HERBAL INDUSTRY

UNIT 5
General Introduction of Herbal Industry
Schedule T – Good Manufacturing Practice of Indian systems of
medicine

PREPARED BY : POOJA MISTRY

(ASST.PROFESSOR AT SNLPCP)
 INTRODUCTION:
 Herbal industry is a sector that produces herbal medicines and herbal
formulations within an economy.
 Entire world is under the impact of green waves of herbal medicine. People
are using herbal medicines from centuries for safety, efficacy, cultural
acceptability and lesser side effects.
 Plant and plant products are utilized with varying success to cure and prevent
diseases throughout history.
 The global herbal medicine market, by category, has been segmented into
herbal pharmaceuticals, herbal functional foods, herbal dietary supplements,
herbal cosmetics which are in increasing demand globally.
 The WHO reported that around 70-80% of the world population relies upon
the use of traditional plant-based medicines which includes medicinal and
aromatic plants.
PRESENT SCOPE OF HERBAL DRUG INDUSTRY:

 Herbs have been known since the era of civilization and are highly esteemed
all over the world as a rich source of medicinal agent.

 The popularity of natural products is increasing day by day due to the fact that
they arecomparatively safe, less toxic, less side effects, easily available and
affordable prices when compared to synthetic drugs.

 The herbal drug industry is a very fast growing sector in the international
market. In India, various system of medicine like Ayurveda, Siddha, Unani,
Homeopathy, Yoga, & Naturopathy are being utilized for the health care of
people.
SCOPE OF HERBAL DRUG MEDICINE AND INDUSTRY:
Indian Herbal Market:
 Herbal drugs constitute a major share of all the officially recognized system of health in
India viz. like Ayurveda, Siddha, Unani, Homeopathy, Yoga, & Naturopathy, expect
Allopathy
 More than 70% of India’s 1.1 billion populations still use these non-allopathic systemsof
medicine. Currently, there is no separate category of herbal drugs or dietary supplements,
as per the Indian Drugs Act.
 In India, raw drugs obtained from around 2,400 plant species. It is the fastest growing
market & may attain to 14,500 crore & export to 9000 crore with a CAGR (Compound
Annual Growth Rate) of 20% to 25% respectively, according to associated chambers of
Commerce & Industry of India (Assocham)
 The “Herbal Industry Biz” has revealed that currently, the Indian herbal market size is
estimated at 7000 crores & over 3600 crores of herbal raw materials & medicine are
exported by India.
 In India, there are about 8000 medicinal plants are used. Out of which 25 manufacturers
are large scale manufacturers. The annual turnover in India was around US $ 300 million
for Ayurvedic & US $ 27.7 million for Unani
 INTERNATIONAL SCOPE OF HERBAL MEDICINES:
 According to the World Health Organization (WHO), approximately 25 per cent of
moderndrugs used in the United States have been derived from plants
 More than 120 active compounds isolated from higher plants are widely used in
modern allopathic medicines today and 80% of them show a positive co-relation
between their modern therapeutic use and the traditional use of the plants from
whichthey are derived
 At least 7000 medicinal compounds derived plants, the ingredients of herbal
medicine,are included in the modern pharmacopeia of drugs
 WHO estimates that 80 per cent of the world’s population currently use
herbalmedicines for some aspects of primary health care
 They are also highly lucrative in the international market, generating billions of
dollarsin revenue.
 To cite few examples, annual revenue from herbal medicines and herbal products
in Western Europe reached US $ 5 billion in 2003-2004 In china, sales of herbal
productstotaled US $ 14 billion in 2005
 Herbal medicine revenue in Brazil was USS 160 million in 2007
 Herbal medicine based Traditional Medical system of treatment is a rapidly
growing healthcare system of economic importance and is now widely
used in many countries of the world. The following leads and development
are the future prospects in the herbal drug industry
 Plant products can also be useful as starting material for the semi synthetic
preparation of other drugs. Examples: Plant steroids (Diosgenin): Oral
contraceptives, hormones. Microorganisms (Streptomyces genus):
Antibiotics (Streptomycin, neomycin, tetracycline, chloramphenicol)
 The interest in natural products as a source of new biologically active
compounds has expanded due to increasing research and development in
phytochemistry
 SOURCE OF DATA: As Per Association Chamber of Commerce & Industry
(ASSOCHAM)
 It has been estimated that 56% of the lead compounds for medicine in BritishNational
Formulary are natural products or are derived from them
 With the development in the techniques of molecular biology, there has been an increase of
interest in the use of naturally occurring proteins as potential therapeutic agents.
 Several genetically engineered natural products have had a significant impact andmore
than 20 biotechnology derived products are now in the market
 Example: tissue plasminogen activator is used as a thrombolytic after myocardial
infractions Erythropoietin is used to treat anaemia associated with renalfailure
 Several colony stimulating factors are used for cancer treatment
 Natural products will continue to be important in the following three areas drug discovery
 As target for production by biotechnology
 As a source of new lead compounds of novel chemical structure
 As the active ingredients for useful treatments derived from traditional system of
medicine
 In the face of the increasing use and fast growing market of herbal medicines and
otherherbal healthcare products, in both developing and developed countries of the
world, policy-makers, health professionals and the public are increasingly expressing
concernsabout the safety, efficacy, quality, availability, preservation, and further
development problem of these herbal products. Public demand has also grown for
evidence on the safety, efficacy and quality of the herbal products and traditional
medicine (TM) and complimentary alternative medicine (CAM) practices

