Schedule P
Schedule P describes the life period of drugs in months (unless otherwise specified) between date of manufacture and date of expiry which the labelled potency period of the drug shall not exceed under the conditions of storage specified.
Schedule T
Contains various regulations and requirements for manufacture of Ayurvedic, Siddha and Unani products.
Part 1: Describes the Good Manufacturing Practice of Ayurvedic, Sidha and Unani Medicines.
A Manufacturing Premises should have adequate space for all daily activity like:
1. Receiving and Storage of Herbs, Packaging material and other raw material.
2. Production and Manufacturing Activity Area.
3. Quality Control Section.
4. Finished Goods Store.
5. Office and Administration.
6. Rejected Products/Drugs Store.
7. Minimum area required for setting up Ayurveda, Sidha and Unani Medicine manufacturing unit is 1200 sq. ft. covered with separate cabins and partitions for each activity. If unani medicines/ayurvedic medicines are manufactured along with ayurvedic medicines/unani medicines additional 400 sq. ft. area is required.
General Requirements:
1. Location 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: 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
conformed 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: Proper waste management care should be done.
5. 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.
6. Stores: Store should have adequate space for independently and separately store
raw material, packaging material and finished products.
7. 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.
8. Health Clothing, Sanitation and Hygiene of Workers.
9. 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.
10. Machinery and Equipment: 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.
11. Batch Manufacturing Record: Each batch record should be maintained irrespective of product manufactured.
12. 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. For drugs who do not have expiry date like Bhasma, Rasa, Asava-arishtha etc. record should be maintained upto five years of the exhausting of stock.
13. Record of Market Complaints.
14. Quality Control: A manufacturer can set-up own quality control section or testing
could be done through government approved testing laboratory read in detail about Ayurvedic, Sidha and Unani manufacturing unit quality control section.
Part 2: Describes list of recommended machinery, equipment and manufacturing premises required for the manufacture of various categories of Ayurvedic, Siddha system of medicines.
Schedule U:
Schedule U describes the particulars to be shown in manufacturing record, records of raw materials and analytical drugs.
Following details are included in Schedule U:
1. Manufacturing Records:
(i) Substances other than Parenteral Preparation: Serial number, Product name, Reference of Master formula records, Batch size and number, Date-time-duration conditions of the process for manufacture, Name of all the ingredients, Specifications, Quantity required, References to analytical report number, theoretical yield and actual production yield of finished product, specimen of
label, date of release of finishes packagings etc.
(ii) Parenteral Preparations: All the above including, Sterility tests such as Leakage, Pyrogen, Clarity and Toxicity tests; records of sterilization etc.
2. Records of Raw Materials: Date of receipt, Invoice number, Name and address of the
manufacturer/supplier, Batch number, Quantities received, Pack size, Dates of manufacture
and expiry, Date of analysis and release/rejection by quality control, Analytical report number with special remarks, quantity and date of issue etc.
3. Particulars to be recorded in the Analytical Records.
(i) Tablet, Capsules and for other drugs: Analytical report number, Sample name, Date of receipt, Batch number, Protocols of test applied, Signature of analyst etc.
(ii) Parenteral Preparations: All the above including, sterility tests.
(iii) Raw Materials: Serial number, Number of materials, Name of manufacturer/ supplier, Quantity received, Challan/invoice number and date, Protocols for test
applied.
(iv) Container and Packing Material: All the above including, Results of tests, Remarks, Signature of examiner etc.
Schedule UI
Schedule UI describes the particulars to be shown in the manufacturing record for cosmetics:
1. Manufacturing Records: Serial number, Product name, Reference of Master formula records, Batch size and number, Date-time-duration conditions of the process for manufacture, Name of all the ingredients, specifications, quantity required, references to analytical report number, theoretical yield and actual production yield of finished product, specimen of label, date of release of finishes packagings, etc,.
2. Records of Raw Materials: Date of receipt, invoice number, name and address of the manufacturer /supplier, batch number, quantities received, pack size, dates of manufacture and expiry, date of analysis and release/rejection by quality control, analytical report number with special remarks, quantity and date of issue etc.
Schedule V
Schedule V describes the standards for patent or proprietary medicines.
Patent or Proprietary medicines containing vitamins for prophylactic, therapeutic or paediatric use shall contain the vitamins in quantities not less than and not more than those
specified in single or in two divided daily doses.
Schedule X
Drugs which are habit forming, psychotropic and other drugs likely to be misused for addictive purposes. Hence import, manufacture, sale and distribution of these are regulated under special provisions.
All the regulations of Schedule H apply. The retailer must keep a copy of the prescription for two years. The drugs must be kept under lock and key. Examples: Amphetamine, Secobarbital, Glutethimide, Cyclobarbital, Phencyclidine, Phenobarbital etc.
