Registered Medical Practitioner.

The drugs mentioned in Schedule X cannot be manufactured, sold without a

valid licence. Further, the drugs mentioned in Schedule X can be sold only on
and in accordance of the prescription of a registered medical practitioner and
all the drugs mentioned in Schedule X bears a label mentioning the same.
Also, the drugs mentioned in Schedule X cannot be advertised. Thus, drugs
mentioned in Schedule X are Prescription drugs / Scheduled Drugs as a
person has to produce the registered medical prescription at the Chemist
counter for dispensing any prescription drugs. Therefore, the drugs
mentioned in Schedule X cannot be sold / purchased without a prescription
from the registered medical practitioner.
 NON SCHEDULE / NON PRESCRIPTION DRUGS
 Schedule K – Drugs exempted from the provisions of Chapter IV of the Act

According to the Rule 123 of DCR, the drugs specified in Schedule K shall
be exempted from the provisions of Chapter IV of the Act and the rules made
thereunder to the extent and subject to the conditions specified in that
Schedule.

Thus, there are certain drugs as specified in Schedule K on which there is no

restriction in selling the same like the one as imposed on scheduled drugs /
prescription drugs by DCA and DCR.

As the drugs mentioned in Schedule K are exempted from the provisions of

Chapter IV of DCA and DCR, thus, the sale of these drugs does not require
prescription from the registered medical practitioner and the said drugs can
be sold without any prescription. Hence, the drugs as mentioned in
Schedule K can be termed as Non Prescription Drugs. However some of
these drugs are sold and prescribed under some specific situations as defined
in the rules.

The illustrative list of drugs as enumerated in Schedule K is as follows:

Sr. Class of Drugs Extent and conditions of exemption
No.

2A Quinine and other antimalarial Persons selling the drug by retail under
drugs. arrangements made by State Government
for sale and distribution of the drugs will
be exempted from the requirement to
take out licences for retail sale under
clause (c) of Section 18 of the Act.

5A Drugs supplied by a hospital or The provisions of Chapter IV of the Act

dispensary maintained or and the Rules thereunder which require
supported by Government or them to be covered by a sale licence,
local body subject to the following conditions :

5B Whole Human Blood I.P.
and/or its components stored
for transfusion by a First
Referral Unit Community
Health Centre, Primary Health
Centre and Hospital.
(1) the dispensing and supply of drugs
shall be carried out by or under the
supervision of a registered pharmacist
(2) the premises where drugs are
supplied or stocked shall be open to
inspection by an Inspector appointed
under the Drugs and Cosmetics Act who
can, if necessary, take samples for test.
(3) the drugs shall be stored under the
proper storage conditions
(4) The drugs shall be purchased from a
manufacturer or a dealer licensed under
these rules or received as transferred
stocks from hospital stores for
distribution. Records of such purchases
or receipts shall be maintained.
The provisions of Chapter IV of the Act
and the rules made thereunder which
require obtaining of a licence for
operation of a blood bank or processing
Whole Human Blood and/or its
components subject to the following
conditions, namely:–
(1) The First Referral Unit, Community
Health Centre, Primary Health Centre
and/or any Hospital shall be approved
by the State/Union Territory Licensing
Authority after satisfying the conditions
and facilities through inspection.
(2) The captive consumption of Whole
Human Blood I.P or its components in
the First Referral Unit, Community
Health Centre, Primary Health Centre
and/or any Hospital shall not be more
than 2000 units annually.
(3) The Whole Human Blood and/or its
components shall be procured only from
Government Blood Bank and/or Indian
Red Cross Society Blood Bank and/or
Regional Blood Transfusion Centre duly
licensed.

(4) The approval shall be valid for a

period of two years from the date of issue
unless sooner suspended or cancelled
and First Referral Unit, Community
Health Centre, Primary Healthy Centre or
the Hospital shall apply for renewal to
the State Licensing Authority three
months prior to the date of expiry of the
approval.

(5) The First Referral Unit, Community

Health Centre, Primary Health Centre
and/or any Hospital shall have the
following technical staff for storage of
blood or its components:-

(a) A trained Medical Officer for proper

procurement, storage and cross matching
of blood and/or its components. He/she
shall also be responsible for identifying
haemolysed blood and ensure non-
supply of date expired blood or its
components.

(b) A blood bank Technician with the

qualification and experience as specified
in Part XII B of Schedule F or an
experienced laboratory technician trained
in blood grouping and cross matching.

(6) The First Referral Unit, Community

Health Centre, Primary Health Centre
and Hospital shall have an area of 10 sq
metres. It shall be well lighted, clean and
preferably air-conditioned. Blood bank
refrigerator of appropriate capacity fitted
with alarm device and temperature
indicator with regular temperature
monitoring shall be provided to store
o o
blood units between 2 C to 8 C and if the
components are proposed to be stored,
specialized equipments as specified in
Part XII B of Schedule F shall also be
 provided.

(7) The First Referral Unit, Community

Health Centre, Primary Health Centre
and Hospital shall maintain records and
registers including details of
procurements of Whole Human Blood I.P
and/or blood components, as required
under Part XII B of Schedule F.

(8) The First Referral Unit, Community

Health Centre, Primary Health Centre
and Hospital shall store samples of
donors blood as well as patients sera for a
period of seven days after transfusion.

10 The following substances which All the provisions of Chapter IV of the

are used both as articles of food Act and the Rules thereunder.
as well as drugs:–
(i) all condensed or powdered
milk whether pure skimmed or
malted, fortified with vitamins
and minerals or otherwise

(ii) Farex, Oats and all other

similar cereal preparations
whether fortified with vitamins
or otherwise excepting those for
parenteral use.

(iii) Virol, Bovril, Chicken

essence and all other similar
predigested foods.

(iv) Ginger, Pepper, Cumin.

