Current Affairs Pharmacy

...says Dr Lukas Utiger, Executive Vice President and Head - Bioscience, Lonza, Maryland, US. Lonza is headquartered in Base!, Switzerland and Is listed on the SIX Swiss Exchange. In 2010, the company had sales of CHF 2.680 billion. Speaking during the sidelines of recently concluded BloAsia 2011, Hyderabad/ Dr Utiger shares his vision for Lonza in India. Arshia Khan & DrAsma Mohd Yousuf Lonza is a global leader in the production and support of Active Pharmaceutical Ingredients (APIs) both chemically and biotechnologically. Biopharmaceuticals are one of the key growth drivers of the pharmaceutical and biotechnology industries. From 1897 to the present day, combining Swiss tradition with global experience, the company has had an enterprising character, adapting its offerings and services to the needs of customers and to changing technologies. We have maintained a strong culture of performance, results and dependability that is valued by all of our customers. And it is through reliability, quality and dependability that a brand stands out. Growth drivers and business model Today it has become essential to find new form of cures for the existing chronic diseases. There is a need for biosimilars in the market. Also, there should be a strong focus on the development of small molecules, which includes chemical, pharmaceutical, protein, cells, antibodies, etc. Lonza has strong capabilities in large and small molecules, peptides, amino acids and niche bioproducts, which play an important role in the development of novel medicines and healthcare products. In addition, Lonza is a leader in cell-based research, endotoxin detection and cell therapy manufacturing. Furthermore, the company is a leading provider of value chemical and biotech ingredients to the nutrition, hygiene, preservation, agro and personal care markets. Moreover, Lonza is one of the world's leading suppliers to the pharmaceutical, healthcare and life science industries. Products and services span its customers' needs from research to final product manufacture. Our focus is to develop as well manufacture molecules. R&D is a very crucial element of our business model. Career graph at Lonza • Dr Lukas Utiger holds a PhD in Chemical Engineering from Imperial College, London. He has also worked at ICI Chemicals & Polymers Division in Runcorn (1988-1992). He joined Lonza as Development Engineer in R&D engineer, Switzerland in 1992. • In 1998, he worked as Group Leader - Process R&D, Fine Chemical Div, Switzerland • From 2000 to 2001, he was the R&D Head Exclusive Synthesis (Chemical Custom Manufacturing), Switzerland • From 2001 to 2006, he was Business Head - Exclusive Synthesis (Chemical Custom Manufacturing), Switzerland • From 2006 to 2010, he was COO - Life Science Ingredients Business Sector, Switzerland • From 2010 he is the Executive Vice President and Head - Lonza Biosciences, Maryland, USA                                                       • Also, since 2001 he is a member of the Lonza Group, Management Committee India strategy India's share in the global biotech market is about two per cent. However, India is not strong when it comes to patented drugs. There is hardly any discovery R&D being conducted on proteins, biosimilars and more...

