Pharma Bio World 2018

VOL 17 | ISSUE 2 | SEPTEMBER 2018 | MUMBAI | TOTAL PAGES 56 | ` 150

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Phytopharmaceuticals

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An overview on Medicinal Plants Market and Industry

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Pharma Bio World

INTERVIEW 8

Phytopharmaceutical: an emerging platform Dr. Ashwini Kumar, CEO, CliniExperts Services Private Limited FEATURES

16

Phytopharmaceuticals & their role in human health Charu Gupta & Dhan Prakash, Amity Institute for Herbal Research & Studies

20

Phytopharmaceuticals: A new drug class regulated in India Dr. Arun Bhatt, Consultant, Clinical Research & Development

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

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Formulation and evaluation of Ayurvedic face wash Amit Ingle, Bajiraoji Karanjekar College of Pharmacy, Sakoli, Maharashtra, India Mayuri B. Meshram, Bajiraoji Karanjekar College of Pharmacy, Sakoli, Maharashtra, India

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DR. ASHWINI KUMAR

Phytopharmaceutical: an Emerging Platform

8 â—„ September 2018

Globally, herbal medicine has been considered an impor tant alternative to modern allopathic medicine. Herbal medicines are very popular throughout the globe, however, only a few medicinal herbs have been scientifically evaluated for their potential in medical treatment.

In most countries, the herbal drugs a r e p o o r l y r e g u l a te d a n d a r e o f te n neither registered nor controlled by the health authorities. In India, plant based products used as medicines come under the category of Phytopharmaceuticals.

They include Ayurvedic, Siddha, Unani (ASU) Drugs and any other plant based product which is used as medicine. The phytopharmaceuticals are under the purview of the Central Drugs Standards Control Organization (CDSCO).

Dr. Ashwini Kumar, CEO of CliniExperts Ser vices Private Limited, which provides end-to-end regulatory services to Domestic & International pharmaceutical markets has a total commitment to medical research and its signiďŹ cance to the world of tomorrow. Dr. Kumar in his interview with PBW talks about Phytopharmaceutical market across the world with a focus on India.

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interview CliniExperts is a complete product pipeline development partner for Phytopharmaceutical companies developing and commercializing drug products and offers end-to-end solution for Phytopharmaceutical Drugs need.

Please give us an insight into the Phytopharmaceutical industry across the world with a focus on India.

Before elaborating on the phytopharmaceutical drugs in India, I would like to inform, that this is the newest division declared by Indian FDA (CDSCO) after AYUSH, & the division is still getting evolved in terms of setting up standards & guidance documents.

For a drug to be in Phytopharmaceutical category, the basic mandate is, it must include purified and standardized fraction with defined minimum four bio-active or phyto-chemical compounds (qualitatively and quantitatively assessed) of an extract of a medicinal plant or its part, for internal or external use of human beings or animals for diagnosis, treatment, mitigation or prevention of any disease or disorder but does not include administration by parenteral route.

Phytopharmaceutical class of drugs have origin in traditional system of medicine as well as phytomedicine.

The modern age may have sovereignty of synthetic drugs however phytomedicine is making a strong and dramatic comeback.

The popularity of AYUSH systems of medicine is growing at a rapid pace due to its effectiveness with sound efficacy, we all should be very thankful to CDSCO for regulating the category under AYUSH & Phytopharmaceuticals.

Globally all the countries are now regulating the category in the same manner under Traditional Medicines. China has already established as top leader of the herbal market, but if we talk about India, we have an additional benefit if having the category defined under pharmacopoeial standards as 10 â—„ September 2018

Ayurvedic Pharmacopoeia. We all should feel very lucky that we had all these herbal (Ayurvedic) medicines standardized centuries ago with proven safety and efficacy.

In India, the interest of pharmaceutical industries towards medicinal plants is increased in last decade, and this is because of increased awareness and interest in medicinal plants by public and the scientific community. Here has been rising interest in herbal drugs, with many players of domestic origin like Patanjali, Dabur, Hamdard, Baidnath, Himalaya and even international players like Herbalife, & Boinorica are also investigating the commercial potential of their herbal products in India. In 2017, the global market for plant-derived drugs grew from $29.4 billion to around $39.6 billion and it is assumed that by 2022 with a compound annual growth rate (CAGR) of 6.1% for the period of 2017-2022.

Fro m th e Indi an m ark et pe rs pec ti v e, phytopharmaceutical is an emerging platform.

Majority of the ayurvedic pharmacies are not conversant with the emerging market for phytopharmaceuticals. Standardized extracts derived from Commiphora guggul, Ginkgo biloba, Silybum marianum and Zingiber officinale are few examples representing herbal class of drugs in Indian market.

The above mentioned standardized herbal extracts are widely prescribed by practitioners of allopathic divisions also.

Herbal medicines are very popular throughout the globe, however, only a few medicinal herbs have been scientifically evaluated for their potential in medical treatment. India has a rich history herbal medicines, so do you think India has a potential Phytopharmaceutical industry in the making?

We do have to accept that with the bang of Allopathic formulations in the Indian market it was very widely accepted by the authorities as well as the end user also and this was just

because of the rapid action of the synthetic drugs on the disease and/or disorder state of the patient, which is the very prime objective of the treatment, and the adverse effects we of the formulations are not playing a major role their approval.

But we are aware of the Supreme Court’s ruling which had declared a number of synthetic (allopathic) formulations as irrational and this is just because of the evolution of the CDSCO with the new stringent requirements for the approval.

Along with this the technology is also evolving at a great pace with help us in justifying the equivalency between the allopathic & herbal formulations and that to without the adverse effects. Means only pros & no cons and who does not require in this manner.

Just because of this only there is growing demand for herbal medicine in the developed as well as developing countries like India, because of their wide biological activities, higher safety of margin than the synthetic drugs and yes obviously at a comparatively lesser costs.

The market of formulations or medicine originating from medicinal plants or natural products is largely based on prescription of around 5 lacs (INDIAN TRADITIONAL, AYUSH and INTEGRATED) practitioners practicing independently and in approximately 3000 hospitals. It has been observed that majority of the Ayurveda practitioners prescribe classical or patent and proprietary medicines in clinical practice. Their knowledge about use of standardized herbal extracts-based formulations is very limited.

As per one estimate, 1300 medicinal plants are used for medicinal purpose. In Ayurveda itself, several drugs have established role in treatment of liver diseases. Picrorrhiza kurroa, Andrographis paniculata, Solanum nigrum, Eclipta alba and Cicohrium intybus are few to mention. The need of the hour is to bring scientifically established herbal drugs under the umbrella of phytopharmaceuticals.

Pharma Bio World

interview Further, it is expected that in coming days, herbal market shall be governed by supercritical extracts owing to improved bioavailability, reduced toxicity and improved dosage form.

Nanophytomedicine is also knocking door of the pharmaceutical industry. In near future, supercritical extracts, nonophytomedicine and phytopharmaceuticals may be seen as driving force of the herbal industry.

developing a new drug if the application of the new drug, the compound from which it is made or the process used to make it can be innovative or at best patent protected. Since new drug development is fairly costly, the pharmaceutical industry remains interested in developing completely new active drug ingredients, as only these are market savvy or patentable.

The CDSCO has released a draft regulation, as an amendment to the Drugs & Cosmetic Rules 1945, which defines and outlines regulations for Phytopharmaceuticals. How challenging is the development of new Phytopharmaceuticals?

The pharmaceutical industry is not generally that interested in medicinal plants as they do not contain a single definable and completely new active ingredient. Phytopharmaceutical producers are also well aware of the patent protection problem and solve it by developing special extracts with production processes that they can protect with a patent. They “invent” a special method to enrich or remove substances from an extract, so that the extract becomes something special.

This invention can then be protected with a patent. These extracts are tested in clinical trials, approval is sought and, all being well, granted, as happens with standard drugs.

Although this special manufacturing process enables manufacturers to protect their plantbased product, other manufacturers can easily find a way around it.

If we talk about the regulations of the Phytopharmaceuticals defined by the CDSCO, yes they are a bit more stringent than AYUSH because the safety and efficacy of the Herbal & Ayurvedic formulations registered under the AYUSH is considered as already safe & sound because they are already proven in the related pharmacopoeias identified by AYUSH, but when talk about the Phytopharmaceutical standard, they are very much equivalent to Allopathic formations like orals, biologicals etc. thus one needs to very stringently define the safety & efficacy as per the guidelines set

by CDSCO, which takes a lot of time & money to be invested. & there are very rare chances of waivers to be given in the process so as to set & define a standard of the formulation which can also be considered by the authorities for the companies seeking approval of the same or relative formulation in the future. In other words we can say that we are in the process of setting up a strong base for the future formulations.

How are new herbal medicines placed on the market?

Established use and scientific backing need to be proven while marketing these products. For the pharmaceutical industry it is imperative to spend time and money on 12 ◄ September 2018

How do the regulatory requirements for herbal medicines, i.e. extracts, differ from those for synthetic drugs?

stringent manner and they are available to the end user against a prescription only.

Additionally if we talk about the standardization of herbal medicines is often a very difficult task due to complexity of their diverse secondary metabolites, with therapeutic action which may vary with different geographical and tropical conditions & genetic differences between the populations & these complications remains same for approval of formulations under AYUSH & Phytopharmaceutical category.

Also, the harvesting process and period, coupled with incidents of adulterations due to the presence of microorganisms and pesticides have profound impact on achieving uniform standards of herbal medicines worldwide. Improvement in the quality of herbal medicines could be achieved by deliberate implementation of good agricultural practices (GAPs) at the point of cultivation of medicinal plants and good manufacturing practices (GMPs) during the process of manufacture and packaging of finished herbal products, as well as post-marketing quality assurance surveillance. Thus complications related to natural resourcing of ingredients of the formulations, identifying its potential of being therapeutically active are not present in Allopathic (synthetic drugs).

If we talk about the herbal formulations, every pharmacopoeial formulation is herbal but every herbal formulation is not pharmacopoeial. Along with herbal f o r m u l a t i o n s a p p r o v e d u n d e r AY U S H considered safe & effective due to their earlier presence in the pharmacopoeial standards and are available to the end user without the prescription, which in itself defines its safety and efficacy due to which there are lot of waivers given by the AYUSH during the approval process.

Quality continues to be a major theme across the nutritional and pharmaceutical ingredients marketplace. How do you see the future of herbal medicine research and development? What is the potential?

But herbal formulations which are approved under Phytopharmaceutical category and also as said earlier are approved in a very

• Cultivation /collection/drying/ minimal processing/ storage and transport of the raw herb.

Quality of any medicine is of paramount importance. It all depends on the ingredients and the processing stage. In a chain, common GMP requirements are implemented which are as follows:

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interview • Grinding/extraction/fractional steps/other operations like spray drying/tray drying/ packing and storage of the botanical process.

• The formulation based on compatibility with excipients/ dosage form choose from product formulation/different steps involved in the manufacture.

Moreover, it is expected that this section will be developed more in the coming future and the applicants are advised to adopt a process that will prohibit contamination, destruction and helps in protecting the quality and veracity of the final product.

The use of cutting-edge analytical techniques and well-thought-out research methodologies, the prospects of advancing the frontiers of knowledge in herbal medicine is now at an alltime high. Additionally, following the current sustained improvements in quality control and regulatory measures in many countries

of the world, it is envisaged that in the near future, herbal medicine will be integrated into conventional medical systems.

Or else I also be said as herbal formulations will soon be replacing the synthetic formulations from the markets of Asian countries and countries like Germany also by the end of the century.

Is patient education still an important topic when it comes to Phytopharmaceuticals?

Yes, patient education will play an important role to differentiate the importance of phytopharmaceuticals with other undocumented herbal formulation present in the market.

2. M e d i c i n a l B o t a n i c a l s / D i e t a r y Supplements: the whole plant or plant-part extracts used for maintenance of health by affecting a body structure and its function 3. Nutraceuticals: the food containing supplements from natural (botanical) sources, that deliver a specific health benefit, including prevention and treatment of disease 4. Cosmeceuticals: the cosmetic products which contain biologically active ingredients having an effect on the user end 5. Herbal raw material: they are prepared using pure and herbal extracts.

The available herbal remedies market can be classified into five strategic areas: 1. Phyto-Pharmaceuticals: the plant-based drugs containing isolated pure active compounds used to treat diseases

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Phytopharmaceuticals & their Role in Human Health Nutraceuticals and functional foods on an average are globally becoming giant players in health sector. In a survey, it was reported that in year 2010 alone, there was a huge market growth of nutraceuticals and food supplements.

Phytopharmaceuticals, nutraceuticals and functional foods have the potential to substantially reduce the expensive, high-tech, disease treatment approaches particularly common in developed countries.

Charu Gupta and Dhan Prakash from Amity Institute for Herbal Research & Studies explores the world of Phytopharmaceuticals and nutraceuticals in this article.

A

popular Hippocratic Oath states that “Let food be thy medicine and medicine be thy food”. This oath truly illustrates the importance of nutraceuticals and functional foods in today’s sedentary lifestyle.

With the increase in the consumption of junk foods, there is a subsequent increase in lifestyle diseases like hypertension, obesity, diabetes etc.

Functional foods and nutraceuticals have emerged out as an attractive natural alternative especially in European countries including US. Today’s consumers have become more health conscious and are aware of the side effects of the allopathic medicines. They look out for a healthier and natural option in the form of functional foods, dietary supplements and nutraceuticals. The major advantage of consuming these food supplements are that they just not only take care of the person’s normal recommended dietary allowance (RDA) balance but also serve as a mechanism for performance enhancement and disease prevention (FICCI). Consumers prefer natural nonGMO (genetically modified organism) and organic foods, beverages and nutritional health supplements.

Phytopharmaceuticals plays a key role in the development of nutraceuticals and functional foods, prevention or treatment of several diseases and maintenance of good general health in human.

Charu Gupta Amity Institute for Herbal Research & Studies Amity University UP

Dhan Prakash Amity Institute for Herbal Research & Studies Amity University UP 16 ◄ September 2018

Phytopharmaceuticals are actually “Bioactive herbal formulations” that contains selective combinations of specific bioactive constituents of plants and/or their parts that possess health-promotive, disease preventing and medicinal properties. These phytochemicals are present in either whole plants or in their specific plant parts like stem, leaves, flowers, and roots. These can aptly be known as ‘Herbiceuticals’ having nutraceutical importance and include nonnutritive phytochemical(s) that maintain

good health. They offer the benefits of both food nutrients and pharmaceutical like defensive or disease protective properties. Phytochemicals are the nonessential nutrients that are produced by the plants under stressful conditions in order to protect themselves. Nutraceuticals comprises of the concentrated source of these phytochemicals that are present in the purified form. Other related terminologies commonly used in this area include dietary supplements, geneticallyengineered designer foods, and functional foods. The important phytochemical constituents commonly found in plants are polyphenols, flavonoids, isoflavonoids, anthocyanidins, carotenoids, fibers, limonoids, glucosinolates, phytoestrogens, phytosterols and terpenoids. All these phytochemicals provide numerous health benefits including prevention and/ or treatment of diseases and various other physiological disorders. Majority of foods, including whole grains, beans, fruits, vegetables and herbs contain all these important phytochemicals.

