15. DRUG AND COSMETICS ACT
PROVISION
• Herbal drugs are regulated under the Drug and Cosmetics Act
1940 and rules 1945 in India where regulatory provisions for
AYURVEDA,UNANI,SIDDHA medicine are clearly laid down.
• Department of AYUSH is the regulatory authority and mandate
that any manufacture or marketing of herbal drugs have to be
done after obtaining manufacturing license,as applicable.
• The D and C Act extends the control over licensing,formulation
composition,manufacture,labelling,packing,quality and export.
16. • Schedule ‘’T’’ of the act lays down the good manufacturing
practice(GMP) requirements to be followed for the manufacture
of herbal medcines.
• In India traditional medicines are governed by D&C Act 1940 and
drug and cosmetics rules 1945 they regulate the
import,manufacture,distribution and sale of drugs and cosmetics.
17.
18. Overview of Ayurvedic Drug Manufacturing
license Approval steps
• Approval of Plan of Premises
• Submission of application with documents to licensing authority
for grant of license
• Inspection of premises by Inspector and Reporting to Licensing
authority for taking action.
• Grant of license by Licensing authority
• Appeal in case of rejection of application
• Renewal of license
• Additional product Permission
19. • Additional of new category in License
• Technical Person approval
20. PART-I
GOOD MANUFACTURING PRACTICES
• Factory premises:the manufacturing plant should have adequate
space for
• 1 Receiving and storing raw material
• 2 Manufacturing process areas
• 3 Quality control section
• 4 Finished goods store
• 5 Offices
• 6 Rejected goods/Drug store
21. Requirements for GMP
1.Location and surroundings
2.Buildings
3.Water supply
4.Disposal of waste
5.Containers cleaning
6.Stores
7.Raw materials
8.Packaging Material
22. 9.Finished goods stores
10.Working space
11.Health,clothing,sanitation and hygiene of workers
12.Medical services
13.Machinery and equipment
14.Batch Manufacturing record
15.Distribution record
16.Record of market complaints
17.Quality control
24. BUILDINGS
• The buildings used for factory should have hygienic
conditions and should be free from insects and Rodents
• Should have adequate provision of light and
ventilation,floors,and walls should not be moist.
25. WATER SUPPLY
• The water used in the manufacture shall be pure and of potable
quality.
• Adequate provision of Water
• Disposal of Water
26. CONTAINERS CLEANING
• Containers such as glass bottles,vial jars should be properly
washed,cleaned and dried.
• They should be properly identified with the label
• Status of raw materials such as “UNDER TEST’’or
“APPROVED’’ or “REJECTED’’ Labels must be written on
Drugs.
27. WORKING SPACE
• Space for orderly placement of equipment and material
used in any of the operations for which these employed so
as to facilitate easy and safe working and to eliminate
cross contamination of one drug by another drug.
28. HEALTH,CLOTHING,SANITATION
AND HYGIENE OF WORKERS
• Workers must be free from contagious disease
• The clothing of the workers shall consist of proper uniform
suitable to the nature of the work and the climate and should be
clean.
• Workers will also be provided facilities for changing their clothes
and to keep their personal belongings.
29. MEDICAL SERVICES
• The Manufacture should also provide
a.Adequate facilities of first aid
b.Medical examination of workers at the time of employment and
periodical check and records shall be maintained.
30. MACHINERY AND EQUIPMENTS
• It is depending on the size of operatn and the nature of product
manufactured,suitable equipment either manually operated or
operated automatically or fully automatic machinery shall be
made available.
• These equipments have to be properly installed and maintained
with proper cleaning.
31. Batch Manufacturing Records
• Manufacturing records are required to provide an account of the
list of raw materials and their quantities obtained from the
store,tests,conducted during the various stages of manufacture.
• It should be essential to maintain the record of
date,manpower,machine and equipments used and to keep in
process record of specific use.
32. Distribution Records
• Records of sale and distribution of each batch of
AYURVEDA,SIDDHA,and UNANI drugs shall be maintained in
order to facilitate and complete recall of the batch,if necessary.
• The duration of record keeping should be the date od expiry of the
batch.
• Records need to be maintained upto five years of the exhausting of
stock.
33. •Record of Market complaints
•Quality control
•Labelling Requirements
