Pharma Bio World - November 2014

November 2014 l

Vol.13

PHARMA BIO WORLD

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Issue 4

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Mumbai

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Price ` 150

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INTERVIEW 10

“Strong patent laws will encourage innovation in the research based pharmaceutical industry” – Ranjana Smetacek, Director General, OPPI

FEATURES 16

10

Plant Based Excipients – The Case of Strychnos potatorum Seed Polysaccharide Nanoparticles – Mohammad Mansour Saleh Saif, Nadimpalli Siva Kumar, Majeti Narasimha Vara Prasad

28

Risk Mitigation for Leachables and Extractables in a Modern GMP Environment – Diane Paskiet

36

Detection of Organic and Inorganic Molecules in ZnO Nanoparticles with Evolved Gas Analysis

by FT-IR and MS – Dr Ilir Beta

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42

Vision Ensuring Quality in Pharmaceuticals Production – Didier Lacroix

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Technology Transfer: Significance and Bottleneck in Pharmaceutical Industry – Dr Vivek Dave, Kriti Kushwaha, Dr Sachdev Yadav, Swapnil Sharma

NEWS UPDATE 36

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Press Release

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Pharma News

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Biotech News

CORPORATE AFFAIRS 68 72

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Product Trends Events Diary

BACKYARD Book Shelf Ad Index Next Issue Focus: Pharmaceutical Technology

8  November 2014

Pharma Bio World

interview

RANJANA SMETACEK

“Strong patent laws will encourage innovation in the research based pharmaceutical industry”

Ranjana Smetacek, Director General, Organisation of Pharmaceutical Producers of India (OPPI), in an exclusive interview with Mahesh Kallayil talks about the need for strong IP law and balancing innovation with access and affordability of medicine.

What is your take on the curtailing of the NPPA’s pricing powers?

Today, India is the most competitive pharmaceutical market in the world, with a flourishing generics industry and multiple alternatives for each drug available at different price points. Arbitrary moves to fix prices harm the investment climate, hamper employment generation and mar India’s image as a business friendly country.

Most importantly, the assumption that patients will have increased access to medicine as a result of price reduction, through price fixing, is unfounded. On the contrary, price fixing could have a negative impact on the market, compromising quality and, perhaps, even availability.

Is there any truth to reports in some media circles regarding the timing of the NPPA’s powers being withdrawn and how it was intended to please the American Pharma giants ahead of the PM’s Visit to US? Obviously, we aren’t privy to the government’s thinking on this. However Government’s withdrawal of the May 2014 Internal Guidelines is not surprising. The July decision to cap the prices of 108 drugs went against the National Pharmaceutical Pricing Policy (NPPP) 2012, which was deliberated by a group of ministers and

10 November 2014

approved by the nation’s highest policy making body, the Cabinet. NPPP 2012 clearly rules that all essential drugs are under price control while those outside the National List of Essential Medicines (NLEM) 2011 should not be under a controlled regime and their prices should be determined by market forces.

How would you like to respond to the widespread allegations from the US-based pharmaceuticals giants that the current IP regime in India is not TRIPs-compliant?

Since 2005, the patent regime in India has allowed the patenting of drugs, with India being a signatory to TRIPs. Where India makes a commitment, it is important that it honour those commitments and be seen as welcoming of innovation. The GIPC (Global IP Center) has, in its second edition of the Global IP Index report, once again ranked India at the bottom. Perhaps we have assumed certain flexibilities under TRIPs that do not exist.

Is the government’s decision to set up a bilateral committee with USA to review Indian IP law a sign of India bowing to the mounting pressure from Big Pharma?

Again, we are not able to comment on why Government chooses a particular course of action. However, we see this as a positive step. It is important to recognise that Pharma Bio World

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interview IP is an important subject for a wide range of businesses, beyond the pharmaceutical industry, that are dependent on innovation and technology. It is our Prime Minister’s declared position that Government is intent on improving India’s business climate. Thus it is not surprising, that when there is an issue of concern to two nations, they engage in dialogue.

Would you agree with the notion propounded by some industry think tanks that a stringent IP regime based on US interests will deter many small and medium Indian generic manufacturers who will eventually be wiped out from the emerging markets?

Strong patent laws will encourage, stimulate and sustain innovation in the research based and technology intensive pharmaceutical industry. Adherence to and implementation of world class patent laws will encourage investment and technology transfer and stimulate local research by Indian and International companies. This will benefit the Indian pharmaceutical industry and lead

to newer and better medicines for Indian patients. There are still huge unmet medical needs in cancer, diabetes and mental illnesses for which we need to continue research for innovative drugs.

Do you think that the Indian government is doing enough to promote generic drugs especially in an open market like India where Big Pharma is foraying aggressively with huge capital investments?

We feel a holistic approach is needed to expand healthcare in India. There is a need to balance innovation with access and affordability, within a robust IP environment.

Access to medicines extends beyond issues of cost to the proximity and functionality of the infrastructure that supports that access. More than affordability, the barrier to healthcare access is the lack of insurance cover. The BJP Manifesto laid out a vision of universal healthcare that is not only accessible and affordable but also aims to reduce out–of-pocket expenses for the common man. Healthcare access for all Indians will require an integrated approach

with all the stakeholders playing a role. OPPI member companies are more than willing to step forward and play their part.

How would you like to react to speculation about the government’s recent pitch to expand the list of life saving drugs, amid severe criticism over NPPA’s extending price control to non-essential drugs?

There is no question that quality medicines must be made available to the most vulnerable sections of the population.

Government could work with the pharma industry on innovative procurement schemes and with the insurance sector to enhance the patient’s ability to pay. It is critical that Government build a collaborative environment, partnering and engaging with all stakeholders to find holistic solutions to India’s healthcare challenges. Arbitrary price fixation is not a sustainable solution!

It would be more helpful if the focus is on ensuring health insurance for all, declared as a priority by Government. Ultimately, the health of the pharmaceutical industry is critical to the health of our nation!

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Plant Based Excipients – The Case of Strychnos potatorum Seed Polysaccharide Nanoparticles This article focuses on the possible application of Strychnos potatorum seed polysaccharide nanoparticles as pharmaceutical excipient.

Mohammad Mansour Saleh Saif Department of Chemistry, Faculty of Science, Ibb University, Ibb, Yemen

Nadimpalli Siva Kumar

Department of Biochemistry University of Hyderabad, Hydrabad

Majeti Narasimha Vara Prasad Department of Plant Science University of Hyderabad, Hydrabad 16 November 2014

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iodiversity provides a variety of resouces for survival and sustenance of human kind particularly for health care. In this regard plant based excipients play a key role in formulating efficient drug delivery mechanisms. Selected examples of botanical excipients are listed below; • Aloe vera - Liliaceae - Gelling agent, emollient, sustained release of drug • Anacardium occidentale - Anacardiaceae - Suspending agent • Anogeissus latifolia – Myrtaceae Ghutti gum • Boswellia serrata - Burseraceae - resin • Firmina simplex - Sterculiaceae Chacolate tree • Leucaena leucocephala – Fabaceae - Mimosoidae – seed emusifying agent • Oscimum – Lamiaceae - seed suspending agent • Senna tora Fabaceae Caesalpinioideae - Binding agent • Trigonella foenum-graecum – Fabaceae -seed gelling agent Strychnos potatorum and Sterculia urens (Gum karaya) are two natural products of global importance that came to lime light because of traditional knowledge.

This write-up deals with only Stychnos potatorum L. Strychnos potatorum L. (Loganiaceae) It is a common tree of medicinal importance in India. It is popularly used to purify drinking water. Past traditions in India reported the use of S. potatorum seeds for cleaning the turbid water. S. potatorum is non-toxic plant and its seeds (popularly known as cleaning nuts) have high economic importance. Its seeds are one of the most important minor forest products collected by the members of the Girijan Co-operative Corporation, Andhra Pradesh (the predominant

participating tribal groups are Bagatas, Valmikis, Nookadoras, Malis, and Kutias) along with other minor forest produc. A commercial product by name “NATFLOC” a “natural polyelectrolyte” has been developed with the seeds of S. potatorum by the GCC. NATFLOC is recommended for water turbidity removal up to 3000 NTU (Nephelometric Turbidity Unit).

Additionally, there are many traditional and medicinal applications of the S. potatorum, in Ayurveda, Siddha, Unani, Folk, Modern, Tibetan and Homeopathy Systems of medicine.

Strychnos potatorum Seed Polysaccharide - Applications There is a growing interest in the use of polysaccharides due to their biocompatible, biodegradable and environmentally benign characteristics.

Polysaccharides are high molecular weight polymers constituted with simple sugar monomers such as glucose, fructose, galactose and mannose. They are abundant in nature, universally found in almost all living organisms. They are present in various tissues of seeds, stems and leaves of plants, body fluids of animals, shells of crustaceans and insects. They are also found in the cell walls and extra cellular fluids of bacteria, yeast and fungi and are thus renewable reservoirs for synthesizing high performance materials. Polysaccharides have complex structures and they are the most abundant of many natural products and the source of most of the biological energy. They consist of monosaccharides linked together by O-glycosidic linkages, and diversification of their monosaccharides yields a variety of properties. Although they are made up of single type of building blocks, their enormous diversity has led to a bewildering variety of species, Pharma Bio World

Figure 1: Plant based excipients of pharmaceutical importance

Figure 2: S. potatorum tree, flowers, fruits, seeds and seed powder

structures and properties all performing a large variety of functions of great significance. They can also easily undergo chemical and biochemical modification to generate novel products with unique rheological and applicative properties. They are found in abundance, widely available, inexpensive, and able to select some properties according to their monosaccharides. The interactions 18 ď‚ƒNovember 2014

of some of the polysaccharides with other synthetic and biopolymers have further increased their range of applicability. The versatility in the structure and properties of the polysaccharides and their derivatives, along with their modifications find widespread applications including food cosmetics petroleum and pharmaceutical industries. Moreover polysaccharides are hydrophilic, biodegradable, non

toxic, stable and safe to use, which suggests their use in targeted drug delivery systems, can profoundly affect the immune system and therefore have the potential as immunomodulators with wide clinical applications. Many of the polysaccharides have specific receptors on the cells so they can be easily taken by the cells, it was reported that hyaluronic acid (HA) was taken by HA specific receptor-mediated endocytosis, and HA was suitable for the targeted drug delivery systems via their specific receptor. Some glycoproteins are known to be suitable for the receptor-mediated drug delivery systems. It was reported that the mannosylated, fucosylated, and galactosylated liposomes showed high accumulation in the liver via each specific receptor. Polysaccharides have been successfully used as drug carriers due to their superior properties and biocompatibility. The polysaccharides can have linear, branched or cyclic structures containing residues of only one type of monosaccharides or of different types of monosaccharides. The polymers of one type of monosaccharide units are called homopolysaccharides (e.g. cellulose, starch, etc) and those containing different monosaccharide units are known as heteropolysaccharides (e.g., glucomannans: polymers of glucose and mannose, galactomannans: polymers of galactose and mannose sugars, Cyclodextrins(CD) are cyclic polysaccharide with six or more glucose units arranged on a doughnut shaped ring. Depending on their structure, monomer composition and conformations, polysaccharides show different physical and chemical properties. Although large varieties of polysaccharides have a multitude of industrial uses, in many cases they need to be further modified to improve their applicability across the wide spectrum of enduses. In the last few decades, wide ranges of chemical derivatives of these polysaccharides were developed. The chemical modifications improved the rheological properties of their solutions Pharma Bio World

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and hydrogels, while still maintaining their biodegradability and biocompatibility.

Storage polysaccharides in seeds are mostly starches or galactomannans, in which the mannan back bone is built of ß (l→4) linked mannose residues and single unit galactose side chains are attached α (l→6) to all or some of the mannose residues.. The extent and pattern of galactosidation on the mannan backbone varies among plant varieties .

Nanoparticles The term nanoparticle is a collective name for any colloidal carrier of submicrometer dimension and includes nanospheres, nanocapsules, and liposome. Nanotechnology is gaining considerable momentum in the Pharma domain.

The delivering of a pharmaceutically active molecule to a specific site in the body was adream and it has been a long-held aspiration with beginnings that may be traced back to Paul Erhlich, who in the early 20th century coined the phrase “magic bullet” to describe such an entity. Drug delivery systems (DDSs) can improve several crucial properties of ‘‘free’’ drugs, such as solubility, in vivo stability, pharmacokinetics, and biodistribution, enhancing their efficacy.

The extensive pharmaceutical research today has led to the development of drug delivery systems and strategies, which go some way to fulfilling this idea, but few which could be described as “magic bullets.” Side-effects and toxicities still afflict these approaches and, hence, Erhlich’s visionary thinking has not yet been fully realized. This is especially relevant in tumour chemotherapy, where selective delivery to neoplastic cells in comparison to surrounding normal cells is an important principle.

Figure 3a-c: Gradual increase in the number of Scientific publications on a) polysaccharides b) galactan and c) galactomannan. Source Scopus scientific web site.

20 November 2014

There are many challenges to be faced while delivering the drug from the point of administration to the specific intended destination site in the body, in Pharma Bio World

Chemical Products Finder | November 2013 | 57

site-specific delivery of drugs is immense due to the numerous obstacles barricading the drug along its desired route. Cellular structures and indeed the very components of the cell itself will either prevent or act in some selective manner to hinder to the migration of drug from its point of administration to the intended destination site. It is obvious that modern medicine still faces many challenges, till today as we are moving forward into the 21st century. Nanotechnology is the area of research that may offer scientific advances in the future, which could lead to significant progress in the improvement of therapeutic outcomes.

Instead of relying on the physicochemical properties of the drug to dictate its biodistribution, the drug is incorporated as a payload into a particle resulting in a different transit mechanism for the drug after administration. In particular, the development of nanoparticulate drug delivery systems may enhance the probability of getting a drug to its target site.The nanoparticle should have flexible nature and several properties which are incorporated onto the particle, mostly by covalent bonding to surface groups. A targeting system, such as a monoclonal antibody, will recognize binding sites that are unique to the target cell and allow the particle to dock onto the exposed surface. Additional target sites on cell surfaces could be receptor glycoproteins that are capable of recdognizing phosphorylated mannooligosaccharide structures (a typical example is the Mannose 6-phosphate receptor MPR 300, Mr 300 kDa that is capable of recognizing lysosomal enzymes that contain these structures and internalize them (Khan et al 2012). For successful delivery, carriers must: (i) form condensed complexes with biomolecules, (ii) facilitate penetration of the cell membrane after complexation, and (iii) unload their payloads inside of cells. The current research in the fields of nanoparticles and drug delivery systems are focusing into developing strategies 22 November 2014

Figure 4: Applications of nanomaterials in biology and medicine

for targeting nanoparticles to the site of drug action. A fusion protein will instigate the process of merging with the target cell, thereby bringing the particle into the cytoplasm. As polymeric nanoparticles are recognized as foreign by the body’s immune system, they are removed quite effectively by phagocytosis on exposure to the endoreticular system. This will prevent the particle from reaching the target site and must be prevented.

