ja:z ,-- pbar:maceutical Juris

Pru.de
. Means the person For th ll~t
12-S) pa e . ter as the grantee or prop .e ritrte
t ntee ·
( d on reg1s rietor
being entere Of
the patent first inventor : It does not .
(13) True a~d ter of an invention into Inct/nch~cle
first impor . f' a, or
either the n invention is irst communicat q
whom a ect fr
person t °. Orn
outside India. NS OF THE ACT :
pROVJSIO
10.4 . N patentable Inventions
(I) List of on
(II) Types of Patents
d re for Getting a Patent
(III) Proce u
, (IV) Term of Patent
(V) Exclusive ~arketing Rights (EMRs)
(VI) Offerices-P~nalties .
(I) LIST OF NON-PATENTABLE INVENTIONS :
(A) Following are consider · not . inventions. patentable
inventipns are supposed to satisfy three criteria :
* Novelty *_. Non~obviousness *Utility.
(1) An invention which is contrary to natural law
and which are F'RIVOLOUS. e.g. different types 0
pe,rpet1:1al motion which violet 3rd law 0
thermodynamics
' '
..
(2) An in~ention which is contrary to laws or morality
or injurious to public health, animal, or plant life.
e.g. preparation 'o f beverage.
1
'
(3) The mere discovery of scientific principle OR
formulation of an.abstract theory. e.g. Raman Effect
'
(4) The · mere discovery of a new Form of a known
substance which does not result in the
th
enhancement of the known efficacy of at
substanc~ or mere discovery of new property or
new use· For .;a known substance or of the mere
use ,o f a kno~n process, machine or apparatus
' unle ss
· sue h . known process results in
· a new
product or employs at least one new reactant.
 tS J\Ct, 1970, 1972, 1999,. 2002, 2005 315
tell
r~·ri b . d .
A substance o t~ine by Just admixture having
(Sl coJllbined properties of the components.
p.rrangerne~t, rearrangement or duplication , of
(6) own devices.
1{11 .
A Jllethod of agriculture or horticulture.
(7) Diagnostic, t h erapeu tics and surgical, curative,
(Bl rophylactic method for treatment of human
~eings of animals or plants.
(g) inventions inj~rious to environment.
(lO) plants and animals other than micro-organisms.
(l l) Change in dosage form, usage form.
(l2) Traditional system of medicines (Indian Medicine)
(13) Naturally occurring life forms, gene sequences or
cell components.
(14) Human body : whole or in a part.
(15) Micro-organisms occuring in nature.
(16) Computer programme or algorithms (Protected by
copyright)
(17) A method of Book-keeping/ Accountancy.
(18) A method of management
(19) A discovery, scientific theory or mathematical
method.
(20) A literary, dramatic, Musical or artistic work or
any other aesthetic creation whatsoever
including · cinemato graphic works and television
Production
(2l) A presentation of information
18)
(22) A t opography of integrated c1rcu1ts
. .
(1) A . . .
n invention relating to atomic energy.
I A-
(II) TYPES OF PATENTS :
· ( 1)An: Ordinary patent ·( Independent Patent) t) for
,, (2) A patent of a,ddition (to some prior. patenhicbS
improvement in or modification of an invention for w
patent has already been applied for or granted.
'. ,r~-r .. -- Patent granted in ' -~~.&., ..::uus
· r· ld d respect "I 1.. 311
sPP licat1on 1e . . un er Sec.- 135 of the Ac 9f,,. a_' ' ,,~flpventidn
, , ,, -
1
o0 !1 app\Jcat1on
. . made in a con vent10n. t,, o/hich' i~•1 b a.~,
cou 1,i1 e\ 'c!
11
' o s11rne invent10n. The conventi on applicat'ntry in re spect , ,
J1Ifade within
• one year
• from the date o f the first
. ion has . to be
J1I ade n a convent10n country in resp ec t of that·1application
An1 inventor has to take separate patent m . each ,n v_e ntion. '
,,uotfl' in .which . he intends
. .to protect his mventwn
. s'.'parate
T0
facilitate this, vanous mternat10nal arrange ment have been
·
forrned . These are :
(al Paris Convention of 1883 - P.C.
(bl Patent Co-operation Treaty - PCT (IDclud_e 119)
i
(c) &uropean Patent Convention _ EPC countnes)

(dl Community Patent Convention

The above (al and (b) (P.C. and PCT) have been signed
by India, the convention is supervised by the World
Intellectual Property Organisation (WIPO) at Geneva. PCT
has a world-wide character and is administered by WIPO.
The PC for the protection of property contains the rules for
protecting an invention internationally. An important
prosrn10n of which is the NATIONAL TREATM&NT

