Ayurvedic Pharmacy

Current Concepts and GMP Norms

Dr. Vipin Bihari Gupta

Head-Pharmaceutics
LMCST, Jodhpur

(Sannidhi 04/ RAU/ 30/10/2004)

Food af e ty
S

Drug i c acy
Eff

Poison
 Priyogah shamyet vyadhim yah
anyamanyamudiret;
Naso vishudhah shudhastu shamyedwau
na kopyet.
(Vagbhatta A. H. Su. 13:16)

The therapy which pacifies diseases and gives

rise to other diseases is not pure therapy. The
pure is one which pacifies without erupting
other problems.
Ayurvedic Medicines
Herbal Medicines Modern Medicines
Holistic Medicines (Disease Management)
(Health Restoration)

Green Pharmacy Red Pharmacy

Green Facts
 Current Global Market: US$150 billion (As per WHO)
 Projection for 2050: US$5000 billion (As per WHO)
 Chinese Foreign Exchange: Rs 22,000 Crores
 Indian Share: Rs 500 Crores
 Chinese Plant Resource: 30%
 Indian Plant Resource: 30%
 Indian System: Time tested, trusted and well
structured
 Chinese System: Not so well trusted and structured
 Some Recent Greens: Ranbaxy, HLL, Colgate
 Export of Herbal
Products From India
 Manufacturing

Quality Control

Quality Assurance
Good Practices
 Good Manufacturing Practices
 Good Laboratory Practices
 Good Agricultural Practices (WHO/ Feb 2004)
The Regulation
Drugs and Cosmetics Act 1940
(Section 33-N)

Drugs and Cosmetics Rules 1945

Drugs and Cosmetics (Amendment) Rules 1999

Schedule T
Schedule T
 Raw materials used in manufacturing of drugs are
authentic, of prescribed quality and free from
contamination.
 The manufacturing process is as has been
prescribed and maintains standards of purity.
 Adequate quality control measures are taken and
 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 manufacture of drugs which
should be documented as a manual and kept for reference and
inspection.
(Vaidyas, Sidhdhas and Hakeems dispensing medicines to their own patients are exempted)
GMP Norms
Factory Premises
The manufacturing plant should have adequate space for:
1. Receiving and storing raw materials
2. Manufacturing process areas
3. Quality control unit including in-house
testing facilities
4. Finished goods store
5. Office
6. Rejected goods store
(Minimum for any one system 1200 sq feet covered area with separate
cabins for each activity. Additional 400 sq feet for each additional
system)
General Requirements
 Location and Surroundings
 Away from open sewage, drain, public lavatory
and factories producing obnoxious odor, fumes,
dust or smoke.
 Buildings
 Hygienic and free from cobwebs, insects and
rodents
 Designed to prevent Cross-contamination
 Water Supply
 Potable & Other
 Disposal of Waste
 Predisposal Treatment
Health, Clothing, Sanitation and Hygiene
of Workers
 Workers to be free from contagious diseases
 Uniform
 Suitable for climate and nature of work including
coverings for hands, feet and head wherever
required
 Facilities for personal cleanliness
 Clean towels, soap, scrubbing brushes, lavatories,
change rooms & place for keeping personal
belongings.
 Medical Services
 First aid
 Medical Examination: At the time of employment
and at least once in a year
Raw Materials
 Separate and adequate facilities for
 Raw materials of metallic origin
 Raw materials of mineral origin
 Raw materials from animal source
 Fresh herbs
 Dry herbs or plant parts
 Excipients etc.
 Volatile oils, perfumes and flavors
 Plant extracts, exudates and resins
 Labeling: ‘UNDER TEST’ or ‘APPROVED’ or
‘REJECTED’
Packaging Material
 Storage
 Testing
 Cleaning
 Controls on printed materials to avoid
wrong labeling
Working Space
 Adequate for orderly placement of
equipments and materials
 To facilitate easy and safe working
 To minimize/ eliminate risk of mix-ups
and cross contamination
Equipments
 Nature, number and sizes
 Installation and maintenance record
 Cleaning SOPs and Records
 Operation SOPs

e.g.
 Anjana/ Pisti: Kharel/ ball mill, sieves/ shifter
 Churna: Grinder/ disintegrator/ pulverizer, powder
mixer, sieves/ shifter
 Ark: Maceration tank, distillation plant, liquid filling
tank with filter/ filter press, visual inspection box
Finished Goods Store
 Quarantine Area
 Approved Finished Goods Stock Area
Quality Control
 Lab
 Personnel: To be headed by an independent
person.
 Duties:
 To prepare specifications and testing methods for
raw materials and finished products.
 To sample, test, approve or reject RMs, PMs,
semi-finished product and finished products.
 To supervise and monitor the adequacy of storage
conditions.
 Maintenance of the records of each process where
testing of finished product is not possible.
Records
 Batch Manufacturing Records (BMR)
 Distribution Records (to facilitate recall)

 Record of Market Complaints and

Adverse Drug Reactions
B. Pharm./ M. Pharm. (Ay)
Quality Control, Legal Aspects & Documentation
1. Quality Perspectives of Ayurvedic-herbal Products:
Status of quality standards for Ayurvedic-herbal products.
Databases for identification and authentication of materials.
Chemoprofiling & bio-profiling of Ayurvedic-herbal products.
Protocols for establishing purity of materials, identification
of adulterants, substitutes, pathogenic bacteria & fungi,
heavy metals and pesticide residues. Validation of
traditional claims through scientific studies and clinical
trials.
2. Quality Control: Control of manufacturing processes,
statistical quality control, control charts, sampling plans,
automated process controls, dosage form controls, Testing
programs methods. Product identification systems, 
adulteration & misbranding. Maintenance of records.
Bioavailability & bio-equivalence. Manufacturer’s reliability.
Manufacturer/drug information profile.      
3. Good Manufacturing Practices: GMP in manufacturing,
processing, packaging and holding of drugs. Control of
Components, containers and closures. Packaging &
labeling controls. Inspection for compliance with GMP.
Potable water standards. Premises- design, construction,
maintenance, equipments. Warehousing.
4. Pharmaceutical Process Validation: Regulatory basis,
validation of sterile products & non-sterile products and
processes thereof. Analytical method validation. Validation
of computer assisted processes.
5. Drug Regulatory Aspects: National and international
bodies for drug regulation. Federal food, drug and cosmetic
acts along with recent amendments. New drug application,
drug efficacy study, implementation review, OTC drug
review, drug listing. Drug recalls, product liability, clinical
trials. ICH guidelines. WHO & ISO certification. Patents,
copyright & trade marks.
6. Documentation: Relevance and importance of
documentation, statuary requirements and procedure for
documentation, critical examination of documents.