Cinnamon and all other similar
spices and condiments unless
they are specially labelled as
conforming to the standards in
the Indian Pharmacopoeia or
the official pharmacopoeias and
official compendia of drug
standards prescribed under the
Act and rules made thereunder

12 Substances intended to be used The provisions of Chapter IV of the Act

 for destruction of vermin or
insects, which cause disease in
human beings or animals, vis.
Insecticides and Disinfectants.
and the Rules thereunder which require
them to be covered by a sale licence
subject to the condition that provision of
condition (17) Rule 65 of the Drugs and
Cosmetics Rules, 1945 are complied with
by the person stocking or selling such
substances.

13. The following household The provision of Chapter IV of the Act

remedies, namely:– and the Rules thereunder which require
(1) Asprin Tablets. them to be covered with a sale licence in
Form 20-A subject to the following
(2) Paracetamol Tablets. conditions: -
(a) the drugs are sold only in a village
(3) Analgesic Balms. having population of not more than one
thousand persons and where there is no
(4) Antacid Preparations licenced dealer under the Drugs and
Cosmetics Act;
(5) Gripe Water for use of
infants. (b) the drugs do not contain any
substance specified in Schedule G, H or
(6) Inhalers, containing drugs X;
for treatment of cold and nasal
congestion. (c) the drugs are sold in the original
unopened containers of the licensed
(7) Syrups, lozenges, pills and manufacturers;
tablets for cough.
(d) when the drugs are sold under clause
(8) Liniments for external use. (a) condition 3 under ―Conditions of
licence‖ of Form 20-B shall not apply.
(9) Skin ointments and
ointments for burns.

(10) Absorbent cotton wool,

bandages, absorbent gauze and
adhesive plaster.

(11) Castor Oil, liquid Paraffin

and Epsom Salt.

(12) Eucalyptus Oil

(13) Tincture Iodine, Tincture

Benzoin Co. and
Mercurochrome solution in
containers not exceeding 100
 ml.

(14) Tablets of Quinine Sulphate

I.P.

(15) Tablets of
Iodochlorohydroxy
quinoline – 250 mg.
14 Mechanical Contraceptives The provisions of Chapter IV of the Act
and rules thereunder, which require them
to be covered by a sale licence, subject to
the condition that the provisions of
condition (17) of rule 65 of the Drugs and
Cosmetics Rules, 1945 are complied with
by the person stocking or selling
mechanical contraceptives.

14A Vaginal Contraceptive pessaries The provisions of Chapter IV of the Act

containing Nonoxynol
15 Chemical contraceptive having The provisions of Chapter IV of the Act
the following composition per and the rules made thereunder which
tablet:-
(1) DL-Norgestrel – 0.3 mg.
Ethinyloestradiol – 0.03 mg.
(2) Levonorgestrel – 0.15 mg.
Ethinylestraditol – 0.3 mg.
(3) Centchroman – 30 mg.
(4) Desogestrel -- 0.150 mg.
Ethinyloestradiol – 0.030 mg
(5) Levonorgestrel -- 0.1 mg.
Ethinyloestradiol -0.02 mg.
16 Cosmetics.
and rules thereunder, which require them
to be covered by a sale licence, subject to
the condition that the provisions of
condition (17) of rule 65 of the Drugs and
Cosmetics Rules, 1945 are complied with
by the person stocking or selling this
contraceptives.
required them to be covered with a sale
licence.
The provisions of Chapter IV of the Act
and the Rules made thereunder, which
require them to be covered by a licence
for sale provided that the cosmetics sold,
if of Indian origin, are manufactured by
licensed manufacturers.
17 Ophthalmic ointments of the Persons authorised by the Government to
Tetracycline group of drugs. distribute or sell the drugs under the
National Trachoma Control Programme
shall be exempted from the provisions of
Chapter IV of the Act and the rules made
thereunder, which require the drugs to be
covered by a sale licence

19 Hair Fixers, namely The provisions of Chapter IV of the Act

mucilagenous preparations and the rules thereunder.
containing gums, used by men
for fixing beard.

23 Drugs supplied by : The provisions of Chapter IV of the Act

(i) Multipurpose Workers and the Rules thereunder which require
attached to Primary Health them to be covered by a sale licence,
Centres/Sub-Centres, provided the drugs are supplied under
(ii) Community Health the Health or Family Welfare Programme
Volunteers under the Rural of the Central or State Government
Health Scheme
(iii) Nurses, Auxiliary Nurse,
Midwives and Lady Health
Visitors attached to Urban
Family Welfare
Cenres/Primary Health
Centres/Sub-Centres and
(iv) Anganwadi Workers.

27 Oral Rehydration Salts The provisions of Chapter IV of the Act

(Manufactured as per the and rules thereunder which require them
following formula) : to be covered by a sale licence, subject to
Sodium chloride 3.5 g/litre. the conditions that such a product has
* Trisodium citrate dihydrate been manufactured under a valid drug
2.9 g/litre. manufacturing licence.
Potassium Chloride 1.5 g/litre
May be replaced by Sodium
bicarbonate (Sodium hydrogen
Carbonate) 2.5 g/litre,
when citrate salt is not available.