 However, in order to ensure quality and safety of herbal medicines, their production,
saleand use should be officially and legally controlled by established rules and
regulations sothat herbal medicinal can be used safety for medical and therapeutic
purposes and effortsshould be made to raise public awareness about the risks and
benefits of using herbal medicines.
 Overview on Plant Based Industries and Research Institutions in India
 List of research institutions and centers in India
 Government of India also has expressed support and encouragement for the
Traditional Indian Medicine (TIM).
 A Separate department for Indian System of Medicine and Homeopathy now
known as AYUSH (Ayurveda, Yoga, Unani, Siddha, Homeopathy) was
establishedin March 1995 to promote indigenous systems.
 Priority includes education standardization of drugs, enhancement of availability
of raw materials, research and development, information, communication and
larger involvement in the national system of delivering heath care
 In the year 1969, the Indian government established a central council for
researchin Indian medicine and Homeopathy (CCRIMH) to develop scientific
research indifferent systems of medicine.
 As the research in herbal products expanded various government and private
research centers developed which are actively engaged in the research and
development of herbal medicines
 The following are the list of few research institutions engaged in research inmedicinal and
aromatic plants in India
 Herbal research institutions/ Centers in India
Name of Institute City
CCRAS (Central Council for Research in Ayurvedic andSiddha) New Delhi

RRL (Regional Research Laboratory) (CSIR) Jammu-Tawi

NBRI (National Botanical Research Institute)(CSIR) Lucknow
Gujarat Ayurveda University Jamnagar
Bhavan’s SPARC Mumbai
National Institute of Ayurveda Jaipur
Arya Vaidya Shala Kottakal
Interdisciplinary School of Health Sciences Pune
Banaras Hindu University Vanarasi
CIMAP (Central Institute for Medicinal and Aromatic Plants) Lucknow

ICMR (Indian Council for Medical Research) New Delhi

National Medicinal Plants Board New Delhi
Regional Medical Research Centre (ICMR) Belgaum
PERD Centre (Pharmaceutical Education and Research Ahmedabad
Development)
CCRUM (Central Council of Research in Unani Medicine) New Delhi

NISCOM (National Institute of Science Communication) New Delhi

IMPCOPS (Indian Medical Practitoners Co-operative Chennai

Pharmacy & stores Ltd.)
IHMMR (Indian Institute of History of Medicine and New Delhi
Medical Research)
Zandu Foundation Mumbai
CDRI (Central Drug Research Institute) (CSIR) Lucknow
IMPLANT Centre (Inter-University Medicinal Plant Rajkot
Laboratory for Analysis, Nurture and Therapeutics)
 LIST OF FEW HERBAL DRUG INDUSTRIES IN INDIA

