Pharmacy Law & Ethics D Pharm II Year.pdf

GYANDEEP ACADEMY
For Notes More Contact:Mr. Arun Patidar (M.Pharm) 9826672215, 9981996566, www.gyandeepacademy.in
Online/Offline Classes for D Pharm, B Pharm, GPAT, Thakur Bhavan Bhawarkuan, Indore
Key Notes: PHARMACY LAW AND ETHICS (206) D Pharm II Year PCI
Emergency Regarding Blood Donner Please Contact – 9826672215, 9644067667 Page 1
KEY NOTES
Drug Enquiry Committee (D.E.C.) 1930: (Chopra committee) Chairman
– Lt. Col. R.N. Chopra, Recommendations (To establish pharmacy councils,
drug control departments, CDL etc.)
Hathi committee: 1975 chairman Jai Sukh Lal Hathi, recommendation
for development of Indian pharmaceutical industry, This committee covered
all aspects of licensing, price control, imports, foreign sector, and quality
control.
Pharmacy act – 1948
Functions of PCI: Education regulation, Minimum eligibility for
admission in pharmacy course, Duration of course, Training period,
Drafting of syllabus, Inspection of institute, Approval of institute, Extension
of approval, Termination of approval, Maintenance of central register.
Constitution of PCI: Constitution for Period of 5 years
 Elected members : 6 by UGC (Pharmachemistry, Pharmacology,
Pharmacognosy & Pharmaceutics), 1 MCI, 1 by SPC.
 Nominated members: 6 by the Central Government, 1
Representative of the U.G.C. & A.I.C.T.E., 1 by State
Government.
 Ex-officio members: Director General of Health Services, The
Drugs Controller of India, The Director of the CDL.
Functions of SPC: Verification of docs, Registration of pharmacist,
Renewal of registration, Termination of registration, Maintenance of first
register and subsequent register, Inspection of drug store and any
pharmaceutical premises
Constitution of SPC: Constitution for Period of 5 years
 Elected members: 6 by registered pharmacist of the state, 01 by
MCI.
 Nominated members: 5 by the State Govt.
 Ex-Officio members: Chief Medical Officer, Officer in-charge
of Drugs Control, Government Analyst.
Joint State Pharmacy Council:
 Elected Members: 3 to 5 from each state, 1 by MCI from each
State.
 Nominated Members: 2 to 4 from each State
 Ex-Officio Members: Chief Medical Officer, Officer in-charge
of Drugs Control, Government Analyst.
Registered pharmacist: name is registered under state pharmacy council of
state.
Procedure for registration of pharmacist: First register, Subsequent
register
Min Qualifications: 18 years old, reside in the concerned State, hold, a
degree or diploma in pharmacy.
Procedure: State Government constitute a Registration Tribunal consisting
of three persons, and shall also appoint a Registrar who shall act as
Secretary of the Registration, Tribunal fixes the date, Application accepted,
examined, if satisfied, entry of the name on the register.
Documents required: form, fee, Marksheet, Training Certificate, proof of
the residence.
Pharmacy Practice Regulations 2015: counsel the patient by qualified
registered pharmacists, Renting of registration prohibited, Pharmacists are
allowed to charge consultation charges for their professional services.
The Drugs and Cosmetics Act, 1940: Ensure that the drugs and cosmetics
sold in India are safe, effective and conform to state quality standards, To
regulate the import, distribution and sale of drugs & cosmetics through
licensing.
Drugs and cosmetics prohibited from import: (No person can import):
Any drug/cosmetic not of standard quality, misbranded, spurious or
