Genes? It's complicated
The advance heralded a decade ago in mapping human DNA is yet to lead to the answers we craved

Ten years ago the $10bn Human Genome Project announced it had completed the first draft of the blueprint for human life. It was hailed as a huge scientific advance, comparable to putting a man on the moon. President Bill Clinton declared: "We'll go from knowing almost nothing about how our genes work to enlisting genes in the struggle to prevent and cure illness. This will be the scientific breakthrough of the century, perhaps of all time."

The project at last laid bare the entire human genetic code – 22,000 or so genes (the precise number is still uncertain) – that make us into the people we are. Several decades of research into the cause of diseases before the project had firmly identified genes as a significant cause of many important diseases.

The first haul of genetic diseases was of those fairly rare but devastating inherited diseases, such as cystic fibrosis and haemophilia, that are caused by single genes. Most of the genes responsible for those had been fished out of the genome long before the sequencing project hauled in its net. But the project was expected to find genes for various far more common conditions, such as cancer, diabetes, heart disease, autism, depression and schizophrenia, because most of these conditions tend to run in families. Studies of families in which these diseases were common, particularly of twins, had established a level of heritability for each condition, and the levels were high. Autism comes out at a whopping 90%, indicating that most autism is caused by faulty genes (and certainly not by faulty vaccines). The heritability of schizophrenia was about 80% whereas conditions such as heart disease, diabetes and cancer came in anywhere between 30% and 70%.

And it wasn't just diseases that were caused by genes. Many behavioural studies indicated that intelligence, personality, sexual orientation and even voting preference seemed to be highly heritable. If genes were so powerful, it should be straightforward to identify the culprits in the genome.

But a decade later these expectations have not been fulfilled. The project that promised so much has, so far, delivered very little. Very few genes have been found that account for more than 1% of the risk of any of those common diseases. And even the most significant intelligence gene yet found is responsible for variation in individual intelligence equivalent to less than one IQ point. The scientists who went in search of whoppers netted only a host of minnows. Where are the missing genes?

Like most things in life, it turns out that genes are more complex than we thought. Those genes responsible for single-gene defects such as cystic fibrosis and haemophilia are the low-hanging fruit. Common diseases, and such attributes as intelligence, are not caused by single genes or even handfuls of genes, but probably by networks of hundreds or even thousands of genes.

To understand these networks, we need to look, not at the branches, but at the roots of the genetic tree. Genes form tangles of interactions with each other such that the effect of chopping one or another is unpredictable and depends on the connectivity of the whole network. Finding a gene responsible for a disease is mostly like finding a root responsible for maintaining a tree.

The task of unravelling the roots of biology is the new science of system biology, in which biologists work with mathematicians and computer scientists to build models of complex networks. This is where the causes of heart disease, diabetes and autism are now being sought. To paraphrase Winston Churchill, the genome project was not the end. It was not even the beginning of the end. But it was, perhaps, the end of the beginning in the search for our genes.

The Mystery of Type 1 Diabetes Unraveled

Type 1 diabetes is increasing three percent per annum globally, according to Eurodiab and WHO registry. Several factors are thought to play a part including increasing recognition of slow onset, non-classical Type 1 in children and LADA (late onset Type 1) in older adults. The possible environmental factors include infectious exposure, Vitamin D deficiency, less exercise and more obesity. Scientists at Scripps Research Institute in the US recently unraveled the forty year old mystery of how certain genetic mutations lead to Type 1 diabetes.

The researchers said their findings could lead to novel therapies for Type 1 diabetes and other autoimmune disease. Three genetic variations in particular (HLA-DQ2, HLA-DQ8, AND HLA-DR0405)- all located in the region of the genome called HLA for “human leukocyte antigen”- are known to increase risk of diabetes.

These three genes encode molecules that present peptides (protein fragments) to the body’s T cells than determine whether the peptide being presented is dangerous and need to be eliminated from the body as in the case of foreign invaders such as bacteria or viruses- or whether the peptides is “self,” part of the host and something the immune system needs to leave alone. However, in the context of Type 1 diabetes, T cells aggressively attack the body’s own cells.

Type 2 is responsible for most of the increase in diabetes with the complications for example, renal failure or severe hypoglycemia.

