Schedules framed under different rules

SCHEDULES ARE FRAMED UNDER DIFFERENT RULES

  • In exercise of the powers conferred by the Drugs and Cosmetics Act the Central government has made a number of Rules for the manufacture, sale and distribution of drugs in India.
  • With the promulgation of theses rules, the rules made by several states in India were repealed.
  • Most of these rules lay down the procedures and details of the enforcement of the provisions of the act.
  • There are prescribed forms of which different applications are to be presented or reports made for different purposes. As per the Drugs and Cosmetics Rules of 1945 a brief summary and the purposes of schedules is given below:
    • Schedule A gives the specimens of prescribed forms.
    • Schedule B states fees for test or analysis by the Central Drugs laboratory or Government Analyst.
    • Schedule C and C1 deals with biological and special products.
    • Schedule D is devoted to exemption regarding import of drugs.
    • Schedule E1 gives a list of poisonous substances under Ayurvedic and unani systems of medicine.
    • Schedule F and F1 give details of the standards of bacterial vaccines made from any micro-organism pathogenic to man or other animal and also the vaccines are from other micro-organisms which have the antigenic value.
    • Schedule FF gives details of the standards fro ophthalmic preparations.
    • Schedules F(II) gives details of standards for surgical dressings and bandage cloth.
    • Schedule F(III ) gives standards for umbilical tapes.
    • Schedule G details of drugs to be labeled with words “Caution” - it is dangerous to take this preparation except under medical supervision”
    • Schedule H deals with drugs and medicines which must be sold by retail only when a prescription by registered professional practitioner is produced.
    • Schedule J gives the list of the ailments for which no drug should claim prevention or cure.
    • Schedule K lays down the condition under which certain cases are exempted from the provisions of Chapter IV of the Drugs Act.
    • Schedule M deals with Good Manufacturing Practices and requirements of premises, plant and equipment. Part I deals with good manufacturing practices and factory premises. Part II deals with plant and equipment.
    • Schedule M1 prescribes in details requirements of factory premises for the manufacture of Homeopathic drugs.
    • Schedule N deals with the minimum equipment of a pharmacy and gives direction regarding: (a.) entrance of a pharmacy, (b.) premises, (c.) furniture and apparatus and (d.) general provisions.
    • Schedule O deals with the provisions applicable to Black disinfectant fluids.
    • Schedule P deals with life period of drugs including combinations with other drugs. It gives period in months for which the drug is expected to retain its potency under the conditions of storage notified by the licensing authority.
    • Schedule Q gives the list of Coal Tar Colours permitted to used in cosmetics.
    • Schedule R describes the Standards for mechanical contraceptives.
    • Schedule T lays down the requirements of factory premises and hygiene conditions for Ayurvedic and Unani drugs.
    • Schedule U and U1 gives the particulars to be shown in manufacturing records.
    • Schedule V gives details of Standards for patent and proprietary medicines.
    • Schedule W gives the name of the drugs which shall be marketed under generic names only.
    • Schedule X gives the names of psychotropic drugs requiring special licences for manufacture and sale.
    • Schedule Y specifies requirements and guidelines on clinical trials, import and manufacture of new drugs.
Last modified: Thursday, 26 April 2012, 11:30 AM