adulterated drug or cosmetic.
Import of Drugs under License or permitted: Drugs specified in
Schedule C, C1, X, Small quantities of drugs imported for the purpose of
examination, test or analysis, Drugs for personal use covered by the
prescription of RMP.
Exempted Drugs: Drugs specified in Schedule D are exempted from
provisions of import- Substances not used for medicinal purpose,
Substances which are both drugs and foods such as: Condensed/Powdered
Milk, Malt, Lactose, Cereal, Oats, Predigested foods, Ginger, Pepper,
Cumin, Cinnamon.
Types of manufacturing licenses:
 License for manufacture of schedule C & C1 drugs
(Biological Product):
- Licensed premises & requirements of GMP as per sch.
M,
- Technically qualified staff (B Pharm with at least 18
months experience in the manufacture of drugs),
- Adequate arrangement for testing, storage, maintain
the manufacturing & analytical records,
- Allow the inspector to inspect the premises.
- Inform to the licensing authority about any changes in
the technical staff.
 License for manufacture of schedule X drugs: In addition to
general conditions as mentioned above the licensee should
observe the following conditions- record of the manufacture
should be maintained in a serially bound & paged register, drugs
are stored in custody of responsible person; submit a report to the
licensing authority every 3 months, physician sample not
supplied.
 License for manufacture of drugs other than those specified
in schedule C & C1, X.
 License Manufacture of drugs for examination, test or
analysis.
 Loan License: License issued to applicant who does not have
his own arrangements for manufacture but who intends to
avail himself of the manufacturing facilities owned by another
licensee. Consent of the licensee whose facilities he is going to
use, requirement as per sch M.
 Repacking License: It means the process of breaking up any
drug from a bulk container into small packages & the labelling of
such package with a view to its sale & distribution.
Types of Licences issued for sale of drug: Drug License Application is the
permission granted under the Drugs and Cosmetic Act to carry out a
drug/medicine or cosmetic business. Central or State CDSCO grants such
License.
License
issued
AppF
orm
Licence Form and Fees
Drugs other than
Sch. C,C1 & X
Sch. C&C1
drugs
Sch. X drugs
Retail 19 20 (1500/-) 21 (1500/-) 20F (500/-)
Wholesale 19 20B (1500/-) 21B (1500/-) 20G (500/-)
Wholesale: Drugs sold only to retailer having license, Min Area 10M2
,
proper storage facility, Reg. Pharmacist, Records of purchase & sale,
Records preserved for 3 years, License displayed on premises
Retail sale:
Minimum Requirements:
 Must fulfil the requirements as per schedule N.
 Min area 10m2
 Facilities for proper storage of drugs,
 Registered pharmacist,
 Maintain records,
 Allows an inspector to inspect the premises & to check the
records,
 Inform to the licensing authority about any change in qualified
staff,
 Drugs specified in schedule H & X should be sold only on
prescription of RMP. In case of schedule X drugs, the
prescription should be in duplicate & should be retained for 2
years.
For retail sale, two types of licenses are issued:
 General license: who have engage the services of qualified
person to supervise the sale of drug & do the compounding &
dispensing.
 Restricted license: not engage the services of a qualified.

