Pharmaceutical Industry Report

Table of Contents A. Company Certificate B. Declaration ............….……………………………………….. (i) C. Acknowledgment …………………………………………..... (ii) D. Preface......... Preface............................ .................................... .................................... .................................... ...................... ..... (iii) E. Execti!e "mmary …………………………………….…… (i!)

#. C$APTE% #& 'ntrodction……………………………………..   *

1.1. Overview of the Industry………….…………………………… 3 1.1.1. Pharmaceutical Industry in India 1.. Com!any Profile……………………………………..………… " 1..1. A#out the Com!any 1... $ission 1..3. %ision 1..&. Our '!eciali(ation 1..&.1. Ay Ayurvedic ) *er#al Products 1..&.. +utraceutical !roducts 1..,. Our 'ervices 1..-. Our $anufacturin Process 1.3. Orani(ation 'tructure ………………………………………….. 31.&. /lim!se of our clients …...................... …............................................. ...........................…….….30 ....…….….30

+. C$APTE% +& 'ntrodction to Pro,ect …………………………..-  -

. C$APTE% & Conceptal Discssion……………….…………....--  -/

3.1. *ow Business Develo!ment taes !lace in Pharma Com!any

-. C$APTE% -& "01T Analysis…….………………………..…… -2  -3

/. C$APTE% /& 4a,or C5allenges faced by t5e 'ndstry …..…..... -6  -*

2. C$APTE% 2& Appendix 7 8ibliograp5y………………………… /  /# 1

1!er!iew of t5e 'ndstry

“The Indian Pharmaceutical industry is a success story providing employment   for millions and ensuring that essential drugs at affordable prices are available to the vast population of this sub-continent.”

2ichard /erster 

P5armacetical 'ndstry in 'ndia

he Pharmaceutical industry in India is the world4s third5larest in terms of  volume and stands 1&th in terms of value.

he Indian !harmaceutical industry currently to!s the chart amonst India4s science5#ased industries with wide ranin ca!a#ilities in the com!le6 field of  dru manu manufact facture ure and tech technolo noloy y.. A hihly or orani( ani(ed ed sect sector7 or7 the Indi Indian an  !harmaceutical industry is estimated to #e worth 8 &., #illion7 rowin at a#out 9 to " !ercent annually. It rans very hih amonst all the third world countries77 in terms of technoloy7 countries technoloy7 :uality and the vast rane of medicin medicines es that aree ma ar manu nufac factu tured red.. It ran ranes es fr from om si sim! m!le le hea headac dache he !il !ills ls to so! so!his histi ticat cated ed anti#iotics anti#ioti cs and com!le6 cardiac com!ounds7 com!ounds7 almost every ty!e of medicine is now made in the Indian !harmaceutical industry. he Indian !harmaceutical sector is hihly framented with more than ;7;;; reistered units. It has e6!an e6 !anded ded dra drasti stical cally ly in th thee la last st tw two o dec decade ades. s. h hee Ph Pharm armace aceuti utica call and Chemical industry in India is an e6tremely framented maret with severe  !rice com!etition and overnment !rice control. he Pharmaceutical industry in India meets around 0;< of the country4s demand for #ul drus7 dru intermediates7 !harmaceutical formulations7 chemicals7 ta#lets7 ca!sules7 orals and in=ecti#les. here are a!!ro6imately ,; lare units and a#out 9;;; 'mall 'cale >nits7 which form the core of the !harmaceutical industry in India ?includin , Central Pu#lic 'ector >nits@. he /overnment has also !layed a vital role in the develo!ment of the India 'oftware Industry. In 1"9-7 the Indian overnment announced a new software !olicy which was desined to serve as a catalyst for the software industry. his was followed in 1"99 with 2

1!er!iew of t5e 'ndstry

“The Indian Pharmaceutical industry is a success story providing employment   for millions and ensuring that essential drugs at affordable prices are available to the vast population of this sub-continent.”

2ichard /erster 

P5armacetical 'ndstry in 'ndia

he Pharmaceutical industry in India is the world4s third5larest in terms of  volume and stands 1&th in terms of value.

he Indian !harmaceutical industry currently to!s the chart amonst India4s science5#ased industries with wide ranin ca!a#ilities in the com!le6 field of  dru manu manufact facture ure and tech technolo noloy y.. A hihly or orani( ani(ed ed sect sector7 or7 the Indi Indian an  !harmaceutical industry is estimated to #e worth 8 &., #illion7 rowin at a#out 9 to " !ercent annually. It rans very hih amonst all the third world countries77 in terms of technoloy7 countries technoloy7 :uality and the vast rane of medicin medicines es that aree ma ar manu nufac factu tured red.. It ran ranes es fr from om si sim! m!le le hea headac dache he !il !ills ls to so! so!his histi ticat cated ed anti#iotics anti#ioti cs and com!le6 cardiac com!ounds7 com!ounds7 almost every ty!e of medicine is now made in the Indian !harmaceutical industry. he Indian !harmaceutical sector is hihly framented with more than ;7;;; reistered units. It has e6!an e6 !anded ded dra drasti stical cally ly in th thee la last st tw two o dec decade ades. s. h hee Ph Pharm armace aceuti utica call and Chemical industry in India is an e6tremely framented maret with severe  !rice com!etition and overnment !rice control. he Pharmaceutical industry in India meets around 0;< of the country4s demand for #ul drus7 dru intermediates7 !harmaceutical formulations7 chemicals7 ta#lets7 ca!sules7 orals and in=ecti#les. here are a!!ro6imately ,; lare units and a#out 9;;; 'mall 'cale >nits7 which form the core of the !harmaceutical industry in India ?includin , Central Pu#lic 'ector >nits@. he /overnment has also !layed a vital role in the develo!ment of the India 'oftware Industry. In 1"9-7 the Indian overnment announced a new software !olicy which was desined to serve as a catalyst for the software industry. his was followed in 1"99 with 2

the orld $aret Policy and the esta#lishment of the 'oftware echnoloy Pars of India ?'P ?'P@@ scheme. In addition7 to attract forein direct investment7 the Indian /overnment !ermitted !ermitted forein e:uity of u! to 1;; !ercent and duty free im!ort on all in!uts and !roducts.

Crrent "cenario he industry has enormous rowth !otential. actors listed

 #elow determine the risin demand for !harmaceuticals. !harmaceutic als.

 he rowin !o!ulation of over a #illion.  Increasin income.  Demand for :uality healthcare service.  Ch Chan ani in n li life fest styl ylee ha hass le led d to ch chan ane e in di dise seas asee !a !att tter erns ns77 an and d incre in creas ased ed dem demand and for new me medic dicine iness to com com#a #att lif lifest estyl ylee rel relat ated ed diseases.

$ore than 9, !er cent of the formulations !roduced in the country are sold in the domestic maret. India is larely self5sufficient in case of formulations. 'ome life savin7 new eneration under5!atent formulations continue to #e im!orted7 im!orte d7 es!ecially #y $+Cs7 which then maret them in India. Overall7 the si(e of the domestic formulations maret is around 2s1-; #illion and it is rowin at 1; !er cent !er annum.

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Demand for drus for treatment of lifestyle5related diseases such as dia#etes7 cardiovascular cardiovas cular diseases7 and central nervous system are on the increase increase.. here are around 0;;7;;; new cases of cancer each year and total of around ., million cases. It is estimated that there are around &; million !eo!le in India with dia#etes and the num#er is risin7 ,.1 million. *I%)AID' !atients7 and 1& million tu#erculosis cases. Accordin to industry re!orts7 while the Indian  !harmaceutical industry witnessed a rowth of 0 !ercent7 the cardio5vascular  sement recorded 1, to 10 !ercent rowth and anti5dia#etes sement of over  1;51 !ercent rowth.

Diagnostic 1tsorcing9 1tsorcing9 Clinical Trails Trails the Indian dianostic services are

 !ro=ected to row at a CA/2 of more than ; !er cent durin ;1;5;1. 'omee of th 'om thee ma ma=or =or Ind India ian n !ha !harm rmace aceuti utical cal fir firms ms77 in inclu cludin din  'u 'un n Ph Phar arma ma77 Cadilla *ealthcare and Piramal ife 'ciences7 had a!!lied for conductin clinical trials on at least 1 new drus in ;1;7 indicatin a rowin interest in new dru discovery research.

:enerics India to!s the world in e6!ortin eneric medicines worth >'8 11

 #illion and currently7 the Indian !harmaceutical industry is one of the world4s larest and most develo!ed. $oreover7 the Indian eneric dru maret to row at a CA/2 of around 10 !er cent #etween ;1;511 and ;1513. >nion $inister of Commerce and Industry and $inister for rade and Industry7 'ina 'i na!or !ore7 e7 hav havee si sine ned d a 4' 4'!ec !ecia iall 'c 'chem hemee fo forr 2e 2eis istr trati ation on of /e /ener neric ic $edicinal Products from India4 in $ay ;1;7 which sees to fast5trac the reistration !rocess for Indian eneric medicines in 'ina!ore.

