Full Text
REGD. No. D. L.-33004/99
The Gazette of India
CG-DL-E-25072026-274789
EXTRAORDINARY
PART II—Section 3—Sub-section (i)
PUBLISHED BY AUTHORITY
No. 595]
NEW DELHI, FRIDAY, JULY 24, 2026/SHRAVAN 2, 1948
MINISTRY OF AYUSH
NOTIFICATION
New Delhi, the 24th July, 2026
G.S.R. 657(E).— Whereas the draft of certain rules further to amend the Drugs Rules, 1945 was published as
required under sub-section (1) of section 33N of the Drugs and Cosmetics Act, 1940 (23 of 1940) in the Gazette of
India, Extraordinary, Part-II, Section 3, Sub-section (i) vide notification of the Government of India, in the Ministry of
Ayush, number G.S.R. 140(E) dated 14th February, 2025, for inviting objections and suggestions from all persons likely
to be affected thereby before the expiry of a period of thirty days from the date on which the copies of the Official
Gazette containing the said notification were made available to the public;
And Whereas, the copies of said Gazette were made available to the public on 19th February, 2025.
And Whereas, objections and suggestions received from the public on the said draft rules have been considered
by the Central Government;
Now, therefore, in exercise of the powers conferred by section 33N of the Drugs and Cosmetics Act, 1940 (23
of 1940), the Central Government, after consultation with the Ayurvedic, Siddha and Unani Drugs Technical Advisory
Board hereby makes the following rules further to amend the Drugs Rules, 1945, namely: -
1. Short title and commencement: - (1) These Rules may be called the Drugs (Eleventh Amendment) Rules, 2026.
(2) They shall come into force on the date of their publication in the Official Gazette.
2. In the Drug Rules, 1945 (hereinafter referred to as the said rules), in rule 154, after sub-rule (3) following sub-rule
shall be inserted, namely: -
"(4) A licence issued under sub-rule (1), shall remain valid perpetually."
3. In the said rules, in rule 154A, after sub-rule (4) following sub-rule shall be inserted, namely:-
"(5) A licence issued under sub-rule (1), shall remain valid perpetually."
4. In the said rules, rule 156 shall be omitted.
5. In the said rules, rule 156 A shall be omitted.
6. In the said rules, in rule 157, -
(i) in sub-rule (1 C), for the proviso, the following provisos shall be substituted, namely: -
"Provided that, this sub-rule shall not be applicable, for extract based single plant-ingredient of Ayurvedic,
Siddha, Sowa-Rigpa or Unani formulation licensed or to be licensed as patent or proprietary medicine as defined under
sub-clause (i) of clause (h) of section 3 of the Act, till one year from the commencement of the Drugs (Eleventh
Amendment) Rules, 2026:
Provided further that, such extract based single plant-ingredient of Ayurvedic, Siddha, Sowa-Rigpa or Unani
formulations shall be named with prefix or suffix with any expression specific to the licencee."
7. In the said rules, in rule 158B, after sub-rule VI, the following sub-rule shall be inserted, namely: -
"VII. Uniform pattern of specific product code shall be given in following manner, namely: -
(a) State or Union Territory code/ D or E (License or Loan license)/serial number of license/system of medicine
(classical or PP)/ serial number of product/years of product approval;
(b) the details regarding State/ Union Territory code shall be specified by Central Government;
(c) the existing product code shall be reissued in such pattern within a period of two years from the commencement
of the Drugs (Eleventh Amendment) Rules, 2026;
(d) State/Union Territory code/ D or E (License or Loan license)/serial number of license in the product code shall
be treated as manufacturing license number.".
8. In the said rules, in rule 160B,
(a) in sub-rule (2), in clause (ii), in sub-clause (b), -
(i) for item (i), the following item shall be substituted, namely: -
"(i) expert in Ayurveda or Siddha or Sowa-Rigpa or Unani medicine who possesses a degree qualification
recognized under schedule II of Indian Medicine Central Council Act, 1970 or under section 35 of the National
Commission for Indian System of Medicine Act, 2020 or a Graduate in Pharmacy (Ayurveda or Siddha or
Sowa-Rigpa or Unani) by a recognised University.";
(ii) after item (iii), the following item shall be inserted, namely: -
"(iv) Microbiologist possessing a bachelor degree with Microbiology awarded by a recognized University,
with six months experience in quality control or possessing a post graduate degree in Microbiology awarded
by a recognised University.”.