GYANDEEP ACADEMY
Procedure: Prepare application, Documentation, Inspection, Grant of
License
Documents required (retail/wholesale):
 Specified Form
 Fee
 Proof of Identity and residential proof, Mark Sheet, Proof of
ownership/rent agreement,
 Site plan and key plan of the premises by,
 Purchase bill of the refrigerator,
 Photo of shop with furniture,
 Documents for pharmacist or qualified person (Passport size
Photographs, Identity proof, Mark Sheet (10th
, 12th
&
Graduation), Registration Certificate of Pharmacist, Proof of
residence, Appointment Letter of Pharmacist).
Schedule:
 Schedule C: List of Biological and special products
(Injectable)
 Schedule C1: List of other special products (non-parenteral)
 Schedule G: List of substances required to be taken only under
supervision of RMP.
 Schedule H: List of prescription drugs
 Schedule K: List of drugs exempted from certain provisions
 Schedule P: Life period of drugs,
 Schedule M: Deals with the Good Manufacturing Practices
(GMP) and requirements of premises, plant and equipment.
 Schedule M1: Prescribes in detail requirements of factory
premises for the manufacture of Homeopathic drugs.
 Schedule M-II: Prescribes requirements of factory premises
manufacture of cosmetics.
 Schedule M-III: Prescribes requirements of factory premises for
manufacture of medical devices.
 Schedule N: List of minimum equipment for the running of a
pharmacy
 Schedule X: List of habit forming, psychotropic, and other such
drugs.
Drug Technical Advisory Board (DTAB): Advisory body, Advice the
central & state govt.
Constitution: 18 members
 Ex-officio members: 8 (Head of- Health Services, CDSCO, PCI,
MCI, CDL, CDRI, IVRI)
 Nominated Members: 5 (1 Industry, 2 Govt Analyst, 2 state
CDSCO)
 Elected Members: 5 (1 pharmacy teacher, 1 medicine teacher,
1IPA, 1IMA, 1ICMR)
Drug Consultative Committee (DCC): Advisory body, Advice DTAB,
central & state govt.
Constitution:
 Two representatives of the Central Government
 One representative of each State Government
Functions:
 To advise the Central Government, the State Governments and
the Drugs Technical Advisory Board on any other matter tending
to secure uniformity throughout India in the administration of
this Act.
 The Drugs Consultative Committee shall meet when required.
 Has power to regulate its own procedure.
Government analyst: State / central government appoint for
analysis/testing of samples of drugs & cosmetics.
 Qualifications: B Pharm + 5 years of exp. / M Pharm 3 years
Exp., no any financial interest in the import, manufacture or sale
of drugs and cosmetics.
 Duties of Government Analyst: analysis or testing of drugs /
cosmetics
 Procedure: receive, check seals & specimen, notes the condition,
test supplies report of analysis in triplicate.
Drug Inspector: State / central government appoints to inspect premises
licensed for manufacture / sale of drugs & cosmetics.
 Qualification: B Pharm, 18 months exp. in the manufacture /
testing of schedule C drugs., no any financial interest in the
import, manufacture or sale of drugs and cosmetics.
 Power: Inspect, Take samples, Enter and search any premises,
Examine & seize any records, Search any person, Stop & search
any vehicle.
 Procedure: inform in writing, take 4 paid sample, sealed &
marked, sample sent to the 1 Govt. analyst, 1 court, 1 warrantor
&1 owner, After the report received, further action.
 Duties of drug inspector: To inspect twice a year, collect
samples of imported drugs, To investigate any complaint,
maintain the records.
Licensing authority: Central government appoints an authority called
licensing authority to issue license for import of drugs. Each state
government appoints licensing authority to issue license for manufacture,
distribution and sale of drugs and cosmetics, for a specified area. Powers:
issue license, refuse license, cancel license, suspend license.
Controlling authority: Appointed by Central or State govt. All inspectors
of central and state are under his control.
NDPS Act 1985: Objective: To regulate mfg, cultivation, collection, sale,
storage, transport, distribution, import, export, processing of NDPS.
NDPS: coca leaf, cannabis (hemp), opium, and poppy straw; and
psychotropic substances include any natural or synthetic.
Authorities and Officers:
 Officers of Central Government: NCB
 Officers of the State Govt
 The NDPS Consultative Committee:
Offences and Penalties: Illicit trafficking: Illegal mfg, cultivation,
collection, sale, storage, transport, distribution, import, export, processing of
NDPS, Financing any activity related to NDPS, Harboring any person
engaged in these activities, Abetting or conspiring related to NDPS.
Punishment:
 I conviction: fine 1lac / 10year imprisonment / both
 II conviction: fine 2lac / 20 year imprisonment / both
Drugs and Magic Remedies (Objectionable Advertisements) Act 1954:
Objectives: The objective is to prohibit certain kinds of advertisements
relating to drugs and magic remedies which make false claims and are likely
to mislead the public.
Prohibited advertisements:
 Termination of pregnancy
 Prevention of conception in women.
 The maintenance or improvement of sexual pleasure.
 The correction of menstrual disorder in women.
 Treatment of disease listed in Schedule J.
 Advertisements of Adulterated drugs, Misbranded drugs &
Spurious drugs
Permitted (Exempted) advertisements:
 Govt. advertisements
 Govt. permitted publications
 Scientific publications
 Label claim of any dosage form
 The advertisement for the guidance to RMP: Therapeutic
indications, Route, Dose, side effects, precaution etc.
Offences and Penalties:
 Imprisonment 6 months or a fine or both on first conviction.
 Imprisonment upto one year or a fine or both on any subsequent
conviction.
Prevention of Cruelty to Animals (PCA) Act-1960: An Act to prevent the
infliction of unnecessary pain or suffering on animals.
CPCSEA (New Name CCSEA): The Committee for Control and
Supervision of Experiments on Animals (CCSEA).
Objective:
 To avoid unnecessary pain before, during and after experiment,
 To promote human care of animal used in research and testing,
 To provide guideline for anesthesia, euthanasia, housing, care,
breeding, and maintenance.
Institutional Animal Ethics Committee (IAEC): committee for review,
approve and supervision of research proposals involving lab animals.