!articularly7 has #een Ad!antag Ad!a ntagee 'ndi 'ndia a he Indian Pharmaceutical Industry7 !articularly7 thee fr th front ont run runner ner in a wi wide de ran rane e of s! s!eci ecialt altie iess inv involv olvin in  com com!le !le6 6 dr drus us44 manufacture7 develo!ment and technoloy. ith the advantae of #ein a hihly orani(ed sector7 the !harmaceutical com!anies in India are rowin at the rate of 8 &., #illion7 reisterin further rowth of 9 5 " < annually. $ore than ;7;;; reistered units are framented across the country and re!orts say that ,; leadin Indian !harmaceutical com!anies control 0;< of the maret share with star !rice com!etition and overnment !rice reulations. 4

Competent workforce workforce:: India has a !ool of !ersonnel with hih manaerial and

technical com!etence com!etence as also silled worforce. worforce. It has an educated wor force and Enlish is commonly used. Professional services are easily availa#le.

Itss tr It trac ac  re reco cord rd of de deve velo lo!m !men ent7 t7

Cost-e Cos t-eff ffect ective ive che chemic mical al sy synth nthesi esiss :

 !articularly in the area of im!roved cost5#eneficial chemical synthesis for  various dru molecules is e6cellent. It !rovides a wide variety of #ul drus and e6!orts so!histicated #ul drus.

 Legal & Financial Framework: India has a ,3 year old democracy and hence

has a solid leal framewor and stron financial marets. here is already an esta#lished international industry and #usiness community.

 Information &Technology: &Technology: It has a ood networ of world5class educational

institutions and esta#lished strenths in Information echnoloy.

hee co count untry ry is com commi mitt tted ed to a fre freee ma mare rett ec econo onomy my and Globalization: h lo#ali(ation. A#ove all7 it has a 0; million middle class maret7 which is continuously rowin.

rstt time in many yea earrs7 the int nteerna nattion onal al Consoliation: or the firs  !harmaceutical industry is findin find in reat o!!ortunities in India. In dia. he !rocess ! rocess of  consolidation7 which has #ecome a enerali(ed !henomenon in the world  !harmaceutical industry7 indus try7 has started tain !lace in India.

he overnment started to encourae the rowth of dru manufacturin #y India Ind ian n com com!an !anie iess in the ea early rly 1" 1"-;s -;s77 and wi with th th thee Pa Paten tents ts Act in 1"0 1"0;. ;. *owever7 economic li#erali(ation in ";s #y the former Prime 4inister P.;. the the then =ina > Dr Dr.. 4an 4anmo5an mo5an "ing5 ena#led the industry to #ecome what it is today. his !atent act removed com!osition !atents from food and drus7 and thouh it e!t !rocess !atents7 these were shortened to a !eriod of five to seven years.

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he lac of !atent !rotection made the Indian maret undesira#le to the multinational com!anies that had dominated the maret7 and while they streamed out. Indian com!anies carved a niche in #oth the Indian and world marets with their e6!ertise in reverse5enineerin new !rocesses for  manufacturin drus at low costs. Althouh some of the larer com!anies have taen #a#y ste!s towards dru innovation7 the industry as a whole has  #een followin this #usiness model until the !resent.

he Indian !harmaceutical sector has come a lon way7 #ein almost non5 e6istent #efore 1"0; to a !rominent !rovider of healthcare !roducts7 meetin almost ", !er cent of the country4s !harmaceuticals needs. he Industry today is in the front ran of Indias science5#ased industries with wide ranin ca!a#ilities in the com!le6 field of dru manufacture and technoloy. It rans very hih in the third world7 in terms of technoloy7 :uality and rane of  medicines manufactured. rom sim!le headache !ills to so!histicated anti#iotics and com!le6 cardiac com!ounds7 almost every ty!e of medicine is now made indienously.

Playin a ey role in !romotin and sustainin develo!ment in the vital field of medicines7 Indian Pharma Industry #oasts of :uality !roducers and many units a!!roved #y reulatory authorities in >'A and >F. International com!anies associated with this sector have stimulated7 assisted and s!earheaded this dynamic develo!ment in the !ast ,3 years and hel!ed to !ut India on the !harmaceutical ma! of the world.

he Indian Pharmaceutical sector is hihly framented with more than ;7;;; reistered units with severe !rice com!etition and overnment !rice control. It has e6!anded drastically in the last two decades. here are a#out ,; lare units that control 0; !er cent of the maret with maret leader holdin nearly 0  !er cent of the maret share and a#out 9;;; 'mall 'cale >nits toether which form the core of the !harmaceutical industry in India ?includin , Central Pu#lic 'ector >nits@. hese units !roduce the com!lete rane of   !harmaceutical formulations7 i.e.7 medicines ready for consum!tion #y

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 !atients and a#out 3,; #ul drus7 i.e.7 chemicals havin thera!eutic value and used for !roduction of !harmaceutical formulations. ollowin the de5licensin of the !harmaceutical industry7 industrial licensin for most of the drus and !harmaceutical !roducts has #een done away with. $anufacturers are free to !roduce any dru duly a!!roved #y the Dru Control Authority. echnoloically stron and totally self5reliant7 the  !harmaceutical industry in India has low costs of !roduction7 low 2GD costs7 innovative scientific man!ower7 strenth of national la#oratories and an increasin #alance of trade.

he num#er of !urely Indian !harma com!anies is fairly low. Indian !harma industry is mainly o!erated as well as controlled #y dominant forein com!anies havin su#sidiaries in India due to availa#ility of chea! la#or in India at lowest cost. $ost !harma com!anies o!eratin in India7 even the multinationals7 em!loy Indians almost e6clusively from the lowest rans to hih level manaement. $irrorin the social structure7 firms are very hierarchical. *omerown !harmaceuticals7 lie many other #usinesses in India7 are often a mi6 of !u#lic and !rivate enter!rise. Althouh many of these com!anies are !u#licly owned7 leadershi! !asses from father to son and the foundin family holds a ma=ority share.

he total Indian !roduction constitutes a#out 13 !er cent of the world maret in value terms and7 9 !er cent in volume terms. he !er ca!ita consum!tion of  drus in India7 stands at >'837 is amonst the lowest in the world7 as com!ared to Ha!an5 >'8&17 /ermany5 >'8 and >'A5 >'81"1.

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A81?T T$E C14PA<@

$ain a#oratories Pvt. td. is a renowned and one of the fastest rowin com!anies in India involved e6clusively into the manufacturin of *er#al) Ayurveda !roducts alon with Dietary) +utraceutical su!!lements. he foundation stone of the com!any was laid down in year 1"9& and the manufacturin o!erations started in the year 1"90 ?he Com!any was incor!orated in the year 1"90@. he ma=or chane in the com!any started immediately after the +ew $anaement too over7 under the leadershi! and uidance of a team of Doctors headed #y Dr. 1.P. "5arma. Dr. 'harma carries the e6!erience of conductin clinical trials on her#al medicines for  over a !eriod of three decades. he com!any which initially started on a small scale has now #ecome a re!uted her#al !roducts manufacturer in the industry.

Dr. 'harma has e6ecuted many ma=or corrections in the infrastructure re:uired for the #etter #usiness e6ecution. he first ste! in the direction was sharin his  !ersonal nowlede of her#s found in the *imalayan reion with the manufacturin technical team of Com!any7 which !roved to #e a #oon in the form of *er#al) Ayurveda medicines to the society. A wide rane of +ew *er#al) Ayurveda !roducts) ormulations has #een develo!ed to cure various ailments. $any new manufacturin !rocedures have #een incor!orated to further increase the !roduct efficacy. *is dream is to mae !eo!le aware of the medicinal utility of these !lants and to !romote *er#al) Ayurveda. he manaement aims to mae !eo!le aware that *er#al)Ayurveda medicines ive lon term fitness as aainst the allo!athic medicines7 also these medicines have less to6icity and no side effects and are very well a#sor#ed in the human  #ody and !rovide !ermanent cure to many ailments.

he com!any is manaed under the leadershi! of youn G dynamic entre!reneur7 4anaging Director 4r. @as5 "5arma  alon with his team of  :ualified scientists and technocommercial !eo!le to manae the day to day o!erations of the com!any. e7 at 4akin aboratories mae use of the latest manufacturin technoloies and !roduce the hihest :uality !roducts. he 8

dilience of the entire team has yielded #rilliant results and has hel!ed us flourish as a !rofound name in the *er#al)Ayurveda industry. It is one of the few manufacturin !lant which #lend modern !roduction technoloy and advanced :uality measures into the area of *er#al) Ayurveda healthcare medicines and nutraceutical. On the commercial front7 we have !resented many new dimensions in !acin7 which is still not very !revalent in Ayurveda Industry7 e.. AlBAl facility with JPrint 2eistration ControlK feature7 $et5  !at finish !roducts etc.

Companys 4ission& e want to offer !roducts of hihest :uality standards at the most com!etitive  !rices in India. e are on a never endin research7 develo!ment and manufacturin of a #road s!ectrum of *er#al) Ayurvedic and nutraceutical  !roducts and thrivin to fulfill the needs of our valued customers in terms of   !roduct rane7 :uality7 efficacy7 safety and !rice.

Companys ;ision& e as!ire to wor on our consistent self5im!rovisin mind5set and #e the #est manufacturer and su!!lier of hih :uality *er#al) Ayurvedic and +utraceutical  !roducts in the country. e also aim at satisfaction and relia#ility of our  associates for :uality and !urity of the !roduct for lifetime.