Schedule Y
Describes requirements and guidelines on Clinical trials for import and manufacture of
new drugs.
1. Clinical Trials
(i) Permission of trials: One must apply for Form 12 for test license (TL). The application shall comprise-data for various phases, protocol for proposed trials, case report forms to be used, names of Investigators and Institutions.
(ii) Responsibility of Sponsor/ Investigator: Sponsors must submit the annual status report of each clinical trial, to the licensing authority. Any termination, unusual,
unexpected or serious adverse drug reactions (ADR) detected during trial must be
communicated to the authority.
(iii) In all trials, informal, written, voluntary consent must be obtained from each volunteer in the prescribed forms.
2. Data required to be submitted with the application for permission to market New Drug
(i) Clinical and Pharmaceutical Informations.
(ii) Animal toxicology: Acute, chronic, reproduction status (fertility, teratogenic and prenatal studies, local toxicology, mutagenicity, carcinogenicity).
(iii) Animal pharmacology.
(iv) Phase - 1,2,3 trials.
(v) Special studies (bioavailability and dissolution studies).
Phase 1 trials (Human/Clinical Pharmacology): Determines the maximum tolerated dose in humans; pharmacodynamics effects, adverse effects etc.
Phase 2 trials (Exploratory Trials): Determines the therapeutic doses, effective dose range, safety and pharmacokinetics.
Phase 3 trials (Confirmatory Trials): To obtain sufficient evidences about the efficacy and safety of the drugs.
The reports of the complete trials shall be submitted by the applicant duly signed by the investigator within a specified period of time. It should include description, actions,
indications, dosage precautions, drug interactions, warning and adverse reactions.
Schedule F:
This contains regulations and standards for running a blood bank.
Schedule FI :
This contains regulations and standards for bacterial vaccines, viral vaccines, antisera and
diagnostic agents.
Schedule F2:
This contains regulations and standards for surgical dressing.
Schedule F3:
This contains regulations and standards for umbilical tapes (polyester and cotton tapes).
Schedule FF:
This contains regulations and standards for ophthalmic preparations (solutions,
suspensions and ointments). The label must bear:
(i) The statement “use the solution within one month after opening the container”.
(ii) Name and concentration of the preservative used.
(iii) ‘’Not for Injection’’.
(iv) Storage instructions.
(v) Warning
(a) If irritation persists or increases, discontinue the use and consult physician.
(b) Do not touch the dropper tip or the other dispensing tip to any surface since this may contaminate the solution.
Part XII-B:
Requirements for the premises, personnel, equipments and organizations and operation
of a Blood Bank and/or for preparation of Blood components. It’s a part under Schedule F.
I. Blood Banks/Blood Components:
(i) General
(ii) Accommodation for a Blood Bank
(iii) Personnel
(iv) Maintenance
(v) Equipments and instruments
(vi) Supplies and Reagents
(vii) Good Manufacturing Practices (GMPs)/ Standard Operating Procedures (SOPs)
(viii) Criteria For Blood Donation
(ix) Special Reagents
(x) Testing of whole blood
(xi) Records
(xii) Labels
II. Blood Donation Camps:
(i) Premises, personnel etc.
(ii) Personnel for Out-door Blood Donation Camp.
(a) One Medical Officer and two nurses or phlebotomists for managing 6-8 donor
tables.
(b) Two medico social workers.
(c) Three blood bank technicians.
(d) Two attendants.
(e) Vehicle having a capacity to seat 8-10 persons, with provision for carriage of
donation goods including facilities to conduct a blood donation camp.
(iii) Equipments.
III. Processing of Blood Components from Whole Blood by a Blood Bank:
(i) Accommodation
(ii) Equipment
(iii) Personnel
(iv) Testing Facilities
(v) Categories of Blood Components
(a) Concentrated Human Red Blood Corpuscles
(b) Platelets Concentration
(c) Granulocyte Concentration
(d) Fresh Frozen Plasma
(e) Cryoprecipitate
Drug and Magic Remedies (Objectionable Advertisements):
The act defines "magic remedy" as any talisman, mantra, kavachas or any other object
which is claimed to have miraculous powers to cure, diagnose, prevent or mitigate a disease
in humans or animal. It also includes such devices that are claimed to have power to
influence structure or function of an organ in humans or animals.
The law prohibits advertising of drugs and remedies for −
(i) Inducing miscarriage or preventing conception in women.
(ii) Improving or maintaining the capacity for sexual pleasure.
(iii) Correction of menstrual disorders.
(iv) Curing, diagnosing or preventing any disease or condition mentioned in an included schedule.