Unit-IV Pharmaceutical Jurisprudence

DRUGS AND MAGIC REMEDIES ACT AND ITS RULES

The Drugs and Magic Remedies Act was passed in 1954 with a view to control and prohibit certain
advertisement of drugs and magic remedies which are likely to mislead the general public.
The act came into effect from April 1st 1955 and amended in 1963.
The act was also called Objectionable Advertisements Act.
Objective
The act has been passed with the aim,
To control certain types of the advertisement relating to drugs.
To prohibit certain kinds of advertisements relating to magic remedies, which falsely claims and
mislead public.
To provide for matters related therewith.
Advertisement
It includes, Any notice, circular, label, wrapper or otherwise such documents and any announcement
made orally or by means of producing or transmitting light, sound or smoke.
Magic Remedy
It includes a Talisman, Mantra, Kavacha and any other charm claiming to possess miraculous powers:
a)For treating and prevention of any disease in human beings or animals or
b)For affecting or altering the structure or organic function of the body or animal.
Drug
A medicines for the internal or external use of human beings or animals.
A substance intended for the diagnosis, cure, mitigation, treatment or prevention of disease in human
beings or animals.
Prohibited Advertisements
1.Advertisements of drugs which may leads to their use for the treatment of certain diseases and
disorders:
a)For the procurement of miscarriage in women.
b)For the Prevention of conception in women.
c)For the correction of menstrual disorders in women.
c)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
specified in the schedule J.
2.Misleading advertisements relating to drugs:
The advertisement relating to a drug or drugs which,
a)Directly or indirectly gives a false impression regarding the true nature of the drug or drugs.
b)Makes any false claims for such a drug or drugs.
3.Advertisement of Magic Remedies for the treatment of certain diseases and disorders which claims
to the efficacious for any of the purposes specified (1) as above.
4.Import and export of all the above mentioned advertisements is prohibited. Any documents
containing any such advertisements are deemed to be goods of which import or export has been
prohibited under the sea customs Act, 1878.
Subject to provisions of any rules made in this behalf, any Gazetted officer authorized by the State
Government may within the local limits of the area for which he is authorized,
a)Enter and search at all reasonable times, with such assistants, as necessary, any place in which has
reason to believe that an offence under this Act has been or is being committed.
b)Seize any advertisement which he has reason to believe contravenes any of the provisions of the
Act.
Search and seizure should be made under the authority of a warrant as provided in the code of
criminal procedure, 1898. an offence punishable under this Act shall be cognizable. A magistrate
should be informed of any seizure and his order should be taken as to the custody thereof.
5.Names of Diseases, disorders and conditions as per the Schedule to this Act:
Appendicitis, Arteriosclerosis, Blindness, Cancer, Cataract, Deafness, Diabetes, Disorders of
menstrual flow, Disorders of brain, Dropsy, Epilepsy, Gangrene, Glaucoma, Goiter, Heart diseases,
Leprosy, Locomotors ataxia, Lupus, Obesity, Plaque, Rheumatism, Typhoid fever, Tuberculosis,
Tumors, Syphilis, Gonorrhea etc.

Mr.T.Boopathi,M.Pharm,AP SSCOP
Unit-IV Pharmaceutical Jurisprudence

Exempted Advertisements
The following classes of advertisement are not prohibited under this act:
1.Any advertisement relating to the drug printed or published by the Government or any other person
with prior permission of the Government.
2.Any advertisement relating to a drug which is sent confidentially in prescribed manner to RMP.
3.Advertisement including any book or treatise (written or printed composition) dealing with any
matter relating to the diseases.
4.Any sign board or notice displayed by RMP on his premises indicating that treatment for any
disease or disorder or condition specified in the rules made under this Act.
5.Advertisement relating to drugs which comply with required conditions as follows:
a)Leaflets or literature along with packing’s of drugs. b)Advertisement of drugs in medicinal,
pharmaceutical, scientific and technical journals.
Exempted Advertisements
c)Therapeutic index or price list published by licensed manufacturer, importer or distributor of drug
(under the D&C Act 1940) or Medical literature review distributed by Medical representatives.
With the condition that:
i)The advertisement should contain only the information, required for the guidance of RMP regarding:
1.Therapeutic indications.
2.Route of administration.
3.Dosage and side effects of such drug or drugs.
4.The precaution to be taken in treatment with the drug.
ii)The distribution of such literature should be given to RMP dispensaries, hospitals, medical and
research institutions, chemists and druggists or pharmacists.
Offences and Penalties
On contravention of any of the provisions of Act and Rules.
First conviction
Imprisonment up to 6 months or with fine or both.
Subsequent conviction
Imprisonment up to 1 year or fine or both.