1r "pecialiation& I.

Ayr!edic 9 $erbal Prodcts

he Ayurveda medicinal system was #ased on her#s which are taen forward in formin the her#al medicines. hese her#al medicines includes her#s7 her#al materials7 her#al !re!aration G finished her#al !roducts that contains as active inredients !arts of !lants or other !lant materials or com#ination.

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II.

<traceticals

 +utraceuticals is a #road um#rella term that is used to descri#e any  !roduct derived from food sources with e6tra health #enefits in addition to the #asic nutritional value found in foods. hey can #e considered non5 s!ecific #ioloical thera!ies used to !romote eneral well5#ein7 control sym!toms and !revent malinant !rocesses. he term JnutraceuticalK com#ines two words  JnutrientK ?a nourishin food com!onent@ and J!harmaceuticalK ?a medical dru@. he name was coined in 1"9" #y 'te!hen Deelice7 founder and chairman of the oundation for Innovation in $edicine7 an American orani(ation located in Cranford7 +ew Hersey. he !hiloso!hy #ehind nutraceuticals is to focus on !revention7 accordin to the sayin #y a /ree !hysician *i!!ocrates ?nown as the father of  medicine@ who said Jlet food #e your medicineK. heir role in human nutrition is one of the most im!ortant areas of investiation7 with wide5 rain im!lications for consumers7 health5care !roviders7 reulators7 food  !roducers and distri#utors.

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I.

Ayr!edic 9 $erbal Prodcts

Ayurvedic !roducts are of two ty!esL 1. *er#al $edicinal . *er#al Cosmetics

1. $erbal 4edicinal Prodcts

'ome !lants contain su#stances that may #e used to treat diseases. $edicinal !roducts that are made from these su#stances are nown as Mher#al medicinal !roductsM. Even thouh they are natural7 a num#er of these !roducts may #e danerous for !atients. his is why they are covered #y  !harmaceutical leislation7 which aims to !rotect !u#lic health #y ensurin the safety7 efficacy and :uality of medicinal !roducts. ithin the rou! of her#al medicinal !roducts7 some have a lon tradition of use.

'ome e6am!les of her#als used in traditional her#al medicinal !roducts areL Calendula

officinalis

N

Echinacea

!ur!urea

.7

$oenchN

Eleutherococcussenticosus ?2u!r. Et $a6im.@ $a6iN oeniculumvulare $iller su#s!. vulare var. vulareN oeniculumvulare $iller su#s!. vulare var. dulce ?$iller@ hellunN *amamelisviriniana N $entha 6 !i!erita . and Pim!inellaanisum .

A her#al !roduct will #e considered a medicinal !roduct where !resented as havin !ro!erties for treatin or !reventin disease in human #eins or where it has a !harmacoloical7 immunoloical or meta#olic action. It is the com!etence and res!onsi#ility of national authorities to decide7 on a case5#y5 case #asis7 whether a her#al !roduct fulfills the definition of medicinal  !roduct.

*owever7 her#al !roducts may #e classified and !laced on the maret as food  !rovided that they do not fulfill the definition of medicinal !roducts and that they do com!ly with the a!!lica#le food law. In !articular7 her#al !roducts mareted in the form of food su!!lements should com!ly with Directive

11

;;)&-)EC on food su!!lements and 2eulation ?EC@ +o 1"&);;- on nutrition and health claims made on foods.

Ad!antages here are a num#er advantaes associated with usin her#al medicines as o!!osed to !harmaceutical !roducts. E6am!les include the followinL •

2educed ris of side effectsL $ost her#al medicines are well tolerated  #y

the

!atient7

with

fewer

unintended

conse:uences

than

 !harmaceutical drus. *er#s ty!ically have fewer side effects than traditional medicine7 and may #e safer to use over time. •

Effectives with chronic conditionsL *er#al medicines tend to #e more effective for lon5standin health com!laints that don4t res!ond well to traditional medicine. One e6am!le is the her#s and alternative remedies used to treat arthritis. %io667 a well5nown !rescri!tion dru used to treat arthritis7 was recalled due to increased ris of  cardiovascular com!lications. Alternative treatments for arthritis7 on the other hand7 have few side effects. 'uch treatments include dietary chanes lie addin sim!le her#s7 eliminatin veeta#les from the nihtshade family and reducin white suar consum!tion.

•

ower costL Another advantae to her#al medicine is cost. *er#s cost much less than !rescri!tion medications. 2esearch7 testin7 and maretin add considera#ly to the cost of !rescri!tion medicines. *er#s tend to #e ine6!ensive com!ared to drus.

•

ides!read availa#ilityL et another advantae of her#al medicines are their availa#ility. *er#s are availa#le without a !rescri!tion. ou can row some sim!le her#s7 such as !e!!ermint and chamomile7 at home. In some remote !arts of the world7 her#s may #e the only treatment availa#le to the ma=ority of !eo!le.

Disad!antages *er#s are not without disadvantaes7 and her#al medicine is not a!!ro!riate in all situations. hese are a few of the disadvantaes to considerL 12

•

Ina!!ro!riate for many conditionsL $odern medicine treats sudden and serious illnesses and accidents much more effectively than her#al or  alternative treatments. An her#alist would not #e a#le to treat serious trauma7 such as a #roen le7 nor would he #e a#le to heal an a!!endicitis or a heart attac as effectively as a conventional doctor  usin modern dianostic tests7 surery7 and drus.

•

ac of dosae instructionsL Another disadvantae of her#al medicine is the very real riss of doin yourself harm throuh self5dosin with her#s. hile you can arue that the same thin can ha!!en with medications7 such as accidentally overdosin on cold remedies7 many her#s do not come with instructions or !acae inserts. here4s a very real ris of overdose.

•

Poison ris associated with wild her#sL *arvestin her#s in the wild is risy7 if not foolhardy7 yet some !eo!le try to identify and !ic wild her#s. hey run a very real ris of !oisonin themselves if they don4t correctly identify the her#7 or if they use the wron !art of the !lant.

•

$edication

interactionsL *er#al

treatments

can

interact

with

medications. +early all her#s come with some warnin7 and many7 lie the her#s used for an6iety such as %alerian and 't. Hohn4s ort7 can interact with !rescri!tion medication lie antide!ressants. It4s im!ortant to discuss your medications and her#al su!!lements with your doctor to avoid danerous interactions. •

ac of reulationL Because her#al !roducts are not tihtly reulated7 consumers also run the ris of #uyin inferior :uality her#s. he :uality of her#al !roducts may vary amon #atches7 #rands or  manufacturers. his can mae it much more difficult to !rescri#e the  !ro!er dose of an her#.

2. $erbal Cosmetic Prodcts

*er#al Cosmetics7 referred as Products7 are formulated7 usin various  !ermissi#le cosmetic inredients to form the #ase in which one or more her#al inredients are used to !rovide defined cosmetic #enefits only7 shall

13

 #e called as J*er#al CosmeticsK. *er#s do not !roduce instant cures. hey offer a way to !ut the #ody in !ro!er tune with nature 3Q. A hue num#er  of cosmetic and toiletry formulations have #een desined and develo!ed  #ased u ! o n Indian *er#s recently. Other than traditionally documented a!!lications7 some modern trials have also #een usin the utility of Indian her#s in Personal Care !roducts. he demand of her#al medicines is increasin ra!idly due to their sin friendliness and lac of side effects. he #est thin of the her#al cosmetics is that it is !urely made #y the her#s and shru#s and thus is side5effects free. he natural content in the her#s does not have any side effects on the human #odyN instead !rovide the  #ody

with

nutrients

and

other

useful

minerals

&Q.

he

term

Cosmoceuticals was first used #y %aymond %eed  foundin mem#er of  >.' 'ociety of Cosmetics Chemist in 1"-1. *e actually used the word to  #rief the active and science #ased cosmetics. he a#ove term was further  used #y Dr Albert ligman in the year 1"9& to refer the su#stances that have #oth cosmetic and thera!eutic #enefits ,Q. Cosmoceuticals are cosmetic5!harmaceutical hy#rids intended to enhance health and #eauty throuh inredients that influence the sin4s #ioloical te6ture and function.

Ad!antages of $erbal Cosmetics o!er "ynt5etic *er#al cosmetics are the modern trend in the field of #eauty and fashion. hese aents are ainin !o!ularity as nowadays most women !refer  natural !roducts over chemicals for their !ersonal care to enhance their   #eauty as these !roducts su!!ly the #ody with nutrients and enhance health and !rovide satisfaction as these are free from synthetic chemicals and have relatively less side5effects com!ared to the synthetic cosmetics.

ollowin are some of the advantaes of usin natural cosmetics which mae them a #etter choice over the synthetic onesL

14

1)


he name itself suests that her#al cosmetics are natural and free from all the harmful synthetic chemicals which otherwise may !rove to #e to6ic to the sin. Instead of traditional synthetic !roducts different !lant !arts and  !lant e6tracts are used in these !roducts7 e.. aloe5vera el and coconut oil. hey also consist of natural nutrients lie %itamin E that ee!s sin healthy7 lowin and #eautiful. or e6am!le7 Aloevera is a her#al !lant s!ecies #elonin to liliaceae family and is naturally and easily availa#le 9Q. here are a risin num#er of consumers concerned a#out inredients such as synthetic chemicals7 mineral oils who demand more natural  !roducts with tracea#le and more natural inredients7 free from harmful chemicals and with an em!hasis on the !ro!erties of #otanicals "Q.

