Drug Store Licensing, Drug Regulatory Authority in India and Schedule Related Drug Store (Drug and Cosmetic Act)

1. "Drug Store Licensing ,Drug Regulatory Authority In India and
Schedules Related Drug Store (Drug And Cosmetic Act)
PRESENT By
THAKOR AJAY B
Guided By:
Dr. Yamini D shah
Head, Department of Pharmaceutics and
Pharmaceutical Technology

2. INDEX
• Drug Store Licensing
• Procedure
• Documents
• Form
• Drug Regulatory authority In India
• Central Drug Standard Control Organisation
• ministry of health and Family welfare
• Indian Council of Medical Research
• Drug Technical Advisory Board
• Central Drug Testing Laboratory
• Indian Pharmacopoeia Commission
• National Pharmaceutical Pricing Authority

3. INDEX
• Important Drug Schedule
• Schedule C/C1
• Schedule G
• Schedule H
• Schedule J
• Schedule M
• Schedule N

4. How To Do Drug Store Licenseing As Owner
Definition of Drug License
Drug license is a permission granted by the competent authority under Drugs
and Cosmetic Act, 1940 to carry out a businessconcerning drugs/medicines or
cosmetics.
Eligibility Of Drug Store Licenseing
For instance in Retail Drug license the competent person has to be a registered
pharmacist (Pass Out D. pharm or B. pharm) from the state pharmacy council
while in Wholesale Drug License the competent person is to have the experience
of working in a drug store/company, preferably situate in the same state where
license to be applied at.

5. Procedure
Documents
License Form :-Form 20 and 21
(1)Application:-in Duplicate on Form 19 Of The D&C Rule 1945.
(2)Challan:-Rs. 3000/-.
(3)Appointment Letter of a Registered Pharmacist.
(4)Consent Letter of a Registered Pharmacist with Details of Previous Service, if
any(Previous Job).
(5)True Copy of Registration Certification issued by Gujarat State Pharmacy
Cauncil.(Also Study Certificate D. pharm or B.Pharm or M.Pharm)
(6)True Copy of Renewal Receipt of Gujarat State Pharmacy Council .
(7)Passport Size Photographs of the Pharmacists.
(8) Affidavit of the Pharmacist on INR 20 Stamp paper.

6. (9)True Copy of Rent Receipt for the Premises.
(10)Copy of Ration Card or PAN Card or Identity Card or Aadhar Card of all
Partners or Directors & Pharmacist.
(11) Affidavit Of The Proprietor on stamp Paper Rs 20/-
(12) education Certificate of The Proprietor.
(13) Affidavit Of Partnership .
(14) Blueprint of Plan layout Prposed Area /Premises.
(15) Electricity bill of proposed area/ premises.
(16)Copy of Refrigerator bill.
(17) Rent agreement ( 50 Rs. Stamp paper).

7. Filing of Application
The drug License applications are filed online(Drug Inspector Provide Username
and Password), including the payment of government fee. All documents are
scanned and uploaded at the time of filing the application. However, filed
documents are verified by the inspector and the same are supposed to be
submitted in original at Authority concerned.

8. Inspection and grant of License
After the application for grant of drug license is filed, the same is marked for
inspection and thereafter the drug inspector personally visits the shop to verify
the documents and correctness of information.( All Documents Uploaded)
Like Refrigerator
For Retail (10 Square Meter)
For wholesale (10 Square Meter)
Retail & Wholesale (15 Square Meter)
Brick Wall With Plaster
R.C.C Ceiling
Minimum Hight 8 Feet

9. Documents Required For Renewal Retail Drug License
(1)Application:-in Duplicate on Form 19 Of The D&C Rule 1945.
(2)Challan:-Rs. 3000/-.
(3)Late Fee :- Rs-500/- Per License.
(4) Original License :- In Case Of First Renewal.
(5) Affidavit:- Given On A Non Judicial Stamp Paper By a Partner if Any Duly
Attested By Oath Commissioner.