PREVENTION OF CRUELTY TO ANIMAL ACT

Prevention of cruelty to animal Act passed by central government in 26th December 1960.
It extends to the whole of India along with Jammu and Kashmir after removal of article 370 in 2019.
Reason
1.In modern day research animals are important experimental subjects because of physiological
similarity to human beings.
2.To establish safety and efficacy of drugs, experiments on animal unavoidable.
3.Clinical trials under Drug and Cosmetics Act preceded by data generation on animal toxicology and
pharmacology.
Objectives
1.The prevention of cruelty to animals’ act 1960 enacted to prevent unnecessary pain or suffering on
animals.
2.“Breeding of and experiments on animals’ rules, 1998” have been incorporated in this act.
Cruelty To Animals Includes
1.Subjecting any animal to unnecessary pain or suffering or treatment.
2.Employing any unfit animal for work or labor.
3.Willfully and unreasonably administering any injurious drug or substance to any domestic or
captive animal.
4.Keeping or confining any animal in any cage of insufficient size not permitting it reasonable
movement.
5.Failure to provide any animal with sufficient food, drink or shelter.
6.Needlessly mutilating any animal or killing any animal in an unnecessarily cruel manner.

Mr.T.Boopathi,M.Pharm,AP SSCOP
Unit-IV Pharmaceutical Jurisprudence

Institutional Animal Ethical Committee (IAEC)

IAEC is a Committee with a group of individuals registered by the Committee for the Control and
Supervision of Experiments on Animals (CPCSEA). The expert Consultant of CPCSEA is at Chennai
and its Member Secretary for Animal Welfare is at New Delhi under the Ministry of Environment and
Forests.
Every IAEC consists of,
A biological scientist.
Two scientists from different biological disciplines.
A veterinarian invited in the case of animals.
The scientist in charge of animal’s facility of the establishment concerned.
A scientist from outside the institution.
A non-scientist socially aware member.
A nominee of CPCSEA.
A specialist may be co-opted while reviewing special projects using hazardous agents such as
radioactive substance and deadly microorganisms.
Objectives of IAEC
1.Experiments shall be performed in every case by or under the supervision of a person duly qualified
in that behalf, i.e., Degree or Diploma holder in Veterinary Science or Medicines or Laboratory
Animal Science of a University or an Institution recognized by the Government for the purpose and
under the responsibility of the person performing the experiment.
2.Experiments are performed with due care and humanity and that as far as possible experiments
involving operations are performed under the influence of some anesthetic of sufficient power to
prevent the animals feeling pain.
3.Experiments on larger animals are avoided when it is possible to achieve the same results by
experiments upon small laboratory animals like guinea-pigs, rabbits, mice, rats etc.
4.Experiments are not performed merely for the purpose of acquiring manual skills.
5.Animals intended for the performance of experiments are properly looked after both before and after
experiments.
6.Records are maintained with respect to experiments performed on animals.
Functions of IAEC
1.IAEC will review and approve all types of research proposals involving small animals
experimentation before the start of the study.
2.For experimentation on large animals, the case is required to be forwarded to CPCSEA in prescribed
manner with recommendation of IAEC.
3.IAEC is required to monitor the research throughout the study and after completion of study through
periodic reports and visit to animal house and laboratory where the experiments are conducted.
4.The committee has to ensure compliance with all regulatory requirements, applicable rules,
guidelines and laws.
Breeding and Stocking of Animals
1.Only registered establishment can carry on the business of animals for purpose of experiment.
2.Apply for registration within 60 days from the date of experiments.
3.For the registration of establishment/breeders (including universities and colleges) the government
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.
4.In case the Committee denies giving registration, the breeder should stop animal breeding. The
breeder or the establishment should apply for registration (in the prescribed format), either to the
Member-Secretary or any other person appointed by the Committee on this behalf.
5.The breeder or the establishment should stock the animal s as specified. Animal houses should be
located in a quiet atmosphere with no traffic.
6.The buildings should be neat, hygienic, and the animals should be protected from drought and
extreme conditions of weather. Small animals should be kept in cages and large animals should be
given shelter under stables for their comfort and to avoid overcrowding.
7.The animals should also be looked after during off-hours and on holidays.
8.The cages or the stable s for the animals should follow the standards given by the Indian Standards
Institution (ISI). The attendants of the animals should be well-trained and experienced in their work.