However, amongst all these, fruits and vegetables contribute to the most significant source of phytochemicals. These phytochemicals function either alone or in combinations and contribute significantly in curing various health related ailments. Functional foods are closely related to nutraceuticals as they often contain nutraceuticals in a foodbased formulation, such as carotenoids, but others are novel biotechnological entities derived from foods, for instance, pre- and probiotics.

Phytochemicals, if consumed regularly in recommended doses, provides health benefits by protecting against chronic degenerative disorders, cancer, diabetes, high blood pressure, inflammation, microbial, viral and parasitic infections, psychotic diseases, spasmodic conditions, ulcers, cardiovascular and neurodegenerative diseases. These nutraceuticals either Pharma Bio World

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alone or in combination have tremendous therapeutic potential in curing various ailments. Nutraceuticals contain bioactive phyto-constituents in purified and concentrated form that offer several health and medicinal benefits.

Nutraceuticals and functional foods on an average are globally becoming giant players in health sector. In a survey, it was reported that in year 2010 alone, there was a huge market growth of nutraceuticals and food supplements. The importance of these products can be ascertained by the fact that in developing and poor countries mortality rate has been increased to up to nearly 40% due to poor nutrition. Thus to maintain the nutritional balance of the individual, it is necessary to take nutraceutical-type products.

As per the recent reports of the popular vision gain, the world market demand for all the nutraceuticals, dietary supplements and functional foods will further boost up to $241.25bn in 2015 alone. This data is justified and supported by the fact that the world’s ageing population is gradually increasing particularly in developed European countries. The aged people are becoming more health conscious across the globe. There are various nutraceuticals available in the market for these geriatric individuals. This has provided an important incentive for the global food industry, which is experiencing an increasing shift towards functional foods and nutraceuticals.

18 â—„ September 2018

The major drawback of marketing of phytopharmaceuticals including functional foods and nutraceuticals is that they are not subjected to rigorous quality regulations as compared to pharmaceutical products particularly in developing countries where there are no stringent laws and government bodies to check the quality of these products, their promotion and distribution.

A food can become a nutraceutical simply by validating through scientific studies.

Phytopharmaceuticals, nutraceuticals and functional foods have the potential to substantially reduce the expensive, high-tech, disease treatment approaches particularly common in developed countries.

Nutraceutical products range from isolated nutrients, dietary supplements and specific diets to genetically engineered foods, herbal products, and processed foods such as cereals, soups, and beverages. Examples of some popular nutraceuticals include glucosamine from ginseng, omega-3 fatty acids from linseed, epigallocatechin gallate from green tea, lycopene form tomato etc. All these products possess several therapeutic benefits.

Chemically nutraceuticals may be classified as carbohydrate derivatives (ascorbic acid, oligosaccharides, non-starch polysaccharides), amino acid derivatives (amino acids, allyl-S compounds, capsaicinoids, isothiocyanates, indoles, folate, choline), microbes (probiotics, prebiotics), fatty acid and structural lipids (n-3 PUFA, CLA, MUFA, sphingolipids, lecithins), minerals (Ca, Zn, Cu, K, Se), isoprenoid derivatives (terpenoids, carotenoids, saponins, tocotrienols, tocopherols, terpenes), and phenolic compounds (couramines, tannins, lignins, anthocyanins, isoflavones, flavonones, flavanoids.

The vitamins A, B6, B12, D, E, folates have been suggested to have anti-cancer, immune-protective and cancer-reducing activity in individuals who used selfmedication.

These nutraceuticals play an important role in maintaining optimal immune response; their deficient or excessive intakes can have negative impact on health. Several preclinical and clinical trial studies have shown that the regular consumption of whole grains, fruits, and vegetables reduces the risk of chronic diseases associated with oxidative damage.

Carotenoids, tocopherols, ascorbates, lipoic acids and polyphenols are strong natural antioxidants with free radical scavenging activity.

Besides, there are several endogenous antioxidant enzymes like super oxide dismutase (SOD), catalase, glutathione peroxidase, glutathione- reductase, minerals like Se, Mn, Cu, Zn, vitamins A, C and E, carotenoids, limonoids and polyphenols exert synergistic actions in scavenging free radicals. Thus all the governing bodies around the world have accepted nutraceuticals as possible nutraceutical therapy in main stream of medical education and health.

Since there are not still any stringent government regulatory bodies, majority of nutraceuticals are purchased based on self-prescription and own individual experiences. It has been found that the benefits of nutraceuticals are phenomenal in the controlled clinical trial studies.

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Phytopharmaceuticals using Biotechnology

development

Biotechnological tools can also be used to develop and improve phytopharmaceutical & nutraceutical products and functional foods. The major advantage is to increase the production of enzymes and other metabolites production through recombinant microbiology. Furthermore, the thermal stability of the enzymes and metabolites and their ability to tolerate wide pH range can further be improved using these biotechnological tools.

Through the use of genetic engineering, it is possible to isolate a specific gene(s) coding for enzymes or other metabolites of interest, from organisms of unknown genetics. For example, it is known that omega-3 fatty acids protect against cardiovascular disease. The various food sources of omega-3 fatty acids are fish, flax seed and some vegetable oils.

It is possible to produce a vegetable oil that can have 10-20 times the amount of

omega-3 fatty acids compared to present day oils using modern biotechnological tools like genetic engineering. Such types of oil can be used to include in the diet of patients prone to heart disease.

Conventional plant-breeding methods can also improve nutraceutical quality and production by enhancing both agronomic and medicinal traits.

In vitro propagation or tissue culture techniques of plants also holds potential for the production of high-quality plant-based medicines.

Besides these, nutritional genomics is a recently used terminology in the area of nutraceutical development which includes nutrigenomics (the science of study of interaction of dietary components with the genome and the resulting proteomic and metabolomic changes) and nutrigenetics (understanding the gene-based differences in response to dietary components and developing tailor-made nutraceuticals that are most compatible with health based on individual genetic makeup).

Phytopharmaceuticals sometimes known as Natural health products are now available in the market in many dosage forms like tablets, capsules, powder, vati, tinctures, solutions, ointments, drops and cream to name a few. These are all the concentrated forms of the bioactive phytochemicals

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suitably extracted from natural sources and they are designed to maintain or promote health, restore or correct human health function(s) and treat or prevent disease.

Some of the common examples of these phytopharmaceuticals include beta-glucan extracted from oats, antioxidants from blueberries, iso-flavonoids from soy, sterols from wood pulp, essential fatty acids from marine or vegetable oil, and soluble fibers from fenugreek. The products that are obtained after grounding, drying, powdering and pressing from plant materials include Echinacea, fenugreek, valerian and ginseng. The products produced, extracted and purified from animals or microorganisms include elk velvet, essential fatty acids, enzymes, carotenoids and probiotics; and products from marine sources include glucosamine, chitosan, algae, seaweed, kelp and fish oils; and vitamin and mineral supplements.

Conclusion As discussed about the promising role of phytopharmaceuticals in the promotion of human health and disease prevention; the health professionals, nutritionists and regulatory toxicologists should strategically work to plan appropriate regulation to provide the ultimate health and therapeutic benefits to mankind. Thus long term clinical trials are required to scientifically validate the efficacy of phytopharmaceuticals in various medical conditions. Besides this, the mode of interaction of phytopharmaceuticals with food and drugs is another area that should also be taken into consideration in the clinical trial studies. Also the effect of different processing methods on the bioavailability and effectiveness of nutraceuticals should also to be ascertained.

Contact: charumicro@gmail.com September 2018 â–ş 19

Phytopharmaceuticals: A new drug class regulated in India The safety of herbal medicines remains a major concern. In the United States, the Food and Drug Administration (FDA) has estimated that over 50,000 adverse events are caused by botanical and other dietary supplements. Dr Arun Bhatt talks about the new phytopharmaceuticals regulations which permits the development of the drug development using advanced techniques of solvent extraction, fractionation, potentiating steps, modern formulation development, etc

Dr. Arun Bhatt Consultant Clinical Research & Development 20 ◄ September 2018

G

lobally, herbal medicine has been considered an important alternative to modern allopathic medicine. Although the herbal medicines are very popular in the society, only few medicinal herbs have been scientifically evaluated for their potential in medical treatment. In most countries, the herbal drugs are poorly regulated and are often neither registered nor controlled by the health authorities. The safety of herbal medicines remains a major concern. In the United States, the Food and Drug Administration (FDA) has estimated that over 50,000 adverse events are caused by botanical and other dietary supplements.[1] In addition, for most herbal drugs, the efficacy is not proved and the quality is not assured. The World Health Organization’s (WHO) Traditional Medicine (TM) Strategy 2014–2023 focuses on promoting the safety, efficacy, and quality of TM by expanding the knowledge base and providing guidance on regulatory and quality assurance standards.[2] In 2012, 119 WHO member states were regulating herbal medicines.[2] Herbal medicine products include herbs, herbal materials, herbal preparations, and finished herbal products that contain parts of plants, other plant materials, or combinations thereof as active ingredients.[3] Herbs include crude plant material, for example, leaves, flowers, fruit, seed, and stems. Herbal materials include, in addition to herbs, fresh juices, gums, fixed oils, essential oils, resins, and dry powders of herbs.

Herbal preparations are the basis for finished herbal products and may include comminuted or powdered herbal materials, or extracts, tinctures, and fatty oils of herbal materials. Finished herbal products consist of herbal preparations made from one or more herbs.

The regulatory scenario regarding herbal preparations varies from country to country.[4] Globally, several diverse regulatory approaches are in vogue such as: • Same regulatory requirements for all products • Same regulatory requirements for all products, with certain types of evidence not required for herbal medicines • Exemption from all regulatory requirements for herbal medicines • Exemption from all regulatory requirements for herbal medicines concerning registration or marketing authorization • Herbal medicines subject regulatory requirements

to

all

• Herbal medicines subject to regulatory requirements concerning registration or marketing authorization.

In Europe, for the marketing approval,[5] the herbal preparations are classified in three categories as follows: • Traditional medicinal use provisions “traditional use” accepted on the basis of sufficient safety data and plausible efficacy • Well-established medicinal use provisions “well-established use” demonstrated with the provision of scientific literature establishing that the active substances of the medicinal products have been in well-established medicinal use within the European Union for at least 10 years, with recognized efficacy and an acceptable level of safety a product can be classified under.

• Safety and efficacy data from the company’s own development “stand alone” or a combination of own studies and bibliographic data “mixed application”.

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FDA Botanical Drug Development Guidance[6] describes appropriate development plans for botanical drugs to be submitted in new drug applications (NDAs) and specific recommendations on submitting investigational new drug applications (INDs). The term botanical means products that include plant materials, algae, macroscopic fungi, and combinations thereof. FDA guidance recommends that IND must contain sufficient information to demonstrate that the drug is safe for testing in humans

• Botanical raw material control • Quality control by chemical test(s) and manufacturing control • Biological assay • Clinical data: Dose-response data and multiple batch clinical data.

In Indian regulations, the major class of Ayurveda, Siddha, or Unani (ASU) drugs included are:[7] a. Classical ASU drugs as mentioned in the authoritative books of ASU system drugs, which are manufactured

The new phytopharmaceuticals regulation permits the development of the drug development using advanced techniques of solvent extraction, fractionation, potentiating steps, modern formulation development, and that the clinical protocol is properly designed for its intended objectives.

In addition to general regulatory requirements for an NDA - nonclinical pharmacology/toxicology studies, clinical evidence of efficacy and safety - for botanical drugs there are special requirements to ensure safety and quality of botanicals[6] as follows: • Description of documentation of experience

product and prior human

• Description of botanical raw materials used and known active constituents or chemical constituents • Prior human experience.

• Quality control • Botanical raw materials • Botanical drug substance and drug product • Identity, chemical characterization, manufacturing processes, biological assay, specifications, stability, current good manufacturing practices, and environmental assessment.

• Evidence to consistency Pharma Bio World

ensure

therapeutic

and named in accordance with the formulations described in the authoritative texts. For this category, issue of license to manufacture is based on citation in authoritative books and published literature, unless the drug is meant for a new indication when proof of effectiveness is required. b. Patent or proprietary medicine makes use of ingredients referred in the formulations of authoritative texts but with intellectual intervention, innovation, or invention to manufacture products different from the classical medicine. For this category issue of a license to manufacture requires proof of effectiveness, based on the pilot study as per relevant protocol for ASU drugs.

In 2010, Department of Ayurveda, Unani, Siddha, and Homeopathy (AYUSH) introduced Rule 158(B) which made the requirement of proof of effectiveness for licensing of a patent or proprietary ASU medicine.[7] This was followed by the release of GCP guidelines[7]

for voluntary use by the researchers interested in taking up clinical trials using ASU medicine.

In India, ASU drugs have been under the purview of Department of AYUSH. In contrast, 2015 regulatory requirements for phytopharmaceuticals are under the purview of the Central Drugs Standards Control Organization (CDSCO).[8] This gazette notification defines regulatory provisions for phytopharmaceuticals and regulatory submission requirements for scientific data on quality, safety, and efficacy to evaluate and permit marketing for an herbal drug on similar lines to synthetic, chemical moieties.

Phytopharmaceutical drug is defined as[8] purified and standardized fraction with defined minimum four bio-active or phytochemical compounds (qualitatively and quantitatively assessed) of an extract of a medicinal plant or its part, for internal or external use of human beings or animals for diagnosis, treatment, mitigation, or prevention of any disease or disorder but does not include administration by parenteral route.[8] In Schedule Y, the newly added Appendix I B describes data to be submitted along with the application to conduct clinical trial or import or manufacture of a phytopharmaceutical drug in the country.[8] The regulatory requirements for NDA for the phytopharmaceutical drug include standard requirements for a new drug-safety and pharmacological information, human studies, and confirmatory clinical trials. For phytopharmaceutical drug, there is a lot of stress on: • Available information on the plant, formulation and route of administration, dosages, therapeutic class for which it is indicated and the claims to be made for the phytopharmaceutical, and supportive information from published literature on safety and efficacy and human or clinical pharmacology information September 2018 ► 21

• Data generated on: • Identification, authentication, and source of the plant used for extraction and fractionation • Process for extraction and subsequent fractionation and purification

develop noble intentions to discover phytopharmaceutical drugs for unmet medical needs.

REFERENCES 1. FDA Should Take Further Actions to Improve Oversight and Consumer Understanding GAO-09-250: Published:

In addition to general regulatory requirements for an NDA nonclinical pharmacology/ toxicology studies, clinical evidence of efficacy and safety - for botanical drugs there are special requirements to ensure safety and quality of botanical.

• Formulation details of phytopharmaceutical drug • Manufacturing process of formulation • Stability data.

The new phytopharmaceuticals regulation permits the development of the drug development using advanced techniques of solvent extraction, fractionation, potentiating steps, modern formulation development, etc.[9] After NDA approval from CDSCO, the marketing status of the new phytopharmaceutical drug would be like that of a new chemical entity-based drug.[9] The new regulation for phytopharmaceutical is in line with regulations in USA, China, and other countries involving scientific evaluation and data generation.[9] This new regulation is expected to promote innovations and development of new drugs from botanicals in a scientific way and would help in the acceptance of the use of herbal products by modern medical profession. It would encourage research in phytopharmaceutical drug development for academia, researchers, and industry.

