Full Text
REGD. No. D. L.-33004/99
The Gazette of India
CG-DL-E-20022025-261188
EXTRAORDINARY
PART II-Section 3-Sub-section (i)
PUBLISHED BY AUTHORITY
No. 106]
NEW DELHI, WEDNESDAY, FEBRUARY 19, 2025/MAGHA 30, 1946
MINISTRY OF AYUSH
NOTIFICAION
New Delhi, the 14th February, 2025
DRAFT RULES
1. Short title, and commencement: - (1) These rules may be called the Drugs (.........Amendment) Rules, 2025.
(2) They shall come into force from the date of their final publication in the Official Gazette.
2. In the Drug Rules, 1945(hereinafter referred to as the said rules), the proviso to the rule 156 shall be omitted.
3. In the said rules, the proviso to the rule 156 A shall be omitted.
4. In the said rules, the proviso to the rule 157 (1C) shall be omitted.
5. In the said rules, after sub-rule V of rule 158(B), the following sub-rule shall be inserted, namely:-
“(VI).Uniform pattern of license numbers shall be given in following pattern:
State code/ D or E (License or Loan license)/serial number of license/system (classical or PP)/ serial number of
product/ licensing year.
Further, the manufacturing license number of the particular product shall be displayed in all the advertisements-
electronic, social media or print media.
PROVIDED that, the existing license number shall be re- issued in this pattern within a period of one year. ".
6. In the said rules, in rule 160В, —
(i) in sub-rule (2), in clause (ii) for sub-clause (b), -
(a) the item (i) shall be substituted, namely, -
"(i) Expert in Ayurveda or Siddha or Unani medicine who possesses a degree qualification recognized under
schedules to the Indian Medicine Central Council Act, 1970 or the National Commission for Indian System
of Medicine Act, 2020; or a graduate in Pharmacy(Ayurveda or Siddha or Unani) by a recognized
university.".
(b) after item (iii), the following item shall be inserted, namely, -
"(iv) Microbiologist who shall possess at least Bachelor Degree with Microbiology as a subject awarded by
a recognized university, with six months experience in quality control or possess a post graduate Degree in
Microbiology awarded by a recognized university.".
7. In the said rules, for sub-rule (1) of rule 161 after the existing proviso, the following proviso shall be inserted,
namely: -
“PROVIDED further that to ensure the readability, the label information or inserts should be of font size of
'nine point' and further the details of the ingredient may be displayed through QR code as an alternate option.".
8. In the said rules, in rule 161B,-
(i) after sub-rule 2, following sub-rule shall be inserted, namely: -
"2(a). If the approval of the drug has been granted on the basis of accelerated stability studies, then: -
(i) The licensee shall submit a self-declaration to the Licensing Authority for submission of completed real
time stability study.
(ii) The licensee shall determine the shelf-life of the respective medicine for one or two years based on the
report of three months or six months accelerated stability study respectively, under intimation to the
Licensing Authority.
(iii) Determination of shelf-life beyond two years shall be based on real-time stability study, under intimation
to the Licensing Authority.".
(ii) after sub-rule 8, following sub-rule shall be inserted namely-
"(9) In cases of change in dosage form of classical medicine like Avaleha Tab. or Bhasma tab etc. the expiry
date of particular medicine category shall be supported by appropriate stability study data.".
9. In the said rules, the sub rule (i) of rule 162 shall be substituted, namely-
"(i) to inspect all premises licensed for manufacture of Ayurveda, Siddha or Unani drugs within the area allotted to
him to verify the compliance with the conditions of licence and the provisions of the Act and rules, as needed as per
risk based approach.".
10. In the said rules, in rule 163-B(B),-
(i) in sub-rule(1), the words "sub-section (2) of section 11 or" shall be omitted.
(ii) after sub-rule (3), following sub-rule shall be inserted, namely:-
"(4) For purpose of sub section 2 of section 11, the NABL accredited Drugs testing laboratory of Autonomous
Organizations of Ministry of Ayush which have been approved under Rule 160E of Drugs Rules 1945 shall act as
Central drug laboratory.".
11. In the said rules, the167 of shall be substituted, namely: -
"167. Qualifications of Inspector. - A person who is appointed as an Inspector under section 33G shall be a person
who has a degree in Ayurvedic or Siddha or Unani system or a degree in Ayurveda Pharmacy, as the case may be,
conferred by a University or a State Government or a Statutory Faculty, Council or Board of Indian Systems of
Medicine duly recognized by the Central Government or the State Government for this purpose.".
12. In the said rules, in sub-rule 3 of rule 169, the following proviso shall be inserted namely-
“PROVIDED that, the quantity of Base material shall also be mentioned on the label".
13. In the said rules, in Schedule M-I,-
(i) In paragraph-1 relating to 'General Requirement',-
(A) in sub-paragraph 1.1, the words 'cleared periodically' shall be substituted by the following
words, namely,-- “ cleaned and sanitized periodically. The drainage shall have the facility to prevent back
siphonage/ back flow.".
(B) for the sub-paragraph 1.2, the following sub-paragraph shall be substituted, namely,-“
"1.2 Building The premises shall not be used for any purpose other than manufacture of homoeopathic
drugs and no part of the manufacturing premises shall be used for any other purpose. Other facilities, if
needed, could be provided in separate building(s) in the same campus. However, the company should have
valid license for it and separate man-material movement. It should also have a separate storage (raw material
and finished product) and production area for the same. Crude raw materials, packing materials, etc. shall be
stored and handled in places ear marked for them and shall not be taken inside the manufacturing areas,
without QC approval. Heating, washing, drying, packing and labelling, etc. wherever needed, shall be done in
dedicated ancillary areas adjacent to the manufacturing sections concerned. The walls and floorings of
manufacturing areas shall be smooth and free from chinks, cracks and crevices and shall be washable. The
design of the windows, windowpanes and all fittings shall be such that they will not facilitate
accumulation/lodging of dust and other contaminants.
(a) Rooms The manufacturing area shall be designed, constructed and maintained to suit the
manufacturing of respective sections. The manufacturing of homeopathic medicine should take
place in an controlled environment and should be of an appropriate level of cleanliness. The
incoming air in the production area shall be filtered through at least five- micron filter.
Where dust is generated (for eg. during sampling, weighing, mixing and processing
operations, packaging of powder), measures shall be taken to avoid cross contamination and
facilitate cleaning. The production area shall be cleaned and sanitized at the end of every production
process and line clearance from Quality Control &Quality Assurance is must before the next batch
is taken into production. Manufacturing area should be maintained at a temperature and humidity,
which is suitable to the comforts of the personnel working with protective clothing, products
handled and operations undertaken. The production areas shall be well lighted. Flame proof
electrical fittings should be provided in the mother tinctures and dilution department (where ever the
consumption of alcohol is more). The licensee shall prevent mix up and cross-contamination of drug
material and drug product (from environmental dust) by proper air-handling system, pressure
differential, segregation, status labeling and cleaning. Proper records and Standard Operating
Procedures shall be maintained.
(b) Water- There shall be validated system for treatment of water drawn from own or any other
source to render it potable in accordance with standards specified by the Bureau of Indian Standards
or Local Municipality, as the case may be, so as to produce purified water conforming to
pharmacopeial specification (Indian Pharmacopoeia). Purified water so produced shall only be used
for all the operations except washing and cleaning operations where potable water may be used.
Water shall be stored in tanks, which do not adversely affect the quality of water and ensure
freedom from microbiological growth. The tank shall be cleaned periodically and records
maintained by the licensee in this behalf.
(c) Disposal of waste
(i) 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.
(ii) All bio-medical waste shall be destroyed as per the provisions of the Bio-Medical
Waste (Management and Handling) Rules, 1996.
d) Factories Act -The provisions of the Factories Act, 1948 (Act 63 of 1948), as applicable shall be
adhered to.
