agenda 249th registration board meeting
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8/15/2019 Agenda 249th Registration Board Meeting
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Agenda for 249th Meeting Registration Board to be held on 18-19th May, 2015.
Ite !o. "etail of Ite
Item No.I Confirmation of minutes of 248th meeting Registration Board
Item No.II Cases referred by Pharmacy Services Division
Item No.III Cases referred by Pharmaceutica !vauation " Registration Division
Item No.I# Cases referred by Bioogica !vauation " Research Division
Item No.# Cases referred by $uaity %ssurance " &ab 'esting Division
%ny other item (ith )ermission of Chair
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Ite !o. I# $onfiration of in%tes of 248th eeting Registration Board.
248th meeting of Registration Board (as hed on *8+*, th-arch 2/*0 and minutes (ere
circuated to a members through e+mai. None of the member for(arded comments and thus
minutes (ere a))roved by the Chairman.
Submitted for consideration of Registration Board.
Ite !o. II# $ases referred by &hara'y (er)i'es "i)ision.
$ase !o.01 "raft !ational A'tion &lan for 'obating the Antii'robial Resistan'e and
establishent and strengthening of !ational and &ro)in'ial &hara'o)igilan'e $enter.
%ntimicrobia resistance is resistance of a microorganism to an antimicrobia drug that
(as originay effective for treatment of infections caused by it. Resistant microorganisms
1incuding bacteria fungi viruses and )arasites are abe to (ithstand attac3 by antimicrobia
drugs such as antibacteria drugs 1e.g. antibiotics antifungas antiviras and antimaarias
so that standard treatments become ineffective and infections )ersist increasing the ris3 of
s)read to others.
'he main driver of %ntimicrobia Resistance 1%-R is the misuse and over use of
%ntimicrobia Drrugs. Poor infection contro )ractices inadeuate sanitary conditions and
ina))ro)riate food+handing encourage the further s)read of antimicrobia resistance.
Ne( resistance mechanisms emerge and s)read gobay threatening our abiity to treat
common infectious diseases resuting in death and disabiity of individuas (ho unti recenty
coud continue a norma course of ife. 5ithout effective anti+infective treatment many
standard medica treatments (i fai or turn into very high ris3 )rocedures.
Infections caused by resistant microorganisms often fai to res)ond to the standard
treatment resuting in )roonged iness higher heath care e6)enditures and a greater ris3 of
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death. %s an e6am)e the death rate for )atients (ith serious infections caused by common
bacteria treated in hos)itas can be about t(ice that of )atients (ith infections caused by the
same non+resistant bacteria. 7or e6am)e )eo)e (ith -RS% 1methiciin+
resistant Staphylococcus aureus another common source of severe infections in the
community and in hos)itas are estimated to be 49 more i3ey to die than )eo)e (ith a
non+resistant form of the infection.
Antii'robial resistan'e is a ma:or concern to the )ubic heath threatening the
)rogress made in treatment of infectious diseases as (e as advances in modern medicine. 'he
use of antimicrobia is strongy in3ed to the deveo)ment of antimicrobia resistance. It is
therefore of great im)ortance to find (ays to assure res)onsibe use baancing bet(een
minimi;ing unnecessary use (ithout com)romising the heath needs of the individua. 'he use of
antimicrobia in food )roduction " agricuture has further aggravated the )robem.
Pa3istan is the si6th heaviy )o)uated country in the (ord com)rising over *8/ miion
)o)uation. &ife e6)ectancy rate for mae is 0 and for femae is years. 'here is an urgent
need for mutisectora coaboration based on eath %))roach? to combat the antibacteria
resistance.
'he same issue has aso been agitated in Senate of Pa3istan to be ta3en as )riority (herea commitment has been submitted by the DR%P to deveo) a nationa )an covering a the
as)ects to address the issue. %ccordingy a Nationa %ction )an has been )re)ared and
submitted before the Board for consideration@+
*b+e'ti)e 1@ Iro)e aareness and %nderstanding of Antii'robial Resistan'e
thro%gh effe'ti)e 'o%ni'ation, ed%'ation and training
Ste)s need to be ta3en immediatey in order to raise a(areness of antimicrobia
resistance and )romote behaviora change through )ubic communication )rogrammes thattarget different audiences in human heath and anima )ractice as (e as consumersA
Incusion of the use of antimicrobia agents and resistance in medicine and )harmacy
curricua (i )romote better understanding and a(areness from an eary age.
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-a3ing antimicrobia resistance a core com)onent of )rofessiona education
training certification and deveo)ment in the heath and veterinary sectors )ractice (i he)
to ensure )ro)er understanding and a(areness among )rofessionas.
*b+e'ti)e 2# (trengthen the noledge and e)iden'e base thro%gh s%r)eillan'e and
resear'h.
%ctions and investments to tac3e antimicrobia resistance (i be su))orted by cear
rationaes of their benefit and cost+effectiveness. Nationa governments intergovernmenta
organi;ations agencies )rofessiona organi;ations nongovernmenta organi;ations industry
and academia have im)ortant roes in generating such 3no(edge and transating it into
)ractice.
Particuary im)ortant ga)s in 3no(edge that need to be fied incude the foo(ing@
• 'he incidence )revaence range across )athogens and geogra)hicaA )atterns
reated to antimicrobia resistance are a information that is needed to guide
the treatment of )atients@ to inform oca nationa and )rovincia actionsA and
to monitor the effectiveness of interventions.
• nderstanding of ho( resistance deveo)s and s)reads incuding ho(
resistance circuates (ithin and bet(een humans and animas and through
food (ater and the environment is im)ortant for the deveo)ment of ne(toos )oicies and reguations to counter antimicrobia resistance.
• 'he abiity ra)idy to characteri;e ne(y emerged resistance in
microorganisms and eucidate the underying mechanismsA this 3no(edge is
necessary to ensure that surveiance and diagnostic toos and methods remain
current.
• nderstanding of the socia science and behavior needed to su))ort and
achievement of =b:ective+*.
• Research into incuding cinica trais of treatments for common bacteria
infections es)eciay in o(+resource settings.• Basic research and transationa studies to su))ort the deveo)ment of ne(
treatments diagnostics vaccines and other interventions.
• !conomic research incuding the deveo)ment of modes to assess the cost of
antimicrobia resistance and the costs and benefits of this action )an.
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*b+e'ti)e /# Red%'e the in'iden'e of infe'tion thro%gh effe'ti)e sanitation, hygiene and
infe'tion re)ention eas%res.
-any of the most serious and difficut+to+treat antibiotic+resistant infections occur in
heathcare faciities not ony because that is (here )atients (ith serious infections are
admitted but aso because of the intensive use therein of antibiotics and inadeuate measures
to )revent and contro infection.
Better hygienic and infection )revention measures are essentia to imit the
deveo)ment and s)read of antimicrobia+resistant infections and mutidrug+resistant
bacteria. !ffective )revention of infections transmitted through se6 or drug in:ection as (e
as better sanitation hand (ashing and food and (ater safety must aso be core com)onents
of infectious disease )revention. -aaria has the greatest )ubic heath im)act of a vector+
borne infectious diseases and is the most affected by antimicrobia resistanceA vector contro
hods the 3ey to maaria )revention contro and eimination.
Immuni;ation can reduce antimicrobia resistance in three (ays.
• !6isting vaccines can )revent infectious diseases (hose treatment (oud reuire
antimicrobia medicines.
• !6isting vaccines can reduce the )revaence of vira infections (hich are often
ina))ro)riatey treated (ith antibiotics.
• se of ne( or im)roved vaccines can )revent diseases that are becoming difficut
to treat or are untreatabe o(ing to antimicrobia resistance.
*b+e'ti)e 4 # *tiie the %se of antii'robial edi'ines in h%an and anial
health.
!vidence that antimicrobia resistance is driven by the voume of use of antimicrobia
agents is com)eing. >igh antibiotic use may refect over+)rescri)tion easy through over+
the+counter saes and more recenty via the Internet (hich are (ides)read in many
countries. Des)ite measures ta3en by some Provinces antibiotic use in humans animas and
agricuture is sti increasing. 'he )ro:ected increase in demand for anima food )roducts
may ead to yet further increases in antibiotic use.
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Data on antibiotics use are coected and anay;ed in many high+ and midde+income
countries. >o(ever data are ac3ing on antibiotic use in human beings at the )oint of care
and at federa and )rovincia eve.
-ore (ides)read recognition of antimicrobia medicines as a )ubic good is needed
in order to strengthen reguation of their distribution uaity and use and encourage
investment in research and deveo)ment. Industrys s)ending on )romoting )roducts is
greater than governmenta investment in )romoting rationa use of antimicrobia medicines
or )roviding ob:ective information.
Decisions to )rescribe antibiotics are rarey based on definitive diagnosis effective
ra)id o(+cost diagnostic toos are needed for guiding o)tima use of antibiotics in human
and anima medicine and such toos shoud be easiy integrated into cinica )harmacy and
veterinary )ractices. !vidence+based )rescribing and dis)ensing shoud be of the standard of
care.
Reguation of the use of antimicrobia agents is inadeuate or )oory enforced in
many )rovinces such as over+the+counter and Internet saes. Reated (ea3nesses that
contribute to deveo)ment of antimicrobia resistance incude )oor )atient com)iance the
)revaence of substandard medicines for both human and veterinary use.
*b+e'ti)e 5# "e)elo the e'onoi' 'ase for s%stainable in)estent that taes a''o%nt of
the needs of all ro)in'es, and in'rease in)estent in ne edi'ines, diagnosti' tools,
)a''ines and other inter)entions.
'he economic case must refect the need for ca)acity deveo)ment incuding training
in o(+resource settings and the need for ne( and accessibe interventions incuding
medicines diagnostics and vaccines.
!conomic im)act assessments are needed on the heath and broader socioeconomic
burden of antimicrobia resistance and shoud com)are the cost of doing nothing against the
cost and benefit of action. &ac3 of such data hindered im)ementation of the 2//* oba
Strategy for Containment of %ntimicrobia Resistance. 'he fe( studies on the economic cost
of antimicrobia resistance are imited chiefy to deveo)ed countries.
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Data on antibiotic use (i be coected and anay;ed in Provinces to deveo) a
database in antibiotic use in animas. >o(ever data are ac3ing on antibiotic use in human
being at the )oint of care and from Provinces.
-ore (ides)read recognition of antimicrobia medicines as a )ubic good is needed
in order to strengthen reguation of their distribution uaity and use and encourage
investment in research and deveo)ment. In some cases industrys s)ending on )romoting
)roducts is greater than governmenta investment in )romoting rationa use of antimicrobia
medicines or )roviding ob:ective information.
Decisions to )rescribe antibiotics are rarey based on definitive diagnosis effective
ra)id o(+cost diagnostic toos are needed for guiding o)tima use of antibiotics in human
and anima medicine and such toos shoud be easiy integrated into cinica )harmacy and
veterinary )ractices. !vidence based )rescribing and dis)ensing shoud be the standard of
care.
Reguation of the use of antimicrobia agents is inadeuate or )oory enforced in
many areas. Such as over+the+counter internet saes and ina))ro)riate )ractices. Reated
(ea3nesses that contribute to deveo)ment of antimicrobia resistance incude )oor )atient
com)iance the )revaence of substandard medicines for both human and veterinary use
7edera overnment is committed to )rovide safe effective and uaity medicine
at reasonabe )rice (ith rationa use to meet the -iennium Deveo)ment oas 1-Ds set
forth.
