Schedules under Drug and Cosmetic Act, 1940 & Rules 1945

Schedules under Drug and Cosmetic Act, 1940 & Rules 1945

D&C Act

In India drugs and medical devices are controlled by “Central Drugs Standard Control Organization(CDSCO)".

India's GMP standards for drugs and medical devices are covered in Drugs and Cosmetics Act (DCA). Followings are the different schedules in the drugs and cosmetics Act. 

Schedules	Description
Schedule A:	Performa for applications for the Licenses, issue and renewal of licenses, for sending memoranda under the act.
Schedule B&B1:	Schedule B describes fees for test or analysis by the Central Drug 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 &C1:	Schedule C describes list of Biological and special products (injectable) applicable to special provisions. Schedule C1 describes list of Biological and special products (non parentral) applicable to special provisions.
Schedule D,D1,D2,D3:	Exemption of drugs from provision of import. Schedule D1 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 D2 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 D3 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&E1:	Schedule E has been omitted. Schedule E1 describes list of poisonous substances under the Ayurvedic, Siddha and Unani systems.
Schedule F,F1,F2,F3,FF:	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&H1:	Schedule H describes list of substances (prescription) that should be sold by retail only on prescriptions of a registered medical practitioner. 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:	Diseases and ailments which a drug may not purport to prevent or cure or make claims to prevent or cure. Disease under this schedule are AIDS, Angina Pectoris,Diabetes,Cancer,Blindness,Deafness,Fairness of skin, Improvement in height of children’s/adults, Obesity etc.
Schedule K:	The class of drugs and extent & condition of exemption from provisions of Drug and Cosmetic Act, 1940 & Rules 1945.
Schedule L&L1:	Schedule L has been omitted and Schedule L1 describes the good laboratory practices and requirements of premises and equipment's.
Schedule M:	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 M1 describes the good manufacturing practices and requirements of premises, plant and equipment for homoeopathic medicines. Schedule M2 describes the requirements of factory premises for manufacture of cosmetics. Schedule M3 describes the quality management system –for notified medical devices and in-vitro diagnostics.
Schedule N:	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&P1:	Schedule P describes the life period of drugs. Schedule P1 describes the pack size of drugs.
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&R1:	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.
Schedule U&U1:	Schedule U describes the particulars shown in manufacturing records of drugs. Schedule U1 describes the particulars shown in 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 of new drugs for sale or to undertake clinical trials.
Schedule Z:	Proposed.