Regulation and Patenting

Natural Prodt-Comm.,Indust.&Regul. (SPP 2

and efficacy of herbal
developed guidelines for the safety
In 3 , an appointed by the Indian government
expert committee that no new herbal
Act and rules. It was proposed
the Drugs and Cosmetics

CHAPTER mealcines wich- were intended to be incorporated into

medicines other than those authorized by the licensing

authorities be allowed to be manufactured
or marketed, except

"authoritative" books for Ayurveda,

for those mentioned
Sidálha and Unani herbal
in and manutactured in compliance with the
formulae given in the

3 Regulation and Patenting medicines.

data in the marketing authorizatio
herbal medicine must include safety data and appropriate eficacy
A manufacturer of a new

application.
the predominant active constituents are
of plat origin.
Herbal preparations are defined as natural products in which
availability, and the nature of the berbs
A classification for berbal medicines was proposed depending on their market
Category 1: Already in use for more than 5 years.
Syllabus Category 2 : In use for less than 5 years
(a) Regulations
(0 Licensing requirements for production and scale of herbal drugs in India Category 3: New medicines.
(in) Schedule T-GMP practices of Indian system of Medicine 3.2 Herbal Drug Regulations in India:
(i) Components of GMP and its been documented in Rigveda. It has been mentioned in Charak
objectives Herbal medicines are being used in India since Vedic age and it has
and gradually a group of experts evolves who
nrastructural requirements woking space, storage area, machinery and equipments, SOP, Health Samhita. Initially herbs have been used by the people traditionally from their experience
& Hygiene
were called as apothecaries.
(v) Documentation & Records countries. In India herbal medicines are being used in Ayurveda,
Herbal medicines are also used since long back in other different
medicines is
(b) Herbal Drug Patenting is being practiced since 6000 B.C., Chinese berbal
Siddha, Unani and Homoeopathic system of medicines. Ayurvedic system
i) Intellectual Property Rights 5000 B.C. wbereas the modem system of medicines started since 1800 A.D.
beingpracticed since
i) Definition and Introduction of Patent 1940 and Rules 1945, initially prescribed the standards of Ayurvedic, Siddha and Unani medicines and
Drugs and Cosmetics Act,
(Gi) Famers Fight & Breeders Right laid down rules and regulation on sale and manufacturing.

baving standards of drugs and

(iv) Biopiracy A positive step has been taken in this direction by publishing of the Herbal Pharmacopoeias,

() Trademark & Copyright formulations.

license from AYUSH The Ministry of AYUSH is located at INA

To manufacture Ayurvedic or herbal products in India we need a
and The AYUSH Department of Delhi is located in Tibbia College, Karol Bagh.