If a))roved by the Registration Board the action )an may be submitted to the Poicy
Board for further deiberation and necessary action and as (e as for the deveo)ment "
strengthening of Pharmacovigiance Centers at federa " )rovincia settings.
Submitted for consideration of Registration Board
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$ase !o.02# &olio nd-ae (trategies-&olio)ir%s 3ye 2 'hallenge st%dy. A i)e Ar
$o%nity Based Randoied 3rial, ara'hi. &aistan.
'he sub:ect tria (as a))ied by Dr. %i 7aisa Saeem De)t. of Pediatrics " Chid
>eath %ga Ehan niversity 1Princi)e Investigator (hich the has been discussed in the -+
24Fth meeting of Registration Board. 'he 3ey feature of the tria is as under@
'ite Poio !nd+game strategies+Poiovirus 'y)e 2 chaenge study. % 7ive %rm
Community Based Randomi;ed 'ria Earachi. Pa3istan.
Phase III
Bac3ground Poio disease is )resent in ony three countries incuding Pa3istan. Since thein:ectabe )oio vaccine has better resuts 5>= =.
-onitor of the
'ria.• Dr. -aha -ohamed Saadedine Saama
>ead Cinica Research SectorG#%CS!R% Cairo!gy)t.
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S)onsor • 5ord >eath =rgani;ation 1eneva
%n e6)ert o)inion from the foo(ing three e6)erts (as aready ta3en and )resented before the
Board to faciitate the decision+ma3ing )rocedure of Board.
(.!o
.
6ert !ae *inion
*. Syed Sohai Lahoor
Laidi Chief Scientist
1#iroogy >ead of De)artment of #iroogy
It is hereby informed that the sub:ect study is (e )anned to
determine the im)roved effect of vaccination (ith combined
formuations i.e bivaent =P# M IP# vaccines to fi+in thega)s in immunity ty)e 2 )oioviruses among Pa3istani
Chidren.
'he study (i be conducted (ith the financia and technicasu))ort of 5>= >ead $uarters eneva and does not )ose
any a))arent burden on the oPGNationa or internationa sta3e
hoders )roviding assistance for the Poio !radication )rogramin the country.
I ho)e that the findings and outcomes of this interventiona
st%dy ill iro)e o%r %nderstandingand he) to devise )rogressive recommendations for vaccination to achieve the
goa of Poio eradication.
2. -r.-a;haruah
-emon Princi)a
Scientific
=fficerG-anager $uaity Contro
&aboratory.
'he five arms )an for !nd ame Poio #irus the )attern of
dosing as described are suitabe for the sub:ect study and the
sub:ect cinica tria is suggested in my o)inion and there is no
financia burden on the overnment of Pa3istan.
K. Dr. >aider Shera;i
Neonatoogy PI-S
Isamabad.
'he e6)ert has recommended the cinica tria.
5herein the Board in its -+24F th meeting after thorough deiberation on the study decided as
under@
Princi)a Investigator 1PI Dr. %i 7aisa %ssistant Prof and Dr. 'ahir
Oousaf ;ai Senior Instructor both from %ga Ehan niversity a))eared before the Board
to deiberate u)on the tria 1(hich is s)ecific to Pa3istan ony.
Registration Board gained 3no(edge from the )resentation given by the above
re)resentatives that they intend to )artiay amend the tria by adding additiona
com)arison through m=P# to aready indicated IP# and IP#2. -oreover there is a need
to submit the detais of )ubished and un)ubished data reated to the tria. 7urther the
reguatory a))rova 1aong(ith summary )rotoco of the IP#2 in the country of origin is
reuired by the a))icant.
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Registration Board a))reciated the )resentation and recommended that the tria
under )resent condition is currenty )remature uness (e have the secondary o)inion from
additiona e6)ert namey Prof. Dr. 'ari Bhutta and aso o)inion from 5>= regarding
the current status of the instant tria at other cinica tria centers in the (ord 1if any.
%dditionay the Princi)a Investigator 1PI G %))icant be advised to ma3e arrangement
for e6tending the sero+testing and viroogy (ith NI> as a secondary arrangement.
Registration Board agreed to the conduct of tria. >o(ever outcome of the e6)ert
o)inions (i be )resented in the forthcoming meeting of the Board for fina decision.?
In )ursuance of above Registration Board decision the additiona e6)ert o)inion on the tria (as
south from Dr. 'ari Bhutta and aso o)inion from 5>= regarding the current status of the
instant tria at other cinica tria centers in the (ord 1if any. No( the Dr. 'ari Bhutta has
re)ied and sent his o)inion through an e+mai (hich is re)roduced as under@
3ari7 Bh%tta tbhutta24/Qgmai.com Sat %)r 4 2/*0 at *@/8 P-
'o@ babar3hanabuham;aQgmai.com babar3hanabuham;aQgmai.com
Dear Mr Babar
Sorry for a delayed reply to your letter regarding the aboved mentioned subject. Dr Ali
Saleems proposal about assessing the protection of type2 polio virus after using bivalent
OP and !P and comparing it "ith protection afforded by tOP only.
#e also plan to $uantify the cross reactivity of bOP on inducing type 2 immunological
reaction. %he type2 "ild polio virus has been eradicated globally in &'''. But the vaccine
derived polio virus crops up in those areas "here the routine coverage of polio immunisation
is poor. %his has happened in Baluchistan as "ell as (a)iristan in the last fe" years.
%his is the reason that (#O is planning to introduce one dose of !P in the *P! program
from +une this year to provide protection against all three "ild types of polio virus "ithout
ris, of APP as "ell as -DP.
!n vie" of these challenges the research proposal by Dr Ali Saleem loo,s interesting and "ill
provide evidence of using only bivalent OP and "ithdra"ing tOP. ! "ould recommend that he may be allo"ed to import trial vaccines as re$uired particularly mOP2 and !P2
and. !P.
3he oinion fro * is still aaited. A reinder has already been iss%ed.
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Regarding Board advice for e6tension in sero+testing and viroogy in NI> the a))icant has submitted its
res)onse through an e+mai as@
Dear %i
5e are committed to test the stoo sam)es at #iroogy NI>.'he NI> sero+testing faciity is
under deveo)ment.
Eind RegardsSohai Laidi
Prima acie this is the case of grant of a))rova of cinica tria )ermission to be conducted as )er
)rotoco a))roved by 5>= at %ga Ehan -edica niversity. 'hree e6)ert o)inions (ere aready in
favour of the conduct of the tria )ermission. >o(ever an additiona o)inion on the direction of the Board
has aso been sought " the same is aso in favour of the tria.
'he case is submitted for consideration so as to grant the )ermission if considered a))ro)riate in the
)ubic interest by the Board.
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$ase !o. 0/# Re'obinant Bo)ine roth orone :rB or rB(3;
% (rit )etition No. */KG2/*0 fied by the Sarfra; %hmed sGo Na;ir %hmed #s State " (rit
)etition N /. **8/KG2/*0 fied by ha;anfar %bbas " Saain %bbas #s State are aready under
submission (ith the >onorabe Court. 'his is based on a))earance of a 7act Sheet comes on thesurface of the internet regarding Re'obinant Bo)ine roth orone :rB or rB(3;
deveo)ed by Ric3 North =regon Physicians for Socia Res)onsibiity November 2/*/(hich is
re)roduced as under@
'he 7D% a))roved the use of recombinant bovine gro(th hormone 1rB> or rBS' in dairy
co(s in *,,K. 'his (as done over the (ides)read ob:ections of farmers )ubic heath advocates
and anima (efare agencies. 'his geneticay engineered hormone (as deveo)ed by -onsanto
and sod to !anco a division of the !i &iy drug com)any in 2//8. Its trade name is Posiac.
'here is over(heming documented evidence that rB> increases the rates of )hysica harm to
co(s.'his )a)er summari;es the case against the use of rB> on anima (efare grounds and
reinforces the ca to disao( it.
"A &osila'< &a'age Insert
%though the 7D% ao(ed rB> to be commerciai;ed it ac3no(edged that it increased the
rates of * harmfu )hysica effects on co(s and reuired an insert isting the foo(ing
conditions be )aced in every )ac3age sod. 'hese incude@
Rerod%'ti)e ffe'ts@ Reduced )regnancy rates increase in days o)en increased
incidence of retained )acenta decreased gestation ength and birth (eight of caves In'reased rate of 'lini'al astitis and In'reased rate of s%b'lini'al astitis :soati'
'ell 'o%nt;
In'reased body teerat%re %nrelated to illness :heat stress;
In'rease in digesti)e disorders, s%'h as indigestion, bloat and diarrhea
In'rease in red%'ed feed intae :off-feed;
In'reased n%bers of enlarged ho's and lesions and in'reased n%bers of foot
disorders
In'reased n%ber of in+e'tion site rea'tions = selling Red%'tions in heoglobin and heato'rit )al%es
"A Ad)erse "r%g Rea'tion Reorts
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%fter rB> (as a))roved farmers submitted re)orts to the 7D% describing harm the drug had
caused to their co(s. 'hese incuded a of the above )us others such as abortions, birth
defe'ts, in'reased tinning rates and laeness.
'hese harmfu effects are (ides)read. 7rom *,,4 to 2//0 the 7D% received 24/8 adverse drug
reaction re)orts from farmers that described harmfu effects to co(s in:ected (ith rB>.
17reedom of Information %ct documents received from 7D% Se)t. 2/*/ 'here are currenty
about 0/// dairy farmers in the .S.
>("A Reorts#
'he SD% )eriodicay issues re)orts on the state of %merican agricuture incuding dairy. 'heir
Dairy 2//2 Re)ort (as cear on rB>@
?"airy rod%'ers ha)e e6ressed 'on'erns abo%t :r;b(3 %se. 3hese 'on'erns in'l%de#
anialhealth . . . and %bli' health 'on'erns . . . "airy rod%'ers that ere not '%rrently
%sing b(3 ere ased to des'ribe their reason for not ileenting a b(3 rogra . . . 'ost
and anial health ere a+or 'on'erns se'ifi'ally identified in all regions . . .@
A'adei' (t%dies#
>enry %n and &esie Buter have done severa studies on (hy farmers started and ater
disado)ted use of rB>. 'heir *,,F+,8 study found ?Many :farers; . . . had robles lie
astitis, laeness, loss of 'ondition, and loered i%ne syste f%n'tions hi'h they
attrib%ted to rb(3 %se.@ 'heir 2//8 re)ort on disado)tion rates in Caifornia found that *09 of
farmers cited high veterinary costs as ?)ery iortant@ in their decision to sto) using rB>.
1>enry %n and &esie Buter eath
Canada November *,,8. %t@
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htt)@GG(((.hc+sc.gc.caGdh)+m)sGvetGissues+en:eu6Grbst+stbrGre)Tcvma+ra)TacdvTtc+tm+eng.)h).