...says Dr Saranjit Singh, Professor and Head, Department of Pharmaceutical Analysis and Dean NIPER, SAS Nagar (Mohali). He reviews the present pharma education system and stresses on the need for infrastructure and aid in government institutes. Chandreyee Bhaumik Your views on the Indian pharma industry. The world is gradually recognizing the quality status of the Indian pharma industry. There is a strong future that lies ahead. The coming times will be tough for those who do not grow at the required pace and are unable to prove the quality of their manufacturing.  It is important for Indian companies to match the international standards. Also, the country needs to improve its regulatory system and raise the standard of academic training to support the industry. How is the current scenario of pharma SME culture in India? The Small and the Medium Enterprises (SMEs) are gaining momentum gradually. However, in order to strengthen their foothold further, SMEs need to update themselves and be prepared for the challenges ahead. Certainly, it is going to be tough for them to do so. Internationally, the slogan being raised is: 'one drug - one quality'. International agencies, including World Health Organization (WHO), are working on this principle and therefore the stringent requirements. This leaves no trend has reversed in the last decade with the mushrooming of private institutions. There are only few private institutions that have state-of- the-art infrastructure and faculty in optimum number and quality. This is harming graduate pharmacy students, who are forced to accept low-paid jobs and are treated as cheap labour. Thus, there is urgent need to bring in semblance in the pharma education sector. NIPER, SAS Nagar is trying its best to live up to its commitment towards quality deliverance and training of post-graduate students. option but to upgrade and meet the quality standards. For this, the SMEs need support from the government, which is reasonable. How well placed are we in terms of pharma education? Historically, pharma education in India has been driven by government institutes and departments, and there were very few private players. The trend has reversed in the last decade with the mushrooming of private institutions. There are only few private institutions that have state-of- the-art infrastructure and faculty in optimum number and quality. This is harming graduate pharmacy students, who are forced to accept low-paid jobs and are treated as cheap labour.   Thus, there is urgent need to bring in semblance in the pharma education sector. NIPER, SAS Nagar is trying its best to live up to its commitment towards quality deliverance and training of post-graduate students. How important is industry- academia interaction? There is a strong need to develop industry-academia linkage for the training and placement of students. This can be done through different modes. One is institution and faculty level interaction.  For this, institution needs to create facilities and faculty has to acquire exclusive practical skills so that industry is attracted to get their specific problems solved. The other mode is setting up of public-private more...

With the pipeline of modern medicines facing a drought and increase in life style diseases, nutraceuticals hold a lot of potential. However, the rural Indian population is still reluctant to go the neutral way due to various reasons. A market check on the prospects that this segment holds...  The term 'nutraceutical' was coined in the 1990's by Dr Stephen DeFelice, Founder and Chairman, Foundation of Innovation Medicine (FIM), Crawford, New Jersey. He defined nutraceutical as: 'Any substance that is a food or a part of a food and provides medical or health benefits, including the prevention and treatment of disease.' Whereas   Health   Canada,   the department of the government of Canada with responsibility of national public health has modified the meaning of the term since its coining by Dr DeFelice, Thus, the definition of nutraceuticals read: 'A product isolated or purified from foods, and generally sold in medicinal forms not usually associated with food and demonstrated to have a physiological benefit or provide protection against chronic disease, e.g., beta-carotene, lycopene.' Speaking on this, Partha Mukherjee, VP - Sales, Angle-French Drugs & Industries Ltd, opines, "Nutraceuticals (often referred to as photochemical or functional foods) are natural bioactive, chemical compounds that have health promoting, disease preventing or medicinal properties."  Continuing in this vein, he says, "They have the potential to play a role in healthy eating and contribute in the prevention and treatment of diseases so that now functional components in food could expand the role of disease prevention and treatment," The definition for nutraceuticals in The Food Safety and Standard Act (FSSA) was specified under Section 22 (I): • Plants/ botanicals: Whole or extracts • Minerals, vitamins, amino acids, enzymes • Substances of animal origin Further, according to various other regulatory bodies, a nutraceutical product    should    not    contain the following: • Drugs defined under the Drug Cosmetics Act (1940) • Drugs that claim to cure or mitigate any health condition or disorder • Narcotic/ psychotropic substance defined   under   the   Narcotic Drugs & Psychotropic Substance Act (1985). Drawing the demographics In our country, majority of to population lives below the poverty line and it is extremely difficult for them to afford nutritional food further, the modern day living has brought in an imbalance in nutrition, intake, which is high on calories an low on nutritional values. This the primary cause for the increase incidence   of   life style   ailments including cardiovascular disease neurodegenerative condition osteoarthritis, osteoporosis, AID; cancer, diabetes and numerous other health   conditions.   Commenting in this regard, Mukherjee avers Nutraceuticals are currently going through a renaissance, and the prospects for alleviating suffering and improving the quality of life are very strong and have generated an excitement the world over. Additionally, the use of innovative nutritional supplements in the prevention as well as treatment of diseases may stand in competition with existing medicines in the near future." The   nutraceutical   market   in India   is   witnessing   substantial growth.    Elaborating    on    this, V Srividyaranjini, Research Associate - Chemicals, Materials and Foods, Frost & Sullivan, explains, "The total more...