2)

"afe to se

Com!ared to other #eauty !roducts7 natural cosmetics are safe to use. hey are hy!o5allerenic and tested and !roven #y dermatoloists to #e safe to use anytime7 anywhere. 'ince they are made of natural inredients7 !eo!le dont have to worry a#out ettin sin rashes or e6!erience sin itchiness. E6am!le

5

B*A

?Butylated*ydro6yanisole@

and

B*

?Butylated*ydro6ytoluene@ are closely related synthetic antio6idants and are used as !reservatives in li!stics and moisturi(ers 1;Q. B*A and B* can induce alleric reactions in the sin 11Q. he international Aency for  2esearch on Cancer classifies B*A as a !ossi#le human carcinoen 1Q. *er#al cosmetics contain natural antio6idants lie vitamin C 13Q.

3) Compatible wit5 all skin types

 +atural cosmetics are suita#le for all sin ty!es. +o matter if you are dar  or fair7 you will find natural cosmetics lie foundation7 eye shadow7 and li!stic which are a!!ro!riate irres!ective of your sin tone. omen with oily or sensitive sin can also use them and never have to worry a#out deradin their sin condition. Coal tar5derived colors are used e6tensively in cosmetics7 Coal tar is reconi(ed as a human carcinoen and the main

15

concern with individual coal tar a color ?whether !roduced from coal tar or  synthetically@ is they can cause cancer 1&Q. But natural colors that are o#tained from her#s are safer.

4) 0ide selection to c5oose from

 +atural cosmetics may still #e a new ty!e in the #eauty industry #ut they already offer a variety of #eauty !roducts for all mae u! cra(y !eo!le out there to choose from. One will find a variety of foundation7 eye shadow7 li!stic7 #lush7 mascara7 concealer and many more which are all naturally formulated. urthermore7 one will find locally made natural cosmetics or  those made #y famous desiners worldwide. here e6ist a lare variety of  her#al e6tracts7 to name a few Androra!hisPaniculata ?Falmeh@7 As!araus 2acemosus ?'hatawari@7 Boswellia'errata ?'alai/ual@7 As!halt ?'hila=it@ etc 1,Q.

5) =its yor bdget

 +atural cosmetics are not that e6!ensive. In fact7 some of these !roducts are more afforda#le than synthetic ones. hey are offered at discounted  !rices and are sold for a chea! !rice durin sales. Hust need to survey enouh to loo for reat deals. An estimate of *O demonstrates a#out 9;< of world !o!ulation de!ends on natural !roducts for their health care7  #ecause of side effects inflicted and risin cost of modern medicine. orld *ealth Orani(ation currently recommends and encouraes traditional her#al cures in natural health care !rorams as these drus are easily availa#le at low cost and are com!aratively safe 1-Q.

6)
'ome cosmetics are initially tested on animals to ensure that they are safe and effective to use for human. *owever7 natural cosmetics need not #e tested on animals. hese natural formulations are tested #y e6!erts in la#oratories usin state of the art e:ui!ment with no animals involved 0Q.

16

7)
he synthetic #eauty !roducts can irritate your sin7 and cause !im!les. hey miht #loc your !ores and mae your sin dry or oily. ith natural cosmetics7 one need not worry a#out these. he natural inredients used assure no side effectsN one can a!!ly them anytime7 anywhere. or  e6am!le her#al cosmetics are free from !ara#ens that are the most widely used !reservative in cosmetics and can !enetrate the sin 10Q. And are sus!ected of interferin with hormone function ?endocrine disru!tion@ 1;Q.

$erbs ?sed in Cosmetics9Cosmeceticals

here are numerous her#s availa#le naturally havin different uses in cosmetic !re!arations for sincare7 hair care and as antio6idants7 frarant etc. 'ome of the im!ortant e6am!les are as followsL

1) "kincare

•

Cocont oil&It is !roduced #y crushin co!ra7 the dried ernel7 which

contains a#out -;5-,< of the oil. Coconut oil contains a hih amount of lycerides of lower chain fatty acids. Coconut oil is derived from the fruit or seed of the coconut !alm tree Cocosnucifera7 family Arecaceae. he meltin !oint of coconut oil is & to ,RC ?0,50-S@ and thus can #e used easily in li:uid or solid forms and is often used in cooin and #ain. Coconut oil is e6cellent as a sin moisturi(er and softener.

•

"nflower oil&It is the non5volatile oil e6tracted from sunflower seeds

o#tained from *elianthus annuus7 family Asteraceae. 'unflower oil contains lecithin7 toco!herols7 carotenoids and wa6es. It has smoothin  !ro!erties and is considered non5comedoenic &Q. A sim!le yet cost5 effective oil7 well tried and tested for enerations in a wide variety of  emulsions formulated for face and #ody Products. 17

•

Fo,oba oil&It is a mi6ture of lon chain7 linear li:uid wa6 esters

e6tracted from the seeds of the desert shru# simmondsiachinenesis7 family simmondsiaceae. Ho=o#a oil is easily refined to remove any odor7 color it is o6idative sta#le7 and is often used in cosmetics as a moisturi(er and as a carrier oil for e6otic frarances. *uman se#um and =o=o#a oil are virtually identical. 'e#um !rotects and moisturi(es the sin and hair #ut is stri!!ed away #y chemicals7 !ollutants7 sun and the ain !rocess7 resultin in dry sin and hair. Ho=o#a oil re!lenishes what sin and hair lose and restores them to their natural !* #alance.

•

1li!e oil&his oil is a fi6ed oil e6tracted from the fruits of 

oleaeuro!aea7 family oleaceae. he ma=or constituents are triolein7 tri!almitin7 trilinolein7 tristearate7 monosterate7 triarachidin7 s:ualene7 T5sitosterol and toco!herol. It is used as sin and hair conditioner in cosmetics lie lotions7 sham!oos etc. It is a !otent fatty acid  !enetration enhancer.

•

Aloe!era&Aloevera is aher#al !lant s!ecies #elonin to liliaceae

family that is found only in cultivation7 havin no naturally occurrin  !o!ulations7 althouh closely related aloes do have !resence in northern Africa 9Q. It is an inredient in many cosmetics #ecause it heals7 moisturi(es7 and softens sin. 'im!ly cut one of the aloe vera leaves to e6tract the soothin el &Q. Aloe vera contains amino acids lie leucine7 isoleucine7 sa!onin lycosides that !rovide cleansin action7 vitamins A7C7E7B7 choline7 B1 and folic acid and !rovide antio6idant activity.

2) Antiaging •

Carrot&It is o#tained from the !lant Daucuscarota#elonin to family

A!iaceae. It is a valua#le her# since aes as due to its richness in %itamin A alon with other essential vitamins. Carrot seed oil is used as anti5ain7 revitali(in and re=uvenatin aent &Q. he carrot ets its characteristic and #riht orane colour from T5carotene7 and lesser  18

amounts of U5carotene and V5carotene. U and T5carotenes are !artly meta#oli(ed into vitamin Ain humans.

•

:ingko&In China and Ha!an7 the leaves and nuts of the /ino

 #ilo#a?/. #ilo#a@ tree have #een used for thousands of years to treat various

medical conditions7

includin

!oor #lood

circulationN

hy!ertensionN !oor memory7 and de!ression7 !articularly amon the elderlyN male im!otence. In addition7 it is ainin a similar re!utation as an antio6idant and anti5inflammatory aent. /ino #ilo#a#elons to family /inoaceae7 which rows to a hue si(e 3;Q. he /.  #ilo#ae6tractE/# 0-17 !re!ared from the tree4s leaves7 is a natural mi6ture containin flavone lycosides ?33<@7 mostly :uercetin and aem!ferol derivatives7 and ter!enes ?-<@7 which has e6hi#ited the ca!acity to reduce the num#er of ultraviolet B ?>%B@5induced sun#urn cells in mice. 3) Dandrff treatment

Ayurveda has numerous natural medications wherein the most common her#s include +eem7 Fa!oor ?na!hthalene@7 and *enna7 *irda7 Behada7 and Amalai7 $aic nut7 Brinara=7 2osary Pea7 'weet la7 Cashmere tree and $andor.

•

$enna& *ennacomes from the !lant awsoniainermisfamilyythraceae7

which contain a dye molecule called awsone7 which when !rocessed  !roduces *enna !owder. Besides lawsone other constituents !resent are allic acid7 lucose7 mannitol7 fats7 resin ?<@7 mucilae and traces of an alaloid. eaves yield hennatannic acid and an olive oil reen resin7 solu#le in ether and alcohol 3Q. awsone isolated from the leaves of .inermishas shown sinificant antifunal anti#iotic effect.

19

•


 #elons to the family $eliaceae. he atini(ed name of +eem5 A(adirachtaindica5is derived from the Persian.

he common treatment for the dandruff is +eem as it !roduces antifunal7 anti#acterial7 !ain5relievin7 and anti5 com!ounds that would treat dandruff.