Steps toward this goal have already been taken with the production of socalled “stealth”nanoparticles. These are nanoparticles which incorporate a biomimetic polymer, usually polyethylene glycol, into their structure to avoid elicitation of an immune response.

Presently, such an idealized nanoparticle with these three important properties has yet to be realized, but attempts have been made to attach some of the subsystems described.

Strychnos (Loganiaceae) comprises of about 200 species distributed in three geographic regions, Central and South America (~73 species), Africa (~75 species), Asia including Australia and Polynesia (about ~44 species). The genus Strychnos is very well known for

its medicinal chemistry and has long been studied for its pharmacological, analgesic and antipyretic properties.

In recent years polysaccharide nanoparticles are being extensively used in various fields of biology and medicine.

The importance of the Strychnos seed material that consists of both Galactomannan, Galactan have been described. The role of plant glycosidases in seeds and in particular reference to a α-mannosidases (their classification, occurrence, molecular properties and potential applications).

Strychnos potatorum Polysaccharides, Galactomannan and Galactan were extracted and used for the nanoparticles preparation. Thesese were characterized for size and morphology by Atomic Force Microscopy, Scanning Electronic Microscopy, and Transmission Electronic Microscopy. Nanoparticles from both Galactan and Galactomannan were successfully prepared by Sol-oil chemistry method. From the AFM images it is shown that the nanoparticles are spherical in shape for both polysaccharides, and from the images of SEM and TEM we found the size of galactomannan nanoparticles are Pharma Bio World

Biomedicine

• Antibacterial creams and powders (Ag) • Gene delivery (CNT) • Biocompatible coatings for implants • Dental composites • Biolabeling and detection (Au, Ag, Quantum dots) • Biosensors (metal oxide, polymer nanoparticles, CNT) • Bone growth promoters (hypoxyapatite ceramics) • Cancer diagnostics and targeted drug delivery (magnetic nanoparticles) • Cell, receptor, antigen, enzyme imaging (Quantum dots) • Fungicides (ZnO, Cu20) • MRI contrast agents (Fe203, Fe304)

Consumer Goods and Personal Care Products

• Anti-bleaching, scratch resistance additives in paints • Anti-scratch coated tiles (alumina) • Barrier packaging (silicates) • Glass coatings for anti-glare, anti-misting mirrors (Ti02) • Skin creams with antioxidant vitamins (nanocapsules) • Sunscreens (ZnO and Ti02) • Water- and stain-repellent textiles • Tennis balls, rackets (nanoclays, carbon nanotubes)

Electronics and Computers

• • • • • • • • •

Chemical mechanical planarization (alumina, silica, ceria) Coatings and joining materials for optical fibers (Si) Conductive coatings/fabrics (rare-earth-doped ceramics) Display technologies (conducting oxides) Ferro-fluids (Fe, FeCo, Fe304) EMI shielding using conducting and magnetic materials Electronic circuits (Cu, Al) Magnetic particles for high-density data storage (Fe) Optoelectronics devices (Gd203, Y 2 0 3 doped with rareearth metals)

Release funds • Anti-scattering layers in photographic film • Molecular sieves to procuring • Conducting/magnetic inks (metal powders) units • Cutting tool bits (A1203, Zr02,WC, TaC) • Chemical sensors • Thermal spray coating techniques (Ti02 , TiC-Co) • Flame retardant polymer formulations (nanoclay) • Lubricants and sealants/hydraulic additives (Cu MoS2) • Pigments (metals and metal oxides) • Polymer composites (nanoclays, Ti02 , Si02) • Spark plugs (metal and ceramic powders) • Wear/abrasion-resistant coatings (alumina, Y-Zr203) Environmental • • • •

Controlled delivery of herbicides and pesticides Self-cleaning glass (Ti02 based coatings) Soil remediation (Fe) Water treatment (photo-catalyst treatments, Ti02)

Food

Flavors and colors in food and beverages (nanocapsules) Frying oil refining catalysis (ceramics) Food pathogen sensing Food packaging materials (nanoclays, Si02, Ti02, Ag) Neutraceutical delivery (liposomes, block copolymer micelles)

Power and Energy

• • • • •

• Anode and cathode materials for solid oxide fuel cells (nanoclays, CNT) • Catalysts for various fuel technologies (metals and metal oxides) • Conducting polymers for bipolar plates in fuel cells • Dye-sensitized solar cells (Ti02 , ZnO, Au) • Thermal control fluids (Cu) • Environmental catalysts (Ti02 , Ce02 as diesel additive) • Fuel cell catalysts (Pt in PEM cells) • Hydrogen storage (metal hydrides) • Improved electrodes in batteries and supercapacitors

Transportation • Automated highways • Battery technology • High strength, light weight composites for increasing fuel efficiency • High temperature sensors • Improved displays • Thermal barrier and wear resistant coatings • Wear-resistant tires Table 1: Potential Applications of Nanoparticles

24 November 2014

varied from 45 nm to110 nm and the size of Galactan nanoparticles also from 37 nm to 100 nm, these nanoparticle can be used for many applications such as Drug delivery (Saif et al 2014).

References Adinolfi M, Corsaro MM, Lanzetta R, Parrilli M, Folkard G, Grant W, Sutherland J (1994) Composition of the coagulant polysaccharide fraction from Strychnos potatorum seeds. Carbohydrate Research, 263: 103-110.

Jayaram K. Murthy IYLN, Lalhruaitluanga H, Prasad M.N.V. (2009) Biosorption of lead from aqueous solution by seed powder of Strychnos potatorum L. Colloids and Surfaces B: Biointerfaces 71, 248–254 Jayaram KS (1993) Indian tree offers nuclear waste treatment. Nature, 365: 779 Khan I and Kumar, N.S, (2012) Mannose 6-phosphate containing nanoparticles: preparation, characterization and interaction with cation independent mannose 6-phosphate /IGF-II Receptor (MPR300) J. of Bionanosciences. Vol.5,19, 2012 Puvvada GVK, Chandrasekhar K (1997) Studies on the metal binding properties of seeds of Strychnos potatorum. NML technical journal, 39 (4): 239-247.

Saif M.M.S., Khan I, Prasad M. N. V., and Kumar N.S, (2014) Preparation and Characterization of Strychnos potatorum L. Seed polysaccharide nanoparticles and affinity matrices: relevance to biological applications. Advanced Science, Engineering and Medicine 6, 1–8, 2014 Saif M.M.S., Kumar N.S, Prasad M.N.V. (2012) Binding of cadmium to Strychnos potatorum seed proteins in aqueous solution: Adsorption kinetics and relevance to water purification, Colloids Surf. B: Biointerfaces 94, 73-79

Contact: prasad.heavymetal@gmail.com Pharma Bio World

Risk Mitigation for Leachables and Extractables in a Modern GMP Environment The complexity of medicines and associated delivery systems continues to evolve, challenging approaches for identifying and qualifying leachables. Regulatory guidance for extractables and leachables exist, but only provide general recommendations for ensuring patient safety. Step-bystep instructions are impractical as dosage form, materials of construction, configurations and dosing are unique for each product; thus, potential impact to the patient must be assessed case by case.

Modern GMP advocates using risk-based approaches to develop drug products that would include consideration of suitable materials to contain and deliver safe medicines.

Diane Paskiet Director - Scientific Affairs West Pharmaceutical Services, Inc 28 ď‚ƒNovember 2014

R

isks associated with safety and compatibility of pharmaceutical packaging components and delivery systems are identified based on intended use from the point of manufacture to patient administration. Risk mitigation can be apparent when meaningful data is acquired and correlated to the end use. A comprehensive test paradigm will encompass an array of chemical, physical and functional attributes.

Understanding the chemistry of components and potential for extractables is critical to assess packaging suitability.

Extractables are compounds that can migrate from components of a container closure system when in the presence of a solvent. These extractables have the potential to become leachable compounds; that is, chemicals originating from packaging components that leach (leachables) into drug products during normal use. It is important to evaluate appropriately at-risk delivery system components (direct or indirect contact) that have the propensity to leach into medicines. Investigation of packaging components early in drug product development will provide necessary knowledge to enable safety and quality assessments. Unfortunately, the package configurations, manufacturing processes, dosage formulation and dosing - all of which can influence leachables - are not entirely defined early in the drug development process 1. There are many types of packaging materials with unique chemistries that can contribute to a leachable profile. Some examples of dosage forms, materials and associated risks, derived from literature, are shown in Table 1 2,3.

Migration of Chemical Substances from Packaging Materials The likelihood that extractables will leach can be viewed in terms of migrant

behavior related to permeation of volatile components in drug products, accumulation of a migrant at the package product interface then partitioning into drug product, precipitation or formation of particulates. The phenomenon of migration covers a range of physical and chemical processes that include extractable rates of diffusion, solubility, permeation and molecular structures.

Time, temperature contact area, concentration of migrant and media/ solvents affect the potential for migration and rate. In the end, it is the drug product sponsor that will have the knowledge to prove the final product is safe for intended use. Although predictive migration models may be employed, there are many contributing factors to multicomponent systems in which models can lead to great uncertainty. There are also conditions in which model extraction studies may not capture all potential leachables or maximum concentrations are not represented fully. Protection of patients relies on properly designed extraction studies followed by full shelflife leachable studies.

Ingredients used in the manufacture and forming of materials, such as additives, processing aids, residuals and cleaning agents, can all be suspected extractables. They also have the potential to transform or degrade products. This does not mean all extractables will become leachables, but that each drug product will have unique susceptibilities.

A controlled extraction study will provide potential for leachables as a first step.

These studies should include extraction after final processing (eg, sterilisation and assembly) to reveal the actual potential leachables because this is the system that will be in contact with the drug product over the shelf life. Once the absence or presence of leachables Pharma Bio World

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BOGE AIR. THE AIR TO WORK.

BOGE India , No. 216, Third Link Street, Industrial Estate, Nehru Nagar, Kottivakkam, Chennai - 600 096, india@boge.com* www.boge.in Chennai Mr. F C Jayakaran

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Risk Category Route of Administration Highest

Dosage Forms Inhalation Injectables

Common Materials of Construction

Components Actuators, Canisters Pump/Valves Assemblies, Vials, Prefillable Syringe Components, Stoppers, IV Bags, Auto Injectors

Polyester, Polyacetal, Epoxy Coatings, Metals, Cyclic Olefin Polymers, Polypropylene, Polyethylene, Glass, Elastomers, Polyvinyl Chloride, Thermoplastic Elastomers/Rubber

High

Ophthalmic Transdermal Patches Nasal Sprays

Bottles, Closures, Tip Caps, Labels, Overwrap

Polyethylenes.

Polypropylene, Polyesters Adhesives, Inks, Paper, Lacquer, Foil Laminates

Low

Topical Oral

Lined Tubes, Closures, Coatings, Bottles, Blister Packs

Metal, Epoxy Coating, Polyethylenes, Polypropylenes, Cyclic Olefins, Foil Laminates

Table 1: Examples of Dosage Forms Materials and Associated Risks

can be confirmed through appropriately conducted studies, the impact to the patient and medicinal product can be evaluated. There are many conceivable substances that have potential to leach, but it is only those that leach above an acceptable safety or quality level that are prioritised. Leachable safety thresholds have been recommended by the Product Quality Research Institute (PQRI) for Component Molecular Weight

orally inhaled and nasal drug products; parenteral dosage forms are currently being extrapolated 4,5. The challenge of identifying and prioritising leachables relies on a thorough understanding of packaging component chemistry; however, extractables data alone cannot predict the impact to patient safety or drug product quality. Understanding the chemistry of components and the

Classes of Potential Leachables

Low < 250 Da

Unreacted Monomers, Degradation Products, Additives

Medium

Monomers, Additives, Reaction Products, Impurities

High >1000 Da

Additives, Oligomers, Condensation Products, Polymeric Additives

Other Aspects

Influencing Factors

Nature of Component Material

Molecular Weight, Structure, Crystallinity, Glass Transition Temperature, Molecular Orientation, Crosslinking, Density

Additive

Chemical Structure, Final Concentration, Molecular Weight, Size, Shape, Interaction, Diffusion Coefficient

Co-Additive

Fillers, Solvents, Monomers, Reactive Chemistry, Co-Diffusants

Processing

Morphology, Homogeneity, Forming Conditions, Cleaning, Packing, Storage Time, Conditions

System and Environment‡

Contact Media Compatibility, Temperature, Pressure Humidity, Exposure Time, Contact Area, Sterilization Methods

Extract Generation ‡‡

Contact Time, Solvent Type, Temperature, Physical Geometry, Area, Extraction Techniques, Introduction for Analysis

‡Combination of all components, drug product, processing and manufacturing ‡‡Varies depending on the purpose of extraction Table 2: Physical Chemical Indicators for Potential Leachables.

30 November 2014

mechanics of migration will aid in developing suitable extractables and leachables methodology to provide the rationale for control strategies grounded in good science.

Extractables can be classified in terms of molecular weight and other aspects to associate probability of extraction by taking into consideration parameters influencing migration. This information is useful to identify appropriate test m e t h o d o l o g y. C l a s s e s o f p o t e n t i a l leachables can indicate potential for a m i g r a n t ’s d i ff u s i v i t y, a n d s u r f a c e interaction leading to appropriate investigations of chemical entities to be considered for developing analytical methodology 6. Influencing factors for risk of potential leachables are referenced in Table 2. The combination of factors relies upon understanding the materials and drug product formulation, manufacturing processes and final storage.

Establishing Extractable Profiles Selection of critical components (individual components of manufacture, containment, storage or other material contacting the drug product) and extraction of the test material is the foundation of an extractable study.

Adequate component sampling is necessary to establish a comprehensive profile as variability of trace level constituents is inevitable. In addition, suitable sample preparation, materialto-solvent ratio, type of solvent and extraction conditions are critical for acquisition of proper data. The function of the critical components, along with knowledge of the component composition and drug product formulation, should be used to guide solvent selection. Multiple extraction techniques and analytical techniques should be employed 7 . The course of the study should be planned to achieve the outcome that will support the drug sponsor study objective to enable appropriate leachable studies.

Pharma Bio World

2-Propanol Reflux Characterization (Exaggerated)

50% Alcohol Room Temp. Simulated (Accelerated)

Figure 1: GC/MS Polypropylene Characterisation Data Compared to Simulation Data

Extractables assessments serve multiple purposes such as: overall chemical characterisation to understand potential for leachables under exaggerated conditions or accelerated model systems to represent intended use to indicate probability for leaching or control of critical additives in a formulation.