9. In the said rules, in rule 161,-
(a) in sub-rule (1) for the second proviso, the following proviso shall be substituted, namely:-
"Provided further that if the list of ingredients contained in the medicine is large and cannot be accommodated
on the label, the same may be printed separately and enclosed with the packing and reference be made to this effect on
the label or may be displayed through QR code or Global Trade Item Number (GTIN) or Bar code.";
(b) in sub-rule (3), for clause (iv), the following clause shall be substituted, namely: -
"(iv) The specific product code of the drug being preceded by the words "specific product code or S.P.C.", which
shall be printed or written within two years of the commencement of the Drugs (Eleventh Amendment) Rules,
2026.";
(c) after sub-rule (3), the following sub-rule shall be inserted, namely: -
"(3A) All the label information may also be displayed through QR code or Global Trade Item Number (GTIN) or
Bar code.".
10. In the said rules, in rule 161B,-
(a) after sub-rule (2), the following sub-rule shall be inserted, namely:
"(2A) If the approval of the drug has been granted on the basis of accelerated stability studies, then, -
(a) 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 and the said report shall be
submitted to the licensing authority as referred to in rule 151;
(b) the report of the real-time stability study shall be submitted by the licensee within one year from the expiry
of the shelf life granted based on the accelerated stability data.
Explanation.- For the purpose of this sub-rule, determination of shelf-life beyond two years shall be based on
real-time stability study.";
(b) after sub-rule 8, the following sub-rule shall be inserted, namely: -
“(9) In cases of change in dosage form of any Ayurvedic, Siddha or Unani drugs defined under clause (a) of
section 3 of Drugs and Cosmetics Act, 1940, the expiry date of particular drug category shall be supported by
accelerated or real-time stability study data, as the case may be.".
11. In the said rules, in rule 162, for clause (i), the following clause shall be substituted, namely: -
"(i) to inspect all premises licensed for manufacture of Ayurveda or Siddha or Sowa-Rigpa or Unani drugs within the
area allotted to such Inspector to verify the compliance with the conditions of licence and the provisions of the Act and
rules, as needed as per risk-based approach.".
12. In the said rules, in rule 163-BB, -
(a) in sub-rule (1), the words, brackets and figures "sub-section (2) of section 11 or" shall be omitted;
(b) after sub-rule (3), the following sub-rule shall be inserted, namely: -
"(4) For the purpose of testing of package or sample of any suspected Ayurveda or Siddha or Unani or Sowa-Rigpa or
Homoeopathy drugs as referred to in sub section 2 of section 11 of the Act, the authorized drugs testing laboratory of
autonomous organization of Ministry of Ayush, which have been approved under part XVIA shall act as Central Drugs
Laboratory.".
13. In the said rules, in rule 163C, -
(a) in sub-rule (1), after the words and brackets “Ghaziabad (Uttar Pradesh)" the words "or Central Drugs
Laboratory, as the case may be” shall be inserted;
(b) in sub-rule (3), after the words and brackets “Ghaziabad (Uttar Pradesh)" the words "or Central Drugs
Laboratory, as the case may be” shall be inserted.
14. In the said rules, for rule 167, the following rule shall be substituted, namely: -
"167. Qualifications of Inspector. - A person who is appointed as an Inspector under section 33G of the act shall be a
person who has a degree in Ayurveda or Siddha or Sowa-Rigpa or Unani system or degree in pharmacy of Ayurveda or
Siddha or Sowa-Rigpa or Unani system, as the case may be, conferred by a University, recognised by the Central
Government or the State Government for this purpose.".
15. In the said rules, in rule 169, after clause 3, the following clause shall be inserted, namely:-
"3A. In addition to the information mentioned under clause 3, the quantity of Base material shall also be mentioned on
the label for the category of Saundarya Prasadak (Husane afza)/ Azhagh-sadhan and shall be printed or written over
label:
Provided that this requirement shall be complied within such time, not later than the 31st day of July, 2028."