For many people, Type 2 diabetes can be managed or prevented by a healthy diet and regular exercise. Many people worldwide do not know they have diabetes, and many of those who do know are in poor control of their diabetes. Lifestyle change is still the first option for the treatment for Type 2 diabetes, experts say treating diabetes early and well not only improves quality of life, but is cost-effective, especially if it prevents hospitalization. There is now conclusive evidence that good control of blood glucose levels can substantially reduce the risk of developing complications and slow their progression in all Types of diabetes.

Regulating P53 Activity in Cancer Cells

The protein BRD7 activates p53 and could therefore suppress the development of cancerous tumours, reports a study online in Nature Cell Biology this week. The transcription factor p53 is a critically important tumour suppressor protein, as inactivation of the p53 pathway contributes to the development of cancer. BRD7 expression is frequently lost in breast cancer, but it is currently not clear how BRD7 might inhibit tumour formation. Reuven Agami and colleagues show that BRD7 binds to and activates p53. BRD7 also regulates chromatin structure at p53-target genes, enabling more efficient transcription at these sites. As such, BRD7 loss permits oncogenic transformation of cultured human cells.

The researchers analyzed over two hundred human breast cancer samples and found that BRD7 expression was lost only in those tumours that contained functional p53. These findings suggest that selective BRD7 loss in human cancers provides an additional means of silencing the p53 pathway, and provide insight into how p53 transcriptional activity is regulated.

Author contact:
Reuven Agami (The Netherlands Cancer Institute, Amsterdam, Netherlands)E-mail: r.agami@nki.nl

CAREER IN THE NEW DECADE

Biomedical Informatics is an academic discipline that bridges medicine and information sciences. With the increasing popularity of IT biomedical informatics is making its presence felt in a big way.


"The role of IT in healthcare has become increasingly necessary for modern practices in medicine, efficient and effective management of healthcare and professional health education. Health professionals recognize an urgent need for skilled scientists who are knowledgeable about both medical environment and information technologies," says Dr. Kumud Sarin, head of the department, Biotechnology and Bioinformatics, Bioinformatics Institute of India (BII), Noida.

For the uninitiated, Biomedical Informatics is the combination of theoretical foundations and the current range of applications within contemporary delivery system. It focuses on structure, algorithms and design of efficient logic necessar2y to organize, store and retrieve as well as analyses the data. It is emphasizing to produce knowledge and under-standing about cognition and representation of biomedical knowledge, management of health care systems, clinical decision making, research, design and development of interactive multimedia systems.

Talking about the program offered by BII, Dr. Sarin says: "The purpose of the program in Biomedical Informatics is to prepare students in the applications of computer and information sciences to support and manage and healthcare activities." These can range from those pertaining to the care of the sick to health promotion and disease prevention, medical and health education, health sciences research and management efforts directed towards solutions of problems in the delivery of health care, including resource optimization and cost-effectiveness.

Those interested in making a career out of a degree in Biomedical Informatics would be delighted to know that its applications are rapidly increasing in healthcare and hospital management systems, laboratory automation, quality assurance, financial management and resource allocation, health services and biomedical research. They can also find placements in clinical decision making, treatment monitoring, networking and registration systems, information storage, retrieval and database management systems, simulation and modeling, pattern recognition, biomedical signal and image processing, and health education, research and support systems.

In terms of a professional career, there are several areas within the field where a qualified person can find opportunities. Data management and information analysis apart, there is scope for placement in medical imaging, enabling telemedicine, genomic mapping, systems and software development, and knowledge management. With respect to those with a professional degree in healthcare, job opportunities are available as consultants with management consulting firms, hospital record managers, data analysts, librarians, and positions with the state health departments.

Careers abound in professional companies that offer end-to-end solutions in Biomedical Informatics for medical facilities including setting up systems for IT-enabled clinical practices, medical/diagnostics decision support systems, multimedia healthcare solutions, healthcare content management, clinical knowledge architecture and sharing of healthcare knowledge between different healthcare groups.

The subject also involves the design and statistical analysis of drug trials. Professionals in this field are much in demand at pharmaceutical companies and research labs to work in the areas of modeling, simulations, gene expression control, clinical databases and medical statistics.

The typical starting salary in the sector ranges from Rs. 25,000 to 30,000. Sarin has a positive picture to paint about the future for those pursuing the course. "Our students do immensely well after the completion of the course as we have 100 per cent placement," she adds.

