Asu drug regulations in india

Regulatory Issues
Regulations in India (ASU DTAB, ASU
DCC), Regulation of manufacture of
ASU drugs-Schedule Z of Drugs &
Cosmetics Act for ASU drugs
ARAVIND R
ASST.PROFESSOR
DEPT.OF PHARMACOGNOSY

 Introduction
 Regulatory Requirements
 Key function of regulatory agencies
 Regulation in India
 DRUG TECHNICAL ADVISORY BOARD
 Drugs Consultative committee-DCC
 Schedule T- GMP for the manufacture of ASU drugs
 Schedule Z of Drugs & Cosmetics Act for ASU drugs.
HERBAL DRUG TECHNOLOGY Aravind R

REGULATORY AGENCIES- INTRODUCTION
 In the present scenario, pharmaceuticals- considered as the most highly regulated
industries worldwide.
 The regulatory body ensures compliances in various legal and regulatory aspects of
a drug.
 Every country has its own regulatory authority, which is responsible to enforce the
rules and regulations and issue the guidelines to regulate drug development
process, licensing, registration, manufacturing:
 The major challenges of these regulatory bodies are
* To promote public health and protect the public from harmful and dubious drugs,
* To establish proper legalization covering all products with a medicinal claim and
all relevant pharmaceutical activities, whether carried out by the public or the
private sector.
* To increase worldwide regulatory growth to ensure safety of people., marketing
and labeling of pharmaceutical products.
3HERBAL DRUG TECHNOLOGY Aravind R

Regulatory agencies of
various country
COUNTRY Name of Regulatory Authority
USA Food and Drug Administration (FDA)
UK Medicines and Healthcare Products Regulatory Agency (MHRA)
Australia Therapeutic Goods Administration (TGA)
India Central Drug Standard Control Organization (CDSCO), AYUSH(ASU Drugs)
Canada Health Canada
Europe European Medicines Agency (EMEA)
Denmark Danish Medicines Agency
Costa Rica Ministry of Health
New Zealand Medsafe - Medicines and Medical Devices Safety Authority
Sweden Medical Products Agency (MPA)

 Herbal drugs are regulated under the Drug and Cosmetic Act (D and C)
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.
 Effective drug regulation is required to ensure the safety, efficacy
and quality of drugs as well as accuracy and appropriateness of the
drug information available to the public

 The need for pharmaceutical drug analysis is driven largely by
regulatory requirements.
 A team consisting of R&D, QC, and QA unit members develops
these quality and compliance systems.
 It should be one of the highest priorities of top management and
QA units to develop and monitor these systems to comply with the
cGMP and GLP expectations.
 Compliance documents are needed, in addition to the regulatory
and research documents, to demonstrate the integrity of the
data.
 Compliance documents refer to those reports required by GMP
and/or utilized during the course of inspection by a health
authority.

 Product registration (drug evaluation, authorization, and
monitoring of drug efficacy and safety);
 Regulation of drug manufacturing, importation, and
distribution;
 Regulation & Control of drug promotion and information.
 Adverse drug reaction (ADR) monitoring.
 Licensing of premises, persons and practices.
 Main goal of drug regulation is to guarantee the safety,
efficacy and quality of drugs available to public.

 Herbal drugs are regulated under the Drug and Cosmetic
Act (D&C) 1940 and Rules 1945 in India, where
regulatory provisions for Ayurveda, Unani, Sidha
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 & C Act extends the control over licensing,
formulation composition, manufacture, labelling,
packing, quality and export.
 Schedule “T” of the act lays down the good
manufacturing practice (GMP) requirements to be
followed for the manufacturing of herbal medicines.

 The official Pharmacopoeias and formularies are
available for the quality standards of the medicines.
 First schedule of the D & C Act has listed authorized
texts, which have to be followed for licensing any
herbal product under the two categories: ASU drugs &
Patent or proprietary medicines.
 In India, traditional medicines are governed by the
Drugs and Cosmetics Act of 1940 and the Drugs and
Cosmetics Rules of 1945.
 They regulate the import, manufacture, distribution
and sale of drugs and cosmetics.

