Country Introduction INDIA India IAST Bhrat officially the

Country Introduction: INDIA India (IAST: Bhārat), officially the Republic of India (IAST: Bhārat Gaṇarājya), is a country in South Asia. It is the seventhlargest country by area, the second-most populous country with over 1. 2 billion people, and the largest democracy in the world. “India: Unity in Diversity” - Smith (Historian)

Overview: • Motto: "Satyameva Jayate" (Sanskrit) "Truth Alone Triumphs” • Anthem: Jana Gana Mana "Thou art the rulers of the minds of all people“ • National song: Vande Mataram "I Bow to Thee, Mother" • Capital: New Delhi. • National Language: NONE. • Official Language: Hindi & English. • Currency: Indian rupee (₹) (INR) National emblem:

INDIA BASIC FACTS Ø 5, 000 years old ancient civilization. Ø 325 language spoken- 1, 652 dialects. Ø 22 regionally official language. Ø 30 states, 7 union territories. Ø 3, 287, 590 km 2 area- 7 th largest. Ø Parliamentary form of Government. Ø Sovereign, socialist, secular, democratic Republic. Ø Worlds largest democracy. Ø 3 rd largest economy in terms of GDP(PPP) and 7 th largest in terms of GDP(Nominal) in 2016. Ø In 2016 India’s GDP growth rate is 7. 5%, currently the fastest growing big economy. Ø World-class recognition in IT, Bio-technology and Space. Ø 2 nd largest English speaking nation in world. Ø 3 rd largest standing army, over 1. 5 million strong.

Diwali Holi All the world religions co-exist together Hundreds of festivals 1. 25 billion people What makes India diverse…

Indian Languages… Sanskrit (the parent language; 梵文) Hindi Urdu Bengali Punjabi Tamil Telegu Kannada Malaylam Gujrati Kashmiri Marathi Manipuri Assamese English …and 140+ more with >500 dialects 印地语 孟加拉语

Religions in India…

City attractions… Taj Mahal, New Delhi (新德里) Bandra-Worli Sea Link, Mumbai (孟买) Queen Victoria Memorial, Kolkata (加尔各答)

INDIAN HEALTHCARE AND PHARMCEUTICAL INDUSTRY PHARMACEUTICAL INDUSTRY HEALTHCARE INDUSTRY Ranked 3 rd globally in terms of volume Attractive outlook Estimated 4. 2% of GDP generated from the healthcare market Over 1. 2 billion denizens benefited from the system are It’s even growing bigger with more opportunities Supplier of 10% of global production (2015) An estimated growth of 163% will take place by 2020 (approx. US$50 bn) Of a total of USD 34 bn market, domestic market consists of USD 10. 9 bn (or INR 660. 7 bn) and constituted around 1. 1% of the global pharmaceutical market in value terms.

India’s healthcare facilities The Indian Government has made the provision of healthcare as one of its key priorities. It launched a new policy to build more hospitals, boost local access to healthcare and improve the quality of medical training, and promised to increase public expenditure on healthcare to 2 -3% of GDP.

Health Insurance: “Health insurance is really a MINOR PLAYER in the health ecosystem. ” The very candid statement from the Report of the National Commission on Macroeconomics and Health of India (2005) goes on to say that only 3% to 5% of Indians are covered by health insurance policies.

Medical Tourism India is one of the major players in this industry Its price is the lowest among any nation in the world attracting about 1. 27 million medical tourists every year.

Public health care system in India Healthcare is one of India's largest service sectors. The 12 th five-year plan (2012– 17) aims to increase the public health investment from 1. 1 per cent to 2– 3 per cent of GDP. Evolution of Public Health System in India After independence, India embarked on a planned effort to raise standard of living of the people and impetus was given to health care, which was made integral part of socioeconomic development. The Central Government has given the policy direction and thrust to healthcare through many national programs. • National Health Policy 1983 • National Population Policy 2000 • Millennium Development Goals • National Health Policy 2002

EXPANDING PHARMACEUTICAL MARKETS: OVERVIEW • 15000 companies (300 -400 large and medium) • 20 -24% are MNCs • 35% of total ANDA approvals by the US-FDA given to Indian companies. • Export to foreign market is worth US$8 billion in 2009 with estimated rise by US$20 billion by 2020 The key drivers are : ØKNOWLEDGE ØSKILLS ØLOW PRODUCTION COSTS ØQUALITY

The Key Segments in the Indian Pharmaceutical Industry are as follows: A. API Manufacturers / Traders ( Bulk Drugs). B. Formulation Manufacturers. C. Contract Research and Manufacturing Services Companies. D. Biotechnology Companies

