► - I ( j t I

PHARMACY LAW
AND ETHICS
- - - -- ~----
Pharmaceutica l Legislation in India
J POINTS TO BF RFM EMBr R
• Drugs Enquir Y comm1ttee
. (DEC) was constituted unde r the
chairmanship of Col R. N. Chopra (Col Ram Nath Chopra) and also
1
known as Chopra committee.
• Prof. Mahadev Lal Schroff is the Father of Indian Pharmacy.
th
col. Ram
• Praffula Chandra Ray along with Ka rtik Chandra Bose established aN• Chopra

Benga l Chemical and Pharmaceutical Works at Cak:utla in 1901. I

• Mr. Bathgate established Chemist Shop in Calcutta in 1811.
• Prof. T.K Gajjar established small factory at Pare! (Bombay) in 1901 ~
and Alembic Che mical wo rks, Baroda in 1901. Prof,M. L.

:J T\Pf<.S Of COI\JMl] l l;.l:.S Schroff

COMMITTEES

MUDALIAR HATHI
BHORE BHATIA COMMlTTEE
COMMITI'EE COMMITIEE
COMMITTEE
• CHAIRMANSHIP

a
CHAIRMANSHIP
CHAIRMANSHIP

S1r Joseph Major General

~
Dr. A. Lakshman )aisukblal
S. L. Bhatia swamy Mudaliar Hatbl
William Bhore

June 1959 In 1953 8th Feb.1974

0ct.1943
Health Survey Pharmaceutical D,.!!!Sand
Health Survey &
and Planning ~nquiry Pharmaceutical
Development
Committee by Committee by Industry by
Committee by
Govt of India Govt of India Govt of India
Govt. of India
-- -- --- ~ .:.:...:~.:::=~ = GPAT DISCUSSION Cl~NTER : MAl(ES Si!T~
UD~Y
~E~A~S ~Y - - - - - - ----......
-,
.
Research Institu Th81·r Location
te and
LABORATORY/ INSTITUTES/ ORGANISATION AND
PLACE
THEIR TESTING SAMPLE
Ghazi ur, Neem uc
h Insti tute of
Cbenna i BCG Vaccines Labo rato •·
• Cent ral Drug Labo rator y (COL) ---- .
Kolkata . . · r moR
• Serolog1st and Chemical Exam me l ~ L a ntige n)
• Food and Dru s Toxicolo Rese arch Cent re
• Cent ral Drug Rese arch Instit ute (CORI) ..,,,
Luck now
• Indu stria l Toxicolo ical Rese arch Cent re
Cent ral Rese arch Insti tute (Sera , solu tions of se rum
proteins
Kasa uli _ c.P1 for injec tion, vaccines, to~in s, antig ens, antit oxin
s, steri lized
sur ical ligat ure and sutu res and bact er io ha es
lzat naga r or Vete rinar y Rese arch Insti tute (Ant isera , Vacc ines
, Toxoids,
Muk tesh war and Diag nost ic antig ens, all for vete rinar y use)
Ghaz iaba d • Cent ral Pha r maco poei a Labo rator y (Sa mple s
of Con d o~s)
• India n Socie ty of Blood Tran sfu sion & Imm unol
ogy -
Pu ne • Nati onal Insti tute of Virology ..,/
• Na tiona l AIDS Rese arch Insti tute ✓
Mu mba i Ente rovi rus Res~ a rch Cent re, H~ e lnsti t!1te
com poun d

Than e Cent ral Drugs Testi ng Labo rator y (lfl!r a-Uterin e

Devices a nd
Falo e
• Natio na l Insti t ute of Comm unic able Dise ases
( NICO ) (For
New Delhi Polio Vacci ne)
• India n Coun cil of Med ica l Rese a rch
• Cent ral Heal th Ed ucat ion Bure au
Jai ur Natio nal A urve dic Insti tute
Gene va Worl d Heal th Orga niza tio n
Head uart er
Kolk ata Pa tent Office
Head uart er
Na ur Pate nt Info rmat ion Cent re
Nold a Na tiona l Insti tute of Biolo icals
Coon oor ' Past eur Insti tute of India Oral Polio m elitis /
Nat iona l Cent re for Biological Scien ces (NCBS) ../
Bangalore
Nati onal Insti tute of Unan i M edi cines ✓
Jai ur Na tiona l Insti tute of A rved a -./

l,p■ I ()1,, lh\,uu l n,hr P,1 1 , I \ "' 11 a:d,h,t lurR ,.. • .,. rd
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I \flW. litt Ortl l'l.M)kJ " ' · , , ,m k 1,tJIU
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"w tl\t&\I
 TIIEORY PIIARMA S
CIST EXAMATYOUR FINGERTIPS : PHARMACY LAW AND ETHIC

l Passing Vear of Different Acts 7

YEAR
LIST OF ACT & RULES

1919 Poiso n act -19 Se t 1919

1930 Da erous Dru Act-1 930
19 4
~ ~ ;:;"c0,~D=ru~&
'- _ __!,',. ~~.;~
~ ,g ~·-11.:..
:=-.::C~o:-=sm~et~ic~s'..!A~c~t-~1~94~0~D~&~C~a~ct-~--'~ ---1. ~~ 1::." C/ J o)
1945 Dru and Cosmetics Rules -1945
1947 Indus trial Dis utes Act
• Pharm acy Act-1 948 (4/M arch/ 1948 ) .
ry Act-1 948 --·
1948 • Facto
• Minim um Wage sAct-1948 ,
• Sho & Estab lishm ent Act-1948
1951 Indus tries Develo ment and Re lation Act
1954 Dru & Ma ic Reme dies Act-1954 Passe d in t5t A ril 1955 ✓
Came into
• Medicinal & Toilet Prepa ration Act-1955 (Passed- 1956,
1955 force d in _1st April 1957)
• Essen tial Commodities Act-1955
1956 Universi Grant s Commission Act and Rules
1957 Co ri ht Act and Dan erous Dru Rules
1958 Trade & Merc handi se Mark Act
1960 Preve ntion of Cruel to Animal Act
1968 Insec ticide s Act
1970 Paten t Act "'
• Medical Term inatio n of Pregn ancy Act-1971 (Rules -1975 )
1971
• Insec ticide s Rules -1971
1984 Hatch Waxman Act
1985 Narcotic Dru ic Subst ances Act I i~ t ',
1987 AICTE Act
2000 Act came into force -11 Ma 2001
2001
2002 National Pharm aceut ical Poli
th 2003
2003 Paten t Rules Came into force 20 Ma
2012 National Pharm aceut icals Pricio Poli
I
Old DPCO Act - 1995
2013 Dru Price Control Order DPCO -2013,
2016 Biomedical Waste Mana emen t Rules
2019 Cons umer Prote ction Act
 , . , ,. . KF$s-ruov 1•:~sv - - - - ~ - - --
-~ ,
jfferent Acts
GrAf lllSCUSSION o .rm.H . .,, .

