Schedules to the D & C Act 1940 and Rules 1945

Schedules to the Act

The First Schedule

The First Schedule to the D & C Act 1940 includes a LIST OF BOOKS AYURVEDIC AND SIDDHA, UNANAI SYSTEMS

The Second Schedule

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

Schedule A describes application forms and licenses types.

Schedule B

Schedule B describes Fees for test or analysis by the Central Drugs Laboratories or State Drugs Laboratories

Schedule B1

Schedule B1 describes fees for the test or analysis by the pharmacopoeial laboratory for Indian medicine (plim) or the government analyst

Schedule C

Schedule C describes the Biological and Special Products

Schedule C(1)

Schedule C(1) describes the Other Special Products

Schedule D

Schedule D describes the import requirements

Schedule D(1)

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)

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 E(1)

Schedule E1 describes the List of poisonous substances under the Ayurvedic (including Siddha) and Unani Systems of Medicine

Schedule F

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

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

Schedule F2 describes the standards for surgical dressings.

Schedule F3

Schedule F3 describes the standards for umbilical tapes.

Schedule FF

Schedule FF describes the Standards for ophthalmic preparations.

Schedule G

Schedule G describes the list of drugs which are mostly in hormonal in nature

Schedule H

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

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

Schedule I has been omitted.

Schedule J

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

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

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 M-1

Schedule M1 describes the good manufacturing practices and requirements of premises, plant, and equipment for homeopathic medicines

Schedule M-2

Schedule M2 describes the requirements of factory premises for the manufacture of cosmetics

Schedule M-3

Schedule M3 describes the quality management system –for notified medical devices and in-vitro diagnostics

Schedule N

Schedule N describes the list of minimum equipment for the efficient running of a pharmacy

Schedule O

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

Schedule P describes the life period of drugs

Schedule P1

Schedule P1 describes the pack size of drugs

Schedule Q

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

Schedule R describes the standards for condoms made of rubber latex intended for single-use and other mechanical contraceptives

Schedule R1

Schedule R1 describes the Indian Standards laid down from time to time by the Bureau of Indian Standards for medical devices.

Schedule S

Schedule S describes the standards for Cosmetics Standards laid down from time to time by the Bureau of Indian Standards

Schedule T

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:

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

Schedule U describes the particulars shown in manufacturing records of drugs

Schedule U1

Schedule U1 describes the particulars shown in the manufacturing record of cosmetics

Schedule V

Schedule V describes the standards for patent or proprietary medicines

Schedule X

Schedule X describes the list of habit-forming and narcotic drugs

Schedule Y

Schedule Y describes the requirements and guidelines for permission to import and/or manufacture new drugs for sale or to undertake clinical trials