India among top 5 government funders of neglected diseases

India along with Brazil are now in the top 5 government funders of neglected disease R&D and are taking the lead on diseases like leprosy and dengue fever. An annual survey of investment into neglected disease R&D released, shows that nearly $2.96 billion was spent on making new products for neglected diseases in 2008. A key finding of the G-FINDER survey was that, for some diseases, traditional donor funding is being replaced by investment from pharmaceutical companies and Innovative Developing Countries (IDCs) such as Brazil, India and South Africa. Where there is no profitable market, as with many of the diseases that affect sub Saharan Africa, R&D remains heavily reliant on traditional donor and philanthropic funding.

“These are tough economic times but, for the first time, we are seeing that for some neglected diseases the traditional reliance on charitable funding and donor aid is being replaced by a market and domestically driven R&D,” said report author, Dr Mary Moran of The George Institute for International Health. “This is good news for new medicines and diagnostics in India, Brazil and South Africa, but not for most of sub Saharan Africa where there is still no market and they will have to rely on donors and philanthropists for some time yet,” she added.

This trend reflects the growing research strength and pharmaceutical markets of India and Brazil, in particular, as well as high local incidence of diseases such as leprosy and dengue. The downside of this trend is that diseases of Africa continue to rely on donors, who still provide more than 85 percent of funds for Buruli ulcer, trachoma, kinetoplastid diseases like sleeping sickness and many helminth infections.

Report Findings

The G-FINDER report shows that in 2008 Innovative Developing Countries (IDC`s) like India, Brazil and South Africa and pharmaceutical companies funded:

1. Nearly 60 percent of R&D for pneumonia and meningitis
2. More than half (51 percent) of leprosy R&D (Brazil and India have the largest number of new leprosy cases per year in the world)
3. Nearly half (46 percent) of R&D for new dengue products (the Americas, particularly Brazil, along with Asia, have the highest global prevalence of dengue)
4. Around 20 percent of funding for new treatments and vaccines for diarrhoeal illnesses, TB and malaria (which occur worldwide)

“The G-Finder survey report has put India as the 5th largest public funder of neglected diseases, and ICMR provides 60 percent of the funds. Visceral leishmaniasis and leprosy are amongst most neglected diseases, and we must further improve our funding for research to find new tools to combat them,” said Dr V M Katoch, Secretary, Department of Health Research, and Director-General, Indian Council of Medical Research, New Delhi.
Other Key Findings.

• Global funding for neglected disease R&D ground to a standstill in 2008, with funding cuts or freezes across the board including a $26.3 million decrease in funding from High-Income Countries (HICs)
• This injection of additional funds led to a net increase of $100.1m (3.9 percent) in global neglected disease R&D investment in 2008.
• Two organizations provided nearly 60 percent of global funding in this area in 2008: the US National Institutes of Health ($1.1 billion, 36.5 percent) and the Gates Foundation ($617 million, 20.9 percent).
• The pharmaceutical industry was collectively the third largest global investor, with companies providing one-eighth ($365 million, 12.4 percent) of global funding for neglected disease R&D.

"This G-Finder report confirms the welcome news that an increasing number of Pharma companies are allocating R+D resources to the neglected diseases surveyed. Although no major financial returns can be expected with medicines for many of these diseases in the foreseeable future, there is a growing sense of responsibility for underprivileged patients and reputational aspects,which are helping to improve the lives of patients”, said Prof Paul L Herrling, Head of Corporate Research for Novartis International.

India says "No" to Bt brinjal for now

India will not get its first genetically modified (GM) food for at least in 2010. In a major decision, overruling a regulatory approval, Indian government has decided not to permit commercial cultivation of the country’s first GM food product, a Bacillus thuringiensis (Bt) brinjal (aubergine) variety, developed by global agri giant Monsanto’s Indian partner, Maharashtra Hybrid Seed Company (Mahyco).

India’s minister for environment, Mr Jairam Ramesh, advanced his date with the decision on Bt brinjal by 24 hours and announced on Tuesday that Bt brinjal will not be released in the farms at least for another six months.

