Study of schedule C and C1, G, H, H1, K, P, M, N, and X. Drugs and Cosmetics Rules 1945 under Pharmacy Law and Ethics.

SCHEDULE C and C1: Biological and Special Products

(Rules 23, 61, and 76 and Part X of the Drugs and Cosmetics Rules 1945)

Schedule C is a list of biological and special products intended for injection. Schedule C1 lists biological and special products not intended for injection

Schedule C.

• 1. Solution of serum proteins intended for injection.

• 2. Vaccines for parenteral injections.

• 3. Toxins.

• 4. Antigen.

• 5. Antitoxins.

• 6. Neo-arsphenamine and analogous substances are used to treat infective diseases.

• 7. Insulin.

• 8. Pituitary (Posterior Lobe) Extract.

• 9. Adrenaline and Solutions of Salts of Adrenaline.

• 10. Antibiotics and preparations thereof in a form to be administered through the parenteral route.

• 11. Any other preparation which is meant for parenteral administration as such or after being made up with a solvent or medium or any other sterile product and which—

  • a. requires to be stored in a refrigerator; or

  • b. does not require to be stored in a refrigerator.

  • c. Sterilized surgical ligature and sterilized surgical suture.

  • d. Bacteriophages.

• 12. Ophthalmic preparations.

• 13. Sterile Disposable Devices for single use only

SCHEDULE C (1): Other Special Products not for Injection

(The Drugs and Cosmetics Rules, 1945 Rules 23, 61 and 76)

• 1. Drugs belonging to the Digitalis group and preparations containing drugs belonging to the Digitalis group not in a form to be administered through the parenteral route.

• 2. Ergot and preparations containing Ergot not in a form to be administered through the parenteral route.

• 3. Adrenaline and preparations containing Adrenaline not in a form to be administered through the parenteral route.

• 4. Fish Liver Oil and preparations containing Fish Liver Oil.

• 5. Vitamins and preparations containing any vitamins not in a form to be administered parenterally.

• 6. Liver extract and preparations containing liver extract not in a form to be administered through the parenteral route.

• 7. Hormones and preparations containing hormones not in a form to be administered through the parenteral route.

• 8. Vaccine not in a form to be administered through parenteral route.

• 9. Antibiotics and preparations thereof not in a form to be administered through parenteral route

• 10. In –vitro Blood Grouping Sera

• 11. In –vitro Diagnostic Devices for HIV, HbsAg and HCV

Schedule G

Drugs intended for internal use and included under Schedule G of Drugs and Cosmetics Rules 1945 are Schedule G drugs. Labels of Schedule G drugs should follow Rule 97 of the Drugs and Cosmetics Rules 1945. Rule 97 states the labeling requirement for Schedule G drugs. As per rule 97, Schedule G drugs should be labeled with the following words – “Caution: it is dangerous to take this preparation except under medical supervision”. These words should be conspicuously printed and surrounded by a line within which there shall be no other words. These words should be written in white fonts against a red background in the box.

Examples: Chlorambucil, Chlorothiazide, benzothiadiazine Chlorpropamide, Chlorthalidone, Cyclophosphamide, Insulin, Mercaptopurine, Metformin, Phenformin, etc. Antihistaminic substances such as Antazoline Bromodiphenhydramine Buclizine Chlorcyclizine Chlorpheniramine Clemizole Cyproheptadine Diphenhydramine Diphenylpyraline Doxylamine Succinate Isothipendyl Mebhydrolin Napadisylate Meclozine Phenindamine Pheniramine Promethazine Thenalidine Triprolidine, etc.Their salts/derivatives are also Schedule G drugs.

Preparations containing drugs and their salts/derivatives mentioned in Schedule G intended for internal application are also considered Schedule G drugs.

Preparations containing drugs mentioned in Schedule G intended for topical or external use are not considered Schedule G preparation.