>eath Canada announced in Hanuary *,,, that ?it had to re+e't the re7%est for aro)al to
%se rb(3 in $anada, as it resents a s%ffi'ient and %na''etable threat to the safety of
dairy 'os.@ 1Institute of 7ood Science and 'echnoogy Information Statement on Bovine
Somatotro)in. 2//4 ). 0 at@
(((.ifst.orgGdocument.as)6UidJ**K
% scientific committee in the ! found rB> use ed to ?ainf%l and debilitating@ conditions
in co(s and ?3herefore fro the oint of )ie of anial elfare, in'l%ding health, the
('ientifi' $oittee on Anial ealth and Anial elfare is of the oinion that :r;B(3
sho%ld not be %sed in dairy 'os.@
1Re)ort on %nima 5efare %s)ects of se of Recombinant Bovine Somatotro)in. Re)ort of the
Scientific Committee on %nima >eath and %nima 5efare. -arch */ *,,,. %t@
htt)@GGec.euro)a.euGfoodGfsGscGscahGout2*Ten.)df
*rganiational (tan'es#
#irtuay every ma:or anima (efare organi;ation in the .S. o))oses rB>. 'his incudes the
>umane Society of the .S. 1>SS >umane 7arming %ssociation and 7arm Sanctuary.
%ccording to -iyun Par3 former #ice President of 7arm %nima 5efare of >SS ?It s‟
sily rong to in+e't 'os ith a s%bstan'e lie rB that in'reases ainf%l and
debilitating diseases lie astitis and laeness.@
1. Hohn
Einsman )resident of the 7amiy 7arm Defenders stated ?3he "A s aro)al . . . did not‟
e)en 'onsider the deonstrated health ia'ts on dairy 'os or the otential riss to
h%an 'ons%ers.@
Coi'es of the arers 3hesel)es = A sall sale#
'iamoo3 dairy farmer Dic3 >eathersha( . . . ?7%it %sing the rod%'t :rB; after noti'ing
'os ere slitting o%t in the el)i' area, ere groing hoo)es at an a''elerated rate and
ere e6erien'ing %n%s%ally high le)els of abs'esses . . . De tho%ght e ere seeing things
in o%r 'os health-isethat e didn t lie and that e hadnEt seen before.E@‟ 1Ca)ita Press
7eb. 20 2//0
? DIt s lie steroids for athletes, said (tehen . 3aylor, !e ashire s $oissioner‟ ‟ ‟
of Agri'%lt%re, Marets and ood and a dairy farer hiself. e said he had tried the
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horone b%t it %t stress on his 'os and ade the thinner.@ 1Ne( Oor3 'imes =ct. F
2//
?. . . ost $o%ntry $lassi' farers eren t een on groth horone be'a%se of the‟
otential harto their sto'. 3he ord aong farers as that groth horone boostedil rod%'tion in the short ter b%t shortened the 'o s rod%'ti)e life.@‟ 1Biings -'
a;ette Se)t. *K 2//8
'he case is being submitted and brought to the notice of the Registration Board as )er
reuirement of rue K/ 1*/ 1a of Drugs 1&icensing Registering and %dvertising Rues *,F
for any further necessary advice and future course of action.
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Ite !o.III &hara'e%ti'al )al%ation F Registration "i)ision.
$ase !o.01# Referen'e reg%latory a%thorities and 'o%ntries for grant of registration
Registration board grants registration of drugs if a drug is registered in any of the
reguatory authorities namey S 7D% !-% '% %ustraia >eath Canada and P-D% Ha)an.
It has been em)hasi;ed by sta3ehoders that this criterion shoud be broadened and other
countries be aso incuded in this ist to ma3e more thera)ies avaiabe to )atients in the country.
'herefore in addition to above reguatory authorities other deveo)ed countries (ith stringent
drug reguatory systems may aso be considered for registration of drugs in the country@
Submitted for consideration of board
$ase !o.02# (egregated fa'ility for sy'hotroi' dr%gs
Centra &icensing Board in its 2KKrd meeting (hie discussing the manufacturing
reuirements for )sychotr)ic drugs decided as foo(s@
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$ase !o.0/# %idelines on stability st%dies
Registration Board too3 foo(ing decision in 248th meeting regarding stabiity data reuired for
registration of drugs@
a. Manufacturers shall submit laboratory scale scientifically rational stability data for their
registration applications ne"1me too4 for consideration of the Board. :rant of registration "ill
be subject to commitment of manufacturer for performing and approval of stability testing as per
!-# 1 (#O guidelines as applicable before sale of drug.
b. All appliacnts "ho have been previously advised to provide stability studies as per !-#1(#O
guidelines "ill be again advised to submit laboratory scale scientifically rational stability data
for further consideration by 0egistration Board.
In ve( of above foo(ing )ro)osaG guideine has been submitted by PP-% for conducting
stabiity studies in Pa3istan.
&%rose#
'he )ur)ose of this )rocedure is to )rovide guideines and instruction for both acceerated
stabiity and ong term stabiity studies of finished )roducts.
&ro'ed%re#
7inished Products shoud be tested at designated testing freuency for certain chemica )hysica
bioogica and microbioogica)ro)erties 1(here a))icabe as )er s)ecifications and abe caim to
confirm the stabiity of the )roduct (ithin the )ro)osed shef ife.
'he stabiity study of the finished )roduct shoud be in the same formuation same s)ecifications
and same container cosure system 1)ac3ing es)eciay )rimary )ac3ing as )ro)osed for
mar3eting.
(torage 'onditions#
'he studies shoud be carried out at foo(ing storage conditions@
a. Intended to be stored at tem)erature beo( K/ VC
%cceerated stabiity 14/°C M 2°C and F09 M 09 R>
&ong 'erm stabiity 1K/°C W 2VC and 0 9 W 0 9 R>
b. Intended to be stored in Refrigerator
%cceerated stabiity 120°C M 2°C and /9 M 09 R>
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&ong 'erm stabiity 10°C W K VC
'. Intended to be stored in free;er
%cceerated stabiity 10°C M K°C
&ong 'erm stabiity 1+2/°C W 0 VC
"%ration and fre7%en'y of testing#
'he duration of acceerated stabiity shoud be months and freuency of testing shoud be
/*K and months.
'he duration of ong term stabiity shoud be 24 months and freuency of testing shoud be
/ K , *2 *8 24 months.
(ele'tion of bat'hes for stability st%dies#
Stabiity studies shoud be )erformed on the foo(ing@
• =ne &ab scae batch.
• '(o Piot batches.
Gab s'ale trial bat'h#
'he sam)e uantity shoud be determined on the basis of testing method G s)ecification and
intervas. Sufficient uantity for one testing muti)ied by number of testing gives the tota
uantity for com)ete studyA uantities reuired on this basis are a))ended beo(@
• 7reuency of tests / * K
" J /4
• Retest1s if reuired J /*
• 'ota tests J /0
(.
!o."osage or Hty. &er 3est
3otal H%antity
Re7%ired
*.'abet G Ca)sue 4/ Nos. 4/ 6 0 J 2// Nos.
2. Dry Sus)ensions G Sachets 1=ra
• Sus)ensions/0 Bottes 0 6 0 J 20 Bottes
• Sachets/0 Sachets 0 6 0 J 20 Sachets
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K.Dry Po(der In:ections /0 #ias 0 6 0 J 20 #ias
4. Semi Soids
• Cream G =intment G e/2 'ubes 2 6 0 J */ 'ubes
0. &iuid 1=ra
• &iuid Syru) G Sus)ension/2 Bottes 2 6 0 J */ Bottes
. Sterie &iuids
• Infusion/2 #ias 2 6 0 J */ #ias
• In:ection/0 %m)s. G #ias 0 6 0 J 20 %m)s. G#ias
• !ye Dro)s/2 Pac3s 2 6 0 J */ Pac3s
F.
Bioogica Products
• Pre+7ied Syringe 1P7S/0 P7S 0 6 0 J 20 P7S
• &iuid vias/0 #ias 0 6 0 J 20 #ias
• &yo)hii;ed vias/0 #ias 0 6 0 J 20 #ias
• %m)oues/0 %m)oues 0 6 0 J 20 %m)oues
%. &ilot Bat'h :10 of $oer'ial Bat'h;
•7reuency of tests 1%cceerated / *K "
J /4
• 1&ong term / K
, *2 *8 24J /
• Retest1s if reuired J /2
• 'ota tests J *2
(.
!o."osage or
Hty. &er
3est
H%antity Re7%ired3otal H%antity
Re7%ired
or 3ests
:A;
orCalidation
:B;:A B;
*. 'abet G Ca)sue 4/ Nos.4/ 6 *2 J
48/
4/ 6 K0 J
*4//
48/ M *4// J
*88/
2. Dry Sus)ensions G Sachets
1=ra
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• Sus)ensions/0 Bottes /0 6 *2 J / /0 6 K0 J *F0 / M *F0 J 2K0
• Sachets/0 Sachets /0 6 *2 J / /0 6 K0 J *F0 / M *F0 J 2K0
K.Dry Po(der In:ections /0 #ias /0 6 *2 J / /0 6 K0 J *F0 / M *F0 J 2K0
4. Semi Soid
• Cream G =intment G
e/2 'ubes /2 6 *2 J 24 /2 6 K0 J F/ 24 M F/ J ,4
0. &iuid 1=ra
• &iuid Syru) G
Sus)ension/2 Bottes /2 6 *2 J 24 /2 6 K0 J F/ 24 M F/ J ,4
. Sterie &iuids
• Infusion/2 #ias /2 6 *2 J 24 /2 6 K0 J F/ 24 M F/ J ,4
•In:ection
/0 %m)s.G
#ias/0 6 *2 J / /0 6 K0 J *F0 / M *F0 J 2K0
• !ye Dro)s/2 Pac3s /2 6 *2 J 24 /2 6 K0 J F/ 24 M F/ J ,4
F. Bioogica Products
• Pre+7ied Syringe
1P7S/0 P7S /0 6 *2 J / /0 6 K0 J *F0 / M *F0 J 2K0
• &iuid vias/0 #ias /0 6 *2 J / /0 6 K0 J *F0 / M *F0 J 2K0
•&yo)hii;ed vias
/0 #ias /0 6 *2 J / /0 6 K0 J *F0 / M *F0 J 2K0
• %m)oues/0
%m)oues/0 6 *2 J / /0 6 K0 J *F0 / M *F0 J 2K0
Iort of ra aterial#
7or conducting Stabiity Studies of &ab Scae and Piot Batches ra( materias (i be im)orted
through courier for reuired uantities ony (ithout concurrence of DR%P
)al%ation of res%lts#
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'he data is to be evauated systematicay for significant changes 1e6ceeding the s)ecifiedG
ao(ed &imits in )articuar attributes of different dosage forms i.e. Descri)tion G Physica
a))earance %ssay G Potency P> Dissoution rate and Disintegration time etc.
A''etan'e 'riteria#
% )roducts must com)y (ith the )hysica chemica microbia and bioogica 1(here
a))icabe )arameters s)ecified in s)ecification of finished )roduct and the )roduct shoud sho(
no significant changes throughout the )eriod of stabiity studies.
(tability data for registration of the rod%'t#
'he data of acceerated stabiity studies of one ab scae batch is to be submitted for registration
of the )roduct. If acceerated stabiity studies data of initia one " three months testing indicates
no significant changes from initia the data may be submitted for registration )ur)ose (ith thecommitmentGunderta3ing to do stabiity studies u) to monthsA a))icants (i submit months
data to DRB for considering their drug registration a))ications.