(e) Medical services –All persons concerned with any activity pertaining to manufacture of drugs
including handling of raw materials, packing materials, packing and labelling of drugs, etc. undergo
medical examination including eye examination, and shall be free from contagious or communicable
diseases and examined in general for fitness at the time of employment and subsequently at periodic
intervals, at least once a year, and records thereof shall be maintained.
(f) Safety measures—
(i) First-aid facilities shall be provided in such a manner that they are easily accessible and
the staff shall be imparted knowledge and training in first-aid measures as may be needed. Fire
control equipment in suitable numbers as recommended and certified by the fire department, shall
be provided at easily accessible places near all sections including stores and warehouses.
(ii) Adequate fire protection measures shall be provided in conformity with the rules of the
concerned civic authority and in accordance with relevant fire safety regulations.
(iii) Regular training on use of fire control equipment should be done at regular intervals
for the staff.
(g) Workbenches— Workbenches suitable to the nature and quantum of the work involved shall be
provided in all sections. Such work benches in general, shall have smooth, washable and impervious
tops made of stainless steel and the parts shall not be rough or rusty or damaged otherwise. Wooden
or plastic furniture shall not be permitted.
(h) Container management-Proper arrangements shall be made for receiving containers, closures
and packing materials in secluded areas and for de-dusting the same, removal of wastes, washing,
cleaning and drying or air-jet machine. Suitable equipment shall be provided as may be needed,
considering the nature of work involved.
When detergents are used to wash containers and closures for primary packing material,
suitable procedure shall be prescribed, followed and finally it should be ensured about the total
removal of such materials from the containers and closures before use. Plastic containers which are
likely to absorb active principles or which are likely to contaminate the contents may not be used.
Plastic containers which are likely to absorb active principles or which are likely to contaminate the
contents are not permitted.
Glass containers used shall be made of neutral glass. The closures and washers used shall be of inert
materials which shall not absorb the active principles or contaminate the contents or which may
otherwise be likely to cause deterioration of quality. The containers, closures and packing materials
shall protect the properties of the medicines. Tablets, if blister-packed, shall have secondary
protective packaging to protect the medicines from moisture, odour etc. Neutral glass phials and
epoxy-coated closures shall be used for eye-drops. Transparent plastic containers may be used for
eye drops containing only aqueous preparations. Sterile plastic nozzles may be provided to eye
drops, separately along with the medicine, wherever needed.".
(ii) the paragraph-2 relating to 'Plant and Equipment', the following paragraph shall be substituted, namely,-
"2. Plant and Equipment:
2.1 General - The design of the plant shall be suitable for the nature and quantum of the activities
involved. The production area shall be designed to allow the production preferably in uniflow and
with logical sequence of operations. Machineries and equipment shall be at least one and half meter
apart to allow orderly and logical placement of equipment, materials and movement of personnel so
as to avoid the risk of mix-up between different category of drugs or with raw materials,
intermediates and in-process material, avoid the possibilities of contamination and cross-
contamination by providing suitable arrangements. Where possible Man and Material entry into the
manufacturing area should be separate, well demarcated and with air lock facility. The personnel
shall have entry into the manufacturing area through cross over bench. The entry to all
manufacturing sections shall be regulated and persons not associated with the activities in the
sections shall not have access to them. There shall be arrangements for personal cleanliness of
workers and toilet facilities and separate lockers. These shall be separate for men and women
workers. There shall be suitable arrangement, separate for men and women, to change from their
outside dress and footwear into the factory dress and footwear. Uniforms of suitable colours and
fabric which facilitate proper washing and which do not shed fibres or other contaminants shall be
provided. Suitable head-covers and glove shall be provided to the workers. Jewellery of any sorts
should be restricted. Nails should be cleaned and trimmed and use of nail polish is prohibited in the
production area as it may flake off and contaminate the product. Persons working in production area
must wear the protective hair net (cap) and no hair should be exposed or protrude from/under the
hair net. Men with moustaches and beard must cover their Moustaches and beard with beard cap.
The manufacturing premises shall not be used for dining. There shall be separate area for the
personnel to take food or rest. Toilets shall not be located in or adjacent to any of the areas
concerned with any manufacturing activity. Spitting, smoking, chewing, littering, etc. in the
manufacturing or ancillary areas shall not be permitted. Standard operating practices (SOPs) for
cleaning and sanitation, personal hygiene of the workers, general and specific upkeep of the plant,
equipment and premises and every activity associated with manufacture of drugs including
procurement, quarantine, testing and warehousing of materials shall be written and adopted. The
contents of all vessels and containers used in manufacture and storage during the various
manufacturing stages shall be conspicuously labelled with the name of the product, batch number,
batch size and stage of manufacture. Each label should be signed/initialed and dated by authorized
technical staff. No person with any contagious disease shall be involved in any of the manufacturing
activities. There shall be proper arrangements for maintenance of the equipment and systems. The
performance of every equipment and system shall be properly validated and their use shall be
monitored. Do's and don'ts in the matter of the use of the plant and equipment as may be applicable
shall be written and displayed in all places. There shall be separate dedicated areas for each ancillary
activity such as receipt, cleaning, warehousing and issue of raw materials, packaging materials,
containers and closures, finished goods etc. Adequate measures shall be taken to prevent
entry/presence etc. of insects, rodents, birds, lizards and other animals into the raw material handling
areas. The area shall be made fly proof by use of "fly catcher" and/or air curtain. Rodent treatments
(Pest control) should be done regularly, at least once in a year and record maintained. There should
be separate bays for receiving and dispatch and to protect materials and products from adverse
weather conditions. Sampling and dispensing of materials shall be conducted under Reverse
Laminar Flow Unit (RLAF), within the warehouse area.
Every material shall have proper identification and control numbers and inventory tags and
labels displaying status of the quality being used, etc. All materials (raw material and finished
product) shall be placed on the raised platforms/racks made of HDPE (High Density Poly Ethylene)
or equivalent and not placed directly on the floor. There shall be proper arrangements and SOPs for
preventing mix-up of materials at every stage of handling. There shall be separate arrangements for
handling and warehousing of materials of different types. Materials with odour shall be kept in
tightly closed containers and shall be well protected from other materials. Fresh materials and
odorous materials shall, preferably be stored in separate dedicated areas. Where bonded
manufacturing and or warehousing facilities are required as per Excise laws, the facilities required
shall be provided without compromise on the requirements specified above. Dispensing of the
material should be done only after issuing of Material dispensing sheet (which is a part of approved
BMR) from Quality Assurance Department. A well-equipped laboratory for quality control/quality
assurance of raw materials and finished products and for carrying out in-process controls shall be
provided. Quality Assurance and Quality Control should be separate departments with pre-defined
roles. Personnel involved in Production should not be a part of the Quality Assurance or Quality
Control team and the testing personnel should have the right to take independent decisions.
2.2 Personnel All manufacturing operations shall be carried out under the direction and
supervision of technical staff approved by the licensing authority and shall possess the qualifications
prescribed in Rule 85 E. Number of personnel employed shall be adequate and in direct proportion
to the workload. The licensee shall ensure that all personnel in production area or into Quality
Control Laboratories shall receive training appropriate to the duties and responsibility assigned to
them. They shall be provided with regular in-service training and record shall be maintained.".
(iii) In paragraph-3 relating to ‘Requirement of Equipment and Facilities', -
(A) for the sub-paragraph 3.2 relating to 'Potentisation section', the following sub-paragraph shall be
substituted, namely,-
"3.2 Potentisation section-The section shall have the following facilities:
(i) Stainless Steel work benches with washable impervious tops;
(ii) Facilities for orderly storage of different potencies and back-potencies of various drugs
in an area where air is filtered through 5µ filter;
(iii) Suitable devices for measuring and dispensing of potencies/back-potencies into the
potentisation phials. All the process should be performed under horizontal laminar air flow
with 0.3 µ filter;
(iv) Potentiser with counter.
An area of 20 square metres shall be provided for basic installations.