3.1 Introduction Below are 3 types

of manufacturing licenses issued by AYUSH:
Complete Manufacturing ILicense
The legal situation regarding herbal preparations varies from country to country. In some, phyomedicines well
are established 2. Loan License
whereas in others they are regarded as food and therapeutic claims are not allowed. Contract Manufacturing/ Third party manufacturing White label Manufacturing / Product to Product manufacturing
3.
Developing countries, however, often have a great mumber of traditionally used herbal medicines and much folk-knowledge about
1. Complete Manufacturing License:
them, but have hardly any legislative criteria to establish these traditionally used berbal medicines as part of the drug legislation.
license. In this case owner will be both marketing and
Complete Manufacturing License is a fully fledged manufacturing
In India. traditional medicines are governed by the Drugs and Cosmetics Act of 1940 and the Drugs and Cosmetics Rules of 1945. the Thus owner will bave to setup his own manufacturing unit. The owner will have to fulfill
all the
manufacturing prodhict.
They regulate the import, manufacture, distribution and sale of drugs and cosmctics. In 1959, the Govermment of India recognized the for the manufacturing license.
requirements stated by state authority of AYUSH. All states in India have different requirements
traditional Indian systems of medicine and amended the Drugs and Cosmetics Act to include drugs which are derived from traditional
As per AYUSH Delhi, the requirements for manufacturing license of Ayurvedic medicines are as follows:
Indian medicine.
The manufacturing unit should be of minimum size of 1200 sq. t. in industrial arca. More space is required if more categories are
No products derived from traditional systems may be manufactured without a licence from the State
Drug Control Authorities. to be manufactured.
Patent and proprietary medicines derived from the tradituonal systens must contaln ingredients which are mentioned in the recognized
as specified in the Drugs Act The govermnent is advised The manufacturing unit should be GMP certified.
books of the above systems,
and Cosmetics by a special commite and an
advisory board for Ayurvedic, Siddha and Unani drugs. Fnanacopocid comnmtees nave been constituted to prepare Two Ayurvedic experts and two Pnarmacists are required.
pharmacopoeias for
all these systems. All the manufacturing and packaging machinery are required.
 3-4 Regulation and Paterting
Natural Prodt.-Comm.,Indust. &Regul. (SPPU)
Natural Prodt.- Comm., Indust. &Regul. (SPPU) 3-3 Regulation and Paenting
The prescribed requirements as per the Act for Layout plan.
Drug inspectors come for regular inspection of the premises. of the Drugs and Cosmetics Act. 1940.
4. The plan is sCrutinized by panel of officers as per the requirements
Loan License:
f necessary the premises is inspected by the concemed Inspector
before plan Approval.
5.
L C e n s e 15 a manufacturing license where a person loan a manufacturing unit of a third party manutacturer o make i s of the Act the layout plan is approved.
6. Finally aftcr scrutiny and compliance as per requirements
Homeopathy drugs is
C e D u s toe person will o t have to own a manufacturing unit. The person has to apply for a Loan neeuSc win a M E the required conditions, licence for the sale of
State Pood & Drugs Adminístration office after fulfiling
c d manutacturer and it will be issued to his company. Then he will have to get an approval for his product irom auhoriaes.
granted.
cn For the sale of Ayurvedic Drugs and Cosmetics no sale licence is required.
D provide the raw materials and packaging material or manufacturer can arrange it from his sources. Finaly 8.
manufacturer gives the ready product 3.2.2 Schedule T for Good Manufacturing Practice (GMP):

any person likes to change the manufacturer, he will have to apply for a Loan license again with a new GMP certified Siddha or Unani drugs shall be issued for a period
The certificate of Good Manufacturing Practices to manufacturers of Ayurveda.
manufacturer. Siddha and Unani
of Good Manufacturing Practices (GMP) of Ayurveda,
of five years to licensees who comply with the requirements
De anutacturer will dugs as laid down in Schedule T.
charge the conversion charges ie. the cost for manufacturing of the product in his facility. The Product label
wIll say that the product is both manufactured Siddha and Unani medicines Good Manmufacturing practices have been made mandatory
and marketed by your company. It will not mention anything about the manuracturer To manufacture good quality Ayurvedic,
you liasioned with. by incorporation of revised Schedule T in the year of 2003 under Drugs & Cosmetics Act, 1940.

As per AYUSH Delhi, some

requirements for Loan license of Ayurvedic medicines are as tollows 3.2.2.1 Important Features of Schedule T
w e need to have a
premise with three min One for raw material
rooms. room storage, one for finished material storage and one Important features ofSchedule T are as follows
oroffice in Part I and Part I to ensure that;
The Good Manufacturing Practices (GMP) is prescribed as follows
.
Loan License has to be renewed regularly. ) Raw materials to be used in manufacture of medicines must be authentic, of preseribed quality and free from contaminatio.
Drug inspectors come for c) Manufacturing process is as prescribed to maintain the standand
regular inspection of your premises.
ii) Adequate quality control measures to be adopted.
No Ayurvedic experts and Pharmacist is required.
iv) Drugs released for sale shall be ofacceptable quality.
T h e company shoud be registered in same state as the manufacturer. To achieve the objectives listed above, the firm is required to maintain the following conditions stringenly :
V)
T h e other information includes details of product marketed and manufactured. (a) Well designed factory premises with sufficient space required to be provided.

. Contract Manufecturing/Third party manutacturing Proper machineries require to be provided.