29 Morphine Tablets The provisions of Chapter IV of the Act

and the rules made thereunder which
require them to be covered by a sale
licence, subject to the following
conditions, namely:-

30 Whole Human Blood collected
and transfused by Centres run
by Armed Forces Medical
Services in border areas, small
mid-zonal hospitals including
peripheral hospitals, Field
Ambulances, Mobile medical
units and other field medical
units including blood supply
units in border, sensitive and
field areas.
(i) The drug shall be supplied by the
Palliative Care Centres approved by the
State Government to terminally-ill cancer
patients.
(ii) The drug shall be kept under the
custody of the Medical Officer in-charge
of the said centre.
(iii) The drug shall be purchased from a
dealer or a manufacturer who holds
licence under these rules, and records of
such purchases showing the names and
quantities together with their batch
numbers, and names and addresses of the
manufacturers or dealers and the names
and addresses of the patients to whom
supplies have been made shall be
maintained. Such records shall be open to
inspection by an Inspector appointed
under the Act, who may also take
samples for test.
All the provisions of Chapter IV of the
Act and rules made thereunder which
require them to be covered by a licence to
operate a Blood Bank for collection,
storage and processing of whole human
blood for sale or distribution subject to
the following conditions-
(i) These Centres shall collect, process
and transfuse blood in emergent
situations which require life saving
emergency surgeries/or transfusion.
(ii) These Centres shall be under the
active direction and personal supervision
of a qualified Medical Officer, possessing
the qualifications and experiences
specified in condition (i) of rule 122-G.
(iii) Each blood unit shall be tested before
for freedom from HIV I and II antibodies,
Hepatitis B surface antigen, malarial

32 First Aid kit supplied along
with motor vehicle by the
manufacture or its distributor at
the time of first saleof vehicle.
33 Nicotine gum containing up to 2
mg. of nicotine.
34 Production of Oxygen 93 per
cent USP, produced from air by
the molecular sieve process, by
a hospital or Medical Institute
for their captive consumption.
35 Custom made devices
parasites and other tests specified under
the monograph ―Whole Human Blood‖
in current edition of Indian
Pharmacopoeia.
(iv) These Centres shall have adequate
infrastructure facilities for storage and
transportation of blood.
(v) The blood collected and tested by
such Centres shall be transfused by the
Centre itself and may be made available
for use of other peripheral Armed Forces
hospitals or centers during operational
circumstances.
The provisions of Chapter IV of the Act
and rules made thereunder which require
them to be covered by a sale licence,
subject to the condition that the drug
items are procured from a manufacturer
or dealer licensed under the rules.
The provisions of Chapter IV of the Act
and the rules made thereunder which
require
them to covered by a sale licence subject
to the condition that such a product
has been manufactured under a
valid drug manufacturing licence .
The provisions of Chapter IV of the Act
and rules made thereunder which require
them to be covered by manufacturing
licence under the rules, provided that the
production facilities shall be open to
inspection by an Inspector appointed
under the Act, who can, if necessary, take
samples for test.
All provisions of Chapter IV of the Act
and the rules made thereunder, subject to
the condition that the device being
specifically made in accordance with a
duly qualified medical practitioner‘s
written prescription under his
responsibility, in accordance with specific
design characteristics and is intended for
sole use of a particular patient and the
label should bear the word ―custom made
device.‖
Explanantion: Mass produced devices
which only need adoption to meet the
specific requirements of the medical
practitioner or any other professional
user shall not be considered to be custom
made devices.
SCHEDULE J : Diseases and ailments (by whatever name described) which a drug
may not purport to prevent or cure or make claims to prevent or cure.

Rule 106 of Drugs and Cosmetics Rules, 1945 defines diseases which a drug may not
purport to prevent or cure:
(1) 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.
(2) No drug may purport or claim to procure or assist to procure, or may convey to
the intending user thereof any idea that it may procure or assist to procure,
miscarriage in women.
OPINION
In view of the above it is opined that there are certain drugs as mentioned in
Schedule E1, G, H, H1 and X which are Scheduled / Prescription Drugs and the said
drugs cannot be sold / purchased without a prescription of medical practitioner or
without any medical supervision. Thus, the drugs mentioned in Schedule E1 can
only be prescribed by Ayurvedic medical practitioner. Similarly, the drugs
mentioned in Schedule G, H, H1 and X can only be prescribed by allopathic medical
practitioner.

Further, the drugs as mentioned in Schedule K being Non Prescription Drugs can be
sold by any person without any licence and the said drugs can be purchased without
any prescription to the extent and subject to the conditions as specified in the
Schedule K.

Also, apart from the drugs mentioned in Schedule K and prescription / schedule
drugs as mentioned in Schedule E1, G, H, H1 and X, there are some other non
scheduled / non prescription drugs which do not require licence for selling or
supplying and which are being sold without any prescription by medical
practitioner. These non prescription / non schedule drugs are commonly known as
Over the Counter Drugs (OTC Drugs) in USA.

In India, there is no exhaustive list of these non schedule / non prescription drugs or
OTC drugs. It is need of an hour that one comprehensive exhaustive list of non
schedule / non prescription / OTC drugs be made.
LIST OF 21 AYURVEDIC DRUGS MENTIONED IN SCHEDULE E1 TO DRUGS

AND COSMETICS RULES, 1945

List of poisonous substances under the Ayurvedic (including Siddha)

and Unani Systems of Medicine

A. AYURVEDIC SYSTEM
Sr. No.
I. Drugs of vegetable origin
1. Ahipena (Except seeds) Papaver somniferum Linn. (Except
seeds)
2. Arka Calotropis gigantea (linn.)R. Br. ex.
Ait.
3. Bhallataka Semecarpus anacardium Linn. F.
4. Bhanga (Except seeds) Cannabis sativa Linn. (Except seeds)
5. Danti Baliospermum montanum Mull.
Arg.
6. Dhattura Datura metal Linn..
7. Gunja (Seed) Abrus precatorium Linn.
8. Jaipala (Seed) Croton tiglium Linn.
9. Karaveera Rerium indicum Mill.
10. Langali Gloriosa superba Linn.
11. Parasika Yavani Hyoscyamus inibar Linn.
12. Vatsanabha / Acontium ferox, Wall. Ex Ser.
Shringivisha Holmes Acontium chasmanthum Stapfex
13. Vishamushti Strychnox nuxvomica Linn.
II Drugs of Animal Origin.
14. Sarpa Visha Snake poison.

