Artifacts in Nuclear Medicine with Identifying and resolving artifacts.
herbal drug Industry.ppt
1. RJSPM
RAJMATA JIJAU SHIKSHAN PRASARAK MANDAL’S
COLLEGE OF PHARMACY
DUDULGAON, PUNE
By
Mr. Suhas N. Ghodekar
Assistant Professor
(RJSPM’s College of Pharmacy)
General introduction to herbal
industry
2. Introduction
Recently there has been a shift in universal trend from synthetic
to herbal medicine, which we can say ‘Return to Nature’
Medicinal plants have been known for millennia & highly
esteemed all over the world as a rich source of medicinal agents
In our country, there are so many plants available, therefore India
known as ‘Medicinal Garden of World’.
In India, system of medicine like Ayurveda, Siddha, Unani,
homeopathy, Yoga & Naturopathy are being utilized for the
health care of people.
One reason for popularity of natural products is that belief that
all are safe, non –toxic, less side effect, easily affordable prices.
In international market now a days, herbal drug industry is very
fast growing sector.
3. Scope of Herbal Drug Industry
In india, raw drugs obtained from more than 2,400 plant species.
The market for medical plants in India stood at Rs. 4.2 billion (US$ 56.6
million) in 2020 and is expected to increase at a CAGR 38.5% to Rs. 14
billion (US$ 188.6 million) by 2026.
Herbal Market: Herbal Medicine Market size was valued at USD 98.60
Billion in 2020 and is projected to reach USD 391.22 Billion by 2028,
growing at a CAGR (Compound Annual Growth Rate) of 18.8 %
from 2021 to 2028.
More than 70% of India's population still use these non-allopathic
systems of medicine. Currently, there is no separate category of herbal
drugs or dietary supplements, as per the Indian Drugs Act.
As per National Medicinal plant board India’s domestic herbal industry
is represented by 8610 licensed herbal units.
4. According to Schedule T
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.
5. General Requirements
A. Location and surroundings
B. Buildings
The building used for factory shall be such as to
permit production of drugs under hygenic
conditions and should be free from cobwebs and
insects/rodents.
The premises used for manufacturing,
processing, packaging and labeling will be in
conformity with the provisions of the Factory
Act.
6. Compatible with other manufacturing operations that
may be carried out in the same or adjacent premises.
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 or omission of
manufacturing or control step.
Designed, constructed and maintained to prevent
entry of insects and rodents.
7. 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 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.
8. C. Water Supply
D. Disposal of Waste
E. Container’s cleaning
F. Stores (Raw Material, Packing Material and
Finished goods)
9. Following different categories of raw
materials.
Raw material of metallic origin.
Raw material of mineral origin.
Raw material from animal source.
Fresh Herbs.
Dry Herbs or plant parts.
Excipients.
Volatile oils/perfumes and flavours.
Plant Resines
10. 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
‘UNDERTEST’ or ‘APPROVED’ or ‘REJECTED’.
The labels shall further indicate and identify the
particular supply in the form of batch No. or lot No. and
the date of receipt of the consignment.
12. Finished Goods Stores
The finished goods transferred from the production
area after proper packaging shall be stored in the
finished goods stores with in an area marked
“Quarentine”.
After the quality control laboratory and the expects
have checked the correctness of finished goods with
reference to its packing/labelling as well as finished
product quality as prescribed then it will be moved to
“Approved Finished Goods Stock” area.
13. Health Clothing Sanitation and Hygiene of
Workers
Workers should be free from contagious disease
Should be in proper uniform, hand should be
covered with over gowning.
Personal cleanliness, clean towel, soap, scrubbing,
brushing, separate lavatories for men & women
Facilities for changing cloths & cupboard for to
keep cloths.
Facilities for keeping Shoes.
14. Medical Services
The manufacturer shall also provide-
⚫Adequate facilities for first aid;
⚫Medical examination of workers at the time of
employment and periodical check up thereafter
by a physician once a
attention being devoted
year, with particular
to freedom from
infections. Records thereof shall be maintained.
15. Batch Manufacturing Records
The license shall maintain batch manufacturing
records of each batch of drugs manufactured
irrespective of the type of product manufactured
Manufacturing records are required to provide an
account of the list of raw materials and their
quantities obtained from physical characteristics and
chemical tests as may be necessary or indicated in
the approved books of Ayurveda, Siddha and Unani
mentioned in the First Schedule of Drugs and
Cosmetics Act.1940 .
16. Distribution Record
Records of sale & distribution of each batch of
Ayurveda, Siddha & Unani drugs should maintain in
order to facilitate complete recall of the batch.
17. Record of Market Complaints
Manufactures shall maintain a register to record all reports
of market complaints received regarding the products sold
in the market.
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.
Once in a period of six months the manufacturer shall
submit the record of such complaints to the licensing
authority.