Regardless of the conditions chosen for the extraction study, the outcome of the test should provide results that identify, correlate and confirm leachables to judge patient safety. A “bridge” between extractables and leachables can be implemented using an approach from a theoretical perspective and/or extraction studies using simulated solvents and accelerated conditions. The outcome of this assessment will provide background information to ensure development of appropri ate l eachable methodology or indicate a potential toxicological concern. These data can have a place in early drug product development to guide the drug product sponsor even when the specific drug product formulation has not been finalised.

32 November 2014

An example of extractable data demonstrating two unique applications, chemical characterisation verses an accelerated study to simulate migration, is illustrated in Figure 1: Polypropylene GC/MS Characterisation Data Compared to Simulation Data 8 . Conditions for characterisation will provide information to understand the chemistry of extractables through maximisation of migrants, while a model extraction study employs simulated conditions intended to indicate or predict actual use. It can be realised from the GC/MS chromatograms that the simulated conditions alone would not provide adequate background to establish a comprehensive extractable characterisation or leachable assessment; however, they can be a gauge for migration behavior.

The preparation of extracts, identification and measurement of extractables or potential leachables, are time consuming and should follow a systematic approach of investigation. Understanding the extractable migration behavior can provide insight into the selection of study

parameters and analytical methodology.

Polymer characteristics to consider for extractable studies are: 9 • P o l y m e r e f f e c t s ( m o r p h o l o g y, molecular structure surface energy, entropy).

• Physical loss of chemical constituents and conversion to associated degradation products.

• Chemical reactions within complex mixtures, formation of by-products or interaction products.

• Migration of chemicals to the surface.

• S o l u b i l i t y i n c o n t a c t m e d i a , precipitation, blooming effect.

• Extractive loss and mass transport based on molecular motion (diffusion rate or volatilisation).

• O u t g a s s i n g ( e v a p o r a t i o n o f r e s t constituents) in headspace or accumulation in solution.

• Permeability or transport of chemicals through a material.

Investigations for actual leachable are drug formulation and manufacturing process dependent and methodologies are considered independently.

Pharma Bio World

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“Investigation of packaging components early in drug product development will provide necessary knowledge to enable safety and quality assessments.”

Leachables Leachable studies are conducted on drug products in their marketed container and are the responsibility of the drug product manufacturer. In these studies the final drug product, stored under controlled conditions over the intended shelf life, should be analysed for leachables.

Extractables serve as an indicator of potential leachables, but the probability for migration of chemical entities into a drug product can be unexpected and proceed slowly, particularly under unique and/or unpredictable conditions.

Container closure systems that are not compatible with the final product can impact patient safety as a result of toxicity and/or substandard drug p r o d u c t q u a l i t y. A n o t a b l e e x a m p l e of incompatibility of a container with final drug product includes occurrence of glass lamellae (flakes) which were detected over time. These lamellae were shed from the interior surface of the glass container into the drug product. Concern for these fragments causing adverse events in patients led to several drug recalls and FDA issued an advisory to drug product manufacturers/ s p o n s o r s 10. A c c e l e r a t e d l e a c h a b l e studies are useful to predict potential outcomes but do not always represent end-of-shelf-life data. If conditions or contact media are too mild, it is possible leachables can be missed. Anomalies also can arise if conditions are too severe. Drug product impurity analysis could reveal leachables or an interaction product of a migrant with a packaging component, but often conditions are not robust or suitable for specified targets.

Independent leachables studies in final drug products are necessary to determine the overall impact on intended shelf life and to enable any correlations.

34 November 2014

Once the materials in contact with the drug product are understood in terms of their extractables or migrants, potential leachables are then assessed.

Informed decisions are necessary to select target species for analysis related to patient safety and drug product quality. The starting point for a leachable study includes: knowledge of target extractables with confirmed identifications, reference compounds for measurements, optimised sample preparation techniques and appropriate robust analysis conditions that are validated for adequate sensitivity. It should be anticipated that the drug product matrix could cause interferences with certain detection techniques.

Ingredients in the final dosage form can challenge methodology because of the trace leachable constituents, potential low leachable response, interfering species masking leachables and binding or interactions of migrant with the drug product matrix. The sponsor of the drug product should determine the necessary targeted studies based on intended use, which would employ optimised/validated methods to allow impact assessments of delivery system.

Understanding the science of extractables and potential for leachables using risk-based strategies will facilitate development and manufacture of quality medicines. The drug product sponsor should provide evidence of drug product quality and safety based on results from meaningful extractables and leachables studies to assure appropriate selection of packaging components and delivery systems for the benefit of patients.

References 1) Bak, A. Scientific Risk Assessment Strategies for Managing the Transition

from Discovery to Development Drug discovery: AAPS News Magazine, July 2010, http://www.nxtbook.com/ nxtbooks/aaps/newsmagazine 2) Container Closure Systems for Packaging Human Drugs and Biologics, CMC Documentation CDER/CBER/FDA Guidance for Industry 1999, http://www. fda.gov 3) Paskiet D., “Strategies for Assessment of Leachables in Parenteral Drug Products,” PMP, 2008.

4) Product Quality Research Institute (PQRI) Research Project Proposal: Reporting and Qualification Thresholds for Leachables in Parenteral and Ophthalmic Drug Products: 2007, http:// www.pqri.org 5) Product Quality Research Institute (PQRI), Leachables and Extractables Working Group, Safety Thresholds and Best Practices for Extractables and Leachables in Orally Inhaled and Nasal Drug Products: November, 2006 http://www.pqri.org 6) Bart J.C J; Polymer Additives Analytics, Industrial Practice and Case Studies, Firenze University Press, 2006 7) Product Quality Research Institute (PQRI), Leachables and Extractables Working Group, Safety Thresholds and Best Practices for and Extractables and Leachables in Orally Inhaled and Nasal Drug Products (OINDP), November 2006, http://www.pqri.org 8 ) H o j n i c k i , P. S t u b b s , L . e t . a l . A Systematic Approach to the Extraction Process, Presented the PDA Workshop; Extractable Puzzle May 22, 2005 9) Bart J.C J; Polymer Additives Analytics, Industrial Practice and Case Studies, Firenze University Press, 2006 10) Advisory to Drug Manufacturers: Formation of Glass Lamellae in Certain Injectable Drugshttp://www.fda.gov/ drugs/drugsafety/ucm248490.htm

Contact: Alok.Chandorkar@westpharma.com Pharma Bio World

Meet us at PMEC- Exhibition 2014, Stall No. L-42, Hall No.-5, Mumbai India, 2-4 December

NNE PHARMAPLAN IN INDIA NNE Pharmaplan started operations India in 1996 and today, we have offices in Bangalore and Noida. During our 18 year presence in India we have executed more than100 projects within active pharmaceutical ingredients, herbal products, oral solid dosage, liquids, sterile production, biopharmaceuticals and vaccines.

WHO WE ARE

WHY WE DO IT Engineering for a healthier world – our role in an industry that improves people’s lives worldwide. To learn more about our company, please visit nnepharmaplan.com

NNE Pharmaplan is the world’s leading engineering and consulting company in the complex field of pharma and biotech. We cover all segments from biopharmaceuticals and vaccines to medical devices and help our customers develop, establish and improve their product manufacturing. NNE Pharmaplan employs 2,000 people at more than 25 locations around the world.

Contact: Mr. Chetan Shroff, Sr. Manager-Business Development, Mobile Phone: +919004053621, Email: csff@nnepharmaplan.com Mr. Sachin D Deshpande, Sr. Project Manager, Mobile phone: +91 9845250302, Email: sdds@nnepharmaplan.com

Detection of Organic and Inorganic Molecules in ZnO Nanoparticles with Evolved Gas Analysis by FT-IR and MS In this article, a sample of thiolcapped ZnO nanoparticles was studied by simultaneous TGA-DSC (STA) using a NETZSCH STA 449 F1 Jupiter thermal analyzer which was coupled to both a NETZSCH QMS 403 Aeolos mass spectrometer and a BRUKER Optics TENSOR FT-IR spectrometer to perform evolved gas analysis by QMS and FT-IR.

Z

inc oxide (ZnO) nanoparticles are being investigated for the synthesis of materials with tunable magnetic and electric properties and for possible medical applications in cancer therapy. In this study, a sample of thiol-capped ZnO nanoparticles was studied by simultaneous TGA-DSC (STA) using a NETZSCH STA 449 F1 Jupiter thermal analyzer which was coupled to both a NETZSCH QMS 403 Aeolos mass spectrometer and a BRUKER Optics TENSOR FT-IR spectrometer (Figure 1) to perform evolved gas analysis

by QMS and FT-IR. The transfer lines, the coupling adapters and the FT-IR gas cell were kept at a constant temperature of 200°C. Measurement Results The thiol-capped ZnO nanoparticles sample with a mass of 11.18 mg was pressed on the bottom of a Pt-Rh DSC crucible to form a layer of about 1 mm thickness and was heated from 30°C to 1200°C at a heating rate of 20 K/min under 60 ml/min nitrogen purge. The TGA, DTG (mass change rate), DSC and Gram Schmidt (total integral of the IR absorption) curves are plotted in

Figure 2. The TGA curve shows fi ve mass-loss steps which have corresponding peaks in the DTG curve and corresponding endothermic features in the DSC curve due to desorption and decomposition processes in the sample.

Apart from the very small eff ect below 200°C, the peak temperatures in theGram Schmidt plot correspond well with the peak temperatures in the DTG curve.

The TGAand DTG curves along with the temperature-dependent integrated band areas (traces) for the O-H stretching of H 2O, the C-H stretching of hydrocarbons and the anti-symmetric C=O stretching of CO 2 are plotted in Figure 3. As can be clearly seen, desorption of H 2O and CO 2 corresponds with the fi rst four mass-loss steps whereas the hydrocarbons evolve in the midtemperature range in good correspondence with the second and third mass loss steps in the TGA curve.

The MS ion-current curves for H 2O (18; 17 and partially 16 u) and CO 2 (44 and partially 16 u) plotted in Figure 4 together with the TGA curve show more details due to the higher sensitivity of the MS, but the results are in agreement with the FT-IR traces that H 2O and CO 2 evolution corresponds with the fi rst four mass-loss steps in the TGA curve.

Dr Ilir Beta

Senior Applications Scientist NETZSCH Instruments North America 36 November 2014

Figure 1: NETZSCH STA 449 F1 Jupiter coupled to a NETZSCH QMS 403 Aeolos and a BRUKER Optics TENSORTM FT-IR spectrometer

Pharma Bio World

Figure 2: TGA, DTG, DSC and Gram Schmidt curves for the thiol-capped ZnO nanoparticle sample

Figure 3: TGA and DTG curves and the FT-IR traces for CO2, CH stretch and H2O for the thiol-capped ZnO nanoparticles sample

Figure 4: MS ion-current curves for mass numbers 16, 17, 18 and 44 u and TGA curve for the thiol-capped ZnO nanoparticles sample

Figure 5: MS ion-current curves for mass numbers 48 and 64 u and TGA curve for the thiol-capped ZnO nanoparticles sample

organic fragments plotted in Figure 6 show that these species evolve as two peaks in very good agreement with the FT-IR results.

Conclusion

Figure 6: MS ion-current curves for mass number 55; 56; 57; 69; 70 and 71 u and TGA curve for the thiol-capped ZnO nanoparticles sample

The MS ion-current curves for SO 2 (64; 48 amu) plotted in Figure 5 along with the TGA curve clearly show that small amounts of SO 2 evolve at elevated temperatures in correspondence with the fifth mass loss step in the TGA curve. Finally, the MS ioncurrent curves for many different 40 ď&#x201A;&#x192;November 2014

A simultaneous TGA/DSC (STA) instrument coupled to MS and FT-IR spectrometers is a very powerful combination for sample characterisation because it supplies data for the mass change (TGA), transformation temperatures and energetics (DSC) and evolved gas analysis (MS, FT-IR) in a single measurement. All the data analysis is carried out with the NETZSCH Proteus software. Simultaneous use of MS and FT-IR for evolved gas analysis is very beneficial because the FT-IR can quickly identify functional groups based on their characteristic bands, but on the other hand, the MS has higher sensitivity and it can also detect homonuclear diatomic molecules (H 2 , O 2 , N 2 ) and atomic gases (He, Ne, Ar, etc) which are not detectable by FT-IR. Contact: GovindaRao.Padmanabhan@netzsch.com Pharma Bio World

Vision Ensuring Quality in Pharmaceuticals Production Ensuring quality is an essential operation of pharmaceutical industry.

This article highlights the need for sophisticated machine vision hardware and tools to stay compliant with regulations, ensure customer confidence and mitigate risks.

I

n no other industry are the incentives to guarantee product safety and packaging integrity as great as they are in the pharmaceutical industry.

As a result, pharmaceutical product manufacturers have been â&#x20AC;&#x153;early adoptersâ&#x20AC;? in the successful deployment and use of machine vision technology.

As the challenges become greater and the stakes higher, pharmaceutical product manufacturers need even more sophisticated machine vision hardware and tools to stay compliant with regulations, ensure customer confidence and mitigate risks. At the same time, these tools need to be easy to use and deliver even more reliable and repeatable results.

Following are some of the major production challenges for the pharmaceutical industry.

Track and Trace The Center for Medicine in the Public Interest (CMPI), USA estimates that there are more than 25,000 pharmaceutical packaging lines worldwide requiring modification to implement effective track and trace technologies. Devising and meeting industry-wide track and trace standards presents substantial challenges to both manufacturers and machine builders. An effective track and trace solution requires implementing three levels of functionality: print and v e r i f y, s e r i a l i z a t i o n a n d t r a c k a n d trace. With this functionality in place, manufacturers can systematically print and verify marking numbers on all products, mark each product with a unique serial number and create a central database of this information.

Didier Lacroix

Vice President International Sales & Marketing Cognex Corporation 42 ď&#x201A;&#x192;November 2014

The central database allows manufacturers to track and store the location and status of each product as it travels through the supply chain until it is sold to the customer. Serialization data can be extracted from four layers

of supply chain operations following the path of an individual medicine from manufacturing through final delivery. In the production facility, each individual drug manufactured is marked with unique serialization data. Any hierarchy-level information appearing on packaging such as blisters, folder cartons, bundles, cartons, packages or containers also is recorded on the production floor.

Since pharmaceuticals manufacturing often occurs in several process stages, serialization information from each process stage is collected and administered throughout the manufacturing facility.

Serialization information is collected at the internal supply chain level where data on product shipments between manufacturing facilities is recorded for further distribution. The process of delivering products to distributors, wholesalers, pharmacists and hospitals is recorded at the external supply chain level. This multi-level approach allows for an end-to-end product verification process.

Global serialization requirements present huge challenges to pharmaceutical manufacturers. With as many as 10 to 15 different country requirements, e a c h w i t h a d i ff e r e n t t i m e l i n e a n d technology, compliance is becoming very complicated. Serialization solutions can be especially effective when quality requirements are high, when the product has an impact on consumer health and safety, when there is a threat of counterfeit products or when there is need for a full product history.