III Drugs of Mineral Origin

15. Gauripashana Arsenic.
16. Hartala Arsenic trisulphide.
17. Manahashila Arsenic disulphide.
18. Parada Mercury.
19. Rasa Karpura Hydrargyri subchloridum.
20. Tuttha Copper sulphate.
21. Hingula Cinnabar.
LIST OF 62 DRUGS MENTIONED IN SCHEDULE G TO DRUGS AND

COSMETICS RULES, 1945

1. Aminopterin
2. L-Asparaginase
3. Bleomycin
4. Busulphan; its salts
5. Carbutamide
6. Chlorambucil; its salts
7. Chlorothiazide and other derivatives of 1, 2, 4 benzothiadiazine
8. Chlorpropamide; its salts
9. Chlorthalidone and other derivatives of Chlorobenzene compound.
10. Cis-Platin
11. Cyclophosphamide; its salts
12. Cytarabine
13. Daunorubicin
14. Di-Isopropyl Eluorophosphate
15. Disodium Stilboestrol Diphosphate
16. Doxorubicin Hydrochloride
17. Ethacrynic Acid, its salts
18. Ethosuximide
19. Glibenclamide
20. Hydantoin; its salts; its derivatives, their salts
21. Hydroxyurea
22. Insulin, all types
23. Lomustine Hydrochloride
24. Mannomustine; its salts
25. Mercaptopurine; its salts
26. Metformin; its salts
27. Methsuximide
28. Mustine, its salts
 29. Paramethadione
30. Phenacemide
31. Phenformin; its salts
32. 5-Phenylhydantoin; its alkyl and aryl derivatives; its salts
33. Primadone
34. Procarpazine Hydrochloride
35. Quinthazone
36. Sarcolysine
37. Sodium-2-Mercaptoethanesulfonate
38. Tamoxiten Citrate
39. Testolactone
40. Thiotepa
41. Tolbutamide
42. Tretamine; its salts
43. Troxidone

Antihistaminic substances the following, their salts, their derivatives, salts of

their derivatives
44. Antazoline
45. Bromodiphenhydramine
46. Buclizine
47. Chlorcyclizine
48. Chlorpheniramine
49. Clemizole
50. Cyproheptadine
51. Diphenhydramine
52. Diphenylpyraline
53. Doxylamine Succinate
54. Isothipendyl
55. Mebhydrolin Napadisylate
56. Meclozine
57. Pheniramine
58. Phenindomine
 59. Pheniramine
60. Promethazine
61. Thenalidine
62. Triprolidine

Substances being tetra-N-Substituted derivatives of Ethylene Diamine or

Prophylenediamine.

Note . – Preparations containing the above substances excluding those intended for

topical or external use are also covered by this Schedule.

