The Pharmacy Act
Drug and Cosmetics Act
Drug and Cosmetics Act contains in the provisions for classification of the drugs that are under given schedules. There are guidelines for the storage, sale, display, manufacturing, packaging, prescription, use, and effects of the drugs in each schedule under the Drug and Cosmetics Act. The notable schedules in Drugs and Cosmetics rules are – schedule G, schedule H, Schedule J, Schedule X.
There are the schedules in the Drug and Cosmetics Act are described with their brief details are as following-
Schedule A- In schedule A contains various forms and formats of letters for applications of licensing etc. In schedule A, there are applications for licenses for import, manufacturing, and sale of Drugs and Cosmetics, the forms in which the licenses are granted, their renewed and other updates of licenses.
Schedule B- In schedule B contains a fee structure for government-run laboratories. Schedule B fees that are for analysis of Drug and Cosmetics that have to be paid to the Central Drug Laboratories or other Government Laboratories.
Schedule C- Schedule C contains various biological products and their regulation. In schedule C there is the list of Biological and Immunological Products, Antibiotics and Ophthalmic lotions and Ointments, and all products for parental use (Injections).
Example– biological products such as sera antigens, toxin, antitoxin, Vaccines for parenteral injections, solution of serum proteins intended for injection, Insulin, etc.
Schedule C-I – List of drugs from biological origin are namely Alkaloids, Hormones, Vitamins and Antibiotics for oral use.
Example- Special products such as fish liver oil, ergot preparations, drugs belonging to digitalis groups, adrenaline, Liver extract, vitamins, hormones Schedules to the Rule.
Schedule D- In schedule D there is the list of drugs exempted from the provision of import of drugs. Schedule D, a discount that has been granted to importers of drugs from complying with the requirements of import and also conditions for such exemption for drugs. Classes of exempted drugs in which are exempted from certain provisions applicable to the import of drugs.
Example- Skimmed milk, powdered milk fortified with vitamins, forex, oats, ginger, pepper, Cummins, etc.
Schedule E- In schedule E, that contains various poisons and their regulation. Examples- Sarpa Visha (Snake venom), Parada (Mercury), etc. Schedule E, there is a list of poisons for which labeling and other requirements are to be complied with. This schedule has been deleted.
Schedule E-I – In schedule E, there is a list of the poisonous substances under the Ayurvedic, Siddha and Unani Systems of Medicines like- CuSo4 Datura, Bhang, Ganja, etc.
Schedule F- In schedule F, contains regulations and standards for running a Blood Bank. There are special provisions to be complied with, for the manufacture, testing, and labeling of biological products for human use like Sera and Vaccines. These provisions have now been deleted. The requirements for running Blood Banks, licensing process and other requirements for Blood Bank are now included in this
1. Schedule F-I- Schedule F- 1, which contains regulations and standards for vaccines. there are special provisions to be complied with for the manufacture, testing, and labeling of Veterinary Biological Products.
In schedule F-1-there are the provisions applicable to the other biological and special products like vaccines, antigens, diagnostic antigens, tuberculin and regarding their production, testing, storage, packing, etc.
2. Schedule F-II– Schedule F-II, that contains regulations and standards for surgical dressing and bandage cloth.
3. Schedule F-III– Schedule F-III, that contains regulations and standards for umbilical tapes.
4. Schedule F-F-F-1
Schedule F-F, that contains regulations and standards for ophthalmic ointments and solutions.
Schedule G- In schedule G, there is the list of drugs which should be used for the patient under medical supervision and the drug label should display text prominently, “ Caution – It is dangerous to take this preparation except under medical instructions, and the label of these drugs is conspicuously printed and that is surrounded by a line within which that there are no other words. There are most of the drugs are hormonal preparations.
There is a list of substances that are required to be taken only under the supervision of RMP (Registered Medical practitioner). It must necessary to make a proper bill of sale of these drugs. The proper records of purchase and sale of these medicines must be maintained for a period of 2 years.
Examples of substances under this schedule: Test lactone, Hydroxyurea, Carbutamide, Primidone L asparaginase, Bleomycin, Busulphan, chlorambucil, chlorothiazide, chlorpropamide, doxorubicin, ethosuximide, Metformin, Insulin all types, Hydroxyurea, Mercaptopurines, etc.
Schedule H- In schedule H, there is the list of drugs which are to be sold by retail with the prescription of Registered Medical Practitioner(RMP) and which the drugs are labeled prominently with words: “Schedule H Drug – Warning: to be sold by retail on the prescriptions of a Registered Medical Practitioner only.”
In schedule H, the drug label must display the texts “Rx” and “Schedule H drug” prominently with red color. These drugs can only sell by licensed parties and registered pharmacist. Schedule H drugs cannot be sold without a prescription and only the amount specified for the drugs in the prescription should be sold. The time and date of prescription of schedule H drugs must be noted in the record. Also, a Schedule H drug comes under the purview of Narcotic Drugs and Psychotropic Substances Act,1985, it must carry the texts “NRx” and “Schedule H drug prominently.
