Pharma Bio World April 2019

VOL 17 | ISSUE 09 | APRIL 2019 | MUMBAI | TOTAL PAGES 60 | PRICE ` 150

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PHARMA BIO WORLD VOL 17 ISSUE 09 APRIL 2019 MUMBAI TOTAL PAGES 60 ` 150 BioPharma World Expo 2019 4-6, December 2019 Venue: HITEX Exhibi�on Center, Trade Fair Office Building, Izzat Nagar, Kondapur PO, Hyderabad, India

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4 ◄ April 2019

Pharma Bio World

FEATURES 12

Pain Point to Gaining Brownie Points: Technology is a Game Changer for Indian Pharma Sector Gauri Angrish, Founder & CEO, CAREDOSE

16

Biosimilars: Advancements, Future and the Role of Indian Pharma Market Dr. Piyush Gupta, Associate Director, GNH India

20

Novel Approaches in Preclinical Research, Pharmacogenomics, Drug Design and Drug Delivery Satish Wagh, Managing Director, Supriya Lifesciences

28

Phytopharmaceuticals - fighting disease with natural substances Dr. Ariane Pott, BIOPRO Baden-Württemberg, GmbH

12

INSIGHTS 31

Indian Pharma: Leapfrogging Beyond Generics

37

Driving Radical Growth To Make India A Pharma Superpower

26

MARKETING INITIATIVES 42

Increasing demand of Fluorosilicone Anuj Singh, Polymer Technologist, Ami Polymer Pvt Ltd

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Events

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BACKYARD 57

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Ad Index

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6 ◄ April 2019

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Pain Point to Gaining Brownie Points: Technology is a Game Changer for Indian Pharma Sector The Indian pharmaceutical industry has come a long way from traditional home-made herbal medicines to being the manufacturer of world class life-saving drugs. However, at the helm of game-changing innovations steering this industry to a whole new level is the implementation of technology.

W

hile providing proper healthcare facilities to the masses in a diverse country like India is a daunting task, it is heartening to note that in spite of challenges, the Indian healthcare industry is constantly moving ahead neck-to-neck alongside the pharmaceutical industry and other allied industries. To support the healthcare needs of a country that has over a billion people, and in helping it realize the vision of universal access to healthcare, the pharma sector forms a major part of the ecosystem.

India has become a crucial destination for manufacture and export of both branded and generic medicines. The Indian pharmaceutical market is projected to cross USD 100 billion by 2025, hence emerging as one of the largest pharmaceutical markets globally. Over the years, the pharma industry in our country has been changing and evolving; but in recent years, with unprecedented thrust on technological advancements and innovation, the pharma sector is growing in a fast track mode.

Overview of Current Challenges of Pharmaceutical Industry in India High Out of Pocket (OOP) expenditure is one of the challenges faced today by the pharma industry or healthcare at large, limiting access to medicines for patients. However, with innovative pharmaceutical products being patented in India, and external pressure from governments and public bodies, the “affordability burden� for this sector is expected to reduce in the near future.

Gauri Angrish Founder & CEO CAREDOSE 12 â—„ April 2019

World Health Organisation informs that more than 50% of people on regular medication do not adhere to their medication. Prescribing medicines to

patients is one thing and making sure patients actually take them is another.

According to standard data, medication non adherence rates can typically range from 30 to 60 per cent. Almost 20 to 80 per cent of patients make errors in taking proper medication and about 20 to 60 per cent stop taking medications when symptoms disappear. What makes the problem of nonadherence even worse is that more than 68 per cent patients do not communicate their non-adherence to their doctors or caregivers.

While this silent epidemic of medical nonadherence needs to be acknowledged and addressed, other major issues we already know about plaguing the industry for a long time include counterfeit medicines, lack of strong IP regulations, and the fragmented structure of the market leading to volatility or non-certainty.

Decoding the Benefits of Tech for the Pharma Industry The recent wave of technological advancements and research, introducing artificial intelligence to cloud computing, is changing the face of pharma industry.

The internet has changed how business operates completely. Today, from online e-commerce platforms selling drugs to online portal on drug information, internet has created empowered patients and/or stakeholders for the pharma sector.

With mobile technology on the rise, sophisticated apps are being developed for disease monitoring, medication adherence support and even health education.

Electronic prescribing (EP) systems not only automate prescribing, but also the supply and administration of medicines from small care unit to hospitals.

At Caredose, for instance, we make use of proprietary tech to track medicine adherence in patients, whilst building Pharma Bio World

big data for healthcare entities and public health programs. We are enabling healthcare entities to manage, track & optimise patient care. This is achieved by partnering up with them and equipping them to track complete medicine adherence in their patients, in real-time.

On the other hand, our service is useful for any individual on regular medication.

With multi-dose dispensers, timely dose reminders, and automated refills, we go

every step to make sure patients take the right medicine at the right time.

Digitization is a boon that not only streamlined the documentation processes but has helped in enhanced record keeping and better security, as well as enhanced safety by eliminating human errors. With automation taking the load of pharmacists, personalized care for every patient no longer remains a distant dream.

“The recent wave of technological advancements and research, introducing artificial intelligence to cloud computing, is changing the face of pharma industry. The internet has changed how business operates completely.�

14 â—„ April 2019

The Road Ahead This is just the beginning. Technology will perhaps complete change the face of the pharmaceutical industry in the coming decade. Some of the possible scenarios can be the change of pharmacy from drug distribution machines to health consultancies, personalized therapies for patients, and printing out drugs on demand using 3-D printing. Let technology solve the limitation and challenges of the pharma industry today for a healthier India tomorrow.

Contact: shalujha@prandit.com Pharma Bio World

Biosimilars: Advancements, Future and the Role of Indian Pharma Market Biosimilars is a fairly new area in pharma as the guidelines and procedures are yet to be set by FDA. Since, they are prepared with the help of living cells, just like biologics, it becomes important to understand the composition and if it is suited for the stated ailment.

B

iologics are drugs regulated by the Food and Drug Administration (FDA) used to treat chronic diseases.

These are large molecule drugs and made up of living cells which make them unique and more complex than a chemically synthesized drug that is made up of small molecules. Due to the complexity of large molecules, characterization of biologics becomes difficult. Slight differences in these products are normal and are accepted by the FDA within certain limits however, it becomes important to maintain and control within-product variations so as to maintain the right amount of active ingredients in the drug.

In order to reach a larger base of patients that need biologics, their identical copies are manufactured with similar bioactivity and structure. These drugs are called biosimilars. These are drugs that are highly similar to biologics in function and structure in addition to being inter-changeable with a FDA- approved biological product. High-end technological support is needed to compare characteristics of a reference product and a biosimilar that includes chemical identity, bioactivity and structure.

The existence of an alternative pathway paves way for providing more treatment options, extended access to important lifesaving medicines and fundamentally lower costs as a result of increased possibilities in front of pharmaceutical companies. Biosimilars are at a nascent stage today with an estimated market size of $2.2 billion out of the total $32 billion Indian pharma market.

Dr. Piyush Gupta Associate Director GNH India 16 ◄ April 2019

It is a fairly new area in pharma as the guidelines and procedures are not set by the FDA for biosimilars. Since, they are prepared with the help of living cells, just like biologics, it becomes important to understand the composition and if it is suited

for the stated ailment. A biological product might be different than a biosimilar in terms of application as the suitability matters for the patients. Hence, biosimilars when developed are clinically tested to test the suitability for a particular patient in question.

Role of Biosimilars Biological products are very complex in nature as they are produced in a living environment that could be yeast, bacteria or a cell. These products have transformed treatment methods for various serious diseases including cancer, dermatological conditions, rheumatoid arthritis, etc. In developing a biological product, vast amount of research and innovation is essential for the end-product. To solve this, biosimilar can play an important role.

Generic drugs are copies of small molecule drugs whereas biosimilars can be similar to or sometimes interchangeable with an FDA approved biological product.

They provide the following advantages in the long run: • More treatment options • Increased access to medication to save lives • Economies of scale FDA’s Abbreviated Pathway Biosimilars are safe and effective, approved by the FDA and cost-competitive.

Biosimilars could provide enormous savings to consumers through more product competition. Inherent variability in case of biosimilars can exist because of their biological nature. The molecules are bigger than that of a chemically synthesized product. Biological products did not have an abbreviated approval pathway that made it difficult for them to be manufactured at low costs as the requirement was of a full data package. This gets reflected in the cost of these products in the marketplace. Data packages between a biosimilar product and Pharma Bio World

the originator product are different and that is where abbreviated approval pathway comes into picture.

Steps to ensure usefulness of a Biosimilar A biosimilar has to be highly similar with no clinically meaningful differences as compared to a reference product in terms of structure and functions. Following are the two steps that a biosimilar goes through in the tests against reference or originator drug.

1 st Step: Analytical comparison for structural and functional usages-The biosimilar should have the same primary sequence and quaternary and tertiary structure that assists the functions 2 nd Step: To see for no clinically meaningful differences – Pharmacokinetics - Exposure in the body, release of drug in the body, its circulation in the body, if the transit is similar to that of the reference drug Safety profile of the drug also needs to be monitored to ensure it has the same profile between the products. Hence, conclusively it is determined if the product is safe and effective and it will work the same way in the body whether it’s a biosimilar or a reference product. It also needs to be ensured that the same clinical result is achieved in any given patient; the application needs to include data or information that supports this. Also, medication given more than once and the impact of switching back and forth between the interchangeable products is evaluated with the switching study.

Indian Pharma market Indian pharma market holds a prominent position in the global market scenario dominating branded generics and making up around 80% of the retail market, according to a report by Mckinsey. Due to the intense competition present in this industry, the price levels tend to be low making it further favorable to the patients.

The pharmaceutical industry in India ranks 3 rd in the world in terms of volume and 10 th in terms of value. The industry has given 18 ◄ April 2019

rise to numerous innovations in products, infrastructure and processes. India’s indigenous manufacturing methods have paved way for the development of another set of generics, this time biogenerics or biosimilars.

According to an Assocham report in 2017, the domestic biosimilars market is expected to reach $40 billion by 2030.

With a CAGR of approximately 30%, biosimilars are slated to become popular very soon, as the more affordable version of biologics. Development of a biosimilar might take approximately 5-9 years to be fully developed with a cost that is only 1/26 th the cost of developing a biologic. Hence, it has the potential of providing treatment options at a significantly lower cost.

Open Market Sourcing for clinical trials Biosimilars face stringent clinical timelines and it becomes important for companies to fast-track the development process of a biosimilar for a release that is well before the market gets crowded. Open market sourcing is considered as an effective strategy to support the growth of the biosimilars market. Open market strategy proves beneficial to the biosimilar makers as the clinical trial data can be kept discreet.

In addition to this, the biologics are made available at shorter lead times due to the availability of stock with the wholesaler or at a known manufacturing site.

Further, to support these clinical trials, a greater emphasis needs to be given in choosing the appropriate Comparator Sourcing Organization (CSO). The requirements range from the ability to source and transport products worldwide to validated storage/shipping systems.

GNH India is an organization with industry experience of over 12 years in comparator sourcing with exports to close to 180 countries around the world. Their validated shipping and storage shipments account for more than 135,000 products in their portfolio that present a great opportunity domestically in front of the market.

Future of Biosimilars in the Indian pharma market With the rising acceptance of this biogeneric, it is fast gaining popularity among pharmaceutical companies in India and abroad. The guidelines and procedures are moving towards providing biosimilars with the status that the industry has been waiting to attain. Adding to the catalysts is the recent USFDA approvals to various pharmaceutical organizations like Pfizer, Biocon, etc. With these progressions, the industry is fast striding forward. Biosimilars are drugs aimed at the treatment of serious and life-threatening diseases.

The Indian pharma companies are focusing all their efforts in developing their portfolio in this segment with the country’s large pharma players investing in huge numbers for the Research and Development of Biosimilars.

As patents of many biologics are expiring in the next few years, this aspect presents a great opportunity for the companies in India to focus their resources on the development of biosimilars.

India has a robust pipeline for biosimilar drugs that is in line with the Indian government’s plans to offer grants to Indian biosimilar manufacturers. According to Decision Resources Group’s analysis, more than 40 biosimilars are in the clinical development phase in India; a number higher than that in the US and almost similar to those in development in the European Economic Area (EEA). Another trick of the trade lies in strategic partnerships with companies outside of the Indian market to uplift their profiles in the world markets.

Differential pricing strategies present another set of opportunity in market expansion. This could work by targeting different economical sections of consumers with differentiated pricing strategies.

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Novel Approaches in Preclinical Research, Pharmacogenomics, Drug Design and Drug Delivery Novel approaches in rug iscovery are reuire as they may reuce cost of D improve safety an efficiency This article highlights novel approaches in rug iscovery ith particular emphasis on preclinical research pharmacogenomics rug esign an rug elivery

Satish agh Managing Director Supriya Lifesciences 20 ◄ April 2019

D

rug discovery is the process by which new chemical entities are discovered.

Historically, drugs were discovered by studying and identifying the active component from traditional remedies. Some have been discovered by serendipity. Later in the classical pharmacology methodology chemical libraries of synthetic small molecules, natural products or extracts were screened in vitro or in vivo to identify substances that have a desirable therapeutic effect. Since the recent past pharmacogenomics has gained lot of significance wherein human genome sequencing is the basis and collated with the pharmacology.

In the modern drug design process High throughput screening is carried out on large compounds libraries against isolated biological targets which are hypothesized to be disease modifying. Hits are then tested in cells and then in animals for efficacy. In the drug development cycle, preclinical development, also named preclinical studies and nonclinical studies, is a stage of research that begins before clinical trials (testing in humans) can begin, and during which important feasibility, iterative testing and drug safety data are collected. The main goals of pre-clinical studies are to determine the safe dose for first-in-man study and assess a product's safety profile. On average, only one in every 5,000 compounds that enters drug discovery to the stage of preclinical development becomes an approved drug.

Drug delivery studies have come a long way and have reached very advanced levels of research in drug administration such as thin film, magnetic, self microemulsifying , acoustic , neural .

The Drug Discoery Cycle Modern drug discovery involves the identification of screening hits, and optimization of those hits to increase the affinity, selectivity, efficacy/potency, metabolic stability, and oral bioavailability.

The identified compound then undergoes the process of drug development prior to clinical trials. Some steps may involve computer-aided drug design.

Modern drug discovery is a capitalintensive process. However despite advances in technology and understanding of biological systems, drug discovery is still a cumbersome process with low chances of new therapeutic discovery.

A singIe new molecular entity (NME) cost was approximately USD 2.0 Billion.

Drug discovery is done by pharmaceutical companies, with research assistance from universities. The drug requires very expensive Phase I, II and III clinical trials, and most of them fail. Small companies have a critical role, often then selling the rights to larger companies that have the resources to run the clinical trials.

Discovering drugs that may be a commercial success, or a public health success, involves a complex interaction between investors, industry, academia, patent laws, regulatory exclusivity, marketing and the need to balance secrecy with communication. A drug discovery process ends up in a patent on the potential drug.

The Drug Discoery Techniues The modern era in pharmacology began with the idea that the effect of a drug in the human body is mediated by specific interactions of the drug molecule with Pharma Bio World

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Figure 1: Drug Discovery Cycle biological macromolecules, (proteins or nucleic acids in most cases) led scientists to the conclusion that individual chemicals are required for the biological activity of the drug. Thus pure chemicals, instead of crude extracts, became the standard drugs. Morphine, the active agent in opium, and digoxin, a heart stimulant originating from Digitalis lanata are Examples of drug compounds isolated from crude preparations. Organic chemistry also led to the synthesis of many of the natural products isolated from biological sources.

In Classical pharmacology, forward pharmacology or phenotypic drug discovery. historically substances, whether crude extracts or purified chemicals were screened for biological activity without knowledge of the biological target. Only after an active substance was identified was an effort made to identify the target. Small molecules were synthesized to specifically target a known physiological/pathological pathway, rather than adopt the mass screening of banks of stored compounds. This led to great success, such as the work of Gertrude Elion and George H. Hitchings on purine metabolism, the work of James Black on beta blockers and cimetidine, and the discovery of statins by Akira Endo.