Notes:
(a) The requirement of potentiser is not mandatory. The process may be done manually also
with proper SOPs. Potentiser, if used, shall be properly validated and shall be calibrated
every time before commencement of work for proper performance.
(b) The manufacturer shall use back-potencies procured from Licensed manufacturers and
the firm shall maintain proper records of purchase or shall prepare own back-potencies.
Every container of potencies and back-potencies shall be kept properly labelled and there
shall not be mix-up of different medicines and different potencies.".
(B) for the sub-paragraph 3.3 relating to 'Containers and Closures Section', the following sub-paragraph
shall be substituted, namely,-
"3.3 Containers and Closures Section.-Separate area for preparation of containers and closures
shall be provided adjacent to the potentisation section. This area shall have the following facilities:
(i) Washing tanks with suitable mechanical or hand operated brushes, bottle washing machines
(rotary/linear) air-jet machine ;
(ii) Rinsing tanks. Purified water shall be used for rinsing;
(iii) Closures washing/macerating tanks;
(iv) Driers.
Notes.-
(a) Different droppers shall be used only for each different medicine and different potency.
(b) All measures shall be in metric system. Measures used shall be of neutral glass or stainless steel.
Metal droppers and plastic droppers shall not be used.
(c) Glass droppers shall be reused only after proper cleaning and sterilization and clearance from
Quality Control& Quality Assurance section.
(d) Potentisation shall be done by the method(s) prescribed in the Homoeopathic Pharmacopoeia of
India.".
(C) for the sub-paragraph 3.4 relating to 'Trituration, Tableting, Pills and Globules making sections', the
following sub-paragraph shall be substituted, namely,-
"3.4 Trituration, Tableting, Pills and Globules making sections—The following basic equipment and
facilities shall be provided as per the requirements of manufacturing process:—
(i) Triturating Machine (Made of suitable material which does not corrode due to friction/trituration
process);
(ii) Disintegrator;
(iii) Mass Mixer;
(iv) Granulator;
(v) Electrical oven;
(vi) Tablets punching Machine (Each tableting machine shall be provided with effective dust control
facilities to avoid cross contamination (GMP model));
(vii) Kettle (steam or electrically heated) for preparing solutions;
(viii) Driers for drying granules and tablets;
(ix) Sieved separator (stainless steel);
(x) Tablet counter;
(xi) Balances;
(xii) Coating Pan with spray-gun;
(xiii) Multi-sifter;
(xiv) Mill with perforations.
An area of 55 square metres shall be provided for basic installations. The area shall be
suitably divided into cubicles to minimize cross contamination, mix-up etc. The medicated tablets in
1X potency should be prepared in hygienic condition to avoid any contamination. Required licence
for the production of globules shall be obtained.
Note. The section shall be free from insects, worms, rodents, dust and other floating particles and
moisture.".
(D) in the sub-paragraph 3.5 relating to 'Syrups and other oral liquids section', after the existing
provisions, the following shall be inserted, namely,-
"(3) Separate area for preparation of syrup and for washing of bottles or machine for air jet cleaning
of bottles shall be provided.
(4) Separate area shall be provided for primary packing and labelling and also for secondary and
tertiary packing.”.
(E) for the sub-paragraph 3.7 relating to 'Ophthalmic preparations section', the following sub-paragraph
shall be substituted, namely,-
"3.7 Ophthalmic preparations section-The following basic equipment and facilities shall be
provided:-
(i) Hot air oven, electrically heated, with thermostatic control;
(ii) Horizontal Laminar Air Flow bench;
(iii) Air Handling Unit with HEPA filters to provide filtered air and positive pressure to the section
and air-locks. Temperature and humidity in the aseptic area shall be 27°2°C and relative humidity
55%±5 respectively;
(iv) Ointment mill/colloidal mill;
(v) Mixing and storage tanks. (Stainless steel of grade 304);
(vi) Pressure vessels, as may be needed;
(vii) Sintered glass funnels, Seitz Filter/Filter candle;
(viii) Vacuum pump;
(ix) Filling machines for liquids ointments etc.;
(x) Autoclaves with pressure and temperature gauges; and
(xi) Necessary workbenches, visual inspection bench, etc.
Area: Minimum area of 20 square metres shall be provided for basic installations.
Notes.-
1. The section shall have a clean room facility of ISO Class 5 clean room (ISO 14644-1 clean room
standard).
2. The section shall be air-conditioned and humidity controlled.
3. Entry to the sections shall be regulated through air-locks with differential air pressures with the
air-lock adjacent to the section having higher pressure and the first one through which entry is made
with the least pressure.
4. Materials shall be passed to the sections through suitable hatches.
5. The personnel shall wear sterile clothing including headgear, which shall not shed fibre.
6. Washing of phials shall be done in separate areas with proper equipment. Proper facilities shall be
provided in the area for washing vessels.
7. Separate area shall be provided for packing and labelling.".
(iv) for the paragraph 4 relating to 'Quality Control Division', the following paragraph shall be substituted, namely, —
"4. Quality Control Division
4.1 Functions -A separate quality control division shall be provided in the premises. The section
shall be under the direct supervision of an approved technical officer, independent of the manufacturing
division and directly responsible to the management.
Quality control shall be concerned with sampling, specifications, testing, documentation, release
procedures which ensure that the necessary and relevant tests are actually carried out and the materials are
not released for use, for sale or supply until it meets/passes the legal/pharmacopeial standards. The quality
control department shall conduct or outsource the stability studies of the products to ensure and assign their
shelf life, wherever applicable, at the prescribed conditions of storage. All records of such studies shall be
maintained. The area of the quality control laboratory may be divided into chemical, instrumental,
microbiological, testing of packaging material: primary, secondary and tertiary. The section shall be
responsible for ensuring the quality of all raw materials, packing materials and finished goods. The section
shall also carry out in-process quality checks of the products. The section shall be responsible for the stability
of the products and for prescribing their shelf life wherever applicable.
The overall functions of the division shall include-
(1) To test the identity, quality and purity of the raw materials and to recommend rejection of the
material of poor quality and approve materials of the prescribed quality only. The worksheet of the testing
data generated shall be documented properly and stored for minimum five years and the reference of the raw
material should be attached to the BMR (Batch Manufacturing Record) of the relevant product.
(2) To test the identity, quality and purity of the finished products and to recommend rejection of the
material of poor quality and to approve materials of the prescribed quality only. The worksheet of the testing
data generated shall be documented properly and stored for minimum five years and the reference of the
finished product should be attached to the BMR (Batch Manufacturing Record) of the relevant product.
(3) To prepare and validate the methods of analysis, validate the equipment, monitor their use, take
steps for proper maintenance, etc.
(4) To approve or reject containers, closures and packaging materials in accordance with the
prescribed norms.
(5) To exercise/carry out in-process control of products.
(6) To prescribe SOPs on all matters concerning quality of materials and products.
(7) To monitor the storage and handling of raw materials, finished products, containers, closures and
packaging materials.
(8) To investigate complaints, on quality of products, take or recommend appropriate measures to
examine returned goods and recommend their disposal. Records of all the above activities to be
maintained.
4.2 Personnel -The quality control staff shall be full-time personnel. Analysis and tests of drugs,
raw materials, etc. shall be done by qualified and approved technical staff. The technical staff shall have the
minimum qualification of degree in Homoeopathy Pharmacy or Science with Chemistry or Botany or
Zoology as the principal subject and experience of not less than two years in the test and analysis of
medicines including handling of instruments as mentioned in sub-rule (1) of Rule 85 E of the Drug Rules,
1945 and a microbiologist who shall possess a Bachelor Degree with Microbiology as a subject with six
months experience in quality control or post graduate Degree in Microbiology awarded by a recognized
university, wherever Microbiology section is there in the quality control lab of the firm.
4.3 Equipment -The following equipment shall be provided depending on the sections approved by the
licensing authority for different dosage forms—
(i) Compound microscope -Trinocular microscope with suitable magnification and photoraphic
device, i.e. digital camera attached to the microscope, computer/laptop facility supporting the software used
to capture the images and record the data;
(ii) Magnifying glass (Needed for macroscopical studies of plants.)
