The ''Drugs and Cosmetics Rules, 1945'' are the rules which the government of India established for the implementation of the Drugs and Cosmetics Act, 1940. These rules classify drugs under given schedules and present guidelines for the storage, sale, display and prescription of each schedule.

Schedules

The Drugs and Cosmetics Rules, 1945 has provisions for classification of drugs under given schedules and there are guidelines for the storage, sale, display and prescription of each schedule. The Rule 67 details the conditions of licenses. The Rule 97 contains the labeling regulations. The notable Schedules include: * Schedule G: These drugs include

hormonal A hormone (from the Greek participle , "setting in motion") is a class of signaling molecules in multicellular organisms that are sent to distant organs or tissues by complex biological processes to regulate physiology and behavior. Hormones a ...

medications (excluding sex hormone medications), antineoplastic drugs,

anticonvulsant Anticonvulsants (also known as antiepileptic drugs, antiseizure drugs, or anti-seizure medications (ASM)) are a diverse group of pharmacological agents used in the treatment of epileptic seizures. Anticonvulsants are also used in the treatme ...

s (e.g. 2,4-oxazolidinediones, ureides), hypoglycemic drugs (e.g.

sulfonylurea Sulfonylureas or sulphonylureas are a class of organic compounds used in medicine and agriculture. The functional group consists of a sulfonyl group (-S(=O)2) with its sulphur atom bonded to a nitrogen atom of a ureylene group (N,N-dehydrourea ...

s, biguanides),

antihistamine Antihistamines are drugs which treat allergic rhinitis, common cold, influenza, and other allergies. Typically, people take antihistamines as an inexpensive, generic (not patented) drug that can be bought without a prescription and provides ...

s, etc. The drug label must display the text ''"Caution: It is dangerous to take this preparation except under medical supervision"'' prominently. Examples of substances under this schedule: All

insulin Insulin (, from Latin ''insula'', 'island') is a peptide hormone produced by beta cells of the pancreatic islets encoded in humans by the insulin (''INS)'' gene. It is the main Anabolism, anabolic hormone of the body. It regulates the metabol ...

preparations, testolactone, hydroxyurea, daunorubicin, metformin,

diphenhydramine Diphenhydramine, sold under the brand name Benadryl among others, is an antihistamine and sedative. Although generally considered sedating, diphenhydramine can cause paradoxical central nervous system stimulation in some individuals, particula ...

, carbutamide, primidone etc. * Schedule H: Each drug's label must prominently display the symbol ''"Rx"'' and a red-boxed warning ''"Schedule H drug. Warning : "Not to be sold by Retail without the prescription of a Registered Medical Practitioner"''. 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 Anabolism () is the set of metabolic pathways that construct macromolecules like DNA or RNA from smaller units. These reactions require energy, known also as an endergonic process. Anabolism is the building-up aspect of metabolism, whereas catab ...

, oestrogenic and progestational substances;

Alprazolam Alprazolam, sold under the brand name Xanax among others, is a fast-acting, potent tranquilizer of moderate duration within the triazolobenzodiazepine group of chemicals called benzodiazepines. Alprazolam is most commonly prescribed in the ...

(Xanax),

Hepatitis B vaccine Hepatitis B vaccine is a vaccine that prevents hepatitis B. The first dose is recommended within 24 hours of birth with either two or three more doses given after that. This includes those with poor immune function such as from HIV/AIDS and ...

Ibuprofen Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that is used to relieve pain, fever, and inflammation. This includes dysmenorrhea, painful menstrual periods, migraines, and rheumatoid arthritis. It can be taken oral administration, ...

Vasopressin Mammalian vasopressin, also called antidiuretic hormone (ADH), arginine vasopressin (AVP) or argipressin, is a hormone synthesized from the ''AVP'' gene as a peptide prohormone in neurons in the hypothalamus, and is converted to AVP. It ...

etc. ** If a Schedule H drug also comes under the purview of Narcotic Drugs and Psychotropic Substances Act, 1985, the drug's label must prominently display the symbol ''"NRx"'' and a red-boxed warning ''"Schedule H drug. Warning : "Not to be sold by Retail without the prescription of a Registered Medical Practitioner"''. * Schedule H1: Notified in 2013, this list includes third and fourth generation antibiotics, some psychotropic drugs and anti-TB drugs. A separate register is to be maintained to track supply of these drugs and labelling requirements are of the symbol ''"Rx"'' and the red boxed warning : ''“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.”'' * Schedule J: Contains a list of various diseases and medical conditions that cannot be treated under any drug currently in market. No drug may legally claim to treat these diseases. * Schedule X: Schedule X lists addictive drugs (e.g.

narcotic The term narcotic (, from ancient Greek ναρκῶ ''narkō'', "I make numb") originally referred medically to any psychoactive compound with numbing or paralyzing properties. In the United States, it has since become associated with opiates ...

s, psychotropics) having medicinal uses that must be kept under lock and key. All the regulations of Schedule H apply. The retailer must keep a copy of the prescription for two years. Various licenses are required for possession and storage of these drugs, including a special licence from the local drug controller. Examples:

morphine Morphine, formerly also called morphia, is an opiate that is found naturally in opium, a dark brown resin produced by drying the latex of opium poppies (''Papaver somniferum''). It is mainly used as an analgesic (pain medication). There are ...

secobarbital Secobarbital, sold under the brand name Seconal among others, is a short-acting barbiturate drug originally used for the treatment of insomnia. It was patented by Eli Lilly and Company in 1934 in the United States. It possesses anesthetic, antic ...

