India CRO market to earn $1B by 2016, says Frost & Sullivan

The CRO market in India earned revenues of $485 million in 2010-11 and is estimated to cross $1.0 billion in 2016, according to new analysis from Frost & Sullivan, “Strategic Analysis of the Clinical Research Organization Market in India.”

The market is growing at a rate of 11%-13% as India builds its track record and gains increasing favor as a base for global clinical trials (phase I-IV). Participants operating in the Indian segment include multinational CROs that still dominate the nation's market, Indian CROs, multinational pharmaceutical companies and Indian pharmaceutical companies. While the first three categories of companies are into global trials, Indian pharmaceutical companies usually look at conducting local trials.

"Therapeutic areas in which research can be conducted in India are varied, and this is likely to result in more number of studies in the country," said Frost & Sullivan research analyst. "Emerging areas, such as diagnostic research, are also expected to drive the India CRO market."

The Indian CRO market is also drive by a large, easy-to-access, treatment-naive population; a high degree of available cost arbitrage of up to 30%-50% over U.S.; and an improved regulatory environment. The market growth is further bolstered by the Drug Controller General of India’s (DCGI) efforts to create a favorable environment for clinical trials. The improved regulatory environment possessing stringent enforcement laws will also bring more credibility to trials in India.

However, increasing competition, quality concerns and lack of quality infrastructure in smaller tier II sites are some factors that impede the growth rate of the CRO market.
"Reliability and consumer confidence in Indian clinical trials data is lacking, greatly impacting the CRO market," elaborated the analyst. "This is the result of a number of small-scale CROs having compromised on the standard of their studies in their bid to compete."

As more established CROs continue to grow, with reliable data and well-established clientele, the impact of this restraint is expected to diminish. The market will also be supported by India's attractiveness as a small base with low costs, high-standard practices, and growing interest from multinationals to include the country as a preferred clinical trials site for their studies.

"Developing a single-window clearance for clinical trials as well as clear guidelines on the types of international/global trials that can be performed on the Indian population will shore up CRO market growth," noted the analyst. "Indian CROs should focus on developing a steep learning curve by collaborating with selected international CROs and merge their talents."

Overall, market participants need to balance regulatory issues, breadth of services and data quality with cost competitiveness, a bigger footprint and innovation to grow their market share, according to the analyst.

Edible Vaccines - A novel approach towards immunization

Future prospects of edible vaccines.

Although still at an early stage of development, the experimental know-how and results strongly suggest that plant derived edible vaccines are likely to become a reality in the next few years. Future research will demonstrate if these vaccines meet the standards of quality (purity, potency, safety and efficacy) defined for vaccines by the WHO.

In future, a great ability for the immunization throughout the glob with the use of edible vaccine can be possible with its economic production will lower down the cost of immunization, separation and purification is easy and pathogenic contamination can be avoided therefore safe, no constricted criteria for its stoarge so can be stored near the site of use, aseptic condition dose not require for oral immunization as it is given through oral route.

GM-plant (Genetically modified plants) may be grown in field and clinical trials are required to define the risk/benefit ration of the GM-plant before registration is granted.  In most countries, plants engineered to produce vaccines fall under the very restrictive rules set up to control GM-crop plants. The present concern, especially in Europe, over the use of biotechnology for the genetic improvement of crop plants also negatively affects the acceptance of GM-plants for medicinal use. 

As a consequence, while the demonstration that plant-derived vaccines are effective on populations at risk is expected to arrive within 1-2 years, a further quarantine of 2-3 years will be required in order to fulfill requirements for registration and marketing. It is hoped that simpler rules will be set up for GM-plants producing vaccines and that they are seen as clearly and legally distinct from GM-plants grown for nutrition purposes.

COINS COLLECTION - INDIA

As we celebrate the 66th year of independence, we'd like to share some interesting facts about India

Interesting Facts about India

• India never invaded any country in her last 100000 years of history.
•  When many cultures were only nomadic forest dwellers over 5000 years ago, Indians established Harappan culture in Sindhu Valley (Indus Valley Civilization)
• Chess was invented in India.
• Algebra, Trigonometry and Calculus are studies, which originated in India.
• The 'Place Value System' and the 'Decimal System' were developed in India in 100 B.C.
• India is the largest democracy in the world, the 7th largest Country in the world, and one of the most ancient civilizations.
• The game of Snakes & Ladders was created by the 13th century poet saint Gyandev. It was originally called 'Mokshapat'. The ladders in the game represented virtues and the snakes indicated vices. The game was played with cowrie shells and dices. In time, the game underwent several modifications, but its meaning remained the same, i.e. good deeds take people to heaven and evil to a cycle of re-births.
• India has the largest number of Post Offices in the world.
• The largest employer in India is the Indian Railways, employing over a million people.
• The world's first university was established in Takshila in 700 BC. More than 10,500 students from all over the world studied more than 60 subjects. The University of Nalanda built in the 4th century was one of the greatest achievements of ancient India in the field of education.
• Ayurveda is the earliest school of medicine known to mankind. The Father of Medicine, Charaka, consolidated Ayurveda 2500 years ago.
• India was one of the richest countries till the time of British rule in the early 17th Century. Christopher Columbus, attracted by India's wealth, had come looking for a sea route to India when he discovered America by mistake.
• The Art of Navigation & Navigating was born in the river Sindh over 6000 years ago. The very word Navigation is derived from the Sanskrit word 'NAVGATIH'. The word navy is also derived from the Sanskrit word 'Nou'.
• Bhaskaracharya rightly calculated the time taken by the earth to orbit the Sun hundreds of years before the astronomer Smart. According to his calculation, the time taken by the Earth to orbit the Sun was 365.258756484 days.
• The value of "pi" was first calculated by the Indian Mathematician Budhayana, and he explained the concept of what is known as the Pythagorean Theorem. He discovered this in the 6th century, long before the European mathematicians.
• Algebra, Trigonometry and Calculus also originated in India.Quadratic Equations were used by Sridharacharya in the 11th century. The largest numbers the Greeks and the Romans used were 106 whereas Hindus used numbers as big as 10*53 (i.e. 10 to the power of 53) with specific names as early as 5000 B.C.during the Vedic period.Even today, the largest used number is Terra: 10*12(10 to the power of 12).
• Sushruta is regarded as the Father of Surgery. Over2600 years ago Sushrata & his team conducted complicated surgeries like cataract, artificial limbs, cesareans, fractures, urinary stones, plastic surgery and brain surgeries.
• India exports software to 90 countries.
• Martial Arts were first created in India, and later spread to Asia by Buddhist missionaries.
• Yoga has its origins in India and has existed for over 5,000 years.

