The ''Drugs and Cosmetics Rules, 1940'' are the rules which the government of India established through the

Drugs and Cosmetics Act, 1940 The Drugs and Cosmetics Act, 1940 is an act of the Parliament of India which regulates the import, manufacture and distribution of drugs in India. The primary objective of the act is to ensure that the drugs and cosmetics sold in India are saf ...

. 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 and their summary: * Schedule G: Most of these drugs are

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 by complex biological processes to regulate physiology and behavior. Hormones are required f ...

preparations. 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:

Testolactone Testolactone (, ) (brand name Teslac) is a non-selective, irreversible, steroidal aromatase inhibitor which is used as an antineoplastic drug to treat advanced-stage breast cancer.

Hydroxyurea Hydroxycarbamide, also known as hydroxyurea, is a medication used in sickle-cell disease, essential thrombocythemia, chronic myelogenous leukemia, polycythemia vera, and cervical cancer. In sickle-cell disease it increases fetal hemoglobin and d ...

Carbutamide Carbutamide (brand name Glucidoral) is an anti-diabetic drug of the sulfonylurea class, developed by Servier. It is classified as first-generation. It was patented in 1953 and approved for medical use in 1956. See also * Hellmuth Kleinsorge ...

Primidone Primidone, sold under various brand names, is a barbiturate medication that is used to treat partial and generalized seizures, as well as essential tremors. It is taken by mouth. Common side effects include sleepiness, poor coordination, nau ...

etc. * Schedule H: The drug label must display the texts ''"Rx"'' and ''"Schedule H drug. Warning : "Not to be sold by Retail without the prescription of a Registered Medical Practitioner"'' 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 An androgen (from Greek ''andr-'', the stem of the word meaning "man") is any natural or synthetic steroid hormone that regulates the development and maintenance of male characteristics in vertebrates by binding to androgen receptors. This incl ...

anabolic Anabolism () is the set of metabolic pathways that construct molecules from smaller units. These reactions require energy, known also as an endergonic process. Anabolism is the building-up aspect of metabolism, whereas catabolism is the breaking ...

oestrogen Estrogen or oestrogen is a category of sex hormone responsible for the development and regulation of the female reproductive system and secondary sex characteristics. There are three major endogenous estrogens that have estrogenic hormonal acti ...

ic and progestational substances;

Alprazolam Alprazolam, sold under the brand name Xanax, among others, is a fast-acting, potent tranquilizer of medium duration in the triazolobenzodiazepine (TBZD) class, which are benzodiazepines (BZDs) fused with a triazole ring. It is most commonly u ...

(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 t ...

, Ibuprofen,

Vasopressin Human 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 then trave ...

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"'' and ''"Schedule H drug. Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only."'' on the label prominently. *

Schedule X Schedule X is a class of prescription drugs in India appearing as an appendix to the Drugs and Cosmetics Rules introduced in 1945. These are drugs which cannot be purchased over the counter without the prescription of a qualified doctor. Also, ...

: All the regulations of Schedule H apply. The retailer must keep a copy of the prescription for two years. The drugs must be kept under lock and key. Examples:

Secobarbital Secobarbital (as the sodium salt, originally marketed by Eli Lilly and Company for the treatment of insomnia, and subsequently by other companies as described below, under the brand name Seconal) is a short-acting barbiturate derivative drug that ...

, Glutethimide etc. * Schedule J: Contains a list of various diseases and conditions that cannot be treated under any drug currently in market. No drug may legally claim to treat these diseases. 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 an ...

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

blood bank A blood bank is a center where blood gathered as a result of blood donation is stored and preserved for later use in blood transfusion. The term "blood bank" typically refers to a department of a hospital usually within a Clinical Pathology laborat ...

. ** Schedule F-I: This contains regulations and standards for

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

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: Contains various substances and 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 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 condoms and other mechanical contraceptives. * Schedule S: Lists various cosmetics and

toiletries Personal care or toiletries are consumer products used in personal hygiene, personal grooming or for beautification. Products Personal care includes products as diverse as cleansing pads, colognes, cotton swabs, cotton pads, deodorant, eye li ...

, and directs the manufacturers of cosmetics to conform to the latest

Bureau of Indian Standards The Bureau of Indian Standards (BIS) is the National Standards Body of India under Department of Consumer affairs, Ministry of Consumer Affairs, Food & Public Distribution, Government of India. It is established by the Bureau of Indian Standar ...

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 physical as well as spiritual ...

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 Indian Medical Association describes U ...

products. * Schedule U: Contains various regulations and requirements for record keeping. * Schedule V: Contains standards for drug

patent A patent is a type of intellectual property that gives its owner the legal right to exclude others from making, using, or selling an invention for a limited period of time in exchange for publishing an enabling disclosure of the invention."A ...

s * Schedule W: Contains Generic Drugs List. * * Schedule Y: Contains requirement and guidelines for

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

Schedules

See also

References

Further reading