GYANDEEP ACADEMY
Composition of IAEC: 8 (1biological scientist, 2 scientists from different
biological disciplines, 1 veterinarian, 1 Scientist in charge, A scientist
outside, 1 social worker, 1 nominee of CPCSEA.
CPCSEA guideline:
 Veterinary care
 Quarantine, stabilization and separation
 Food and water, Bedding
 Animal care and technical personnel
 Sanitation and cleanliness
 Durations of experiments
 Personal hygiene
 Transport of laboratory animals
 Physical facilities
 Record, Disposal
 Anaesthesia and euthanasia
Poisons Act-1919: control the import, possession and sale of Poisons.
Objective: To regulate import, possession & sale of poison, To avoid the
malpractice of poison in case of using it to kill a person or animal (mixing
poison with fodder of cattle).
Import of poisons: Central Govt. gives license for import of Poisons.
Without license Import of Poisons is prohibited.
Possession & sale of poisons: The State Government regulate wholesale
or retail sale of poison.
 Also, empowered to regulate the possession of any specified
poison in local area - Murdering or Mischief or Poisoning Cattle
where such instances are frequent,
 The grant of licences for sale of poison,
 Define maximum quantity of sale to a person,
 Maintenance of record for sale of poison,
 The storage of poison in safe custody and labelling,
 Inspection and examination.
Offence: Import or possession or sale of any poison not mentioned in the
Act.
Penalty: 1st conviction: Imprisonment upto 3 months or fine upto Rs. 500
or both. 2nd conviction: Imprisonment upto 6 months or fine upto 1000 Rs.
or both.
FSSAI (Food Safety and Standards Authority of India): Established in
2008 to regulate manufacture, storage, distribution, sale and import, to
ensure availability of safe food for human consumption.
Composition of FSSAI: The FSSAI is made up of a Chairperson and 22
members, one-third of who must be women.
Functions of FSSAI:
 Setting Rules and Guidelines
 Granting License
 Test the Standard of Food
 Regular Audits
 Spreading Food Safety Awareness
 Maintain Records and Data
 Keeping the Government Updated
National Pharmaceutical Pricing Authority (NPPA): Established by
central govt to fix/ revise the prices of controlled bulk drugs and
formulations and to enforce prices and availability of the medicines in the
country.
DPCO 2013: The government has notified the DPCO 2013 under the
Essential Commodities Act, 1955, which will give power to the NPPA to
regulate prices of 348 essential drugs under NLEM 2011.
Objectives:
 To make sure that the essential drugs are available to all at a
reasonable price.
 To ensure that quality of the drugs does not go down with the
fixation of prices
 To promote rational use of prescribed drugs in a cost-effective
manner.
 To Achieve Adequate Production, To regulate Equal Distribution,
To Maintain and Increase Supply Of Bulk Drugs, To make at Fair
Prices.
Formula for Retail price calculation:
R.P. = M.C.+C.C.+P.M.+P.C. ) x ( 1+ MAPE /100)+E.D.
Where, R.P. (retail price), M.C (material cost), C.C. (conversion cost),
P.M. (packing material cost), P.C. (packing charges), MAPE (Maximum
Allowable Post-manufacturing Expenses), E.D. (excise duty).
National List of Essential Medicines (NLEM): NELM is those that satisfy
the priority healthcare needs, based on: efficacy, safety, quality and the total
cost of treatment. The purpose of the list is to ensure safety, quality,