NAME CITY
Ansar Drugs Laboratories Surat (Gujarat)
Acis Laboratories Kanpur (UP)
Allen Laboratories Pvt. Ltd. Kolkata
Basic Ayurveda Ghaziabad
Dabur India Ltd. Ghaziabad
Herbals (APS) Pvt. Ltd. Patna
Herbo-Med (Pvt. Ltd.) Kolkata
The Himalaya Drug Co. Mumbai
Shipachem Indore
Hamdard (Wakf) Laboratories Delhi
Zandu Pharmaceutical works Ltd. Mumbai
Shhri Baidyanath Ayurved Bhavan Patna
Charak Pharmaceuticals Mumbai
 Biocon India Pvt. Ltd. Bengaluru
Cipla Research Centre & Factory Bengaluru
Government Quinine Factory Mungpoo
Vicco Laboratories Nagpur
Nagarjuna Herbal Concentrates Kerala
Shree Dhootapapeshwar Ltd. Mumbai
Sandu Pharmaceuticals Ltd. Goa
Patanjali Ayurved Uttarkhand
Sri Sri Ayurveda Bengalore
 SCHEDULE T – GOOD MANUFACTURING PRACTICE OF INDIAN
SYSTEMSOF MEDICINE
 COMPONENTS OF GMP (SCHEDULE - T) AND IT’S OBJECTIVES:
GMP:
 Good Manufacturing Practice (GMP) is a production and testing practice that helps to
ensure a quality product.
 GMP guidelines are not prescriptive instructions on how to manufacture products.
 These are a series of general principles that must be observed during manufacturing.
 When a company is setting up its quality program and manufacturing process,
theremay be many ways it can fulfill GMP requirements.
 It is the company’s responsibility to determine the most effective and efficient
quality process.
OBJECTIVES:
 The Good Manufacturing Practices for ASU Drugs as described in Rule 157 of
Drugs & Cosmetics Rules1945 with conditions as specified in Schedule T/GMP are
to ensure that:
 Raw materials used in the manufacture of drugs are authentic, of prescribed
qualityand are free from contamination
 The manufacturing process is as has been prescribed to maintain the standards
 Adequate quality control measures are adopted
 The manufactured drug which is released for sale is of acceptable quality
 To achieve the objectives listed above, each licensee shall evolve methodology
and procedures for following the prescribed process of manufacture of drugs
which shouldbe documented as a manual and kept for reference and inspection.
 However, under IMCC Act, 1970 registered Vaidyas, Siddhas and Hakeems who
prepare medicines on their own to dispense to their patients and not selling such
drugsin the market are exempted from the purview of Good manufacturing
Practice (GMP)
 BASIC PRINCIPLES OF GMP:

 Many countries have created their own GMP guidelines & procedure. These GMP
guidelinesremain more or less similar to the ultimate goals of safeguarding the health
of the patient as well as producing good quality medicine.

 Manufacturing processes are clearly defined and controlled. All critical

processes arevalidated to ensure consistency and compliance with
specifications.
 Manufacturing processes are controlled, and any changes to the process are
evaluated.Changes that have an impact on the quality of the drug are validated
as necessary.
 Instructions and procedures are written in clear and unambiguous language.
 Operators are trained to carry out and document procedures.
 Records are made manually or by instruments during manufacture that
demonstrate that all the steps required by the defined procedures and instructions
were in fact takenand that the quantity and quality of the drug was as expected.
Deviations are investigated and documented.
 Records of manufacture (including distribution) that enable the complete history
of abatch to be traced are retained in a comprehensible and accessible form.
 A system is available for recalling any batch of drug from sale or supply.
 Complaints about marketed drugs are examined, the causes of quality defects
are investigated, and appropriate measures are taken with respect to the
defective drugsand to prevent recurrence.
SCHEDULE T:
 Requirements (GMP) of factory premises for Ayurvedic, Siddha, Unai drugs

 For getting a certificate of “Good Manufacturing Practices” of Ayurveda, Siddha-

Unani drugs, the applicant shall made application on plain paper, providing the
information on existing infrastructure of manufacturing unit, and the licensing
authority shall after
 verification of the requirement as per Schedule “T” issue the certificate within a
period of 3months in form of 26-E
 GOOD MANUFACTURING PRACTICES FOR AYURVEDIC, SIDDHA AND
UNANI MEDICINES
 COMPONENTS OF GMP:
 GMP schedule for ISM manufacturing units is quite elaborate and broadly covers each
and every component of manufacturing process. Different components of GMP are
given below in order of appearance in Schedule – T.
 The Good Manufacturing Practices (GMP) are prescribed as follows in Part I and Part
II.
PART-I

 Factory Premises:

 The manufacturing plant should have adequate space for:

 Receiving and storing raw material

 Manufacturing process areas
 Quality control section
 Finished goods store
 Office
 Rejected goods/drugs store.
 GENERAL REQUIREMENTS:
 Factory Premises:
I. Location and surroundings
II. Buildings
III. Water supply
IV. Disposal of Waste
V. Container cleaning
VI. Stores (Raw materials, packing materials, Finished goods stores)
VII. Working Space
VIII.Health, Clothing, Sanitation and Hygiene of Workers
IX. Medical Services
X. Machinery and Equipment
XI. Batch Manufacturing Records
XII. Distribution records
XIII.Record of Market Complaints
XIV.Quality control

 REQUIREMENTS FOR STERILE PRODUCT:

A. Manufacturing area
B. Precautions against contaminations and mix
 FACTORY PREMISES:
 Location and surroundings:
 Location and surroundings of the pharmacy should be situated where there is:
 No open sewage
 No drainage coming from public areas & pubic lavatory
 No factory fume
 No excessive soot and smoke and dust
 Buildings:
 Hygienic conditioned
 No cobwebs/insects/rodents.
 Adequate light & ventilation.
 No dampness or Moisture on floor and walls.
 Wall & floors should be even.
 Premises used for manufacturing, processing, packaging and labeling should be inconformity with the
provisions of Factory Act.
 Compatible with manufacturing Operations.
 Adequate working space
 Logical placement of equipment to avoid risk of mixing, cross contamination and riskof omission of a control
step. Designed, constructed and maintained well to prevent entry of insects/rodents.
 Interior surface should be smooth, easy for cleaning and disinfection.
 Mooring should be smooth and even so as not to permit retention or accumulation ofdust or waste products.
 Water Supply:
 The water used in manufacturing should be pure and of potable quality. Adequate supply of
water is required for washing the premises and containers.
 Disposal of Waste:
 In the manufacturing section and laboratories the waste water and residues which might
the prejudicial to the work as well as public health shall be disposed of after suitable
treatment asper guideline of pollution control to be followed.
 Containers Cleaning:
 In factories where operation involving the use of containers such as glass bottles, vials
andjars are conducted. Adequate arrangement for washing, cleaning & drying of
containers.
 Stores:
 It should provide adequate space for stores of different type of material such as raw
material,packing material and finished products. Store should have proper ventilation
and should be free from dampness.
 Raw Materials:
 Raw material store should have appropriate containers which would protect the qualityof raw materials and
prevent from contamination or rodents and Insect infestation.
 Suitable cabins for raw material of
 Mineral origin
 Metallic origin
 Animal origin
 Fresh herbs
 Dry herbs or plant parts
 Excipients, Volatile oils/perfumes and Flavors
 Plants extracts, Exudates/Resins etc.
 Each container used for raw material storage should 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.
 Label of raw material should clearly indicate Batch No or Lot No, and date at receiptof the consignment.
 All raw materials shall be sampled and got tested either by the in-house quality controltechnical person or by
laboratories approved by the Government and should be used only on approval after verifying.
 Records of the receipt, testing and approval or rejection should be maintained.
 Packing Materials: All packing materials such as bottles, Jars, capsules etc. should be stored properly.
 All Container and Closure lids should be properly cleaned and Dried before packing the products.
 Finished Goods Stores:
 The finished goods transferred from the production area after proper packaging should be stored in
proper shelves within an area marked Quarantine.
 After the quality control laboratory: and the experts have checked the correctness of finished goods
with reference to its packing/labeling as well as the finished productquality described, then it will be
Moved to Approved Finished Goods Stock area.
 Only approved finished goods should be dispatched as per marketing requirements. Distribution
records should be maintained as required. Specific storage conditions should be provided for special
drugs.
 Working Space:
 The manufacturing area shall provide adequate space (manufacture and qualitycontrol) for orderly
placement of equipment and material used in any of the operations.
 Facilities for easy and safe working, facilities to minimize or eliminate mixing up of the drugs should
be provided. To prevent cross contamination of one drug by anotherdrug that is manufactured, stored
or handled in the same premises.
 Health, Clothing, Sanitation and Hygiene of Workers:

 Workers should be free from contagious diseases.

 Workers should use proper uniform suitable to work.
 Hands should be covered with cloth or synthetic covering.
 Personal cleanliness, clean towel, soap, scrubbing brushes, separate lavatories for men and
women and facility for changing of clothes and cupboards to keep clothes/belongings should
be maintained.

