Schedule A – Z

Schedule A – Z post thumbnail image

 

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, may be 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 authorised 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 equipments

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 manufacture of sterile products, parenteral preparations (small volume injectables and large volume parenterals) and sterile ophthalmic preparations.
Part 1B: Specific requirements for manufacture of oral solid dosage forms (tablets and capsules)
Part 1C: Specific requirements for manufacture of oral liquids (syrups, elixirs, emulsions and suspensions)
Part 1D: Specific requirements for manufacture of topical products , i.e. external preparations (creams, ointments, pastes, emulsions, lotions, solutions, dusting powders and identical products)
Part 1E: Specific requirements for manufacture of metered-dose-inhalers (mdi)
Part 1F: Specific requirements of premises, plant and materials for manufacture of active pharmaceutial 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 homoeopathic medicines

Schedule M-2: Schedule M2 describes the requirements of factory premises for 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, colour and pigments
Part 1: List of dyes, colours and pigments permitted to be used in cosmetics and soaps
Part 2: List of colours 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 manufacturing of rasaushadhies or rasamarunthukal and kushtajat (herbo-mineral-metallic compounds) of ayurveda, siddha and unani medicines.

Schedule TA: Schedule TA describes form for record of 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 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 of new drugs for sale or to undertake clinical trials

Schedule Z: Proposed

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