Counterfeiting According to estimates from the World Health Organization, up to 15 per cent of all medicinal products in the world are counterfeit. On a worldwide scale, perhaps millions of patients are not receiving the therapeutic benefit of the Pharma Bio World

authentic product, and they run the risk of coming into contact with materials which may be hazardous or toxic.

• • • •

• • •

Empty glass verification Label placement Final product inspection Component inspection (stoppers/ caps/glass) Seal surface integrity Stopper position inspection Product quantity verification

Counterfeit pharmaceuticals containing authentic active ingredient(s) at inefficacious levels or in undesirable chemical forms may lead to decreased levels of bio-availability and the development of resistant strains of disease. In other cases, unrelated pharmaceutical products have been altered or repackaged so they can be passed off as a more profitable product, costing manufacturers in lost revenue.

Machine Vision Meeting the Challenges of the Pharmaceutical Industry

Recent CMPI research estimates that activities related to counterfeit drugs generate USD 75 billion annually. CMPI expects that figure to grow by 20 per cent annually in the coming years, giving drug counterfeiters comparable revenue to some of the world’s largest health care companies.

Serialization and Tracking: Ensuring Product traceability with Advanced 2-D Code Reading

There is no single tool capable of confirming complete authenticity of pharmaceutical products. Several verification and inspection methods need to be applied simultaneously in order to build complete confidence in the process.

Defect Detection and Quality Control To control costs, ensure product safety and maintain consumer confidence it is essential that pharmaceutical manufacturers control quality and prevent defective products and packaging from entering the supply chain.

Four major environmental challenges on a pharmaceutical production line: • Poor or variable lighting • Tight spaces • Part changeovers • Surface variation (flat, curved, shiny)

Defect Detection: 100% Product Quality Entering the Pharmaceutical Wholesale Chain

A high speed pharmaceutical product testing company has defined a machine that uses two vision systems to inspect delicate glass vials in fractions of a A major international integrator of item second. The vision system-equipped level serialization and tracking solutions machine can check approximately 6,000 deployed a complete traceability solution packages and in its fastest version can featuring ID readers to ensure product even test up to 12,000 test units per hour. traceability for a global manufacturer that produces and distributes 60 million In this application, a vision system medicine boxes annually. determines the cake height of the freeze-dried contents and detects the To a c h i e v e t h e r e q u i r e d l e v e l s o f traceability, this company chose ID presence of any foreign objects on their readers because they can consistently surface. At the same time, it looks for d e l i v e r a c c u r a t e a n d r e l i a b l e c o d e “splashings” or splatters caused by reading. The ID reader system is able unwanted boiling during the freeze-drying to read multiple codes within one field process. The vision system overcomes of view and overcome the challenges of vibration stresses without sacrificing reading blurred or distorted codes on the inspection speed.

production line. In just 1.4 seconds, an ID reader decodes all 2-D codes printed with inkjet onto the surface of each Some of the quality checks performed on medicine package in a single action. the production line include: Any defective products trigger an alarm • Cap/seal presence verification and are removed. This procedure not • Box/label inspection only ensures all packages ready for •Particle inspection shipment are fully traceable, but also • Alphanumeric, 1-D, and 2-D code improves production processes for both verification code marking and wrapping operations • Liquid fill verification as defects are addressed immediately.

• Product insert presence • P r e s e n c e o f d a m a g e d p r o d u c t With the accurate and reliable read rates delivered by ID readers, the customer or packaging 44 November 2014

is 100 per cent satisfied that all 2-D codes are fully readable before leaving the facility.

A n a d d i t i o n a l s y s t e m i n s p e c t s t h e underside of the glass vials for cracks.

For freeze-dried products, the vision system also checks the vials for unwanted particles and “meltbacks” (condensate residue that can arise during the freeze drying process of protein-containing substances). A color vision system checks both the vial cap and the flip-off seal, inspecting for the presence of the parts, the color of the cover and, for aluminum caps, the correct processing of the crimp. While the Pharma Bio World

which also reduces the changeover time, and eliminates the risk of cross contamination.

Thanks to the vision system, the machine can handle all liquid packaging needs for many pharmaceutical companies, contract manufacturers and compounding pharmacies at hospitals at far less expense than comparable solutions.

C o d e Ve r i f i c a t i o n : E n s u r i n g Compliance for Pharmaceutical Products A pharmaceutical products manufacturer worked with vision systems to design and implement a print and code verification solution to ensure compliance with GS1 codes readability regulations, completely eliminate operator errors caused by data input, reduce product waste, and improve coding quality.

glass containers rotate 360°, the vision system checks that the aluminum sleeves have been fitted completely around the edge of the glass and the stoppers are tightly inserted.

This system ensures that only the glass vials with 100 per cent product quality are distributed to clinics, pharmacies, and medical practices worldwide.

Process Automation: Vision-guided Robots Help Automate Vial And Syringe Filling An engineering company with focus on design of custom production equipment for a range of industries used a vision system to develop an automated, single-platform machine to fill vials, 46 November 2014

syringes and other containers for pharmaceutical manufacturers. This machine features exact positioning functionally to address each product’s unique size and type and eliminates the need to purchase multiple filling machines, or tolerate lengthy changeovers when switching between container types.

A vision system precisely locates each container and stopper and provides the robots these locations prior to processing. This approach allows for rapid changeover from one container type or size to another by loading a new robot programme, replacing the products carriers, and instructing the robot to change out the end of arm tooling. The system’s use of disposable materials is used on all process contacting parts

This solution is designed as a mobile system, which can be adapted for packing lines and installed along the production process, as required. A vision system with track and trace software provides information to a PC database to create an audit trail. As the products pass along the line, the required codes are printed onto the packaging.

A vision system reads the printed data and verifies against the selected information camera at a speed of 300 parts per minute. The integrated track and trace software delivers a readyto-deploy data capture and verification solution designed to help pharmaceutical manufacturers achieve unit-level product traceability. Incorrect codes are identified immediately and the offending product is removed from the line. After batch completion, a production report is created to ensure complete product traceability and maintain operational efficiency.

Contact: mails@mindmatterscorp.com Pharma Bio World

december ads.indd 15

20-01-2014 17:50:45

Technology Transfer and Issuance of Access to Medicines In the period of increasingly globalised trade, pharmaceutical play an important role in the availability and affordability of essential medicines for people living with disease in resource limited countries. Governments have the primary responsibility for ensuring access to medicine for health care for all citizens. This article examines alternative frameworks for empirical analysis of supply side activities, namely, the manufacture and distribution of medicine, through the application of New Institutional Economics (NIE) concepts. The article also focuses on problems related to the pricing of essential medications, relationships between health and human right, affordability of essential medicines, frameworks and manufacture, distribution and funding of medicine.

Vivek Dave

Department of Pharmacy Banasthali University

Kriti Kushwaha

Department of Pharmacy Banasthali University

Sachdev Yadav

Department of Pharmacy Banasthali University

Swapnil Sharma

Department of Pharmacy Banasthali University 48 ď&#x201A;&#x192;November 2014

T

he World Trade Organization (WTO) is an international organisation of 160 member countries in 2014 dealing with the rules of trade, adhere to specific agreements called trade related aspects of intellectual property rights (TRIPS) establishes minimum standards for a set of intellectual property r i g h t s t h a t W TO m e m b e r s i n s t i t u t e through national legislation. The doha declaration gave primacy to public health over private intellectual property, and clarified WTO Members rights to use TRIPS safeguard. Improving access to medicines in developing countries has focused attention on the macroeconomic context and defining the demand side needs, based upon disease categories and purchasing power in a range of middle income and least developed countries. Pharmaceutical companies produce hundreds of life saving drugs every year and every year millions of people in developing countries die from preventable and treatable illnesses diseases such as HIV/AIDS, malaria and tuberculosis, because they cannot afford to buy the drugs they need. A product is available in a market if there is a manufacturer prepared to make the product, and willing to sell it in that market, and a purchaser who is able to pay for that product 1. Access to medicines is a human right and the bedrock of an effective primary health care system.

Therefore good quality essential drugs for the prevention and treatment of prevalent diseases should be available at all times, in adequate amounts, in appropriate dosages and at a price the community can afford. Improving access to medicines in developing countries has been conducted in the context of the complex interaction between macroeconomic progress, disease patterns and healthcare needs and provision. The World Health Organization is preoccupied with improving health status, is an objective that many see

as self evidently best pursued within institutional, or public sector frameworks.

The new global health fund, is now operational and supporting a range of diseases, initiatives primarily in HIV/AIDS, Malaria and tuberculosis 2-3 .

Figure 1 shows the top factors leading to disease, disability or death clearly reflects the interrelationship of poverty and health. Drugs are often the most important cost driver of health care spending on hospitals and ambulatory care. Patients that have access to adequate and effective drugs at the time of need are more likely to be happy with the treatment they receive. When such drugs are not available or ineffective after use, patients will go elsewhere, even if they have to pay high prices to private providers, to get the care they think they need.

The availability of affordable and effective drugs is one of the most visible indicators of the quality of health services.

Satisfaction with the drugs received is a key determinant of utilisation of health services and return visits in the public sector. And out of pocket spending on drugs is a major contributor to the impoverishing effects of illness. Many factors influence whether poor people can obtain affordable drugs of good quality, includes issues related to pricing and procurement of existing drugs, new product development, patents intellectual property rights, manufacturing or import of drugs, macroeconomic constraints, and foreign exchange fluctuations. In the context of access to medicines, public health principles are supported by a variety of national and international legal and policy instruments, including the constitution of the WHO. From a human rights point of view, implementation of intellectual property rules should be governed by those principles which support public health goals and access to medicines, thus ensuring a rapid and Pharma Bio World

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Developed Countries • Tobacco products • Alcohols products • Obesity • High cholesterol level • High blood pressure • Physical inactivity • Iron, calcium and other nutrients deficiency • Unsafe sex • Illicit drug uptake • Low fruit and vegetable intake

Poorest countries • • • • • • • • •

Underweight Unsafe water, sanitation, and hygiene Indoor smoke from solid fuel Zinc, iron deficiency Vitamin A ,D,E deficiency Less medical supply High blood pressure Tobacco and there product High cholest

Figure 1: Top risk factors leading to diseases, disability or death

effective response to public health needs and crises, supply of quality medicines at affordable prices, effective competition through a multiplicity of potential suppliers, the provision for a wide range of pharmaceuticals to meet the basic health needs of the population, and equality of opportunities for countries in need, irrespective of their membership in the WTO level of technological capacity, or lack of manufacturing capacity.

I n p a r t i c u l a r, c o n c e r n s h a d b e e n increasing that patent rules might limit access to reasonable medicines for populations in developing countries in their efforts to control diseases of public health importance, such as HIV, tuberculosis and malaria. Legal challenges by the pharmaceutical industry to legislation enabling parallel imports of medicines, and provisions enacted on compulsory licences, highlighted the differing interpretations of the TRIPs agreement obligations.

The lack of access to medicines also has serious social and economic consequences. More than 100 million people per year come under the category of poverty not able to pay health care e x p e ns e s fo r s i c k fa m i l y m em be r s .

One of the main reasons for the lack of access to essential medicines is the high cost of medicines produced. The patent system, used and promoted by pharmaceutical companies, raises the prices of medicines. For this there are 50 November 2014

some factor defines the level of access to medicines was showed in Figure 2 6-7.

Relationship between Health and Human Rights The World Health Organization (WHO) target on health and human rights need attention to the remarkably complex linkages between the violations and lack of attention to human rights such as torture, violence against children, conventional unsafe practices, and discrimination can result in serious health consequences, health policies and programs can promote or violate human rights as a consequence of their design or implementation (discrimination against certain parts of the population, disregard of certain diseases), vulnerability to morbidity and mortality can be reduced by good governance, including spending resources according to actual needs

and progressively with rising means.

The healthier relationship was showed in Figure 3.

Trade, Price, Patents, and Access to Medicines International trade regulation is becoming increasingly significant for health services. Trade policies, with their emphasis on the removal of import and export duties, mean that the health sector and trade in health related services are open to foreign investors.

This affects not only the availability and price of medicines but also the tax revenue available to governments to fund health and other public services. The liberalisation of health services forces the public sector to compete with the private sector that already attracts the best qualified health personnel. National health systems will grow weaker and, once again, it will be the poorest who suffer most. Moreover, when intellectual property rights, such as patents and data exclusivity, are included in trade agreements, access to cheaper generics is not easy and poor countries find it hard to access essential medicines 1, 11.

An important factor influencing price and purchase of drugs are therefore the chosen level of profit of the drug companies, and the barriers to entry to drug manufacture. The price of medicines is determined by the company that produces them. When a company

Selection of medicines

Affordable prices

Factors define the level of access to medicines

Reliable health and supply system

Sustainable financing

Figure 2: Factors defining the level of access to medicine

Pharma Bio World

Ill health result from human right violation

Health and Human Right

Conventional unsafe practices Torture, slavery Violent behaviour against women

Through health development, promotion of human right

Through human right reducing vulnerability to ill health

Participation right Freedom from discrimination Freedom from movement Privacy right

Information right Education right Food and nutrition right Water right

Figure 3: Relationships between health and human right

or an individual has a new medicine approved, it gets a patent to compensate for the expenses of developing the new medicine. The patent grants the company exclusive rights (monopoly) of production, distribution, terms of sale and pricing of the medicine for 20 years. During this time other companies cannot produce or sell cheaper generic versions of the patented medicine. The absence of competition prompts the manufacturer to set high prices in order to increase profits. As a result, medicines are expensive and people in developing countries cannot afford the treatments they need 1-2, 11-13 . The pharmaceutical industry underscores the importance of effective patent protection as an incentive for continued investment in the discovery and development of medicines.

The patent system provides incentives for pharmaceutical innovation, the market exclusivity conferred by patents leads to company profits that often outstrip the associated research, development and production costs altogether. The patent system has also not provided sufficient motivation for research and development of new medicines needed 52 ď&#x201A;&#x192;November 2014

for diseases that provide benefit to public health, including neglected diseases and orphan drugs, because forecasts believe the market too small or commercially unattractive 14.

In many developing countries, the current concern is how adoption of intellectual property regimes as required under the TRIPs agreement can be balanced with efforts to maintain public health treatment programmes while boosting multiple sources of pharmaceuticals and controlling cost. Although patent protection systems for pharmaceutical products are available in most developing countries, multinational companies have not patented their products in all of them because companies may not think it worth the expense to obtain and maintain patent protection in countries where the market is small and the risk of infringement low. If patents do not exist for particular products and countries, the patent system may still have an effect on access to medicines.

The existence of patents in potential supplier countries may allow the patentee to prevent supplies being exported to

another country. Key provisions of TRIPS generic production are possible for the great majority of essential medicines, since they are currently not protected by patents in developing countries but it is not accurate for new medicines.