affordability and accessible of medicines for the population.
Drugs in NELM:
2011:348 (Deleted 43, Added 47)
2015:376 (Deleted 70, Added 106)
2022:384 (Deleted 26, Added 34)
Code of Pharmaceutical Ethics: The code of pharmaceutical ethics is
formulated by PCI for the guidance of Indian pharmacist. It helps to guide
the pharmacist as to how he should conduct himself in relation to: his job,
his trade, his fellow pharmacist, with medical profession, with his
profession (pharmacy), with general public.
 Pharmacist in relation to his job: Registered premises should
be opened as pharmacy, Prevent error of contamination in
dispensing, preparation and supply of medicines, Handling of
prescription, Training of pharmacist, The dispenser must be:
Organized, Knowledgeable, Trained, Honest and Communicative.
 Pharmacist in relation to his trade: Price should be fair, quality
should be good, Fair trade practice, Always purchased drug from
genuine resources, Hawking of drugs should not be encourage,
self service method should not be used.
 Pharmacist in relation to medical profession: Pharmacist
under no circumstances, take to medical practice i.e. Diagnosis
and prescribing medicines. In emergency he can give first aid to
the person, not offer any commission or any other advantage.
 Pharmacist in relation to his profession: Careful watch on
possible danger and difficulties, Stable profession, Join the
professional organisation like IPA.
Pharmacists Oath: Promise of a pharmacist. As a pharmacist, I vow to
serve humanity and to support my profession's ideals and commitments.
 I swear by the code of ethics of Pharmacy Council of India.
 I shall uphold the laws and standards governing my profession.
 I shall strive to perfect and enlarge my knowledge to contribute to
the advancement of pharmacy and public health.
 I shall follow the system which I consider best for Pharmaceutical
care and counseling of patients.
 I shall endeavor to discover and manufacture drugs of quality to
alleviate sufferings of humanity.
 I shall hold in confidence the knowledge gained about the
patients in connection with my professional practice and never
divulge unless compelled to do so by the law.
 I shall associate with organizations having their objectives for
betterment of the profession of Pharmacy and make contribution
to carry out the work of those organizations.
 While I continue to keep this oath unviolated, may it be granted
to me to enjoy life and the practice of pharmacy respected by all,
at all times.
 Should I trespass and violate this oath, may the reverse be my lot.
Medical Termination of Pregnancy Act (MTP Act) 1971: The MTP Act
came into effect from 1 April 1972 and was amended in the years 1975 and
2002 with objectives to
Objectives: Improve the maternal health, reducing the incidence of illegal
abortion and consequent maternal mortality and morbidity, Legalizes
abortion services, Promotes access to safe abortion services to women.
Legal Termination of Pregnancy (Time Period, Conditions):
 Life of the woman in danger, Risk to mental or physical health,
 The pregnancy is due to rape,
 The pregnancy is due to the failure of any contraceptive,
 Significant risk that if the child is born (Unhealthy child),
would suffer from such physical or mental abnormalities.
- Pregnancy less than 12 weeks: 1 RMP
- Pregnancy more than 12 week & less than 24 weeks: 2
RMPs

