Pharma Bio World May 2019

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4 ◄ May 2019

Pharma Bio World

FEATURES

08

23

08

Laboratory Expertise Helps Unlock Potential Kai Koch, Research & Development, Romaco and Susanne Silva, Market Communications, Romaco Group

14

Weighing the Strengths and Weaknesses of India’s and Chinese Bulk Drug Industry D Naveen Kumar, Senior Manager - Corporate Ratings, CARE Ratings Ltd and Vidhyasagar L, Associate Director - Corporate Ratings, CARE Ratings Ltd

19

Good Clinical Practices: Challenges and the Road Ahead Bhavik Narsana, Partner, Lifesciences and Healthcare and the , Corporate M&A and PE Team, Khaitan & Co. and Pavi Jain, Senior Associate, Lifesciences and Healthcare and the, Corporate M&A and PE Team, Khaitan & Co

21

Contract Manufacturing Organizations: Navigating Serialization Implementation Arthur Smith, Vertical Marketing Manager, Videojet Technologies

23

Pharma 4.0 – Impact of IIoT in Pharmaceutical Manufacturing

25

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

28

Can Indian traditional medicinal systems show the way forward?

MARKETING INITIATIVES

25

38

Accurate Flow Control for Cancer Research

39

NEWS

CORPORATE AFFAIRS 46

Products

56

Events

BACKYARD

38

6 ◄ May 2019

57

Book Shelf

58

Ad Index

Pharma Bio World

Laboratory Expertise Helps Unlock Potential Pharmaceutical manufacturers continuously optimise their processes and develop new formulations.

Romaco is supporting its customers in this effort by providing laboratories, where manufacturers can analyse process parameters, carry out scale-up tests and obtain assistance from the company’s application specialists. Kilian’s KiTech laboratory specialises in tableting, while Innojet’s expertise at InnoTech is granulation and coating. The newly opened Romaco China Solids Process Centre in Changsha is Romaco’s first laboratory outside Europe and the first one to feature technologies by Kilian as well as Innojet.

Kai Koch Research & Development Romaco E-mail: kai.koch@romaco.com

Susanne Silva Market Communications Romaco Group E-mail: susanne.silva@romaco.com 8 ◄ May 2019

P

harmaceutical manufacturers worldwide face a daunting challenge: to reconcile ever higher cost pressure with increased quality requirements. In order to satisfy market demands, they must optimise existing processes and push ahead with the development of high quality, cost-efficient formulations. The Romaco Group invests continuously in the development of new and improved, advanced laboratory technologies and is thus excellently equipped to provide research and development services. Whereas Romaco Kilian develops tableting technologies in Cologne, Romaco Innojet specialises in granulation and coating at its facility in Steinen.

“All-in-one” for Drying, Granulation and Coating “Two things matter particularly to our customers: they want to generate costefficient processes and at the same time reduce the risk of side-effects for end-users to a minimum. Our laboratory technology offers valuable support here, from process development to scale-up tests”, explains Dr Andreas van Kampen, Laboratory Manager at Romaco Innojet.

The laboratory scale VENTILUS® V 5 dries, granulates and coats powders, granules, crystals, pellets and microtablets, as well as other similar bulk materials, of any size from 10-µm to 2.0-mm in batches from 1,500-ml to 5,000-ml. All process steps are possible using a single product container. The homogeneous flow conditions inside this container and the scalable spray rate are just two special features. The uniquely homogeneous coatings open up a whole series of options for API release.

Furthermore, the amount of active ingredient can be reduced, depending on the formulation.

Lab Sessions for Pharmacists Manufacturers from all over the world travel to InnoTech, the Innojet test centre in the small south-west German town of Steinen, with their product ideas and process requirements. “We get together with them to analyse the process parameters, identify specific possibilities and develop exact-fit solutions”, says Dr Andreas van Kampen when asked to describe the concept. Laboratory equipment with a filling volume of 2.5 and 5 litres is available for the trial sessions.

And since the end of 2018, scale-ups to real production conditions have likewise been feasible on a 100 litre system.

Hot-melt Process Provides Long-term Stability Romaco has reported a marked increase in trials with hot melt technology. Around 35 per cent of all sessions are meanwhile accounted for by melt coatings. The quantity which must be applied in order to obtain a good coating is much smaller with this process than the amount of spray solution or suspension that would be needed to achieve the same effect.

In contrast to polymer coatings, no aqueous or organic solvents have to be evaporated. There is a growing interest in hot melt technology: “Natural products are inherently prone to instability and so the degree of reproducibility required by the pharmaceutical industry could not be guaranteed in the past”, Dr Andreas van Kampen comments. However, melt coatings providing long-term stability have only recently appeared on the market. Their lower energy consumption and up to 85 per cent shorter processing times are further points in their favour.

Romaco Innojet’s IHD Hot Melt Device, which is GMP-compliant, is installed upstream of the VENTILUS® processing Pharma Bio World

or agitator wheels.

“Integrating innovative machine components can demonstrably improve efficiency”, claims Thomas Bröker, Applications Engineer at the Romaco Kilian KiTech lab. “Close collaboration with our Design department is essential here, so that day-to-day production experience can be taken into account and built-on. Our aim is to help our customers get the most out of their machines.”

All-rounder for Research and Development

Figure 1: The KiTech laboratory in Cologne with the Romaco Innojet STYL’ONE Evolution single-stroke-press and the VENTILUS® processing machine.

machine while manufacturing hot melt coatings for the pharmaceutical industry.

Hot melt coatings are used, amongst other things, to mask the taste of APIs which are processed as orodispersible tablets (ODx). Taste masking – whether with hot melt or polymer coatings – is a core competency of Romaco Innojet.

feasibility studies and performance tests or to optimise their formulations or their machine settings. Apart from analyses to determine flow properties or the opportunity for scale-up tests, they also have a chance to try out various machine features such as fill shoe systems, sealing segments

The STYL’ONE Evolution is a versatile, single-stroke press which is used for research and development activities. In combination with ANALIS, the intelligent PAT software, the technology is also ideal for developing and analysing new or existing formulations. The compression force and performance that are necessary to produce tablets with the required wall dimension or breaking strength, for example, can be easily determined in this way. The STYL’ONE additionally simulates the compression force profiles of all standard high-speed presses and carries out fully automatic compression and performance studies. It

Committed to Tableting Anyone seeking to optimise their tableting processes will not only find suitable equipment at Romaco Kilian’s KiTech test laboratory in Cologne but can also obtain support to match from a pharmaceutical technologist and an application specialist. A fully furnished laboratory, three air-conditioned rooms for tableting trials and five conference areas are available there for compression tests. The test machines include tablet presses in all performance classes for the production of mono-layer, multi-layer or core tablets. Clients in the pharmaceutical, food and chemical industries take advantage of the broad array of KiTech services to carry out 10 ◄ May 2019

Figure 2: The moisture content of a granulate is determined.

Pharma Bio World

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COMPLETE CONTAINER SOLUTION The complete sprinkler or fire-fighting system can be supplied in a container with all internal pipings led via bulkheads through the container wall for connection to supply and pressure line.

The base plate is well-dimensioned, precisely levelled and ready for simple and quick mounting. Further, the complete unit is fitted with fuel tank and start batteries.

ELECTRONIC CONTROL UNIT A complete sprinkler system includes an electronic control panel. The panel is connected to the pressure switch in the piping system and automatically starts the pump system when receiving a pressure drop alert.

SPRINKLER PUMPS WITH ELECTRIC MOTOR OR DIESEL ENGINE The complete unit can be supplied on base plate. Further, as the pumps are also designed for diesel duty, they can be built together with electric motor or diesel engine. Pump and motor are fitted on base plate via a flexible coupling.

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Figure 3: Micro coating trials at InnoTech, the Romaco Innojet test centre in Steinen. achieves compression forces of up to 80- to offer comprehensive services to both kN with a maximum output of 1,750 tablets prospective clients and long-time users per hour. This results in realistic powder looking to develop new formulations compression and remarkably precise test or optimise their processes. The batches. Processes can be optimised in this lab sessions on high-tech machines way, scale-up tests conducted and errors are accompanied and supported by diagnosed. “The STYL’ONE is a fundamental specialists and documented in detail. part of our lab routine”, emphasises Dr The laboratories can additionally be Carola Hanl, Laboratory Manager, KiTech. used for machine training. The expert “It’s a user-friendly technology that saves seminars organised by Romaco Innojet us a lot of time and effort for both tableting and Kilian in co-operation with premix and data evaluations. In that respect, and carrier suppliers are regularly the innovative R&D tablet press is extremely fully booked. convenient.”

Worthwhile Sessions in the Lab Thanks to its InnoTech and KiTech laboratories, Romaco is in a position 12 ◄ May 2019

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

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Pharma Bio World

Weighing the Strengths and Weaknesses of India’s and Chinese Bulk Drug Industry The authors of this article compare bulk drug manufacturing industry of India vis-à-vis China and how can India get back to its past glory.

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

Vidhyasagar L Associate Director - Corporate Ratings CARE Ratings Ltd E-mail: vidhya.sagar@careratings.com 14 ◄ May 2019

I

ndian pharmaceutical sector companies have a strong footprint globally in generic segment to become the third largest in terms of volume and thirteenth in terms of value.

By the product classification, Indian Pharmaceutical Industry (IPI) can be classified into formulations, API (Active Pharmaceutical Ingredient)/bulk drugs and CRAMS (Contract Research & Manufacturing Services). Although, IPI has a strong footprint globally and is known as a leader in manufacturing and supplying of branded generic finished dosage formulations surpassing China in pharmaceutical exports over the past half a decade, the concern of its (IPI’s) excessive dependence on China for sourcing some of the vital key starting materials and intermediates continue to loom.

Over-dependence for the raw material on any one country or few suppliers can create significant supplier concentration risk not only for the industry but also to the nation. The Indian companies during FY17 to FY-19 have encountered the above risk wherein China alone contributed about 60 per cent of all pharmaceutical imports by volume and 70 per cent by value till FY-18. During April 2016, the Chinese government has enacted the new environmental laws to address the environmental issue. As per the order the chemical plants that do not comply with safety and environmental regulations have to either relocate or shut-down their operations. Thus, in order to enforce the law, the Chinese authorities have shut thousands of chemical ingredient plants gradually during FY-17 and also during FY-18. The above conundrum has

resulted in acute demand – supply gap for Key Starting Materials (KSM) and intermediates. Notwithstanding the rise in input raw material prices on one side and obligation to honour the contractual orders at predetermined price on the other side has hit the profitability margins of Indian Pharmaceutical companies.

Considering the fact that IPI is relying heavily on import of raw material from China, it pellucid the vulnerable state industry is exposed in the event of any dissension between the two countries.

The current article delineates on some of the factors wherein both the countries weigh similar and the factors in which they weigh strong or weak specifically concerning to pharmaceutical industry.

While both India and China have some resembling factors, India eventually has emerged as one of the leading generic formulations manufacturer and China has emerged as leading low-cost raw material (such as KSMs and intermediates) provider.

Some of the key resembling factors of the two countries pharmaceutical markets which made primary choice for global drug companies to source raw materials and formulations or to outsourcing their contract research and/or manufacturing work are their technical capabilities, ability to observe global regulatory standards and to provide relatively low-cost services and/or products as compared to those of regulated markets.

Although there exists few resemblances as mentioned above, a large number of differences between these two countries exist in various factors of which primary ones are presented below: Pharma Bio World

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Factor of Government support: India

China •

•

The Chinese government has been providing various

The support from Indian government towards the industry in terms of providing incentives has remained inadequate

incentives and sops to the industry such as subsidised

especially towards bulk drug manufacturing companies.

debt, tax and duty breaks on capital equipment.

•

The corporate tax rate in China is about 25%.

•

The corporate tax rate in India is about 30%.

•

The financial institutions lending interest rates in

•

The banks and financial institutions lending interest rates in India was about 10-12%.

China was about 4-5%.

•

•

As per World Banks Ease of Doing business rankings

report in 2018 amongst 190 countries, India is

report in 2019 amongst 190 countries, China is

ranked 77 th.

ranked 46 . th

•

As per World Banks Ease of Doing business rankings

•

Chinese government for considerable period of time

First of all to set up an industrial unit in India the land has to be acquired from Government for a consideration and

has been offering industrial land to the industrial

it does not have uniform policy to acquire land, adding to

enterprises without any consideration in return or

above woe is the complex process and time-consuming

imposed time limit for its usage. This significantly

nature has overall led to increase in the project cost thus

reduces project cost for both greenfield and brownfield

lowering the returns on investment.

projects and improves returns on investment.

Following charts illustrates the comparison of various parameters in terms of ease of doing business Dealing with construction permits

Registering the property 69.1

155.1

94.8

23.7 23.7

Time (days)

11.1

Building Cost (% of warehouse quality control value) index (0-15)

India

China

India

4.6

8.7 8.7

Quality of land

Procedures (Number)

5.4 2.9

8.3

Cost (% of property value)

14

9 Time (days)

20.4 17.9

3.6

Procedures (Number)

9

30)

Starting business

China

Source: A world bank group flagship report on Doing Business 2019.

16 ◄ May 2019

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Factors effecting operational efficiency: China

India

•

In China the government has developed and nurtured the SEZ with fiscal and tax incentives. Further the SEZ area in China are large sprawling thousands of hectare each. And many of these parks derive operational synergy with common effluent treatment plants, R&D infrastructure, data storage platforms, etc. The above factors helps in deriving the benefits for larger economies of scale thus improving the operational efficiency immensely.

•

The Indian government although has approved about 420 SEZ parks and out of which 14 SEZ parks are dedicated to pharmaceutical industry, the area of these parks remain very limited with average size of about 300 hectare which is about 1% of the average of Chinese SEZs.

•

The average labour cost in China during last decade has increased gradually and the same was about $240-$250 per head during FY-18.

•

•

China although may have competent information technology infrastructure, the language barrier forms a growth inhibiting factor to some extent. It is being reported that due to lack of adequate communication skills, the companies had to pay dear price.

•

The average labour cost in India during last decade has increased gradually, however, the same has remained relatively low at about $240-$250 per head during FY-18.

In terms of better infrastructure in information technology, India has its advantageous position with many IT companies providing services such as data centers, data management, bioinformatics and clinical trials. Further the Indian pharma market’s business culture is proximate to regulated counterparts especially USA, UK, Europe, etc, which provides favorable avenue for Indian companies to congenially negotiate and strike the deals effectively.

•

China has abundant natural resources for manufacturing of basic chemicals, key starting materials and intermediates, which contributed about 50% of their chemical sector.

•

The India’s focus on the manufacturing of basic chemicals had been weak, which account to about 30% of the chemical sector thus leading to dependency on China for procuring the same.

•

China contributes about 80% of the about 2,000 APIs manufactured across the globe, on accord of which it is recognised as the world’s largest API producer.

•

On the contrary, Indian API producer manufacture only about 400 APIs.

Conclusion From the above deliberations it can be ascertained that in majority of the parameters, Chinese bulk drug industry outweighs due to various factors such as government support in the form of incentives and subsidies, sprawling industrial parks with necessary facilities, benefits derived by their enterprises due to large economies of scale, etc. Indian bulk drug industry on the contrary lags 18 ◄ May 2019

in most of the factors especially from government support front. As per World Bank report on ease of doing business, India has jumped 23 positions, ie, from 100 th position as per report in 2018 to 77 th position as per report in 2019.

Nevertheless, the Indian government have to synchronize to provide ease of approval process by way of singlewindow clearance, incentivise the critical API’s, provide conducive regulatory environment, encourage capacity

additions and to set-up and promote R&D investment with various sops, lest the headwinds can detrimentally effect on the performance of bulk industry, thus in turn affecting the formulations industry. Apart from above if the chronic problems are not addressed, the sequel consequences can also create a concern for nation’s security.

Pharma Bio World

Good Clinical Practices: Challenges and the Road Ahead Clinical trials are emerging as an important activity in India as it is an essential component of the drug discovery and development program to which India is committed. The only robust way to evaluate a new medicine is by doing properly designed clinical trials. This article depicts clinical research scenario in India and historical perspective on Good Clinical Practices, challenges and future of clinical research in India.

hai arsana Partner ifesciences and Healthcare and the Corporate M&A and PE eam haitan & Co.

Pai ain Senior Associate ifesciences and Healthcare and the Corporate M&A and PE eam haitan & Co Pharma Bio World

I

ndia has a robust platform and an equal potential to contribute meaningfully towards the global clinical research and drug development. India presents an attractive platform with a vast population and patient-pool, minimal research costs and quality skill sets in the form of medical practitioners. However, despite the previously targeted growth projections and expansion reports, growth of Indian clinical research has not materialised due to several challenges. he past two decades have seen the rise and fall of clinical trials in India. he Indian clinical trial market grew by 20.3 per cent compound annual growth rate (CAGR) between 2005 and 2010 and decreased by - 14.6 per cent CAGR between 2010 and 2013 1. he slowdown in the clinical trial market was a result of the unprecedented regulatory framework, slow regulatory approval process, unwarranted and negative media coverage along with activist engagement, lack of awareness in the public and recuperative initiatives.

serious adverse events 2. On the other hand, compliance with Indian GCP guidelines are only recommended and does not have a statutory status.

Indian Clinical rial raewor

he genesis of GCP surfaces from the aftermath of World War II, when the importance of protecting participants in clinical research was recognised and the first code addressing the ethical conduct of biomedical research, the uremburg Code, 1947 was released. In fact, the Declaration of Helsinki was developed using principles of the uremburg Code and the Declaration of Geneva. GCP is now considered the international ethical and quality standard for the design, recording, performance, monitoring, auditing, recording, conduct and reporting of clinical trials that involve participation of human subjects. 3 Internationally, the International Conference on Harmonization (ICH) GCP guideline is being revised to keep pace with the scale and complexity of clinical trials. he primary responsibility of maintaining GCP

he Indian clinical trial set-up is mainly governed by: (a) regulations of Schedule Y along with rules 122A, 122, 122D, 122DA, 122DAC and 122E of the Drugs and Cosmetics Act, 1940 (D&C Act); (b) the Ethical Guidelines for iomedical Research on Human Subjects prescribed by the Indian Council of Medical Research; and (c) the Indian Good Clinical Practice (GCP) guidelines. Per law, it is mandatory that all clinical research that falls under the ambit of Schedule Y complies with the necessary requirements, which inter -alia comprises of formats for clinical trial protocols, informed consent forms, responsibilities of the sponsors, investigators and monitors, templates for independent ethics committee (IEC) approval and format for reporting of

GCP Genesis GCP is a standard for clinical studies or trials that encompasses the design, conduct, monitoring, termination, audit, analyses, reporting and documentation of the studies. It ensures that the studies are implemented and reported in such a manner that there is public assurance that the data from clinical trials is credible, accurate and that the rights, integrity and confidentiality of the subjects are protected. he guidelines seek to establish two cardinal principles: (i) protection of the rights of human subjects; and (ii) authenticity of biomedical data generated. he Indian GCP guidelines have been prescribed by the Central Drugs Standard Control Organisation (CDSCO).

May 2019 ► 19

lies on the sponsors, clinical investigators, ethics committees, institutional review boards, contract research organizations, monitors etc.

Regulatory Concerns and Changes Currently, to conduct a clinical trial in India one needs: (a) permission of the Drugs Controller General, India and permission of the new drug advisory committees consisting of sector experts; (b) approval from ethics committee; and (c) mandatory registration on the ICMR maintained website www.ctri.in.

Following the judgment of the Supreme Court in Swasthya Adhikaar Manch 4 and in response to the 59 th report of the Parliamentary Standing Committee, the Indian regulators passed several amendments to Schedule Y of the D&C Act, many of which lead to immediate fall out of pharmaceutical industry sponsored clinical trials. While mandatory registration of clinical research organisations 5 is a welcome change, the other amendments like structure of the ethics committee, tougher site selection process, audio video recording of informed consent process and the reporting deadlines for serious adverse events were taken as adverse.

Amongst the various steps being taken by the government to give an impetus to the clinical trial industry after the slowdown in 2010-2013, the government has brought a fresh slew of reforms including: (a) CDSCO's recently launched new tool (called SUGAM) for online applications as part of efforts to increase accountability, transparency, and efficiency of processing applications with speed 6; (b) taking away the restriction of only 3 trials per principal investigator; and (c) removing the restriction of minimum 50 bedded hospital requirement for conducting clinical trials, which now can instead be decided by the ethics committee.

20 â—„ May 2019

Some of the issues faced by this industry, which if dealt, with will lead to greater protection and participation under a clinical trial, include providing protection to, and ensuring a fair treatment for, the clinical trial subjects, particularly, the vulnerable class such as illiterate and poor people and fair compensation and insurance structure.

Differences between ICH-GCP and Indian GCP Indian GCP is largely based on the ICH-GCP, has certain areas stricter than the ICH-GCP and endorses all the internationally endorsed principles.

Certain Indian GCP requirements are more progressive and stringent as compared to those formulated at the international level, for example registration of IEC 7, clinical trials with the registry and usage of language to encourage participants diverse cultural and economic backgrounds 8.

Conclusion Good clinical practices are important for quality products, safety of patients and also general good health of the industry.

Although, lot needs to be done, with the recent amendments and progressive changes to the conduct of clinical trial process, the government is taking the right steps in promoting and encouraging clinical trials in India. India is primarily known for its generics capability and with the right changes, India has the capability, and can do well, as a drug innovator also.

2. G o g t a y N J , R a v i R , T h a t t e U M .

Regulatory requirements for clinical trials in India: What academicians need to know. Indian J Anaesth 2017;61:192-9.

3. G o o d C l i n i c a l P r a c t i c e R e s e a r c h Guidelines Reviewed, Emphasis Given to Responsibilities of Investigators: Second Article in a Series. Journal of Oncology Practice. 2008;4(5):233235. doi:10.1200/JOP.0854601.

4. Swasthya Adhikar Manch And Anr. v Union of India (UOI) and Others (WP(C)No. 33/2012 with WP(C)No. 79/2012) 5. B a b u G . C e n t r e r e l e a s e s d r a f t rule for chedule Y-1 mandating registration of CROs? Pharmabiz.com, Mumbai. 2009. Jul 11. Available from: http://pharmabiz.com/NewsDetails. aspx?aid=51414&sid=2 .

6. Notice by CDSCO; 05 October 2016 (CDSCO/IT/2015-(48)). Available from: http://www.cdsco.nic.in/writereaddata/ notice%20-dated05-10-2016.pdf.

7. B u r t T , S h a r m a P , D h i l l o n S , Manchanda M, Mittal S, Trehan N. Clinical Research Environment in India: Challenges and Proposed Solutions. Journal of clinical research & bioethics. 2014;5(6):1-8. doi:10.4172/2155-9627.1000201.

8. P a n d e y A , A g g a r w a l A R , M a u l i k M, Gupta J, Juneja A, et al. The upgraded Clinical Trials Registry India: a summary of changes. Indian J Med Ethics. 2011;8:186

References 1. B u r t T , S h a r m a P , D h i l l o n S , Manchanda M, Mittal S, Trehan N. Clinical Research Environment in India: Challenges and Proposed Solutions. Journal of clinical research & bioethics. 2014;5(6):1-8. doi:10.4172/2155-9627.1000201.

Contact:titas.dutta@perfectrelations.com

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Contract Manufacturing Organizations: Navigating Serialization Implementation This article looks at the importance of getting serialization right for Contract Manufacturing Organizations (CMOs).

I

n recent years the pharmaceutical industry has seen a significant change to the way its manufacturers and supply chains operate, due to the establishment of several serialization and track and trace regulations mandated globally.

The prominent driving force behind such regulations is the issue of counterfeit medications and supply chain diversion.

It is estimated that in the developed world around 1 per cent of all medications sold are counterfeit. In developing countries that percentage rises as far as 30 per cent 1. Governments around the world have recognised the severity of this issue, and as a result are beginning to put in place several major serialization regulations.

Deadlines for implementation in key markets such as the US and EU are close, while in countries such as Turkey, Brazil and Argentina, regulations have been commonplace for many years now.

In Europe, the Falsified Medicine Directive (FMD) was published in February 2016 and gives the industry three years to comply from that date.

In the US, the Drug Supply Chain Security Act (DSCSA) has three key deadlines; lot-level management was already established in January 2015, item-level serialization on each individual single product will be required by November 2017, and by 2023 electric pedigree and full aggregation of products throughout the supply will be mandated.

Challenges of Implementing Serialization Regulations for CMOs

Arthur Smith Vertical Marketing Manager Videojet Technologies Pharma Bio World

For Contract Manufacturing Organizations (CMOs) the process of implementing

serialization is complicated, mainly due to the lack of certainty among their customer base as to their requirements.

This can cause delays for the CMOs and pose a real concern now that deadlines are approaching.

For CMOs there are two key considerations to address when implementing serialization into existing packaging lines; understanding what is required from them as a company and also understanding what their customers need. Furthermore, CMOs need to understand what markets their customers sell in, be it globally or locally, as regulatory requirements can differ.

Similar to traditional manufacturing operations, CMOs must also be conscious of the fact that, as they implement more complex processes to their packaging lines, the Overall Equipment Efficiency (OEE) of their systems may be negatively affected.

It is important to understand that good preparation, the right equipment and a focus on operator training can significantly reduce the negative impacts on operations.

Ensuring that code formatting is correct and lead times on key equipment are accounted for are other important factors to overcoming challenges.

Operational Framework Undertaking a serialization programme requires a comprehensive understanding of the stages of implementation. The typical framework for implementing a serialization programme consists of six phases.

• • The initial phase involves defining the strategy, identifying what needs to be done in terms of serialization, which stakeholders need to be involved and what the goals of implementation are.

May 2019 â–ş 21

•• Once the strategy has been established, an organization must undertake an indepth analysis of each system, as well as the IT infrastructure, and identify what needs to be replaced and what new systems are required. At this point, stakeholders and others involved in the project going forward should also commence the training process.

•• Next follows the design phase; based on a clear definition of what needs to be achieved the contract manufacturer starts to design the solution, examining the hardware and process facets, as well as the IT and qualification, testing and validation features. Now is the time to start preparing what is called the organizational change management identifying how the program affects how people work within the company. This is vital, as serialization implementation will impact both processes at the manufacturing line and also at the warehouse stage when it comes to shipping and receiving goods.

•• The forth phase involves the building of the solution based on individual, well defined user requirements. Changing and testing of the individual equipment commences and customers start to look at how the systems will be integrated from an IT point of view.

•• The penultimate phase is where the final solution is built and the project goes live.

•• The final phase involves dealing with issues which arise as a result of the implementation, such as temporary reduction of efficiency on the packaging line, and also measuring whether the benefits of implementation are being realized once the process is underway.

If an organization engages in a structured framework of serialization implementation there is an opportunity to create real business value from a programme.

22 ◄ May 2019

Preferred Equipment

Conclusion

As packaging standards continue to grow in complexity due to regulatory developments, both manufacturers and contract manufacturers are faced with the challenge of how to gain a return on the investments they make in their packaging lines. Improperly selected printer technologies can seriously impede the speed and productivity of packaging lines, which can have a detrimental effect on profit margins. Selecting the correct printing technology from a dependable supplier is one of the most important considerations manufacturers need to make when implementing a serialization program.

Serialization and trace and trace regulations are becoming commonplace within the pharmaceutical packaging industry, and interpreting how to implement serialization practices within existing packaging lines does not come without its challenges for manufacturers across the board. However, understanding how to structure a serialization programme, being conscious of key regulatory deadlines and understanding customer requirements are keys to success for CMOs in the pharmaceutical industry.

Along with regulatory factors, the need for high resolution printing and printer cleanliness have also been driving forces behind the innovation of existing and new printing technologies in recent years.

Consequently, packaging engineers now have a varied selection of printing technologies from which to pick, the most popular being Thermal Inkjet (TIJ) and Laser.

Finding a partner who is able to support that process from start to finish has significant benefits, as the smoother the transition, the less downtime will be experienced. Having the backing of a global service network is something to be mindful of, as is finding a partner who has significant experience in implementing serialization solutions and the structure in place to deliver to requirements - from a single coding unit to a turnkey project.

TIJ coding and marking systems are inkbased, non-contact printers generally used to print traceability information, including 2D DataMatrix codes, onto commonly used packaging. The printer uses small resistors to propel ink drops onto packaging as it passes by the printhead. This system is used for high-resolution printing, utilizing heat and surface tension to move ink onto a package surface.

Laser printing systems use a beam of infrared light focused and steered with a series of carefully controlled small mirrors to create marks where the heat of the beam interacts with the packaging surface. Laser marking can be used to print 2D bar codes as well as human readable codes.

Contact : itan@abipr.com

Pharma Bio World

Pharma 4.0 – Impact of IIoT in Pharmaceutical Manufacturing

W

ith the growing number of medical ailments across the globe, the pharmaceutical industry will undoubtedly become more important than ever in the near future. There is a paradigm shift from the mass production of drugs to offering more customized and specialized drugs to a smaller group of patients and this is greatly expected to improve the effectiveness of treatments.

The Pharma 4.0 initiative is expected to not only address productivity issues but also provide the industry with smarter tools that can help ensure drug safety.

Everyday factory equipment, people, and processes are thus getting increasingly smarter with the advent of digitization.

The introduction of digitization in pharmaceutical manufacturing will also be instrumental in enabling a seamless data exchange across the pharmaceutical supply chain. The connectivity of product, people and process is what constitutes the Industrial Internet of Things (IIoT).

Manufacturing will undoubtedly be the biggest beneficiary of IIoT. Thus, industries such as pharma and healthcare will certainly stand a good chance to continue to benefit from IIoT. Analyticsenabled data management vis-Ă -vis traditional paper-centric approaches will come a long way in being crucial enablers for important management decisions. The pharmaceutical industry should consider making investments in IIoT technologies, most of which are already mature in other industries and have proven effective in improving the efficiency of complex manufacturing operations. Leveraging lessons from this should help companies improve their financial and operational performances.

integrating the different manufacturing departments that are otherwise not adequately connected. IIoT technologies will enable manufacturers gain a 360-degree view of their plant operations with the ability to drill down to any level of detail at any stage of product development. This essentially would mean that data would be made available at just a tap of the screen. Manufacturing companies will transform from being small local hubs to global market places with the introduction of IIoT. The pharmaceutical industry has been among the forerunners in adopting these digital technologies that can help improve process efficiencies, reduce efforts, and increase profits. Within the industry there has always been an impetus to manage manufacturing processes more effectively.

However, the pharmaceutical industry faces several challenges in being one of the most regulated manufacturing industries. The industry demands a good understanding of manufacturing processes and strict adherence to stringent regulatory standards that guide these processes. Due to regulatory

compliance issues in this sector, it has become mandatory for companies in the pharma industry to implement digital technologies. As is the case with any other industry, pharmaceutical manufacturing is faced with challenges, such as the need to enhance product quality, improve process efficiencies, reduce cycle times, reduce scrap and rework, track products, ensure adherence to regulatory guidelines, reduce downtime, and connect the supply chain among several others. This wall of challenges will however crumble eventually, thanks to the advancing benefits of digitization.

With emerging benefits of industrial IoT and its increased applications in manufacturing, the dynamics of the industry is changing considerably. All information about machines, people, and materials involved in pharmaceutical manufacturing is required to be recorded according to mandatory requirements set down by government agencies such as the Food and Drug Administration (FDA). There is also an increasing demand for real-time reporting within the industry and IIoT plays a crucial role

Digital technologies have thus become a quintessential component of the manufacturing industry in automating operations, streamlining processes, and

Pharma Bio World

May 2019 â–ş 23

in making the requisite data available.

Connectivity ensures management and monitoring of manufacturing operations on the factory floor. Digital initiatives can by large provide a strong foundation for initiatives, such as Industry 4.0 to take over factory management. Manufacturers will be required to constantly upgrade their digital systems until such time when Industry 4.0 can be implemented in a fullfledged manner.

Factory machines may already be connected and controlled by systems such as Supervisory Control and Data Acquisition (SCADA) or Manufacturing Execution Systems (MES) or even Distributed Control systems (DCS).

Industrial IoT is an added perk that brings along with it the power of data and computational prowess. This could now imply bringing in the power of analytics to generate valuable insights that can help oversee plant workflows and track and maintain machine activities much ahead of a breakdown. The benefits of IIoT in pharma manufacturing will pretty much be the same as is the case with several other industry verticals. The 24 â—„ May 2019

distinguishing advantage, however, could be in the fact that IIoT can go a long way in helping pharma manufacturers ensure a proper documentation during production for compliance reasons. Industry 4.0 could also help steer the pharma industry towards a paperless environment with lesser human intervention involved. This could involve terabytes of data being stored and processed on the cloud, as traditional methods of data storage get completely phased out. Introduction of IIoT in pharma would also mean making a fundamental shift towards outcome-based targeted therapies characterised by a more individualized production method.

Pharma is also an industry that has extremely sensitive storage conditions.

The manufactured products typically are of high value and have a short storage life.

They also mostly need to be stored under prescribed storage temperatures, which cannot be monitored if not for critical components of IIoT such as sensors and connectivity. IIoT has become an integral part of manufacturing and therefore it is only natural that the pharma industry should look to adopting it at the earliest.

This would involve manufacturing companies taking important decisions such as phasing out legacy systems and transforming business models.

IIoT plays an important role in the continuous monitoring of connected factory equipment and personnel. This real-time tracking of equipment can help improve effectiveness of factory processes by enabling informed decisions through data resultant of connectivity.

The other important benefit of IIoT in pharma manufacturing is the modular automation of pharma production plants, which enables a faster time-to-market for pharma products.

The IIoT may be at its nascent stages of development, but its impact on pharmaceutical manufacturing is certainly indisputable. Only those market participants able to see the potential gains and start taking those small baby steps will be the ones who will eventually be able to reap benefits from IIoT.

Article courtesy: Frost & Sullivan 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 May 2019 ► 25

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 26 ◄ May 2019

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INSIGHT INTO THE PHARMACEUTICAL AND BIOTECH INDUSTRIES

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

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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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May 2019 ► 27

research

Can Indian traditional medicinal systems show the way forward?

Indian traditional codified medicinal systems and folk medicine are a vast lexicon of herbal formulations and medicinal plants. In last few decades, the popularity of herbal medicine/ products has increased worldwide, not only as part of conventional treatment strategies but also for health care management, and thus the opportunity to promote Indian traditional medicine is increasing globally. Recently people from several developed and developing countries have been attracted toward traditional Indian herbal medicines. A large number of modern medicines are derived from the plants used in Ayurveda and other traditional medicinal systems.

Ayurveda and other traditional herbal medicines are capable of addressing some modern unmet medical needs, and can provide the basis for developing potential medicines. Lack of drug standardization, information, quality control, and strict monitoring are the primary lacunae in the promotion of traditional Indian herbal products. In recent years several regulatory and promotional approaches have been undertaken to overcome such problems. Quality control, rigorous research to establish the effectiveness and safety, and credible clinical trials of the herbal products are required. Thus, the careful and scientific integration of Indian traditional herbal medicine into evidence-based clinical management of diseases is essential to provide better health care facilities to people.

I

ndia, a rich chest of biodiversity, has a large diversity of plant species. India consists of 2.4% of the total geographical area of the world, but accounts for 8% of global biodiversity, with around 49,000 plant species of which 5,150 species are endemic. 1–3 The Himalayan range, Western Ghats, North-Eastern Indian hills (Khasi and Mizo hills), and Vindhya and Satpura ranges of the northern peninsula of India are the gold mine of higher plant species.

Herbal medicine has special importance in the society, culture, and traditional medicine of India. 1 Plant-based medicines are at the root of the modern health care system, and are acknowledged for their economic importance also. 4 Traditional medicinal knowledge and plants play a central role in biological research and drug development.

Herbal products or constituents are not only used directly as curative agents, but also as lead molecule in the discovery of new drugs. Current research and understanding suggest that the use of crude herbs or herbal products can confer real benefits on health when used long-term. 2,5 Increasing population and the incidence of side effects 28 ◄ May 2019

of synthetic medicines also accelerate the popularity of alternative medicines. The World Health Organization acknowledged that the goal of ‘Health For All’ cannot be accomplished without herbal medicines.

In a wider context, demand for medicinal plants, herbal medicines, health products, pharmaceuticals, food supplements, cosmetics, etc is growing in all parts of the world, which indicates the popularity and belief of people in herbal medicines. This in turn has created great scope for India to utilize its traditional knowledge of herbal medicine and repository of medicinal plants in the service of the world population and for the economic growth of India. 2,6,7

such systems to prepare curative agents, but use of plants have been the basis of treatment in these systems. It is estimated that Ayurveda uses 1,200 species of plants, while Siddha and Unani include 900 and 700 species of plants, respectively, in their medicinal preparations. 11 Ayurveda and other ISMs are judicious combinations of modern science and contemporary clinical medicine, which have the potential to cure a number of diseases in better ways and leverage new leads for modern medicine. 12 Currently, more that 1.5 million traditional medical practitioners in India are using medicinal plants for preventive, promotional, and curative purposes. 13

Indian systems of medicine Concepts and practices of different traditional medicinal systems in India are about several thousand years old. A large proportion of the Indian population still believes in and receives traditional medical care, which is based on the principles of three ancient codified Indian systems of medicine (ISMs): Ayurveda, Siddha, and Unani. 8–10 Though different chemicals, minerals, and animal products are used in

Ayurveda, perhaps the most ancient (6000 BC) of the different organized traditional medicinal systems, is native to the Indian subcontinent and has been practiced since the beginning of the Indian civilization. It can be described as the ‘science of life’, accounting for an integrated observation of the mental, physical, spiritual, and social facets of human beings. 14,15 Preventive and curative measures are the key components of the Ayurvedic system.

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research Major treatment approaches include the use of ‘aushadhi’ (drugs); ‘anna’ (diet); and ‘vihara’, which includes exercises and a healthy mode of life. 14–16 The Charak Samhita, Sushrut Samhita, and Samhitas of Vagbhat, together referred to as the Brihattrayee, are considered the three key classics in Ayurveda. Charak Samhita and Sushrut Samhita(100–500 BC) describe over 700 plants, along with their detailed classification, pharmacological, and therapeutic characteristics. 12,17 In the pre-Vedic period (approx. 3000 BC2000 BC), the Siddha system of medicine originated in the southern part of India, 18 ‘siddhas’ (ancient practitioners of Siddha medicine) are believed to have developed this system which are written in Tamil and mainly practiced in Tamil Nadu. 14,18 The Siddha medicinal system recognizes three humoural concepts: ‘vata’ (wind), ‘pitta’ (bile), and ‘kapha’ (phlegm). Examination of the pulse, urine, and different anatomical features like the tongue, voice, complexion, eyes, touch (to find dry, warm, cold, sweating condition), and stools are commonly used as diagnostic criteria in Siddha medicine. 16,18,19 The basics of the Unani system of medicine were laid by Hippocrates and later by Galen. In the eleventh century, the Unani system was introduced in India by Arabs and Persians. The fundamental theory of the Unani system is ‘humoral theory’, which presupposes the presence of four humors – blood, phlegm, yellow bile, and black bile – in the body, and for Unani practitioners diagnosis mainly depends on pulse reading, and examination of the urine and stools. 20,21 The main therapeutic approaches in this system include dietotherapy, or ‘Ilaj-bighiza’ (use of specific diet); regimental therapy, or ‘Ilaj-bil-tadbeer’ (exercise, change of climate, massage, venesection, leaching, cupping); pharmacotherapy, or ‘Ilaj-bi-dawa’ (use of medicines from herbal, mineral, and animal sources); and surgery, or ‘Ilaj-Bil-Yad’. 20–22 Folk medicine (also known as ‘tribal’ or ‘indigenous’ medicine) also plays an important role in Indian society, mostly in rural/indigenous/ethnic communities.

This type of knowledge is usually passed verbally from ancestors of the particular group of people without any written script.

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It has been estimated that more than 8,000 species of plants are used by the tribal and ethnic communities in India as part of their healthcare systems. 7,23 Approximately 25,000 effective plant-based formulations are used in folk medicine and are commonly used by rural and ethnic communities in India. 13

medicinal systems believe in a holistic approach, and are considered as ancient forms of system-biology-based medicine.

Diagnosis and treatment strategies provide more individualized methods. ISMs have a very complex and logical approach to diagnosis, which are based on rational observation, and use a number of potent herbal preparations. They thus have become an important target of medical research.

Importance of herbal medicine Herbal medicines are truly in a league of their own, and have stood the test of time until now. But unfortunately the utilization of herbal medicine for the management of diseases is less despite of its potential. A large number of ethnic and rural people use and stoically play a crucial role in protecting the ancient medicinal knowledge related to plants from fading away into oblivion.

Herbal medicine is due for a revival.

However, incorporating herbal medicine into the true mainstream of modern health care and ensuring modern safety and efficacy standards is not an easy task.

A key area for the popularity of herbal products is nutritional supplements. Herbal supplements afford nutrients that are lacking or not consumed in an adequate quantity through the diet. Herbal supplements may contain vitamins, minerals, macronutrients, and antioxidants, etc, which are essential for good health. Thus, the demand of several Indian formulations – like chyawanprash, musli pak, and ashwagandhadi lehyam – is increasing. 27 Figure.1 shows the strategy for advancement and integration of traditional herbal medicine into modern medicine.

In India, about 65% of the population mainly uses traditional medicine for their health care needs. Inequities in the accessibility, availability, and affordability of modern healthcare make herbal drugs more popular in rural and remote areas .24,25 Demand for traditional medicine in developed countries is also increasing. About 40%–50% people in Germany, 42% in the USA, 48% in Australia, and 49% in France are using traditional medicine. In the twenty-first century, herbal drugs and products from plant sources are increasingly being acknowledged in developed countries and also among the people who can afford costlier allopathic medicines, with the hope of a more ecofriendly, bio-friendly, and relatively safer treatment strategy. 4,24,25 Among the 49,000 plants of the Indian subcontinent, about 20% are global species. It was estimated that more than 3,500 higher and lower plant species have medicinal value, although only 500 species of medicinal plants are used by the Ayurvedic industry. 1,2 Several reports have suggested that almost 80% of drug molecules are of natural origin or inspired by natural origin. It has been estimated that almost 50% of drugs approved since the 1990s are based on natural products. 26 Undoubtedly, a lot of plants contain substances of medicinal value which have yet to be discovered. Indian traditional

Present scenario and future Review of different national pharmacopeia reveals that at least 120 distinct chemical products/moieties from herbal sources have been utilized as lifesaving drugs.

It is predicted that among the estimated 250,000-400,000 plant species of world only 6% have been screened systematically for their biological activity and 15% have been investigated phytochemically. 28 It is predictable that natural compounds and their derivatives comprise nearly 60% of all drugs in clinical use and medicinal plants contribute not less than 25%. Between 1981 to 2002, around 119 drugs were approved and of those around 60% of anticancer and 75% anti-infective drugs could be related to natural substances. 29 Thirteen natural products were approved as drugs between 2005 and 2007. Currently, more than 100 natural products (drugs) are in clinical trials and about 100 molecules or compounds are in the preclinical phase of drug discovery. 30 Several bioactive molecules from plants, especially from those used in Ayurveda, have been discovered, such as reserpine for high blood pressure, psoralens for vitiligo, alkaloids from Holarrhena antidysenterica (L.) against amebiasis, Mucuna pruriens for Parkinson’s disease, piperidines as bioavailability enhancers, vasicine and vasicinone as bronchodilators, May 2019 ► 29

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research Cultivation, cell culture, and use of other scientific approaches to save endangered species

integration and advancement of indian herbal medicine Record of unpublished folk information

Gathering of scientific evidence

Indian traditional herbal medicine

Identify potential plant species Pharmacological screening of plant extract or fraction

Traditional herbal formulation

Biological activity

Marketed herbal formulation

in ISMs have the potential to become the drugs of the future. Indian herbal medicine could meet some modern unmet medical needs, provide basic health care needs, and can offer the basis for developing potential medicines. Increase in the demand and utilization of herbal products provides fertile ground for the revival of Indian herbal medicine. 34

Role of Indian organizations Phytochemicals from ISMs, particularly from Isolation and characterization Ayurveda, are beginning to attract interest of active molecule Preclinical study across the world and huge efforts have toxicological profile been initiated to include traditional herbal Preclinical trial medicine in modern medicine. India has enormous facilities for research; the Central Semisynthetic/synthetic molecule Clinical study Clinical trial Drug Research Institute (CDRI), Council of Scientific and Industrial Research (CSIR), Promoting the drug Structural modification Central Institute of Medicinal and Aromatic New drug molecule (internationally) Plants, National Botanical Research Figure 1 Strategy for advancement and integration of traditional herbal medicine intoofmodern medicine.

Figure 1 Strategy for advancement and integration traditional herbal medicine into modern medicine. Institute, Regional Research Laboratories, and National Chemical Laboratory are hydroxycitric acid for obesity, bacosides especially Ayurveda, around the world is playing vital roles in this regard. Several accessibility, availability, affordability of modern health A key forbeing the popularity herbal products is nutrigovernment and nongovernmental to treat and mental retention, picrosides as mainly duearea to its a holisticofapproach 32 organizations hepatoprotective agents, phyllanthins to treatment.

Ayurveda, a well-written care make herbal drugs more popular in rural and remote tional supplements. Herbal supplements afford nutrients from different countries have actively started researching on plants and infections, andinwithanolides and medical text, describes scientific traditional medicine developed counareas.24,25 Demandforforviral that are lacked or not consumed in anview adequate quantity 28 formulations steroidal lactones as immunomodulators. on diseases and treatment that makes it tries is also increasing. About 40%–50% people in Germany, through the diet. Herbal supplements may contain vitamins,described in Ayurveda.

Current scientific knowledge along with unique. Currently, Ayurveda is included 42% in the USA, 48% in Australia, and 49% in France are minerals, macronutrients, and antioxidants, etc, which better clinical observation would help to in the Indian national health care system. Indian traditional medicinal plants in using traditional explore medicine.Indian In the traditional twenty-firstmedicine century, herbal are essential for good demand of several preclinical and clinical trial in an Several countries, like health. the UK,Thus, the the United drugs and products from plant sources are increasingly being Indian formulations – like chyawanprash, musli pak, and acceptance of Ayurveda is increasing advanced way and utilize old molecules for Arab Emirates, Sweden, Indonesia, and Global 27 demand therapeutic applications. instance, USA have acknowledged the Ayurvedic acknowledged innew developed countries and alsoFor among the the Figureand 1 shows thefor medicinal plants from India ashwagandhadi lehyam – is increasing.

35 is in upsurge. is currently acknowledged system andandmore than of 30traditional strategycare for advancement integration herbal In recent years, a number people who can forskolin afford costlier allopathic medicines, as witha health potent adenylate cyclase activator and countries are modern on the medicine. verge of doing the of drugs from ISMs have undergone clinical the hope of a more eco-friendly, bio-friendly, and relatively medicine into 33 antimicrobial berberine alkaloids are used to same.

It has been estimated that almost trials to verify their efficacy. Products safer treatment strategy.4,24,25 Among the 49,000 plants of cure dyslipidemia. 26,31 A typical, systematic two-thirds of people in the USA use one or from Ayurveda have been successfully the Indian subcontinent, 20% to arefind global It more Present scenario andstrategies, future of evaluated in clinical trials for the treatment research about on plants newspecies. bioactive alternative treatment Reviewmost of different pharmacopeia that at asthma, rheumatoid arthritis, was estimated that more thanis 3,500 higher and plant which of bronchial molecules expensive and lower inefficient. are drugsnational from herbal sources. revels least demand 120 distinct chemical products/moieties from herbal species have medicinal value, species of The heart disease, and cancer, among The high cost although of and theonly time500 taken for this for dietary supplements and ischemic 1,2 of the other illnesses. 28,38–41 Indian medicinal arethethe main hurdles.

One medicines is high in the US drugs. and It sources have been utilized as lifesaving is predicted medicinal plants process are used by Ayurvedic industry.

Several traditional herbs (eg, of ashwagandha, guggulu, haridra, most important approaches in themolecules discovery thus more than 1,500 herbals are sold for plant that among the estimated 250,000-400,000 species reports have suggested that almost 80% of drug 31 kutki, shatavari, of a new drug would be recourse to the such proposes.

A survey in 2007 revealed are of natural origin or inspired by natural origin. It has been world only 6% have been screened systematically for their atmaupta, amruta, brahmi, information accessible in traditional Indian that more than 200,000 American adults guduchi, amla, and ginger) and complex been investigated phyestimated that almost 50% of drugs approved since 1994 biological activity and 15% have medicinal systems, which are based on the have used Ayurvedic medicine. 34 Ayurveda herbal formulations (rasagenthi lehyam, 26 28 tochemically.

Undoubtedly, lot medicinal of plants is It is predictable natural compounds are based on natural products. brahma and rasayana, semecarpus lehyam, proven therapeutic utility of athe gaining momentum as a that successful contain substances of medicinal their derivatives comprise nearly 60% of all drugs in clinitriphala, and other rasayanas) were plants of India. 12 value which have yet to be alternative to the conventional medicinal evaluated through preclinical studies and through its systematic strategy not of less discovered. Indian traditional medicinal systems believe in system cal use and medicinal plants contribute than 25%.

33,42,43 reported to Indian herbal medicine makes numerous curing and preventing diseases using natural a holistic approach, and are considered as ancient forms of Between 1981 to 2002, around 119 drugs were approved and possess positive effect.

35 The US National Center for Complementary medicalmedicine. claims Diagnosis for the and treatment of resources.

Increased and and misuse system-biology-based treatment of those around 60% of use anticancer 75% anti-infective Alternative Medicine has funded many acute and chronic diseases and of current allopathic medicines provides and strategies provide more individualized methods. ISMs have drugs could be related to natural substances.29 Thirteen symptoms, the prevention of disease, enthusiasm for integrating alternative several research works based on Ayurvedic a very complex and approach to diagnosis, are medicine natural products approved as drugs between 2005 and 36 medicine – for example, on the use of andlogical the improvement of qualitywhich of life. and were conventional medicine. based on rationalHerbal observation, and use potent Ayurvedic 2007. Currently, than confers 100 natural products (drugs) are in cardiovascular diseases, a curcuminoids medicines alsoa number contain ofdifferent herbal more medicine benefits herbal preparations, thus have becomethat an important in 75% clinical trials and about 100 molecules compounds chemical constituents could act target singly to of the sub-continental population of orcompound from M. pruriens (L.) used against or synergistically. The advancement and 1,000 and millions of others around the 30side effects of anti-Parkinson’s drugs, of medical research. are in million the preclinical phase of drug discovery.

Several success of Indian traditional medicine, the world. 37 Herbal therapies or plants used the use of three plants (ginger, turmeric, Botanics: Targets and Therapy 2015:5

30 ◄ May 2019

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research and Boswellia) to cure arthritis and asthma, and to validate the effect of Centella asiatica (L.) against Alzheimer’s disease. 34 Potent vaccine adjuvant activities of Withania somnifera (L.) and Asparagus racemosus wild have been evaluated in experimental systems, which suggest their importance in immunobiological preparations.

Controlled clinical trials are essential to establish the effects of drug and to compare the potency of traditional medicines with allopathic medicines. Clinical trials on Indian traditional medicines are encouraging but warrant many more. For instance, ‘piperine’, a bio-enhancer from pipali, has been successfully evaluated in clinical studies; a multicenter study found that Vijayasar (aqueous decoction of Pterocarpus marsupium Roxb) was effective as a hypoglycemic and antidiabetic drug; a US patent has been approved for the development of a herbal anti-psoriatic medicine containing Argemone mexicana (L.); the CDRI developed a product containing fraction of gugulipid from Commiphora wightii for the treatment of hyperlipidemia and atherosclerosis. Boswellia serrata Roxb gum resin has been commercialized by Regional Research Laboratories (Jammu) as a nonsteroidal anti-inflammatory drug, which also demonstrates hypolipidemic effect.2 8,44–47 A double-blinded clinical trial has been carried out with “arogyawardhini” (an Ayurvedic product containing amla, bahera, harar, guggulu, kutki, neem, chitrak mool) in viral hepatitis, while effects of M. pruriens, Phyllanthus amarus, and Tinospora cordifolia have been investigated in the treatment of Parkinson’s disease, hepatitis, and obstructive jaundice, respectively.48 The CSIR and CDRI have developed a bacoside-enriched standardized extract of plant brahmi (Bacopa monnieri L.) used to enhance memory and learning; the product is already marketed in Asian and European countries under different brand names.

Brahmi is described in the Charak Samhita and Sushruta Samhita, and has been used as a brain tonic for 3,000 years. 49 Traditional medicinal formulations containing plants A clinical trial of a well-known classical Pharma Bio World

Ayurvedic formulation, ‘triphala’, which is prepared by combining the fruits (without seeds) of Terminalia chebula Retz, Terminalia bellerica Roxb, and Emblica officinalis Gaertn, showed potent effects against constipation and other gastric problems.50 A standardized formulation prepared with purified extract of ashwagandha (W. somnifera), guggulu (B. serrata), and haldi (Curcuma longa) was effective in improving a joint-swelling condition and has a good safely profile when given to people suffering from rheumatoid arthritis. 39 Another classical example of herbal formulation is `prostalyn’, which contain two traditional Indian medicinal plants (Murraya koeniggi and Tribulus terrestris) and used to treat benign prostate hyperplasia. A short-term clinical trial demonstrated that ‘tarika’, an Ayurvedic pimple remover herbal powder (containing T. chebula fruit, T. bellerica fruit, Santalum album heartwood powder, Curcuma aromatic rhizome, Embelia ribes fruit, Berberis aristata dried stem, Acorus calamus rhizome, Embelia officinalis fruit, Taxus baccata leaf, Myristica officinalis fruit endosperm, and Cyperus rotundus rhizome) has good effect in patients suffering from moderate to severe degrees of acne vulgaris. 52 ‘Guduchyadi ghrita medhya rasayana’, an Ayurvedic formulation containing several Indian medicinal plants like guduchi, apamarga, vidanga, shankhapushpi, vacha, haritaki, kushtha, and shatavari has showed promising effects in clinical trials by improving the mental health, memory, stress, and depression conditions, which might be helpful in slowing down the aging process.53 ‘Amalki rasayana’, an Ayurvedic herbal product, has showed promising effects in patients suffering from age-related macular degeneration. 54 A number of traditional plant-based formulations have been developed by the CSIR. Some of these are α, β arteether (E-mal – which was included in India’s National Malaria Control Programme) and elubaquine (Aablaquin) as antimalarial drugs; Asmon to cure asthma; Sallaki of B. serrata to treat rheumatoid arthritis and osteoarthritis; Livzon poly-herbal formulation, which has been evaluated as a hepatoprotective agent; and immines, a multi-herbal drug to cure immune-modulatory activity. 55 A number of Siddha herbal formulations like Gly Cyn Neu ointment against diabetic neuropathic

symptoms, combination of amukkara choornam and linga chenduram, and two other poly-herbal (for internal and external use) formulations against rheumatoid arthritis have also undergone successful clinical trials. 56–58 Since the Vedic period, ISMs have been enriched with a number of herbal drugs to cure jaundice and viral hepatitis. It has been estimated that more than 6,000 commercial herbal medicines are used worldwide for the management of liver disorders, and among them nearly 40% patents are for poly-herbal formulations (including silymarin from Silybum marianum L. Gaertn seed, Picrorhiza kurroa Royle ex Benth extract, and extracts of plants of different Phyllanthus sp. and glycyrrhizin preparation) consisting of different combinations of 93 Indian herbs, which are widely available in the Indian market. 48 Several patented and proprietary herbal medicines, like Arishtas, Churnas, Rasayanas, Ghrits, and Ras, have been marketed in the form of modern medicines such as tablets, capsules, powders, syrups, ointments, or even as gels. According to a survey, more than 70% of all drugs sold as Ayurvedic medicine in the Indian market are branded editions – patented and proprietary medicines.12 The Traditional Knowledge Digital Library (TKDL) is a unique approach by the Government of India to compile and preserve traditional medicinal knowledge and is in the public domain. Currently, a number of botanicals are undergoing clinical trial using reverse pharmacology processes to find new drugs to cure/prevent hepatotoxicity, viral hepatitis, cancer, diabetes, and arthritis based on the traditional knowledge of India. 12 Herbal medicines and medicinal plants described in ISMs, including folk medicine, have emerged as a great source of new drugs.

Potent phytochemicals from Indian medicinal plants Turmeric (C. longa) is a classical Indian medicinal herb recognized for its great clinical utility by ISMs. It is used in the treatment of pain, wounds, and sprains, as well as skin, pulmonary, gastrointestinal tract (GIT), and liver disorders. ‘Curcumin’, the bioactive component of turmeric, has emerged as a potential therapeutic molecule against Alzheimer’s disease, different malignant May 2019 ► 31

research diseases, diabetes, allergies, and arthritis, among other disorders. 59,60 Rauwolfia serpentina L. (sarpagandha), an ancient medicinal plant of India, is used to treat hypertension, mental disturbance, insomnia, gastrointestinal disorders, epilepsy, anxiety, and schizophrenia. The plant is also used to cure several hypertension-related problems like headache, dizziness, amenorrhea, oligomenorrhea, and dysmenorrhea in Siddha medicine.61,62 In the beginning of 1930, R. serpentina was investigated for its tranquilizing and sedative effects. In 1949, Indian cardiologist Rustom Jal Vakil reported a hypotensive effect of its root extracts, which attracted the interest of researchers.

The alkaloids ajmaline (an antiarrhythmic agent) and reserpine were isolated from sarpagandha root in 1931 and 1952, respectively.63 The discovery of reserpine was a breakthrough for the treatment of hypertension and psychotic disorders, though this drug is seldom used now.48 B. monnieri is a potent medicinal herb of Ayurveda used to cure epilepsy, asthma, ulcers, tumors, and inflammation, among other things. Subsequent investigations led to the discovery of bacosides. 51,64 A labdane diterpene, ‘forskolin’ was isolated from the root of Indian medicinal herb Coleus forskohlii (makandi). Forskolin has a potent and direct adenylate cyclase activating property and could be a potent molecule to treat congestive cardiomyopathy, glaucoma, and asthma.

Clinical studies of forskolin to manage obesity and weight are ongoing. A number of semi-synthetic derivatives of forskolin have been developed and have been approved for several clinical studies. 65,66 ‘Flavopiridol’ and ‘P-276-00’ are the novel semi-synthetic derivatives of an alkaloid (rohitukine) isolated from Amoora rohituka (Roxb) Wight and Arn. and Dysoxylum binectariferum (Hook.f.), and are in advanced stages of clinical trials as anticancer drugs. 67,68 The anti-inflammatory, anticancer, anti-fertility, anti-implantation, and immunomodulatory activities of rohitukine have also been investigated. ‘Dysobinin’, a compound from D. binectariferum fruits, has exhibited potent central nervous system depressant and mild anti-inflammatory effects. 69 Both the plants (A. rohituka and D. binectariferum) have been used by physicians of ISMs for a number of disorders related to the liver and 32 ◄ May 2019

spleen enlargement and inflammation. 69,70 ‘Diosgenin’ is a major bioactive steroidal sapogenin isolated from several traditional medicinal plants including Trigonella foenumgraecum L. and Dioscorea spp. These plants are commonly used in Ayurvedic and Siddha formulations. Dioscorea bulbifera L. (varahi) is used to treat dysuria, urinary calculus, urine disorders, calculus, and trauma, while T. foenum-graecum (methi) is used against pain, facial palsy, abdominal problems, hernia, and neurological disorders. 71,72 Catharanthus roseus L. (nityakalyani) has a long history in ISMs as a diuretic, antidysenteric, hemorrhagic, and antidiabetic drug.

Two alkaloids, vinblastine and vincristine, have been isolated from Catharanthus roseus leaves and recognized as anticancer agents for variety of cancers such as lymphocytic lymphoma, Hodgkin’s disease, testicular carcinoma, and choriocarcinoma.

Vincristine is used in acute leukemia, lymphosarcoma, and Wilms’ tumor. 73 Guggulsterone was discovered from the gum resin (guggulu) of Commiphora mukul.

Guggulu is an important constituent of Ayurvedic medicine used to cure several disorders like obesity, bone fractures, arthritis, inflammation, and cardiovascular disease. 74 The CDRI has successfully completed clinical trials of gugulipid as a lipid-lowering agent, and marketed it in the form of tablets and granules .50 ‘Darakchasava’, an ancient Indian herbal preparation containing grape (Vitis vinifera L.) extracts, is used as a cardio tonic and for the treatment of other disorders. Analysis of darakchasava indicated the presence of resveratrol and pterostilbene. Resveratrol was isolated in 1940 from Veratrum grandiflorum, and is also found in grapes, berries, and peanuts. Resveratrol has been found to possess cardioprotective and anticancer effects. 74 W. somnifera L., a medicinal plant described in Ayurveda, is known to possess antiinflammatory, cardioactive, and central nervous system boosting properties.

Withanolides, which is extracted from W. somnifera and used in Ayurvedic medicine to cure arthritis and menstrual disorders, has been found to be an inhibitor of angiogenesis, inflammation, tumor development, and oxidative stress, as well as a promoter of

cardioprotection. 74 The gum resin of salai guggul (B. serrata) is used in Ayurveda to cure rheumatic diseases and respiratory and liver disorders. Several researchers have discovered the active biomolecule of this resin to be boswellic acid. Boswellic acid and its derivatives have emerged as future anticancer agents. 74,75 The chemical investigation of a few Ayurvedic antiarthritic drugs has led to the discovery of synthetic anti-inflammatory drug molecules like phenylbutazone, indomethacin, and corticosteroids. 28 Indian medicinal plants have been found to be a source of many different modern bioactive agents; for example, quinine from Cinchona spp., pilocarpine from Pilocarpus jaborandi, atropine from Atropa belladonna L., cocaine from Erythroxylum coca Lam., morphine and codeine from Papaver somniferum L., cardiac glycosides from Digitalis spp., artemisinin from Artemisia annua L., paclitaxel from Taxus baccata L. and Taxus brevifolia L., berberine from Berberis spp., pristimerin from Celastrus paniculatus Willd., quassinoids from Ailanthus spp., plumbagin from Plumbago indica L., allicin from Allium sativum L., emetine from Cephaelis ipecacuanha (Brot.)

L.Andersson, glycyrrhizin from Glycyrrhiza glabra L., nimbidin from Azadirachta indica A. Juss., catechin from Acacia catechu Willd., sophoradin from Sophora subprostrata, thevenerin and neriifolin from Thevetia spp., podophyllin from Podophyllum emodi, homoharringtonine from Cephalotaxus, camptothecin from Camptotheca acuminata. 73 Challenges The National Medicinal Plants Board, India, estimated about 77% of the medicinal plants used in the country for several traditional medicinal formulations are from forests and wastelands. The International Union for Conservation of Nature Species Survival Commission estimated that there are 19 extinct, 43 extinct/endangered, 149 endangered, 108 vulnerable, and 256 rare plant species in India. 4 Thus, reducing overexploitation, stopping deforestation, cultivating medicinal plant, and using cell cultures and other scientific methods are required to protect the medicinal plants.

Further, the incidence of biopiracy is a major Pharma Bio World

research impediment to the advancement of Indian herbal medicine. A survey by a TKDL task force based on 4,896 references revealed that 90 medicinal plants were listed in the US Patent and Trademark Office database, and about 80% of references were related to seven medicinal plants (kumari, mustaka, tamraparna, garjara, atasi, jambira, and kharbuja) of Indian origin. The task force also revealed that 360 of 762 patents were based on medicinal plants that could be classified as ‘traditional’. 76 This indicates the potential of Indian traditional knowledge and herbal drugs to address a large number of ailments in the future.

The primary lacunae with Ayurvedic and other traditional herbal products are the lack of drug standardization, information, quality control, and strict monitoring. 73 About 13 Asian herbal products have been found to contain a number of contaminants.

A study has found that among 260 Asian patented medicines, about 25% contained heavy metals beyond the limit, while undeclared drugs to increase therapeutic efficacy were found in 7% of those medicines. A large number of Ayurvedic formulations are available in spurious, adulterated, or misbranded forms, and several preparations do not follow the traditional proper rules or texts on how to prepare such formulations. 28,77 A report on Ayurvedic medicine has found that about 20% of such medicines purchased through the internet contained high levels of lead, mercury, and arsenic. Recently, the US Food and Drug Administration found that several herbal supplements contained currently available drugs like lovastatin (e.g, Mevacor), sildenafil (e.g, Viagra), estrogen, alprazolam (e.g, Xanax), indomethacin (e.g, Indocin), and warfarin (e.g, Coumadin) as adulterants.34,78 Herbal manufacturers from India usually follow World Health Organization guidelines for quality control, but the adulteration of formulations remains a major concern for both the domestic and export markets of Indian herbal products. 28,77 The majority of Ayurvedic formulations contain crude extracts in mixtures of different ingredients. Some studies have showed that the active principles of such products fail to produce the desired effects Pharma Bio World

when isolated individually. This may due to the synergistic activity of several components present in a formulation. In the absence of pharmacopoeial data on such herbal formulations, it is difficult to isolate or standardize the active components.

Currently, the Ayurvedic Pharmacopeia has been compiled on modern lines and is updated often as per requirement. 73 Quality control and drug–herb interaction are other drawbacks. Several herbal products can interact with food, allopathic drugs, or pharmaceuticals, but unfortunately, for the majority of products, such information is lacking. In general, after 1 year of collection, herbs lose their medicinal value; powders prepared from such herbs remain effective for nearly 6 months, while pastes or ointments are effective for 1 year.77 Several herbs may be responsible for serious adverse effects – for example, creosote bush causes hepatotoxicity, ephedra may be responsible for cardiovascular complications and hepatotoxicity, and kava may also induce hepatotoxicity. Several manufacturers do not follow the appropriate methods of preparation and do not use the proper parts of the plant, which may be responsible for toxicity – as in the case of kava-induced toxicity.79 This situation needs to be addressed properly for the growth of Indian herbal medicine.

In the last 30 years ISMs, especially Ayurveda, have become remarkably popular in European countries; it has been estimated that over 5 million European people have used such traditional medicine in the last few decades. Due to the popularity of traditional medicine, thousands of under-/non-qualified traditional medicinal practitioners/institutions have emerged in Europe, which has led to a serious situation. 37 In the last decade, the European Union demanded bibliographic evidence and preclinical safety data before the marketing of traditional medicinal products.

Thus, proper standardization, research and data on the products’ quantitative and qualitative particulars of constituents, methods of manufacturing, therapeutic uses, contraindications, toxicity profiles, posology, forms, and routes of administration are essential for the promotion of Indian traditional medicine in Europe. 80 In Europe, due to some legal problems, the future of

Ayurvedic medicine is in the dark, and this requires urgent attention.81 A recent survey has concluded that Ayurveda has the potential to satisfy the needs of therapists and patients, despite differences of opinion in Europe.82 Herbal medicine and Indian economy Markets for medicinal plants and herbal medicine are lucrative and important for economic growth of India. Several pharmacopoeias have included a number of important herbs and herbal products.

For instance, the Ayurvedic Pharmacopoeia of India included monographs for 258 Ayurvedic drugs, the Indian Pharmacopoeia 2010 incorporated 89 monographs for herbs and herbal products, while the Indian Herbal Pharmacopoeia 2002, published by the Indian Drug Manufacturers Association, included 52 monographs on widely used medicinal plants of India. 4,28 Domestic trade of the ayurveda, yoga, naturopathy, unani, siddha, and homeopathy (AYUSH) industry is about INR 80 – 90 billion. Exports of medicinal plants and their products from India are about INR 10 billion. In 2010, the production of herbal drugs in India was about INR 4,000 crores, with 1,650 herbal formulations.4 The global trade of herbal products has crossed US$100 billion and is expected to reach to US$7 trillion by 2050. 83 In spite of the vast potential, the Indian share of this trade is at present quite low.

About 500 plant species are used in Chinese medicine, whereas more than 7,000 species are used in ISMs. China’s global share of medicinal plant exports is about 28%, while India’s share is only 8.13%. India ranked second in medicinal plant exports after China in 2009. 4 A report from the Associated Chambers of Commerce and Industry of India estimated that the value of the herbal industry was about INR 7,500 crores in 2010 and that its value would reach INR 30,000 crores by 2030. 85 India’s share in export of AYUSH products has shown an average increase of 10% per year over the past 5 yrs. Globally, the demand for Indian herbs and herbal medicines is increasing. Growth of about 11% annually in the export of herbs and herbal medicines to the European Union has been noted for the past 5 years. 83 It has been estimated that about 880 medicinal plants are involved in Indian trade. Of these, 42 species are imported and 48 species are May 2019 ► 33

research exported.85 European countries hold the greatest share of the total herbal market (45%), followed by ASEAN (19%), Japan (16%), and North America (11%).86 Some of the important medicinal plants/products of India are E. officinalis Gaertn, isabgol (psyllium husk), the leaves and pods of senna, the leaves and powder of henna, myrobalans, jojoba seed, gymnema powder, and garcenia. 4,86 Traditional Indian medicinal knowledge and the diversity of plants in India are well recognized and therefore urgent attention is required to use this knowledge nationally and internationally.

Future aspects and India’s position Currently, the paradigm of medicine has shifted from not only curing clinical diseases but also maintaining good health. Today, medicines are available not only for treating illnesses but also for enhancing quality of life and health more broadly. 87 Thus, the integration of traditional herbal medicine into the modern health care system is the need of the time. The inclusion of traditional herbal medicine in modern health care offers a large benefit to society: it tenders reciprocal advantages to each system, improves the knowledge of general health care, increases the number and quality of practitioners, endorses the dissemination of primary health care knowledge, and is also helpful in providing basic health care to people in all parts of society. 78 However, several fundamental problems – like basic differences between different medicinal systems, differences in the concept of spiritualism, fear of the harmful effects of traditional preparations, and decline in the quality due to lack of regulation and standardization – are associated with this. 88 The increasing use of herbal traditional therapies like Ayurveda has to be supported with more systematic and sound scientific evidence vis-à-vis the therapies and the effectiveness of the medicines. 28 The promotion and globalization of Indian traditional herbal medicine requires a more realistic and strong approach to overcome the difficulties. China has effectively modernized its approaches by introducing government-sponsored proactive agricultural policies and good manufacturing practices for traditional medicine. Similar integrated strategies are essential for the growth of Ayurveda, 34 ◄ May 2019

Siddha, and Unani medicines globally. The Government of India has started several drug testing laboratories and upgraded several existing laboratories for ISMs. India has also introduced new regulations since the year 2000 and several approaches like the introduction of good manufacturing practices have been initiated for traditional systems of medicine. These measures have created high hope for fruitful results. A good example is that, after such measures were put in place, a US patent was granted to a poly-herbal formulation (Artrex) for the treatment of arthritis. 28 Current approaches to promote Ayurvedic medicine are in process. The Indian Government formed the Department of AYUSH, which has accountability and authority related to the production, development, quality assurance, and standardization of ISMs. In 2010, the Department of AYUSH modified several rules to facilitate the licensing and export of Ayurvedic herbal medicines under the categories of Ayurvedic cosmeceuticals, Ayurvedic nutraceuticals, and Ayurvedic extracts. Several other Indian organizations, like the Banaras Hindu University, Gujarat Ayurveda University, National Institute of Ayurveda, Institute of Ayurveda and Integrative Medicine, are working on the global promotion of Ayurveda. 35 India has acknowledged the importance of Ayurveda for providing better primary health care to all people and thus Ayurveda was integrated into the Indian national health care system a few years back.33 It has been a useful measure to provide basic health care facilities to all and has proven the effectiveness of Ayurveda for public healthcare to a certain extent.

A recent status report released by the Ministry of AYUSH on Indian medicine and folk healing highlighted the health-seeking activities of consumers and the existing policy of the government on the integration and globalization of Ayurveda, Unani and Siddha medicine.

In the 21st century, medical tourism emerged as a key approach to attract people toward herbal medicine and to promote international business. With globalization,

patients have the opportunity to seek better treatment strategies across the globe. In several countries, including Japan, USA, UK, and European nations, the number of elderly people has increased rapidly since life expectancy has increased progressively, which has resulted in increased demand for natural health care strategies. 90,91 India has the ability to deliver such strategies. It was estimated that about 1.27 million medical tourists from several countries around the globe, such as UK, USA, Canada, China, Bangladesh, and Sri Lanka, visit India with the hope of better, safer traditional herbal medicinal treatment. It has been estimated that foreign-exchange earnings for this are nearly US$ 4 billion and the market will grow to around US$ 10 billion by 2020. 91 These figures clearly indicate the benefit and acceptance of Ayurveda and other Indian medical systems around the world. The potential of ISMs would increase manifold if it is integrated into the modern health care system. Medical tourism also presents the opportunity to boost the country’s economic conditions and will encourage more and more Indians as well toward its ancient and effective traditional herbal medicinal systems. 91 The Materia Medica of India contains 2,000 drugs of natural origin along with their therapeutic utilities, which are derived from traditional systems of medicine.

Among these, 400 are from mineral and animal sources, and the rest are from plant sources. 92 The TKDL contains information regarding 500 Ayurveda, 500 Unani, and 200 Siddha formulations and also includes information about 291 plants that are used as ingredients in different traditional formulations. 76 There are plenty of opportunities to develop new products or formulations based on the therapeutic potential of Ayurvedic medicinal plants and getting them accepted as dietary supplements, nutraceuticals, prescription drugs and over-the-counter medicines. 24 In India, a lot of public and private hospitals as well as private dispensaries are providing treatment based on Ayurveda and other ISMs. These approaches are showing inspiring results and have attracted the attention of people globally especially with reference to public healthcare. For centuries, herbal medicine has been acknowledged as having safer drugs and Pharma Bio World

research more compatibility with physiological flora.

Indian traditional medicine provides the scientific basis and process of utilizing medicinal plants to cure several ailments.

In combination with modern science, technologies and approaches, Indian herbal products/medicinal plants can provide basic and advanced medical care around the world.

Conclusion Indian traditional herbal medicine is prevalent around the globe and a large number of people have integrated them along with moden medicine for their different health needs. In spite of their popularity, the rational design, proper standardization, and careful monitoring of Indian traditional herbal formulations and botanicals, along with robust scientific evidence, are essential for their promotion.

Indian traditional herbal medicine can cause a global shift in healthcare if it is promoted based on the parameters of modern evidence-based medicine.

Thus, the identification of resources and finding of molecular mechanisms are essential, as it could be a resource for new medicine. Current research has shown the potentiality of Indian medicinal plants in drug discovery, though a lot of plants have not been studied and need to be investigated. The careful and scientific integration of herbal medicines from ISMs into the modern system is essential in safeguarding the interests of the Indian people and to provide better health care facilities for all.

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(Saikat Sen & Raja Chakraborty, Institute of Pharmacy, Assam Down Town University, India.)

May 2019 ► 37

marketing initiatives

Accurate Flow Control for Cancer Research

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n basic cancer research, the main aim is to unravel differences between normal cells and cancer cells in order to exploit these differences in the hunt for specific cancer vulnerabilities, so that ways can be found to attack cancer cells while leaving normal cells unaffected.

Application Requirements A dedicated incubator needs to be established that houses the living cells and that ‘keeps them alive’ under conditions that resemble the various oxygen tensions and other conditions encountered in the human body, while being able to be observed by the microscope.

Since living cells reveal much more information than dead ones, at the reputed Cancer Institute advanced microscopy techniques are used to extract information about proteins and their interactions in single living cancer cells. To investigate these living cells in their ‘natural habitat’, they have asked to deliver devices for supplying water vapour and gases such as nitrogen, oxygen and carbon-dioxide to mimic the conditions in our body.

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Flow scheme

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oxygen content are especially relevant, as solid tumours are well-known to be hypoxic, ie, they contain less than a few percentage of oxygen - and this completely alters the physiology of the cells, as well as their response to anti-cancer drugs.

All experiments conducted under these controlled conditions showed consistent results.

An Artifact of the relatively high operational temperature of 37°C was that the DMEM medium, a salt solution used for supporting the growth of the living cells, evaporated rather fast. To replenish the evaporated water from the medium, a μ-FLOWmass flow controller for liquids was used to supply a very stable flow of deionised water.

Combined with a local BRIGHT controller with PiPS (Plug-in Power Supply), the μ-FLOW device supplied a controlled water flow between 0.5 and 9.6 micro-litres per minute.

Empirically, the Cancer Institute found that a value of 1.3 μl/min completely compensated for evaporation. Since then, they have been capable of keeping cells alive for weeks while observing them by microscopy. Using this configuration, the relative humidity was kept below 60 per cent, which was necessary to avoid condensation that might damage the sensitive electronics in the setup.

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For details contact: Toshniwal Hyvac Pvt Ltd 267 Kilpauk Garden Road Chennai 600 010 E-mail: sales@toshniwal.net 38 ◄ May 2019

Pharma Bio World

press release Takeda Announced Andrey Potapov as ICMEA Area Head New Delhi, India: Global biopharmaceutical company Takeda has announced Andrey Potapov as its Area Head for India, CIS (the Commonwealth of Independent States), the Middle East including Turkey, and Africa (ICMEA).

Potapov’s appointment has been followed Takeda’s recent acquisition of Shire Pharmaceuticals – enabling Takeda to become a global, value-based, R&D-driven biopharmaceutical leader headquartered in Japan. Potapov will be instrumental in guiding the successful integration of Takeda and Shire under the Takeda brand, reinforcing the company’s leadership position across its global footprint while strengthening its research and developmentdriven pharmaceutical operations.

The acquisition and subsequent integration will see Takeda evolve its operational focus from the NEMEA region (Near East, Middle East and Africa) to ICMEA (India, CIS, Middle East including Turkey, and Africa). The move will reduce complexity within the organization, while increasing agility and moving Takeda closer to the patients it serves.

Handling the reigns from Takeda’s Dubai hub, Potapov will spearhead Takeda’s continued growth across the region, while upholding the organization’s unwavering commitment to serving patients and its long-held reputation as an employer of choice. Potapov will work closely with Taka Horii, the outgoing NEMEA Area Head for Takeda, to maintain his success to date. Since Horii’s appointment in 2018, the outgoing Area Head has helped define a successful operating model for the area, focusing on key business priorities such as portfolio optimization, Specialty Care product launches, and talent development. Taka will now transition to a new role as General Manager for the Middle East.

“Now is a great time to be heading up Takeda’s regional operations as we look ahead to the integration of Shire into our business and the many opportunities this will bring to better serve patients,” commented Andrey Potapov. “In this role, putting people first will remain a key principle of mine because the success of our company is determined by our employees, above all else. Ultimately, success for Takeda is reflected in the wellbeing of patients and fair access to the most effective treatments. I am committed to seeing that Takeda continues to ensure both of these outcomes,” he added.

In his most recent role as General Manager of Takeda Russia and Head of the CIS Area, Potapov oversaw the successful launch of new pharmaceutical products, while delivering above market profit growth for the past five years. He spent over 15 years of his career at Nycomed, which was acquired by Takeda in 2011. During his time with Nycomed, Potapov held various positions, from Finance Pharma Bio World

Manager at the company’s Novosibirsk office to Finance Director of the Russia and CIS region. He was promoted to Vice President and Chief Financial Officer of Russia-CIS in 2007, before taking up the role of Country Manager of Nycomed Russia in 2011.

Start-up Ecosystem Promotion Initiative by NASSCOM and GE Healthcare Collaboration Noida, India: National Association of Software and Services Companies (NASSCOM) through its Center of Excellence-Internet of Things (CoEIoT), announced a strategic partnership with GE Healthcare at the 5th edition of Life Sciences & Healthcare Innovation Forum (LHIF).

This partnership is intended to promote the start-up ecosystem in the country, and to bring the digital healthcare solutions to the market.

Technology adoption in the Indian healthcare sector is poised for substantial growth, as it continues to emerge as a game changer in the Healthcare Service Delivery. From operation to services, Healthtech as a sector has shown major advancements and continues to showcase the growth. The industry has been rapidly adopting new-age technologies such as the Internet of Things (IoT) and Artificial Intelligence (AI) to improve access and outcomes. The healthtech sector is committed to connect doctors and patients, providing low-cost medical devices along with tech-enabled diagnostics.

NASSCOM CoE-IoT is India’s largest deep-tech Innovation hub for start-ups, which provides a platform for collaborative innovation. This strategic partnership will help GE Healthcare to tap the flourishing healthtech start-up ecosystem in the country to co-create solutions for real-world healthcare challenges in the areas of digital applications for early detection, productivity solutions, and remote and connected care among others. It will also help the two partners work with policymakers in the Government/Administration, to shape policies around digital health.

Speaking on the occasion, Ms. Debjani Ghosh (President, NASSCOM) stated, “The future of healthcare is shaping up in front of our eyes mainly through digital technologies, such as the Internet of things, artificial intelligence, VR/AR, 3D-printing, robotics or nanotechnology.

In medicine and healthcare, digital technology can help to transform unsustainable healthcare systems into sustainable ones, to equalize the relationship between medical professionals and patients, and to provide cheaper-faster-and-more-effective solutions for diseases.”

Sharing his thoughts, Dileep Mangsuli, Chief Technology Officer, GE Healthcare South Asia said, “Digital solutions help drive access to better quality healthcare, to significantly reduce cost of treatment, and to improve the quality of health outcomes. We are committed to drive digital adoption in India; but we know that we can’t do it alone. We need an ecosystem of partners with whom we can work to supplement the work already underway at our research centers. This partnership with NASSCOM CoE-IoT will help us bring to market solutions that improve people’s life.”

This LHIF innovation conclave is focused at discussing means and methods for enhanced digital propulsion that will improve healthcare delivery. It is expected to significantly reduce the cost of treatment while improving the quality of offerings.

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press release Glenmark launched novel, globallyresearched anti-diabetes drug Remogliflozin in India Mumbai, India: Glenmark Pharmaceuticals Ltd. (Glenmark) – a research-led global integrated pharmaceutical company – announced the launch of its novel, patent protected, and globallyresearched sodium glucose co-transporter-2 (SGLT2) inhibitor Remogliflozin etabonate (Remogliflozin) in India. The drug is indicated in the treatment of Type-2 Diabetes Mellitus in adults.

SGLT2 inhibitors are novel anti-diabetic drugs that help in achieving glycemic control by acting on the SGLT2 receptors in the proximal tubule of the kidney, thereby preventing renal reabsorption of glucose and promoting excretion of glucose in the urine. SGLT2 drugs provide glycemic control, induce weight loss, and reduce cardiovascular risks.

Glenmark is the first company in the world to launch the novel SGLT2 inhibitor Remogliflozin; and India is the first country to get access to this innovative drug. Glenmark will commercialize Remogliflozin in India under the brand names “Remo” and “Remozen”.

The company received regulatory approval for Remogliflozin etabonate 100 mg tablets, twice daily, after successfully completing Phase-3 clinical trials in which Remogliflozin demonstrated good efficacy and safety profile in a head-to-head comparison against Dapagliflozin.

Remogliflozin, the latest drug in SGLT2 inhibitors’ class to get regulatory approval in the world, has gone through 26 clinical trials across the globe, covering around 2,500 people from various ethnicities.

Remogliflozin was discovered and developed by Japanese firm Kissei Pharmaceutical Co. Ltd. and later developed by GlaxoSmithKline plc and Glenmark collaborator BHV Pharma, a wholly owned subsidiary of Avolynt, Inc. which is based in North Carolina, USA. Glenmark secured certain rights to Remogliflozin through a licensing collaboration agreement with BHV Pharma, and conducted the Phase-3 clinical trial.

“Globally, SGLT2 inhibitors are emerging as a preferred treatment for management of type-2 diabetes and Glenmark is proud to introduce a novel molecule in this class, which is cutting-edge and researched extensively. Diabetes is a key area of focus for Glenmark and with the launch of Remogliflozin, the company aims to improve access to SGLT2 inhibitors by providing an effective, high quality, and world-class treatment option to patients in India,” said Sujesh Vasudevan, President, India Formulations, Middle East and Africa at Glenmark Pharmaceuticals.

The American Diabetes Association and the European Association for the Study of Diabetes have recommended use of SGLT2 inhibitors as an alternative first line treatment to Metformin or as an adjunctive treatment in the management of Type-2 Diabetes Mellitus. SGLT2 40 ◄ May 2019

inhibitors are particularly recommended for use in patients that have certain established cardiovascular diseases.

India is estimated to have around 72 million adults living with diabetes, according to the International Diabetes Federation’s Diabetes Atlas 2017.1 According to data from IQVIA, India’s diabetes market is estimated at ` 11,413 crore (approx. USD 1630mn) as of MAT March 2019. The market size of SGLT2 inhibitors is estimated at ` 574 crore (approx.

USD 82mn) as of MAT March 2019.

Glenmark appointed Dr. Yasir Rawjee as CEO of Glenmark Life Sciences Mumbai, India: Glenmark Pharmaceuticals Ltd, a research-led global integrated pharmaceutical company, has announced that it has appointed Dr. Yasir Rawjee as the Chief Executive Officer of Glenmark Life Sciences Ltd, its subsidiary for the API (Active Pharmaceuticals Ingredients) business.

Dr. Yasir joined Glenmark Life Sciences from Mylan Inc where, most recently, he was the Head of Global API Operations. He held the positions of increasing responsibility at Mylan including Senior Vice President of API Technical Operations, and Senior Vice President and Head for Sales and Marketing for the API Business. He started his career with SmithKline Beecham Pharmaceuticals by being based in the USA; and was associated with GlaxoSmithKline and Matrix Laboratories Ltd. previously. He has had over 25 years of experience in the pharmaceutical industry. Academically, he holds a Ph.D. in Chemistry from Texas A&M University, USA; and a B.Sc.(Tech.) from UDCT Mumbai, India.

Glenmark’s API business has witnessed robust growth rate of 15 percent CAGR over the last 5 years while maintaining its leadership position globally across several molecules. To provide a strategic focus to this business, Glenmark had transferred their API business to a wholly-owned subsidiary Glenmark Life Sciences, earlier this year.

“We see significant growth potential in our API business given the increasing demand for good quality and sustained supply of APIs globally. With this view, we housed our API business into a separate subsidiary, which will be run independently. We are happy that Dr. Yasir Rawjee will now spearhead the API unit and take it to greater heights with his rich experience both in the technical and marketing aspects of the business,” said Glenn Saldanha, Chairman and Managing Director, Glenmark Pharmaceuticals.

“Glenmark Life Sciences has built strong partnerships across the globe and has a very focused approach to further expand the API business. I am pleased to join the organization at a time when I believe I am getting an opportunity to contribute meaningfully in scaling up and shaping the next leg of growth for the API unit,” said Dr. Yasir Rawjee.

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press release Drug Resistant Infections are Now Under UN’s Purview New York, USA: United Nation (UN) has released a groundbreaking report demanding immediate, coordinated, and ambitious action to avert a potentially disastrous drug-resistance crisis.

If no action is taken – warns the UN Ad hoc Interagency Coordinating Group on Antimicrobial Resistance, who released the report – drugresistant diseases could cause 10 million deaths each year by 2050; and catastrophic damage to the economy thus causing 2008-2009 global financial crisis. By 2030, antimicrobial resistance could force up to 24 million people into extreme poverty.

Currently, at least 700,000 people die each year due to drug-resistant diseases, including 230,000 people who die from multidrug-resistant tuberculosis. More and more common diseases, including respiratory tract infections, sexually transmitted infections and urinary tract infections, are untreatable; lifesaving medical procedures are becoming much riskier, and our food systems are increasingly precarious.

The world is already feeling the economic and health consequences, as crucial medicines become ineffective. Without investment from countries in all income brackets, future generations will face the disastrous impacts of uncontrolled antimicrobial resistance.

Recognizing that human, animal, food, and environmental health are closely interconnected, -- the report calls for a coordinated, multisectoral “One Health” approach.

It recommends countries: • To prioritize national action plans to scale-up financing and capacitybuilding efforts; • To put in place stronger regulatory systems and support awareness programs for responsible and prudent use of antimicrobials by human, animal, and plant health professionals; • To invest in ambitious research and development for new technologies to combat antimicrobial resistance; • To urgently phase out the use of critically important antimicrobials as growth promoters in agriculture.

Amina Mohammed, UN Deputy Secretary-General and Co-Chair of the IACG said, “Antimicrobial resistance is one of the greatest threats we face as a global community. This report reflects the depth and scope of the response needed to curb its rise and protect a century of progress in health. It rightly emphasizes that there is no time to wait; I urge all stakeholders to act on its recommendations, to work urgently to protect our people and planet, and to secure a sustainable future for all.”

The recommendations require immediate engagement across sectors, from Governments and the Private Sector, to Civil Society and Academia.

Convened at the request of world leaders after the first ever UN HighLevel Meeting on Antimicrobial Resistance in 2016, the expert group brought together partners across the UN, International organizations, and individuals with expertise across human-animal-and-plant health; as well as the food, animal feed, trade, development, and environment sectors, to formulate a blueprint for the fight against antimicrobial resistance.

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José Graziano da Silva, Director-General of the Food and Agriculture Organization of the United Nations (FAO) said, “The report’s recommendations recognize that antimicrobials are critical to safeguard food production, safety and trade, as well as human and animal health, and it clearly promotes responsible use across sectors. Countries can foster sustainable food systems and farming practices that reduce the risk of antimicrobial resistance by working together to promote viable alternatives to antimicrobial use, as laid out in the report’s recommendations.”

This report reflects a renewed commitment to collaborative action at the global level by the World Food and Agriculture Organization of the UN (FAO), the World Organisation for Animal Health (OIE) and the World Health Organization (WHO).

Dr. Monique Eloit, Director General of the World Organisation for Animal Health (OIE) said, “Antimicrobial resistance must be addressed urgently, through a One Health approach involving bold, long-term commitments from governments and other stakeholders, supported by the international organisations. This report demonstrates the level of commitment and coordination that will be required as we face this global challenge to public health, animal health and welfare, and food security. We must all play our part in ensuring future access to and efficacy of these essential medicines.”

Dr. Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization and Co-Chair of the IACG said, “We are at a critical point in the fight to protect some of our most essential medicines. This report makes concrete recommendations that could save thousands of lives every year.”

The report highlights the need for coordinated and intensive efforts to overcome antimicrobial resistance: a major barrier to the achievement of many of the UN Sustainable Development Goals, including universal health coverage, secure and safe food, sustainable farming systems, and clean water and sanitation.

Dr. Reddy's Laboratories announced Testosterone Gel, 1.62% Launch in the US Market Hyderabad, India and Princeton, NJ, USA : Dr. Reddy’s Laboratories Ltd. has announced the launch of Testosterone Gel 1.62 per cent, a therapeutic equivalent generic version of AndroGel (testosterone gel) 1.62 per cent, approved by the US Food and Drug Administration (USFDA).

The AndroGel (testosterone gel) brand and generic had US sales of approximately 815.6 million USD MAT for the most recent twelve months ending in February 2019 according to IQVIA Health.

Dr. Reddy’s Testosterone Gel 1.62 per cent (20.25 mg/1.25 g pump actuation) is available in a net quantity of 88 g pump which dispenses 20.25 mg of testosterone per actuation. Each metered-dose pump is capable of dispensing 60 metered pump actuations.

May 2019 ► 41

press release Abbott Received WHO Prequalification Approval for Breakthrough HIV Point-ofCare Test Illinois, USA: WHO Prequalification approval allowed Abbott to bring critical technology to more resource-limited settings; confirmed that the m-PIMA HIV-1/2 VL meets global standards of quality, safety, and efficacy.

Abbott announced today that m-PIMA™ HIV-1/2 VL, the world's first point-of-care viral load diagnostic test, has received the World Health Organization's Prequalification Approval (WHO PQ). The test received CE Mark in December 2018. "m-PIMA HIV-1/2 VL is the only truly portable molecular point-of-care test designed specifically for use in resource-limited settings such as in sub-Saharan Africa," said Damian Halloran, Vice President, Infectious Disease – Emerging Markets, Rapid Diagnostics, Abbott. "With WHO PQ, global funders and ministries of health can now confidently expand access to viral load testing, reaching more people who need the test, with the most compact and efficient point-of-care HIV diagnostic platform available anywhere in the world today."

To provide the most effective HIV treatment and care, the WHO recommends that everyone receiving antiretroviral therapy (ART) undergoes a viral load test at 6 months and 12 months, and annually thereafter, if the individual is stable on ART. Viral load testing is the gold standard for monitoring ART treatment failure.

Unfortunately, very few people in resource-limited settings, such as select countries in sub-Saharan Africa, Asia and Latin America, have access to the necessary level of care.

Abbott’s m-PIMA HIV-1/2 VL is a quantitative nucleic acid amplification test for viral load measurement of HIV type 1 groups M/N and O, and HIV-2 in plasma samples. The platform is portable, so it can be brought into the most remote locations. It’s easy to use, deployable at the point of care, and designed to measure viral load in under 70 minutes, while the patient is still present. This allows people to receive results during the same visit and enables immediate treatment decisions, thereby reducing the number of people lost to follow-up. The test’s quick turnaround time is particularly valuable for monitoring the viral load of HIV-positive pregnant women and in cases of suspected HIV treatment failure.

The m-PIMA HIV-1/2 VL is part of Abbott’s comprehensive portfolio of diagnostic solutions for HIV screening, monitoring, and viral load management. From the core lab to the point of care, Abbott provides critical tools to help healthcare providers make informed treatment decisions for people living with HIV.

Glenmark Therapeutics expands Specialty Portfolio with OTIPRIOÒ Mumbai, India: Glenmark Therapeutics Inc., USA, a wholly-owned subsidiary of Glenmark Holding SA., announced a co-promotion agreement with Otonomy Inc, a biopharmaceutical company dedicated 42 ◄ May 2019

to the development of innovative therapeutics for neurotology.

Glenmark Therapeutics is dedicated to developing and commercializing a franchise of branded products for Glenmark Pharmaceuticals and is focused in the areas of respiratory and dermatology.

Ryaltris(olopatadine hydrochloride [665 mcg] and mometasone furoate [25 mcg]), formerly GSP 301 Nasal Spray, is the company’s leading respiratory pipeline asset and currently under review with the US Food and Drug Administration (FDA) as a treatment of seasonal allergic rhinitis in patients 12 years and older. “Ryaltris” has been conditionally accepted by the FDA as the brand name.

This agreement provides Glenmark Therapeutics with an exclusive right to promote OTIPRIO (ciprofloxacin otic suspension) for the treatment of acute otitis externa (AOE) in patients 6 months of age and older due to Pseudomonas aeruginosa and Staphylococcus aureus in ear, nose, and throat specialist offices in the United States and its territories. Financial terms for the multi-year agreement were not disclosed; however, Glenmark Therapeutics will provide Otonomy an annual co-promotion fee and provide reimbursement of a proportion of product support expenses. In addition, Otonomy will retain a share of the adjusted gross profits from the sale of OTIPRIO to Glenmark's accounts. Commercial rights for use of OTIPRIO in other indications, including treatment of bilateral otitis media with effusion in patients 6 months and older who need ear tubes, will remain with Otonomy.

“We are pleased to collaborate with Otonomy on this agreement, which represents an excellent opportunity to fit within our respiratory franchise; and supports our strategy of maintaining commercial emphasis on specialists,” said Robert Matsuk, President North America for Glenmark Therapeutics. He added, “With FDA review of our first New Drug Application for Ryaltris well underway, we remain focused on developing new partnerships that bolster our specialty portfolio and commercial footprint in the US. This agreement is a clear example of Glenmark Therapeutics’ efforts to maximize and grow our presence by pursuing opportunities both through external partnerships and our internal R&D pipeline.”

Cipla received Final Approval for ANDA for Ambrisentan Mumbai, India: Cipla Limited and its subsidiary Cipla USA, Inc., (hereafter referred to as “Cipla”) has announced receipt of final approval for the Abbreviated New Drug Application (ANDA) for Ambrisentan Tablets 5mg & 10mg from the United States Food and Drug Administration (US FDA).

Cipla’s Ambrisentan Tablets 5mg & 10mg are AB-rated generic therapeutic equivalent version of Gilead Sciences, Inc’s Letairis.

Ambrisentan tablet is an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability and delay clinical worsening.

The US Sales of Letairis® Tablets USP stood at $943 million in 2018.

The product is available for shipping immediately.

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press release Sygnature Discovery Announced Collaboration with SilcsBio to Enhance Structure-based Drug Design Nottingham, UK: Sygnature Discovery, a leading independent integrated drug discovery and pre-clinical services company, has announced a collaboration with SilcsBio, a scientific software company focused on high-throughput fully atomistic simulations of protein targets and protein-ligand structures.

SilcsBio has provided Sygnature with access to its SILCS (Site Identification by Ligand Competitive Saturation) and SSFEP (Single Step Free Energy Perturbation) software. Sygnature’s researchers are now able to offer clients the benefits of these powerful techniques in their drug discovery projects.

The SILCS software identifies binding site hot spots on a protein’s surface. This could, potentially, include ‘cryptic pockets’ – binding sites for which little structural information is available. SILCS methodology involves performing molecular dynamics simulations on a protein in an aqueous solution of chemically diverse small molecules. This generates probability distributions of fragment types, termed FragMaps.

These FragMaps can be used rapidly and with minimal computational expense to predict or refine ligand binding poses, quantitatively score ligands in the binding pocket, and generate multiple receptor-based pharmacophore models for use in virtual screening campaigns. This has been shown to be a more effective technique than standard docking studies or receptor-based pharmacophore modelling.

In a complementary manner, the SSFEP software has demonstrated success in ranking compound binding affinities to target proteins. In particular, the SSFEP approach is about 1000-fold faster than the more widely used FEP methodology. It achieves this speed by post-processing molecular dynamics simulation data of a ligand, and using it to estimate the alchemical free energy change of chemically modifying that ligand.

Such a rapid assessment of the drug design team’s ideas could be advantageous in speeding up the design-test-optimise cycle. Being able to evaluate and prioritise design ideas in just a few days can have a significant impact in structure-based design projects.

In the past six months, Sygnature has applied the SilcsBio software suite successfully in various hit-to-lead and lead optimization projects.

The company believes these new software tools will offer substantial benefits to its customers, not least because of the time savings the software can provide.

EXAMPLES OF SILCSBIO’S SOFTWARE SUCCESSES INCLUDE: • Cryptic/transient binding pocket detection in GPCRs, Nuclear receptors & other transmembrane proteins • Revealed previously unknown binding pockets, allowing customers to design more potent ligands • Predicted crystallographic binding modes of customers’ newly designed inhibitors • Provided crucial insights to drive medicinal chemistry refinement of BCL6 inhibitors Pharma Bio World

• 2019 NIH award to fund expansion of SILCS software to enable its use with biological therapeutics, especially for excipient design “We’re delighted to be collaborating with Sygnature Discovery to bring the advantages of our drug design software to Sygnature’s projects and customers. This collaboration is very meaningful to us as Sygnature continues to be a great partner and it opens the door to new markets for SilcsBio”, says Ken Malone, Chief Executive Officer of SilcsBio. “SilcsBio software suite, with its robust physics-based algorithms and user-friendly interface, provides great leverage in the structurebased drug design area and enables us to rapidly validate new ideas/hypothesis” commented Bill Tatsis, Computational Chemist at Sygnature Discovery.

Glenmark Pharmaceuticals received ANDA approval for Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg and 40 mg Mumbai, India: Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) for Esomeprazole Magnesium DelayedRelease Capsules USP, 20 mg and 40 mg, a generic version of Nexium®1 Delayed-Release Capsules, 20 mg and 40 mg, of AstraZeneca Pharmaceuticals LP. According to IQVIATM sales data for the 12 month period ending March 2019, the Nexium Delayed- Release Capsules, 20 mg and 40 mg market2 achieved annual sales of approximately $395.1 million*.

Glenmark’s current portfolio consists of 153 products authorized for distribution in the US marketplace and 58 ANDA’s pending approval with the USFDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.

1 All brand names and trademarks are the property of their respective owners.

2 Market includes brand and all available therapeutic equivalents *IQVIATM National Sales Perspectives: Retail & Non-Retail, March 2019

Biocon Retained Economic Interest in Global Commercialization of Hulio inlicensed by Mylan

Bangalore, India: Following the successful approval and European launch of Hulio, (biosimilar Adalimumab) in- licensed by our partner Mylan from Fujifilm Kyowa Kirin Biologics, the commercialization rights have been extended from Europe to Global Markets. Biocon, under the terms of its global partnership with Mylan for monoclonal antibodies, retains its economic interest in this expanded in-licensing arrangement and will gain a share of profits from Global Markets. Biocon is committed to enable patient access to affordable biosimilars and this partnership accelerates that process.

May 2019 ► 43

press release Malaria Elimination Research Alliance (MERA) – ICMR’s New Initiative

New Delhi, India: Malaria Elimination Research Alliance (MERA) – India, is the new initiative by ICMR. On the launching date of 24th April 2019, they organized the Stakeholders’ Meeting at ICMR Headquarter situated in New Delhi, to have vibrant discussions on the Alliance-Roadmap. National and International Leaders of Malaria Research, Officials from Government of India, and many allied NGOs had participated in this daylong meeting.

Malaria Elimination Research Alliance-India (MERA-India) is a conglomeration of partners working on malaria control. The principal activity of this alliance is to prioritize, to plan, to conduct, to scale up and to translate relevant research in a coordinated and combinatorial way for having a tangible impact on the malaria-risk-prone population.

The purpose of MERA India is to identify, to articulate, to prioritize, and to respond to the research needs of the country to eliminate malaria from India by 2030. MERA India will facilitate trans-institutional coordination and collaboration around a shared research agenda, which responds to not only to programmatic challenges, but also addresses the gaps in available tools. It also proactively contributes to targeted research.

IIT Mandi Research Team develops New Fluorescent Nanodot Markers to show Distribution of Water inside Biological Cells

Mandi, Himachal Pradesh: An Indian Institute of Technology Mandi Research Team has shown, using fluorescent nanodots, how water is distributed inside biological cells. Their preliminary research indicates that the distribution of water inside normal cells is different from that inside cancerous cells, which, if understood better through future studies, could enable an alternative easy way of detecting cancer cells.

Their research work was undertaken by a team led by Dr. Chayan K. Nandi, Associate Professor, School of Basic Sciences, IIT Mandi; and was recently published in the Journal of Physical Chemistry C. The human body is composed of trillions of cells, with their own specialized functions. Cells have multiple constituents, of which water amounts to 80 per cent Water molecules close to one another, are weakly attached to each other through feeble bonding forces called hydrogen bonds.

The Hydrogen bonds are dynamic; and change according to the interactions of water with the surroundings. The subtle changes in intracellular water, governing the cellular functionality, may initiate a series of biomacromolecular dysfunction that can lead to cancer or neurological disorders.

Markers are usually used to detect internal structures and components of cells. A ‘marker’ as name suggests, binds to specific components and shows their presence in some form; a fluorescent marker would emit light to show the presence and structure of the component to which it is attached. There have been, hitherto, no markers that can bond exclusively to water inside cells, thereby making fluorescence microscopy unsuitable for detection of intercellular water.

44 ◄ May 2019

Dr. Nandi’s team at IIT Mandi has synthesized a fluorescent nanodot, a material that is in the scale of nanometres – about 80,000 times smaller than the width of human hair. Dr. Nandi’s nanodot is made of carbon and contains both hydrophilic (water loving) and hydrophobic (water hating) parts, much like a soap molecule. The presence of water repellent and water attracting parts within the same nanodot make them organise themselves according to the nature of the hydrogen bonding caused by the water molecules, like the formation of soap micelles around grease.

In addition, the nanodot can fluoresce, i.e. emit light in the far ultraviolet wavelengths when illuminated with near ultraviolet light, and the time taken before it fluoresces depends upon the micellar arrangement of the nanodots around the hydrogen bonding network.

By introducing these nanodots into cells, Dr. Nandi and his research team have shown that the hydrogen bonds and hence water contents are different in different parts of the cell. More important is the observation that the hydrogen bonding network is different in cancer and normal cells. Their work provides the first evidence that the nuclei of cancer cells contain more free water than normal cells.

Speaking about the significance of this research, Dr. Nandi said, “It has been difficult to understand and experimentally analyse the extent of hydrogen bonding in intercellular water. This is the first probe to provide direct evidence of the hydrogen bonding network in an entire cell.”

He added that given the difference in water distribution in different types of cells, future research would enable the utilization of these nanodots for detecting dysfunctional and diseased cells.

Cipla appointed Dr. Raju Mistry as Global Chief People Officer

Mumbai, India: Cipla Limited has announced the appointment of Dr. Raju Mistry as President and Global Chief People Officer (GCPO) of Cipla.

Dr Raju Mistry is an accomplished and veteran Human Resource leader with over 27 years of global experience across diverse sectors such as Chemicals, Pharma, FMCG, IT, Engineering, and Textiles. Prior to joining Cipla, he was the Chief Human Resource Officer (CHRO) at Jubilant Life Sciences Ltd. Before that, for 13 years, he led the talent, employer brand, and leadership programmes of the Aditya Birla Group; and was the CHRO of Grasim’s Pulp and Fibre business. He has previously worked with Tata Sons, Colgate Palmolive, Siemens, and Mastech Corporation, Canada.

In his role at Cipla, Dr Mistry will oversee Human Resources, Administration, and Facility Management. He will be a member of the Management Council of Cipla, and will report to Mr. Umang Vohra, Managing Director & Global Chief Executive Officer.

Commenting on the appointment, Mr. Umang Vohra, Managing Director & Global Chief Executive Officer of Cipla said, “We are delighted to welcome Dr Raju to the Cipla family. In the last few years, Cipla has successfully worked towards strengthening its core, reiterating its values and focusing on building a future-ready organisation. Dr Raju brings with him the experience to continue the journey and help us reach new milestones.”

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press release Clariant Fights Malaria with New DualAction Anti-Mosquito Masterbatch Muttenz, Switzerland: Clariant, a focused and innovative specialty chemical company, has announced its introduction of the most technologically advanced antimosquito masterbatch for use in Royal Guard longlasting insecticide-treated nets (LLIN). The new product Clariant Fights Malaria with New Dual-Action Anti-Mosquito Masterbatch. is the result of a 10-years’ effort to deal with increasing resistance of malaria-carrying mosquitos to pyrethroid insecticides.

“As efforts to control malaria have ramped up over the last 10 years, particularly in sub-Saharan regions, there has been a dramatic increase in the use of pyrethroid insecticides in treated nets and in indoor spraying campaigns,” explains Francis Baud, Global Business Development Fiber Segment for Clariant Masterbatches. “Although pyrethroids have been very effective, their widespread use has led to a dramatic increase in resistance in mosquito populations. Globally, malaria still kills almost half a million people each year; and hundreds of millions of people, especially children and people with weakened immune systems, are at risk.”

“Since resistance threatens to undermine the progress against malaria, all stakeholders are trying to find solutions to this very complex problems.”

Baud continues, “As we prepare to mark World Malaria Day on April 25, Clariant and Disease Control Technologies are excited and proud to announce the introduction of our new dual-action masterbatch solution and first in class Royal Guard LLIN.” Disease Control Technologies LLC (DCT), Greenville, S. Carolina, U S A., has been a leading innovator in LLIN technology and is the first to use the dual-action Clariant Masterbatch in nets offered under the new Royal Guard brand name. The safety, quality, and efficacy of the product has been evaluated by the World Health Organization (WHO); and DCT’s Royal Guard became the first in class next-generation, dual active ingredient LLIN, containing a pyrethroid and insect growth regulator, to be added to the group‘s list of prequalified (PQ) vector control products in March of this year.

The new CESA-antimosquito additive concentrates incorporate the pyrethroid insecticide Alphacypermethrin, a strong neurotoxic agent that is the standard anti-mosquito ingredient, which Clariant has used in LLINs since 2002. They also employ another active ingredient, Pyriproxyfen, which inhibits the reproduction ability of the female mosquitos. Any pyrethroid-resistant mosquitos that escape the effects of the Alphacypermethrin will still be affected by the Pyriproxyfen growth inhibitor, which limits egg laying, larvalpupal transformation, and the emergence of functioning young adult mosquitos; thus reducing the overall mosquito-population.

Pharma Bio World

What makes the Clariant technology special is the way in which the insecticides are blended into the masterbatch, allowing a permanent but slow release to the surface -- just enough to kill any mosquito by contact.

LLIN are made of high-density polyethylene (HDPE) monofilaments. The masterbatch is introduced into the HDPE during extrusion of the fibers.

Orientation of the PE molecules binds the precise amount of insecticide inside each filament before they are knitted into nets. Once in use, and over the three year service life of the LLIN, small amounts of the active ingredients migrate to the surface of the fibers so that mosquitos that land on them are immediately affected. Because the active ingredients are tightly bound on a molecular level inside each monofilament, the LLIN nets can be washed up to 25 times with no loss of efficacy.

DCT introduced its first LLIN, dubbed the Royal Sentry, in 2008 and earlier this year, it launched Royal Sentry 2.0. Both are pyrethroid-only nets. With the introduction of Royal Guard LLIN, the company now offers three different mosquito control nets, all of which take advantage of the innovative Clariant masterbatch technology.

The new CESA-antimosquito masterbatches have qualified for the Clariant EcoTain label, which is applied to products that offer outstanding sustainability advantages. EcoTain-designated products undergo a systematic, in-depth screening process using 36 criteria in all three sustainability dimensions: social, environmental, and economic. EcoTain products significantly exceed sustainability market standards, have bestin-class performance, and contribute to overall sustainability efforts of the company and our customers.

GVK MIAL awarded “CEIV PHARMA” certification by IATA Mumbai, India: The GVK led Mumbai International Airport Limited (MIAL) has become the first airport in India and third in Asia to achieve “IATA CEIV” certification. This certificate is an industry recognition, supporting the air transport industry to comply with pharmaceutical manufacturers’ requirements.

The Mumbai International Airport has achieved this quality milestone for Pharma Logistics following successful completion of training courses, on-site assessment, and complex validation processes.

Acknowledging the importance of this initiative, MIAL has initiated the certification process in a community approach together with its air cargo supply chain partners. The IATA CEIV Pharma certification was introduced to prevent temperature excursions of Pharma products during air transport with the key objective of patient safety and reduction of losses attributed to logistical issues.

Apart from being awarded with this key accreditation, GVK MIAL is also a strategic member of ‘Pharma Aero’ and the project lead for ‘Airside Transport Benchmark’. The airport will soon be launching India’s largest Temperature Controlled Solution for the transport of pharmaceuticals on the Tarmac region.

The IATA CEIV aims to improve the handling of pharmaceutical cargo by complying with existing national and international regulations. The authorization ensures adequately equipped facilities, safety & security, standardization, and transparency across the air transport supply chain.

May 2019 ► 45

Machine Learning

Ultra-compact Industrial PC

Beckhoff offers a machine learning (ML) solution that is seamlessly integrated into TwinCAT 3 software. Building on established standards, TwinCAT 3 Machine Learning brings to ML applications the advantages of system openness familiar from PCbased control. In addition, the TwinCAT solution supports machine learning in real-time, allowing it to handle even demanding tasks like motion control. These capabilities provide machine builders and manufacturers with an optimum foundation to enhance machine performance, eg, through prescriptive maintenance, process selfoptimisation and autonomous detection of process anomalies.

For more information, please contact:

Beckhoff Automation Pvt Ltd Suyog Platinum Tower, 9 th Floor Naylor Road, Off Mangaldas Road Pune, Maharashtra 411 001 Tel: 020-67064802 Fax: 91-020-67064899 E-mail: a.phatak@beckhoff.com / info@beckhoff.co.in

With dimensions of only 129 x 133 x 104 mm, the C6032 Industrial PC extends the range of ultra-compact Industrial PCs by a high-performance device in modular design. For this purpose, the C6032 adds a further circuit board level to the C6030 single-board Industrial PC, which is comparable in terms of computing power, to allow for accommodation of modular interface and functional extensions. With the use of compact PCIe modules, the C6032 can be optimally adapted to the requirement profile of individual applications.

For more information, please contact:

Beckhoff Automation Pvt Ltd Suyog Platinum Tower, 9 th Floor Naylor Road, Off Mangaldas Road Pune, Maharashtra 411 001 Tel: 020-67064802 Fax: 91-020-67064899 E-mail: a.phatak@beckhoff.com / info@beckhoff.co.in

Lubricated Vacuum Pumps Toshniwal’s oil lubricated vacuum pumps of the TMS Series are single stage oil lubricated rotary vane vacuum pumps with oil re-circulation system. Pumping capacity ranges from 15 m 3/hr, 35 m 3/hr, 65 m 3/hr and 100 m 3/hr. Toshniwal’s TMS Series pumps has economical features which matches together to achieve high pumping speed over the range of absolute pressure of 1,000 mbar to 0.5 mbar; high water vapour tolerance and low noise level; air cooled; no pollution; and built-in anti suck-back system.

Designed for continuous operation at high intake pressure, the pump is used in various applications like pick and place, packaging, degassing, low boil distillation, solvent recovery, heat treatment, bottle filling, vacuum drying, etc. The company also provide special B Series oil lubricated pump for high pressure (rough vacuum) application upon request.

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

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Pharma Bio World

Control Systems Ross control and data acquisition systems offer unprecedented accuracy and flexibility in the mixing and blending process. Their system monitor an array of process parameters while they control essential mixing parameters as mixing time, speed, temperature and vacuum/pressure. Windows-based software allows manual or automatic operation, with simple cycle programming. Ross offers a variety of choices in control designs from simple relay-operated units to pre-fabricated pulpit-style PLC control rooms with graphical user interfaces.

Ross Systems & Controls is a member of the NFPA. The company can also provide UL-listed systems for both hazardous and non-hazardous locations.

For more information, please contact: Ross Process Equipment Pvt Ltd Plot No: D-233/3, Chakan Indl Area Phase II, Village: Bhamboli, Tal: Khed Dist: Pune, Maharashtra 410 501 Tel: 02135-628400, 628401, 628402, 628403 E-mail: mail@rossmixers

Servo Drive System The AMP8000 distributed Servo Drive system provides ideal support for the implementation of modular machine concepts. With the new AMP8620 supply module in a high protection rating, the entire system can now be relocated directly to the machine, ie, through consistent decentralization, drive technology can be implemented entirely without control cabinets. That means max possible savings on material, space, costs and assembly work.

While previously with the coupling modules, the requirements for connecting distributed AMP8000 drives to the control cabinet were already reduced to just one cable, they can now be completely eliminated when the AMP8620 supply module is used. Eliminating the need for a control cabinet further reduces the floor space and cabling requirements for the entire machine. The air-conditioning resources, which would otherwise be necessary for control cabinet cooling, can also be eliminated.

The AMP8620 module is directly connected to the mains supply. It contains all circuitry components required for that purpose, such as mains filters, rectifiers and charging circuits for the integrated DC link capacitors. The supply module enables optional connection of additional distribution modules or distributed AMP8000 Servo Drives. It is equipped with two EtherCAT P outputs, through which either EtherCAT P modules can be supplied or else additional supply modules can be connected that may be required for system expansion. The safe 24 V power supply unit integrated in the supply module ensures that the logic power supply does not exceed the permissible level. The DC link capacitors integrated in the supply module store the regenerative energy of the entire system and then make it available again for acceleration processes. This ensures best-possible utilisation of the energy supplied.

For more information, please contact:

Beckhoff Automation Pvt Ltd Suyog Platinum Tower, 9th Floor Naylor Road, Off Mangaldas Road Pune, Maharashtra 411 001 Tel: 020-67064802 Fax: 91-020-67064899 E-mail: a.phatak@beckhoff.com / info@beckhoff.co.in

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Compact Vacuum Packages

Toshniwal provide solution to your vacuum applications.

It replaces multi-stage water/liquid ring pumps and steam jet ejectors with high performance compact vacuum packages.

The volume flow from 180 to 97,000 m /hr. There is energy savings resulting from low motor rating. Integral pipe work allows easier installation.

Constant vacuum is in the range 0.1 to 400 mbar (absolute).

Booster and rotary pump may be started at the same time.

Built-in bypass value to protect from overloads.

Clarifiers Clarifiers are extensively used for continuous mechanical removal of settleable solids from water and wastewater.

This assortment is designed to meet client’s requirements and is available in different specifications as per the application.

3

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

Technologies involved are high rate solid contact clarifier (HRSCC); tube settler (TSU); and clariflocculator.

It finds application in removal of colloidal silica, colour removal and primary treatment of wastewater.

For more information, please contact: WTE Infra Projects Pvt Ltd 26/6 Apte Colony, B/h Ayappa Temple Pune-Nashik Road, Bhosari Pune, Maharashtra 411 039 E-mail: enq@watertreatmentindia.net

Double-sided Rotary Press The tablet presses in the Romaco Kilian K Series impress with their excellent value for money. The K 720 double-sided rotary press was configured by Romaco Kilian for the production of mono and bi-layer tablets and can be switched flexibly between the two operating modes. This high speed press has a max output of 1,000,000 tablets per hour. The technology is used both in the pharma industry and in the non-pharma sector, and is particularly suited for compressing effervescent tablets, nutraceuticals and drugstore items. The systematic reduction of product loss was a top priority when Romaco Kilian developed the K Series. Amongst other features, this is achieved by means of product scrapers, which are in constant contact with the die table surface due to magnetic force. Targeted measures to improve the Kilian K 720’s productivity, availability and quality have simultaneously increased its overall equipment effectiveness (OEE). The hermetic separation of the tablet press process area from the changeover and service areas moreover restricts cleaning to a minimum and extends the production time of the Romaco Kilian K 720 rotary press.

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

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Pharma Bio World

Laboratory Dry Vacuum Pump A laboratory vacuum pump is an adaptable tool that can aid a wide diversity of research scientists and engineers. Laboratory vacuum pumps are used routinely in labs to provide suction to drive the aspiration or filtration of liquid or suspended samples; to induce or control solvent evaporation by reducing vapour pressure, as in ovens, rotary evaporators, gel dryers, and concentrators; and to collect gas samples from test chambers or the atmosphere. Vacuum filtration uses a pressure differential (atmosphere above filter paper and vacuum beneath) to drive a solution through filter paper. The vacuum pump should pump under corrosive atmosphere; conventional vacuum pump often fails, the dry chemical vacuum pump will be suitable.

For example, the Chemker can handle corrosive vapour basically a chemical-resistant dry pump and for evaporation up to 100 Torr for corrosive media for laboratory oven for rotary flash evaporator.

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

Single Quadrupole Mass Spectrometry Technology Chromatographers looking for bold confidence in their samples can now benefit from a single quadrupole mass spectrometer designed for ease-of-use while offering application flexibility and reliable results for challenging mass confirmation analyses. Driven by industry demand for a robust, easy to implement system, Thermo Fisher Scientific designed the Thermo Scientific ISQ EM single quadrupole mass spectrometer for high performance and productivity standards in laboratories. With a mass range of 10-2,000 m/z, the system offers the power to detect and quantify small and large molecules, and supports analytical needs across an extensive range of applications – from drug development to manufacturing support and quality control. The system’s high-performing heated electrospray ionization (HESI) and dual HESI/atmospheric pressure chemical ionization (APCI) probes facilitate the measurement of polar and non-polar analytes, enabling application flexibility.

The ISQ EM is integrated with HPLC systems and fully controlled by Thermo Scientific Chromeleon Chromatography Data System (CDS), which offers tools to guide users through LC-MS method development and select appropriate source conditions. Thermo Scientific Chromeleon XPS Open Access software also supports the ISQ EM with walk-up workflows for simple daily operation.

Additionally, full integration with native control in Chromeleon CDS enables users to benefit from the entire productivity suite, from method creation through final reporting. A built-in reference standard also automates instrument calibration for a user-friendly experience. The introduction of the ISQ EM further expands the product portfolio introduced in 2017 with the launch of the Thermo Scientific ISQ EC single quadrupole mass spectrometer. The ISQ EC was designed to integrate with both ion chromatography and liquid chromatography systems and deliver low-molecular-weight performance for the detection and quantification of ions with limits of detection in the single-digit-parts-per-billion range.

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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May 2019 ► 49

Nitrogen Gas

Argon Gas

Nitrogen gas is odourless, colourless gas and makes up approximately 78.09 per cent by volume of the air we breathe. It is non-flammable gas and does not support combustion. Nitrogen gas is required in many processes of the pharma and chemical industry. There is multi-usage of nitrogen gas in various industrial sectors such as metal manufacturing process, chemical, pharma, petroleum, fertilizer, rubber and plastic, food and beverage industry. Thermal flow meters directly measure the mass flow rate of gas with no need of temperature and pressure correction.

Argon is commonly employed as a blowing gas in steel manufacturing to avoid the formation of nitrates. Mass flow meters are commonly used to measure argon in steel production process. PCD offers inline thermal mass flow meter with in-built display to regulate the flow rate and to check the commutative gas flow.

PCD thermal mass flow meter TMF Series offer rugged, leak-proof construction, high turn-down ratio of 100:1 with high accuracy, which makes the flow meter user demandable.

It has a negligible pressure drop across the flow meter with high turn-down ratio and is available in sizes as small as Ÿ� tubing up to larger line sizes.

For more information, please contact:

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

For more information, please contact:

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

Multi-effect Glass Evaporation Unit The purpose of this equipment is a cost-effective, complete recovery of the acidic streams emanating during the acid concentration processes.

The possibility of recovering these acids back grants a full implementation of the zero liquid discharge concept design into any re-concentration process involving mineral acids such as nitric acid, sulphuric acid, hydrochloric acid, phosphoric acid, etc.

The perfect combination between highly corrosion-resistant materials like borosilicate glass, silicon carbide and tantalum, as well as its multi-effect principle make this unit a very efficient tool in performing the operation.

This innovative way of solving the problem of residual acidic water is a valid alternative to their neutralisation with the advantage of an environment-friendly approach to the problem.

The unit is also available as a standalone package in different capacities from 5 m 3/day to 100 m 3/day.

For more information, please contact: ATR-ASAHI Process Systems (P) Ltd 668, GIDC Makarpura Vadodara, Gujarat 390 010 Fax: 91-0265-2633423 E-mail: prosys@atrasahi.com

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Absorption Dryers The application of compressed air used in hi-tech machinery is highly essential. The damp atmospheric air compressed to 7 bar and then cooled down to working temperature results in condensation of water vapour in the compressed air line. The condensate binds the surrounding atmospheric gases such as CO 2, CO, H 2S and NO and becomes highly aggressive with pH values down to 4 and 3. The mixture of the condensate, atmospheric impurities and lubricating oil from the compressor is the destructive factor in all compressed air systems leading to downtime, increased wear, higher energy consumption, lower product quality and delays in delivery dates. High efficiency ALD/MSD dryers have everything you need to produce clean, dry, compressed air control system, pre-filters, dryer, after filter, condensate drains and silencers, all as a single complete unit, and you save on installation. This complete dryer is easy to setup and install.

ALD/MSD dryers operate continuously between 9 and 100 per cent of its rated capacity providing constant compressed air quality.

For more information, please contact: Ultrafilter (India) Pvt Ltd Plot No: 70, Bomasandra Indl Area Bengaluru, Karnataka 560 099 Tel: 080-41429900 Fax: 91-080-41419903 E-mail: info@ultrafilterindia.com

Oil Removal Filters The efficient filtration of compressed air is a complex problem. And the new 2100 Series from ultrafilter offers the right solution by providing not only higher efficiency but also higher capacity at a lower price and a choice of quality pressure die-cast housings with the new generation of ultrafilter filter elements.

Filters manufactured by Ultrafilter reduce wear and tear in pneumatic equipment, tools and instruments, cut down production stoppages, lower repair costs to improve the quality of production and reduce energy costs.

The unique element has a three stage filtration effect. Oil and dirt laden compressed air flows through the filter element from inside to outside. The coarse particles of dirt and pipe scale are retained inside the pre-filter. Oil, water and the remaining fine particulate matter then pass to the main medium, a three dimensionally layered microfiber medium which provides the next two stages of filtration. Here, up to 99.99999 per cent of all oil and water aerosols and dirt particles down to a size of 0.01 micron are trapped. Liquid attach to the fibre and by coalescing the oil and water aerosol, bulk liquid is formed. This in turn is carried by the air flow to the outer foam sock which has a very high surface area. Within the cellular structure of the sock, the air and water separate, the air flows from the element in the upper section, whilst the water and oil gravitate to the bottom of the element and fall into the quiet zone at the bottom of the filter housing. The oil and water are discharged by a drain without the need of any maintenance.

For more information, please contact: Ultrafilter (India) Pvt Ltd Plot No: 70, Bomasandra Indl Area Bengaluru, Karnataka 560 099 Tel: 080-41429900 Fax: 91-080-41419903 E-mail: info@ultrafilterindia.com

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Membrane Absolute Filter Cartridge Nylon absolute rated membrane filter cartridges are highly retentive hydrophilic membrane filters that have been specially designed for critical applications.

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

Air Valves Normally in horizontal pipeline, due to unevenness in ground level, there will be an entry of air into the pipeline. CRI air valve is connected with delivery pipeline to eliminate the trapped air in the system and ensures pipe life.

For more information, please contact: CRI Pumps Pvt Ltd 7/46-1 Keeranatham Road Saravanampatty Coimbatore, Tamil Nadu 641 035 Tel: 0422-3027000 Fax: 91-0422-3027005 E-mail: corp@cripumps.com

Vacuum Concentrators SpeedVac Vacuum Concentrators offers preset and custom-made programs for optimal application flexibility. The Thermo Scientific Savant SpeedVac systems achieve fast, one-click solvent evaporation. Chemists, chromatographers and molecular biologists can now benefit from the firstever line of vacuum concentrators offering a library of pre-programmed protocols, while also allowing users to create custom programs, for fast and reliable evaporation of a broad range of solvents.

Built on Thermo Fisher’s leading vacuum concentration technology, the upgraded Thermo Scientific Savant SpeedVac systems provide users with the flexibility to choose from a selection of preset or custom-made programs to suit varying application needs. Like their predecessors, the new vacuum concentrators achieve a reduced drying time and are compatible with a large number of solvents, helping to boost laboratory efficiency and productivity across a wide array of pharma, biotechnology, academic research, industrial, agricultural and food testing applications. The Savant SpeedVac line of products consists of eight vacuum concentrators, ranging from a compact, integrated device designed for low-volume sample preparation, to mediumcapacity models available in either integrated or modular designs, to large, modular systems addressing high-volume sample preparation needs. The Savant SpeedVac portfolio includes: Model DNA130 – A compact, integrated system designed for lowvolume preparation of samples, including nucleic acids, polymerase chain reaction (PCR) preps and synthetic oligonucleotides, to support DNA and RNA applications; Model SPD120 – A medium-capacity, modular system, which is resistant to aggressive solvents used in DNA and biological applications, such as methanol and acetonitrile w/0.1% trifluoroacetic acid (TFA). It is also suitable for applications where freeze-drying or lyophilization is needed; Model SPD130DLX – A medium-capacity, modular system, which is resistant to aggressive solvents used in combinatorial chemistry applications, including TFA and dimethyl sulfoxide (DMSO); Model SPD140DDA – A medium-capacity, modular system, used for drying aggressive organic solvents, strong acids, bases and combinatorial chemistry solvents; Models SDP1030 and SDP2030 – Medium-capacity, fully integrated systems, combining a concentrator, a refrigerated cold trap, a diaphragm pump and a vacuum gauge in a single, compact unit; Model SPD210 – A large-capacity, modular system, suitable for drying aqueous and organic solvents in large sample volumes; and Model SPD300DDA – A large-capacity, modular system, used for drying aggressive organic solvents, strong acids, bases and combinatorial chemistry solvents in large sample volumes.

For more information, please contact:

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

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Intermittent Motion Cartoner A mere 3.5 m long, the Promatic PCI 915 intermittent motion cartoner convinces with its compact design and very small footprint. The strictly ergonomic system concept simplifies operation as well as format and product changes. The poka-yoke design of the format parts, for instance, prevents incorrect assembly. The cGMP compliant balcony architecture ensures good access to all components and speeds up safe line clearance. For one thing, the operator has an excellent view of all processes and for another, numerous camera systems permit seamless monitoring of the various steps.

Furthermore, reproducible parameters guarantee a highly reliable process. All in all, the Promatic has a max output of 160 cartons a minute.

For more information, please contact:

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

Refrigeration Air/Gas Dryers The air given off by any compressor always contains water vapour the amount of which depends on the temperature and the relative degree of humidity. When the air is compressed, the volume decreases proportionately, but the exhaust water vapour still remains in the air. When temperature decreases and reaches a value at which the air becomes saturated, the water vapour in the air begins to condense. This is called dew point. With an appropriate aftercooling unit which reduces the temperature of the air produced by the compressor, approximately 60-70 per cent of the water gets condensed. The UE/UR Series dryers are basically made of two different circuits – a compressed air circuit, divided into two heat exchangers and a refrigerating circuit. The hot and humid inlet compressed air passes through the air – air heat exchanger and then reaches the evaporator (air-freon heat exchanger), where it is cooled by the refrigerating circuit until it reaches the preset dew point, thus condensing the moisture it contains. In the separator the condensed moisture is then separated and removed. The advantages of such a system are essentially two: first of all the inlet air is pre-cooled, so the refrigerating system can be sized in order to guarantee a more limited thermal jump, with an energy saving of about 40-50 per cent, and secondly no cold air is conveyed through the compressed air line, thus preventing the overall formation of condensate on the external surface of the piping. Condensate corrodes piping, solenoid valve and pneumatic tooling, forcing the user to withstand expensive repair interventions, especially the expensive down time heavy costs which cannot be easily controlled. When compressed air is used as process air for painting equipment, in chemical industries, food processing industries, glass factories and in plants for conveying and handling hygroscopic raw materials, the installation of ultrafilter dryer is essential to eliminate the condensate which pollutes the production cycle.

For more information, please contact: Ultrafilter (India) Pvt Ltd Plot No: 70, Bomasandra Indl Area Bengaluru, Karnataka 560 099 Tel: 080-41429900 Fax: 91-080-41419903 E-mail: info@ultrafilterindia.com

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Antistatic Silicone Tube

Anti-static Silicone Tubing

Anti-static Silicone Tube

Anti-static silicone Anti-static silicone tubing a nontube complies transparent colour with FDA 21 CFR (milky white or 177.2600. It has black) is specially anti-static properties developed to to dissipate charges remove static through rubber electric charge surface and volume while transfer of and is used for flammable fluid. flammable solvent Antistatic Silicone Tube is complies FDA 21 CFR 177.2600.

Antistatic properties to dissipate Used for flammable solvent transfer peristaltic pump application. transfer andwith peristaltic pump application.

It has non-transparent charges through rubber surface & volume. It is used for flammable solvent transfer & peristaltic Available in 60 Shore A and 70 Shore A hardness pump or asapplication. per It has colour (milky white or black) and is available in 60 Shore A and non-transparent color (milky white or black). It is available in 60 Shore A & requirement. Anti-static tubing is successfully tested70 for Shore A hardness as perbyrequirement.

It is sterilisable Shorefood A hardness70 or as per requirement.

It is or sterilizable using different techniques like Autoclaving, Oxide and Gamma Radiation.

It is available FDA compliantethylene color codingoxide grade FDA 21 CFR 177.2600 test. Specially developed StaticEthyleneby using different techniques likewith autoclaving, for ease of identification and custom dimension, hardness & length size also available.

Dissipative Formulation (107 to 109 Ί-cm). It has anti-static and gamma radiation. It is available with FDA compliant colour coding for ease of identification and is also available in custom properties to dissipate charges through rubber surface volume.

Ami Polymer Pvt. Ltd.dimension, hardness and length size.

319, Mahesh Industrial Estate, Opp. Silver Park, Mira-Bhayander Road, Mira Road (E), Thane 401104, Maharashtra. INDIA

For more information, please contact:

For more information, please contact:

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

Ami/ Polymer Ltd 13935 Tel.: +91 22 28555 107 / 631 914 | Cell: Pvt +91 86910

319 Mahesh Indl Estate, Opp: Silver Park

Email: mktg@amipolymer.com | Web: www.amipolymer.com Mira-Bhayander Rd, Mira Road (E)

Thane, Maharashtra 401 104 Tel: 022-28555107, 28555631, 28555914 E-mail: mktg@amipolymer.com

Tri-clover Gaskets Imaclamp - tri-clover gaskets are used for connecting two pipes in food and drug plant. Triclover gasket is available in food grade silicon, food grade viton, food grade EPDM, etc. It can be supplied as per the sizes on request.

Tri-clover gaskets are 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 Tri-clover 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 Rd, Mira Road (E) Thane, Maharashtra 401 104 Tel: 022-28555107, 28555631, 28555914 E-mail: mktg@amipolymer.com

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Blister Packaging Machine Romaco’s Noack NBP 950 is an extremely compact blister machine for pharma applications that saves a lot of space in cleanroom areas. The blister packaging machine’s individual stations such as forming, feeding, sealing, coding, perforating and punching are installed on a very small footprint for this reason. The result is a blister technology that is up among the leaders in the mid-performance class in terms of both space use and output, with a remarkable 500 blisters per minute. The intuitive HMI panel, with its short learning curve, is a further advantage of the user-friendly blister machine. Equipped with Romaco Noack’s patented QuickFeed feeding system, the NBP 950 speeds up product changes because the complete module can be replaced in a few simple steps. The optimal access to all components moreover simplifies cleaning of the blister line. Reproducible format parameters and QuickAdjust, the automatic station control system, simultaneously reduce the run-in times to almost zero. Separate servo drives ensure safe operation at the individual stations. In short, the NBP 950 blister packaging machine from Romaco Noack offers excellent opportunities for improving overall equipment effectiveness (OEE).

For more information, please contact:

Romaco Group Am Heegwald 11, 76227 Karlsruhe Germany Tel: +49 (0)721 4804 0, Fax: +49 (0)721 4804 225 E susanne.silva@romaco.com

Mobile Dust Extractors Whatever material, dust, chips or fumes you would like to remove or transport from or within the workplace, we have the solutions, even in dangerous environments, such as ATEX zones. With such a wide range available we have developed a diverse customer base, including clients from construction, heavy industry, aerospace and transport as well as the food industry, to name a few. Dustcontrol supplies industrial mobile dust extractors and air cleaners, on-tool suction casings, stand-alone separators and cleaning accessories. This helps companies worldwide achieve cleaner and more efficient production, in addition to improved product quality. All of our mobile vacuums and air cleaners are delivered as standard with Hepa H13 filtration and built to Application Class H for hazardous dusts and the most demanding environments. Their vacuums all feature cyclone-based separation and are fitted with pleated cartridge filters to provide high and consistent performance in the most energy-efficient way. Reverse pulse filter cleaning also means filters can be kept clean without the need for removing them in the workplace. All machines are designed to be as ergonomic as possible, so they are easy to handle, move around and transport, as well as being simple to maintain.

Dustcontrol has over 45 years’ experience in developing high-efficiency dust extraction solutions including machines, capture hoods for hand-held power tools and fixed equipment and a wide range of cleaning accessories.

For more information, please contact: Dustcontrol UK Ltd 7 Beaufort Court, Roebuck Way Knowlhill Milton Keynes MK5 8HL U.K. Tel: 01327 858001, Fax: 01327 858002 E-mail: sales@dustcontrol.co.uk

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events diary    

  

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

Dates: 8-11 August 2019 Venue: India Exposition Mart, Greater Noida

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

This event is a one-stop destination to address the

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

manufacturing requirements of the OEMs of various industry sectors in Tier II and Tier III cities of India. It will cover the entire gamut of metal working machine tools for both metal cutting and metal forming including automation and robotics, tooling systems, CAD/CAM and other technologies essential for today’s manufacturing.  Indian Machine Tool Manufacturers’ Assn Bangalore International Exhibition Centre 10th Mile, Tumkur Road Madavara Post, Bengaluru Karnataka 562 123 Tel: 080-66246600 E-mail: imtma@imtma.in

 

      

Dates: 25-27 September 2019 Venue: India Exposition Mart, Greater Noida

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

Electronica India is the leading platform in India focusing on electronic components, systems and applications. It features semiconductors, embedded systems, display, micro and nano-systems, and sensor technology, automotive, wireless and much more.

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

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

 Messe Muenchen India Pvt. Ltd. INIZIO 507 & 508 Cardinal Gracias Rd Chakala, Andheri (E) Mumbai 400 099 Tel: 022-42554700 Fax: 91-022-42554719 E-mail: info@mm-india.in

56 ◄ May 2019

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

Pharma Bio World

bookshelf Industrial Solutions_book mouckup copy Author: Cole-Parmer India Price: Free Pages: 324 Publisher: Cole-Parmer India Cole-Parmer launched its Industrial Solutions catalog. The catalog is dedicated to meet diverse industrial application needs of the customers from F&B/FMCG, chemicals and petrochemicals, paints, pigments and coatings, automotive and industrial manufacturing, power, steel and mining, and testing houses. Cole-Parmer is considered as a preferred partner for its pharmaceutical customers delivering comprehensive solutions for their research to production. The company is now expanding its reach in the Industrial markets and has introduced Industrial Solutions catalog, addressing the challenges of the customers and keeping in mind their applications needs. From research and development to assessing product quality, and material testing, the catalog offers wide range of instruments and application solutions that significantly enhance your quantitative and qualitative performance, ensuring greater processes, quality control and safety across various processes.

The 324-page catalog is filled with thousands of equipment, supplies and consumables to keep your research on track and your lab organized. The portfolio features integrated solutions for enhanced efficiency, from sample preparation, analysis to environmental health safety (EHS). Customers can choose from the latest in fluid handling, chromatography, electrochemistry, test and measurement, safety solutions, lab essentials, instruments and supplies, from company’s renowned brands like Masterflex®, Cole-Parmer®, Kinesis®, Jenway®, Stuart®, Oakton®, Traceable®, Digi-Sense®, VapLock®, StableTemp®, polystat® and OmegaZen™ to name a few.

To request your copy of Industrial Solutions catalog, visit ColeParmer.in/catalog or contact 022-61394444 / response@coleparmer.in

How to Overcome the Antibiotic Crisis: Facts, Challenges, Technologies and Future Perspectives Authors: Marc Stadler & Petra Dersch (Editors) Price: $161 Pages: 496 Publisher: Springer This volume focuses on antibiotics research, a field of topical significance for human health due to the worrying increase of nosocomial infections caused by multi-resistant bacteria. It covers several basic aspects, such as the evolution of antibiotic resistance and the influence of antibiotics on the gut microbiota, and addresses the search for novel pathogenicity blockers as well as historical aspects of antibiotics. Further topics include applied aspects, such as drug discovery based on biodiversity and genome mining, optimization of lead structures by medicinal chemistry, total synthesis and drug delivery technologies. Moreover, the development of vaccines as a valid alternative therapeutic approach is outlined, while the importance of epidemiological studies on important bacterial pathogens, the problems arising from the excessive use of antibiotics in animal breeding, and the development of innovative technologies for diagnosing the ‘bad bugs’ are discussed in detail. Accordingly, the book will appeal to researchers and clinicians alike.

The reality of pharmaceutical care-based medication therapy management: Patients’, pharmacists’ and students’ perspectives

Authors: Djenane Ramalho de Oliveira Price: $68 Pages: 400 Publisher: Lambert Academic Publishing This book is the result of the author’s immersion in the world of pharmaceutical care practice, Medication Therapy Management (MTM) services, for one year. As part of her PhD thesis, Djenane Oliveira conducted field observation, in-depth interviews, focus groups, and analysis of documents in order to understand the practice as it is in the real world. Patients, pharmacists and pharmacy students narrated their experiences as they received, delivered and learned about pharmaceutical care practice. The text is a realistic and a comprehensive account of the process of building a new professional practice in a convoluted health care system. It illuminates the skills and knowledge required to be a patient-centered practitioner and provides invaluable guidance on how to better prepare students for this role. This volume should be read by pharmacists, pharmacy students, pharmacy educators, managers and decision makers in the health care system as it unveils what patients value and want from their providers, and what they need with regards to their medications. This cutting-edge text is a must-read for individuals committed to meeting patients’ drug- related needs.

Pharma Bio World

May 2019 ► 57

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Process Industry's Gateway to Indian Market

International Exhibition and Conferences 4-6 December 2019

ChemTECH

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

SOUTH WORLD EXPO 2019

Concurrent Events

L AB

Exhibitors Profile •

Chemical Processing

•

Pharma & Biopharma processing

•

Laboratory Technology

•

Measuring & Testing

•

Quality Control

• •

&

ANALYTIX

South World Expo 2019

SOUTH WORLD EXPO 2019

WaterEX

SOUTH WORLD EXPO 2019

Industry Pumps, Valves & Fittings SOUTH WORLD EXPO 2019

Visitors Profile

End User Industry Connect

•

Chairmen, MDs , CXOs, Directors, Presidents & Vice Presidents

•

Heads of : Technology, Operations, Manufacturing, Procurement, Purchase & R&D

•

Decision makers & representatives from State Governments, Industrial Development Corporations & Regulatory bodies

Analytical Instruments

•

Scientists, Lab Managers & Technicians

Lab Equipment

•

Quality Control /Assurance Managers

•

R&D Officers and Executives

•

Professors & Lecturers, Chemists & Bio Chemists, Microbiologists & Pathologists

•

Lab Directors, Purchase Managers, Analysts, Research Scholars, Scientific Officers

•

Representatives from Municipal Corporation, Water Bodies and Regulators

•

Environmental and Pollution Control Boards

•

Ministry of Rural Development and Drinking Water Mission

•

Pumps Valves & Fittings

•

Automation

•

Water & Wastewater treatment

•

EPCs

•

Engineering Consultants

•

Environmental services

•

Emission Control

•

Safety

Facts & Figures South 2017

AUTOMATION

& Control South 2019

182

EXHIBITORS

5971 VISITORS

• • • • • • • • • • • • • • • • • • •

25

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

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128

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