PHARMACEUTICAL JURISPRUDENCE (BP 505 T ) Unit 4

This course is designed to impart basic knowledge on important legislations related to the profession of pharmacy in India.

2. •Act passed 1954

•Rule passed and came into force 1st April 1955

•The Act extends to whole of India except the state of Jammu and Kashmir.

OBJECTIVES
1.To control some of the drug related advertisements which can mislead the public.

2.To prohibit certain kind of advertisements related to magic remedies which make false
claims and are likely to mislead the public.

3.The Act was also referred as Objectionable Advertisements Act.

3. Definitions
1.Advertisement: It includes all the notices, labels, circulars, wrappers or other documents and
all the announcements made orally or by means of producing or transmitting light, sound.

2.Drug: Any substance intended to be used for or in the diagnosis, cure, mitigation, treatment
or prevention of diseases in human beings or animals.

3.Magic Remedy: It includes talismans, mantras, kavachas and any other charm of any kind
which is alleged to possess miraculous powers for or in the diagnosis, cure, mitigation,
treatment or prevention of any diseases in human beings or animals.

4. Prohibited Advertisements
(a)For The procurement of miscarriage or prevention of conception in women.
(b)For the correction of menstrual disorders in women.
(c)For the maintenance or improvement of the capacity of human beings for sexual pleasure.
(d)The diagnosis, cure, mitigation, treatment or prevention of any disease, disorder or condition
(e)Directly or indirectly gives a false impression regarding the true character of the drug.
(f)Make a false claim for the drug.
(g)Are otherwise false or misleading in any material particular

5. Exempted Advertisements
•Any sign boards or notices displayed by Registered Medical Practitioner (RMP) indicating that
treatment is undertaken for the disease or disorder.

•Advertisement including any books dealing with any matter related to the disease

• Any advertisements related to a drug which is send confidentially, in the prescribed manner,
to RMP’s.

•Any advertisement relating to a drug printed or published by the Government or by any
person with the prior permission of the Government (Spread the awareness)

•Advertisements, labels or set of instructions which are permitted under the Drugs and
Cosmetics Act.

•Advertisement in journals responsibility for to prove the any claim of advertisement in
respect to the not false

6. •Price list of manufacture, distributor, importer of drug advertisement only contain technical
information for guidelines for RMP

•Advertisement of chemical contraceptive for oral

Offences And Penalties

•Any one who do not full fill the rule of drug and magic remedies act is punished with
imprisonment up to 6 months or with fine or both

•And second conviction imprisonment up to 1 year or fine or both

8. •Act passed 1960
•Rule passed 1998
•Rule and regulation Extend to whole India except Jammu and Kashmir

Objectives
1)It prevents the infliction of unnecessary pain or suffering on animals and also to prevent
cruelty to animals.

2)The term animals comprises of any living creature but not the human being.

3)The term cruelty has not been defined under this Act however it means the infliction of
unnecessary pain or suffering.

9. Definitions
1.Animal: is any living creature other than a human being

2.Breeder: is a person owing an institution, which breeds animals for transferring to the
authorized institution for performing experiments.

3.Committee: is constituted under Section 15 of the Act for control and supervision on
animals

4.Board: It means the animal welfare board establishment under section 4 of the Act.(Maintain
animal stock)

5.Institute animal ethics committee: Means a body comprises of a group of person recognized
and registered by the committee for the purpose of control and supervision on animal
performs in an establishment which is constituted and operated in accordance with
procedures specified for the purpose by the committee

10. Cruelty To Animal
•Any animals to unnecessary pains or suffering or treatment.
•Employing any unfit animals for works or labor.
•Willfully and unreasonably administration any injurious drugs or substance.
•Failure to provide any animals with sufficient food, drink or shelter by its owner.
•Needlessly mutilating any animals or killing any animals in unnecessarily cruel manner etc.

11. INSTITUTIONAL ANIMAL ETHICS COMMITTEE (IAEC)
•A biological scientist.
•Two scientist from different biological disciplines.
•Veterinarian invited in the case of animals.
•The scientist in charge of the animal facility of the establishment concerned.
•Scientists from outside the institution.
•Nonscientific socially aware member.(like NGO)
•Representative or nominee of the committee.