LIST OF 507 DRUGS MENTIONED IN SCHEDULE H TO DRUGS AND
COSMETICS RULES, 1945

63. ABACAVIR
64. ABCIXIMAB
65. ACAMPROSATE CALCIUM
66. ACEBUTOL HYDROCHLORIDE
67. ACLARUBICIN
68. ALBENDAZOLE
69. ALCLOMETASONE DIPROPIONATE
70. ACTILYSE
71. ACYCLOVIR
72. ADENOSINE
73. ADRENOCORTICOTROPHIC HORMONE (ACTH)
74. ALENDRONATE SODIUM
75. ALLOPURINOL
76. ALPHACHYMOTRYPSIN
77. ALPROSTADIL
78. AMANTADINE HYDROCHLORIDE
79. AMIFOSTINE
80. AMIKACIN SULPHATE
81. AMILORIDE HYDROCHLORIDE
82. AMINEPTINE
83. AMINOGLUTETHIMIDE
84. AMINOSALICYLIC ACID
85. AMIODARONE HYDROCHLORIDE
86. AMITRIPTYLINE
87. AMLODIPINE BESYLATE
88. AMOSCANATE
89. AMOXOPINE
90. AMRINONE LACTATE
91. ANALGIN
92. ANDROGENIC ANABOLIC, OESTROGENIC & PROGESTATIONAL
SUBSTANCES
93. ANTIBIOTICS
94. APRACLONIDINE
95. APROTININ
96. ORGANIC COMPOUND OF ARSENIC
97. ARTEETHER
98. ARTEMETHER
99. ARTESUNATE
100. ARTICAINE HYDROCHLORIDE
101. ATENOLOL
102. ATRACURIUM BESYLATE INJECTION
103. ATORVASTATIN
104. AURANOFIN
105. AZATHIOPRINE
106. AZTREONAM
107. BACAMPICILLIN
108. BACLOFEN
109. BALSALAZIDE
110. BAMBUTEROL
111. BARBITURIC ACID
112. BASILIXIMAB
113. BENAZEPRIL HYDROCHLORIDE
114. BENIDIPINE HYDROCHLORIDE
115. BENSERAZIDE HYDROCHLORIDE
116. BETAHISTINE DIHYDROCHLORIDE
117. BETHANIDINE SULPHATE
118. BEZAFIBRATE
119. BICALUTAMIDE
120. BICLOTYMOL
121. BIFONAZOLE
122. BIMATOPROST
123. BIPERIDEN HYDROCHLORIDE
124. BIPHENYL ACETIC ACID
125. BITOSCANATE
126. BLEOMYCIN
127. PRIMONIDINE TARTRATE
128. BROMHEXINE HYDROCLORIDE
129. BROMOCRIPTINE MESYLATE
130. BUDESONIDE
131. BULAQUINE
132. BUPIVA CAINE HYDROCHLORIDE
133. BUPROPION
134. BUSPIRONE
135. BUTENAFINE HYDROCHLORIDE
136. BUTORPHANOL TARTRATE
137. CABERGOLINE
138. CALCIUM DOBESILATE
139. CANDESARTAN
140. CAPECITABINE
141. CAPTOPRIL
142. CARBIDOPA
143. CARBOCISTEINE
144. CARBOPLATIN
145. CARBOQUONE
146. CARISOPRODOL
147. L-CARNITINE
148. CARTEOLOL HYDROCHLORIDE
149. CARVEDILOL
150. CEFADROXYL
151. CEFATOXIME SODIUM
152. CEFAZOLIN SODIUM
153. CEFUROXIME
154. CELECOXIB
155. CENTCHROMAN
156. CENTBUTINDOLE
157. CENTPROPAZINE
158. CETIRIZINE HYDROCHLORIDE
159. CHLORMEZANONE
160. CHLORPROMAZINE
 161. CHLORZOXAZONE
162. CICLOPIROX OLAMINE
163. CIMETIDINE
164. CINNARIZINE
165. CIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE /
LACTATE
166. CISPLATIN
167. CITALOPRAM HYDROBROMIDE
168. CLARITHROMYCIN
169. CLAVULANIC ACID
170. CLIDINIUM BROMIDE
171. CLINDAMYCIN
172. CLOBAZAM
173. CLOBETASOL PROPENATE
174. CLOBETASONE 17-BUTYRATE
175. CLOFIBRATE
176. CLONAZEPAM
177. CLONIDINE HYDROCHLORIDE
178. CLOPAMIDE
179. CLOPIDOGREL BISULPHATE
180. CLOSTEBOL ACETATE
181. CLOTRIMAZOLE
182. CLOZAPINE
183. COLCHICINE
184. CORTICOSTEROIDS
185. COTRIMOXAZOLE
186. CYCLANDELATE
187. CYCLOSPORINS
188. DACLIZUMAB
189. DANAZOLE
190. DAPSONE
191. DESLORATADINE
192. DESOGESTROL
193. DEXRAZOXANE
194. DEXTRANOMER
195. DEXTROPROPOXYPHENE
196. DIAZOXIDE
197. DICLOFENAC SODIUM/POTASSIUM/ACID
198. DICYCLOMIN HYDROCHLORIDE
199. DIDANOSINE
200. DIGOXINE
201. DILAZEP HYDROCHLORIDE
202. DILTIAZEM
203. DINOPROSTONE
204. DIPIVEFRIN HYDROCHLORIDE
205. DI-SODIUM PAMIDRONATE
206. DISOPYRAMIDE
207. DOCETAXEL
208. DOMPERIDONE
209. DONEPEZIL HYDROCHLORIDE
210. DOPAMINE HYDROCHLORIDE
211. DOTHIEPIN HYDROCHLORIDE
212. DOXAPRAM HYDROCHLORIDE
213. DOXAZOSIN MESYLATE
214. DOXEPIN HYDROCHLORIDE
215. DOXORUBICIN HYDROCHLORIDE
216. DROTRECOGIN-ALPHA
217. EBASTINE
218. ECONOZOLE
219. EFAVIRENZ
220. ENALAPRIL MELEATE
221. ENFENAMIC ACID
222. EPINEPHRINE
223. EPIRUBICINE
224. EPTIFIBATIDE
225. ERGOT, ALKALOIDS OF WHETHER HYDROGENATED OR NOT,
THEIR HOMOLOGOUES, SALTS
226. ESOMEPRAZOLE
227. ESTRADIOL SUCCINATE
228. ESTRAMUSTINE PHOSPHATE
229. ETANERCEPT
230. ETHACRIDINE LACTATE
231. ETHAMSYLATE
232. ETHINYLOESTRADIOL
