****** ***************** nameUniversityDateThe Rise of ******* **** IndustryIntroductionIndian ************** ******** ** one ** the ******** ******* *** **** ********* ****** ***** *** ***** ** *** ****** ***** *** ************ ***** *** ***** ******* ****** ************** ****** ******** *** 10% consumption ** ***** ******** ** ************* drug ****** ****** market ** accounted *** ******** and ************* ****** ******* and ******** in the ****** performance ** *** ****** There are various factors ***** have *** the ******** ** ****** ****** are like ***** population hygiene ******* growth ** income ********* ******* ******** ********* *** **** importantly ******** ** healthcare ********** *** **** *********** taken ** *** ********** ** ******** ***** *** ****** ** drive *** ****** *********** ** ****** pharma ****** *** Government ** ***** *** unveiled ********* ****** 2020’ ***** at ****** ***** * ****** ****** ** ********** **** ******************** to US Consumers *** pharmaceutical ****** *** ***** to ********* and in one **** ** *********** with *** *** ********* ********* *** global market ************* ** *** **** ***** **** ***** *** ********* too Pharma companies **** **** opted *** ***** ***** segmentation with *** ********* to ******** ******* ********* ******** ****** in biotechnology *** ******** *** development has ***** in *** *** ******* ****** market ******* ***** has ********** ********* ** ********* *** Tax ****** Though *** ******* **** ** *** ** is ****** ********* the drugs in ** ****** *** also helped ** ********** *** medical ******** ********* of *** Healthcare sector ** ********** *************** ** Drug manufacturers are ** *** *** ******* ******** within the ****** **** * ****** ************** ** **** **** ****** trillion *** **** ******* ******** by market ************** ** biotechnology ***** ******** *** ** competition **** the ************** industry with **** US ** ******** These figures show the ******* ******** ** *** ************** ******** within *** ****** *** the **** *** ****** ** *** ********** ****** *** ************ ******* position ** the ****** ******** can ** ********* ** ******** factors First *** ********* ********* within the ****** *** ****** **** ** *** ******* *** **** profitable ** *** global ****** **** *** ******* Pfizer or ***** ***** ********* ******* *************** ** *** ******* of their business ********* *** **** an impact ** ******** ********* *** geographiesAnother ****** **** explains **** ******* ******** is *** nature ** *** ************** ******** ** ***** ** ******* ***** pharmaceutical companies ***** ******** ** ******* *** **** ***** in R&D **** ******** copious investments ** **** *** intellectual *** *** physical part ** *** research According to *** IMS *** ******* cost ** ********** * *** **** is $15 ******* According ** *** same ****** *** ******* **** period ******** to research **** ******* and ****** a new drug ** 10 – 15 ********* *** ********** ****** ************** *** ************** ******** ** **** *** of the **** ********** within the sector *** ****** *** economy ********** ** *** US *** ****** ******** has * ****** ** equity ** **** This ****** ** ********* ********** *** ********* *** companies ******* ** enter the ************** ****** ******** this ** *** ****** ************ In ******** *** ** ****** industry *** a *** ****** margin ** *** one *** **** ********** ****** *** ******** ******* ***** high ************* ******* *** **** ** ******** ** *** industry *** should *** be taken into ******* **** ** ********** The ************** ******** ******** extremely ********** **** ******** extremely **** *********** and ******* * **** *********** cost ** addition ******** the cost ** ******** *** ****** ***** *** be **** if *** have * ****** or * ******* competitive ********* it ** usually practically impossible *** ***** to exit since it is * very *********** industryIt *** **** estimated the ****** ** ********* operating ****** *** ******** *** **** ********** ********** ** **** ** *** ****** ** ********* ******* within the ******** This ******** ****** *** *********** ** making *** pharmaceutical ******** more and **** *********** ******* *** ********* To ********* *** constant ****** ***** *** ******* ********* **** *** ******** has *** revenue ***** ***** a ******** ****** increase in ******** ******* *** ******* ******** ********** ********* *********** *** ****** ********** **** being ******** In *** ****** ** ** ***** **** *** **** **** ** *** year **** *** ************** ******** ******** ****** ******* *** **** ** *** number ** companies operating within *** ******** which **** **** **** **** *** ** **** **** **** ** *** ***** ** *** ******** ** ************** ****** ********** opportunities *** ****** all ******* of the ******** ***** US ************** sales ******* ****** US ****** ** **** **** ***** ***** the **** of its nearest rival *** US boasts *** largest individual markets ****** *** ***** **** subsectors ***** **** be ******** later ** These ********** *** the patented generic *** over-the-counter ***** **************** on International ***** ***** ** the generator ** drugs *** *** ******** ** the ********* *** *** ** ***** ***** *** *** ********* ************ ******* pharma ********* **** ***** ***** center ** India **** **** aspect ***** has *** got *** ****** ** ****** ** original ********* ***** ********* into ****** ***** ** pharma ****** ** Company is not ******* ** ****** its ***** to participating ******* ****** *** ** the ***** in ***** ********** *** ** ******** ** *** ******** ***** **** **** ** approved ** the *** *** **** *** **** Administration *** ** *** is ****** ******** ** one ** the **** developed ********** ******** ** the ***** As * ****** of **** ** FDA ******* ********** *** **** as * ********* ** **** ******* countries ******* **** ******* ** the ** *** **** ***** repercussions ** * product’s ********** ********* ******** elseAlthough the *** ** known for some ** *** strict ******** *** ** the ****** ****** ****** ********** **** competitors elsewhere *** *** ******* ** ** is the ********* ** ****************** *********** *** ************ drugs **** ** ********* ****** *** resulted ** ********* ******** ** even **** ******* **** in the ** with **** ******* **** to influence ********* ******* *** ***** that *** * strong ********* on *** ****** ** ******** In ***** ** ********* ********* ********** ****** ******* the US operating environment ** ********** considerable ****** *** ******** ** ****** **** ** ********** ******* drugs *** universal ********** **** have * major ****** ** *** ****** ** *** ** **** *************** *** to demonstrate the **** ***** ** the ** market is ** ********* *** value ** *** ***** ***** ************** ******* Using personal ****** **** **** *** Bureau ** ******** Analysis a report **** Business ******* International ******** several ** ****** with ***** *********** in ******** *********** applied to ***** countries *** example *** ***** ** ******* *** $1927bn) ******** * ******* ***** ** ********* to ****** ********* This can **** ** **** ** comparisons ******* Russia *** $1792bn) *** ******** *** ******** ***** (US ******** and ************ *** ******** *** ****** (US $1174bn) *** New ****** ********* **** ****** ***** * **** **** ** *** ***** *** potential of *** US ****** ** *** ***************** ********** **************** is extremely ********* ** *** ************** industry ********* ******* ** *** ********** *** ** ******* *** ************ ******** ****** that the companies *** ****** ******* ** *** which ******* *** **** *********** **** *** ********* make in ******** *** *********** The ***** ************** ******** ** ****** ********* and the ********** controls *** ****** ** * ***** ****** ** **** ***** *** ************ These *********** have ** impact on *** ****** margins *** ******** *** *********** ******* ** both ******** *** ******* ************ it ** ******* ** **** ** how *********** in **** industry ******* what changes **** made **** *** ***** *** *** ***** ******* ******** the ******** *** main ********** body ** ***** ** the Central **** ******** ******* ************ ******* ***** *** Ministry of ****** and ****** ******* ***** ** ******** **** by *** Drug Controller-General ** ***** ****** *** ** ** ****** of ******** of licenses for ***** ** **** *** Central *** state ****** ***** introduced the ******* patent regime ** ********** with the TRIPS agreement ** January **** **** ** ********* ** *** ****** ****** ******** ** ********** ************* *** ** recent legislation *** ****** updates ************* ***** should ****** to **** ************* practices ***** ******** ** ******** * of *** ***** and ********* *** ************* ***** are ******** to comply with *** *** *** ************* ********* ** ********** The National ************** Pricing Authority ****** is *********** for ****** *** controlling the prices ** ** bulk ***** *** formulations under the Essential *********** ****** ******* ******* approved *** ********* ** *** ******* **** ********* ***** ** ******* ******* proposed organizational structure ** the *** ** to be ********* ** the ***** *** ****** ********* **** ** the ************** ******** **** ** a nodal ****** in *** ******* related to *** ****** ** *************** In ***** to **** ******** attention ** day-to-day ******** ***** ** the ********* *** **** ********* **** ******* ********************** *** *** Missions ****** *** **** **** ******** *********** **** ** export *** ****** ** pharmaceuticals ** *** ******* *** ******** ************ ****** *********** on ********** *** ********** ***** *** pharmaceutical exports *** **** *** been ********* with *** ************ ** ******** *** ********* on ********* quality control ************ *** of important countries ** as ** ******* domestic ********* *** exporting their ******** It communicates **** *** ******** ****** ** ******* *********** ******* ** ************** ******** ** ***** ********* **** as ****** ** the ************** ******** ******* of ************* ********** for ********* ** pharmaceutical ********* as **** as ************ *** ********* ******* of ************** ****** **** *********** ** local ********** *********** **** details ** ****** **** system health ********** *** ********* disease ******* ******* of ******* ** pharmaceuticals of ***** ********* ******* of joint venture ***** *** *************** operating ** these countries *** ** provides commercially useful *********** to *** ****************** *** ******** ************** ********** REGULATIONThe ******* ******* Direct ********** ****** ** the Government ** ***** ********** FDI ** ** *** *** cent ** the case ** bulk ***** ***** intermediates *** ******************* ***** ******** ** *** use ** *********** *** *********** would be ******* ***** *** automatic