22 â—„ April 2019

Another champion of the approach of developing chemical analogues of known active substances was Sir David Jack at Allen and Hanbury's, later Glaxo, who pioneered the first inhaled selective beta2-adrenergic agonist for asthma, the first inhaled steroid for asthma, ranitidine as a successor to cimetidine, and supported the development of the triptans. Gertrude Elion, working mostly with a group of fewer than 50 people on purine analogues, contributed to the discovery of the first anti-viral; the first immunosuppressant (azathioprine) that allowed human organ transplantation; the first drug to induce remission of childhood leukaemia; pivotal anti-cancer treatments; an anti-malarial; an anti-bacterial; and a treatment for gout.

Cloning of human proteins made possible the screening of large libraries of compounds against specific targets thought to be linked to specific diseases.

This approach is known as reverse pharmacology and is the most frequently used approach today. Thus a paradigm shift has occurred in the drug design methodology.

The drug target is usually the naturally existing cellular or molecular structure involved in the pathology of interest that

the drug-in-development is meant to act on. There are two types of drug targets, established and new. "Established targets" are those for which there is a good scientific understanding, supported by a lengthy publication history, of both how the target functions in normal physiology and how it is involved in human pathology. target is fully understood. Rather, "established" relates directly to the amount of background information available on a target, in particular functional information.

The process of gathering such functional information is called target validation in pharmaceutical industry parlance.

Established targets also include those that the pharmaceutical industry has had experience mounting drug discovery campaigns against in the past; such a history provides information on the chemical feasibility of developing a small molecular therapeutic against the target and can provide licensing opportunities and freedom-to-operate indicators with respect to small-molecule therapeutic candidates.

"New targets" are all those targets that are not "established targets" but which have been or are the subject of drug discovery campaigns. These typically include newly Pharma Bio World

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discovered proteins, or proteins whose function has now become clear as a result of basic scientific research.

chemists will attempt to use structureactivity relationships (SAR) to improve certain features of the lead compound:

The majority of targets currently selected for drug discovery efforts are proteins.

Two classes predominate: G-proteincoupled receptors (or GPCRs) and protein kinases.

•• increase activity against the chosen target

In this decade to date an estimated 435 human genome products were identified as therapeutic drug targets of FDAapproved drugs.

This process will require several iterative screening runs, during which, it is hoped, the properties of the new molecular entities will improve, and allow the favored compounds to go forward to in vitro and in vivo testing for activity in the disease model of choice.

1) High Throughput Screening The process of finding a new drug against a chosen target for a particular disease usually involves high-throughput screening (HTS), wherein large libraries of chemicals are tested for their ability to modify the target. For example, if the target is a novel GPCR, compounds will be screened for their ability to inhibit or stimulate that receptor (see antagonist and agonist): if the target is a protein kinase, the chemicals will be tested for their ability to inhibit that kinase.

Another important function of HTS is selectivity ie to show how selective the compounds are for the chosen target.

To this end, other screening runs will be made to see whether the "hits" against the chosen target will interfere with other related targets - this is the process of cross-screening. Cross-screening is important, because the more unrelated targets a compound hits, the more likely that off-target toxicity will occur with that compound once it reaches the clinic.

It is more often observed that several compounds are found to have some degree of activity, and if these compounds share common chemical features, one or more pharmacophores can then be developed. At this point, medicinal 24 ◄ April 2019

•• reduce activity against unrelated targets •• improve

the drug likeness or ADME properties of the molecule.

While HTS is a commonly used method for novel drug discovery, it is not the only method. It is often possible to start from a molecule which already has some of the desired properties. Such a molecule might be extracted from a natural product or even be a drug on the market which could be improved upon (so-called "me too" drugs).

Other methods, such as virtual high throughput screening, where screening is done using computer-generated models and attempting to "dock" virtual libraries to a target, are also often used.

2) Drug Design Another important method for drug discovery is drug design, whereby the biological and physical properties of the target are studied, and a prediction is made of the sorts of chemicals that might (e.g.) fit into an active site. One example is fragment-based lead discovery. Novel pharmacophores can emerge very rapidly from these exercises. In general, computer-aided drug design is often but not always used to try to improve the potency and properties of new drug leads.

Once a lead compound series has been established with sufficient target potency and selectivity and favorable drug-like

properties, one or two compounds will then be proposed for drug development.

The best of these is generally called the lead compound, while the other will be designated as the "backup".

3) Combinatorial Chemistry Combinatorial chemistry was a key technology enabling the efficient generation of large screening libraries for the needs of high-throughput screening.

However, now, after two decades of combinatorial chemistry, it has been pointed out that despite the increased efficiency in chemical synthesis, no increase in lead or drug candidates has been reached. This has led to analysis of chemical characteristics of combinatorial chemistry products, compared to existing drugs or natural products.

The chemo-informatics concept chemical diversity, depicted as distribution of compounds in the chemical space based on their physicochemical characteristics, is often used to describe the difference between the combinatorial chemistry libraries and natural products. The synthetic, combinatorial library compounds seem to cover only a limited and quite uniform chemical space, whereas existing drugs and particularly natural products, exhibit much greater chemical diversity, distributing more evenly to the chemical space.

The most prominent differences between natural products and compounds in combinatorial chemistry libraries are the number of chiral centers (much higher in natural compounds), structure rigidity (higher in natural compounds) and number of aromatic moieties (higher in combinatorial chemistry libraries). Other chemical differences between these two groups include the nature of heteroatoms (O and N enriched in natural products, and S and halogen atoms more often present Pharma Bio World

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in synthetic compounds), as well as level of non-aromatic unsaturation (higher in natural products). As both structure rigidity and chirality are both well-established factors in medicinal chemistry known to enhance compounds specificity and efficacy as a drug, it has been suggested that natural products compare favorable to today's combinatorial chemistry libraries as potential lead molecules.

Many drugs that are currently available are "one size fits all," but they don't work the same way for everyone. It can be difficult to predict who will benefit from a medication, who will not respond at all, and who will experience negative side effects (called adverse drug reactions).

Adverse drug reactions are a significant cause of hospitalizations and deaths in the United States.

4) Structural Elucidation

With the knowledge gained from the Human Genome Project, researchers are learning how inherited differences in genes affect the body's response to medications.

These genetic differences will be used to predict whether a medication will be effective for a particular person and to help prevent adverse drug reactions.

The elucidation of the chemical structure is critical to avoid the re-discovery of a chemical agent that is already known for its structure and chemical activity.

Mass spectrometry is a method in which individual compounds are identified based on their mass/charge ratio, after ionization.

Chemical compounds exist in nature as mixtures, so the combination of liquid chromatography and mass spectrometry (LCMS) is often used to separate the individual chemicals. Databases of mass spectras for known compounds are available, and can be used to assign a structure to an unknown mass spectrum.

Nuclear magnetic resonance spectroscopy is the primary technique for determining chemical structures of natural products. NMR yields information about individual hydrogen and carbon atoms in the structure, allowing detailed reconstruction of the molecule's architecture.

Pharmacogenomics Pharmacogenomics is the study of how genes affect a person's response to drugs. This relatively new field combines pharmacology (the science of drugs) and genomics (the study of genes and their functions) to develop effective, safe medications and doses that will be tailored to a person's genetic makeup.

26 ◄ April 2019

The field of pharmacogenomics is still in its infancy. Its use is currently quite limited, but new approaches are under study in clinical trials. In the future, pharmacogenomics will allow the development of tailored drugs to treat a wide range of health problems, including cardiovascular disease, Alzheimer disease, cancer, HIV/AIDS, and asthma.

Preclinical Research Each class of product may undergo different types of preclinical research. For instance, drugs may undergo;

Most preclinical studies must adhere to GLPs in ICH Guidelines to be acceptable for submission to regulatory agencies such as the Food & Drug Administration in the United States.

Typically, both in vitro and in vivo tests will be performed. Studies of a drug's toxicity include which organs are targeted by that drug, as well as if there are any long-term carcinogenic effects or toxic effects on mammalian reproduction.

Animal Testing The information collected from these studies is vital so that safe human testing can begin. Typically, in drug development studies animal testing involves two species. The most commonly used models are murine and canine, although primate and porcine are also used.

Choice of Species The choice of species is based on which will give the best correlation to human trials. Differences in the gut, enzyme activity, circulatory system, or other considerations make certain models more appropriate based on the dosage form, site of activity, or noxious metabolites.

Depending on a drug's functional groups, it may be metabolized in similar or different ways between species, which will affect both efficacy and toxicology.

••

pharmacodynamics (what the drug does to the body) (PD),

••

Pharmacokinetics (what the body does to the drug) (PK),

Importantly, the regulatory guidelines of FDA, EMA, and other similar international and regional authorities usually require safety testing in at least two mammalian species, including one non-rodent species, prior to human trials authorization.

••

Absorption, distribution, metabolism, and excretion, (ADME),

NOAEL

••

Toxicology testing.

This data allows researchers to estimate a safe starting dose of the drug for clinical trials in humans.

Based on preclinical trials, No Observable Adverse Effect Levels (NOAEL) on drugs are established, which are used to determine initial phase 1 clinical trial Pharma Bio World

dosage levels on a mass API per mass patient basis. Generally a 1/100 uncertainty factor or "safety margin" is included to account for interspecies (1/10) and interindividual (1/10) differences.

improving product efficacy and safety, as well as patient convenience and compliance. Drug release is from: diffusion, degradation, swelling, and affinity-based mechanisms.

Drug Deliery

Most common routes of administration include the preferred non-invasive peroral (through the mouth), topical (skin), transmucosal, (nasal, buccal / sublingual, vaginal , ocular and rectal) and inhalation routes. Many medications such as peptide and protein, antibody, vaccine and gene based drugs, in general may not be delivered using these routes because they might be susceptible to enzymatic degradation or can not be absorbed into the systemic circulation efficiently due to molecular size and charge issues to be therapeutically effective.

Many protein and peptide drugs have to be delivered by injection or a nano needle array precisely for this reason

This refers to approaches, formulations, technologies, and systems for transporting a pharmaceutical compound in the body to safely achieve its desired therapeutic effect safely as needed . Drug delivery is often approached via a drug's chemical formulation, but it may also involve medical devices or drug-device combination products. The concept of drug delivery is in synchronization with dosage form and route of administration Drug delivery technologies modify drug release profile, absorption, distribution and elimination for the benefit of

Current efforts in the area of drug delivery include the development of targeted delivery in which the drug is only active in the target area of the body (for example, in cancerous tissues), sustained release formulations in which the drug is released over a period of time in a controlled manner from a formulation, and methods to increase survival of peroral agents which must pass through the stomach's acidic environment. In order to achieve efficient targeted delivery, the designed system must avoid the host's defense mechanisms and circulate to its intended site of action. Types of sustained release formulations include liposomes, drug loaded biodegradable microspheres and drug polymer conjugates. Survival of agents as they pass through the stomach typically is an issue for agents which cannot be encased in a solid tablet.

Contact satishsupriyalifesciences.com

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April 2019 ► 27

Phytopharmaceuticals - fighting disease with natural substances Phytopharmaceuticals are herbal medicines whose efficacy is down to one or several plant substances or active ingredients.

They have been used for treating diseases since time immemorial. This traditional knowledge is still the basis for many medicinal products made from plants or parts thereof.

P

lants produce an incredible variety of natural compounds. It is therefore not surprising that humans make use of this huge diversity. Historical sources show that the use of medicinal plants goes way back to the Bronze Age. Europe has a culture of using medicinal plants that starts with Hildegard von Bingen, continues with Friedrich Sertürner who was the first to isolate morphine in pure form and ends with the modern-day production of herbal medicines.

Plant etracts as the basis ointments tablets and teas

for

The secret of phytopharmaceuticals, i.e. herbal medicines lies in plants. Plants or parts thereof are used for the production of herbal medicines. In pharmacology, crude drugs are, amongst other things, defined as the naturally occurring, unrefined material of plant, animal or microbial origin used for medicine. Herbal crude drugs (also called herbal material, starting material) are therefore plants or parts (e.g. flowers, seeds, fruit and stems) thereof in an unprocessed state, in either fresh or dried condition, whole or reduced in size by grinding or chopping.

They usually contain a large number of chemical compounds with or without medical effect. They are the basis for finished herbal products, i.e. phytopharmaceuticals.

Herbal crude drugs are processed into herbal extracts (i.e. herbal preparations) by drying, extracting, etc., thus leading to an enrichment of the bioactive compounds.

Phytopharmaceuticals, i.e. herbal medicines, therefore consist of several compounds with a therapeutic effect. Herbal medicines are sold in dry form as granules, tablets, capsules and lozenges. Medicinal oils such as arnica flower oil can be used to make ointments.1 Dr. Ariane Pott BIOPRO Baden-Württemberg GmbH 28 ◄ April 2019

Phytotherapy is not the same as homoeopathy The German Medicines Act (AMG) defines what herbal medicines are (see definition).

The AMG regards plant compounds that can be isolated in pure form from plants such as atropine and morphine as chemically defined compounds, and therefore classifies them as classical medicines. Phytopharmaceuticals, on the other hand, always contain entire plants, parts or materials thereof.

Phytopharmaceuticals are used for treating diseases based on scientific knowledge (phytotherapy). Although the AMG classifies phytopharmaceuticals, homoeopathic and anthroposophic drugs as special therapy options, phytopharmaceuticals differ from homoeopathic and anthroposophic drugs in terms of production, approval and the therapeutic approach for which they are used.

AMG § 4 Other definitions (29): Herbal medicinal products are medicinal products which exclusively contain, as active substances, either one or more herbal compounds, one or more herbal preparations, or one or more such herbal compounds in combination with one or more such herbal preparations.” (http:// www.gesetze-im-internet.de/englisch_amg/ englisch_amg.html#p0074) The German Federal Institute for Drugs and Medical Devices (BfArM) grants marketing authorisation for medicinal products, including herbal medicinal products. Drug manufacturers must provide documentation on the efficacy, safety and quality of the product they want to register with the BfArM. Traditional herbal medicines that have been in use for 15 years within the EU and 30 years outside the EU are subject to a simpler approval procedure than traditional chemical drugs on the basis of monograph collections, and no additional clinical trials are required.

Phytopharmaceuticals are made from secondary plant metabolites But what determines whether plants are suitable as food and for use as remedies for Pharma Bio World

defense barriers. Filipendula ulmaria (commonly known The glycoalkaloids as meadowsweet), and a salicylic acid tomatine and derivative, acetylsalicylic acid, which is dehydrotomatine produced by willows, have a long tradition protect green of reducing pain and fever, but have been tomatoes from produced using chemical methods for over being eaten by a century. 3 herbivores, and from infection by St. John's wort is a well-known herbal fungi and lichens. medicine They are gradually St. John’s wort is an excellent example degraded as the for illustrating the variety of structures and tomatoes mature. effects of secondary plant metabolites. The Ripe tomatoes herbal medicine (Hyperici herba) is extracted contain little or from dried Hypericum perforatum flowers no tomatine and and aerial parts. Amongst other things, the dehydrotomatine preparation contains naphthodianthrone Figure 1: Relationship between the different terms used inphytopharmaceutical and are safe hypericin (antiviral effect), the phloroglucinol production (modified from Hänsel and Sticher1) © Dr. Ariane Pott to eat.

Some derivative hyperforin (antibacterial effect) plant metabolites are as well as other flavonoids (hyperoside) humans and animals? All plants function secondary with a so-called primary metabolism that formed only when the plant is infested and xanthones. The presence of all these microbial pathogens.