Reports of any adverse reaction resulting from the use of
Ayurvedic, Siddha and Unani drugs shall also be
18. Quality Control
The quality control section shall have the following
facilities:
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 will be kept for 3 years
19. List of machinery, equipment and minimum manufacturing premises
SR.
No.
Category of
Medicine
Minimum manufacturing space
required
Machinery/equipment
recommended
1200 Square feet covered area with separate cabins partitions for each activity.
1 Habb (Pills) and
Tablets
100 sq. ft Ball Mill, Mass Mixer
Powder mixer, Granulator
drier, tablet compressing
machine, pill/vati cutting
machine, staineless steel
trays/container for storage
and sugar coating, polishing
pan in case of
sugar coated tablets,
mechanised chatoo, (for
mixing of guggul) where
required
20. SR.
No.
Category of
Medicine
Minimum manufacturing space
required
Machinery/equipment
recommended
2 Sufoof (Powder) 200 sq. ft. Grinder/Pulveriser, Seiver,
Trays, Scoups, Powder
mixer, (where required).
3 Raughan (Oils) 100 sq. ft. Oil Expeller, S.S. Patilas
Oil filter bottle filling
machine, bottle drier, Bhatti.
4 Marham, Zimad
(Ointment)
100 sq. ft. Kharal, Bhatti, End runner,
Grinder, Pulversiser, Tripple
Roller Mill.
5 Qurs (Tab) 100 sq. ft. Grinder/Pulveriser,
Sieves,power mixer (where
needed),Granulator, Drier,
Tablet compressing machine,
Die punches Trays, O.T.
Apparatus, Balance with
weights, Scoops, Sugar
coating pan, Polishing pan,
Heater.
6 Capsule 100 sq. ft. Pulveriser, Powder mixer
(where needed), capsule
filling machine, Air
conditioner, De-humidifier
balance with weights,
storage containers, glass.
21. General Instructions to applicants for License for manufacturing
of Drugs and Cosmetics through online application software
All the documents should be scanned in 150 dpi, gray
scale/Black & White, and then should be uploaded at
relevant space provided.
Show all the original documents to the inspector at the
time of inspection.
Be sure that, all the information is filled precisely for
respective application mentioned under standard
document and only then e-send the application. In case
of rejection of your application for incomplete
information.
If necessary, the licensing authority may ask for any
other relevant documents.
22. These guidelines are subject to change as and when necessary
and will be updated from time to time.
Every application needs to be ‘e-send’, or it will not be
forwarded to the office.
In case of Change in Constitution, (Change in partner,
proprietor, Pvt. Ltd. to Ltd, etc.), except in case of death of
proprietor, applicant is required to obtain a fresh license.
Fees for Licence is as per table.
24. Steps for grant of manufacturing license by applicant
APPLICANT APPLY FOR
PASSWORD AND USER ID
THROUGH ONLINE
SYSTEM
AFTER RECEIPT OF
PASSWORD AND USER
ID, APPLICANT UPLOAD
NECESSARY DOCUMENTS.
PAY PRESCRIBE FEES
THROUGH GRAS SYSTEM
(GOVERENMENT RECEIPT
ACCOUNTING SYSTEM)
ALLOTMENT OF
APPLICATION. AFTER
RECEIPT OF APPLICATION,
ASSISTANT COMMISSIONER
ALLOCATES IT TO THE
CONCERN DRUGS
INSPECTOR.
APPLICATION IS
RECEIVED BY
CONCERNED ASSISTANT
COMMISSIONER.
AFTER PAYMENT OF
FEES, THROUGH GRAS
SYSTEM, PRINT
PAYMENT RECEIPT AND
UPLOAD THE SAME IN
SYSTEM.
INSPECTION STAGE.
AFTER RECEIPT OF
APPLICATION AREA
INSPECTOR
ALONG WITH CDSCO DRUGS
INSPECTOR, JOINT
INSPECTION CARRIED OUT
RELATED TO THE PREMISES
AND FACILITY.
VERIFICATION OF
UPLOADED
DOCUMENTS
INSPECTOR MAKE
ENTRIES RELATED TO
INSPECTION REPORT
25. Continue……
INSPECTOR WILL FORWARD
REPORT TO ASSISTANT
COMMISSIONER WITH
RECOMMENDATION.
ASSISTANT COMMISSIONER
WITH HIS REMARK AND
RECOMMENDATION FORWARD
TO LICENSING AUTHORITY
FOR FURTHER ORDERS.
LICENSING AUTHORITY
WILL VERIFY ENTRIES,
UPLOADED DOCUMENTS
AND INSPECTION
REPORT OF INSPECTOR.
LICENSING AUTHORITY
WILL MAKE NECESSARY
REMARKS REGARDING
GRANT OR REJECTION OF
APPLICATION.