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Unit-IV Pharmaceutical Jurisprudence

9.The Committee or IAEC should lay down some conditions to make sure that the animals do not
suffer from needless pain or problems either before, during, or after the experiments have been
performed on them.
10.These conditions become effective when the Committee plans to approve the conduction of
experiments. The Committee can also ask for information or reports after the experiments from the
establishments, IAEC, and individuals performing experiments on animals.
Performance of Experiments
1.When experiment are performed in any institution the responsibility is placed on the person in
charge of the institution.
2.Experiments shall be performed by or under the supervision of duly qualified person.
3.The qualified person shall hold a Degree or Diploma in Veterinary Science or Medicines, Post
graduate or above in life science/pharmaceutical science or any other Natural science, Degree or
Diploma in Pharmacy, Diploma or certificate in laboratory animal technique science from institution
recognized by the government.
4.Experiments shall be performed with due care and humanity.
5.Animals must not subject to unnecessary pain or suffering before, during or after the performance of
experiments on them.
6.Experiments with severe operations shall be done under anesthetic environment by a trained person
to prevent the animal feeling pain.
7.In the experiment under anesthesia if animal injures severely that recovery involve pain and
suffering then they shall be destroyed humanely.
8.No experiment shall be repeated without previous justification, if the result of such experiment is
already known.
Records
1.Every establishment/IAEC shall maintain a record of the animals in its control and custody and
furnish such information as the committee may from time to time require in the specified format.
2.All laboratories shall inform the exact number/species of animals to the secretary or any other
officer in this regard by the committee as per the specified format.
Transfer and Acquisition of Animals For Experiment
1.Transfer of any animal by way of sale by a breeder to an unregistered establishment is not
permitted.
2.After acquisition animals shall not be transferred to any person except to a registered breeder.
3.The animals used for experimentation in a breed improvement program may be given out by the
breeder institution for domestic use.
Power To Suspend or Revoke Registration
1.The failure to comply with the provisions of these rules, committee (CPCSEA) suspend the
registration of such establishment/breeder.
2.If the committee is satisfied that the rules made by it are not being followed by any
establishment/Breeder/IAEC, the committee may after giving reasonable opportunity of being heard
the matter revoke the same either for a specified period or indefinitely or may allow the establishment
to such special conditions as the committee may impose.
3.Import of any animal in the country by a breeder is also not allowed.
4.A breeder shall comply with the directions given by the committee for the purpose of control and
supervision of experiments on animals.
5.In the event of revocation or suspension of registration of an establishment, the committee may
issue direction for the care and protection of the animals which are under the custody of such
establishment.
Offences and Penalties
1.Treating animal cruelly is an offence punishable with fine up to Rs.50 in the first instance and if a
second offence is committed within three years of the previous offence, the fine may extend up to
Rs.100 or with imprisonment up to 3 months or with both.
2.Breaching of any condition is punishable with fine extending to Rs.200.
3.When the contravention takes place in institution the person in charge shall be guilty of the offence
and shall be punishable accordingly.