The TRIPs agreement introduced global minimum standards for protecting and enforcing nearly all forms of intellectual property rights (IPR), including those for patents 2, 15-16. Depending on the patent laws in place, conditions will be created to favour more or less competition between manufacturers of patented and generic medicines. Increased competition is proven to result in lower prices, which in turn contribute to improved access to medicines. Although access depends on numerous factors, high prices of drugs constitute a key obstacle that cannot be addressed in a comprehensive and sustainable manner through foreign aid and drug donations alone. The TRIPs Agreement requires WTO Members to provide protection for a minimum term of 20 years from the filing date of a patent application for any invention including for a pharmaceutical product or process. Prior to the TRIPs Agreement, Pharma Bio World

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patent duration was significantly shorter in many countries. Both developed and developing countries provided for patent terms ranging from 15 to 17 years, whilst in a number of developing countries patents were granted for shorter terms of 5 to 7 years. The TRIPs Agreement also requires countries to provide patent protection for both processes and products, in all fields of technology.

Before TRIPs, many countries provided only process but not product patents.

Product patents provide for absolute protection of the product, whereas process patents provide protection in respect of the technology and the process or method of manufacture. Protection for process patents would not prevent the manufacture of patented products by a process of reverse engineering, where a different process or method from that which has been invented (and patented) is used. National legislation requiring only process patent protection has enabled manufacturers in certain countries to make generic versions of patented medicines.

Generic Medicine and Affordability of Essential Medicine When a patent expires other laboratories can produce the medicine without patent. This generic contains the same active ingredients and pharmaceutical properties as the patented medicine.

As both are identical in dose, strength, safety and efficacy they should produce the same effect. Generic medicines are named after the main active ingredient while the patented one has a brand name given by the owner of the patent. Generic medicines are legitimately produced but are much cheaper than the brand one because they have no research costs. TRIPs flexibilities played an important role in the reduction of prices of medicines by allowing the production and export of generics. Competition between brand medicines and generics has been very effective in reducing the cost of drugs. The WHO list of essential 54 ď&#x201A;&#x192;November 2014

Private Donation by Pharmaceutical Companies

Individual pharmaceutical companies have schemes to donate essential medication free of charge to developing countries.

Price Reduction

Pharmaceutical companies reduce the prices of their patented essential drugs, in order to make them available to more people in need.

Public Private Partnership

It proposes to work together with pharmaceutical companies and developing world governments to secure sustainable price reductions.

Figure 4: Affordability of essential medicine by pharmaceutical company

medicines (EML) contains about 300 active substances. From it each country selects its own list according to disease prevalence, efficacy evidence, safety, and comparative cost effectiveness 1 .

In past treatment was not available for diseases like HIV/AIDS, tuberculosis, hepatitis, malaria etc. due to affordability of therapy and that was the main cause of several death . When patent-protected vaccines, drugs, therapy for treatments were first introduced, the cost was very high, putting them out of reach of the vast majority of patients in developing countries. Figure 4 describe many efforts have been made to reduce prices by pharmaceutical companies, including private donations by pharmaceutical companies, price reductions, public private partnerships.

Role of the Doha Declaration

right to grant compulsory licenses and the freedom to determine the grounds upon which licences are granted, the right to determine what constitutes a national emergency and circumstances of extreme urgency, and the freedom to establish the regime of exhaustion of intellectual property rights. The doha declaration states that each member has the right to grant compulsory licences and the freedom to determine the grounds upon which such licences are granted.

Since many patented products are sold at different prices in different markets, the rationale for parallel importation is to enable the import of lower priced patented products. Parallel importing can be an important tool enabling access to affordable medicines because there are substantial price differences between the same pharmaceutical products sold in different markets 2, 8-9.

Although the TRIPs agreement affords considerable discretion on how its obligations are interpreted and implemented by governments, developing countries have faced obstacles when seeking to implement measures to promote access to affordable medicines.

Thus, developing countries required to clarify through adoption of the doha declaration that the provisions in the TRIPs agreement did provide sufficient flexibility and discretion to ensure access to medicines in the interests of public health. The doha declaration refers to several aspects of TRIPs, including the

Doha declaration should, as a matter of law, guide the interpretation of the TRIPS agreement in a more health friendly direction in future disputes over patents.

Those interpretations should also take into account countries obligations under international law to protect and promote the right to health. The doha declaration may also help developing countries fend off pressure tactics by rich countries who invoke the TRIPs agreement and threaten trade sanctions when developing countries limit exclusive patent rights in order to make medicines more affordable. The doha declaration Pharma Bio World

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At the heart of it all

Chemical

Biological

Basic chemical manufacturing

Specialist synthesis

Final active ingredient synthesis

Fermentation of antibiotics

Protein peptide synthesis

Process development

Quality assurance

Recombinant DNA technolo-

Scale-up fermentation

Purification

Formulation and packaging Figure 5: Flow diagram of pharmaceutical manufacturing process

also extended until 2016 the deadline for least developed countries to implement the sections of TRIPs that require them to grant exclusive, 20 year patent rights to pharmaceutical products 8-10, 20, 25.

T h e Te c h n o l o g i c a l E c o n o m i c s o f Medicines: Manufacturing Capabilities and Resources The manufacture of active ingredients is by far the most expensive in terms of sunk cost investment in capital equipment and process development.

Most pharmaceutical plant is multi purpose, in that a range of different products can be manufactured in the same equipment, subject to extremely thorough procedures to avoid cross contamination. Figure 5 describe the outline of the main components of manufacturing processes. Primary or active ingredient manufacture may be either chemical or biological in nature, involving quite different types of plant, technologies, skills and knowledge.

56 ď&#x201A;&#x192;November 2014

The chemical and biological stages involved vary greatly from product to product in conditions of their robustness, o r r e l i a b i l i t y. T h e m o r e m o d e r n o r complicated the products, the greater are likely to be the need for a highly skilled capability to develop and maintain the processes. The skilled scientist and engineers, laboratory facilities and instruments are specific assets, which may be limited in many middle income countries because some products require dedicated plant. In such cases capital investment is clearly a high risk activity for a new product, because if the product does not achieve technical regulatory approval by government authorities, or fails to capture significant sales in competitive markets, then the plant will have to be on paper. Secondary manufacture, or formulation into tablets, capsules or injection, is routine for many products, involving long established technologies. There are important imperatives in terms of procedures and operational disciplines needed to

ensure high quality standards. For both formulation and packaging in a developed world context, these processes are highly automated with low lab or costs, whereas in developing world situations, with low labor costs, it may be more efficient to make lower investments in automated computer based equipment and rely upon manual processes. However the latest highly automated investment offers a higher guarantee of quality in substantially eliminating the scope for human error22-23.

All major international suppliers are to build staff and operate plants that are approved by leading national regulatory authorities. There is an increasing drive across the world to establish and enforce common high standards. The requirements of regulators take two discrete forms. â&#x20AC;˘ The first consists of a highly specific master file for each product, which defines scientific data on input materials, processes and the quality specification of the final product.

Pharma Bio World

Low

> Regular manufacture of organic intermediates > Common antibiotic manufacture

High

> Quality assurance > Process maintenance > Regulatory compliance

Very High

> Specialised organic synthesis > Synthesis and purification of modern biologicals > Recombinant DNA technologies

Figure 6: Beneficial specificity and pharmaceutical manufacturing

â&#x20AC;˘ The second, which is much less well understood, is operational or procedural and is based upon the cumulative experience over many years of how to organise manufacturing systems, procedures and documentation to avoid mistakes or errors at all stages.

The enforcement of these standards is through regular inspection of plants by experts from the authorities. On a routine basis, the guardian of these standards, effectively on behalf of the agencies, performs the quality assurance function.

This group, which organisationally stands apart from the normal manufacturing function, is responsible for approving the release of product batches from the site for distribution and sale. Normally, pharmaceutical companies do not strive to operate plants close to their maximum output capacity, because demand fluctuates across many markets, and, under the terms of their licenses, companies have a legal obligation to keep markets supplied. The economics of capacity planning is an important issue in the context of improving access to medicines, because the unit cost of increasing volume output on a self effacing incremental basis in an existing plant may be very low but, at the point at Pharma Bio World

Issuance of Access.indd 59

which new or extended plant is required, a quite different computation must be done to account for the capital and operating costs of additional capacity and services. Figure 6 showed the description of low high or very high, as somewhat

Manufacturer

International

National

subjective look for to represent the realities of the current situation. Thus, whereas at one end of the spectrum for most of the products on the WHO essential drug list, asset specificity is low and it is possible to go to the market and obtain multiple competitive offerings which ensure price competition, for some newer biological products, asset specificities are high, market competition low and prices will be accordingly high.

We would particularly draw attention to assets, particularly experienced, skilled s t a ff i n q u a l i t y a s s u r a n c e , p r o c e s s maintenance and regulatory compliance, which are the key to ensuring that the highest quality standards are maintained.

International Strategies for Improving Access to Medicines: Relationships between Manufacturers, Distributors and Funders Formulating a consensus on policies and strategies involves an increasingly complex network of international

Distribution

Funding

International whole sale/traders

Global fund International govt. agencies

Generic MNC

Generic distribution network

Public private partners

MNCs R&D

MNC distribution network

Not for profit NGOs

MNC affiliates

MNC affiliates

National tender purchase

National private manufacturers

National wholesales traders

National insurance system

National state manufacturers

Pharmacies, doctors, health centres hospitals

Private health insurance

Patient Out-of pocket

Figure7: Maps of manufacture, distribution and funding of medicine

November 2014ď&#x201A;&#x201E; 59

21-11-2014 18:00:07

agencies, interacting with national governments. The plan is to analyse the primary alternative funding and supply mechanisms, based upon the transactions involved and the capabilities and resources necessary for organisations to fulfil their roles under conditions of hierarchical governance.

Improving access to unavoidably medicine depends upon the economics of supply, in terms of balancing costs and the flow of funds available. There are a multiplicity of combinations of funding, manufacture and distribution available. In new institutional economics (NIE) terms all of these offer different combinations of activities, some carried out under corporate governance and some contracted for under market or quasi market conditions. Clearly a rigorous application of transaction cost analysis (TCA) principles to compare transaction costs and evaluate their relative merits represents a formidable challenge and focus attention on the following components R&D based multinational companies (MNCs), emerging international generic suppliers, national manufacturer and distributors, alternative public sector combinations, new public private partnerships (PPPs).

Figure 7 showed maps of the main components involved in this process. A distinction is made between international and national entities and between public or not for profit agencies and private sector ones. This model has two obvious limitations. Firstly it cannot reflect the wide range of national situations that exist. Secondly by consigning the pharmacy and healthcare infrastructure systems to a single box, we are in danger of overlooking important differences, which might influence choices at an earlier stage in the supply demand sequence. However, its primary function here is to display visually the alternative combinations of pathways that are possible, in order to discuss their utility in improving access. Included the funding options in the final analysis, improving access inescapably depends 60 ď&#x201A;&#x192;November 2014

Issuance of Access.indd 60

4 Strategic Pillars

Commitment

Transparency

Performance

Innovation

General access to medicine management Public policy and market influence Research and development 7 Technical Areas

Pricing, manufacturing and distribution Patent and licencing Capability advancement Product donation

Figure 8: Accesses to Medicine Index Methodology Framework 2012

upon the economics of supply, in terms of balancing costs and the flow of funds available 4-5,23-24 .

Access to Medicine Index 2014 In order to industry progress in line with society evolving expectations, the access to medicine index methodology is systematically formulated and reviewed every two years, and maintaining as much consistency as possible for the purpose of trend analysis, the methodology is adjusted when and where it needed. The 2014 access to medicine index is currently in preparation: the Index team is now completing the data analysis, comparing companies access to medicine policies and practices. The methodology for the 2014 access to medicine index remains mostly same as the methodology for the previous index 2012. The 2014 index will use as framework for analysis, which continues to be constructed along seven technical areas with indicators measured across four strategic pillars. The weights within the framework remain unchanged and most of the indicators remain the same, though the number of indicators has been reduced. Figure 8 showed access to medicine index methodology framework

2012 26. Updating methodology of access to medicine framework The Index is produced over a two year cycle. In the first year, the access to medicine foundation reviews the index methodology on the basis of intensive expert stakeholder feedback and defines the methodology for the next access to medicine index. An expert review committee and technical subcommittees, which offer strategic guidance, stakeholder perspectives and technical expertise, are formally consulted during this process. In the second year, pharmaceutical company data is collected, analysed and published in the access to medicine index report 26 .

Conclusion The study mainly focus on the affordability of necessary medicine require at time with affordable prices for the treatment of many serious diseases. There are many pharmaceutical industry current initiatives to ensure that poor people have access to medicines. The TRIPs agreement does not prevent members from allowing generic substitution. But if implementation of TRIPs compliant national legislation and regulations are Pharma Bio World

21-11-2014 18:01:05

inappropriate the introduction of new generic drugs can be postponed. The adoption of the doha declaration marked a watershed in the debate on intellectual property and access to medicines, there remain major challenges for developing countries to interpret and implement the TRIPs agreement and other intellectual property rules in a manner supportive of their efforts to protect public health and promote access to medicines for all. This paper examines issues surrounding the development and transfer of technologies for addressing the problem of innovation and access to medicines.

References 1) Balasubramaniam, K. (2001) Access to Medicines: Patents, Prices and Public Policy Consumer Perspectives, paper presented at Oxfam International Seminar on Intellectual Property and Development: What Future for the WTO TRIPS Agreement?, Brussels, March 20, 2001 2) WHO Drug Information, Access to Medicines Intellectual property protection: impact on public health, Vol.19, No. 3, 2005.

3) Department of Technical Cooperation for Essential Drugs and Traditional Medicine, World Health Organization. http://www.who.int/medicines. ( accessed on 13-9-2014) 4) C. James Attridge and Alexander S. Preker, Improving Access to Medicines in Developing Countries, Application of New Institutional Economics to the Analysis of Manufacturing and Distribution Issues Health, Nutrition and Population (HNP) Discussion Paper,1-21 march 2005.

5) Preker A.S. and Harding A, The Economics of Public and Private Roles in Health Care - Insights from Institutional Economics and Organisation Theory, HNP Discussion Paper, The World Bank,. Washington, USA.2001.

6) Richard Elliott and Marie-Hélène Bonin Patents, International Trade Pharma Bio World

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L a w A n d A c c e s s To E s s e n t i a l Medicines, Canadian HIV/AIDS Legal Network & Medicines Sans Frontières Canada, 2002.

7) Julie Stauffer, Access to medicines: Ranking the social responsibility of pharmaceutical companies, Archives, Health Economics, Dec 1, 2008.

8) Udo Schüklen, Affordable access to essential medication in developing countries: conflicts between ethical and economic imperatives.