16. In the said rules, in Schedule M-I, -
(a) in paragraph 1 relating to General Requirement, -
(i) in sub-paragraph 1.1, for the words 'cleared periodically' the words, "cleaned and sanitized periodically and the
drainage shall have the facility to prevent back siphonage or back flow shall be substituted;
(ii) for 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 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 earmarked for them and shall not be
taken inside the manufacturing areas, without quality control 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 or 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 and quality assurance is a 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. 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 a 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. Purified water so produced shall 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 shall be maintained by the licensee in this behalf.
(c) Disposal of waste
(i) The disposal of sewage and effluents (solid, liquid and gas) from the factory shall be in conformity
with the requirements of Pollution Control Board.
(ii) All bio-medical waste shall be destroyed as per the provisions of the Bio-Medical Waste
(Management and Handling) Rules, 2016.
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 or
vitrified tiles 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 shall not be used.
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.";
(b) for paragraph 2, 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. Wherever 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 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 or 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.
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 or 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 or 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.";
(c) in paragraph 3 relating to Requirement of Equipment and Facilities, -
(i) for sub-paragraph 3.2, the following sub-paragraph shall be substituted, namely: -
"3.2 Potentisation section-The section shall have the following facilities, namely:-
(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;
(iv) potentiser with counter;
(v) potentisation shall be done by the method(s) prescribed in the Homoeopathic Pharmacopoeia of
India;
(vi) an area of 20 square metres shall be provided for basic installations.
Note 1: 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.
Note 2 : 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.";
(ii) for sub-paragraph 3.3, 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, namely: -
(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.
Note 1:- Different droppers shall be used only for each different medicine and different potency.
Note 2:- 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.
Note 3:- Glass droppers shall be reused only after proper cleaning and sterilization and clearance from
quality control and quality assurance section.";
(iii) for sub-paragraph 3.4, 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, namely: -
(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.
Note 1:- 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 2:- The section shall be free from insects, worms, rodents, dust and other floating particles and
moisture.";
(iv) in sub-paragraph 3.5, after item (2), the following items 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.";
(v) for sub-paragraph 3.7, the following sub-paragraph shall be substituted, namely: -
"3.7 Ophthalmic preparations section-The following basic equipment and facilities shall be
provided, namely: -
(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.
Note 1:- The section shall have a clean room facility of ISO Class 5 clean room (ISO 14644-1 clean
room standard). The section shall be air-conditioned and humidity controlled. 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.
Note 2:- Materials shall be passed to the sections through suitable hatches.
Note 3:- The personnel shall wear sterile clothing including headgear, which shall not shed fibre.
Note 4:- Washing of phials shall be done in separate areas with proper equipment. Proper facilities
shall be provided in the area for washing vessels.
Note 5:- Separate area shall be provided for packing and labelling.";
(d) for paragraph 4, 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 division 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 or 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, namely: -
(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)high-Performance Thin-Layer Chromatography (HPTLC) / Thin-Layer Chromatography (TLC)
instrument;
(iv) ultraviolet (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.
(xx) 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.
(xxi) safety shower and eyewash facility in the quality control lab.";
(e) in paragraph 5,-
(i) for sub-paragraph 5.1, the following sub-paragraphs shall be substituted, namely: -
"5.1. 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) Authorised 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.
5.1.1 Raw materials of plant origin
(a) The raw materials of plant origin used for manufacture of drug shall be of the following specifications:
(i) the materials shall be those recently collected and dried and shall be free from moisture so as to
eliminate the risk of deterioration and infestation with pests, moulds, etc. The materials shall be collected
when the atmospheric temperature is suitable where its active constituents are not
changed/damaged/destroyed;
(ii) the materials should be taken from healthy plants and shall be free from parasites, moulds, etc.;
(iii) the materials shall conform to the pharmacopoeial standards;
(iv) when dry materials are procured, they shall be from healthy plants and shall be in un-processed
form, free from all extraneous matters such as fungus, insects, moulds, pathogenic organisms, etc. [xxx].
Plant materials of Agaricaceae, which are perishable shall be used within one week of collection.