SYSTEM GENERATED SMS
WILL FORWARD TO
APPLIACNT
FINAL ORDER OF GRANT
OR REJECTION OF
APPLICATION BY
LICENSING AUTHORITY.
DRAFT COPIES OF
LICENSES VERIFIED BY
LICENSING
AUTHORITYBEFORE FINAL
ORDER OF GRANT OR
REJECTION OF
APPLICATION.
FINAL PRINT OUT OF
LICENSES CAN TAKE OUT
BY APPLICANT WITH IN
THREE DAYS FROM THE
GRANT OF LICENSES/
PERMISSION
27. HOW TO OBTAIN LOGIN ID AND
PASSWORD
Steps Action
1. Visit https://fda.maharashtra.gov.in/Home.aspx web site. Use Google
Chrome OR Mozilla Browser.
2. Click on XLN Manufacturing Website link on home
page
3. Popup tab will take yu the site or alternatively you can visit
https://xlnindia.gov.in/login.aspx?ST=6j4eq4PwS%2fg%3d&XLNMFG=MF
G web site.
4. Click for Mfg ID & password.
5. Enter your firm’s details precisely & upload Company or Proprietor’s
Pan Card in JPEG File Format within file Size – 75 KB. SELECT
OWN OR LOAN AS APPLICABLE
6. Wait for 24 hrs to receive ID and password on the mobile number
provided.
28. Approval of plan For Own Manufacturer.
(All documents should be in PDF format)
S. No Document type Format Copy
1 Covering letter (with brief of company, categories of
products, dosage forms proposed to manufacture)
Hard copy Soft
copy
01
01
2 GRN generated by payment of fees through
https://gras.mahakosh.gov.in/echallan/ Upload in MFW
module.
Hard copy Soft
copy
01
01
3 Site Plan and layout of the building with name, address, scale,
measurements of the Area as per Schedule- T requirement
(For Ayurvedic, Siddha, and Unani)& as per Schedule- M
requirement (Allopathic Medicines)& as per Schedule- M -
II requirement (For Cosmetics)
Hard copy Soft
copy
(A4 size PDF)
03
01
4
Self attested copies of documents pertaining to the possession
of premises such as, Register ownership /rent /
lease/ allotment letter/ Possession Letter, Tax
Receipt,(Documents should be Registered with appropriate
Authority)
Hard copy Soft
copy
01
01
5 Consent to establish from Maharashtra Pollution Control
Board.
Hard copy Soft
copy
01
01
29. Information of Directors, Partners, Trustees,
proprietor should be in Format as follows.
Sr No. Name Educational
Qualification
Designation PAN
No. &
Adhar
No.
Residential
Address
Mob.
No. &
Ph. No.
Email ID Date oF
Joining
*This format should be signed by responsible person and then it should be uploaded
30. Documents for grant of license
(All documents should be in PDF format)
S. No Document type Format
1 A) Application in form 24 & 27 (for allopathic medicine)
B) Application in form 24-b (for licence to repack)
C) Application in form 24d (for ayuverdic medicine)
D) Application in form 31 (for cosmetics)
E) Application in form 24c (for homoeopathic medicine)
Soft copy
Soft copy
Soft copy
Soft copy
Soft copy
2 Challan of Fees Paid To Be Upload In MFW Module Soft copy
3 Specific Power of Attorney In FavorAuthorized Signatory For
Submitting Application On Behalf Of The Company
Soft copy
4 List Of CompetentTechnical Staff, With Their
Qualification, Registration, Experience, Previous FDA Approvals,
Etc. TO BE UPLOADED AT MFT MODULE
Soft copy
5 Appointment/Acceptance Letter Of Competent Technical Staff Of
Manufacturing Section. TO BE UPLOADED AT
MFT MODULE
Soft copy
31. Continue….
S.
No
Document type Format
6 Appointment/Acceptance Letter Of Competent Technical Staff Of
Testing Section. TO BE UPLOADED AT MFT MODULE
Soft copy
7 Section Wise List Of Plant And Machineries Soft copy
8 Plan Layout Of The Premises Approved By The Licensing Authority Soft copy
9 Consent To Establish & Consent To Operate From Maharashtra State
Pollution Control Board.
Soft copy
10 NOC of Department Of Industrial Safety & Health Soft copy
11 Details Of Manufacturing Process, Process Flow Chart (For Bulk
Drug)
Soft copy
12 AHU Installation And Validation Certificate (Wherever Necessary) Soft copy
13 Water System Installation And Validation Certificate (Wherever
Necessary)
Soft copy
32. LOAN LICENCE
A license which a licensing authority may issue to an
applicant who does not have his own arrangements for
manufacture but who intends to avail himself of the
manufacturing facilities owned by a licensee