The manufacture, sale, and distribution of Schedule G drugs and their preparations require a valid license issued by the drug licensing authority. Disobeying Schedule G regulations is a punishable act. Punishment is imprisonment from 1 year to 10 years. Fine from Rs. 10000/- to Rs. 100000/-. On a second conviction, imprisonment shall be from 3 years to 10 years.

Schedule H and H1.

(Rules 65 and 97 of the Drugs and Cosmetics Rules 1945)

Drugs mentioned in Schedule H are prescription drugs. Schedule H contains the names of 536 drugs. Preparations intended for internal use and containing Schedule H drugs or their salts/derivatives come under Schedule H. Schedule H drugs are regulated by rules 65 and 97 of the Drugs and Cosmetics Rules 1945. Rule 65 states the conditions of licenses to manufacture Schedule H drugs. Rule 97 states labeling conditions for Schedule H drugs. Rule 97 states that

• • Preparation containing a substance specified in Schedule H shall be labeled with the symbol Rx. Symbol Rx shall be displayed on the left top corner of the label and be also labeled with the following words: “Schedule H drug- Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only”,

• • Preparation containing a substance specified in Schedule H and also comes under the Narcotic Drugs and Psychotropic Substances Act, 1985 shall be labeled with the symbol NRx. NRx shall be in red and displayed on the left top corner of the label. It shall also be labeled with the following words: Schedule H drug -Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only”

• • Preparation containing a substance specified in Schedule H and also comes under Schedule X shall be labeled with the symbol XRx. XRx shall be in red conspicuously displayed on the left top corner of the label and be also labeled with the following words: Schedule X drug -Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

For preparation containing a substance specified in Schedule H1, the drug formulation shall be labeled with the symbol Rx which shall be in red displayed on the left top corner of the label, and shall also be labeled with the following words in a box with a red border: “SCHEDULE H1 DRUG – WARNING. - It is dangerous to take this preparation except by the medical advice. -Not to be sold by retail without the prescription of a Registered Medical Practitioner”.

Preparations containing drugs mentioned in Schedule H intended for topical or external use (except ophthalmic and ear or nose preparations) are not considered Schedule H preparation.

The following drugs and their derivatives/salts are some examples of Schedule H drugs

Amikacin sulfate, Amino salicylic acid, Atenolol, Captopril , Cetirizine hydrochloride, Clotrimazole , Chlorpromazine, Diclofenac sodium/potassium, Digoxine , Diltiazem , Glucagon. Halogenated hydroxyquinolines. Haloperidol. Heparin. Hepatitis b. Vaccine , etc.

The following drugs and their derivatives/salts are some examples of Schedule H1 drugs. Antibiotics, anti-TB drugs, and habit-forming drugs are moved from Schedule H to Schedule H1. There are 46 drugs under Schedule H1.

Alprazolam, Doripenam, Balofloxacin, Ertapenem, Buprenorphine, Ethambutol Hydrochloride, Capreomycin, Ethionamide, Cefdinir, Feropenam, Cefditoren, Gemifloxacin, Cefepime, Imipenem, Cefetamet, Isoniazide, Cefixime, Levofloxacin, Cefoperazone, Meropenem, Cefotaxime, Midazolam, Cefpirome, Moxifloxacin, Cefpodoxime, Nitrazepam, Ceftazidime, Pentazocine, Ceftibuten, Prulifloxacin, Ceftizoxime, Pyrazinamide, Ceftriaxone, Rifabutin, Chlorodiazepoxide, Rifampicin, Clofazimine, Sodium Para-aminosalicylate, Codeine, Sparfloxacin, Cycloserine, Thiacetazone, Diazepam, Tramadol, Diphenoxylate, Zolpidem

Schedule M

Drug and Cosmetic Act and Rules 71, 74, 76 and 78

“Good Manufacturing Practices and Requirements of Premises, Plant, and Equipment for Pharmaceutical Products”. Schedule M was previously known as “Good Manufacturing Practices”. Schedule M was amended on the 28th of December 2023.