GYANDEEP ACADEMY
Place where pregnancy may be terminated:
 A hospital established or maintained by Government, approved
by Government, under safe and hygienic conditions
 Facilities required: Operation table, instruments, anesthetics
equipment, resuscitation equipment, sterilization equipment,
Drugs and parenteral fluids for emergency use.
Qualification of RMP (Who can terminate):
 RMP who has a recognized Medical qualification,
 registered in MCI,
 3 year experience in the practice of Gynaecology and obstetrics,
Completed six months of house surgery in Gynaecology and
obstetrics or assisted a RMP in the performance of twenty five
cases of MTP.
Consent requirement: In form C only the consent of a women is required,
If age <18 years or a mentally ill patient, consent of guardian is required.
Offences and penalty:
 Terminator not an RMP – murder case filed – life sentence or
death penalty
 Illegal termination – Rs. 1000/- fine / 6 Month Imprisonment /
both
Central Drugs Standards Control Organization (CDSCO): Regulatory
body for regulation of pharmaceutical, medical devices and Clinical Trials.
Head office of CDSCO is located in New Delhi. Also has 6 zonal offices, 7
sub zonal offices, 13 Port offices and 7 laboratories spread across the
country.
 Functions of CDSCO: Approval of new drugs and clinical trials,
Import Registration and Licensing, Licensing of for
manufacturing, Amendment to D&C Act and Rules, Banning of
drugs and cosmetics, Testing of drugs by Central Labs etc.
 Drugs Controller General of India (DCGI): responsible for
approval of New Drugs, Medical devices and Clinical Trials,
appointed by the central government, advised by DTAB & DCC.
 Zonal offices: 6, Mumbai, Kolkata, Chennai, Ghaziabad,
Ahemdabad, Hyderabad.
 Sub-zonal office: 7, Bangalore, Varansi, Goa, Jammu, Indore,
Guwhati, Baddi.
Central Drugs Testing Laboratories: 7
- Central Drug Laboratory (CDL), Kolkata
- Central Drug Testing Laboratory (CDTL), Chennai
- Central Drugs Testing Laboratory (CDTL), Hyderabad
- Central Drug Testing Laboratory (CDTL), Mumbai
- Regional Drug Testing Laboratory (RDTL), Guwahati
- Regional Drug Testing Laboratory (RDTL), Chandigarh
- Central Drug Laboratory (CDL), Kasauli: Engaged in the testing
of vaccines.
Function of Central Drugs Testing Laboratories:
- These laboratories are responsible for quality control of drugs
and cosmetics in the country.
- Analysis of Drugs and Pharmaceuticals, Cosmetics and Medical
Devices manufactured in the country.
- Analysis of Import drugs & Cosmetics samples entering
through the port offices of CDSCO.
- Analysis of Drugs & Pharmaceutical formulations received as
Survey Samples from CDSCO and its Zonal Offices.
- Imparting Training to Drugs Analysts deputed by the
Government laboratories from time to time.
Indian Pharmacopoeia Commission (IPC): Autonomous Institution of the
Ministry of Health and Family Welfare, Govt. of India. IPC is created to
set standards of drugs in the country.
Functions of IPC: Publishing IP and its Addenda at regular intervals.
 Preparation, certification and distribution of IP Reference
Substances (IPRS) to the stakeholders.
 Publishing National Formulary of India (NFI).
 Running Pharmacovigilance Programme of India
 Analysis of the new drug candidate,
 Skill development, International collaborations etc.
Objectives of IPC: To develop monographs, review existing monographs,
collaborate with pharmacopoeias like the BP, USP, JP, To organize
educational programs and research activitie , To publish the NFI, To act as
a National Coordination Centre for Pharmacovigilance Programme of India.
Good Regulatory practices (GRP): GRP can be defined as a set of