These substances in the finished medicinal product, produces and degrades amino acids, by fats, carbohydrates and nucleotides. so-called phytoalexins have an antimicrobial which is produced from hydroalcoholic extracts (ethanol 50-60%, methanol 80%), These synthesis pathways are therefore effect. 1,2 is determined during the production process present in all plants and also quite using thin-layer chromatography. While the Active plant substances for treating similar between different plant families. antiviral and antibacterial effects of the congestive heart failure The so-called secondary metabolism herbal substance are derived from hyperforin The example of tomatoes shows that is connected to the primary one as it uses building blocks from the primary active plant ingredients are not necessarily and hypericines, the actual mechanism of metabolism to produce a large number individual active ingredients, but a mixture action in the plant’s proven antidepressant of specialised compounds. These are of several. Only a few classified into a very small number of herbal ingredients are groups according to their biosynthetic used for therapeutic applications without origins and chemical structures. further processing. is one Alkaloids and amines are formed from amino Digitoxin acids. Other secondary metabolites include such compound. It is polyketides, steroids and phenylpropanoids. isolated in pure form Around 80,000 unique chemical structures from purple foxglove purpurea) have been isolated from secondary higher (Digitalis and is effective as a plant metabolites.1 Different plant families cardiac glycoside for produce different secondary metabolites, congestive which also vary considerably in their treating chemical structure, resulting in a huge heart failure. However, number of closely related structures. Plants in the majority of cases produce different secondary metabolites in natural compounds are different developmental phases. Secondary used as models for metabolites are important for communicating chemically synthesised and interacting with other organisms p h a r m a c e u t i c a l and with the environment. Tomatoes are substances: salicylic an excellent example for illustrating the acid, which is Figure 2: Colchicine is a toxic alkaloid and the major one found in effect of certain secondary metabolites as produced by the plant autumn crocuses (Colchicum autumnale). © NEUROtiker Pharma Bio World

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Figure 3: The flavonoid quercetin is synthesised through the polyketide pathway and large quantities of quercetin are found in lovage (Levisticum officinale). © Yikrazuul, effect is not yet known. In this case, the total extract exerts the medical effect, and is thus the active ingredient of the medicine. 1

Plants still harbour many secrets These examples show that even though the use of medicinal plants has a long tradition in Europe, intensive research is continuing in this area to optimise existing drugs and identify new indications for known medicinal

plants. Researchers from the Institute of Naturopathic Medicine and Clinical Pharmacology at the University of Ulm, in cooperation with colleagues from France and Tunisia, have shown in the mouse model that arglabin, which has promising antitumour activity, also has the ability to reduce the progression of type 2 diabetes mellitus. Arglabin is extracted from plants of the Artemisia genus, including mugwort.

Ongoing research therefore contributes to the discovery of new areas where known secondary plant metabolites can be used.

References: 1 Pharmakognosie –Phytopharmazie, R. Hänsel and O. Sticher (eds.), 9., revised edition, Springer Medizin Corporate Publishing, Heidelberg 2010 2 Ernährungsumschau 08/07, C. Weiß 3 Vorbild Natur, Stand und Perspektiven der Naturstoff-Forschung in Deutschland, 2007 DECHEMA e.V., Frankfurt am Main

Figure 4: St. John’s wort extract is a popular herbal medicine for treating depression. © Dr. Willmar Schwabe

30 ◄ April 2019

This article was first published in https://www.gesundheitsindustrie-bw.de/en

Each monthly edition of PBW covers a separate area of pharma and biotech industry and includes articles from a range of peers, consultants and commentators, interview with industry experts, Market research analyzing industry trends, News Features, News Updates, Product Trends, Events Diary and Bookshelf.

Target readers for PBW are Drug manufacturers, Intermediates, Pharma machinery/equipment manufacturers and suppliers, Pharma packaging firms, Research institutes, Academic institutes, Biotechnology firms, Consultants and Government bodies.

You are most welcome to share editorial content with us such as technical articles, case studies and product write-ups. The length of the article should not exceed 1500 words with maximum three illustrations, images, graphs, charts etc. All the images should be high-resolution (300 DPI) and attached separately in JPEG or JPG format.

Have a look at our editorial calendar on our website www.pharmabioworld.com.

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insights

Indian Pharma: Leapfrogging Beyond Generics The past decade will be earmarked as a transition period in Indian pharma industry, where the idea of going beyond generics has been seeded into many established companies and at the same time, there is slow, yet a steady upswing in the number of aspiring ventures attempting to crack the code in novel drug discovery and development. The innovation ecosystem has evolved and has been nurtured from several ends. Some of the notable developments are briefly discussed below.

Ease of access created for seed and early risk funding As a fore-runner in innovation funding, Technology Development Board (TDB) under DST has been providing financial assistance up to 50% of project cost in the form of soft loans. Additional extramural funding that was introduced by DBT through BIRAC since 2012 has proven to be a strong pillar of financial support for R&D ventures in the country, especially for early stage funding. BIRAC alone, through its several vectors has supported 617 projects that have filed closed to 150 patents as of September 2017. BIRAC’s flagship scheme (Biotechnology Ignition Grant) has supported more than 140 entrepreneurial ideas at pre-proof of concept stage. Given the various non-dilutive funding platforms created, most biotech entrepreneurs can today access seed capital without any hindrance and can often leverage such funding platforms for early support to the range of USD 100 thousand to USD 1 million. This has empowered ventures to pursue ideas and advance to in-vitro proof of concept stage with Government support.

Several other evolving newer initiatives such as Start-Up India and BIRAC’s i3 program further nurture the path of innovation and provide additional boost to the innovation ecosystem in the country.

Several of these funding programs also serve as technology de-risking funding that larger companies can access and thus have the potential to catalyze greater corporate investment in innovation led portfolio development.

Pharma Bio World

BIRAC i3 Program Birac’s i3 is a USD 250 million corpus created as part of Biopharma Mission to fund biotech startups and accelerate innovation in the areas of vaccines, bio-therapeutics and medical devices. With USD 125 million from the World Bank and an equal contribution from Government of India, the program will fund companies to advance assets and other capacity building efforts Incubation infrastructure and nurturing of innovation hubs There is significant global evidence that life science innovation is fostered more effectively in clusters. There has been both a natural evolution as well as a concerted effort to support various thriving geographic hubs in the country. The nucleus continues to be Hyderabad, Bangalore and Pune but there is considerable level of investment an engagement in other locations such as Delhi and Chennai and emerging engagement in nascent hubs such as Bhubaneshwar and Trivandrum. This has been supported by creation of required incubation infrastructure through various Government programs funded by DST, DBT and even NITI Aayog.

Access to shared labs and bench equipment for initial proof of concept research is no more change for life science ventures.

Combined with the expansion of early stage funding platforms, this has supported the spurt of innovation led ventures across the breadth of the country.

Regulations and Fiscal Incentives The ecosystem has been supported by a supportive regulatory framework and a forthcoming approach from regulators to pro-actively work with industry to create an

enabling environment. Examples of proactive regulatory change include the Medical Device Rules 2017 and the revised guidelines for Biosimilars issued in 2016. With the draft guideline for gene editing expected to be put in the public domain for comments soon, the anticipated of continued proactive approach from the regulatory system provides great impetus for the young innovation ecosystem.

While tax benefits on R&D investments are been gradually phased out, the country has introduced taxation on royalty income at a concessional rate of 10%, down from corporate tax rate of around 30%.

Need for International Benchmarking The transition from a large generics base to an innovation led era is complex due to the significant step up in risk level and nature of investments needed. Given the rapidly evolving global context where several economics around the world are trying to catapult into higher margin innovation led growth, it is very essential that India can leapfrog level of engagement. While there is no single recipe to do so, it would be myopic to assess areas that call for attention without benchmarking with quantum and nature of efforts being driven by economies that have made similar transitions or are doing so. As a precursor to a discussion on the way ahead for India to advance to the next realm, we present below a brief summary of notable global initiatives: International Benchmarks for Innovation Benchmarks discussed below have been strategically chosen for their relevance.

Israel stands out as the one of the most prolific innovation hubs globally, including in the area of biopharmaceuticals. The country April 2019 ► 31

insights has been extended to include the start-up community of incubatees of the Hong Kong Science and Technology Parks Corporation (HKSTPC) and Cyberport. Additionally, to encourage the spirit of innovation in the startup community, the Government subsidizes these parks to recruit up to 2 graduates from local universities as interns with a monthly allowance of up to $ 16,500.

South Korea: South Korea is a highly pertinent global Public Sector Trial Scheme and Internship Programme: Hong Kong’s Public Sector Scheme reference given the Trial commendable provides funding support for production of prototypes/samples and conducting of trial schemes transformation of the country from a in the public sector to facilitate commercialization of R&D results focused under public projects.

As partto a domestically generics industry of the budget 2017-18, the scope of this funding strong has been extendedforce to include the start-up innovation in pharmaceuticals, community of incubatees of the Hong Kong Science with and Technology (HKSTPC) USFDA andParks EMACorporation approved drugs today.

and Cyberport. Additionally, to encourage the spirit of innovation in the start-up community, the Government subsidizes these parks to recruit up to 2Korea graduatesDrug from local universities as interns Development Fund with a monthly allowance of up to $ 16,500.

(KDDF): KDDF has been a strong driving

has delivered several blockbusters to the world, including small molecule oncology drugs such as Doxil and more recently, the one of the first few CAR-T cell therapies to be approved by USFDA (Kite Pharma). South Korea attempted the transition from small molecules generics to biologics in parallel with India and now boasts of an active pipeline. Lastly, Hong Kong has gained great relevance in the recent past, especially for initiatives around access to capital for innovation led ventures.

Hong-Kong: Hong Kong is undeniably one of the thriving global hot spot today, teeming with innovation. Although it is more popular as a FinTech hub, the government thrust on innovation and makes it a good global case study with significant recent measures taken towards fostering transformative growth of innovation-led start-up ecosystem.

force behind the evolution of South Korea as South Korea: companies, and allowing companies valued a strong powerhouse intransformation global pharmaofindustry South Korea is a highly pertinent global reference given the commendable the over HK$10 billion, already listed in other stock country from a domestically focused generics industry strong force in today. A $to1.5abillion fundinnovation from the Government, exchanges, a secondary listing in Hong Kong, pharmaceuticals, with USFDA and EMA approved drugs today.

KDDF specifically provide grants for drug to name a few. Considering the high criticality

development companies, lofty target Korea Drug toDevelopment Fund (KDDF): KDDF has been a strong driving with forcethebehind the of of access capital for late stage validation creating 10 blockbuster drugs by year 2020.

A evolution of South Korea as a strong powerhouse in global pharma industry today.

A $ 1.5 billion and market entry of young ventures, this is a to its success, it has fund from the Government, KDDF specifically grantsprogram for drugen-route development companies, favorable move that deserves emulation provide in powerful a robust pipeline program of novel drugs in the with lofty target of creatingto 10 rapidly blockbuster drugsfostered by year 2020.

A powerful en-route othertheemerging economies, propel toinnovation its success, it has a robust pipeline of novel drugs in as theshown country today, country today, below . as shown from labsfostered to market. below2.

25 •Leads

43 •Candidates

25 •NonClinical

20 •Phase I

14 •Phase II

0 •Phase III

HK Benefits $ 2 Billion Fund: Acquisition: In September Fiscal for Technology Tax credits and benefits to Fiscal Benefihave ts been for introduced Technology 2017, the Innovation Technology encourage technology and IPand acquisitions.

Corporate tax on income by benefi SMEs ts and Acquisition: Taxgenerated credits and have Commission (ITC) of companies Hong Kong launched specified medium-scale from the transfer of patents to a Korean national is reduced been introduced to encourage technology an50%. innovative HK$ 2 are billion whereby VC activities by Tax incentives alsofund provided for M&A that furthers innovation of and IP acquisitions.

Corporate potential tax on income funds from When within aasdomestic well as Korean outsidefirm Hong the country. merges with a technology-led SME the merger generated by SMEs and specified mediumKong can co-invest with thetaxgovernment company is eligible to avail a 10% credit on the payment made, up to the value of the acquired scale companies from the transfer of patents in local technology-led start-ups. The technology.

Government and the eligible Fund will invest

to a Korean national is reduced by 50%.

Robust Stock Exchange: Korea is home to a robust NASDAQ like stock exchange favoring Overhaul of listing policies: With in an approximate 1: 2 ratio on each venture. Tax incentives are also provided for M&A innovation-led ventures, allowing them a pre-revenue listing based on a technology assessment. activities that furthers innovation potential of

the stock exchanges of New York, Shanghai, This is an innovative measure is expected to trigger VC interest in local startups and the country. When a domestic Korean firm London and Singapore leading as IPO hubs for Israel: merges with a technology-led SMEand theismerger Over the pastinnovations few decades, has cemented its reputation as the "Start-up Nation" the to Israel markets. raising equity capital for young ventures, Hong accelerate second most innovative nation in the world, according to the World Economic Forum’s Global company is eligible to avail a 10% tax credit Kong had until recently stayed out of the race, Public Sector Trial Scheme and on the payment made, up to the value of the content with most listed companies being large industrial or financial ventures. The city repealed Internship Programme: Hong Kong’s acquired technology.

Sector Trial Scheme provides funding its listing policies in December 2017 that are 2 Public KDDF website set to be effective in mid-2018, in an attempt support for production of prototypes/samples Robust Stock Exchange: Korea to attract younger ventures. The new rules and conducting of trial schemes in the public is home to a robust NASDAQ like stock have brought in significant changes favoring sector to facilitate commercialization of R&D exchange favoring innovation-led ventures, technology-led companies, such as waiving results under public projects. As part of the allowing them a pre-revenue listing based on revenue track record in the city for lower valued budget 2017-18, the scope of this funding a technology assessment.

32 ◄ April 2019

Pharma Bio World

insights Israel: Over the past few decades, Israel has cemented its reputation as the “Start-up Nation” and is the second most innovative nation in the world, according to the World Economic Forum’s Global Competitiveness Report 2016-2017. Between 1999 and 2014, Israelis started 10,185 companies, with half of them still in operation and 2.6% having annual revenues of over $100 million.

Growing trend of incubation spaces and co-working spaces: The Israeli government founded the Technology Incubator program in the early 1990s with over 25 incubators now been privatized. The incubators also offer government funding of up to 85% of early stage project costs for two years. Israel also has a number of city-funded co-working spaces which have been growing rapidly over the last few years.

Incentives for supporting foreign R&D centers of MNCs in Israel: The number of multinational corporation (MNC) R&D centers in Israel is among the world’s highest, and is the highest per capita. There are more than 320 global companies having R&D labs in Israel today, with 80 of them being Fortune 500 companies.

Israel has entered more than 40 bilateral industrial R&D support programs all over the world Israel Innovation Authority: The Israel R&D fund facilitates the operations of the IIA which provides a variety of support programs, on an annual budget of about USD 400 million . The main program is the R&D Fund that offers R&D grants of up to 40% of the approved R&D program cost.

IIA also offers bi-national funds (joint R&D programs with foreign counterpart such as China, Canada, USA, etc.), which are entitled to financial assistance of 50% of the Israeli company’s R&D costs. IIA also manages the grant programs as part of the tax benefit approval for eligible companies.

Funding efforts to nurture startups: Israeli government has set up special purpose vehicles to give $600,000 riskfree loans to promising starts ups with no requirements to payback on failure and 3% royalty for successful companies. The government also provides employment grants for R&D centers and large enterprises with a 4-year grant scheme covering on average 25% of the employer’s cost of salaries for each new employee. The R&D fund of Israel Pharma Bio World

also provides financial grants of 20%-50% of approved R&D programs. In geographical areas designated as National Priority Areas (NPAs) the benefit can reach 60%.

Tax benefits: Israeli tax and investment laws have played an enabling role in enhancing the innovation ecosystem in the country. The Israeli Income Tax Ordinance enables companies to deduct their R&D expenses from their current income in the year they were paid. The Israeli Investment Law also enables foreign companies to benefit from a reduced company tax rate and investment grants. The Angel Law in Israel also provides tax benefits to single investors who invest in Israeli companies in their initial R&D stage (seed) to facilitate more financing sources for early stage investments.

Catalyzing Transition to the Next Realm of Growth It is clearly evident that the Indian pharma industry is more than ready to leapfrog from its currents status of a global generics hotspot to become emerge as a notable innovation hub in the global arena. Many companies are advancing towards their next leg of growth, have novel drug discovery programs in place, with active pipelines.

There is also a vibrant start-up ecosystem with a handful of companies aspiring to crack the code in indigenous drug development.

However, success doesn’t come easily in this long drawn and capital intensive stream of business. Many large companies that have attempted to test the waters have fallen back, curbing their discovery programs altogether and stands testament to the high level of binary risk and other challenges obstructing the path to success. The issues involved are complex and cover different aspects of research and development, funding and market access. It is imperative that such challenges are addressed and the path to market streamlined in order make novel drug discovery a success in the Indian context.

Critical challenges and key recommendations for catalyzing this transition to innovation led growth are summarized below.

