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Schedules are the set of provisions for classifications of drugs, forms, fees, standards, requirements and regulations related to pharmaceutical, Ayurvedic (including siddha), unani and tibb system of medicines, homeopathy, blood and realted products etc under Drug and Cosmetic Act, 1940 and Rules, 1945.
The schedule to the drugs and cosmetics act are Schedule A, B, C, D, E, F, G, H, I, J, K, L, M, N, O, P, Q, R, S, T, U, V, W, X, Y.
Drug and cosmetic rules are divided into schedules alphabetically and named also alphabetically like Schedule A, Schedule B etc till Schedule Y. The schedules to the drugs and cosmetics act are important part. Every schedule contains specific information as discussed below.
Schedule A: Schedule A describes application forms and licenses types. Download Schedule A Pdf
Schedule B: Schedule B describes Fees for test or analysis by the Central Drugs Laboratories or State Drugs Laboratories. Download Schedule B Pdf
Schedule B1: Schedule B1 describes fees for the test or analysis by the pharmacopoeia laboratory for Indian medicine (plim) or the government analyst. Download Schedule B1 Pdf
Schedule C: Schedule C describes the Biological and Special Products. Download Schedule C Pdf
Schedule C(1): Schedule C(1) describes the Other Special Products. Download Schedule C1 Pdf
Schedule D: Schedule D describes the import requirements.
Download Schedule D Pdf
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. Download Schedule D1 Pdf
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. Download Schedule D2 Pdf
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. Download Schedule D3 Pdf
Schedule E(1): Schedule E1 describes the List of poisonous substances under the Ayurvedic (including Siddha) and Unani Systems of Medicine. Check Download Schedule E1 Pdf
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. Download Schedule F Pdf
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. Download Schedule F1 Pdf
Schedule F2: Schedule F2 describes the standards for surgical dressings. Download Schedule F2 Pdf
Schedule F3: Schedule F3 describes the standards for umbilical tapes. Download Schedule F3 Pdf
Schedule FF: Schedule FF describes the Standards for ophthalmic preparations. Download Schedule FF Pdf
Schedule G: Schedule G describes the list of drugs which are mostly in hormonal in nature. Download Schedule G Pdf
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. Download Schedule H Pdf
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. Download Schedule H1 Pdf
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. Download Schedule J Pdf
Schedule K: Schedule K describes the class of drugs and extent & condition of exemption from provisions of Drug and Cosmetic Act, 1940 & Rules 1945. Download Schedule K Pdf
Schedule L and L1: Schedule L has been omitted and Schedule L1 describes the good laboratory practices and requirements of premises and equipment's. Download Schedule L, L1 Pdf
Schedule M: Schedule M describes the good manufacturing practices and requirements of premises, plant and equipment for pharmaceutical products. Download Schedule M Pdf
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. Download Schedule M1 Pdf
Schedule M-2: Schedule M2 describes the requirements of factory premises for manufacture of cosmetics. Download Schedule M2 Pdf
Schedule M-3: Schedule M3 describes the quality management system –for notified medical devices and in-vitro diagnostics. Download Schedule M3 Pdf
Schedule N: Schedule N describes the list of minimum equipment for the efficient running of a pharmacy. Download Schedule N pdf
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
Download Schedule O Pdf
Schedule P: Schedule P describes the life period of drugs. Download Schedule P Pdf
Schedule P1: Schedule P1 describes the pack size of drugs. Download Schedule P1 Pdf
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
Download Schedule Q Pdf
Schedule R: Schedule R describes the standards for condoms made of rubber latex intended for single use and other mechanical contraceptives. Download Schedule R Pdf
Schedule R1: Schedule R1 describes the Indian Standards laid down from time to time by the Bureau of Indian Standards for medical devices. Download Schedule R1 Pdf
Schedule S: Schedule S describes the standards for Cosmetics Standards laid down from time to time by the Bureau of Indian Standards. Download Schedule S Pdf
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.
Download Schedule T Pdf
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. Download Schedule TA Pdf
Schedule U: Schedule U describes the particulars shown in manufacturing records of drugs. Download Schedule U Pdf
Schedule U1: Schedule U1 describes the particulars shown in manufacturing record of cosmetics. Download Schedule U1 Pdf
Schedule V: Schedule V describes the standards for patent or proprietary medicines. Download Schedule V Pdf
Schedule X: Schedule X describes the list of habit forming and narcotic drugs. Download Schedule X Pdf
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. Download Schedule Y Pdf
Schedule Z: Proposed
Reference: Drug and Cosmetic Act 1940 and Rules 1945
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Schedule B: Schedule B describes Fees for test or analysis by the Central Drugs Laboratories or State Drugs Laboratories. Download Schedule B Pdf
Schedule B1: Schedule B1 describes fees for the test or analysis by the pharmacopoeia laboratory for Indian medicine (plim) or the government analyst. Download Schedule B1 Pdf
Schedule C: Schedule C describes the Biological and Special Products. Download Schedule C Pdf
Schedule C(1): Schedule C(1) describes the Other Special Products. Download Schedule C1 Pdf
Schedule D: Schedule D describes the import requirements.