(b) To facilitate proper identification and purity of the material and to exercise proper quality control of the material,
the following conditions must be satisfied:
(i) the raw materials of plant origin shall be as per pharmacopoeia;
(ii) if the material used is a mould or of the plant families Agaricaceae,
Polyporaceae/Amanitaceae/Boletaceae/Russulaceae, a whole specimen plant/mould shall be available
in properly dried form;
(iii) the materials shall be free from insecticides, fungicides, etc.;
(iv) fresh herbs shall be stored in open mesh bags and materials in closed containers;
(v) each consignment of the material shall be accompanied by a statement of the supplier's name; name
of the plant with description of the part supplied; the Pharmacopoeial reference, place of collection, date
of packaging and weight.";
(ii) in sub-paragraph 5.2, after the words, 'shall accompany the materials.', the words “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 or fume hood." shall be inserted;
(iii) for sub-paragraph 5.4, 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.";
(f) for paragraph 7, 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 or 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.";
(g) for paragraph 8, 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 quality control before being used. All labels should abide by extant
Laws. Labels should be kept in a temperature controlled environment to prevent loss of gumming.”;
(h) for paragraph 10, 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 should be conducted for the
staff and the record for the same should be maintained by quality assurance section.";
(i) for paragraph 11, 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.";
(j) after paragraph 11, the following paragraph shall be inserted, namely:-
12. The amendments made to this Schedule by the Drugs (Eleventh Amendment) Rules, 2026 shall be complied within
such time, not later than the 31st day of July, 2029".
17. In the said rules, in Schedule T, -
(a) In paragraph 1, -
(i) in item (iv), after the words "acceptable quality”, the word, “and”, shall be inserted.
(ii) for item (v), the following 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:
PROVIDED that under the Indian Medicine Central Council Act, 1970 or the National Commission for
Indian System of Medicine Act, 2020 (14 of 2020), registered Vaidyas, Siddhas and Hakeems who
prepare medicines on their own to dispense to their patients and not selling such drugs in the market are
exempted from the purview of Good Manufacturing Practices.”;
(b) in Part I, relating to "GOOD MANUFACTURING PRACTICES", -
(i) in sub-heading "factory premises", for clause (i), the following clause shall be substituted, namely:-
"(i) receiving and storing raw and packaging material.";
(ii) for sub-paragraph 1.1, 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 or 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 or 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 or any other
effective measures. 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 and 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 or Bhatti section could be covered with tin roof and proper ventilation, but sufficient
care should be taken to prevent 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-Wherever required, there shall be separate space for drying of raw material, in
process medicine or medicines that require drying before 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 and cleaning, wherever applicable.
(iv) Water treatment systems shall be documented.
1.1(D) Disposal of waste and effluent
(i) Appropriate measures shall be taken for disposal of sewage and effluents (solid, liquid and gas) from
the factory.
(ii) Additional precautions shall be taken for the storage and disposal of rejected drugs with special
attention to schedule El ingredients.
(iii) Records shall be maintained for rejected waste of Schedule E I ingredients.
(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 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 and breeding of insects.
(ii) Storage areas shall be of sufficient capacity to allow orderly storage of the various categories of
materials and 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 maintained in such a way to avoid cross contamination and to
ensure protection from the weather influence.
(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) Storage shall be provided for rejected or recalled or returned materials or products.
(vii) Periodic audit of warehouses shall be conducted, and its record shall be maintained.
(viii) Inflammable and hazardous substances shall be segregated and stored in safe and secure areas, 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) Swaras, Kalka, Extracts or Uşāra, Amla Pishti, Rasoushadhis such as Bhasma or Kushta, Kupi Pakva,
Kajjali or Kajli and similar products, when used as intermediates or semi-processed raw materials,
should be procured only from GMP-certified manufacturing facilities, and the purchase vouchers
should reflect the manufacturing license details of the facility. 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.
(iii) All incoming materials shall be quarantined immediately after receipt.
(iv) 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 any other suitable material and not placed directly on
the floor.
(v) 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.
(vi) The manufacture based on the experience and the characteristics of the particular raw material used in
Ayurveda, Siddha, Sowa-Rigpa 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.