233. ETIDRONATE DISODIUM
234. ETODOLAC
235. ETOMIDATE
236. ETOPOSIDE
237. EXEMESTANE
238. FAMCICLOVIR
239. FAMOTIDINE
240. FENBENDAZOLE
241. FENOFIBRATE
242. FEXOFENADINE
243. FINASTERIDE
244. FLAVOXATE HYDROCHLORIDE
245. 5-FLUOROURACIL
246. FLUDARABINE
247. FLUFENAMIC ACIDS
248. FLUNARIZINE HDROCHLORIDE
249. FLUOXETINE HYDROCHLORIDE
250. FLUPENTHIXOL
251. FLUPHENAZINE ENANTHATE AND DECANOATE
252. FLURAZEPAM
253. FLURBIPROFEN
254. FLUTAMIDE
255. FLUTICASONE PROPIONATE
256. FLUVOXAMINE MALEATE
257. FORMESTANE
258. FOSFESTRIL SODIUM
259. FOSINOPRIL SODIUM
260. FOSSPHENYTOIN SODIUM
261. FOTEMUSTINE
262. GABAPENTIN
263. GALANTHAMINE HYDROBROMIDE
264. GALLAMINE, ITS SALTS, ITS QUATERNARY COMPOUND
265. GANCYCLOVIR
266. GANIRELIX
267. GATIFLOXACIN
268. GEMCITABINE
269. GEMFIBROZIL
270. GEMTUZUMAB
271. GENODEOXYCHOLIC ACID
272. GLICLAZIDE
273. GLIMEPIRIDE
274. GLUCAGON
275. GLYCOPYRROLATE
276. GLYDIAZINAMIDE
277. GOSERELIN ACETATE
278. GRANISETRON
279. GUANETHIDINE
280. GUGULIPID
281. HALOGENATED HYDROXYQUINOLINES
282. HALOPERIDOL
283. HEPARIN
284. HEPATITIS B. VACCINE
285. HYALURONIDASE
286. HYDROCORISONE 17-BUTYRATE
287. HYDROTALCITE
288. HYDROXIZINE
289. IBUPROFEN
290. IDEBENONE
291. IINDAPAMIDE
292. IMIPRAMINE
293. INDINAVIR SULPHATE
294. INDOMETHACIN
295. INSULIN HUMAN
296. INTERFERON
297. INTRAVENOUS FAT EMULSION
298. IOBITRIDOL
299. IOHEXOL
300. IOPAMIDOL
301. IOMEPROL
302. IOPROMIDE
303. IRBESARTAN
304. IRINOTECAN HYDROCHLORIDE
305. IRON PREPARATION FOR PARENTERAL USE
306. ISEPAMICINE
307. ISOCARBOXSIDE
308. ISOFLURANE
309. ISONICOTNIC ACID HYDRAZINE AND OTHER-HYDRAGINE
DERIVATIVES OF ISONICOTINIC ACID
310. ISOSORBIDE DINITRATE/ MONONITRATE
311. ISOTRETINOIN
312. ISOXSUPRINE
313. ITOPRIDE
314. KETOCONAZOLE
315. KETOPROFEN
316. KETOROLAC TROMETHAMINE
317. LABETALOL HYDROCHLORIDE
318. LACIDIPINE
319. LAMIVUDINE
320. LAMOTRIGINE
321. LATANOPROST
322. LEFUNOMIDE
323. LERCANIDIPINE HYDROCHLORIDE
324. LETROZOLE
325. LEUPROLIDE ACETATE
326. LEVAMESOLE
327. LEVARTERENOL
328. LEVOBUNOLOL
329. LEVOCETIRIZINE
330. LEVODOPA
331. LEVOVIST
332. LIDOFLAZINE
333. LINEZPLID
334. LITHIUM CARBONATE
335. LOFEPRAMINE DECANOATE
336. LOPERAMIDE
337. LORAZEPAM
338. LOSARTAN POTASSIUM
339. LOTEPREDNOL
340. LOVASTATIN
341. LOXAPINE
342. MEBENDAZOLE
343. MEBEVERINE HYDROCHLORIDE
344. MEDROXY PROGESTERONE ACETATE
345. MEFENAMIC ACID
346. MEFLOQUINE HYDROCHLORIDE
347. MEGESTROL ACETATE
348. MEGLUMINE IOCARMAT
349. MELAGENINA
350. MELITRACEN HYDROCHLORIDE
351. MELOXICAM
352. MEPHENESIN, ITS ESTERS
353. MEPHENTERMINE
354. MESTEROLONE
355. METAXALONE
356. METHICILLIN SODIUM
357. METHOCARBAMOL
358. METHOTRAXATE
359. METOCLOPRAMIDE
360. METOPROLOL TARTRATE
361. METRIZAMIDE
362. METRONIDAZOLE
363. MEXILETINE HYDROCHLORIDE
364. MIANSERIN HYDROCHLORIDE
365. MICONAZOLE
366. MIFEPRISTONE
367. MILRINONE LACTATE
368. MILTEFOSINE
369. MINOCYCLINE
370. MINOXIDIL
371. MIRTAZAPINE
372. MISOPROSTOL
373. MITOXANTRONE HYDROCHLORIDE
374. MIZOLASTINE
375. MOCLOBEMIDE
376. MOMETASONE FUROATE
377. MONTELUKAST SODIUM
378. MORPHAZINAMIDE HYDROCHLORIDE
379. MOSAPRIDE
380. MYCOPHENOLATE MOFETIL
381. NADIFLOXACIN
382. NADOLOL
383. NAFARELIN ACETATE
384. NALIDIXIC ACID
385. NAPROXE
386. NARCOTICS DRUGS LISTED IN NARCOTIC DRUGS &
PSYCHOTROPIC SUBSTANCES ACT, 1985
387. NATAMYCIN
388. NATEGLINIDE
389. N-BUTYL-2-CYANOACRYLATE
390. NEBIVOLOL
391. NEBUMETONE
392. NELFINAVIR MESILATE
393. NETILMICIN SULPHATE
394. NEVIRAPINE
395. NICERGOLINE
396. NICORANDIL
397. NIFEDIPINE
398. NIMESULIDE
399. NIMUSTINE HYDROCHLORIDE
400. NITROGLYCERIN
401. NORETH ISTERONE ENANTHATE
402. NORFLOXACIN
403. OCTYLONIUM BROMIDE
404. OFLOXACIN
405. OLANZAPINE
406. OMEPRAZOLE
407. ORNIDAZOLE
408. ORPHENADRINE
409. ORTHOCLONE STERILE