The environment ministry is likely to announce this decision in the Supreme Court of India on February 10, which is hearing a public interest litigation (PIL) against the introduction of the Mahyco-developed Bt brijal hybrid, which incorporates a Cry1Ac gene derived from a soil bacterium, Bt.


“My decision is the best interest of science and public interest,” said the minister after pouring over the overwhelming number of representations received from anti-GM groups from across the country during his seven public consultations held across the country in the last four weeks.

“There is no unanimity even among the scientific community,” justified the minister, even after the biotech regulator, the Genetic Engineering Approval Committee (GEAC), in the environment ministry had voted overwhelmingly on October 14, 2009, to allow commercial cultivation of Bt brinjal hybrids of Mahyco.


The India Edition of BioSpectrum, in its February 2010 issue had predicted that the government may not permit the cultivation of Bt brinjal for now even though the regulatory approval has been given to it.

There has been intense pressure on the issue within the government with the agriculture minister, Mr Sharad Pawar, and minister for science and technology, Mr Prithviraj Chavan, batting for Bt brinjal. Mr Ramesh tried to go over GEAC by announcing a national public consultation, within days of regulatory approval. The environment minister heard the views of over 8,000 people in seven cities, with anti-GM activists led by civil society groups, farmer associations strongly opposing the introduction of Bt brinjal.

The environment minister’s hand was also forced by the announcement of at least eight state governments, which together account for over 70 percent of brinjal production, to ban cultivation of GM food crops in their areas.

India grows over eight million tonnes of brinjal annually and is the second largest grower of this vegetable in the world after China. The annual market for brinjal is estimated to be around Rs 8,000 crore ( $1.8 billion) and nearly 40 percent of the crop is lost due to attack by a major pest, Fruit and Shoot Borer. The Bt variety would have offered resistance and killed this major pest.

Pharma cos see opportunity in India

Indian state unveils Millenium Biotech Policy II

Karnataka Government on December 9, 2009, unveiled its Millennium Biotech Policy II, which replaces the earlier policy statement issued in 2001. The new policy lists the progress made since then and also outlines steps to further spur the development of the biotechnology industry and harness its benefits for the common citizen in the years to come. As a focus area, the policy makes special commitments in the area of biofuels. The State of Karnataka, India, has joined the international movement to go green. The state has set a goal to meet 20 percent of its fuel needs from biofuels by 2020.

The state together with the Government of India has proposed to set up a Bio IT park in the Institute of Bioinformatics and Applied Biotechnology (IBAB) campus on a PPP model with an investment of Rs 20 crore (about $4.28 million). The Bio IT facility will be a hub for both IT and life sciences organizations, research institutions and academia.

In a step towards improving the quality of human resources for the biotechnology sector, the government will promote 10 biotech finishing schools selected by the Association of Biotechnology Led Enterprises (ABLE) and the Vision Group on Biotechnology with the government financial support of Rs one crore (about $0.21 million) per finishing school.

According to Mr Ashok Kumar Manoli, Principal Secretary, Information Technology and Biotechnology, Karnataka, “The concessions to the biotechnology companies including the tariffs in the state is likely to amount to a minimum of Rs 400 crore (about $85.64 million).”

Among the new concessions offered by the new policy, which was formulated by the Vision Group on Biotechnology, is the waiver for biotech research and development units from approvals by the State Pollution Control Department. The policy also offers agri-biotech companies greater freedom to conduct field trials. They will be facilitated in acquiring tillable agricultural land to the tune of 15-20 acres. This will solely be for companies performing agri-biotech related research and will be in the form of a 35 year lease.

Among the fiscal incentives on offer are interest-free loans from the government for paying value added tax, and subsidies for registration of patents, power and water. Moreover, biotech units will also be eligible for subsidies to meet expenses incurred for standardization certification. Apart from these exemptions, biotech units will also be eligible for other benefits that are provided for industries on terms set in the state industrial policy. The policy sets to establish five specialized biotech parks in Mysore, Mangalore, Dharwad and Bidar, apart from the Bangalore Helix Park that is under construction. The government would invest Rs 100- 150 crore (about $21.40-32.11 million) in each of the facilities.