The manufacturing premises shall be used exclusively for the production of drugs and no other manufacturing activity shall be allowed. Each licensee shall develop appropriate methodology, systems, and procedures. These shall be documented and maintained for inspection and reference.

Schedule M classifies drug manufacturers into two classes.

• 1. Large manufacturer: Turnover of more than Rs. 250 crores

• 2. Small and medium manufacturers: Turnover Rs. 250 crores or less.

There are 13 parts of Schedule M under the Drugs and Cosmetics Rules 1945.

• Part-I: Good Manufacturing Practices For Pharmaceutical Products: Main Principles.

• Part II: Specific requirements for manufacture of sterile products, parenteral preparations (small volume injectables and large volume parenteral), and sterile ophthalmic preparations

• Part III: Specific requirements for manufacturing pharmaceutical products containing hazardous substances such as sex hormones, steroids (anabolic, Androgenic) or cytotoxic substances

• Part IV: Specific requirements for the manufacture of biological products

• Part V: Specific requirements for radiopharmaceutical products

• Part VI: specific requirements for phytopharmaceuticals

• Part VII: specific requirements for the manufacture of investigational pharmaceutical products for clinical trials in humans

• Part VIII: specific requirements for manufacture of oral solid dosage forms (tablets and capsules)

• Part IX: Specific requirements for the manufacture of oral liquids (syrups, elixirs, emulsions, and suspensions)

• Part X: Specific requirements for the manufacture of topical products i.e., external preparations (creams, ointments, pastes, emulsions, lotions, solutions, dusting powders, and identical products)

• Part XI: Specific requirements for manufacture of metered–dose– inhalers (MDI)

• Part XII: Specific requirements for manufacture of active pharmaceutical ingredients

• Part XIII: Requirements of plant and equipment.

GOOD MANUFACTURING PRACTICES FOR PHARMACEUTICAL PRODUCTS: MAIN PRINCIPLES.

• 1. Suitable equipment with a minimum area of thirty square meters for basic installation and ten square meters for ancillary area separately for each section such as External preparations, Oral Liquid Preparations, Powders, Capsules for the penicillin section, capsules for non-penicillin section, Surgical dressing, and Repacking of drugs and pharmaceutical chemicals:

• 2. Tablets- The Tablet section shall be free from dust and floating particles and may be air-conditioned. Separate sections for Mixing, Granulation and Drying section, Tablet compression section, Packaging section, and Coating section (wherever required). Suitable equipment with Area- A minimum area of sixty square meters for basic installation and twenty square meters for ancillary area is recommended for un-coated tablets.

• 3. A minimum additional area of thirty square meters for the coating section for basic installation and ten square meters for the ancillary area is recommended. .

• 4. Ophthalmic preparations:- For the manufacture of ophthalmic preparations, separate enclosed areas. Suitable equipment with a minimum area of twenty-five square meters for basic installation and ten square meters for ancillary

• 5. Parenteral Preparations:- A separate area or room Parenteral preparations in glass containers, Containers and closures preparation area, Solution preparation area, Filling, capping and sealing area, Sterilisation area. Quarantine area. Visual inspection area, Packaging area. Area: A minimum area of one hundred and fifty square meters for the basic installation and an ancillary area of one hundred square meters for Small Volume Injectable. For Large Volume Parenterals, an area of one hundred and fifty square meters each for the basic installation and for ancillary area. These areas shall be partitioned into suitable enclosures with airlock arrangements. Areas for formulations meant for external use and internal use shall be separately provided to avoid mixup. Packaging materials for large volume Parenteral shall have a minimum area of one hundred square meters.

REQUIREMENTS OF PLANT AND EQUIPMENT

• 1. The Pharmaceutical Quality System (PQS) outlines the responsibilities and requirements for the quality of pharmaceutical products. It emphasizes the role of senior management in maintaining an effective quality system, Good Manufacturing Practices (GMP), and Quality Risk Management (QRM). The Key points include the importance of product realization, managing product and process knowledge, adherence to GMP, quality control operations, proper handling of materials, and certification by authorized persons before product release.

