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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;

(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;

(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: —

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

(a) preparations intended for animal treatment; (b) preparations intended for external use;

(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 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 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: —

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 : (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.

5B Whole Human Blood I.P. The provisions of Chapter IV of the Act and/or its components stored and the rules made thereunder which for transfusion by a First require obtaining of a licence for Referral Unit Community operation of a blood bank or processing Health Centre, Primary Health Whole Human Blood and/or its Centre and Hospital. 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 and the Rules thereunder which require insects, which cause disease in them to be covered by a sale licence human beings or animals, vis. subject to the condition that provision of Insecticides and Disinfectants. 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 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. 15 Chemical contraceptive having The provisions of Chapter IV of the Act the following composition per and the rules made thereunder which tablet:- required them to be covered with a sale (1) DL-Norgestrel – 0.3 mg. licence. 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. 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:-

(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.

30 Whole Human Blood collected All the provisions of Chapter IV of the and transfused by Centres run Act and rules made thereunder which by Armed Forces Medical require them to be covered by a licence to Services in border areas, small operate a Blood Bank for collection, mid-zonal hospitals including storage and processing of whole human peripheral hospitals, Field blood for sale or distribution subject to Ambulances, Mobile medical the following conditions- units and other field medical units including blood supply (i) These Centres shall collect, process units in border, sensitive and and transfuse blood in emergent field areas. 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 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.

32 First Aid kit supplied along The provisions of Chapter IV of the Act with motor vehicle by the and rules made thereunder which require manufacture or its distributor at them to be covered by a sale licence, the time of first saleof vehicle. subject to the condition that the drug items are procured from a manufacturer or dealer licensed under the rules. 33 Nicotine gum containing up to 2 The provisions of Chapter IV of the Act mg. of nicotine. 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 . 34 Production of Oxygen 93 per The provisions of Chapter IV of the Act cent USP, produced from air by and rules made thereunder which require the molecular sieve process, by them to be covered by manufacturing a hospital or Medical Institute licence under the rules, provided that the for their captive consumption. production facilities shall be open to inspection by an Inspector appointed under the Act, who can, if necessary, take samples for test. 35 Custom made devices 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 [Label advice. ‘— 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;