Download Schedule D Pdf
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. Download Schedule D1 Pdf
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. Download Schedule D2 Pdf
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. Download Schedule D3 Pdf
Schedule E(1): Schedule E1 describes the List of poisonous substances under the Ayurvedic (including Siddha) and Unani Systems of Medicine. Check Download Schedule E1 Pdf
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. Download Schedule F Pdf
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. Download Schedule F1 Pdf
Schedule F2: Schedule F2 describes the standards for surgical dressings. Download Schedule F2 Pdf
Schedule F3: Schedule F3 describes the standards for umbilical tapes. Download Schedule F3 Pdf
Schedule FF: Schedule FF describes the Standards for ophthalmic preparations. Download Schedule FF Pdf
Schedule G: Schedule G describes the list of drugs which are mostly in hormonal in nature. Download Schedule G Pdf
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. Download Schedule H Pdf
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. Download Schedule H1 Pdf
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. Download Schedule J Pdf
Schedule K: Schedule K describes the class of drugs and extent & condition of exemption from provisions of Drug and Cosmetic Act, 1940 & Rules 1945. Download Schedule K Pdf
Schedule L and L1: Schedule L has been omitted and Schedule L1 describes the good laboratory practices and requirements of premises and equipment's. Download Schedule L, L1 Pdf
Schedule M: Schedule M describes the good manufacturing practices and requirements of premises, plant and equipment for pharmaceutical products. Download Schedule M Pdf
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. Download Schedule M1 Pdf
Schedule M-2: Schedule M2 describes the requirements of factory premises for manufacture of cosmetics. Download Schedule M2 Pdf
Schedule M-3: Schedule M3 describes the quality management system –for notified medical devices and in-vitro diagnostics. Download Schedule M3 Pdf
Schedule N: Schedule N describes the list of minimum equipment for the efficient running of a pharmacy. Download Schedule N pdf
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
Download Schedule O Pdf
Schedule P: Schedule P describes the life period of drugs. Download Schedule P Pdf
Schedule P1: Schedule P1 describes the pack size of drugs. Download Schedule P1 Pdf
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
Download Schedule Q Pdf
Schedule R: Schedule R describes the standards for condoms made of rubber latex intended for single use and other mechanical contraceptives. Download Schedule R Pdf
Schedule R1: Schedule R1 describes the Indian Standards laid down from time to time by the Bureau of Indian Standards for medical devices. Download Schedule R1 Pdf
Schedule S: Schedule S describes the standards for Cosmetics Standards laid down from time to time by the Bureau of Indian Standards. Download Schedule S Pdf
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.
Download Schedule T Pdf
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. Download Schedule TA Pdf
Schedule U: Schedule U describes the particulars shown in manufacturing records of drugs. Download Schedule U Pdf
Schedule U1: Schedule U1 describes the particulars shown in manufacturing record of cosmetics. Download Schedule U1 Pdf
Schedule V: Schedule V describes the standards for patent or proprietary medicines. Download Schedule V Pdf
Schedule X: Schedule X describes the list of habit forming and narcotic drugs. Download Schedule X Pdf
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. Download Schedule Y Pdf
Schedule Z: Proposed
Reference: Drug and Cosmetic Act 1940 and Rules 1945
Question and Answer:
Question: Drug and cosmetic rules are divided into how many schedules
Answer: Drug and cosmetic rules are divided into 25 schedules from Schedule A to Schedule Y. Out of which few are omitted and few are further sub divided into sub schedules.
Question: How many rules are under Drug and cosmetic act & rules?
Answer: Drug and Cosmetic act & rules have 169 rules.
Question: All the prescription drugs comes under which schedule of drugs and cosmetics act 1940
Answer: Prescription drugs comes under different schedules i.e. Schedule C-C1, Schedule H, Schedule H1, Schedule G etc.
Question: What is the first schedule to the drug and cosmetic act 1940?
Answer: Schedule A is the first schedule to the drug and cosmetic act 1940.
Question: Cosmetics are covered under which schedule of d and c act?
Answer: Cosmetics are covered under schedule M2, Q, S and U1 of D&C act.
Question: Drug and cosmetics rules are divided into how many schedules and rules?
Answer: Drug and cosmetics rules are divided into 25 schedules and 169 rules.
Question: Schedule FF to the drugs and cosmetics rules, 1945 contains the list of which drugs?
Answer: Schedule FF to the drugs and cosmetics rules, 1945 describes the Standards for ophthalmic preparations.
Question: Life period of drugs belong to which schedule?
Answer: Life period of drugs belong to schedule P.
Question: Standard for cosmetics are given in which schedule?
Answer: standard for cosmetics are given in schedule S.
Question: Schedule d in drugs and cosmetics act refers to which?
Answer: schedule d in drugs and cosmetics act refers to import requirements.
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Hi sir please contact me i want to start medical device business
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