DETAILED STUDY OF THE SCHEDULES
Schedule G:
Most of these drugs are hormonal preparations. The drug label must display the text.
"Caution: It is dangerous to take this preparation except under medical supervision" prominently.
Examples: Testolactone, Hydroxyurea, Carbutamide, Primidone, Mercaptopurine,
Methsuximide, Thiotepa etc.
Schedule H:
The drug label must display the texts "Rx" on the left top corner of the label and "Schedule H drug.
Warning : To be sold by retail on the prescription of a Registered
Medical practitioner only" prominently. It can only be supplied to licensed parties. It cannot be sold without a prescription and only the amount specified in the prescription should be sold. The time and date of prescription must be noted. Examples: Androgenic, anabolic,
oestrogenic and progestational substances; Alprazolam, Hepatitis B vaccine, Adrenocorticotrophic hormone, Ibuprofen, Vasopressin etc.
If a Schedule H drug also comes under the purview of Narcotic Drugs and Psychotropic Substances Act, 1985, it must carry the texts "NRx" in red on the left top corner of the lable
and "Schedule H drug. Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only." on the label prominently.
Schedule M (GMP-GOOD MANUFACTURING PRACTICES):
It is defined as “the part of quality assurance which is aimed to ensure that the product are consistently manufactured to the quality appropriate to their intended use”. It prescribes the requirements of premises, plant and equipment needed for setting up manufacturing
unit. Also documents every stage of manufacture, packing, storage, transportation checking and testing of medicinal product, maintenance or keeping records.
Part-1: Requirements for Premises and Materials
1. Locations and Surroundings:
The factory building shall be situated and constructed to avoid contamination from open sewerage, drain, disagreeable or obnoxious odour, dust and smoke etc.
2. Buildings and Premises:
A building for manufacturing unit shall permit work under hygienic conditions. It should be free from any insects/rodents. Light and ventilation facility should be adequate. Walls and floor should be free from cracks and damp. Premises should also be confirmed with provisions of factory act.
3. Water Supply:
Water supply should be pure and of potable quality. Adequate provision of water for wasting the premises shall be made.
4. Disposable of Waste:
(i) Disposal of sewage and effluents from the factory should be as per “Environment Pollution Control Board’’.
(ii) All bio-medical wastes should be destroyed as per “Biomedical Waste management rules-1996”.
(iii) Hazardous, toxic and inflammable substances should be stored in suitably designed and segregated in enclosed areas, as prescribed by Central and State legislations.
5. Stores:
Store should have adequate space for independently and separately store raw material, packaging material and finished products.
6. Working Space:
Manufacturing area should be adequate for orderly placement of equipment, machinery and material used during manufacturing operations and quality control to facilitate easy and safe working and to minimize or eliminate any risk of mix-up between different drugs, raw materials and to prevent the cross contamination during manufacturing, storage and handling operations.
7. Sterile Products:
For the manufacture of sterile products separate enclosed areas shall be provided with the air lock system for the entry and shall be essentially dust free and ventilated with an air supply for all areas where aseptic manufacturing has to be carried out.
8. Container’s Cleaning:
Washing, cleaning and drying section of containers such as bottles, vials and jars should have adequate arrangement and should be separated from manufacturing operations.
9. Machinery:
To carry out manufacturing process, adequate machinery and equipment require. These machinery could be manually operated or semi-automatic or fully automatic based upon your need and investment.
10. Raw-Materials:
The licensee shall keep on inventory of all raw material to be used at any stage of manufacture of drugs and maintain the record as per schedule U.
11. Equipment:
Equipment used for the manufacturing of drugs shall be constructed designed, installed and maintained to
(i) Achieve operational efficiency to attain desired quality.
(ii) Prevent physical, chemical and physico-chemical change through surface contact.
(iii) Prevent contact of any substance required for operation of the equipment like lubricant etc.
(iv) Facilitate through cleaning wherever necessary.
12. Batch Manufacturing Record:
Each batch record should be maintained irrespective of product manufactured
(i) Manufacturing records are required to provide an account of the list of raw materials and their quantities obtained from the store, tests conducted during the various
stages of manufacture like taste, colour, physical characteristics and chemical tests as may be necessary or indicated in the Drugs and Cosmetics Act.
(ii) These tests may include any in-house or pharmacopoeial test adopted by the manufacturer in the raw material or in the process material and in the finished product.
Master Formula Records:
The licensee shall maintain MFR relating to all manufacturing procedure for each product which will be prepared and endorsed by the competent technical staff that is head of production and quality control.
