SCHEDULES UNDER DRUGS & COSMETICS ACT.pptx

SCHEDULES UNDER DRUGS & COSMETICS

1. SCHEDULES (Act 1940 and Rules 1945)

2. Legal definition of Schedules to the Act and Rules: The Act consists of Five Chapters , and each Chapter is related to particular subjects: CHAPTER-I: INTRODUCTION CHAPTER-II: THE DRUG TECHNICAL ADVISORY BOARD, THE CENTRAL DRUG LABORATORY AND THE DRUG CONSULTATIVE COMMITTEE, GOVT. ANALYST, DRUG INSPECTOR. CHAPTER-III: IMPORT OF DRUGS AND COSMETICS CHAPTER-IV: MANUFACTURE, SALE, DISTRIBUTION OF DRUGS AND COSMETICS CHAPTER-IVA : PROVISION RELATED TO AYURVEDA, SIDDHA AND UNANI DRUGS. CHAPTER-V: MISCELLANEOUS THERE ARE TWO SCHEDULES TO THE ACT AND TWENTY SEVEN SCHEDULES TO THE RULES.

3. Schedule to the Act First Schedule: Name of the Books under Ayurveda , Siddha , Unani . Second Schedule: Standard to be compiled with by imported drugs and by drugs manufactured for sale, sold, stocks or exhibited for sale or distribution.

4. Schedule-F: This contains regulations and standards for running a blood bank Requirements of blood and/or its components including blood products regulated by the Drugs and Cosmetics Act, 1940 and its subsequent amendments. BLOOD BANK A place or organization or unit or institution or other arrangements made by such organization, unit or institution for carrying out all or any of the operations for collection, storage, processing and distribution of blood drawn from donors and/or for preparation, storage and distribution of blood components.

5. Human blood is covered under the definition of ‘Drug’ under Sec. 3(b) of Drugs & Cosmetics Act. Hence, it is imperative that Blood Banks need to be regulated under the Drugs & Cosmetics Act and rules there under. In the year 1967, Central Govt. (Ministry of Health) enacted a separate provision in Schedule F Part XII B of Drugs and Cosmetic Rules . Application in Form 27C for grant/renewal of licence for the operation of a  Blood Bank License shall be issued in Form 28-C or Form-28-E or Form 26- G or Form 26-I as the case may be Various requirements such as Accommodation, Technical staff, equipments etc for operation of blood bank were included in this Part. State Drugs Controllers were authorized to issue the licenses for blood banks. The standards for ‘Whole Human Blood’ was prescribed in Indian Parmacopoeia .

6. Sch -F Part XII-B describes the requirements for the functioning and operation of a Blood Bank I. Blood Banks/Blood Components   i. General: Location & surrounding-pollution free ii. Accommodation for a Blood Bank-100 sq m,50 addn for prepn iii. Personnel iv. Maintenance v. Equipment vi. Supplies and Reagents vii. Good Manufacturing Practices (GMPs)/ Standard Operating Procedures (SOPs) viii. Criteria For Blood Donation ix. General Equipments and Instruments x. Special Reagents xi. Testing of whole blood xii. Records xiii. Labels  

7. II. Blood Donation Camps A. Premises, personnel etc. B. Personnel for Out-door Blood Donation Camp C. Equipments

8. III. Processing of Blood components from whole blood by a Blood bank: A . Accommodation B. Equipment C. Personnel D. Testing Facilities E. Categories of Blood Components Concentrated Human Red Blood Corpuscles Platelets Concentrates Granulocyte Concentrate   Fresh Frozen Plasma Cryoprecipitate-Portion of Plasma

9. Part XII C:   I . Requirements for manufacture of Blood Products A. General Requirements B. Collection and Storage of Plasma for Fractionation C. Personnel D. Production Control E. Viral Inactivation Process F. Quality Control G. Testing of Blood Products H. Storage of finished products I. Labelling J. Records K. Master Formula Record