Examples are- Allopurinol, Acyclovir, Amikacin, Atenolol, Cimetidine, Ciprofloxacin, Cefuroxime, Diclofenac, Glimepiride, Buspirone, Alprazolam, Azathioprine, Clindamycin, diazepam, Captopril, Carbidopa, etc.
Schedule I- In Schedule I, there were listed details of poisons about the proportion of poisonous drugs in certain cases. Schedule I was linked with Schedule E but Schedule E was deleted in 1982 so Schedule I was also deleted.
Schedule J- In Schedule J, contains a list of various diseases and conditions that cannot be treated under any drug currently in the market. There is no drug may legally claim to treat these diseases. Schedule J, here names of diseases and ailments which a drug may not purpose to prevent or cure by means of claims made on the label of the container of the drugs.
Schedule J consists of the table of pain, diseases, and maladies by which a drug may not claim to prevent or cure. Some of the diseases and ailments under this schedule are like – AIDS, Angina Pectoris, Appendicitis, Arteriosclerosis, Baldness, Blindness, Bronchial Asthma, Cancer and Benign tumor, Cataract, change in color of the hair and growth of new hair, Change of fetal sex by drugs. There are almost 51 ailments mentioned in Schedule J.
Schedule K- Schedule K, here contains various substances and drugs and their corresponding regulation. In Schedule K, there are names of drugs or classes of drugs which are consist of the list of drugs exempted from certain provisions applicable to the manufacture of drugs and sale and standards of drugs. In this class of drugs, these are not sold for medicinal use and that each container is labeled conspicuously with the words “NOT FOR MEDICINAL USE”.
Medicines that consist under the ‘household remedy’ class as- Antacid Preparations, Paracetamol tablets, Calcium preparations with or without Vitamin D, Analgesic Balms, Gripe Water for use of infants, Inhalers (containing drugs for the treatment of cold and nasal congestion), Syrups lozenges, pills and tablets for cough, cold or sore throat. These drugs should not contain any substance specified in Schedules G, H, X of D and C act and Rules. The shopkeepers are also to ensure that there are the drugs sold in the original unopened containers of the licensed manufacturers. Note- Aspirin and Quinine Sulphate have been removed from the list of schedule K.
Schedule L – In schedule L, there is a list that is required to be sold by retail against the prescription of a Registered Medical Practitioner. Subsequently, drugs listed in Schedule L were transferred to Schedule H. Schedule L was deleted in 1982 from the list of schedules.
Schedule M- In schedule M, deals with various regulations for manufacturing, premises, waste disposal, and equipment. Schedule M that contains, Good Manufacturing Practices (GMP) and the requirements of premises, plant, and equipment of manufacture of drugs. schedule M contains in different parts are as follows –
Schedule M (Part I) – Here is, Good Manufacturing Practices for premises and materials.
Part I-A – Here is, specific requirements for the manufacture of sterile products, parenteral preparation, and sterile ophthalmic preparations.
Part I-B – Here is, specific requirements for the manufacturing of oral solid dosage forms like– Tablets and Capsules.
Part I-C – Here is, specific requirements for the manufacture of oral liquids like – Syrups, elixirs, emulsions, and suspensions.
Part I-D – Here is, specific requirements for the manufacture of topical products i.e. external preparations, like – creams, ointments, pastes, emulsions, lotions, solutions, dusting powders, and identical products.
Part I-E – Here is, specific requirements for the manufacture of metered-dose-inhalers (MDI).
Part I-F – Here is, specific requirements of premises, plants, and materials for the manufacture of active pharmaceutical ingredients (Bulk drugs).
Schedule M (Part II) – Here is, requirements of plant and equipment.
Schedule M (I) Here is, requirements for factory premises of Homeopathic Medicines.
Schedule M(II) Here is, requirements for factory premises of Cosmetics.
Schedule M(II) Here is, the requirement for factory premises for the manufacture of Medical Devices.
Schedule N – In schedule N, a list that contains various regulations minimum equipment, requirements of premises for the effective running of a pharmacy. There is a list of minimum equipment for the efficient running of pharmacy and requirements.
Schedule O – In schedule O, contains various regulations and requirements for disinfectant fluids. Schedule O regulates standards for Disinfectant fluids. The disinfectants shall be classified as follows:
(A) Black fluids – These contain the homogeneous dark brown solution of coal tar acid or similar acids with or without hydrocarbons, and/or other phenolic compounds, and their derivatives.
(B) White fluids – There is the finely dispersed homogeneous emulsion of coal tar acid or similar acids with or without hydrocarbons, or other phenolic compounds, and their derivatives.
Schedule P –Schedule P, that contains regulations regarding the life period and conditions of storage of various drugs. Schedule P contains the life period of the drug.