Last year Dr. Tu Youyou won the Nobel Prize in medicine for her discovery of artemisinin isolated from Artemisia annua for malaria. Hope with the new phytopharmaceutical regulation, the Indian scientists would 22 ◄ September 2018

29 January, 2009. Publicly Released: 2 March, 2009. [Last accessed on 2016 Mar 07]. Available from: http://www.gao. gov/products/GAO-09-250 .

2. WHO Traditional Medicine Strategy 2014-2023. Geneva, Switzerland: World Health Organization; 2013. [Last accessed on 2016 Mar 07]. Available from: http://www.who.int/medicines/publications/traditional/trm_strategy14_23/en/

gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ UCM458484.pdf .

7. Good Clinical Practice Guidelines for Clinical Trials of ASU Medicine. [Last accessed on 2013 May 25]. Available from: http://www.indianmedicine.nic.in/writereaddata/linkimage s / 5 11 0 8 9 9 1 7 8 - F i n a l % 2 0 B o o k % 2 0 28-03-13.pdf .

8. Ministry of Health and Family Welfare Gazette Notification G.S.R. 918(E) [Last accessed on 2016 Feb 18].

Available from: http://www.cdsco.nic. in/writereaddata/GSR%20918-E-dated-30-11-2015.pdf .

9. Narayana DA, Katiyar C. Draft amendment to drugs and cosmetics rules to license science based botanicals, phytopharmaceuticals as drugs in India. J Ayurveda Integr Med. 2013;4:245–6.

[PMC free article] [PubMed]

3. World Health Organization General Guidelines for Methodologies on Research and Evaluation of Traditional Medicine. 2000. [Last accessed on 2016 Mar 04]. Available from: http:// www.whqlibdoc.who.int/hq/2000/WHO_ EDM_TRM_2000.1.pdf .

4. World Health Organization. Regulatory Situation of Herbal Medicines a Worldwide Review. 1998. [Last accessed on 2016 Mar 04]. Available from: http://www.who.int/medicinedocs/pdf/ whozip57e/whozip57e.pdf .

5. European Medicines Agency Herbal Medicinal Products. [Last accessed on 2016 Mar 07]. Available from: http://www.ema.europa.eu/ema/index. jsp?curl=pages/regulation/general/general_content_000208.jsp# .

6. Food and Drug Administration Botanical Drug Development Guidance for Industry. 2015. Aug, [Last accessed on 2016 Feb 24]. Available from: http://www.fda.

Contact: arun_dbhatt@hotmail.com Pharma Bio World

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.

Plants 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 Pharma Bio World

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 September 2018 ► 23

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 24 ◄ September 2018

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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 Pharma Bio World

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

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Formulation and evaluation of Ayurvedic face wash Acne vulgaris is an extremely common disorder of skin [pilocebaceous unit] that affects virtually all individuals at least once during life.

1. Introduction Acne vulgaris is an extremely common disorder of skin [pilocebaceous unit] that affects virtually all individuals at least once during life. The incidence of acne peaks at teenage, but substantial numbers of men and women between 20-30 years of age are also affected by the disorder.[1] Acne may be classified as comedonal, popular, pustular, cystic & nodular.

Comedonal acne is non- inflammatory & divided into two types: whiteheads & blackheads. White heads (closed comedo) present as fresh or white coloured, raised bumps whereas blackhead (open comedo) present as open pores containing dark coloured skin roughage consisting of melanin, sebum & follicular cells. Papules appear as red, solid, elevated lesions often less than 5mm in diameter. Puastules are circumscribed skin elevations containing purulent material. Cysts & nodules are solid, elevated lesions involving deeper dermal & subcutaneous tissue. Cysts are less than 5 mm in diameter whereas nodules exceed 5mm.

Amit Ingle Bajiraoji Karanjekar College of Pharmacy, Sakoli, Maharashtra, India

The pathogenesis of acne involves multiple physiological factors. These include 1).

Follicular hyper- proliferation, 2). Increased sebum production due to higher androgen levels & colonization of organism, 3).

Propionibacterium acnes & staphylococcus epidermidis.[4] Novel concept have emerged to help better understand its pathogenesis, these includes variation in target cell sensitivity, biological markers, neuro-endocrine, genetic, & environmental factors. Plenty of herbal as well as synthetic ingredients are reported to have remarkable beneficial effect on acne vulgaris.[3-5] They may have different mechanism like, a) Control sebum secretion.

Mayuri B. Meshram Bajiraoji Karanjekar College of Pharmacy, Sakoli, Maharashtra, India 26 â—„ September 2018

b) Antibiotics which inhibits Propionoibacterium acne & Staphylococcus epidermidis, the main causative organism of acne.

c) Keratolytic which removes the keratin layer & prevents the trapping of sebum under the skin. d) Anti-inflammatory which prevents the worsening of condition due to inflammation or redness etc.

Numbers of formulations are available in the market with variety of active pharmaceutical ingredients for the treatment of acne. Topical formulations, available in the market are as follows: Gel, Cream, Lotion, Face wash or cleanser, Face pack or mask. Neem (Azadirachta indica, Meliaceae), turmeric (Curcuma longa) & nutmeg (Myristica fragrance, Myristic aceae) are reported to have very beneficial effect on acne due to anti-microbial, anti- inflammatory & antioxidant activities of different chemical constituents.

Face skin is the major part of the body, which indicates the health of an individual.

It is a consist of materials such as amino acids, lipids and carbohydrates etc so that a balanced nutrition is required for the skin to keep it clear glossy and healthy, it deals with the formulation and characterization of cosmetic herbal face wash preparation. In ancient times women are very conscious about their beauty and started to dress themselves because they wanted to increase their own beauty.[6] Even today, people especially in rural areas, and hilly region select the natural remedies like plants extracts for cosmetics perposous like neem, orange rose. Herbal cosmetics are products which are used to purify and beautify the skin. The main advantage for using an herbal cosmetic is that it is pure and does not have any side effects on the human body men have rough skin and when they don’t take sufficient care then the skin turns dark due to over exposure of the Pharma Bio World

Sr. No

Ingredients

Botanical name

Uses

1.

Neem leaves

Azadirachta indica

Antibacterial, antifungal, anti-inflammatory, antiseptic, and highly beneficial for oily and acne prone skin.

2.

Turmeric rhizomes

Curcuma longa

Antibacterial, antifungal and it protects the skin from many infections and also adds glow to the face.

3.

Nutmeg seed

Myristica fragnance

Antibacterial, anti-inflammatory, antiseptic, bactericide.

4.

Liquorice root

Glycerrhiza glabra

Delivers valuable soothing properties to the skin. Highly rejuvenating and nutritive qualities are attributed to it.

5.

Honey

Apise mellifera

Light humectants and nutrients used as a thickening agent to give body to facial mask, creams and lotion.

6.

Orange tincture

Citrus reticulate

As perfume.

7.

Lemon juice

Citrus lemon L

To lighten skin and reduce blemish marks on the skin .it also quite effective for treating acne and pimples. As a natural pH adjuster in cosmetics.

8.

Xanthan gum

9.

Orange peel extract

10.

Rose water

11.

Propyl paraben

Preservatives

12.

Methyl paraben

Preservatives

13

Sodium laury sulfate

Surfactant

Xanthomonu

A gum produced by the pure culture fermentation of a carbohydrate also called Corn Sugar Gum. it is used as a non toxic thickener and stabilizer

scompestres Citrus reticulata

Antioxidant, anti-inflammatory, anti-microbial, orange-peel properties can maintain the natural balance of skin oils and tighten the skin by absorbing excess oils and removing dead skin cell Used as solvent; it also has antibacterial and antiseptic properties which eventually cure acne.

Rosa

Table 1a: List of ingredients Sr. No

Ingredients

Uses

Qtfor15ml

1.

Neem extract

antibacterial

50mg

2.

Turmeric extract

antiinflammatory

5mg

3.

Methyl paraben

preservatives

0.05mg

4.

Sodium laury sulfate

Foaming agent

1.5mg

Table 1b: Composition of himalaya face wash sun.[2] In this article we share home best homemade face packs and face mask to whiten the skin naturally for men’s and women skin. These face packs have natural skin lightening and can be easily prepared at home.[7] Facial skin is delicate and ordinary soaps can cause to lose moisture. A face wash is a mild cleanser that does the vital job of keeping skin clean, germ free smooth, and fresh and moisturizes the horny layer without any harshness to the skin look younger and energetic. The purpose of face-wash may be to impart cleansing, antiwrinkle effect, Pharma Bio World

Anticancer property, moisturizing effect and fairness of skin.[8] 2. Experimental work 2.1 Methods 2.1.1 Collection Leaves of neem were collected from the local areaof Sakoli. Fruits of Nutmeg, orange peel, liquorice root, turmeric root, rosewater were collected from the local market of Sakoli.

2.1.2 Preparation of extracts Leaves of neem, roots of liquorice, rhizomes of turmeric, orange peel, were kept in hot air oven for draying purpose

at 45 c and grinded into small pieces by using grinder. Seeds of nutmeg and shahijeera (Cumin) were crushed to make powder. Desired quantities of herbal drugs were weighed and each herb macerated with rose water in conical flask. Dried herbs were allowed to mix with rose water by moderate shaking of conical flask for 3 days.

Separately After 3 days, contents were filtered out by using simple filtration method and filtrates were collected in vessels separately.[13] 2.1.3 Filtration Filtration of extract was done by using simple filter muclin cloth and funnel for two times.

2.1.4 Evaporation Evaporation was done by using water bath. Filtrates were allowed to evaporate in water bath at 60°C temperature until the desired concentration of the extract was obtained.

September 2018 â–ş 27

Sr. No

Ingredients

Uses

Qy for 50 ml (f1) batch

1.

Neem Extract

Antibacterial, Antiseptic

2.5ml

2.

Turmeric Extract

Anti-inflammatory, Antibacterial and improve fairness

1.25ml

3.

Nutmeg Extract

Bactericide

1.25ml

4.

Liquorice Extract

Soothing properties

1.25ml

5.

Orange peel extract

Anti-oxidant, antimicrobial

0.5ml

6.

Orange Tincture

As perfume

0.5ml

7.

Lemon juice Extract

Lighten skin, and natural pH adjuster

0.5ml

8.

Honey

Thickening agent, emollient, antiseptic and astringent, nutritive.

2.5ml 0.5ml

9.

Xanthan Gum

Stabilizer and thickening agent

10.

Rose Water

Solvent

11.

Methyl paraben

Preservative

0.0.5mg

12.

Propyl paraben

Preservative

0.03 mg

13.

Sodium laury sulfate

Foaming agent

1.05 g

q.s

Table 2: Composition of developed formulation 2.1.5 Development of Formulation Various formulation batches were prepared according to the Table 2.

The desired concentration of gelling agent i.e. xanthium gum was weighed accurately and dispersed in hot rose water (not more than 60°C; 50 % weight of the batch size) with moderate stirring, avoiding air entrapment and allowed to soak overnight. Desired quantity of lemon juice was dissolved in desired amount of honey by gentle stirring.

Desired quantity of concentrated herbal extracts were added to the remaining amount of rose water and mixed with above honey mixture by gentle stirring.

This was finally mixed with previously soaked gel formulation. Prepared formulations were filled in a suitable container and labeled accordingly.

2.2 Comparative evaluation of formulation The prepared face wash was evaluated forvarious parameters as follows [9].

2.2.1 Physical evaluation Physical parameters such as colour, appearance & consistency were checked visually.

2.2.1.1 Washability Formulations were applied on the skin then easily remove by washing with water were checked manually.[10] 28 ◄ September 2018

2.2.1.2 Colour The colour of the face wash was checked visually [10].

2.2.1.3 pH pH of 1% aqueous solution of the formulation was measured by using a calibrated digital pH meter at constant temperature[12] 2.2.1.4 Viscosity The viscosity of face wash was determined by using Brookfield Viscometer. The Values Obtained for sample is noted.

2.2.1.5 Spreadability Spreadability denotes the extent of area to which the gel readily spread on application to skin or the affected part. The bioavailability efficiency of a gel formulation also depends on its spreading value [13]. The spreadability is expressed in terms of time in seconds taken by two slides to slip off from the gel, placed in between the slides, under certain load. Lesser the time taken for separation of two slides, better the spreadability. Two sets of glass slides of standard dimensions were taken. The herbal gel formulation was placed over one of the slides. The other slide was placed on the top of the gel, such that the

gel was sandwich between the two slides in an area occupied by a distance of 6 cm along the slide. 100gm weight was placed upon the upper slide so that the gel between the two slides was pressed uniformly to from a thin layer. The weight was removed & the excess of the gel adhering to the slides was scrapped off.

The two slides in position were fixed to stand without slightest disturbance & in such a way that only the upper slide to slip off freely by the force of weight tied to it. A 20gm weight was tied to the upper slide carefully. The time taken for the upper slide to travel the distance of 6 cm7 separated away from the lower slide under the influence of the weight was noted. The experiment was repeated three times both formulated gels & marketed gel & the meantime taken for calculation [13].

Spreadability was calculated by using the following formula,

S=M×L/T

S- Spreadability M- Weight tied to the upper slide L- Length of the glass T- Time in sec.

Pharma Bio World

2.3 Irritancy test The face wash was applied on left hand dorsal surface of 1 sq. cm and observed in time interval 1 to 2 hrs.[15] 3. Result and discussion The results of evaluation are displayed in Table 3. Formulation was orange in color, whereas, marketed formulation was green in color. Formulation was found to have semisolid consistency. The formulations were found homogenous, easily washable.

The formulated face wash has slightly alkaline pH which is compatible with normal physiology 4. Conclusion Natural remedies are more acceptable in the belief that they are safer with fewer side effects than the synthetic ones.

Herbal formulations have growing demand in the world market. It is a very good attempt to establish the herbal face wash containing aqueous extracts of neem leaves, turmeric rhizomes, liquorice root, and seed of nutmeg. This study revealed that the developed herbal formulation of batch f1 was comparatively better than other formulation.

The herbal face wash is one of the most well recognized acne treatments, herbal face wash not only moisturized, they also used as a cleanser. Preferably they used for oily and dry skin physiology. It provides numerous essential nutrients to the required for maintaining the normal skin functioning. it also promotes the natural glow to the skin. The herbal face wash was prepared from various herbs like Neem, Turmeric, Nutmeg, Liquorice, Honey, and the soothing agent as Xanthungum used for formulation. It gives beneficial effects to the face. The various parameters like colour, pH, consistency, washability, irritability and spreadability was checked and evaluated hence, from the present investigation it was found that the formulated herbal face wash was found to be more efficient as compared to the marketed face wash.

Pharma Bio World

Sr. No

Parameter

Marketed Formulation

Formulated Batch (F1)

1.

Colour

Green

Orange

2.

Consistency

Semi-solid

Semi-solid

3.

Wash ability

Good

Good

4.

pH

6.9

6.5

5.

Viscosity

1690 cp

1566cp

6.

Spreadability

2.16

1.72

7.

Irritation test

Non irritant

Non irritant

Table 3: Evaluation of formulation At this formulation contains all herbal ingredients its nighters produce any harmful action on skin and are reliable.

8.

of Poly-herbal Face wash gel, World Journal of Pharmacy and Pharmaceutical Sciences, 2015; 4(6): 585-588.

Kanlayavattanakul M., Lourith N. Therapeutic agents and herbs in topical applications for acne treatment.

International Journal of cosmetics Science, 2011; 33: 289-297.

Mitusi T. New Cosmectic Science; Elsevier Science B.V., the Netherlands;1sted; 148149 Indian standard -6608- 1978; Govt of India 1997: 4-5 Baby, A. R., Zague, V., Maciel, C.P.M., Kaneko, T. M., Consiglieri, V. O., Velasco and M. V. R. Development of Cosmetics Mask Formulations. Rev Bras Cienc.

Farm 2004; 40(10):159-161.

Ahmed, S.A. and M. Grainage, Use of indigenous plant resources in rural development, potential of neem tree. Int. J. Dev. Technol., 1985; 3: 123-130.

Quddus, M. A., The cropland agroforestry experiences of the village and farm forestry project in Northwest Bangladesh.

National Workshop, September 16-17, 2001 Gazipur, Bangladesh, 2001: 229-239.

References 1. Sowmya K.V., Darsika C.X., Grace F., Shanmuganathan S. Formulation & Evaluation of Poly-herbal Face wash gel. World Journal of Pharmacy & 9.

Pharmaceutical Sciences, 2015; 4(6): 585-588.

2. Ashawat MS, Banchhor M. Herbal 10. in skin care Cosmetics. Trends formulation. Pharmacognosy Rev 2009; 3 (5): 82-89.

3. Singh H.P., Samnhotra N., Gullaiya S., Kaur I. Anti- acne synergistic Herbal 11. face wash gel Formulation, Evaluation, & Stability study, World Journal ofPharmaceutical Research, 2015; 4(9): 1261-1273.

12.

4. Kanlayavattanakul M., Lourith N., Therapeutic agents & herbs in topical applications for acne treatment, International Journal of cosmetic Science, 2011; 33: 289-297.

5. Kapoor V.P., Joshi H., Chaubey M., Applications of seed gums in pharmaceutical formulations, J Med Arom Plant Sci. 2000; 22/4A & 23/1A: 42-44.

6. Kubo I., Muroi H., Kubo A., Naturally occurring anti-acne agents, J Nat Prod, 1994; 57(1): 9-17.

7. Sowmya K.V., Darshika C.X., Grace F., Shanmuganathan S. Formulation and evaluation Figure 1: Marketed Face-wash

September 2018 â–ş 29

14.

15.

16.

Figure 2: Formulated Face- wash 13. Joshi, P.C. and O. Prakash, Allelopathic effects of Litter extract of some tree species on germination and seedling growth of agricultural crops. Proceedings of the 1st National Symposium on

17.

Allopathy in Agroecosystem, (NSAA’92), Indian Society of Alleopathy, Hisar, India, 1992:127-128.

Singh H.P., Samnhotra N., Gullaiya S., Kaur I., Anti- acne synergistic Herbal face wash gel Formulation, Evaluation, & Stability study, World Journal of Pharmaceutical Research, 2015; 4(9): 1261-1273.

Singh H.P., Samnhotra N., Gullaiya S., Kaur I., Anti-acne synergistic Herbal face wash gel Formulation, Evaluation, and Stability study, World Journal of Pharmceutical Research, 2015 ; 4(9): 1261-1273.

Ashi, Aswal, MohiniKalra and Abhiram Rout; preparation and evaluation of Polyherbal Cosmetics Cream; Der Pharmacia letter, 2003; 5(1): 83:83.

Dureja H., Kaushik D., Gupata M., Kumar V., Lather V., Cosmeceuticals: An Emerging Concept, Indian Journal of Pharmacology, 2005; 37(3): 155-159.

18. Rasheed A., Reddy G., Mohanalakshmi S., Kumar CK., Formulation & Comparative evaluation of Poly-herbal anti-acne face wash gel, Pharmaceutical Biology, 2011; 49(8): 771-774.

19. Rashmi MS., Topical Gel: A review, Pharm Rev., 2008; 1-3.

20. Aburijat T., Natsheh F.M., Plants used in cosmetics, Phytother Res., 2003; 17: 9871000.

21. Ashawat MS., Banchhor M., Herbal Cosmetics: Trends in skin care formulation Pharmacognosy Rev., 2009; 3(5): 82-89.

First appeared in International Journal of Phytopharmacy. Reprinting the article with permission from International Journal of Phytopharmacy (IJP).

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Pharma Bio World

Analysis on the issues raised by the regulatory authorities on Indian Pharma companies and inputs provided by them Pharmaceutical industry across the globe bench marks the standard of regulatory processes carried out by Food and Drug Administration of USA (USFDA).

India which has th e highest number of USFDA approved plants outside of USA itself, has been confronted with slew of warning letters and import alerts from the said regulatory authority, which especially were accentuated during last six years i.e. from FY13-FY18. The current article delineates upon analysis on classification of violations cited by FDA for Indian Pharma cos, inputs provided by them while concluding with solutions to overcome majority of the regulatory observations.

D Naveen Kumar Senior Manager CARE Ratings Ltd Tel: 040-67937416 E-mail: dnaveen.kumar@careratings.com

Vidhyasagar L Associate Director CARE Ratings Ltd Pharma Bio World

W

ith market size of around $ 35 bn in FY2018, Indian pharmaceutical industry is ranked third globally in terms of volume and thirteenth in terms of value. Indian pharmaceutical companies, over decades of arduous efforts, have gradually developed the necessary technology, capacities and capabilities to meet the demand and to explore the opportunities provided by global regulated markets; and currently, United States of America (USA) contributes about one third of the total Indian pharmaceutical exports. Furthermore, Indian pharmaceutical manufacturing companies accounted for 36% of the total Abbreviated New Drug Application (ANDA) approvals by USA in 2017 as compared with 34% in 2016; the total number of ANDA approvals has increased from 201 to 304 during the same period. India has second highest number of USFDA (United States Food and Drug Administration) approved manufacturing plants, ie, about 700 units with over 5000 ANDA approved drug products during last decade i.e. 2008-2017.

With all the aforesaid accolades, however, lately, it has been noted that there has been a spurt in the issuance of the import alerts and warning letters for domestic manufacturing facilities significantly over the past years following USFDA’s increasing focus on compliance of guidelines of cGMP. This restricts the manufacturing units to supply drugs to the US market from that facility resulting in the decline of revenue for the companies particularly to US market and also from other markets subsequently if the issues are not closed out to the earliest.

Sequence observed by USFDA in regulatory enforcement: USFDA’s Office of Regulatory Affairs (ORA) is the lead office for all the field activities, including inspections and enforcement, which carries out the inspections of the manufacturing facilities approved by them in regular intervals. At the completion of inspection a report is prepared by the agency and is termed as ‘Establishment Inspection

Report’ which details inspectional findings.

All the inspections carried out USFDA are categorized in three buckets: No Action Indicated (NAI), Voluntary Action Indicated (VAI) and Official Action Indicated (OAI).

NAI = No Action Indicated, meaning no objectionable conditions or practices were found during the inspection (or the significance of the documented objectionable conditions found does not justify further action).

VAI = Voluntary Action Indicated, meaning objectionable conditions were found and documented but the agency is not prepared to take or recommend regulatory action.

OAI = Official Action Indicated, meaning objectionable conditions were found and regulatory action should be recommended.

Out of the total inspections carried out during CY12 and CY13 about 33% of cases were categorized under Official action indicated and the same during CY15 and CY16 in this category were 29% and 20% respectively, which subsequently were converted into warning letters and alerts. However, during CY17 the total number of cases falling under OAI has reduced to about 14%. India having experienced the headwinds from the heightening regulatory requirements during CY12-CY16, have improved their processes leading to lower inspections falling under OAI category during CY17.

A warning letter restricts the ability of that manufacturing unit to supply new drugs to the US from that facility. The company in that case needs to appoint consultants to advice on corrective actions and also monitor implementation of the same. After this, the company approaches the FDA and makes a request for re-inspection. If the regulator is satisfied with the corrective measures, it can issue a close-out letter.

However FDA can also choose to issue Import Alerts immediately whenever it determines that it already has sufficient evidence to conclude that the products manufactured from a specific September 2018 ► 31

Chart illustrating the steps observed by USFDA During an inspection, if investigators do not observe any objectionable conditions at the plant site, the said manufacturing unit (which is outside USA) can continue to export to USA, however if any objectionable conditions are observed then based on the investigator’s judgement, ‘ FDA Form 483’ is issued to the manufacturer.

Thereafter the companies are fostered to respond to the ‘FDA Form 483’ in writing with respective corrective action plan and subsequently implement the plan expeditiously.

If the response to ‘FDA Form 483’ submitted by the company deemed insufficient, a warning letter may be issued by US FDA to the respective firm.

FDA then checks back to ensure that the corrections taken by the company are adequate. And in case they find the explanations or corrective measures taken by the company is inadequate then they would issue alert.

YES

Plant can continue to export

USFDA carries out the inspection

NO

The company needs to implement appropriate remediations process

Observations

YES Whether satisfied with revert?

USFDA issues Form 483 immediately

USFDA can issue import alert with immediate effect followed by warning letter

USFDA can issue Warning letter and gives time line of 15 working days to revert

NO

Source: Compiled by CARE Ratings Ltd

Source: Chart illustrating the steps observed

by Compiled USFDA by CARE Ratings Ltd

unit appear to be adulterated, misbranded, or place the responsibility back on the importer to carry out the inspection post to implementation. unapproved, and has made serious deviations ensure that the products being imported into the Once the FDA finds that all the process are in from cGMP, then they may be refused from United States are in compliance with FDA laws place then unit can restart the export of the drugs to US. importing. In such cases warning letter would and regulations. follow the issue of import alerts. The basic Post to issue of import alert the company needs Note: The import alert falling under the category purpose of import alert is to prevent voilative to implement appropriate remediations process ‘Detention Without Physical Examination’ products from being circulated in United States; religiously. dentnumber (DWPE) pertainsinto India the Drugs from firms Categories of inspections carried out in India Once the company is confi Total of66-40 inspections provide uniform coverage across country; and about its processes, it can invite USFDA to which have not met Drug GMPs. 185 118 139 74

70

58 39 6 2012

45

36

17

14 2014 NAI

0 2016

2015 OAI

VAI

Categories of inspections carried out in India 32 ◄ September 2018

111

101

87

42

29

17 2013

53

77

119

42

20 2017

2012 2013 Source: USFDA

2014

2015

2016

2017

2018 (Jan-Apr)

Total number of inspections in India Source: USFDA

Pharma Bio World

Source: USFDA

Data Manipulation/Data integrity

6

Lack of data documentation discipline

1

Failure to Maintain Quality and Purity

2

Inadequate investigation of critical deviations or a failure 2

1

1 1

12

9

15

12

6

61

3

9

4

4

2

23

5

1

4

11

7

31

7

2

3

5

2

22

Lack of procedural awareness

4

2

4

2

1

1

14

Unhygiene

2

3

2

3

3

1

14

Compliance

0

2

1

2

2

Grand Total

17

5

33

29

33

The following table and graph delineates upon the entire classification of observations mentioned in warning letters received from USFDA into various categories and it can be inferred that that about 50% of the warning letters issued to the Indian Pharma companies pertain to Data manipulation, data integrity and lack of data documentation discipline.

Following are some of the inputs provided by the regulatory authorizes and consultancies in order to avoid the observations and incorporate systems in place: • To maintain strong systems in place with proper qualified and designated personal to handle the data in order to prevent unauthorized access or changes to data, and to provide adequate controls to prevent omission of data.

• As about 50% of the observations pertain to data integrity, manipulation and/or discipline, USFDA necessitates that a pharmaceutical manufacturing company approved by it to observe standard operating procedures meticulously. Further those SOPs have to Pharma Bio World

0

7 36

19

172

clearly written, modified, and maintained in a consistent and timely manner, and be centrally accessible. Problems and accidents generally take place if the employees do not have current written instructions for their tasks or if they do not observe written instructions in toto.

• To maintain complete data derived from all testing, and to ensure compliance with established specifications and standards as many data integrity observations fall under the category “Failure to provide records required to be readily available for authorized inspection”.

• To maintain the buildings used in the manufacturing, processing of a drug product in a clean and sanitary condition and keep them free of infestation by rodents, birds, insects, and other vermin.

• While addressing the observations made by the regulatory authority, the company needs to take care that every observation should have a thorough root cause analysis performed and, if necessary present, one or more corrective and preventive actions

2

1

2

35%

Compliace

4% Unhygiene

2

7

17 5 33 29 33 36 19 172

Data Manupulation/D ata integrity

Total

2017

2016

2015

2014

2013

2012

2011

Classification of Warning letters

Compliance

Number of import alerts and WL Grand Total

Number of warning letters issued by USFDA across globe vis-à-vis India

13%

8%

Lack of procedural awareness

8%

18% 13%

Lack of data documentation discipline Failure to Maintain Quality and Purity

Inadequate investigation of critical deviations or a failure

Source: Compiled by CARE Ratings Ltd

identified very clearly with specific timelines of implementation.

• It is in the benefit of the company to peruse to obtain closeout letter at the earliest for which the remediation process should start right from the day of receipt of Form 483 or a warning letter. USFDA generally looks for a response to most of its compliance notices within 15 business days. The USFDA, although doesn’t confirm to the company’s response immediately but it would be appropriate to contact the agency and confirm receipt.

Conclusion: As majority (about 50%) of the observations fall under data integrity, manipulations and discipline category the best approach for minimizing the human errors is to establish a system where each step has to be followed by implementing an enterprise quality management software system. The plausible and best-practice features include prompting users with selected data which is just need to be accessed or entered by the specific task performer. This would significantly reduce data entry related errors and avoid mistakes common in manual document management and data entry. Apart from above the implementation of aforementioned systems would also take care the procedural errors.

September 2018 ► 33

marketing initiative

Bosch Packaging Technology showcases laboratory competence in R&D and Industry 4.0

O

ne of the leading suppliers of process and packaging technology, Bosch Packaging Technology’s new laboratory device Xelum R&D for continuous manufacturing is an example of how the Bosch Pharma Service and Industry 4.0 solutions support pharmaceutical manufacturers in increasing transparency and efficiency of their laboratory processes. “With our wide range of laboratory solutions, we offer our customers an ideal starting position for a fast time-to-market of their pharmaceuticals,“ says Fritz-Martin Scholz, product manager at the Bosch subsidiary Hüttlin.

Reduced development time thanks to continuous production The Xelum R&D offers pharmaceutical manufacturers an ideal start to continuous OSD production. “The Xelum R&D is the first R&D machine to combine charging, dosing of several ingredients and blending with granulation, drying and discharging in one unit,” Fritz-Martin Scholz explains. In contrast to continual mass flow, the Xelum R&D doses excipients and active ingredients as a discrete mass. This way, customers can dose even smallest amounts of APIs of less than one percent. Individual packages, socalled X-keys, continuously run through the process chain and are removed successively from the machine as packages into bins.

With the Xelum R&D, Bosch allows pharmaceutical manufacturers an ideal start to continuous manufacturing.

Moreover, the X-key approach makes the phases of OSD forms. Every year, roughly product traceable at all times. It reduces the 1,000 experiments with substances for various system’s failure susceptibility and process indications are conducted at the company’s complexity, while increasing the product’s competence center in Schopfheim, Germany. accuracy and quality. Time-consuming scale- “The key to achieving a fast time-to-market up is not needed, since the laboratory device while meeting the highest quality standards uses the same components as the Xelum is extensive experience and know-how,” says production platform. The identical process Dr Marcus Knoell, Head of Pharma Service parameters can be directly transferred 1:1, Solid at Hüttlin. “We offer customers everything which leads to a reduced development time. from a single source: from formulation and Additionally, the customer has the opportunity analytical development, to stability tests to move his product to continuous production and bioequivalence studies and dossier or to a conventional batch process. preparation.” A specific focus is on scale-up Customer support starts with the and technology transfer: every product that is formulation developed at the Bosch laboratory is tailored to Bosch’s laboratory portfolio supports the customer’s machines, so that they can later customers in all development and production manufacture the product in-house.

For details contact:

Hamish C. Shahani Managing Director & CEO Klenzaids Contamination Controls Pvt. Ltd. hamishshahani@klenzaids.com

The R&D device for the production of oral solid dosage (OSD) forms ensures short time to market and an optimum dosing of smallest amounts of API. 34 ◄ September 2018

Dr. Andreas Mattern Director Product Management Robert Bosch Packaging Technology GmbH Tel. +49 711 811-57340 Andreas.Mattern@bosch.com Pharma Bio World

marketing initiative

ECOFLUX* Corrugated Tube Heat Exchanger

H

RS Process Systems Ltd, India, is part of UK-based HRS group of companies, a leading heat transfer technology provider. HRS is equipped with a strong network all across domestic and international market like UK, Spain, USA, India, Australia, New Zealand and Malaysia to fulfil technology needs of process industries.

The high demand for heat transfer equipments in industries like chemical, pharmaceutical, agrochemical, petrochemical, oil and fats, fertilizer, food and beverages, engineering and others is driving the advancement in heat transfer technology. Heating, cooling, chilling, condensing, re-boiling, pasteurizing, sterilizing, evaporating are the key processes in these industries. To carry out such processes effectively, heat exchanger becomes heart of the process plant.

During heat transfer process, over a period of time, deposition of substance occurs. Formation of this boundary layer is referred to as FOULING, a factor which

poses resistance to product flow. Fouling is typically high in shell and tube (smooth tube) heat exchangers and significantly impacts the heat transfer process.

HRS offers ECOFLUX corrugated tube heat exchanger (CTHE), which is a shell and tube heat exchanger where “corrugated tubes” are used instead of plain tubes. This is a definitive option to tackle fouling seen in regular shell and tube heat exchangers.

The tubes in ECOFLUX CTHE are corrugated to induce turbulence in both the flows (product and service) even at lower

velocity. Corrugated tube thus, boosts heat transfer multi-fold even at low Reynold’s number with minimum increase in pressure loss. This enables efficient heat transfer even in liquids with high viscosity, large fibers or particulates.

ECOFLUX corrugated tube heat exchangers are compact in yet give significantly enhanced performance over smooth tube heat exchanger. It can be customized according to the process needs with wide choice of MOC like SS-304L, SS-316L, 904L, 321, Titanium, Duplex, Hastellloy, Alloy 20 and Copper depending upon compatibility of process fluids.

ECOFLUX CTHE is offered in a range of models as per ISO, TEMA and latest design standards to suit different process applications. It enables continuous process running for longer duration, requires low maintenance and also gives high response to CIP. This proves to be a versatile, economical and energy-efficient equipment for multiple process industries.

For details contact:

HRS Process Systems Ltd 201-202 Karan Selene 851 Bhandarkar Institute Road Pune, Maharashtra 411 004 Tel: 020-25663581, 25663582, 66047894 E-mail: info@hrsasia.co.in Website: www.hrsasia.co.in Pharma Bio World

September 2018 ► 35

marketing initiative

WACKER Invests in Jena Biotech Site

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he Munich-based chemical group WACKER has enhanced its production facilities for biopharmaceuticals – also known as biologics – with new equipment.

“In recent years, we have been continuously expanding our contract manufacturing capacity for biopharmaceuticals in Jena.

The new, modern production equipment has further enhanced the site, making our company fit for the future,” explained Dr. Guido Seidel, Managing Director Operations of the wholly-owned WACKER subsidiary Wacker Biotech GmbH. The company invested €2.5 million in, among other things, a fully automated fermentation plant including a new bioreactor with a capacity of 350 liters, a new separator for efficiently isolating cells and a new GMP cell-bank suite. The suite enables independent cell-bank production and expands storage capacity for customer cell banks. Furthermore, analytical capacities were expanded with a new micro-biology laboratory and equipment for process and 36 ◄ September 2018

product characteri zation. A modern eDMS system now enables the automatic handling of GMP documentation. As a result, Wacker Biotech’s Jena site is fully equipped to supply the fast-growing market for biologics.

Future-oriented therapeutic agents now make up 25 percent of the global pharmaceuticals market.

Another positive signal came with the recent visit from the Brazilian health authority ANVISA. After a five-day inspection of the production facility in April 2018, the ANVISA team confirmed that the Jena site complies with the Good Manufacturing Practice (GMP) principles and standards for the production of high-quality active ingredients.

The health authority not only praised the GMP system itself, but also the outstanding organization and the professionalism of the WACKER employees.

Wacker Biotech has been producing the active ingredient using a new, efficient, recombinant method since 2016. “We already received approval from the

European Medicines Agency (EMA) in February 2016. With the successful ANVISA inspection, we now have further confirmation from a respected authority that we are able to provide our customers with outstanding managing director of Wacker Biotech GmbH. “This positive assessment makes Wacker Biotech an expert and certified partner for all customers who want to sell their products on the Brazilian market.”

For details contact: Wacker Chemie AG Media Relations & Information Christof Bachmair Tel. +49 89 6279 -1830 christof.bachmair@wacker.com www.wacker.com Pharma Bio World

More than 9,500 visitors: analytica Anacon India, India Lab Expo 2018 and PHARMA Pro&Pack Expo smashes all the records

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ore than 9,500 visitors: analytica Anacon India, India Lab Expo 2018 and PHARMA Pro&Pack Expo smashes all the records • 9,641 trade visitors attended • 261exhibitors from India and overseas at the trade fair trio • Smart Lab Summit, Anacon India Conference and Buyer-Seller Forum well received

Manufacturers Association among others attended. Huge participation at the networking forums has reinstated our position as the most important innovation platform for the industry.”

“Preparing for the future of research and instrumentation” Gautam Rajan, President, Indian Analytical Instruments Association on Anacon India conference said: “We organized the conference to cover advancements in analytical solutions for life sciences. This is a very relevant topic today, because the future of research and instrumentation lies in this industry. There are many changes taking place and this conference addressed these changes and how the industry will cope with such changes.”

took place on the opening day focused on Advances in and Analytical Solutions for Life Science Research, where industry stalwarts shared deep comprehensions about the state-of-the-art development in the analytical industry. The esteemed speakers deliberated upon topics including Evolution of Life Sciences, role of advanced analytics, new methods for BioMolecular imaging, advanced analytics for biosimilar development: addressing safety and efficiency concerns and many others.

With 9,641 visitors and 261 exhibitors, analytica Anacon India, India Lab Expo The Smart Lab Summit, which took place and PHARMA Pro&Pack Expo has chalked on the second day of the event focused on up the best-ever result in its decade-old the theme ‘Building your lab for tomorrow’ history and surpassed all expectations. where prominent speakers from Aurobindo The number of visitors rose by 25% over Pharma, Dr Reddy’s Laboratories, the previous edition in Hyderabad. Jointly Lupin Limited, Reliance Life Sciences, held with PHARMA Pro&Pack Expo for the Wockhardt and others deliberated on second year, the synergies between the “Good footfall – we look forward to come the need to move towards the smart trade fairs has resulted to setting of new back next year” laboratories, the need for investing smartly One of the exhibitor representing Siemens in Labs, transforming Laboratories through records.

Limited, Ajay Bhosle, Chief Manager Big Data, and understanding the future of Visitors from pharmaceuticals, chemicals, -Healthcare & Pharmaceuticals said: We workforce in Smart Laboratories. food processing, research and development participated for the first time at analytica among other segments explored the latest Anacon India and India Lab Expo where Business matchmaking at the Buyerinnovations from the laboratory technology, the footfall has been good and as per our Seller Forum analysis, biotechnology, diagnostics, expectations. We look forward to taking Buyer-Seller Forum proved to be another pharma packaging and processing. Almost part in the next edition of the trade fairs.” important networking platform where all top companies within and around 912 face-to-face meetings took place Hyderabad attended in large numbers and “Fifth time participation and many more in three days, an increase of 7% from delegation trips were arranged by Messe to come” past edition. The discussions between Keith Hulme, Director at Starna Scientific participating buyers and exhibitors Muenchen India for several companies.

Limited said: “We have been participating were fruitful. Delighted with the good “The most important innovation platform at the show for the last four years. We response, Dr. Atul Kolte, Group Leader connected with many customers who are at Hetero Healthcare Limited shared: for the industry” In view of the new record figures, Bhupinder interested in our range of products. We “This is indeed a great platform for the Singh, CEO of Messe Muenchen India, have been successful in developing our industry where we received useful stated: “We are pleased with the positive business these last four years and will information about various technologies results and with the positive feedback from continue to participate at the trade fairs to and instruments on a single platform. I our exhibitors on the quality of attendees. grow our business further.” would like to thank to the organizers who Large delegations from Hetero, Aurobindo, have done a great job with these trade Karnataka Drugs and Pharmaceuticals Excellent response at the supporting programs fairs, as well as for conceptualizing the Manufacturers Association, Indian Drugs The analytica Anacon conference which buyer-seller forum.”

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September 2018 ► 37

news features

Growing From Strength to Strength: Bosch & Klenzaids Forerunners in the pharma and FMCG packaging industry walking alongside pioneers in the clean room technology business, Bosch and Klenzaids partnership has grown from strength to strength in time. Offering integrated solutions to manufacture and package high-quality products, challenging regulatory hurdles and abiding by compliance norms, the joint-venture is now treading novel initiatives to achieve sustainability goals.

We explore insights from the partners on an exclusive rendezvous with Dr. Andreas Mattern, Director Product Management, Robert Bosch Packaging Technology GmbH and Hamish Shahani, Managing Director & CEO, Klenzaids Contamination Controls Pvt. Ltd.

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olding undisputable predominance in the areas of processing, packaging, and clean-room technology for the global food and pharmaceutical industry in India, Bosch and Klenzaids partnership has seen different market developments. In 2015, Bosch and Klenzaids came together to expand global reach particularly in liquid pharmaceuticals and filling machines for clean-room environments. As a part of the joint-venture agreement, both parties decided to bring in their expertise to boost value.

Merging the expertise of Klenzaids in cleanroom and processing technologies as well as peripheral systems, with Bosch’s strength in innovative filling technologies to serve customers in India from both private and public sectors - not just with plants, systems, and accessories but also with turnkey solutions - they got started.

Klenzaids focused on expanding its business to include sales and service of imported Bosch systems for the pharmaceutical industry in India. Today, the partners continue their successful collaboration in the clean-room industry in India, which is little thronged by new entrants into the space.

Clean-rooms in Focus

After several years of offering integrated solutions to manufacture and package high quality products, Bosch and Klenzaids now intend to take their efforts further by branching out into new possibilities within clean-rooms.

A lot of emphasis is placed on tight containment and barrier systems in the clean-room industry. However, more and 38 ◄ September 2018

more companies are also looking for a green pathway to sustainability. The companies hope this strategic maneuvering will help to reduce the environmental and ecological footprint in time.

To achieve this goal, Bosch and Klenzaids put together solids, liquids, compact, contained complete solutions that require smaller footprint compared to a conventional cleanroom, thus allowing for less refrigeration for cooling and heating systems as well as less energy needs. This energy-efficient approach will help reduce environmental footprint by bringing together mechanical and electronic technologies.

Dr. Andreas Mattern, Director Product Management, at Robert Bosch Packaging Technology comments, “A lot of companies have been building their entire medical products in clean rooms. The clean-rooms are usually Grade B to Grade A for liquid injectables. This means if the clean-room is grade B, the actual physical work is conducted in a Grade A environment on the filling equipment.” Bosch and Klenzaids are now focusing on Grade A settings in Grade C environments.

“Energy costs and the cost of creating a Grade B clean room are substantial, and microbiologically controlling it, is even more expensive. So the idea is to reduce the overall microbiological challenge.”

A global trend from the regulatory side is evident, with companies opting increasingly for isolator technologies in liquid filling operations. “They ensure that products and

operators are separated from each other the best possible way”, says Dr. Mattern. “Bosch manufactured the first isolator more than 30 years ago, and is still pioneering in this field. Together with Klenzaids, we can now serve the Indian market even better with our solutions.”

“Typically clean-rooms can be described as a box in a box. We are now trying to reduce the number of boxes through a well-designed, highly accurate process and repeated methodology. Bosch is known for refining all of these attributes to make the process repeatable, sustainable and transparent, with limited human intervention. The expertise works in favour of meeting regulatory compliance objectives.

Packaging Technology Solutions

“Our strategic partnership intends to offer new technologies and joint solutions for Indian market customers depending on the challenges that they face,” asserts Hamish Shahani, Managing Director & CEO, Klenzaids Contamination Controls Pvt. Ltd. The highly accurate filling machines will continue to be built by world-leading Bosch sites while the corresponding isolators will increasingly be provided by Klenzaids in joint containment systems.

In India, Bosch Packaging Technology is currently focused on two businesses– food and pharma. The company develops horizontal and vertical flow wrapping machines in Goa focused on food packaging for the FMCG industry, and also packaging for the pharma industry requiring similar Pharma Bio World

news features sophisticated equipment and need to operate within the regulatory framework with imported equipment as well as the partnership with Klenzaids. Klenzaids also works for the cosmetic industry, e.g. by offering equipment for cosmetic therapeutic line of under-eye creams and ointments.

Emphasizing on the need for companies to be aware of the ingredients used in their products, Hamish Shahani believes, “Not knowing what ingredients make for your product is dangerous, companies need to be fully aware of all ingredients used to produce their products.” Looking at it from the regulatory framework and composition elements, pharma industry is still ahead of the FMCG industry in terms of ingredients and compliance.

Technology trends in the pharma industry and healthcare Asked about the most important trends in the pharmaceutical industry, Dr. Mattern reports: “Modern technology should help save costs and be energy-efficient. For example, the cost and energy usage of generating water for a pharmaceutical plant by destillation can turn out to be extraordinarily expensive. The water should be generated at an economic impact price. So is the case with purchase of equipments that provide alternative energy-efficienct technologies based on membrane processes.

In the pharma industry, you will see a trend emphasizing on the need for drugs manufactured to adhere to higher quality standards. Indian FDA requires more inspectors to conduct quality regulations. There is an overall pressure on the health system with developed economies focusing on generics and basic healthcare. However, the continuing boom in the generics space is proving beneficial for the Indian pharmaceutical industry, having established itself as a provider of high quality generics worldwide.

In big pharma companies and MNCs, a trend towards specialty medication and orphan drugs is picking pace. The corresponding batch sizes are getting smaller and the products are becoming more expensive, targeting niche applications and niche therapy areas. The basic healthcare infrastructure should be such, as to make the whole system affordable.

Pharma Bio World

Personal medication elevates the oncoming trend by requiring customized treatment plans and specific therapies to address health issues of a single individual.

A further trend is to be seen in digitization of pharmaceutical processes. Companies worldwide are showcasing acceptance and interest in Industry 4.0 to harness potentials of the vast data repository already available, conduct analytics and achieve performance efficiency. Some of the emerging markets probably have an advantage here, because of young workforce and youth culture with a high acceptance of digital technologies.

Business Growth and Expansion Plans

“Wherever we are, we aim to grow at a faster rate than the market average,” affirms Dr. Mattern. “The market for packaging products is growing between 4 to 7 percent approximately and we are looking at growth faster than this, in the next five years.

Globally, according to last year figures we have been achieving this target.

“However, we see optimistic growth outlook for generic companies in the near future. It is equally important for the industry to not underestimate the influence and control of Indian generic manufacturers operating in the US, serving the international market and promoting sale of generics in the country itself. For these companies it is essential to get equipment at the right price point – delivering high end performance and quality but at acceptable investment and operating expenses to make a viable business in the competitive generics industry. Here we strongly believe that the Bosch and Klenzaids cooperation can offer a “best of both worlds” approach with solutions tailored to customer needs and budgets.

A number of companies are not just investing in India, but most often in markets where they see regulatory hurdles. This is because over time companies have realized that overcoming regulatory challenges is the key to success and progress. So companies that were once shying or running away from exploring new markets, are now on their way towards embracing regulatory hiccups,” Hamish Shahani explains.

“Previously companies followed the concept of “run” approach, today on the contrary they are “attacking” hurdles, which is interesting to observe. We at Bosch and Klenzaids have already been there and done that. We hope to do it again for a lot more people with a new pricing, strategic timeline, the agility to do things faster than anybody else. So the business challenge for us is speed and to be able to provide the best installed quality with a sustainable infrastructure.”

Companies with offices in multiple locations face standardization issues, as regards training the workforce and streamlining the entire pharmaceutical process - related to perhaps an equipment design or manufacturing protocol. It is important for companies to be able to exhibit common standards; hence we are educating companies and spreading the need to opt for SOPs.

Importance of Training for Gen-Next Workforce “We provide basic training right from installation of equipments to hiring competitive engineers in the team for handling the equipment. Convertible training and sessions using virtual reality tools and platforms are provided for training workforce on certain products and technologies, wherein companies associating with us can even purchase the training content and set up schedules for educating the workforce on equipment usage. We provide practical hands-on training right from equipment installation to virtual reality, all in a package customized to the customers’ business requirements,” Dr. Mattern elucidates.

“On-site training on GMPs (Good manufacturing practices) and GLPs (Good laboratory practices) is provided to employees, since we believe it is important to ensure that the overall process and equipment is safe and reliable to make highquality drugs. Training the entire environment on effective clean-room practices, GMPs, GLPs, industrial automation and how to operate within a FDA compliant facility is a central part of the Bosch and Klenzaids partnership,” Hamish Shahani adds.

September 2018 ► 39

press release Dr Reddy's Laboratories announces the launch of Neostigmine Methylsulfate Injection, USP in the U.S. Market Dr Reddy’s Laboratories Ltd announced the launch of Neostigmine Methylsulfate Injection, USP, a therapeutic equivalent generic version of Bloxiverz (Neostigmine Methylsulfate) Injection approved by the U.S. Food and Drug Administration (USFDA).

The Bloxiverz brand and generic had U.S. sales of approximately $111 million MAT for the most recent twelve months ending in July 2018 according to IMS Health*.

“I’m proud that our products, originating from INSERM and the University of Nantes and supported by Bpifrance and Atlanpole Biotherapies, hold the potential to lead to new therapeutic options for the treatment of cancer patients. Such IL-2/IL-15Rβγ agonists represent a new and very promising class of drugs in the immune-oncology segment as they have shown to re-induce responses in patients after failure to checkpoint inhibitors treatment,” adds David Bechard, President and COO of Cytune. “The continued financial support by PPF combined with SOTIO’s clinical development expertise will be instrumental in accelerating the development of SO-C101 in multiple clinical trials, ultimately for the benefit of cancer patients.”

The financial terms of the transaction are not disclosed.

Dr Reddy’s Neostigmine Methylsulfate Injection, USP is available in 5 mg/10 mL and 10 mg/10 mL multi-dose vials.

XchangePoint, an integrated workflow management system for medication SOTIO and PPF Complete Acquisition of optimization Cytune Pharma EXILANT Technologies, a QuEST Global Company, has successfully SOTIO, a biotechnology company owned by the PPF Group, announced the completion of the acquisition of Cytune Pharma by PPF. SOTIO will continue to develop the lead program SO-C101 (RLI-15) within its pipeline and intends to initiate first-in-human clinical trials in early 2019.

SOTIO is spearheading all of PPF’s activities in the biotech sector and closely cooperated during Cytune’s acquisition process. All Cytune projects will be developed as part of SOTIO’s pipeline.

Cytune Pharma develops IL-15 based therapies for the treatment of cancer. The lead molecule of Cytune’s pipeline, SO-C101 (RLI-15), is a human fusion protein of IL-15 and the high-affinity binding domain of IL-15Rα and acts as a specific IL-2/IL-15Rβγ agonist.

The deal announced in 2015 between PPF Group and Cytune involved investments into Cytune and a staged-acquisition of the company, which has now been completed with the acquisition of all outstanding shares of Cytune. Cytune becomes an important part of SOTIO’s activities in the biotech sector and will also closely collaborate with its affiliate Accord Research on the future development of the lead program SO-C101, and other earlier-stage targeted RLI-15 programs. SOTIO is planning to initiate a first-inhuman study with SO-C101 in selected European countries and the US in early 2019. A key part of this early clinical program is the combination with immune checkpoint inhibitors.

“We are excited about the completion of the acquisition and welcome Cytune to the PPF Group. Cytune and SOTIO have been closely and very successfully collaborating over the course of the last few years and we very much look forward to initiating the first clinical trials with SO-C101 in a few months,” commented Radek Spisek, CEO of SOTIO. “SO-C101 will become a core program of our pipeline, together with our clinical programs in ovarian, lung and prostate cancer based on our autologous dendritic cell therapy platform DCVAC.” 40 ◄ September 2018

partnered with PharmaPoint, a technology-enabled pharmacy management and software company in the United States, to unveil the latest version of XchangePoint, an integrated workflow management system for medication optimization.

The new release includes real-time video conferencing capabilities to extend a pharmacist’s reach to patients in need of a medication consultation. XchangePoint’s analytical engine has also been enhanced to include socio-economic factors as an option for targeting potentially at-risk patients in need of additional services.

“We are proud to partner with EXILANT, a QuEST Global company,” said Bobby Middleton, Vice President of Product Operations for PharmaPoint. “Their work on product development for XchangePoint allows us to efficiently roll out enhancements and new features to our clients in a timely manner. We look forward to continuing to disrupt the healthcare industry together with innovative solutions that result in the highest quality of patient care.”

XchangePoint prioritizes high risk patient populations, operationalizes “meds to beds” workflow, provides complete and accurate pharmacyled medication reconciliation, and offers customized discharge medication instructions. Essentially, XchangePoint serves as the process communicator and enabler that converts analytics into action resulting in improved outcomes and optimal staff productivity.

Commenting on the successful release of the latest version of XchangePoint, Krish Kupathil, Head – Digital and Hi-Tech, QuEST Global, said, “Analytics is playing a crucial role by helping organizations in different industries to ensure accurate planning, make better business decisions and improve customer satisfaction. We are excited to partner with PharmaPoint to integrate data from various sources to provide effective bedside programs, medication reconciliation, post follow-up and coordinated transition of care via the XchangePoint solution. At QuEST Global, we support customers to enhance their product experience and lead their industries by co-innovating products using the latest software and digital technologies.”

Pharma Bio World

press release Eisai's LENVIMA (LENVATINIB) Capsules Approved for First-Line Treatment of Unresectable Hepatocellular Carcinoma (HCC) in South Korea

LENVIMA has been approved as a treatment for refractory thyroid cancer in over 50 countries including the United States, Japan, in Europe and Asia, and as combination with everolimus as a secondline treatment for RCC in over 45 countries including the United States and in Europe.

Eisai Co, Ltd announced that its South Korea subsidiary Eisai Korea Inc. received approval for the kinase inhibitor LENVIMA (lenvatinib mesylate) as a single agent for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC) from the Ministry of Food and Drug Safety (MFDS) in South Korea. An application seeking approval of LENVIMA for use in the treatment of unresectable HCC was submitted in South Korea in March 2018.

This approval for LENVIMA in South Korea marks the second in Asia following approval in Japan. LENVIMA is the first new treatment option approved in ten years as a first-line systemic treatment for HCC in South Korea.

Since the initial launch, more than 10,000 patients have been treated with LENVIMA, which is approved in more than 50 countries worldwide.

In Japan, approximately 3,000 HCC patients have been treated with LENVIMA since the approval of the HCC indication in March 2018.

In March 2018, Eisai and Merck & Co, Inc, Kenilworth, N.J, U.S.A, through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of LENVIMA. The companies are expected to commence co-commercialization efforts for LENVIMA in South Korea by the end of 2018.

This approval was based on results from REFLECT (Study 304), an open-label, Phase III trial where LENVIMA demonstrated a treatment effect on overall survival (OS)(1) by statistical confirmation of noninferiority when compared with the standard of care, sorafenib, in 954 patients with previously untreated unresectable HCC. LENVIMA also demonstrated statistically significant superiority and clinically meaningful improvements in progression-free survival (PFS)(2) and objective response rate (ORR)(3).

REFLECT showed that LENVIMA achieved the primary endpoint, demonstrating a treatment effect on OS by statistical confirmation of non-inferiority to sorafenib. Patients treated with LENVIMA experienced a median OS of 13.6 months compared to 12.3 months with sorafenib (Hazard Ratio [HR]: 0.92; 95% Confidence Interval [CI]: 0.79-1.06). The OS analysis was conducted as prespecified in the statistical analysis plan when 351 events had occurred in the LENVIMA arm and 350 events had occurred in the sorafenib arm. Regarding secondary efficacy endpoints, according to independent imaging review based on mRECIST criteria, LENVIMA showed statistically significant superiority and clinically meaningful improvements as compared to sorafenib in median PFS: LENVIMA 7.3 months versus sorafenib 3.6 months (HR: 0.64; 95% CI: 0.55-0.75; ) Liver cancer is the second leading cause of cancer related deaths and is estimated to be responsible for approximately 750,000 deaths per year globally. Additionally, approximately 780,000 cases are newly diagnosed each year, about 80% of which occur in Asian regions.(1) HCC accounts for 85% to 90% of primary liver cancer cases. Unresectable HCC, for which treatment options are limited, is extremely difficult to treat, and the development of new treatments is necessary.

Pharma Bio World

Eisai positions oncology as a key therapeutic area, and is aiming to discover revolutionary new medicines with the potential to cure cancer. Eisai is committed to exploring the potential clinical benefits of LENVIMA, in collaboration with Merck & Co., Inc., Kenilworth, N.J., U.S.A., as it seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to cancer patients, their families, and healthcare providers worldwide.

(1) Overall Survival (OS): The time period from the commencement of cancer treatment up until death by any cause. Whether the cause of death is cancer or not is not taken into consideration for this variable.

(2) Progression Free Survival (PFS): PFS is the objectively confirmed time from the commencement of cancer treatment to the date of disease progression, or date of death from any cause, whichever occurs first.

(3) Objective Response Rate (ORR): ORR is the combined proportion of patients whose tumor was eliminated (complete response) and whose tumor was reduced by over 30% in size (partial response) as verified by imaging assessment.

REFLECT Trial (Study 304) was a large (n=954) Phase III, randomized, multicenter, open-label trial conducted by Eisai to compare the efficacy and safety of lenvatinib versus sorafenib as a first-line systemic treatment in patients with unresectable hepatocellular carcinoma (HCC). Patients at 154 trial sites in 20 countries were randomized to receive lenvatinib 12 mg or 8 mg once a day depending on body weight (>/=60 kg or In addition, LENVIMA showed statistically significant superiority and clinically meaningful improvements in the secondary efficacy endpoints of PFS and ORR, as confirmed by a blinded independent imaging review (IIR).

Median PFS was doubled with LENVIMA compared to sorafenib: 7.3 months versus 3.6 months (HR: 0.64; 95% CI: 0.55-0.75; p In addition, median time to progression (TTP) was doubled with LENVIMA compared to sorafenib: 7.4 months versus 3.7 months (HR: 0.60; 95% CI: 0.51-0.71; p The results of the REFLECT trial were published in The Lancet 2018, 391 (10126), 1163-1173 (published online on February 9, 2018).

September 2018 â–ş 41

press release Pushing the Boundaries in Automation - Markus Regner takes over as MD of Romaco Lonza’s Next-Generation Robotic Solution for Pharmatechnik GmbH at the Karlsruhe facility Endotoxin Detection The Romaco Group has just appointed Markus Regner (51) as new Managing Director of Romaco Pharmatechnik GmbH, the facility where Romaco’s Noack and Siebler brands are manufactured in Karlsruhe (Germany). Amongst other things, Regner will be responsible for sales, customer service, operations and engineering.

He will work alongside Carsten Strenger, who will remain CFO/COO of Romaco Holding GmbH as well as joint Managing Director of Romaco Pharmatechnik GmbH.

Consistent with the FDA’s Process Analytical Technology (PAT) initiative, Lonza is introducing a new generation of automated endotoxin detection driven by its market leading WinKQCL Endotoxin Detection Software.

A few of the highlighted features include: • Adapting to changes: WinKQCL Software can generate robotic scripts and adapt to changing sample dilution requirements.

• Offering a “walk-away” solution: The WinKQCL Software can control the procedure from start to finish.

• Saving time and reducing risk: WinKQCL Software can import sample test worklists from a sample management system and export the results back out to the same system, preventing transcription errors and saving time over manually entering data.

The need for accurate and dependable endotoxin testing technology is greater than ever, with the pharmaceutical industry increasingly focusing on the development of innovative biotherapeutics that carry a higher risk of endotoxin contamination. However, endotoxin testing traditionally involves a number of manual data entry and test template creation steps, which are inherently prone to human error. As a consequence, confidence in results is reduced, the retest rate is increased and the potential for proper second person review of the methods is reduced. Furthermore, the lack of metadata to be associated with manual steps has a negative impact on traceability and the laboratory’s audit capability.

As an add-on to Lonza’s industry-leading WinKQCL Endotoxin Detection Software, the automation module in version 6.0 simplifies the process of setting up an automated endotoxin testing run and requires minimal human intervention while enhancing assay performance. The simplicity of the WinKQCL Endotoxin Automation Software Module means that no programming or robotic scripting knowledge is required. Results are automatically read and saved, and can be easily transferred into and out of LIMS, CAPA, MODA or other database systems.

“Our presentation at the Endotoxins Workshop highlights Lonza’s commitment to support QC testing labs with solutions that promote data integrity and maximize productivity,” Robert Porzio, Product Manager at Lonza said. “At the same time, we will have experts on hand at Booth #7 to demonstrate how our wider endotoxin testing product offering can help our customers deliver the next high-quality, breakthrough products.”

42 ◄ September 2018

A graduate in Aerospace Engineering, Markus Regner began his career in the solar technology sector in the mid-nineties. He switched to the pharmaceutical packaging industry, which has remained his professional home to this day, at the turn of the millennium. He has held various executive positions with pharmaceutical technology groups over the past 20 years, most recently as Technical Manager at a supplier of customised machines for filling liquids.

Markus Regner explains his move to Romaco as: “I believe Romaco has everything it takes to be very successful. My aim is to systematically strengthen this innovation capability and drive those technologies forward. It’s an exciting challenge and I’m looking forward to it immensely.”

Sun Pharma launches Volini Maxx, India’s Strongest Pain Relief Spray Sun Pharma Consumer Healthcare, a division of Sun Pharmaceutical Industries Ltd announced the launch of Volini Maxx, India’s strongest pain relief spray*. The company has signed Virat Kohli, Captain of Indian Cricket Team as the new brand ambassador of Volini. A 3600 marketing campaign featuring Virat Kohli goes live today.

Volini Maxx is a new variant of Sun Pharma’s popular brand, Volini - the No.1 pain relief spray in India#. Its unique formulation of 2% diclofenac makes it 100% stronger than the existing 1% diclofenac sprays available in the Indian market. Volini Maxx is targeted for severe pains including musculoskeletal, joint and low back. Its 3600 technology ensures standardised drug delivery at all angles.

“Volini has been a trusted pain relief partner for over two decades.

We are happy to introduce Volini Maxx spray which is stronger than any other topical pain relief spray available in India*. It will provide effective relief to people suffering from back and joint pain and also in sports injuries,” said Kal Sundaram, CEO – India, Emerging Markets & Consumer Healthcare, Sun Pharma. “Known for pushing the limits of physical endurance, Virat echoes the brand vision of constantly improving performance and not letting pain come in the way of going that extra mile,” he added.

The overall topical analgesic market in India is valued at ` 3380 crores growing at 11% (AC Nielsen MAT June 18). Out of this, the spray category is around ` 356 crores growing at 18% (AC Nielsen MAT June 18).

Pharma Bio World

Submersible Pumps In today’s water parched world, it has become strenuous for local water bodies to be able to provide a steady supply of water. The concept of rainwater harvesting in buildings has been the need of the hour. To help buildings with their rainwater delivery systems Grundfos has excellent dewatering systems. One of the prime examples would be the DWK and the DPK pumps.

Grundfos DWK and DPK are submersible pumps designed for dewatering and drainage applications. The castiron construction and the hydraulic design contribute durability and high efficiency. The differences between the DWK and DPK pump ranges lie in the discharge arrangement and the installation type.

The DWK range of submersible pumps combines durable performance with ease of installation. With a solid cast iron construction and narrow design this pump range is ideal for pits, temporary or fixed installation, or in situations where effective dewatering is needed. In cases where there is a presence of abrasives like sand or where power supply is limited, the DWK pumps prove to be ideal.

DPK pump variant comes with a long-life motor, which helps in bringing down the maintenance costs; circuit operates independently and is responsible for providing the necessary protection against overheating of the motor; SS, high-chrome impeller helps ensure an increased lifetime For more information, please contact: Grundfos Pumps India Pvt Ltd 118 Rajiv Gandhi Salai, Thoraipakkam Chennai 600 097 Tel: 044-45966800 Fax: 91-044-45966969

Prime Freezer Doors Gandhi Automations Pvt Ltd offers high-speed freezer doors. Prime Freezer Doors are the ideal solution where temperature control is critical and safety concerns are at a premium. The doors are manufactured with European collaboration and technology with innovative and creative engineering.

The high operating speed combined with an excellent seal optimizes the internal traffic flow and provide energy savings. Heavy duty motor: 400 V three-phase, opening speed up to 2.5 m/s with inverter system. It can be equipped with transparent PVC vision windows. It is suitable for both positive and negative temperature, operating temperature range +5 to -35 oC. Prime freezer door has special double curtain construction with space in-between. High speed freezer doors are the ideal solution for internal heating system provided within the guide prevents ice formatting even during intensive cooling and effectively operate in any situation. Innovative insulated curtain with high thermal efficiency is available optionally, for additional saving on energy costs. High speed freezer doors have revolutionary soft bottom edge and sensor combine to ensure operator safety at all times.

For more information, please contact: Gandhi Automations Pvt Ltd Chawda Commercial Centre Link Road, Malad (W), Mumbai 400 064 Tel: 022-66720200, 66720300 Fax: 91-022-66720201 E-mail: sales@geapl.co.in

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September 2018 â–ş 43

Tri-Clover Gaskets

IonTrap Mass Spectrometer

Tri-Clover Gaskets are used for connecting two pipes in food and drug plant. Tri-Clover Gasket is available in Food Grade Silicon, Food Grade Viton, Food Grade EPDM, etc. It can be supplied in different sizes upon request. Tri-Clover Gaskets is made from Platinum-cured Silicone Rubber, Fluoro Elastomer (FKM), EPDM and PTFE. It conforms to FDA 21 CFR.177.2600 and USP Class VI requirements. It is Animal Derived Ingredient Free. Silicone TriClover Gaskets are available with collar for better grip and also without collar. It is available in red/orange/white and transparent colour. Imaclamp has different types like T/C gaskets, Mesh T/C gaskets, PTFE Envelop gaskets, Sensor T/C gaskets and Validation T/C gaskets.

For more information, please contact:

Ami Polymer Pvt Ltd 319 Mahesh Indl Estate, Opp: Silver Park Mira-Bhayander Road, Mira Road (E), Thane Maharashtra 401 104 Tel: 022-28555107, 28555631, 28555914 E-mail: mktg@amipolymer.com

Thermo Scientific LTQ XL ion trap LC-MS mass spectrometer delivers high-sensitivity MS performance to generate extensive structural information for routine proteomics and metabolism application. Its high capacity 2D linear ion trap configuration with powerful software is a complete solution for structural elucidation questions. The LTQ XL MS offers multiple dissociation techniques, PQD, ETD and CID. PQD is a proprietary technique that eliminates the low mass cut-off concern inherent with all ion traps. It gives extensive coverage for predicted and unpredicted metabolites.

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

High Speed Doors Prime King is oversized design for large openings - unique folding design and strong lifting belts, constructed of polyester, wear and traction-resistant can operate in the most diverse situations even in windy conditions. Resistance to wind load is according to EN 12424 Class 2/3, and size up to 15,000 x 10,000 mm (W x H). Integrated motorisation for very heavy duty use: 400 V three phase, opening speed up to 2.0 m/s.

It has a galvanised steel structure as Standard, SS structure, which integrates traction unit, rapid wirings and safety photocells.

Reinforced flexible curtain in self-extinguishing material fitted with strong tubes to ensure proper door functioning in large openings and wind exposed areas.

For more information, please contact: Gandhi Automations Pvt Ltd Chawda Commercial Centre Link Road, Malad (W), Mumbai 400 064 Tel: 022-66720200, 66720300 Fax: 91-022-66720201 E-mail: sales@geapl.co.in

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Pharma Bio World

Axial/Basket Extruders for Powder Extruder is used to convert wetted powder/dough material into uniform size extrudes/granules with addition of binders. Applications are mainly pharma, chemicals, agrochemicals, foods, confectionery industries, etc.

They are available from 1 to 5,000 kg capacity. Forming pharma extrudates prior to spheronisation for controlled release applications; production of water dispersible and water soluble granules of agriculture chemicals; densification of organic chemicals; formation of free-flowing vulcanisation compounds; different models in extruders such as single screw axial, double screw axial, radial extruder and basket extruder; change of extrusion diameter/pellet size by changing die and sieve; etc, are some of the features.

For more information, please contact:

Prism Pharma Machinery Plot No: 3713, Phase IV, GIDC Vatva, Ahmedabad, Gujarat 382 445 Tel: 079-29095204 Fax: 91-079-25841623 E-mail: mkt@prismpharmamachinery.com / sales@prismpharmamachinery.com

Automation of Centrifuges The API production and schedule M drugs limitations require time-based production with necessary process steps. The dependence of production on human-beings may spoil the quality of production.

ACE has thoroughly studied all the process steps of bottom discharge centrifuge. The total control of the machine is done electronically.

Use of variable frequency drive (VFD) coupled with PLC has opened the gateway of automation.

Their FLP control system has been incorporated with HMI/MMI. The user can easily get the following time-based benefits with their flameproof control panel: batchwise recordings of individual steps with respect to date/time/batch numbers are stored in the system and the printout is available as and when required.

The total cyclic operation can be different for different products. The control of the equipment can be managed from a particular desktop computer.

The use of VFD in centrifuges is a great advancement. The VFD of a standard make is used preferably one that has an in-built braking chopper and resistor. The centrifuge runs with high starting and braking torque. Although ACE clutch pulleys and hand brakes are sturdy enough to do the job, the VFD does it electronically. The wear and tear of brake and clutch liners is negligible. It is worthwhile to invest in a VFD. The variable speed is welcome to save power. The VFD gives smooth centrifuging operation. Also, the work of feeding and washing can be done at lower basket speeds and the centrifuge drying can be done at higher speeds, if the basket charge is properly balanced.

For more information, please contact: ACE Industries (India) Pvt Ltd 113 Alpine Indl Estate, Marol Military Road Andheri (E), Mumbai 400 069 Tel: 022-42258000m 29201763 Fax: 91-022-29204939 E-mail: ace_centrifuges@yahoo.co.in

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September 2018 â–ş 45

Tight Head Drums

Digital Refractometer

Liquids present particular challenges when they are transported, stored and handled, especially if they are high purity or problematic substances.

They pose no problem, however, for Muller’s highly practical and ruggedly constructed tight head drums. These drums can also be used with the cleverly designed Muller emptying systems.

Anton Paar’s range of Abbematrefractometers embody over years of technical expertise. They measure the refractive index and concentration of liquids, gels and solids. These truly universal refractometers cover all applications in all industries.

Abbematrefractometers are built with care and precision using the highest quality materials.

They are available from 23 to 240 litre capacity containerisable, stackable and completely drainable. Internal and external surface coatings galvanised, UN Certified and FDA/BGA/BAG-compliant versions on request.

It is designed for routine analysis and quality control ranging from checks on incoming raw materials to intermediate and final product.

Selectable from industry specific sets of scale. Built-in LCD screen and membrane keys are resistant to spillage and dirt.

For more information, please contact: Vinisa E I Pvt Ltd 6 Himalaya House, Palton Road Mumbai 400 001 Tel: 022-22614088, 22622391 E-mail: vinisa@vsnl.net

For more information, please contact:

Shreedhar Instruments 16 Shreeji Krupa Society Opp: MGVCL Circle Office, Next to GNERS Medical College Gotri Road, Vadodara, Gujarat 390 023 Telefax: 91-0265-2323041 E-mail: sales@shreedhargroup.com

Pump Impeller The KSB Group offers a special impeller for its Movitec multi-stage high-pressure pumps. This new impeller significantly improves these pumps’ suction characteristics (NPSH value).

It proves its worth particularly in applications with critical inlet conditions (eg, boiler-feed applications) as well as applications in which the pump is required to take in water from low-lying tanks or at higher temperatures. Under these conditions, a pressure drop in the intake area may cause cavitation to occur in the first pump stage. This can result in excessive wear of pump parts or motor bearings as well as a reduced service life of the pump due to damaged parts and an unbalanced hydraulic system.

The new impeller features a modified inlet dia, vanes allowing a slightly diagonal throughflow and a newly designed stage casing, all of which serve to substantially improve the pump’s NPSH curve.

The multi-stage centrifugal pumps from the Movitec range are designed for handling fluids such as water, coolants, condensate and mineral oils. They are ideal for a wide variety of applications ranging from industrial boiler feed installations in steam circuits, recirculation and fire-fighting systems, cooling water circuits and washing plants to pressure boosting in general process applications.

For more information, please contact: KSB Pumps Ltd Mumbai-Pune Road Pune, Maharashtra 411 018 Tel: 020-27101231 Fax: 91-020-27426000 E-mail: Yagnesh.Buch@ksb.com

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Pharma Bio World

Emulsion Stabilizer for Droplet Microfluidics Dolomite Microfluidics, part of the Blacktrace Group, offers its new Pickering emulsion stabilizer Fluoro-Phase, a fluorinated continuous phase that has been specially formulated to stabilize aqueous droplets in microfluidic systems. Unlike most emulsion stabilizing oils, which use molecular surfactants, Fluoro Phase relies on functionalized silica nanoparticles that support highly stable emulsions, making it ideal for biomedical applications involving droplets with complex compositions. This novel development offers a number of advantages over traditional surfactants, including faster droplet formation and compatibility with a broader range of reagents in the droplet phase.

For more information, please contact: Dolomite Microfluidics (Part of Blacktrace Holdings Ltd) Unit 3, Anglian Business Park Royston SG8 5TW, U.K. Tel: +44 (0)1763 242491

BOD Incubator Mack Pharmatech offers cost-effective PLC-based BOD incubator with European Standard “CE” in different capacities.

Their BOD incubator temp range is 10°C to 60°C, accuracy: ±0.2°C, uniformity: ±1.0°C control system: PLC (Allen Bradly).

Mack Pharmatech is the only company who gives all equipment with PLC-based control system, 21 CFR software, touch screen display (HMI), standby refrigeration system, PT 100 sensor, GSM technology, hooter system, password protected door system, GMP Model, full view glass door, bullet feet levelling legs, tray spacing every ½” adjustable and many more features.

For more information, please contact: Mack Pharmatech Pvt Ltd B-48 Malegaon MIDC, Sinnar Dist: Nashik, Maharashtra 422 113 Telefax: 91-02551-230877 E-mail: sales@mackpharmatech.com

Photostability Chamber Mack Pharmatech offers cost-effective PLC-based photo stability chambers with European Standard “CE” in different capacities.

Photo stability chambers temp range is 20°C to 50°C, accuracy: ±0.2°C uniformity: ±1.0°C and control system: PLC (Allen Bradly).

Mack Pharmatech is the only company who gives all equipment with PLC-based control system, 21 CFR software, test samples on fluorescent light or UV lights separately as well as simultaneously, lights automatically shut-off after a specified exposure level or time duration, HMI (touch screen display), GSM technology, hooter system, full view glass door, bullet feet levelling legs, GMP Model and many more features.

For more information, please contact: Mack Pharmatech Pvt Ltd B-48 Malegaon MIDC Sinnar, Dist: Nashik Maharashtra 422 113 Telefax: 91-02551-230877 E-mail: sales@mackpharmatech.com

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September 2018 ► 47

Thermoplastic Elastomer Tube (TPE) Imaprene manufactured and packaged in dust-free environment of ISO 9001 QMS, ISO 14001 and OHSAS 18001 Certified facility uses advanced grade thermoplastic elastomer is opaque tubing especially known for its excellent flexibility and superior flex crack resistance durable for any application. It has excellent chemical and solvent resistance (Ex IPA). It has smooth bore to ensure least contamination. It is non-toxic and non-haemolytic. It is highly recommended for medical, food and pharma applications. It is sterlisable by using different techniques like autoclaving, ethylene oxide and gamma radiation.

For more information, please contact: Ami Polymer Pvt Ltd 319 Mahesh Indl Estate, Opp: Silver Park Mira-Bhayander Road Mira Road (E), Thane Maharashtra 401 104 Tel: 022-28555107, 28555631, 28555914 E-mail: mktg@amipolymer.com

Condition Monitoring & Predictive Maintenance NORD DRIVESYSTEMS uses condition monitoring and predictive maintenance to achieve max plant availability and high cost-efficiency.

While condition monitoring only enables the state of wear to be detected, predictive maintenance can ideally enable a maintenance date to be planned well in advance.

This requires intelligent frequency inverters with integrated PLCs, which can take autonomous decisions and evaluate motor and gear unit status data from virtual and physical sensors. With the aid of virtual sensors based on mathematical algorithms and the PLC which is integrated into the NORD frequency inverter, in combination with the known physical characteristics of the gear oil, the lifespan of the oil can be determined with sufficient accuracy from the calculated drive output which is determined from the measured electrical data. This allows an assessment of the degree of use of the gear oil and the predicted date for the oil change.

For industrial gear units, physical temperature and vibration sensors are both economical and advisable. Especially vibration sensors offer a range of advantages. Detailed manufacturers’ databases exist for all of the bearings which are installed in industrial gear units.

These databases contain the characteristic vibration frequencies for all components of each bearing type. The individual frequencies can therefore be clearly identified and attributed to particular components. The frequency spectrum can be analysed on the basis of the time signal or an FFT analysis (Fast Fourier-Transform). This not only enables the ideal or necessary maintenance time to be calculated, it also indicates the location of the fault and which replacement parts are required.

The autonomous drive communicates its status data to a secure cloud. There, this data is available for analysis with filter and analysis tools, so that monitoring of the drive units can be carried out from anywhere in the world. The data are transparently presented in a browser-based web interface and the plant can be viewed at a glance in a clear 3D illustration.

For more information, please contact: Getriebebau NORD GmbH & Co KG Getriebebau-Nord-StraĂ&#x;e 1 22941 Bargteheide/Hamburg Germany Tel: +49 45 32 / 2 89 -0 Fax: +49 45 32 / 2 89 -22 53 E-mail: Joerg.Niermann@nord.com

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Hydro-transportation System Hydro-transportation devices are considered by some to be the latest generation of sand removal devices. The operating principle is the introduction of wash water in a vortex manner. While effecting initial mobilisation of accumulated solid particles, an area of low pressure is produced at the centre of the induced vortex, which is utilised, by means of strategically placed piping, to transport the produced slurry out of the vessel.

For more information, please contact:

Fenix Process Technologies Pvt Ltd K 6/1 Malini, Erandwane Co-op Hsg Scty Nr Mangeshkar Hospital, Opp: Sevasada School Erandwane, Pune, Maharashtra 411 004 Tel: 020-65008772, 60508770 E-mail: info@fenix.in

Self-cleaning Filters The Russell Eco Filters safeguards the quality of your liquids by eliminating oversized contamination. The strainer achieves consistently high flow rates with the unique SpiroKlene System, which continuously cleans a reusable strainer element.

It improves product quality by eliminating contamination; increases productivity with easy clean and tool-free maintenance; and safeguards operators’ health and the environment.

For more information, please contact: Russell Finex Pvt Ltd A-1201 Rustomjee Adarsh Regal Adarsh Vihar Complex, Off Marve Road Malad (W), Mumbai 400 064

Noble Gas MS Take the next step in noble gas mass spectrometry. The new Series of Thermo Scientific noble gas mass spectrometer gives you unsurpassed precision, sensitivity, dynamic range, linearity and stability.

Improve age precision in Ar-Ar dating by an order of magnetude. Get all five argon isotopes simultaneously with the Thermo Scienific Argus VI static vacuum noble gas mass spectrometer.

Redetermine the isotope ratios of neon, argon, crypton and xenon by unsurpassed high resolution and precision of the Thermo Scientific Helix MC Plus Multicollector noble gas mass spectrometer.

Enter new fields of research with unique subpermil precision by using the new Thermo Scientific Helix SFT split flight tube noble gas mass spectrometer.

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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September 2018 ► 49

Homogeniser

Blenders Homogeniser is complete sophisticated machinery designed for pharma, life science, bio-technology, agricultural, microbiology, chemical research and development.

They are available in capacities ranging from 2 to 30 HP, highly customisable to suit client’s requirements.

For more information, please contact:

IPEC Engg Pvt Ltd Plot No: 5175, GIDC Ankleshwar, Gujarat 393 002 E-mail: md@ipecengg.com / marketing@ipecengg.com

Multi-collector ICP-MS Meet the ever-expanding application demands of earth sciences, nuclear sciences and other fields requiring high precision isotope ratio measurements with the Thermo Scientific Neptune Plus high resolution multicollector ICP-MS system.

The Neptune Plus system combines field-proven technology with the latest innovations.

This powerful double-focusing mass spectrometer, with high mass resolution, variable multi-collectors, and multi-ion counting capability, offers ground breaking sensitivity, high dynamic ranges, unsurpassed linearity and robust stability.

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

50 ◄ September 2018

The blender is a simple machine with GMP compliance to blend dry powder and granules. The geometry of blender with the baffle fitted inside the blender makes the system perfect to achieve homogeneous mix in reasonable time.

They are available in R&D Models 5, 10, 20 and 30-litre; and Production Models 50, 100, 200, 300, 500, 1,000, 1,500, 2,000 and 3,000-litre capacity.

For more information, please contact:

Sunsai Pharma Equipments Pvt Ltd Plot No: 1, Survey No: 77 Nr Laxmi Indl Estate Sativali Road, Vasai (E), Thane Maharashtra 401 208 Tel: 0250-3200130 E-mail: sunsai.pharma@rediffmail.com / sunsaipharma@gmail.com

Thermal Ionisation MS Get high-precision isotope ratio measurements of your precious samples with the Thermo Scientific Triton Plus multicollector thermal ionization mass spectrometer (TIMS).

With a proven thermal ionization source and a unique variable multi-collector system that can be configured to suit the application, the Triton Plus TIMS system is ideal for dating of geological samples and control of isotropic compositions of nuclear materials. It has outstanding sensitivity, dynamic range, linearity and stability.

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

Pharma Bio World

Vacuum System The condensor helps in reducing the process time of drying, distillation, etc, by effectively condensing the condensable vapours.

The condensor has been standardised with 1.5-m², 3-m² and 6-m² cooling surface area. The material of construction (MoC) can be given in mild steel / SS-304/SS-316 for Shell and Copper/Cu Nickel/SS-304/SS-316 for the cooling coil.

Vacuum systems finds application in many fields, including pharma, chemical, plastic, food and pasta production, leather, chemicals and centralized vacuum systems.

Vacuum systems are variable and optimized by the selection for the application and working parameters. It is possible to decrease power, saving in the range 30-40 per cent. It improves the quality and productivity, is compact in design, and easy to install and service.

For more information, please contact: Toshniwal Instruments (Madras) Pvt Ltd 267 Kilpauk Garden Road, Chennai 600 010 Tel: 044-26448983, 26448558 E-mail: sales@toshniwal.net

Direct Drive Electronic Elesa+Ganter wide range of standard machine elements has recently extended its range of electronic position indicators by introducing the new DD52R-E that joins the DD51-E model.

Elesa+Ganter electronic position indicators are characterized for their wide orientable display (DD51-E – 5 digit of 8,0 mm height and DD52R-E – 6 digit of 12,0 mm height) that ensures excellent readability even from a distance and from different viewing angles.

The AISI 304 stainless steel bushing ensures a high corrosion resistance. Diameter: DD51-E – 14 mm and DD52R-E – 20 mm.

The internal lithium battery ensures a long life: DD51-E of over 5 years and DD52R-E of over 8 years. The battery replacement can be performed easily, without disassembly of the indicator from the control shaft and without the loss of parameter configuration.

The window in transparent technopolymer moulded over the case protects the LCD display against accidental shocks. The ultrasonic welding between the base and the case avoids dust and liquids penetration offering a high IP protection class (IP65 or IP67). For this reason the electronic position indicators are suitable for applications that require frequent washing, even with water jets.

Thanks to the available functions and the programmable parameters, one item can be used for many applications.

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

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events diary 

   

Date: 2 nd - 4 th October 2018 Venue: Doubletree Suites by Hilton Hotel Boston Cambridge, Boston, U.S.A.

Date: 20 th – 23 rd February 2019 Venue: Bombay Exhibition Center, Mumbai

Ensuring safer drugs to market by analyzing latest developments in drug safety and risk management. Pharmacovigilance will bring together top pharma, biotechnology and regulatory representatives under one roof that will address the key issues of the industry. The entire program will cover the detection, analysis and prevention of adverse drug reactions. It will be studied with the help of case studies and industry experiences. This conference will help the drug safety representatives from the pharma industry and academic and quality research organizations who wish to understand how to avoid common deficiencies in inspections by learning from the experiences of others; to gain a greater understanding of new and existing PV requirements, and to improve their organizations’ compliance with PV requirements.

Also it can help you control your product’s lifecycle, your patient’s trust, and your revenue. Hence, this conference will provide an important platform for pharmacovigilance stakeholders to discuss and share best practices in expediting PV development.  Virtue Insight 40 Alwarthirunagar, 2 nd Street, Lakshmi Nagar Chennai

BioPharma World Expo 2019 will be a perfect destination for Bioprocess Solution Providers, CROs/CMOs, Clinical Trial Supply Chain Providers, Cold Chain Packaging & Cargo, Global Pharma, Regulatory Consultants, Analytical Instrument Manufacturers, Local Biotechs & Start-ups, Quality Control Consultants, Academics, and Regulators to showcase and promote their product and services as well as offer unique opportunity to meet, network and discuss current industry trends, establish business partnerships and be updated on investment opportunities in India.

The concurrent conference tracks will explore areas like biosimilars and vaccines development, antibodies, orphan drugs, stem cells, innovations in biologics manufacturing and regulatory compliance; growing issues in generic drug manufacturing and more.  Amrita Patkar Event Coordinator Tel: 91-22- 4037 3617 Email: amrita_patil@jasubhai.com

 

      Expo

Dates: 31 October-02 November 2018 Venue: Shanghai New International Expo Centre (SNIEC), Shanghai, China

Date: 16 th - 17 th April 2019 Venue: Mumbai Exhibition Centre, Mumbai

This event is involved with various laboratory technologies which are used in the medical and health labs all over the world. The event is involved in displaying the modern equipment which aims to benefit the visitors with its application.

Analytica Anacon India and India Lab Expo are together the biggest show in laboratory technology, analysis and biotechnology in India. The international trade fair is the most important industry gathering in India. Get to know the entire range of topics that pertain to laboratories in research and industry. This is a trade fair which showcases chromatographies, spectroscopes, microscopes and imaging, bioinformatics, medicine and diagnostics, life sciences, analytical instrumentation systems, instruments for physical and chemical analysis, laboratory furniture, equipment, machines, laboratory diagnostics, etc.

Many industrialists who have gained success in the respective fields are present in this event and provide information and solution to the issues of the visitors. The show is strongly supported by the Chinese government and other leading institutions. The location also adds to the popularity of the event as Shanghai is known as the most economical state of China  Messe Munchen GmbH Messegelaende Muenchen, Germany Tel: +(49)-(89)-94920720 Fax: +(49)-(89)-94920119

52 ◄ September 2018

 Messe Muenchen India Pvt Ltd INIZIO 507 & 508, 5th Floor Cardinal Gracias Road Opp: P&G Bldg Chakala, Andheri (E) Mumbai 400 099

Pharma Bio World

bookshelf Freshwater Phytopharmaceutical Compounds

Authors: Santhanam Ramesh, Rajabalaya Rajan and Ramasamy Santhanam Price: $118.07 No of pages: 250 pages (Hardcover) Publisher: CRC Press (1 st Edition) About the book: Herbal medicines have been used as prophylactic measures and curative treatments throughout human history, and crude herbal extracts are commonly used in pharmaceutical research.

Producing a variety of structurally novel bioactive compounds or secondary metabolites, freshwater plants provide a diverse and unique source of bioactive lead compounds for the discovery of modern drugs. These include antibiotics, mycotoxins, alkaloids and phenolic compounds.

In an effort to bring together the disciplines of biology and pharmacy for the identification and large-scale collection of pharmaceutically important organisms, Freshwater Phytopharmaceutical Compounds presents key information on freshwater flora, including common names, classification, global distribution, habitats and biology― all organized according to the activities of their bioactive compounds.

Phytopharmaceuticals

Authors: Amrita Mishra and Arun K Mishra Price: $42.00 No of pages: 60 pages (Paperback) Publisher: LAP LAMBERT Academic Publishing About the book: The term comes from two Greek words: “pharmakon” meaning drug or medicine, and “gnosis” means knowledge. The American Society of Pharmacognosy explains pharmacognosy as “the branch in which we study of the physical, chemical, biochemical and biological properties of drugs, drug substances or potential drugs or drug substances of natural origin as well as focus is laid on search for new drugs from natural sources”. Plant based preparations are said to be medically beneficial in a condition when they are used to promote health above the basic nutritional requirement. The knowledge of drugs from herbs includes the subjects of chemistry, botany and pharmacology. Botany includes the identification (taxonomy), genetics, and cultivation of plants.

Chemical characterization of these drugs includes the isolation, identification and quantification of active phyto-constituents from plant materials. In this, we study of the biological effects that the chemicals in medicinal plants exert on cell cultures, animals and humans.

Phytopharmaceuticals Market Research Authors: Mihaela Stoia and Simona Oancea Price: $69.00 No of pages: 112 pages (Paperback) Publisher: LAP LAMBERT Academic Publishing About the book: New dimension was given to the demand of dietary supplements and we consider very useful the overview on current statistics and trends suggestively illustrated here, as well as the scientific evidence which support the health reasons for using phytopharmaceuticals since their health claims are still a debatable issue. In our opinion, manufacturers of herbal supplements, as key-actors involved in developing a safe and modern phytotherapy besides pharmacists, physicians and consumers, should be informed on topics like plant bioactive compounds, market research, and world health statistics in order to meet the health needs of an ageing population. Because Romania is considered the most attractive market in the next years in the Central Europe Region, we have used this opportunity to make publicly available our national dietary supplement market assessment completed with an original case study analysis. Through this work we have also capitalized our professional experience in public health and in experimental research, closely linked to finding practical solutions to promote health by means accessible to a multidisciplinary team of specialists.

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Pharma Bio World

R.N.I. No.: MAHENG/2002/08502. Date of Publication: 26th of every month. Postal Registration No: MCS/207/2017-19 Posted at Patrika Channel Sorting Office, Mumbai 400001, on 27th of every month. Total Pages:- 56