 In 1959, the Government of India recognized the traditional Indian
system of medicine and amended the Drugs and Cosmetics Act to
include drugs which are derived from traditional Indian Medicine.
 No products derived from traditional systems may be manufactured
without a licence from the State Drug Control Authorities.
 Patent and proprietary medicines derived from the traditional systems
must contain ingredients which are mentioned in the recognized books
of the above systems, as specified in the Drugs and Cosmetics Act.
 The government in advised by a special committee and an advisory
board for Ayurveda, Siddha and Unani drugs.
 Pharmacopoeia committees have been constituted to prepare
Pharmacopoeias for all these systems.
 Schedule Z of the D and C act, 1940 was amended for regulation for the
Clinical trial guidelines for ASU drugs.

 The Central Government constitute a Board (to be
called the ASU-Drugs Technical Advisory Board) to
advise the Central Government and the State
Governments on technical matters arising out of the
administration of D&C, Act 1940
 The Board shall consist of the following members:

 Director General of health Service(Chairman)
 Drug Controller, India
 Principle officer of ISM
 Director of the Central drugs Laboratory, CDL
 Government Analyst
 Pharmacognocist
 Phyto-chemist
 4 person from ASU pharmacopeia committee
 1 teacher in Dravyaguna & Bhaishajya Kalpana
 1 teacher in Ilmul-advia
 1 teacher in Gunapadam
 3 person from ASU drugs industry
 3 practitioner of ASU medicine

 It advices matter related to Drugs.
 The nominated and elected members of the Board
shall hold office for three years, but shall be
eligible for re-nomination and re-election. The
Board may, subject to the previous approval of the
Central Government, regulating its own procedure.

 It is also an Advisory Body consist of two representative
central government to be nominated by Government .
 One representative of each state Government to be
nominated by the State Government.
Function
 DCC to advise the Central Government, the State
Governments and the ASU-DTAB on any matter for the
purpose of securing uniformity throughout India in the
administration of this Act in so far as it relates to ASU
drugs.
 It shall meet when required.
 It has power to regulate its own procedure.

❖ Misbranded Drugs:-
• If it is so colored, coated, powdered or polished that damage
is concealed or if it is made to appear of better or greater
therapeutic valve.
• If it is not labelled in the prescribed manner.
• If its label or container or anything accompanying the drug
bears any statement, design or device which makes any false
claim for the drug or which is false or misleading in any
particular
❖ Adulterated Drugs:-
• If it consists, in whole or in part, of any filthy, putrid or
decomposed substance.
• If it has been prepared, packed or stored under insanitary
conditions whereby it may have been contaminated with filth
or whereby it may have been rendered injurious to health

SCHEDULE T-GOOD
MANUFACTURING PRACTICE FOR
ASU DRUGS
By, ARAVIND R
ASST.PROFESSOR

OBJECTIVE
 Raw materials used in the manufacture of drugs
are authentic, of prescribed quality and are free
from contamination.
 The manufacturing process which 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.
HERBAL DRUG TECHNOLOGY Aravind R 17

However
 Under IMCC Act 1970(Indian Medicine Central Council
Act, 1970) registered Vaidyas, Siddhas and Hakeems who
prepare medicines on their own to dispense to their
patients and not selling such drugs in the market are
exempted from the purview of G.M.P.

SPECIFICATIONS
 A Manufacturing Premises should have adequate space for all daily activity like:
 Receiving and Storage of Herbs, Packaging material & other raw material
 Production and Manufacturing Activity Area
 Quality Control Section
 Finished Goods Store
 Office and Administration
 Rejected Products/Drugs Store
 Minimum area required for setting up Ayurveda, Siddha and Unani Medicine manufacturing
unit is 1200 square feet covered with separate cabins and partitions for each activity.
 If unani medicines/ayurvedic medicine are manufactured along with other type of
medicine, additional 400 square feet area is required.