(iii) HPTLC instrument;
(iv) UV lamp viewer;
(v) Monopan Digital Electronic Balance;
(vi) Hot air oven;
(vii) Distillation apparatus;
(viii) Water Bath;
(ix) Polarimeter;
(x) Refractometer;
(xi) Melting point apparatus;
(xii) PH meter;
(xiii) Magnetic stirrer;
(xiv) Table Centrifuge;
(xv) Muffle furnace/electric Bunsen;
(xvi) Moisture determination apparatus;
(xvii) U.V. Spectrophotometer;
(xviii) Rotary micro tome/Section cutting facilities;
(xix) Tablet Disintegration Machine for Microbiological section, necessary lab facilities, equipment,
chemicals, culture media required for testing of following tests
a. Sterility Test
b. Microbial Limit Test
c. Microbial air sampling
d. Microbial Testing of water as per IP.
(xx) Safety shower and eyewash facility in the Quality Control lab.".
(v) In the paragraph 5 relating to 'Raw materials'-
(A) the following shall be inserted before sub-paragraph 5.1, namely,-
"5. Raw Materials. 1. All incoming materials shall be quarantined immediately after receipt or
processing. All materials shall be stored under appropriate conditions and in an orderly fashion to
permit batch segregation and stock rotation by a 'first in/first expiry' 'first-out' principle. All
incoming materials shall be checked to ensure that the consignment corresponds to the order placed.
2. All incoming materials shall be purchased from approved sources under valid purchase vouchers.
3. Authorized staff appointed by the licensee in this behalf, which may include personnel from the
Quality Control Department, shall examine each consignment on receipt and shall check each
container for integrity of package and seal. Damaged containers shall be identified, recorded and
segregated.
4. If a single delivery of material is made up of different batches, each batch shall be considered as a
separate batch for sampling, testing and release.
5. Raw materials in the storage area shall be appropriately labelled. Labels shall be clearly marked
with the following information:
(a) designated name of the product and the internal code reference, where applicable, and
analytical reference number;
(b) manufacturer's name, address and batch number;
(c) the status of the contents (e.g. quarantine, under test, released, approved, rejected); and
(d) the manufacturing date, expiry date and re-test date.
6. There shall be adequate separate areas for materials “under test”, “approved" and "rejected" with
arrangements and equipment to allow dry, clean and orderly placement of stored materials and
products, wherever necessary, under controlled temperature and humidity.
7. Containers from which samples have been drawn shall be identified.
8. Only raw materials which have been released by the Quality Control Department and which are
within their shelf-life shall be used. It shall be ensured that shelf life of formulation product shall not
exceed with that of active raw materials used.
9. It shall be ensured that all the containers of raw materials are placed on the raised platforms/racks
made of HDPE (High Density Poly Ethylene) or equivalent and not placed directly on the floor.
Wooden material is not permitted for placing of the raw material.".
(B)Point a (ii) and b (ii), (iii) of sub paragraph 5.1 shall be omitted.
(C) In sub-paragraph 5.2, after the existing words, 'shall accompany the materials.', the following words
shall be inserted, namely, “Flammable and hazardous chemicals shall be stored in separate dedicated areas.
Staff should be trained for safety measures to handle such chemicals. Handling of such chemicals should be
done under Laboratory safety/ fume hood.".
(D) the sub-paragraph 5.4, relating to 'Sarcodes', the following sub-paragraph shall be substituted namely,-
"5.4. Sarcodes- The materials shall be those collected from healthy animals and shall be of
pharmacopoeial specification. The materials shall be those collected, packed and transported under
proper hygienic conditions, well protected from all contamination and should be stored in controlled
temperature to avoid microbial contamination. The materials shall be accompanied by statements as
in the para 'a' above. The materials shall be tested to see that they are free from pathogenic
organisms such as E.Coli, Salmonella, etc.".
(vi) for the paragraph 7 relating to 'Laboratory Controls', the following paragraph shall be substituted, namely, -
"7. Laboratory Controls: Tests as per the pharmacopoeia and requirements shall be carried out on products
and materials. The stability of the products shall be established by as per recommended/approved guidelines
by Government of India. Sterility tests, wherever applicable, shall be carried out. Control samples shall be
preserved for not less than three years after the last sales.".
(vii) for the paragraph 8 relating to 'Packing and Labelling', the following paragraph shall be substituted, namely,
"8. Packing and Labelling: A minimum area of 50 square metres shall be provided for packing and labelling
section. Labels should be approved by QC before being used. All labels should abide by extant Laws. Labels
should be kept in a temperature controlled environment to prevent loss of gumming.".
(viii) for the paragraph 10 relating to 'Standard Operating Practices', the following paragraph shall be substituted,
namely, -
"10. Standard Operating Practices: Standard Operating Practices (SOPs) shall be developed for various
activities such as receipt, identification, cleaning, drying, warehousing, issue, handling, sampling etc. of all
materials. SOPs should be written in English as well as in a local language. Labels and packing materials
shall be examined for correctness and compliance with rules. Records shall be maintained for their printing,
use, destruction etc. Staff should be familiar with the SOPs. Regular training sessions shall be conducted
for the staff and the record for the same should be maintained by Quality Assurance section.".
(ix) for the paragraph 11 relating to 'Records and Registers', the following paragraph shall be substituted, namely,
"11. Records and Registers: Records shall be maintained for all the activities. These shall include records of
production, records of raw materials, records of testing, records of sales and other supplies, records of
rejection, complaints and actions taken, SOPs and records in respect of compliance thereof, log books of
equipment, master formula records, records of medical examination and fitness of personnel etc. All records
shall be maintained for a period of one year after the expiry of a batch or for three years whichever is later.
Records of the staff available with files of every staff member need to be maintained. Training records need
to be maintained.".
14. In the said rules, in Schedule T,-
(i) In paragraph 1,-
(A) in item (iv) after the existing words, 'acceptable quality.' The following word, 'and', shall be
inserted.
(B) the item (v), shall be substituted, namely, -
"(v) to achieve the objectives listed above, each licencee shall evolve methodology and
procedures for following the prescribed process of manufacture, packaging and quality of
drugs which should be documented as a manual and kept for reference and inspection.
However, under IMCC Act, 1970 or National Commission for Indian System of Medicine
(NCISM) Act, 2020 (14 of 2020) registered Vaidyas,
their patients and not selling such drugs in the market are exempted from the purview of
Good Manufacturing Practices (GMP).".
(ii) In Part-I relating to 'Good Manufacturing Premises',
(A) in sub-paragraph relating to 'Factory Premises', the following shall be substituted, namely,-
"Factory premises:
The manufacturing plant should have adequate and designated space/ area for—
(i) Receiving and storing raw and packaging material;
(ii) Manufacturing process areas;
(iii) Quality control section;
(iv) Finished goods store;
(v) Office;
(vi) Rejected goods/drugs store; and
(vii) Ancillary area.".
(B) the sub-paragraph1.1 to relating to General Requirements', the following sub-paragraph shall be
substituted, namely,
"1.1 General requirement:
1.1(A) Location and surroundings
i. The layout and design of premises must aim 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.
ii. Where dust is generated (e.g., during sampling, weighing, mixing and processing
operations or packaging of powder), measures shall be taken to avoid cross-
contamination and facilitate cleaning.
iii. Premises shall be situated in an environment that, when considered together with
measures to protect the manufacturing process, presents minimum risk of causing any
contamination of materials or products.
iv. Premises used for the manufacture of finished products shall be suitably designed and
constructed to facilitate good sanitation.
V.
Premises shall be carefully maintained, and it shall be ensured that repair and
maintenance operations do not present any hazard to the quality of products.
vi. Premises shall be cleaned, pest controlled and where applicable, disinfected according
to detailed written procedures and records shall be maintained.
vii. Electrical supply, lighting, temperature, humidity and ventilation shall be appropriate
and they do not adversely affect, directly or indirectly, either the products during their
manufacture and storage or the accurate functioning of equipment.