Mr.T.Boopathi,M.Pharm,AP SSCOP
Unit-IV Pharmaceutical Jurisprudence

NATIONAL PHARMACEUTICAL PRICING AUTHORITY

National Pharmaceutical Pricing Authority (NPPA) was established in 1997.
It is an independent body regulated by the Department of Pharmaceuticals, Ministry of Chemicals and
Fertilisers.
It aims to fix and revise the prices and formulations of controlled bulk drugs, and enforce prices and
availability of medicines under DPCO, 2013. It also regulates the prices of decontrolled drugs to keep
them at reasonable levels. The regulator implements and applies the provisions of DPCO.
It also recovers the amounts overpriced by the manufacturers for controlled drugs from the
consumers.
Drugs Price Control Order - 2013
The latest Drug Price Control Order (DPCO-2013) was issued on 15th May, 2013 by the Ministry of
Chemicals and Fertilisers based on the basis of National Pharmaceutical Pricing Policy, 2012 (NPPP).
The NPPP was issued on 7th December, 2012 with the main purpose to control the price of the
medicines listed under National List of Essential Medicines -2011 (NLEM-2011), issued by the
ministry of Health and Family welfare.
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
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.
Important Definitions of DPCO
Bulk drugs: It means any pharmaceutical, chemical and biological or plant product including its salts,
esters, isomers, analogues and derivatives, confirming to standards specified in the drug and
cosmetics act 1940.
Brand: It means a name, design, symbol, trade mark or any other feature that identifies one seller
drug as distinct from those of others sellers.
Ceiling price: It means a price fixed by the government for scheduled formulations in accordance
with the provision of this order (DPCO).
Generic medicine: It means a formulation sold in pharmacopeia name or the name of the active
pharmaceutical ingredient contained in the formulation without any brand name.
Manufacturer: For the purpose of this order means any person who manufacturer or importer or
markets drugs for distribution and sale in the country.
Maximum retail price: It means ceiling price or the retail price + local taxes and duties as
applicable, at which the drug shall be sold to the ultimate consumer and where such price is
mentioned on the pack.
National list of essential medicines: It means national list of essential medicines 2011 published by
the ministry of health and family welfare as updated or revised from time to time and included in the
first schedule of this order by government through a notification in the official gazette.
Retailer: It means a dealer carrying on the retail business of sale of drugs to consumers.
Wholesaler: It means a dealer or his agent or stockiest engaged in the sale of drugs to a retailer,
hospital, dispensary, medical, education and research institution or any other agency.
Wholesale price index: It means annual wholesale price index of all commodities as announced by
the department of industrial policy and promotion government of India, from time to time.
Prices of Bulk drugs
The order authorized the central government to fix the maximum sale prices of bulk drugs
manufactured in the country and listed in I and II schedule to the order with the ultimate objective of
making the same available at fair prices from different manufacturers.
In fixing price of a bulk drug government may take into consideration:
A post tax return of 14% on net worth or
Return of 22% on capital employed or
For new plant, a rate of return of 12% based on long term marginal costing.

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Unit-IV Pharmaceutical Jurisprudence

In case of production is from basic stage, post tax return of 18% on net worth or 26% on capital
employed.
Provided further that the option with regard to the rate of return once exercised by a manufacturer
shall be final and no change of rates shall be made without the prior approval of the government.
No person can sell a bulk drug at a price higher than the one fixed for it.
Any manufacturer who commences the production of any bulk drug specified in the First Schedule,
after the commencement of this order, is required to furnish the necessary details in Form I within 15
days of the commencement of the production of such bulk drug to the Government.
The Government may then, after making the necessary inquiries, fix the maximum sale price of the
bulk drug by notification in the Official Gazette.
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 manufacturer to submit information about,
Scheduled bulk drug
Non-scheduled bulk drug
Need to submit information up to 30th September of each year in form no.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.
Retail Prices of Formulations
For calculating of retail prices of any drug formulations the following formula has to be used,
R.P = (M.C+C.C+P.M+P.C) x 1 +MAPE/100+E.D
R.P – Retail price.
M.C – Material costs.
C.C – Conversion costs.
P.M – Packing material costs.
P.C – Packing charges.
MAPE – Maximum allowable post manufacturing expenses.
E.D – Excise duty.
Maximum retail price:
MRP of scheduled formulations = Ceiling price + local taxes as applicable.
After fixing retail price, manufacturer can apply for fixation or revision of retail price in form 3 and 4.
Calculation of Ceiling Price of a Schedule Formulations
Step 1:
The calculation of average price of scheduled formulation i.e. P(s) to retailer shall be calculated as
under,
P(s) = Pm (1-Pi 1 + Pi 2…)/ (N*100)
Pm = Price to retailer of highest priced scheduled formulation under consideration.
Pi = % reduction in average price to retailer of other strengths and dosage form.
N = Number of such other strength or dosage forms or both in the list of schedule formulations.
Step 2:
The ceiling price of the scheduled formulation i.e. P(c) shall be calculated as under,
P(c) = P(s) 1 + M/100
P(s) = Average price to retailer of the scheduled formulations as calculated in step 1.
M = % margin to retailer.
DPCO 1995 DPCO 2013
It is governed by essential It is governed by national pharmaceutical pricing
commodities act 1995. authority based on NLEM.
Price of only 74 drugs was
Prices of 652 drugs are regulated by this act.
regulated by this act.
If once the price are fixed they Based on simple average price (SAP) the highest
cannot be change as per the act. prices can be lowered depending on their margins.