(vii) 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.
(viii) 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, namely: -
(1) raw material of metallic and mineral origin;
(2) raw material from animal sources;
(3) fresh Herbs;
(4) dry Herbs or plant parts;
(5) excipients etc;
(6) volatile oils or perfumes and flavors and
(7) plant concentrates extracts and exudates/resins;
(8) ingredient of Schedule E I;
(9) inflammable substances/ raw materials.
(ix) 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.
(x) Dedicated area shall be provided for sampling of raw material and excipients to avoid contamination
and cross-contamination.
(xi) All the raw materials shall be sampled as per written Standard Operating Procedures (SOP) and tested
either by the in-house Ayurvedic, Siddha, Sowa-Rigpa and Unani experts (quality control technical
person) or by the laboratories approved by the Government and shall be used only on approval after
verifying.
(xii) All raw materials will be monitored for fungal, bacterial contamination with a view to minimise such
contamination.
(xiii) The rejected raw material should be removed from other raw material store and should be kept in
separate areas 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 and recalled or 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 and secure area.
(ii) Status labels shall have appropriate colour code such as"UNDER TEST" or "APPROVED" or
"REJECTED", by use of colour coded status label – yellow, green and red respectively.
(ii) All containers and closures 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) Upon verification by the quality control Laboratory that the finished goods conform to the specified
quality standards and comply with prescribed packaging and labelling requirements, the batch shall be
transferred for storage and subsequent dispatch.
(iii) Only approved finished goods shall be dispatched as per marketing requirements.
(iv) Distribution records shall be maintained as required.
(v) If any Ayurveda, Siddha, Sowa-Rigpa 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 for manufacturing and quality control
operations, ensuring the smooth movement of personnel and materials. It shall allow for the orderly
placement of equipment and materials to facilitate safe and efficient operations, minimize the risk of
mix-ups between different drugs and raw materials, and prevent cross-contamination between
products manufactured, stored, or handled within the 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, wherever
possible.
(v) The manufacturing area shall not be utilized for dining purposes.
(vi) The manufacturing area shall be sanitized regularly using an appropriate disinfectant to ensure
effective microbial control while maintaining a high level of safety for personnel and the environment.
Accordingly, the periodical records 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 and 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 and 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.
(x) 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) 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 and rows of machines. This 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 and periodic calibration shall be maintained separately.
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 production.
(ii) Analytical Report (AR) number and Lot number of all the raw materials and excipients used should
be mentioned in the BMR.
(iii) The record of specific method and procedure preparation such as, "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,
Sowa-Rigpa and Unani mentioned in the First Schedule of the Drugs and Cosmetics Act, 1940 (23 of
1940), shall be mentioned in the form of their report number in BMR.
(v) Before commencing a batch, cleaning status of all machines and equipment to be used should be
checked and recorded in BMR and date of last calibration done, shall be recorded in BMR.
(vi) BMR should also mention the name and signature of the personnel who has performed or conducted
the task and also who has supervised the manufacturing or 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.
(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, Sowa-Rigpa 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 reports of market complaints related to quality
control 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) The manufacturer shall submit the report of such complaints annually to the licensing authority.
(iv) The Register shall also be available in the premises.
(v) Adverse drug reaction (ADR) monitoring: The licensee shall have a pharmacovigilance mechanism
for collecting and documenting reports of adverse drug reactions arising from the use of drugs
manufactured or marketed by them and shall forward such reports to the licensing authority for
information.
1.1(N) Quality Control -Every licensee is required to provide facility for quality control section in his own premises
or through State or Union Territory Government approved testing laboratory. The test shall be as per the Ayurveda,
Siddha, Sowa-Rigpa and Unani pharmacopoeial standard. Where the pharmacopoeial tests are not available, the test
should be performed according to the manufacturer'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 atleast 150 sq. feet area for quality control section.
(ii) for identification of raw drugs, reference books and reference samples should be maintained.
(iii) record of analytical test and other processes should be maintained.
(iv) to test the finished products, controlled samples of furnished products of each batch will be kept for
duration of expiry period plus minimum three months.