9) European Commission. Press release: Commissioner Lamy pledges action on access to medicines, 2000. http:// europa.eu.int/comm/trade/whats_new/ medic.html (accessed on 14-9-2014) 10) World Trade Organization, TRIPS: Agreement on Trade-related Aspects of Intellectual Property Rights. http:// www.wto.org/english/tratop e/trips e/t agm1 e.htm ( accessed on 13-9-2014) 11 ) K l a u s M . L e i s i n g e r, C o r p o r a t e Responsibilities for Access to Medicines, Journal of Business Ethics, Springer,1-21,2008 12) Attaran, A., ‘How do Patents and Economic Policies Affect Access to Essential Medicines in Developing Countries?’ Health Affairs 23(3), 155– 166.2004.

13) Department for International Development, Department of H e a l t h , D e p a r t m e n t o f Tr a d e a n d Industry: 2005 14) Increasing People’s Access to Essential Medicines in Developing Countries: A Framework for Good Practices in the Pharmaceutical Industry. A UK Government Policy Paper, London.

15) U . K . D e p a r t m e n t f o r I n t e r n a t i o n a l Development, Fact Sheet: Access to Medicines (London), 2006.

16) Investing for life, Meeting poor people’s needs for access to medicines through responsible business practices, Oxfam Briefing Paper, November 2007.

17) Subramaniam ‘Medicines, Patents and TRIPS’, Finance & Development 41 (1), 2004.

18) Oxfam International ‘All costs, no benefits: how TRIPS-plus rules in

the US-Jordan FTA affect access to medicines’, Oxfam Briefing Paper No. 102, Oxford: Oxfam. 2007.

19) World Health Organisation Commission on Intellectual Property Rights, Innovation and Public Health, op.cit. p. 172, 2006.

20. Abbott E.M., The TRIPS agreement, access to medicine and WTO Doha ministerial conference, Geneva; Quaper united nation office. 2001 http:// www.quno.org/geneva/pdf/economic/ occassional/access-to-medidicine 7.pdf. ( accessed on 12-9-2014) 21) Frederick M. Abbott, Innovation and Technology Transfer to Address Climate Change: Lessons from the Global Debate on Intellectual Property and Public Health, Paper No. 24, 1-9, 2009.

22) Catherine Olivier1, Bryn WilliamsJones1, Béatrice Godard1, Barbara M i k a l s o n 2 a n d V u r a l O z d e m i r, Personalized Medicine, Bioethics and Social Responsibilities: Re thinking the Pharmaceutical Industry to Remedy Inequities in Patient Care and International Health, Current Pharmacogenomics and Personalized Medicine, 6, 108-120, 2008.

23) Lita Nelsen, The Role of University Technology Transfer Operations in Assuring Access to Medicines and Vaccines in Developing Countries, Yale Journal of Health Policy, Law, and Ethics ,Volume 3,Issue 2 , artical 6, 2013.

2 4 ) E l l e n F. M . T H o e n , T R I P S , Pharmaceutical Patents and Access to Essential Medicines: Seattle, Doha and Beyond, 2003.

25) WTO General Council Decision of 30 August 2003 on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health (WT/L/540), 2 September 2003.

26)http://www.accesstomedicineindex. org/review-consultations (accessed on 12-9-2014)

Contact: vivekdave1984@gmail.com November 2014 61

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press release Shantha’s Pediatric Pentavalent Vaccine Launched in India Sanofi Pasteur, the vaccines division of Sanofi, has announced the launch of Shan5, its pediatric pentavalent vaccine developed and manufactured by its affiliate Shantha in India. The launch of Shan5 vaccine received prequalification status from the World Health Organization (WHO) in April 2014.

Shan’s prequalification gives many more children in India access to the latest high-quality, fully-liquid, 5-in-1 vaccine. Further, the prequalification helps Shan5 secure the supply of pentavalent combination vaccines in over 50 emerging and low-income countries. It adds to the existing list of four vaccines that Shantha manufactures, including Shanchol – the innovative cholera vaccine.

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Applikon Biotechnology Sign Distributor Agreement with Spinco Biotech Applikon Biotechnology, a world leading supplier of bioreactor systems for the biopharmaceutical industry, has announced the signing of a new Distributor Agreement with Spinco Biotech Pvt. Ltd for sales and service in India.

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and Mass Spectrometry, Bioresearch and Process Technology.

This has enabled Spinco to provide enhanced focus on these niche high-end products and in the process they have ensured better customer delight, cementing the foundations for long lasting relationships with all their customers.

In Vitro Diagnostics Players Go Global as US and EU Markets Slow Down Despite economic and industry challenges, the global in vitro diagnostics (IVD) market is growing robustly – at double the rate of the global pharmaceutical industry. The market will remain buoyant as the recent success of cost-saving companion diagnostics tests and personalised medicine is driving the uptake of various IVD tests and opening up the opportunity to expand test menus. While the US and European markets remain important, their slowdown is demanding an alignment with the global market. As a result, the Asia-Pacific region is becoming a lucrative destination for IVD manufacturers.

New analysis from Frost & Sullivan’s Analysis of the Global in Vitro Diagnostics Market finds the market earned USD 47.27 billion in revenue in 2013 and estimates this to reach USD 62.63 billion in 2017. The study covers immunochemistry, self-monitoring blood glucose (SMBG), point-of-care testing (POCT), molecular diagnostics, hematology, clinical microbiology, hemostasis and tissue diagnostics.

Pharmtech 2014: A New Syringe Production Line for Gerresheimer Gerresheimer put a new production line for its famous Gx RTF sterile syringe systems into operation this year. At Pharmtech in Moscow the Gerresheimer experts will be explaining the optimisations that can be achieved with the new line and how syringes meet the different requirements of biotech and ophthalmic applications. A special presentation will also illustrate the advantages of Gx MultiShell plastic containers.

The fourth production line is located in a brand new production bay at the Gerresheimer Competence Center for Ready-to-Fill Syringes in Bünde (Germany). It is associated with some decisive process improvements, including the avoidance of glass-glass and glass-metal contact through the use of pick-and-place and segment transport systems. The washing and siliconisation processes have been optimised, and more effective, camerabased quality inspections have been introduced. The camera system, which was developed by Gerresheimer, can identify cracks the size of a very fine hair.

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press release H e a l t h E x p e r t s P r e s s f o r E a r l y FDA Approves Genzyme’s Lemtrada Introduction of IPV in India Genzyme, a Sanofi company, announced that the US Food Top doctors and medical professors who participated at the Ranbaxy Science Foundation’s 32 nd Round Table Conference on “Lessons from the Success of Polio Elimination” highlighted the importance of switching from the oral polio vaccine (OPV) to the injectable polio vaccine (IPV) in India beginning next year. They warned that any delay in introducing it can have detrimental effect on public health.

According to health experts, IPV, though more expensive, carries inactive forms of all three strains (Type 1, 2 and 3) of the polio virus, with no risk of virulence. In contrast, OPV carries live but weakened form of the virus which can give rise to occasional cases of polio, especially of the Type 2 strain, the wild counterpart of which is now absent. Said Dr Jacob John: “IPV is much more effective than OPV in a country like India when introduced in the routine immunisation programme. Had we adopted IPV earlier, we could have banished polio years ago from our shores due to it having much higher efficacy than OPV. As India moves to IPV next year, it would be critical to achieve and retain high levels of routine immunisation in all states.”

Lilly Shares Insights from DecadeLong Technology Transfer Experience Eli Lilly and Company has published details of its long-standing technology transfer programme to increase the global supply of medicines for multidrug-resistant tuberculosis (MDR-TB).

Begun in 2003, the effort included Lilly donating manufacturing technology and know-how for two antibiotics to pharmaceutical manufacturers in China, India, Russia and South Africa – all MDR-TB ‘hot spots.’ It also served as the foundation for the Lilly MDR-TB Partnership, the company’s largest-ever philanthropic effort.

The technology transfer was Lilly’s response to a dramatic global rise in MDR-TB cases in the late 1990s and early 2000s. Until that time, Lilly manufactured and supplied nominal quantities of two TB medicines – capreomycin and cycloserine. Later, Lilly doubled production and subsidised prices of the medicines. However, global demand was projected to quickly outpace manufacturing capacity, and Lilly sought a longer-term solution for people needing these medicines. After close consultation with global TB experts, Lilly embarked on a novel approach: transferring its manufacturing technology and know-how for capreomycin and cycloserine free of charge to seven manufacturers. In India, the technology transfer of second line drug cycloserine has been completed with Shasun Chemicals and Drugs Ltd. Chennai.

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and Drug Administration (FDA) has approved Lemtrada (alemtuzumab) for the treatment of patients with relapsing forms of multiple sclerosis (MS).

The FDA approval of Lemtrada is based on two pivotal randomized Phase III open-label rater-blinded studies comparing treatment with Lemtrada to Rebif (high-dose subcutaneous interferon beta-1a) in patients with relapsing remitting MS who were either new to treatment (CARE-MS I)1 or who had relapsed while on prior therapy (CARE-MS II).

Lemtrada has a unique dosing and administration schedule of two annual treatment courses. The first treatment course is administered via intravenous infusion on five consecutive days, and the second course is administered on three consecutive days, 12 months later.

GSK Releases First Call for Proposals for Africa NCD Open Lab GSK has launched the first call for proposals for its Africa NCD Open Lab, to support much-needed scientific research into non-communicable diseases (NCDs) in Africa. Up to 4 million pound will be available in this first funding round, to support successful proposals from researchers in Côte d’Ivoire, Cameroon, Ghana, The Gambia, Nigeria, Kenya, Uganda and Malawi.

The Africa NCD Open Lab was established by GSK earlier this year, with a commitment of 25 million pound funding over five years, as part of a series of strategic investments in subSaharan Africa. In this region, and across developing countries, non-communicable diseases, such as cancer and diabetes, are becoming more prevalent, and we need to learn more about how – and why – these diseases manifest differently in this setting.

The Africa NCD Open Lab aims to address this through the creation of an innovative research network that will see GSK scientists collaborate with researchers across Africa on high quality epidemiological, genetic and interventional research, from its hub at GSK’s Stevenage R&D facility in the UK. The aim is that this will specifically inform interventions for the prevention and treatment of five priority diseases - cancer, cardiovascular disease, diabetes, chronic kidney disease and chronic respiratory disease – while helping build local expertise and creating a new generation of African NCD experts.

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press release Merck, MUHS Launches Diabetes Awareness and Prevention Campaign Merck, a leading company for innovative and top-quality hightech products in the pharmaceutical, chemical and life-science sectors, rolls out its Diabetes awareness and prevention campaign in collaboration with Maharashtra University of Health Science (MUHS) in order to improve diabetes awareness and community health level in India.

On the occasion of World Diabetes Day, Merck is supporting Diabetes awareness at 15 medical colleges in Maharashtra, aiming to screen and educate more than 15,000 community members across Maharashtra state. Dubbed ‘Get InformedGet Active- Get Healthier’, the campaign aims to reverse this worrying trend by preventing or delaying the development of diabetes in the Indian population.

Merck has provided the necessary support to conduct Diabetes free screening and education to each medical college in Maharashtra University during the week of the WDD to raise awareness about diabetes and empower community members on how to better manage and prevent the disease.

Oviya Introduces Drug Safety Service Packages for RoW Region Oviya MedSafe, a global pharmacovigilance consulting & drug safety services company based out of Coimbatore, India and London, UK has launched comprehensive drug safety service packages in line with the compliance requirements for pharmaceutical companies and marketing authorisation holders operating in the RoW (Rest of World) region. Oviya MedSafe will also render pharmacovigilance consulting support to the regulatory agencies and the pharmaceutical industry in this region. This strategy is aimed at promoting the adoption of international standards of pharmacovigilance practices, especially among small & mid-sized innovators and generic drug marketers of any size in the fast-emerging RoW region, by fulfilling their end-to-end drug safety obligations in an economical and efficient manner.

The term RoW region, traditionally meant to refer to the countries in the Asia Pacific, Latin American, Eastern Europe, African and Middle East regions, is a very important market for exporters of pharmaceutical products and medical devices globally. The need for pharmacovigilance compliance in RoW assumes more significance as the demand for harmonization and implementation of regulations is growing across all markets.

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Oviya MedSafe’s comprehensive service packages include assessment of the marketing authorization holders’ obligations and execution of the applicable pharmacovigilance tasks such as adverse event reporting (including electronic submissions where required), literature monitoring, aggregate reporting, risk management planning, signal detection and any other services, as appropriate

Medtronic and CARE Hospitals to Set up HF Clinics Medtronic Inc, the global leader in medical technology, has announced a strategic partnership with CARE Hospitals to set up Heart Failure (HF) Clinics for the prevention and management of Congestive Heart Failure (CHF). The first HF Clinic will be launched at the CARE Outpatient Centre, Banjara Hills, Hyderabad, within a few weeks.

The HF Clinics will be set up by Medtronic Healthcare Solutions and CARE Hospitals to provide integrated care in a patient-focused environment for the diagnosis, treatment and management of HF. A key focus area would be the education of patients, families, members of the community and healthcare professionals on HF management.

Despite Patent Cliffs, Pharmaceutical Market Shows Signs of Stability The pharmaceutical market is beginning to show signs of stability, with a review of 30 leading companies highlighting combined revenues of USD 718.7 billion in 2013, down just 0.2 per cent from 2012, according to research and consulting firm GlobalData. The company’s latest report states that while overall industry revenues were relatively unchanged, a familiar pattern saw a number of companies recording significantly lower sales in 2013 than in the previous year.

According to GlobalData, Biogen Idec was the peer group revenue growth leader in 2013. Biogen’s sales increased to USD 5.5 billion in 2013, a 25.7 per cent rise from the USD 4.2 billion the company reported in 2012.

Looking forward to 2014, the analyst adds that Gilead is well on track to make a significant impact, with its blockbuster hepatitis C drug, Sovaldi (sofosbuvir). Approved by the US Food and Drug Administration in December 2013, Sovaldi posted unprecedented sales of $5.8 billion in the first half of this year.

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pharma news GVK BIO to Acquire Vanta Bioscience AMAG Acquires Lumara Health’s Maternal Health Business Asia’s leading Discovery Research and Development organization, GVK BIO, announced the signing of a definitive agreement to acquire Vanta Bioscience, a full service preclinical GLP toxicology and safety assessment contract research organization operating out of Chennai, India.

Complying with OECD GLP, ISO, USFDA GLP (21 CFR Part 58 rev. 2009) regulatory guidelines, the company offers toxicology evaluation services for the pharmaceutical, biotech, food supplements and feed additives industries. Vanta Bioscience also offers toxicology services using alternative methods for the Cosmetics industry.

The state-of-the-art facility is GLP and AAALAC accredited, is armed with high-end equipment, and has infrastructure like ‘Individually ventilated Cages’ and `Intelligent Building Management’ systems. The facility houses GLP trained scientific personnel with experience and expertise in study design and execution of regulatory directed studies leading to IND filings.