()Quality control laboratory require to be provided with required instruments and well qualified personnel.
Contract/ Third-Party Manufacturing are a License where person will the license
use manufacturing of a third-party manufacturer
(d) Shal evolve methodology and procedures for following the prescribed process of manufacture.
to manufacture the product The people who apply for third party manufacturing will be just marketing the and will
product not
()Which should be properly documented and kept for reference and inspection?
have to own any manufacturing unit nor get any license. All liasoning with AYUSH office will be done by the manufacturer.
3.2.2.2 Components of GMP and ts Objectives :
The person who applies far third party manufacturing will use manufacturing licence of the manufacturer, the manufacturer will
Basic Principles of GMP:
have to get approval for product from authornties. Either one can provide the raw materials and packaging material or manufacturer
Many countries have legislated that pharmaceutical and medical device companies must follow GMP procedures, and have created
can arrange it from his sources. Finally manufacturer g ves only the ready product. The Product label will that
say the product is
their own GMP guidelines that corespond with their legislation. Basic concepts of all of these guidelines remain more or less similar to
manufactured by the XYZ manufacturer and marketed by the company who apply for third party licence.
the ultimate goals of safeguarding the bealth of the patient as well as producing good quality medicine.

The manufacturer will charge the conversion Charges 1e. e cosE TOr manuracturing your product in his The legal provisions related to GMP are described under Drugs and Cosmetics Rules 1945. particularly Rule 151 to 160 and
facility, product approval
fees and make a legal document stating that company own the product Legal document should also say that in of any
Schedule T.
case dispute,
Applicant Company remains the owner of the product. Although there are a number of them, all guidelines follow a few basic principles i

3.2.1 Licensing Requirement for Production and Sale of Herbal Drugs in India : Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and

compliance with specifications.

Food and Drug Administration ot the statle grants owI aidtactunng ncenses 1or Drugs (Allopathy, Homoepathy,
Ayurvedic, Manufacturing processes are controlled, and any changes to the process are evaluated.
Siddha, Unani) and Cosmetics
Changes that have an inmpact on the quality of the drug are validated as necessary.
For Approval of Lay out Plan the APplicant has o subintS DIUeprint copies of plan to the concerned
Licensing Authority.
2 The plan should be as per the requiremenis precnbed tomanuractunng premises in the Dugs and Cosmetics Act.
Ct. 1940.
 Natural Prodt.- Comm., Indust. &Regul. (SPPU) Regulation and Patenting 3-6
Regulation and Patenting
Natural Prodt-Comm., Indust. &Regu. (SPPU)
Instructions and procedures are written in clear and unambiguous language. that may be caried out in the same or adjacent premises.
) Compatible with other manufacturing operations
and materials to avoid the
Operators are trained to and document procedures. allow orderly and logical placement of equipment
carry out
(i) Adequately provided with working space to
control the possibility of cross contamination by
other
thereof and
that demonstrate that all the steps requirea Dy ne defned nsk of mix-up between diferent drugs or components
addally or by instruments during manufacture
of manufacturing or control step.
a d 0stucuons weTe in fact taken and that the quantity and quality of the drug was as expecied. DEvialons are
drugs or substances and avoid the risk of omission any
and rodents. Interior surface (walls, floors and ceilings)
investigated and documented. )Designed, constructed and maintained to prevent entry of insects
shall be smooth and free from cracks and permit easy cleaning
and disinfection. The walls of the room in which the
Kecords of manufacture (including distribution) thbat enable the complete history of a batch to be traced are retainca m a
to and be capable of being kept clean. The flooring
shall be
comprehensible and accessible form manufacturing operations are carried out shall be impervious
smooth and even and shall be such as not to permit retention or accumulation of dust or waste products.
A system is available for recalling any batch of drug from sale or supply. fixtures in the
area. The sanítary fittings and electrical
(iv) Provided with proper drainage system in the processing
O p i a i n t s adout marketed drugs are examined, the causes of quality defects are investigated, and approprale measures a e taken
manufacturing area shall be proper and safe.
with respect to the defective drugs and to prevent recurrence. ventilation, but sufficient care should be taken to prevent
()Furnace/Bhatti section could be covered with tin roof and proper