1.1(B) Buildings
i.
The design of the windows, windowpanes and all fittings shall be such that they will
not facilitate accumulation/lodging of dust and other contaminants.
ii.
Pipework, electrical fittings, ventilation openings and similar service lines shall be
designed, fixed and constructed to avoid accumulation of dust.
iii.
The building used for factory shall be such as to permit production of drugs under
Hygienic conditions and should be free from cobwebs and insects/rodents.
iv.
It should have adequate provision of light and ventilation.
V.
The floor and the walls should not be damp or moist.
vi.
The premises used for manufacturing, processing, packaging and labelling shall be in
conformity with the provisions of the Factory Act, 1948.
vii.
It shall be located so as to be:-
(a) Compatible with other manufacturing operations that may be carried out in the same or
adjacent premises.
(b) Adequately provided with working space to allow orderly and logical placement of
equipment and materials to avoid the risk of mix up between different drugs or components
thereof and control the possibility of cross contamination by other drugs or substances and
avoid the risk of omission of any manufacturing or control step.
(c) Designed constructed and maintained to prevent entry of insects, lizards, birds, worms
and rodents. The area shall be made insect proof by use of "fly catcher" and /or air curtain.
Interior surface (walls, floors and ceilings) shall be smooth and free from cracks and permit
easy cleaning and disinfection. The walls of the room in which the manufacturing
operations are carried out shall be impervious to and be capable of being kept clean. The
flooring shall be smooth and even shall be such as not to permit retention or
accumulation of dust or waste products.
(d) Provided with proper drainage system in the processing area as well as in storage &
laboratory, which will prevent back-flow and control entry of rodents & insects. The
sanitary fitting and electrical fixtures in the manufacturing area shall be proper and safe. It
should be ensured that there is no contamination of water from drainage lines.
(e) Furnace/Bhatti section could be covered with tin roof and proper ventilation, but
sufficient care should be taken to pre-vent flies and dust.
(f) Fire safety measures -Adequate fire protection measures shall be provided in conformity
with the rules of the concerned civic authorities and in accordance with relevant fire safety
regulations. Regular training on use of fire control equipment should be done at regular
intervals for the staff.
(g) Drying space—There be separate space for drying of raw material, in process medicine
or medicines require drying be-fore packing. This space will be protected from
flies/insects/dusts etc., by proper flooring, wire-mesh window, glass panes or other
material.
1.1(C) Water Supply
(i) Adequate provision of water shall be made.
(ii) The water used in manufacture shall be pure and of potable quality meeting the
Pharmacopoeial specifications.
(iii) Potable water can be used for washing & cleaning, wherever applicable.
(iv) Water treatment system shall be documented and validated, wherever applicable.
(v) Storage tank should be monitored for microbial growth by periodical testing, wherever
applicable.
(vi) Records of validation & testing of water shall be maintained.
(vii) Brief description of water system (schematic drawings of systems), including
sanitation; shall be maintained, wherever applicable.
1.1(D) Disposal of waste and effluent
(i) 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.
(ii) All bio-medical waste shall be destroyed disposed as per the provisions of the Bio-
Medical Waste (Management and Handling) Rules, 1996.
(iii) Additional precautions shall be taken for the storage and disposal of rejected drugs
with special attention to schedule El ingredients.
(iv) Records shall be maintained for all disposal of waste.
(iv) Provisions shall be made for the proper and safe storage of waste materials awaiting
disposal.
(v) Hazardous, toxic substances and flammable materials shall be stored in suitably
designed and segregated, enclosed areas.
1.1(E) Container's cleaning. In factories where operations involving the use of containers such as
bottles, vials and jars are conducted, there shall be adequate arrangements separated from the manufacturing
operations for washing, cleaning and drying and/or air jet cleaning of such containers.
1.1(F) Stores
i.
Storage should have proper ventilation, acceptable temperature and it shall be free from dampness
and prevent entry &breeding of insects.
ii.
Storage areas shall be of sufficient capacity to allow orderly storage of the various categories of
materials and products with proper separation and segregation; starting and packaging materials,
intermediates, bulk and finished products, products in quarantine and released, rejected, returned or
recalled products.
iii.
Storage areas shall be designed or adapted to ensure good storage conditions. In particular, they shall
be clean, dry, sufficiently lit and maintained within acceptable temperature limits. Where special
storage conditions are required (e.g., temperature, humidity) they shall be provided, controlled,
monitored and recorded, where appropriate.
iv. Receiving and dispatch bays shall be separated and shall protect the materials and products from the
weather. Receiving areas shall be designed and equipped to allow containers of incoming materials
to be cleaned, if necessary, before storage.
V.
Where quarantine status is ensured by storage in separate areas, these areas must be clearly marked
and their access restricted to authorized personnel. Any system replacing the physical quarantine
shall give equivalent security.
vi.
Segregation shall be provided for the storage of rejected, recalled or returned materials or products.
vii. Periodic audit of warehouses shall be conducted and its record shall be maintained.
viii. Flammable and hazardous substances shall be segregated and stored in safe and secure area, entry to
which shall be restricted.
1.1(F)(A) Raw materials
i. All raw materials procured for manufacturing shall be stored in the dedicated raw materials store.
ii. All intermediate or semi-processed raw materials should be procured only from GMP certified
manufacturing facility and the purchase vouchers should reflect the manufacturing license details of the
facility.
iii. All incoming materials shall be checked to ensure that the consignment corresponds to the order placed.
All incoming materials shall be purchased from approved sources under valid purchase vouchers.
iv. All incoming materials shall be quarantined immediately after receipt or processing.
v. It shall be ensured that all the containers of raw materials are placed on the raised platforms/racks made of
HDPE (High Density Poly Ethylene) or equivalent and not placed directly on the floor. Wooden material
is not permitted for placing of the raw material.
vi. If a single delivery of material is made up of different batches, each batch shall be considered as a
separate batch for sampling, testing and release.
vii. The manufacture based on the experience and the characteristics of the particular raw material used in
Ayurveda, Siddha and Unani system shall decide the use of appropriate containers which would protect
quality of the raw material as well as prevent it from damage due to dampness, microbiological
contamination or rodent and insect infestation, etc. All steel containers should be preferably of SS grade
304.
viii. If certain raw materials require such controlled environmental conditions, the raw materials stores may be
sub-divided with proper enclosures to provide such conditions by making suitable cabins.
ix. While designing such containers, cabins or areas in the raw materials stores, care may be taken to handle the
following different categories of raw materials:—
(1) Raw material of metallic and mineral origin (other than ingredients mentioned in Schedule E I of the
Drugs &Cosmetics Rules, 1945).
(2) Raw material from animal source.
(3) Fresh Herbs.
(4) Dry Herbs or plant parts.
(5) Excipients etc.
(6) Volatile oils/perfumes &flavours and
(7) Plant concentrates extracts and exudates/resins.
Further, ingredients mentioned in Schedule E I of the Drugs Rules, 1945 should be kept separately. Inflammable
substances/ raw materials items shall be kept separately at secure area/ place.
x. Each container used for raw material storage shall be properly identified with the label which indicates name of the
raw material, source of supply and will also clearly state the status of raw material such as "UNDER TEST" or
"APPROVED" or "REJECTED", by use of colour coded status label – Yellow, Green and Red respectively. The
labels shall further indicate the identity of the particular supply in the form of Batch No. or Lot No. assigned to it
on receipt and the date of receipt, date of expiry and retest date of the consignment.
xi. Dedicated area shall be provided for sampling of raw material & excipients to avoid contamination & cross-
contamination.
xii. All the raw materials shall be sampled as per written Standard Operating Procedures (SOP) and got tested either by
the in-house Ayurvedic, Siddha and Unani experts (Quality control technical person) or by the laboratories
approved by the Government and shall be used only on approval after verifying.
xiii. The rejected raw material should be removed from other raw material store and should be kept in separate area
until it is disposed off; as per written Standard Operating Procedures (SOP).
xiv. Procedure of 'First In First out (FIFO)' and 'First Expired First Out (FEFO)' should be adopted for raw materials.
xv. Entry to quarantine & recalled/returned goods shall be restricted only to Authorized persons.
xvi. Records of the receipt, testing and approval or rejection and use of raw material shall be maintained.