A. Scale-Up Funding and Tech Access Mechanisms Initiatives and innovative programs from DBT and DST has ensured that India today has a strong foundation of funding for early seed and proof of concept validation. Complemented by

international grants, philanthropic funding and state government resources, there is a robust umbrella of risk capital for entrepreneurial aspirants. Unfortunately, the current funding mechanisms do not differentiate the level of funding based on level of risks of business segment or disparity in time to markets. The field of novel drug discovery differs from other sectors of life sciences in many ways: Significantly Longer Time to Market: While products such as medical devices and diagnostics have relatively shorter paths to market, the early seed funding tides ventures over by a large measure. On the other hand, novel drug discovery is a much more capital intensive business segment with a much extended time to market. New drugs and vaccines in particular can take between 8 to 10 years to develop and progressively need increasing amounts of capital as the asset is advanced through stages of pre-clinical and clinical validation.

Binary Risk: The threat of binary risk in late stages of the product development lifecycle in terms of regulatory approvals adds an extra layer of complexity in conducting business in novel drugs.

Low Risk Appetite in Large Companies: Indian pharma industry is traditionally entrenched in low risk market segments and thus even deep-pocketed large pharma firms have low risk appetite and are apprehensive about expanding investments in their discovery programs. Past failures of peers or from first-hand experience demotivate greater momentum or funding allocation for high risk portfolio development.

Thus, there is an urgent need to enhance the level of match funding for large corporates by a large measure to catalyze higher level of initial investments in portfolio development until a stage of initial commercial reward that can then ensure continued corporate investment.

High Venture Mortality: There is a much higher level of venture mortality in this field as smaller venture do not have the financial muscle Ventures are at a much more difficult situation. With expanded extramural funding possibilities, an active innovation ecosystem has been seeded and overall more than 500 life sciences ventures have been created in the country. However, access to April 2019 ► 33

insights capital beyond the initial half a million remains a challenge. There are several pipeline ventures in the country that have advanced to the in-vitro stage but are stagnated due to the challenge of access to equity capital that has appetite for binary product development risk in biopharmaceuticals. Fruits of all the efforts invested in creating this impressive pipeline of startups will only be realized if this challenge of access to equity is declogged and a net of VC funds with appetite for technology risk are seeded with interest in the segment. It is disheartening to note that there has been negligible allocation to biotech ventures early stage funding even by Funds that have been funded by the Rs. 10,000 crore Fund of Funds created under the Startup India Program. To avert venture mortality and fleet of Indian ventures to domiciles where capital is available, it is critical that we quickly address this challenge of access to equity captial.

Based on the current pipeline in India and continued venture creation, we estimate that aggregate investment required for developing assets until stage of commercialization is USD 6.2 Billion Technology access is another gap in the country’s innovation ecosystem today. While several large pharma companies remain apprehensive in triggering indigenous R&D for novel drug discovery from the ground up, an easier mechanism would be to access technologies and in-license candidates from other parts of the world. While there is little evidence of success from such a strategy yet, with exceptional examples such as Sun Pharma’s ILUMYA, which was acquired as a late stage asset from Merck, it is important to trigger the thinking in that direction through directed initiatives.

To support companies in nurturing a risk balanced portfolio of early to late stage assets, it would be ideal to incentive technology access through fiscal and financial incentives.

There are global benchmarks where countries have supported access to both upstream and downstream technology as a critical step in nurturing their own ecosystems. This will be most impact in supporting larger companies in their quest for this transition into a higher risk segment.

34 ◄ April 2019

Recommendations • Given the high dearth of scale up funding for aiding R&D in novel drugs, it is essential to increase the quantum of funding under existing programs for ventures and newer initiatives enhance the level of engagement in risk mitigation especially for smaller ventures.

• Match funding for large corporates need to be enhanced multifold for supporting innovation-led R&D in big pharma • There is a high need for incentivizing technology access initiatives as a derisking mechanism to actualize Indian made novel drugs. South Korea could serve as a comparable benchmark, where the corporate tax on income generated by SMEs and specified medium-scale companies from the transfer of patents to a Korean national is reduced by 50%. Such schemes provide impetus to the industry for inlicensing technologies and are worth emulating.

B. Nurturing a Convergent Ecosystem for Innovation Indian ventures have a large skill pool to develop deep-science based products and technologies. But the country lacks a strong foundation for nurturing ideas and translating from labs to global markets. While there is evident momentum in the medical devices space with initiation of programs such as National Biodesign Alliance, a parallel in the pharmaceutical sector remains absent.

Therefore, there is a very small subset of ventures that pursue high complexity areas of innovation such as novel drug discovery, next generation regenerative therapies, genomics and novel biomarker discovery, with very little activity in institutional research in these areas.

Protection of IP remains a long and hard battle for most entities in the Indian ecosystem. IP related challenges loom over the industry as a whole, affecting research across institutes, young ventures and larger companies. Indian institutes usually fall short in well-formulated mechanisms to reward inventors for IP creation.

In cases where institutional research facilities support incubation of novel ideas, they lack adequate engagement with the market and adequate capacity in technology transfer to

third parties. This results in either research with low translational market potential, or worse, high potential research with inaccessible market channels. Resultantly, there are very few institutional spin-offs in the pharma sector.

The handful of ventures which reach the next stage of business cycle often get stuck in limbo because of dearth of equity funding.

To add fuel to the fire, India has long dealt with global perception of poor IP policy & enforcement. Although, the perception is often harbored without awareness of details of either legal cases or circumstantial context, it prevents global companies from promoting and absorbing Indian innovation. In the case of start-ups as well as established pharma companies exploring novel drug discovery, their entire value-creation potential pivots on the IP value of their innovation and thus this issue has a huge bearing on nurturing global relationships and asset-partnerships. The select few ventures that attract interest of global investors on the strength of their innovation are often required to engage in IP inversion and redomicile their IP assets in a different geography.

Even established pharma companies that enjoy reputed market presence in regulated markets today often tread a harder path than their global peers do to partner their assets.

Conclusively, the high level of risk and investment involved, currently lower level of institutional spin-out creation, and dearth of entrepreneurs experienced in global context of drug discovery and development tend to be significant deterrents that need to be addressed.

As India progressively begins to make its mark on global platform for sophisticated and upstream technological advancements, there is an urgent need to sustain and intensify the momentum by designing catalytic solutions to address these specific challenges C. Need for Globally Benchmarkable Fiscal Incentives To anchor a well-rounded innovation ecosystem, fiscal benefits need to evolve further to reward continued innovation momentum, and be globally comparable.

Tax regimes on royalty incomes and inhouse R&D expenditure reflects the fiscal benefits provided for innovative ventures.

The Indian 2016 budget received a mixed response from the life sciences community, one of the main industries entrenched in innovation. On one hand, it introduced Pharma Bio World

insights Recommendations • Regulatory processes needs to be streamlined especially for clinical trials, and time to markets for novel drugs accelerated multifold • With a handful of Indian ventures engaged in therapeutics for rare diseases, next generation solutions such as gene therapy and emerging areas of regenerative medicine, it is critical that the policy frameworks evolve accordingly to support the evolution in science in the country.

• The high out of pocket market in India hinders ease of implementation of any value based healthcare pricing approach.

However, alternative solutions such as cross-subsidization are great models to consider in the Indian context. This model has also witnessed proven success in the Indian vaccines industry, where affordable access through public channel is compensated for higher pricing allowance in private markets. It is imperative that the fear of value realization in companies pursuing innovation is alleviated and rightful reward for innovation is considered. the special ‘royalty tax’ that provides tax rebates on royalty income earned from out-licensing technologies. The discounted royalty tax is 10% against the standard rate of 30% after deducting expenses, which is definitely a positive step towards incentivizing indigenous innovation.

However, this was also accompanied by a lower tax benefit on overall in-house R&D expenditure. The tax deductions of 200% offered on in-house R&D expenditure was reduced to 150% for 2017-2020 and 100% thereafter. Such a decrease in tax benefit on in-house R&D expenditure is very discouraging, especially for the pharma sector in the country that is just formulating its initial steps in innovation and is already facing several funding related tailwinds.

Additionally, the royalty incentive should also be broader to truly catalyze innovation led growth – it needs to cover royalty on inlicensed assets and global patents which are currently not included in the provision as well as sale of IP or other mechanisms for monetization.

Several superior global benchmarks exist today that support R&D activities with Pharma Bio World

better tax regimes, indirectly incentivizing innovation. Some such benchmarks are highlighted below.

Singapore • A base level of 100% deduction is given which is followed by additional 50%.

• Additionally, a 250% (for Singapore-based R&D) or 300% (for non-Singapore based R&D) enhanced deduction is given Switzerland • Differential tax schemes for companies based on size • 130% tax exemption on R&D expenditure for large companies and 230% for SMEs Malaysia • 200% super deduction is given and an Investment tax allowance of 100 % on qualified capital expense for R &D Services. The above incentive applies to R&D conducted outside Malaysia as well.

Ireland • Besides having one of the lowest corporate tax rates of 12.5%, a 25% volume based credit is given on the expenditure on infrastructure, with the option of carrying forward unused credits indefinitely to reduce any preceding tax liability.

• IP Tool Box scheme also provides incentives for innovations in products and processes.

Recommendations When benchmarked with global ecosystems that are encouraging greater biopharmaceutical R&D engagement, our fiscal incentives fall behind. Considering the pharma industry in India is at the cusp of its next big growth avenue in novel drug development, the path to success needs streamlining and calls for globally comparable fiscal incentives as well as strategic initiatives that will encourage greater investments in new product development.

D. Furthering Market Openness and Rightful Reward for Innovation As all the above described building blocks for a robust innovation ecosystem are geared in place, the most crucial component in actualizing innovation success, the right environment for commercialization, also needs to be nurtured in order to ensure smooth bench-to-bedside transition of promising drug candidates. The lure of

regulated markets is already high for pharmaceutical companies due to better value realization potential. Thus, only if existing commercialization challenges in the country are alleviated, there is scope for Indian innovations to benefit the domestic ecosystem.

Today, much of the commercialization related challenges persist in either sailing through regulatory hurdles or because of the lack of rightful reward for innovation.

Augmenting better Precision in Policy and Regulations: Indian drug approval regulations need better streamlining in order to accelerate time to markets for innovative drug pursuits. Delay in clinical trial approvals is a significant concern in India, which is often pushing even CROs to consider alternate trial sites in other emerging econ. Although India is home to 15% of global population, and is a popular destination for cost minimization in any industry, less than 2% of global clinical trials are today conducted in India.

Thus, it is time to undertake measures to ease the uncertainty and ambiguity in regulatory frameworks and chart a clearer pathway for companies pursuing novel drugs. Additionally, India lags behind global standards in certain policy frameworks in newer drug avenues such as biosimilars and regenerative medicine.

Rethinking Price Capping as means for Affordable Access: India has long-battled with price capping as a means to ensuring affordable access of key medicines which has demotivated even large pharma companies from across the world to launch revolutionary drugs in India. Thus, price capping has many a times proven to be counter-intuitive and caused a much delayed access of innovative drugs to Indian patients. With several innovative ventures in the country making in-roads into novel drug discovery and development, the timing can’t be more perfect for rethinking drug pricing and access to ensure that pursuit of novelty doesn’t becomes an exercise in vain for pharma companies, which is a no-win situation that will come back to affect the patients involved.

April 2019 ► 35

insights Recommendations • Strengthening the institutional backbone: There is a high need for fostering multidisciplinary training and leapfrogging the level of institutional engagement in industry-relevant translational research in pharmaceutical drug development with targets that are globally benchmarkable.

• Industry-academia collaboration: Platforms for industry-academia engagement need to be multipliedeline. This is and global translational researchhighly critical collaborations need to be enhancedfor nurturing multi-fold. A stronger collaboration will necessitate dedicated technology transfer cells, and more market-relevant research.

• Change IP related perception: EXPAND In addition ADVERTISE to constructing TO stronger your reach mechanism to create, commercializethrough and monetize IP, India needs to urgently change the perception around unreliability and inadequacy of the IPR policy, and create awareness around the quality of innovation pipeline. This is highly critical for nurturing globally translatable drug development and enhanced value creation for Indian-made assets.

(Source: Sathguru Management Consultants)

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insights

Driving Radical Growth To Make India A Pharma Superpower The Indian pharma industry ranks 3rd in volume and 13th in terms of value. It is the 2nd largest supplier of generic medicines to the US indicating the ability to produce quality products. We are highly fragmented both in manufacturing with more than 10,000 facilities and in the domestic market the largest company has just about 7 – 8% market share. However, several challenges exists that put the brakes on the industry growth including trust deficit on product quality and integrity of data, sub-scale operations in API manufacturing limiting cost competitiveness, investment crunch to fund R&D in NCE, unfavourable and at times unpredictable policies, and inadequacies in the drug regulatory infrastructure, to name a few.

The Path to Growth Among the enablers of growth of the domestic market, expansion of healthcare reach to the rural areas aided by increased healthcare spend by the government is being seen as a key factor. E-Commerce is considered as one way to reach out to the larger populace. However, without having the right ecosystem and infrastructure this is not going to be as helpful in improving reach. A need to strengthen our primary care centres, the district hospitals, community centres is necessary.

Additionally, increasing the medical profession base through more medical colleges is seen as vital. Other enablers include insurance penetration, maybe even making it compulsory. An implementation of Jan Aushadhi on the lines of the Aadhaar Card may turn out to be a possible game changer. Mega tenders for medicines are expected from the government, however, these may have a mixed impact on growth – increasing the volume, but not moving the needle radically from a value perspective. It is considered vital to address the patient factor by improving the journey from diagnosis of the disease to management of the disease and focus on wellness and prevention.

Pharma Bio World

Cost of transaction is seen to be high with retailer and distributor margins contributing to 30% of the cost to the patient and bringing in efficiencies here is necessary. For exports, tapping into opportunities in markets like Japan, Australia, New Zealand, Korea, Thailand, whole of South-East Asia, Latin America, GCC is the new imperative. Among these, Japan is seen as a key target as it is the third largest pharmaceutical market and are opening up to generics at favourable pricing levels and above all, it is open to sourcing from India. Focus on generic plus incremental innovation, complex generics, 505(b)2 play; emphasis on investing and leveraging technology are all necessary along with diversification, backward/ forward integration, foray into OTC, nutraceuticals, and entry to services based offerings as potential growth drivers.

Skill upgradation and development is also a key enabler of growth. There is a view that we are limiting our focus on skills that are already in existence, for example, we know chemical technology well and hence we should additionally be focusing on biopharmaceuticals; our skills in biology have to be reinforced through a partnership or collaboration.

A revamp of education to make it more technically relevant, and help it serve enhanced management needs of export oriented manufacturing and globalization is a dire need. Increased collaboration with academia is important and mutually beneficial and mechanisms for this to happen need to be functionalised – if required through policy push by the government.

The overall theme is to excel in quality and the vision is to be the global benchmark of quality. The focus is not just on compliance, but also includes the drug regulatory infrastructure and overall quality excellence. It is suggested that India should consider becoming part of IGDRP (International Generic Drug Regulatory Programme) as this would enable India to influence the decision making at this level purely based on science. The industry has been working with the government to make a statement to abide by the UN high level panel’s report and provide a stable TRIPs compliant – no TRIPs minus or TRIPs plus - IPR regime.

Perceived threats to growth include challenge on the formulation front from China on the same scale as for APIs. A word of caution is also to be noted regarding cyber security.

April 2019 ► 37

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As a trend, one can expect increase in demand for APIs as several countries are encouraging domestic production of formulations to support 100% coverage of medication under insurance, for instance, countries in Latin America, SE Asia, and South Korea. This could be an additional growth driver. Biosimilars and the entire biotechnology domain are considered as high growth areas with a lot of work being done in genomics, rare diseases and Oncology.

APIs We import close to about, $8bn worth of APIs, from China, and on the other hand we export $6bn to regulated markets. The paradigm is one where the volume difference is significant; what we export is low volume, high value; imports into India are very high volume and with low pricing.

Additionally, the domestic industry is vulnerably dependent on Chinese APIs – to the extent of 90% of the supply.

