Section 127 in the drugs and cosmetics rules, 1945. The prevention of food adulteration act, 1954 drugs and cosmetics act, 1940 biomedical waste management and handling rules, 1998 the pharmacy act, 1948. Drugs and cosmetics act differentiates prescription drugs, narcotic and psychotropic 2 substances, over the counter drugs and medical devices, with a view to promote safety in public health. Thailand cosmetics act thailand law forum thailand legal. Drugs and cosmetics act national health portal of india. A astrology joint director, drugs control administration. 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 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. Declaration form this must be filled in and returned to the assitant director of drugs control along. The drugs and cosmetics rules, 1945 as corrected upto 30. Jain book agency, delhi based book store for all your books related needs. The drugs and cosmetics act, 1940 and the rules, 1945 is there to make sure that good medicines reach doctors and their patients. Dec 11, 2016 schedules of drug and cosmetics act and rulesii. Also recent notifications and orders have been given to.
The licence shall comply with the provisions of the drugs and cosmetics act, 1940 and the rules thereunder for the time being in force 3. The drugs and cosmetic act, 1940 was passed in british india to regulate the manufacture, distribution, and sale of drugs in the colony. The amendment rules are effective since 30 th march, 2017. In force the drugs and cosmetics rules, 1945 are the set of rules under the drugs and cosmetics act, 1940 1 which contains provisions for classification of drugs under given schedules and there are guidelines for the storage, sale, display and prescription of each schedule. The drugs and cosmetics rules, 1945 dadra and nagar haveli. Verify the same from drugs and cosmetics rules, 20 india dr.
Basics of the narcotic drugs and psychotropic substances act 1985. An act to regulate the import, manufacture, distribution and sale of drugs 2 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. Addresses of the premises where the drugs are stocked. Drugs and cosmetics act 2008guidelines under new penal provision. Whereas it is expedient to regulate the 3 import, manufacture, distribution and sale of drugs 2. Sep 07, 2012 s 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. Conditions of licence for allopathic loan licence manufacturing. Schedules c and ci to the drugs and cosmetics rules. Rules are given for pharmaceuticals and schedules are there to comply with those rules. 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. Exempt controlled substances, other drugs, devices and cosmetics. Designation of special courts for trial of offences in respect of adulterated and spurious drugs all offences relating to adulterated and spurious drugs made cognizable and non bailable restrictions on bail bail cannot be.
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 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. Drugs inspector, mahaboobnagar district had drawn sample of rabpraz tablets from g. The standards for manufacture, sale, distribution and import of drugs and cosmetics have been mentioned in two separate schedules appended to the act. Controlled substance means a drug, substance, or immediate precursor included in schedules i through v of this act. Pennsylvania controlled substance, drug, device and cosmetic act. The licensee shall report to the licensing authority any change in the qualified staff in charge within one month or such change.
An act to regulate the import, manufacture, distribution and sale of drugs. Schedule m is a part of drug and cosmetic act 1940. Full details about the drugs and cosmetics act, 1940 india. Drugs falling under clause bi of section 3 of the drugs and cosmetics act not intended for medicinal use. Apr 07, 2017 the ministry of health and family welfare has issued the drugs and cosmetics sixth amendment rules, 2017 amendment rules thereby amending the drugs and cosmetics rules, 1945 principal rules. Main principles, annex 2, who technical report series 986, 2014 schedule l1 schedule u. Drug and cosmetic act 1940 and rules 1945 session 1 part 1. A 22384 control of drugs and cosmetics regulations 1984 arrangement of regulations preamble part i preliminary regulation 1. The controlled substances, drugs, device, and cosmetic act. It is gmp for pharmaceuticals that should be followed by pharmaceutical manufacturing units in india. Drugs and cosmetics sixth amendment rules, 2017 lexplosion. An act relating to the manufacture, sale and possession of controlled substances, other drugs, devices and cosmetics. The excipients used in ism drugs should be in accordance to which of the following rule of drugs and cosmetics rules 1945 1 165 2 169 3 157 4 153 8. 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.
The salient features of the amended provisions of the drugs. Medical and general stores, atmakur by allegedly following procedure prescribed by law. No drug shall be sold unless such drug is purchased under case or credit. Chapter ii shall take effect only from such date after the commencement of the drugs and cosmetics amendment act, 1972 19 of 1972, as the central government may, by notification in the official gazette, appoint. In the drugs and cosmetics rules, 1945, for schedule m, the following schedule shall be substituted, namely. The drugs and cosmetics act, 1940 and the rules, 1945 is there to make sure that good medicines reach doctors and their patients once people get into govt service they lose their conscience, ethics, morals and whatever that makes us what we are.
The drugs belonging to the systems of ayur veda, siddha and unani asu systems. 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. Salient features of the amended provisions of the drugs. 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 2 and cosmetics the import of which is prohibited under this chapter, and officers of customs. Application for licence to manufacture drugs other than those specified in schedules c and c1 to the drugs and cosmetics rules. Schedules of drug and cosmetics act and rulesii youtube.
Chapter iii shall take effect only from such date5 after the commencement of the drugs and cosmetics amendment act, 1972 19 of 1972, as the central government may, by notification in the official gazette, appoint in this behalf. Which rule of drugs and cosmetics rules 1945 provide the qualifications for state drug licensing authorities. Form and manner of application for import licence 1. Act, 1964, the drugs and cosmetics amendments act, 1972, the drugs and. Bangoriya assistant professorquality assurance department s. Whereas it is expedient to regulate the import, manufacture, distribution and sale of drugs and cosmetics. The ministry of health and family welfare has issued the drugs and cosmetics sixth amendment rules, 2017 amendment rules thereby amending the drugs and cosmetics rules, 1945 principal rules. Jan 14, 2014 1 the cosmetics of which manufacture of importation for sale requires a license under section 51 of cosmetics act b. A useful article about the drugs and cosmetics act, 1940 india. Once people get into govt service they lose their conscience, ethics, morals and whatever that makes us what we are.
An application for an import licence shall be made to the licensing authority in form 8 for drugs excluding those specified in schedule x, and in form 8a for drugs specified in schedule x, either by the manufacturer. Comparison of guidelines of indian gmp with who gmp. An act to regulate import, manufacture, distribution and sale of drugs and cosmetics. Medical and general stores, atmakur by allegedly following procedure prescribed by law and. The license in form 25a shall be deemed to be cancelled or suspended, if the. Ministry of health and family welfare department of health. All the provisions of chapter iv of the act and the rules thereunder subject to the conditions that the. Law relating to drugs and cosmetics by vijay malik. The drug and cosmetic act and rules jobin kunjumon vilapurathu asst. The drugs act, as enacted in1940, has since been amended several times and is now titled as the drugs and cosmetics act, 1940. Section 5 and 7 not to apply ayurvedic, siddha or unani drugs. Thailand cosmetics act thailand law forum thailand. Short title this chapter shall be known and may be cited as the georgia pharmacy practice act.
Drugs and cosmetics amendment act, 2008 salient features of the act. Drugs and cosmetics act,1940 and rules, 1945 as amended up to the 31st december, 2016. The act has been further amended as drugs amendment act 1964 of 1964 to include ayurvedic and unani drugs. The drugs and cosmetics rules, 1945 are the set of rules under the drugs and cosmetics act, 1940 1 which contains provisions for classification of drugs under given schedules and there are guidelines for the storage, sale.