 Medical Services:

 Annual medical check-up of all employees should be done to ensure freedom from Infectious
diseases.
 First-Aid facility should be available.
 Health record of all the employees should be maintained
 Machinery and Equipment:

 Equipment should be according to the size of operation, nature of product

manufactured.
 Suitable Machinery manually operated; semi- automatic or automatic should be
available in the manufacturing unit.
 These may include machines for use in the process of manufacture such as crushing,
grinding, powdering, boiling, mashing, burning, roasting, filtering, drying, filling, labeling
and packing etc.
 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 Equipment have to be properly installed and maintained with proper cleaning.
 Proper standard operational procedures (SOPs) for cleaning, maintaining and
performance of every machine should be laid down.
 Batch Manufacturing Records:

 Ayurvedic, Siddha, Unani drug manufacturer should maintain batch manufacturingrecord of every
manufacturing.
 List of raw materials used, Quantity obtained from the store, tests conducted during the various stages
of manufacture like taste, color, physical characteristics and chemical tests as may be necessary or
indicated in the approved books of Ayurvedic, Siddha and Unnai.
 These tests may include any in-house or pharmacopoeia test adopted by the manufacturer in the raw
material or in the process material and in the finished product.
 Details of transfer of manufactured drug to the finished product store along withrecord of the
finished product, packaging etc. should be maintained.
 All manufacturing records should be duly signed by Production and Quality ControlPersonnel
respectively.
 It should be essential to maintain the record of date, manpower, machine, equipmentused along with
in process record of various shodhana (purificatory procedures of poisonous drugs), Bhavana
(trituration) in terms of internal use.
 Distribution Records:

 Records of sale and distribution of each batch of Ayurveda, Siddha and Unani Drugs should
be maintained in order to facilitate prompt and complete recall of the batch, if necessary.

 Record of Market Complaints:

 Manufacturers should maintain a register to record of the complaints as well ascorrective

action initiated to prevent recurrence regarding the products.

 Once in a period of six months, the complaint records have to be sent to the licensing
authority.

 Register should be available for inspection during any inspection of the premises.

 Reports of any adverse reaction resulting from the use of Ayurvedic, Siddha, Unanidrugs
should be maintained in separate register.
 Quality Control:

 Every licensee is required to provide facility for quality control section in his own premises or
through Government approved testing laboratory.

 The test shall be as per the Ayurveda, Siddha and Unani pharmacopoeia standard.

 There should be 150 sq. feet area for quality control section.

 For identification of raw drugs, reference books and reference samples should be maintained.
Manufacturing record should be maintained for the various processes. To verify the finished
products, controlled samples of finished products of each batch willbe kept for 3 years.

 To supervise and monitor adequacy of conditions under which raw materials, semi- finished products
and finished products are stored.

 Keep record in establishing shelf life and storage requirements for the drugs.

 Manufacturers who are manufacturing patent proprietary Ayuveda, Siddha, and Unani medicines
shall provide their own specification and control references in respect of such formulated drugs.
 The record of specific method and procedure of preparation, that is, Bhavana, Mardana and
Puta (earthen pits) and the record of every process carried out by themanufacturer shall be
maintained.
 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.
 All raw materials will be monitored for fungal, bacterial contamination with a view to
minimize such contamination.
 Quality control section will have a minimum at one person with Degree qualification in
Ayurveda/Siddha/Unani (A.S.U.) as per Schedule II of Indian Medicine Central Council
Act, 1970 (84 of 1970) of a recognized university or Board.
 Provided that Bachelor of Pharmacy, Pharmacognosy and Chemistry may be associated
with the quality control section.
REQUIREMENT OF STERILE PRODUCT
Manufacturing Areas:
Manufacturing area for the production of sterile of Ayurvedic, Siddha, Unani
product, separate enclosed area should be provided. This area should be
aseptic, dust-free, moisture less and should have bacteria free air supply
 Precautions against contamination and mix:
 a) Carrying out manufacturing operations in a separate block of
adequately isolated building or operating in an isolated enclosure within the
building,
(b) Using appropriate pressure differential in the process area.
(c) Providing a suitable exhaust system.
(d) Designing laminar flow sterile air system for sterile products.
(b) The germicidal efficiency of UV lamps shall be checked and recorded
indicating theburning hours or checked using intensity.

(c) Individual containers of liquids and ophthalmic solutions shall be examined

against black-white background fitted with diffused light after filling to
ensure freedom from contamination with foreign suspended matter.