route *** ***** 75 *** cent *** manufacturing of bulk ***** **** ** ********** ** *** ********** ** **** ** **** ***** *** manufacture of **** ***** **** ***** stages *** ***** ************* and **** ***** ******** by *** *** ** *********** DNA ********** ** well as *** ******** *********** ******** ************ ******** ** ******** ************* **** ***** stagePharmaceutical ************ ******** RightsThe ********** ** ************ property ** ***** ** **** *********** at all ****** – ********* ************** and ******** The Agreement ** ***** Related ******* of ************ ******** ****** ******* **** **** force ** 01 ******* 1995 ** **** **** minimum ********* *** ********** *** *********** ** intellectual ******** rights ** member countries ***** *** ******** ** ******* *** effective *** adequate ********** of ************ ******** **** * **** ** reducing *********** *** *********** ** international ********** ** * ********** country *** * ********** ****** ** five ***** ***** ****** **** ** January 1995) ** ***** ** ******* 2000 ** ***** *** ********** ** the ********* ******* in **** *** changes ** ***** and ********** ********* ************* of ***** **** for ************** and ************* ** trade-marks ************ systems *** a comprehensive review ** *** ***** and *********** Marks *** **** *** **** *** * **** to repeal *** replace *** **** *** *** ***** been ****** ** ********** *** ******** ** *** ******* ** 30121999 This Act not only makes ***** ***** *** ***** ************* *** also ********** ** with international ******* and practicesSome *** Features ** *** ****** ******* Act of 2005 *************** of ******* ******* *** ***** ********* *** ***** ********* products ** ******** ************ Patent term made 20 ***** **** *** **** ** ********** of *** ******** **************** ********* *********** ** patent ************ after ** ****** ** *** ******** date ********** **** for ***** publication on ********** Creation of an appellate ***** *** ********** *** *********** ** **** ***** relevant ** the ************** ******** including ********* **** *** invention *** ************** ************* Reduction ** ****** ** ***** ***** price control ** ** as against 74 100 *** **** ******* ********** automatically permitted; ********* ******** for Foreign ********** ************* *********** ** ********** licensing *** **** drugs ************* *** formulationsPOLICY *********** AND ****** MEASURES 2009-10 ****** *********** ******* *** ******* **** **** ** *** **** ** * *** cent ** ******* of ****** *********** ***** *** ***** **** ***** *** ******** ******** **** ** breast cancer ********* ********* ********* etc ******* **** *** **** reduced from 75 *** **** to * *** cent ** *** ********* *********** devices **** ** *** ********* ** ***** ********** These ******* are *** ***** ****** **** ****** **** *** ************** **** ***** ******* *** government *** approved the ***** *** ******** (Amendment) **** 2008 ***** ***** **** ******** *** **** *** ************ **** five years to ** ***** 10 years ***** *** ****** ** ******** and raises *** **** **** ** ***** ** Rs ******** or ***** times the value ** the drug *********** *** manufacturers of ******** *** *********** ******** *** DCGI *** made *** ************ ** *** ******** ****** ********** *** ****** ********* ***** **** ** 2009 ******* the registration ** clinical ****** by ******* institutions *** companies *** ********* *** **** has ************ ******** of the ******* *********** for **** ************** products *** ***** ************** Regulatory InfrastructureThe first ***** that *** ******* looking at ********* * patented ******* ** * *** ****** ***** ** is ** ******** *** regulatory infrastructure of that ******* ** ensure **** *** intellectual ******** ** ************** protected *** ************ ** ******* ******* in ***** in 2005 *** opened up *** ****** for ****** launches However ******* companies are still **** ** India’s ** and ********** system *** ******* ** ***** ** ******* ******************** to ******* ************ the ****** ** ********* ***** ** *** domestic ****** *** been relatively **** Between January **** *** ***** **** **** ** patented ******** **** ******** ** ***** ** * ********* **** *** ******** the ****** ************** ********** ** regulatory ********* *** ***** ambiguities ********** ** ******* including exclusivity *** ********* *** ********** ********** ** ********* ******** to the ** regulatory infrastructure **** ******** *** ******* ********* feel the **** ** have * centralized regulatory **** This *** ******* *** ******* ** ******* the approvals *** ********** for * drug launchReferencesBhaumik * * ********* N & Pal * ****** **** ********* ********* of *************** ***** ****** their ******* FDI? The **** ** *** ****** ********** and ************** ************** ** International ******** ************ 437-450Fink * ********* ******** patent ********** in ***** ***** affect *** behavior ** ************* ************** industries ***** **** Development ******** ***** *********** * (2007)The ********* ** India’s ************** ******** *** ************ *** *** ** generic **** ****** US ************* ***** ********** ****** of ************ *** ***** * ***** ***** * * ***** ********* ******* of ********* ** ********** ********** ******* in ************** ************ *** ********

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