Evolution of the Indian Pharmaceutical Industry The Indian pharmaceutical industry has grown rapidly over the last few decades. Prior to 2005, the Indian regulatory system recognized only process patents. The different phases that the Indian pharmaceutical industry has gone through, during the pre-patent (till 2005) and post-patent (post 2005) regimes are as follows: Pre-patent regime (Before 2005) • Indian Patent Act, 1970 • Drug Price Control Order (DPCO), 1970 • Decline in share of MNCs Post-patent regime (Post 2005) • Enactment of product patent regime • Implementation of Schedule M • Drug law • New Drugs (Prices Control) Order (DPCO), 2013

The Pharmaceutical Supply Value Chain

Regulatory Environment in India On the basis of established regulations and patent laws, the global pharmaceutical industry can be broadly classified into: HIGHLY REGULATED MARKET • USA, EU, JAPAN SEMI-REGULATED • INDIA, CHINA, SOUTH AFRICA

The pharmaceutical regulatory environment in India comprises of the participants as displayed in the schematic arrangement below:

The Indian Advantages of Pharma Industry India has emerged as a pharmaceutical supplier in the international market

Indian companies have done well in the generics market internationally

Increasing share in ANDA fillings The US FDA has approved a total 400 final ANDAs during the year 2013 as against 476 in the previous year and it approved total 86 tentative ANDAs during 2013 as against 94 during 2012. Out of the total approvals, Indian companies grabbed 38. 5% final approval during 2013 as against 37. 4% in the previous year. Similarly, Indian companies received 44. 2% of total tentative approvals as compared to 42% in the previous

Contract Research and Manufacturing Service : 'The Indian Story' The global CRAMS market (excluding clinical trials) reached USD 75 billion in 2013, with the Indian sector being valued at USD 4 billion or a little over 5% of the total market.

US FDA PLANTS Outsourcing of activities such as manufacturing and R&D to low cost destinations such as India and China. The US FDA has already approved over 100 manufacturing sites in India– more than in any country except the US. Among six offices that the US FDA has overseas, two are located in India, in Delhi and Mumbai.

Investments in Pharmaceuticals The recent deal between Sun Pharmaceuticals and Ranbaxy has paved the way for further consolidation and M&A in this sector. Some of the highlights of the Sun Pharma and Ranbaxy deal:

KEY PHARMACEUTICAL DEALS IN 2013 AND 2014

Export India exports pharmaceuticals to more than 200 countries and on a country-wise basis, India’s five largest export markets are the United States (28 percent), Russia (11 percent), Germany (10 percent), the United Kingdom (8 percent), and China (7 percent).

Major Indian Companies: Key Differentiators

Success Story: Sun Pharmaceutical Industries Ltd.

PHARMACEUTICAL EDUCATION IN INDIA The beginning of Pharmaceutical education in India was initiated at the Banaras Hindu University way back in 1932 by Professor M. L. Schrof & Prof MM Malaviy. Formal pharmacy education leading to a degree began with the introduction of a 3 -year bachelor of pharmacy (BPharm). Before India gained independence in 1947, there were 3 institutions offering pharmacy degree programs. In 1944, the Punjab University started a pharmacy department; in 1947 L. M. College was established in Ahmedabad.

EDUCATIONAL PROGRAMS : variety of pharmacy degree programs are offered in India: Ø Diploma In Pharmacy (D. Pharm) Ø Bachelor Of Pharmacy (B. Pharm) Ø Master Of Pharmacy (M. Pharm) Ø Master Of Science In Pharmacy [MS (Pharm)] Ø Master Of Technology In Pharmacy [M. Tech (Pharm)] Ø Doctor Of Pharmacy (Pharm. D) Ø Doctor Of Philosophy In Pharmacy (Ph. D)

First 10 Pharmacy Colleges/Universities Offering Degree Programs in India

Research Exposure : There are 6 National Institutes of Pharmaceutical Education and Research (NIPERs) in India offering MS(Pharm), MTech(Pharm), and higher-level degrees. The NIPERs were created with the vision of providing excellence in pharmacy and pharmacy-related education

Growth of Pharma Institutions in Year Wise : SL NO YEAR PHARMACY INSTITUTES ADDED IN YEAR 01 2009 -10 629 29 02 2010 -11 665 36 03 2011 -12 854 189 04 2012 -13 1021 167 05 2013 -14 1054 33 06 2014 -15 1102 48 Gro w th of Pharma In s t i t u t i o n s i n Y ea r Wi se Pha rm a c y I n st i t u t e s 1200 1000 800 600 400 2009 - 10 2010 - 11 2011 - 12 2012 Year - 13 2013 - 14 2014 - 15

Growth of Seats in Pharma in Year wise : S. N. 01 Year 2009 -10 Seats 32708 Added in Year 4680 02 2010 -11 39517 6809 03 2011 -12 52334 12817 04 2012 -13 64211 11877 05 2013 -14 72836 8625 06 2014 -15 103867 31031

TOP 20 PHARMACY COLLEGES IN INDIA :

PHARMACY GRADUATES EMPLOYMENT AND MARKET DEMANDS The spectrum of pharmacy profession in India is very wide. It covers opportunities in pharmaceutical industry – manufacturing & retail, healthcare sector, pharmacy education, and regulatory bodies.