In Schedule P, deals with the label of drugs like– Life period of drugs, name of Drug, Period in Month, Conditions of storage are mentioned.
In the label of drugs, the Period in months (unless otherwise specified) between the date of manufacture and date of expiry which the labeled potency period of the drug that they should not exceed under the conditions of storage Specified. Schedule P includes labeling of antibiotics, vitamins, insulin preparation, normal human plasma, sera toxins, toxoids, other toxins, anti-toxins, miscellaneous drugs, etc.
Schedule P-I: contains regulations regarding the retail package size of various drugs. That gives the names of drugs, along with the dosage form and the pack size. There is no other pack size than the one listed is allowed to be marketed.
Schedule Q- Schedule Q, that contains a list of permitted dyes and pigments in soap and cosmetics. Schedule Q contains the list of Coal Tar colors permitted to be used in Cosmetics. Schedule Q deals with a list of coal tar colors permitted to be used in drugs and cosmetics. Here is no drug contains a color other than specified below –
(1) Natural Colors Carotene, Chlorophyll, Red Oxide of Iron, Yellow Oxide of Iron, Titanium Dioxide, Black Oxide of iron.
(2) Artificial Colors Caramel.
(3) Coal Tar Colors.
Schedule R – Schedule R, which contains various regulations and requirements for condoms and other mechanical contraceptives. In schedule R, here standards for condoms made up of rubber latex intended for single-use and other mechanical contraceptives. Schedule R deals with the standards and labeling requirements of Condoms, Copper T and Contraceptive Tube Rings.
Schedule R (I)- Here is, Standards to be complied with by medical devices.
Schedule S – In schedule S, here are the standards for cosmetics. Schedule S deals with the lists of various cosmetics and toiletries, and directs the manufacturers of cosmetics to conform to the latest Bureau of Indian Standards (BIS) requirements.
The cosmetics in finished form should conform to the Indian Standards specifications laid down from time to time by the Bureau of Indian Standards (BIS) are like – 1. Skin Powders 2. Skin Powder for infant 3. Tooth Powder 4. Toothpaste 5. Skin Creams 6. Hair Oils.
Schedule T – In schedule T, contains various regulations and requirements for the manufacturing of Ayurvedic, Siddha, and Unani products.
Schedule T deals with the requirements of factory premises and hygienic conditions to be complied with by the manufacturer of Ayurvedic, Siddha, and Unani drugs.
You may read- Medical books here.
Schedule U – In Schedule U, contains various regulations and requirements for record-keeping of drugs department. Schedule U deals with the particulars to be shown in the manufacturing records, record of raw materials and in the analytical records of drugs.
Schedule U (I) – Here is, particulars to be shown in the manufacturing records.
Schedule U (II) – Here is, records of raw materials.
Schedule U (III) – Here is, particulars to be recorded in the analytical records.
Schedule V – In schedule V, which contains standards for the drug patents. Schedule V contains the standard for patent of drugs with a proprietary medicine. The maximum and minimum quantities of vitamins are permitted to be added in preparations for oral use of vitamins.
Schedule V that deals with standards for patent and proprietary of medicines and for patent and proprietary of medicines containing vitamins.
Schedule W – In schedule W, there are the names of drugs which shall be marketed under generic names only. Schedule W contains a list of drugs that shall be marketed under generic names only. This schedule contains only five drugs that shall be marketed under generic names only: – Aspirin, Analgen, and its salt, Chlorpromazine and its salt, Piperazine, Ferrous sulfate, and its salts.
Schedule X – In schedule X, all the regulations of Schedule H apply. The retailer must place a copy of the prescription for up to two years. These drugs must be placed under lock and key. Schedule X contains names of psychotropic drugs for which special control measures have been laid down and also the list of habit-forming, psychotropic, and other such drugs.
Schedule X contains a list of drugs which needs discretion while dispending and pharmacist should ensure that these drugs are not sale without any prescription. These drugs are having a warning mentioned on the label, “Schedule X Drug’ – Warning: to be sold on retail on the prescription of a registered medical practitioner only”. The label of these drugs having a symbol ‘XRx’ in red & that conspicuously displayed on the top left corner of the table. After dispending these drugs, the pharmacist must Stamp the prescription. The pharmacist must maintain a record of purchase and sale of these drugs, Preserve the record for a period of 2 years from the date of transactions.
Examples of few drugs under schedule X are – Amobarbital, Amphetamines, Dexamphetamine, Glutethimide, Methylphenidate, etc.
Schedule Y- Schedule Y deals with the requirement and guidelines for clinical trials. Schedule Y contains requirements and guidelines for clinical trials, import, and manufacturing of new drugs.
The schedule covers details of the drugs are like –
o chemical and pharmaceutical information
o Animal tests, toxicology, and pharmacology
o Clinical Trails –
• Nature of trials
• Permission for trials
• Responsibility of sponsor / Investigator
Here’s the complete details about Drug and Cosmetics Act.