Current Affairs Pharmacy

Lupin Ltd and Natco Pharma have formed an alliance to jointly commercialize generic lapatinib ditosylate tablets used for the treatment of breast cancer in the US market. Lapatinib ditosylate tablets are sold under the brand name Tykerb in the US market. The patent of Tykerb is with Glaxo. Natco had filed an Abbreviated New Drug Application (ANDA) seeking US Food and Drug Administration (US FDA) approval for marketing generic equivalent of Tykerb® in 250 mg tablets. Lupin, the 5th largest and the fastest growing top 5 generics player in the US (by prescriptions), the only Asian company to achieve that distinction along with Natco, believes that they are first-to-file an ANDA containing a Paragraph IV certification for Lapatinib. Tykerb® had sales of $113.6 million as of March 2011 according to IMS health.

Glenmark Pharmaceuticals has recently announced that it has received final approval from USFDA for its generic mupirocin ointment, used for the treatment of skin infections. The US subsidiary of Glenmark Generics has been granted a final Abbreviated New Drug Approval (ANDA) from USFDA for mupirocin ointment USP 2 per cent, the company said in a statement. Based on IMS health data for the 12-month period ending March 2011, mupirocin ointment, used in treatment of bacterial skin infection impetigo, garnered annual sales of $55 million and achieved a 9 per cent increase in growth compared to the same period last year. The ointment is available in a 22-gram tube. The company has 39 ANDAs pending for approval and has a portfolio of 68 products for distribution in the American market.

OncoTrack, an international consortium, managed by Bayer HealthCare Pharmaceuticals and the Max Planck Institute for Molecular Genetics launched one of Europe's largest academic-industry research projects to develop a novel approach for identification of new markers for colon cancer. Their prime objective is to establish new methods for systematic next generation oncology biomarker development, with the intention to generate top quality genomic and epigenetic sequence data from clinically well- defined tumours and their metastases. The data acquired from all phases of the project will enable OncoTrack to address important questions about the relationship between tumour genotype and phenotype, the project has collaborations with leading global pharmaceutical companies, such as AstraZeneca, Bayer HealthCare Pharmaceuticals, Merck, Pfizer and Roche Diagnostics, whose in-kind contributions to the project are around € 25.8 million. Dr David Henderson, Principal Scientist – Translational ^Sciences, Bayer HealthCare Pharmaceuticals, said, "We have assembled a team of clinicians, molecular scientists, bioinformaticians and associated experts, thus creating a Burope-wide network of complementary capabilities extending far beyond the scope of a traditional 'one-on- one' industry-academic collaboration."

For   new   biologicals and   biosimilars, the innovative Spedia NMR™ technology from Spinnovation Biologies provides a real advantage for optimizing cell cultures, monitoring and standardizing manufacturing processes in preparation for larger scale production. Within the past four months, this has been validated by 37 companies developing biologies or delivering services to this industry. This premium Nuclear Magnetic Resonance (NMR) analysis service rapidly identifies a wide selection of feed components, metabolites and toxic compounds in culture media. By comparing media profiles from different cell culture batches, Spedia-NMR™ identifies how a cell consumes and metabolizes the media along the culture process. This allows the composition of the media to be fine-tuned to improve cell viability, reach highest yields of biologic product and perform rapid process troubleshooting. Talking about the value of Spedia-NMR™ in biotech companies, Dr Frederic Girard, CEO, Spin ovation, explained, "In a short term, Spedia-NMR™ will fill the gap in knowledge to strengthen and speed up cell culture development and upstream processing. Clients need to know what is going on in their cell culture and they need to know it fast." This technology is available on a fee-for-sample or as a contract service to all biotech companies.