The government would also establish a Bio Venture Fund with a corpus of Rs 50 crore (about $10.70 million) in partnership with a professional venture capital firm. Only certain hi-tech areas with a strong social relevance such as transgenics, stem cell biology and biomanufacturing would be eligible for funding. The government will have 26 percent stake in the proposed fund and the balance 74 percent will come from financial institutions or VC firms. Also on the agenda is the creation of a fund to commercialize research findings. The Karnataka State Government will set apart a corpus fund of Rs 15-20 crore (about $3.21-4.28 mn) which will be used to issue grants in Rs 10-29 lakh (about $0.021-0.062 mn) range in each case.

Biotechnology, key to food, nutritional security

Medanta, Duke Medicine to open translational research facility in India

Medanta–The Medicity and Duke Medicine signed a joint venture agreement to launch the Medanta Duke Research Institute (MDRI), a early phase clinical research facility at Medanta.

The MDRI project will aim to transform the global framework for clinical development and evaluation of human biology, diseases, drugs & devices by leveraging cutting edge technologies and applying systems biology & molecular medicine to clinical research.

MDRI will collaborate with Duke affiliated early phase research units in the US & Singapore to develop a best-in-class global network for proof of concept clinical research. The collaboration will unlock the potential for undertaking simultaneous early phase clinical studies in three countries with diverse populations.

This network will enable globally relevant pharmacogenomic studies and also facilitate faster and more accurate early phase clinical trials.Industry statistics report that advancing a new compound through the clinical trials process is a long and expensive endeavor, with only about 11 percent of investigational compounds ultimately become drugs. Furthermore, one in four compounds fails even after completing registration trials, resulting in a loss of billions of dollars while also exposing patients to toxic agents. The objective of a typical early phase study is to provide information about the dosing, safety and toxicity of a drug by giving it to a relatively small number of healthy people and capturing pharmacokinetic, and other basic data, as well as patient reported adverse events.

The new paradigm being established with the launch of MDRI, and the associated global network of proof-of-concept facilities, will enable the elucidation of much more comprehensive insights at the front end of the clinical trials process by studying early compounds in small numbers of real patients – as opposed to healthy volunteers – utilizing proteomics, metabolomics, advanced imaging and other state-of-the-art research tools.

Pharmac India 2009 to be held in Ahmedabad from Nov 7 to 9

The Indian Drug Manufacturers Association Gujarat State Board (IDMA -GSB) is organising India's largest pharma & healthcare exhibition 'Pharmac India 2009' in Ahmedabad from November 7 to 9. While Pharmexcil is the co-organiser of the event, it is supported by Federation of Pharma Entrepreneurs (FOPE), Sabarkantha District Drug Manufacturers Association, BDMA and Rajasthan Pharmaceutical Manufacturers Association.

The exhibitor profile includes manufacturers of pharmaceutical formulations like ayurvedic/herbal products, nutraceutical products, dietary supplements, cosmetics products, veterinary drugs, medical & disposal , pharmaceutical machinery, flavours & fragrances, diagnostic reagents, recipients ,food additives, natural extracts , active pharma ingredients, pharmaceutical packaging material and machinery, R&D/testing labs, analytical services, Contract Research Organizations (CROs), laboratory equipment, laboratory chemicals, associations, publications, consultants pharma ancillary & utility suppliers.

This will enable an exhibitor to launch his products in India and meet end-users directly, get immediate feedback on product range and corporate image, build and enlarge prospects database, research the market and competition and assess market potentials, locate possible agents and distributors and initiate cooperation, alliances and joint ventures.

Benefits from the event for the contract manufacturers include first hand information on the latest technology and update, probable business tie ups for joint ventures, technology and know-how exchange, improvement in quality standards, R&D to meet with the global competition, explore the new areas and markets for exports and imports, dissemination of the information and direct and indirect employment opportunities.

India a strategic hub for growth in Asia Pacific region: CEO Sartorius Group

Sartorius, a bio-process, lab equipment and weighing scales major has invested Rs 45 crore (Euros 5 million) to set up a full-fledged facility including a R&D and production plant at Neelamangala the outskirts of Bangalore. It is equipped with an advanced research lab, manufacture, clean room and training centre.

Dr Joachim Kreuzburg, CEO Sartorius Group, who was in India to inaugurate the new plant said that India is a recognized as a strategic hub in the Asia Pacific region. Country's knowledge resource and pharma-biotech infrastructure are the key attractions for global players to augment their investments here.

