Sat. Dec 14th, 2019

Drugs and Cosmetics Rules, 1945

‘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]

Contents

  • 1 Schedules
  • 2 See also
  • 3 References
  • 4 Further reading

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 Vitamins 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]

  • Drug policy of India
  • Drugs and Cosmetics Act, 1940
  • Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954

References[edit]

  • ^ a b Dr. Lily Srivastava. Law & Medicine. Universal Law Publishing. pp. 216–. ISBN 978-81-7534-949-0..mw-parser-output cite.citation{font-style:inherit}.mw-parser-output .citation q{quotes:”””””””‘””‘”}.mw-parser-output .citation .cs1-lock-free a{background:url(“//upload.wikimedia.org/wikipedia/commons/thumb/6/65/Lock-green.svg/9px-Lock-green.svg.png”)no-repeat;background-position:right .1em center}.mw-parser-output .citation .cs1-lock-limited a,.mw-parser-output .citation .cs1-lock-registration a{background:url(“//upload.wikimedia.org/wikipedia/commons/thumb/d/d6/Lock-gray-alt-2.svg/9px-Lock-gray-alt-2.svg.png”)no-repeat;background-position:right .1em center}.mw-parser-output .citation .cs1-lock-subscription a{background:url(“//upload.wikimedia.org/wikipedia/commons/thumb/a/aa/Lock-red-alt-2.svg/9px-Lock-red-alt-2.svg.png”)no-repeat;background-position:right .1em center}.mw-parser-output .cs1-subscription,.mw-parser-output .cs1-registration{color:#555}.mw-parser-output .cs1-subscription span,.mw-parser-output .cs1-registration span{border-bottom:1px dotted;cursor:help}.mw-parser-output .cs1-ws-icon a{background:url(“//upload.wikimedia.org/wikipedia/commons/thumb/4/4c/Wikisource-logo.svg/12px-Wikisource-logo.svg.png”)no-repeat;background-position:right .1em center}.mw-parser-output code.cs1-code{color:inherit;background:inherit;border:inherit;padding:inherit}.mw-parser-output .cs1-hidden-error{display:none;font-size:100%}.mw-parser-output .cs1-visible-error{font-size:100%}.mw-parser-output .cs1-maint{display:none;color:#33aa33;margin-left:0.3em}.mw-parser-output .cs1-subscription,.mw-parser-output .cs1-registration,.mw-parser-output .cs1-format{font-size:95%}.mw-parser-output .cs1-kern-left,.mw-parser-output .cs1-kern-wl-left{padding-left:0.2em}.mw-parser-output .cs1-kern-right,.mw-parser-output .cs1-kern-wl-right{padding-right:0.2em}
  • ^ Pillay (30 November 2012). Modern Medical Toxicology. Jaypee Brothers Publishers. p. 30. ISBN 978-93-5025-965-8. Retrieved 22 February 2015.
  • ^ 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.
  • ^ 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]

    • “Drugs and Cosmetics Rules, 1945” (PDF). Central Drugs Standard Control Organization. Archived from the original (PDF) on 31 October 2005.
    • A Review on the Current Classification and Regulatory Provisions for Medicines in Drug & Cosmetic Act, in the light of Present Day Context Recommendations for Drugs & Cosmetics Rules with context of Drug Schedules


    Source: https://en.wikipedia.org/wiki/Drugs_and_Cosmetics_Rules,_1945

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