A streamlined chemist-patient interaction can ease a lot of burden from the physician, and also helps the less educated patient population. Using innovative sales techniques, companies spend 3 fortunes to get their drugs to the consumer, and it is time to utilize the chemist's counter by making it an efficient and innovative tool to aid the patient population. The marketing manager and his team are always looking for ideal opportunities to make sure that their selling strategies get quickly converted into profits for the organization. Most of the rime the focus for promoting their products is limited to astounding doctors with in-clinic detailing by the Medical    Representatives (MRs), providing great literature and journals, seminars,      workshops and gifts. Innovative   ideas   are applied mainly to impress physicians. The MR may dress like a commando or the manager may request the doctor to inaugurate a pack of new skin cream by cutting the ribbon. Free drug samples are given away to patients under the guise of 'medical camps.' Companies also try to modernize the packaging and presentation of their products   to   magnetize patients who purchase these medicines. Schemes to maintain patient loyalty are publicized in drug packs. Somewhere in between the doctor and the patient, a huge marketing opportunity seems to be lost by most of the industry! The prescription's voyage Once the sales rep makes his pitch, it is the doctor who is the prime mover of pharmaceutical products. When a patient visits a clinic for treatment, the doctor chooses the appropriate drug to ameliorate the patient's symptoms. The physician's prescription makes its journey to the local chemist where the attendant dispenses the drug. To a general observer the entire scenario looks very simple: the chemist dispenses drugs, the patient consumes it as recommended and the patient is cured. However, in reality, the expedition from the clinic to the first chemist's shop could lead to varied situations before the patient actually consumes the drug. Here are some possible scenarios that often take place after the prescription leaves the physician's cabin: • The most ideal possibility is that the chemist precisely honours the prescription in toto • The patient gets part of the drugs accurately,   whereas   some   are substituted with other brands • The chemist is unable to understand the actual names of some medicines prescribed by the doctor and the patient has to hunt for it elsewhere • The patient, being not-so-literate, is given some other inexpensive alternative drug by the chemist. In this case, the patient is blissfully unaware   of   the   substitution. This brings us to the primary point that in India just as the average patient trusts his doctor, he also has tremendous faith in the chemist. He assumes that the chemist would interpret the healer's scrawl accurately and also that the drugs prescribed would be available freely. The patient also believes that his chemist would dispense the drug correctly and substitutions made, if any, would be   legitimate   and   accurate. Obviously, if the drugs dispensed are perfect, the consequences are more...