"India offers a huge talent pool. We have established a clear cut road map to chart our future business efforts for the Asia-Pac region from here. This country is on our radar for growth initiatives and is already a strategic location for us," Dr Kreuzburg said.

Sartorius which has a presence in India for over two-decades has been extensively catering to the lab and bio-process engineering customer requirements. The Bangalore plant was engaged in the development and production of bio-reactors, fermenters, lab equipment for bio-pharma companies and weighing scales for life sciences and industrial applications.At the new site, the company has combined its five decentralized individual locations in Bangalore into a single
location to create new capacity. From bulk drugs to formulation research and manufacture, Sartorius can offer a value chain in engineering services and validation. This has helped the Indian operations to play a pivotal role in terms of revenues.

Indian operations have the second largest personnel which is around 500. The Group across its global sites has a total of 2,200 staff. The team in India not only has an excellent basic technical education, but they also have a good grasp of the knowledge and experience in the various industries for different business processes. "Therefore, we have turned the spotlight to India which is now our base to increase our presence in the Asia-Pacific region. From here, we
have already started tapping Korea and Taiwan markets which are regions known for the huge state-of the art bio-manufacturing plants that need Sartorius products," said Dr Kreuzburg.
This is an age of disposable technologies. Sartorius already has a vast range of disposable technologies for the production and research labs. The new facility will see business expansion here to the tune of 30 to 40 per cent in future which will include a range of products of the future, said Amit Chatterjee, managing director, Sartorius India Group.In 2008, Sartorius Group earned sales revenue to the tune of Euros 611.6 million. The India operations registered a turnover of Rs 160 crore.

Academy of Intellectual Property Studies to hold workshop for drug regulatory professionals

The Academy Of Intellectual Property Studies (AIPS), Mumbai is holding a two-day workshop for drug regulatory professionals. The workshop will focus on Drug Master Files – Compilation & Compliance on November 13 and on November 14 it will concentrate on Drug Marketing Authorization Procedures in Europe.

A Drug Master File (DMF) is a confidential, proprietary asset containing complete information on an API. It is a submission to the FDA, and plays a crucial role when applying for regulatory approvals and market authorization. Acting as a master document, the DMF is important in maintaining current supplier agreements as well as in developing new business relationships and their preparation is, therefore, an important function in pharmaceutical organizations.

This workshop will train executives on how to prepare reliable and efficient DMFs that are compliant with official guidelines and requirements. Participants will gain an understanding of how to compile a DMF in different jurisdictions including what to include/ not include, maintenance of the DMF, strategy to avoid unfavourable reviews, etc. Executives from the RA, R&D, quality assurance and control, manufacturing and validation will find participation especially useful

The European Union offers a very profitable market for pharmaceutical products - the EU market is, however, highly regulated, and the related regulatory requirements are both complex and dynamic.
day-2 of the workshop will focus on the EU compliant Application process required to secure marketing approval and access the market, and include discussion on topics like authority (HMA) responsibilities, different MA procedures and their scope, documentation required, post Authorization activities etc. Manufacturers and exporters in the pharma sector seeking to improve their export prospects to the EU will find the participation useful, as will professionals dealing in drug regulatory affairs.

For more details contact: gita@aips.ac.in or info@aips.ac.in

SPIC calls for raising SSI exemption limit to Rs 5 cr in next Union Budget

The SME Pharma Industries Confederation (SPIC), representing the majority of small scale units, has strongly demanded raising of pharma SSI exemption limit to Rs 5 crore in the coming budget at any cost to support the ailing sector.

In a revised memorandum to the Department of Pharmaceuticals in response to the call for suggestions to be forwarded to the Finance Ministry and to be included in the next budget, the SPIC has pointed out that the Department of Revenue which stalled the proposal for increasing the SSI exemption limit for two years cannot do the same any more.

“Pharma cannot be rated at par with other service providers who neither regulated nor covered under price control. The DOR has no qualms in losing crore of rupees annually by adamantly holding on to the anomalous MRP excise to extend benefit to the units in excise free zones. But now, the 5000 SMEs are more important and they need to survive after being victims for five years,” the representation said, urging for the immediate clearance of the proposal.

