Legal Definitions of Schedules to Drugs and Cosmetics Act 1940 and Rules 1945 under Pharmacy Law and Ethics.

Legal definitions of schedules to the Drug and Cosmetic Act and Rules

Schedules to Drugs and Cosmetics Act and Rules 1945

• There are two schedules to the Drugs and Cosmetics Act 1940 and several schedules to the Drugs and Cosmetics Rules 1945.

• Schedules are divided alphabetically like Schedule A, Schedule B, etc till Schedule Y.

Schedules to the rules are given below

• Schedule A: Application forms and license types.
  Schedule B: Fees for test or analysis by the Central Drugs Laboratories or State Drugs Laboratories.
  Schedule B1: Fees for the test or analysis by the Indian Pharmacopoeial Laboratory for Indian medicine or by the government analyst.
  Schedule C: Biological and Special Products
  Schedule C(1): Other Special Products
  Schedule D: List of drugs exempted from certain provisions of Drug import requirement.

• Schedule D(1): Information and undertaking required to be submitted by the manufacturer or his authorized agent with the Application Form for a Registration Certificate.

• Schedule D(2): 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.

• Schedule D(3): 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): List of poisonous substances under the Ayurvedic, Siddha, and Unani System of Medicines.
  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 the preparation of blood components. Part XII D describes the requirements for the collection, processing, testing, storage, banking, and release of umbilical cord blood-derived stem cells.
  Schedule FF: Standards for ophthalmic preparations
  Schedule F1: 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: standards for surgical dressings.
  Schedule F3: the standards for umbilical tapes.
  Schedule G: a list of drugs that are mostly hormonal
  Schedule H: It describes the drugs that can be sold out in retail against the prescription of registered medical practitioners only i.e. prescription drugs
  Schedule H1: It describes the drugs that can be sold out in retail against the Prescription and registered medical practitioner only.  This schedule contains mostly antibiotics and habit-forming drugs.
  Schedule I: Schedule I has been omitted.
  Schedule J: It describes the diseases and ailments (by whatever name described) that a drug may not purport to prevent or cure or make claims to prevent or cure.
  Schedule K: It describes the class of drugs and the extent & condition of exemption from provisions of the 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: It describes the good manufacturing practices and requirements of premises, plants, and equipment for pharmaceutical products.

• Schedule N: the list of minimum equipment for the efficient running of a pharmacy
  Schedule O: It  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: It describes the life period of drugs
  Schedule P1: the pack size of drugs
  Schedule Q: the list of dyes, 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: It describes the standards for condoms made of rubber latex intended for single use and other mechanical contraceptives.
  Schedule R1: It describes the Indian Standards laid down from time to time by the Bureau of Indian Standards for medical devices.
  Schedule S: It describes the standards for Cosmetics Standards laid down from time to time by the Bureau of Indian Standards
  Schedule T: the good manufacturing practices for Ayurvedic, Siddha, and Unani Medicines.

• Schedule T-A: form for record of the utilization of raw material by Ayurveda, Siddha, or unani licensed manufacturing units during the financial year
  Schedule U: the particulars shown in manufacturing records of drugs.
  Schedule U1: the particulars shown in the manufacturing record of cosmetics.
  Schedule V: the standards for patent or proprietary medicines.
  Schedule X: list of habit-forming and narcotic drugs.
  Schedule Y: the requirements and guidelines for permission to import and/or manufacture of new drugs for sale or to undertake clinical trials.

Alok Bains