principles and practices applied to the development, implementation and
review of regulatory laws, regulations and guidelines to achieve public
health policy objectives in the most efficient way.
Principles of good regulatory practices: Legality, Consistency,
Independence, Impartiality, Proportionality, Flexibility, Clarity, Efficiency,
Transparency.
BCS (Biopharmaceutical Classification System) classification of drugs:
Classifying a drug substance based on its aqueous solubility & intestinal
permeability & dissolution rate.
 Class I: High Permeability and high Solubility
 Class II: High Permeability and Low Solubility,
 Class III: Low Permeability and High Solubility
 Class IV: Low Permeability & High Solubility
Clinical Trials: Clinical trial is a systematic investigation in human
subjects for evaluating the safety & efficacy of any new drug. Objectives of
clinical trials: To determine whether a new drug or device is safe and
effective for people to use.
Phases of Clinical Trials
 Phase I: Studies usually involve a small number of healthy
volunteers (20–100) and are designed to assess the safety of a
drug.
 Phase II: To Determine efficacy and further evaluate its safety.
(100–300).
 Phase III: effectiveness of a new drug, Compare new agent with
standard treatment, studies are carried out on large groups (i.e.
several hundred to several thousands).
 Phase IV: Post market Long-term safety and efficacy studies.
(i.e. thousands).
Protocol: Clinical trials are conducted according to a plan, called a
protocol.
Principal investigator (PI): The Investigator is the person who conducts
the trial.
New Drug Application (NDA): The vehicle through which drug sponsors
formally propose that the regulatory body approve a new pharmaceutical for
sale and marketing (Form 44). The data gathered during the animal studies
and human clinical trials of an Investigational new product become part of
the NDA. Formal proposal for the FDA/DCGI to approve a new drug for
sale. The goals of the NDA are to provide enough information to permit
FDA reviewers to establish the complete history of the candidate drug.
Abbreviated new drug application (ANDA): ANDA contains data which
is submitted to FDA for the review and potential approval of a generic drug
product. Once approved, an applicant may manufacture and market the
generic drug product to provide a safe, effective, lower cost alternative to
the brand-name drug it references.
 Goal of ANDA: To reduce the price of the drug, To reduce the
time development, Increase the bioavailability of the drug in
comparison to references list drug.
 ANDA Requirement: Signed FDA form 356h, index, Condition
for use, Route of administration, dosage form & strength,
Labelling, Chemistry, Manufacturing & Controls, Human
Pharmacokinetics & Bioavailability etc.
 ANDA Approved: After all components of the application are
found to be acceptable an approval or tentative approval letter is
issued to the applicant.
IPR: Intellectual Property Rights (IPR) are the statutory rights once granted
allows the creator(s) or owner(s) of the intellectual property to exclude
others from exploiting the same commercially for a given period of time.
Types:
 Industrial Property: Patent, Design, Trademark, Geographical
Indications
 Non-industrial Property: Copyright
The Indian Patent Act 1970: In India the grant of patents is governed by
the patent Act 1970 and Rules 1972.
Patent: A patent is a grant from the government which confers on the
guarantee for a limited period of time the exclusive privilege of making,
selling and using the invention for which a patent has been granted.