Furthermore, it highlights the need for a system of continual improvement, implementation of QRM, reporting and investigation of deviations and defects, and periodic management reviews.

• 2. Quality Risk Management (QRM): It is a systematic process for assessing, controlling, communicating, and reviewing risks related to the quality of medicinal products. The key principles of QRM include basing risk evaluation with a focus on patient protection.

The document emphasizes the importance of regular product quality reviews for pharmaceutical products. These reviews aim to verify process consistency, assess current specifications for starting materials and finished products, and suggest improvements. The reviews cover various aspects, including materials used, in-process controls, finished product results, deviations, changes in processes or methods, stability monitoring, quality-related returns, complaints, recalls, equipment qualification, and technical agreements.

The manufacturer evaluates the review results. Corrective and preventive actions may be initiated under the product quality system. These actions must be completed in a timely and effective manner. A technical agreement defines responsibilities for the quality review among involved parties, and the authorized person overseeing final batch certification ensures the timely and accurate performance of the quality review.

• 3. Good Manufacturing Practices (GMP) for pharmaceutical products are an integral part of quality management, ensuring consistent production and control according to specified quality standards for intended use, as required by licensing conditions, clinical trial permissions, or product specifications. GMP is focused on managing and minimizing risks inherent in pharmaceutical manufacturing to ensure product quality, safety, and efficacy. The following are the main features of GMP:

  • · Clearly Defined Manufacturing Processes: Processes are clearly defined, systematically reviewed processes for associated risks and capable of producing pharmaceutical products of the required quality.

  • · Qualification and Validation: Qualification and validation processes are performed to ensure the reliability and effectiveness of manufacturing processes.

  • · Provision of Necessary Resources: Adequate resources are provided, including qualified personnel, suitable premises, equipment, materials, approved procedures, storage, transport, and compliance with relevant regulations and guidance documents.

  • · Clear Instructions and Procedures: Instructions and procedures are written in clear and clear language.

  • · Correct Procedure Implementation and Personnel Training: Procedures are correctly implemented, and personnel are adequately trained to carry them out.

  • · Record Keeping: Records are maintained during manufacturing to demonstrate procedures. Significant deviations in the process are recorded, investigated, and addressed with appropriate corrective and preventive actions.

  • · Traceability and Record Retention: Records covering manufacture and distribution enable the complete history of a batch to be traced and are retained in a comprehensible and accessible form.

  • · Proper Storage and Distribution: Products are stored and distributed to minimize any risk to their quality.

  • · Recall System: A recall system is in place to promptly withdraw any batch of product from sale or supply if necessary.

  • · Handling of Complaints: Complaints about marketed products are examined, and investigations into the causes of quality defects are conducted. Appropriate measures are taken to address defective products and prevent recurrence.

Schedule K

Rule 123 of the Drugs and Cosmetics Rules 1945 specifies that the drugs in Schedule K shall be exempted from the provisions of Chapter IV of the Act and the Rules. Chapter IV specifies conditions for the manufacture, sale, and distribution of drugs and cosmetics. The following are a few examples included in Schedule K.

• 1. Not intended for medicinal use. Its container should be labeled with the words “NOT FOR MEDICINAL USE”

• 2. Quinine and other antimalarial drugs

• 3. Drugs supplied by a registered medical practitioner to his own patient or any drug specified in Schedule C supplied by a registered medical practitioner at the request of another such practitioner.

• 4. Drugs supplied by a hospital or dispensary maintained or supported by Government or local body

• 5. Whole Human Blood IP and/or its components stored for transfusion by a First Referral Unit, Community Health Centre, Primary Health Centre and a Hospital

• 6. Magnesium Sulphate

• 7. The following substances which are used both as articles of food as well as drugs –

  • · All condensed or powdered milk whether pure, skimmed, or malted, fortified with vitamins and minerals or otherwise.