(tability data-&ost-registration#
• =n com)etion of acceerated stabiity studies and rea time stabiities of one ab scae
batch and t(o )iot batches data (i be submitted to DR%P
•
=ngoing stabiity record of acceerated and ong term stabiity study of retained sam)esof first three commercia batches shoud be maintained in the )remises for record
Submitted for consideration of the board.
$ase !o. 04# Registration ali'ations of ne dr%g an%fa't%ring li'enses
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)al%ator II
Sr.
No
.
Name and
address of
-anufacturer G
%))icant
Brand Name
1Pro)rietary name
M Dosage form M
Strength
Com)osition
Pharmacoogica
rou)
7inished )roduct
s)ecification
'y)e of 7orm
Initia date
diary.
7ee incuding
differentia fee
Demanded
Price G Pac3
si;e
Internationa
status in stringent
reguatory
agencies
-e+too status
-P status as
de)icted in
ins)ection re)ort
1dated
Remar3s G =bservations
*. Ms Aaan
&hara /0,
(heih%%ra
Road Gahore.
D-& No.
///8/8 dated@
20+/2+*0
&iuid
In:ection
%m)oue
1enera
No. 7.*+G2/*K+
&ic dated 2nd
-arch 2/*0
%ua Pro In:ection
!ach am)oue
contains@
5ater for In:ection
1B.P X..0m
1Sovent G Diuent
1BP S)ec.s
7orm 0
Dy.No@ *448
Dated@ /+/K+
2/*0
Rs. 2////G+
Rs. 0/G+ 0m Y
*// am)oue
BN7 @ 5ater for
In:ection
Ne( D-&
2. +do+ Eamevi In:ection
!ach 2m contains@
Pheniramine
-aeate 1B.P
X.40.0mg
1%ntiaergic
1-anufacturers
S)ec.s
7orm 0
Dy.No@ *44F
Dated@ /+/K+
2/*0
Rs. 2////G+
Rs. 40/G+Pac3
of *// am)oue
of 2m
Not )rovided
%ervi In:ection
Indus Pharma
*.Internationa avaiabiity in
S+7D% !-% >eath
Canada '% " ->&5 for
same generic dosage form
" strength not )rovidedGnot
confirmed.
2. 7irm has caimed that the
formuation is avaiabe in
Bangadesh.
K. +do+ Eamefenac
In:ection
!ach Km contains@
Dicofenac Sodium
X.F0mg
7orm 0
Dy.No@ *44
Dated@ /+/K+
2/*0
Rs. 2////G+
#otra of
Novartis E
%mefenac
In:ection
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1Non Narcotic
%nagesic G %nti+
infammatory
1-anufacturers
S)ec.s
Rs. 0/G+Pac3
of *// am)oue
%meer Pharma
4. +do+ Eamefenac Pus
In:ection
!ach Km contains@
Dicofenac Sodium
1B.P XF0mg
&ignocaine >C
1B.PX2/mg
1Non Narcotic
%nagesic G %nti+
infammatory
1-anufacturers
S)ec.s
7orm 0
Dy.No@ *440
Dated@ /+/K+
2/*0
Rs. 2////G+
Rs. 2K/G+Pac3
of Km Y0
am)oue
Not )rovided
Dico+Cane
In:ection
%meer Pharma
1R.No /042*,
*.Internationa avaiabiity in
S+7D% !-% >eath
Canada '% " ->&5 for
same generic dosage form
" strength not )rovidedGnot
confirmed.
0. +do+ D.H.-oe In:ection
!ach 2m contains@
Paracetamo 1B.P
X.K//mg
&ignocaine+>C
1B.PX2/mg
Non+Norcotic
%nagesic
%nti)yretic
1-anufacturers
S)ec.s
7orm 0
Dy.No@ *40*
Dated@ /+/K+
2/*0
Rs. 2////G+
Rs. ,/G+Pac3 of
2m Y0am)oue
Not )rovided
Chi3ymo+&
1%meer Pharma
R. No. /4F///
*.Internationa avaiabiity in
S+7D% !-% >eath
Canada '% " ->&5 for
same generic dosage form
" strength not )rovidedGnot
confirmed.
. +do+ -averine
In:ection
!ach 2m contains@
Drotaverine >C
X.4/mg
%ntichoinergic and
anagesic
7orm 0
Dy.No@ *402
Dated@ /+/K+
2/*0
Rs. 2////G+Rs. 4//G+Pac3
of 20 am)oue
Not )rovided
No+S)a In:cetion
1Sanofi %ventis
*.Internationa avaiabiity in
S+7D% !-% >eath
Canada '% " ->&5 for
same generic dosage form
" strength not )rovidedGnot
confirmed.
F. +do+ -ecobaamine
In:ection
!ach m contains@
7orm 0
Dy.No@ *40K
Dated@ /+/K+
%))roved in -+248
!gin 1Novartis
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-ecobaamine 1HP
X0//mcg
Coen;yme+ty)e
#itamin B*2
1HP
2/*0
Rs. 2////G+
Rs. /G+Pac3
of */ am)oue
8. +do+ -acine In:ection
!ach m contains@
>yoscine+N+
butybromideX.2/
mg
%ntichoinergic and
anagesic
1BP S)ec.s
7orm 0
Dy.No@ *40F
Dated@ /+/K+
2/*0
Rs. 2////G+
Rs. //G+Pac3
of K/ am)oue
BN7 @ Busco)an
1Boehringer
Ingeheim vo
of in: is *m
Busco)harm
In:ection
1!)harm &ab
,. +do+ %)egent In:ection
!ach m contains@
entamycin
Su)hate1SP
euivaent to
entamycin baseX
4/mg
1%minogycoside G
%ntibiotics
1SP S)ec.s
7orm 0
Dy.No@ *40/
Dated@ /+/K+
2/*0
Rs. 2////G+
Rs. 20/G+Pac3
of
2m Y0
am)oue
BN7 @ Cidomycin1Sanofi+%ventis
enticyn
In:ection
1Ray Pharma
*/. +do+ &incomycinIn:ection
!ach 2m contains@
&incomycin >C
monohydrate
1SP euivaent to
&incomycin
baseX.//mg
&incosamide+
%ntibiotics
1SP S)ec.s
7orm 0
Dy.No@ *44,
Dated@ /+/K+
2/*0
Rs. 2////G+
Rs. 20/G+Pac3
of
0 Y2m
am)oue
7D%@ &incocin
&incocin
In:ection
Pfi;er
**. +do+
&iuid
In:ection
Progesterone
In:ection
!ach m contains@
Progesterone 1SP
7orm 0
Dy.No@ *42
Dated@ /+/K+
BN7@ estone
1Nordic
Not confirmed
*.-e+too status not confirmed.
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%m)oue
1>ormones
No. 7.*+G2/*K+
&ic dated 2nd
-arch 2/*0
X..0/mg
Progestogen
1SP S)ec.s
2/*0
Rs. 2////G+
Rs. *K/G+Pac3
of *m Y
*/ am)oue
*2. +do+ %)evinan In:ection
!ach m contains@
>ydro6y)rogestero
ne Ca)roate 1SP
X20/mg
=estradio #aerate
1SPX0mg
=estrogenGProgesto
gen 1>ormone
1-anufacturer
s S)ec.s
7orm 0
Dy.No@ *40
Dated@ /+/K+
2/*0
Rs. 2////G+
Rs. **/G+Pac3
of
*m 6 *
am)oue
Not )rovided
ravibinan
In:ection
Schering
*.Internationa avaiabiity inS+7D% !-% >eath
Canada '% " ->&5 for
same generic dosage form
" strength not )rovidedGnot
confirmed.
*K. +do+ Eameone+20
In:ection
!ach m contains@
Nandroone
Decanoate 1SP
X.20mg
%naboic Steroid
1SP
7orm 0
Dy.No@ *44
Dated@ /+/K+
2/*0
Rs. 2////G+
Rs. /G+Pac3 of
*Y*m am)oue
Not )rovided
Deca+duraboinIn:ection 1=BS
Pharma
*.Internationa avaiabiity in
S+7D% !-% >eath
Canada '% " ->&5 for
same generic dosage form
" strength not )rovidedGnot
confirmed. 7irm has
caimed that the
formuation is avaiabe in
South %firca.
*4. +do+ Eameone+0/
In:ection
!ach m contains@
Nandroone
Decanoate1 SP
X.0/mg
%naboic Steroid
1SP
7orm 0
Dy.No@ *4F
Dated@ /+/K+
2/*0
Rs. 2////G+
Rs. /G+Pac3 of
*Y*m am)oue
BN7@ Deca+
Duraboin
1-SD
Deca+duraboinIn:ection 1=BS
Pharma
*0. +do+ %)eone In:ection
!ach m contains@
Nandroone
7orm 0
Dy.No@ *4K
Dated@ /+/K+
Not )rovided
Duraboin
In:ection
1=BS
*.Internationa avaiabiity in
S+7D% !-% >eath
Canada '% " ->&5 for
same generic dosage form
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Phen)ro)ionate1S
P X.20mg
%naboic Steroid
1SP
2/*0
Rs. 2////G+
Rs. *K/G+Pac3
of *m Y
K am)oue
" strength not )rovidedGnot
confirmed. 7D% a))roved
DR%B=&IN is
discontinued.
*. +do+ Haberone In:ection
!ach m contains@
'estosterone
!nanthate 1SPX
20/mg
%ndrogen G Se6
>ormone
1SP
7orm 0
Dy.No@ *44
Dated@ /+/K+
2/*0
Rs. 2////G+
Rs. 2F0G+Pac3
of
*m YK
am)oue
BN7@'estosterone
!nantate 1Non+
)ro)rietary
'estovirone
In:ection
1Bayer
*F. +do+ 'esterone+*//
In:ection
!ach m contains@
'estosterone
)ro)ionate 1B.PX
K/mg
'estosterone
)heny)ro)ionate
1B.PX/mg
'estosterone
Isoca)roate 1B.PX/mg
'estosterone
Decanoate 1B.PX
*//mg
1%ndrogen G Se6
>ormone
1-anufacturers
S)ec.s
7orm 0
Dy.No@ *4F/
Dated@ /+/K+
2/*0
Rs. 2////G+
Rs. 2*/G+Pac3
of
*m YK
am)oue
BN7@ Sustanon
20/ 1-SD
Sustanon 1=BS
*8. +do+ =6ytocin+0
In:ection 1IG- IG#
!ach m contains@
=6ytocin X.0I
=6ytocic
1SP
7orm 0
Dy.No@ *48Dated@ /+/K+
2/*0
Rs. 2////G+
Rs. 0/G+Pac3
of
*m Y *//
am)oue
BN7@Syntocinon
1%iance
Syntocinon
In:ection
Novartis
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*,. +do+ =6ytocin+*/
In:ection 1IG- IG#
!ach m contains@
=6ytocin X.*/I
=6ytocic
1SP
7orm 0
Dy.No@ *4,
Dated@ /+/K+
2/*0Rs. 2////G+
Rs. //G+Pac3
of
*m Y *//
am)oue
BN7@Syntocinon
1%iance
Syntocinon
In:ection
Novatis
2/. +do+ =stogen In:ection
!ach m contains@
!stradio
#aerateX.0mg
1=estrogenic
>ormone
1SP
7orm 0
Dy.No@ *4F*
Dated@ /+/K+
2/*0
Rs. 2////G+
Rs. *K/G+Pac3
of
*m Y K
am)oue
Not )rovided
=vogen
In:ection Lafa
*.Internationa avaiabiity in
S+7D% !-% >eath
Canada '% " ->&5 for
same generic dosage form
" strength not )rovidedGnot
confirmed.