10. Schedule F(I ): Provision applicable to vaccines, toxins, antigens, and sera, etc. Part-I: Vaccines: A. Provisions applicable to the production of bacterial vaccines 1. Definition 2. Staff of Establishment 3. Proper Name 4. Records 5. Combined Vaccines 6. Preparation 7. General Standards 8. Labelling 9. Storage 10. Date of manufacture

11. B. Provisions applicable to the production of viral vaccines 1. Definition 2. Staff of Establishment 3. Proper Name 4. Records 5. Tests 6. Storage 7. Condition of housing of animals 8. Labelling 9. Date of Manufacture

12. Part II: Anti-sera Provisions applicable to the production of all Sera from Living Animals 1. Definition 2. Staff of Establishment 3. Proper Name 4. Records 5. Cultures 6. Quantity 8. Unhealthy or Infected Animals 9. Conditions and Housing of animals

13. Part III : Diagnostic Antigens Provisions Applicable to the Manufacture and Standardisation of Diagnostic Agents (Bacterial Origin) Description: Clear opalescent or coloured liquid. Identification: Some exhibits specific agglutination. Sterility test: All antigens should be tested for sterility in accordance with rules-114 to 119. Standardisation: Either by determining the definite cell concentration in the products or by observation local reaction.

14. Schedule F-II: Standards for surgical dressings Items: Bandages cloth, bleached bandage cloth, Rolled, Open Wove and Cotton bandages. Packing, labelling & storage: Absorbent gauze is folded and packed with such materials so that it protect its absorbency. The packages shall be labelled with the words-Non-sterile (for not sterile) and Sterile for sterilized one. Stored in packed condition protected from moisture and dust.

15. Schedule F-III : Standards for Umbilical Tapes A . Standards for Sterilised Umbilical Polyster Tape . Uniform shape & size White to yellowish-white in colour Sterilized by Gamma Radiation Tensile strength of not less than 4 kgs on straight pull. B . Standards for Sterilised Umbilical Cotton Tape. In addition to above: Packaging & labelling: P roper name, manufacturer name & address, batch no., licence no., date of manufacture & expiry, length & width. Storage: Cool place

16. Schedule FF: Standards for ophthalmic preparations Part-A : Ophthalmic Solutions and suspensions.   Condition/criteria: Sterile Sold in unopened containers Free from foreign matters Should contain- Benzalkonium chloride,Phenyl mercuric nitrate, chlorbutanol , phenyl ethyl alcohol (Within the Pharmacopeial limits). Part B: Ophthalmic Ointments Sterile Sold in unopened containers Free from foreign matters Labelling should be shown on the container/package leaflet.

17. Schedule-G Drugs which are required to be taken only under supervision of a registered medical practitioner : All the operations related to drugs should be done by qualified persons Proper bill of sale Record should be maintain for 2 year Caution: Its dangerous to take this medicine except under medical supervision. Few drugs are listed below: Aminopterin L- Asparaginase Bleomycin Busulphan ; its salts Carbutamide Chlorambucil ; its salts Chlorothiazide and other derivatives of 1, 2, 4 benzothiadiazine Chlorpropamide ; its salts Chlorthalidone and other derivatives of Chlorobenzene compound. Cis-Platin Cyclophosphamide ; its salts Cytarabine Daunorubicin Di-Isopropyl Eluorophosphate Disodium Stilboestrol Diphosphate Doxorubicin Hydrochloride Ethacrynic Acid, its salts Ethosuximide

18. Hydantoin ; its salts; its derivatives, their salts Hydroxyurea Insulin, all types Lomustine Hydrochloride Mannomustine ; its salts Mercaptopurine ; its salts Metformin ; its salts Methsuximide Mustine , its salts Paramethadione Phenacemide Phenformin ; its salts 5-Phenylhydantoin; its alkyl and aryl derivatives; its salts Primadone Procarpazine Hydrochloride Quinthazone Sarcolysine Sodium-2-Mercaptoethanesulfonate Tamoxifen Citrate Testolactone Thiotepa Tolbutamide Tretamine ; its salts Troxidone Antihistaminic substances the following, their salts, their derivatives, salts of their derivatives Antazoline Bromodiphenhydramine Buclizine Chlorcyclizine Chlorpheniramine Clemizole Cyproheptadine Testolactone Thiotepa Tolbutamide Tretamine ; its salts Troxidone Antihistaminic substances the following, their salts, their derivatives, salts of their derivatives Antazoline Bromodiphenhydramine Buclizine Chlorcyclizine Chlorpheniramine Clemizole Cyproheptadine Diphenhydramine Diphenylpyraline Doxylamine Succinate Isothipendyl Mebhydrolin Napadisylate Meclozine Phenindamine Pheniramine Promethazine Thenalidine Triprolidine