  • · Farex, Oats, and all other similar cereal preparations whether fortified with vitamins or otherwise except those for parenteral use.

  • · Virol, Bovril, Chicken essence, and all other similar predigested foods.

  • · Ginger, Pepper, Cumin, Cinnamon, and all other similar spices

• 8. Substances intended to be used for the destruction of vermin or insects that cause disease in human beings or animals, such as Insecticides and Disinfectants

• 9. The following household remedies, namely-

  • · Aspirin tablets,

  • · Paracetamol Tablets,

  • · Analgesic Balms. Antacid preparations.

  • · Gripe Water for use of infants.

  • · Inhalers, containing drugs for the treatment of cold and nasal congestion,

  • · Syrups, lozenges, pills, and tablets for cough,

  • · Liniments for external use,

  • · Skin ointments and ointments for burns,

  • · Absorbent cotton wool, bandages absorbent gauze, and adhesive plaster.

  • · Castor Oil, Liquid Paraffin, and Epsom Salt. Eucalyptus Oil,

  • · Tincture Iodine, Tincture Benzoin. and Mercurochrome in containers not exceeding 100 ml.

  • · Tablets of Quinine Sulphate I.P.

  • · Tablets of Iodochlorohydroxy quinoline-250 mg

  • · Mechanical Contraceptives,

• 10. Mechanical Contraceptives

• 11. Vaginal contraceptive pessaries containing Nonoxynol

• 12. Chemical contraceptives have the following composition per tablet :

  • · DL-Norgestrel-0.30 mg. and Ethinyloestradiol-0.03 mg.

  • · Levonorgestrel-0.15 mg and Ethinyloestradiol-0.03 mg.

  • · Centchroman-30mg and Desogestrel -0.150mg.

  • · Ethinyloestradiol 0.030mg and Levonorgestrel 0.1mg.

  • · Ethinyloestradiol 0.02mg

• 13. Cosmetics Ophthalmic ointments of the Tetracycline group of drugs

• 14. Hair Fixers, namely mucilaginous preparations containing gums,

• 15. Radio Pharmaceuticals

• 16. Tablets of Chloroquine Salts

• 17. Medicated Dressing and Bandages for First Aid

• 18. First Aid kit supplied along with motor vehicle by the manufacturer or its distributors at the time of first sale of a vehicle

• 19. Nicotine gum and Lozenges containing up to 2 mg of nicotine

• 1. Drugs supplied by ( i ) Multipurpose Workers attached to Primary Health Centres/sub-centers, (ii) Community Health Volunteers under the Rural Health Scheme, (iii) Nurses, Auxiliary Nurses, Midwives and Lady Health Visitors attached to Urban Family Welfare Centres/Primary Health Centres/Sub-Centres and 41[(iv) Anganwadi Workers,

• 2. Oral Rehydration Salts (Manufactured as per the following formula) :

  • · Sodium chloride 3.5 g/litre.

  • · Trisodium citrate dehydrate 2.9 g/litre

  • · Potassium Chloride 1.5 g/liter.

• May be replaced by Sodium bicarbonate (Sodium hydrogen Carbonate) 2.5 g/ litre, when citrate salt is not available

Schedule P

• Rule 96 of the Drugs and Cosmetics Rule states Schedule P which is the life period in months (shelf life) and storage conditions of various drugs and storage conditions. The life period of drugs shall be labeled between the date of manufacturing and the date of expiry.

Rule 109 states Schedule P1 which is pack sizes of the drugs.

Note:

• 1. The term ―cool place means a place having a temperature between 10 degrees C and 25 degrees C.

• 2. The term ―cold place means a place having a temperature not exceeding 8 degrees C.

• 3. Capsules should be kept in a well-closed container at a temperature not exceeding 30 degrees C.

• 4. Wherever the condition of storage is not specified it may be stored under normal room temperature.

• The following are a few examples

Antibiotics

• 1. Ampicillin Trihydrate: 30 Months, Store in a cool place.