Section, and Chapter• of D

_ -==---===-- -__,

38
6
ks Subs ta nces Act 83
Dr . 16
On ol Orde r 32
Medi cal Term inati on of Pre nanc Act 8
Medicinal & Toile t Pre 143 9
Pate nt Act 163 23
Fact ories Act 120 11
Trad e and Merc hand ise Act 136 11
Indu strie s Act 31 6
Medical Term inati on Pre nanc Act 8
Inse ctici de Act 38
Mini mum Wa es Act 31

/ Pharmacy Ac t J
::J IMPORTANT OATES AND POINTS
• Pharmacy Act passed in 1948 .
• Came into force in 4 th March 1948 .
• Ame ndm ent-1 976, 1959 and 1981 .
• Objective is to regulates the practice of pharmacy
in India and regu latio n of the
Pharmacy Education fo r the purpose of registratio
n as a phar macist.
• Central council - PC! constitutes under section 3.
• Central regi ster - Regi stere d of phar mac ist
maintained by central council under
section 15A.
□ FUNCTIONS AND DUTIES
• To presc ribe minimum standard of educ ation
• Framing of Education Regu lations
• To ensure uniform implementation of the education
al standards
• To appr ove the course of study and examination for
pharmacists
• To approve qualifications granted outside the territ
ories i.e., the approval of foreign
qualification.
• To approve the course of study and exam ination for
phar maci sts.

t .p.. r u,,
u ~ ( to l, 1 J'\ I l hi. \ -~1-'1
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► -- -- -- -- -- -- --·-
Tlmon v l'I IAltMA( 'l'""I' 'X '
f'I , ,. AMA:l'VOIJltli'IN<mtn'IPS : PIIAl{M
A( 'VI .AWAND •:nucs
. - -- -
-

• l n~qw,·110 11 ol Pl , , under th e Pharm acy Act to

1.,, 111:1ry f 11 slilul lo11H s1•eklt1U aprrov al
v1·rl l y ·1v·1lbl1lllt Y nl I lw pr<-snlh od norn1H.
,, · · .
• l o wi thdraw If) 1I, , 1 1. course of study or an approv ed examin ation
~ · I ov.i , I lh c ::ip provcd
'll 'll not rnniln 1· lo he In rn nlorin lly wi th 1hc oduca lional
11 st.anuards prescribed by
l lw PCI .

..J flJAl<M \I' I f)IIN( II 01 fNl>IJ\ (P< IJ

• PC:I (Cctllra l Cou nci l of' JmU.i) Is constllutcd by Cen tral government.
• l1frlll c,·nl} ,II C'Ounrll was c:o nsllLutcd In l 'J 1'J -

. .. ~ ••• 011\tllulc•rl Ill c.:_v1·ty r;J'.(',11'\ , -

• period not exceed ing 5 years.

1lok.l office fo r ;,i

).
• Dr. Montu M. Patel Is the presid ent of PCI (6'" Apnl 2022 he has elected
• Prof. (Dr.) l'ranao<I Yc•olc Is Vice-Pre~idcnt of PCI.
NOTE: • Prc1,idc11t and Vice-Pr esiden t of PCI will change in future. So,
go throug h Goo~.

MEMBERS OF PHARMACY COUNCIL OF INDIA

MEMB1ms1~ NO. OF Ml·.MBl:HS QUALIFICATION
At least one teacher each in pharm ace utical
(, chemistry, pharmacology and pharmacognosy on the
Elected
teachin g staff and members are elected by the UGC
memb ers
1 Elected by the MCI from amongst its membe rs
(8)
I,
Registered pharmacist to represe nt each state
1
elected by state council from amongst its membe r.
At least 4 studen ts possess ing degree or diploma in
6
pharma ( y nom inated bv the central government.
Nominated
z One from UGC & one fro m AICTE.
members One rcgi!>tered pha rmacis t fro m each State
(9) J nom ina ted by th e State Govt /Union Territory
Admini stration.
Ex-offi cio (i) Directo r Genera l of Health Service s (~GHS)
members 3 (ii) Directo r of Centra l Drug Laboratory.
(3) (i ii) Drug Controller of India.

❖ Role of Centra l Counci l

• Education regubtion
• The equipm ent & facilitie s to be provid ed for studen t.
• Approv al to the course of study & examin ation
• Withdrawal of approval
l & if
• Central Council shall appoin t registr.1r who shall act a~ secreta ry to the counci
need as i~ treasure mo.
& other
• Central council constilllte executive committee consist president and vice president
5 memb er elected by central council from among its membe r.
• nu~s are made by central govern ment and regulation by state govern ment
 GPAT DIS<1.l S..liJION CENTER: MAI< ~ 5"f1J0V EASY - ~-----,iii-ai,- pr,f]r,r■
w LOUL \rlON Rlt.UL ,\I lON Cl Hl l'IS'J
• Erluc~lion rcRula tion tor O. Ph ann Course have bee n framed by PCI. JIil:.
val of T
• PCl also make s regul::\ti on calle d Nluca tion rcgL,J;ttlon with appro ■\Ji.hi ,H■
'"""'"·•

•
1972
C~ntrnl ~lW~rnnwnt.
• Minim um Qualltlco tlon a perso n who has ,1tt,1ln th e age 18 year.
fh1rd t.11
❖ P~rio ~ of study oml of 1>mctl cal trotnlnn
ths '198 1
• Not k!ss than 500 hours sprea d over a period of nol a::,,, 5·s than three mo_!). -
. .
• Not less than 2 50 ho urs arc devoted to actu al dis pensin g of
presc n pti o~s ~
in a recog nised hospital/ dispensary or Ph arm acy/ Chemi St a nd
or licensed drug manufacturin g uni t)
Orugg iS
t
i
L'S ■
.J 1.. l \ l R..\l RH~\~ U.R Ol· l'llt\RMAU ~ l'~
2020
• Central Council (PCI) is tn maintain a register of pharmaciSIS
known
as the Central Register.
• Regis ter conta ins the name s of all persons fo r the time being
entered in th e regi sters
of different states .
'3 Each State Counc il is required to supply five copies of its register
to the Central Council
as s~on as after the ~April every year.
• Central Register is a compilation of all State registers.
Q STATE PHARMACY COUNCIL
• State Pharmacy Council and Joint State Council are also
const ituted by the Statt:
Government.
• Two or more states may also agree that the state council
• Duration of each council - 5 years ✓
• The state council may appoint a registrai: - Secretary and also as
Jreasurer.
STATE COUNCIL I JOINT STATE COUNCIL
~
Elected member
_, .I

• 6 Registe red pliarmacists amongst • 3-5 ➔ Regist ered pharmacist

themselves.
• 1 member elected by the MCl of each
• 1 member elected by MCl of the state . state from amon gst its memb ers.
Nominated members
• r:- memb ers at least 3 are possessi ng a • 2 -4 memb ers nominated by each state of
degree and di ploma in Pharmacy/ whom more than half shall possess ing a
Pharmaceutical Chemistry / Registered degre e and diploma in Pharmacy/
pharmacist, nomin ated by state Pharm ace utical Chemistry / Regist ered
govern ment. pharm acist.
Ex-officio members
• Chief Admi nistrative Medic al Officer of • Chi ef administrative medical offi cer of
the State. each of the participating state.
/
• Office r-in -charg e of D and C Act,1940. • Office r in charg e of drug contro l
• Govt . Analy st under the drug and organizati on of each participatin g state.
cosmetic Act as state govt. may appoint • Govt. analys t of each participating state.
in this behalf.
( ptt Ohtu \JOI! ( rnltr ,., ~
1 I ti "'"" ii:Jd i,

I
o,·, l ,\,, i1ld1 1h,1cu,1.111 i,:Llqq ,tu iJ~nu1l.cn m
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l Mt>t.il~l , , -1 ,.
f-; ~77ff"' h41MW
u1trn i.l
1
l '\ IKHU Pl"" '\ \ ~1 111'. IJI l Ill (. II \ /1 \8\IJ 111 1\
l1 \ " \\\ \ R 1BR'\lt\l \VI H \II \llh l
 •
►
- _ THll'.O~ ~ PIIARM A( 'IH'rli:XAMAT YOl flt trtN( a,:tnll'l'l : t•IIAltMM 'YI .AW/\ Nl> lf.'1111( '!"