410. OXAZEPAM
411. OXAZOLIDINE
412. OXCARBAZEPINE
413. OXETHAZAINE HYDROCHLORIDE
414. OXICONAZOLE
415. OXOLINIC ACID
416. OXPRENOLOL HYDROCHLORIDE
417. OXYBUTYNIN CHLORIDE
418. OXYFEDRINE
419. OXYMETAZOLINE
420. OXYPHENBUTAZONE
421. OXYTOCIN
422. OZOTHINE
423. PACLITAXEL
424. PANCURONIUM BROMIDE
425. PANTOPRAZOLE
426. PARA-AMINO BENZENE SULPHONAMIDE,ITS SALTS &
DERIVATIVES
427. PARP-AMINO SALICYLIC ACID, ITS SALTS,ITS DERIVATIVES
428. PARECOXIB
429. PAROXETINE HYDROCHLORIDE
430. D-PENICILLAMINE
431. PENTOXIFYLLINE
432. PEPLEOMYCIN
433. PHENELZINEH SULPHATE
434. PHENOBARBITAL
435. PHENOTHIAZINE, DERIVATIVES OF AND SALTS OF ITS
DERIVATIVES
436. PHENYLBUTAZINE
437. PIMOZIDE
438. PINDOLOL
439. PIOGLITAZONE HYDROCHLORIDE
440. PIRACETAM
441. PIROXICAM
442. PITUITORY GLAND, ACTIVE PRINCIPLES OF, NOT OTHERWISE
SPECIFIED IN THIS SCHEDULE AND THEIR SALTS
443. POLIDOCANOL
444. POLYESTRADIOL PHOSPHATE
445. PORACTANT ALFA
446. PRAZIQUANTEL
447. PREDNIMUSTINE
448. PREDNISOLONE STEAROYLGLYCOLATE
449. PRENOXDIAZIN HYDROCHLORID
450. PROMAZINE HYDROCHLORIDE
451. PROMEGESTONE
452. PROPAFENON HYDROCHLORIDE
453. PROPANOLOL HYDROCHLORIDE
454. PROPOFOL
455. PROTRISTYLINE HYDROCHLORIDE
456. PYRVINIUM
457. QUETIAPINE FUMERATE
458. QUINAPRIL
459. QUINIDINE SULPHATE
460. RABEPRAZOLE
461. RACECADOTRIL
462. RALOXIFENE HYDROCHLORIDE
463. RAMIPRIL HYDROCHLORIDE
464. RANITIDINE
465. RAUWOLFIA, ALKALOIDS OF, THEIR SALTS, DERIVATIVES OF
THE ALKALOIDS OR RAUWOLFIA
466. REBOXETINE
467. REPAGLINIDE
468. REPROTEROL HYDROCHLORIDE
469. RILMENIDINE
470. RILUZONE
471. RISPERIDONE
472. RITONAVIR
473. RITODRINE HYDROCHLORIDE
474. RITUXIMAB
475. RIVASTIGMINE
476. ROCURONIUM BROMIDE
477. ROPINIROLE
478. ROSOXACIN
479. ROSIGLITAZONE MELEATE
480. SALBUTAMOL SULPHATE
481. SALICYL-AZO-SULPHAPYRIDINE
482. SALMON CALCITONIN
483. SAQUINAVIR
484. SATRANIDAZOLE
485. SECNIDAZOLE
486. SEPTOPAL BEADS & CHAINS
487. SERRATIOPEPTIDASE
488. SERTRALINE HYDROCHLORIDE
489. SIBUTRAMINE HYDROCHLORIDE
490. SILDENAFIL CITRATE
491. SIMVASTATIN
492. SIROLIMUS
493. SISOMICIN SULPHATE
494. S-NEOMINOPHAGEN
495. SODIUM PICOSULPHATE
496. SODIUM CROMOGLYCATE
497. SODIUM HYALURONATE
498. SODIUM VALPROATE
499. SODIUM AND MAGLUMINE IOTHALAMATES
500. SOMATOSTATIN
501. SOMATOTROPIN
502. SOTALOL
503. SPECTINOMYCIN HYDROCHLORIDE
504. SPIRONOLACTONE
505. STAVUDINE
506. SUCRALFATE
507. SULPHADOXINE
508. SULPHAMETHOXINE
509. SULPHAMETHOXYPYRIDAZINE
510. SULPHAPHENAZOLE
511. SULPIRIDE
512. SULPROSTONE HYDROCHLORIDE
513. SUMATRIPTAN
514. TACRINE HYDROCHLORIDE
515. TAMSULOSIN HYDROCHLORIDE
516. TRAPIDIL
517. TEGASEROD MALEATE
518. TEICOPLANIN
519. TELMISARTAN
520. TEMOZOLAMIDE
521. TERAZOSIN
522. TERBUTALINE SULPHATE
523. TERFENADINE
524. TERIZIDONE
525. TERLIPRESSIN
526. TESTOSTERONE UNDECOANOATE
527. TERATOLOL HYDROCHLORIDE
528. THALIDOMIDE
529. THIOCOLCHICOSIDE
530. THIOPROPAZATE, ITS SALTS
531. THYMOGENE
532. THYMOSIN-ALPHA 1
533. TIAPROFENIC ACID
534. TIBOLONE
535. TIMOLOL MALEATE
536. TINIDAZOLE
537. TIZANIDINE
538. TABRAMYCIN
539. TOLFENAMIC ACID
540. TOPIRAMATE
541. TOPOTECAN HYDROCHLORIDE
542. TRANEXAMIC ACID
543. TRANYLCYPROMINE, ITS SALTS
544. TRAZODONE
545. TRETINOIN
546. TRIFLUPERAZINE
547. TRIFLUPERIDOL HYDROCHLORIDE
548. TRIFLUSAL
549. RIMETAZIDINE DIHYDROCHLORIDE
550. TRIMIPRAMINE
551. TRIPOTASSIUM DICITRATE BISMUTHATE
552. TROMANTADINE HYDROCHLORIDE
553. UROKINASE
554. VALSARTAN
555. VASOPRESSIN
556. VECURONIUM BROMIDE
557. VENLAFAXINE HYDROCHLORIDE
558. VERAPAMIL HYDROCHLORIDE
559. VERTEPORFIN
560. VINCRISTINE SULPHATE
 561. VINBLASTINE SULPHATE
562. VINDESINE SULPHATE
563. VINORELBINE TATRATE
564. XIPAMIDE
565. ZIDOVUDINE HYDROCHLORIDE
566. ZIPRASIDONE HYDROCHLORIDE
567. ZOLEDRONIC ACID
568. ZOPICLONE
569. ZUCLOPENTHIXOL