1 De many ways tor a

company to fulfil the GMP requirements while setting up its quality program and manufacturing fies and dust.
proces. It is the company's responsibility to determine the most effective and efficient quality proces
There should be fire safety measures and proper exits should be there.
(vi)
3.2.2.3 Roles and Responsibilities medicine or medicines which require
of Inspectors Conducting GMP Inspection (vii) Drying space- There should be separate space for drying of raw material, in process
will be from flies/insects/dusts, etc., by proper flooring. wire-mesh window,
drying before packing. This space protected
The powers which may be exercised by an Inspector and the duties which may be performed by him and the conditions,
glass pans or other material.
imitations, or restrictions subject to which such powers and duties may be exercised or performed shall be such as may be
of water for
prescribed in Drugs & Cosmetics Act 1940 and Rules there under. 1.1(C) Water Supply: The water used in manufacture shall be pure and of potable quality. Adequate provision
washing the premises shall be made.
In relation to Ayurvedic, Siddha Unani and Homeopathy drug, an inspector appointed by the Central Govemment or a State
Government under section 33G of Drugs & Cosmetics Act 1940 is called as Inspector. L.1D) Disposal of Waste : From the manufacturing sections and laboratorics the waste water and the residues which might be
prejudicial to the workers or public health shall be disposed off añer suitable treatment as per guidelines of pollution control
3.2.3
Infrastructural
SOP, Health andRequirements
Hygiene:
Working Space, Storage Area, Machinery and Equipments, authorities to ender them harmless.

1.1E) Containers' Cleaning : In factories where operations involving the use of containers such as glass bottles, vials and jars are
PART-I: conducted, there shall be adequate arrangement separated from the manufacturing operations for washing, cleaning and drying of

Factory Premises: such containers.

The manufacturing plant should have adequate space for; 1.1(F) Stores: Storage should have proper ventilation and sball be free from dampness. It sbould provide independent adequate
(i) Receiving and storing raw material space for storage of different types of material, such as raw material, packaging material and finished products.

(i) Manufacturing process areas 1.1FMA) Raw Materials All aw materials procured for manufacturing will be stored in the raw materials store
ii) Quality control section The manufacture based on the experience and the characteristics of the particular raw material used in Ayurveda, Sidalha and

iv) Finished goods store Unani system shall decide the use of appropriate containers which woud protect the quality of the raw material as well as prevent
from damage due to dampness, micraobiological contamination or rodent and insect infestation, etc. If certain raw materials
() Office
require such controlled environmental conditions, the raw materials stores may be sub-divided with proper enclosures to provide
(vi) Rejected goods/dnugs store
such conditions by suitable cabinization. While designing such containers, cabins or areas in the raw materials store, care may be
1.1 General Requirements: taken to handle the following different categories of raw materials.
1.1(A) Location and surroundings: ) Raw material of metallic origin. i) Raw material of mineral origin
The factory building for manufacture of Ayurveda. Siddha and Unani medicines shall be so situated and shall have such (1i) Raw material from animal source (iv) Fresh Herbs
construction as to avoid contamination from open sewerage. drain, public lavaiory or any factory which produces disagreeable or
() Dry Herbs or plant parts (vi) Excipients
obnoxious odour or fumes or excessive soot, dust or smoke.
(vi) Volatile oils/perfumes and flavours (vn) Plant concentrates/extracts and exudates/resins
1.1(B) Buikdings: The building used for factoy shall be such as to pemit production of drugs under hygienic conditions and Each container used for raw material storage shall be properly identified with the label which indicates name of the raw material,
should be free from cobwebs and insects/rodents. It should have adeguate provision of light and ventilation. The floor and the source of supply and will also clearly state the status of raw material such as UNDER TEST or "APPROVED' or "REJECTED.
walls should not be damp or moist. "The premises used for manufacturing. processing. packuging and labeling will be in
The labels shal further indicate the identity of the particular supply in the form of Batch No. Or Lot. No. and the date of receipt of
with the provisions of the Factory Act.
conformity consignment. All the raw materials shall be sampled and got tested either by the in-bouse Ayurvedic, Siddha and Unani experts
It shall be located so as to be :
 Regulation and Pate
3-7
Natural Prodt.-Comm., Indust.&Regul. (SPPU) shall e use only on
approval h Natural Prodt.- Comm., Indust. &Regul. (SPPU) 3-8
Regulation and Patenting
byapproved
Governnent
au Kept in a separate
uanty control technical person) or by the laboratories
other raw
materials
s*
store
and shouid
e

room aternal or n the process material and in the finished product. These records shall be duly signed by Production and Quality
material should be removed from Kecords of the
the receip testing
receipt
venfying. Tbe rejected raw
necessary.
including dates and quantity
Details of transfer of manufactured drug to the finished products
wherever store
Procedure of 'First in first our' sbould be adopted for raw matenals
0 0
o gs e respectively.
uransiemed along with record of testing of the finisbed product, if any, and packaging, records shall be maintained. Only
and of raw material shall be maintained.
spproval or ejection use
all be stored be cleared fo sale. Ii should be essential
materials such as botes. jas.
psules, .
properly. are
anufactured drugs have been verified and accepted quality shall be allowed
to