(d) Expert technical staff approved by the Licensing Authority shall check and
compare actual yield against theoretical yield before final distribution of the
batch.

 All process controls as required under master formula including room

temperature, relative humidity, volume filled, leakage and clarity shall be
checked and recorded
 PART – II
 List of recommended machinery, equipment and minimum manufacturing premises
required for the manufacture of various categories of ayurvedic, siddha system of
medicines
 One machine indicated for one category of medicine could be used for the manufacturing of
other category of medicine also. Similarly some of the manufacturing areas like powdering,
furnace, packing of liquids and Avaleha, Paks, could also be shared for these items.

S. NO CATEGORY OF MINIMUM MACHINERY/

MEDICINE MANUFACTU EQUIPMENT RECOMMENDED
RING SPACE
REQUIRED
1200 Square feet covered area with separate cabins or partitions for each activity. If Unani
medicines are manufactured in same premises an additional area of 400 sq. feetwill be
required.
1 Anjana/Pisti 100 sq. feet Kharal/mechanized/motorizedKharal,
End runner/Ball–mill,Sieves/Shifter.
2 Churna/Nasya/Ma 200 sq. feet Grinder/Disintegrator/Pulveriser/Pow
njan/Lepa/Kwath dermixer/Sieves/Shifter.
Chur
3 Pills/Vati/ 100 sq. feet Earthen lamps for collection of Kajal, Triple
Gutika Matirai and Roller Mill, End Runner, Sieves, S.S.Patila,
tablets Filling/ packing and manufacturing room
should be provided with exhaust fan and ultra
violet lamps

4 Kupi pakava / Ksara/ 150 sq. feet Bhatti, Karahi/Stainless steel Vessels/ Patila,
Parpati/ Lavana Flask, Multani Matti/Plaster ofParis, Copper
Bhasma Rod, Earthen container,Gaj Put Bhatti,
Satva/Sindura Mufflefurnace(Electrically operated),
Karpu/ Uppu/ Param End/Edge Runner, Exhaust Fan, Wooden/
S.S.Spatula.
5 Kajal 100 sq. feet Earthen lamps for collection of Kajal,Triple
Roller Mill, End Runner, Sieves, S.S.Patila,
Filling/ packing and manufacturing room
should be provided with exhaust fan and
ultra violet lamps
6 Capsules 100 sq. feet Air Conditioner, De-humidifier,
hygrometer, thermometer, Capsulefilling
machine and balance.
7 Ointment 100 sq. feet Tube filling machine, Crimping Machine,
/Marham Pasai Ointment Mixer, End
Runner/ Mill (Where required), S.S. Storage
Container S.S.Patila.
8 Pak/Avaleh 100 sq, feet Bhatti section fitted with exhaust fan and
/Khand/ should be fly proof, Iron Kadahi/S.S. Patila
Modak/Lakaya and S.S. Storage
container
9 Panak, Syrup / 150 sq, feet Tincture press, exhaust fan fitted and fly proof,
Pravahi Kwath Bhatti section, Bottle washing machine, filter
Manapaku press/Gravityfilter, liquid filling machine,
P.P.Capping Machine
10 Asava/Arishta 200 sq. ft. Same as mentioned above. Fermentation
tanks, containers and distillation plant where
necessary,
Filter Press.
11 Sura 100 sq. ft. Same as mentioned above plus Distillation
plant and Transfer pump
12 Ark Tinir 100 sq. ft. Maceration tank, Distillation plant, Liquid
filling tank with tap /Gravityfilter/Filter press,
Visual inspectionbox.
13 Tail / Ghrit Ney 100 sq. ft. Bhatti, Kadahi/S.S. Patila, S.S.Storage
containers, Filtration equipment, filling tank
with tap/Liquid filling
machine
14 Aschyotan / Netra 100 sq. ft. Hot air oven electrically heated with
Malham Panir/Karn thermostatic control, kettle gas or electrically
Bindu/Nasa- bindu heated with suitable mixing arrangements,
collation mill, or ointment mill, tube filling
15 Each manufacturing 200 sq. ft.
unit will have a separate
area for Bhatti, furnace
boilers, puta, etc. This
will have proper
ventilation, removal of
smoke, prevention of
flies,insets, dust etc.
The furnace section
could have tin roof.
A. List of machinery, equipment and minimum manufacturing premises required for the
manufacture of various categories of unani system of medicines
 One machine indicated for one category of medicine could be used for the manufacturing of
other category of medicine also. similarly some of the manufacturing areas like powdering,
furnace, packing of liquids could also be shared for these items.
S. No CATEGORY OF Minimum Machinery/equipmentrecommended
MEDICINE manufactur
ing space
required
1200 square feet covered area with separate cabins, partitions for each activity. If Ayurveda/Siddha
Medicines are also manufactured in same premises an additionalarea of 400 square feet will be required.
1 Itrifal Tirya/majoon/ 100 sq. feet Grinder/Pulveriser, Sieves, powder mixer (if
Laooq/Jawarish required), S.S. Patilas, Bhattiand other
Khamiras accessories, plant mixer for
Khamiras.
2 Arq. 100 sq. feet Distillation Plant (garembic), S.S. storage
tank, Boiling Vessel, Gravity filter,
Bottle filling machine, Bottle washing
machine,
Bottle drier.
3 Habb (Pills) andtablets. 100 sq. feet Ball Mill, Mass Mixer/Powder mixer, Granulator drier, tablet
compressing machine, pill/vati cutting machine, stainless steel
trays/ container for
storage and sugar coating, polishing