US FDA Grants Fast Track Designation for Threshold Pharma’s TH-302 Threshold Pharmaceuticals, Inc has announced that the US Food and Drug Administration (FDA) granted Fast Track designation for TH-302, an investigational anticancer drug, for the treatment of previously untreated patients with metastatic or locally advanced unresectable soft tissue sarcoma (STS).

The FDA established the Fast Track designation process to facilitate the development and expedite the review of drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. An important feature of Fast Track is that the FDA may consider a “rolling review” of completed sections of the New Drug Application (NDA) before the complete application is submitted.

“We are pleased that FDA has granted Fast Track status for TH-302 for the treatment of previously untreated patients with metastatic or locally advanced unresectable soft tissue sarcoma,” said Barry Selick, PhD, Chief Executive Officer of Threshold. “Our ongoing Phase 3 trial of TH-302 in these patients is being conducted under a Special Protocol Assessment with the FDA. If successful, the Fast Track designation may provide an added benefit of facilitating the NDA review process.

Currently, we anticipate the primary analysis of overall survival of the Phase 3 trial to be conducted in the first quarter of 2016.”

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AMAG Pharmaceuticals, Inc has completed the acquisition of Lumara Health Inc, a specialty pharmaceutical company with a particular focus on maternal health. The transaction was announced on September 29, 2014 and included upfront consideration of USD 600 million in cash and 3,209,971 shares of AMAG common stock, and additional contingent consideration of up to USD 350 million based on the achievement of sales milestones.

Lumara Health is the exclusive marketer of Makena (hydroxyprogesterone caproate injection), the only US Food and Drug Administration (FDA)-approved product indicated to reduce the risk of preterm birth in women who are pregnant with one baby and who have delivered one preterm baby spontaneously in the past. Lumara Health is committed to contributing to the fight against prematurity in a meaningful way. The company’s focus includes helping to ensure that cost is not a barrier for patients. Its customer support center, the Makena Care Connection, has helped tens of thousands of women in the past year alone, providing insurance benefits and financial assistance, including assistance with commercial insurance copayments and providing the drug at no cost to eligible uninsured women.

Mylan Launches Generic Loestrin 24 Fe Mylan Inc has announced the US launch of its Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.02 mg and Ferrous Fumarate, which is the generic version of Warner Chilcott’s Loestrin 24 Fe. Mylan received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Mylan has begun shipping product.

Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.02 mg and Ferrous Fumarate had US sales of approximately USD 24.4 million for the 12 months ending September 30, 2014, according to IMS Health.

Currently, Mylan has 287 ANDAs pending FDA approval representing USD 112.2 billion in annual brand sales, according to IMS Health. Forty-three of these pending ANDAs are potential first-to-file opportunities, representing USD 29.3 billion in annual brand sales, for the 12 months ending June 30, 2014, according to IMS Health.

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pharma news KLOX’s LumiHeal Gets European CE GSK Seeks Regulatory Approval for Mepolizumab Mark Approval KLOX Technologies Inc, a leading life sciences specialty pharma company based in Laval, Quebec, Canada, has received CE mark approval in Europe for its topical photo-converter gel, LumiHeal, as a Class IIb Medical Device for the treatment of acute and chronic wounds.

This gel is part of KLOX’s innovative, non-invasive, and patented BioPhotonic platform which is designed to promote healing of wounds while addressing bacterial contamination. KLOX plans to independently commercialise LumiHeal in Europe in 2015.

“KLOX’s global strategic partnerships in dermatology have enabled us to solidify our position as a leading specialty pharma company. With this regulatory approval in hand, we intend to focus our financial and human resources on independently commercialising and realising the value of our promising wound care franchise as part of a multi-billion dollar global market. We plan to initially launch LumiHeal in Europe and subsequently leverage the CE mark in other geographies where the CE mark is recognised,” stated Dr Lise Hébert, President and CEO of KLOX.

Aegerion Buys Myalept from AstraZeneca Aegerion Pharmaceuticals, Inc has entered into a definitive agreement with AstraZeneca to acquire Myalept (metreleptin for injection), an orphan product that is indicated to treat complications of leptin deficiency in patients with generalised lipodystrophy.

Myalept is the first and only product approved in the US for the treatment of generalized lipodystrophy, and it has orphan drug designation in the US, EU, and Japan. Myalept is a recombinant analogue of human leptin, indicated in the US as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalised lipodystrophy.

Under the terms of the agreement, Aegerion will pay AstraZeneca USD 325 million upfront to acquire the global rights to develop, manufacture and commercialise Myalept, subject to an existing distributor license with Shionogi covering Japan, South Korea, and Taiwan. The transaction does not include the transfer of any AstraZeneca employees or facilities.

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GlaxoSmithKline plc has filed regulatory submissions in the USA and Europe for mepolizumab for approval as a maintenance treatment for patients with severe eosinophilic asthma, identified by a blood eosinophil count of at least 150 cells per microlitre at the start of treatment or 300 cells per microlitre in the past 12 months.

The submissions comprise a Biologics Licence Application to the US Food and Drug Administration as an add-on maintenance treatment for severe eosinophilic asthma in patients aged 12 years and older with a history of exacerbations and a Marketing Authorisation Application to the European Medicines Agency as an add-on treatment for severe eosinophilic asthma in adult patients with a history of exacerbations and/or dependency on systemic corticosteroids.

Mepolizumab is a monoclonal antibody that is delivered in a 100mg dose via subcutaneous injection every four weeks. The regulatory submissions in the USA and Europe are based on studies of patients with severe asthma and include the phase III MENSA1 and SIRIUS2 studies published in the New England Journal of Medicine in September 2014 as well as the earlier phase IIb/III DREAM3 study published in the Lancet in 2012.

Both the MENSA and SIRIUS studies evaluated patients with blood eosinophils of either 150 or more cells per microlitre at initiation of treatment or 300 or more cells per microlitre in the previous 12 months.

Isis, AstraZeneca to Co-develop Delivery Methods for Antisense Oligonucleotides Isis Pharmaceuticals, Inc and AstraZeneca have announced a strategic alliance to discover and develop novel delivery methods for antisense oligonucleotides. The new delivery approaches seek to target the desired tissue more effectively. The agreement builds on an existing collaboration between AstraZeneca and Isis Pharmaceuticals, a leader in the field of antisense, and supports AstraZeneca’s research and development capabilities in the area of antisense oligonucleotide-based therapeutics and RNA biology. Initial project areas will be oncology and cardiovascular and metabolic diseases (CVMD).

Antisense oligonucleotides are short, single strands of DNA or RNA molecules. Rather than modulating the activity of alreadyformed proteins, antisense oligonucleotides act before proteins are produced at the level of messenger RNA in the cell, thus opening up new opportunities for therapeutic intervention.

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biotech news Biocon, CytoSorbents Expand Partnership for CytoSorb Biocon Ltd, Asia’s premier biopharmaceuticals company, and US-based CytoSorbents Corporation have expanded the scope of their strategic partnership for CytoSorbents’ CytoSorb cytokine reduction therapy to treat patients experiencing severe whole body inflammation, often called a Systemic Inflammatory Response Syndrome (SIRS). SIRS is caused by a wide range of life-threatening conditions seen in the intensive care unit and can also be caused by surgical interventions, particularly cardiac surgery.

CTI BioPharma Buys Tosedostat Rights from Vernalis & Chroma CTI BioPharma Corp has acquired worldwide rights to tosedostat through concurrent transactions with Vernalis R&D Limited, the originator of tosedostat, and Chroma Therapeutics Ltd, through which CTI previously held a sublicense with respect to tosedostat in North, Central and South America. Tosedostat is a first-in-class selective inhibitor of aminopeptidases, which are required by tumor cells to provide amino acids necessary for growth and tumor cell survival. Tosedostat is currently being evaluated in multiple Phase 2 clinical trials for the treatment of patients with Acute Myeloid Leukemia (AML) or high-risk Myelodysplastic Syndrome (MDS), which are intended to inform the design for a Phase 3 registration study to support potential regulatory approval.

US FDA Gives Fast Track Status to Promedior’s PRM-151 Promedior, Inc, a clinical stage biotechnology company developing novel therapeutics for the treatment of fibrosis has announced that US Food and Drug Administration (FDA) granted Fast Track designation to PRM-151 for the treatment of myelofibrosis (MF), a serious, life-limiting cancer characterized by fibrosis of the bone marrow. This Fast Track designation covers Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, and Post-Essential Thrombocythemia Myelofibrosis.

The FDA grants Fast Track designation to a product that is intended to treat a serious condition and that has demonstrated the potential to address an unmet medical need. The advantages of Fast Track designation include actions to Pharma Bio World

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expedite development and FDA review including opportunities for frequent interactions with the FDA review team and eligibility for priority review depending on clinical data at the time of Biologics License Application submission. PRM-151 was awarded orphan drug designation for myelofibrosis in September 2014.

Lonza, Celladon Sign Strategic Commercial Manufacturing Deal Lonza, a global leader in the field of viral therapy and biologics manufacturing, and Celladon Corporation, a biotechnology industry leader in the field of cardiovascular gene therapy, have entered into an agreement providing for the future commercial production of MYDICAR (AAV1/SERCA2a), Celladon’s enzyme replacement therapy for advanced heart failure that is currently in Phase 2b clinical development.

This agreement follows a successful multi-year clinical manufacturing relationship and provides for initiation of preconstruction activities and the reservation of Lonza resources giving Celladon an opportunity to trigger construction of the dedicated facility and secure a long term commercial supply arrangement.

BioAtla, BioDuro to Jointly Develop Two Antibody Therapeutics BioAtla, a global biotechnology company focused on the development of differentiated biological therapeutics, has announced an agreement with BioDuro to collaborate on the development of two therapeutic monoclonal antibodies in China. The two novel antibodies target specific indications with combined addressable populations of millions of patients.

“Working together with BioDuro through our ongoing relationship and leveraging the strengths of each company, we have identified two high-quality antibody candidates that address large market opportunities in China,” said Jay Short, PhD, President, Chief Executive Officer and Chairman of BioAtla.

Under the terms of the agreement, BioAtla will direct BioDuro’s efforts to advance these compounds through the preclinical and Phase I clinical phases. Under the direction of BioAtla, each candidate will be licensed to local Chinese biopharmaceutical companies for later stage clinical development and commercialisation in China.

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Automation Software B&R offers its revolutionary new mapp technology. These modular software blocks simplify the development of new programs and reduce the development time for new machines and systems by an average of 67%. At the same time, mapp reduces overall service and maintenance expenditures. mapp eliminates these recurring programming tasks for developers by providing preconfigured blocks that are easy to use and already extensively tested. Programmers can then concentrate on their main task: implementing machine or system processes in the application software. mapp blocks are seamlessly integrated into B&Râ&#x20AC;&#x2122;s automation software landscape. This means that any developer who works with Automation Studio can implement mapp blocks to make their work easier and their application software clearer. The end results speak for themselves: increased machine availability, lower maintenance costs and much easier team collaboration.

Sifter cum Multi-mill Uni-Granulator has been developed basically to maintain the batch sanctity for the requirement of uniform sizing of dried granules and to obtain an output with a negligible product loss.

The earlier system used to pass the dried granule through sifter and then pass the oversized granules through the multi-mill or to pass the dried granules through the milling machine. Both these processes were dust generation points besides being quite cumbersome.

Features high productivity machine with a capacity of 4 to 10 kg output per minute; easy dismantling, cleaning and reassembling in short duration of 10 to 15 minutes; sieve drums are available in 4 to 40 mesh sizes and can be easily changed for different products; feed and product discharge is continuous and has dust-free transfer system, both for charging and discharging of product; complete vibration-free and soundless design complete tool less design for easy dismantling and assembling reducing downtime; etc.

For more information, please contact:

For more information, please contact:

B&R Industrial Automation Pvt Ltd 8 Tara Heights, Mumbai-Pune Road Wakdewadi, Pune, Maharashtra 411 003 Tel; 020-41478999 | Fax: 91-020-41478998 E-mail: shyam.padwal@br-automation.com

Tapasya Engg Works Pvt Ltd A/212, Road No: 30 Wagle Indl Estate Thane (W), Maharashtra 400 606 Tel: 022-25822287, 25823250 | Fax: 91-022-25825243 E-mail: sales@tapasyaindia.net / info@tapasyaindia.net

Multi-functional Fluid Beds Solace Engineers offers multi-functional fluid beds for granulating/drying/pelletizing/coating. Features cartridge filter system for continuous process made of SS-316 easily removable for cleaning purpose; online sampling arrangement; unique spray gun for chokeless and uniform spray; reduced energy consumption; equipment management by means of automation; high product integrity is achieved by complete strict separation of technical and production area; dust-free handling as per cGMP norms; and integrated cleaning. All process parameters are interlocked, thus no possibility of batch failure. Special design and components are offered for individual applications and customer requirements. The hot and dry air is blown through a perforated distribution plate at the bottom of the fluid bed to ensure rapid, gentle and even drying of material until the required residual moisture content is obtained. The top spray granulator agglomerates fine powder by spraying liquid binding agents, into free-flowing granules that dry in the process. The bottom spray on the powder falling due to gravity ensures every granule being uniformly coated during fluidization and drying. The tangential spray system is used for making pellets, powder layering, granulating and film coating process.

For more information, please contact: Solace Engineers (Mktg) Pvt Ltd Gokulesh Comml Complex, 3 rd Floor, Sun Pharma Road, Tandalja Vadodara, Gujarat 390 020 Tel: 0265-2681543, 2681544 | Fax: 91-02662-222719 E-mail: info@solaceeng.com / solacekg@gmail.com

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Conical Screw Mixers Conical screw mixers, also called Nauta Mixers, make use of a conical chamber with a vertical screw that mixes the powder or substance. The convective mixing effect is created by following three factors: axial mixing by the screw; radial mixing by shape of the cone; and tangential mixing by the arm. The conical mixer can be equipped with a high speed rotor for liquid addition or de-lumping products. Rotating up to 20 m/s, this rotor creates vortex effect and injects the liquid through the paddles directly in the product resulting in an excellent dispersion or coating. By spraying the liquid in the mass itself in a vortex, overmoistening of particles is avoided and risk of sticking phenomena on the vessel. This intensifier can replace several lump breakers.

For more information, please contact: Saan Engineers Pvt Ltd Plot R-841, TTC Indl Area, MIDC Rabale, Navi Mumbai 400 701 Tel: 022-27606242 | Fax: 91-022-27606244 E-mail: saanengineers@saanengineers.com

Square Cone Blender Solace square cone blender is used in pharma industry mainly for mixing of granules and powder. It is steady in transmission, reliable in structure fully capable and highly uniform in mixing.

Inner wall of the hopper is slippery, easy to clean and has no dead angles. It has a fabricated butterfly valve having safety facility against wrong operation. This machine can blend in fully closed state and make dust-free environment for production complying with cGMP requirements.