13. Health Clothing, Sanitation and Hygiene of Workers.
14. Medical Services:
Adequate facility for first aids should be provided by manufacturer. Medical examination of workers at the time of employment and periodical
check-up should be conducted at least once in a year and proper record should be maintained.
15. Distribution Record:
Distribution record (Dispatch register) should be maintained to facilitate process of prompt and complete recall of the batch. Distribution record should be maintained till expiry of batch.
16. Record of Market Complaints:
A complain register should maintain to record all reports of market complaints received regarding the products sold in the market.
17. Quality Control:
A manufacturer can set-up own quality control section or testing could be done through government approved testing laboratory.
Part-2: Requirements for Plant and Equipments
1. Area:
(i) Basic installation - Requires minimum of 30 sq. mt. (for tablets manufacturing, upto 60 sq. mt.)
(ii) Ancillary area: 10 sq. mt. (for tablets manufacturing, upto 20 sq. mt.)
2. Equipment:
Colloidal mill, mixing and storage tanks, stainless steel containers, Planetary mixer, Triple roller, tube filling equipments, filter proof cap sealing machine, water distillation unit, clarity testing inspection unit, disintegrator and sifter, granulator, tray or fluidized bed driers, weighing machine, tablet compression machine (single-multi-rotary punch), tablet inspection unit, dissolution test apparatus, hardness tester, friability tester, disintegration test apparatus, air conditioners, polishing pan, jacketed kettle, leakage test apparatus, capsule filling unit, hot air ovens, Laminar air flow unit, bottle washing machines, autoclave, transfer pumps, trimming machine, cutting machine etc.
Parts of Schedule M
Part 1: Describes Good Manufacturing Practices For Premises and Material.
Part 1A: Describes the specific requirement for manufacture of sterile products.
Parenteral preparations (Small Volume Injections and Large Volume Parentrals) and Sterile Ophthalmic Preparations.
Part 1B: Describes the specific requirements for manufacture of oral solid forms (Capsule and Tablets)
Part 1C: Describes the specific requirements for manufacture of oral liquids (syrups, elixirs, emulsions and suspensions).
Part 1D: Describes the specific requirements for manufacture of topical products i.e. External Preparations (Cream, Ointments, Pastes, Emulsions, Lotions, Solutions, Dusting Powders and Identical Products)
Part 1E: Describes the specific requirements for manufacture of Metered Dose Inhalers (MDI).
Schedule N:
Describes the facilities and equipments for efficient running of a Pharmacy.
1. Entrance:
Front of a pharmacy shall bear an inscription “Pharmacy” in front.
2. Premises:
(i) Separated from rooms, well built, dry, well lit and ventilated with sufficient dimensions for stock of medicaments.
(ii) Poisons to be kept in a clearly visible and appropriate manner.
(iii) Dispensing department shall be not less than 6 sq. m. for one pharmacist working therein with additional 2 sq. m. for each additional pharmacist.
(iv) Height of the premises shall be at least 2.5 metres.
(v) Floor of the pharmacy shall be smooth and washable.
(vi) Walls shall be plastered or tiled or oil painted so as to maintain smooth, durable and washable surface devoid of holes, cracks and crevices.
(vii) A pharmacy shall be provided with ample supply of good quality water.
(viii) The dispensing department shall be separated by a barrier to prevent the admission of the public.
3. Furniture and Apparatus:
(i) A pharmacy shall contain furniture and apparatus, drawers, containers, glasses of suitable sizes and designed to prevent dust entry.
(ii) Every container shall bear a labels, easily readable with names of medicaments as
given in the Pharmacopoeias.
(iii) Shall be provided with a dispensing bench, washable top etc.
(iv) Separate cupboards with lock and key for Poisons, and shall be marked in red
letters as ‘’POISON’’ on a white background.
(v) All concentrated solutions shall be labelled as ‘’To be diluted’’.
(vi) Pharmacy shall bear all the prescribed apparatus and books for official preparations and prescriptions.
(a) Balance
(b) Beakers, bottles, funnels
(c) Filter and litmus papers
(d) Mortar and pestle, other glasswares
(e) Spatula, scissors, stands
(f) Spirit lamp, thermometer
(g) Water bath, distillation apparatus
(h) Watch glasses, pill machines, suppository mould etc.
4. General provisions:
Pharamcist shall always wear a clean white overalls, records and registers shall be maintained as per the law, medicaments must bear labels when supplied as per the law.