10. Drug Regulatory authority In India
Drug
"All medicines to be used for diagnosis, treatment, mitigation or prevention of
any disease or disorder in human beings or animals."
LIST
1.Central Drug Standard Control Organisation(CDSCO)
2.ministry of health and Family welfare (MHFW)
3.Indian Council of Medical Research (ICMR)
4. Drug Technical Advisory Board (DTAB)
5.Central Drug Testing Laboratory (CDTL)
6. Indian Pharmacopoeia Commission (ic)
7.National Pharmaceutical Pricing Authority (NPPA)

11. Central Drug Standard Control Organisation(CDSCO)
The CDSCO of India is main regulatory body for regulation of pharmaceutical,
medical devices and Clinical Trials.Head office of CDSCO is located in New Delhi
and functioning under the control of Directorate General of Health
Services,ministry of health and family welfare Government of India.
V. G. Somani Current Chairman Of Central Drug
Standard Control Organisation.

12. Function
1. Approval of new drugs and clinical trials.
2. Import Registration and Licensing.
3. Licensing of Blood Banks, LVPs, Vaccines, r-DNA products and some Medical
devices and Diagnostic agents.
4. Amendment to D&C Act and Rules.
5. Participation in WHO GMP certification schemes.
6. Banning of drug And cosmetic.
7. Testing new Drug.
8. Grant of test license, personal license,NOCs for Export.

13. Drugs Controller General of India [DCGI]
He/she is a responsible for approval of New Drugs, Medical devices and Clinical
Trails to be conducted in India.He is appointed by the central government under
the DCGI the State drug control organization will be functioning.The DCGI is
advised by the Drug Technical Advisory Board {DTAB} and the Drug Consultative
Committed {DCC}.

14. Ministry Of Health And Family Welfare (MHFW)
Ministry of Health and Family Welfare, Government of India/Founded In1976.The
Ministry of Health and Family Welfare is an Indian government ministry charged
with health policy in India. It is also responsible for all government programs
relating to family planning in India.The Minister of Health and Family Welfare
holds cabinet rank as a member of the Council of Ministers. The current minister
is Harsh Vardhan.
The Department of Health deals with health care, including awareness
campaigns, immunisation campaigns, preventive medicine, and public health.
• National AIDS Control Organisation (NACO) (see HIV/AIDS in India)
• National Cancer Control Programme
• National Filaria Control Programme (filariasis)

15. • National Iodine Deficiency Disorders Control Programme. (iodine deficiency)
• National Leprosy Eradication Programme. (leprosy)
• National Mental Health Programme. (mental health)
• National Programme for Control of Blindness. (blindness)
• National Programme for Prevention and Control of Deafness .(deafness)
• National Tobacco Control Programme. (tobacco control)
• National Vector Borne Disease Control Programme. (NVBDCP) (vector-borne
disease)
• Pilot Programme on Prevention and Control of Diabetes, CVD and Stroke
(diabetes, cardiovascular disease, stroke)
• Revised National TB Control Programme .(tuberculosis)
• Universal Immunisation Programme.

16. Research councils
• Central Council for Research in Ayurveda and Siddha (CCRAS)
• Central Council for Research in Unani Medicine (CCRUM)
• Central Council for Research in Homoeopathy (CCRH)
• Central Council for Research in Yoga and Naturopathy (CCRYN)

17. Functions: Ministry of Health and Family Welfare
1. International health relations and administration of post quarantine.
2. Administration of Central Institutes such as All India Institute of Hygiene and
Public Health, Kolkata.
3. Promotion of research through research centers.
4. Regulation and development of medical, pharmaceutical, dental and nursing
Professions.
5.Establishment and maintenance of drug standards.
6. Census and collection and publication of other statistical data.
7. Immigration and emigration.
8. Regulation of labor in the working of mines and oil fields.
9. Coordination with states and with other ministries for promotion of health.

18. Indian Council of Medical Research(ICMR)
The Indian Council of Medical Research (ICMR), New Delhi, the apex body in
India for the formulation, co-ordination and promotion of biomedical research,
is one of the oldest medical research bodies in the world.Indian Research Fund
Association (IRFA) Set up in 1911 Was re-designated in 1949 as the Indian
Council of Medical Research (ICMR).

19. AIM AND OBJECTIVES
ICMR promotes biomedical research in the country through intramural
research (through its own Institutes/Centres) and extramural research (through
grants-in-aid given to projects in non-ICMR Institutes).ICMR's 26 National
Institutes address themselves to research on specific health topics like
• Viral diseases including AIDS
• Malaria
• Vector control
• Nutrition
• Food & drug toxicology
• Reproduction
• Immuno-haematology
• Medical statistics etc.