Function
•Control and supervision on animal

12. COMMITTEE FOR THE PURPOSE OF CONTROL AND SUPERVISION OF
EXPERIMENTS ON ANIMALS (CPCSEA)
CPCSEA GUIDELINES
•Killing (cruel manner) any animal without any need
•Unnecessary pain or suffering
•Unfit animal for work or labor
•Insufficient food, drink or shelter
•Confining in any cage or insufficient size or difficult in movement
•Administering any injurious drug or substances (unreasonable)

13. BREEDING AND STOCKING OF ANIMALS
•Only registered establishments can carry on the business of breeding of animals for the
purpose of experiment

•Apply for registration within 60 days from the date of experiment

•For the registration of establishment/breeders (including universities and college) the Govt. of
India has set up the committee for the purpose of control and supervision of experiment on
animal (CPCSEA) under the ministry of social Justice and empowerment, shastri bhavan, New
Delhi.

•The secretary of the committee may ask for the information relating to the premises where
the experiments are to be conducted, animal house facilities, details of breeding of animals
and its trade, other infrastructure including availability of manpower trained in handling
animals and for verification of facts mentioned in the application for registration.

•And if satisfied, shall register such establishment or the breeder.

•A breeder shall comply with all the conditions specified at the time of registration.

14. PERFORMANCE OF EXPERIMENT
•All experiment shall be performed by or under the supervision of duly qualified person
Degree holder.

RECORDS
•Every establishment /institutional animal ethics committee shall maintain a records of the
animal under the control and custody and furnish information.

15. Transfer of animals for experiment
•Transfer of any animal for sale purpose to an unregistered breeder is not permitted.

•A breeder can't acquire any animal by sale except from a registered breeder.

•Acquired animal can't be sale except from registered breeder.

•Experiment in production breed improvement programmed, animals may be given out by
breeder institution for domestic use.

•Genetic experiment on rat and mice not available in India, if such, the breeder shall take the
permission from Institutional Animal Ethics Committee (IAEC).

16. Power to suspend or revoke registration
•Rules made by the committee are not followed or not satisfied by the committee.

•The Committee is given a reasonable opportunity for rectification, after that the registration
may revoke a specific period or indefinitely or grant the license on a special condition.

•Failure of compliance of Rule and regulation, the committee may impose pending or suspend
the registration.

•During suspension period, the breeder shall take care of animals, cease to perform any
experiment or acquire or transfer of any animal is prohibited.

17. OFFENCE AND PENALTIES
OFFENCE PENALTIES
Treating animals cruelty Fine up to 0-100 /3 month jail
Contravention if any order made by or
committing breach of any condition by the
committee
Fine extending 200 with jail

19. Introduction
•National Pharmaceutical Pricing Authority (NPPA) was established in 1997

•It is an independent body and regulated by department of pharmaceuticals ministry of
chemical and fertilizer.

•It aims to fix and revise the prices and formulations of controlled bulk drugs, and enforce
prices and availability of medicines under DPCO, 2013

•Under the latest DPCO 2013, the prices of 348 drugs listed in the National List of Essential
Medicines 2011 covering around 628 formulations have been brought in the section of price
control by the latest DPCO-2013.

Objectives
1)To ensure the availability of all the essential drugs at a reasonable price.

2)To confirm that the quality of drugs does not decline with price fixation.

3)To promote the rational use of prescribed drugs in a cost-effective manner

20. Important date
Essential commodities act

1955
National List of essential medicine

2011
National pharmaceutical pricing policy

2012
DPCO (Drug price controlled order) come into force

15 may 2013

21. The DPCO has the following classes of schedules of drugs:
Schedule I:
•It contains the list of essential bulk drugs that are included in 27 different sections of National
list of Essential Medicines (NLEM), 2011 rule.

Schedule II:
•It contains various forms for the approval, fixation or revision of prices of Scheduled
formulations

Schedule III:
•It specifies the maximum per-tax return on the sales turnover of manufacturers or importers
of formulations.