U IU:.<il\ I HJ\ I H)N 01· PIIAHMJ\< ,I\ I.,

• Rcgl Sln1tlo11 of philrmaclsL'i to 1'CRU~1lf• llw cuu·y of por~mns ht thl1 pn>fCH"lou.
• Names of the reKl stc rc d pharniuclNto.. an: 1•11wrod In th !! rtigl 11 lNHrnoln lilln<'d by 1111'
State Councll'l .md the Ccn trn l C:ound L
• St\lt' c;owrnnll'nt arc rcsponslhk! for I lw prcparn l Ion of' t lw ttr~t H•1tl ~t<•rs
• Subsequent register appoi nted hy Stile Govcrnmcnl
• Minimum age presc ri lw d fo r n•glstralion ol' pharmacist 111 India I~ 18 ycan..
.J OH I NW..\ .M{D l ' I I\J II I L\

s.No. I Ol-'1-'ENCES I l'EN/\1:rrns

Pa lsely claiming to be rer,lstcrcu 1~, couvlcllou - I<,, 500/ •
1.
phtirmacist 211 11 cor,vktion • Rs 1000~ Mc,11 t l1•, r11 hot h _
Dispensing by unregistered
'J. . Rs 1000/ 6 Months or both
per~on
Pa ilure to surrender ccrti flcate
-
3. Rs 50/ -
of regis tration ~

Wllfully obstruction an inspecwr

4. Rs 1000/ 6 Months or both
in the exercise of his nowcr

All India Council for Technical

Education (AICTE) Act
..J r.QLN'l S TO BE BEMI t-WLI{

• Ac I p,1ssell 111 I 1JH 7

• Ca me lntn force In 12 1" May 1988.
• AICTE established by Central Govcrn mc nl
• Headquarter - Delhi.
._I J\IC Ir M~MBl•. H\
• Chairman and Vice chairma n appointed by the Centra l Governmen t.
• One member - Ministry of Finance Lo be appointed hy th e Central Government
One mcmher - Mini stry of Sci en ce and Tec hnology, to he appo lntcu hy the ( c ntra l
Governme nt
• Four members - Ministries and Departm ents other th an those specified above , to he
appointed by the Ce ntra l Government
• Two members of Parli ament of wh om one shall he ele cte d by th e llou sc of People
and one by th e Council of States
• Eight members - ~tes and th e Union Tc critori cs, on the recomm endation of th e
respective Governmen ts, to be appointed by the Ce ntra l Governm ent
• Four members · Orga nizations in th e ti elu of Indu stry and cum nicn:e, to hl' Jppointcd
by the Cen tral Governmen t

-
 MISBRANDED DRUGS
• If it is
. .
not labelled in the prescribed manner
d
d ·r ·t ·
is conceaIe or I I is
• If 1t 1s so coloured, coated, powdered or polished that amage
made appear of better or greater therapeutic value than it's really.
• If · h d g bears any statement,
its 1abel or container or anything accompanying t e ru . . c.
. . d or which 1s 1a1se or
design or deVJce which makes any false claim for the rug
misleadin in an

• lf it is imported under a name which belongs to another drug. .

• If 1·t 1s · • • of, or a substitute for, another d rug or resembles
· an 1m1tat1on · another drug m
a manner.
• If the label or the container bears the name of an individual or company pur porting
to be the manufacturer of the drug, w hich individual or company is fictitious.
• If it has been subst ituted wholly or in part by another drug or subS t ance.
• If it ur orts to be the roduct of a manufactu rer of whom it is not trul a roduct.

L.J SCHEDULES TO THE ACT AND THE RULES

• Drugs & Cosmeti cs Rues have been divided in to 18 parts.
• There are 2 schedules to the Act and 23 schedule to the Rules
❖ Schedules to the Act

First Names of books under Ayurved ic. Sicldha a nd Una ni Ti bbs sys te ms.
Schedule
Second Standard to be comp iled wit h by imported dr ugs a nd by drugs
Schedule man ufa ct u red for sale, stotk~d or exh ibited fo r sale o r dis trib uted.

❖ Schedules to the Rules

SCHEDULES SIGNIFICANCE
A l'ertorm,1 t J, \ 1 >lit t <
B R.1tt·, of It t for test or anal sis b the r r or sta te d ru s laboratories
Ft•<'s fo1 the tl ~t u1 .1 , 1, by the Pl1.i 1at0JW< 1a J. 1h01 1tory for
Indian Medicine PLIM or the Governme nt Anal st
C List of Hu lo 1 11. I , l di 1 (l t~ (i njecta ble);,-
ical dressin · aratio ns etc
List of other ~pet. - teral) '/
· drenaline, Fish liver oil etc
D Lis t of dru s exem ted from the rovision of 11n o-t ot dru ,
Jnform.1t10n .111d ur dcrl.il· 1g I equ r l to be ubm,uect hy tht.
m.mufactun r with the a lication form for a re istration certlftcate
Dz Information n:quired to be submitted ov the m .. 1ut ll II er with che
a pplication form for registration of a bulk drug/formufatfon/speclal
roduct for its im a rt into India

, . ~, I · f t n.t r r" ~ ..... " ._ ""'• tM,tt -' ◄ .,.

.\l I \t"O..uJ .iu ''" M t tlllfl \I R ,u•t ~ l \ll W. .. tt.,,l .,lJlJtLJ P\ ,. , ,...j 1, t t IJH I U 4./l \tHU l)lt AA , t:'l¥o..\ll t-i(AJ, -14.l"\. Ill \ll ~,1-u
► THEORY PffARMACISTEXAMATYOUR FINGERTIPS : PHARMAC Y LAW AND ETHICS ..:..:=--------
D3 Information and undertak inp required to be submitted by the
manufacturer or his authorise d importer /distribu tor / agent with the
application form for a registration certifica te
E, I ist of J , 11,onous ,uhst.mu , under ASU system of medicines. I' a I
I
F Part XII B Requ irement for the hm<u111 •· I I

h ml and / or for the pre paration of blood compone nt

Part XII CI Requirements for m.rnuflc 1 01 JI n l I I
Requirements for manufacture of loo I ducts fro
11
Part XII C 11
h Jlk tm1.shed I roo 1rt
Part XII D Requirements for collection , processing, testing, storage,
banking and release of umbilical cord blood derived stem
cells
Part XIII General
F1 . Part I A Production of b .. cterial \a( mes
Part I B Production of I al vaccines
I I,
Part 11 Production of ~ I -, r I 1 I • ..,
Manufacture and standardization of .., IOStl C ai l
Part III . I \
'"'
Part IV General
F, Standards of sui £,1C dressings
F1 Standards of sterilized 11 l I apes
FF Standards for o., 'lt
List of substances to be used under the edical suprn isi II and which are
G
to be labelled accordingly
List of drugs to be sold on the rrscr 1pt1on of an RMP/ l I t of
H
pr I I lI I I · ~

D1 C ,t S 'I d, 1
1
ll l which a drug may not purport to prevent or cure
J or make claims to prevent or cure
K Drugs • llllJ> c 1 from provisions related to 1 11Jll,1 • of irugs
Go< d I 1hor t ) I' l. and requirem ents of premises and
L1
Equipment's
M Requirements of n anufactunng premise~. GMP 1'lqu1 ·ements of factory
P' em' aL JI, 1 '·- ".nd equipme nt
Goo( l P LI' Ct l pr, ~tin' f H pr I I s~1,i111 . Is
Part I
Part IA Specific requirements for manufacture of sterile products,
parenteral preparations (small volume injectabl es and large
volume parenterals) and sterile ophthalmic prepa rations
Part 1B Specific requirements fo r manu fa cture of oral solid dosage
forms (Tablets and Capsules )
Part IC Specific requirements for manufacture of oral liquids
(Syrups, Elixirs, Emulsions and Suspensions)
Part ID Specific requirements for manufacture of topical products,
i.e., external preparations (Creams, Ointments, Pastes, Lotions
etc.)
' , t . 1 I
' - I