, glutethimide etc. Other Schedules and their summary: * Schedule A: Contains various forms and formats of letters for applications of licensing etc. * Schedule B: Contains fees structure for government-run labs. * Schedule C: Contains various biological products and their regulation. Examples: serums,

adrenaline Adrenaline, also known as epinephrine, is a hormone and medication which is involved in regulating visceral functions (e.g., respiration). It appears as a white microcrystalline granule. Adrenaline is normally produced by the adrenal glands a ...

vitamin Vitamins are Organic compound, organic molecules (or a set of closely related molecules called vitamer, vitamers) that are essential to an organism in small quantities for proper metabolism, metabolic function. Nutrient#Essential nutrients, ...

s etc. * Schedule D: List of drugs exempted from the provision of import of drugs * Schedule E: Contains various poisons and their regulation. Examples: ''Sarpa Visha'' (

Snake venom Snake venom is a highly toxic saliva containing zootoxins that facilitates in the immobilization and digestion of prey. This also provides defense against threats. Snake venom is usually injected by unique fangs during a Snakebite, bite, though ...

), ''Parada'' ( Mercury) etc. * Schedule F: This contains regulations and standards for running a blood bank. ** Schedule F-I: This contains regulations and standards for

vaccine A vaccine is a biological Dosage form, preparation that provides active acquired immunity to a particular infectious disease, infectious or cancer, malignant disease. The safety and effectiveness of vaccines has been widely studied and verifi ...

s. ** Schedule F-II: This contains regulations and standards for surgical dressing. ** Schedule F-III: This contains regulations and standards for umbilical tapes. * Schedule F-F: This contains regulations and standards for ophthalmic ointments and solutions. * Schedule K: Drugs not meant for medicinal use,

quinine Quinine is a medication used to treat malaria and babesiosis. This includes the treatment of malaria due to ''Plasmodium falciparum'' that is resistant to chloroquine when artesunate is not available. While sometimes used for nocturnal leg ...

and other antimalarial drugs, drugs supplied by government hospitals, registered medical practitioners, contraceptive drugs, and their corresponding regulation. * Schedule M: Contains various regulations for manufacturing, premises, waste disposal and equipment. * Schedule N: Contains various regulations and requirements for a pharmacy. * Schedule O: Contains various regulations and requirements for

disinfectant A disinfectant is a chemical substance or compound used to inactivate or destroy microorganisms on inert surfaces. Disinfection does not necessarily kill all microorganisms, especially resistant bacterial spores; it is less effective than ...

fluids. * Schedule P: Contains regulations regarding life period and storage of various drugs. ** Schedule P-I: Contains regulations regarding retail package size of various drugs. * Schedule Q: Contains a list of permitted dyes and pigments in soap and cosmetics. * Schedule R: Contains various regulations and requirements for

condom A condom is a sheath-shaped Barrier contraception, barrier device used during sexual intercourse to reduce the probability of pregnancy or a Sexually transmitted disease, sexually transmitted infection (STI). There are both external condo ...

s and other mechanical contraceptives. * Schedule S: Lists various cosmetics and

toiletries Personal care products are consumer products which are applied on various external parts of the body such as skin, hair, nails, lips, external genital and anal areas, as well as teeth and mucous membrane of the oral cavity, in order to make th ...

, and directs the manufacturers of cosmetics to conform to the latest Bureau of Indian Standards requirements. * Schedule T: Contains various regulations and requirements for manufacture of Ayurvedic,

Siddha ''Siddha'' (Sanskrit: '; "perfected one") is a term that is used widely in Indian religions and culture. It means "one who is accomplished." It refers to perfected masters who have achieved a high degree of perfection of the intellect as we ...

and

Unani Unani or Yunani medicine (Urdu: ''tibb yūnānī'') is Perso-Arabic traditional medicine as practiced in Muslim culture in South Asia and modern day Central Asia. Unani medicine is pseudoscientific. The term '' Yūnānī'' means 'Greek', ref ...

drugs. * Schedule U: Contains various regulations and requirements for record keeping. * Schedule V: Contains standards for drug patents * Schedule W: Lists

generic drug A generic drug is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents. Generic drugs are allowed for sale after the patents on the original drugs expire. Because the active ch ...

s. * Schedule Y: Contains requirement and guidelines for

clinical trial Clinical trials are prospective biomedical or behavioral research studies on human subject research, human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel v ...

s. * Schedule Z: Lists approved drugs for veterinary use.

Schedules

See also

References

Further reading