The threat of any political, geopolitical, economic issues disrupting supply looms large. Recently, 50 – 60% of the manufacturing in China was curtailed because they wanted to control the pollution, consequently, there was a crisis in the Indian formulation industry, because Indian manufacturers of API had abandoned vanilla APIs. 38 ◄ April 2019

A word of caution being sounded is that if we do not protect our ground on APIs we could be in a real threat from China, impacting not just domestic sales, but also sales to semi-regulated markets.

Current trends do not portend well. As per Pharmexcil, exports of APIs have shown a decline. A contrarian view is that dependence on China is for commodity APIs such as Paracetamol, Metformin and similar products. For products going off patent where Indian companies want to be first-to-file, Indian firms are conducting inhouse development. It is argued that the industry has continued to grow in spite of this dependence on China, especially the 20 odd companies that contribute to 80% of exports, so is this really a problem?

There are two issues here, supply for the domestic / semi-regulated markets and the regulated markets. The former is under threat. Several factors are being cited for the dependence on API, including the impact of reservation of certain molecules for small scale industries and license raj limiting capacity growth; also for pricing purposes API from China was used as a benchmark rendering several entities sick. The pertinent question is: why is it that China is able to make intermediates at about 20 – 50 % of our cost? The main concern is that the variable cost of manufacturing of an API in India is higher

than the selling pricing of Chinese APIs. This is mainly due to indirect subsidies.

Based on cases successfully fought at the WTO against the Chinese manufacturers a few Indian companies were able to prove this point and introduce anti-dumping duty for Ceftriaxone from China.

While it is considered necessary to build scale, and increase investment on API to reduce dependence on China, the onus of action lies with the government and also on the industry. Proponents of the view of need for support from the government feel that if the government is looking to contain drug prices for essential medicines, it would be necessary for it to support API manufacturing. Additionally, the remit of the government should be limited to creating a level playing field for both Indian and foreign manufacturers. The government should also probe into the reasons for the low cost APIs from China and address these appropriately.

Fermentation has been identified as a critical area where support from the government was sought in the form of some kind of an EMI, on zero discharge, due to the high capital outgo. Similar support is being proposed to enable creation of scale – a must have in the API industry to remain cost competitive.

Some possible mechanisms for the same Pharma Bio World

insights political ramifications.

The measure of how standards are implemented is found to be different.

One approach is determination of quality by testing the product for its identity, strength and purity. Regulated markets on the other hand consider the manner in which the product is manufactured, for instance, non-compliance with the good manufacturing practices requirements leads to the product being declared as adulterated. The distinction between quality and compliance is also to be noted.

The key point being highlighted here is that implementation of the standards determines the extent of compliance.

are capital subsidies, facilitation of a low rate of interest: LIBOR + 3%, and subsidy on utilities – since it is the single biggest cost in API manufacturing contributing 20 - 25% of the total cost. Also, the need for land not too far away from current technology hubs has been expressed strongly by the industry.

key starting materials such as Benzene or commoditized APIs as the margins are slim. So the required expansion will have to come from either new entrants or Small/ Medium Enterprises. It is obvious that unless the industry received a reasonable return on investment it will be difficult to sustain investment in commoditized APIs.

A solution considered more pragmatic is the waiver of charges on power supply to API units provided through a captive power plant within the SEZ; co-location of the API complex to petrochemicals complex to enable availability of solventson-tap, removing the need to transport and store solvents, and similarly, collection of solvent again by a pipeline. It is suggested that states with high API player concentration should take a lead in setting up such SEZs. At the same time, it is also being suggested that subsidies from the government as misplaced in light of the perceived high profitability of the pharma industry and potential for other industries to demand similar subsidies. Moreover, it is felt that in cases of anti-dumping duties, the onus of proof has to be on the industry.

Additionally, in the API space, it was opined that one cannot expect large pharma firms to backward integrate into manufacturing

Regulations and their adherence Regulatory standards across the world are the same and the difference lies in enforcement of those standards. It has been accepted that dual standards of implementation prevail for products supplied for regulated markets versus those for semi-regulated markets.

Dedicated high class facilities are being used for regulated markets while facilities for the domestic market are found to be sub-standard and located in distant parts of the country. The MSME sector currently is largely non-compliant with regulatory standards. It is being questioned as to why dual standards of implementation are being permitted by the Government of India. It is acknowledged, however, that the strict enforcement of Schedule M for this sector could lead to potential closure of these units and associated unemployment – with

Pharma Bio World

Standards are the same but if their implementation is poor, it essentially translates into lower standards. The lower quality standard for products for the domestic market is mainly because the defaulters are not penalized for noncompliance with standards, whereas one has higher standards for regulated markets because there is a high penalty for non-compliance. The inadequate level of compensation from the domestic market is also being cited as a reason.

The issue of lack of harmonization in standards of implementation across various state regulatory authorities and differences from those of the centre is also to be noted. A need for a central drug authority which governs what products can be launched has also been felt by the authorities. In terms of division of State/ Centre roles, it has been proposed that states can have a role to play in regulation by issuing and monitoring chemist / druggist licenses, and conducting manufacturing inspections. Another point to be noted is the lack of clarity on who will audit manufacturing facilities as the Centre is hiring auditors for this purpose, and this impinges on the boundaries of the State – an issue that needs resolution. It is proposed that the creation of centres of excellence in SEZs, could help address April 2019 ► 39

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the issue around environment, supply chain, etc since the state and centre both benefit. There is no duality or conflicts around SEZs as the sharing mechanism is designed so in that policy. The need for a more proactive policy to regulations is a priority especially for clinical trials as the decline of the clinical trials industry was due to a reactive policy. Currently, the e-pharmacies domain needs regulation; additionally a policy to encourage academia to collaborate with the industry is also sorely missing. It is recognized that we need to be clear about what it is that we are trying to do and then align our view on ethics.

If India has to become a global player and a force to be reckoned with, then we need to recognize that domestic patients are not different from global patients and act accordingly from a regulatory compliance standpoint. The image of India’s drug regulator will be key to driving growth of India’s export industry. India should consider joining the PIC/S (Pharmaceutical Inspection Co-operation Scheme). Joining PIC/S would establish a pathway of how the Indian drug regulator would develop, 40 ◄ April 2019

and it would take at least 5 years, if not 7 to reach the level to qualify to become a member of the PICS. The pathway would also define the reforms that would take place between centre and state.

Now, increasingly global regulators are working together and any quality issue with a particular regulatory agency may trigger action by various regulatory agencies.

A cabinet position for the Ministry of Pharmaceuticals would drive efficiencies in interface with the Centre. It seems that the efforts of the centre in improving quality compliance are bearing fruits.

The CDSCO has shortlisted companies for inspection based on number of samples from the market that are found to be ‘Not of Standard Quality’ – NSQ; companies which had maximum incidence of NSQ, were chosen for inspection first.

Frequent quality lapses have widened the trust deficit between the industry and government.

There are a large number of industrial clusters where the centralized approach of a common effluent treatment system is not working. Reasons cited for this are

that permission given by the regulator was only specific to a particular set of APIs. If the manufacturer wanted to change the APIs produced, permission needed to be sought again and this is not an easy process apart from being time consuming.

Resultantly, some manufacturers actually produced different products than what have been approved and the effluent treatment plant simply could not keep track of what is being manufactured.

A decentralized approach may be the solution whereby the approach has to be changed from a license monitoring regime to a self-regulation regime on environmental aspects. Post the enactment of the Environmental Act, Indian companies have taken more than a decade to effectively manage waste and this has led to a capacity gap. It is felt that the government should leave it to the industry to self-regulate this aspect.

One neglected aspect regarding compliance is the use of vernacular language in manufacturing facilities. The use of vernacular languages has the potential to improve compliance by 30 – 40%. Also, IT can be leveraged to ensure more compliance and productivity.

Innovation As a percentage of GDP spent on R&D, India spent a mere 0.9%, versus 1.9% by China and companies are not taking a long term vision on this aspect. India needs to show some commitment to innovation, and that again will come not just by the industry but also by research collaborations with academia. In some quarters, India is not seen as a market which either respects innovation, or is even willing to invest in that; and there is need for a cultural change. The necessity for a body similar to the NIH in the US, whether public or private has been felt for quite some time.

A contrarian view has been put forth that it is not that Indian companies have not done work on NCEs as many Indian firms have patents on NCEs, but what is needed is Pharma Bio World

insights government gives a matching grant on the amount spent on research.

an Indian company to introduce an NCE in regulated markets. It takes 70% more effort to take the product to regulated markets and the issue is of funding and skillset.

Additionally, big companies now require proof-of-concept before collaborating and it is becoming a big challenge today for small-scale companies since only 1/3rd of the total amount of product development investment is required till PoC. This, in the Indian context could be INR 200cr to INR 250cr, and Indian companies are capable of managing development on their own till this stage. Funding is only required for work beyond Phase 2.

NCE development is a risky proposition with a very high rate of failure: 99%, and even if one is able to develop a product till Phase 2, this translates into a large investment considering the failure rates.

Some experts feel that if we expect Indian companies to invest billions of dollars and wait for an NCE, it is not going to happen, and instead we should aim for the low hanging fruits that incremental innovation may yield with relatively less funding. In this regard, it is suggested that the government should recognize incremental innovation and companies should be allowed to benefit from it through a provision of exclusivity period.

To address the issue of funding, Indian companies may want to look at partnering with smaller innovator companies as done Pharma Bio World

by the IT industry but the Indian pharma industry needs to market itself well as these small startups may have very little knowledge about India.

One area to consider may be precision medicine, as it is considered as the next era of innovation with a lower likelihood of failure. Another option is to collaborate with big pharma/ academia/ financial institutions or a combination thereof. In the US, it is already happening, for example, smaller players in Boston have tied up with the big pharma and with academic institutions.

There are now companies that are being formed which are LLCs and separate from the parent company. There are actually established models for this type of collaborations, including how the royalties are split and how the patents are treated. IPR need not be an issue as commonly perceived since there are several instances of collaborations between Indian and global players. In fact, there is the opportunity for Indian players to do global registrations in such cases. It is generally agreed that the industry needs to convey the key issues in pharma innovation to the government, especially regarding long gestation, high risk of failure, and funding like other developed countries, where the

Summary In summary, the key takeaways for the industry are: growth through market 1. Drive expansion, move up the value ladder, incremental innovation and rural outreach 2. Drive indigenisation of commodity API manufacturing 3. Push for self-regulation and incremental innovation 4. Investing in NCEs R&D and working closely with government research institutes On the other hand the government is urged to: 1. Enhance investment in healthcare infrastructure by increasing spend from 1% to 2% of GDP. 2. Create a level playing field for the API industry by subsidizing capital and operating cost for building mass scale API units 3. Setting up API zones next to petrochemical plants 4. Levying anti-dumping duties on Chinese API 5. Foster collaboration and innovation

(Source: CPhI Report on The Indian Pharma Industry) April 2019 â–ş 41

marketing initiatives

Increasing demand of Fluorosilicone

F

l u o ro s i l i co n e ru b b e r is c a l l e d as m o d if ie d ve rsio n of s i l i co n e ru b b e r w h ich h a s b e e n f l u o rin a t e d t o f in ish u p t h e p o l y m e r ch a in s so t h a t it s c h e m i c a l re s i st a n ce is im p ro ve d . f l u o ro s i l i c o n e i s a lso kn o w n a s FV M Q (f l u o ro v i n y l m e t h ylsilo xa n e ).

It can be processed by compression molding, calendaring, extrusion, and liquid injection molding. Fluorosilicone rubber displays a working range between -60°C and +225°C. Fluorosilicone rubber is formulated from fluorosilicone polymers that contain a (-Si-O-) repeating group on the polymer backbone. One unique difference, compared to their dimethylsiloxane counterparts, is the incorporation of a fluorine component attached to the polymer backbone.

Fluorosilicone polymers replace one (methyl) side group on each silicon with a (trifluoropropyl) side group.

Structure fluorosilicone rubber contains trifluoropropyl groups that enhance its chemical resistance to non-polar solvents, fuels, oils, acids, and alkaline chemicals.

And also a flame retradance.

The unique properties of fluorosilicone make it a problemsolving material 42 ◄ April 2019

Figure1: Properties of FVMQ ( 4: Excellent, 3: Good, 2: Average, 1: Bad)

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It will be easy to understand with the difference.

FSR Difference with others Other FVMQ Silicone Rubber (MQ/ (Fluorovinylmethylsiloxane) VMQ/PVMQ) Ordinary resistance to fluids.

Superior resistance to many fluids.

It has lesser low temperature flexibility.

It has better low temperature flexibility.

Cannot be Can be operated operated in a in a wide range of wide range of temperatures. temperatures.

FSR can be blended with other silicones to obtain a fluid resistance that is intermediate between the two polymer types. Since FSR has a significantly higher cost than other silicones, due to the extremely polar fluorine element in the chemical structure, FSR shows superior resistance to many fluids Pharma Bio World

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press release Cipla launches Niveoli, India’s first extrafine ICS-LABA combination HFA inhaler Mumbai: Cipla Limited has announced its launch of Niveoli, India’s first extra-fine particle beclomethasone-formoterol combination hydrofluoroalkane (HFA) inhaler for adults, targeting drug delivery to the small airways. Niveoli is a proprietary Cipla inhaler, and the latest offering from Cipla in respiratory inhalation therapy that addresses an unmet need associated with obstructive airway diseases (OAD) such as asthma and chronic obstructive pulmonary disorder (COPD).

Asthma and COPD are lung conditions that affect the ability to breathe.

Extensive research and an evolved understanding of the diseases over the years have shown the significant role of small airway disease e.g. asthma and COPD. A recent meta-analysis showed that small airway disease is prevalent in 50-60 percent of asthma patients. Another study has indicated that routine lung function tests can underestimate the problems in the small airways. Small airway disease is a common feature of COPD and gets worse with increasing severity of the condition.

Niveoli’s novelty and strength lies in HFA propelled delivery of extra-fine beclomethasone particle, an inhaled corticosteroid (ICS) and formoterol, a fast-onset long acting beta agonist (LABA) to the small airways.

Commenting on the launch, Nikhil Chopra – the Head of India Business, said, “Cipla is pleased to offer another milestone in respiratory inhalation therapy – Niveoli, which marks a first in acknowledging and addressing the issue of drug delivery to the small airways. Cipla has a long history of blazing the trail in innovations at combination formulations and drug-device combinations in the respiratory therapy; and Niveoli is a painstaking result of these strengths.

Be it the transparent dry powder inhaler, or be it the static-free spacer with valve mechanism, -- the mask-spacer combination for children or our novel breath-actuated inhaler with dose-counter called Synchrobreathe, the list is long. We see our market leadership as well as the range and depth of our R&D and manufacturing capabilities in this therapy as a privilege and a responsibility to do more for patients. In keeping with our purpose of ‘Caring for Life’, we are constantly studying OADs and working towards products that offer greater efficacy, ease of use, and drug delivery to patients. I believe Niveoli represents a new paradigm in inhalation therapy.”

Indian Pharma sector growth to moderate at 8-10% CAGR over FY 2018-21 period : ICRA

The growth trajectory for the Indian pharmaceutical industry is likely to be moderate at 8-10 percent over FY2018 to FY2021, on the back of healthy demand from the domestic market given increasing spend on healthcare along with improving access. The growth would however be constrained by regulatory interventions and also by slowing growth from the US given the relatively moderate growth prospects. According to an ICRA report covering a sample of 21 firms in the industry, the domestic market concerns pertain to price control and mandatory genericisation; whereas, US concerns pertain to relatively moderate proportion of large size drugs going off-patent, increased competition leading to price erosion albeit at moderate pace, generic adoption reaching saturation levels, and regulatory overhang along with base effect catching up. According to Gaurav Jain, Vice President & Co-Head, ICRA, “The revenue growth from US remained healthy at Q3FY2019 at 16.2 percent (9.6 percent 9mFY2019) compared to -13.1 percent in FY2018 led by currency depreciation, new 44 ◄ April 2019

product introductions, and consolidation benefits. During the quarter, INR depreciated by 11.4 percent on an average on Y-o-Y basis. The growth momentum for US business is likely to remain moderate for FY2020, led by limited near term first to file (FTF) generic opportunities, pricing pressures, and product rationalization for US base business. The base business in US continuing to face mid-to-high single digit price erosion (compared to low to mid-teens in CY2017 and 10-12 percent in CY2018); and regulatory overhang for select companies.”