Mr.T.Boopathi,M.Pharm,AP SSCOP
Unit-IV Pharmaceutical Jurisprudence

National List of Essential Medicines (NLEM) Under DPCO Act

Section 1: Anesthesia.
1.1 General Anesthetics and Oxygen - Ether, Halothane with vaporizer, Isoflurane, Ketamine
Hydrochloride, Nitrous Oxide, Oxygen, Thiopentone Sodium, Sevoflurane, Propofol
1.2 Local Anesthetics - Bupivacaine Hydrochloride, Lignocaine Hydrochloride, Lignocaine
Hydrochloride + Adrenaline, EMLA cream
1.3 Preoperative Medication and Sedation for Short Term Procedures- Atropine Sulphate, Diazepam,
Midazolam, Morphine Sulphate, Promethazine
Section 2: Analgesics, Antipyretics, Non-steroidal Anti-inflammatory Medicines, Medicines used
to treat Gout and Disease Modifying Agents used in Rheumatoid Disorders.
2.1 Non-Opioid Analgesics, Antipyretics and Non-steroidal Anti-inflammatory Medicines- Acetyl
Salicylic Acid, Diclofenac, Ibuprofen, Paracetamol
2.2 Opioid Analgesics - Morphine Sulphate, Tramadol, Fentanyl
2.3 Medicines used to treat Gout - Allopurinol, Colchicine
2.4 Disease modifying agents used in Rhcumatoid disorders - Azathioprine, Methotrexate,
Sulfasalazine, Hydroxychloroquine phosphate, Leflunomide
Section 3: Antiallergics and Medicines used in Anaphylaxis - Adrenaline Bitartrate,
Chlorpheniramine Maleate, Dexchlorpheniramine Maleate, Dexamethasone, Hydrocortisone Sodium
Succinate, Pheniramine Maleate, Prednisolone, Promethazine, Cetrizine
Section 4: Antidotes and Other Substances used in Poisoning
4.1 Non-specific - Activated Charcoal
4.2 Specific - Atropine Sulphate, Specific Antisnake venom, Calcium gluconate, Desferrioxamine
mesylate, Methylthioninium chloride (Methylene blue), Penicillamine, Dimercaprol, Flumazenil,
Sodium Nitrite, Sodium Thiosulphate, Naloxone, Pralidoxime Chloride (2-PAM), N acetylcysteine
Section 5: Anticonvulsants/Antiepileptics
Carbamazepine, Diazepam, Magnesium sulphate, Phenobarbitone, Phenytoin Sodium, Sodium
Valproate, Lorazepam
Section 6: Anti-infective Medicines
6.1 Anthelminthics
6.1.1 Intestinal Anthelminthics - Albendazole, Piperazine
6.1.2 Antifilarials - Iethylcarbamazine citrate
6.1.3 Antischistosomals and Antitrematode Medicines - Praziquantel
6.2 Antibacterials
6.2.1 Beta lactam medicines - Amoxicillin, Ampicillin, Bezathine, Benzylpenicillin, Cefotaxime,
Cefriaxone, Cephalexin, Cloxacillin, Amoxicillin + Clavulinic acid
6.2.2 Other antibacterials - Amikacin, Azitromycin, Ciprofloxacin chloride, Co-Trimoxazole,
(Doxycycline, Eryihromycin Estolate, Gentamicin, Metronidazole, Nitrofurantoin, Sulphadiazine,
Vancomycin Hydochloride
6.2.3 Antileprosy medicines - Clofazimine, Dapsone, Rifampicin
6.2.4 Antitubercular medicines - Ethambutol, Isoniazid, Ofloxacin, Pyrazinamide, Rifampicin,
Streptomycin Sulphate
6.3 Antifungal medicines - Griseofulvin, Nystatin, Amphotericin B, Clotrimaxole, Fluconazole
6.4 Antiviral medicines
6.4.1 Antiherpes medicines - Acyclovir
6.4.2 Antiretroviral medicince -
6.4.2.1 Nucleoside reverse transcriptase inhibitors - Didanosine, Lamivudine, Lamivudine +
Nevirapine + Stavudine Lamivudine + Zidovudine, Stavudine, Zidovudine, Stavudine + Lamivudine,
Zidovudine + Lamivudine + Nevirapine
6.4.2.2 Non-nucleoside reverse transcriptase inhibitors - Efavirenz, Nevirapine
6.4.2.3 Protease inhibitors - Indinavir, Nelfinavir, Ritonavir, Saquinavir
6.5 Antiprotozoal Medicines
6.5.1 Antiamoebic and Antigiardiasis medicines - Diloxanide Furoate, Metronidazole
6.5.2 Antileishmaniasis medicines - Amphotericin B, Pentamidine Isothionate, Sodium
Stibogluconate
6.5.3 Antimalarial Medicines