I ' '°' ._._ •hu w l ~ •• -' ~ 'f t J

p ) t t In ) I \ , ,1

OU HI l, ILV.J <\li\lJ BlllU '\" '-1\\\k Bll-'ll \-1\JJlN. \II \I B\I

\ I I \ lt \U\.U Ull \':tt'lR 81111 \ I k \lfllk l ._ llR lJ IIOP'\l 1l'l><>kl n,1 " \ '1111\.
 'S sTU DY li',ASY
•!t : MAK I'· ~'
<.;r,\T 01sn1ss10N <TNTlr
'· -
. -- - - . f etered•dose• -
Part IE Speci11c requirements for ma nufact ure o m
tnhnlcrs tJ\!DU __ - pla nt a nd mater ials for
- - -
Part IF Specl Oc requ ire me nts o f P remaccu
mlses,
tlcal Ingredients (Bu Ik
m111111focturc or l\cllve Phar
- -- I dr~ I 111
Part - II ol pl 1111 lfll 1_!!1111111H
- - - -
----Requirement--s for- - t tpHI 1•111 111
- - - -
fa ctory premi ses, etc.
for til e manufacture of
M1
lhutn•o,,.,th H ,hug, __ - • of tosme t1t~
M, .
Reu\li remen ts for facto ry pre mises f th e 111,n1 u 1,1t 1u 11
or t:-u
Requt reme11ts for facto ry pre mises . ~ the 111,111 u , turc· of rncdi
M3 or
dt'\ tn•,
N List of ma nu facture 1•,1u11rnw11t lot thl' t•IIH H•nt I unnrn g of cJ ph,11 rnacy
0 Stand ard for di,inl t-d,m t 11111th . d bite fluids
Part I Provis ion ap plicable to bla ck fluids an w .
Part II Provis ions applic. h d'sinf ectan t fluids
able to ot e r •
p I Ill' 11,•no d of drugs
P, P.1c k ,11.Ps of drugs
Pa rt I List of dvt , colou rs and pigme nt~ permi tted in ~l!l~l li'.s
Q and soaps ~
Part II List of ml mrs pcrmi ttc d to be used in ,soaps_
Stand ards for condo ms made of rubbe r latex intend ed and other
R
mecha nical contra ceptives
R, Stand ards for medil ti d 1•vaccs
s Stand ards for cosmc:t1cs
T l.MP for Ayurvedic, Siddha and Unani medic ines
PART I Good Mauu f 1<. ur I it Pr 1ct c s
PART II A List of m.1lhi nc ry, ·qui1 [Pl t nd J 11 I '
111<1nutactunng premi ses requir ed for Ayurv edic, Siddh a
system of medic ines
PART II B List of madrn rv, tquip m •nt and m 11i111 1m manuf acturi ng
p remise s requir ed for Unani system of medic ines
PART II C List of equipm ent for in hou-, qu. lifv rm ti ,11 sectio n
PART II D Su ppll'nH.'n t,iry guidc lim•s for manuf acturi ng ol
Rasau shadh ies or Rasam arunth ukal and Kusht
aj at of ASU
System of Medicines
u Ma intena nce of manuf acturi ng and a nalytical 1 t rnrcl,; of <l • u1-.,
Maint enanc e of manuf acturin g, raw material and a nalyti cal
U1 1 t•rord s ol
(.()~ flll tlCS
V Stand ards for paten l ,rnd prn1J1·1t."taq· medic ines
w List of drugs which can be marke ted unde r J!t'l\t r tt 11.nnc , o nly
List of drugs whose impor t , manut .,ctnn • a11d
X sale 1 Lihdi ng and
packa l!ing are govern ed by s pecial provis ion
Requi remen ts and guidel ines for pe rmission
y to impor t and
manuf acture of new drugs for sale or to under take cltml ,ti , uh I or
1

(, fliil l)l\1 -.up (C'II l',1 . lhl ' ,,.'°'~~1hll v.'"'klt1n1 J 1:J, J1:tl0\ M1f , ti, IOI ~l~
111
\I I \fl \fl \U UII \\.)'l W t,1111 \I N\11 l 1l I \ 11 tt
HIHlf'.\I
t II• t M,1 I °' ,.MUI
l \h(HU ••l \ t ' " Ult\ I IH I Ill i C.11 \/1 \H\h Ultl h\'\I "'i\\ \1l 1Hhl1'1
\f-\. U \-I I \IU\ I
 _ _o_R_\_' Pl_:!_.~ ~1ACIST EXAM AT YOUR FINGERT IPS: PHARMACY L AW AND ETfDCS
_ _ _ _11-IE
- - - ----
CJ AfilUNlSill.t..\T lQ N t 1llli ,\ ( r " ~U> u mILI ~
• flu cc .1dm1m~ll .ll I\,, hoctu•,

J\DMINISTIV\TIVE BOl>U-:\

Advisory bodies Ana lytical bod ies Executive bodies

Drug Technical Central 01 ugs Controlling Authorities

Advisory Board l.aboratory
Licensing Auth orities
Drugs Consultative Drugs Control
Committee Laboratories in States Drug Inspector

Government Analyst Customs Collectors

❖ Drug Technical Advisory Board (DTAB)

• Constituted by the Central Government

1. Director General of Health services - Chairman

2. Drug controller of India
3. Director of Central Drug Laboratory, Kolkata
Ex-officio
4. Director of Central Research Institute, Kasauli
members
5. Director Indian Veterinary Research Institute, Izzatnagar
(Total= 8)
6. Director of Central Drug Research Institute, Lucknow
7. President - Medical Council of India (MCI)
8. President - Pharmacy Council of India (PCI)
1. Two Person nominated by the central govt. amongst person who
Nominated are incha rge of drug control in States.
members 2. One person from pharmace utical industry, nominated by central
(Total= 5) govt.
3. Two govt. analyst nominated by central govt.
1. A teacher in pharmacy or pharmaceutical chemistry or
pharmacognosy, elected by executive committee of PC!
2. A teacher in medicine or therapeutics, elected by executive
Elected committee of MCI
members 3. One pharmacologist elected by Governing body of Indian Council
(Total= 5) of Medical Research :r,c µ ~
4. One person elected by the council of Central Medical Association
of
5. One person to be elected by the c ouncil
Pharmaceutical Association
the Indian
-
❖ Drug Consultltive Committee (DCC)
• Constituted by the Cen tral Gove rnme n t
• Function is to advise the Central Government, or Stlte Governmem and DTAB
✓ Cons titution
• Two pe rsons are nominated by the Central Govt
• One person from each State is nominated by that concerned Stlte Govt

,, I t n ( \'DI r l'\l. t ti 1; ~ \\ (Ii,• o ' ,\ J, n I 11 11 1 m,11 ~ K .. !2J-' l'.. ->" u 11 1,1,, j

I
\I l 4.tt \.8 \ll tJJl. \\I I k Hllll \I H.-\IPl R I "' l U HIIOJ'\I 1'lk Kl rt '\f ',,11th. l l I Ill t ·11 \/I
1 \I) ,r, 8HI R ,,1 \\,\ \I( UR\Ji\1-\t'l k \ll \Hhl
 GPAT DISCUSSIONCENTER : MAKES sTtJI>Y EASY

:J IMPORTANT "I ERM. IN DRLl(j &_C.Q~MLJE_M.1'.5 ~

State Gover nmen t

GOVERNMENT
• Appoin ted by Ce n~ vernm ent o_r
• In relation to any other Drug and Cosme
Uc - Section 20