19. Schedule-H Schedule H is a class of prescription drugs in India appearing as an appendix to the Drugs and Cosmetics Rules, 1945 introduced in 1945. Must display the texts “Rx” Warning: To be sold by retail on the prescription of a RMP only. Contain about 550 drugs These are drugs which cannot be purchased over the counter without the prescription of a qualified doctor.

20. Schedule M Good manufacturing practices and requirements of premises, plant and equipment for pharmaceutical products

21. Schedule-M: Good manufacturing practices and requirements of premises, plant and equipment for pharmaceutical products PART – I: General requirements: 1.1. Location and surroundings: Avoid risk of contamination from external environment including open sewage, drain, public laboratory or any factory which produces disagreeable or unpleasant, odour, fumes, excessive soot, dust, smoke, chemical or biological emissions. 1.2. Buildings and premises: Factory shall be designed, constructed, adapted and maintained to suit the manufacturing operations so as to permit production of drugs under hygienic conditions . Laid down in the Factories Act, 1948 (63 of 1948).

22. The premises used for manufacturing, processing, warehousing, packaging, labelling and testing purposes shall be Compatible with other drug manufacturing operations Adequately provided with working space to allow orderly and logical placement of equipment, materials and movement of personnel so as to : Designed/constructed /maintained to prevent entry of insects, pests, birds, vermins , and rodents. Fire protection Interior surface (walls, floors, and ceilings) shall be smooth and free from cracks, and permit easy cleaning, painting and disinfection Air conditioned. shall be well lighted, effectively ventilated . Provided with drainage system.

23. 1.3 Water system: V alidated system for treatment of water drawn from own or any other source. Potable in accordance with standards specified by the Bureau of Indian Standards. to produce Purified Water conforming to Pharmacopoeial specification. Water shall be stored in tanks . Freedom from microbiological growth. 1.4 Disposal of waste: The disposal of sewage and effluents (solid, liquid and gas) from the manufactory shall be in conformity with the requirements of Environment Pollution Control Board . All bio-medical waste shall be destroyed as per the provisions of the BioMedical Waste (Management and Handling) Rules, 1996. Hazardous, toxic substances and flammable materials shall be stored in suitably designed and segregated.

24. 2. Warehousing Area: Adequate areas shall be designed to allow sufficient and orderly warehousing of various categories of materials and products Temperature controlled Quarantine facilities 3. Production area: Uniform with logical sequence of operations Avoiding cross contamination Proper positioning of machines Proper service lines 4. Ancillary areas: Rest and refreshment rooms shall be separate from other areas. Facilities for changing , storing clothes and for washing and toilet purposes shall be easily accessible and adequate for the number of users Maintenance workshops shall be separate and away from production areas

25. 5. Quality Control area: Independent Designed properly Separate areas shall be provided each for physico -chemical, biological, microbiological. Quality Control Laboratory shall be divided into separate sections i.e. for chemical, microbiological and wherever required, biological Testing 6. Personnel Direct supervision of competent technical staff with prescribed qualifications and practical experience Written duties of technical and Quality Control personnel shall be laid and followed strictly. Periodical training Number of personnel employed shall be adequate and in direct proportion to the workload.

26. 7. Health, clothing and sanitation of workers Protection from Beta- lactum antibiotics exposure, wherever applicable. Periodical medical check-up All persons, prior to and during employment, shall be trained in practices which ensure personnel hygiene. Proper toilet facilities at a distance. Direct contact shall be avoided between the unprotected hands of personnel and raw materials, intermediate or finished, unpacked products. All personnel shall wear clean body coverings appropriate to their duties Smoking, eating, drinking, chewing or keeping plants, food, drink and personal medicines shall not be permitted in production, laboratory, storage and other areas where they might adversely influence the product quality.