Mr.T.Boopathi,M.Pharm,AP SSCOP
Unit-IV Pharmaceutical Jurisprudence

6.5.3.1 For curative treatment - Artesunate (To be used only in combination with Sulfadoxine +
Pyrimethamine), Chloroquine phosphate, Primaquine, Pyrimethamine, Quinine sulphate, Clindamycin
6.5.3.2 For prophylaxis - Mefloquine
6.5.4 Anti Pneumo Cystosis and Anti Toxoplasmosis medicines - Co-Trimoxazole (Trimethoprim +
Sulphamethoxazole), Pentamidine Isothionate
Section 7: Anti migraine medicines
7.1 For treatment of acute attack - Paracetamol, Acetyl Salicylic Acid, Dihydroergotamine,
7.2 For Prophylaxis - Propranolol hydrochloride
Section 8: Antineoplastic, immunosuppressives and medicines used in palliative cure
8.1 Immunosuppressive medicines - Azathioprine, Cyclosporine
8.2 Cytotoxic medicines - Actinomycin D, Alpha Interferon, Bleomycin, Busulphan, Cisplatin,
Cyclophosphamide, Cytosine arabinoside, Danazol, Doxorubicin, Etoposide, Flutamide, 5-
Fluorouracil, Folinic Acid, Gemcitabine hydrochloride, L-Asparaginase, Melphalan, Mercaptopurine,
Methotrexate, Mitomycin-C
8.3 Hormones and antihormones - Prednisolone, Raloxifene, Tamoxifen Citrate
8.4 Medicines used in palliative care - Morphine Sulphate, Ondansetron, Filgrastim,
Allopurinol
Section 9: Antiparkinsonism medicines
Bromocriptine, Mesylate, Levodopa + Carbidopa, Trihexyphenidyl Hydrochloride
Section 10: Medicines affecting the blood
10.1 Antianaemia medicines - Cyanocobalamin, Ferrous Sulphate/Fumrate, Folic Acid, Iron Dextran,
Pyridoxine
10.2 Medicines affecting coagulation - Heparin Sodium, Protamine sulphate, Phytomenadione,
Warfarin sodium, Enoxaparin
Section 11: Blood products and Plasma substitutes
11.1 Plasma Substitutes - Dextran-40, Dextran-70, Fresh frozen plasma, Hydroxyethyl Starch
(Hetastarch), Polygeline
11.2 Plasma fractions for specific use - Albumin, Cryoprecipitate, Factor VIII, Concentrate Factor IX
Complex (Coagulation Factors II, VII, IX, X), Platelet Rich Plasma
Section 12: Cardiovascular medicines
12.1 Antianginal medicines - Acetyl salicylic acid, Diltiazem, Glyceryl Trinitrate, Isosorbide 5
Mononitrate/Dinitrate, Metoprolol, Clopidogrel
12.2 Antiarrhythmic medicines - Adenosine, Amiodarone, Diltiazem, Esmolol, Lignocaine
Hydrochloride, Procainamide Hydrochloride, Verapamil
12.3 Antihypertensive medicines - Losartan Potassium, Methyldopa, Nifedipine, Sodium
Nitroprusside, Hydrochlorthiazide Amlodipine, Atenolol, Enalapril Maleate
12.4 Medicines used in heart failure - Digoxin, Dobutamine, Dopamine Hydrochloride
12.5 Antithrombotic medicines - Acetyl Salicylic Acid, Heparin Sodium, Streptokinase, Urokinase
12.6 Hypolipidemic Medicines - Atorvastatin
Section 13: Dermatological medicines (Topical)
13.1 Antifungal medicines - Miconazole
13.2 Antiinfective medicines - Framycetin Sulphate, Methylrosanilinium Chloride
(Gentian Violet), Neomycin + Bacitracin, Povidone Iodine, Silver Sulphadiazine, Acyclovir
13.3 Antiinflammatory and antipruritic medicines - b-methasone, Dipropionate, Calamine
13.4 Astringent Medicines - Zinc Oxide
13.5 Medicines affecting skin differentiation and proliferation - Dithranol, Glycerin, Salicylic Acid,
Coal Tar
13.6 Scabicides and Pediculicides - Benzyl Benzoate, Permethrin
Section 14: Diagnostic agents
14.1 Ophthalmic medicines - Fluorescein, Lignocaine, Tropicamide
14.2 Radiocontrast media - Barium Sulphate, Iopanoic Acid, Meglumine Iothalamate,
Meglumine Iotroxate, Propyliodone, Sodium Iothalamate, Sodium Meglumine, Diatrizoate
Section 15: Disinfectants and antiseptics
15.1 Antiseptics - Acriflavin + Glycerin, Benzoin Compound, Cetrimide, Chlorhexidine, Ethyl
Alcohol 70%

