Schedules to the Act
The First Schedule to the D & C Act 1940 includes a LIST OF BOOKS AYURVEDIC AND SIDDHA, UNANAI SYSTEMS
The second schedule to the D & C act 1940 include STANDARDS TO BE COMPLIED WITH BY IMPORTED DRUGS AND BY DRUGS MANUFACTURED FOR SALE, VOLD, STOCKED OR EXHIBITED FOR SALE OR DISTRIBUTED
Schedules to the rules
Schedule A describes application forms and licenses types.
Schedule B describes Fees for test or analysis by the Central Drugs Laboratories or State Drugs Laboratories
Schedule B1 describes fees for the test or analysis by the pharmacopoeial laboratory for Indian medicine (plim) or the government analyst
Schedule C describes the Biological and Special Products
Schedule C(1) describes the Other Special Products
Schedule D describes the import requirements
Schedule D(1) describes the Information and undertaking required to be submitted by the manufacturer or his authorized agent with the Application Form for a Registration Certificate. The format shall be properly filled in for each application in Form 40. The detailed information, secret in nature, may be furnished on a Computer Floppy
Schedule D(2) describes the Information required to be submitted by the manufacturer or his authorized agent with the Application Form for the registration of a bulk drug/formulation/special product for its import into India. The format shall be properly filled in and the detailed information, secret in nature, maybe furnished on a Computer Floppy
Schedule D(3): Schedule D(3) describes the information and undertaking required to be submitted by the manufacturer or his authorized importer/distributor/agent with the application form for a registration certificate
Schedule E1 describes the List of poisonous substances under the Ayurvedic (including Siddha) and Unani Systems of Medicine
Schedule F part I to Part XIIA were omitted. Part XII B describes the requirements for the functioning and operation of a blood bank and / or for preparation of blood components. part xiid describes the requirements for collection, processing, testing, storage, banking and release of umbilical cord blood derived stem cells.
Schedule F1 is divided into parts. Part 1 describes about vaccines. Part 2 describes the antisera. Part 3- Diagnostic antigens which describes the Provisions Applicable to the Manufacture and Standardization of Diagnostic Agents (Bacterial Origin) . Part 4 – General
Schedule F2 describes the standards for surgical dressings.
Schedule F3 describes the standards for umbilical tapes.
Schedule FF describes the Standards for ophthalmic preparations.
Schedule G describes the list of drugs which are mostly in hormonal in nature
Schedule H describes the drugs which can be sold out in retail against prescription of registered medical practitioner only i.e. prescription drugs
Schedule H1 describes the drugs which can be sold out in retail against prescription of registered medical practitioner only. This schedule contains mostly antibiotics and habit forming drugs.
Schedule I has been omitted.
Schedule J describes the diseases and ailments (by whatever name described) which a drug may not purport to prevent or cure or make claims to prevent or cure.
Schedule K describes the class of drugs and extent & condition of exemption from provisions of Drug and Cosmetic Act, 1940 & Rules 1945.
Schedule L and L1
Schedule L has been omitted and Schedule L1 describes the good laboratory practices and requirements of premises and equipment
Schedule M describes the good manufacturing practices and requirements of premises, plant, and equipment for pharmaceutical products.
Part 1: Good manufacturing practices for premises and materials
Part 1A: Specific requirements for the manufacture of sterile products, parenteral preparations (small volume injectables and large volume parenteral), and sterile ophthalmic preparations.
Part 1B: Specific requirements for the manufacture of oral solid dosage forms (tablets and capsules)
Part 1C: Specific requirements for the manufacture of oral liquids (syrups, elixirs, emulsions, and suspensions)
Part 1D: Specific requirements for the manufacture of topical products, i.e. external preparations (creams, ointments, pastes, emulsions, lotions, solutions, dusting powders, and identical products)
Part 1E: Specific requirements for the manufacture of metered-dose-inhalers (MDI)
Part 1F: Specific requirements of premises, plant, and materials for the manufacture of active pharmaceutical ingredients (bulk drugs)
Part 2: Requirements of plant and equipment
Schedule M1 describes the good manufacturing practices and requirements of premises, plant, and equipment for homeopathic medicines
Schedule M2 describes the requirements of factory premises for the manufacture of cosmetics
Schedule M3 describes the quality management system –for notified medical devices and in-vitro diagnostics
Schedule N describes the list of minimum equipment for the efficient running of a pharmacy
Schedule O describes the standard for disinfectant fluids
Part 1: Provision applicable to black fluids and white fluids
Part 2: Provisions applicable to other disinfectant fluids
Schedule P describes the life period of drugs
Schedule P1 describes the pack size of drugs
Schedule Q describes the list of dye, color, and pigments
Part 1: List of dyes, colors, and pigments permitted to be used in cosmetics and soaps
Part 2: List of colors permitted to be used in soaps
Schedule R describes the standards for condoms made of rubber latex intended for single-use and other mechanical contraceptives
Schedule R1 describes the Indian Standards laid down from time to time by the Bureau of Indian Standards for medical devices.
Schedule S describes the standards for Cosmetics Standards laid down from time to time by the Bureau of Indian Standards
Schedule T describes the good manufacturing practices for ayurvedic, Siddha and Unani medicines
Part 1: Good Manufacturing Practice
Part 2: A – List of recommended machinery, equipment, and minimum manufacturing premises required for the manufacture of various categories of ayurvedic, Siddha system of medicines. B- List of machinery, equipment, and minimum manufacturing premises required for the manufacture of various categories of Unani system of medicines. C- List of equipment recommended for in-house quality control section. D- Supplementary guidelines for the manufacturing of rasaushadhies or rasamarunthukal and kushtajat (herbs-mineral-metallic compounds) of Ayurveda, Siddha, and Unani medicines.
Schedule TA describes form for record of the utilization of raw material by Ayurveda or Siddha or Unani licensed manufacturing units during the financial year
Schedule U describes the particulars shown in manufacturing records of drugs
Schedule U1 describes the particulars shown in the manufacturing record of cosmetics
Schedule V describes the standards for patent or proprietary medicines
Schedule X describes the list of habit-forming and narcotic drugs
Schedule Y describes the requirements and guidelines for permission to import and/or manufacture new drugs for sale or to undertake clinical trials