GYANDEEP ACADEMY
Patentee: Patentee means the person for the time being entered on the
register as the grantee or proprietor of the patent.
Term of Patent: The term of every patent in India is 20 years.
Objective of Patent:
 To enjoy the exclusive rights over the invention.
 The patent is to ensure commercial returns to the inventor for the
time and money spend in generating a new product.
 To encourage inventions by promoting their protection and
utilization.
What can be patented?
 The invention must fall into one of the five "statutory classes':
Processes, Machines, Manufactures Compositions of matter, and
New uses of any of the above
 The invention must be "useful"
 The invention must be "novel"
Types of Patents:
 An Ordinary Patent
 A Patent Of Addition
 A Patent Of Convention
Patent office and its establishment: Kolkata (H.O) Branches: Delhi,
Mumbai, Chennai.
Blood Bank: The Blood Bank provides licensed facilities for the collection,
storage, processing and distribution of human blood and blood components.
Services provided in the Blood Bank/ Functions of blood bank:
 Blood storage, Blood grouping and compatibility testing.
 Testing for transmissible diseases.
 Assessing of immunological compatibility between donor and
patient
 Safe delivery and handling of blood components
 Inventory and stock management
Minimum requirement for establishing a hospital blood bank:
 General: Location and Surroundings, Building, Health, clothing
and sanitation of staff.
 Area: 100 square meters for its operations and an additional area
of 50 square meters for preparation of blood components.
 Personnel: Medical Officer, Blood Bank Technician, Technical
supervisor etc.
 Maintenance: The premises shall be maintained in a clean and
proper manner.
 Equipment: Equipment shall be maintained in a clean and proper
manner and so placed as to facilitate cleaning and maintenance.
The equipment shall be observed, standardized and calibrated on
a regularly scheduled.
 Supplies and reagents: All supplies and reagents used in the
collection, processing, compatibility, testing, storage and
distribution of blood and blood components shall be stored at
proper temperature in a safe and hygienic place, in a proper
manner.
Clinical Establishment Act 2010: Regulation of all clinical establishments
in the country with a view to prescribing the minimum standards of facilities
and services.
Clinical Establishment: It is defined as all hospitals, maternity home,
nursing home, dispensary, clinic, etc or an institution by whatever name
called that offers services, facilities requiring diagnosis, treatment or care
for illness, injury, etc.
Minimum Standards to be followed by Clinical Establishments:
 The minimum standards of facilities and services
 The minimum requirement of personnel
 Provisions for maintenance of records and reporting
Biomedical waste: Biomedical waste comprises human & animal
anatomical waste, treatment apparatus like needles, syringes and other
materials used in health care facilities in the process of treatment and
research. This waste is generated during diagnosis, treatment or
immunisation in hospitals, nursing homes, pathological laboratories, blood
bank, etc.
Importance of Bio-Medical Waste Disposal: Scientific disposal of
biomedical waste through segregation, collection, and treatment in an
environmentally sound manner minimizes the adverse impact on health
workers and the environment, Improper disposal increases the risk of
infection.
Bioethics: Bioethics is the study of ethical, social, and legal issues that arise
in biomedicine and biomedical research.
ICMR’s National Ethical Guidelines & General Principles for Biomedical
and Health Research involving human participants:
 Principle of essentiality
 Principle of voluntariness
 Principle of non-exploitation
 Principle of social responsibility
 Principle of ensuring privacy and confidentiality
 Principle of risk minimization
 Principle of professional competence
 Principle of maximization of benefit
 Principle of institutional arrangements
 Principle of transparency and accountability
 Principle of totality of responsibility
 Principle of environmental protection
Consumer Protection Act 1986: An Act to provide for the better
protection of the interests of consumers.
The Rights of the Consumer:
 Right to Safety
 Right to Choose
 Right to be informed
 Right to Consumer Education
 Right to be heard
 Right to seek compensation
Where do we complain?
 Complaints District forum
 State commission
 National commission
Disaster: Calamity or grave occurrence in any area, arising from natural /
manmade causes which results in substantial loss of life or human suffering
or damage to, and destruction of property, or damage to, or degradation of,
environment of the affected area.
Objectives Disaster Management Act 2005:
 Mitigation or reduction of risk of any disaster or its severity or
consequences.
 Capacity building including research & knowledge
management.
 Prompt response to any threatening disaster situation or disaster.
 Assessing the severity or magnitude of effects of any disaster.
The following governing bodies are established by DMA 2005.
 National Disaster Management Authority (NDMA)
 National Executive Committee
 State Disaster Management Authority
 District Disaster Management Authority
 National Disaster Response Force (NDRF)
Objectives of Indian Medical Devices Regulatory Act (IMRDA) 2009:
 Provide notification of essential principles
 Provide for risk based classification of devices
 Notify standards and guidelines
 Provide a post market surveillance system
Medical Devices: A medical device can be any instrument, apparatus,
implement, machine, appliance, implant, material or other similar or related
article, intended by the manufacturer to be used, alone or in combination for
a medical purpose.
Medical device risk classification:
Classes Types Examples
Class A Low-risk absorbent cotton balls, alcohol swabs, etc.
Class B Moderate-low
risk
Hypodermic needle, thermometer, BP
monitoring device, etc.
Class C Moderate-high
risk
Lung ventilator, bone fixation plate etc
Class D High-risk heart valve, Implantable device etc.
Manufacture and sale of Medical Devices: CDSCO released schedule M-
3 and created a body within the CDSCO to regulate medical devices in
India. DCGI takes the responsibility for approval of Manufacturing,
Registration, Import and Sale of Medical Devices in India.

Pharmacy Law & Ethics D Pharm II Year.pdf

Pharmacy Law & Ethics D Pharm II Year.pdf

Recommended

Recommended

More Related Content

What's hot

What's hot (20)

Similar to Pharmacy Law & Ethics D Pharm II Year.pdf

Similar to Pharmacy Law & Ethics D Pharm II Year.pdf (20)

Recently uploaded

Recently uploaded (20)

Pharmacy Law & Ethics D Pharm II Year.pdf