Pckaging Materials: All packaging and to keep in process record of vañous shodhana,
L.1 NB) before packing the Pro
L D the record
of date, manpower, machine and equipments used
coDtainers and closures shall be adequately cleaned and dried
atterproper packagingshall be stan
area
bhavana, burning in fire and specific grindings in terms of internal use.
transferred from the production
1.1FXC) Finished Goods Stores: The finisbedgoods laboratory and tthe
experts have checle Siddha and Unani Drugs shall be
control ) Sribution Records: Records of sale and distribution of each batch of Ayurveda,
After the quality
in the finisbed goods stores within an area marked "Quarantine". finished product quality as prescribet
naintained in order to facilitate prompt and complete recall of the batch, if necessary. The duration of record keeping
shoukd be the
the
as well as
the correctness of finished goods with reference to its packing/labelling ched
shall be dispatched :as ale of expiry of the batch, Certain categories of Ayurvedic, Siddha and Unani medicines like Bhasma, Rasa, Kupi- pakva, Parpati,
per
it will e moved to "Approved Finished Goods Stock" area Only
approved
finished goods
marketing their efficacy increases with the
Indura, KarpuUpru/Puram, Kushta, Asava-arista, etc. Do not have expiry date;
in contrast
aquirements passage of time. Hence, records need to be maintained up to 5 years of the exhausting of stock.
Ayurvedic. Siddha and Unan1 ang neES
speel storage condit
DnDuon records shall be maintained as required. If any 1.1M) Record of Market Compaints: Manufacturers shall mainlain a register to recond all eports of market complais
finisbed goods sore shall provide necessary environmental requirements rece1ved Tegarding the products sold in the market. The manufacturer shall enter all data received on such market complaints,
LI(G) Working Space : The manufacturing area shall provide adequate space ( d
nd quality control) for
orderty DYesugaions camed out by the manufacturers regarding the complaint as wel as any corective action initiated to preve

which these are employed

so as to faciitate easy and recurence of such market complaints shall also be reconded. Ooce in a period of six months the manufachurer shall sabmit the
Pacement of equipment and maternal used in any of the operations for

and to mnimize or to eliminate any risk of mix-up between different drugs,

raw matenais and
to prevent the possibiliyot record such complaints to the Liceasing Authority. The Register shall also be available for inspecticn during any inspection of the
wOng
or handled m the same premises.
TsSDnamunaton of one drug by another drug that is manufactured., stored premises.
11E) Health, Cothing, Sanitation and Hygiene of Workers: All workers employed in the Factory shall be free fom
Reports of any adverse reaction resulting from the use of Ayurvedic, Siddha and Unani drugs shal also be maintained in a separate
congrous aiseases. Tbe clothing of the workers shall consist of proper uniform suitable to the naure ot work and the climate a
and register by each manufacturer. The manufacturer shall iavestigate any of the gdverse reaction to find if the same is daue to any
shall be clean. defect in the product, and whether such reactions are already reported in the literature or it is a Dew observation.
wherever requined. Adequate
The uniform shall also inclade cloth or synthetic covering for hands, foet and head
facilidesf 1.10) Quality Control : Every licensee is required to provide facility for quality control section in his own premises or through

persoal cieanliness such clean towels soap and scnubing brushes shall be provided. Separaie provision shall
as
be mates Govemment-approved testing laboratory. The test shall be as per the Ayurveda, Siddha and Unani pharmacopocial standard.
lavatories to be used by men and women, and such lavatories shall be located at places separated from the processing
ooms Where the tests are not available, the test should be performed according to the manufacturer's specification or other information
Workers will also be provided facilities for changing their clothes and to keep their personal belongings. available. The quality control section shall verify all the raw materials, monitor in process, gquality checks and control the qnaity of

1.1 Medical Services - The manufacturer shall also provide : finished product being released to finished goods store/warehouse. Preferably for such quality control there will be a separate
expert
)Adequate facilities for first aid
The quality control section shall have the following facilities
Modical examinaion of workers at the time of employment and periodical checkup thereafter by a physician once
with paricular antenion being devoted to freedom from infections Records thereof shall be maintained.
ayea (a)Thereshouldbe 150 sq. . area for quality control section.

