Agenda 249th Registration Board Meeting

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@


17/741

$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>

17


18/741

&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

18


19/741

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

19


20/741

• 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#

20


21/741

'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

21


22/741

)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

22


23/741

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*,


S+7D% !-% >eath




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///


S+7D% !-% >eath




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


S+7D% !-% >eath




confirmed.

F. +do+ -ecobaamine

In:ection

!ach m contains@

7orm 0

Dy.No@ *40K

Dated@ /+/K+

%))roved in -+248

!gin 1Novartis

23


24/741

-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.

24


25/741

%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




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


S+7D% !-% >eath




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


S+7D% !-% >eath



25


26/741

Phen)ro)ionate1S

P X.20mg

%naboic Steroid

1SP

2/*0

Rs. 2////G+

Rs. *K/G+Pac3

of *m Y

K am)oue


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

26


27/741

*,. +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


S+7D% !-% >eath




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

27


28/741

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


S+7D% !-% >eath




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


S+7D% !-% >eath




confirmed. BN7 a))roved

estone 1Nordic strength

is 0/mgGm.

28


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


S+7D% !-% >eathCanada '% " ->&5 for



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


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


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-&


S+7D% !-% >eath




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


32/741

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


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


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


33/741

Ca)sues

!ach ca)sue

contains@+

Ce)hae6in

monohydrate

euivaent to 0//mg Ce)hae6in

=ra ce)haos)orin

antibiotic

SP S)ecification


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


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


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


34/741

mg Ca)sues

!ach ca)sue

contains@+

Ce)hradine 1SP20/ mg

=ra ce)haos)orin

antibiotic

SP S)ecification


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


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


35/741

Ist+generation =ra

ce)haos)orin

antibiotic

SP S)ecification


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


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


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


S+7D% !-% >eath



35


36/741

!ach 0 m

Contains@+

C!P>R%DIN!

20/ mg

*

st

eneration =race)haos)orin

antibiotic

SP S)ecification


%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


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-&


S+7D% !-% >eath




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


37/741


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


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


38/741

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+

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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

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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

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1,F4

Rs.2////G+%s )er SR=G

*s

7D%@ Boniva

1Roche

Ibandro*0/ mg tabet

1Pharm!vo 1Pvt

&imited

38


39/741

1-anufacturers

S)ec.s

rant 7or

registration of

drugs of ne(

icense dated /2+

/4+2/*0

0F. +do+ =;in 'abets


&ine;oidX..//

mg

1=da;oidinone

%nti+Infective

1-anufacturers

S)ec.s

7orm 0

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7D%@ Lyvo6

1Pharmacia&imited E

!casi // mg

'abet

1Sami

Pharmaceuti

cas

Earachi

rant 7orregistration of


/4+2/*0

08. +do+ No6i 'abets


&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


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


40/741

tabet contains@

%facacidoXX

/.0 mcg

!ementa Cacium

1as Cacium

CarbonateX. 4//

mg1#itamin+D

%naogue Cacium

Su))ement


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




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

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1,8*

Rs.2////G+

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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


41/741

*0/ and K//mg

1et; Pharma

Pa3istan

rant 7or

registration of


/4+2/*0

4. +do+ Bin Ca)sues

!ach ca)sue

contains@

PregabainX

K//mg

1%nti e)ie)tic

anticonvusant

agent


7orm 0

*F+/4+2/*0

1,8/

Rs.2////G+

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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



*.&egai;ed -P certificate of

)eets and stabiity studies

are reuired.

41


42/741

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


/4+2/*0



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



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



are reuired.

42


43/741

)eets e. to

=me)ra;oe...

2/mg

1Proton Pum)

Inhibitor

1SP S)ec.s


&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(


,. +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


&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(


*.&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


44/741

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(


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


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(


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


46/741

1Ce)haos)orin

1SP S)ecs rant 7or

registration of

drugs of ne(


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


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


S+7D% !-% >eath


46


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


icense dated /2+

/4+2/*0



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


48/741

=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


49/741

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


50/741

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


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


/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


51/741

!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

Documents

Agenda 249th Registration Board Meeting