Pharma Industry

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Generic Industry

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Pharmaceutical Industry:

Pharmaceutical Industry

Introduction:

Introduction In 1930, in Calcutta the first pharmaceutical company called Bengal Chemicals and Pharmaceutical Works The history of Indian pharmaceutical market in 1970s was almost non- existent. Today, India has gained immense importance and carved a niche for itself in the pharmaceutical domain. In fact, it has emerged as a big mart for the pharmaceutical industry. Formulations, bulk drugs, generics, Novel Drug Delivery Systems, New Chemical Entities, or Biotechnology, etc. Indian companies are dominating in the marketplace which was traditionally manned by MNC.

Introduction:

Introduction India is the third largest player in the world with 500 different APIs and ranks fourth globally in terms of production volumes, and 13th globally in domestic consumption value .

Indian Pharmaceutical Evolution:

Indian Pharmaceutical Evolution

Current Scenario:

Current Scenario   India is now among the top five pharmaceutical emerging markets, Pharmaceutical industry contributed 1.71% of GDP in 2011 . Domestic formulation market stood at Rs 58,300 crore (US$ 10.88 billion) and has been ranked third in terms of volume and tenth in terms of value, globally   The country is the largest exporter globally of generic formulations in volume .  

Current Scenario:

Current Scenario The growing size of the Indian geriatric population will be a key factor in influencing the growth of the chronic segmen t The Indian population is experiencing a shift in disease profiles. Traditionally, the acute disease segment held a significant share of the Indian pharmaceutical market

Current Scenario:

Current Scenario The varied functions such as contract research and manufacturing, clinical research, research and development pertaining to vaccines are the strengths of the Pharma Industry in India. Multinational pharmaceutical corporations outsource these activities and help the growth of the sector The Indian Pharmaceutical Industry has a bright future .

Top players in India:

Top players in India Dr. Reddy’s Laboratories Ltd 1024 Cipla Ltd 892 Ranbaxy Laboratories 892 Lupin Ltd 500 Aurobindo Pharma Ltd. 486 Glaxosmithkline Pharmaceuticals Ltd 430 Sun Pharmaceutical Inds . Ltd 420 Piramal Healthcare Ltd 417 Cadila Healthcare Ltd 375 Wockhardt Ltd 290 Ipca Laboratories Ltd. 241 Aventis Pharma Ltd 234 Orchid Chemicals & Pharmaceuticals Ltd

Government Policies:

Government Policies The government of India has undertaken several including policy initiatives and tax breaks for the growth of the pharmaceutical business in India. Some of the measures adopted are: Pharmaceutical units are eligible for weighted tax reduction at 150% for the research and development expenditure obtained.

Government Policies:

Government Policies Two new schemes namely, New Millennium Indian Technology Leadership Initiative and the Drugs and Pharmaceuticals Research Program have been launched by the Government. The Government is contemplating the creation of SRV or special purpose vehicles with an insurance cover to be used for funding new drug research. The Department of Pharmaceuticals is mulling the creation of drug research facilities which can be used by private companies for research work on rent.

Issues for the Industry:

Issues for the Industry Between 2012-2018, the “patent cliff" will wipe an estimated $148 billion off pharmaceuticals industry revenues due to many drugs coming out of patents Rising cost of R&D, the cost of bringing a molecule to market globally is estimated to be from $800 million to $4 billion.

Issues for the Industry:

Issues for the Industry On average, out of every 10,000 molecules been developed; only one or two are likely to reach the market . Increasing government pressure, with harsher price controls and taxes . European Medical Agency (EMA) and the US Food and Drug Administration (USFDA) are focusing on risk management; thereby putting pressures on profitability of pharmaceutical companies.

Future outlook:

Future outlook India's pharmaceutical sector is expected to touch US$ 74 billion in sales by 2020 from the current US$ 11 billion, according to a PricewaterhouseCoopers (PwC) report The Indian pharmaceutical market is expected to grow at a compound annual growth rate (CAGR) of 14-17 per cent over 2012-16 The outlook on the Indian pharmaceutical industry remains favorable, according to a report by ICRA and Moodys .

Future outlook:

Future outlook The Indian Pharmaceutical sector is also expected to be among the top ten Pharma based markets in the world in the next ten years The national Pharma market would experience the rise in the sales of the patent drugs

SWOT analysis of Pharmaceutical Industry In India :

SWOT analysis of Pharmaceutical Industry In India Strengths Weakness Opportunities Threats Low cost of skilled manpower Access to large pool of highly trained scientists Strong marketing and distribution network Proven track record in design of high technology manufacturing devices Stringent pricing regulations Poor transport and medical infrastructure Lack of data protection Very competitive environment Poor health insurance coverage Increase in per capita income Global demand for generics rising Increasing population with more sedentary lifestyle Increasing health insurance sector Significant investment from MNCs Medical tourism Other low cost countries affecting demand Government regulations changing Expanding of Drugs Price Control Order Lack of investment in infrastructure Wage inflation SWOT

Generic Drugs :

Generic Drugs

PowerPoint Presentation:

It is a well documented fact that 80% of Generic Medicines produced in our country are exported to many developed countries, but in our country these Generic Medicines are available only in municipal or government hospitals to in-patients. Generic Drug

Generic Drugs ???? :

Generic Drugs ???? A copy of a brand-name drug, which must have the: Same quality Same safety Same strength

PowerPoint Presentation:

Generic Drugs

PowerPoint Presentation:

History 1906 Pure Food and Drug Act-Establishes regulation of Food and Drug 1938 Food, Drug and Cosmetic Act –introduced safety standards 1962 Kefauver –Harris Amendments to the FDA and C Act-tightened safety standards and introduced requirements that drug must be effective

PowerPoint Presentation:

History 1984 Hatch –Waxman Act –created an abbreviated mechanism for approval of Generic copies of all drugs originally approved after 1962,by stating that preclinical and clinical testing does not have to be repeted for generic .

