An act to control the advertisement of drugs in certain cases, to prohibit the advertisement for certain purposes of remedies alleged to possess magic qualities and to provide for matters connected therewith. Interpretation in this act, except where the context otherwise requires advertisement includes any representation by any means whatsoever. Federal food, drug, and cosmetic act as amended through p. The drugs and magic remedies objectionable advertisements. A astrology joint director, drugs control administration. 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 april, 1940 as amended by act no. The hatchwaxman act provides, among other things, a mechanism for accelerated approval of generic drugs through an abbreviated new drug application. Through the hatchwaxman act, congress created a carefully balanced regulatory framework facilitating the introduction of lowercost generic drugs while preserving incentives for innovation. Corresponding enhancement in punishment for repeated offenders. The drugs and cosmetics act 1940 with 2005 amendments. An act to regulate the import, manufacture, distribution and sale of drugs.
Federal food, drug, and cosmetic act hereinafter revised draft guidance. In this act, unless there is anything repugnant in the subject or context, 7 a. Act of june 25, 1938 federal food, drug, and cosmetic act. 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. Whereas it is expedient to regulate the 3 import, manufacture, distribution and sale of drugs 2 and cosmetics 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 and matters ancillary thereto as are. The act prohibits the manufacture of substandard or spurious drug in the country. The controlled substance, drug, device and cosmetic act act of 1972, p. The fees to be paid by a person submitting to the government analyst under section. 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. Importation of certain fdaapproved human prescription. 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. Schedule h includes drugs that shall be sold by retailer on prescription of the registered medical practitioners.
An act to regulate the import, manufacture, distribution and sale of drugs 2and cosmetics. The fdas online reference edition of the federal food, drug and cosmetic act is based on the. The revised draft guidance, which is part of the fdas. If product contains a substance specified in schedule h be labelled with the symbol rx and conspicuously displayed on the left top corner of the label and be also labelled with the following words in red color. The drugs and cosmetics amendment act, 2008 sjtpc 4. Further reading drugs and cosmetics rules, 1945 pdf. Federal food, drug, and cosmetic act as amended through december 31, 2004 see note below chapter ishort title chapter iidefinitions chapter iiiprohibited acts and penalties chapter ivfood chapter vdrugs and devices. The federal food, drug, and cosmetic act and subsequent amending statutes are codified into title 21 chapter 9 of the united states code. Commonwealth of pennsylvania the controlled substances, drugs, device, and cosmetic act act of 1972, p. The person dispensing a prescription containing a drug specified in schedule h and schedule h1 and schedule x shall comply with the following requirements in addition to other requirement of these rules the prescription must not be dispensed more than once unless the prescriber has. The drugs and cosmetics amendment bill, 20 a bill further to amend the drugs and cosmetics act, 1940. The drugs and cosmetics act, 1940 23 of 19401 10th april, 1940 passed by the indian legislature. Power of central government to prohibit manufacture, etc. Whereas it is expedient to regulate the 3import, manufacture, distribution and sale of drugs 2and cosmetics.
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. Whereas it is expedient to regulate the 3import, manufacture, distribution and sale of drugs 2and. The act has been further amended as drugs amendment act 1964 of 1964 to include ayurvedic and unani drugs. Purchaser of drug or cosmetic enabled to obtain test or analysis. The person dispensing a prescription containing a drug specified in schedule h and schedule h1 and schedule x shall comply with the following requirements in addition to other requirement of these rules.
This act also governed the import of the drugs in the country. An act to regulate import, manufacture, distribution and sale of drugs and cosmetics. Short title, extent and commencement1 this act may be called the drugs 1 and cosmetics act, 1940. Schedule x describes the habit forming and narcotics drugs list. Code chapter 9 federal food, drug, and cosmetic act.
Federal act means the federal food, drug, and cosmetic act, as amended 21 u. Short title this act may be cited as the food, drugs and chemical substances act. And whereas the legislatures of all the provinces have passed resolutions in terms of. Persons bound to disclose place where drugs or cosmetics are manufactured or kept. Food and drug administration fda to oversee the safety of food, drugs, medical devices, and cosmetics. 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 above.
This guidance document is being distributed for comment purposes only. The controlled substances, drugs, device, and cosmetic act. Drugs and cosmetics amendment act, 2008 salient features of the act. Power of central government to prohibit manufacture etc. Whereas it is expedient to regulate the import, manufacture, distribution and sale of drugs and cosmetics. Act of june 25, 1938 federal food, drug, and cosmetic act, public law 75717, 52 stat 1040, which prohibited the movement in interstate commerce of adulterated and misbranded food, drugs, devices, and cosmetics, 6251938. Code section numbers, which can be used to narrow your search on the law revision counsel website. Page 141 title 21food and drugs taining a new animal. Subchapter ishort title section 301 subchapter iidefinitions 321 321d subchapter iiiprohibited acts and penalties 331 337a subchapter ivfood 341 350l1 subchapter vdrugs and devices 351 360fff7. Cosmetic manufacturers are responsible for ensuring that products comply with the law before they are marketed. Drugs and cosmetics amendment act 2008 national portal. 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. Powers of central government to regulate, restrict or prohibit manufacture, etc. Full text of the federal food, drug, and cosmetic act enforced by the u.
This act shall be known and may be cited as the controlled substance, drug, device and cosmetic act. The drugs and cosmetics rules, 1945 dadra and nagar haveli. Commonwealth of pennsylvania pennsylvania department. The drugs and cosmetics act and rules the drugs and cosmetics act, 1940 as amended by the drugs amendment act, 1955, the drugs amendment act, 1960. Drugs and cosmetics act, 1940 bare acts law library. The drugs and cosmetics rules, 1945 are the set of rules under the drugs and cosmetics. The act regulates the import of drugs in india, so that no substandard or spurious drug will enter into our country. Drugs and cosmetics act,1940 and rules, 1945 as amended up to the 31st december, 2016. 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. 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 drugs act, as enacted in1940, has since been amended several times and is now titled as the drugs and cosmetics act, 1940. Select legal issues congressional research service 2 for safety. Get details on the drugs and cosmetics amendment act, 2008 which includes amendments in the drugs and cosmetics act, 1940. Users can access information about the act, its objectives, short title and commencement. The drugs and cosmetics act and rules the drugs and cosmetics act, 1940 as amended by the drugs amendment act, 1955, the drugs amendment act, 1960, the drugs amendment act, 1962, the drugs and cosmetics amendments act, 1964, the drugs and cosmetics amendments act, 1972, the drugs and cosmetics amendments act, 1982, the drugs and. Section 107c of such public law concerned the applicability of the amendments, and is included in the appendix to this compilation. Rules are given for pharmaceuticals and schedules are there to comply with those rules. 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. For an official copy of the statute please contact the pennsylvania legislative reference bureau.
Ministry of health and family welfare department of health. Page 141 title 21food and drugs taining a new animal drug. Be it enacted by parliament in the sixtyfourth year of the republic of india as follows. Drug and cosmetic act pharmaceutical drug pharmacy. The drugs control act, 1950 an act to provide for the control of the sale, supply and distribution of drugs. Drugs and cosmetics act national health portal of india. Cognizance can be taken on the complaint of any gazetted officer.
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