• 2. Amoxycillin Trihydrate: 37 Months, Store in a cool place.

• 3. Amoxycillin Trihydrate Dry Syrup: 18 Months

• 4. Chloramphenicol: 60 Months, Store in a cool place

• 5. Cloxacillin: 36 Months, Store in a cool place

• 6. Doxycycline Hydrochloride: 48 Months, Store in a cool place

• 7. Doxycycline Monohydrate: 36 Months, Store in a cool place

• 8. Erythromycin Ethyl Succinate tablet: 24 Months

• 9. Gentamycin sulphate injection: 36 Months

Vitamins

• 1. Vitamin A injection: 24 Months

• 2. Vitamin B1 injection: 24 Months

• 3. Vtamin B6 tablets: 36 Months

• 4. Vitamin C: 48 Months, Store in a well-closed container, protected from light, in a cool place.

• 5. Folic Acid tablets: 36 Months.

Insulin Preparations

• 1. Globulin zinc insulin injection: 24 Months: At temperature between 2 degrees C and 8 degrees C, must not be allowed to freeze

• 2. Insulin Injection: 24 Months: At temperature between 2 degrees C and 8 degrees C, must not be allowed to freeze: 24 Months: At temperature between 2 degrees C and 8 degrees C, must not be allowed to freeze

• 3. Insulin Zinc Suspension: 24 Months: At temperature between 2 degrees C and 8 degrees C, must not be allowed to freeze

• 4. Isophane Insulin Injection: 24 Months: At temperature between 2 degrees C and 8 degrees C, must not be allowed to freeze

• 5. Human Insulin Injection: 30 Months: At temperature between 2 degrees C and 8 degrees C, must not be allowed to freeze

NORMAL HUMAN PLASMA

• 1. Dried Plasma: 60 Months, At a temperature not exceeding 25 degrees C

• 2. Dried Normal Human Serum Albumin, 60 Months, At a temperature not exceeding 25 degrees C

• 3. Frozen Plasma, 60 Months, In a deep freezer.

SERA TOXIN AND TOXOID

• 1. Diphtheria Toxoid, 24 Months, In cold place

• 2. Tetanus Toxoid, 36 Months, In Cold Place

Other Vaccines

• 1. BCG Vaccine, 24 Months, In Cold Place

• 2. Cholera Vaccine, 18 Months, In Cold Place

• 3. Polio Vaccine, 24 Months, at minus 20 degrees C.

• 4. Polio Vaccine, 6 Months, at Zero degree C.

• 5. Rabies vaccine, 6 Months, In Cold Place

• 6. Typhoid vaccine, 18 Months, In Cold Place

• 7. Typhoid Para Typhoid A, B & C and Tetanus Vaccine: 18 Months, In Cold Place

Schedule N

Rule 64 (1) OF THE Drugs and Cosmetics Rule 1945 states Schedule N is List of Minimum Equipment for the Efficient Running of a Pharmacy. The following conditions shall be fulfilled to run a pharmacy.

• 1. Entrance. - The front of a pharmacy shall bear an inscription ―Pharmacy.

• 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. The premises shall have sufficient dimensions to allow the goods in stock. Medicaments and poisons shall be kept in a clearly visible and appropriate manner. Dispensing area shall be not less than 6 square meters for one pharmacist. There shall be additional 2 square meters area 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 walls shall be plastered or tiled or oil painted. Wall shall be smooth, durable and washable without holes, cracks and crevices.

  A pharmacy shall be provided with ample supply of good quality water.

  The dispensing department shall be separated by a barrier. Public entry into dispensing area shall not be allowed.

• 3. Furniture and apparatus: - The furniture and apparatus of a pharmacy shall correspond to the size and requirements of the establishment.

  Drugs, chemicals, and medicaments shall be stored in at appropriate place and storage conditions. Storage conditions maintained to prevent deterioration. Drawers, glasses and other containers used for medicaments shall be of suitable size. These shall be 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 have a dispensing bench. The top of which shall be covered with washable and impervious material like stainless steel, laminated or plastic, etc.