Goose, a Hyderabad-based leading innovator of business reengineering solutions, has new    regulatory packaging guideline, detect counterfeit and protect their brand reputation. Procon™ Tracker is a new addition to Goose wide range of Procon solutions adopted by several leading global pharma companies to increase business processes efficiency. Procon™ Tracker features robust encrypted serialization and package authentication capability designed to ensure consumer safety, reduce counterfeiting & diversion and therefore meet multiple stakeholder expectations throughout the product supply chain from the point of manufacturing to consumer end. The Procon™ Tracker supports pedigree (an electronic record keeping requirement) and is capable of multi-printer interface. It also supports automated and manual lines with added competency to work offline when there are no bar code capable printers. Deb Pattnaik, Founder, Goose, said that the recent directive from the government to pharma industry to implement track and trace automatic identification process to offset counterfeits opens an opportunity for Procon™ Tracker.

...says Dr Panchapagesa Murali, Managing Director and CEO, Evolva India. He was also the Founder and Director of Dalmia Centre for R&D. He holds more than 20 years of experience in pharmaceutical and healthcare R&D. He discusses the future of R&D in the Indian market. Jasleen Kaur Batra After spending considerable time at Dalmia Centre, why the switch to Evolva? Switching to Evolva from Dalmia was never about the job or opportunities; it was purely on the basis of trying to understand science and the various options it offers. At Dalmia (one of India's oldest and most distinguished business houses, which is into developing and launching natural products) we worked with natural products that were found in plants, we used whole cell plant cocktails and tried to launch a process where one may hot even know what is the active molecule or the mechanism of the action; one could only show efficacy. In the present day scenario, people are inquisitive and want to know the  step  by  step  mechanism, for instance what goes behind making a compound, how it works, what is the reaction, how does that affect the result and more. One can only give answers to such questions in a drug discovery organization. R&D enables one to not only find the answers to these questions but also prove their findings and make it more authentic and reliable. Evolva is a company that deals with synthetic biology, which is a Hew area of biological research that    combines    science    and engineering. It encompasses a variety of approaches, methodologies and disciplines. I wanted to be associated with an organization where we could add credibility to our work by proving its mechanism and functionality. This was possible only at Evolva as we make the drug from scratch and monitor its reaction, the outcome is a definite structure and has a long list of findings attached to it, making it reliable and authentic. This was purely the reason behind the shift. It was the next best thing to do, and change was the only way I could grow and explore the other options within R&D. How has the journey with Evolva been so far? My tenure in Evolva began in 2006 as the CEO of Evolva India. The journey so far has been incredible. One really needs to keep in touch with technology or else he/she would have to chase it. Even after spending 25 years in this field, when it comes to evolving technology I believe I do not belong here. One has to try to be ahead of the curve. This was one of the reasons I joined Evolva, I wanted to learn   about the   technological   advancements that have taken over the world and Evolva gave me the chance to not only learn and keep myself updated but also to apply that and see how it changes the outcome. Evolva has been a good experience as far learning is concerned. In 2009 Evolva experienced   this   transformation and got listed under the more...