2*. +do+
&iuid
In:ection
am)oue
1Steroid
No. 7.*+G2/*K+
&ic dated 2nd
-arch 2/*0
Betasone In:ection
!ach m contains@
Betamethasone 1%s
Sodium Phos)hate
X..4mg
ucocorticoid
1SP
7orm 0
Dy.No@ *40,
Dated@ /+/K+
2/*0
Rs. 2////G+
Rs. */G+Pac3
of
*m Y0
am)oue
BN7 @ Betneso
1RP>
BetnesoIn:ection
SE
22. +do+ Eamede6 4mg
In:ection
!ach m contains@
De6amethasone
disodium
Phos)hate e. to
De6amethasone
Phos)hate X.4mg
7orm 0
Dy.No@ *40Dated@ /+/K+
2/*0
Rs. 2////G+
Rs. 20/G+Pac3
of
*m Y 20
am)oue
BN7@
De6amethasone
1Non+)ro)rietary
De6ame6
In:ection
1Bosch
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ucocorticoid
1SP S)ec.s
2K. +do+ Eamede6 *mg
In:ection
!ach m contains@
De6amethasone
Sodium Phos)hate
e. to
De6amethasone
Phos)hate X.*mg
ucocorticoid
1SP
7orm 0
Dy.No@ *480
Dated@ /+/K+
2/*0
Rs. 2////G+
Rs. *K/.0FG+
Pac3 of
*m Y 20
am)oue
Not )rovided
Not confirmed
*.Internationa avaiabiity in
S+7D% !-% >eath
Canada '% " ->&5 for
same generic dosage form
" strength not )rovidedGnot
confirmed.
2.-e+too status needs
confirmation.
24. +do+ Eamecort In:ection
IG- IG
!ach m contains@
'riamcinoone
%cetonideX4/mg
1ucocorticoid
1BP S)ec.s
7orm 0
Dy.No@ *400
Dated@ /+/K+
2/*0
Rs. 2////G+
Rs. /G+Pac3 of
*m Y*
am)oue
BN7@ Eenaog
Intra+articuarGIntramuscuar
1Suibb
Eenacort %
1SE
20. +do+ Eamedro+De)o
In:ection
!ach m of aueous
sus)ension
contains@
-ethy)rednisoon
e %cetateX.4/mg
ucocorticoid
1BP S)ec.s
7orm 0
Dy.No@ *404
Dated@ /+/K+
2/*0
Rs. 2////G+
Rs. 2//G+Pac3
of
*m Y*
am)oue
BN7 @ De)o+
-edrone
1Pharmacia
De)o+medro
In:ection1Pfi;er
2. +do+ Preone+*0
In:ection
!ach m contains@
Prednisoone
Sodium Phos)hate
X.*0mg
7orm 0
Dy.No@ *4/
Dated@ /+/K+
2/*0
Rs. 2////G+
Rs. *0/G+Pac3
of
Not )rovided
Not )rovided
*.Internationa avaiabiity in
S+7D% !-% >eath
Canada '% " ->&5 for
same generic dosage form
" strength not )rovidedGnot
confirmed. BN7 a))roved
estone 1Nordic strength
is 0/mgGm.
28
-
8/15/2019 Agenda 249th Registration Board Meeting
29/741
ucocorticoid
1SP
*m Y*
am)oue
2.-e+too status not confirmed.
2F. +do+ Preone+K/
In:ection
!ach m contains@
Prednisoone
Sodium Phos)hate
X.K/mg
ucocorticoid
1SP
7orm 0
Dy.No@
Dated@ /+/K+
2/*0
Rs. 2////G+
Rs. 2//G+Pac3
of
* am)oue
Not )rovided
Not )rovided
*.Internationa avaiabiity in
S+7D% !-% >eathCanada '% " ->&5 for
same generic dosage form
" strength not )rovidedGnot
confirmed. BN7 a))roved
estone 1Nordic strength
is 0/mgGm.
2.7irm has )rovided reference
of Prednisoone sodium
)hos)hate In:ection Sim)e6
)harma 1Ne( Dehi India.
K.-e+too status not confirmed.
28. M( inthro6
Gaboratories
:&)t.; Gtd. &lot.
!o. =219=A,
(.I.3.. &hase
II, (%er
ighay
ara'hi.
D-& No1///8/F dated
20./2.*0
!ye Dro)s
1enera
Section No. 7.
*+K8G2/**+&ic
dated 2nd -arch
2/*0.
=)tibre6+D !ye
Dro)s
Contains@+ !ach m
of sus)ension
contains@
'obramycin 1SP
X.. K mg "
De6amethasone
1SPX. *mg.1%ntibacteria (ith
Corticosteroid
1SP S)ec.s
7orm 0
2+/K+2/*0
1Dy. No. *8,0
Rs. 2////G+
Rs.28/.// )er
)ac3 of 0 m.
7D%@ 'obrade6
!ye Dro)s
1%con
Brade6 !ye
Dro)s 1=)a
&abs.G%;ron
rant of D-& by(ay of
formuation
recommended
12.*2.2/*4.
2,. +do+ Prednimus !ye
Dro)s
!ach m of sus)ension
contains@
Prednisoone
acetate 1SPX..
*/ mg.
1Corticosteroid
7orm 0
2+/K+2/*0
1Dy. No.*,/2Rs. 2////G+
Rs.8/.// )er
)ac3 of 0 m.
BN7@ Dro)s
1%ergan
Pred 7orte !ye
Dro)s
1%erganGBarrett
>odgson
rant of D-& by
(ay of
formuation
29
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30/741
1SP S)ec.srecommended
12.*2.2/*4.
K/. +do+ =)tinac !ye Dro)s
!ach m of
sus)ension
contains@
Ne)afenacXX..
*mg
1Non+Steroida
%nti+Infammatory
1NS%ID
1-anufacturers
S)ec.s
7orm 0
2+/K+2/*0
1Dy. No.*,//
Rs. 2////G+
Rs.4//.// )er
)ac3 of 0 m.
Nevanac !ye
Dro)s 1%con
Nevanac !yeDro)s 1%con
rant of D-& by
(ay of
formuation
recommended
12.*2.2/*4.
K*. +do+ =)tige /.2 9 !ye
Dro)s e
!ach gramcontains@
Poyacryic %cid
1Carbomer 1BP
X.2mg
1!ye &ubricant
1B.P S)ec.s
7orm 0
*8+/K+2/*0
1Dy. No.*8,FRs. 2////G+
Rs.*0/.// )er
)ac3 of */ gm.
BN7@ #iscotears
iuid ge 1%con
&oca@ #iso e
!ye Dro)s 1%tco
Rs.*24.//
rant of D-& by
(ay of
formuation
recommended
12.*2.2/*4.
K2. +do+ =)ti3et /.0 9 !ye
Dro)s
!ach m contains@
Eetoroac
'romethamine
1SP
XX.. 0mg
1Non+Steroida
%nti+Infammatory
1NS%ID
1-anufacturersS)ec.s
7orm 0
2+/K+2/*0
1Dy. No.*,/4
Rs. 2////G+
Rs.2//.// )er
)ac3 of 0 m.
BN7 @ %cuar
1%ergan
Dyac !ye Dro)s
1=)a
&abs.G%;ron
rant of D-& by
(ay of
formuation
recommended
12.*2.2/*4.
KK. +do+ Na;oine !ye
Dro)s
!ach m contains@
Na)ha;oine >C
1SPX.. /.20mg
Pheniramine
7orm 0
2+/K+2/*0
1Dy. No.*8,8
Rs. 2////G+
Rs.8/.// )er
)ac3 of *0 m.
7D%@
Na)hcon+% !ye
Dro)s 1%con
Nafamine !ye
Dro)s 1!thica
30
-
8/15/2019 Agenda 249th Registration Board Meeting
31/741
-aeate 1SP
XX.. Kmg
1%nti+histamine G
DecongestantG
Sym)athomimetic
1SP S)ec.s
&abs.
rant of D-& by
(ay of
formuation
recommended
12.*2.2/*4.
K4. +do+ =)tim !ye Dro)s
!ach m contains@
'imoo maeate
euivaent to
'imoo 1SP
XXX.. 0mg
1Beta Boc3er
1SP S)ec.s
7orm 0
2+/K+2/*0
1Dy. No.*,/*
Rs. 2////G+
Rs.*0/.// )er
)ac3 of 0 m.
BN7@ 'imo)to
1-SD
-editim !ye
Dro)s 1-edi)a3
rant of D-& by
(ay of
formuationrecommended
12.*2.2/*4.
K0. Ms Mission
&hara'e%ti'al
s&)t.; Gtd. &lot
!o. A-94,
(.I.3.. (>&R
IAJ
ARA$I
&aistan.
D-& No.
///8/, dated
20+/2+2/*0
1Ca)sue
Ce)haos)orin
section@ dated
2F+/2+2/*0
-!PR=LI&
Ca)sue
1 Cef)ro;i 0//mg
!ach ca)sue
contains@+
Cef)ro;i
monohydrate
1SP euivaent to
0// mg Cef)ro;i
1=ra 2nd
generation
ce)haos)orin
antibiotic
1-anufacturers
S)ec.s
7orm 0
/+/4+2/*0
1 2K82
Rs. 2////G+
%s Per SR=
* 6 */S
Bister Pac3
Demanded
)rice Rs. 00/./
Cef)ro;i 'eva
'eva nited
States
LI&PR=
5I&S>IR!
G>=RIL=N
Ne( D-&
*.Internationa avaiabiity in
S+7D% !-% >eath
Canada '% " ->&5 for
same generic dosage form
" strength not )rovidedGnot
confirmed.
K. +do+ C!7=ZI&
1Cefadro6i 0//
mg
Ca)sues
!ach ca)sue
contains@+
7orm 0
/+/4+2/*0
1 2K8F
Rs. 2////G+
%s Per SR=
* 6 *2S
Bister Pac3
Demanded
C!7%DR=ZI&
0//mg Ca)s
S7D%
N!C!7
0//mg Ca)sue
Sami
Ne( D-&
31
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Cefadro6i
-onohydrate
1SP euivaent to
0// mg Cefadro6i
1=ra ce)haos)orinantibiotic
SP S)ecification
for finished )roduct
)rice Rs. *,/./
KF. +do+ 7%C&=R
1 cefacor 20/ mg
Ca)sues
!ach ca)sue
contains@+
Cefacor
monohydrate
euivaent to 20/
mg Cefacor
=ra ce)haos)orin
antibiotic
SP S)ecification
for finished )roduct
7orm 0
/+/4+2/*0
12K,K
Rs. 2////G+
%s Per SR=
* 6 *2S
Bister Pac3 Demanded
)rice Rs. 2/./
BN7@ Eeftid
Cecor 1%P
Ne( D-&
K8. +do+ 7%C&=R 1 cefacor 0//mg
Ca)sues
!ach ca)sue
contains@+
cefacor
monohydrate
euivaent to 0//
mg cefacor
=ra ce)haos)orin
antibiotic
SP S)ecification
for finished )roduct
7orm 0/+/4+2/*0
12K,4
Rs. 2////G+
%s Per SR=
* 6 *2S
Bister Pac3
Demanded
)rice Rs. 4,/./
BN7@Distacor
17ynn
Cecor 1%P
Ne( D-&
K,. +do+ &!ZI-
1Ce)hae6in 0//
mg
7orm 0
/+/4+2/*0
12K8*
E!7&!Z
0//mg Ca)s
S7D%
32
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Ca)sues
!ach ca)sue
contains@+
Ce)hae6in
monohydrate
euivaent to 0//mg Ce)hae6in
=ra ce)haos)orin
antibiotic
SP S)ecification
for finished )roduct
Rs. 2////G+
%s Per SR=
* 6 *2S
Bister Pac3.