PART 1-GENERAL REQUIREMENTS
 1. Location and Surroundings: The factory building for Ayurveda,
Sidha and Unani Medicine manufacturing shall be situated and
constructed to avoid contamination from open sewerage, drain,
disagreeable or obnoxious odour, dust and smoke etc.
 2. Buildings: A building for manufacturing unit for Ayurvedic, Sidha
and Unani Medicines shall permit work under hygienic conditions. It
should be free from any insects/rodents. Light and ventilation
facility should be adequate. Walls and floor should be free from
cracks and damp. Premises should also conformity with provisions of
factory act. It shall be located so as to be:
 Building should compatible of other manufacturing operations
carried out in same premises.
 Space should be adequate for Placement of equipment and materials
to avoid mix-up/contamination risk of different drugs and
components.

GENERAL REQUIREMENTS
 Design & construction to be maintained to prevent entry of insects and
rodents. 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
impervious to and 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.
 Building should have a proper drainage system. Sanitary fitting and electric
fixtures shall be proper and safe.
 Burner/Bhatti section could be covered with tin roof and proper ventilation
but care should be done to prevent flies and dust.
 Proper fire safety measures and proper exists should be there.
 Drying space for raw material, in process medicines should be separate and
measures should be done to prevent it from flies/insects/dust etc.

 Water Supply: Water needed for manufacturing should be pure and of
potable quality. Adequate provision of water for wasting the premises shall
be made.
 4. Disposable of Waste: Proper waste management care should be done.
 5. Container’s Cleaning: Washing, cleaning and drying section of
containers such as bottles, vials and jars should have adequate
arrangement and should be separated from manufacturing operations.
 6. Stores: Store should have adequate space for independently and
separately store raw material, packaging material and finished products.
 7. Working Space: Manufacturing area should be adequate for orderly
placement of equipment, machinery and material used during
manufacturing operations and quality control to facilitate easy and safe
working and to minimize or eliminate any risk of mix-up between different
drugs, raw materials and to prevent the cross contamination during
manufacturing, storage and handling operations.

8. Health Clothing, Sanitation and Hygiene of Workers:
9. Medical Services: to employees
10. Machinery and Equipment: details about machinery and equipment in
Part II of Schedule T.
11.Batch manufacturing Records:
Each batch record should be maintained irrespective of product
manufactured (classical preparations or patent or proprietary
medicines). 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 like
taste, colour, 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 the Drugs and Cosmetics Act.

12.Distribution Record: Distribution record (Dispatch register)
should be maintained to facilitate process of prompt and
complete recall of the batch. Distribution record should be
maintained till expiry of batch.
For drugs who don’t have expiry date like Bhasma, Rasa, Asava-
arishtha etc, record should maintain up to five years of the
exhausting of stock.

13. Record of Market Complaints: A complain register should maintain 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. The Register shall also be available for inspection during
any inspection of the premises.
Reports of any adverse reaction resulting from the use of Ayurvedic, Siddha
and Unani drugs shall also be maintained in a separate register by each
manufacturer. The manufacturer shall investigate any of the adverse reaction
to find if the same is due to any defect in the product, and whether such
reactions are already reported in the literature or it is a new observation.
14. Quality Control: A manufacturer can set-up own quality control section
or testing could be done through government approved testing laboratory..

PART-II
(A)
➢ 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.
(B)
➢ List of machinery, equipment and minimum manufacturing
premises required for the manufacture of various categories
of unani system of medicines.