Mr.T.Boopathi,M.Pharm,AP SSCOP
Unit-IV Pharmaceutical Jurisprudence

15.2 Disinfectants - Bleaching Powder, Formaldehyde Solution, Glutaraldehyde, Potassium

Permanganate
Section 16: Diuretics - Furosemide, Hydrochlorothiazide, Mannitol, Spironolactone
Section 17: Gastrointestinal medicines
17.1 Antacids and other Antiulcer medicines- Aluminium Hydroxide + Magnesium Hydroxide,
Omeprazole, Ranitidine, Pantoprazole, Famotidine
17.2 Antiemetics - Omperidone, Metoclopramide, Promethazine, Ondansetron
17.3 Antiinflammatory medicines - 5-Amino Salicylic Acid (5-ASA)
17.4 Antispasmodic medicines - Dicyclomine Hydrochloride, Hyoscine Butyl Bromide
17.5 Laxatives - Bisacodyl, Ispaghula
17.6 Medicines used in Diarrhorea
17.6.1 Oral dehydration salts - Oral Rehydration Salts
17.6.2 Antidiarrhoeal medicines - Zinc Sulfate
Section 18: Hormones, other endocrine medicines and contraceptives
18.1 Adrenal hormones and synthetic substitutes - Dexamethasone, Hydrocortisone, Sodium
Succinate, Methyl Prednisolone, Prednisolone
18.2 Androgens - Testosterone
18.3 Contraceptives
18.3.1 Hormonal Contraceptives - Ethinyl Estradiol + Levonorgesterol, Ethinylestradiol +
Norethisterone, Hormone Releasing IUD
18.3.2 Intrauterine devices - IUD containing Copper
18.3.3 Barrier methods - Condoms
18.4 Estrogens Ethinylestradiol
18.5 Medicines used in diabetes mellitus
18.5.1 Insulins and other Antidiabetic agents - Glibenclamide, Insulin Injection (Soluble),
Intermediate Acting (Lente/NPH Insulin), Metformin, Premix Insulin 30:70 Injection
18.5.2 Medicines used to treat hypoglycemia - glucagon, 25% Dextrose
18.6 Ovulation Inducers - Clomiphene Citrate
18.7 Progestogens - Medroxy Progesterone Acetate, Norethisterone
18.8 Thyroid and antithyroid medicines - Carbimazole, Levothyroxine, Iodine
Section 19: Immunologicals
19.1 Diagnostic agents - Tuberculin, Purified Protein derivative
19.2 Sera and immunoglobins - Anti-D immunoglobin (human), Polyvalent Antisnake
Venom, Antitetanus Human immunoglobin, Diphtheria Antitoxin, Rabies immunoglobin
19.3 Vaccines
19.3.1 For Universal Immunization - C.G. Vaccine, D.P.T. Vaccine, Hepatitis B
Vaccine, Measles Vaccine, Oral Poliomyelitis vaccine (LA)
19.3.2 For Specific Group of Individuals - Rabies Vaccine, Tetanus Toxoid
Section 20: Muscle Relaxants (Peripherally acting) and Cholinesterase Inhibitors