27. 8. Manufacturing Operations and Controls Under the supervision of technical staff approved by the Licensing Authority The licensee shall prevent mix-up and cross- contamination of drug material and drug product (from environmental dust) by proper air-handling system Proper records and Standard Operating Procedures thereof shall be maintained. The licensee shall ensure processing of sensitive drugs like Beta- Lactum antibiotics, sex hormones and cycotoxic substances in segregated areas or isolated production areas within the building Packaging lines shall be independent and adequately segregated Before packaging operations are begun, steps shall be taken to ensure that the work area, packaging lines, printing machines, and other equipment are clean and free from any products, materials and spillages Maintained of temperature, humidity & cleanliness The manufacturing environment shall be maintained at the required levels of temperature, humidity and cleanliness. All process controls checked under master formula.

28. 9. Sanitation in the manufacturing premises: Written down and validated cleaning procedure The manufacturing premises shall be cleaned and maintained in an orderly manner, so that it is free from accumulated waste, dust, debris and other similar material. The manufacturing areas shall not be used for storage of materials A routine sanitation program shall be drawn up and observed. 10. Raw materials: Properly identified, analysed, containers of raw materials inspected for any damage, stored at optimum temperature, systematically sampled by quality control personnel, tested for compliance of required standard. Different areas- Quarantine, sampling, and approved materials. Inventory control and record mainlining as per sch -U Properly labelled as ‘under test’, ‘approved’ and ‘rejected’.

29. 11. Equipment: Proper located and maintained to suit the operations to be carried out. To minimise the risk of errors and permit effective cleaning and maintenance in order to avoid cross-contamination, build-up of dust or dirt and, in general, any adverse effect on the quality of products Periodical validated Balances and other measuring equipment of an appropriate range, accuracy and precision, these shall be calibrated and checked on a scheduled basis The parts of the production equipment that come into contact with the product shall not be reactive, additive or adsorptive to an extent that would affect the quality of the product. Defective equipment shall be removed from production and Quality Control areas or appropriately labelled Written down cleaning procedure for each.

30. 12. Documentation and records Documentation is an essential part of the Quality assurance (QA)system and Part of GMP Documents designed, prepared, reviewed and controlled, wherever applicable, shall comply with these rules. Documents shall be approved, signed and dated by appropriate and authorized persons Documents shall specify the title, nature and purpose . They shall be laid out in an orderly fashion and be easy to check The records shall be made or completed at the time of each operation Data may be recorded by electronic data processing systems or other reliable means, but Master Formulae and detailed operating procedures relating to the system in use shall also be available in a hard copy to facilitate checking of the accuracy of the records SOP shall be made and followed strictly.

31. 13. Labels and other Printed Materials: Necessary for identification of the drugs and their use. The printing shall be done in bright colours and in a legible manner. The label shall carry all the prescribed details about the product All containers and equipment shall bear appropriate labels. Different colour coded labels shall be used to indicate the status of a product (for example: under test, approved, passed, rejected) To avoid chance mix-up of printed packaging materials, product leaflets, relating to different products, shall be stored separately. Prior to packaging and labelling of a given batch of a drug, it shall be ensured by the licensee that samples are drawn from the bulk and duly tested, approved and released by the quality control personnel.

32. 14. Quality Assurance: This is a wide ranging concept concerning all matters that individually or collectively influence the quality of a product A part of TQM, GMP,GLP,GCP. The final products are not released for sale before authorized persons have certified each batch, produced and controlled in accordance with the requirements of the label claim. 15. Self inspection and quality audits: Should be done to evaluate compliance with GMP. Team of independent, experienced an qualified persons for inspection. 16. Quality Control system Detailed instruction for quality control for raw materials and finished products; quality control for packaging and labelling; adequacy of storage, quality control procedure revised as and when possible and qualitative examination of returned products.