ANALYST • Ayurvedlc, Siddh a and Unani - Sect~on 3 ~-F

• Re orts of Government Anal sts · Section 2 5 ✓
• Appointed by Central government or State government
• In relation to any other Drug and Cosme tic - Section 21
DRUG INSPECTOR • Powers of drug inspec tors appom • t d under Section 22
e
• Proce dure of Inspe ctors appointed under. Section 23
• A rvedic , Siddha and Unani - Section 33-G
Drug store shall be displayed by such licensees who do not
DRUG STORE requir e the services of a Regist ered Pharm acist/ Qualified
erson
Chemists and Druggists shall be displayed by such li censees who
CHEM IST AND employ the servic es of a Registered Pharmacist/q ualifi ed person
DRUGGIST but do not maintain a Pharmacy fo r compounding agains t
· tions
PHARMACIST, Licens ees employ the services of a 'qualified person' and
DlSPENSING CHEM IST ma intain a 'Pharmac tions .
..J OFFENCES & Pl l\0Lrll5 I •1POnJ Of f)RtJc;s & lQSMl ncs ACT
OITEN<:ES
Import of adulterated or spurious drugs or
I Pl-:Ni\t:rll•: S

1purto111 cosmetic or any cosme tics containing Pint: Subsequent:

I
any ingredient which may render it unsafe or Fine Rs. 5000/ Fine 10,000 / 5
harmful for use under the directions recommended. 3 years year~ \
I
Import of any drugs or cosmetic other than Fine Rs. 500/ 6 Floe Rs. 1000
months or \
referred above, the import of which is prohibited / 1year or
both both
tmport of any drug or cosmetic in contravention Fine Rs. 5000 / 3 years
of any noti fi cation issued under section 10A.
or both
:.J FORMS FOR IMPORT. MA~UFAf TURE. REPACKAGING AND SALE OF
DRUGS
PURPOSE DRUGS APPLI CATION LICENSE
GRANTED
(i) Drugs specifi ed in schedule C 8 10
and Cl
(ii) Drues specified in schedule X
IMPORT BA tOA
(iii) Import of dru~ for testing and 12
analysis 11
·(iv) For personal use 12A 128
►
- TIIEORY PffAR MAc1s T EXAM ATYO UR FINGERT WS

1. Homo eopat hic dru gs

: PHARM ACY LAW AND ETHICS

24 C
-- -- --
25C
2. Cosme tic 31 32
3. Ayurv edic and Unani Drugs 24D 25D
4. (i) Drugs speci fied in sched ule C, 27B 28B
Cl, and X
(ii) Dru gs specif ied in sched ule C 27 28
a nd Cl exclud i~ those
MAN UFAC T URE
specified in Sched ule X
(iii) Drugs other than those 24 25
specified in sc hedu le C, Cl
and X
(iv) Drugs speci fied in schedule X 24F 25 F
30 29
5. Man ufa cture for exami nation test
or analys is
REPACKING LICENSE Drugs other than specified in 248 258
sched ule C and Cl -- - r

SALE or DRUGS
~

~ - -

198 20C, 20D

(A) (i) Homo eopat hic Drugs
WHOLE SALE (ii) Drugs other than those specified 19 20B
in sched ule C, Cl and X
(iii) Drugs other than those 19AA 20B8
specified in schedule C, Cl from
a motor veh icle
(iv) Drug specif ied in sched ule X 19C 20G
(v) Drugs specifi ed in sched ule C 19 21B
a nd Cl but not includ ed in
sched ule X
(vi) Drugs specified in sched ul e C 19AA 2 18B
and Cl but not includ ed in
Sched ule X from a motor
vehicl e
198 20C, 20 D
(B) (i) Home opath ic drugs
(i i) Drugs other than those specified 19A 20
RETAIL SALE
in sched ule C, Cl and X
(iii) Drugs specif ied in C and Cl 19 21
exclud ing X
(iv) Drugs specified in sched ule X 19C 20F
specified ---- 20A
(C) RESTRICT ED (i) Drugs other than those
in sched u le C, Cl & X
(ii) Drug specified in C, Cl but not ---- 21 A
in sched ule X
G DOSAGE FORM
..J ,\REA REQUIRED FOR MANUFACTURING OF FOLLOWIN
al shop or pharm acy or
• Minimum area of10 squar e mete rs is required to start a medic
wholesale.
of 15 squa re mete rs is
• Pharm acy business combines ~tail and ~ ho~s~ ~:__a_!!li_nimu m
required
ll2" ,U ~ ,
l t U • t I'•' ~ """' " ~ ""'
BkAll~P ll! \I L
\I "IXllU l'I
, 11 .. 1,B,ll , l!Jl \>1'!11. , BIULAI K•JPlR i l-Hlll i 811UP
- -
CPAT lllSCUSSIONC'ENTER : MA ~ ssTV
-
DY EASV - - - - - - - -
-

• Powder
• External pre par atio n 10 m2
• Ora l liqu id 30 m 2 1om2
• Tab let coa ted 1om2
Uncoate d tab let 60 m 2
zom 2
• Cap sule 1om2
2
• 0 hth alm ic re arat ion 25 m 1om2
• Pes sari es & Sup pos itor y
• Inh aler Vitr alla e 20m 2
• Rep ack ing of Dru gs
· al Dre ssin 30 m 2
mat eria l for LVP 100 m2 50 m2
Aer oso l
15m2
:J SPECIAL LABELLING REQUIREMENTS

CLASS OF
DRUGS
NAME OF MEDICINE IN
WH ICH CONTAINED
I PARTICULAR WHICH SHOULD APPEAR
LABEL
ON

a) The words caution : It is dan gero us

to take
this prep arat ion exc ept und er med
Medicine mad e up read y ical
Schedule G for inte rnal use of sup ervi sion .
b) Tho se wor ds shal l be con spic uou sly
hum an ailm ents prin ted
and surr oun ded by a line with in whi
ch
ther e shal l be no othe r wor ds.
a) The sym bolW ons picu ous ly disp laye d
Sch edule on
Made up read y for the lctt op crn ncr ot th , 1 tbc{f
H
inte rnal use b) The w ords -Sch edu le H dru g sho uld be
medicin es
writ ten with the W'l n .11 ;i : - "To be sold
by
reta il on the prescrip tion of a RMP only
."
Falling und er Dan gero us
a) The sym bol ' N10 in red con spic uously
Schedule disp laye d on the ldt to, , l 1 >. I ,l I
D~ u~ Act,1930 (Now b) The wor ds Sch edu le H dru g U,n
H r tp n : - "To
NDPS, 198 5) be sold by reta il on the pres crip tion
of a
RMP only".
a) The sym bol NR
in , r~ con spic uou sly
Sch edu leX disp laye d on the left tvp corn er ot I till L
For inte rnal use b) The wor ds ; 'Sch edu le X dru g - War-1ing,
med icin es
"To be sold by reta il on the pres crip tion
of
R.M.P only"

Scb edu leX Med icin es in bulk form The sym bol XR con spic uou sly disp laye d on the
left toµ corn er of the labe l in red .
- THEORY PffAR.J\.fAqs r EXAM AT YOUR FINGEITTIPS: pHARM ACYLA
W A.'-'D ETIDCS