Blending uniformity reaches up to 99 per cent and the loading capacity quotient reaches between 50 and 80 per cent. Working parameters like mixing time and rotating speed can be set. With speed controlled by frequency variation this machine is stable and without vibration during start and shutdown.

For more information, please contact: Solace Engineers (Mktg) Pvt Ltd Gokulesh Comml Complex, 3 rd Floor Sun Pharma Rioad, Tandalja, Vadodara, Gujarat 390 020 Tel: 0265-2681543, 2681544 | Fax: 91-02662-222719 E-mail: info@solaceeng.com / solacekg@gmail.com

Automation PC The new Automation PC 2100 from B&R unites the PC world with hard real-time applications. If needed, Automation Runtime and Windows can run at the same time thanks to powerful Intel Atom multi-core processing technology, allowing the Automation PC 2100 to be used simultaneously as a high-performance industrial controller as well as a PC for things like sophisticated HMI applications.

And with such compact dimensions, it takes up hardly any space in the control cabinet at all.

Available with single-, dual- or quad-core processors, the computing power of the Automation PC 2100 is fully scalable. At the upper range of performance, it even exceeds the performance of many Core i-Series processors. Other standard features include two gigabit Ethernet interfaces as well as one USB 2.0 and one USB 3.0 interface. Fieldbus connections such as POWERLINK or CAN can be individually configured, and compact MLC-based CFast cards with 60 GB or more are available to meet every memory need.

The graphics engine used by Intel Atom processors is derived from Core i technology and provides powerful processing all the way up to Full HD. This is also the first time that support for DirectX 11 is provided in this segment, opening up even more possibilities for enhanced graphic capabilities in SCADA and other HMI systems.

For more information, please contact: B&R Industrial Automation Pvt Ltd 8 Tara Heights, Mumbai-Pune Road Wakdewadi, Pune, Maharashtra 411 003 Tel; 020-41478999 | Fax: 91-020-41478998 E-mail: shyam.padwal@br-automation.com

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Water Ring Vacuum Pump Vacunair Engg Co Pvt Ltd offers water ring vacuum pump and compressors having non-pulsating vacuum and pressure energy saving pump designed by operating at low periphery speed and offer vacuum pump for specific power of 60 to 65 m 3/hr per kW. Pump is available in wide selection for any requirement range 20 to 7,000 m 3/hr, vacuum up to 700 mm Hg and vacuum up to 25 mm Hg absolute. No lubrication is required and can handle air/gas/air with water comfortably.

Standard pumps are available with stuffing box type gland seal arrangement and can also offer with mechanical seal.

Easy to maintain the pump as axial clearance are in mm size.

Impellers are duly dynamically balanced as per ISO 19401973 (E) Class G 6.3. Vacuum pumps are available in CIFG260, gun metal, phosphor bronze, aluminium bronze, SS-304, SS-316 and other alloy steel. It finds application in industries like chemical, pharma, fertilizers, etc

Industrial Hose Pump Verderflex offers the Verderflex Dura 55 designed to deliver over 20% more flow, increasing the Dura Hose pump family’s flow range. The addition of the Verderflex Dura 55 expands the Dura range’s flow rates from <1 l/hr to 15.3 m³/hr at pressures up to 16 bar. The Verderflex Dura 55 can reduce life cycle costs, maximise plant uptime and incorporate special design features for arduous heavy duty applications.

It solves pumping problems associated with dry running liquid streams, shear sensitive polymers, high viscosity sludge and pastes, variable speed dosing, abrasive solids in suspension and off-gassing fluids. This makes it ideal for use in a wide variety of applications including; biogas production, fly ash recirculation, chemical manufacturing, industrial processing, water treatment, etc. The Verderflex Dura 55 delivers more flow per revolution.It has a unique, patent pending port flange that totally encloses the hose. This flange also includes an innovative quarter turn lock system, halving hose change times to maximise plant uptime.

For more information, please contact:

For more information, please contact:

Vacunair Engg Co Pvt Ltd Nr Gujarat Bottling, Rakhial, Ahmedabad, Gujarat 380 023 Tel: 079-22910771 Fax: 91-079-22910770 E-mail: info@vacunair.com

Verder India Pumps Pvt Ltd Plot No: 3b + 3part 11, D-1 Block MIDC Block Chinchwad, Pune, Maharashtra 411 019 E-mail: sales@verder.co.in

Hot Water Recirculation Pump KSB offers hot water recirculation pumps for large industrial heating systems as well as forced circulation boilers and district heating systems. The horizontal, radially split single-stage volute casing pumps feature a back pull-out design. Their ratings and dimensions comply with ISO 2858; with regard to handling hot water, organic or synthetic heat transfer fluids, they also meet the technical requirements of ISO 5199.The HPK-L Pump Series, which comes in 49 different sizes, can be operated at temp of up to 400°C without any additional cooling devices, and is designed for pressure classes of up to PN 40. A fan impeller fitted at the pump shaft end generates a continuous flow of air between the large cooling fins surrounding the mechanical seal chamber. A service life of up to 25,000 operating hours is ensured by large, product-lubricated silicon carbide plain bearings fitted close to the impeller and by two angular contact ball bearings in back-to-back arrangement sealed on both sides and mounted at the “cold” end of the shaft. The patented venting profile, VenJet, makes sure that the gas contained in the fluid is separated near the mechanical seal and that it collects in the venting chamber.

For more information, please contact: KSB Pumps Ltd Mumbai Pune Road Pune, Maharashtra 411 018 Tel: 020-27101000, 27101241 | Fax: 91-020-27426000 E-mail: bipin.kode@ksb.com

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Candle Filters

Pool Test Application Instrument

SAP make candle filter provides pressure filtration as well as heel filtration in an enclosed and pressure tight housing. The filter media can be any type of cloth with a clean removal efficiency in the 1-5 micron range. As the cake builds up on the candle the efficiency improves to less than 1-micron.

Cake discharge via back washing or blow back by gas. After discharge the cycle begins again.

It finds application in recovery of catalyst like nickel, platinum, palladium, etc; removal of activated carbon, charcoal in pharma plants; resin filtration; filtration of hazardous liquids; all types of polishing filtration; bleaching earth removal in vegetable oil plants; etc.

The PTWS 4000 is a specialised 4-litre dissolution tester version that enables the user to perform either pooled tests or test for dosage that contain high concentrations of active material. The instrument is supplied with six stirred 4-litre and two unstirred 1-litre dissolution vessels.

This instrument can also be easily adapted to handle 2-litre and 1-litre vessels. The instrument control is the same as for all other PTWS instruments described above but the framework is substantially different. Two lift pillars are used to move the upper head housing. Staggered and synchronous stirrer start is possible. The system comes in a SS design, which is one of the highlights of the instrument.

For more information, please contact:

For more information, please contact:

SAP Filter Pvt Ltd

Pharma Test Instruments India Pvt Ltd 2, 2 nd Floor, Sree Datri Niwas Nagwara Circle, Outer Ring Road Opp: Manyata Softech Park Bengaluru, Karnataka 560 045 E-mail: c.neelam@pharma-test.de

Plot No: A-5, Sector 1, Vasai Taluka Indl Co-op Estate Ltd Goraipada, Vasai (E), Thane Maharashtra 401 208 Tel: 0250-2458982, 2023040, 3208273, 2450366 Fax: 91-0250-2481095 E-mail: info@sapfilter.com / sales@sapfilter.com

Rotating Dialysis Cell The PTSW 0 can be used to test the dissolution rate of suppositories and other lipophilic samples as well as gel capsules. It cannot only be incorporated into any PTWS tablet dissolution bath offering the staggered stirrer start option (PTWS 610, 1210, D610 and 4000), but also into the PTWS 310. The drive of the rotating cell is attached to the individual stirrer shafts of the dissolution bath while the built-in gearbox of the PTSW 0 reduces the nominal tool speed by a ratio of 4:1.

The sample is placed into the cell together with about 5 ml of dissolution media. The cell is sealed and the complete instrument is placed into a standard USP/EP dissolution glass vessel. This is usually filled with water at 37 OC. The active material will diffuse out through the membrane which covers the cell into the outer media, leaving bulking agents, such as wax or cocoa butter, behind. Sampling and measuring of the active content can be carried out by using a standard stainless sampling probe; no additional filter needs to be used.

For more information, please contact: Pharma Test Instruments India Pvt Ltd No: 2, 2 nd Floor, Sree Datri Niwas Nagwara Circle, Outer Ring Road, Opp: Manyata Softech Park Bengaluru, Karnataka 560 045 E-mail: c.neelam@pharma-test.de

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events diary

BioPharma World Expo 2015

P-Mec India

Date: 28 th -31th January 2015

Date: 2 nd - 4 th December 2014

Venue: Bombay Exhibition Centre, Mumbai

Venue: Bombay Exhibition Centre, Mumbai

BioPharma World Expo 2015 will be organised concurrently during the 27 th edition of CHEMTECH World Expo scheduled from January 28-31, 2015 at Bombay Exhibition Grounds, Goregaon (East), Mumbai. CHEMTECH has scheduled one day conference on BioPharma under the Chairmanship of Dr Harish Iyer , managing Director, Shantha Biotech on January 30, 2015.

The international conference aims at bringing the icons from the pharmaceutical and allied biotech sector to deliberate and discuss the expectations of the industry towards realising the vision of Make in India of the Honourable Prime Minister and building a healthy nation. The BioPharma Expo will provide an opportunity to connect with the eminent personalities from the industry presenting cutting-edge discoveries, research and opportunities for new business practices and partnerships.

P-MEC India will be held alongside the ICSE and CPhI events, offering complete coverage of all developments in the pharmaceutical word. The event will provide the opportunity to showcase their latest accomplishments in pharmaceutical machinery and equipment.

Contact: Amrita Patil Tel: +91-22-4037 3617 | Mob: +91-9224404990 Fax: +91-22-4037 3635 Email: amrita_patil@jasubhai.com

BioFIT 2014 Pharma and Biotech Event Date: 2 nd – 3 rd December 2014 Venue: Lille Grand Palais, France A partnering event entirely dedicated to tech transfer and open innovation in the Life Sciences sector. BioFIT attracts over 800 attendees from 30 countries among which top leaders from the pharma and biotech industry, academics and practitioners in technology transfer, intellectual property and licensing.

Together, they will share best practices, know-how and will maximise qualified alliances thanks to a cutting-edge partnering system.

Contact: Marion Sigier +(33) 3 28 55 90 60 72 November 2014

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Contact: Vikram Rao Sales Manager +31 20 40 99 524 Email: vikram.rao@ubm.com

66 th Indian Pharmaceutical Congress Date: 23 rd -25 th December 2014 Venue: Hitex Exhibition Centre in Madhapur, Hyderabad 66 th Indian Pharmaceutical Congress is one of the focused events on the Pharmaceutical Industry and will bring who’s who in the pharmaceutical profession.

The event will be held at Hitex Exhibition Centre, Hyderabad.

The Conference will be hosted by The All India Drugs Control Officers’ Confederation (AIDCOC) one of the constituent member of Indian Pharmaceutical Congress Association (IPCA) and exhibition will be organized by Federation of Indian Chambers of Commerce & Industry (FICCI).

The Event provides a platform for Joint venture partnership, project collaborations, and transfers of technology, investments and R&D. Contact: P Venkateshwarlu Chairman -Registration Committee, 66 th IPC Mob: 08297851100 E-mail: registration@66ipchyd.com Pharma Bio World

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bookshelf Handbook of Pharmaceutical Excipients (Hardcover) Authors: Raymond C Rowe, Paul J Sheskey, Walter G Cook, Marian E Fenton (Editors) Price: USD 470.25 No of Pages: 1064 Pages About the Book: The Handbook of Pharmaceutical Excipients is internationally recognised as the authoritative source of information on pharmaceutical excipients giving a comprehensive guide to uses, properties and safety. The handbook collects together essential data on the physical properties of excipients as well as providing information on their safe use and potential toxicity.

All 380 monographs are also thoroughly cross-referenced and indexed to allow their identification by chemical, non-proprietary or trade names.

Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems (Hardcover) Authors: Ashok Katdare, Mahesh Chaubal (Editors) Price: USD 117.45 No of Pages: 452 Pages About the Book: Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems serves as a comprehensive source to improve understanding of excipients and forge new avenues for regulatory review and allowance to use. This book presents detailed, upto-date information on various aspects of excipient development, testing, and technological considerations for their use. It addresses specific details such as historical perspective, preclinical testing, safety, and toxicology evaluation, as well as regulatory, quality, and utility aspects. The text also describes best practices for use of various functional excipients and extensive literature references for all topics.

A Review & Research on Natural Excipients in Drug Delivery (Paperback) Authors: Subas Chandra Dinda (Authors) Price: USD 97.85 No of Pages: 372 Pages About the Book: A Review & Research on Natural Excipients in Drug Delivery is a compilation of review and research work in the area of natural excipients such as gums, polymers and coloring agents utilised towards formulation and development of drug delivery systems. It highlights on the current area of ongoing research as well as focus on established natural excipients, which may encourage the readers to update their knowledge in the field of natural excipients.

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ad index Sr. No

Page No

1

Aimil Ltd

17

2

Ani Engineers

51

3

B & R Automation

Front Cover

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Bhavya Polymers

51

5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

Boge Compressors India Pvt Ltd Bry-Air (Asia) Pvt. Ltd Busch Vacuum India Pvt Ltd Citizen Industries Cole-Parmer India De Dietrich Process Systems India Pvt Ltd Fluorotech Engineering Works Fristam Pumps India Pvt Ltd Hanna Equipments (India) Pvt Ltd Ingersoll Rand (India) Ltd Inos Technologies Kirloskar Brothers Ltd M K Silicone Products Pvt Ltd Markem Image India Pvt Ltd Nichrome India Ltd NNE Pharmplan (India) Pvt Ltd Pharma World Expo 2015 PPI Pumps Pvt Ltd Praj HiPurity Systems Ltd Premium Transmission Ltd Sharplex Filters (India) Pvt Ltd SPX Flow Technology (India) Pvt Ltd SSP Pvt Ltd Technofour Electronics Pvt Ltd UNP Polyvalves (India) Pvt Ltd Vega India Level Pressure Measurement Pvt Ltd Watson Marlow India Pvt Ltd

74 November 2014

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Client’s Name

29 55 47 45 Inside Cover 5 49 13 49 33 43 Inside Cover I 53 25 31 35 Inside Cover II 53 Back Cover 23 11 19 37 41 21 9 7

Pharma Bio World

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R.N.I. No.: MAHENG/2002/08502. Date of Publication: 26th of every month. Postal Registration No: MH/MR/SOUTH-284/2014-16 Posted at Patrika Channel Sorting Office, Mumbai 400001, on 26th & 27th of every month. Total Pages:- 76