Over 300 million people suffer from asthma worldwide. The global drug market is estimated to be over $15 billion. While drugs to manage asthma have existed for several decades, pharmaceutical companies have developed faster acting and more effective products over the years. Here is a prediction of the business of drugs used for this respiratory condition until the year 2017. According to  reports  of Global Data,   the   global asthma market valued at S 12.4 billion in 20U9 is expected to grow with a Compounded Annual Growth Rate (CAGR) of approximately 1.5 per cent to S14 billion by 2017. Although the respiratory market has expanded considerably from 2004 to 2009, growth in the seven major markets is expected to slow down from 2010 to 2012.The decline in sales during this period would be due to patent expiries of leading brands. Growth is driven by the expansion of sales in existing classes, the launch of major new products with safety and convenience advantages like route of administration, once- daily administration, combinational therapies, etc. Strong competition The current competition in the asthma market is becoming intense due to the increased entry of combination    therapies,    inhaled corticosteroids and   beta-agonists.  According to projections Symbicort. Advair artd Singulair will be the leading competitors of the global asthma   market.   GlaxoSmithKline, AstraZeneca and Merck wilt continue to be the market leaders until the patents on their drugs expire in between 2010-2012. Xolair is the only biologic available for the treatment of asthma. The asthma market is expected to witness a marginal decline in sales due to patent expiries of major blockbuster drugs like Advair, Singulair and Symbicort. Late stage pipeline There are over 229 molecules in various stages of the pipeline. Flutiform, MFF2 58   (Mo m etason e- Formote roll Roflumilast and VR315 are some of the late stage pipeline molecules. GSK159797/642444 (Beyond Advair), QMF149, Ogleimlast and SB-2405637 are some of the promising therapies in the phase II stage of the pipeline. These pipeline molecules differ in their larget of action from existing therapies. In addition to nest-in-class molecules, the pipeline has new technology like Potelligent and Morphodoma, which make it strong. The late stage pipeline is strong, phase II and phase I has innovations so it is expected that the asthma market will grow in the near future. A tremendous increase in the prescription of combination products is expected due to increased awareness and ease of administration of these products. The future of asthma market is denned by the product lifecycle management in terms of new combinations, new delivery options and combinations. Unmet needs with regard to safety and efficacy of the present marketed products Though there are several conventional therapies for the treatment of asthma like oral corticosteroids, long acting beta2 is agonists, combination therapies and biologics, combination therapies have gained importance in recent times. They offer substantial efficacy combined with durable response and convenient dosing    frequency. Combination therapies rule the market and are preferred first-line: therapy for asthma. Asthma drugs do not completely cure more...

Curtains came down on the eleventh edition of India's premier biotechnology event Bangalore INDIA BIO, when the plethora of participants and several global organizations came together on. This platform. It reflected promising prospects in biopharma, agri-biotechnology and industrial biotechnology, as well as called for greater government industry interaction, especially in the regulatory landscape. A report...  Manas R Bastia  Welcome to   the   new world   order!   Global biotechnology market is increasingly looking at emerging economies like India, Brazil, China as the destination next to drive growth, of the industry, "1'he Indian biotechnology sector, especially buoyed by promising prospects in biophaima, agri- biotechnology, industrial biotechnology, among others is likely to reach the $10-billion revenue milestone by 2015. To put this in perspective, the biotech sector in the country is currently pegged at around S4 billion of which nearly 40 per cent is contributed by more than 180 companies based in Karnataka. However, when one considers the SISO-billion global .' biotech industry vis-a-vis India s minuscule share in it. the potential opportunities and the enormous efforts needed to tap it call for strategic vision and well-planned execution, to begin with. These marked some of the key reflections from the recently concluded Bangalore INDIA BIO 2011. Grand inauguration Aptly themed as 'Biotech for a better tomorrow', the eleventh edition of India's premier biotechnology event was inaugurated by B S Yeddvurappa, Chief Minister of Karnataka and Dr V S Acharya, Minister for Information Technology and Biotechnology, Higher Education, Planning & Statistics, Muzi-ai, Government of Karnataka. Addressing the  august  audience, Yeddyurappa said, "Bangalore offers favourable ecosystem for biotechnology industry in the state. The government will make every effort to further boost growth of this industry. We will open four biotechnology parks in various parts of the state." On the state's initiative in promoting biotech finishing schools to create skilled workforce for the industry, he added, "Around 12 finishing schools will begin their next academic session in a few months, which will impart the required skill to the students." The guests of honour included Dr Vishwa Mohan Katoch, Secretary to the Government of India, Department of Health Research, Ministry of Health & Family Welfare and Director General. Indian Council of Medical Research; Jerome Bonnafont, Ambassador of France to India and Freddv Svane, Ambassador of Denmark to India. Among other dignitaries present were M N Vidyashankar, fA.S, Principal Secretary to Government, Department of IT, Biotechnology and S&T, Government of Karnataka; Dr Kiran Mazumdar-Shaw, Chairperson, Karnataka Vision Group on Biotechnology, and CMD, Biocon Ltd. On this occasion, VSdyashankar observed, "This event has truly become a gateway to India for the international biotech community. I am glad that the Bangalore Helix project will be put on fast track with the completion of selection process." In the words of Dr Mazumdar- Shaw, "The biotech world is all about partnering, collaborations, leveraging each other's strengths and svnergisins them to deliver affordable innovation. It is also about making sure that entrepreneurs are recognized, celebrated and born every day." According to a few dignitaries present more...