Aggregate revenues of sample grew at 14.0 percent in Q3FY2019 (12.3 percent 9mFY2019) vis-à-vis the prior year, as against FY2018 growth of 0.1 percent. The aggregate domestic growth was 7.8 percent in Q3FY2019 (10.1 percent 9mFY2019) compared to 4.6 percent in FY2018. The lower growth during the quarter was on account of last year’s high base led by reversal of channel inventory de-stocking seen during Q1FY2018 led

by GST implementation. The growth during Q3FY2019 was supported by 3.4 percent WPI linked price increase on National List of Essential Medicines (NLEM) portfolio, volume as well as new product introduction.

Growth of European market has been benefitted from higher tender wins, new product introduction in B2B segments and low base effect through healthcare reforms resulting in price cuts continue to pose challenge.

Unlike in the past, when several Indian pharma companies ramped up their R&D spend, targeting pipeline of specialty drugs, niche molecules and complex therapies, this time around companies are optimising their R&D spend. This is led by challenging US market conditions characterized by steep pricing pressures, high competitive intensity led by faster ANDA approvals, and lower than expected revenue growth. Also with competitive pressures expected to sustain in the near-to-medium term, companies are exiting product development of easy-to-manufacture, simple generics with multiple players; and focusing on complex generics and specialty products.

The aggregate R&D spends of top few domestic companies, which had increased from 5.9 percent of sales in FY2011 to close to 9.0 percent in FY2017, moderated to 8.8 percent during FY2018 and further to 7.8 percent in 9mFY2019. ICRA expects R&D budgets to remain at 7.5 percent-8.5 percent given the growing focus both on regulated markets and complex molecules/therapy segments such as injectables, inhalers, dermatology, controlled-release substances and bio-similars. Indian companies have gained adequate scale and drug development capabilities over last decade of growth which will keep them in good stead to capture new opportunities in the developed market. As for industry’s profitability, the same has remained moderated over the last few years with aggregate EBITDA margins of 20.9 percent 9mFY2019 (vis-a-vis 22.9 percent FY2017). This is due to growth pressures along with sustained R&D and compliance related investments. Though margins remain healthy, the lower margins are due to pricing pressures for the US based generic business and limited competitive products. Higher share of domestic business and operational efficiencies have however provided overall cushion to margins.

Mr. Jain concluded, “The credit metrics of leading pharma companies are expected to remain stable in view of future growth prospects in regulated markets and also to the point of relatively strong balance sheets. The capital structure and coverage indicators are expected to remain strong despite pressure on profitability and marginal rise in debt levels given inorganic investments. The key sensitivity to ICRA’s view remains: productivity of R&D expenditure, increasing competition in the U.S. generics-space, and operational risk related to increased level of due diligence by regulatory agencies.”

Pharma Bio World

press release SIRIO Pharma Announces Global Collaboration Asia, Europe & The United States: Sirio Pharma (SIRIO) – the nutraceutical contract development and manufacturing organization (CDMO) – has announced global collaboration to help customers bring innovative, safe, and effective products quickly to market.

With access to the most recent market data, Sirio’s 100+ scientists and industry experts – based in Asia, Europe, and the United States – will combine research and development efforts to focus on proactive innovation. By combining its expertise, Sirio is now even better positioned to work with customers worldwide.

“The industry demands products that are more natural and additive free, with consumer friendly labelling and increased transparency.

The challenge for brand owners is how to develop these products quickly without compromising on quality. Our global collaboration will be instrumental in helping our customers to develop innovative products that conform with these trends. It’s a big challenge for companies to improve existing formulations – it requires a large and experienced in-house R&D team. With over 500 stock formulas, our R&D specialists will explore novel combinations of ingredients, thus ensuring products are effective, shelf stable, and great tasting” commented Rui Yang, CSO of Sirio Pharma.

The global collaboration will enable Sirio to keep abreast of regional trends, new ingredients, dosage forms, and claims to provide customers unique product ideas for line extensions. Another key objective is to provide customers cleaner label options for their products, such as natural flavours, colours, sweeteners, and ecofriendly packaging solutions. Ultimately, Sirio seeks to empower customers from all markets to advance product R&D more rapidly and confidently to launch new products faster. Great examples of this new collaborative effort at work include new products such as Curcumin Gummies, as well as Probiotic and Collagen Supplements.

“This collaboration is the natural evolution of our commitment to continuous improvement and forward thinking. The key in this industry is speed to market – being able to rapidly bring new products from concept to commercialization. We take an extremely proactive approach to our new product development pipeline, planning up to three years in advance as to where consumer preferences are heading”, added Rui Yang, - CSO of Sirio Pharma. Sirio has a long history of developing new approaches and of proactive innovation. The company successfully launched a premium nutra-consumer brand Treerly Health in China, which was acquired by Pfizer in Yr. 2016.

Cambrex Doubles cGMP Liquid Filling Capacity at its Mirabel, Québec Facility East Rutherford, NJ: Cambrex Corporation – the leading small molecule company providing drug substance, drug product, and analytical services across the entire drug lifecycle – has announced its plan to double the liquid packaging capacity and

Pharma Bio World

weekly output at its Mirabel, Québec site in Canada, by adding a cGMP packaging line and a new filler on the existing packaging line. By June 2019, the monthly capacity is expected to reach 1.2 million bottles compared to the present figure of 600,000 per month approximately.

This new cGMP liquid packaging line allows the use of two fillers (XP and non-XP) working in parallel from process development to cGMP commercial production; and offers flexibility to accommodate ethanol and isopropanol-based solutions, aqueous solutions, lotions, or suspensions. A new vision system has also been installed for online serialization.

“This investment effectively doubles the liquid packaging capacity and weekly output at the site, while improving production cycle time and providing greater flexibility to customers,” said Maryse Laliberte, VP & General Manager, Cambrex Mirabel, “By operating multiple liquid packaging lines that utilize the same technology, we are able to improve reaction times for our customers’ specific requirements and to support unexpected demand increase”.

The new cGMP packaging line is linked to the existing storage tank and to explosion proof rating-tanks, thus allowing to fill solutionsand-suspensions containing 100 percent alcohol or peroxide. The next-generation automatic-inline high-precision filler machine will be in operation by June 2019.

Cambrex acquired the 226,000 sq. ft. Montreal facility, formerly part of Halo Pharma, in September 2018. The plant is dedicated to formulation-development and finished-dosage manufacturing services. It can accommodate a wide range of solid and liquid drug product dosage forms, including suspensions and solutions, non-steriles, semi-solids, lotions, creams, ointments, and suppositories. It can also support high-volume and small-batch manufacturing, and offers a variety of packaging services for bottles, tubes, and cartons.

Lupin’s Pithampur Unit-3 (Indore) receives EIR from US FDA Mumbai: Pharma major Lupin Limited has announced the receipt of the Establishment Inspection Report (EIR) for its Pithampur (Unit-3) facility. The inspection was conducted from 8th to 18Th October 2018.

Lupin’s Pithampur Unit-3 is involved in manufacturing Metered Dose Inhalers (MDIs), Dry Powder Inhalers (DPIs), and Topical Formulations for the regulated markets.

Commenting on the development, Mr. Nilesh Gupta - the Managing Director of Lupin said, “Receiving the EIR for our Pithampur Unit3 facility is a very positive development and brings us one step closer to bringing important MDIs and DPIs in the market. We are committed to ensuring the quality, safety, and efficacy of the products that we manufacture across our facilities.”

April 2019 ► 45

press release Intas Pharmaceuticals launches its Trastuzumab biosimilar, Eleftha Ahmedabad: Intas Pharmaceuticals Limited, one of India’s fastest growing pharmaceutical companies, has announced a revolutionary step towards making human epidermal growth factor receptor 2 positive (HER2) breast cancer therapy more accessible to patients through the launch of its trastuzumab biosimilar, Eleftha. Trastuzumab is a targeted therapy, which inhibits the growth of human cancer cells (the disease overexpresses HER2 protein) and has thus revolutionized the breast cancer management.

The Maximum retail price (MRP) of Eleftha will be ` 19,995 for the dose strength of 440 mg, which makes it ~65 percent more economical than the currently available options. Presently, the MRP of most of the trastuzumab brands in India ranges between ` 58,000 to ` 63,000 per 440 mg vial. In patients with HER 2 positive early breast cancer, almost 18 cycles of trastuzumab based therapy are required, and which presently costs more than 10 lakh rupees in India. However, with this unprecedented step by Intas, the cost of treatment comes down to less than 4 lakh rupees. It will enable many more patients to avail the benefit of trastuzumab. This would also be a great relief to the patient-families financially burdened-and-distressed for the cancer treatment.

Breast cancer consumes more Indian women lives than any other form of cancer. As per the published data, almost 25 percent of Indian patients with breast cancer are HER2 positive. Trastuzumab is used to treat HER 2 positive breast cancer and has been available in India since the Yr. 2000. Before the advent of trastuzumab biosimilars, almost 80 percent of patients could not afford trastuzumab. However, with the advent of biosimilars, the access to trastuzumab has been improved; but still a lot of patients cannot afford this drug.

Intas is a pioneer in biosimilars, having developed and launched one of the highest numbers of indigenous biosimilars in India. The company has a rich history of making quality biosimilars accessible to the masses. Being the most affordable treatment options, Intas’ products like Neukine (filgrastim), Pegasta (Pegfilgrastim), Mabtas (rituximab), Razumab (ranibizumab), and Bevatas (bevacizumab) have transformed the management of their respective therapies. Eleftha is the latest testament to Intas-Biosimilars for Billions philosophy, fulfilling its commitment to provide quality cancer care to the masses. These get manufactured at the company’s state-of-the-art European Union – Good Manufacturing Practices (EU-GMP) certified biotechnology plant located near Ahmedabad, Gujarat.

IndiaRF Announces USD 144 million Investment in Panacea Biotec Ltd.

Mumbai, India: India Resurgence Fund (IndiaRF), promoted by Piramal Enterprises Limited and Bain Capital Credit along with its affiliates, has announced an investment of up to INR 992 crores / USD 144 million in New Delhi based Panacea Biotec Limited (“Company”). The investment proceeds will be used for a one46 ◄ April 2019

time settlement with existing lenders, general working capital, and growth requirement of the Company.

This investment is structured by way of Non-Convertible Debentures (NCDs) of up to INR 864 crores and subscription amount of INR 32 crores towards share warrants to be allotted on a preferential basis. The subscription amount represents 25 percent of total amount – INR 128 crores – proposed to be raised upon issuance of equity shares against warrants as per SEBI (Issue of Capital and Disclosure Requirements) Regulations, 2018. Subject to exercise of warrants, IndiaRF (along with its affiliates) will collectively end up owning 10.4 percent stake in the company on a fully diluted basis.

Commenting on the investment, Shantanu Nalavadi – the Managing Director of IndiaRF said, “We are pleased to partner with Panacea Biotec, as it embarks on an exciting journey to enhance its market position as a strong research-focused pharmaceutical-andbiotechnology company. The purpose of this investment is not only to restructure the Company’s balance sheet, but more importantly, to work closely with the promoters and management team to drive rapid revenue growth and sustainable profitability improvement. IndiaRF continues to remain focused on providing long term strategic solutions that enable an effective turnaround for high quality companies and that have the potential for accelerated growth and profitability”.

Dr. Rajesh Jain, the Managing Director of Panacea Biotec said, “We are delighted to partner with IndiaRF at this critical juncture in Panacea Biotec’s journey. We look forward to leveraging their proven global expertise in restructuring and turnarounds, and are certain that our combined efforts will now help accelerate our ambitious growth and profitability targets”.

Panacea Biotec is a progressive, innovative, research-anddevelopment-focused biotechnology company; and is focused on manufacturing and marketing of pharmaceutical formulations, biopharmaceuticals, and vaccines.

Brescon & Allied Partners LLP were the exclusive advisors to the Company on this transaction, advising on the one-time-settlement with the banks and raising funds to back the revival plan.

Lupin Bioresearch Centre completes fifth successful US FDA inspection Mumbai: Pharma major Lupin Limited announced the successful completion of the United States Food and Drug Administration (U.S. FDA) inspection at its Lupin Bioresearch Centre (LBC) without any observations. This is the fifth successive inspection without any 483 observations, indicating superior quality compliance maintained at this global bio-research facility.

Lupin Bioresearch Centre (LBC) conducts the in-vivo and in-vitro bioequivalence studies for Lupin in Pune. This inspection also included the reviews done at the center’s new site – Lupin Research Park, Pune.

Commenting on the successful inspection, Mr. Nilesh Gupta (Managing Director of Lupin) expressed his satisfaction about LBC’s quality management system by mentioning “Such a high level of compliance reiterates Lupin’s commitment to high-quality standards across its world class research-centres”.

Pharma Bio World

press release About 22.5 lakh cancer cases recorded Roche launched new therapy Emicizumab for people with Hemophilia A on World every year Hemophilia Day Mumbai - As per a research done by NICPR, the estimated number of people living with the disease is around 22.5 lakh, with new cancer patients registered every year over 11,57,294. In Yr. 2018, 7,84,821 people died for Cancer or related issues. The five most frequently occurring cancers (ranking defined by the total number of cases) in India between men and women are breast, cervical, oral cavity, lung, and colorectal. These top five account for 47.2 per cent of all cancers.

As per NICPR’s research, different areas in India have specific reasons for the increasing Cancer incidents.

Area

Leading Cancer

Risk Factors

North East

Oral and Stomach cancer

Tobacco, household burning of wood

West Bengal

Lung, Urinary Bladder cancer

Air and Water pollution

South and Coastal India

Stomach cancer

Diet rich in spices salt

Goa

Colon Cancer

Red meat, alcohol and tobacco

Gujarat and Rajasthan

Head and neck cancer

Tobacco and paan masala

Punjab, Malwa Belt

Kidney, Urinary bladder, breast cancer

Pollution, pesticides, toxin in food

Gangetic Plain (UP, Bihar and West Bengal)

Gall bladder, head and neck cancer

Polluted water, sediments in the water, diet rich in animal protein or fish

Madhya Pradesh

Oral Cancer

Tobacco and paan masala

However, fortunately new treatments for cancer are also on the horizon and may help save patients. One such strategy is personalized medicine.

Speaking about the India cancer findings, Cancer research expert Roy de Souza said, “When a member of my family was diagnosed with cancer, it was a surprise and deeply worrying situation. It also caused me to take up the mission and spend my time-and-effort to help find better treatments for cancer. I became determined to find a personalized medicine solution for many patients and maybe even a cure for this disease for some. I now see that we can get there soon.”

Roy has used his experience in cloud based worldwide scalable technology in the new field of personalized medicine, which requires software to design a different treatment for each person. The treatment he believes in, could cure colon cancer, is called a Personalized Neoantigen Vaccine”.

Pharma Bio World

Mumbai: Roche announced that Emicizumab (Hemlibra) has been approved in India for Hemophilia A with factor VIII inhibitors. It is indicated as a prophylactic (preventive) treatment to prevent or reduce the frequency of bleeding episodes. Hemlibra is the first weekly subcutaneous (under the skin) prophylaxis injection shown to prevent or reduce the frequency of bleeding episodes and to improve the quality of life. It is designed to bring together the factor IXa and factor X proteins required to activate the natural coagulation cascade; and thus to restore the blood clotting process for people with Hemophilia A. All current prophylactic treatment options for people with Hemophilia A with factor VIII inhibitors require intravenous infusions several times a week. Even then, some people may experience joint bleeds that can lead to long-term damage.

The approval of Emicizumab is an important advancement for the entire Hemophilia A community. It is a first-in-class treatments since past 20 yrs for people with severe Hemophilia A, with inhibitors. The clinical evidence of Hemlibra is supported by a comprehensive and extensive development program in Hemophilia A across all ages.

“The introduction of Emicizumab (Hemlibra) is a significant milestone in Hemophilia A treatment in India. And it reaffirms our commitment to bring Roche's groundbreaking medicines to patients in India as early as possible”, said Lara Bezerra – the Chief Purpose Officer (MD) of Roche Pharma India, “This breakthrough medicine represents a completely new way to manage Hemophilia A and redefines the standard of care. With this new therapy, patients now have a stronger chance of leading a healthy and active life.”

