Md Rifat at 21:16, 25 March 2026

2026-03-25T21:16:28Z

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{{Short description|Indian federal government rules}}
{{Use dmy dates|date=November 2018}}
{{Use Indian English|date=November 2018}}

{{Infobox legislation
|short_title = Drugs and Cosmetic Act, 1945
|legislature =
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|territorial_extent = [[India]]
|enacted_by =
|date_passed = 1940
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|amended_by = 1955, 1964, 1972, 1982, 1986, 1995
|repeals =
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|summary = An act to regulate import, manufacture, distribution and sale of Drugs and Cosmetics.
|keywords =
|status = in force
}}

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.<ref name="Srivastava">{{cite book|author=Dr. Lily Srivastava|title=Law & Medicine|year=2010 |url=https://books.google.com/books?id=A5_TSdG13M4C&pg=PA216|publisher=Universal Law Publishing|isbn=978-81-7534-949-0|pages=216–}}</ref><ref name="Pillay2012">{{cite book|author=Pillay|title=Modern Medical Toxicology|url=https://books.google.com/books?id=MFcHBAAAQBAJ&pg=PA30|accessdate=22 February 2015|date=30 November 2012|publisher=Jaypee Brothers Publishers|isbn=978-93-5025-965-8|page=30}}</ref>

==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.<ref name="Srivastava"/> The Rule 67 details the conditions of licenses. The Rule 97 contains the labeling regulations.<ref name="D&C Act" />

The notable Schedules include:

* '''Schedule G''': These drugs include [[hormonal]] medications (excluding [[sex hormone medication]]s), [[antineoplastic drug]]s, [[anticonvulsant]]s (e.g. [[2,4-oxazolidinedione]]s, [[ureide]]s), [[hypoglycemic drug]]s (e.g. [[sulfonylurea]]s, [[biguanide]]s), [[antihistamine]]s, etc.<ref name="Guharaj2003">{{cite book|author=P.V. Guharaj|author-link=P.V. Guharaj|title=Forensic Medicine|url=https://books.google.com/books?id=cLemGip2794C&pg=PA327|accessdate=2023-12-20|year=2003|publisher=Orient Blackswan|isbn=978-81-250-2488-0|page=327}}</ref> 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]] preparations, [[testolactone]], [[hydroxyurea]], [[daunorubicin]], [[metformin]], [[diphenhydramine]], [[carbutamide]], [[primidone]] etc.<ref name="D&C Act" />
* '''[[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]], [[oestrogen]]ic and [[Progesterone|progestational]] substances; [[Alprazolam]] (Xanax), [[Hepatitis B vaccine]], [[Ibuprofen]], [[Vasopressin]] etc.<ref name="D&C Act">{{cite web|title=Drugs and Cosmetics Act, 1940|url=http://cdsco.nic.in/html/copy%20of%201.%20d&cact121.pdf|archive-url=https://web.archive.org/web/20051031023525/http://cdsco.nic.in/html/Copy%20of%201.%20D%26CAct121.pdf|url-status=dead|archive-date=31 October 2005|publisher=[[Central Drugs Standard Control Organization]]|accessdate=19 February 2015}}
</ref>
** 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,<ref>{{Cite news |date=2013-09-27 |title=Government notifies Schedule H1 drugs |url=https://www.thehindu.com/news/national/government-notifies-schedule-h1-drugs/article5176491.ece |access-date=2024-10-10 |work=The Hindu |language=en-IN |issn=0971-751X}}</ref> 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.<ref name="D&C Act" />
* '''[[Schedule X]]''': Schedule X lists addictive drugs (e.g. [[narcotic]]s, [[psychotropic]]s<ref>{{Cite web |title=Schedule H, Schedule X and Schedule H1 Drugs - GKToday |url=https://www.gktoday.in/schedule-h-schedule-x-and-schedule-h1-drugs/#:~:text=Here%20the%20drug%20retailer%20has,and%20psychotropic%20substances-based%20drugs. |access-date=2023-12-20 |website=www.gktoday.in}}</ref>) 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.<ref>{{cite web |last=Dey |first=Sushmi |date=2012-09-24 |title=Plan to ease morphine procurement for use in pain relief |url=https://www.business-standard.com/article/economy-policy/plan-to-ease-morphine-procurement-for-use-in-pain-relief-112092402012_1.html |access-date=2023-12-20 |website=[[Business Standard]]}}</ref> Examples: [[morphine]], [[secobarbital]], [[glutethimide]] etc.<ref name="D&C Act" />

Other Schedules and their summary:

* '''Schedule A''': Contains various forms and formats of letters for applications of licensing etc.<ref name="D&C Act" />
* '''Schedule B''': Contains fees structure for government-run labs.<ref name="D&C Act" />
* '''Schedule C''': Contains various biological products<ref name="Guharaj2003"/> and their regulation. Examples: [[Serum (blood)|serums]], [[adrenaline]], [[vitamin]]s etc.<ref name="D&C Act" />
* '''Schedule D''': List of drugs exempted from the provision of import of drugs
* '''Schedule E''': Contains various poisons<ref name="Guharaj2003"/> and their regulation. Examples: ''Sarpa Visha'' ([[Snake venom]]), ''Parada'' ([[Mercury (element)|Mercury]]) etc.<ref name="D&C Act" />
* '''Schedule F''': This contains regulations and standards for running a [[blood bank]].<ref name="D&C Act" />
** '''Schedule F-I''': This contains regulations and standards for [[vaccine]]s.<ref name="D&C Act" />
** '''Schedule F-II''': This contains regulations and standards for [[Dressing (medical)|surgical dressing]].<ref name="D&C Act" />
** '''Schedule F-III''': This contains regulations and standards for umbilical tapes.<ref name="D&C Act" />
* '''Schedule F-F''': This contains regulations and standards for [[ophthalmia|ophthalmic]] ointments and solutions.<ref name="D&C Act" />
* '''Schedule K''': Drugs not meant for medicinal use, [[quinine]] and other [[antimalarial drugs]], drugs supplied by government hospitals, registered medical practitioners, contraceptive drugs, and their corresponding regulation.<ref name="D&C Act" />
* '''Schedule M''': Contains various regulations for manufacturing, premises, waste disposal and equipment.<ref name="D&C Act" />
* '''Schedule N''': Contains various regulations and requirements for a pharmacy.<ref name="D&C Act" />
* '''Schedule O''': Contains various regulations and requirements for [[disinfectant]] fluids.<ref name="D&C Act" />
* '''Schedule P''': Contains regulations regarding life period and storage of various drugs.<ref name="D&C Act" />
** '''Schedule P-I''': Contains regulations regarding retail package size of various drugs.<ref name="D&C Act" />
* '''Schedule Q''': Contains a list of permitted dyes and pigments in soap and cosmetics.<ref name="D&C Act" />
* '''Schedule R''': Contains various regulations and requirements for [[condom]]s and other mechanical contraceptives.<ref name="D&C Act" />
* '''Schedule S''': Lists various cosmetics and [[toiletries]], and directs the manufacturers of cosmetics to conform to the latest [[Bureau of Indian Standards]] requirements.<ref name="D&C Act" />
* '''Schedule T''': Contains various regulations and requirements for manufacture of [[Ayurvedic]], [[Siddha medicine|Siddha]] and [[Unani]] drugs.<ref name="D&C Act" />
* '''Schedule U''': Contains various regulations and requirements for record keeping.<ref name="D&C Act" />
* '''Schedule V''': Contains standards for [[drug patent]]s<ref name="D&C Act" />
* '''Schedule W''': Lists [[generic drug]]s.
* '''Schedule Y''': Contains requirement and guidelines for [[clinical trial]]s.<ref name="D&C Act" />
* '''Schedule Z''': Lists approved [[veterinary drug|drugs for veterinary use]].<ref>{{Cite web |title=Modifications in Drugs and Cosmetics Act (1940) and Rules {{!}} Centre for Science and Environment |url=https://cdn.cseindia.org/userfiles/CSE_recommendations_modifications.pdf |access-date=2023-12-20 |website=cseindia.org }}</ref>

==See also==
* [[Drug policy of India]]
* [[Drugs and Cosmetics Act, 1940]]
* [[Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954]]

==References==
{{Reflist}}

==Further reading==
* {{cite web|title=Drugs and Cosmetics Rules, 1945|url=http://cdsco.nic.in/html/copy%20of%201.%20d&cact121.pdf|archive-url=https://web.archive.org/web/20051031023525/http://cdsco.nic.in/html/Copy%20of%201.%20D%26CAct121.pdf|url-status=dead|archive-date=2005-10-31|publisher=[[Central Drugs Standard Control Organization]]}}
* A Review on the Current Classification and Regulatory Provisions for Medicines in Drug & Cosmetic Act, in the light of Present Day Context [https://iabcr.org/index.php/iabcr/article/view/66/64 Recommendations for Drugs & Cosmetics Rules with context of Drug Schedules]

[[Category:1945 in Indian law]]
[[Category:Acts of the Imperial Legislative Council]]
[[Category:1945 in India]]
[[Category:Cosmetics law]]
[[Category:Drug control law in India]]

Drugs and Cosmetics Rules, 1945 - Revision history

Md Rifat at 21:16, 25 March 2026