4 Sufoof (Powder) 200 sq. feet Grinder /pulveriser, Sieves, Trays,Scoops, Powder mixer
(where
required).
5 Raughan (oils) 100 sq. feet Oil Expeller, S.S. Patilas, Oil filter bottle, Filling machine,
(Crushing andboiling) Bottle drier,Bhatti

6 Shiyaf, Surma, Kajal 100 sq. feet End runner, mixing S.S. Vessel.

7 Marham, Zimad 100 sq. feet Kharal, Bhatti, End runner, Grinder,Pulveriser, Triple Roller
(Ointment) Mill (if required).

8 Qurs (Tab.) 100 sq. feet Grinder/Pulveriser, Sieves, Powder mixer (where needed),
Granulator, Drier, Tablet Compressing Machine, Die
punches Trays, O.T. Apparatus, Balance with weights,
Scoops, Sugar Coating Pan, polishingpan, Heater
9 Kushta 100 sq. feet Bhatti, Kharal, Sil Batta, Earthen pots.
10 Murabba 100 sq. feet Aluminium Vessels 50-100 kgs. Capacity,
Gendna, Bhatti
11 Capsule 100 sq. feet Pulveriser, Powder mixer (where needed),
capsule filling machine, Air conditioner, De-
humidifier, Balance with weights, storage
containers, glass
12 Sharbat andJoshanda 100 sq. feet Tinctum Press, exhaust fan fitted, Bhatti
section, Bottle washing machine, Filter
Press Gravity filter, Liquid filling tank with
tap/liquid filling machine, hot air oven
electrically heated with thermostatic control,
kettle
13 Qutoor-e-Chashm and Marham (Eye 100 sq. feet Hot air oven electrically heated with
drops, eye ointment) thermostatic control, kettle.
14 Each manufacturing unit will have a 200 sq. feet
separate area for Bhatti, furnace boilers,
puta, etc.
This willhave proper ventilation,
removal of smoke, prevention of flies,
insets, dust etc
C. List of equipment recommended for in-house quality control
section
A CHEMISTRY SECTION B PHARMACOGNOSY SECTION
1 Alcohol Determination Apparatus 1 Microscopic Binocular
(complete set)
2 Volatile Oil Determination 2 Dissecting Microscope
Apparatus.
3 Boiling Point Determination 3 Microtome
Apparatus
4 Melting Point Determination 4 Physical Balance
Apparatus
5 Refractometer 5 Aluminium Slide trays
6 Polarimeter 6 Stage microscope
7 Viscometer 7 Camera Lucida (Prism and Mirrortype)
8 Tablet disintegration apparatus 8 Chemicals, Glass-ware etc.
9 Moisture meter
10 Muffle Furnace
11 Electronic Balance
12 Magnetic stirrer
13 Hot air oven
14 Refrigerator
15 Glass/Steel Distillation Apparatus
16 LPG Gas Cylinders with Burners
17 Water Bath (Temperaturecontroller)
18 Heating Mantles/Hot plates
19 TLC Apparatus with allaccessories (Manual)
20 Paper chromatography apparatuswith accessories
21 Sieve size 10 to 120 with sieveshaker
22 Centrifuge Machine
23 Dehumidifier
24 pH Meter
25 Limit Test Apparatus