4) "kin Protection

•

:reen tea& he tea !lant ?Camellia sinensis@ has #een cultivated in

Asia for thousands of years 3,Q. he & ma=or !oly!henoliccatechins  !resent in reen tea leaves are ?@5e!icatechin ?EC@7 E/C7 ?@5EC535 allate7 and E/C/7 which is the most a#undant 3-730Q. It was found that reen tea e6tracts or an individual reen tea !oly!henol ?/PP@7 es!ecially e!iallocatechin ?E/C@535allate ?E/C/@7 inhi#ited two5 stae

chemical

carcinoenesis

?e7

induced

#y

0715di5

methyl#en(?a@anthracene D$BAQ and 15O5tetra5decanoyl!hor#ol 135acetate PAQ@7 and !hotocarcinoenesis ?induced #y >%B@.

•

Calendla&Calendulaofficinalisis re!orted to have a remara#le

antio6idant activity7 anti5 inflammatory activity and wound healin activity 3"Q. A !revious study demonstrated that the essential oil of  Calendula consists mainly of U5thu=ene7 U5!inene7 1795Cineole7 dihydrotaetone and 5muurolol .

•

Trmeric&It is a dee! yellow5to5orane !owder that comes from the

underround stems of the tro!ical !erennial her# Curcuma lona of the family Wini#eraceae&1Q. urmeric contains a wide rane of   !hytochemicals

includin7

demetho6ycurcumin7

 #isdemetho6ycurcumin7 (ini#erene7 curcumol7 curcumenol7 euenol7 tetrahydrocurcumin7 triethylcurcumin7 curcumin7 turmerin7 turmerones7 and turmeronols. Curcumin is the !hytochemical that ives a yellow color to turmeric and is now reconi(ed as #ein res!onsi#le for most 20

of the thera!eutic effects &Q. >ses of turmeric include antise!tic7 analesic7

anti5inflammatory7

antio6idant7

antimalarial7

insect5

re!ellant7 and other activities associated to turmericiure 13@.

5) $aircare

•

Amla&Amla is the name iven to the fruit of a small leafy tree

?Em#licaOfficinalis@7 which rows throuhout India and yields an edi#le fruit. It is hihly !raised #oth for its hih vitamin C content and for the !recious oil7 which is e6tracted from its seeds and !ul! and used as a treatment for hair and scal! !ro#lems. It is used in eye syndromes7 hair loss7 and children ailments etc.

•

"5ikakai&Acaciaconcinna inn. ?euminosae@ is a medicinal !lant

that rows in tro!ical rainforests of southern Asia. he fruits of this  !lant are used for washin hair7 for im!rovin hair rowth7 as an e6!ectorant7 emetic7 and !urative. he !owder of Acacia Concinna inn shows the !resence of sa!onins7 alaloid7 suar7 tannin7 flavanoids7 anthra:uinone lycosides.

6) Essential oils

•

%ose oil&2oses are widely referred to as the worlds favorite flower in

 !art due to their vast diversity in !lant ha#itat and floral characteristics. here are mainly four s!ecies of roses for oil !roduction. hese are 2osa

damascena$ill.72.

allica.7

2.

moschata*errm.

and2.

centifolia. 2ose oil and rose water have many thera!eutic effects. 2ose oil hel!s soothe the mind and heals de!ression7 rief7 nervous stress and tension. It also hel!s to heal wound and sin.

•

Ecalypts oil&here are around 0;; different s!ecies of Eucaly!tus

in the world7 of which at least ,;; !roduce a ty!e of essential oil. It is  !roduced #y steam distillation from the leaves of Eucaly!tus s!ecies 21

?E. cinerea . $uell.7 E. #aueriana . $uell.7 E. smithii 2. . Baer7 E.  #ridesiana 2. . Baer7 E. microtheca . $uell.7 E. foecunda'chau.7 E. !ulverulenta 'ims7 E. !ro!in:ua Deane and $aiden7 E. erythrocorys . $uell.@ etc. hey are widely used in the !re!aration of liniments7 inhalants7

couh

syru!s7

ointments7

tooth!aste

and

also

as

 !harmaceutical flavors. he Euro!ean Pharmaco!oeia monora!h for  Eucaly!tus

oil

s!orts

a

chromatora!hic

!rofileL

1795cineole

?eucaly!tolN not less than0;<@7 limonene ?&5 1<@7 U5!inene ?59<@7 U5 !hellandrene ?less than 1.,<@7 T5!inene ?less than ;.,<@7 cam!hor  ?less than ;.1<@.

7) Antioxidants

•

Tamarind&amarind

or

amarindusindica.

of

the

a#aceae7

su#family Caesal!inioideaeconsists of amino acids7 fatty acids and minerals of tamarind !lant !arts. he most distinuished characteristic of tamarind is its sweet acidic taste due to tartaric acid. Besides #ein a rich source of suars7 tamarind fruit is also an e6cellent source of  vitamin B and contain minerals7 e6hi#it hih antio6idant ca!acity that a!!ear to #e associated with a hih !henolic content7 and thus can #e an im!ortant food source.

•

;itamin C&%itamin C is necessary for the hydro6ylation of !roline7

 !rocollaen7 and lysine. %itamin C im!roves the chanes caused #y  !hoto damae. %itamin C has #een used effectively to stimulate collaen re!air7 thus removin some of the effects of !hoto5ain on sin 13Q.

•

;itamin E&?Al!ha5toco!herol@ is the ma=or li!o!hilic antio6idant in

 !lasma mem#ranes and tissues. he term vitamin E collectively refers to 3; naturally occurrin molecules ?& toco!herols and & tocotrienols@7 all of which e6hi#it vitamin E activity. Its ma=or role is enerally considered to #e the arrest of chain !ro!aation and li!id !ero6idation 22

 #y scavenin li!id !ero6yl radicals7 hence !rotectin the cell mem#rane from destruction.

I.


 The term nutraceuticals was coined from “nutrition and “!harmaceutical "# $te!hen %efelice &%' founder and chairman of the foundation for inno(ation in medicine )*I&+ ,ranford' -ew ers#' in 1989. /ccordin to %efelice “-utraceuticals are food or !art of a food that !ro(ides medical or health "enets includin the !re(ention andor treatment of a disease. ree !h#sician I,/T$ )nown as father of medicines+ said “let food "e #our medicine The !hiloso!h# "ehind is “focus on !re(ention ther words used in the conte:t are %ietar# su!!lements' functional food' multi;functional food' etc. *unctional foods are ordinar# foods that ha(e com!onents' inredients that incor!orated into i(e them a s!ecic medicinal or health "enet moreo(er nutritional e
Accordin to Dietary 'u!!lement7 *ealth and Education Act ?D'*EA@7 dietary su!!lements are !roducts intended to su!!lement the diet that #ears or contains one or more of the followin dietary inredientsL a vitamin7 a mineral7 an her# or other #otanical7 an amino acid7 a dietary su#stance for  use #y man to su!!lement the diet #y increasin the total daily intae7 or a concentrate7 meta#olite7 constituent7 e6tract7 or com#inations of these inredients. It may #e taen in the form of !ill ca!sule7 ta#let7 or li:uid form. It is not re!resented for use as a conventional food or as the sole item of a meal or diet. It is la#eled as a Jdietary su!!lement.K >nder the D'*EA ?1""&@7 the manufacturer of a dietary su!!lement is res!onsi#le for ensurin that the dietary su!!lement is safe #efore it is mareted.

23

'im!ly7 +utraceuticals means7 +>2II%E X P*A2$ACE>ICAL A food stuff ?as a fortified food or dietary su!!lement@ that !rovides health  #enefits.

he functional food conce!t can #e defined as Jood !roducts to #e taen as !art of the usual diet in order to have #eneficial effects that o #eyond  #asic nutritional functionK

$ealt5 8enefits

•

Avoid the side effect.

•

$ay increase the health #eneficial effect.

•

$ay have naturally dietary su!!lement7 so do not have un!leasant side effect.

•

$ay increase the health value7 our diet and im!rove medical condition of human.

•

$ay easily #e availa#le and economically afforda#le.

 +utritional thera!y is a healin system usin dietary thera!eutics or  nutraceuticals as a com!lementary thera!y. his thera!y is #ased on the  #elief that foods can not only #e sources of nutrients and enery #ut could also !rovide medicinal #enefits.

Accordin to nutraceutical and nutritional thera!y theory7 it achieves this oal #y usin efficacy of such nutraceuticals in deto6ifyin the #ody7 avoidin vitamin and mineral deficiencies7 and restorin healthy diestion and dietary ha#it. Phytonutrients #asically is !lant nutrients with !articular   #ioloical activities in su!!ortin human health.

he !hytochemical wor #y followin wayL 1. 'u#strate for #iochemical reactions. 2. Cofactors of en(ymatic reactions. 3. Inhi#itors of en(ymatic reactions. 24

4. A#sor#ents that #ind to and eliminate undesira#le constituent in the

intestine. 5. Enhance the a#sor!tion and)or sta#ility of essential nutrients. 6. 'elective rowth factor for #eneficial #acteria. 7. ermentation su#strate for #eneficial #acteria. 8. 'elective inhi#itors of deleterious intestinal #acteria. 9. 'caveners of reactive or to6ic chemicals. 10. iands that aoni(e or antaoni(e cell surface or intracellular 

rece!tors.