20. VISION & MISSION
ICMR is now one of the constituent bodies of the newly created Department of
Health Research (DHR), whose vision is To bring modern health technology to
the people through innovations related to diagnostics, treatment methods and
vaccines for prevention to translate them into products and processes and in
synergy with concerned organizations to introduce these innovations into
public health systems.
The Mission of the ICMR is to promote better health in India It provides
stewardship, conducts and supports health research, generates knowledge and
ensures its utilization, and develops resources for health research in areas of
national public health importance.

21. FUNCTIONS OF ICMR:
Provides financial assistance to promote biomedical and health research.
Proposals in fundamental/ strategic research, development and evaluation of a
tool, clinical and operational research are considered for ICMR support.
It provides assistance by way of grants to scientists in regular employment in the
universities, medical colleges, postgraduate institutions, recognized research and
development laboratories and NGOs.
The ICMR also funds task force studies which emphasise a time- bound, goal-
oriented approach with clearly defined targets, specific time frames,
standardised and uniform methodologies, and often a multicentric structure.

22. ICMR also provides international fellowship programme for research and
training and exposure of Indian biomedical scientists in various countries as well
as offering opportunities to scientists from developing countries to come and
work in Indian institutes/laboratories.
It also encourages human resource development in biomedical research through
Research Fellowships, Short-Term Visiting Fellowships, Short-Term Research
Studentships, and various training programmes and workshops conducted by
ICMR institutes and headquarters.

23. Drug Technical Advisory Board (DTAB)
What is Drugs Technical Advisory Board?
The Drugs Technical Advisory Board advises the Central Government and the State
Governments on technical matters arising out of the administration of Drugs &
Cosmetics Act and carry out functions assigned to it by this Act.

24. Who are the members of DTAB Drugs Technical Advisory
Board?
(i) The Director General of Health Services, ex officio, who shall be Chairman.
(ii) The Drugs Controller, India, ex officio.
(iii)The Director of the Central Drugs Laboratory, Calcutta, ex officio.
(iv) The Director of the Central Research Institute, Kasauli, ex officio
(v) The Director of Indian Veterinary Research Institute, Izatnagar, ex officio.
(vi) The President of Medical Council of India, ex officio.
(vii) The President of the Pharmacy Council of India, ex officio.
(viii) The Director of Central Drug Research Institute, Lucknow, ex officio.
(ix) Two persons to be nominated by the Central Government from among
persons who are in charge of drugs control in the States; one person, to be
elected by the Executive Committee of the Pharmacy Council of India, from
among teachers in pharmacy or pharmaceutical chemistry .

25. (xi) One person, to be elected by the Executive Committee of the Medical
Council of India, from among teachers in medicine or therapeutics on the staff
of an Indian university or a college affiliated thereto.
(xii) One person to be nominated by the Central Government from the
pharmaceutical industry.
(xiii) One pharmacologist to be elected by the Governing Body of the Indian
Council of Medical Research.
(xiv) One person to be elected by the Central Council of the Indian Medical
Association.
(xv) One person to be elected by the Council of the Indian Pharmaceutical
Association.
(xvi) Two persons holding the appointment of Government Analyst under this
Act, to be nominated by the Central Government.

26. National Pharmaceutical Pricing Authority (NPPA)
The National Pharmaceutical Pricing Authority (NPPA) is a government regulatory
agency that controls the prices of pharmaceutical drugs in India[1].National
Pharmaceutical Pricing Authority (NPPA) was constituted vide Government of
India Resolution dated 29th August, 1997 as an attached office of the
Department of Pharmaceuticals (DoP), Ministry of Chemicals and Fertilizers as an
independent Regulator for pricing of drugs and to ensure availability and
accessibility of medicines at affordable prices.
National Pharmaceutical Pricing Authority
Formed 29 August 1997
Jurisdiction India
Headquarters :-3rd/5th Floor, YMCA Cultural Center Building 1, Jai Singh Road,
New Delhi, India

27. Functions
To implement and enforce the provisions of the Drugs (Prices Control) Order in
accordance with the powers delegated to it.
To deal with all legal matters arising out of the decisions of the Authority.
To monitor the availability of drugs, identify shortages, if any, and to take
remedial steps.
To collect/ maintain data on production, exports and imports, market share of
individual companies, profitability of companies etc, for bulk drugs and
formulations.
To undertake and/ or sponsor relevant studies in respect of pricing of drug.
To recruit/ appoint the officers and other staff members of the Authority, as per
rules and procedures laid down by the Government.

