Drugs and cosmetics act 1940 and rules 1945 pdf

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 drugs and cosmetics act, 1940 23 of 1940 10th april, 1940 passed by the indian legislature received the assent of the governor general on the 10th april, 1940. Whereas a draft of certain rules further to amend the drugs and cosmetics rules, 1945 was published as required by section 12 and section 33 of the drugs and cosmetics act, 1940 23 of 1940 vide notification of the government of india in the ministry of health and family welfare department of health and family welfare number g. Whereas it is expedient to regulate the 3import, manufacture, distribution and sale of drugs 2 and cosmetics.

Drug and cosmetic act 1940 and rules 1945 session 1 part 1 duration. The drugs and cosmetics rules, 1945 dadra and nagar haveli. The present edition incorporates the fully amended and updated text of the drugs and cosmetics act, 1940 as amended by amending act 26 of 2008 enforced on august 10, 2009 and the drugs and cosmetics rules, 1945 as amended up to the second amendment rules, 2016, along with caselaw notes, allied acts, rules, orders and notifications. Dcgi directs state drug authorities to expedite licensing. Homoeopathic medicines are defined under rule 2dd of drugs and cosmetics rules, 1945. The drugs specified in schedule d shall be exempt from the provisions of chapter iii of the act and of the rules made thereunder to the extent, and subject to the conditions specified in that schedule. Drugs and cosmetics act, 1940 and rules, 1945 as amended up to the 31st december, 2016. If you continue browsing the site, you agree to the use of cookies on this website. The drugs and cosmetics rules, 1945 are the set of rules under the drugs and cosmetics act, 1940 which contains provisions for classification of drugs under given schedules and there are guidelines for the storage, sale, display and prescription of each schedule. Law relating to drugs and cosmetics by vijay malik.

The drug laws were publicizing in 1945 december and imposition of these laws started in 1947. The drugs act, as enacted in1940, has since been amended several times and is now titled as the drugs and cosmetics act, 1940. Drugs and cosmetics 5th amendment rules, 2017, notified. Order under section 22 1c of the drugs and cosmetics act, 1940 requiring a person not to dispose of stock in his possession. The drugs and cosmetic act, 1940 was passed in british india to regulate the manufacture, distribution, and sale of drugs in the colony.

Drugs and cosmetics act 1940 and rules 1945 prepared by. The drugs and cosmetics act, 1940 act 23 of 1940 as amended up to act 26 of 2008 10th april. The drugs and cosmetics act, 1940 23 of 19401 10th april, 1940 passed by the indian legislature. Rules are given for pharmaceuticals and schedules are there to comply with those rules. The drugs and cosmetics rules, 1945 as corrected upto 30. Hand sanitizers are licensed under drugs and cosmetics rules, 1945. A astrology joint director, drugs control administration.

To prevent substandard in drugs, presumably for maintaining high. An act to regulate the import, manufacture, distribution and sale of drugs 2 and cosmetics. Drugs falling under clause bi of section 3 of the drugs and cosmetics act not intended for medicinal use. All the provisions of chapter iv of the act and the rules thereunder subject to the conditions that the. Manufacture, distribution and sale of drugs and cosmetics by qualified persons only. Drugs and cosmetics act 1940 and rules 1945 slideshare. Vide this amendmentin rule 96, in subrule 1, new clause xiii shall be inserted which reads as. And the drugs and cosmetics rules, 1945 as corrected up to the 30th april, 2003. And whereas the legislatures of all the provinces have passed resolutions in terms of section 103 of the government of india act, 1935, in relation to such of the abovementioned matters.

An act to regulate the import, manufacture, distribution and sale of drugs 2 and cosmetics whereas it is expedient to regulate the 3 import, manufacture, distribution and sale of drugs 2 and cosmetics. All medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of. Application of rule 122dd of drugs and cosmetics rules, 1945 with regard to ethics committee. The drugs act, as validated in 1940, has since been amended many times and is now entitled as the drugs and cosmetics act, 1940. All medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or. To clarify the amendments held recently in certain labeling rules 2018 of drugs and cosmetics rules, 1945, which was published, as required under subsection 1 of section 12 and subsection 1 of section 33 of the drugs and cosmetics act, 1940 23of 1940. All about drugs and cosmetics act, 1940 by nisha singla download pdf the author, nisha singla is a 5th year student of rayat bahra university school of law. The act has been further amended as drugs amendment act 1964 of 1964 to include ayurvedic and unani drugs. The primary objective of the act is to ensure that the drugs and cosmetics sold in india are safe, effective and conform to state quality standards. The drugs and cosmetics act 1940 and rules 1945 government of india ministry of health and family welfare department of health presented by.

Where as a draft of certain rules further to amend the drugs and cosmetics rules, 1945 was published as required by sections 12 and 33 of the drugs and cosmetics act, 1940 23 of 1940, at page 42, with the notification of the government of. Receipt for stock of drugs or cosmetics for record, register, document or material object seized under section 22 1 c or cc of the drugs and cosmetics act, 1940. Dcgi directs state drug authorities to expedite licensing of manufacturers of hand sanitizers to tackle shortage. Drugs and cosmetics act national health portal of india.

India cosmetics products in india are regulated under the drugs and cosmetics act 1940 and rules 1945 and labeling declarations by bureau of indian standards bis. The related drugs and cosmetics rules, 1945 contains provisions for classification of drugs under. This act also governed the import of the drugs in the country. The act has been additionally amended as drugs amendment act 1964 of 1964 to include ayurvedic and unani drugs. Drugs and cosmetics 1 st amendment rules, 1992 was published on 22 jan 1993 vide gsr 28e. Hydroxychloroquine is now a schedule h1 drug, and can be sold on prescription only. Drugs and cosmetics act 2008guidelines under new penal provision.

Sohansinh vaghela assistant professor, sips, gandhinagar. Ministry of health and family welfare department of health updates this time to time. Whereas a draft of certain rules further to amend the drugs and cosmetics rules, 1945 was published, as required by sections 12 and 33 of the drugs and cosmetics act, 1940 23 of 1940, in the gazette of india, extraordinary, part ii, section 3, subsection i dated the 2nd february, 2005, under the notification of the government of. Drugs and cosmetics act 1940 and rules 1945 department of pharmacy dr. The drug and cosmetic act, 1940 and rules, 1945 by mr. Drugs and cosmetics act, 1940 bare acts law library. According to a gazette notification issued by the union health ministry, the sale of the drug. And whereas the legislatures of all the provinces have passed resolutions in terms of section 103.