The SPIC also reiterated their earlier demands including the inclusion of pharma industry in the lowest slab as in case of precious metals when the Goods and Service Tax (GST) will replace the excise duty from April 1, 2010. The association also called for amalgamating different taxes into GST to save time and energy. All types of forms (C, H, etc) and road permits for transportation from one state to another should be scrapped with levy of GST. Rates of GST and State GST should be kept uniform for all states and the filing procedures should be simple and transparent to enable filing by SMEs themselves without support from CAs, which are additional cost for no reason, it said.

The anomalous fiscal policies coincided with implementation of Schedule M which mandated upgradation at an enormous cost at a time when SMEs were rendered redundant owing to MRP excise. Schedule M has escalated the cost of setting up a moderate sized SME unit to Rs 20 crore. Hence no new SME units have come up in the last three years except in Excise Free Zones, simply because they are enviable. An SME entrepreneur cannot repay loans given the small turnover of the business. The number of Pharma SMEs has reduced drastically. If SMEs are not protected, it will be handing over the entire local market worth Rs 50,000 crore to MNCs. India cannot forget that prior to advent of SMEs in 1960, prices of medicines in India were highest in the world, the representation said.

Cipla net jumps by 82% Q2 to Rs 276 cr

Friday, October 30, 2009

Cipla, the third largest pharma company in India has achieved impressive growth in profitability during the second quarter ended September 2009. Its net profit moved up by 82.1 per cent to Rs 275.74 crore from Rs 151.43 crore in the similar period of last year. Its net sales, however, improved marginally by 5 per cent to Rs 1,384 crore as against Rs 1,318 crore. Though the domestic sales improved by 6.8 per cent to Rs 631 crore, its exports declined by 3.4 per cent to Rs 581.91 crore from Rs 602.34 crore. The sales of API & others increased smartly by 37.5 per cent to Rs 170.56 crore from Rs 124.02 crore.

For the first half ended September 2009, Cipla’s net sales increased by 8.7 per cent to Rs 2,723 crore from Rs 2,505 crore in the same period of last year. Its net profit went up by 77.5 per cent to 517.45 crore from Rs 291.47 crore. Exports increased by 10 per cent to Rs 1,129 crore in the first half of 2009-10 from Rs 1,027 crore. Similarly, its domestic sales moved up by 9.1 per cent to Rs 1,283 crore from Rs 1,177 crore.

Indian pharma industry to grow 12-15% CAGR during 2008-13

According to ORG IMS Research, a leading producer of information for sales to the Global Healthcare industries, operating in over 90 countries, the Indian pharmaceutical industry will continue to grow at over 12% CAGR (compound annual growth rate) in the next five years as against the global industry growth of over 4%.

The ORG IMS Research noted that in 2009 the industry in India is expected to growth 14-15%, which is slightly lesser than the registered a growth of 16.6% in 2008. The drop in the growth was due to the global economic meltdown.ORG IMS Research also pointed out that the pharmaceutical industry will see a growth of 12-14% in 2010, 14-16% in 2011, 13-16% in 2012 and 12-15 % in 2013. In 2013, India will remain 13th position in global market rankings.

Suven's SUVN-502 secures product patents

Suven Life Sciences (Suven) has announced that its clinical candidate SUVN-502 for Alzheimer’s disease secured several product patents granted at all the key market countries such as India, Mexico, South Africa, Singapore, New Zealand, Korea, Eurasia, Australia and Europe. The product patents for SUVN-502 in all the countries are valid until June 2023. SUVN-502 is an exclusive intellectual property (IP) of Suven and was achieved through the internal discovery research efforts. The granted patent has been validated in all the nine member countries of Eurasia (including Russia) and 37 member countries of Europe including major markets like Germany, Switzerland, Denmark, Spain, France, United Kingdom, Italy, Netherlands, Poland, Sweden and Finland.

SUVN-502 completed the Phase-I single ascending and multiple ascending studies at Switzerland and demonstrated to be very safe at all doses tested with excellent bioavailability and half life for potential once in a day treatment. Suven is planning to initiate the clinical phase-II proof-of-concept (POC) studies during 2010. The company targets launching of SUVN-502 in later part of 2013 or early part of 2014.