Ayurvedic drug manufacturing license
approval:
 (1)Approval of Plan of Premises
 (2)Submission of Application with documents to LA
for grant of License
 (3)Inspection of Premises by Inspector & reporting to
LA for taking action
 (4)Grant of license by LA
 (5)Appeal in case of rejection of application
 (6) Renewal of License
 (7) Additional Product Permission
 (8) Addition of new Category in License
 (9) Technical Person approvalHERBAL DRUG TECHNOLOGY Aravind R 27

Approval of plant of premises (area
requirement)
1) Manufacturing areas- As per Sch-T ( areas are insq.feets)
2) Office- 100 SFt
3) Workers Room-80 SFt/Each sex
4) Raw material store-100 SFt
5) Finish Product store-100 SFt
6) Quarantine Room-100 SFt
7) Packaging material store-100 SFt
8) Bottle washing Room-100 SFT
9) Bottle drying Room-100 SFT
10) Packing & labeling Room-100 SFt
11) Q.C.Laboratory-100-150 SFt- (Chemistry & Cognosy Lab.)HERBAL DRUG TECHNOLOGY Aravind R 28

For Public Testing Laboratory-800SFt-in
 (i) Chemistry
 (ii) Pharmacognosy,
 (iii) Ayurveda, Siddha and Unani
 (iv) Microbiology
 (v) Sample Room,
 (vi) Office-cum-Record Room
 Rule-160B-List of Equipment given

Submission of plant of premises to LA for
approval (document required)
1) Forwarding letter address to LA
2) Original challan for Fee-Rs.50
3) 4 Copies of Plan- It includes the following
-Key plan,
-plan,
-elevation,
-end view,
-Address of Premises & Signature of a person having Authorisation.
4) Plan is scrutinized by Plan Committee & approved for
construction of premises.
5) Premises is to be constructed as per approved plan, Machineries
and equipments are to be installed, Technical Persons are to be
employed, all documents are to be prepared and then application is
to be submitted to LA for issuing License.HERBAL DRUG TECHNOLOGY Aravind R 30

Application submission to LA
➢ Forwarding letter address to LA for obtaining
License in Application Form. No.-24D dully
filled & signed by Auth. Person. Form of Firms
details dully filled & signed by Auth. Person
➢ Original challan for lic. Fee as per requirements-Rs.1000/-
+Rs. 500/-GMP certi. Fee. Original plan of premises -1
copy
➢ Document regarding possession of the premises
➢ Document regarding constitution of the Firm(P/D,MOAA,TD etc)
➢ List of Products-category wise-4 copies along with product details Form-
with similar productHERBAL DRUG TECHNOLOGY Aravind R 31

 Draft label of each product-3 copies
 List of
Machineries &
Equipments-1 copy
List of Laboratory
equipments-1 copy
 List of approved Technical persons with their degree & experience
certificates, appointment letter, acceptance letter, forms -4 copies
 Detail of method of analysis
of products & Raw materials
 Consent letter of Public
Testing Laboratory
 List of SOP
 Master Formula card of each product
 Xerox copy of Ref. Book for product’s ingredient

Inspection of premises by inspector
and report to LA
 Inspection of Premises by Inspector is carried out for
verification of-
1) Areas of Premises
Documents
Machineries & Equipments
Laboratories Equipments Technical
Persons requirements
Other requirements if any as per law
2)
3)
4)
5)
6)
- Detail report of inspection is submitted to LA by Inspector along with his recommendations
for grant/rejection/compliance of License.
-LA grant/reject application for License.( Lic.Form.No.-25D)
- License granted is valid for 5 years from the date of grant.
-License granted in Form No. 25D is to be renewed for another period of 5 years.
-New License is to be obtained in case of change in constitution of the Firm within three
months.
-Separate License is to be obtain for change of Premises.

Procedure for addition of new category
in existing license
 New plan showing old and new category is to be submitted for approval to LA
as discussed earlier. Fee Rs-20 is to be paid by challan.
❑ Plan is approved by plan committee. Premises is to be constructed for new
category as per new plan, Machineries and equipments are to be installed,
Technical Persons are to be employed, all documents are to be prepared and
than application is to be submitted to LA for granting new category of
cosmetics.The following documents are to be submitted to LA.
1) Forwarding letter address to LA
2) Original challan for Fee of products as per requirements-No fees at present
3) Original new plan of premises -1 copy
4) List of Products-category wise-4 copies along with product details Form
5) Draft label of each product-3 copies
6) List of Machineries & Equipments-1 copy
7) List of Laboratory equipments-1 copy
8) List of approved Technical persons-4 copies
9) Detail of method of analysis of products & Raw materials
10) Copy of original License along with list of products