Demanded
)rice Rs. 2//./
C!P=R!Z
0//mg Ca)s
s3
Ne( D-&
4/. +do+ &!ZI-
1Ce)hae6in 20/
mg Ca)sues
!ach ca)suecontains@+
Ce)hae6in
monohydrate
euivaent to 20/
mg Ce)hae6in
=ra ce)haos)orin
antibiotic
SP S)ecification
for finished )roduct
7orm 0
/+/4+2/*0
12K8K
Rs. 2////G+%s Per SR=
* 6 *2S
Bister Pac3.
Demanded
)rice Rs. *//./
E!7&!Z
20/mg Ca)sS7D%
C!P=R!Z
20/mg Ca)s
s3
Ne( D-&
4*. +do+ -!PR%DIN
1 Ce)hradine 0//
mg Ca)sues
!ach ca)sue
contains@+
Ce)hradine 1SP
0// mg
=ra ce)haos)orin
antibiotic
SP S)ecification
for finished )roduct
7orm 0
/+/4+2/*0
1 2K,F
Rs. 2////G+
%s Per SR=
* 6 *2S
Bister Pac3.
Demanded
)rice Rs. 244.F
BN7@ Nicef
#eosef
Bristo -yres
Ne( D-&
42. +do+ -!PR%DIN
1 Ce)hradine 20/
7orm 0
/+/4+2/*0
BN7@ Nicef
33
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mg Ca)sues
!ach ca)sue
contains@+
Ce)hradine 1SP20/ mg
=ra ce)haos)orin
antibiotic
SP S)ecification
for finished )roduct
1 2K,8
Rs. 2////G+
%s Per SR=
* 6 *2S
Bister Pac3.
Demanded )rice Rs.
*24.00
#eosef
Bristo -yres
Ne( D-&
4K. +do+
1=ra Dry
)o(der
Sus)ensionsection
Ce)haos)orin
dated 2F+/2+
2/*0
C!7=ZI& =ra dry
sus)ension
1 Cefadro6i*20
mg
!ach 0 m
Contains@+
Cefadro6i
monohydrate
euivaent to *20
mg Cefadro6i
Ist+generation =ra
ce)haos)orin
antibiotic
SP S)ecification
for finished )roduct
7orm 0
/+/4+2/*0
12K88
Rs. 2////G+%s Per SR=
/ m Botte
Pac3.
Demanded
)rice Rs.
**.K
7D%@ Cefadro6i
1Ranba6y
Duricef By SE
Ne( D-&
44. +do+ C!7=ZI& =ra dry
sus)ension
1Cefadro6i 20/
mg!ach 0 m
Contains@+
Cefadro6i
monohydrate
euivaent to 20/
mg Cefadro6i
7orm 0
/+/4+2/*0
12K,,
Rs. 2////G+
%s Per SR=
/ m Botte
Pac3.
Demanded
)rice Rs.
2*.8/
7D%@ Cefadro6i
1Ranba6y
Duricef
By SE
Ne( D-&
34
-
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35/741
Ist+generation =ra
ce)haos)orin
antibiotic
SP S)ecification
for finished )roduct
40. +do+ 7%C&=R =ra dry
sus)ension
1 Cefacor *20 mg
!ach 0 m
Contains@+
Cefacor
monohydrate
euivaent to *20
mg Cefacor
Ist+generation =ra
ce)haos)orin
antibiotic
SP S)ecification
for finished )roduct
7orm 0
/+/4+2/*0
1 2K,0
Rs. 2////G+
%s Per SR=
/ m Botte
Pac3.
Demanded
)rice Rs. *F/./
BN7 @ Distacor
17ynn
Cecor By
%P
Ne( D-&
4. +do+ 7%C&=R =ra dry
sus)ension
1 Cefacor 20/ mg
!ach 0 m
Contains@+
Cefacor
monohydrateeuiva
ent to 20/ mg
Cefacor
Ist+generation =ra
ce)haos)orin
antibiotic
SP S)ecification
for finished )roduct
7orm 0
/+/4+2/*0
12K80
Rs. 2////G+
%s Per SR=
/ m Botte
Pac3.
Demanded
)rice Rs.
K28.0K
BN7 @ Distacor
17ynn
Cecor By%P
Ne( D-&
4F. +do+ -e)radin =ra dry
sus)ension
1 C!P>R%DIN!
20/ -
7orm 0
/+/4+2/*0
12K,8
Rs. 2////G+
Not confirmed
#eosef
Bristo -yres
*.Internationa avaiabiity in
S+7D% !-% >eath
Canada '% " ->&5 for
same generic dosage form
35
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!ach 0 m
Contains@+
C!P>R%DIN!
20/ mg
*
st
eneration =race)haos)orin
antibiotic
SP S)ecification
for finished )roduct
%s Per SR=
/ m Botte
Pac3.
Demanded
)rice Rs. 2*/./
Ne( D-& " strength not )rovidedGnot
confirmed.
2.All >(-"A aro)ed
brands of for%lation
ha)e been dis'ontin%ed.
48. +do+ -e)radin =ra dry
sus)ension
1 C!P>R%DIN!
*20 -
!ach 0 m
Contains@+
C!P>R%DIN!
*20 mg
*st eneration =ra
ce)haos)orin
antibiotic
SP S)ecification
for finished )roduct
7orm 0
/+/4+2/*0
12K8
Rs. 2////G+
%s Per SR=
/ m Botte
Pac3.
Demanded
)rice Rs. *2/./
Not confirmed
#eosef
Bristo -yres
Ne( D-&
*.Internationa avaiabiity in
S+7D% !-% >eath
Canada '% " ->&5 for
same generic dosage form
" strength not )rovidedGnot
confirmed.
2.All >(-"A aro)ed
brands of for%lation
ha)e been dis'ontin%ed.
4,. +do+ -IZI-! =ra dry
sus)ension
1 Cefi6ime2// mg
!ach 0 m
Contains@+
Cefi6ime
1%s'rihydrate
1SP euivaent
to Cefi6ime 2//
mg.
Krd+generation =ra
ce)haos)orin
antibiotic
SP S)ecification
7orm 0
/+/4+2/*0
12K,
Rs. 2////G+
%s Per SR=
K/ m Botte
Pac3.
Demanded
)rice Rs. 2*0./
BN7@ Su)ra6
1Sanofi+%ventis
Cefiget
et; Pharma
Ne( D-&
36
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37/741
for finished )roduct
0/. +do+ -IZI-! =ra dry
sus)ension
1 Cefi6ime *// mg
!ach 0 mContains@+
Cefi6ime
1%s'rihydrate
1SP euivaent
to Cefi6ime *//
mg.
Krd+generation =ra
ce)haos)orin
antibiotic
SP S)ecification
for finished )roduct
7orm 0
/+/4+2/*0
12K8/
Rs. 2////G+
%s Per SR=K/ m Botte
Pac3.
Demanded
)rice Rs. *K0./
BN7@ Su)ra6
1Sanofi+%ventis
Cefiget
et; Pharma
Ne( D-&
0*. M( GI!3A
&hara'e%ti'al
s :&)t; Giited
lot !o 0/,
(treet !o (-5,
!ational
Ind%strial Kone
Raat,
Islaabad.
D-&No ///8*/dated /2+/4+2/*0
'abet enera
No.7. *+4G2/**+
&ic
Dated /K+/4+
2/*0
Nate D
F/mgGF/mcg
'abets
!ach 'abet
contains@
%endronate 1as
%endronate
Sodium 1B.P
XX..F/ mg
Choecacifero1B.P XX F/ mcg128// I
1Bis)hos)honateG#i
tamin D anaogue
1-anufacturers
S)ec.s
7orm 0
*+/4+2/*0
1,F0
Rs.2////G+
%s )er SR=G
*64s
7D%@ 7osama6
Pus D 1-erc3
Drate Pus D F/
mgG F/ mcg
'abet1SH"
7a;u Iahi
Earachi
rant 7or
registration ofdrugs of ne(icense dated /2+
/4+2/*0
02. +do+ Rein 'abets
!ach 'abet
Contains@
Piro6icam+beta+
cycode6trin e. toPiro6icamXX2/
mg
1Non+ Steroida
%nti+infamatory
1-anufacturers
S)ec.s
7orm 0
*+/4+2/*0
1,F2
Rs.2////G+
%s )er SR=G26*/s
BN7@Bre6ido1C
hiesi
Pharmaceuticas
Cycode6 2/ mg
'abet 1 PatinumPharmaceuticas
1Pvt &imited
rant 7or
registration of
drugs of ne(
icense dated /2+
/4+2/*0
37
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0K. +do+ 7ude 'abets
!ach 7im coated
'abet
Contains@
Sodium 7usidate
1B.PXX
20/ mgBP S)ecification
1%nti Biotic
7orm 0
*+/4+2/*0
1,F
Rs.2////G+
%s )er SR=G
26*/s
7D%@
7ucidin1&!=
Pharmaceuticas
7usiderm
20/ mg 'abet
1 -artin Do(&imited
rant 7or
registration ofdrugs of ne(
icense dated /2+
/4+2/*0
*.Potentiometer is reuired for
assay. 7irm has submitted
an underta3ing that they
(i )urchase before
)roduction of )roduct.
04. +do+ !to 'abets
!ach 7im coated
tabet coated tabetcontains@
!torico6ibX../mg
1NS%ID
1-anufacturers
S)ec.s
7orm 0
*+/4+2/*0
1,FKRs.2////G+
%s )er SR=G*/s
7D%@ %rco6ia
1-SD
Starco6
/ mg 'abet1et; Pharma
1Pvt.