Classification  +utraceuticals or functional foods can #e classified on the #asis of their  natural sources7 !harmacoloical conditions7 or as !er chemical constitution of the !roducts. 1. On the #asis of natural source7 it can #e classified as the !roducts

o#tained from !lants7 animals7 minerals7 or micro#ial sources. 2.  +utraceuticals as !er the chemical rou!ins.

Category of <traceticals

•

'u#stances with esta#lished nutritional functions7 such as vitamins7 minerals7 amino acids7 and fatty acids+utrients.

•

*er#s or #otanical !roducts as concentrates or e6tracts*er#als.

•

2eaents derived from other sources ?e..7 !yruvate7 chondroitin sulfate7 steroid hormone !recursors@ servin s!ecific functions7 such as s!orts nutrition7 weiht5loss su!!lements7 fortified conventional foods7 and meal re!lacementsDietary su!!lements.

Dietary su!!lements are not intended to treat or cure disease7 whereas nutraceuticals more em!hasi(e the e6!ected results of these !roducts7 such as !revention or treatment of diseases.

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'ome of the most common ways of classifyin nutraceuticals can #e #ased on food sources7 mechanism of action7 chemical nature7 etc. he food sources used as nutraceuticals are all natural and can #e cateori(ed as 1. Dietary i#er. 2. Pro#iotics. 3. Pre#iotics. 4. Polyunsaturated fatty acids. 5. Antio6idant vitamins. 6. Poly!henols. 7. '!ices

 +utraceutical can #e #roadly classified into the followin  rou!sL i@ Potential nutraceuticals. ii@ Esta#lished nutraceuticals.

A !otential nutraceutical could #ecome an esta#lished one only after  efficient clinical data of its health and medical #enefits are o#tained.

Global Demand of Nutraceutical

he nutraceutical industry lies under three main sements which include functional foods7 dietary su!!lements7 and her#al)natural !roducts. /lo#al nutraceutical maret is estimated as >'D 110 #illion ?I+2 ,1&9 #illion@. In ;;07 nutraceuticals sale is !ro=ected to reach 80&.0 #illion at an AA/2  of "."<. his assumes a world economic recovery in ;;3 and an end to  !rice com!etition.

<tracetical market in different contries

Accordin to a recent re!ort7 the total maret for nutraceuticals in India is rowin at 1 !ercent !er annum. It is currently valued at I+2 &&#n ?Y-1 m@7 #ut could #e worth more than I+2 ",#n in four years. 26

As a conce!t7 J+utraceuticalsK is still in its stae of infancy in India. But it has #een rowin much faster than lo#al rates at CA/2 of 19< for the last 3 years driven #y functional food and #everaes cateories. he most ra!idly rowin sements of the industry were dietary su!!lements ?1".,  !ercent !er year@ and natural)her#al !roducts ?11.- !ercent !er year@.

%eglations

A food stuff ?as a fortified food or a dietary su!!lement@ that !rovides health #enefits7 if indeed a claim was made that im!lied medicinal #enefit reardin a nutraceutical !roduct7 the !roduct would #e re:uired to com!ly with the reulatory re:uirements for medicinal !roducts7 in res!ect of  safety7 efficacy7 and :uality testin

and maretin authori(ation

 !rocedures. or decades7 DA reulated dietary su!!lements as foods to ensure that they were safe and wholesome and that their la#elin was truthful and not misleadin. In ;;-7 the Indian overnment !assed ood 'afety and 'tandard Act to interate and streamline the many reulations coverin nutraceuticals7 foods7 and dietary su!!lements. he act calls for  the creation of the ood 'afety and 'tandards Authority ?''A@.

8enefits of 'mplementation of =""A' Acts

•

>nification of eiht laws7 i.e. ste!s to *armoni(ation.

•

Alinment of international reulations.

•

'cience5#ased standards.

•

Clarity and uniformity on novel food areas.

•

*el! cur# corru!tions.

>nlie the >'7 where the D'*EA is in !lace to reulate these !roducts7 in India the /overnment is in the !rocess of draftin a law to reulate manufacturin7 im!ortin7 and maretin of health foods7 dietary su!!lements7 and other nutraceuticals and finally Indian food safety standard #ill ;;, sined into law7 !romisin a ma=or im!act on Indian

27

food !rocessin industry. he Indian ood 'afety and 'tandard Act came into enforcement in ;;- with the followin two main o#=ectivesL •

o introduce a sinle statute relatin to food7 and

•

o !rovide for scientific develo!ment of the food !rocessin ;;" industry.

:o!ernment %eglations B <EA #**

 +utrition a#elin and Education Act of 1""; ?+EA@ defines how food is la#eled7 includin nutrition la#elin7 in accordance with definitions esta#lished #y DA7 and !rovidin for the use of claims a#out the relationshi! #etween nutrients and diseases or health5related condition.

8enefits of %eglation

•

Allows reater leal security and more !redica#le environment.

•

'u!!orts innovation ?food and drin !roducts@.

•

Prevents unfair com!etition from manufactures usin false or  misleadin claims.

•

If !ositive claims cannot #e made7 the reulation does not o#lie anyone to mae neative claims a#out the !roduct.

1r "er!ices e can offer the followin servicesL



Offer our #rands for Domestic as well as International 'ales.



Contract manufacturin of our #rands in your la#el and !acain.



Contract manufacturin of your #rands in your la#el and !acain.



Contract manufacturin under neutral code customi(ed for end user   !acain.

28



Develo! and manufacture new her#al !roducts or su!!lements in your   #rand and !acain.

4anfactring =acility

he com!any is head:uartered at Indore ?$P@ and has /$P a!!roved manufacturin facility in Industrial area of Pit5ampr Dist. D5ar   alon with I'O ";;1 accreditation. It is a#out 3, Fm from the cor!orate office located at Indore. he facility already has /$P and I'O ";;1 accreditation and will have *O5/$P accreditation shortly #y the end of  Han ;1,. It is servin as a contract manufacturer for a num#er of re!uted  !harmaceutical com!anies in India. he com!any has #een successful audited and a!!roved #y the ma=or Indian Com!anies7 namin fewL

a. 4anfactring %ange

4akin aboratories P!t. td.   is e:ui!!ed with the most modern

state5of5the5art !lant to manufacture thera!eutic dosae forms lieL

 a#lets  Ca!sules  i:uids  Oils  o!icals  Ointments and /els  Powders

1r 4anfactring Policy

 2aw materials ) *er#al E6tracts used in the manufacturin of   !roducts are from authentic and re!uted sources7 of !rescri#ed :uality and are free from any contamination 29

 he manufacturin !rocess com!lies with 'OPs as !rescri#ed to maintain the standards  Ade:uate :uality control measures are ado!ted. Zuality control measures includin IPZC are strinent.  he manufactured !roducts released for sale are of hihest international :uality.

 #. Gality Control and Gality Assrance

e #elieve in total :uality manaement and total :uality com!liance7 we !rovide validation throuh inde!endent la#oratory testin also.

1r 4anfactring Process

30

Gality 4anagement "ystem

Gality Policy&Our :uality !olicy is to ensure that the :uality of the !roduct is to satisfy the customer and society accordin to the current ood la#oratory and manufacturin !ractices.

Gality 1b,ecti!es&o achieve the desired :uality of the !roduct7 the :uality o#=ectives areL •

•

• •

o manufacture the !roduct remem#erin the re:uirements of the customer and society. o achieve the :uality with current ood manufacturin and la#oratory !ractices. o maintain the wor !lace and environment neat and clean. o a!!ly the corrective chanes for im!lementin the system.

Gality Control

1. 2aw materialsL he first ste! in maintainin :uality is careful selection of  the materials to #e used. $aterials should #e of the same :uality as the sam!le that was sent to the #uyer. If the same materials are unavaila#le or need to #e su#stituted7 the #uyer must #e notified. All materials should also #e e6amined for :uality. ood should #e !ro!erly dried or final !roducts will crac. e6tiles should #e checed for color fastness and shrinin. ittins and fasteners should function !ro!erly and withstand use. All materials used should #e consistent in :uality and color. In eneral7 it is not a ood idea to com!romise :uality for cost #y usin ine6!ensive7 #ut !oorly made materials. Payin a little more for ood :uality materials will !ay off in the lon run #y  #uildin #uyers confidence in your !roducts.

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. Production ProcessL our order must match the sam!le a!!roved #y the  #uyer. o assure this7 it is essential to maintain counter sam!les of the sam!le sent to the #uyer. his will avoid confusion of what the #uyer is e6!ectin. Production of the order should #e com!ared to the counter sam!le several times durin the !roduction !rocess7 not =ust once the !roduct is finished. 'ome #uyers may re:uest that a !roduction sam!le ?!hoto or actual !roduct@  #e sent to them for their a!!roval to assure that matches their s!ecifications  #efore it is shi!!ed. Zuality control throuhout !roduction can hel! identify mistaes and correct them #efore they result in costly errors. >se a thorouh :uality control chec list for monitorin consistency and :uality of  your !roduction.

3. rainin of artisansL *andcrafts are often made in small worsho!s7 and lare orders may #e filled #y a num#er of different !roducers. In this case7 e6tra care must #e taen to mae sure that the final !roducts are all alie and are the same as the sam!le. rainin and ood communication with the artisans is essential. Artisans should understand what is involved in !roducin crafts for e6!ort and how to meet :uality re:uirements. All artisans should #e trained in how to chec for :uality issues as they mae the !roducts and #e  !rovided with a chec list of what to loo for when monitorin the :uality of  their !roduction.

