Schedule G, H, H 1, N. Drugs and cosmetics act 1940 and rules 1945

Pharmaceutical Jurisprudence - Schedule G, H, H1, N

1. DETAILED STUDY OF THE SCHEDULES UNIT II

2. SCHEDULE G Most of these drugs are hormonal preparations. The drug label must display the text. "Caution: It is dangerous to take this preparation except under medical supervision" prominently. Examples: Testolactone , Hydroxyurea, Carbutamide , Primidone, Mercaptopurine, Methsuximide , Thiotepa etc. SCHEDULE G

3. SCHEDULE H It prescribes list of drugs which are to be sold by retail only on the prescription of Registered Medical Practitioner. Schedule H drugs are labelled with direction Warning - “To be sold by retail only on the prescription of Registered Medical Practitioner.”

4. The drug label must display the texts "Rx" on the left top corner of the label and "Schedule H drug. Warning : To be sold by retail on the prescription of a Registered Medical practitioner only" prominently. It can only be supplied to licensed parties. It cannot be sold without a prescription and only the amount specified in the prescription should be sold. The time and date of prescription must be noted. Examples: Androgenic, anabolic, oestrogenic and progestational substances; Alprazolam, Hepatitis B vaccine, Adrenocorticotrophic hormone, Ibuprofen, Vasopressin etc. If a Schedule H drug also comes under the purview of Narcotic Drugs and Psychotropic Substances Act, 1985, it must carry the texts "NRx" in red on the left top corner of the label and "Schedule H drug. Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only." on the label prominently.

5. SCHEDULE H I It is introduced under the Drugs and Cosmetics (4 th amendment) rules 2013, by MOHFW (Ministry of health welfare and family welfare) on 30August 2013 to regulate sale of antibiotics. It includes 3 rd & 4 th generation antibiotics, anti tuberculosis drugs and certain habit forming drugs like Psychotropic drugs. Separate register at time of dispensing with name and address of prescriber, name of the patient and name of the drug with quantity supplied. Record maintained for 3 years. Rx in red displayed clearly on left corner of the drug. Warning words in box with red border. SCHEDULE H I

6. 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.” “SCHEDULE H1 DRUG– Isoniazid, Alprazolam, Cefixime, Levofloxacin, Codeine, Diazepam, Rifampicin etc

7. SCHEDULE J: Diseases which a drug may not purport to prevent or cure.- 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.  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. Explanation. Diseases and ailments (by whatever name described) which a drug may not purport to prevent or cure or make claims to prevent or cure. AIDS,  Angina Pectoris, Appendicitis, Arteriosclerosis, Baldness, Blindness, Bronchial Asthma, Cancer and Benign tumour , Cataract, Change in colour of the hair and growth of new hair, Change of foetal sex by drugs, Congenital malformations, Deafness, Diabetes, Diseases and disorders of uterus, Epilepticfits and psychiatric disorders, Encephalitis, Fairness of the skin, Form, structure of breast, Gangrene, Genetic disorders, Glaucoma, Goitre , Hernia, High/low Blood Pressure, Hydrocele, Insanity, Increase in brain capacity and improvement of memory, Improvement in height of children/adults, Improvement in size and shape of the sexual organ and in duration of sexual performance, Improvement in the strength of the natural teeth, Improvement in vision, Jaundice/Hepatitis/Liver disorders, Leukaemia , Leucoderma , Maintenance or improvement of the capacity of the human being for sexual pleasure, Mental retardation, subnormalities and growth, Myocardial infarction, Obesity, Paralysis, Parkinsonism, Piles and Fistulae, Power to rejuvenate, Premature ageing, Premature greying of hair, Rheumatic Heart Diseases, Sexual Impotence, Premature ejaculation and spermatorrhoea , Spondylitis, Stammering, Stones in gall-bladder, kidney, bladder, Vericose Vein.

8. Schedule N Describes the facilities and equipment's for efficient running of a Pharmacy. Entrance: Front of a pharmacy shall bear an inscription “Pharmacy” in front. Premises: Separated from rooms, well built, dry, well lit and ventilated with sufficient dimensions for stock of medicaments. (ii) Poisons to be kept in a clearly visible and appropriate manner. (iii) Dispensing department shall be not less than 6 sq. m. for one pharmacist working therein with additional 2 sq. m. for each additional pharmacist. (iv) Height of the premises shall be at least 2.5 metres . (v) Floor of the pharmacy shall be smooth and washable. (vi) Walls shall be plastered or tiled or oil painted so as to maintain smooth, durable and washable surface devoid of holes, cracks and crevices. (vii) A pharmacy shall be provided with ample supply of good quality water. (viii) The dispensing department shall be separated by a barrier to prevent the admission of the public.

9. 3. Furniture and Apparatus: A pharmacy shall contain furniture and apparatus, drawers, containers, glasses of suitable sizes and designed to prevent dust entry. (ii) Every container shall bear a labels, easily readable with names of medicaments as given in the Pharmacopoeias. (iii) Shall be provided with a dispensing bench, washable top etc. (iv) Separate cupboards with lock and key for Poisons, and shall be marked in red letters as ‘’POISON’’ on a white background. (v) All concentrated solutions shall be labelled as ‘’To be diluted’’.

10. (vi) Pharmacy shall bear all the prescribed apparatus and books for official preparations and prescriptions. Balance (b) Beakers, bottles, funnels (c) Filter and litmus papers (d) Mortar and pestle, other glasswares (e) Spatula, scissors, stands (f) Spirit lamp, thermometer (g) Water bath, distillation apparatus (h) Watch glasses, pill machines, suppository mould etc. ( i ) Books: The Pharmacopoeia (current edition), National Formulary of India, The Drugs and Cosmetic Act 1940 and rules 1945, The Pharmacy Act, Narcotic and Psychotropic substances Act, 1985 etc. 4. General provisions : Pharamcist shall always wear a clean white overalls, records and registers shall be maintained as per the law, medicaments must bear labels when supplied as per the law.