Schedule x is a class of prescription drugs in india appearing as an appendix to the drugs and cosmetics rules introduced in 1945. Quality control laboratories shall be independent of the production areas. According to rule 71 of drug and cosmetics rules 1945 the licenes shall comply with the. 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 amendment act, 1972 19 of 1972. In the drugs and cosmetics rules, 1945, for schedule m. 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 drugs and cosmetics amendment act, 1964 of 1964 8. 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 india in the ministry of health and family welfare department of health, no. 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. Schedulem schedule m is a part of drug and cosmetic act 1940. And the drugs and cosmetics rules, 1945 as corrected up to the 30th.
An act to regulate import, manufacture, distribution and sale of drugs and cosmetics. The drugs and cosmetics amendment bill, 20 a bill further to amend the drugs and cosmetics act, 1940. Schedule x describes the habit forming and narcotics drugs list. Schedule m is a part of drug and cosmetic act 1940. Schedule j drugs for purpose of curing, preventing and treating any disease or ailments 10. Mar 19, 2018 ministry of health and family welfare vide notification dated march, 2018 has notified the drugs and cosmetics first amendment rules, 2018 further amending the drugs and cosmetics rules, 1945. March 2017 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. Pharmaceutical jurisprudence important acts updated list, years and dates. Which are required to be printed or written under these rules, the label of inner most container of the following. 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. 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 drugs and cosmetics amendment act, 1995 22 of 1995. Basics of the narcotic drugs and psychotropic substances act 1985. The drugs and cosmetics rules, 1945 dadra and nagar haveli. These are drugs which cannot be purchased over the counter without the prescription of a qualified doctor. The drugs and cosmetics amendment act, 1986 71 of 1986 11. That i shall abide by all the instruction issued under the provision of the drugs and cosmetics act, 1940 and. Schedule k exemption of drugs from provisions related to manufacture of drugs. Principles of schedule m the first who draft text on gmp was prepared in 1967 by a group of consultants, at the request of the twentieth world health assembly. Comparison of guidelines of indian gmp with who gmp.
A licence in form 28, form 28b or form 28d shall be subject to the special conditions, if any, set out in schedule f or schedule f1, as the case may be, which relate to substance in respect of which the licence is granted and to the following general conditions. Schedule m2 is titled as requirements of factory premises for manufacture of cosmetics. Schedules of drug and cosmetics act and rulesii youtube. Contains various regulations for manufacturing, premises, waste disposal and equipment. Different type of forms is also given for the different type of approvals from drug authorities. 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. A licence in form 28, form 28b or form 28d shall be subject to the special conditions, if any, set out in schedule f or schedule f1, as the case may be, which relate to substance in respect of which the licence is. December 31, 2003 to the manufacturers, who are presently licensed to manufacture for sale of drugs. And whereas the legislatures of all the provinces have passed resolutions in terms of section 103. 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.
Be it enacted by parliament in the sixtyfourth year of the republic of india as follows. Whereas it is expedient to regulate the 3 import, manufacture, distribution and sale of drugs 2. Ministry of health and family welfare vide notification dated march, 2018 has notified the drugs and cosmetics first amendment rules, 2018. An act to regulate the import, manufacture, distribution and sale of drugs 2and cosmetics. 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. 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 rules, 1945 are the set of rules under the drugs and cosmetics.
Drugs and cosmetics act, 1940 bare acts law library. Comparison of guidelines of indian gmp with who gmp reference indian gmp, schedule m drugs and cosmetics act 1940 drugs and cosmetics rules 1945 3 who gmp who good manufacturing. A astrology joint director, drugs control administration. Apr 12, 2018 drugs and cosmetics amendment rules, 2018 notification of ministry of commerce and industry, no. It contains 168 rules from 1 to 168 and 25 schedules from schedule a to schedule y. The drugs and cosmetics rules, 1945 are the set of rules under the drugs and cosmetics act, 1940 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 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. Prohibition of manufacture and sale of certain drugs and cosmetics. Schedule m good manufacturing practice presented by. Rules are given for pharmaceuticals and schedules are there to comply with those rules. The drugs and cosmetics rules, 1945 contains provisions for classification of drugs under the given schedules and there are guidelines for the storage, sale, display and prescription of each schedule. The drugs and cosmetics amendment act, 1982 68 of 1982 10. 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. Medical and general stores, atmakur by allegedly following procedure prescribed by law.
Schedule x prescription drugwarning to be sold by retail on the prescription of a registered medical practitioner only. 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. List of schedule c and c1 drugs and formulations pharmagang. The drugs act, as enacted in1940, has since been amended several times and is now titled as the drugs and cosmetics act, 1940. Schedules of drug and cosmetics act and rulesii pharmacy lessons made easy.
Schedule m, m1, m2, m3 are parts of drugs and cosmetics act. And whereas the legislatures of all the provinces have passed resolutions in terms of section 103 of the government of india act, 1935 26 geo. Schedule y, the current regulator cdsco central drugs standard control organization enforced law in india has been established under drugs and cosmetic act 1945. Schedule m2 gmp for cosmetics, drugs and cosmetics act. They contain gmp for drugs such as pharmaceuticals, cosmetics and medical devices. Schedule g substances required to be used under medical supervision accordingly. Conditions of licence for allopathic loan licence manufacturing.
Drugs inspector, mahaboobnagar district had drawn sample of rabpraz tablets from g. These schedules contains various biological products and their regulation. Drugs and cosmetics act and rulesrachana and sheetal madam. With minimum of 18 months experience in manufacturing or testing of drugs falling under schedule c. Mar 23, 2016 schedule m in pharmaceutical industries 1. Also, the retailer has to preserve the prescription for. Schedule m 2 of drugs and cosmetics rules define the gmp requirements for cosmetics manufacturing in india. It defines good manufacturing practices and requirements of premises, plant and equipment for various type of cosmetics. 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. 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. Government notifies shri ram janmabhoomi teerth kshetra to be place of historic. Separate areas shall be provided each for physicochemical, biological, microbiological or radioisotope analysis. Comparison of guidelines of indian gmp with who gmp reference indian gmp, schedule m drugs and cosmetics act 1940 drugs and cosmetics rules 1945 3 who gmp who good manufacturing practices for pharmaceutical products. 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.
It is gmp for pharmaceuticals that should be followed by pharmaceutical manufacturing units in india. Kindly note that a right enjoyed by an rmp will not vanish when he is in a place called a hospital, hisher. This schedul e holds a list o f 98 boo ks of different systems o f medicines as mentioned below. Bangoriya assistant professorquality assurance department s.
Schedule ui describes the particulars to be shown in the manufacturing record for cosmetics view schedule u download pdf. The act has been further amended as drugs amendment act 1964 of 1964 to include ayurvedic and unani drugs. M2 requirement of factory premises for manufacturing of cosmetics. Drugs and cosmetics act, 1940 4 chapter iv manufacture, sale and distribution of drugs and cosmetics sections 16. Act, the central government, after consultation with drugs technical advisory board, hereby makes the following rules further to amend the drugs and cosmetics rules, 1945, namely. Drugs and cosmetics act national health portal of india.
An act to regulate the import, manufacture, distribution and sale of drugs 2 and cosmetics. 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. The other requirements regarding animal houses shall be those as prescribed in rule 150c3 of the drugs and cosmetics rules, 1945 which shall be adopted. The regulations to be followed when conducting clinical trials in india are clearly documented to a large extent in this document.