SCHEDULES !
-- DRUGS
Sera, Toxins , Antige n, Antito xins Insulin , Bacte riopha ges.
Soluti on of serum prote ins inten ded for injection .
Vaccin es fo r pare nteral injecti ons.
sp eci fic
Neo-a rsp henam ine and analogo us substa nces used for the
treatm ent of infecti ve diseas es.
Pituita ry (Poste rior Lob e) Extrac t.
Sched ule C
Adr enalin e and Soluti o ns of Salts of Adr enaline.
is tere d
Antibiotics and prepa ration s thereo f in a form to be admin
paren te rally.
Sterili zed surgical ligatur e and steri lized surgic al su tu re.
Ophth almic prepa ration s.
10. Sterile Dis osable Device s for sin le use on l
1. ~ ot in - a fo r'!l to be _adm inister ed pare~tera l!Y -
Digita li s grou p,
t a nd
Adren alin e and prepar ations contai ni ng Adren alin e, Ergo
tions,
prepa ration s, Vitam ins and prepar ations , Live r ext ract a nd pre para
ns
Sched ule C1 Horm ones and prepar ations , Vaccine, Antibi otics and prepa ra tio
Fis h Liver Oil
In-vitr o Blood Group ing Sera.
In-vitr o Dia nostic Devices for HIV. HbsA a nd HCV.
1

pa m ide a nd
Amin opteri n , Bleomycin. Ca rbutam ide. Chloro thiazide, Chlo rpro
to in ; its
its salt.5, Diphe nhyd ra mine. Ethosu ximi de, _9,libe ncla m ide, Hydan
in, P~,: :1 in ,
Sched ule G sal ts; its deriva tives. their salts, Insulin a ll tyQe~ M!!_form
Thiote pa, Tripro li d ine,
Ph eniram me, Prome thazin e, Tol butam ide.
Chl or he nirami ne etc.
ACTH , Analgi n, Alpraz olam, Barb1turic aci d & th eir sa lts,
Digox ine, Estrog enic and Proge station al s ubstan ces, Allop urin ol,
;Sche dule H Betam e thason e, Chlora lhydra te, Clonidi ne, Dapso ne,
__
_f a ptopri1
an tib io tics,
Digox in e, Di clofen ac
sod ium /potas s ium / ac id, Car bidopa , Th iotepa , Primid one, Ethacr
ynic acid,
...

C clo hos hamid e, Mebe ndazo le. Ox toci n etc.

Alp razola m,
Car ba penem class and Ill & IV gener ation of a ntibi otics,
m ifloxa cin,
Bup ren orph ine, Etham bu to l Hydro chlo ride, Eth io nami d e, Ge
Sched ule Midaz ola m ,
Cefep ime, lmipe nem, lsonia zide, Cefixi me, Levofloxaci n,
Ht Cod eine,
Nitraz e pa m, Ceftaz idime, Pentaz ocine, Prulifl oxacin , Rifam picin,
S a r fl oxacin , C closeri ne, Diaze am, Trama dol, Zol id em etc.
n, Lepro sy,
AIDS, Athero scle rosis, Cance r; Diseas e and disord er o f b rai
id, Small
Goiter, Tuber culos is, Jaundi ce, Paraly sis, Ge netic diso rde r, Typho
Sched ule J gue, Syph ili s,
pox, Ulcer; Obesity, Pneum o nia, Epilep sy, blood poiso ning, Pla
Gonor rhoea, Sterili in woma n, Gan ene etc.
 GPAT DISCUSSION CENTER: MAKES sruoYEASY
. Alizarin, Curcumin,
Amaranth, Tartrazine, Eosine, Indigo, Erythrosme,
Schedule Q
Cochineal, Na hthol blue, E rosine elloW etc.
b ' I o exampheta mine,
Amobarbital, Amphetamine, Barbital, C~clobar ~i
Meprobamat e,
Schedule X
Ethclorvynol, Glutethimide, Ketamme 'b. Pentobarbi tal
Methampheta mine, Methylphenid ate, Methylpheno bar ita 1' •
Phenc clidine, Phenometrazine, Secobarbital. h
Analgin, Aspirin and its salt, Chlorpromazine and its salt, Ferrous SU 1P ate,
Schedule W
Pi erazine and its salt.
Bacitracin, Chlo ram phenicol,
Ampicillin,
Erythromycin , Gentamycin,
Ooxycycline,
Kanam cin, Penicillin etc.
cold place Liquid plasma, all vaccine, sera and toxo1ds,
other vaccine like BCG, Cholera, DHL,
Measles, Pia ue, Rabies etc.
ed ng 5°C Carbenicillin, N statin
Schedule P

-
Insulin laj_e~tion, Hut_!.1an Insulin Injection
etc.
dos Thiamine, Riboflavin, Vitamin 8(11
Cyanocobalamin, Hydroxycobalami n,
ht I cool plan: Calcium p,mtothenale, Vitamin C, Vitamin
I , ' Di/D , Vitamin E, Follc acid, Vitamin K,
.I .
N1acinamide

The Narcotic Drugs and Psychot ropic

Substan ce Act and Rules
u lMPORl lNI ll \I l ~
Narcotic Dnu[s & Psvchotroolc Substance Act and Rules 198S
Act came In force 14th November 1985 ,J

OoiumAct 1857.1878 .
Dane:erous Druas Act 1930 .....-
Dane:erous Druas Rules 1957 ✓

□ POIN Is ro BE REM EBER

• Ccn tr-.il government shall appoint - ~ ~ m mlsstoner"
h ave powers and perform all functions relating to the
cultivation of the opium poppy and production of
opium.
• Central go vt co nstituen t
narcotic drugs and
psychotrop ic substance con~~~~~ - ~oJJJmittee
(NM'I 2u ml•mbcf'•J
 •
►
__~
_ ·_ R_Y_PHAR: · :.:
,:_:
_1A .::::.::
ClST = ·~
EXA! T~
A:!..
~t'.: ~ ::
YO ~ ·~
~ ff\i
t::R c~ER ~~"~fA
PJIAR;
~ :!:
~ l~l.PS ~ \\~'A:
~ LA
~CY ~ ~cs
~'i~iD~ETI{J ~ - - --
------ :-THEO
• Government opium f .
. actDry - Gaz1pur (UPJ, \ecmuch (~P)
• . .
D1strkt opium offi cer- Appomton e of the _ 1~rhJr- o' ~?.. ,oppy
T k.n wh
asl '-mbc1rdar in each Vl'-6e · · cultivated
poppy is
ere opium
• Coca, Opium and Hemp comes under Dangero us Drugs Act.
===---- - -
:.J DEFINITIOS
Me d icin_l Medicin al hemp, means any extract oi:_tincture of cannabis (hemp)
~--- M J 5

~ ar '-VUr (.J ~
Coca leaf, Cannabis (hemp), Opium, Poppy straw & included all
manufac tured drugs
Plant of the ge nus Cannabi s
, Bhang: Lea\'..?S of plant C wbt< r .
► Ganja: no~e::-1 ~ .,r ~iting topr of the cannabis plant (exclude
Cannabi s plan
seed or leaves)
-
, Charas: Separate d resin and resin known as h~hl~h oil or liquid
hashish.
Coca nlant Plant any s pecies of the genu~ Ervthrox vlon ~
• Crude cocaine i.e., extract ot coca leaf
Coca • Ecgonine and its derivatives
derivat1\cs • Cocain e: M_;th ,:_: ester ofbenL,I ecgonine & its salts (MEBE) .
• All pre paration conc.arnrn e mort: than 0.1 o/o of cocaine.
• Leaf of coca plant except the leaf from which all ecgo nin e, coca in e
and any other ecgonmc alkaloids have been removed .
Coca leaf
• With or without an}' neutral material but does not include any
pre pa ration contarntn !? NMT 0.1 % o f cocai ne .
• Coagu lated Juice of opium poppy
• With or without any neutral matenal of the coagulate d juice of the
Opium
opium po ppy but does not include any preparati on conta ining
NMT 0.2 % of morphin e
• Phenant hre ne alkaJoid s - Morphine , Codeine, Theba ine and its
salts
Opium • ~iacetyl morphine (DAM) - Also known as d1amorp hine or
de, 1vatl\e heroin and its salts
• All preparati on containin g more than 0.2% of morphi ne or
containin g any diacetvl morohine .
01um J>OT> ll Pla nt of the s pecies Paoaver somni{e rum L.
ouv~ strrm All part (except the seed) of the opium poppy.
Any su bstance which the Central Governm ent may, having regard to
C.ontroll ed the availab le informati on as to its possi ble use in the producti on or
.
•• t 11. •_.nee
manufac tu re of narcotic drues or psychotr opic substanc es .
 GPAT DISCUSSION CENTER . MAK
ESST UD>Y,rIEA
~ ~S~Y_ __ _ _ _ _ _ __
-
- - t al material or any
-
Any substance, natural or synthetic,
or any na ur
salt or preparation of such substance . I ·ncJude d m. th 1' t
e is
or materia 1
of psychotropic substan ces specified in
schedule
Psy d,o tro pi, eg- Amphetamine, Pentazocine, Secobarbital,
Pentobarbital,
snh st,l lll es Alprazolam, Amfepramone, Barbital, h t m'n
. . Benzp e a 1 e ' Cloxaz.olam ,
D1azepam, ketam me, Kctazo lam , Lop L
razo 1am, 0 razepam' Mazmdol,
Medazepam, Me thyprylon, Nimetazepam, N'traz epam Oxazepam, 1
1
Oxazolam, Phenobarbital etc.
1 llli r • Cultivating any coc a plant or gather
t , .,tfo c:,,. ing any..£._Oi:!!£~ of~':_cl Pl a!1t