Pfizer-Wyeth integration takes time in India

The much talked about integration of Pfizer and Wyeth had finally been completed globally and operations as a merged entity commenced on 0ctober 16, 2009. Under the terms of the transaction, each outstanding share of Wyeth's common stock has been converted into the right to receive $33 in cash (without interest) and 0.985 of a share of Pfizer's common stock. The $68 billion acquisition of Wyeth by Pfizer earlier this year was a blessing in disguise for the latter as it was mentally preparing itself for a sharp dip in its revenues following the patent expiry of its blockbuster drugs.
In India, however, the integration would take some time, maybe a couple of months, due to issues related to infrastructure and manpower, revealed an inside source of the company. Globally, almost all the teams and units have been integrated. In India, there are many units where the integration is still in process. There are four divisions within Pfizer which would remain out of the purview of the integration. These four divisions, which come under the diversified business of the company include, animal health, consumer health, nutraceuticals and Capsugel.
A look at both the companies’ ranking and performance in India will reveal that unlike the global platform wherein Pfizer’s ranking is number one and Wyeth is listed within the top 15 (according to IMS rankings), in India, Pfizer is ranked within 18 while Wyeth does not even figure within the top 30. “According to ORG IMS, the Indian market share for Pfizer comes to around 2.2 percent while that of Wyeth comes up to 0.8 percent; so together their market share is of 3-3.5 percent,” added an analyst. A reliable source study also mentions that Pfizer's retail sales amounts to $134 million (market cap of $329.68 million) while Wyeth's sales comes up to $69 million (market cap of $201.66 million). As a combined company, the retail sale revenues will increase to approximately $198 million.
Pfizer at present has big plans for India in the coming months. To prevent a drop in sales due to patent expiry of blockbuster drugs, Viagra and Lipitor, and to compete with the generic companies, Pfizer is venturing into generics which also includes the biosimilars space. Recently, Pfizer has launched a drug for hypertension. “Yes, we are looking at the generic space and by December we should be launching 2-3 more generic drugs,” mentioned Mr Kewal Handa, MD, Pfizer India. There were market speculations about the company looking at possible alliances with Indian generic companies but a company spokesperson rubbished the rumors mentioning, “We do not comment on market speculations and these are all just wrong assumptions.”

Indian pharma market to reach $44.99 bn by 2018

According to a new market research report from companiesandmarkets.com, the $14.23 billion Indian pharmaceutical market is forecast to reach a value of $44.99 billion by 2018, representing a CAGR of 12.2 percent. The main drivers of growth are a booming economy, increasing access to medicines, more investment in healthcare infrastructure and a greater incidence of chronic diseases.

The report notes that India’s intellectual property IP regime is far below international standards; however, there are signs that the situation is changing. In August 2009, health activists and some generic drug companies severely criticized the Indian Commerce Ministry’s decision to accept the Mashelkar committee’s recommendations to grant patents to new drugs.

The adoption of the recommendations indicates that new patents will be allowed on incremental innovation under Section 3(d) of the Indian Patent Act, in the event that the candidate drug offers enhanced therapeutic efficacy. Patent experts supported the decision as it is in line with international norms. Pharmaceutical regulations are rapidly improving in India. In July 2009, the Indian Department of Biotechnology (DBT) planned to create a separate IP regulator for the biotechnology sector. The National Biotechnology Regulatory Board would be responsible for identifying and controlling drugs and vaccines which are developed from natural sources.

That same month, the Drug Controller General of India (DCGI) identified six research and development (R&D) centers in which new drugs will be tested before they are launched. Meanwhile, in May 2009 the DCGI decided to withdraw the powers given to state-level regulators to issue export quality licenses, which are called Certificates of Pharmaceutical Products. The move was designed to centralize and standardize procedures. Unfortunately, India’s pharmaceutical industry is gradually developing an undesirable reputation for producing sub-standard medicines. During Q3 2009, regulators in the US and UK have blacklisted select batches of drugs made by firms based in the South Asian country.

The report also noted that due to the absence of some form of government-provided universal healthcare, India’s health insurance market is one of the most promising sectors in the world. This was underlined in June 2009, when India-based Religare Enterprises signed an agreement with Swiss Re to establish a joint venture with an initial investment of $100million. Operations are expected to start in 2010. At that time, Swiss Re was already present in the India health insurance market, holding a 26 percent stake (the maximum permissible) in TTK Healthcare Services.