Procedure for additional product
permission in existing license
 For additional item –No fee is prescribed.
1) Application is to be made to LA forobtaining
permission for additional items with-
2) List of Products-category wise-4 copies along with
product details Form
3) Draft label of each product-3 copies
4) Detail of method of analysis of products & Raw
materials
5) Copy of original LicenseHERBAL DRUG TECHNOLOGY Aravind R 35

Approval of technical person by LA
 For getting approval of TP for particular section an
application along with documents is to be made to LA by
concern manufacturer if degree & experience is as per
Rules.
 Documents are-(1) Appointment letter of TP (2)Acceptance
letter of TP (3) Copy of Degree Certificate of TP
(4)Experience Certificate of TP (5) Forms of TP dully filled
with.
 Verification of Degree , experience is carried out by an
Inspector & report is submitted to LA.
 LA is approving TP for concern section if report is OK.
 Approval given by LA is valid for all Manu. Units.HERBAL DRUG TECHNOLOGY Aravind R 36

Procedure for obtaining loan license
• Forwarding letter address to LA for obtaining
License. Application form-24E along with fee
Rs.600/- (challan) Form-1,2,3 Properly filled & sign
by applicant
• Copy of Manu. licences of own firm along with list of approved
products. List of loanee firms till date.
• Form of Firms details dully filled & signed by Auth.Person
• Document regarding possession of the premises-
• Wholesale Licence.
• Document regarding constitution of the Firm(P/D,MOAA,TD
etc)
• MOAA means ‘Medical officers Ayurveda Association’
• TD-a document that transfers the legal title to property to a trusteeHERBAL DRUG TECHNOLOGY Aravind R 37

 List of Products-category wise-4 copies along with product details
 Draft label of each product-3 copies
 Detail of method of analysis of products & Raw materials
 Consent letter of Public Testing Lab
 List of SOP
 MFR of each product
 Documents regarding supervisory chemist
 Validity of licence Is for 5 years from the date of grant.
 In case of any change in the constitution new license is to be obtained
within three months.

Schedule Z -good clinical
practices (GCP) for clinical
trials on ASU medicines
Department of Ayush has adopted and formulated this
guidelines based on CDSCO document on GCP Guidelines that
was released in 2001 for clinical trials on pharma products.

• Although the ASU systems are known for their long history of safe and effective
use, yet validation of safety and efficacy using scientific and evidence-based
methodologies is needed for the purpose of universal acceptability.
• The arguments of having long standing in the medical practice or market are
often unconvincing and there has been persistent and increasing demand of
documented proof of clinical safety and efficacy of ASU medicine.
• In this perspective, the clinical trials in ASU systems need to be guided on the
principle of ‘Good Clinical Practice’.
• Researchers, sponsors and drug manufacturers, therefore, have to be well
versed with the standard scientific procedures that are required to be followed
while conducting clinical trials with ASU interventions to achieve objective and
reproducible results.
INTRODUCTION

➢Good Clinical Practice is a set of guidelines which
encompasses the design, conduct, termination, audit,
analysis, reporting and documentation of the studies
involving human subjects.
➢The fundamental tenet of GCP is that in research on man,
the interest of science and society should never take
precedence over considerations related to the well being
of the study subject.

• The fundamental objective of Good Clinical Practice guidelines for ASU
medicine include protection of human rights as a subject in clinical trial.
• It also provides assurance of the safety and efficacy of the newly
developed as well as conventionally used ASU formulations.
• These guidelines include standards of how clinical trials should be
conducted; and define the roles and responsibilities of clinical trial
sponsors, clinical research investigators, monitors etc.
• The guidelines on the whole adopt the basic principles outlined by the
CDSCO for engaging in Good Clinical Practice albeit with necessary
modifications to suit the ASU principles and treatment methodologies.