As packaging lines in pharma gathers momentum/ there is an increasing need for adequate quality check to maintain the standard of products. ACG Inspection with its hi-tech systems aims to eliminate possible danger and loss. chandreyee Bhaumik Over the last four decades ACG Worldwide has been dedicated  to  providing end-to-end solutions for the pharma industry and fulfilling the requirements of over 1500 customers in more than 80 countries. It is one of the few companies globally that offers technology solutions for pharma manufacturing, packaging, security and R&D solutions, all under one roof. With globalization and increased speed of packaging lines, there is a major challenge for effective online checks to maintain product quality. Thus, ACG Worldwide addressed this requirement of the industry by establishing ACG Inspection in 2009. It is a company that aims to provide hi-tech camera systems to increase the possibilities of revenue and reputation. The group offers technology and expertise that has helped several Indian and multinational pharma companies fulfill their vision of producing quality products and providing solutions that are distinct and meet global standards. Customer at the forefront Customer relationships have always been one of the topmost priorities of the Group and the same legacy has been passed over to ACG Inspection. The company boasts of a strong service team of highly trained vision system professionals with some of them having an experience spanning over 7 years in camera installation in the pharma industry. Further, inspired to offer quality services, the company also claims to comprehend the value of a satisfied customer and traverses all lengths to understand the root cause of any issues at customer site and resolve it completely. Informs Harpal Singh, Director-Business      Development, ACG Inspection Systems Pvt Ltd, "We offer quality-related services by manufacturing top quality high-speed cameras. We get the most accurate components based on the clients' needs in terms of design. Today, we have 80 people working in this company." Craving and carving success In order to live up to the changing demands of the customers and stay ahead of competition in the field of operation, innovation along with customer satisfaction is the mantra for most companies. ACG Inspection is no exception. Elaborating on the relevancy of innovation, Singh avers, "We try to instill passion among our employees so that they are interested in performing more. With our aim to offer world- class products and services, we have achieved top of line activities without compromising on the quality of our products." Highlighting the quality standards, Singh continues, "For every work there is a type of internal review highlighting our achievements and goals. We have more than 700 systems that provide a plethora of end-to-end solutions. Also, what gives us an edge over other companies is that it is not just our sites that use these cameras but any manufacturing site can use these cameras." Innovation being the mantra, the company has profusely invested in innovative R&D. Talking about the investment pattern of the company, Singh avers, "For us it is more...

Market overview Today, India is considered the "pharmacy of the world' as it now supplies one third of all the pharmaceutical products sold worldwide. Indian drug manufacturers attribute this success to continuous R&D on products and standardized process infrastructure. India has the largest number of FDA-approved manufacturing plants outside the US. Combined with a low cost of production, innovative scientific manpower and increased outsourcing of manufacturing processes to India, this makes Indian pharmaceuticals a powerful industry group. The sector is currently experiencing an annual growth rate of around 16%. This phase of rapid expansion is due to the anticipated loss over the next few years of patent protection on major blockbuster drugs worth US$120 billion, with Indian generic drug manufacturers planning to capture more of this market.  There are approximately 250 large units and about 8000 small-scale units that form the core of the pharmaceutical industry in India. This includes five Central Public Sector Units. It is now the third largest in the world in terms of volume and stands 14th in terms of value. According to data published by the Indian Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, total industry turnover between September 2008 and September 2009 was US$ 21.04 billion, of which the export market was worth US$ 8.25 billion. In an aggressive growth scenario, the Indian pharmaceuticals market has the potential to reach up to US$70 billion by 2020. The country is committed to a free market economy and globalization and, for the first time in many years, the international pharmaceutical industry is finding great opportunities in India. It was once an extremely fragmented market with severe price competition and government price control. Now, the process of consolidation, which has become a generalized phenomenon in the world pharmaceutical industry, has started taking place in India. Risks and issues Over the past decade, pharmaceutical companies have entered a difficult period where shareholders, the market and regulators have created significant pressures for change within the industry. The Indian pharmaceutical industry has had to contend with several challenges, including the effects of new product patents, drug price control, infrastructure development, regulatory reforms, quality management and conformance to global standards.  The pharmaceutical business is a global one and, if manufacturers' markets include the US and Europe, they must abide by the regulatory requirements set by the US Food & Drug Administration (FDA), and the European Medicines Agency (EMEA), as well as national boards such as the Drug Controller General of India (DCGI). In particular, compliance with the regulations dealing with the migration of contaminants from packaging to contents should be a major focus for India. The migration process Where glass containers were impervious to chemicals leaching through, the same does not apply to the new generation of drug containers and delivery systems that are made of plastics such as LDPE, HDPE and PP. Plastic containers are very convenient, especially for small units and where squeezing is required. They also offer increased efficiencies and reduced breakages and costs, BUT it is more...