28. Important Schedule For Drug Store
Schedule H (Drugs & cosmetics (2nd amendment)Rules 2006)
Prescription drugs which are required to be sold by retail only when a
prescription by RMP (Register medical Practitioner)
Drugs come under Schedule H should be labelled with the symbol Rx and
conspicuously displayed on the left top corner of the label. These Schedule
Contain 536 Drug.
Drugs specified in Schedule H, and comes within [Narcotic Drugs and
Psychotropic Substances Act, 1985 ]labelled with the symbol NRx which shall be
in red and conspicuously displayed on the left top corner of the label.

29. For monitoring use and misuse of antibiotics
Schedule H of the drug and cosmetics act contains a list of 536 drugs which are
required to be dispensed on the prescriptions of a registered medical
practitioner.
In order to have separate regulation to check unauthorized sale of antibiotics,
a separate schedule as Schedule H1 was introduced under the Drugs and
Cosmetics (4h amendment) rules 2013 to regulate sale of antibiotics exclusively.
Warning:- It is dangerous to take this preparation except in accordance with the
medical advice. Not to be sold by retail without the prescription of a RMP.
Condition For Sale:- Supply Of a Schedule H1 Drug Has to Be Recorded
Separate Register.The Record Should Be Maintain For 3 Year And Open For
Inspection.

30. if it contains a drug substance specified in Schedule X, be labeled with symbol
XRx, which shall be in red and conspicuously displayed on the left top corner of
the label and shall also be labeled with the following words in legible black
coloured font size in completely red rectangular box.(Amendment 26
April,2018)

31. Schedule C/C1
For manufacturing for sale and distribution of Schedule C and C(1) drugs, A
license on Form 28 is required which is issued by Drug Department of
concerned state government or center government. For retail selling of these
drug, a license on Form 21 is required where as for wholesale and distribution
purpose, license on Form 21-B is required. Below are the list of products that
are covered under Schedule C and C(1).
Schedule C: Biological and Special Products
• Sera.
• Solution of serum proteins intended for injection.
• Vaccines for parenteral injections.
• Toxins.

32. • Antigen.
• Antitoxins.
• Insulin.
• Pituitary (Posterior Lobe) Extract.
• Adrenaline and Solutions of Salts of Adrenaline.
• Antibiotics and preparations thereof in a form to be administered
parenterally.]
• does not require to be stored in a refrigerator.
• Sterilized surgical ligature and sterilized surgical suture.
• Bacteriophages.
• Ophthalmic preparations.
• Sterile Disposable Devices for single use only.

33. Schedule C (1): Other Special Products
• Drugs belonging to the Digitalis group and preparations containing drugs
belonging to the Digitals group not in a form to be administered parenterally.
• Ergot and preparations containing Ergot not in a form to be administered
parenterally.
• Adrenaline and preparations containing Adrenaline not in a form to be
administered parenterally.
• Liver extract and preparations containing liver extract not in a form to be
administered parenterally.
• Hormones and preparations containing Hormones not in a form to be
administered parenterally.
• Vaccine not in a form to be administered parenterally.

34. Provisions (Container)
No substance specified in Schedule C shall be sold or offered for sale unless it
has been sealed in a previously sterilized container made of glass or any other
suitable material approved for the purpose. When any such substance is issued
in liquid form in containers which are sealed in such a manner that portions of
the contents can be withdrawn for use on different occasions, the liquid shall
contain a sufficient proportion of some antiseptic to prevent the growth of any
organism.

35. Provisions (Labelling)(Amendment)
The particulars, if any, as are specified in Schedule F or Schedule F(1), as the case
may be, shall be printed or written in indelible ink on the label of every phial,
ampoule or other container of a substance specified in Schedule C and on every
other covering in which such phial, ampoule or container is packed.
• Tests for confirm standards
• Tests for strength and quality
• Application of tests for sterility.
• Test for freedom from abnormal toxicity.
• Test for pyrogens.