According to World Federation of Hemophilia, India records for the highest number of Hemophilia patients in the world. With the current birth rate in India being 32/1000, 1,3001 new patients with Hemophilia are born each year. As of Yr. 2018 estimates there are about 50,000 patients suffering from Hemophilia, of which 20,000 people have been identified, and there are still about 30,000 unidentified hemophilic people in India.

Lack of disease awareness and inadequate infrastructure result in high rates of under-diagnosis and sub-optimal treatment, which strongly influence both the quality of life but also the lifespan of hemophilic people.

Hemlibra is approved by multiple regulatory authorities across the world; and is now also approved and available in India. As per the HAVEN 1 pivotal Phase III clinical study, 62.9 percent of patients had zero-bleed with Hemlibra prophylaxis. As per the HAVEN 2 study, 87 percent of pediatric patients had zerotreated-bleed.

April 2019 ► 47

PP Filter Cartridges Polypropylene pleated filter cartridges have been designed as an effective membrane prefilter and as final polishing filter for many liquid processing

For more information, please contact: SS Filters Pvt Ltd Plot No: D-13/8, TTC Indl Area MIDC, Turbhe, Navi Mumbai 400 705 Tel: 022-27633362, 27633363, 27633364 E-mail: info@ssfilters.com

SS Filter Cartridge Stainless Steel sintered powder filter cartridges are recommended for the filtration of air or liquid at higher operating temperatures and corrosive environment.

For more information, please contact: SS Filters Pvt Ltd Plot No: D-13/8, TTC Indl Area MIDC, Turbhe, Navi Mumbai 400 705 Tel: 022-27633362, 27633363, 27633364 E-mail: info@ssfilters.com

Vacuum Concentrators The Thermo Scientific Savant SpeedVac systems achieve fast, one-click solvent evaporation. SpeedVac Vacuum Concentrators now offer preset and custom-made programs for optimal application flexibility. Chemists, chromatographers and molecular biologists can now benefit from the first-ever line of vacuum concentrators offering a library of pre-programmed protocols, while also allowing users to create custom programs, for fast and reliable evaporation of a broad range of solvents. Built on Thermo Fisher’s leading vacuum concentration technology, the upgraded Thermo Scientific Savant SpeedVac systems provide users with the flexibility to choose from a selection of preset or custom-made programs to suit varying application needs. The new vacuum concentrators achieve a reduced drying time and are compatible with a large number of solvents, helping to boost laboratory efficiency and productivity across a wide array of pharma, biotechnology, academic research, industrial, agricultural and food testing applications. The Savant SpeedVac line of products consists of eight vacuum concentrators, ranging from a compact, integrated device designed for low-volume sample preparation, to medium-capacity models available in either integrated or modular designs, to large, modular systems addressing high-volume sample preparation needs.

The Savant SpeedVac portfolio includes: Model DNA130 – a compact, integrated system designed for low-volume preparation of samples, including nucleic acids, polymerase chain reaction (PCR) preps and synthetic oligonucleotides, to support DNA and RNA applications; Model SPD120 – a medium-capacity, modular system, which is resistant to aggressive solvents used in DNA and biological applications, such as methanol and acetonitrile w/0.1% trifluoroacetic acid (TFA). It is also suitable for applications where freeze-drying or lyophilization is needed; Model SPD130DLX – a medium-capacity, modular system, which is resistant to aggressive solvents used in combinatorial chemistry applications, including TFA and dimethyl sulfoxide (DMSO); Model SPD140DDA – a medium-capacity, modular system, used for drying aggressive organic solvents, strong acids, bases and combinatorial chemistry solvents; Models SDP1030 and SDP2030 – a medium-capacity, fully integrated systems, combining a concentrator, a refrigerated cold trap, a diaphragm pump and a vacuum gauge in a single, compact unit; Model SPD210 – a large-capacity, modular system, suitable for drying aqueous and organic solvents in large sample volumes; and Model SPD300DDA – a large-capacity, modular system, used for drying aggressive organic solvents, strong acids, bases and combinatorial chemistry solvents in large sample volumes.

For more information, please contact:

Thermo Fisher Scientific India Pvt Ltd 102, 104, Delphi C-Wing, Hiranandani Business Park, Powai Mumbai 400 076 Tel: 022-67429494, Fax: 91-022-67429495 E-mail: sagar.chavan@thermofisher.com

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Pharma Bio World

Oval Wheel Meters

Liquid Ring Vacuum Pump Toshniwal Hyvac Pvt Ltd offers oval wheel meters, Type OI. The oval wheel displaces a precisely known volume of liquid through the meter, from inlet to outlet. The number of revolutions, therefore, is directly proportional to the measured volume.

For the protection of oval wheel meters and turbine meters against foreign matter and solids contained in the liquids, measured with these meters.

These strainers may also be used for protection of piping systems for contamination - Strainers Type N... without heating jacket in sizes 15 to 100 mm (1/2” to 4”). Features high accuracy with low pressure drop; pulse and current output for remote transmission; high flow capacity with little space requirement; safe operation and long service life. Approved by Weights and Measures Authorities.

For more information, please contact: Toshniwal Hyvac Pvt Ltd 267 Kilpauk Garden Road Chennai 600 010 Tel: 044-26445626, 26448983 E-mail: sales@toshnwial.net

POMPETRAVAINI is one of the leading worldwide manufacturer of liquid ring vacuum pumps with single stage (TRS) and two-stage (TRH) pump series.

With the ex perienc e a c q u ir e d through dec ades of e n g in e e r in g res earc h. Continual in v e s tme n ts in the lates t te c h n o lo g ic a l adv anc ed mac hi n e r y and s ound mec hanic al k n o w - h o w, Pompetrav av ini’s product is today s y nony mous with high quality, hig h e ffic ie n c y, robus t c ons truc tion and max reliability.

It finds application in central vacuum system; de-aeration; impregnation; boiling processes; vacuum condensing; distillation; drying; sterilization; filtration and solvent recovery;

For more information, please contact:

Toshniwal Instruments (Madras) Pvt Ltd 267 Kilpauk Garden Road, Chennai 600 010 Tel: 044-26448983, 26448558 Fax: 91-044-26441820 E-mail: sales@toshniwal.net

Evaporators and Dryers Concentration by evaporators of water and drying are very important operations in the food processing industry. Apart from the process performance, hygienic construction of the equipment and the facility itself play a major role. The final product is also defined by various qualitative characteristics such as mouthfeel, texture, colour, flavour, etc, which also decide the pricing of the product.

Special properties such as product size, instant properties are also important in some cases.

SS Techno Ltd offers tailor-made turnkey plants with state-of-the-art evaporation and drying technologies for milk, tea, coffee, fruit juices/pulp, lactose, lactulose, etc. The plants are CIP compatible and are designed to produce the product with the required quality parameters. The type of evaporator and dryer, their combination and the total scheme depends specifically on the characteristics of the product.

For more information, please contact:

SS Techno Ltd 502 Mayfair Towers I, Wakdewadi, Shivajinagar, Pune Maharashtra 411 005 Tel: 020-66524431, Fax: 91-020-66524434 E-mail: marketing@sstechno.com

Pharma Bio World

April 2019 ► 49

Indexing Plungers Corrosion resistance, hygiene and material quality are properties which are highly appreciated in the pharma industry, food industry, in hospital engineering, fresh water supply and wastewater engineering, the aerospace industry, conveyor engineering and in machine and plant construction. For these industries Elesa+Ganter’s standard machine elements has added to its product range of index plunger Models GN 613/GN 617 and GN 617.1 the design variant with stainless steel knob - the first all stainless steel index plunger.

The GN 613 indexing plungers have no collar and boast extremely small dimensions, designed to absorb axial forces in their end position.

The GN 617 and GN 617.1 indexing plungers are each fitted with a collar, with the GN 617.1 indexing plunger featuring an additional indexing lock. These are used if the index pin is temporarily not allowed to protrude. To engage, the knob is turned by 90° after pulling out. An index notch prevents the disengaged knob inadvertently turning back under the impact of vibrations. All SS indexing plungers are made in consistently high quality and feature a long service life. Options Ganter has to offer include the holding fixtures GN 612.1 and GN 412.1 as mounting aids for indexing plungers, cam action-indexing plungers and positioning bushings (GN 412.2). Find out more at www.elesa-ganter.in For more information, please contact: Elesa and Ganter India Pvt Ltd A-54, Sector 83 Noida, Uttar Pradaesh 201 305 Tel: 0120-4726666 E-mail: info@elesaganter-india.com

UV-Vis Spectrophotometer Agilent Technologies Inc offers Cary 3500 UV-Vis system for the Indian market. While the Cary 3500 UV-Vis system is an innovative spectrophotometer designed to help life science, pharma and biopharma research communities simplify their analyses, optimize laboratory productivity, and ultimately help bring new therapeutics to market faster. Global growth in the development of biological drugs is leading to the evolution of many new biological entities (NBEs). Before these NBEs are adapted into therapeutics, laboratories must accurately characterize each new product and continuously monitor the quality of these products throughout the development process. The Agilent Cary 3500 provides a critical tool that allows laboratories to do this more quickly and accurately than is currently possible. Drawing upon from our 70 years of insight and customer collaborations, Agilent’s spectroscopy unit has created a faster, more robust system that comes with a lower cost of ownership.

The Cary 3500 represents the first significant advancement in UV-Vis architecture in decades. The new system enables laboratories to make substantial gains in efficiency as it can run multiple experiments simultaneously, allowing labs to obtain more results in the same amount of time - and it also extends the opportunity to design experiments in ways that have not been possible before. The product harnesses the power of a state-of-the-art software platform and a fast and powerful Xenon flash lamp that is redefining UVVis spectrophotometry. Indeed, the system’s rapid, accurate, temperature control permits temperature experiments at ramp rates previously thought to be unattainable, providing more reliable and robust measurements.

For more information, please contact: Agilent Technologies India Pvt Ltd Plot No: 8, ABW Elegance Tower Jasola District Centre New Delhi 110 025 Tel: 011-46237100 E-mail: customercare.india@agilent.com

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Pharma Bio World

Levelling Elements Elesa+Ganter has always focused on satisfying the designers needs, thanks to the wide variety of standard machine elements, various types of assembly and the range of customization. This philosophy has led to the introduction, as standard to the wide range of Elesa+Ganter products, of new levelling elements with AISI 304 SS stem with adjusting square and LSQ.A-SST, LVQ.A-SST, LVQ.F-SST and LVQ.FO-SST technopolymer bases.

The stems with adjusting square are manufactured efficiently through machining of AISI-304 SS round bar. They represent a cost-effective solution and offer a high ease of use: the adjusting square giving a rotation angle by 90o.

The stems of the new levelling elements with adjusting square SMQ-SST have standard threads (M8, M10, M12, M16, M20 and M24) and same static load as the SM-SST with regulation hexagon and can also be used combined with LS.A, LV.A, LV.F and LV.FO technopolymer bases (tables ofthe possible combination bases/stems). Products technical data sheets, along with drawings and tables with codes and dimensions, are available on website www.elesa-ganter.in

For more information, please contact:

Elesa and Ganter India Pvt Ltd A-54, Sector 83, Noida, Uttar Pradesh 201 305 Tel: 0120-4726666, Fax: 91-0120-4726600 E-mail: info@elesaganter-india.com

Gas Chromatography Systems Agilent Technologies Inc offers two new gas chromatography systems for the Indian market.The new Agilent 8890 and 8860 GC systems extend the company’s industry-leading portfolio of robust analytical instruments.

They will incorporate innovative and intelligent ‘self-aware’ predictive technology, expanding their suite of smart-connected GC instruments. Integrating intuitive colour touch interfaces, the 8890 and 8860 GCs are built on a next-generation electronic architecture platform, based on the innovative technologies of the Intuvo 9000 GC, Agilent’s flagship existing GC system. Continuous system monitoring, automated diagnostics and built-in troubleshooting routines will help labs avoid unplanned downtime and increase lab efficiency. Remote connectivity through mobile devices such as tablets and laptops, allows operators and managers to securely access instrument status and function while away from the lab. Agilent also introduced two powerful Blank and Detector Evaluation smart routines on the 8890 and 8860 GC systems, enabling automatic determination of system readiness. These new predictive functions will also be available for upgrade on Agilent’s Intuvo 9000 GC systems. The new GC systems have been designed with a clear strategy for providing customers with continual expansion of system intelligence functions. These new functions are also available for Agilent’s existing GC systems. Automated diagnostics and troubleshooting routines will allow operators to attend to more high-value activities such as reviewing data and attending to new customer needs, helping them to grow their enterprises. Agilent has incorporated the innovations of their previous GC designs and at the same time leveraged many of their proven oven, inlet, and detector technologies, recognized in the industry for their performance and quality. This will ensure streamlined method transfer for applications previously developed on legacy GC systems since it is an important consideration for a significant segment of existing customers. The 8860 system is designed to support many core routine applications, while the 8890 system is designed to support ultimate flexibility and expandability, supporting customer needs both today and tomorrow. The 8890 is not only intelligent but highly configurable, able to extend its capacity as lab needs grow – future-proofing the customer’s investment. While the 8860 is the GC for core routine applications, it is anything but routine, given its intelligent features.

For more information, please contact:

Agilent Technologies India Pvt Ltd Plot No: 8, ABW Elegance Tower, Jasola District Centre New Delhi 110 025 Tel: 011-46237100 E-mail: customercare.india@agilent.com

Pharma Bio World

April 2019 ► 51

Twin Screw Range of Pumps The working principle of Roto gear timed dual flow twin screw pumps is dependent on the rotation of two screw spindles in closed compartment. Wherein a pre-defined clearance is maintained between the screw spindles as well as between the outside diameter of the screw spindles and the bore of the casing/liner in which the screw spindles are located. Each half of the screw spindles is left-handed and righthanded. Thus, when the spindles start rotating, driven by a pair of timing gears located at the end of the screw spindles, the liquid is drawn towards the end of the screw spindles and entrapped between the bore of the pumping compartment as well as the flanks of the screws and is then propelled axially from both the ends towards the centre. Such a dual flow nullifies the axial thrust completely thereby enabling the screw spindles to remain in a state of hydraulic balance.

Rotor’s unique double profile of the screw spindles contributes to a higher volumetric efficiency, thus an improved overall efficiency.

For more information, please contact: Roto Pumps Ltd RotoHouse, 13 Noida SEZ, Noida Uttar Pradesh 201 305 Tel: 0120-2567902 Fax: 91-0120-2567911 E-mail: contact@rotopumps.com

Promatic PTT 250 Track & Trace System The Promatic PTT technology offers a platform for mass serialization of pharma secondary packaging units. If required, it can be equipped with selected printers and labellers to apply the prescribed security features. Camera based inspection systems allow precise identification and verification of the tamperevident features. The PTT is additionally suitable for integrating serialisation solutions. Users are free to decide themselves which suppliers they eventually purchase their seamless track and trace systems from. Romaco Promatic then designs the modular machine according to each customer’s individual requirements.

The Promatic PTT 250 achieves a max output of 250 cartons per minute. As a stand-alone machine, the Promatic PTT can be linked up to any standard cartoner. Configurations with a monobloc design are likewise possible in line with the Promatic PCI 915 intermittent motion cartoner.

For more information, please contact: Romaco Group Am Heegwald 11 76227 Karlsruhe Germany Tel: +49 (0)721 4804 0 Fax: +49 (0)721 4804 225 E-mail: susanne.silva@romaco.com

Liquid Ring Vacuum Pumps Toshniwal, leader in vacuum engineering for over 60 years, now provide further solution to your vacuum needs in manufacturing of liquid ring vacuum pumps that offer optimum performance and reliability.

They offer minimal water consumption and an innovative impeller design that assure extremely quite operation and extends its life even under harsh conditions the most advanced manufacturing process with the objective to reduce manufacturing and shortening delivery time. Hydrotwin - PLC-controlled roots + LRVP package for high vacuum application with total liquid re-circulation, capacity to 3,900-m 3/ hr and max vacuum 2-mbar. Hydrosys - centralized package vacuum units with total or partial water re-circulation, capacity to 3,500-m 3/hr max vacuum 33-mbar. It finds application in distillation, drying/ material transfer/power and steel/food processing/paper/general vacuum/textile, etc.