--
_ ... -
• CultivatinE! the opium ooo ov or any cannabis olan_t
,A
-
.J DlFF,ERENT FORMS OF llRlll;S AND
< OSML fl( S /\CT
FORMS I DESCRIPTION
For m 1 Licence to Grow O · for Production of O ium or Po
For m2 Straw
Application fo r Grant of Licence for Opium Pop
py Cultivation for
Straw
For m3 Licence for Manufacture of Manufactu
red Dru s
For m4 Certificate of official a
For ms Authorisation for Offi
rt
..J OFFENCtS .\~D PfNALTlES

OFFENCES
I FIRST CONVICTION
1. In rela tion to poppy plant i. Where
(Op ium )-trans port, contravention
sale,
purcha se, imp ort, exp ort involves small 6 M/lQ,000 or both
2. In rela tion to cannabis 2la nt ~ anti ~
(Opium)-trans port, sale, ii. Lesser than
purcha se, imp ort, exp ort comme rcial
3. In rel atio n to psychotropic quantity but greater 10 Y/1 lakh
--
-
pla nt (Opium)-transport, sale,
pur cha se, import, exp ort iii.
-- - -
than small quantity
Commercial
4.
--
Illegal transpor!,
purchase, import, exp ort of
psy cho tro pic sub sta nce
sale,
-- --
quant_!!y
10-20 Y/ ~-2 lakh

In rel atio n to coc a plant- transport

, sale, purchase
Em bez zle me nt or illegal dis pos ing l0Y / 1 lakh
of opi um by cultivators 10-20Y / 1-2 lakh
External dea ling s in narcotic dru gs
and psy cho tro pic l0Y / 1 lakh
All ow ing pre mis es to be use d for
com mis sio n of offe nce
10Y / 1 lakh
L-,Pinancing illicit traffic and harbor
ing off end ers 10 - 20 Y/ 1-2 lakh
~n sum pti on of nar cot ic and psycho
tropic sub sta nce s 1 Y/ 20,000 or both
~
Lp,1 lt1H , i It •'
• ' ' " -
\ I I \B \lHI) , tHI ,..,t l'l{ , , \ rn .. 1
KJI II \I It \11'1 H I \ Ilk Ull11t i ',, \ tu ,
I '\l I\J 10t0 Pl \t '.\",Hf. ._ UI I ttl ,<, ti \/1 '"' ,. ' u~t MW
\U \ l) HIii I\ \\I\\\ \Jl UH.\II \I \ l't 1
I( l\1l :\UHi
►
- TIIEORY PffARMACISTEXAMATYOUR FINGERTIPS: PHARMACY LAW AND

Certain acts by licens e or his servants:

ETHICS

(a) Fails to pr oduce with out any reason able cause such license , 3 years or with fine or
.
permit or authorization on deman d of any officer with both
5
Kee an accoun ts or makes an statem ent which is false.
Triable onl b th e S ecial Court consti tuted for the area More than t hree ears

Medicinal and Toi let Preparation Act and Rules

:l IMPORTANT DATES AND POINTS
• An Act to provide fo r the levy and collection 1955
Act was passed
of dut ies of excise on medici nal and toilet
Rule was passed 1956
prepar ations contai ning alcoho l, narco tic Came into force 1st April 1957
drug or narcot ics.
• Alcoholic prepa ration s can be stored in a wareh ouse for a maxim um
years
period of 3
-
issione r.
• Licens e to manufacture in bonde d laboratories is issued by Excise Comm
• A non- bonde d manufacturer shall be inspected by the other officer
at least once in a
month .
U I)I Fll\l'I ION
TERMS I DEFINITIONS
Medical All drugs for intern al or extern al use
preparation
Pre paratio n intende d for use in the to ilet of the human body or in perfum ing
or
Toilet appeal of any description or any substa nce intende d to clears, improv e
alter the complex io n, hairs, skin, or teeth include deodo rants and perfum
e
preparation

It means the permit approv ed a nd licensed for the manufa cture and storage
Bound ed
manuf
Non
actory
hemp, which duty has not pa id. -
of medicinal and toilet prepar ation containing alcohol, opium Indian

Means premis es approv eo an-cflicen sed for the manufa cture and storage
of

bound ed the medicinal and toilet preparation contain ing alcohol, opium Indian
manufactory hem p, which dutv has paid,
Rectified It means plain undena tured alcohol of a s trengt h not less than 50.0°
spirit Over Proof and include absolu te alcoho l.
These are medicinal prepar ation which are consid ered as capabl e of being
Restri cted misuse d as ordina ry alcoholic beverages specifi ed in the schedu le and
preparation include every prepar ation declare by central govern ment as restric ted
prepar ation.
Unrest ricted Medicinal prepar ation contain ing alcohol but other than a restric ted
pre paration preparation a spurio us preparation.

f n ( nt r l''tl. I liS \ '"'°"

\l I \llo\Ho\U HII "n k KUil \I k \lf'l k l \
- - - - - - - - -~
G~PA~T~D~IS~C~U~SS
~IO
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~ENT~~E~
R_:!
: MAKE
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AS Y _ _ _~-:-- - - - - -
. t· 0 nable
Drugs And Magic Remedies (0 b~ec •
Advertisements) Act
D IMPORTANT DATES AND POINTS
• Act was passed in the year 1954.
Act and Rules came into effect on 1' April 19 5 5 and was ameD ded in 1963 ·
1
•
• The Act was also referred as Objectionable Advertisements Act.
• The object to control the advertisements of dr~g~ certain cases a nd to prohibit the
advertisements for certain purposes.
□ DEFINITION

TERMS I DESCRIPTIONS
Any notice, circular, label, wrapper, or other document and any
Advertisement
announcement by light, sound, and orally.
Talisman, Man tra, Kavacha and any other charm claiming to possess
Magic remedy
miraculous power f;; or in the diagnosis, cure mitiga tion, treatment.
A medicine fo r the internal or external use of human being or
Drug
animals.

LJ SOME IMPOR'IANT SECT(or-,;s

Prohibi tion of advertisement of certa in drugs for trea tm ent of certa in

Section 3
afseases and di sorders.
Section 4 Pro hib ition of mi sleading adve rti se ments relatin g to dru gs.
Section 5 ~
di seases and <li sord ers
-
Pro hlb ition of adverti se ment of magi c re medi es for tre::i tm enl of ce rtain

Pro hibi tio n of import into, and .::_POrt fro m, Indi a of certain
Section 6 -
adverti se ments.