36. Schedule J
The Schedule J of the Drugs and Cosmetics Rules, 1945 of India contains a list of
diseases and ailments which a drug may not claim to prevent or cure. Under Rule
106 of the Drugs and Cosmetics Act, 1940, a drug cannot make claims to treat or
prevent any of the diseases or reform the conditions listed.
The Union health ministry will soon amend Schedule J of the Drugs and Cosmetics
Rules, 1945 to prohibit misleading advertisements for the treatment of ailments
which are also under the purview of Drugs and Magic Remedies (Objectionable
Advertisements) Act (DMR), 1954 and Rules, 1955.
The thrust of the proposed amendment is to put restriction on advertisements in
respect of any drug claiming treatment, mitigation, prevention or cure of diseases
covered under DMR.

37. List of Diseases
• AIDS
• Angina Pectoris
• Appendicitis
• Arteriosclerosis
• Blindness
• Blood poisoning
• Bronchial asthma
• Cancer and benign tumour
• Change in colour of hair and growth of new hair
• Change of foetal sex by drugs
• Diabetes
• Diseases and Disorders of the uterus
• Epileptic fits and psychiatric disorders

38. • Fairness of the skin
• Form and structure of the breast
• Gangrene
• Genetic disorders
• Glaucoma
• Goitre
• Jaundice/Hepatitis/Liver disorders
• Leukaemia
• Myocardial infarction
• Obesity
• Paralysis
• Parkinsonism
• Rheumatic heart diseases
• Sexual impotence, premature ejaculation and spermatorrhoea
• Stones in gall-bladder, kidney, bladder

39. The Union health ministry will soon amend Schedule J of the Drugs and
Cosmetics Rules, 1945 to prohibit misleading advertisements for the treatment
of ailments which are also under the purview of Drugs and Magic Remedies
(Objectionable Advertisements) Act (DMR), 1954 and Rules, 1955.
The thrust of the proposed amendment is to put restriction on advertisements
in respect of any drug claiming treatment, mitigation, prevention or cure of
diseases covered under DMR.(amendment 25 May ,2018)

40. Schedule G
SCHEDULE G PRESCRIPTION DRUG – CAUTION
It is dangerous to take this preparation except under medical
supervision.Explanation: The drugs that come under the preview of Schedule G
drugs will simply labeled with the black colour font size in completely Red
Colour Rectangular Box.(Amendment,26 April,2018)

41. Labeling requirements:(Amendment)
If product contains a drug substance specified in Schedule G, be labeled with
following words in legible black colored font size in completely red rectangular
box.
SCHEDULE G PRESCRIPTION DRUG – CAUTION: It is dangerous to take this
preparation except under medical supervision.
Also Purchase Record Maintain 2 Year.
• Ex:Aminopterin
• L-Asparaginase
• Bleomycin
• Busulphan; its salts
• Carbutamide Chlorambucil;its salts

42. Schedule M
Schedule M is titled “Good Manufacturing Practices And Requirements Of
Premises, Plant And Equipment For Pharmaceutical Products”. The GMP
requirements in schedule M are for Pharmaceutical Products. It specify GMP
requirements for premises such as buildings, air conditioning, waste
management, sanitation of workers, record keeping, etc for pharmaceutical
products.
• Parts 1 A deals with the specific requirements for sterile products,
parenteral preparations and sterile ophthalmic preparations.
• Part 1 B has specific requirements for manufacture of oral solid dosage
forms. Tablets And Capsules)
• Part 1 C has specific requirements for the manufacture of oral liquids.
(Syrup, Elixirs, Emulsions And Suspensions)

43. • Part 1 D Specific requirements for manufacture of topical products, i.e. External
preparations (creams, ointments, pastes, emulsions, lotions, solutions, dusting
powders and identical products)
• Part 1 E Specific requirements for manufacture of metered-dose-inhalers
• Part 1 F Specific requirements of premiscs, plant and materials for manufacture
of active pharmaceutial ingredients (bulk drugs)
• Schedule M1 is titled “Good Manufacturing Practices And Requirements Of
Premises, Plant And Equipment For Homoeopathic Medicines”. Complete
Schedule M: Schedule M In Drugs and Cosmetics Rules, For GMP In
Pharmaceuticals.

44. Schedule M-1
Schedule M-1 is titled "Good Manufacturing Practices And Requirements Of
Premises, Plant And Equipment For Homoeopathic Medicines".The GMP
requirements in schedule M1 are for Homeopathic Products. It specify GMP
requirements for premises such as buildings, ventilation, waste management,
quality control etc for Homeopathic medicines. Schedule M1 prescribe basic
equipment and facilities for different sections such as potentiation section,
container section, lotions section, opthalmic preparation section etc.Complete
Schedule M1: Schedule MI GMP In Homeopathic Medicines, Drugs And
Cosmetics Act.