  A pharmacy shall be provided with a cupboard with lock and key for the storage of poisons. It shall be clearly marked with the word “POISON” in red letters on a white background.

  Containers of all concentrated solution shall bear special label or marked with the words ―To be diluted.

  A Pharmacy shall be provided with the following minimum apparatus and books necessary for making of official preparations and prescriptions:-

  Apparatus: :

  • ii. Balance, dispensing, sensitivity 30 mg.

  • Balance, counter, capacity 3 Kgm., sensitivity 1 gm. Beakers, lipped, assorted sizes.

  • Bottles, prescription. Corks various sizes and tapers.

  • Cork, extractor.

  • Evaporating dishes, porcelain. Filter paper.

  • Funnels, glass.

  • Litmas paper, blue and red.

  • Measure glasses cylindrical 10 ml, 25 ml, 100 ml and 500 ml. Mortars and pestles, glass.

  • Mortars and pestles, wedgwood.

  • Ointment pots with bakelite or suitable caps. Ointment slab, porcelain

  • Pipette graduated, 2 ml, 5 ml and 10 ml. Ring, stand (retort) iron, complete with rings. Rubber stamps and pad

  • Scissors

  • Spatulas, rubber or vulcanite Spatulas, stainless steel. Spirit lamp

  • Glass stirring rods. Thermometer, 0 degree C to 200 degrees C. Tripod stand.

  • Watch glasses. Water bath.

  • Water distillation still in case Eye drops and Eye lotions are prepared. Weights, Metric, 1 mg. to 100 gm.

  • Wire Gauze.

  • Pill finisher, boxwood.

  • Pill Machine.

  • Pill Boxes.

  • Suppository mould.

• Books

  • i. The Indian Pharmacopoeia (Current Edition). National Formulary of Indian (Current Edition). The Drugs and Cosmetics Act, 1940.

  • ii. The Drugs and Cosmetics Rules, 1945.

  • iii. The Pharmacy Act, 1948.

  • iv. The Dangerous Drugs Act, 1930. Drugs and Cosmetics Rules 1945.

• 4. General provisions. - A pharmacy shall be under the continuous personal supervision of a Registered Pharmacist. The name of the registered pharmacist shall be displayed conspicuously on the premises.

  • The Pharmacist shall always put on clean white overalls (Laboratory Coat/Appron).

  • The premises and fittings of the pharmacy shall be properly kept and everything shall be in good order and clean.

  • All records and registers shall be maintained in accordance with the laws in force.

  • Any container taken from the poison cupboard shall be replaced immediately after use and the cupboard locked. The keys of the poison cupboard shall be under the personal custody of the responsible person.

  • Medicament labels must be per the provisions of laws in force.

• Note: - The above requirements are subject to modifications at the discretion of the licensing authority. The licensing authority may relax the above requirements or impose additional. The decision of the licensing authority in that regard shall be final.

Schedule X

Rules 23, 61, 75, 97, and 105A of the Drugs and Cosmetics Rules state Schedule X which is a list of addictive drugs (For example Narcotics, Psychotropics) that have also medicinal uses. All rules of Schedule H are also applicable to the Schedule X drugs. The following are examples of Schedule X drugs: Amobarbital, Glutethimide, Pentobarbital, Ketamine hydrochloride, Amphetamine, Meprobamate, Phencyclidine, Barbital, Methamphetamine, Phenometrazine, Cyclobarbital, Dexamphetamine, Methylphenidate, Secobarbital, Ethclorvynol, Methylphenobarbital

Salts of these drugs also come under Schedule X. Preparations containing Schedule X drugs or their salts also come under Schedule X.

Preparations containing Meprobamate in combination with other drugs may be exempted by the Licensing Authority, if satisfactory evidence is adduced that these preparations are not liable to be misused.