Drugs and cosmetics act,1940 and rules, 1945 as amended up to the 31st december, 2016. Application for licence to import drugs specified in schedule x to the drugs and cosmetics rules, 1945. The drugs and cosmetics amendment act, 2008 sjtpc 4. Cosmetics are among the safest of all consumer products sold in the. 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.
It is gmp for pharmaceuticals that should be followed by pharmaceutical manufacturing units in india. Drugs and cosmetics act 2008guidelines under new penal provision. 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. In april 2016, the office began work to redesign the process.
The pharmacy act 1994 act 489 was subsequently passed in 1994 to establish the pharmacy council to control the practice of the pharmacy profession and the registration of pharmacists. Pharmacy compounding of human drug products under section. Special act on safety control of childrens dietary life. For all cosmetic products sold in california, the act requires the manufacturer, packer, andor distributor named on the product label to provide to the california department of public health cdph a list of all cosmetic products that contain any ingredients known. The drugs and cosmetics act, 1940 is an act of the parliament of india which regulates the. Be it enacted by parliament in the sixtyfourth year of the republic of india as follows. Drugs falling under clause bi of section 3 of the drugs and cosmetics act not intended for medicinal use. The license in form 25a shall be deemed to be cancelled or suspended, if the license owned by the licensee in form 25 whose manufacturing facilities have. Law relating to drugs and cosmetics by vijay malik. Operating procedures manual and shall operate in the manner for which it was. 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. Form 17a see rules 56a and 145aa receipt for samples of drugs or cosmetics taken where fair price tendered thereof under subsection 1 of section 23. Also recent notifications and orders have been given to.
A astrology joint director, drugs control administration. Schedule m is having the details about company premises, quality control system, quality control laboratories, gmp in production, cleaning of equipments, housekeeping, crosscontamination and other related topics. Also, the retailer has to preserve the prescription for. The drugs and cosmetics amendment act, 1986 71 of 1986 11. The drugs act, as enacted in1940, has since been amended several times and is now titled as the drugs and cosmetics act, 1940. This alert summarizes title iii of the act on drug and device development. 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 stated thereon that it.
Detailed fda regulations govern where and how ingredients must be listed on the package. Government of india law commission of india report. An act to regulate the import, export, manufacture, distribution and sale of drugs, cosmetics and medical devices to ensure their safety, efficacy. Application for licence to import drugs excluding those specified in schedule x to the drugs and cosmetics rules, 1945 form 8a. The related drugs and cosmetics rules, 1945 contains provisions for classification of drugs under.
Drugs with less than 60% shelf life allowed to be imported on condition according to rules, the import of such drugs may be permitted after taking an undertaking from the importers by the port officers of cdsco that the drug will be utilised or consumed before the expiry date and no part of it will be available. The drug and cosmetic act and rules jobin kunjumon vilapurathu asst. All the provisions of chapter iv of the act and the rules thereunder subject to the conditions that the. Although the food and drugs law was passed as far back as 1992, it was not until 26th august, 1997. The drugs and cosmetics amendment act, 1982 68 of 1982 10.
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, 1972 19 of 1972. Guideline for risk assessment of cosmetic products. In addition to the food, drug, and cosmetics act, the fair packaging and labeling act authorizes fda to require ingredient labeling of cosmetic and personal care products sold to consumers. 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. Pharmacy compounding of human drug products under section 503a of the federal food, drug, and cosmetic act guidance june 2016. Whereas a draft of certain rules further to amend the drugs and cosmetics rules, 1945, was published, as required by section 12 read with 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, number g. These are drugs which cannot be purchased over the counter without the prescription of a qualified doctor. As a result, no penalties could be imposed on the bill and melinda gates foundationfunded programme. Law relating to drugs and cosmetics by vijay malik dattani.
Law relating to drugs and cosmetics with free cd ebc webstore. Drugs and cosmetics act, 1940 medical council of india act, 1956 amended in 2002 central council for medicine act, 1970 guidelines for exchange of biological material moh order, 1997 rti act, 2005 1. Information in respect of restrictions imposed, if any, on the use of the drug in other countries, e. 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. The translated document herein reflects the ministry of food and drug safety notificationno. The drugs and cosmetics sixth amendment rules, 2016. 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 has been further amended as drugs amendment act 1964 of 1964 to include ayurvedic and unani drugs. Drugs and cosmetics act national health portal of india. 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. Law relating to drugs and cosmetics with free cd ebc. Regulations on the report of a track record of manufacturing or importing. Short title, extent and commencement1 this act may be called the drugs 1 and cosmetics act, 1940. Drugs and cosmetics act differentiates prescription drugs, narcotic and psychotropic2 substances, over the counter drugs and medical devices, with a view to promote safety in public health.
The drugs and cosmetics act, 1940 drugs control department. 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. Schedule x describes the habit forming and narcotics drugs list. The drugs and cosmetics rules, 1945 dadra and nagar haveli. The drugs and cosmetics amendment bill, 20 a bill further to amend the drugs and cosmetics act, 1940. The current twentysixth edition, provides the fully amended and updated text of the drugs and cosmetics act, 1940, as amended by amending act no. Enforcement rule of the cosmetics act enforcement rule of the cosmetics act 2. Regulations 30 1 the governor in council may make regulations for carrying the purposes and provisions of this act into effect, and, in particular, but without restricting the generality of the foregoing, may make regulations a declaring that any food or drug or class of food or drugs is adulterated if any prescribed substance or class of substances is present. Certificate of test or analysis by the central drugs laboratory.
The translated document into english herein is a service provided for users convenience and it shall not be construed as having official authority. Schedule m is a part of drug and cosmetic act 1940. The federal food, drug, and cosmetic act and subsequent amending statutes are codified into title 21 chapter 9 of the united states code. The california safe cosmetics act pdf the act was signed into law in 2005.
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 the drugs and cosmetics rules, 1945 as amended up to the 31st december, 2016 2 list of abbreviations used. The drugs and cosmetics act and rules linkedin slideshare. The drugs and cosmetics amendment act, 1964 of 1964 8. Notification issued under the drugs and cosmetics act. Manual and shall operate in the manner for which it was designed so as to. Likewise, if the drug has been withdrawn in any country by the manufacturer or by. 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 the drugs and cosmetics rules, 1945 as amended up to the 31st december, 2016. Code section numbers, which can be used to narrow your search on the law revision counsel website. Schedule x is a class of prescription drugs in india appearing as an appendix to the drugs and cosmetics rules introduced in 1945.
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. Compilation of drug and cosmetic acts 1940 and rules 1945 passed with objective of regulating the import, manufacture, sales and distribution and sale of drugs and cosmetics. The drugs and cosmetics amendment act, 1995 22 of 1995. The act amends the federal food, drug, and cosmetic act fdca and public health service act phsa, among other laws, with the aim of accelerating the discovery, development, and delivery of new medicines and medical technologies.
280 1480 1331 21 645 1297 860 1355 248 92 1528 459 1000 731 958 1027 731 496 1313 369 1428 1655 358 197 1539 1335 472 299 620 270 322 1556 909 1233 712 1638 215 814 139 1336 766 1461 1076 88 279 1313 1204 123