33. 17. Batch packaging record: It is based on relevant parts of packaging instructions. Packaging record shall be kept for each batch. Transcription errors ( typographical mistakes) to be avoided; packaging equipments should be clean and proper maintenance of packaging record. 18. Batch processing records BPR for each batch for each product; clean equipment; name of product; number and batch being manufacture; dates and time of commencement of operation 19. Standard operating procedure (SOP) For receipt of each delivery of raw, primary and printed packing materials; sampling; instrument and equipment; internal labelling; quarantine and storage; batch numbering; testing, record of analysis.

34. 20. Product containers: Compliance with pharmacopoeia requirements; cleaning procedure and sterilization procedure should be properly followed . 21. Master formula records (MFR) Licence should maintain records relating to all manufacturing procedure for each product and batch size to be manufactured. Maintained in hard copy Also related to patent or proprietary status , name of formulation along with generic name, if any; name quantity, reference number of starting materials, strength, dosage form, description; identification. Prepared and endorsed by the competent technical staff. 22. Distribution records: Record properly maintained; record of complaints; adverse reactions and other reactions from consumers are also maintained .

35. 23. Reference samples: Reference and control samples shall be kept as per rules for all the batches. 24. Recall/ Recovering: As and when required.

36. PART II: Plant and Equipments (Salient Features) External Preparations: It covers ointments, emulsions, lotions, solutions, pastes, creams, dusting powders and other identical preparations . Minimum area:  30 square meters for basic installation and 10 square meters for ancillary area. Requirements:  mixing and storage tanks, jacketed kettles of different types, electric mixer, planetary mixer, colloid mill, triple roller mill, liquid and tube filling equipments, etc.

37. Jacketed kettles Colloid mill Planetary mixer Triple roller mill

38. 2. Oral Liquid Preparations It covers syrups, elixirs, emulsions and suspensions. (a) Minimum area:   30 square meters for basic installation and 10 square meters for ancillary area; (b) Requirements: Mixing and storage tanks, jacketed kettles of different types, electric stirrer, electric colloidal mill, emulsifier, filtration equipment, bottle filling machine, cap sealing machine, water distillation unit, clarity testing unit, etc .

39. Emulsifier Cap sealing machine

40. 3. Tablets For effective production, tablet production department is divided into four sections ( i ) Mixing, granulation and drying section (ii) Tablet compression section (iii) Packaging section (strip/blister) (iv) Coating section (a) Minimum area:   A minimum of 60 square meters for basic installation and 20 square meters for ancillary area for un-coated tablets. For coated tablet, additional area of 30 square meters for coating section and 10 square meters for ancillary area. (b) Requirements:  Disintegrator, sifter, powder mixer, mass mixer, planetary mixer, rapid mixer granulator, granulator, hot air oven, weighing machines, compression machine (single, multi-punch, rotary), punches and dies storage cabinets, table de-duster, table inspection unit/belt, dissolution test apparatus, single pan balance, hardness tester, friability and disintegration test apparatus, strip/blister packaging machine, leak test apparatus, tablet counter, jacketed kettles of different types, SS coating pan, polishing pan, weighing balance, exhaust system and vacuum dust collector, air-conditioning system (wherever applicable), etc.

41. Disintegrator

42. 4. Powders Area:  Minimum 30 square meters ; additional room for actual blending Requirements:  Disintegrator, electric mixer, sifter, SS vessels and scoops of suitable sizes, filling equipment, weighing balance, etc. 5. Capsules Area:  A separate enclosed area, suitably air-conditioned and dehumidified. A minimum area of 25 square meters for basic installation and 10 square meters for ancillary area each for penicillin and non-penicillin section. Requirements (for hard gelatin capsules):  Electrical mixing and blending equipment, capsule filling units (semi-automatic and automatic), capsules counters, weighing balance, disintegration test apparatus, capsule polishing equipment, etc.