BE PROUD TO BE AN INDIAN. जय हिंद

ACRI has consistently achieved 100% placement. ACRI appreciates the collective hard work of placement, academic and marketing team. Keep up the good work.

Mandatory clinical trials for herbal drugs soon

India, which has now jumped to the second spot after China as the leading exporter of herbal products, will soon make it mandatory for all new traditional medicines to undergo clinical trials before hitting the market.

This will include only the new patented drugs and not the classical formulations that find mention in India's ancient texts, some of which are 5,000 years old.

Till now, there has been no formal protocol on how traditional drugs should be tested for safety.Besides, the Drug Controller General of India (DCGI) has no expertise to handle herbal medicines.

The department of AYUSH (Ayurveda, Unani, Siddha and Homeopathy) is now pushing a proposal to have two separate drug controller generals - one for allopathic medicine and another for traditional medicine.

The Expenditure Finance Committee has also approved creation of Central Drug Controller for AYUSH drugs. There are around 10,000 ASU (Ayurveda, Siddha and Unani) drugs' manufacturing units in the country.

Latest figure shows in 2010 exports of AYUSH and herbal products stood at $790 million as against $1,329 million for China.

Secretary AYUSH Anil Kumar said on Wednesday, "Till now, it was never felt necessary to check the standard of ASU drugs as most of them were part of ancient Indian texts with their benefits proven for hundreds of years. However, now we are going in for strict enforcement of quality and safety of herbal drugs. We will soon make it mandatory for all new patented herbal medicines to undergo human trials before they are introduced in the market."

Union health minister Ghulam Nabi Azad recently said, "To ensure the quality and standards of ASU medicines and effective enforcement of the provisions of the Drugs & Cosmetic Act, the Ayurveda, Siddha and Unani Drugs Consultative Committee (ASUDCC) recommended creation of separate drug controllers for ASU drugs. It will facilitate the increased acceptability of Ayurveda, Unani, Siddha and Homoeopathy medicines within the country and abroad."

Quality of India's herbal drugs has always been in question, especially in the Western countries. According to European Union's Traditional Herbal Medicinal Products Directive (THMPD), companies making herbal products will have to provide clinical data to demonstrate its safety through use of those products within the EU for a minimum of 30 or 15 years within the EU, and 30 years outside the Union.

AYUSH, however, has asked the EU to change the clause into 30 years of use anywhere in the world or country of origin.

According to data compiled by Pharmexcil from UN Comtrade, the export of India and China in 2010 was $790.56 million and $1329.72 million, respectively, out of total global export of $7592.08 million (for 165 countries). This pertains to export of medicinal plants, herbs and value-added products like extracts including essential oils, gums and resins.

Kumar said the strength of AYUSH system lies in preventive and promotive healthcare, diseases and health conditions relating to women and children, non-communicable diseases, stress management, palliative care and rehabilitation.

"AYUSH has very little side-effect, has a soft environmental footprint and is engrained in local temperament. Its huge resource of hospitals beds (62,000), and health workers (7.85 lakhs) need to be efficiently utilized," Kumar added.

The department is also looking at putting together a composite National Essential Drug List containing both allopathic and AYUSH medicines. Clinical management protocols or a "Joint behavior change plan" incorporating AYUSH-based lifestyle guidelines for adolescent health, geriatric care, mental health, non-communicable diseases, anemia and nutrition are also being developed.

"Standardization of classical formulations, AYUSH therapies and yoga practices are being given due focus," steering committee on health said.

The department estimates that there are around a million village-based, traditional AYUSH community health workers who possess knowledge related to various streams like midwifery, primary healthcare and bone setting. There are also more than 100 million households that possess knowledge of home remedies, ethnic foods and nutrition.

ACRI INDIA CLINICAL RESEARCH REVIEW

The course offered at ACRI has been extremely valuable to me as throughout those 7 months. I have learnt so much that I could put into practice as a CRA at St John’s. My personal review on Avigna clinical Research Institute (ACRI): The course exceeded my expectations significantly in providing me knowledge in clinical research subject I am Immensely grateful to ACRI’s placement Division who provided me with excellent interview Opportunities.. 

Thank you ACRI.

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