&imited
rant 7or
registration of
drugs of ne(
icense dated /2+
/4+2/*0
00. +do+ >ico6 'abets
!ach fim coatedtabet contain@
-o6ifo6acin 1as
>CX..4// mg
1$uinoone
1-anufacturers
S)ec.s
7orm 0
*F+/4+2/*01,F
Rs.2////G+
%s )er SR=G
0s
BN7@ %veo6
1Bayer
-ora6
4//mg 'abet
1oba
Pharmaceuticas
1Pvt &imited
rant 7or
registration of
drugs of ne(icense dated /2+
/4+2/*00. +do+ Bi(a 'abets
!ach fim coated
tabet contain@
Ibandronic acid 1asSodium
-onohydrate
X..*0/ mg
1Bis)hos)honate
7orm 0
*F+/4+2/*0
1,F4
Rs.2////G+%s )er SR=G
*s
7D%@ Boniva
1Roche
Ibandro*0/ mg tabet
1Pharm!vo 1Pvt
&imited
38
-
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39/741
1-anufacturers
S)ec.s
rant 7or
registration of
drugs of ne(
icense dated /2+
/4+2/*0
0F. +do+ =;in 'abets
!ach fim coatedtabet contain@
&ine;oidX..//
mg
1=da;oidinone
%nti+Infective
1-anufacturers
S)ec.s
7orm 0
*F+/4+2/*01,F/
Rs.2////G+
%s )er SR=G
*/s
7D%@ Lyvo6
1Pharmacia&imited E
!casi // mg
'abet
1Sami
Pharmaceuti
cas
Earachi
rant 7orregistration of
drugs of ne(icense dated /2+
/4+2/*0
08. +do+ No6i 'abets
!ach fim coatedtabet contain@
&orno6icamX..8
mg
1NS%ID
1-anufacturers
S)ec.s
7orm 0
*F+/4+2/*01,8
Rs.2////G+
%s )er SR=G
*/s
Zefo Ra)id
1'a3eda Ireanda))roved -+24
&orno6 8 mg
'abet 1Ray
Pharma Earachi
rant 7or
registration ofdrugs of ne(
icense dated /2+
/4+2/*0
0,. +do+ 'ri+P 'abets
!ach fim coated
tabet contains@
Paracetamo 1SP
XX
K20mg
'ramado
>C& 1SP
X.KF.0mg1Non+o)iod
%nagesic
1SP
S)ecifications
7orm 0
*F+/4+2/*0
1,,
Rs.2////G+
%s )er SR=G
*/s
7D%@ tracet
tabets
1Hanssen
'onofe6+P K20
mgG KF.0 mg
'abets 1Sami
Earachi
rant 7or
registration of
drugs of ne(
icense dated /2+/4+2/*0
/. +do+ %fa+C 'abets
!ach uncoated
7orm 0
*F+/4+2/*0
Not )rovided *.Internationa avaiabiity in
S+7D% !-% >eath
39
-
8/15/2019 Agenda 249th Registration Board Meeting
40/741
tabet contains@
%facacidoXX
/.0 mcg
!ementa Cacium
1as Cacium
CarbonateX. 4//
mg1#itamin+D
%naogue Cacium
Su))ement
1-anufacturersS)ec.s
1,F*
Rs.2////G+
%s )er SR=G
*/s
Bonecare+C /.0
mcgG*/// mcg
'abet 1Scha;oo
La3a 1Pvt
&imited &ahore
rant 7orregistration of
drugs of ne(
icense dated /2+
/4+2/*0
Canada '% " ->&5 for
same generic dosage form
" strength not )rovidedGnot
confirmed.
*. +do+
Ca)sue enera
No.7. *+4G2/**+
&ic 1-+///8*/Dated /2+/4+
2/*0
%fa+2 Ca)sues /.0
mcg
!ach ca)sue
contains
%facacido 1B.PXX../.0 mcg
1#itamin Danaogue
1-anufacturers
S)ec.s
7orm 0
*F+/4+2/*0
1,8*
Rs.2////G+
%s )er SR=GK 6 */s
7D%@ =ne+%)ha
1&eo
Pharmceuticas
Denmar3
Biodo /.0 mcg
ca)sues1Bio+&abs Pvt
&imited
Isamabad
rant 7or
registration of
drugs of ne(
icense dated /2+
/4+2/*0
*.$uantity of active is very
ess. Registration Board is
referring such formuations
for )roduct s)ecific
ins)ection for
manufacturing and testingfaciity.
2. +do+ %fa+2 Ca)sues *
mcg
!ach ca)suecontains
%facacido 1B.P
XX.. * mcg
1#itamin D
anaogue
1-anufacturers
S)ec.s
7orm 0
*F+/4+2/*0
1,82Rs.2////G+
%s )er SR=G
K 6 */s
BN7@ Rocatro
1Roche
%)ha+Pus /*
mcg ca)sues
1Rote6 -edica
1Pvt &imited
rant 7or
registration of
drugs of ne(
icense dated /2+
/4+2/*0
*.$uantity of active is very
ess. Registration Board is
referring such formuations
for )roduct s)ecific
ins)ection for
manufacturing and testing
faciity.
K. +do+ Bin Ca)sues
!ach ca)suecontains@
PregabainX
*0/mg
1%nti e)ie)tic anticonvusant
agent
1-anufacturers
S)ec.s
7orm 0
*F+/4+2/*01,F,
Rs.2////G+
%s )er SR=G
2 6 Fs
7D%@ &ORIC%
Ca)sues 120 0/F0 *// *0/2//
220 and K//mg
1Pfi;er
Pharmaceuticas
%BIC%
Ca)sues 10/ F0
*//
40
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*0/ and K//mg
1et; Pharma
Pa3istan
rant 7or
registration of
drugs of ne(icense dated /2+
/4+2/*0
4. +do+ Bin Ca)sues
!ach ca)sue
contains@
PregabainX
K//mg
1%nti e)ie)tic
anticonvusant
agent
1-anufacturersS)ec.s
7orm 0
*F+/4+2/*0
1,8/
Rs.2////G+
%s )er SR=G
2 6 Fs
7D%@ &ORIC%
Ca)sues 120 0/
F0 *// *0/2//
220 and K//mg
1Pfi;er
Pharmaceuticas
%BIC%Ca)sues 10/ F0
*//*0/ and K//mg
1et; Pharma
Pa3istan
rant 7or
registration of
drugs of ne(
icense dated /2+
/4+2/*0
0. +do+ Rush ca)sue
2/mg
!ach Ca)sueContains@+
!some)ra;oe1 as
!some)ra;oe
magnesium
trihydrate enteric
coated )eets
1SP
X2/ mg
1Proton Pum)
Inhibitor1SP S)ec.s
[Source of )eets@-Gs . &ee Pharma
&td. Sy. No. *,,
Pot No. K " 4
D.No. 0+,+20G* "
2
Ra:eevgandhinagar
Prasanthinagar I.!
Eu3at)ay Ranga
7orm 0
*F+/4+2/*0
1,84Rs.*/////G+
%s )er SR=G
2 6 Fs
N!ZI-
Ca)sue
1%straLeneca
!+C%P 4/mg
Ca)sues
11Broo3es
Pharmaceuticas
1Pvt &imited
rant 7or
registration ofdrugs of ne(
icense dated /2+/4+2/*0
*.&egai;ed -P certificate of
)eets and stabiity studies
are reuired.
41
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Reddy District
'eangana State
India\
. +do+ Rush ca)sue 4/mg
!ach Ca)sue
contains
!some)ra;oe1 as!some)ra;oe
magnesium
trihydrate enteric
coated )eets e.
to
!some)ra;oeX4/
mg
1Proton Pum)
Inhibitor
1SP S)ec.s[Source of )eets@
-Gs . &ee Pharma&td. Sy. No. *,,
Pot No. K " 4
D.No. 0+,+20G* "
2
Ra:eevgandhinagar
Prasanthinagar I.!
Eu3at)ay Ranga
Reddy District
'eangana State
India\
7orm 0
*F+/4+2/*0
1,80
Rs.*/////G+%s )er SR=G
2 6 Fs
N!ZI-
Ca)sue
1%straLeneca
!+C%P 4/mg
Ca)sues
1Broo3es
Pharmaceuticas
1Pvt &imited
rant 7or
registration of
drugs of ne(icense dated /2+
/4+2/*0
*.&egai;ed -P certificate of
)eets and stabiity studies
are reuired.
F. +do+ Na:at Ca)sue
20/mg!ach ca)sue
Contains
%;ithromycin
dihydrate 1SP e.
to
%;ithromycinX
20/mg
1-acroide
%ntibiotic
1SP
S)ecifications
7orm 0
*F+/4+2/*01,8K
Rs.2////G+
%s )er SR=G
*/s
BN7@
Lithroma61Pfi;er
Litama6 20/mg
Ca)sues
Pfi;er
&aboratories
&td.
rant 7or
registration ofdrugs of ne(
icense dated /2+/4+2/*0
8. +do+ =s)ra ca)sue
2/mg!ach Ca)sue
Contains@
=me)ra;oe
1enteric coated
7orm 0
*F+/4+2/*01,FF
Rs.*/////G+
%s )er SR=G
2 6 Fs
BN7@ &osec
1%straLeneca
RIS!E 2/mg
Ca)sue
et; Pharma
*.&egai;ed -P certificate of
)eets and stabiity studies
are reuired.
42
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)eets e. to
=me)ra;oe...
2/mg
1Proton Pum)
Inhibitor
1SP S)ec.s
[Source of )eets@-Gs . &ee Pharma
&td. Sy. No. *,,
Pot No. K " 4
D.No. 0+,+20G* "2
Ra:eevgandhinagar
Prasanthinagar I.!
Eu3at)ay Ranga
Reddy District
'eangana State
India\
1Pvt.
&td
rant 7or
registration of
drugs of ne(
icense dated /2+/4+2/*0
,. +do+ =s)ra ca)sue4/mg
!ach Ca)sue
Contains@
=me)ra;oe
1enteric coated
)eets e. to
=me)ra;oe...
4/mg
1Proton Pum)
Inhibitor
1SP S)ec.s
[Source of )eets@-Gs . &ee Pharma
&td. Sy. No. *,,
Pot No. K " 4
D.No. 0+,+20G* "2
Ra:eevgandhinagar
Prasanthinagar I.!
Eu3at)ay Ranga
Reddy District
'eangana State
India\
7orm 0*F+/4+2/*0
1,F8
Rs.*/////G+
%s )er SR=G
2 6 Fs
BN7@ &osec1%straLeneca
RIS!E 4/mg
Ca)sue
et; Pharma
1Pvt.
&td
rant 7or
registration of
drugs of ne(
icense dated /2+/4+2/*0
*.&egai;ed -P certificate of )eets and stabiity studies
are reuired.
F/. +do+ #otsa ca)sue K/mg!ach Ca)sue
Contains@
&anso)ra;oe
1enteric coated
)eets e. to
&anso)ra;oe
1SP ... K/mg
1Proton Pum)
7orm 0*F+/4+2/*0
1,8
Rs.*/////G+
%s )er SR=G
2 6 Fs
7D%@ Prevacid1Novartis
Pharmaceuticas
Inhibito K/mg
Ca)sue
1>ighnoon
&aboratories
&imited
*.Source &egai;ed -Pcertificate of )eets and
stabiity studies are
reuired.
43
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Inhibitor
1SP S)ec.s
[Source of )eets@
-Gs . &ee Pharma
&td. Sy. No. *,,
Pot No. K " 4D.No. 0+,+20G* "
2
Ra:eevgandhinagar
Prasanthinagar I.!Eu3at)ay Ranga
Reddy District
'eangana State
India\
rant 7or
registration of
drugs of ne(
icense dated /2+
/4+2/*0
F*. +do+
Ca)sue
Ce)haos)orin
No.7. *+4G2/**+
&ic 1D-& No+
///8*/
Dated /K+/4+
2/*0
Ei6 Ca)sues 20/
mg
!ach hard geatin
ca)sue contains@+
Ce)hae6in
monohydrate SP
e. to Ce)hae6in
XX.20/mg.
1Ce)haos)orin
1SP S)ecs
7orm 0
*F+/4+2/*0
1,8F
Rs.2////G+
%s )er SR=G
*2s
BN7@ Ce)ore6
1Co+Pharma
Ci)ore6 20/ mg
ca)sues 1SE
Pa3istan Private
&imited
rant 7or
registration of
drugs of ne(
icense dated /2+/4+2/*0
F2. +do+ Ei6 Ca)sues 0//
mg
!ach hard geatin
ca)sue contains@+
Ce)hae6in
monohydrate e. to
Ce)hae6in
XX.0//mg.
