Drugs and Cosmetics Rules, 1945

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The Drugs and Cosmetic Act, 1940
Territorial extentIndia
Date passed1940
Amends
1955, 1982, 1995
Summary
An act to regulate import, manufacture, distribution and sale of Drugs and Cosmetics.
Status: In force

The Drugs and Cosmetics Rules, 1945 are the set of rules under The Drugs and Cosmetics Act, 1940 [1] which contains provisions for classification of drugs under given schedules and there are guidelines for the storage, sale, display and prescription of each schedule.[1][2]

Schedules[edit]

The Drugs and Cosmetics Rules, 1945 contains provisions for classification of drugs under given schedules and there are guidelines for the storage, sale, display and prescription of each schedule.[1] The Rule 67 details the conditions of licenses. The Rule 97 contains the labeling regulations.[3]

The notable Schedules and their summary:

  • Schedule G: Most of these drugs are hormonal preparations.[4] 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, Hydroxyurea, Carbutamide, Primidone etc.[3]
  • Schedule H: The drug label must display the texts "Rx" 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 (Xanax), Hepatitis B vaccine, Ibuprofen, Vasopressin etc.[3]
    • 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: 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, Glutethimide etc.[3]
  • 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.[3]

Other Schedules and their summary:

  • Schedule A: Contains various forms and formats of letters for applications of licensing etc.[3]
  • Schedule B: Contains fees structure for government-run labs.[3]
  • Schedule C: Contains various biological products[4] and their regulation. Examples: Serums, Adrenaline etc.[3][ Vaccines ]>
  • Schedule D: List of drugs exempted from the provision of import of drugs
  • Schedule E: Contains various poisons[4] and their regulation. Examples: Sarpa Visha (Snake venom), Parada (Mercury) etc.[3]
  • Schedule F: This contains regulations and standards for running a blood bank.[3]
    • Schedule F-I: This contains regulations and standards for vaccines.[3]
    • Schedule F-II: This contains regulations and standards for surgical dressing.[3]
    • Schedule F-III: This contains regulations and standards for umbilical tapes.[3]
  • Schedule F-F: This contains regulations and standards for ophthalmic ointments and solutions.[3]
  • Schedule K: Contains various substances and drugs and their corresponding regulation.[3]
  • Schedule M: Contains various regulations for manufacturing, premises, waste disposal and equipment.[3]
  • Schedule N: Contains various regulations and requirements for a pharmacy.[3]
  • Schedule O: Contains various regulations and requirements for disinfectant fluids.[3]
  • Schedule P: Contains regulations regarding life period and storage of various drugs.[3]
    • Schedule P-I: Contains regulations regarding retail package size of various drugs.[3]
  • Schedule Q: Contains a list of permitted dyes and pigments in soap and cosmetics.[3]
  • Schedule R: Contains various regulations and requirements for condoms and other mechanical contraceptives.[3]
  • Schedule S: Lists various cosmetics and toiletries, and directs the manufacturers of cosmetics to conform to the latest Bureau of Indian Standards requirements.[3]
  • Schedule T: Contains various regulations and requirements for manufacture of Ayurvedic, Siddha and Unani products.[3]
  • Schedule U: Contains various regulations and requirements for record keeping.[3]
  • Schedule V: Contains standards for drug patents.[3]
  • Schedule Y: Contains requirement and guidelines for clinical trials.[3]

See also[edit]

References[edit]

  1. ^ a b Dr. Lily Srivastava. Law & Medicine. Universal Law Publishing. pp. 216–. ISBN 978-81-7534-949-0.
  2. ^ Pillay (30 November 2012). Modern Medical Toxicology. Jaypee Brothers Publishers. p. 30. ISBN 978-93-5025-965-8. Retrieved 22 February 2015.
  3. ^ a b c d e f g h i j k l m n o p q r s t u v w x y z aa "Drugs and Cosmetics Act, 1940" (PDF). Central Drugs Standard Control Organization. Archived from the original (PDF) on 31 October 2005. Retrieved 19 February 2015.
  4. ^ a b c P.V. Guharaj (2003). Forensic Medicine. Orient Blackswan. p. 327. ISBN 978-81-250-2488-0. Retrieved 21 February 2015.

Further reading[edit]