1.10) Mechinery and Equipents: For carrying out manufacturing depending on the size of operaion and the nature (b) For identification of raw drugs, reference books and reference samples should be maintained

manufactured, aitable cquipment either manually operated or operated

ofprodat
semi-automatically (electrical
or team based) fully
or ()Manufacturing record should be maintainoed for thevarious processes
automatic machinery shall be made available. These may include machines for in the process of manufacture such
use
crushing
as ) T o verify the finished products, controled samples of finished products of each batch will be kept till the expiry date of
grinding. powdering, boiling, mashingg. buming. roasting, filhering. drying, filing, labelling and
packing. etc. To ensure ease in product
movement of workers and orderliness in operations a
suitably adequate space will be ensured between two machines or
machines. Proper standard operational procedures (SOPs) for
rows o ( T o supervise and monitor adequacy of conditioe: vnder which raw materials,semifinisbed prodacts and finished products
cleaning maintaining and performance of machine
laid down.
every should be are stored.

(0 Keep record in establishing shelf ife and storage requirements for the drags.
1.1(K) Batch Manufacturing Records: The icensee shall mainain batch
manufacturing record of each batch of
Ayurvedt Manufacturers who are manufacturing patent proprietary Ayurvoda, Siddha and Unani medicines shall provide their owa
Siddha and Unani drugs manufactured inrespective of the of
ype product manufactured (classical
propnietary medicines). preparation or patent am specificaion and control references in respect of such formuilated drugs.

(h) The record of specific method and procedhure of preparation, that is, "Bhavana", "Mardana" and "Puta" and the record of
Manufacturing records are required to provide and account of the list of raw materials
and their
testsconducted during the various stages of manufacture ike taste, colour, quantities obtained from the store every process caried out by the manufacturer shall be maintained.
physical characteristics and chemical tests as
necessary or indicated in the approved books of Ayurveda, Siddha and
Unani mentioned in
may (i) The standads for identity, purity and strength as given in
respective pharmacopocias of Ayurveda. Siddha and Unani
the Fist Schedule of the
Cosmetics Act, 1940. These tests may inciuoe any -ouse or Drugs an systems of medicines pubished by Govermment of India Shall are complied with.
pharmacopoeial test
adopted by the manufacturer in the ra
 Regulauon and Patenta
3-9
Natural Procdt Conmm.,Indust.&Regul. (SPPU) ation,
sucth c o n t a m i n n t i

contamination
with a view lo
iInize

Natural Prodt. Comm., Indust. &Requl, (SPPU) 3-10

Regulation and Patenting
will be mxnitorvd for fungal, hacterial
All nulenals
) av
(il) Espert technical saff approved by the Lcensing Authority thal check and compare actual yield against theoretical yrco petone
final distribution of the batch.
()Quality omtroI SOchm will have a minimum of
under Sched humidity, volume fliea, lcakage and
le Il Poonirols as required under master formula including room temperature, relative
tecognizecd
qualiication
a degnee
Unani who possess clarity shall be checked and recorded.
( Evpert in Ayurvoda or Siddha or
Indian Medticine Central Council Act. 1970.
or l'harmacy (A PART
Bachelor Dege in
Scicnce or
Pharmucy
urveday OTCOmended machinery, equipment and minimum manufacturing premises required for the manutacture or yanous
Snail poSsess at least a

Categories of Ayurvedic, Siddha system of Medicines.