Note:

1. Preparations exempted under proviso to para 2 of Note to Schedule X shall

also be covered by this Schedule
2. The salts, esters, derivatives and preparations containing the above
substances excluding those intended for topical or external use (except
ophthalmic and ear / nose preparations containing antibiotics and / or
steroids) are also covered by this Schedule.
LIST OF 46 DRUGS MENTIONED IN SCHEDULE H1 TO DRUGS AND
COSMETICS RULES, 1945
SR. NO. DRUG

1. Alprazolam

2. Baloflaxacin

3. Buprenorphine

4. Capreomycin

5. Cefdinir

6. Cefditoren

7. Cefepime

8. Cefetamet

9. Cefexime

10. Cefoperazone

11. Cefotaxime

12. Cefpirome

13. Cefpodoxime

14. Ceftazidime

15. Ceftibuten

16. Ceftizoxime

17. Ceftriaxone

18. Chlordiazepoxide

19. Clofazimine

20. Codeine

21. Cycloserine

22. Diazepam

23. Diphenoxylate

24. Doripenem,
 25. Ertapenem

26. Etambutol HCl

27. Ethinamide

28. Feropenem

29. Gemifloxacin

30. Imipenem

31. Isoniazid

32. Levofloxacin

33. Meropenem

34. Midazolam

35. Moxifloxacin

36. Nitrazepam

37. Pentazocine

38. Prulifloxacin

39. Pyrazinamide

40. Ribabutin

41. Rafampicin

42. Sodium Para-aminosalicylate

43. Sparfloxacin

44. Thiacetazone

45. Tramadol

46. Zolpidem

Note: Preparations containing the above drug substances and their salts excluding
those intended for topical or external use (except ophthalmic and ear or nose
preparations) containing above substances are also covered by this Schedule.
LIST OF 16 DRUGS MENTIONED IN SCHEDULE X TO DRUGS AND
COSMETICS RULES, 1945
SR. NO. DRUG

1. Amobarbital

2. Amphetamine

3. Barbital

4. Cyclobarbital

5. Dexamphetamine

6. Ethchlorvynol

7. Glutethimide

8. Ketamine hydrochloride

9. Meprobamate

10. Methamphetamine

11. Methylphenidate

12. Methylphenobarbital

13. Pentobarbital

14. Phencyclidine

15. Phenmetrazine

16. Secobarbital

Note:
2. Any stereioscometric form of the substance specified in this Schedule, any salt

of the substance and preparation obtaining such substances are also covered by
this Schedule.
3. Preparations containing the above substances are also covered by this
Schedule.
LIST OF 51 DISEASES AND AILMENTS (BY WHATEVER NAME DESCRIBED)
WHICH A DRUG MAY NOT PURPORT TO PREVENT OR CURE OR MAKE
CLAIMS TO PREVENT OR CURE AS MENTIONED IN SCHEDULE J OF THE
DRUGS AND COSMETICS RULES, 1945

1. AIDS
2. Angina Pectoris
3. Appendicitis
4. Arteriosclerosis
5. Baldness
6. Blindness
7. Bronchial Asthma
8. Cancer and Benign tumour
9. Cataract
10. Change in colour of the hair and
growth of new hair.
11. Change of foetal sex by drugs.
12. Congenital malformations
13. Deafness
14. Diabetes
15. Diseases and disorders of uterus.
16. Epilepticfits and psychiatric
disorders
17. Encephalitis
18. Fairness of the skin
19. Form, structure of breast
20. Gangrene
21. Genetic disorders
22. Glaucoma
23. Goitre
24. Hernia
25. High/low Blood Pressure
26. Hydrocele
27. Insanity
28. Increase in brain capacity and
improvement of memory.
29. Improvement in height of
children/adults.
30. Improvement in size and shape of
the sexual organ and in duration of
sexual performance
31. Improvement in the strength of the
natural teeth.
32. Improvement in vision
33. Jaundice/Hepatitis/Liver disorders
34 Leukaemia
35. Leucoderma
36. Maintenance or improvement of the
capacity of the human being for
sexual pleasure.
37 Mental retardation, subnormalities
and growth
38. Myocardial infarction
39. Obesity
40. Paralysis
41. Parkinsonism
42. Piles and Fistulae
43. Power to rejuvinate
44. Premature ageing
45. Premature greying of hair
46. Rheumatic Heart Diseases
47. Sexual Impotence, Premature
ejaculation and spermatorrhoea
48. Spondylitis
49. Stammering
50. Stones in gall-bladder, kidney,
bladder
51. Vericose Vein.
Restrictions H H1 X E1 G

Incorporated
on 1st March
2014

26/46 drugs
shifted from
Schedule H
and 20 more
drugs added

Prescriptio Yes Yes Yes No No

n of
Medical
Practitioner
required
for Sale /
Supply

Label Rx, be Label should XRx, which

conspicuously contain RX shall be in red
displayed on symbol in conspicuously
the left top red color at displayed on
corner of the the left top the left top
label corner corner of the
label

If it comes
within the
purview of
the Narcotic
 Drugs and
Psychotropic
Substances
Act, 1985 (61
of 1985) be
labelled with
the symbols
NRx which
shall be in red
and
conspicuously
displayed on
the left top
corner of the
label

Caution / Warning: To Warning -it Warning: To be Caution: Caution: it

Warning be sold by is dangerous sold by retail on is
retail on the the prescription To be
to take this dangerous
prescription of a Registered taken to take this
of a preparation Medical
under preparation
Registered except in Practitioner
Medical only medical except
accordance
Practitioner supervisio under
only with the
n medical
medical
supervision
advice. [Label
‘—
both in
-not to be
English
sold without
and Hindi
the
language]
prescription
of a
registered
medical
practitioner"

. Supply of a
drug
included in
Sch. H1
requires to
be recorded
in a separate
register at
the time of
supply
including
the Name &
address of
the
prescriber,
Name &
address of
the patient,
Name of the
drug and
quantity
supplied.
The record
requires to
be preserved
for 3 years
and made
ready for
 inspection.

Bear a Yes No Yes No Yes

conspicuou
s red
vertical line
on the left
side
running
throughout
the body of
the label
which
should not
be less than
1mm in
width

Advertisem Cannot be Cannot be Cannot be No No

ent advertised advertised advertised restriction restriction

Storage of Substances
Drugs specified in
Schedule X
kept in retail
shop or
premises used
in connection
therewith shall
be stored—

(a) under lock

and key in
cupboard or
drawer
reserved solely
for the storage
of these
substances; or

(b) in a part of
the premises
separated from
the remainder
of the premises
and to which
only
responsible
persons have
access;