A pharmaceutical company seamlessly upgraded its SAP system, enabling operators to focus on the core business of making pharma products. Concerns arose about whether existing transactions and links would work, or even exist, once the upgrade was completed. All these were answered. The goal of a SAP interface system is to alleviate manual data entry into SAP performed by production operators. The SAP interface system helps operators to request production material and product to their suite from the same terminal that is used for operating equipment. A major North American pharmaceutical company implemented its Manufacturing Execution Systems (MES) in 2005 with the help of Grantek Systems Integration, a Rockwell Automation Solution Provider. The pharma company needed to upgrade its corporate SAP system from SAP R/34.6C to SAP ECC 6.0. The focus of the upgrade was on the technical aspects and the impact on the validated systems, Testing is vital for migration A pharmaceutical company uses multiple systems for production. A system controls Self-Guided Vehicles (SGV) to transport material in bins and totes to locations throughout its facility. The tote high bay storage area is controlled by a warehouse controls system. Whenever inventory is moved, a corporate SAP server has to be updated to reflect the inventory's new location. The   company's   previous   MES solution completed about 19 different SAP transactions types within the manufacturing suites. Therefore, each of these transactions types had to be tested to ensure the upgraded SAP version worked in the same manner as the previous version. The company also had to ensure all automated data transactions worked correctly. The upgrade team chose to automate the typical SAP operator transactions, reduce operator training time, ensure 100 per cent accuracy and simplify operator experience in the manufacturing suites. When operators do not need to interact with the SAP graphical interface, they can spend most of their time on the core business of manufacturing pharmaceutical products. Grantek and the pharmaceutical company used a specific method of communicating with SAP for the MES application, called Remote Function Call (RFC). RFC is a standard SAP interface for communication between SAP systems. It calls a function to be executed in a remote system. Derek Kostelnik, Team Leader, Grantek, was confident that the application would upgrade seamlessly. However, he knew that the only way to be sure was to set up the 'sandbox' environment and test every transaction. The sandbox is an SAP client built solely for development, testing or training purposes. Implementing the upgrade Grantek's approach was to implement a variety of Rockwell Software® FactoryTalk® applications before the SAP upgrade. This mitigated potential production downtime and distributed the required validation workload. To accomplish this, the upgraded version of FactoryTalk applications had to be tested against the new version of SAP and the existing SAP version, using several SAP environments.  This pharmaceutical manufacturer has three types of SAP environments:   Production, Quality Assurance (QA) and Sandbox. The production servers are redundant, high-availability servers used in the production environment. The QA servers are identical to the more...

With the annual turnover (from domestic sales and exports) inching towards the $23-billion mark along with a steady double-digit growth rate, the Indian Pharma Inc never had it so good. Furthermore, according to a report by McKinsey, the country is poised to rank among the top 10 markets of the world by 2015. Amid this extensive growth and given the knowledge-intensive nature of pharma business, the strategic role of human resources cannot be overemphasized. There are multiple perspectives to this evolving success story. While the present opportunities and future prospects make a bright case for a successful career in pharma, the challenge seems to be in not only recruiting the right talent with the required experience but also retaining these resources for a reasonable time. The span of requirement ranges from workforce in research to manufacturing, marketing to supply chain management, among others. One of the key questions facing the pharma industry today is getting the 'employability quotient' right among the new joiners. To bridge this apparent gap between academic curriculum and industry's requirement, it is imperative to fortify the former with specialized courses in the fields of drug discovery, clinical research, quality assurance and regulatory affairs in line with global practices. This will go a long way in not just filling up the talent gap in the country, but also help India become a global talent pool for the pharma industry. For more on this soft yet critical part of the pharma value chain, where both value and volume matter, turn to 'Market Trends'. That said, the last-mile connectivity is as crucial for pharma as for other sectors. To elaborate, availability and accessibility of pharma products at the right place and right time can make a key difference in a brand's success. Especially with rural penetration being high on the priority list of the pharma industry, an effective supply chain management is the need of the hour. However, a lot is desired in terms of warehousing, transportation and distribution to provide an uninterrupted and cohesive pharma supply chain in India, which is currently highly fragmented and unorganized.