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DRUGS CONTROL ADMINISTRATION
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?The Drugs Control Administration has the prime object of enforcement of the following enactments for regulating the Manufacture, Distribution and Sale of Drugs and Cosmetics:-
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The Director of Drugs Control is the Controlling and licensing Authority for grant and renewal of licences for manufacture and for sale of Allopathic, Ayurveda, Siddha, Unani drugs, Homoeopathic Medicines and Cosmetics and also licensing Authority for Blood Banks in Tamil Nadu along with the Central licence approving authority.
There is a Mobile Squad with Madurai as its headquarters and a legal-cum-intelligence Wing in this Directorate to attend complaints relating to spurious drugs and to investigate specific complaints in the southern region and in Chennai respectively.? Apart from this work, the legal-cum-intelligence wing processes legal matters and undertakes special investigations.??
??????????? There is a full fledged Drugs Testing Laboratory attached to this department which undertakes testing of samples, drawn by the Drug Inspectors (other than Parenteral Preparations) from various retail, wholesale units, manufacturing units and hospitals, Government as well as private.? The parenteral reparations are tested at King Institute, Guindy.
??????????? ?From receiving the samples for testing to the final issue of test reports, every procedure followed in the laboratory is completely computerized and this work is being carried out since 1.4.2003.
ACHIEVEMENTS DURING 2003-2004
This directorate has drawn a number of samples of drugs and specific instructions were also issued to the Inspectors for the drawal of samples with reference to antibiotics etc. The samples drawn were sent for analysis as per the provisions of Drugs and Cosmetics Act and based on analytical reports both administrative and legal action have been taken against the persons on merit. Accordingly, this directorate has given sanction to prosecute 10 manufacturers / dealers for having manufactured and supplied Not of Standard quality drugs.?
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Further, this directorate has also cancelled the licence in respect of the product of two manufacturers which have been reported as Not of Standard quality.? The drug licences of? 37 manufacturers were suspended for the product reported as Not of Standard Quality.?
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This directorate is carrying out surprise inspections of manufacturing units through the Inspectors of the intelligence wing and based on the inspection report, five licensees were directed to stop production and distribution of drugs as per Rule 85(2) of the Drugs and Cosmetics Rules 1945.
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Based on specific pattern of drawal of samples by the Inspectors, this directorate was able to detect the movement of spurious drugs in the market and was able to limit the supply of such drugs in the market.? This detection was carried out at an early stage itself and almost the entire stock manufactured and supplied have been seized and further investigation is under progress.
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This directorate has also detected manufacture of drugs without licence by two manufacturers and legal action is being initiated against them.? This directorate is also closely watching the activities of the Blood Bank and in the process one Hospital running a Blood Bank without licence was detected and sanction has been accorded for the prosecution of the same.? Further, the sale of CPD Blood Bags required to operate a Blood Bank was also monitored and accordingly one Stockiest of Blood Bag was prosecuted for contravention of Drugs & Cosmetics Act 1940.
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Four cases under Drugs & Magic Remedies (Objectionable Advertisement) Act have been detected for having caused objectionable advertisement (1) for the treatment of asthma, sinus, smoke and dust allergy; (2) for the treatment of crambs, menses too late;? (3) for the cure of disorder of menstrual flow and for having advertised for the treatment of sexual potency and (4) for having stocked material with objectionable advertisement attracting the provisions of Drugs & Magic Remedies (Objectionable Advertisement) Act.
??????????? This directorate is also conducting surprise inspections of all the Sales Concerns to detect (1) the sale of habit forming drugs (ie) Calmpose, Fortwin, Altrox; (2) to detect the sale of physician samples; (3) to detect the sale of date expired drugs; (4) to detect the sale of drugs without bills; (5) to detect the sale of drugs without licence; (6) to detect the sale of drugs without the supervision of qualified persons and from these above categories this directorate has given sanction of prosecution to prosecute 150 individuals / concerns.? Thus, this directorate is taking every steps to enforce the Drugs & Cosmetics Act and Rules in public interest.
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1.????????????????? Provision of Computers, accessories and furniture to all Zonal offices under the control of Drugs Control Administration at a total cost of Rs.7.50 lakhs.
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2.????????????????? Not less than 32,160 inspections are proposed to be carried out in the Sales Concerns as well as in the Manufacturing Units / Blood Banks / Approved Laboratories and the Government Hospitals.
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3.????????????????? Not less than 4,550 samples are proposed to be drawn for testing the quality of drugs available in the market as well as in the manufacturing Units.
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4.????????????????? A Training Programme for the Drugs Inspectors and Senior Drugs Inspectors for equipping them with the latest Technical innovation in the process of Manufacture and Quality Control of Drugs? is proposed to be conducted.
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5. ????????It is proposed to set up of a Drug Information Centre for the benefit of the public.?
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