&. orin conditionsL /ood :uality is also a factor of the worin conditions of the artisans. orin conditions include thins lie fair waes7 !ro!er wor  areas and e:ui!ment7 and worer incentives. he !rice !aid to the artisan can im!act the :uality of !roduction7 as does the time they have to fulfill an order. If artisans have to !roduce a lare order in a short amount of time7 this could result in :uality #ein com!romised. If artisans are !aid a low wae7 they have little incentive to invest time into main a ood :uality item. Artisans also need to have access to funds to !urchase raw materials of the :uality desired. 'ome artisan orani(ations have develo!ed a savins and loan !roram7 to lend money to artisans for the !urchase of raw materials when they need it. $ost fair trade orani(ations should offer !re5financin when !lacin an

32

order7 to assure that artisans can cover the costs of !urchasin materials and  !roducin the !roducts. inally7 ood :uality !roduction also de!ends on worsho! conditions. or areas should #e e!t clean and artisans should have the minimal tools needed. 'ometimes somethin as sim!le as main sure the artisans have ta!e measurers can mae a #i difference.

,. Pro!er !acinL Zuality can also #e com!romised if !roducts are not  !ro!erly !aced for shi!!in. A !roduct may have #een made well7 #ut #e damaed durin shi!!in7 resultin in losses. Entire #o6es of !roducts can arrive damaed #ecause they were !aced when still wet7 were !aced too tihtly or without ade:uate !rotection. Zuality control also includes !acin  !roducts so that they are !rotected from damaes until they reach the #uyer. Pro!er !acin is the res!onsi#ility of the !roducer. or more on !acin7 see the Pacin and Pacain section.

Effective Zuality Control



$aintain counter sam!le oriinals of the same :uality sam!le sent to  #uyer.



Chec :uality control at multi!le !oints throuhout !roduction  !rocess.



>se a thorouh :uality control chec list for monitorin consistency and :uality of your !roduction.



Provide chec list for all staes of !roduction and mae sure all artisans now how to chec for :uality issues as they mae the  !roducts.

33

Gality Assrance Process 7 Procedres

$eetin customer e6!ectations comes from consistently meetin standards. our com!any is only as ood as its last customer e6!erience. If your  em!loyees do not meet your standard7 your !atrons may see out the com!etition the ne6t time a need arises. Deliverin consistent results is at the core of :uality assurance !rocedures. hether you are manufacturin a million widets or fi6in com!uters for local clients7 every em!loyee needs to now the com!any4s :uality standards and how to achieve them.

•

T5e "5ew5art Cycle

o deliver !roducts and services with consistent results7 you can im!lement the 'hewhart Cycle7 which uses four ste!sL Plan7 Do7 Chec  and Act ?PDCA@. In the Plan ste!7 state the desired oals for your !roduct and how they will #e achieved. he Do ste! is your im!lementation of the  !lan. Once the !roduct is in !roduction7 it is time to Chec to mae sure it is meetin the standard you set in the Plan ste!. Act re:uires you and your  team to mae necessary corrections when the !roduct is not meetin the correct standards.

34

•

Defining Gality

Zuality assurance relies on a strict definition of what is acce!ta#le and not acce!ta#le from a !roduct or service. If a customer has ordered a widet from your com!any that is to #e cut into three5inch !ieces7 then a four5inch  !iece does not meet the :uality standard. A cleanin service may have a standard that calls for #athroom mirrors to #e cleaned free of smudesN a finer!rint left #ehind falls outside of the standard. It is your res!onsi#ility to your com!any4s success to mae sure that every em!loyee understands the :uality definitions and how he is to mae certain those standards are met.

•

4easring Gality

$easurin the :uality that is delivered is critical for consistent results. $anaers and su!ervisors should chec an em!loyee4s wor as it relates to :uality standards. hen :uality falls short7 su!ervisors are res!onsi#le for  main the chane re:uired to #rin :uality #ac to the !ro!er standard.

•

'mpro!ing Gality

he old e6!ression7 Mhere is always room for im!rovement7M rins true when it comes to :uality assurance. o ee! your #usiness on the cuttin ede7 you should always #e asin the :uestion7 M*ow can we mae this  #etter[M By tweain the !rocess here and there or #y raisin standards a small #it each year7 you will see your overall #usiness :uality im!rove to levels reater than you ever imained.

35

"trctre of t5e 1rganiation

36

1r Clients

:lenmark P5arma

37

Alkem P5arma

Emcre

opran

38

pin

4icro abs td.

Troikaa P5arma

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TT $ealt5care

?nic5em aboratories td.

'ntrodction to Pro,ect

he Pharmaceutical industry is a dynamic industry7 with new !roducts are launched every three months. he #usiness develo!ment division of the com!any acts as the first interface to the e6istin and the !ros!ective clients. As intern in a Business develo!ment division of this com!any my res!onsi#ilities were. 1. Act as liaison #etween e6istin clients and manufacturin facility. . Pros!ect :ualifyin and Consultative sales. 3.

$anain relationshi! with e6istin clients7 Client retention.

&. Clientele e6tension. ,. 2P)2I)Bid !re!aration -. Contract and deal neotiation and closin. 0. 'ales manaement 40

1b,ecti!e of t5e "tdy

1. Academic O#=ectiveL 'u#mission of internshi! re!ort to fulfill deree com!letion re:uirements. . Fnowlede O#=ectiveL o understand !ractical im!lications of  theoretical conce!ts of #usiness develo!ment activities 4a,or earning %1E D'4E<"'1<" A
his is a full5time role with the !ur!ose of develo!in new #usinesses from clients in the !harmaceutical sector. his will #e achieved throuh #uildin7 maintainin and increasin a client contact #ase. It fosters client interaction throuh client meetins7 #riefin and !resentations. +ew !roducts will #e introduced to e6istin and !ros!ective clients. Product is develo!ed as !er the  !roduct re:uirements iven #y the client. In chanin #usiness environment the decision maers are also re:uired to mae dynamic decisions and #usiness develo!ment teams often need to face challenin scenarios. he role re!orts into and will su!!ort the Business Develo!ment Director. %eHirements

o meet)e6ceed sales tarets7 win ratios7 contract values and activity in line with sales stratey. Planning and 1rganiation •

o manae worload effectively in line with overall sales stratey7 taret sectors7 taret shows7 weely !lan and chanin #usiness  !riorities.

•

$aintain accurate records of all calls made and customer contact information on 'tae.

•

Performance monitorin of sales tarets and revenue.

•

aret7 !lan and !re!are for any trade shows that are attended. Ensurin that sales su!!ort tools and follow u! information are in line with o#=ectives at shows.

41

•

o !lan and diari(e reular contact with !ros!ective clients in order to maintain relationshi! and ain information a#out their oals and o#=ectives and com!etitive activities.

•

o #e aware of de!artmental worloads and manae client e6!ectations accordinly.

'nterpersonal "kills •

o effectively sell in the heads #rand services to clients to ain commitment to tender for #usiness.

•

o form relationshi!s with ey !ersonals in the client com!anies.

•

o understand clients relationshi!s such that ey information re:uired for :ualifyin the o!!ortunity is o#tained early on.

•

o trac and review with BD Director !ersonal develo!ment o#=ectives to #uild sellin sills.

Teamwork  •

o wor

across #usiness manain

relationshi!s

with

other 

de!artments at all staes of the sales !rocess. •

o wor with other areas of #usiness ensurin necessary lead times are understood in order to deliver a :uality !ro!osal.

•

o hel! other de!artments achieve their oals at all times and es!ecially durin !ea worload.

•

o hold half yearly and annual a!!raisals with manaement to identify  !erformance achievement7 !ersonal oals and develo!ment oals.

Commnication •

o ensure that all communication with !ros!ective clients is focused and a!!ro!riate for their #usiness sector.

42

•

o !re!are client #riefs and #rief other de!artments effectively ?new and e6istin clients@.

•

o !rovide feed#ac to de!artments on interim desins and costs such that client needs are met.

•

o !re!are and !resent hih :uality client !ro!osals in a clear7 structured and customer focused format.

•

o !rovide client feed#ac to all de!artment heads in a !ositive and constructive way on wins)losses.

•

o maintain sills in the use of tools for the role e.. 'ae7 s!read sheets7 document !re!aration.

:eneral •

o ensure that all administrative !rocesses and !rocedures are adhered to and com!leted in a timely manner.

•

o o!erate within allotted #udetary !arameters e.. with travel and attendance at shows.

•

o understand and ado!t safe worin !ractices.

•

o adhere to all com!any !olicies and uidelines as sti!ulated in contract of em!loyment.

Personal Galities •

o !ro=ect a smart and !rofessional imae at all times.

•

o #e !roactive in all as!ects of the =o# role.

•

Be res!onsi#le for own self5develo!ment7 es!ecially ee!in a#reast of  current ha!!enins.

%ele!ant "kills> nowledge and Experience •

$inimum

35,

years

e6hi#ition

e6!erience

within

develo!ment role or e:uivalent telesales environment •

/ood communication7 !resentation G inter!ersonal sills.

