Pharmacy compounding of human drug products under section. Act of june 25, 1938 federal food, drug, and cosmetic act. Full text containing the act, drugs and cosmetics act, 1940, with all the sections, schedules, short title, enactment date, and footnotes. Be it enacted by parliament in the sixtyfourth year of the republic of india as follows. 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. Powers of central government to regulate, restrict or prohibit manufacture, etc. Users can access information about the act, its objectives, short title and commencement. The drugs and cosmetics rules, 1945 dadra and nagar haveli. The drugs and cosmetics act, 1940 23 of 19401 10th april, 1940 passed by the indian legislature. Schedule h includes drugs that shall be sold by retailer on prescription of the registered medical practitioners. Federal act means the federal food, drug, and cosmetic act, as amended 21 u. 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. Whereas it is expedient to regulate the 3import, manufacture, distribution and sale of drugs 2and. 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 and cosmetic act, 1940 was passed in british india to regulate the manufacture, distribution, and sale of drugs in the colony. This guidance document is being distributed for comment purposes only. The act regulates the import of drugs in india, so that no substandard or spurious drug will enter into our country. 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.
Act, 1964, the drugs and cosmetics amendments act, 1972, the drugs and. This act shall be known and may be cited as the controlled substance, drug, device and cosmetic act. The drugs and cosmetics amendment bill, 20 a bill further to amend the drugs and cosmetics act, 1940. Power of central government to prohibit manufacture etc.
The drugs control act, 1950 an act to provide for the control of the sale, supply and distribution of drugs. Federal food, drug, and cosmetic act as amended through p. Drugs and cosmetics amendment act 2008 national portal. The controlled substance, drug, device and cosmetic act act of 1972, p. The drugs and cosmetics act 1940 with 2005 amendments. The controlled substances, drugs, device, and cosmetic act. Code section numbers, which can be used to narrow your search on the law revision counsel website. Whereas it is expedient to regulate the import, manufacture, distribution and sale of drugs and cosmetics. 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. Section 107c of such public law concerned the applicability of the amendments, and is included in the appendix to this compilation.
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. 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. Persons bound to disclose place where drugs or cosmetics are manufactured or kept. This act may be cited as the federal food, drug, and cosmetic act. Food and drug administration fda to oversee the safety of food, drugs, medical devices, and cosmetics. 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. Short title this act may be cited as the food, drugs and chemical substances act. Drugs and cosmetics act,1940 and rules, 1945 as amended up to the 31st december, 2016. Page 141 title 21food and drugs taining a new animal.
Full text of the federal food, drug, and cosmetic act enforced by the u. An act to regulate the import, manufacture, distribution and sale of drugs 2and cosmetics. Drugs and cosmetics act national health portal of india. Importation of certain fdaapproved human prescription. Get details on the drugs and cosmetics amendment act, 2008 which includes amendments in the drugs and cosmetics act, 1940. Power of central government to prohibit manufacture, etc. Cosmetic manufacturers are responsible for ensuring that products comply with the law before they are marketed. An act to regulate 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.
Cognizance can be taken on the complaint of any gazetted officer. Federal food, drug, and cosmetic act hereinafter revised draft guidance. An act to regulate the import, manufacture, distribution and sale of drugs. 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. Ministry of health and family welfare department of health. Code chapter 9 federal food, drug, and cosmetic 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. The fdas online reference edition of the federal food, drug and cosmetic act is based on the.
Ministry of health and family welfare department of health updates this time to time. 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. Schedule x describes the habit forming and narcotics drugs list. The drugs and cosmetics rules, 1945 are the set of rules under the 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. In this act, unless there is anything repugnant in the subject or context, 7 a. Purchaser of drug or cosmetic enabled to obtain test or analysis. Select legal issues congressional research service 2 for safety. And whereas the legislatures of all the provinces have passed resolutions in terms of. Short title, extent and commencement1 this act may be called the drugs 1 and cosmetics act, 1940. 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.
The drugs and magic remedies objectionable advertisements. 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 act also governed the import of the drugs in the country. Interpretation in this act, except where the context otherwise requires advertisement includes any representation by any means whatsoever. The act prohibits the manufacture of substandard or spurious drug in the country. 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.
Commonwealth of pennsylvania pennsylvania department. The federal food, drug, and cosmetic act and subsequent amending statutes are codified into title 21 chapter 9 of the united states code. 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. Page 141 title 21food and drugs taining a new animal drug. The act has been further amended as drugs amendment act 1964 of 1964 to include ayurvedic and unani drugs. The drugs and cosmetics amendment act, 2008 sjtpc 4. For an official copy of the statute please contact the pennsylvania legislative reference bureau. Through the hatchwaxman act, congress created a carefully balanced regulatory framework facilitating the introduction of lowercost generic drugs while preserving incentives for innovation. Further reading drugs and cosmetics rules, 1945 pdf. Drugs and cosmetics act, 1940 bare acts law library. Commonwealth of pennsylvania the controlled substances, drugs, device, and cosmetic act act of 1972, p. Rules are given for pharmaceuticals and schedules are there to comply with those rules. The revised draft guidance, which is part of the fdas.
The hatchwaxman act provides, among other things, a mechanism for accelerated approval of generic drugs through an abbreviated new drug application. Drugs and cosmetics amendment act, 2008 salient features of the act. 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. 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 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. A astrology joint director, drugs control administration. The fees to be paid by a person submitting to the government analyst under section. 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. Corresponding enhancement in punishment for repeated offenders. Drug and cosmetic act pharmaceutical drug pharmacy.
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