1.1. (F)(B) Packaging Materials-
i.
All packaging materials such as bottles, jars, capsules, printed packaging material like labels,
cartons etc. shall be segregated and stored properly in safe & secure area.
ii.
Status labels shall have appropriate colour code such as"UNDER TEST" or "APPROVED" or "RE-
JECTED", by use of colour coded status label – Yellow, Green and Red respectively.
iii.
All containers and closure shall be adequately cleaned and dried before packing the products.
1.1(F)(C) Finished Goods Stores
i. The finished goods transferred from the production area after proper packaging shall be stored in
the finished goods stores within an area marked "Quarantine".
ii. After the approved quality control laboratory and the experts approved quality control personnel
have checked the correctness compliance of finished goods with reference to its packing/labelling as
well as the finished product quality as prescribed, then it will be moved shall be moved to
"Approved Finished Goods Stock" area.
iii. Only approved finished goods shall be dispatched as per marketing requirements.
iv. Distribution records shall be maintained as required.
v. If any Ayurvedic, Siddha and Unani drug needs special storage conditions, finished goods store
shall provide necessary environmental requirements.
1.1(G) Working space
i. The manufacturing area shall provide adequate space (manufacture and quality control) for smooth
passage of men & material preferably separate &for orderly placement of equipment and material
used in any of the operations for which these are employed so as to facilitate easy and safe working
and to minimize or to eliminate any risk of mix- up between different dines, raw materials and to
prevent the possibility of cross contamination of one drug by another drug that is manufactured,
stored or handled in the same premises.
ii. As far as possible unidirectional and logical flow shall be maintained in all operations.
iii. Man and material entry into the manufacturing area should be separate, well demarcated and with
air lock facility, wherever possible,
iv. The personnel shall have entry into the manufacturing area through cross over bench.
v. The manufacturing area shall not be utilized for dining purpose.
vi. The manufacturing area shall be sanitized regularly with disinfectant based on a complex silver
ions and hydrogen peroxide as an oxidizing agent for aerial fumigation, keeping it in view to
provide high level of protection for humans and environment.
vii. Records of sanitation should be maintained.
1.1(H) Health Clothing, Sanitation and Hygiene of Workers
i.
All workers employed in the Factory shall be free from contagious diseases.
ii.
Smoking, chewing tobacco, eating & storing food or medicines shall not be permitted in working
areas such as stores, processing, laboratory, etc.
iii.
Wearing any sort of jewellery should be discouraged and use of nail polish should be prohibited in
the manufacturing area.
iv.
The clothing of the workers shall consist of proper, clean uniform suitable to the nature of work,
ensures safety & comfort and of suitable colours and fabric.
V.
Clothing shall be laundered or cleaned in such a way that it does not gather additional particulate
contaminants that can later be shed.
vi.
The uniform shall also include cloth or synthetic covering for hands, feet and head wherever
required which shall be non-contaminant.
vii.
Handling any material with uncovered hands should be avoided.
viii.
Adequate facilities for personal cleanliness such as clean towels, soap, hand sanitizers and scrubbing
brushes shall be provided.
ix.
Separate provision shall be made for lavatories to be used by men and women, and such lavatories
shall be located at places separated from the processing rooms.
Χ.
Workers shall also be provided with facilities for changing their clothes and to keep their personal
belongings.
1.1(I) Medical Services —The manufacturer shall also provide-
(a) Adequate facilities for first aid including Ayush drugs;
(b) Medical examination of workers shall be performed at the time of employment and periodical
checkup thereafter by authorized medical personnel under The Factories Act, 1948 or by a registered
medical practitioner of recognized system of medicine by Government of India once a year, with
particular attention being devoted to freedom from infections.
(c) All persons concerned with any activity pertaining to manufacture of drugs including handling of
raw materials, packing materials, packing and labeling of drugs, etc. shall undergo medical
examination including eye examination, and shall be free from contagious or communicable
diseases and examined in general for fitness at the time of employment and subsequently at periodic
intervals, at least once a year and records thereof, shall be maintained.
1.1(J) Machinery and Equipments
i.
For carrying out manufacturing depending on the size of operation and the nature of product
manufactured, suitable equipment either manually operated or operated semi-automatically
(Electrical or steam based) or fully automatic machinery shall be made available. These may include
machines for use in the process of manufacture such as crushing, grinding, powdering, boiling,
mashing, burning, roasting, filtering, drying, filling, labelling and packing etc.
ii.
As far as possible, the machinery and equipment should be in uniflow and with logical sequence of
operations as far as possible.
iii. To ensure ease in movement of workers and orderliness in operations a suitably adequate space will
be ensured between two machines or rows of machines. These machinery and equipments have to be
properly installed and maintained with proper cleaning. List of equipments and machinery
recommended is indicated in Part IIA.
iv. Proper standard operational procedures (SOPs) for cleaning, maintaining and operation of every
machine should be laid down.
v. Records of cleaning & maintenance must be kept.
1.1(K) Batch Manufacturing Records.-
Batch Manufacturing Records (BMR) are required to provide:
i. BMR should clearly indicate quantity of raw material used for production, quantity of raw material
dispensed/issued by the store and Quantity of raw material received and used by the production.
ii. Analytical Report (AR) number and Batch number of all the raw materials used, should be mentioned in
the BMR.
iii. The record of specific method and procedure preparation that is, "Bhavana" "Mardana" and "Puta" and the
record of every process carried out by the manufacturer shall be maintained
iv. Tests conducted during the various stages of manufacture like taste, colour, physical characteristics and
chemical tests as may be necessary or indicated in the approved books of Ayurveda, Siddha and Unani
mentioned in the First Schedule of the Drugs and Cosmetics Act, 1940 (23 of 1940), may be mentioned in the
form of their report number in BMR.
v. Before commencing of a batch, cleaning status of all machines and equipment to be used should be
checked and recorded in BMR. Calibration record of the machine and equipments may be maintained
separately and date of last calibration done, may be recorded in BMR.
vi. BMR should also mention the name and signature of the personnel who has performed/conducted the task
and also who has supervised the manufacturing/testing procedure at all stages.
vii. During the entire batch manufacturing process, line clearance for all machines and equipment should be
given by the approved personnel before manufacturing, before filling and also before commencing of
packing of the finished product.
viii. BMR should clearly mention the quantity of packing material ordered, quantity issued, quantity used,
quantity rejected, and quantity of the packing material returned to the stores. (Rejected material should be
destroyed by the stores and record of which shall be maintained by the stores).
ix. BMR should clearly mention the theoretical and actual yield of the finished product.
x. At the end of the manufacturing process, the Quality control department will release the final batch on the
basis of the tests performed as per specification and also after checking that all batch manufacturing records
are properly filled and duly signed.
1.1 (L) Distribution Records - Records of Finished Goods transfer, sale and distribution of each batch of
Ayurveda, Siddha and Unani Drugs, shall be maintained in order to facilitate prompt and complete recall of the batch,
if necessary.
1.1 (M) Record of Market Complaints
i. Manufacturers shall maintain a register to record all re-ports of market complaints received
regarding the products sold in the market.
ii. The manufacturer shall enter all data received on such market complaints, investigations carried
out by the manufacturers regarding the complaint as well as any corrective action initiated to
prevent recurrence of such market complaints shall also be recorded.
iii. Once in a period of six months the manufacturer shall submit the record of such complaints to
the licensing authority.
iv. The Register shall also be available for inspection during any inspection of the premises.
v. Adverse Drug Reaction (ADR)-The licensee shall have a pharmacovigilance system in place for
collecting, processing and forwarding the reports to the licensing authorities for information on the
adverse drug reactions emerging from the use of drugs manufactured or marketed by the licensee.