For more information, please contact: Toshniwal Instruments (Madras) Pvt Ltd 267 Kilpauk Garden Road Chennai 600 010 Tel: 044026445626, 26448983 E-mail: sales@toshniwal.net

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Pharma Bio World

Mechanical Vapour Recompressors Everest mechanical vapour recompressors are the latest and first of its kind recompression blowers in India. These specially designed blowers are meant to handle steam vapours across itself which can further be reused to recover the latent heat of vaporisation, in-turn providing heavy savings in energy. Being positive displacement type of compressors, the different temperature and pressure that can be achieved across Everest MVRs is high, resulting in improved process results. Due to the increasing cost of steam (boilers) and allied problems related to the same, there has been a growing demand of mechanical vapour recompressors. These act as a very energy efficient and pollution-free alternatives. MVRs can typically even be termed as energy recovery equipment.

Available in flow rates 200 to 6,000 kg/hr of water vapour.

For more information, please contact: Everest Blowers Pvt Ltd B-44, Mayapuri Indl Area, Phase 1 New Delhi 110 064 Tel: 011-45457777 E-mail: enquiry@everestblowers.com

Steam Air Heaters Steam air heaters for heating air using steam as heating medium at low to high pressures are manufactured using finned tubes manufactured in their factory. Their designs of finned tube heating coils result in economical designs coupled with low air side pressure drops. Flash steam can be used to preheat the air in the flash steam to air pre-heater placed before the main live steam air heater for efficient heat recovery from flash steam. Steam coil air pre-heaters are manufactured to heat the ambient air to desired temperatures. Steam air heaters (steam coils, steam radiators) made are being used in dryers in food industries, pharma drying equipment, coated paper industry, steel strip coating and finishing lines, chemical and dye dryers. Base tubes of carbon steels, copper and copper alloys, SS-304 and 316 and other SS grades finned with galvanised mild steel, copper and SS fins are used in fabrication of air heating exchangers. The body material used so far is carbon steel and SS.

For more information, please contact: Reliable Thermocraft S No: 81/82, Plot No: 18, MIDC Ambad, Nashik, Maharashtra 422 010 Tel: 0253-6628665 E-mail: works@reliablecrafts.com

Console Gear Pump Drive The new Cole-Parmer Console Gear Pump Drive is compact and cost-effective, offering simple variable speed control for many fluid handling applications. When coupled with an appropriate gear pump head, this new drive handles system pressures up to 21 bar, differential pressures greater than 5 bar and flow rates as high as 5,850 mL/min - ideal for applications like pressure filtration, but also excellent for many other laboratory- and industrial-scale, continuous-duty flow applications.

These modern, reliable pumps feature 100:1 speed-control to deliver fluid over a wide flow range. A separate power switch enables the pump operator to maintain the speed setting when turning the drive On or Off. Convenient remote control of start or stop is available via a DB9 connector on the back of the drive. Gear pump heads - purchased separately - are available in cavity or suction-shoe configuration and offer smooth, pulseless, accurate and repeatable fluid delivery.

For more information, please contact: Cole-Parmer India 403, A-Wing, Delphi Hiranandani Business Park, Powai Mumbai 400 076 Tel: 022-61394410, 61394444 Fax: 91-022-61394422 E-mail: vinita.singh@coleparmer.in

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April 2019 â–ş 53

Oxygen Gas Oxygen makes up important proportion of the atmosphere that is about 20.94 per cent by volume and 23 per cent by weight. It is colourless, odourless and is highly reactive. It reacts strongly with combustible materials releasing heat because of its oxidising properties in the process. Oxygen gas has a low boiling point (-183 oC) and it is around 1.1 times heavier than air. Uses of oxygen in the industry are immense.

Oxygen gas is also known as the second largest industrially consumed gas. It has reactivity that it finds application in steel processing, welding and cutting of steel. Steel industry is known as the huge consumer of commercially produced oxygen. For production of steel basic oxygen furnace uses oxygen in large proportion. The use of oxygen also helps to minimise the amount of fuel needed to make a given product.

Oxygen is used with fuel gases like acetylene in flame.

For more information, please contact:

Process Control Devices Plot No: 22 Rautara Indl Estate Shil-Mahape Road, Shil Phata Thane, Maharashtra 400 612 E-mail:sales@pcd-flowmeter.com / sales.pcdpl@gmail.com

Candle Filter SAP Microbac candle filter consists of elements made in multi-tubes of equal diameter either in metals and or plastics such as SS-304, SS-316, SS-316 L, SS-904 L Hastelloy or PP, PVDF and PTFE depending upon specific application.

The entire element is dressed with seamless filter bag tested at high pressure, depending upon the area worked out for enquired application. The length of the element is fixed considering installation qualification for the space provided, the diameter of the element remain the same. The possible discharge may be dry or slurry form.

The mode is back blowing the element with adequate pressure of permissible gas or liquid in process.

Slurry to be filtered is pressured with pump and enters the vessel where several elements are mounted on registers. The vessel is air-vented and then the outlet valves are opened and it is circulated for some time. During circulation max surface straining and surface filtration occurs and a precoat layer of high porosity is obtained on each bag which itself acts as a filter media. Other two mechanisms such as depth straining and depth filtration during circulation is minimum. Once the clarity is obtained circulation is switched over to filtration. As the slurry quantity exhausts the filter is scavenged either with air/nitrogen or steam and remaining is drained out and cake dried further.

Lastly, cake is discharged by back blowing with gas and collected in bags for disposal. If the cake is pyrophoric in nature it is slurry discharged with mother liquer.

For more information, please contact:

SAP Filter Pvt Ltd Plot No: A-5, Sector 1 The Vasai Taluka Indl Co-op Estate Ltd Goraipada, Vasai (E), Dist: Thane, Maharashtra 401 208 Tel: 0250-3208273, Telefax: 91-0250-2458982 E-mail: info@sapfilter.com / sales@sapfilter.com

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Condition Monitoring of Equipment FAG SmartQB is a new type of plug and play multichannel complete solution for the condition-monitoring of equipment: clearly understood plain text messages in the touch panel on the possible defect cause when changes occur in the condition of the equipment; 24/7 monitoring for max plant availability; pre-configured for capture of anomalies in motors, pumps, fans, etc; output of up to five defect causes on the display: bearing damage, unbalance, friction/ cavitation, temperature increases and basic variations; complete commissioning in only 5 minutes.

For more information, please contact: Schaeffler Technoologies AG & Co KG Georg-Schaefer-Strasse 30 97421 Schweinfurt Germany Tel: +49 9721 91-0 E-mail: FAGinfo@schaeffler.com

Lab Reactor ELA 5 is an easily transportable process development unit for gas liquid reactions, which comprises a reactor unit operative in an EX-proof area and a support unit with a process thermostat. It can be operated at EKATO laboratories or at the customer’s site.

EKATO’s specialists can facilitate the design and planning of your process development trials for data analysis and scale-up to plant scale. EKATO has extensive process know-how for complex and challenging process conditions including 2 or 3 phase systems. One can benefit from this vast knowledge base and experience gained over many years of development and implementing innovative mixing technologies.

For more information, please contact: EKATO India Pvt Ltd D-182/3, TTC Indl Area, MIDC, Nerul Navi Mumbai 400 706 Tel: 022-27621104, 27621105, 27621106 E-mail: india@ekato.com

Horizontal Pharma Peeler It is a batch type automatic/semi-automatic filtering centrifuge. The axis of rotation of the basket is horizontal. It is ideally suited for a clean room installation, through the wall using a flexible membrane as required in pharma applications.

A filter media is fixed to the cylindrical surface of a perforated basket. The feed slurry is directed to the basket wall using a feed pipe. Feeding is carried out while the basket is rotating at an appropriate speed. After the required cake is built, feeding is stopped. The centrifuge is run for some time to partially de-water the solids. Feeding can be repeated if there is adequate space for further build-up of cake. After feeding, washing is carried out by pumping wash liquid through the liquid cum wash pipe. The basket is run at spinning speed to complete the de-watering process. The speed of the basket is reduced to scraping speed. A scraper knife cuts the solids, discharging them through the chute. Some material remains on the filter media after scraping and is called residual heel. This heel can be removed by using the heel removal system. Centrifuge can be cleaned using a CIP system.

For more information, please contact: D Parikh Engg Works 115 Marol Co-op Indl Estate Off M V Road, Nr Saki Naka Andheri (E), Mumbai 400 059 Tel: 022-28504787 Fax: 91-022-28505979 E-mail: sales@dparikh.com

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events diary       

      

Dates: 4-5 May 2019 Venue: Hotel Skypark Kingstown Dongdaemun, Seoul, South Korea

Dates: 14-15 May 2019 Venue: Flora Grand Hotel, Dubai, UAE

This event is designed for scientists, scholars, engineers and students from the Universities all around the world and the industry to present ongoing research activities, and hence to foster research relations between the Universities and the industry. This conference provides opportunities for the delegates to exchange new ideas and application experiences face to face, to establish business or research relations and to find global partners for future collaboration.

The International Conference on Chemical and Environmental Sciences is a prestigious event organized with a motivation to provide an excellent international platform for the academicians, researchers, engineers, industrial participants and budding students around the world to share their research findings with the global experts.

 ISERD Malaysia South City Mall Condominium Block A-2-3A Jalan Serdang, Kajang Selangor, Malaysia 43300 E-mail: info@iserd.co

 ISERD Malaysia South City Mall Condominium Block A-2-3A Jalan Serdang, Kajang Selangor, Malaysia 43300 E-mail: info@iserd.co

   

      

Date: 16 – 18 July, 2019 Venue: Pragati Maidan, New Delhi

Date: 4-6 December, 2019 Venue: HITEX Exhibition Centre, Hyderbad

Indian Pharma Expo (IPE) will provide an opportunity for the participating companies to display their products & services to the gamut of visitors, globally from pharma and healthcare industries. The 3-day expo will bring together eminent personalities from various sectors of pharma, nonpharma and healthcare industries. IPE is one stop juncture to all those who are planning to expand their business through various channels of franchise and distribution; as well as wholesalers and hospital purchase personnel who seek to buy bulk products at concessional rates.

BioPharma World Expo 2019 is the best platform for both Indian and international manufacturers/service providers/ startups connected with pharma machinery, CR AMS, CROs/CMOs, packaging, logistics, exports, APIs, generics, biotech, regulatory affairs, etc . It offers a unique opportunity to meet, network and establish business partnerships.

The concurrent conference tracks would highlight latest technological developments, market trends, investment opportunities and challenges facing the industry. The technical sessions would cover pharmaceutical technology, biosimilars, green chemistry, compliance, etc.

 CIMS Medica Boomerang, Unit No. 403 B1 Wing 4th floor, Chandivali Farm Road, Chandivali, Andheri (East), Mumbai - 400 072. India Tel: +91-22-66122612 / 627 Email: ipe@cims.co.in

 Jasubhai Media Taj Building, 210, Dr. D.N. Road, Fort, Mumbai - 400 001 Tel: 91-22- 40373636 Email: amrita_patil@jasubhai.com

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bookshelf Pharma Resource Book 2019-2020 Author: Cole-Parmer India Price: Free No of pages: 336 pages Publisher: Cole-Parmer India About the book: Cole-Parmer, a leading manufacturer and supplier of laboratory and industrial products, instrumentation, and supplies, recently launched its biggest Pharma Resource Book 2019-20, dedicated to meet application needs of pharmaceutical and biopharma customers. For biopharma product development, the pharma resource book addresses the pain areas of the customers such as compliance, SOP concerns, customized solutions, validation support and much more, in addition to offering numerous unique and new products, as well as returning favourites, making it the biggest Pharma Resource. Whether it is a lab set-up or scale-up, the book has everything pharmaceutical and biopharma customers need - a wide range of laboratory essentials, cleanroom and safety products, fluid handling products, lab equipment, electrochemistry, test and measurement, cell culture, and chromatography products. The products and specifications meet many pharmaceutical industry standards. Cole-Parmer’s close association with the pharmaceutical industry has enabled them to develop products and solutions to meet Industry’s stringent requirements for testing and manufacturing. Their application knowledge and expertise combined with in-depth understanding of customers’ needs enables them to provide integrated solutions that address their customer’s requirements. Cole-Parmer today is seen as a substantial, superior value, one-stop package of innovative products, quality service and technical support. Leading pharmaceutical companies rely on them for comprehensive solutions for their research to production. The company aims at continuous growth and has added many renowned brands in the last three years to widen it’s pharma solutions – Kinesis®, Jenway®, Stuart®, Traceable®, Electrothermal®, Argos Technologies, VapLock®, and Ismatec® to name a few. The latest products from these brands are added in the book, making it a biggest Pharma Resource for the customers. It all adds up to a promise that Cole-Parmer as ‘Scientific Experts’ works to fulfil every day: delivering solutions customers trust and therefore is considered as a preferred partner for end-to-end solutions to the Pharmaceutical Industry. To request your copy of Pharma Resource Book, contact 022-61394444 / response@coleparmer.in or visit ColeParmer.in/catalog

Leachables and Extractables Handbook Editors: Douglas J Ball, Daniel L Norwood), Cheryl L M Stults and Lee M. Nagao Price: $70.00 No of pages: 700 pages (Hardcover) Publisher: Wiley; (1 st Edition) About the book: A practical and science-based approach for addressing toxicological concerns related to leachables and extractables associated with inhalation drug products Packaging and device components of Orally Inhaled and Nasal Drug Products (OINDP) - such as metered dose inhalers, dry powder inhalers, and nasal sprays - pose potential safety risks from leachables and extractables, chemicals that can be released or migrate from these components into the drug product.

Addressing the concepts, background, historical use, and development of safety thresholds and their utility for qualifying leachables and extractables in OINDP, the Leachables and Extractables Handbook takes a practical approach to familiarize readers with the recent recommendations for safety and risk assessment established through a joint effort of scientists from the FDA, academia, and industry. Coverage includes best practices for the chemical evaluation and management of leachables and extractables throughout the pharmaceutical product life cycle, etc.

Talent Wins Authors: Ram Charan, Dominic Barton and Dennis Carey Price: $16.74 No of pages: 192 pages (Hardcover) Publisher: Harvard Business Review Press About the book: Most executives today recognize the competitive advantage of human capital, and yet the talent practices their organizations use are stuck in the 20th Century. Typical talent-planning and HR processes are designed for predictable environments, traditional ways of getting work done and organizations where lines and boxes still define how people are managed. As work and organizations have become more fluid - and business strategy is no longer about planning years ahead but about sensing and seizing new opportunities and adapting to a constantly changing environment - companies must deploy talent in new ways to remain competitive.

Turning conventional views on their heads, talent and leadership experts provide leaders with a new and different playbook for acquiring, managing and deploying talent - for today’s agile, digital, analytical, technologically driven strategic environment - and for creating the HR function that business needs. Filled with examples of forward-thinking companies that have adopted radical new approaches to talent, as well as the juggernauts and the start-ups of Silicon Valley, this book shows leaders how to bring the rigor that they apply to financial capital to their human capital - elevating HR to the same level as finance in their organizations. Providing deep, expert insight and advice for what needs to change and how to change it, this is the definitive book for reimagining and creating a talent-driven organization that wins.

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Process Industry's Gateway to Indian Market

International Exhibition and Conferences 4-6 December 2019

ChemTECH

Venue: HITEX Exhibition Center, Trade Fair Office Building Izzat Nagar, Kondapur PO, Hyderabad, India

SOUTH WORLD EXPO 2019

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Exhibitors Profile •

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ANALYTIX

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SOUTH WORLD EXPO 2019

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Lab Equipment

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EPCs

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Environmental services

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Emission Control

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Safety

Facts & Figures South 2017

AUTOMATION

& Control South 2019

182

EXHIBITORS

5971 VISITORS

• • • • • • • • • • • • • • • • • • •

25

Pharma & Biopharma Bulk Drugs APIs Biotechnology Chemical Processing Chemicals & Petrochemicals Agrochemicals Fine & Specialty Chemicals Oil, Fats & Oleo Chemicals Food & Beverages Advanced Materials Material Testing & Inspection Contract Research & Manufacturing Research Laboratories Clinical Research Labs Government Agencies Municipalities & ETPs Pollution Control Boards Water & Waste Management

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