ü The vast majority of pharmacists with a BPharm degree normally seek positions (such as production, quality control, and marketing) ü MPharm degree holders in any discipline including an MPharm in clinical pharmacy may join industries in any of the above positions. Many MPharm graduates entering the pharmaceutical industry choose positions in areas such as research, formulation development, and clinical trials ü Pharmacists with a Ph. D mainly work in academia and in the research and development section of pharmaceutical industries.

Suggestions to the Cooperation in Pharmaceutical Industry and education between China and India Cooperation in Pharmaceutical Industry High price of generic drug in China: China now provides universal coverage of medical insurance to its citizens but at a very low level for farmers, only about US$ 20 person. Medical counseling fee in China ranges from RMB 4— 14 (US$ 70 cents to 2. 5 dollars) and is very affordable. But medicines are very expensive. Price of generic drug is very high in China. A normal cold could cost US$ 20. India has big generic drug market and medicines are very affordable price in India. Now, China is a main supplier of raw material and active pharmaceutical ingredients (API) to India and India processes it into medicines and export to third countries. If China and India work to reach an early bilateral agreement on pharma trade so that Chinese patients can benefit from Indian medicines and at a lower price

China-India Partnership can supply global generic medicine needs : The collaboration between the two will give an edge over the developed countries. Together they can meet the generic drugs' requirements of the world. The meet is also aimed at promoting the growing trade between the two countries and repairing the ties which have been dogged non-trade issues. Bilateral trade in healthcare products between January-October 2010 stands at Rs 14, 446 crore ($3. 1 billion), up from Rs 13, 048 crore ($2. 8 billion) in the corresponding period of last year. The Indian Drug Manufacturer's Association (IDMA) has urged Chinese pharmaceutical companies to cooperate with their Indian counterparts in a win-win partnership to supply global generic medicine needs.

Collaboration between China-India can supply cheaper rate of API to whole world: The Chinese side is represented by delegates who are part of the 400 -strong Chinese business executives accompanying Chinese Premier Wen Jiabao who is on an official visit to India. Both India and China are expected to propel the global pharma market to Rs 5. 13 lakh crore ($1. 1 trillion). Both the countries have capability to produce active pharmaceutical ingredients (APIs), which are 60 per cent cheaper than in the western world. These two countries can accept to each other’s products at reasonable price : China is the second largest API manufacturer, and if china collaborate with India on regard of pharmaceutical products, both of them will be benefitted. China will be benefitted to get affordable price of generic drug from India. And India also can manufacture generic products by using reasonable price of API from China.

Cooperation In Education: Education Relation: India and China signed Education Exchange Programme (EEP) in 2006, which is an umbrella agreement for educational cooperation between the two countries. Under this agreement, government scholarships are awarded to 25 students, by both sides, in recognized institutions of higher learning in each other’s country. The 25 scholarships awarded by India are offered by Indian Council for Cultural Relations (ICCR). During the visit of Prime Minister Sh. Narendra Modi to China, both the countries have signed fresh Education Exchange Programme (EEP) on May 15, 2015. The same provides for enhanced cooperation between institutions in the field of vocational education; collaboration between Institutes of higher learning, etc.

Scholarship Provided by these two country: Chinese students are annually awarded scholarships to study Hindi at the Kendriya Hindi Sansthan, Agra to learn Hindi. For the year 2015 -16, 8 chinese students have been selected to study in Agra under this scheme. Also large number of Indian students award Chinese scholarship to study Engineering, medical, Chinese language and Health Science in China. The cooperation in the education sector between the two sides has resulted in an increase in the number of Indian students in China. During the Academic Year 2014 -15, there were 12998 Indian students studying in various Universities in China in various disciplines. Similarly, and large number Chinese students are studying in various educational institutions in India. CBSE decided to introduce Mandarin Chinese as a foreign language: In 2010, it was decided to introduce Mandarin Chinese as a foreign language in the Central Board of Secondary Education (CBSE) syllabus. A Memorandum of Understanding was signed in August 2012, between Central CBSE and Confucius Institute, where both signatories agreed to exchange academic staff, teachers and trainees as well as exchange information on the system and structure of teaching Mandarin Chinese as a second language in schools in India. As a part of this Mo. U, the first batch of 22 Chinese teachers is teaching in select CBSE schools for one year, since early 2014.

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Our Team Arpan Mahanty Dept. of Pharmaceutics Parikshit Banerjee Dept. of Pharmaceutics Arka Sen Chaudhuri, Dept. of Pharmaceutics Debmalya Roy Dept. of Pharmacology

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