22. Definitions
Ceiling price:
•It means a price fixed by govt for scheduled formulation in accordance with of this order.

Margin to retailer:
•It means percentage of price to retailer.

Maximum retail price (MRP):
•It means the ceiling price or the retail price plus local taxes and duties as applicable, at which
the drug.

National list of essential medicines:
•National list of essential medicines 2011 published by ministry of health and family welfare.

Non-scheduled formulation:
•It means formulation, the dosage form and strength of which are not specified in the first
schedule.

23. Local taxes:
•It means any taxes or leavy paid or payable to the govt or the state govt.

Price to retailer:
•It means the price of a drug at which it is sold to a retailer which include duties but does not
include local taxes.

Retail price:
•It means price fixed by the govt. for a new drugs.

Schedule formulation:
•It means any formulation include in the first schedule whether referred to by generic version
or brand name

24. Sale Prices of Bulk Drugs
•The Government notifies the Official Gazette and on periodic intervals fixes a maximum sale
price at which the bulk drug should be sold.

•make it available at a reasonable price from different manufacturers.

•The manufacturers should allow the inspection of their manufacturing area by the
Government for verification of the manufacturing procedures, facilities, and records.

•No person should sale a bulk drug at a price more than the maximum sale price.

•Until the price of a bulk drug is fixed by the Government.

•If a manufacturer wants to revise the maximum sale price of a bulk drug, he should make an
application to the Government in Form 1.

•The Government on receiving the application should make enquiry and within 4 months from
the date of receiving the full information, either fixes a revised price for the bulk drug or
cancels the request of revision if not satisfied with the furnished records.

25. Retail Price of Formulations
The following formula should be used to calculate the retail price of a formulation…

R.P. = (M.C. + C.C. + P.M. + P.C.) × (1 + MAPE/100) + E.D

•RP = Retail price
•MC = Material cost
•CC = Conversion cost
•PM = Packing material
•PC = Packing charges
•MAPE = Maximum Allowable Post manufacturing Expenses
•ED = Excise duty.

26. Retail Price of Scheduled Formulations

•The Government can timely fix the retail price of any scheduled formulation in accordance
with the formula discussed above.

•He should make an application to the Government in Form -III for revision of the price of all
the formulations within 30 days of such fixation or revision

•The Government on receiving the application if feels satisfied fixes or revise the formulation
price.

27. Calculation of Ceiling Price of Scheduled Formulations

•The calculation of ceiling price of a scheduled formulation of a specific strength and dosage
can be calculated as given below:

Step 1: The average price to the retailer of the scheduled formulation [P(s)] is calculated as
follows:




Average Price to Retailer [P(s)] =
(Sum of prices to retailer of all the brands and generic
versions of the medicine having markets share more than or
equal to 1% of the total market turnover on the basis of
moving annual turnover of that medicine)

(Total number of such brands and generic versions of the
medicine having market share more than or equal to 1% of
total market turnover on the basis of moving annual
turnover for that medicine)

29. National List of Essential Medicines (NLEM)

•The National List of Essential Medicines (NLEM) is a list released by the Ministry of Health and
Family Welfare.

•The medicines listed in the NLEM are sold below a price ceiling fixed by the National
Pharmaceutical Pricing Authority (NPPA).

•What is Essential Medicines- These are the medications to which people should have access
at all times in sufficient amounts. The prices should be at generally affordable levels.

•The WHO developed a directory of such medicines in 1977 and named it WHO Model List of
Essential Medicines

•This list is updated in every 2 years, and in March 2011 its current version was updated.

30. National List of Essential Medicines 2015
(A)Anaesthetic Agents
❑ Halothane
❑ Isoflurane
❑ Ketamine

(B) Analgesics, Antipyretics & NSAIDS
❑ Diclofenac
❑ Ibuprofen
❑ Paracetamol

(C) Anti-Allergic & Anaphylaxis
❑ Adrenaline
❑ Cetirizine
❑ Prednisolone

31. (D) Antidotes
❑ Atropine
❑ Naloxone
❑ Neostigmine

(E) Anticonvulsants
❑ Carbamazepine
❑ Diazepam
❑ Clobazam