AYUSH GCP guide line
 AYUSH guideline contains GCP guideline for the
ayurvedic, unani and siddha drugs.
 It contains followings:
➢ Introduction
➢ Definitions
➢ Pre-requisites for the study
➢ Protocol
➢ Ethical and safety consideration
➢ Informed consent process
➢ Compensation for participation
➢ Responsibilities of sponsor, monitor and investigator

➢ Record keeping and data handling
➢ Quality assurance
➢ Statistics
➢ Special concerns
➢ Appendix I: guideline for evaluation of ayurvedic,
unani and siddha medicine
➢ Appendix II: ethical issues
➢ Appendix III: investigator’s brochure
➢ Appendix IV: essential document

2.3.1 Relevant components of Protocol
2.3.1.1 General information
a. Protocol title, protocol identifying number and date.
b. Name, address & contact details of the sponsor and the monitor / CRO
c. Name and designation of the persons authorized to sign the protocol and
the protocol amendments for the sponsor
d. Name, title, address and contact details of the sponsor’s medical expert
for the study
e. Name(s), title(s), address(es) and details of the investigator(s) who is /
are responsible for conducting the study, along with their consent letter(s)
f. Name(s), address(es) and details of the institution(s) - clinical
laboratories and/or other medical and technical departments along with the
particulars of the head(s) of the institution(s) and the relevant
department(s)
g. Disease Review, which includes prevalence, economical burden, historical
aspects, clinical features, existing diagnostics and treatment including the
details of adverse drug reactions (ADRs) as described in respective ASU
system along with related information(s) in modern system (if available).
h. ASU drug / Patent or Proprietary Medicines review, which includes of
details of ingredients with supporting relevant scientific study and published
papers (if available).HERBAL DRUG TECHNOLOGY Aravind R 45

2. Pre-requisites for the Study
2.1 Investigational ASU Drug/Patent or Proprietary Medicines: Physical, chemical
(wherever available), pharmaceutical properties and the formulation of the
Investigational ASU drug / Patent or Proprietary Medicines must be documented
to permit appropriate safety measures to be taken during the course of a study.
Instructions for the storage and handling of the dosage form should be
documented.
2.2 Pre-clinical supporting data The available pre-clinical data and clinical
information on the Investigational ASU drug / Patent or Proprietary Medicines
should be adequate and convincing to support the proposed study as per
guidelines.
2.3 Protocol - A well designed study relies predominantly on a thoroughly
considered, well-structured and complete protocol.

2.3.1.2 Objectives and Justification
a. Aim and objectives of the study, indicating the Phase to which the study
corresponds
b. Name and description of the investigational product(s)
c. A summary of findings from non-clinical studies (if any) that potentially have
clinical significance and from clinical studies that are relevant to the study and
bibliographic references.
d. Summary of the known and potential risks and benefits, if any, to human subjects
e. Description of and justification for the route of administration, dosage regimen
and treatment periods for the ASU drug / Patent or Proprietary Medicines being
studied and the product being used as control. Dose-response relationships should
be considered and stated if required.

 2.3.1.3 Ethical Considerations
 2.3.1.4 Study design
 2.3.1.5 Inclusion, Exclusion & Withdrawal of Subjects
 2.3.1.6 Handling of the Product(s)
 2.3.1.7 Assessment of Efficacy
 2.3.1.8 Assessment of Safety
 2.3.1.9 Statistics
 2.3.1.10 Data handling and management
 2.3.1.11 Quality control and quality assurance
 2.3.1.12 Finance and Insurance
 2.3.1.13 Publication policy
 2.3.1.14 Evaluation

REFERENCE
 Drug and cosmetic act 1945
 AYUSH GCP guidelines
 General Guidelines For Drug Development Of
Ayurvedic Formulations, CENTRAL COUNCIL
FOR RESEARCH IN AYURVEDIC SCIENCES
Ministry Of AYUSH, Government Of India New
Delhi

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