Drug and cosmetic act 1940-administrative part

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1 Guide: Dr. Shivkanya Fuloria

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T he Central government and State Government appoint following bodies for efficient running of the Act. A] Advisory : 1) Drugs Technical Advisory Board 2)Drugs Consultative Committee B] Analytical : 1) The Central Drugs Laboratory. 2) Drugs Control Laboratories in States. 3) Government analyst. C] Executive : 1) Licensing Authorities. 2) Drug Inspectors. 3) Customs Collectors. 2

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DRUGS TECHNICAL ADVISORY BOARD (D.T.A.B.) Under the provision of the Act , the Central Government appoints the Drugs Technical Advisory Board to advice the Central and the State Government on technical matters Arising out of the administration of this Act , and to carry out the other assigned to it by this Act. 3

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Constitution of the D.T.A.B. : The board consist of the following members. Ex-officio members.: 1) The director general of the Health Services , who is the Chairman of the board. 2) The drugs controller of India. 3) Director of the central Drug laboratory , Kolkata 4) The Director of the C entral Research Institute , Kasuali 5) The Director of the Indian Veterinary Research Institute , Izatnagar. 6) Director , Central Drug Research Institute , Lucknow. 7) The President Pharmacy Council of India. 8) The President Medical Council India. 4

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Nominated members : The following members are nominated by Central Government. 9) Two Persons from among persons who are incharge of the drug control in the States. 10) One person from the pharmaceutical industry. 11) Two Government Analysts. Elected members : 12) A teacher in Pharmacy 13) A teacher in Medicine 14) One person elected by the central council of Indian Medical Association and one from council of the Indian Pharmaceutical Association. 5

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DRUGS CONSULTATIVE COMMITTEE (DCC) It is also an advisory body constituted by central government. 1) Constitution: Two representatives of the Central Government One representative of each State Government 6

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Drugs Consultative Committee(DCC) Functions : To advise the Central Government, the State Governments and the Drugs Technical Advisory Board on any other matter tending to secure uniformity throughout India in the administration of this Act. The Drugs Consultative Committee shall meet when required Has power to regulate its own procedure . 7

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Central Drug Laboratory (CDL) : Established in Calcutta, under the control of a director appointed by the Central Government Functions: Analysis or test of samples of drugs/cosmetics sent by the custom collectors or courts . Analytical Q.C. of the imported samples. Collection, storage and distribution of internal standards. Preparation of reference standards and their maintenance. Maintenance of microbial cultures. Any other duties entrusted by Central Government. Acting as an appellate authority in matter of disputes. 8

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Government Analysts : The State Government and The Central Government appoint Government Analyst. Government Analyst should have no financial interest in the import, manufacture or sale of the drug or cosmetics. Qualification : Should be : Graduate in Medicine/science/pharmaceutical chemistry of a recognised university and have 5 years post graduate experience in the testing of drugs in a laboratory under the control of i) a G overnment Analyst or ii) Head of an Institute or testing laboratory. Duities of Govrenment Analyst : To analyse or test the samples of drugs and cosmetics sent by D rug Inspector. To forward to the government the reports of analytical and research work. 9

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Licensing Authorities : Any application for the grant or renewal of a licence for the import, manufacture ,sale , distribution etc of any drug or cosmetic is to be made to the L.A. Qualification : No person shall be qualified to be a licensing authority under the Act unless – 1) He is a graduate in Pharmacy/ pharmaceutical Chemistry/ Medicine with specialization in clinical Pharmacology/ Microbiology , from a recognised university and 2) He has Experience in the manufacturing or testing of drugs or enforcement of the provisions of the Act for a minimum period of 5 years. 10

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Drug Inspectors : Inspector means i) in relation to Ayurvedic , Siddha or Unani drugs, an Inspector appointed by the Central Government or a State Government u/s 33-G i i) in relation to any other drug or cosmetic an Inspector appointed by the Central Government or a State Government u/s 21 Drug Inspectors are deemed to be public servants and are officially subordinate to the controlling Authority. Qualifications of Inspectors : For appoinment as Drugs Inspector a person must have a degree in Pharmacy or Pharmaceutical Sciences or Medicine with specialization in clinical pharmacology or microbiology from an Indian University. 11

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Drug Inspector must have 1) at least 18 months experience in the manufacturing of at least one of the substance specified in Shedule C ; OR 2) at least 18 months experience in testing of at least one of the substances in Shedule C in an approved testing laboratory ; or 3) gained experience of not less than three years in the inspection of firm All Inspectors appointed by the Central or State Government shall be under the respective controlling authority. Powers of Inspectors : A) Inspect : a) Any premises where any drugs or cosmetic is being manufactured and the means employed for standardizing and testing the drug or cosmetic; b ) Inspection of premises where any drug or cosmetic is being sold, or stocked or exhibited or offered for sale or distributed. 12

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B) Take Samples of any drug or Cosmetic : 1) Which is being manufactured or being sold or stocked or offered for sale or exhibited or being distributed. 2) From any person , conveying , delivering or preparing to deliver any drug or cosmetic to a purchaser or a consignee C) Search any person in connection with the offence. D) Enter and Search any place in which an offence relating to manufacture,sale or distribution of drugs or cosmetic has been committed E) Stop and search any vehicle or conveyance which he has reason to believe, used for carrying any drug or cosmetic in respect of which offence has been committed. F) Give order in writing to the person in possession of drug or cosmetic in respect of which offence has been committed or is being committed, G) Examine any record ,document or any other material found while exercising above powers. 13

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DUTIES OF DRUG INSPECTOR 1) Duties in relation to the sale of drugs and cosmetics : a ) To inspect at least once a years all establishment licensed for sale of drugs in the area assigned to him and to check wheather the conditions of the licences are observed or not. b ) procure and send for test or analysis , if necessary, imported packages which he has reason to suspect contain drugs being sold in contravention of the provision of the Act c ) Investigate any complaint in writing made to him d ) to maintain a record of all inspections made and action taken by him and submit to controlling authority. e) make such enquiries and inspections as may be necessary to detect the sale of drugs in contravention of the Act. To detain the imported packages, if he suspect to contain drugs , the import of which is prohibited. 14

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2) Inspection of manufacture of drugs or cosmetics : 1)To inspect not less than once a year , all premises licenced for the manufacture of drugs within the area allotted to him . 2) In case of establishment licenced to manufacture products specified in Schedules C and C1 to inspect the plant and the process of manufacture , means employed for standardization and testing of drugs,storage conditions qualifications of technical staff employed. 3) To send after each inspection a detailed report of inspection to the controlling authority. 4)To take samples of drugs manufactured on the premises and send them for test or analysis. 5) To institute prosecution in respect of the breaches of the Act and Rule. 15

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References A TextBook of Forensic Pharmacy : N.K.JAIN. 16

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