PRINCIPLE.
The PCT does not provide for the grant of
"International Patents". This says that in all member
states, national applicants and applicants from other Paris
Union member states have the same rights.
The advantage is one can file an application initially in
a given member country (receiving office) and designate
other countries where the applicant wants to protect the

invention.
ln India the competent receiving office is Indian Patent
Office, Calcutta. The receiving office through the
International Searching Authority carries out the search
(for prior art) and sends the results to the individual patent
o 1ce
. of. the designat
, ed countnes.
. Another important
, point
,
5
isff tne r~ght of pnority , which means that the date of an
app\icauon m one member state is taken into account
 Pharmaceutical Jur·
318 lSpl'lt
. 11 member states, if the subsequent applicatio
m a . .
filed w1 thin 12
months from t h e f'1rs t r·11mg.
· l-
Benefits of PCT :
* Single filing procedure for all countries.
* Sufficient time for translations
Drafted in ~ccordance to PCT is valid every h
* . w~
* Flexibility of payment of fees
* Advanta.ge of maximum designation fee
* Transmitted of priority need not be monitored
* Provision of wilhdraw~ls .
Pr6visi9n of A~en4ments
*
EPC is a ~egional 'a rp:1ngemen t of European Countries
Both . search and . supstantiy,e examination are centralised:
Again, the appl/c~nt · h~~ , t0 designate the particular
European Countries he · is . interested. Although an
European Patent ', is . granted by EPO with designated
countries, subseque·n t enfor;cement and administration are
handled by the courts of the individual European member
1, I 1,

countries.
(4) World Patent : There' is no institution which may
grant a patent yalid through out the world. European
patent office can . grant patents valid in 9 countries. PCT
facilitate the procedure to s'e ek protection internationally.
' "
 cruelty to Animal Act-1960 1998
iJ Of , ' 397
~tl 0
JSJ.ft
ltudonal Animal Ethics comm·tt
, . . .
1
ee \IAEC\ .
PREVENTION 0 tl'/,161 s l:l
1,oa. y compnsmg of a grou Of
"'' · d P persons •
ANIMAL AC .Aee.!l
l'' d !..d ~reg1stere by the comm1'tt
l:l.. ee f or the
riise f control and supervision of experime t
11.1. OBJECTS:
'
l o~ e o rfotned m
rP 05 pe
· •
.
n s on
an establishment wh' h .
ic is
\,t.
nil
itil"~is ed .,,d operated m accordance with procedures
Modern medical and pharmaceuticals . r l:l»
· c1enc tit\Jt tbe purpose by the committee
are_ "','idely_use~ to per~orm :xperiments to stuct es, anitttai~ tis fof . ·
t~x1c1ty ahd therapeutic efficacy of drugs as t / th e Safety c-0 cified sioNS OF THE ACT : ·
similar to hu_man systems. ey are much
l ,. f'ftoVI entatton
, . on , animals
. . carried out 'in
1s d' 1
•·"' ri:trl . . . me 1ca ,
Animals may be subjected to injury pa· i"Pe .cal and biological science.
, in or s a,cetltl ,
and even death. Uffering p~1:1!rfl 1iartllaceutical I_ndustries animals are used for the
IJ'.1 fl of era, vaccmes, Hormones and Enzymes.
The Act prevent the infliction of unneces 5
sary Pai
suffering on animals. Act prevent the man from b n or nro dtlct10 tbe esthettc . . t f view
pom o . the procedure 0
· . ehavi ng r ao~
rt' 1iould be so .
effective n
that animal do not suffer
cruelty toward ammal.
als s . . . .
11.2. DEFINITIONS : a!lifll . ble pain or tnJUrtes.
a!IY avo1da.,,,rnent constit1:1te
. .
a committee which look after
(1) Animals : It include any living creature • Gover••
. and i control
, the use of animals for,
. . 1.e. all
species of Ammals (except human bemg) as well as spe . sUP erV1se
. ntation whereby. they are saved and sufferance of
- cies
of Birds.
eicpefl~e .
(2) Cruelty Roughly it means 1·nn·1c t·ion f . ble pains. I , ·
vo1da.
0 a ~nixnal Welfare ~oard of India
unnecessary pain or suffering.
gstablishe_1 .bY ,: ~ntrai government
(3) Breeder : Means a person including an inst1tufion,
which breeds animals for the purpose of transfer to other ,unctioJlS : ' " , ,,·
authorised institution for performing experiments. • To promote animal welfare
To protect ,}f·ni~~s from ~.mnecessary pain or ·
(4) Establishment : Means any individual, company
firms, corporation, institution other then schools upto · ,suffering . ill 11 1 •,J· , , ,
higher secondary level, which performs experiments on , To Advise the central government regarding the
animals. , amend,m ents ,,, 1 , 1 :,t.
(5) Experiment : Means any programme/project • To a,dvise gov~;r:~~~nt on making rules
involving use of an animal for the acquisition of knowledge • To suggest,· the goverinment any improvement in the
of a biological, psychological, ethological, physical or cldesign ·o f tv'ehicle,', so , as to lessen the · ,burden on
chemical nature, and includes the use of animal in the draught"'animals u 1 \.: .1 i .i_,
. ' .
production of reagents and product such as antigens and • To take u~ the steps For amelioration of animals by
antibodies routine diagnostics, testing activity and pro:viding•,facilitiesi,ofl shed, water troughs etc.
establishment of transgenic stocks, for the purpose of saving I To·I co-operate with th'e Association established to
or prolonging life or alleviating suffering or for combating prevent unne~essary of pain ,
1
'
any disease whether on human beings or animals.
398 Pharmaceutic
CONSTITUTION OF COMMITTEE :
(1) Two members of Indian council of
Research (ICMR) are nominated by
Government.
(2) Two members of Indian council of A .
Research (ICAR) are nominated bygrtc'Ult\l
C re
Government. entra1
(3) Two members of scientific and Ind .
. Ustna\
Research are nom1anted by Central Govern
ment.
(4) Two members representing universities gr .
anting
medical and veterinary degree, nominated by
Central Government.
(5) One member of the lok-sabha elected by the
house.
(6) One member of the Rajya-sabha elected by the
house.
(7) Five non-official persons actively engaged in the
promotion of animal welfare, nominated by the
Central Government.
Committee is authorised to make rules.
 doll of Cruelty to Animal Act-1 960 401
o,e\'e~ , 1998
1/. sREEDING OF ANIMALS :
1JJ
J) •4.I'
~,estabhs
. fh ment. shall carry on th e business. of
1
0
breeding o animals . . or trade of animals
. for the
purpose of experiments unless it is registered.
/21 gver)' breeeder
• •/ establishment carrying on t, he b usmess
.
.
of breeding .
animals or trade of animals for th e purpose
of expenments shall, apply for registration within sixty
Of days from the date of commencement of these rules and
stop breeding of animals if registration is subsequentl'
. b h . y
I refused to 1t y t e committee.
The application for registration by breeder under sub-
(3) rule (b) of rule-_
3 and an establishment under sub-rule