43. 6. Surgical Dressings Area:  Minimum 30 square meters for basic installation ; for medicated dressing additional room required. Requirements:  Rolling, staining, cutting, folding and pressing machines; mixing tanks, hot air oven, steam sterilizer, work tables, etc. 7. Ophthalmic Preparations It includes eye-ointment, eye lotions and other preparations for external use. Separate enclosed areas with air-lock arrangements required. Area:  Minimum 25 square meters for basic installation and 10 square meters for ancillary area. https://www.pharmacy180.com/article/schedule-m---gmp-(good-manufacturing-practices)-and-requirements-of-premises,-plant-and-equipment-1770/

44. Schedule-N: The list of minimum equipment for the efficient running of a pharmacy General: A pharmacy shall be conducted under the continuous personal supervision of a Registered Pharmacist whose name shall be displayed conspicuously in the premises . The pharmacy shall be properly kept and everything shall be in good order and clean. Records and Registers shall be maintained i n accordance with the laws in force Components: 1. Entrance: The front of a pharmacy shall bear an inscription “Pharmacy” in front. 2. Premises: The premises of a pharmacy shall be separated from rooms for private use. The premises shall be well built, dry, well lit and ventilated and, of sufficient dimensions to allow the goods in stock, especially medicaments and poisons to be kept in a clearly visible and appropriate manner. The areas of the section to be used as dispensing department shall be not less than 6 square meters for one pharmacist working therein with additional 2 square meters for each additional pharmacist. The height of the premises shall be at least 2.5 meters. The floor of the pharmacy shall be smooth and washable. The dispensing department shall be separated by a barrier to prevent the admission of the public.

45. Pharmacy Shops

46. 3. Furniture and apparatus: The furniture and apparatus of a pharmacy shall be adapted to the uses for which they are intended and correspond to the size and requirements of the establishment. Drugs, chemicals, and medicaments shall be kept in a room appropriate to their properties and in such special containers as will prevent any deterioration of the contents or of contents of containers kept near them. Drawers, glasses and other containers used for keeping medicaments shall be of suitable size and capable of being closed tightly to prevent the entry of dust. Every container shall bear a label of appropriate size , easily readable with names of medicaments as given in the Pharmacopoeias. A pharmacy shall be provided with a cupboard with lock and key for the storage of poisons and shall be clearly marked with the word “POISON” in red letters on a white background.

47. Apparatus:

48. Books The Indian Pharmacopoeia (Current Edition) National Formulary of Indian (Current Edition) The Drugs and Cosmetics Act, 1940 The Drugs and Cosmetics Rules, 1945 The Pharmacy Act, 1948 The Dangerous Drugs Act, 1930

49. Schedule-P: Includes Life period and Storage conditions

50. Schedule-P(I): Pack size

51. Schedule-X: List of Narcotic, habit forming, psychotropic and other such drugs Contain the list of Narcotic drugs and psychotropic substances and any stereoisometric forms. Must display the texts “Rx” Warning: To be sold by retail on the prescription of a RMP only. Application form 24F, GoL -Form 25F, RC-26F. These are drugs which cannot be purchased over the counter without the prescription of a qualified doctor. After dispending the drug, the pharmacist must stamp & retain the prescript details for 2 years. Maintain & record purchase & sale of the drugs and preserve it for a period of 2 years from the date of transactions. Comply with schedule-H. The drugs must be kept under lock & key.

52. Schedule-Y: Requirement and guidelines on clinical trials for import and manufacture of new drug Application for permission to import or manufacture new drugs for sale or to undertake clinical trials shall be made in Form 44

53. Clinical Trial

54. Schedule-Y(I) Amended under the rule 122 DAB ( Injury and death in clinical trials and compensation). Includes the Registration of Clinical Research Organisation (CRO) for conducting the clinical trials. Deals with compensation in case of injury/ death during clinical trial.

55. Colour permitted: No drug shall contain the colour other than that specified below: Natural colours: Annatto, Carotene, Chlorophyll, Cochineal, Curcumin , Red oxide of iron, yellow oxide of iron, titanium dioxide, black oxide of iron. Artificial colour: Caramel, Riboflavin. Coal Tar Colours: Quinazarine green, Alizarin cyanin green, tartrazine , red(erythrosine), Sudan red iii, indigo carmine, orange G, Resorcin brown, Naphthol blue-black.

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