Introduction:

Introduction The Indian pharmaceutical industry is growing at about 8 to 9 percent annually . The domestic Indian pharmaceutical market was worth $12.24 billion in 2013 Indian firms manufactured products for nearly 60,000 generic brands

Introduction:

I ntroduction 4.The Government of India has initiated several measures to keep the prices of medicines at reasonable levels. Some of these include- Price Control through National Pharmaceutical Pricing Authority (NPPA) on about 20% of the retail market in India. Jan Aushadhi , Janatha Bazaar .

The real movement of these medicines started in Amritsar and then in Rajasthan.:

Generic Medicine was started by Prabodhan Aushadhpedhi In Rajasthan . The real movement of these medicines started in Amritsar and then in Rajasthan. Life Saving Generic Medicine

Price difference between generic drugs and popular branded drugs:

Price difference between generic drugs and popular branded drugs Used as Generic Drug Price Branded Drug Price Painkiller Paracetamol Rs. 2.45 Crocin Rs.11       Calpol Rs. 10.70   Paracrtamol syrup Rs.9.00 Crocin (Syrup) Rs.15       Febrex Rs.20.50   Diclofenac Sodium+ paracetamol Rs. 4.4 Diclogesic Rs. 19.40 Antrobiotic Amoxyclin Rs. 13.2 LMX Rs. 40       Remox Rs. 38.7   Azithromycin Rs.41.8 Azee Rs. 107       Azithral Rs.128.55 Anti-TB Ethambutal Rs.14.8 Myambutal Rs.15.3 Vitamin Folic acid Rs. 2.8 Folivite Rs.11.8   B-complex Rs.1.8 Becosul Rs. 11.0 Cardiovascular (Blood Pressure) drug Atenolol Rs. 7.0 Aten Rs. 23.8

Patent ?????? :

Patent ??????

Branded Medicines and Generic Medicines :

Branded Medicines and Generic Medicines Similarities According to the FDA, to substitute a generic for brand name drug: It must contain the same active ingredients (the chemical substance that makes the drug work). 2. It must have the same dosage strength (the amount of active ingredients, for example 20 mg or 40 mg). 3. It must have the same dosage form (that is; it needs to be available in the same form as the original - for example as liquid, pill, etc.)

Branded Medicines and Generic Medicines :

Branded Medicines and Generic Medicines The Differences They look different (Federal law requires this) they could have different sizes, shapes, color or markings. They have different names. Generic costs less than the brand name drugs.

PowerPoint Presentation:

Brand Name Drug Generic Drug For reformulations of a brand-name drug or generic versions of a drug, FDA reviews data showing the drug is bioequivalent to the one used in the original safety and efficacy testing. FDA evaluates the manufacturer's adherence to good manufacturing practices before the drug is marketed. FDA reviews the active and inactive ingredients used in the formulation before the drug is marketed. FDA reviews the actual drug product. FDA reviews the drug's labeling. Manufacturer must seek FDA approval before making major manufacturing changes or reformulating the drug. Manufacturer must report adverse reactions and serious adverse health effects to the FDA. FDA periodically inspects manufacturing plants. FDA monitors drug quality after approval. FDA Requirements for Brand-Name and Generic Drugs

PowerPoint Presentation:

Source: www.drugchannels.net

PowerPoint Presentation:

Print Public Service Ads for Consumers

PowerPoint Presentation:

Top Generic Drug Companies

PowerPoint Presentation:

Karnataka has set up Janatha Bazaar Generic Drug Stores

Facts… :

Facts… Globe sale of Generic drug in 2013 was 51% 40% of Generic drugs are sold in India India supplies Generic drugs to more than 200countries around the globe including highly regulated market of US, Japan and Europe According to gold saches study, it is estimated that India is estimated to be the fifth largest pharmaceutical market in the world by 2020

Facts… :

Facts… Generic stores in India (Jan Aushadhi ) Rajasthan 21 ,Punjab 21,Odisha 14,Andhra Pradesh 3,Hyderbad is closed due to administrative reason ,West Bengal 3,Delhi 3,Haryana 4,Uttrakand 2,Jammu and Kashmir 1,Himachal Pradesh 5.

Suggestion :

Suggestion Government needs to create awareness about Generic Medicine. People feel there is difference in Quality but there is no difference in quality so we need to make aware to public. Doctor/Pharmacist needs to prescribe Generic medicine to people. Still more Generic Store must open .

Conclusion:

Conclusion Industry –academic relationship can be further explored Income tax exemptions should be given on clinical trials & contract research done outside the company & abroad Spurious drug problem should be tackled

Thank you… :

Thank you…

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