1.1(N) Quality Control -Every licensee is required to provide facility for quality control section in his own
premises or through State/UT Government approved testing laboratory. The test shall be as per the Ayurveda, Siddha
and Unani pharmacopoeial standard. Where the pharmacopoeial tests are not available, the test should be performed
according to the manufacturers's specification or other information available. The quality control personnel shall test
all the raw materials, monitor in process quality checks and the quality of finished product being released to finished
goods store. Preferably for such quality control, there will be a separate personnel as defined in 1.1 (N) (ix) of this
Schedule. The quality control section shall have the following facilities:-
i.
There should be atleast150 sq. feet area for quality control section.
ii.
For identification of raw drugs, reference books and reference samples should be maintained.
iii.
Analytical record should be maintained for the various processes.
iv.
To testthe finished products, controlled samples of furnished products of each batch will be kept for
3 years.
V.
To supervise and monitor adequacy of conditions under which raw materials, semi-finished products
and finished products are stored.
vi.
Keep record for establishing shelf life and storage requirements for the drugs.
vii.
Manufacturers who are manufacturing patent proprietary Ayurveda, Siddha and Unani medicines
shall provide their own specification and control references in respect of such formulated drugs.
viii.
The standards for identity, purity and strength as given in respective pharmacopoeias of Ayurveda,
Siddha and Unani systems of medicines published by Government of India shall be complied with.
ix.
All raw materials will be monitored for fungal, bacterial contamination with a view to minimise
such contamination.
X.
Quality control section shall comprises Quality Assurance (QA) and Quality Control (QC) activities.
They shall have a minimum of—
(a) Expert in Ayurveda or Siddha or Unani medicine who possess a degree qualification
recognized under Schedule II of Indian Medicine Central Council Act, 1970 or notified in the
Schedules to the Indian Medicine Central Council Act, 1970 (48 of 1970); or National Commission
for Indian System of Medicine (NCISM) Act, 2020 (14 of 2020) or ;
(b)Chemist, who shall possess at least a Bachelor Degree in Science or Pharmacy or Pharmacy
(Ayurveda) awarded by a recognized University; and
(c) Botanist (Pharmacognosist), who shall possess at least a Bachelor Degree in Science or
Pharmacy or Pharmacy(Ayurveda) awarded by a recognized University:
(d) Microbiologist who shall possess a Bachelor Degree with Microbiology as a subject with six
months experience in quality control or post graduate Degree in Microbiology awarded by a
recognized university, wherever Microbiology section is there in the quality control lab of the firm.
xi.
A mechanism of internal audit should be developed by the manufacturer.
xii.
The manufacturing unit shall have a quality control section as explained under section 35(ii).
Alternatively, these quality control provisions will be met by getting testing etc., from a recognised
laboratory for Ayurveda, Siddha and Unani drugs; under rule 160A of the Drugs and Cosmetics Act. The
manufacturing company will maintain all the records of various tests got done from outside recognised
laboratory.
xiii.
List of equipments recommended is indicated in Part II C.
xiv.
Validation of each process, equipment, instrument and testing method shall be carried out as per
written SOP. It should be done whenever there is a change in method, process parameters and/ or equipment
and record should be maintained.
1.1(0) Training
i.
All personnel shall have adequate training in appropriate fields such as Ayush systems,
pharmaceutical technology, taxonomic botany, phytochemistry, pharmacognosy, hygiene,
microbiology, handling of complaints and related subjects in periodic manner.
ii.
Training records shall be maintained and periodic assessments of the effectiveness of training
programmes shall be made.
1.1(P) Qualification and Validation
i.
A section of Qualification and validation of equipment's, Process & Test procedures including SOPs
for cleaning, maintenance & performance of every machine may be included.
ii.
Calibration of each measuring/ weighing equipment, analytical instruments, pressure temperature
gauges shall be carried out at appropriate frequency.
iii.
A formal change control system should be established to evaluate the potential effects of any changes
on the quality of the Product. Scientific judgement should be used to determine which additional
testing and validation studies are appropriate to justify a change in a validated process.
1.1(Q) Internal audits (self-inspection) -
i.
In order to verify compliance with the principles of GMP, regular internal audits shall be performed
in accordance with an approved schedule.
ii.
Audit findings and corrective actions shall be documented and brought to the attention of the
responsible management of the firm. Agreed corrective actions shall be completed in a timely and
effective manner.".
(iii) In Part-II,
(A) in the Table relating to the List of recommended machinery, equipment and minimum
manufacturing premises required for the manufacture of various categories of Ayurvedic, siddha systems of
medicines,
(1) in column 2 relating to serial no. 4, the words 'Kupi pakava/Ksara/
Parpati/LavanaBhasm a Satva/Sindura Karpu/ Uppu / Param", shall be substituted by the following
words, namely, "Ksara/Lavana/ Satva (plant origin)/ Uppu".
(2) after the existing categories, the following categories shall be inserted, namely, –
+-----+------------------------+-------------+-----------------------------------------------+
| "16.| Saundaryaprasadhak | 100 sq.ft. | Mixing and heating tank , Filling |
| | | | machine. |
+-----+------------------------+-------------+-----------------------------------------------+
| 17. | Swarasa | 100 sq.ft. | Juicer Grinder (according to the |
| | | | requirement), filter, mixing tank, |
| | | | packaging equipments. |
+-----+------------------------+-------------+-----------------------------------------------+
| 18. | AushadhaGhana/ extracts| 200 sq.ft. | Boiler, Extractor, condenser, receiver, |
| | | | column, distillation, tray dryer, |
| | | | vaccum dryer, grinder blender, |
| | | | shifter. |
+-----+------------------------+-------------+-----------------------------------------------+
| 19. | Nasal Spray | 300 sq.feet.| Reverse laminar airflow, weighing |
| | | Adequate | balances, manufacturing vessel, |
| | | space for | jacketed manufacturing vessel, bulk |
| | | the | holding vessel, diaphragm pump, |
| | | packaging | filter assembly, automated filling line |
| | | and holding | including vial washing machine, |
| | | will be | sterilizing and Depyrogenation tunnel, |
| | | required | autoclave, vial filling machine (filling, |
| | | | sealing, crimping, transfer conveyor |
| | | | etc.). |
+-----+------------------------+-------------+-----------------------------------------------+
Note - (i) Equipment of Stainless Steel (SS) shall be grade of 304 and above.
(ii) List of machinery or equipments are only suggestive in nature. Manufacturer may use
appropriate machinery as per latest emerging technology.
(iii) Nasal spray dosage form is not mandated to be sterile. In case any formulation warrants
sterility, manufacturing and quality instrumentation, to be utilized accordingly.".
(B) the existing description under sub-paragraph D shall be substituted, namely, --
"D. Supplementary guidelines for manufacturing of Rasaushadhies or rasamarunthukal and
kushtajat (herbo-mineral-metallic compounds) of Ayurveda,Siddha and unani medicines
These guidelines are intended to complement those provided above and should be
read in conjunction with the parent guidelines. The supplementary guidelines are to provide
general and minimum technical requirements for quality assurance and control in
manufacturing Rasaushadhis or Rasamarunthukal and Kushtajat (Herbo-mineral-metallic
formulations). These supplementary guidelines deal with Bhasmas, Sindura, Pishti, Kajjali,
KhalviyaRas, Kupipakwa, Rasayan, Parpati, Potali Rasa, Satwa (of Metals and Minerals
origin) DrutiParpam, Karpu, and Kushta etc. used in Ayurvedic, Siddha andUnani Systems
of medicine.