J-} THESCHEDULE

'SCHEDULE J .J Prohibition of advertisement of certain drugs for treatment of certain

diseases and disorders
AIDS, Arteriosclerosis, Asthma, Blindness, Blood poisoning, Bright's disease, Cancer,
Cataract, Deafness, Diabetes, Diseases and disorders of brain, optical system and uterus;
Dis9rders of menstrual flo w, nervous system and prostatic gland; Dropsy, Epilepsy, Female
diseases (i n general), Fevers (in general), Gall stones, kidney stones and bladder stones;
Gangre ne, Glaucoma, Goitre, Heart diseases, High or low blood pressure, Leprosy,
Leucoderma, Lockjaw, Locomotor ataxia, Lupus, Nervous debility, Obesity, Paralysis,
Plague, Pleurisy, Pneumonia, Rheumatism, Sexual impotence, Smallpox, Stature of
persons, Sterility in women, Trachoma, Tuberculosis, Typhoid fever, Ulcers of
gastrointestinal tract, Venereal diseases including syphilis, gonorrhoea, venereal
granuloma and lymoho granuloma.
 Ttmo Rv l'IIA1t MA< .1L,1. ETHICS
---- ,.,. EXAM AT \'OlJR r lNCERT JPS : PHARMACY LAW AND
-------
U Vl'l I·~ ~ \NI> l'J NJ\I I ll·S
<WFENC:1•:s PENA tTIES
first conviction : Wh oever contravenes any
,rovlslon of this act or rul es
Second conviction : Subse quent of the first --
6 month or with fine or both

ronvi cll on
---- -
One year or fine or both any subse quent

l Drug Price Control Order (DPCO) 7

U 1.MP Olff\N T IMTl 'i/\NI> l'OI NT'i
• DPC0 - 2 013 replaced the DPCO -199 5
• Ca me in effect - 15 th May 2013.
Under section 3 of the Essential commodities Act -1955
•
• Ceilin g price - Price fixed by the Central Governmen t
J
for Scheduled formulation s. ~ I

• Retll l price - Pri ce fi xed by the Central Gover nmen t

for a new dru g.
• Fixin g the maxi mum sale price of a bulk drug: Post-tax
return of 14% on net worth or
a return of 22% on capi ta l em ployed
on net-worth or a return of
• Prod uctio n is from basic stage: Post-tax return of 18%
26% on capi ta l emplo yed
drugs and form ulatio ns
• Obj ective is to maintain and incre ase the supp lies of bulk
U Hll{M~ 01· fil!,_O I ()l)C} \Ni> l_)fl( O 20 I J

FORM I 1995 I 2013

applic ation for p!ife
Form of inform ation /appli cation Proforma fo r
drug
fo r fixation or revision of prices of ~ / revision of a new
FORM - I fo rmula tion related to NLEM
Scheduled bulk drugs.
formu lation
Form of info rmation in respect of Proforma fo r submission of
FORM - II price of non-Scheduled bulk drugs
. revise d-pric es
formu lations
for sched uled

erly _retu rn in
---
Application for approval/revision Profo rma fo r ~uart
respect of produ ction /impo rt and
FORM - Ill of price of scheduled fo rm ulation.
sale of NLEM drugs
ission of the
Application for approval/revision Proforma fo r subm
ation
of price of sched uled fo rmulation details in respe ct of disco ntinu
FORM- IV impo rted in finished form. of the production and/ or impo rt of
sched uled formulation
Profo rma for orice list.
FOR M-V Form of price list.
Yearly informati on on turno ver and lf t _( /r-.., l {t t,A //~
FOR M-VI alloca tion of sales and expenses. y

" "
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,11 •lnll"' bll ,,J'\ II
1, ' \
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 ... . :
GPAT DISCUSSION CENTER: MAKE

DPCO 1995
ss'f{JDmY~ EAS
__:::...

b
~ Y ~ --------..

OPCO 2013
National pharm aceu tical
Governed by Essential Commodities Act - Governed Y . . (DPCO has enable
1995 . . authorities.
pncmg rice of@ 4 drug ~ hat
NPPA regulate p
der NLEM 2022
come un . 652 drugs")
They regulate price of only 74 rugs The regulate pnce o .
.~ . ainly based on simp le
If once price 3 fixed they canno t change Pncmg is m
according to act . be lowe red depe nden cy
average pnce
u on mar in.
Retailer margin 16% Retailer margin 16 %, ..,
Wholesale mar in~ BO/o
Formula: Calculation of Retail price :

R.P= (M .C +C .C +P .M+P . C)x 1 +-1•IA

-
1 00
PE
+ED • MRP
---
• MRP of Scheduled formulation =
1Ceilin g price + Local .taxes
of N~ drug =(E~~il_E: i~e +
R.P = Retail price -
Loca l taxes"' '·
M.C = Material cost • ~ili ng price of a sche dule d
C.C = Conversion price formulation -
P.M = Packing mate rial cost
P.C = Packing charges
Ceiling price = Ps ( \~; J
MAPE = Maximum all owab le pQ_st • P(s) = Average Price to Retdile1
manufacturing expense ~MT ~ !of' • M = % Margin to retailc>r
E.D. = Excise du

/ Poison Ac t J
D IMPORTANT DATES AND POlf\ r~
• Passed in ~ ~ tcmbe1 191 lL POISON
• Act extends to whok! of India but is not applicabi! to the
state of Jam mu & Kash mir
• Objective is to consolidating and amending the laws regul
ating the impo rt, posse ssion
for sale and sale of poiso ns.
• Impo rt of Poiso ns - Central Gove rnme nt regulates the
grant of licen ses
• Poss essio n for sale and resale of poiso n - State Gove
rnme nt make s ru les to regulate
the possession fo r sak! and resai! of poiso n
_;IIssue of warrant - District magi strate , S~b-divisiona l magi
c,trate and lomm i s,ion Pr
of polic e
'- -
::J SUBSTANCES DEEMED TO BE POISONOUS
~

Aconite, Acon ine, Arsen ic, Atropine, Belladonn a, Cantharide

s, Chlo ral Hydrate,
Coca, Corrosive Sublimate, Potassi um cyanide, Dia morphine
List A (He roin) Diethyl
Barbituric Acid, Digitalis, Ecogonine , Ergot of Rye,
Lead, Nux -Vo rnica,
Strychnine Mo rp hine.
,~- - --- - -- -- _T YO~
_ A
THEORYPHARM ~ ~EXAM FINGERTIPS:PHARMACY LAWA ND ET_HJC~'S _ _ _

Essenti al oil of Almonds, Antim onial win es all salts of barium except Barium
List B sulph ate, Tinctu re of Co nI lwrld cs, Carboli c aci d, Chloroform, Mercuric
Sul nhocva nid e, Oxa lic aci d, PoDn ies All oxides of mercur v, Zin c chl ori de.
~ Ql:}l:Nl l·~ \Nn l't.NJ\I nrs
s.No. I OFFENCES I PENALTIES
First conviction: Anyo ne wh o either imports or
1. possesses or sell any poiso ns except as 3 month s / upto 500/*
orescri bed under this Act
2. Second conviction: Subsea uent co nvictio n 6 month s/ uoto 1000/-

Med ical Term ination of

Pregnancy Act and Rules

.J IMPORTANT DATES AND POINTS

• Act passed in 1971 and Rules in 1975 and Regulation in 2003
related
• Object is to provide the termination of certain pregn ancies by RMP and
matters.
power to
• Centra l Govern ment has power to make rule and State Govern ment has
make regulations
:J TERMINATION OF PREGNANCIES
• Length of pregnancy
✓ Does not exceed tw~lve ~-~ s, if such medical practitioner
✓ exceeds twelve weeks but does not exceed twenty weeks ,
if not less than two

registe red medical practitioners

Opinion that
of
a) Its continuance woukl result into serious injury to the physica l or mental health
pregnant women
b) Child to be born would be seriously handicapped due to physical or mental
abnormalities
RE UIREM ENT FOR TERMI NATIN G PREGNANCY
TIME SINCE
CONCEPTION
One RM P
U to 12 weeks One RMP ,,.
TwoRM P
12 to 20 weeks Two RM P ~
r Not allowe a'
20 to 24 weeks Medica l Board in case of
More than 24 Not allowed
weeks substa ntial fo etal abnorm ali

Any time during One RMP, if immediately necessary to save pregna nt woman's life

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