Atracurium besylate, Neostigmine, Pyridostigmine, Succinyl Choline Chloride, Vecuronium
Section 21: Ophthalmological Preparations
21.1 Anti-infective agents - Chloramphenicol, Ciprofloxacin Hydrochloride, Gentamicin, Miconazole,
Povidone Iodine, Sulphacetamide Sodium
21.2 Antiinflammaory agents - Prednisolone Acetate, Prednisolone Sodium Phosphate
21.3 Local Anaesthetics - Tetracaine Hydrochloride
21.4 Miotics and Antiglucoma medicines- Acetazolamide, b-xolol Hydrochloride, Pilocarpine,
Timolol Maleate
21.5 Mydriatics - Atropine Sulphate, Homatropine, Phenylephrine
21.6 Ophthalmic Surgical Aids - Methyl Cellulose
Section 22: Oxytocics and Antioxytocics
22.1 Oxytocics - Methyl Ergometrine, Mifepristone, Oxytocin, Misoprosd
22.2 Antioxytocics - Terbutaline Sulphate, Nifedipine, b-methasone
Section 23: Peritoneal Dialysis Solution - Intraperitoneal Dialysis Solution
Section 24: Psychotherapeutic Medicines

Mr.T.Boopathi,M.Pharm,AP SSCOP
Unit-IV Pharmaceutical Jurisprudence

24.1 Medicines used in Psychotic Disorders - Chlorpromazine hydrochloride, Haloperidol,

Olanzapinenn
24.2 Medicines used in mood disorders
24.2.1 Medicines used in Depressive disorders - Amitriptyline, Fluozetine hydrochloride, Imipramine
24.2.2 Medicines used in Bipolar disorders - Lithium Carbonate, Sodium Valproate
24.3 Medicines used for Generalized Anxiety and Sleep Disorders - Alprazolam, Diazepam
24.4 Medicines used for obsessive compulsive disorders and panic attacks – Fluoxetine hydrochloride
Section 25: Medicines acting on the respiratory tract
25.1 Antiasthmatic medicines - Beclomethasone Dipropionate, Hydrocortisone sodium succinate,
Salbutamol sulphate, Ipratropium bromide
25.2 Antitussives - Codeine phosphate, Dextromethorphan
Section 26: Solutions correcting water, electrolyte and acid-base disturbances
26.1 Oral - Oral Rehydration Salts
26.2 Parenteral - Glucose, Glucose with sodium chloride, Normal Saline, N/2 Saline,
N/5 Saline, Potassium Chloride, Ringer Lactate, Sodium Bicarbonate
26.3 Miscellaneous - Water for Injection
Section 27: Vitamins and Minerals
Ascorbic Acid, Calcium Carbonate, Multivitamins (As per Schedule V of Drugs and Cosmetics
Rules), Nicotinamide, Pyridoxine, Riboflavin, Thiamine, Vitamin A, Vitamin D (Ergocalciferol),
Calcium gluconate.

Mr.T.Boopathi,M.Pharm,AP SSCOP