1Ce)haos)orin
1SP S)ecs
7orm 0
*F+/4+2/*0
1,88
Rs.2////G+
%s )er SR=G
*2s
BN7@ Ce)ore6
1Co+Pharma
Ci)ore6 20/ mg
ca)sues 1SE
Pa3istan Private
&imited
rant 7or
registration of
drugs of ne(
icense dated /2+
44
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45/741
/4+2/*0
FK. +do+ #eo Ca)sues 20/
mg
!ach hard geatin
ca)sue contains@+
Ce)hradine
monohydrate SP
e. to
Ce)hradineXX.20
/mg.
1Ce)haos)orin
1SP S)ecs
7orm 0
*F+/4+2/*0
1,8,
Rs.2////G+
%s )er SR=G
*2s
BN7@ Cefradine
1Non+)ro)rietary
#eosef 20/ mg
ca)sues 1SE
Pa3istan Private
&imited
rant 7or
registration of
drugs of ne(
icense dated /2+/4+2/*0
F4. +do+ #eo Ca)sues 0//
mg
!ach hard geatin
ca)sue contains@+
Ce)hradine
monohydrate SP
e. to
Ce)hradineXX.0/
/mg.
1Ce)haos)orin
1SP S)ecs
7orm 0
*F+/4+2/*0
1,,/
Rs.2////G+
%s )er SR=G
*2s
BN7@ Cefradine
1Non+)ro)rietary
#eosef 0// mg
ca)sues 1SE
Pa3istan Private
&imited
rant 7or
registration of
drugs of ne(
icense dated /2+
/4+2/*0
F0. +do+ =sef Ca)sues 0//
mg
!ach hard geatin
ca)sue contains@+
Cefadro6i
monohydrate SP
e. to Cefadro6i
XX.0//mg.
7orm 0
*F+/4+2/*0
1,,4
Rs.2////G+
%s )er SR=G
*2s
BN7@ Cefadro6i
1Non+)ro)rietary
Duricef 0// mg
ca)sues 1SE
Pa3istan Private
&imited
45
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1Ce)haos)orin
1SP S)ecs rant 7or
registration of
drugs of ne(
icense dated /2+/4+2/*0
F. +do+ 'e3or Ca)sues
20/ mg
!ach hard geatin
ca)sue contains@+
Cefacor
monohydrate e. to
Cefacor
XX.20/mg.
1Ce)haos)orin
1SP S)ecs
7orm 0
*F+/4+2/*0
1,,0
Rs.2////G+
%s )er SR=G
*2s
BN7@ 1Non
)ro)rietary
Cecor 20/ mg
ca)sues 1%P
heathcare
Private &imited
rant 7or
registration ofdrugs of ne(
icense dated /2+
/4+2/*0
FF. +do+ 'e3or Ca)sues
0// mg
!ach hard geatin
ca)sue contains@+
Cefacor
monohydrate e. to
Cefacor
XX.0//mg.
1Ce)haos)orin
1SP S)ecs
7orm 0
*F+/4+2/*0
1,,
Rs.2////G+
%s )er SR=G
*2s
BN7@ Distacor
17ynn
Cecor 0// mg
ca)sues 1%P
heathcare
Private &imited
rant 7or
registration of
drugs of ne(
icense dated /2+
/4+2/*0
F8. +do+ Li6 Ca)sues 2//
mg
!ach hard geatin
7orm 0
*F+/4+2/*0
Not )rovidedGNot
confirmed
Cefim 2// mg
*.Internationa avaiabiity in
S+7D% !-% >eath
Canada '% " ->&5 for
46
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47/741
ca)sue contains@+
Cefi6ime trihydrate
e. to Cefi6ime
XX.2//mg.
1Ce)haos)orin
1-anufacturers
S)ec.s
1,,2
Rs.2////G+
%s )er SR=G
0s
ca)sues 1>iton
Pharma Private
&imited
rant 7or
registration ofdrugs of ne(
icense dated /2+
/4+2/*0
same generic dosage form
" strength not )rovidedGnot
confirmed.
F,. +do+ Li6 Ca)sues 4//
mg
!ach hard geatin
ca)sue contains@+
Cefi6ime trihydrate
e. to Cefi6ime
XX.4//mg.
1Ce)haos)orin
1-anufacturers
S)ec.s
7orm 0
*F+/4+2/*0
1,,K
Rs.2////G+
%s )er SR=G
*/s
7D%@ Su)ra6
1&u)in
Pharmaceuticas
Inc. S%
Cefim 4// mg
ca)sues 1>iton
Pharma Private
&imited
rant 7or
registration of
drugs of ne(
icense dated /2+
/4+2/*0
8/. +do+ Denar Ca)sues
K// mg
!ach hard geatin
ca)sue contains@+
Cefdinir 1SP
XX.K//mg.
1Ce)haos)orin
1SP S)ecs
7orm 0
*F+/4+2/*0
1,,*
Rs.2////G+
%s )er SR=G
*2s
7D%@ Cefdinir
1Sando;
Saus K// mg
ca)sues 1>imont
Pharmaceuticas
Private &imited
rant 7or
registration of
drugs of ne(
icense dated /2+
/4+2/*0
8*. +do+ Li6 Dry Po(der for
sus)ension *// mg
7orm 0 7D%@ Su)ra6
1&u)in
47
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=ra dry )o(der
sus)ension
Ce)haos)orin
No.7. *+4G2/**+
&ic 1-+///8*/
Dated /2+/4+
2/*0
!ach 0 m
contains@+
Cefi6ime trihydrate
e. to Cefi6ime
XX.*//mg.
1Ce)haos)orin
1SP S)ecs
*F+/4+2/*0
1*/*
Rs.2////G+
%s )er SR=G
K/ m
Pharmaceuticas
Inc. S%
Cefim *// mgG
0m Dry Po(der
for Sus)ension1>iton Pharma
Private &imited
rant 7or
registration of
drugs of ne(
icense dated /2+
/4+2/*0
82. +do+ Li6 Dry Po(der for
sus)ension 2// mg
!ach 0 m
contains@+
Cefi6ime trihydrate
e. to Cefi6ime
XX.2//mg.
1Ce)haos)orin
1SP S)ecs
7orm 0
*F+/4+2/*0
1*/*F
Rs.2////G+
%s )er SR=G
K/ m
7D%@ Su)ra6
1&u)in
Pharmaceuticas
Inc. S%
Cefim 2// mgG
0m Dry Po(der
for Sus)ension
1>iton Pharma
Private &imited
rant 7or
registration of
drugs of ne(
icense dated /2+
/4+2/*0
8K. +do+ =rid Dry Po(der
Dro)s 0/ mg
!ach 0m
contains@+
Cef)odo6ime as
Pro6ite X.0/mg.
1Ce)haos)orin
1SP S)ecs
7orm 0
*F+/4+2/*0
1*/*,
Rs.2////G+
%s )er SR=G
0/ m
7D%@
Cef)odo6im
Pro6ite
1Ranba6y
$in3 0/ mgG 0m
Dry Po(der for
Sus)ension15ishire
&aboratories
Private &imited
rant 7or
registration of
drugs of ne(
48
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icense dated /2+
/4+2/*0
84. +do+ =rid Dry Po(der
for Sus)ension *//
mg
!ach 0m
contains@+
Cef)odo6ime as
Pro6ite X.*//mg.
1Ce)haos)orin
1SP S)ecs
7orm 0
*F+/4+2/*0
1*/*8
Rs.2////G+
%s )er SR=G
0/ m
7D%@
Cef)odo6im
Pro6ite
1Ranba6y
$in3 *// mgG
0m Dry Po(der
for Sus)ension
15ishire
&aboratories
Private &imited
rant 7or
registration of
drugs of ne(
icense dated /2+
/4+2/*0
80. +do+ 'e3or Dry Po(der
for Sus)ension *20
mg
!ach 0m
contains@+
Cefacormonohydrate e. to
Cefacor
XX.*20mg.
1Ce)haos)orin
1SP S)ecs
7orm 0
*F+/4+2/*0
1*/2/
Rs.2////G+
%s )er SR=G
/ m
7D%@ Cefacor
1ON S>IN
P>%R-
Cecor Dry
Po(der for
Sus)ension *20
mg 1%Pheathcare
Private &imited
rant 7or
registration of
drugs of ne(
icense dated /2+
/4+2/*0
8. +do+ 'e3or Dry Po(der
for Sus)ension 20/
mg
!ach 0m
contains@+
Cefacor
7orm 0
*F+/4+2/*0
1*/2*
Rs.2////G+
7D%@ Cefacor
1ON S>IN
P>%R-
Cecor Dry
Po(der for
Sus)ension 20/
49
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monohydrate e. to
Cefacor
XX.20/mg.
1Ce)haos)orin
1SP S)ecs
%s )er SR=G
/ m
mg 1%P
heathcare
Private &imited
rant 7or
registration ofdrugs of ne(
icense dated /2+
/4+2/*0
8F. +do+ 'e3or Dry Po(der
for Dro)s 0/ mg
!ach m contains@+
Cefacor
monohydrate e. to
Cefacor XX.0/mg.
1Ce)haos)orin
1SP S)ecs
7orm 0
*F+/4+2/*0
1*/22
Rs.2////G+
%s )er SR=G
*0 m
7D%@ Cefacor
1ON S>IN
P>%R-
120/mgG0m
Cecor Dry
Po(der for Dro)s
0/ mg 1%P
heathcare
Private &imited
rant 7or
registration of
drugs of ne(
icense dated /2+
/4+2/*0
88. +do+ =sef Dry Po(der
for Sus)ension *20mg
!ach 0m
contains@+
Cefadro6i
monohydrate e. to
Cefadro6i
XX.*20mg.
1Ce)haos)orin
1SP S)ecs
7orm 0
*F+/4+2/*0
1*/24
Rs.2////G+
%s )er SR=G
/ m
7D%@ Cefadro6i
1Ranba6y
Duricef Dry
Po(der for
Sus)ension *20
mg 1SE
Pa3istan Private
&imited
rant 7or
registration of
drugs of ne(icense dated /2+
/4+2/*0
8,. +do+ =sef Dry Po(der
for Sus)ension 20/
mg
7orm 0
*F+/4+2/*0
7D%@ eneric
1%R=BIND=
Duricef Dry
50
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!ach 0m
contains@+
Cefadro6i
monohydrate e. to
Cefadro6iXX.20/mg.
1Ce)haos)orin
1SP S)ecs
1*/20
Rs.2////G+
%s )er SR=G
/ m
Po(der for
Sus)ension 20/
mg 1SE
Pa3istan Private
&imited
rant 7or
registration of
drugs of ne(
icense dated /2+
/4+2/*0
,/. +do+ Ei6 Dry Po(der
for Sus)ension 20/
mg
!ach 0m
contains@+
Ce)hae6in
monohydrate e. to
Ce)hae6inXX.20
/mg.
1Ce)haos)orin
1SP S)ecs
7orm 0
*F+/4+2/*0
1*/2K
Rs.2////G+
%s )er SR=G
/ m
BN7@ Eefe6
17y
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