(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 or proprietary Ayurveda, Siddha, Sowa-Rigpa and Unani
medicines shall provide their own specification and reference standards in respect of such formulated
drugs.
(viii) Inhouse standards and testing protocol of drugs defined under section 3(h) shall be required as
submitted to the licensing authority.
(ix) 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 Sowa-Rigpa 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 of any system of
medicine awarded by a recognized University; and
(c) Botanist (Pharmacognosist), who shall possess at least a bachelor degree in Science or Pharmacy
of any system of medicine 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.
(x) A mechanism of internal audit should be developed by the manufacturer.
(xi) The manufacturing company will maintain all the records of various tests got done from outside
recognised laboratories.
(xii) List of equipments recommended is indicated in Part II C of this schedule.
(xiii) 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(O) Training
(i) All concerned 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) 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.";
(c) in Part-II,-
(i) in the heading “list of recommended machinery, equipment and minimum manufacturing premises required for the
manufacture of various categories of Ayurvedic, Siddha system of medicine", in the Table, -
(A) in column (2), against serial number 4, for the words 'Kupi pakava/Ksara/ Parpati/Lavana Bhasm a
Satva/Sindura Karpu/ Uppu / Param", the words, "Ksara/ Lavana or Satva (plant origin) or Uppu shall be
substituted;
(B) after the serial number 15, the following serial numbers shall be inserted, namely:
+-----+-----------------------------------+------------+-------------------------------------------------------------+
| No. | Category | Area | Equipment |
+=====+===================================+============+=============================================================+
| 16. | Saundaryaprasadhak/ Alaku | 100 sq.ft. | Mixing and heating tank , Filling |
| | catanap porutkal | | machine. |
+-----+-----------------------------------+------------+-------------------------------------------------------------+
| 17. | Swarasa/Caru | 100 sq.ft. | Juicer Grinder (according to the |
| | | | requirement), filter, mixing tank, |
| | | | packaging equipments. |
+-----+-----------------------------------+------------+-------------------------------------------------------------+
| 18. | AushadhaGhana/ extracts/cattu | 200 sq.ft. | Boiler, Extractor, condenser, receiver, |
| | etuttal | | column, distillation, tray dryer, |
| | | | vaccum dryer, grinder , blender, |
| | | | shifter. |
+-----+-----------------------------------+------------+-------------------------------------------------------------+
| 19. | Nasal Spray/ Naciyam | 200 sq. ft | Reverse laminar airflow, weighing |
| | | | balances, manufacturing vessel, |
| | | | jacketed manufacturing vessel, bulk |
| | | | holding vessel, diaphragm pump, |
| | | | filter assembly, automated filling line |
| | | | including vial washing machine, |
| | | | sterilizing and Depyrogenation |
| | | | tunnel, autoclave, vial filling machine |
| | | | (filling, sealing, crimping, transfer |
| | | | conveyor etc.). |
+-----+-----------------------------------+------------+-------------------------------------------------------------+
Note 1: Equipment of Stainless Steel (SS) shall be grade of 304 and above.
Note 2: List of machinery or equipments are only suggestive in nature. Manufacturers may use appropriate
machinery as per latest emerging technology.
Note 3: The space and Machinery required for Dosage forms, which are not mentioned above may be decided
by the manufacturer and approved by the licensing authority as per the requirement.";
(ii) in the heading “list of machinery, equipment and minimum manufacturing premises required for the manufacture of
various categories of Unani system of medicine", in the Table, -
(A) after the serial number 14, the following shall be inserted, namely: -
+-----+--------------+------------+-------------------------------------------------------------+
| No. | Category | Area | Equipment |
+=====+==============+============+=============================================================+
| 15. | Husne Afza | 100 sq.ft. | Mixing and heating tank , Filling |
| | | | machine. |
+-----+--------------+------------+-------------------------------------------------------------+
| 16. | Mā' al-'Aqāqīr | 100 sq.ft. | Juicer Grinder (according to the |
| | | | requirement), filter, mixing tank, |
| | | | packaging equipments. |
+-----+--------------+------------+-------------------------------------------------------------+
| 17. | Uşāra | 200 sq.ft. | Boiler, Extractor, condenser, receiver, |
| | | | column, distillation, tray dryer, |
| | | | vaccum dryer, grinder , blender, |
| | | | shifter. |
+-----+--------------+------------+-------------------------------------------------------------+
| 18. | Nasal Spray | 200 sq. ft | Reverse laminar airflow, weighing |
| | | | balances, manufacturing vessel, |
| | | | jacketed manufacturing vessel, bulk |
| | | | holding vessel, diaphragm pump, |
| | | | filter assembly, automated filling line |
| | | | including vial washing machine, |
| | | | sterilizing and Depyrogenation |
| | | | tunnel, autoclave, vial filling machine |
| | | | (filling, sealing, crimping, transfer |
| | | | conveyor etc.). |
+-----+--------------+------------+-------------------------------------------------------------+
Note 1: Equipment of Stainless Steel (SS) shall be grade of 304 and above.