45. Schedule M-2
Schedule M-2 is titled “Requirements Of Factory Premises For Manufacture Of
Cosmetics". The GMP requirements in schedule M2 are for Cosmetic Products.
It specify GMP requirements for premises such as buildings, equipments, basic
sanitation etc for cosmetic products. Schedule M2 prescribe basic equipment
and facilities for different sections such as creams, nail polishes, lipstics, hair
dyes and powders etc. Complete Schedule M2: Schedule M-2 GMP For
Cosmetics, Drugs And Cosmetics Act.

46. Schedule M-3
Schedule M-3 is titled "Quality Management System - For Notified Medical
Devices And In-Vitro Diagnostics”. The GMP requirements in schedule M3 are
for notified medical devices. It specify GMP requirements for premises such as
buildings, equipment, design and development validation, record keeping etc
for medial devices and diagnostic products. Schedule M3 also has Annexures
from A to C. Complete Schedule M3: Schedule M3 GMP Medical Devices And
Diagnostics, Drugs And Cosmetics Act.

47. Schedule N
Schedule N describes the list of minimum equipment for the efficient running of a
pharmacy.
1. Entrance: The front of a pharmacy shall bear an inscription “Pharmacy” in
front.
2. Premises: The premises of a pharmacy shall be separated from rooms for
private use. The premises shall be well built, dry, well lit and ventilated and, of
sufficient dimensions to allow the goods in stock, especially medicaments and
poisons to be kept in a clearly visible and appropriate manner. The areas of the
section to be used as dispensing department shall be not less than 6 square
meters for one pharmacist working therein with additional 2 square meters for
each additional pharmacist. The height of the premises shall be at least 2.5
meters.

48. The floor of the pharmacy shall be smooth and washable. The walls shall be
plastered or tiled or oil painted so as to maintain smooth, durable and
washable surface devoid of holes, cracks and crevices. A pharmacy shall be
provided with ample supply of good quality water. The dispensing department
shall be separated by a barrier to prevent the admission of the public.
3. Furniture and apparatus: The furniture and apparatus of a pharmacy shall be
adapted to the uses for which they are intended and correspond to the size and
requirements of the establishment. Drugs, chemicals, and medicaments shall
be kept in a room appropriate to their properties and in such special containers
as will prevent any deterioration of the contents or of contents of containers
kept near them. Drawers, glasses and other containers used for keeping
medicaments shall be of suitable size and capable of being closed tightly to
prevent the entry of dust.

49. Every container shall bear a label of appropriate size, easily readable with
names of medicaments as given in the Pharmacopoeias. A pharmacy shall
be provided with a dispensing bench, the top of which shall be covered with
washable and impervious material like stainless steel, laminated or plastic,
etc.
A pharmacy shall be provided with a cupboard with lock and key for the
storage of poisons and shall be clearly marked with the word “POISON” in
red letters on a white background. Containers of all concentrated solution
shall bear special label or marked with the words “To be diluted” A
Pharmacy shall be provided with the following minimum apparatus and
books necessary for making of official preparations and prescriptions.

50. 4. General provisions: A pharmacy shall be conducted under the continuous
personal supervision of a Registered Pharmacist whose name shall be displayed
conspicuously in the premises.The Pharmacist shall always put on clean white
overalls.
The premises and fittings of the pharmacy shall be properly kept and everything
shall be in good order and clean.All records and registers shall be maintained in
accordance with the laws in force.
Any container taken from the poison cupboard shall be replaced therein
immediately after use and the cupboard locked. The keys of the poison
cupboard shall be kept in the personal custody of the responsible person.
Medicaments when supplied shall have labels conforming to the provisions of
laws in force.

51. Note: - The above requirements are subject to modifications at the discretion of
the licensing authority, if he is of opinion that having regard to the nature of
drugs dispensed, compounded or prepared by the licensee. It is necessary to
relax the above requirements or to impose additional requirements in the
circumstances of a particular case. The decision of the licensing authority in that
regard shall be final.

52. Reference
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54. 21.Original Research Article Drug schedules: knowledge among
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55. 29.Manual And Diagnosis Laboratory Testing,Pavana Pavana,Sixth Addition.
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56. Thank You