The supplementary GMP guidelines for Rasaushadhi or Rasamarunthukal and
Kushtajat are needed to establish the authenticity of raw drug, minerals and metals, in-
process validation and quality control parameters to ensure that these formulations are
processed and prepared in accordance with classical texts and for which safety measures
are complied with. Storage, handling, transport & processing including discard and
recovery of metals & minerals especially Mercury, Lead & Arsenic shall be done in
accordance with available guidelines such as Environmentally Sound Management of
Mercury Waste Generated from the Health Care Facilities issued by Central Pollution
Control Board.".
(C) the sub-paragraph 2 relating to 'Manufacturing Process Areas', shall be substituted, namely, -
"2. Manufacturing Process Areas:
For the manufacture of Bhasma and Kupipakwa and Rasaushadhi preparations made from metals
and minerals the following specific areas shall be provided, which should be completely segregated from the
production area used for preparation of plants and animal ingredient-based formulation to avoid cross-
contamination. At least following exclusive areas are required for Rasaushadhies or Rasamarunthukal and
Kushtajat:-
2.2. (a) Bhatti or Heating Devise section for Bhasma and Rasaushadhies: 100 Sq. feet for heating,
burning, putta and any heat related work with proper ventilation, exhaust and chimney with scrubbing system
to avoid emission of any hazardous substance into the environment complying to National Ambient Air
Quality Standards (NAAQS) of Central pollution Control Board, in accordance with Pollution Control
regulation. The size and dimensions of each Bhatti section would be so designed to suit the batch size or
quantity of materials to be processed, keeping in mind the processing is done as per the conditions of Drug
and Cosmetics Act, 1940 mentioned under Schedule I official books.
(b) Grinding, Drying and Processing section for Bhasma and Rasaushadhies: 100 Sq. feet (Manual or
Mechanical, drying shade or oven, etc.). Drying shall be done in a space which is covered by glass or other
transparent material to allow entry of sunrays on the material to keep for the purpose. If drying is being done
in oven, appropriate temperature should be selected to prevent any adverse effect on the quality.
(c) Rashaushadi Related Store. 100 Sq. feet.
In addition to the fuels prescribed in the schedule books namely coal, firewood, cow dung cakes
etc., use of other heating devices such as electrical heating, oil or gas fired furnaces and others shall be
employed so as to provide the required temperature as per the nature of material and object of heating.
Depending on the formulation being manufactured, manufacturers may adopt aerobic or anaerobic process.
Properly baked and clean earthen pots or crucibles and glass containers or appropriate design shall be used.
The manufacturing area should be designed with special attention to process the products that
generate toxic fumes like S02 arsenic and mercury vapour, etc. When heating and boiling of the materials is
necessary, suitable ventilation and air exhaust flow mechanism should be provided to prevent accumulation
of unintended fumes and vapours. Such areas may be provided with properly designed chimneys or ducts
fitted with exhaust system and suitable scrubbing system to remove fumes and smoke, to ensure 'Zero
Emission' of any hazardous substance complying to NAAQS standards of Central Pollution Control Board,
so that safety of personnel and environment is not affected.
In order to ensure that any hazardous substance does not enter the effluent, proper SOP should be
developed to clean the premises and to collect accidental spill of hazardous substance like heavy metals, must
be provided. The drainage in such areas should be preferably in the form of easily accessible drains, to
facilitate collection of spillage and cleaning. The effluent shall be treated with appropriate treatment to ensure
that no hazardous substance escapes into drainage.
Since processing of Rasaushadhis may introduce heavy metal contamination and cross-
contamination etc., therefore, cleaning of equipment is particularly important after every process by using
appropriate cleaning agent which should not react with material of equipment and must be non-corrosive and
non-absorbent.
2.3 Records shall be maintained specially for temperatures attained during the entire process of Bhasmikaran,
Kupipakwarasayana while employing different kinds of classical puta, furnaces using oil, gas or electricity.
Appropriate temperature measuring instrument should be employed such as pyrometer and, pyrograph for
manual reading or recording by heat sensors, connected to computer as the case may be. The time
temperature data shall be recorded on the BMR.
In order to handle large quantities, appropriate technology like use of hand operated extruders for
making chakrikas or pellets may be adopted. However, such equipments made up of aluminium or its alloys
should not be used.
Access to manufacturing areas shall be restricted to minimum number of authorized personal only.".
(D) In sub-paragraph 3 relating to 'Quality Control', for sub-clause B, the following sub-clause shall be
substituted, namely,-
"B. Product Quality Control:
The specifications for finished Rasaushadhi are primarily intended to define the quality
rather than to establish full characterization, and should focus on those characteristics found to be
useful in ensuring the quality. Consistent quality for Rasaushdhi can only be assured if the starting
material-metals and minerals of pharmacopoeial standards are used. In some cases more detailed
information may be needed on aspects of their process. The manufacture shall ensure in-house
standards for the uniform quality of product.
Quality testing will be carried out as per official Pharmacopoeia or Schedule I books for
test namely, colour, taste, varitaratwa, Rekhapurnatwa, Laghutva, Nirdhumatwa,
DutagreKachakacha, Niruttha, Apunarbhava and Nischandratwa. Record of such tests shall be
maintained.
Master Formula of each product should be evolved and followed up. The Particle size of
the product should be tested by adopting microscope fitted with micrometer or particle size analyzer
or any appropriate other techniques. Required physio-chemical characterization of the product
should be undertaken by appropriate analytical equipment. The Standard Manufacturing Process of
the product should be evolved/ follow up. The disintegration time of pills-vati and tablets should
also be monitored. All tests carried out and results obtained should be recorded along with rough
notes.".
(E) the sub-paragraph 4 relating to 'Product recalls', the following sub-paragraph shall be substituted,
namely,-
"4. Product recalls
Literature inserted inside the product package should indicate the name address of
the manufacturing unit or registered office and telephone number for reporting of any
adverse drug reaction by physicians or patients. On receipt of such Adverse Drug Event
report, it will be the responsibility of the manufacturer to investigate the report and recall
the concerned batch of the product from the market if warranted.
Standard operating procedures (SOP) should be included for storage of recalled
Rasaushadhies in a secure segregated area, complying with the requirements specified for
storage, till their final disposal.".
(F) the sub-paragraph 5 relating to 'Medical examination of the Employees', the following sub-paragraph
shall be substituted, namely,-
"5. Medical examination of the employees:
Employees engaged in manufacturing of rasaushadhi should be medically examined
periodically at least once a year to detect any adverse effect (occupational hazard) on the vital
organs of the employees. Records of medical examination reports of the employees shall be
maintained and made available to statutory inspectors during Good Manufacturing Practices
inspections. Personnel engaged in manufacturing of Rasaushadhi should be rotated at appropriate
intervals to limit the extent of exposure.".
(G) the sub-paragraph 6 relating to 'Self Inspection', the following sub-paragraph shall be substituted,
namely,-
"6. Self-Inspection:
The release of Rasaushadhis should be under the control of a person who has been trained
in the specific features of the processing and quality assurance of Rasaushadhis. Personnel control
of Rasaushadhis should have appropriate training in the specific subject of Rasaushadhis. He will be
at least a degree holder in Ayurveda/ Siddha/Unani medicine or B. Pharma degree holder in
Ayurveda/Siddha/Unani medicine.".
(H) in sub-paragraph 7 relating to 'Dosage form of Rasaushadhi', for the words, “the Ayurvedic
Pharmacopoeia of India or Indian Pharmacopoiea as updated from time to time.", the following words shall
be substituted, namely, “the Rule 169 of the Drugs Rules, 1945.".
(I) in sub-paragraph 8, in the table, for the entries relating to S.no 4 in column 2, the following shall be
substituted, namely, “Kupi Pakva/ Parpati/ Dhatu Satva/ Sindura Karpu/Param.".
[F.No.T-11011/5/2024-DCC (AYUSH)]
Dr.. KOUSTHUBHA UPADHYAYA, Adviser (Ayurveda)
Note: The principal rules were published in the Gazette of India, vide, notification No. F. 28-10/45-H(1), dated the
21st December, 1945 and last amended, vide, notification number G.S.R.
dated the --.
Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064
and Published by the Controller of Publications, Delhi-110054.