I (b) of rule-4 shall be made in the specified format to

the :Member-Secretary or any other officier
authorised in this regard by the committee.
(4) The member - secretary or the authorised officer of
the committee may for deciding the issue of
registration, ask for information relating to -
* Premises where experiment are to be conducted
* Animal housing facilities
*

I
Details of breeding of animals and its trade
* Other infrastructure
* Availability of trained man power.
A breeder or the establishment on registration for the
(5) purpose of performing experiments on animals shall
comply with conditions as may be specified, at the
time of registration, by the Member Secretary of the

Committee.
(6) The animals shall be stocked by the breeder and the
establishment in the following manner :-
{a) Animal houses shall be located in a quiet atmosphere
undistrurbed by traffic and the premises kept tidy,
hygienic and the animals protected from drought and
extremes of weather.
(bl Animal cages for small animals and stables for large
animals shall be such that animals can live in comfort
-.. and overcrowding is avoided.
402 Pharmaceutical J
Urisprud
(c) Where standards have been laid down
. .. th y the I
Standards Institution, e cages, the stable nct ian
case may be, shall conforms to those stand ards.
' as the
d) Animals attendants must
. be suitably t rained
.
(
experienced in the duties allotted to them. anct
(e) Animals shall be looked after, before and
. after th
experiments by a tramed and experienced att e
. enctant
(f) There shall be satisfactory arrangement £or look' ·
after the animals during off house and on hol 1'days,ing
(7) A breeder shall not transfer
. any animal bY sale
otherwise to an establishment which is not reg· t or
. . is erect
(8) No ammal shall be imported by a breeder or ·
establishment which is available in the country. an
(9) A breeder/ establishment shall comply with t
directions given by the committee. he
11.5. RECORDS :
(1) Every establishment/Institutional Animals Ethic
Committee shall maintain a record of the animal:
under its control and custody in the specified format.
(2) Every establishment/Institutional Animals Ethics
Committee shall furnish such information, as the
committee may, from time to time require in the
specified format.
(3) All laboratories shall inform the exact number/ species of
animals to the Member Secretary OR any officer
authorised in this regard in the specified format.
,< - ,rflE DRUGS (PRlCE CONTROL
ORDER - 1987, 1995, ) -1
.
I
1 oPVC'fJON :
2013