•

A#ility to influence and ain areement of !ros!ective clients

•

/ood Plannin G oranisational sills

43

#usiness

•

/ood written and ver#al communication sills

•

'elf5$otivated and hard worin.

•

Annual7 Zuarterly and $onthly O#=ectives will #e set #y the Business Develo!ment Director and reviewed reularly aainst !erformance measures detailed aainst the o#=ectives.

•

A#ility to lead a team creatively7 nurturin team mem#ers.

•

/ood analytical sills com#ined with a#ility to reconise and im!lement !lans.

•

E6cellent !lannin G oranisational sills.

•

E6cellent technical G creative sills.

$ow 8siness De!elopment takes place in t5e manfactring nit of P5armacetical Company

Business development is the creation of longterm value for an organization from customers, markets, and relationships. 8siness de!elopment ?BD@ com!rises a num#er of tass and !rocesses

enerally aimin at develo!in and im!lementin rowth o!!ortunities within and #etween orani(ations. It is a su#set of the fields of #usiness7 commerce and orani(ational theory. Business develo!ment is the creation of lon5term value for an orani(ation from customers7 marets7 and relationshi!s.

44

he #usiness develo!er is concerned with the analytical !re!aration of  !otential rowth o!!ortunities for the senior manaement or  #oard of directors as well as the su#se:uent su!!ort and monitorin of its im!lementation. Both in the develo!ment !hase and the im!lementation  !hase7 the #usiness develo!er colla#orates and interates the nowlede and feed#ac from the orani(ations s!ecialist functions. E6am!les are 2GD7  !roduction7 maretin7 and sales to assure that the orani(ation is ca!a#le of im!lementin the rowth o!!ortunities successfully. he #usiness develo!ers4 tools to address the #usiness develo!ment tass are the #usiness model of continuous evaluation of #usiness o#=ectives.

Business develo!ment !rofessionals fre:uently have had earlier e6!erience in sales7 financial services7 investment #anin or manaement consultinN althouh some find their route to this area #y clim#in the cor!orate ladder in functions such as o!erations manaement. 'ill set and e6!erience for  #usiness5develo!ment s!ecialists usually consist of a mi6ture of the followin ?de!endin on the #usiness re:uirements@L •

'ales

•

inance

•

$aretin

•

$erers and ac:uisitions

•

eal

•

'trateic manaement

•

Pro!osal manaement or ca!ture manaement

he M!i!elineM refers to flow of !otential clients which a com!any has started develo!in. Business5develo!ment staff assined to each !otential client in the  !i!eline with o#=ective of convertin !ros!ect into a successful client7 with  !ro=ected sales5volumes attached. Planners can use the weihted averae of all the !otential clients in the !i!eline to !ro=ect staffin to manae the new activity when finali(ed. Enter!rises usually su!!ort !i!elines with some ind of customer relationshi! manaement ?C2$@ tool or C2$5data#ase7 either we#5#ased solution or an in5house system. 'ometimes #usiness develo!ment

45

s!ecialists manae and analy(e the data to !roduce sales manaement information ?$I@. 'uch $I could includeL •

•

reasons for wins)losses  !roress of o!!ortunities in relation to the sales !rocess

•

to! !erformin sales !eo!le)sales channels

•

sales of services)!roducts

or larer and well5esta#lished com!anies7 es!ecially in technoloy5related industries7 the term M#usiness develo!mentM often refers to settin u! and manain strateic relationshi!s and alliances with other7 third5!arty com!anies. In these instances the com!anies may leverae each other4s e6!ertise7 technoloies or other intellectual !ro!erty to e6!and their ca!acities for identifyin7 researchin7 analy(in and #rinin to maret new  #usinesses and new !roducts. Business5develo!ment focuses on im!lementation of the strateic #usiness !lan throuh e:uity financin7 ac:uisition)divestiture of technoloies7 !roducts7 and com!anies7 !lus the esta#lishment of strateic !artnershi!s where a!!ro!riate.

"01T Analysis he 'O analysis of the industry reveals the !osition of the Indian  !harmaceutical industry in res!ect to its internal and e6ternal environment.

a) "trengt5s

 *iher /DP rowth leadin to increased dis!osa#le income in the hands of eneral !u#lic and their !ositive attitude towards s!endin on healthcare.

46

 ow5cost7 hihly silled set of Enlish s!eain la#or force and !roven trac record in desin of hih technoloy manufacturin devices.  /rowin treatment naive !atient !o!ulation.  ow cost of innovation7 manufacturin and o!erations.

b) 0eaknesses

 'trinent !ricin reulations affectin the !rofita#ility of !harma com!anies.  Poor all5round infrastructure is a ma=or challene.  Presence of more unorani(ed !layers versus the orani(ed ones7 resultin in an increasinly com!etitive environment7 characteri(ed #y stiff !rice com!etition.  Poor health insurance coverae.

c) 1pportnities

 /lo#al demand for enerics risin.  2a!id OC and eneric maret rowth.  Increased !enetration in the non 5 metro marets.  are demand for :uality dianostic services.  'inificant investment from $+Cs.  Pu#lic5Private Partnershi!s for strenthenin Infrastructure.  O!enin of the health insurance sector and increase in !er ca!ita income 5 the rowth drivers for the !harmaceutical industry.  India7 a !otentially !referred lo#al outsourcin hu# for !harmaceutical  !roducts due to low cost of silled la#or.

d) T5reats

 ae inflation.  /overnment e6!andin the um#rella of the Drus Price Control Order ?DPCO@.

47

 Other low5cost countries such as China and Israel affectin outsourcin demand for Indian !harmaceutical !roducts  Entry of forein !layers ?well5e:ui!!ed technoloy5#ased !roducts@ into the Indian maret.

4a,or C5allenges =aced 8y t5e 'ndstry he Indian !harmaceutical industry was on a stron rowth tra=ectory in the last decade. It has achieved several milestones and is well !ositioned to leverae emerin o!!ortunities. *owever7 the industry needs to tacle various issues related to its o!erations and reulations. It faces several challenes in the form of !ricin of !harmaceutical !roducts and im!act of some areements. his section touches u!on several ey issues and challenes faced #y the industryL 48

•

'mpact of :ATTBT%'P" agreement&  he /eneral Areement on

ariffs and rade1 ?/A@ and rade 2elated as!ects of Intellectual Pro!erty 2ihts ?2IP'@ have an adverse im!act on !ricin of  !harmaceutical !roducts. Pharmaceutical com!anies are not allowed to re5enerate e6istin drus and formulations and chane the e6istin  !rocess and manufacture the same dru. +ew investments are re:uired to !erform research. his is a ma=or o#stacle for !harma com!anies7 es!ecially the micro7 small and medium enter!rises. $oreover7 transfer  of technoloy from a#road is difficult and e6!ensive. Conse:uently7 revenue of the !harma com!anies is im!acted. *ence7 ade:uate measures should #e taen to su!!ort the industrys revenue and minimi(e losses.

•

Pricing& At !resent7 !ricin of 0& #ul drus and their formulations7

which account for a lare share in the retail !harma maret7 are controlled #y the Dru Price Control Order ?DPCO@51"",. he /overnment had considered reducin the num#er of reulated drus7  #ut it has not #een im!lemented. here is a need to reduce the num#er of reulated drus to facilitate the rowth of the !harmaceutical industry.

•

Drg di!ersions by instittions& $ost of the institutional clients of

the Indian !harmaceutical com!anies com!rise overnment hos!itals7 the Indian defense service and !rivate hos!italsN the defense sector is mandated to #uy dru stocs throuh tenders in :uantities twice as lare as the !ro=ected demand for those drus in the followin year at a discounted !rice. At the year5end7 sur!lus availa#le at the institutions is  !ushed to reular channels #y leverain the !rice discounts7 resultin in a loss for com!anies throuh the reular distri#ution channel.

49

8'8'1:%AP$@

$ain a#oratories Private imited is a Private Com!any incor!orated on " A!ril 1"90. It is classified as Indian +on5/overnment Com!any and is reistered at 2eistrar of Com!anies7 /walior. Its authori(ed share ca!ital is 2s. 07,;;7;;; and its !aid u! ca!ital is 2s. ,7"9;7;;;.It is involved in %eterinary activities.

50

 !akin Laboratories "rivate Limite#s $nn%al General !eeting $G!' was last hel on () *eptember +), an as per recors from !inistry of Corporate $ffairs !C$'.

Company Information ,om!an# -ame

&/=I- >/?/TI$ I@/T >I&IT%

o,

o,;walior

eistration -um"er

3930

/cti(it#

@eterinar# acti(ities Aincludin clinico;!atholoical and other dianostic acti(ities !ertainin to animals and "irdsB.

,om!an# ,ateor#

,om!an# limited "# shares

,om!an# $u" ,ateor#

Indian -on;o(ernment ,om!an#

,lass of ,om!an#

ri(ate ,om!an#

/uthoriCed ,a!ital )in s.+

7'500'000

aid u! ca!ital )in s.+

5'980'000

-um"er of

;

&em"ers)/!!lica"le onl# in case of com!an# without $hare ,a!ital+ %ate of Incor!oration

29 /!ril 1987

mail I%

manassociatesDmail.com

/ddress 1

lot no 48' $ector III

/ddress 2

itham!ur 51