awanded by a recognized University.
in deience (Medical) or Ph Onc acntbe ndicated for one category of medicine could be used for the manufacturing of other category of medicine also.
Bachelor Degree
at least a
A Botanist(Pharmacognosist) who shall possess
be shared for these
or Phammacy (Ayuneda) awarded by a neognized University
Similarly some of the manufacturing areas Hike powdering, furnace. packing of liquids and Avaleha. Paks, coukd also
ed under Section 35(). Alternatively,thes items.
as
manufactunng unit shall have a quality control
section exprad for Ayurveda, Sidta
fo
laboratory
from a recognized
etc.,
testing.
quality control provisions will be met by.getting manufacunng comparny will mainttinaal Machinerylequipment reeommended
Cosnetics Act. The Category of Mediclne Minimom manufacturing
D Unani dnugs; under Rule 160-A of the Drugs and
No space required
Une recond of vanous tests got done from outsidc recognized laboralony
(üi) List of equipment recommended is indicated in Part l1-C
1200 Square feet covered area with
12 Requirementfor Sterile Product
separate cabins or partitions for
(A)ManutecturingAreas each activity.
areas specincany GeSIgned Tor the purpo
e manutacture of sterile Ayurvedic, Unani and Siddha drugs, separate enclosed f Unani medicines are
shall be providod. manufactured in same premises an
and shall be essentially dust
free and For
venulatea w n an air supply. al additional area of 400 sq. feet will
TDese areas shall be provided with air locks for entry
bactenia retaning filers (HEPA Filen)
shall be filered through
arcas where asepüc manufacture has to be camied out. air supply
for pertomance on installation. and
be required
and shal be at a pressure higher than in the adjacent areas. The
filters shall be checked
Anjana/Pisti 100 sq. 1 Kharal (motar and pestle) mechanized/ motorized
in sterile manufactuning areas shall be
designed to
penodically thereafter the record of checks shall be maintained. All the surfaces Kharal, End runoer/Bal-mall, sieves/shifter
counts of all Ayurvedic, Siddha and Unani drug
facilitate cleaning and disinfection. For sterile manufacturing routine microbial
count shall be checked against
established in-house Churna/Nasya 200 sq. ft Grinder/Disintegrator
manufactunng arcas shall be carmied out during operations. Results of such
standards and record maintained. Access to manufacturing areas shall be restricted to minimum number of authorized personnel Manjan/epa/ Kwath/Churna Pulveriser/ Powder mixer/Sieves/Shifler.
shall be written down and displayed.
Special procedure to be followed for entering and leaving the manufacturing areas PillsVati /Gutika and tablets 100sq. ft. Ball Mill, Mass mixertpowder mixer, Granulalor
For the manufacturing of Ayurvedic, Siddha and Unani drug that can be sterilized in their final containers, the design of the areas drier, tablet compressing machine. pillvati cutting
shall preclude the possibility of the products intended for sterilization being mixed with or taken to be products already sterilized. machine, stainless steel trayscontainer for storage
In case of terminally sterilized products, the design of the areas shall preclude the possibility of mix-up between non-sterile and sugar coating. polishiog pan in case of sugar

products. coated tablets

(B) Precautions againstcontamination and mix: Kupi pakava/Ksara/ IS0sq.. Bhati, Karahi (pan) Stainless steel Vessels/ Patila,

Carrying out manufacturing operations in a separate block of adequately isolated building or operating in an isolated enclosure ParpatiLavana/Bhasma Flask. Multani Matti/Plaster of Paris, Copper Rod,
(i)
within the building. Satva/Sindura Earthen container, Gaj Put Bhatti Mufle furmace
u) Using appropriate pressure differential in the process area. (Electrically operated) End/EdgeRunner. Exhaust
(i) Providing a suitable exhaust system
Fan, Wooden/S.S.Spatula.
Kajal 100 sq. f Eartben lamps for collection of Kajal, Triple Roller
(iv) Designing laminar flow sterile air system for sterile products.
Mill, End Runner, Sieves, S.S.Patila. Filing/
The germicidal efficiency of UV lamps sball be checked recorded indicating the buming hours or checked
(v) and
using intensity packing and manufacturing room should be provided
(vi)Individual containers of liquids and ophthalmic solutions shall be examined against black-white background fited with diffused
light afer filling to ensure freedom from contamination with foreign suspended matter.
withexhaustfan and utra violet lamps.
 Regulation and Paten.
& Regul. (SPPU)_
3-11
Natural Prodt. Comm.,
Indust. Regulation and Patenting
Machinery/equipment recommende Natural Prodt.- Comm., Indust. &Regul. (SPPU) 3-12
Minium manufacturing author and the
Sr. Category of Medicine
M including genus, species, variety,
space required
e sCientific botanical name according to the binominal system
No common name if used for the
labeling should be stated.