Note 2: List of machinery or equipments are only suggestive in nature. Manufacturers may use appropriate
machinery as per latest emerging technology.
Note 3: The space and Machinery required for Dosage forms, which are not mentioned above may be decided
by the manufacturer and approved by the licensing authority as per the requirement.";
(iii) for paragraph D, the following paragraphs shall be substituted, namely: -
"D. Supplementary guidelines for manufacturing of Rasaushadhies or rasamarunthukal and kushtajat (herbo-mineral-
metallic compounds) of Ayurveda, Siddha, Sowa-Rigpa 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) Druti Parpam, Karpu, and Kushta etc. used in
Ayurveda, Siddha and Unani 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 and
minerals especially Mercury, Lead and Arsenic shall be done in accordance with available guidelines.";
(iv) for paragraph 2, the following paragraph shall be substituted, namely: -
"2. Manufacturing Process Areas:
For the manufacture of Bhasma or Parpam and Kupipakwa or Kuppiputak Karuvi and Rasaushadhi
or Racam cernta maruntukal 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. 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 mentioned in authoritative books of Schedule I of Drug
and Cosmetics Act,1940.
(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 SO2, 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 the safety of personnel and the
environment.
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,
Kupi-pakwa rasayana while employing different kinds of classical puta, furnaces using oil, gas or electricity.
Appropriate temperature measuring instruments 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 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.";
(v) in paragraph 3, 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 the authoritative books
mentioned under first schedule of Drugs and Cosmetics Act, 1940 for test namely, colour, taste,
Varitaratwa, Rekhapurnatwa, Laghutva, Nirdhumatwa, Dutagre Kachakacha, Niruttha, Apunarbhava
and Nischandratwa. Record of such tests shall be maintained.
Master Formula record 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.";
(vi) for paragraph 4, the following 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.";
(vii) for paragraph 5, the following 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.";
(viii) for paragraph 6, the following paragraph shall be substituted, namely: -
"6. Release of Rasaushadhis out of factory premises:
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 or Siddha or Sowa-Rigpa or Unani medicine or B. Pharma degree
holder in Ayurveda or Siddha or Sowa-Rigpa or Unani medicine.";
(ix) in paragraph 7, for the words, "the Ayurvedic Pharmacopoeia of India or Indian Pharmacopoiea as updated
from time to time.", the words and figures, "Rule 169 of the Drugs Rules, 1945." shall be substituted;
(x) in paragraph 8, in the table, against serial number 4, in column 2, for the words “Kupi Pakva/Ksara/Parpati/
Lavana Bhasma/ Satva/ Sindura Karpu/ Uppu/ Param / Qushta/ Jawhar.", the words “Kupi Pakva/ Parpati/
Dhatu Satva/ Sindura Karpu/ Param." shall be substituted;
(xi) after paragraph 8, the following paragraph shall be inserted, namely:-
"9. The amendments made to this Schedule by the Drugs (Eleventh Amendment) Rules, 2026 shall be complied 'within
such time, not later than the 31st day of July, 2029".
[F. No. T-11011/1/2025-DCC (AYUSH)]
DR. A. RAGHU, 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. 607(E) dated the 8th July 2026.
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.
KUMER Digitally signed by
CHAND KUMER CHAND
MEENA MEENA
Date: 2026.07.25
08:49:44 +05'30'
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