~fJt _1 r was made under Section f

l
J• 1,;s
orueAct 195 5 . Th e fi1rst Act Perta3· .o esse ntial
, 1 ·es ' . inin g to pr·
ditl d as "Drug Pnce" (Display and C ice
11110
tcJ111e then amen d e d as follow : on trol) order
1966'
/ 1
. 1(0
1
_,1 •0 ifl price control order (DPCO) is a . .
. 1,;~ dJ1.lg . n order issued
, · ffle ent under the Essential Cornrn d 't•
vernrn . o 1 ies Act Which
1ego f].)C the pnces of some essential b. lk
n1,U 5 I·t to . s u drugs and
, ,bJe .,,,1..1lattor . · t
1I" fw !• 1· f .
e ·r fa ' National 1st o essentionl rnedi' . ·
Ji ir,1: .l I · r· : '1 '\ ' , 'l,.1 rr _Clnes_,
I ~ ,-ff .. N.~tic;n;ial ph~q na~eut,i,c~,l~, p~iping, pl olic-'y ,, ' ,, '
l'J ' 1(.. l l l _,/ / ) . r

rl1' · '·.: , Nati0nal -phannae2eutic.als •;ttr 1·,...;,....,g 7"'"'th ' . ··

. .' . .•· P . u-a..i, OJ:ilt y.
·. .n '-l
ril'l'" . g :(P,fice,lControl) !@rd:e11, Q19f7 0 :,:h: .(, , ,_ ·.
1J
,QJU • . . . , 1 ,1T. ,,''.Yln\c.

# I g· rl\pfit:ef C-ontrdI) ,(frdh, ri9V-8 !( , -, ,1 ,,;:,1·1·-- . • . •,

·i., 0ru 1 -- ·· • .. , "j: n
1 orug (Price Co~tro_l) _or~; r a~~ -~:1-1,g policy'fg?gi w: 1-, ;
1
' •,1
- vrJg"(Pric~tc
n'
.... n' i-,1Hfrpf(?1-uh ~na-afJJ~olify)(i cJs5U·1)987
, r; n,,, l !.C\ ,; 1:, '· •tj·,1,., . , .
# I .,,r: ,_. ' .(Price _:c;:onJ::rol) grder i 9Q 1'. . )J . '. 1
''. 1.· :
I ',;( ''..C:
.# oru. g_ ·r,r:: : J .Jr, ,Ji: l ,J ' ),J , , f,fc:,' 1·,,,,.,·1 ·· ..
j . ,-.,•-, ; .

~· o·~ii W
rJif fr~tr H,9r5\~~i~-m;\flrµ~P?Jii)gifa,
If·"• IJ ' . ,._ '. • I ... ti. ),- : ' ,.., ::::- l
0
11
11
' • '' ~101P,P/NLE
.1M : 2:,_;:- c,;.,-;t ,,, -, - } ,-l - - '· ·-
!'i _ -u ; .lf:.!:d,..l .t·~-~~; i" ·:1 ).
·1 # ;(! _,.. {,) ."'\ .,,\,":·, · - . ,.,,o,,"·, , ,
. r'•·1 1NPRAF
' '
20.1z,s,,
'.
!., ' I .r ·.'L, ' -. r•_.!; ,Jr. rn ,r_.' ·,ol J r;•,,,
.,
,·,·,,, '•,-
. ' '••2
•\''' ''' PC0. '2·(1). :k,-3·;r.. ..,r. ,.,.
I'
'" ' ,c.,r, .. , .. : ·, . . ·1 ·· r
I.
(D ' - .' ,, ,, ' . , ,_; ._,. ·. ,, ,c,-,.,",:· .''i -c
. .., ~. I '· • ~- ' ' • ''--• J. \ .I

:;:,; N'LEM12df s'. : ,J.1(; ·1, ;r_j__, . :) 1lh -, - ;-:: ;" ,; :·, :.