Following an audit conducted in February 2011, Gracure has received European Union-Good Manufacturing Practice (EU-GMP) certification for its manufacturing site in Bhiwadi, India, by Belgium's Federal Agency for Medicines & Health Products (FAMHP). The site has been approved for manufacturing of non-sterile dosage forms, which includes capsules (hard shells), liquids, tablets, semi solid and other (dry syrup for reconstitution with water). The Belgium's FAMHP certificate is accepted by all EU Health Authorities and by authorities of several other countries that recognize EU Certification. A S Bhargava, CMD, Gracure Pharmaceuticals Ltd stated, "This achievement would help Gracure enter European countries with its products and gain confidence and recognition from existing and new clients. "EU GMP is an important milestone in scaling up for new ventures and it was a tremendous team effort of the entire Gracure team which resulted into this success," he added. The long and rigorous preparation for EU-GMP, which had started in April 2009, finally paid off with receiving the certificate, which further confirmed Gracure and its team’s commitment for quality. 

IPF Ingenieria a Barcelona based major manufacturer of special machines destined for high profile industrial customers needed a special machine capable of tackling the challenge of inspecting small vials of serum for its customer, Fresenius Kabi, a global leader in infusion therapy and clinical nutrition. IPF provided them with a machine equipped with In-Sight vision systems from Cognex as recommended and integrated by Cognex partner, Edge Vision. In this application, In-Sight cameras were installed to inspect the levels of liquid in vials of serum as well as inspecting for impurities at a speed of 10,000 bottles an hour.

The product has a market size of approximately $ 2.4 billion for the twelve months ending September 2010 according to IMS and will be launched after June 1, 2011. Aurobindo now has a total of 134 ANDA approvals (103 final approvals and 31 tentative approvals) from USFDA.  ï»¿ Aurobindo  Pharma  Ltd has received a tentative Abbreviated   New  Drug Application approval for Venlafaxine  hydrochloride extended-release capsules 37.5 mg, 75 mg and 150 mg (ANDA No 200834) has received the final approval from the US Food & Drug Administration (USFDA). Venlafaxine hydrochloride extended-release capsules 37.5 mg, 75 mg andl50 mg are the generic equivalent of Wyeth Pharmaceuticals Inc's Effexor®XR capsules 37.5 mg, 75 mg and 150 mg. Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of major depressive disorder (MDD) and falls under the neurological therapeutic category.  

Suven   Life   Sciences   Ltd, a    Hyderabad-based    bio- pharmaceutical company, has been awarded the Bio-Excellence Award   under   Bioservices category at Bangalore India Bio 2011, a biotech event held from May 4-6, 2011 at Bengaluru. Instituted by the department of IT-BT & ST, government of   Karnataka,   the   Bio- Excellence award recognizes and honours biotech leaders for their outstanding achievements in the field of science and technology. The bio-pharmaceutical company that was initiated from 1989 is committed to discovery of New Chemical Entities (NCE) for central nervous system (CNS) disorders, provide niche scientific services through drug discovery research services and conduct research collaborative projects with major pharmaceutical companies. The company has been declared as a winner of Bio-Excellence Award under Bioservices category by the jury of Industry experts constituted by Association of Biotechnology Led Enterprises. The company is engaged in drug discovery and developmental activities for CNS disorders in India, the US, Europe, and rest of Asia.