An act further to amend the drugs and cosmetics act, 1940. July 2008 prescription drugs fdas oversight of the promotion of drugs for offlabel uses highlights of gao08835, a report to the ranking member, committee on finance, u. The current twentysixth edition, provides the fully amended and updated text of the drugs and cosmetics act, 1940, as amended by amending act no. Medicines and related substances amendment act, 2008. Drugs and cosmetics act 2008 guidelines under new penal provision. 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. The drugs and cosmetics rules, 1945 dadra and nagar haveli. 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 act 23 of 1940 as amended up to act 26 of 2008 10th april, 1940 an act to regulate the import, manufacture, distribution and sale of drugs and cosmetics. Power of central government to prohibit import of drugs and cosmetics in public interest.
Notification issued under the drugs and cosmetics act. Regulate the import, manufacture and sale or distribution of. 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. The drugs and cosmetics act, 1940 23 of 19401 10th april, 1940 passed by the indian legislature received the assent of the governor general on the 10th. The act has been further amended as drugs amendment act 1964 of 1964 to include ayurvedic and unani drugs. Federal act means the federal food, drug, and cosmetic act, as amended 21 u. Section 5 and 7 not to apply ayurvedic, siddha or unani drugs. The schedule j of the drugs and cosmetics rules, 1945 of india contains a list of diseases and ailments which a drug may not claim to prevent or cure. The drugs and cosmetics amendment act, 2008 sjtpc 4. The petitioners 1 to 5a1 to a5 are accused of offences punishable under sections 27d of the drugs and cosmetics act, 1940 in short, the act for violation of section 18ai16 and scheduleii and punishable under section 27c of the act for violation of section 18ai17bd of the act. An act to regulate the import, manufacture, distribution and sale of drugs.
The drug price competition and patent term restoration act of 1984, also known as the hatchwaxman amendments, established the approval pathway. Be it enacted by parliament in the fiftyninth year of the republic of india as follows. Users can access information about the act, its objectives, short title and commencement. It was last amended by the public law listed in the as amended through note above and below at the bottom of each page of the pdf version and. Assist in setting and implementation of standards for drugs, cosmetics and medical devices through it. Drugs magic remedies objectionable advertisement act, 1954. An act to regulate the import, manufacture, distribution and sale of drugs and cosmetics whereas it is expedient to regulate the import, manufacture, distribution and sale of drugs and cosmetics. The drug and cosmetics act, 1940 was enacted by the department of health. Senate the food and drug administration fda, an agency within the department of health and human services hhs, regulates the promotion of prescription drugs to. It amendment act 2008 2349 kb this pdf file is non accessible through use of assistive technologies i. Constitution of central drug authority under consideration.
Ministry of health and family welfare department of health the drugs and cosmetics act and rules the drugs and cosmetics act, 1940 23 of 1940 as amended up to the 31st december, 2016 and. This publication is a compilation of the text of chapter 675 of the 75th congress. Purchaser of drug or cosmetic enabled to obtain test or analysis. Power of central government to prohibit manufacture, etc.
Information technology act ministry of electronics and. Under rule 106 of the drugs and cosmetics act, 1940, a drug cannot make claims to treat or prevent any of the diseases or reform the conditions listed. Act, 1964, the drugs and cosmetics amendments act, 1972, the drugs and. Drugs and cosmetics amendment act, 2008 salient features of the act. 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. 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. Law relating to drugs and cosmetics by vijay malik. The gazette of india released on 23 rd october 2008 on excipients. A astrology joint director, drugs control administration. In india the drugs and cosmetic act 10 operates the regulations of cosmetics. Drugs and cosmetics act,1940 and rules, 1945 as amended up to the 31st december, 2016. Central drugs standard control organisation cdsco guidelines on registration o import of cosmetics. The drugs and cosmetics amendment act, 2008 act no. Fda cfr title 21 food and drugs act, cosmetic regulations c.
Drugs and cosmetics act national health portal of india. The federal food, drug, and cosmetic act and subsequent amending statutes are codified into title 21 chapter 9 of the united states code. The related drugs and cosmetics rules, 1945 contains provisions for classification. The drugs and cosmetics act, 1940 asu medicines covered under the act by inserting chapter iv a. Short title, extent and commencement1 this act may be called the drugs 1 and cosmetics act, 1940. The drugs and cosmetics amendment act, 2008 passed by the parliament on 5 th december 2008 provides deferent penalties for offences relating to manufacture of spurious or adulterated drugs which have serious implications on public health. Drugs and cosmetics act, 1940 4 chapter iv manufacture, sale and distribution of drugs and cosmetics sections 16. 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. A one page guide to global cosmetic compliance guidelines.
Short title this chapter shall be known and may be cited as the georgia pharmacy practice act. The drugs and cosmetics act and rules linkedin slideshare. Compliance guide for the chemical import requirements of tsca table of contents this guide describes the chemical imports requirements under the toxic substances control act tsca. Medicines and related substances amendment act 72 of 2008. Corresponding enhancement in punishment for repeated offenders cognizance can be taken on the complaint of any gazetted officer authorized by central or state government cases to be tried by sessions court 422012 67. Details regarding amendments and sections of the act are also available. For user information document title is the gazette of india part ii dated february 5,2009. Code section numbers, which can be used to narrow your search on the law revision counsel website.
All about drug and cosmetics act, 1940 by nisha singla latest laws. An act to amend the federal food, drug, and cosmetic act to revise and extend the userfee programs for prescription drugs and for medical devices, to enhance the postmarket authorities of the food and drug administration with respect to the safety of drugs, and for other purposes. Whereas it is expedient to regulate the import, manufacture, distribution and sale of drugs and cosmetics. 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 act 2008guidelines under new penal provision. The drug and cosmetic act and rules jobin kunjumon vilapurathu asst. Be it enacted by the senate and house of representatives of. The core primary legislation presently regulating drugs was passed in 1940 and has been amended at least ten times. Drugs and cosmetics amendment act 2008 national portal.
The drugs and cosmetics amendment act, 2008 passed by the parliament on 5th december 2008 provides deterrent penalties for offences relating to manufacture of spurious or adulterated drugs which have serious implications on public health. Persons bound to disclose place where drugs or cosmetics are manufactured or kept. When examining indias drug laws, several conclusions stand out. The law for the time being in force relating to sea customs and to goods, the import of which is prohibited by section 18 of the sea customs act, 1878 8 of 18781 shall, subject to the provisions of section of this act, apply in respect of drugs 2and cosmetics the import of which is prohibited under this chapter, and officers of customs. It is a compliance assistance tool only and is not a.
Further reading drugs and cosmetics rules, 1945 pdf. Select legal issues congressional research service 2 for safety. First, the current drugs and cosmetics act is old and deficient. Prohibition of manufacture and sale of certain drugs and cosmetics. Federal food, drug, and cosmetic act as amended through p. Compliance guide for the chemical import requirements of. Cosmetics are defined by the fdca as articles intended to be rubbed, poured, sprinkled, or sprayed on or introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance.
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