''' * 2 16 '_"''i'\ ;· · ' •~ 'Y; :::'.-;

* NPPA~ .; --! · :, /·: ! ,r-;; :i ; .:-: _·,~::;,'.'':.i ,It. .,... ,
1 ;:1 c.. U~I,i": ·1r --,.. ·-,
\(.:;
,72,. o
··)s
·' 'JECTS ,:
1- - rn<'. JJ ' !G .·.
--, .. 1.,· , .. : . .. •. .
,..,c. _ ·• i,J; ., .- , .... ,.
·- . . • , "
',.: . . ' -_, :',h ",Jc
1 1
;1,-T·0· en' sure equitable d1stn\)1Jt10~_. 9f~~~~PJt~1. • hµ:U~,dr•qg$.,-,; i
[I . ..
To fix ;the. '.m ~iml,lµi retaj:l; ptj:ce&. o( . d:ru:g.•·fot mulatjons
' O'" -~ -

[Z). rL · k fit · d · · ·-
in order to chec pro 1 eenng ten enc1es a,ncl:tens:ure ,
. availability, at •ireaso11able prices-' of .e~sentiat . aqd ,. life
'. ,sa,yi~g ~d prophylac;tic medicines .of -good quality. _. _
131 . To exercise ,government control over the , price of bulk .
drugs and drug formulations.
 . I

. 1
(

in Aug. 1997.
For the' 'pur pose 6f eriqui?y':! ·details' i~ _'. 'tbrrri' 1·: 1· and
additional details ' furnish~d by'
~anufachirer''fwic·ej a!yei:f. ; '
 ~ f-l

252 Pharmaceutic
a1 J,. .
In fixing price of a bu Ik drug gov "?'ls
lltti a
ern1n '{
following things : "•ent
Col"\
A post tax return of 14% on net
* production is from basic stage) OR "-'()rth
A return of 22% on capital e
* . Tnp\oy d
production is from basic stage) OR e (~fi'r.
Internal rate return of 12% based
* on I0 ng
marginal costing. for a new plants.
Manufacturer may exercise any option .
Once the option for the return is e .
manufacturer, it shall be final and for any chaXercisect
'. by
nge in h
of return _prior approval of the government shall b l e till
e neces
No person can sell a bulk drug at a price h h sat)
. . ig er th-
one fixed for it. Plus local taxes 1f any. "t\ Q

After this order if any manufacturer .

· ·
manufacture bulk drug. 01:' ,ex1stmg manufactur \VJshe
. s
. er \V1sh
manufacture addihonal bulk-drug, they have to . es
necessary detru··1 s· w1'th·m 15 d ays of t h e com me give ·'
. . , . . nceinent
production so goyernment can notify its price.
Any i;nanufacturer,' who desires revision of the .
rnax1rnu
sale price of a bulk drug fixed, shall make an appli' .
· . . cation
the government m form-1, ·after makmg enquiry gov
, , ernrn(
fix a revised price (within 4 months) .
No manufactµrer
,, or distributor can refuse sale of a w
,
(bu~k) to any.dealer.
The governn;ient can direct any manufacturer of b
drug to sell the_same to formulators.
II. RETAIL PRICES OF FORMULATIONS :
After NPPA was establjshed, in Aug. 1997 the price,
665 formulation packs have been fixed/ revised. In the cas,
302 packs, prices were reduced. In the case of 269 pa1
prices were increased and prices remain ed unchanged
24 formulation packs.
The retail price (R.P.) of
the formu laton shall
calculated in accordance with the following fo rmula :
 . e Control) Order-1987, 1995 ' 2013
(PflC
253

,orvgs[ M- C·+C.C.+P.M.+P.c. ] X [ 1+ M.
100
U.l + ED
~_p. -:- (As per order 1979)
+ P.C. = Ex-Factory Cost
c. + C.c. + P.M.
/M·
p.
0
[r,1.c.+C.C.+P.M.+P.C.
l[
'
MAPE]
I+ IOO + ED

I<· i (As per order 1987)

Ex-factory Cost (As per order 1995)

w11ere
== Retail Price
j<.P.
fv1.C.
== Material Cost (drugs + pharmaceutical
aids + averages + process loss)
= Conversion Cost
c.C.
p.M.
Packing Material Cost
p.C.
= Packing Charges ·
M.lJ. == Mark Up
M.A.P.E. Maximum Allowable Post - Manufactur-
ing Expenses. (Cost of ex-factory to
retailling + Trade Margin)
E.D. Excise duty
Post Manufacturing All cost incurred by a manufac-
Expenses turer from the stage of ex-factory
(MAPE Includes) cost to retailing and include trade
margin.