100 sq. ft.

Air Conditioner, De-humidifier, hygrometer, 3. Productionprocess
6. Capsules thermomete, Capsule filhng machine and balan in the production should be
a E and address of the intended producer(s) and the proposed site(s) or facilities involved
their involvement and of other
describcd. Parties other than the intended producerts) may be involved and, in this case(s),details of
sole or shared
Tube filling machine, Crimping Machine, Ointmen desses be provided, together with information on the contractual arrangements regarding
must
7. Ointment/Marham
100 sq. ft. S material of the same quality.
Mixer, End Runner/ Mill (Where required), p o n s i u e s and demonstrated
proof that any altermative production arrangements yield
S.S. Storage Container S.S.Patila
4. Deseriptlon of manufacturing process and process controls:
100 sq. ft. Bhatti section fitted with exhaust fan and should be 0OELADOD, shoulkd be provided that adequately describes the plant production and plant collection, includingg Geographical
8. Pak/Avaleh
ly proof, Iron Kadahi/S.S. Patila and S.S. Storapge SOurcels) conditions. Pre and post harvest chemical treatments,
of
drug. Cultivation, harvesting. drying
herbal and storage
container e.g. pesticides, fumigants, any other treatment.
150 sq. ft Tincture press, exhaust fan fitted and
9. Panak. Syrup / Pravahi . Characterization:
fly proof, Bhatti section, Bottle washing with
Kwath nrormadon shoukd be provided on the botanical, macroscopic, microscopic and phytochemical characterization, together
machine, filter press / CGravity filter. iquid fiing biological activity, if oecessary. This data sbould aso inclade additional feaures that distinguish the herbal drug from potential
machine, PP. Capping Machine adulterants and substitutes in case the monograph does not sufficiently cover this aspect.

10. Asava / Arishta 200 sq. ft Same as mentioned above. Fermentation 5. Impurities
tanks, containers and distillation plant where Where applicable, possible impurities/coataminants originating from prodtuction and lor degradation should be listed, and their
necessary, Filter Press probable origin/canse should be discussed. If altermative production processes/sources are described. possible

11. Tail/Ghrit 100sq1t Kadahi/S.S. Patila, S.S. Storage impurities/contaminants must bed is cussed separately for each process/route.

containers, Filtration equipment, filing tank with Thisincludes:

tap/Liquid filling machine
) Starting material is herbal material.
12. Netra Malbam 100sq. ft. Hot air oven electrically heated with Discrimination between related species, wbere relevant.
Nasa- bindu thermostatic control, kettle gas or electrically (ii) Potential adulterants/substitutes/contaminants those are likely to be present.
heated
with suitable mixing arrangements, collation iv) Foreign organic matter
mill, o
ointment mill, tube filling ()Inorganic impurities/contaminants or toxic metals the discussion should be based on the knowledge of the plant species,
13. Each manufacturing unit will have a 200 sq. ft. whether it is wild or culdivated and the production conditions.
separate area for Bhatti, furnace,
(vi) Pesticides and fumigation agents.
boilers, puta, etc.
The potential for residues of pesticides should be considered taking into account whether the plant material is wild or cultivated
This will have proper
ventilation, and any treatments given. These include fumigants, Radioactivity, Water content, Loss on drying, Microbial contamination,
removal of smoke, prevention of Degradation products, Poiential toxicity of impurities/contaminants. These points shoutd be discussed justified with proposed
flies, insects, dust etc. The furnace limits.

| section could have tin roof. 7. ASsay

3.2.4 Documentation and Records An assay for the content of the constituents with kuown therapeutic activity, active or analytical markers is required, in accordance
with the specific monograph. The selection of markers different to those described in the monograph should be strongly justified
1. General information:
and indicative of
stability
History of the product Where applicable, the following data should be
given. Length of time the berbal 8. Analytical procedures:
accordance with the application and included as an drug has been produced u
ingredient in producis approved by a This section includes the tests described in the corresponding monograph for the herbal drug and the full description of any
which it has been used; and the medicinal
products in which it has competent authority; the countries
been used. additional test methods applied to ensure the quality of the herbal drug.
2. Nomenclature:
Validation of analytieal procedures: