Pharma Bio World

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Pharmaceutical IP in India: Unique Challenges Intellectual property (IP) rights are extremely important for the pharmaceutical industry. The use of the IP system by SMEs in the pharmaceutical industry depends largely on the business strategy of a company, its size, resources, innovative capacity, competitive context and field of expertise. Research-based, innovation-led companies that seek to develop new drugs, improve or adapt existing drugs or develop new pharmaceutical/ medical equipment or processes, tend to rely heavily on the patent system to ensure they recover the investments incurred in research and development. Vinita Radhakrishnan, Senior Partner, Chief Patent Officer (Research, Risk Clearance and Strategy) at BananaIP, specializes in Bio/ Pharma patent law and Patent Strategy talks about the unique challenges faced by Indian Pharmaceutical companies with regards to IP.

Vinita Radhakrishanan Senior Partner, Chief Patent Officer (Research, Risk Clearance & Strategy), BananaIP. 8 ◄ August 2018

A

constant and continuous effort towards harmonizing and standardizing Intellectual Property (IP) regime worldwide, in its own capacity, has been contributing towards the making of a Global Economy. Despite its jurisdictional nature, loyal adherence to the TRIPS agreement by its member states has brought in certainty, all be it to a limited extent, with regard to the protection of Intellectual property rights across the world.

Having said that, the extent and strength of protection conferred to the same piece of IP vary significantly from country to country depending on its social, economic, political and moral structuring. This is particularly true in case of the protection rendered to IP in the Pharmaceutical industry.

In their pursuit to find the fine balance between incentivizing innovation and facilitating optimum access to health, most nations exploit the flexibilities available to them under the TRIPS agreement to adopt a differential protection system for pharmaceutical inventions, India being at the forefront of such efforts.

With population of over a 1.3 billion and less than 20% covered under health insurance, enabling access to affordable health care becomes one of the primary objectives of all health reforms in India.

Being the world’s largest provider of generic medicines and producers of 70% of the domestic pharmaceutical supply, the Indian Generic industry is one of the key contributors to the countries’ rising GDP and thus has a strong influence on the

policy framework in the country relating to Pharmaceutical Industry. It is against this backdrop the philosophy and framework of Patent Law in India has evolved.

Securing IP rights, more specifically Patent rights, significantly enhances the commercial prospects of Innovative businesses.

This is particularly applicable to the pharmaceutical sector where research, development and commercialization are both risk and cost intensive. By granting exclusivity for a period of 20 years the patent system aims to provide pharmaceutical industry an opportunity to recoup their investments.

However, owing to the patent regime that India has adopted, the perceived benefits of the patent system do not filter down to innovators in India to its full extent. The innovator companies face several unique challenges while protecting their IP in India few of which are discussed here.

Exclusion from Patentaility To comply with TRIPS, the Indian Patent system re-adopted the once abandoned Product Patent regime for pharmaceutical inventions. However, this inclusion came with riders that restrict the scope of protection conferred to pharmaceutical patents in India. Although the amended law allowed patents for both process and product related inventions, in an effort to ensure that there is no lingering effect of exclusivity post the stipulated patent term (the so called “ever greening effect), several categories of pharmaceutical inventions that are patentable

“Being the world’s largest provider of generic medicines and producers of 70% of the domestic pharmaceutical supply, the Indian Generic industry is one of the key contributors to the countries’ rising GDP and thus has a strong influence on the policy framework in the country relating to Pharmaceutical Industry.”

Pharma Bio World

across the globe, were specifically excluded from patentability, posing a unique hindrance to the pharmaceutical innovator companies conducting business in India.

Section 3 (d) of the Indian Patent Act excludes new forms of a known substance, including salts, esters, ethers, polymorphs etc., from the ambit of patentable subject matter, if such new form does not provide enhanced therapeutic efficacy.

This necessarily means that even if the invented form provides other benefits such as better bioavailability or better stability compared to the known form, unless and until the applicant is able to

pharmaceutical innovators. Contrary to the practice followed by regulatory bodies in other jurisdictions for example the EMA in Europe, and the FDA in US, the Central Drug Standard Control Organisation (CDSCO), the drug regulatory body in India, does not provide data exclusivity for the applications submitted to them for Approval. The lack of data exclusivity provisions over and above the challenges faced due to the non patentability of new forms, use and new combinations of known drugs, makes it very difficult for the innovators in the business of repurposing pharmaceutical products to sustain in the Indian Market.

“To comply with TRIPS, the Indian Patent system re-adopted the once abandoned Product Patent regime for pharmaceutical inventions. However, this inclusion came with riders that restrict the scope of protection conferred to pharmaceutical patents in India.” show enhanced therapeutic efficacy at the time of patent filing, new form of a known substance will not be awarded a patent.

Similarly, section 3 (d) also excludes the new use of known substance from the ambit of patentable subject matter. A recent study indicated that 45% of all rejected pharmaceutical patent applications cited Section 3(d) as a reason for rejection.

Novel combinations of known drugs also fall outside the scope of patentable subject matter as per section 3 (e) unless the said combination shows synergistic effect when administered together. Given that the requirement for generating undue experimental data is time intensive and the act of filing a patent before your competitor does, is time sensitive, the pharmaceutical innovators often find themselves in a dilemma as to when and whether to file for a patent in India.

Lack of Data Exclusivity The lack provided in India existing

of provision for data exclusivity by the drug regulatory body (CDSCO) adds to the already challenges faced by the

10 ◄ August 2018

Shrinkage of Patent Term Shrinkage of patent term is a challenge most pharmaceutical innovators have to deal with in most parts of the world. The 20 years term of exclusivity for a patent is mostly notional in case of pharmaceutical inventions. The long drawn regulatory approval process effectively eats into at least half of the patent term provided under the law. Unlike in case of other technologies, the commercial exploitation of a pharmaceutical patent is not possible till the regulatory approval process is completed. In India, this challenge is more severe when compared to many other countries. Recognizing the disadvantage caused to the patent applicant due to delay in regulatory approval, many countries including United States, Japan and countries of the European Union allow a patent term adjustment beyond the 20 years of patent life to compensate for the delay in the approval process. Such a provision is not available in India due to which the term of exclusivity available for Indian Patents in the pharmaceutical sector is

reduced further when compared to the term available for the same invention in other jurisdictions.

Compulsory Licensing Having to deal with a strong Compulsory license regime coupled with a very powerful Generic industry is another challenge that is unique to pharmaceutical innovators in India. Although, India has issued only one Compulsory license till date (for Bayer’s sorafenib tosylate in 2012), this decision has nevertheless incentivized many generic players in the market to seek compulsory licenses for patented drugs being sold in India. Even though, the compulsory license applications, which do not satisfy the legal requirements, are being promptly rejected by the patent office, the uncertainty of the fate of a patent in addition to the other challenges discussed above, makes it difficult for an innovator company to assess the value their pharmaceutical patent will generate in the Indian market.

Despite these uncertainties and challenges, probably the sheer size of the Indian market is incentive enough to keep the big pharmaceutical innovators interested in the Indian market. Having said that, in our effort to finding the fine balance between innovation and access to health, are we tipping the balance by over-incentivizing the already powerful generic industry at the cost of domestic innovators, giving them fewer reasons to research, develop and innovate in the pharmaceutical field, is a question we need to seek answer for.

Contact: vinita@bananaip.com Pharma Bio World

Protecting the IP Worldwide, overall technology is flourishing exponentially, specifically in areas of Information Technology, Biotech & Pharmaceutical sciences, Automobiles.

Intellectual Property (IP) is emerging as one of the most fundamental economic forces, where strong IP protection can encourage innovations across various industries. To encourage the pharmaceutical or biotech sector to create new drug molecules, therapy,

Amit Aggarwal Co-founder, Effectual Knowledge Services

Rohit Agarwal Senior Manager, Effectual Services and leads the LifeSciences team.

Ishita Rustagi Manager with LifeSciences, Effectual services.

12 ◄ August 2018

medical devices and other technologies, there is a strong need to protect rights of manufacturing, sales and distribution of the innovative products/processes.

The team at Effectual Knowledge Services talks about Challenges and Strategies faced by the Pharmaceutical industry related to IP.

W

orldwide, overall technology is flourishing exponentially, specifically in areas of Information Technology, Biotech & Pharmaceutical sciences, Automobiles. Intellectual Property (IP) is emerging as one of the most fundamental economic forces, where strong IP protection can encourage innovations across various industries. To encourage the pharmaceutical or biotech sector to create new drug molecules, therapy, medical devices and other technologies, there is a strong need to protect rights of manufacturing, sales and distribution of the innovative products/processes.

For pharmaceutical it takes between 10 and 15 years to develop a new medicine and can cost approximately $2.56 billion for bringing a product to market. Thus, it is important for pharmaceutical scientists to have a better understanding of patent fundamentals. It is imperative to accelerate drug development process and at the same time apply different strategies to extend the life time of the patent to gain economic incentives.

In pharmaceutical industry, generally two types of protection needed: first one is for creating new molecule, composition,

or medical device; and second one is formulation of expired or near to expire molecule or composition. Majority of big-size pharmaceutical companies are increasing their business by creating new molecules, composition or medical devices, whilst the others are enhancing businesses by developing generics and biosimilars.

aacuticals  Callns an tatis Filing patents in pharmaceutical domain is cumbersome activity as the process required investment of huge amount of money and time, however the risk of infringing their inventions is more likely.

The other major challenge is reduced life of pharmaceutical patents because of the need to fulfill all criteria of clinical trials to assure safety and efficacy to regional regulatory bodies such as US FDA. The companies are continuously putting immense efforts to reduce the long time span required for clearing various clinical trial stages.

The high cost involved in R&D means the majority of pharmaceutical companies apply for patent protection during research stages and before clinical trials. The early patenting activity reduces the life of the patents as well as shortens the time available for product marketing. Therefore, the average effective patent life for pharmaceuticals is just 11.5 years, which is much lesser than the ideal 20 years protection.

To overcome the challenges, pharmaceutical companies should consider obtaining patents for the broadest possible scope during the R&D process. The companies can later target to file ‘Methods of use’ and ‘Formulation’ patents during the clinical trial stages or when the product’s use is clearly defined.

In US, the pharmaceutical companies can apply for a term extensions to balance the reduced patent life. Though, the term extensions do not always equal the actual

Pharma Bio World

to soaring population and demands for novel products which positively impacts the demand for innovation in the region.

Artificial intelligence market finds its potential application in drug discovery, as AI plays a vital role in drug identification, discovery, screening, and design.

time lost. The patents can only be extended for half the time period that was consumed for the regulatory approvals and for a maximum patent term of 14 years.

The pharmaceutical companies can also target to develop orphan drugs to treat a rare medical condition referred to as an orphan disease such as Tourette’s syndrome. There are governments and patient organizations such as EURORDIS providing economic incentives such as an extended period of market exclusivity to encourage development and marketing of orphan drugs.

Another approach is filing of “label patents” covering methods or products recited in the FDA-approved drug label.

The label patents cover repurposed drugs targeting new patient population, new disease area, or new dosage forms, dosing regimens. The patent term for such new patents is 20 years from date of filing, which can significantly extend the period of exclusivity for the repurposed drug.

Additional patent protection can also be taken for new routes of administration for known drugs. For example, migraine treatment drug Imitrex (Sumatriptan) by GSK - the patent directed to the original compound expired in 2006, the company later obtained patents directed to Imitrex formulations for intranasal delivery and took FDA approvals.

14 ◄ August 2018

Trade secret is also becoming an increasingly useful tool for pharmaceutical industry particularly in the US. The period of protection conferred by a trade secret can be indefinite. Trade secret entails significant risk, but can aid in speeding up the process of drug development.

Pharmaceutical industry can focus on implementing artificial intelligence (AI), machine learning, and programmed logic in healthcare inventions. AI-based systems allow better diagnosis, cure and treatment of debilitating conditions. This can help in accelerating the process of developing pharmaceuticals and identifying the patients who are most likely to benefit.

Recently in 2018, the AI-powered bionic pancreas secures approval of the FDA to conduct clinical trials for fast acting insulin to cure diabetes Type-1. The device monitors a person’s food intake and the rise in blood sugar levels and releases insulin automatically in accordance with it.

Smart Medical Devices Market size is projected to experience significant growth from 2017 to 2024. Europe smart medical devices market is foreseen to gain significant industry revenue share over the forecast period. As per the Reflection and Orientation Paper, in 2016 European Union contributed USD 43.5 million for the innovation of wearable medical devices, hence, driving the business growth. Asia Pacific is the fastest growing region due

It is interesting to note that in the recent decades, stem cell technologies and personalized regenerative medicine has become increasingly recognized and shows a great potential in enhancement precision medicine. For example, a patient’s own cells can be isolated and differentiated to produce the tissue of interest. Some approaches involve stem cells production for engineering tissue and returning the tissue to the patient. Chimeric antigen receptor (CAR) T-cell therapy has changed the way cancer was treated earlier. It uses patients’ immune cells to target tumours.

Patent filing activity in this area has increased significantly since 2015, with major focus on United States and China market. However, despite of significant research in this area, the technology remains nascent and has a lot of scope of innovation leading to patent protection opportunities.

Conclusion Despite the challenges, there have been several recent accomplishments in the pharmaceutical sector. Continued efforts to build clinical trial design expertise and infrastructure and efforts toward research prioritization will support the future growth of the pharmaceutical industry.

Patents are vital to protect IP owners from significant revenue loss and to safeguard the pharmaceutical industry’s development and innovation in the future. Future priorities are to continue to improve the understanding of developing robust patent system.

Contact:amita@effectualservices.com rohit.agarwal@effectualservices.com ishita.rustagi@effectualservices.in Pharma Bio World

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Protecting IP assets A number of challenges face pharmaceutical companies protecting their IP assets domestically within India, and globally. This article is intended to highlight some key issues facing the global pharmaceutical industry. Indian pharmaceutical companies are particularly wellpositioned to compete globally because of their significant expertise built up over the last 30 or 40 years.

The domestic industry began by serving Indian markets with lowcost generic products with no patent protection. These drugs would not otherwise have been available to the wider population because of cost. Indian companies had (and still have) a competitive advantage relative to foreign pharmaceutical companies because they can produce generic drugs more cheaply than the originator.

The legal IP framework in

India reflected this need to protect the local population and worked well for many years.

However, the advent of The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) between member states of World Trade Organisation (WTO), including India, altered forever the legal and commercial landscape within India for pharmaceutical companies.



acgoun

India has only relatively recently recognised patents for pharmaceutical products but the legal framework has advanced quickly in that time.

The implementation of India’s TRIPS obligations into national law on 1st January 1995 changed the patent landscape radically. Previously, Indian law provided no patent protection for pharmaceuticals. In 1995, the Indian Patent Office first received applications for pharmaceutical subject matter in “mail box” applications. At that time, there were no facilities to examine these applications which were simply afforded a filing date and number.

On 1st January 2005, further amendments to national law enabled the prosecution of pharmaceutical patent applications in exactly the same way as many overseas jurisdictions.

olution o the nian haaceutical inust

Dr Jonathan D.M. Atkinson - Partner, Head of the Asia Team at HGF. HGF Limited 16 ◄ August 2018

As the law in India evolved, so did the nature of the activities of the domestic pharmaceutical companies.

These companies started seeking their own IP protection in India for generic formulations

and synthetic processes. Some companies also started work on research programs to generate new pharmaceuticals and capture relevant IP. Many also looked overseas to the US and European for sales. It is within this context which the wider challenges in the pharmaceutical industry must be considered.

aising the a

Patent systems around the world are becoming harmonised and interconnected. A Trilateral Agreement between the European Patent Office (EPO), United States Patent and Trademark Office (USPTO) and Japanese Patent Office (JPO) has led to cooperation on searching and examination of patents.

Similar approaches to the examination of subject matter are adopted and prior art sharing occurs between these offices.

The Patent Prosecution Highway (PPH) also allows applicants to use examination results in one patent office to streamline the prosecution in another. The PPH agreement includes the patent offices of Europe, US, Japan, China, Korea, Australia and Canada.

One consequence of this cooperation is that standards for assessing patentability have generally been raised to the requirements of the more rigourous countries. The Trilateral Agreement also recognised the need to “raise the bar” and established stricter grounds for allowing patent protection.

echnical challenges

Particular challenges arise in the area of secondary patents. This includes patents for methods of treatment, new formulations, and dosing regimens. Some of these innovations are based on observations made during clinical trials. Secondary patents, although weaker than compound patents, are very important because of the potential additional patent life they afford.

Historically, the test for novelty of subject matter meant that the conduct of clinical trials did not prevent an applicant for subsequently obtaining a patent for inventions arising from Pharma Bio World

them. Indeed, it was quite common for the results of clinical trials to be scrutinised for potential inventions.

Early case law at the Boards of Appeal of the EPO, such as T158/96, confirmed this point.

Following a shift towards more transparency in clinical trials there has been a tendency in the case law for resulting inventions to be open to challenge based on publiclyavailable information. However, in T2506/12, a challenge based on disclosures of clinical trials relating to two known anti-cancer medications was not ultimately successful in prejudicing the novelty of a combination of both medications since, separately, they did not disclose the safety and efficacy of the combination. The prior art effects of clinical trial disclosures can be an issue but inventions arising from trials remain patentable; applicants just need to exercise extreme care.

Stricter assessment of the requirements for patentability causes problems for applicants when considering plausibility and data surrounding a disclosure. In Europe, the origins of this issue can perhaps be traced back to T939/92 which concerned a patent covering a huge number of herbicidal compounds. The Board held that it was not credible that all compounds within the claim scope had herbicidal activity. This author understood from private discussions at the time with senior members of the EPO that an internal policy decision had been taken by the Examining Division to try and control overly-broad chemical patent claims which were becoming prevalent at the time. Broad claims could be challenged on the grounds of lack of inventive step. Reasonable predictions of the relationship between chemical structure and biological activity are in principle possible but it must be credible that substantially all the claimed compounds possess the relevant activity. If not, then the claimed technical effect is considered arbitrary and lacking in an inventive step.

More recently, in T0488/16, the Board decided that it is not always necessary to include experimental data or results in an application but it is essential to demonstrate Pharma Bio World

the technical problem is at least plausibly solved. If, as in that case, the invention relies on a technical effect which is neither self-evident nor predictable or based on a conclusive theoretical concept, at least some technical evidence is then required.

The practice point is that applicants must ensure that the scope of claims is proportionate to the availability of data to support the application. The case law has progressed in the direction of requiring adequate data to substantiate inventions around pharmaceutical activity. This presents an increasing burden to applicants and heightens the tension between seeking an early filing date, when little data may be available, and delaying filing until sufficient data has been acquired but then risking a third party may have filed first.

Legal challenges

Changes in the legal framework also present potential challenges (and opportunities, depending on circumstances) to patent holders. For example, implementation of the Unified Patent Court is likely to alter significantly the patent litigation landscape in Europe when it comes into existence (and this author believes that this should take place soon) because it will immediately enable third-party challengers to invalidate a patent with pan-European effect. Generics will no longer need to seek revocation in each territory where they plan to launch a drug. Similarly, an originator will not need to engage in separate national patent infringement proceedings in each territory where patent infringement occurs. The situation surrounding BREXIT should not prevent the Unified Patent Court coming into existence since the UK has already agreed to sign up to the UPC agreement. A significant change in the litigation landscape is expected when the UPC commences.

In the US, The America Invents Act established post-grant review (PGR) as a further mechanism for challenging the validity of issued patents. Congress intended the PGR process to be similar to European opposition proceedings. A post-grant review can be filed up to 9 months after issue of any

patent with an effective filing date on or after 16 March 2013. Validity of the patent can be challenged on grounds including: novelty, inventive step and written description. Inter partes review (IPR) can be initiated once the period for filing a PGR has expired but is much more limited in the grounds that can be raised. In IPR proceedings only novelty and obviousness may be raised and then only on the basis of prior art consisting of patent or printed publications. The PGR provides potentially fertile grounds for challenges to invalidate issued US patents and is expected to significantly affect the way in which pharmaceutical patent litigation is conducted in the US. The legal framework for pan-European patent term extensions presents another challenge.

The situation surrounding supplementary protection certificates (SPCs) has yet to be clarified under the new UPC regulations.

To date, no new legal framework governing patent term extensions has been proposed to sit alongside the UPC. We do know that the UPC system will apply to SPCs which raises two important issues. Firstly, how will SPCs based on existing and future classical European patents be treated? Secondly, what provisions might be created to govern SPCs based on new unitary patents? At the moment, pharmaceutical companies can only base their future plans on the current framework.

Conclusion

The industry is rapidly changing as originator and generic companies expand their activities into each other’s territory.

Major patent systems around the world are becoming stricter, placing increasing burdens on applicants. Patent law will continue to develop as increasingly complex innovations require deeper consideration of the technical and legal issues they present. The legal framework will also continue to develop as the debate between market exclusivity and public access to medicines continues.

The most significant challenge facing any pharmaceutical company is the ability to judge how those factors will impact on their own future developments.

Contact: jatkinson@hgf.com August 2018 â–ş 17

Internet of Medical Things and changing Healthcare IP dynamics The Pharma IoT concept involves digitalization of medical products and related care processes using smart connected medical devices and IT services (web, mobile, apps, etc.) during drug development, clinical trials and patient care. The outcomes of Pharma IoT in development and clinical trials can employ combinations of advanced technologies and services to create totally new kinds of disease treatment possibilities.



  

The Internet of Things (IoT) ecosystem provides a platform for bidirectional communication between enabling technologies such as sensor, actuator, and communication protocol networks. The feasibility of this technology trend appears to be successful in applications such as smart grids, smart homes, intelligent logistics, and smart towns along with healthcare.

The Internet of Medical Things (IoMT), a healthcare application of the IoT technology, would essentially comprise a network of connected components that monitor physiological data in real time and enables intervention. Figure 1 illustrates the architecture of patient and physician components of this technology.

The implementation framework would potentially transform the clinical practice areas in patient evaluation, clinical decision making and treatment follow-ups. The communication and storage component of system would enable efficient patient information storage, real-time data acquisition, wearable connectivity, and data transfers to control end user applications.

Data analytics components enables data-driven decision processes for cyber physical systems, which remotely connects patients with computer-based systems and facilities at tertiary care centers.

Dr. Yogesh Shelke Medical Professional, Assistant Manager-Technology Research & Advisory Aranca

Arpit Sharma Manager - Technology Research & Advisory Aranca 18 ◄ August 2018

Clinical technologies in IoMT environment would be realized in the form of multiple wellness and health monitoring devices, hospital care devices, wound monitoring swabs, drug delivery and pacing systems which will interact with other machines.

Table 1 lists the key benefits and limitations of IoT implementation in healthcare domain. The foreseen impacts of machineto-machine interaction, data flow and real time intervention solutions will radically

transform the healthcare delivery, affordability and reliability in near future.

Additionally, increased patient engagement in decision making, personalization of treatment plans, and device performance optimization will boost compliance and overall service satisfaction. As a result of this, technology adoption rate will increase in coming years to grow this market to reach $156 Billion by 2020; a primarily growth driver for recent research in sensor, networks, cloud, mobility and big data domains.

Apart from their utility in managing regular health statuses, IoMT have also been used for disease prevention, fitness promotion, and remote intervention in emergency situations. Some IoMT end application areas are discussed as follows: • Building family history at patient and community level • Chronic disease management • Remote assisted living (Tele health) • Wellness and preventive care (Lifestyle assessment) • Remote intervention in emergency • Improved drug management

        The existing medical devices can be transformed into IoMT connected devices to monitor real-time data for patients through enhancements such as bio-sensors, signal convertors, and communication modems. IoMT devices have been conceptualized in various forms of smart wearable devices, homeuse medical devices, point-of-care kits, and mobile healthcare applications, and are able to communicate with medical experts in remote locations. The macrolevel architecture of such devices comprises three layers: local devices, connectivity, and data analytics and solutions as follows: Pharma Bio World

Figure 1: IoMT components

PATIENT

PHYSICIAN Storage device: Data

Image digitiser: Includes

storage hardware

main, auxiliary and document

Physician display:

Used

for remote intervention and

camera/scanner

monitoring

Measurement device: Includes ECG, BP measurement and oxygen monitor

Data analytics:

Network: Used for

Processes

User display:

Displays

Modem: Receives real-time

wireless or wired transfer of data

the patient data from receivers,

data from network

transducers for monitoring

data to mobile or computer screens

Physician camera: Includes main, auxiliary and

Modem: converts digital data

document camera

into electrical signal

Communication network

Home care unit

Figure 1: IoMT Table 1: components IoMT Advantages

and limitations

Report Type

Advantage Report Title l Client Name l Confidential l Month DD, YYYY 





Healthcare Terminal

Patient benefits –

Limitations 

2

Technical challenges –

•

Real time interventions in emergency situations

•

Security of IoT data - hacking and unauthorized use of IoT

•

Cost reduction

•

Lack of standards and communication protocols

•

Reduced morbidity and financial burden due to less follow up visits

•

Errors in patient data handling

•

Data integration

•

Need for medical expertise

•

Managing device diversity and interoperability

•

Scale, data volume and performance

Health care service providers – •

Optimal utilization of resources and infrastructure

•

Reduced response time in case of medical emergency

Device manufacturers – •

Standardization/ compatibility and uniformity of data available

•

Capability to sense and communicate health related information to remote location



Market challenges – •

Physician compliance

•

Data overload on healthcare facility

•

Mobile hesitation

•

Security policy compliance

Table 1: IoMT Advantages and limitations biosensors to measure operational Local systems and control layer Localized intelligence is among the key parameters, converters to generate digital technological shift in IoMT devices. In inputs, smart controllers to make realtime decisions based on physiological localized intelligence, the prime Reportobjective Type Reportintelligent Title l Client Name l Confidential DD, YYYY readings andl Month network interfaces to share is to build a medical device with sensing, predicting the next course of data with other machines / central servers. action, provides secured transmission Innovations in this domain mainly covers and failsafe control capabilities. Current devices in the form of wearable monitors, R&D efforts by hardware manufacturers monitoring implants, and physician are streamlined to develop innovative handheld diagnostic devices.

Pharma Bio World

Device connectivity and data layer The layer primarily focuses on transmitting data from the networked device and storing it in pre-defined data stores in secured manner. Criticality and sensitivity of the healthcare information demands mitigation of cyber risks, hence driving research in encryption technologies, block chain applications and new networking protocols. Networking firms such as Cisco August 2018 ► 19

3

Local patient systems and controls

Device connectivity and data management

Analytic solutions

Figure 2: Architecture of IoMT system

Servers and cloud solutions Real-time analytics

Database solutions Network devices

Firmware/Software

Controllers

Sensors and actuators Physical systems

Typesystem Figure 2: Architecture Report of IoMT

4

Report Title l Client Name l Confidential l Month DD, YYYY

and Qualcomm are quite active in providing advanced technologies at this level along with new entrants.

Analytic solutions layer Irrespective of the types of healthcare solutions enabled, the remote server collects data from multiple devices over the networks.

The key innovations at solutions layer are observed in built-in algorithms to analyze real-time operational data, and electronic health records to provide data driven suggestions to treating physicians. This data-driven diligence helps with diagnostic ability, disease prediction, and implementing preventive measures on mass scale.

The IP filed in this domain covers the softwares, and embedded systems for comprehensive evaluation of data from different sources such as implants and smart devices and teach machines to provide differential diagnosis and treatment options based on patient condition.

20 ◄ August 2018

    Major IP related to IoMT comprises the equipment, materials, design and software, as well as services and/or processes enabling remote monitoring and intervention capabilities.

Software IP related to IoMT includes the algorithms covering data acquisition, transmission and processing to support telemetry applications.

Such control algorithms with embedded software are protectable by patents or copyrights.

Copyright protection covers source code from proprietary applications and programming, but provides competitors the freedom to develop equivalent software by using independently formulated coding techniques.

The functional components of physical layers include hardware and embedded controls that perform sequential tasks in order to sense, convert and transmit vital information. Hardware patent primarily

comprises of sensors, signal convertors, controllers and communication modems.

IP evolution The IP in IoMT technologies were conceptualized in 1970 with a patent filed by both Warner–Lambert and Pacemakers Diagnostics clinic of America to disclose the telemetry and telephone transmission link system, to transmit healthcare data to remote locations. However, actual patent filing activities grew robustly after 1989, with the milestone improvements in biosensing and integration capabilities.

The bio-sensing and integration technologies in connectivity and solution layer captures dynamic physiological data and transmit it through wireless networks.

The IP filings after 1989 marks evolution of telemedicine and IoT devices, which comprise a closed interdependent system of networked sensors, protocols, and cloud computing inventions.

Pharma Bio World

Local patient systems and controls

Device connectivity and data management

Analytic solutions

Figure 3: Key IP assignees in IoMT

Servers and cloud solutions Real-time analytics

Database solutions Network devices

Firmware/Software

Controllers

Sensors and actuators Physical systems

Report in Type Figure 3: Key IP assignees IoMT

5

Report Title l Client Name l Confidential l Month DD, YYYY

The Internet-based medical device and remote healthcare assistance segments first flourished in the US due to the country’s major market share in conventional medical devices. Remote location-enabled technologies were rapidly adapted in the market due to their widespread clinical acceptance and healthcare policies.

Due to this, major corporations opted to protect their inventions in North America, followed by Europe which constitutes 90% and 30% of IP jurisdictional coverage.

Key players also adopted to protect their invention in Japan, Australia, and China market pertaining to growing demand and increasing reliance on tele-health services.

Key players Philips, GE Healthcare, and Medtronic are among leading players in IoMT technology.

Philips offers IoMT products that enable cardiac monitoring, remote patient communication devices, and sensors to detect physiological parameters. GE and Medtronic provide comprehensive Pharma Bio World

integrated products that support cloud-based technologies in existing monitoring devices, implants, and cardiac pacemakers

cited frequentl. The Figure 4 shows total number of citing patents for each key patent family.

Figure 2 shows the key players at various architectural level and their patent publication trend in last five years. Other players such as Siemens and IBM extend solutions in upper layers, which enable data analytics and cloud-based services to biometric data obtained from physical devices and sensors.

Roche and Cerner focus on the integration of smart communication technologies that have the ability to connect diagnostic devices to remote locations.

Recent IP filing focus Analysis of IP filed in last five years reveals that applications in the areas of network connectivity, sensor integration, cloud based data solutions, artificial intelligence enabled diagnostics are on the rise. Synergistic technologies such as 3D imaging, augmented reality enabled patient education tools, encrypted patient record management, point-of-care devices and wearables are also witnessing the spurt in patent filing due to development of dependent technologies.

Milestone innovations Key technological innovations are classified under the medical data handling (US5924074A), remote networking technologies in medical devices (US5867821A), and data capturing sensor technologies (US6024699A) categories.

The following key patents cover the landmark IoMT patents and have been

  The IoT implementation in healthcare domain is currently in a nascent stage of development. Although implementation of this technology is likely to provide a number of advantages; device security, interrupted communication and reliability pose main August 2018 ► 21

Figure 4: Key IP assignees in IoMT 1800

1593

1600

No of citing

1400

1597

1335

1255

1220

1137

1200

906

1000 800

980

885 603

600 400 200 0 US5924074A

US5867821A US6168563B1 US6024699A

US5997476A

US5544649A

US6047259A

US5772585A

US5301105A

US5544661A

INPADOC family member

Figure 5: Key Inventions concerns in mass adoption. The foreseen clinical practices advantages would drive the emergence of new innovations and IP players in this opportunity.

Currently explored areas such datadriven decision making algorithms, disease prediction capabilities, faster and secure data transmission, autonomous healthcare logistics, robot enabled interventions, deep-learning based professional assistance, large capacity storages and integration of device would be key focus in future IP filings. The connected systems are forecast to reduce cost for patients, increase treatment adherence, and offer the advantage of locally smart devices that can control health automatically, would be incremental solution offerings.

22 ◄ August 2018

As long distance connectivity, secure transmission, uninterrupted storage and processing of high volume of data would be major factors governing successful implementation of IoMT; Hence companies providing these services (such as Telecom front end back-haul providers, Cloud storage service providers/ datacenter owners and security solution providers) would be major beneficiary of this trend and likely to emerge as leading IP filers in coming years.

On the other side, tier 2 supplier companies such as Vodafone, Verizon, AT&T, NTT, Sprint would also play a significant role in implementing IoMT. These companies could1. Collaborate with Implantable/ Wearable device manufacturers or doctors; or 2. Develop service business models such as:

• One time fees for implantable device, per person • Monthly recharge for few devices, per person • Family based fitness plans to develop new IP and play a pivotal role.

• Considering the above benefits and challenges, IoMT seems a promising solution to improve healthcare monitoring and treatment outcomes. By leveraging core capabilities in data acquisition, transmission and processing, we believe that telecom front end back-haul providers, Cloud storage service providers/ datacenter owners and security solution providers are set to promote personalized care and improve living standards.

Pharma Bio World

Considerations for Extraction, Stabilization and Quantification by PCR for Sensitive Sample Such as RNA This article talks about careful selection of an extraction system that helps stabilize and protect targets, especially RNA, or which allows for immediate analysis.

T

he accessibility of PCR and qPCR systems has increased to where they are almost considered a commodity product today. This is certainly the case for end-point PCR systems and some qPCR units also allowing researchers to carry out gene expression analysis more conveniently and quickly. This accessibility has been an innovative development in the community and will continue to move research forward for years to come.

There have been concerns with regards to reverse transcriptase (RT-PCR) and real-time RT-PCR analysis of sensitive sample types such as RNA due to the stability of the sample during process and storage. Just how much impact this has had upon the results may go unknown. Recent advances into techniques such as digital PCR and new advances in extraction stabilization systems have sought to address some of these concerns.

Extraction In theory, the extraction process is a relatively trivial matter: disrupt the sample’s cellular integrity and collect the released nucleic acids. However, it is never that simple. Multiple factors must be addressed.

When performing any nucleic acid extraction (especially RNA), stability and integrity of that extract must be considered. Samples being extracted in remote field studies must also take into consideration logistical concerns such as power supply, temperature control, availability to equipment, and shipping if samples are not to be tested onsite immediately.

Andrew J Birnie, PhD Global Life Sciences Product Manager Cole-Parmer Pharma Bio World

Another concern with general tissue extracts is the heterogeneous mixture of cell states and types being sampled or extracted from.

The result of performing an extraction from a mixed population of cell is apparent and will result in a gene expression profile which

represents, at best, an average for that cell population. When considering tissue extracts in diseased or infected sample against wildtype expression, care must be taken to limit the number of wild-type cells in the diseased sample as these may affect the expression profile, or the wild-type cells themselves may have an altered gene expression due to proximity to a diseased or infected cell.

This has previously been documented when bulk extracts are compared with laser microdissected cells. Due to the above, an ability to extract smaller volumes reliably and minimize loss of target material, or in some instances perform expression profiles on one specific cell, has driven the development of singlecell gene expression analysis kits.

The single-cell extraction and gene expression kits typically have few steps and contain reagents for the sample extraction, reverse transcription, a means to inhibit cellsourced RNase and the qPCR components, making it a rapid system. Due to the small number of targets, the extraction process can have an impact upon the results of the real-time RT-PCR which must be performed quickly. Contaminating DNA can be removed with the inclusion of a DNase treatment step, typical of most RNA extraction systems. The advantages of such kits are apparent as there are limited chances to lose sample, and the target can be the exact cell type that should be profiled. A limitation of such kits could be their apparent high cost per extraction, but the possible advantages of gene profiling experiments from one cell cannot be overlooked.

Other more standard kits, such as silica column-based extraction systems that typically need more starting material than single-cell kits, require multiple liquid handling steps and washes, and require additional heating equipment and centrifugation. These type of extraction systems often require a specific kit for a August 2018 â–ş 23

Figure 1: Quantification by PCR has become more accessible but care must be taken when choosing the correct unit for the correct application. sample type or to extract either DNA or RNA. Samples once extracted may be subject to degradation unless stored and treated correctly, especially RNA extractions. These kits are more commonly adopted, perhaps in part to the familiarity of the protocols, performance and the cost per extraction can be less than some other approaches.

Development of new extraction systems has continued and recently a novel extraction system has been introduced to the market requiring only two steps, limiting the manual pipetting error which can occur when multiple pipetting steps are required, and can be completed in three minutes at room temperature. The Arcis Sample Prep Kit provides high-quality, PCR-ready templates without the need for additional laboratory equipment such as centrifuges or hot blocks that are required with other approaches.

The simplified workflow has maintained high yields and the Arcis Sample Prep Kit is compatible with common applications such as PCR (end-point, RT-qPCR), real-time PCR, isothermal amplification (LAMP), sequencing (Sanger, Pyro and 24 â—„ August 2018

Next Generation) and genetic profiling (electrophoresis).

This novel Arcis Sample Prep Kit relies upon smaller volumes of starting material than some column-based systems and, unlike other products, can extract both DNA and RNA at the same time removing the need and cost associated with having separate DNA and RNA extraction kits. The system is not enzymatic and has an added benefit of stabilizing samples at ambient temperatures, both DNA and RNA, for extended periods of time with minimal impact on Cqs or sample integrity. Stability data currently shows 100+ days for DNA and 6 days for RNA when stored in the Arcis Sample Prep Kit at ambient temperatures.

Developments such as the Arcis Sample Prep Kit could enable more robust analysis of transcript levels, especially for those assays which are targeting low target expression, by limiting the degradation common in extracted RNA targets as well as simplify the process of transporting temperature-sensitive nucleic acids between sites as no cold chain logistics would be required in most cases.

Techniques: qPCR Controls are key in any scientific approach and developments in the PCR/qPCR field have attempted to limit spurious amplicon production which negatively impacts upon the target experiment’s efficiencies.

Polymerases have become better immobilized prior to PCR and primer and probe developments have also helped reduce inappropriate binding and amplification.

Buffer formulation for polymerases has also enhanced the performance of polymerases and made them more specific, sensitive and tolerant to difficult templates.

The results of poorly controlled qPCR have been well documented and can have significant impacts on the community and beyond. A well-documented issue which arose from publications in 1998 and 2002 in which an apparent association of the MMR vaccine and bowel inflammation with developmental disorders in children caused a number of incidences where children were not immunized.

A number of court cases soon followed.

Pharma Bio World

developed to quantify DNA or RNA transcript copy number as accurately as possible. dPCR reaction components will be similar to qPCR and often use hydrolysis probes like qPCR. A differentiator from qPCR is that dPCR does not reference an internal control or standard curve instead counting the exact transcript number in the assay. This can increase the accuracy of the measurement when compared to qPCR. dPCR setup differs from qPCR in that after the similar reaction components are assembled, one large reaction mixture will then be partitioned into approximately 20,000 smaller reaction vessels by creating oil droplets within the reaction well. Each oil droplet has within it the required components for PCR to occur, and after amplification each droplet is then scored for presence or absence of the specific target being investigated and a profile for that target generated.

Figure 2: Protection from degradation for RNA extractions is an important and sometimes overlooked aspect of gene In these two papers, it was shown that the qPCR data was not correctly controlled and standard operating procedures were not followed, data analysis was incorrect and there were issues associated with the RT steps before the qPCR. The combined effect caused incorrect conclusions.

This and other cases resulted in scientists in the community generating the MIQE (Minimum Information for Publication of Quantitative Real-Time PCR Experiments) guidelines. The goal was to develop guidelines to promote laboratory consistency, help ensure the integrity of scientific literature, and increase transparency of experiments. These guidelines also provide information necessary for providing the minimum information for evaluating and reporting qPCR experiments.

Pharma Bio World

System (PCR hardware) effects must also not be overlooked when carrying out sensitive assays. In general terms, variability across a PCR/qPCR systems thermal block is best limited to as little as possible as variability in temperature control may impact the result.

Ideally systems with high uniformity should be used to limit data variability. Systems such as the Eco/Prime Pro from Cole-Parmer which utilise a liquid filled block to deliver best in class uniformity would be examples of such systems.

Digital PCR Digital PCR (dPCR) was first developed in the mid-90s and recently has grown in popularity due to investment from some of the larger manufacturers. The technique was

dPCR could still suffer from the issues previously discussed with regards to extraction but will have the advantage of scoring exact transcript number rather than determining this by plotting unknowns against a standard curve. dPCR has also been shown to have advantages in multiplex environments or when high sensitivity is required compared to other techniques.

Conclusion There are several issues to be addressed when attempting to accurately define the transcript level of a specific target, not all of which have been covered here. Careful selection of an extraction system that helps stabilize and protect targets, especially RNA, or which allows for immediate analysis must be considered. The systems used after extraction must also be considered and careful selection regarding system accuracy may also factor into the decision.

Contact: response@coleparmer.in August 2018 â–ş 25

Pharma Technology will be Shaped by New Challenges for Product Manufacturing Pharma technology is rapidly evolving due to requirements and challenges of new products and developments. Biologics and biosimilars and their packaging create more specialised demands for material performance.

This article elaborates on the new developments in pharma technology and the Indian market playing a key role with research and development facilities being increasingly built in India.

Rahul Dev Vice President - India Datwyler 26 â—„ August 2018

W

ith the increasing demands for highly sensitive drugs such as biologics and biosimilars, the requirements for drug packaging and elastomer components are ever-evolving and rapidly changing. The number of biologics stored and administered in prefilled syringes today is constantly increasing. This also triggers a growing complexity of formulations and the surge in novel device designs. Due to the sensitivity of biologics during storage and their complexity during administration, packaging requirements of biologics and biosimilars are creating more specialized demands for material performance. Consequently, market trends indicate a growth in fluoropolymer coated elastomeric closures which help to mitigate risks related to drug compatibility and stability. For therapeutic proteins, the exact chemical make-up and threedimensional conformation can influence the efficacy of the drug. As recognized by the (US) Food and Drug Administration 1 , the interaction of proteins with silicone oil can present a risk to the safety and efficacy of therapeutic proteins.

Conformational changes, degradation and / or aggregation can lead to the inefficacy or immunogenicity of the protein, ultimately impeding or preventing the success of the drug. Therefore, many manufacturers of biologics or biosimilars are already relying on fluoropolymer coated closure solutions today.

However, fluoropolymer coatings need special properties which make them as safe and reliable as possible. They are of particular importance to closures and components for pre-filled syringes.

In storage, the drugs are in constant contact with the rubber component, e.g.

the plunger of a prefilled syringe. When it comes to silicone oil migrating into a prefilled syringe formulation, the plunger has been found to be the larger source of free silicone than the barrel – despite the fact, that more silicone oil is applied to the barrel. 2 Low levels of silicone oil particles in coatings for pharmaceutical packaging components provide advantages for every step of the way in terms of application. They not only make the products safer and more efficient; the reduction or elimination of silicone oils in rubber components and closures can also reduce time-to-market. As authorities such as the FDA recognise the risks which extractables and leachables are posing to sensitive medication, low particle levels can accelerate the approval process.

Cleanroom Manufacturing as standard for state-of-the-art facilities To ensure that (coated) components for pharmaceutical packaging, particularly for biosimilars, are of the highest standard, a look at the manufacturing environment is often worthwhile. A cleanroom manufacturing environment, incorporating state-of-the-art solutions and standards, is crucial. The socalled fully integrated GMP (Good Manufacturing Practice) environment incorporates innovative automated processes and conforms to the highest industry standards. Each zone has been meticulously designed and constructed to prevent bio-contamination and is equipped with material airlocks. State-ofthe-art pass-through washing equipment Pharma Bio World

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1. Immunogenicity Assessment for Therapeutic Protein Products, GUIDANCE. Food and Drug Administration, Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER), August 2014.

2. Felsovalyi et al, J Pharm Sci, 2012,Vol 101(12), p 4569.

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Currently, India’s role and the role of its pharma companies are quite centered around generic medication and the delivery thereof. However, this doesn’t mean that they will continue on this path. Rather we will see a considerable shift towards establishing facilities for research and development. There are several reasons for this: one reason is certainly that the international regulatory authorities have long been observing Indian manufacturing sites closely. On the one hand, this guarantees quality products and a high aspiration for good manufacturing standards. On the other hand, it also creates the desire to further excel in production. The ambition to keep this position as a market leader is strong, resulting in more high-end and state-ofthe-art facilities. This trend is here to stay, as global companies have started to recognize the market’s potential.

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India is one of the most important drivers in the international pharmaceutical market and will continue to grow and strengthen its position. Currently, the market has the highest number of USFDA approvals and with more companies buying from Indian manufacturers, this development will continue.

Datwyler Sealing Solutions is a prime example for introducing high-end products to India. The newly built extension of the current facility in Pune already produces approx. four billion components per year.

It will be fully aligned with Datwysler’s state-of-the-art manufacturing standard First Line and produce highly complex Omni Flex coated elastomer components, eg, for prefilled syringes. This investment paves the way to introducing new pharma technology to the Indian market.

As a result, the market and its biggest customers will be catered to with locallyproduced components, proving that its future and perspectives are set out to be long-lasting and successful.

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India is playing a key role

Many pharma majors are merging with or acquiring Indian pharma companies and are heavily investing in Research & Development. The main focus used to be on production, but now a substantial amount of the annual profits is going into R&D investments. Many of the major global players are also setting up own R&D facilities in India. Next to generics, R&D will become a major stronghold for India in the future.

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has its automatic loading side in one zone and its automatic unloading side in a zone of even higher cleanliness.

In addition, the latest generations of camera inspection techniques are used.

It exceeds the most stringent quality standards of regulatory authorities and is certified to ISO 15378. All production lines operating under the First Line standard are designed to operate under a zero-defect philosophy. The process flow, gowning protocols, personnel and material flow, and state-of-theart automation all result in the lowest endotoxin, bioburden, particulate, and defect levels available in the industry.

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Contact:sealing.ch@datwyler.com

Fort, Mumbai-400 001 Tel.: 91-22-40373636 Fax: 91-22-40373635 E-mail: industrialmags@jasubhai.com

August 2018 ► 27

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 28 ◄ August 2018

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).

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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.

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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

August 2018 â–ş 29

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

Satish agh Chairman Basic Chemicals, Cosmetics & Dyes Export Promotion Council (Chemexcil) 30 ◄ August 2018

D

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

"New targets" are all those targets that are not "established targets" but which have been or are the subject of drug discovery campaigns. These typically include newly August 2018 â–ş 31

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

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

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

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

•• increase activity against the chosen target

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

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

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

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

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

It is more often observed that several compounds are found to have some degree of activity, and if these compounds share common chemical features, one or more pharmacophores can then be developed. At this point, medicinal 32 ◄ August 2018

•• reduce activity against unrelated targets •• improve

the drug likeness or ADME properties of the molecule.

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

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

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

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

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

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

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

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

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

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

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

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

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

4) Structural Elucidation

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

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

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

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

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

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

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

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

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

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

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

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

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

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

••

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

••

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

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

••

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

NOAEL

••

Toxicology testing.

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

Based on preclinical trials, No Observable Adverse Effect Levels (NOAEL) on drugs are established, which are used to determine initial phase 1 clinical trial August 2018 ► 33

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

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

Drug Deliery

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

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

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

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

Contact Chairmanchemexcil.gov.in

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Pharma Bio World

nSMOL - A Novel Approach to Quantification of Therapeutic Monoclonal Antibodies!                                                                                                         

        Pharma Bio World

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                                                                                                                                                                                                                                                                 

                                                                                                                                                                                                                               August 2018 ► 35

                                                           

                                                                               

                                                                                          

                                                                                                                                                                              

                                    36 ◄ August 2018



Pharma Bio World

news features

New supporting programs at analytica Anacon India and India Lab Expo this year in Hyderabad • Launching new conference ‘Smart Lab Summit’ • Buyer Seller Forum continues to offer business matchmaking service to exhibitors and visitors • Seminar on ‘Analytical Solutions for Life Sciences Research‘ to be jointly organized with Indian Analytical Instruments Association More than 300 companies will be exhibiting at India’s leading trade fair for laboratory technology, analysis, biotechnology and diagnostics industry displaying the best of the technologies.

It comprehensively covers the entire value chain for pharma, food, chemical, industrial and research laboratories. The trade fair is accompanied by compelling supporting programs to further enhance the visitor experience.

Co-Location brings benefits

For the second time in a row, the co-location with PHARMA Pro&Pack Expo brings a pool of manufacturers and suppliers of pharmaceutical machinery, laboratory and analytical equipment to analytica Anacon India and India Lab Expo. Buyers and trade visitors of analytica Anacon India and India Lab Expo will benefit from attending product segments of PHARMA Pro & Pack Expo and vice-versa. This cross-display of technology will allow visitors to witness a wider range of exhibits and thus, will position the three trade fairs as the most important gathering for the pharmaceutical machinery, analysis and laboratory industry.

New: Smart Lab Summit

Visitors to analytica Anacon India and India Lab Expo have the opportunity to engage themselves in a knowledge based forum – Smart Lab Summit, which will be a talking point with respect to latest products, technologies and innovations concerning the laboratory and research & development Pharma Bio World

sector. This will be a top notch forum with a gathering of scientists and key industry experts sharing deep insights about their industry enabling a strong interactive and engaging platform with the audience.

Growing interest for Buyer-Seller Forum: 1,000 meetings expected The buyer seller forum has been an integral supporting program at the trade fair as it involves focused business discussions between the buyers and sellers of the technology. The one-toone meetings facilitate direct contact between exhibitors and buyers from domestic and international markets through prescheduled meetings. This tailored match-making platform allows exhibitors to connect with possible business partners filtered by branch, position or companies. In return, it allows visitors to search for specific applications or brands. In this edition, more than 1,000 meetings are expected to take place during the show days.

Seminar: Analytical Solutions for Life Sciences Research Attendees will also benefit from an additional supporting program at the analytica Anacon India and India Lab Expo. The seminar on Analytical Solutions for Life Sciences Research will lead to informative sessions and discussions pertaining to key analytical solutions compatible with life sciences and research. The attendees to the seminar will take away important insights about the latest technologies and the best of their applications.

“Year on year, we have been receiving an overwhelming response for our supporting programs. This year, we are delighted to launch a new conference, ‘Smart Lab Summit’ keeping in view the feedback of the industry. We are confident that our attendees will witness a balanced mix of latest technologies and knowledge-rich

supporting programs, making the most of their visit to the trade fairs.”, Bhupinder Singh, CEO, Messe Muenchen India, summing up the event.

About analytica Anacon India and India Lab Expo analytica Anacon India addresses the rapidly growing Indian market with exhibition sectors for analysis, laboratory technology, biotechnology and diagnostics. It is being held in conjunction with India Lab Expo, one of India’s leading trade fairs for analysis, laboratory technology and biotechnology.

The next events take place from September 6 to 8, 2018 in Hyderabad.

About analytica worldwide

Messe München is the world’s leading trade fair organizer for laboratory technology, analysis and biotechnology: Part of the analytica network are the trade fairs analytica China, analytica Anacon India and India Lab Expo in Mumbai and Hyderabad, analytica Vietnam and analytica Lab Africa.

Messe München

Messe München is one of the leading exhibition organizers worldwide with more than 50 of its own trade shows for capital goods, consumer goods and new technologies. Every year, a total of over 50,000 exhibitors and around three million visitors take part in more than 200 events at the exhibition center in Munich, at the ICM – Internationales Congress Center München and the MOC Veranstaltungscenter München as well as abroad. Together with its subsidiary companies, Messe München organizes trade shows in China, India, Brazil, Russia, Turkey, South Africa, Nigeria, Vietnam and Iran. With a network of associated companies in Europe, Asia, Africa and South America as well as around 70 representations abroad for over 100 countries, Messe München has a global presence.

August 2018 ► 37

press release Get ready to witness the best of pharmaceutical New supporting programs at analytica Anacon machinery and allied technologies in Hyderabad India and India Lab Expo this year in Hyderabad Under the new management of Messe Muenchen India, the leading exhibition on pharma processing & packaging machineries – PHARMA Pro&Pack 2018 is expected to feature over 100 exhibitors and attract more than 3,000 quality trade visitors from 6-8 September 2018 at HITEX Exhibition Centre in Hyderabad.

Taking place at the pharmaceutical hub of India- Hyderabad, which is home to about 1000+ pharmaceutical companies, the exhibition will be attended by top decision makers. Having a rich experience of organizing professional events on various industries, Messe Muenchen India is also organizing analytica Anacon India and India Lab Expo simultaneously with the trade fair which is expected to attract over 300 exhibitors and more than 8500 trade visitors.

In order to ensure high potential buyers, Pharma Pro&Pack 2018 will be hosting top buyers from across country via the hosted buyer program.

Bhupinder Singh, CEO of Messe Muenchen India said: “We are delighted to offer one solid trade platform for the domestic & international suppliers and buyers. In order to expand our reach and network, we are organizing promotional roadshows across India, well ahead of the trade fairs at Ahmedabad, Bengaluru, Chennai, Puducherry, Visakhapatnam and Hyderabad.”

Mahendra Mehta, President of Indian Pharma Machinery Manufacturers Association (IPMMA) stated: “The response of the industry has been overwhelming and we have participation from all key industry leaders. To ensure high-quality buyers at the show, we are organizing a hosted buyer program this year as well. Our synergies with analytica Anacon India and India Lab Expo will also benefit our participants.”

The exhibition has garnered whole-hearted support from leading trade associations and media publications in the country. Some of the distinguished personalities namely Mr. Kaushik Desai (Chairperson- FAPA & Secretary General- IPEC India), Mr. Chakravarthi AVPS (CEO & MD - Ecobliss India Pvt Ltd), Dr. S. B. Rijhwani (MD- Preomed Laboratories Pvt Ltd), Mr. S V Veerramani (Chairman & MD- Fourrts Laboratories Pvt Ltd), Mr. Sanjit Singh Lamba (MD - Eisai Knowledge Centre), Mr. Daara Patel (Secretary General – IDMA) & Mr. S.M. Mudda (Chairman – Regulatory Affairs Committee at IDMA) are the advisory committee members of Pharma Pro&Pack 2018.

“This year, we have a wider participation and encourage all industry professionals to come and join the trade fairs and take business to new heights this year.” Concluded Singh.

Organized by Messe Muenchen India, PHARMA Pro & Pack Expo will take place from September 6-8, 2018 at HITEX Exhibition Center in Hyderabad. The event is co-located with analytica Anacon India, India Lab Expo.

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More than 300 companies will be exhibiting at India’s leading trade fair for laboratory technology, analysis, biotechnology and diagnostics industry displaying the best of the technologies. It comprehensively covers the entire value chain for pharma, food, chemical, industrial and research laboratories. The trade fair is accompanied by compelling supporting programs to further enhance the visitor experience.

Co-Location brings benefits For the second time in a row, the co-location with PHARMA Pro&Pack Expo brings a pool of manufacturers and suppliers of pharmaceutical machinery, laboratory and analytical equipment to analytica Anacon India and India Lab Expo.

Buyers and trade visitors of analytica Anacon India and India Lab Expo will benefit from attending product segments of PHARMA Pro & Pack Expo and vice-versa. This cross-display of technology will allow visitors to witness a wider range of exhibits and thus, will position the three trade fairs as the most important gathering for the pharmaceutical machinery, analysis and laboratory industry.

New: Smart Lab Summit Visitors to analytica Anacon India and India Lab Expo have the opportunity to engage themselves in a knowledge based forum – Smart Lab Summit, which will be a talking point with respect to latest products, technologies and innovations concerning the laboratory and research & development sector. This will be a top notch forum with a gathering of scientists and key industry experts sharing deep insights about their industry enabling a strong interactive and engaging platform with the audience.

Growing interest for Buyer-Seller Forum: 1,000 meetings expected The buyer seller forum has been an integral supporting program at the trade fair as it involves focused business discussions between the buyers and sellers of the technology. The one-to-one meetings facilitate direct contact between exhibitors and buyers from domestic and international markets through prescheduled meetings.

This tailored match-making platform allows exhibitors to connect with possible business partners filtered by branch, position or companies.

In return, it allows visitors to search for specific applications or brands.

In this edition, more than 1,000 meetings are expected to take place during the show days.

Seminar: Analytical Solutions for Life Sciences Research Attendees will also benefit from an additional supporting program at the analytica Anacon India and India Lab Expo. The seminar on Analytical Solutions for Life Sciences Research will lead to informative sessions and discussions pertaining to key analytical solutions compatible with life sciences and research. The attendees to the seminar will take away important insights about the latest technologies and the best of their applications.

Pharma Bio World

Multi-point Full Body Bottom Cake Discharge The pharma and fine chemicals manufacturing sectors have to face the challenge of impurities below PPM (parts per million) levels. A clean centrifuge is a must.

ACE offers full dome opening machines in its entire range of basket sizes. The simplicity of the bottom discharge arrangement is also taken care of. The multi-point full body bottom cake discharges without sweepers, the hydraulic scraper, the cake sensor, the zero speed interlock, the safety switches, the anti-vibration tripper, the DIN pressure test for air-tight operation, nitrogen purging with oxygen analyser, the GMP version, are all a part of the ACE bottom discharge centrifuge.

For more information, please contact:

Separation of Powders & Liquid Slurries The Finex Ultima offers large movements in capacity, accuracy, noise levels and upgradeability over spring separators.

These high performance separators offer a costeffective solution to any requirement, including sizing, scalping, safety screening, dewatering, and grading or product recovery.

It improves product quality through accurate particle size separators; increases productivity with higher capacities, and improves operator health and safety by lowering noise levels.

They are available in sizes 750, 1,000, 1,200 and 1,500 mm.

For more information, please contact:

ACE Industries (India) Pvt Ltd 118 Alpha Indl Estate Marol Military Road, Andheri (E) Mumbai 400 059 Tel: 022-42258000 E-mail: ace_centrifuges@yahoo.co.in

Russell Finex Pvt Ltd A-1201 Rustomjee Adarsh Regal Adarsh Vihar Complex, Off Marve Road Malad (W), Mumbai 400 064 E-mail: sales.rfsf@russellfinex.com

Integrated Wet Granulation Line Prism integrated granulation lines as per current GMP requirements is fully contained during processing to protect operators and environment. Also improves productivity through closed materials transfer, automation, increase yields and efficient cleaning procedures.

An integrated granulation line for solid dosages is available from 2 to 1,200 litre working capacity; closed process technology for grading, mixing, granulating, drying, milling, blending and tabletting; reduced amount of transfer operation; better containment for highly potent materials; materials transfer by vacuum transfer system; and sophisticated PLC controls with HMI touch screen.

For more information, please contact: Prism Pharma Machinery Plot No: 3713, Phase IV GIDC, Vatva, Ahmedabad Gujarat 382 445 Tel: 079-29096204 Fax: 91-079-25841623 E-mail: mkt@prismpharmamachinery.com sales@prismpharmamachinery.com

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August 2018 â–ş 39

Fluidized Bed Granulation & Pellet Coating Prism fluid bed processing involves drying, cooling, agglomeration, granulation and pellets coating of particular materials. It is ideal for heat sensitive and non-heat sensitive products in pharma, biotech, nutraceuticals, chemicals and other industries.

They are available in 2 to 1,200 litre working capacity; wurster coater – bottom spraying system for pellets and granules coating; single pot technology for mixing, granulating, drying and pellet coating; precise flow rate spray system with atomised spray gun and peristaltic pump; easy mechanism to change from process of granulation to coating; sophisticated PLC controls with HMI touch screen; top spraying system for granulation; etc.

For more information, please contact: Prism Pharma Machinery Plot No: 3713, Phase IV, GIDC Vatva, Ahmedabad, Gujarat 382 445 Tel: 079-29096204 Fax: 91-079-25841623 E-mail: mkt@prismpharmamachinery.com sales@prismpharmamachinery.com

Ultra EC Brushless Motors with Ultra High Torque Portescap is globally ISO 9001:2008 certified and their production site in India is also ISO 14001:2004 and OHSAS 18001:2007 certified. Portescap offers 2 more new length sizes under its ECT range of Ultra EC Brushless Slotless motors: the 35 mm 22ECT35 and the 48 mm 22ECT48.

These new 22ECT motors along with higher torque capacity are light in weight and come in a compact package which helps in further miniaturization of the customer application.

Their 22ECT motors are specially optimized for high continuous torque at low to medium speeds, maximizing power between 10K and 20K rpm.

The 22ECT motors are powered by their patented Ultra Coil Technology and patented multipolar rotor design, which provides torque of up to 41.6 mNm. The 22ECT motor weighs almost 28 per cent lesser than comparative motors and it is the lightest 4 pole motor which can be adapted in most applications in the medical and industrial markets especially in industrial hand tools where high torque lightweight motor is required to reduce the fatigue of the user. The new 22ECT is also an ideal choice for applications such as humanoid robots, lab automation equipment, electric grippers and land surveying devices.

Portescap succeeds in providing a high quality, long lasting and high performance brushless motor which is an ideal choice for geared applications because of its minimal speed drop and low motor heating under load. Their low inertia makes them an exceptional option for applications requiring fast stopping, starting and acceleration. The new 22ECT motors are available with hall sensors and a total of 3 different coils to match your speed and voltage requirements. Upon request, Portescap can also provide options for customization including gearboxes, encoders, coil variations and mechanical interface modifications.

For more information, please contact: Portescap Unit No: 2, SDF-1 SEEPZ-SEZ Andheri (E), Mumbai 400 096 Tel: 022-42006200 Fax: 91-022-42004036 E-mail: sales.asia@portescap.com

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Pharma Bio World

Pilot Ointment Plant

Spherodizer

Pilot ointment plant is available in standard cGMP and customised models with SS304/316/316L contact parts.

It caters to the demand of cosmetic and pharma industries for cream/ointment manufacturing fabricated with high grade, rust-proof materials attuning to international quality standards.

Precision engineered with high strength and superior functionality.

For more information, please contact: IPEC Engg Pvt Ltd Plot No: 5175, GIDC Ankleshwar, Gujarat 393 002 Tel: 02646-221175 Telefax: 91-02646-225175 E-mail: md@ipecengg.com

tensile

Spherodizer is particularly designed to make sphere pellets from extruded materials and enables uniform coating of pellets for accurate free-flow filling into capsule/drug applications within the pharma industry require consistent smooth surface particles, with a narrow size distribution. Feed extruded material to the spherodiser falls into the high speed rotating chequered plate within cylinder shell and small sharply-edged pyramids which cut the feed granulation to length, than centrifugal and gravitational forces create a fluidised ring of these particles with these impacts, they are reformed into spheres with a slight surface densification.

For more information, please contact: Prism Pharma Machinery Plot No: 3713, Phase IV, GIDC, Vatva Ahmedabad, Gujarat 382 445 Tel: 079-29095204 Fax: 91=079-25841623 E-mail: mkt@prismpharmamachinery.com

Liquid Filler A Macofar LF 202 attached to a Promatic PC 4000 continuous motion cartoner is latest member of Romaco’s Macofar LF product family was likewise designed for processing non-sterile liquids and is ideal for filling not only pharmaceuticals and cosmetics but also nutraceuticals. To meet the requirements of such diverse applications, the Macofar LF 202 can be equipped with various filling, check and closure systems. The version with a table top design has two closing stations to enable dosing caps to be fitted to bottle screw caps, for instance.

With a max output of 12,000 bottles per hour, the Macofar LF 202 is up among the leading performers at high speeds. The actual production speed always depends on the bottle size and the filling volume, which ranges from 0.5 to 500 millilitres. The positive bottle handling principle and the positive transfer of the stoppers and caps by means of pick and place guarantee a highly reliable process whatever the application. If necessary, the Macofar LF 202 can also be equipped with laminar flow or supplied in an ATEX version.The filled and stoppered bottles are transferred to Romaco’s Promatic PC 4000 continuous motion cartoner and packed in cartons at a max speed of 250 units per minute. In addition to the obligatory leaflet, various medical devices such as spoons or pipettes can be inserted depending on the customer’s requirements.

For more information, please contact: The 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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Gas Isotope Ratio MS Measure isotope signature with extreme precision and sensitivity to provide the unique insight into the history and origin of compounds with Thermo Scientific isotope ratio mass spectrometry.

Combine all isotope ratio mass spectrometry applications in a single analyser. The Thermo Scientific Delta V IRMS systems combine outstanding sensitivity with excellent linearity and stability to address applications as diverse as the detection of honey adulteration by EA-IRMS to δ13C analysis of PAHs in soil with GC-IRMS. Get the highest sensitivity and precision for the determination of isotope ratios with the Thermo Scientific MAT 253 stable isotope ratio mass spectrometer. It provides a flexible and open platform for the connection of inlet systems and preparation devices for the smallest amounts of sample in IRMS. 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 E-mail: sagar.chavan@thermofisher.com

New Xelum R&D Bosch Packaging Technology offers its R&D device for the continuous production of oral solid dosage (OSD) forms. The platform ensures a short time to market and optimum dosing of APIs. As opposed to the common complex mass flow rate, excipients and active ingredients are dosed as a discrete mass in the Xelum R&D. This makes it possible to dose even smallest amounts of APIs of less than one per cent. The system doses, mixes and granulates individual packages, so-called X-keys, which continuously run through the process chain and are removed successively from the machine as packages into bins.

Current continuous production systems for wet granulation mostly use twin screw granulators. The Xelum system relies on fluid bed processors developed by the Bosch subsidiary Hüttlin. In the fluid bed, granulation and drying take place in the same process chamber. Pharma manufacturers obtain granulates with the desired characteristics including unimodal particle size distribution, as well as excellent flow and tableting properties combined with high production yields.

The controls of the Xelum R&D correspond to a modern production system. All relevant process parameters are continuously recorded.

The production and the product transfer, as well as the cleaning process are recipe-controlled and ensure reproducible results. The user-friendly handling of the system is complemented by a DoE (Design of Experiment) software support.

For more information, please contact: Commha Consulting GmbH & Co KG Poststraße 48 D-69115 Heidelberg, Germany Tel: +49 6221 18779-32 E-mail: bosch@commhaconsulting.com

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Pharma Bio World

Force & Torque Measurement A leading designer and manufacturer of force and torque test equipment; Mecmesin offers precision test instruments and systems that are accurate, reliable and has excellent value for money.

Shreedhar Instruments provide a tailormade service creating the ideal testing platform, which is robust, easy to operate and gives top level performance time after time.Features fast and easy measurement of torque like bottles for tablets and syrups; fast and easy measurement of force like penetrability testing for vials as per USP; CRC testing; force testing for prefilled syringes, cartridges, etc.

For more information, please contact: Shreedhar Instruments 16 Shreeji Krupa Society Opp: MGVCL Circle Office Next to GMERS Medical College Gotri Road, Vadodara, Gujarat 390 023 E-mail: sales@shreedhargroup.,com

Radial Diaphragm Valves Cipriani Harrison’s radial diaphragm valves are made from forged AISI 316L as per ASME BPE specifications. Radial diaphragm valves are widely accepted due to their unique design features which minimise dead legs in critical pharma and biotech operations. The aseptic design minimises hold-up volumes helping to avoid contamination. The diaphragms of these valves are compliant with FDA 177.2600 and UJSP Class VI. The available sizes ranges from ½” to 2” both in manually and pneumatically actuated versions.

For more information, please contact: Cipriani Harrison Valves Pvt Ltd Sub Plot No: 2, B/s Margin Impex Ltd Nr Phase IV, GIDC Estate V U Nagar, Anand, Gujarat 388 121 Tel: 02692-235082, 235282 Fax: 91-02692-236385 E-mail: info@harrisonengineers.com

Dry Granulation – Roller Compactor The Roll Compactor machine is used for increased bulk density, making granules dust-free processing and reducing particle size of pharma ingredients in pharma, API, food and chemical industry for densification and granulation.

They are available in 1 to 500 kg working capacity. The material in form of powder passes through the two counter rotating rolls of roller compactor under very high pressure. In line dry granulation with powder loading system, roll compactor, granulator and grading machine. It has uniform force distribution granulation with hydraulic pressure; water cooling system for rolls and hopper; and vacuum deairation and pre-compression.

For more information, please contact: Prism Pharma Machinery Plot No: 3713, Phase IV, GIDC Vatva, Ahmedabad Gujarat 382 445 Tel: 079-29095204 Fax: 91=079-25841623 E-mail: mkt@prismpharmamachinery.com

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Walk-in Humidity Chamber Mack Pharmatech Pvt Ltd offers walk-in humidity chamber in the temperature of 20°C to 60°C and humidity of 40%RH to 95%RH; accuracy ±0.2°C and ±2.0% RH. and uniformity ±1.0°C and ±3.0%RH control system PLC (Allen Bradley).

Test is suitable for 25°C and 60%RH, 30°C and 65%RH, 40°C and 75%RH, and 30°C and 75%RH. Features PLC-based control system; 21 CFR software; HMI (touch screen display); standby refrigeration system; standby humidity system; imported hygroflex sensor; 8+8 scanner; GSM technology; hooter system; full-view glass door; bullet feet levelling legs; tray spacing every ½” adjustable; GMP Model.

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

Strainer & Filtration Solutions Including Airpel and Plenty brands, the vast array of products within the SPX FLOW filtration portfolio forms one of the biggest collection of filtration solutions available from a single supplier in the marketplace. Manufactured in Western Europe, the quality, durability and effectiveness of SPX FLOW filters and strainers have, for a long time, made them the solution of choice within industries such as oil and gas, water and wastewater, petrochemical, automotive and power generation. The diverse range of filtration solutions includes single, dual and multi-basket designs for pressures up to 50 bar; automatic and self-cleaning filters, back-flushing strainers, and models in a full range of sizes up to 36”.

Standard, ‘commodity’ models are complemented by fully engineered, customized solutions, fabricated to meet customer needs in a range of materials including cast iron, cast steel, SS, duplex and super duplex.

Large filtration areas reduce pressure drop and the amount of cleaning required, while quick release covers promote rapid and easy maintenance to reduce any process downtime. Duplex strainers provide two filtration chambers with an integral flow changeover valve, enabling cleaning and replacement of baskets to be carried out without any interruption to the flow and providing that one of the chambers is always in operation for continuous service. Models also have a compact design to offer a small footprint and easy installation.

From cost-effective, standard models to custom-fabricated solutions; SPX FLOW has the experience and capability to deliver value, benefit and complete peace of mind to its customers.

For more information, please contact: SPX International Ltd Lodge Park House Kettering Parkway Kettering Venture Park Kettering NN15 6XU, U.K. Tel: +44 (0)1604 889921 E-mail: Maryanne.Johnson@spxflow.com

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Pharma Bio World

Fluid Bed Processor The system is based on air suspension technology with GMP compliance. The SFBP is designed for drying/ granulation/coating of powders/granules/ pallets (capable of being fluidised) by means of top spray or bottom spray.

During the process fluids are sprayed through air atomising spray gun while fluidising the material in the expansion chamber. The drying is done with filtered, heated and dehumidified air.

For more information, please contact: Sunsai Pharma Equipments Pvt Ltd Plot No: 1, Survey No: 77 Nr Laxmi Indl Estate Valive Phata, Sativali Road Vasai (E), Dist: Thane Maharashtra 401 208 Tel: 0250-3200130 E-mail: sunsai.pharma@rediffmail.

Weir Diaphragm Valves Cipriani Harrison’s weir diaphragm valves are made from bar stock/ forging and cover a range of sizes from 1/2” to 1”.

These valves are made as per the ASME BPE specifications. All the elastomers used for the diaphragms (Viton, EPDM, PTFE, Buna) are FDA approved USP Class VI Grade rubbers are also available on request. The standard surface finish of the valve is 0.4Ra and 0.2Ra available on request. Cipriani Harrison’s diaphragm valve utilises a patented new diaphragm design called hygieniseal.

For more information, please contact: Cipriani Harrison Valves Pvt Ltd Sub Plot No: 2, B/s Margin Impex Ltd Nr Phase IV, GIDC Estate V U Nagar, Anand Gujarat 388 121 Tel: 02602-235082, 235282 Fax: 91-02692-236385 E-mail: info@harrisonengineers.com

Booster Pumps (CMB Series) The CM booster pump is one of the highly efficient booster pumps offered by Grundfos. Combined with a high efficiency motor this innovative horizontal multi-stage centrifugal pump is designed to cover a wide range of applications. Its built-in thermal protection enables the pump to handle liquid temperatures ranging from 20°C to 120°C. CM booster pump’s electro-coated cast iron parts with corrosion and wear-resistant SS components along with dry running protection gives this pump a long life. CM booster pumps with pressure controller for constant water pressure is ideal when space is a constraint near overhead tanks and can also be installed inside homes.

It is also supplied with pressure tank in which the pump will start when the water pressure drops below the pre-set level and stops once the pressure reaches the pre-set level. CM boosters makes minimal sound even when the auto On-Off feature is continuously under operation.

Available in many variants like CMB Pressure Manager 1, CMB Pressure Tank, CMB with Pressure Switch, etc, these pumps can be used for pressure boosting for home and gardening, supplying water from shallow wells and many more

For more information, please contact: Grundfos Pumps India Pvt Ltd 118 Rajiv Gandhi Salai Thoraipakkam Chennai 600 097 Tel: 044-45966800 Fax: 91-044-45966969

Pharma Bio World

August 2018 ► 45

Humidity Chamber Mack Pharmatech Pvt Ltd offers humidity chamber in the temperature of 20°C to 60°C and humidity of 40%RH to 95%RH; accuracy ±0.2°C and ±2.0% RH. and uniformity ±1.0°C and ±3.0%RH control system PLC (Allen Bradley).

Test is suitable for 25°C and 60%RH, 30°C and 65%RH, 40°C and 75%RH, and 30°C and 75%RH. Features PLC-based control system; 21 CFR software; HMI (touch screen display); standby refrigeration system; standby humidity system; imported hygroflex sensor; 4+4 scanner; GSM technology; hooter system; full-view glass door; bullet feet levelling legs; tray spacing every ½” adjustable; GMP Model.

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

Solar Pumps Grundfos has always been a forerunner in developing sustainable pump solutions that not only protect our water resources, but also save on the energy consumed by the pumps. To do so, they have developed pumping systems that are capable of utilizing renewable energy to operate.

They are: SQFlex Pumps: Submersible Pumping System The SQFlex system is an environmentally-friendly water supply system developed by Grundfos. With its built-in electronics and protections, the pump is compatible with both DC and AC power supply without requiring an external inverter. The solar submersible SQFlex pumps are fitted with a permanent magnet motor, which enables the efficient use of solar energy.

The SQ Flex pumps can be adapted to any water supply need according to the conditions of the installation site as it is very light weight and flexible with regard to the energy supply and performance.

Smart Solarz is a solar powered self-priming pump, which is manufactured for domestic purposes. It comes in play where the power supply is erratic. It is extremely lightweight and easy to install. Also to prevent corrosion, the wet parts of the pump are made of food grade engineered polymers. These pumps are best suited for houses and buildings, who have a max of two additional floors apart from a ground floor, making it ideal for farmhouses, beach houses and can also be used in rural and semi-urban areas.

It operates with solar panels of 250 W / 36 V (open circuit) and has a 150 W \ 24 V BLDC motor.

For more information, please contact: Grundfos Pumps India Pvt Ltd 118 Rajiv Gandhi Salai Thoraipakkam Chennai 600 097 Tel: 044-45966800 Fax: 91-044-45966969

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Pharma Bio World

Pressure Relief Valve

Isotope Ratio Infrared Spectrometry CORTEC, a leading manufacturer of high quality API chokes, valves and manifolds offers its new CRV26 pressure relief valve (PRV).

The CRV26 PRV is a product of the CORTEC Fluid Control division of CORTEC, which provides a complete line of high-end valves designed and manufactured according to specific project specifications. CRV26 PRV is engineered to protect drilling systems against the dangers of over-pressurization and is the first of its kind to be rated to 10,000 PSI systems. The CRV26 PRV is suitable for frac system relief, mud pump relief and managed pressure drilling (MPD) and is compatible with API 6A and NACE MR0175 requirements.

For more information, please contact: CORTEC Fluid Control 208 Equity Blvd Houma, LA 70360, U.S.A. Tel: +1 985-223-1966 Fax: 985-223-1936 E-mail: sales@uscortec.com

Sparkler filter is available in standard cGMP and customised models with SS-304/316/316L contact parts. Filtration is done under positive pressure. Sparkler filter is provided with safety valve and sample collection device. They are available in Models 8”, 14”, 18”, 24” and 30” dia as per client’s requirements.

For more information, please contact:

Pharma Bio World

This analyser empowers you to make profound scientific discoveries in a wide variety of research fields like greenhouse gas monitoring, ecology and plant science, volcano monitoring, carbon storage and sequestration.

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 E-mail: sagar.chavan@thermofisher.com

Vibro Sifter

Sparkler Filter

IPEC Engg Pvt Ltd Plot No: 5175, GIDC, Ankleshwar, Gujarat 393 002 Tel: 02646-221175 Telefax: 91-02646-225175 E-mail: md@ipecengg.com

Utilise state-of-the-art mid-infrared spectroscopy with the Thermo Scientific Delta Ray Isotope Ratio Infrared Spectrometer (IRIS) that enables simultaneous determination of 13 concentration, δ C and δ18C of CO2 at ambient concentrations with a precision as low as 0.05%.

The vibro sifter works on gyratory principle.

Gyro motor gives horizontal, vertical and tangential component of vibration due to which material spread over the screen starts rotating throughout the periphery and gets sieves from the attached mesh.

Sunsai Pharma Equipments Pvt Ltd offers Vibro Sifter.

For more information, please contact: Sunsai Pharma Equipments Pvt Ltd Plot No: 1, Survey No: 77 Nr Laxmi Indl Estate, Valive Phata, Sativali Road Vasai (E), Dist: Thane, Maharashtra 401 208 Tel: 0250-3200130 E-mail: sunsai.pharma@rediffmail.com

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Integrated Line for Tableting & Packing Dishwasher Tabs Romaco Kilian and Theegarten-Pactec offers an integrated solution for tableting and packing triple-layer dishwasher tabs together with an AZO powder feeding system. The powerful Kilian KTS 1000 is tailor-made for processing corrosive, abrasive or acidic products. The dishwasher tabs are transferred to the Theegarten-Pactec FPC5 and wrapped in flow packs with a max output of 1,500 tablets per minute. In addition to numerous industrial applications, the Kilian KTS 1000 is also ideal for the food and cosmetics segments.

The extra-robust KTS 1000 tablet press is offered in three different configurations. The 3L model for compressing triple-layer tablets is shipped by Kilian with three fill shoes and four compression stations. The tablet press achieves compression forces of up to 120 kN with a pitch circle of 840 mm. Targeted measures reduce in-process vibration to a minimum. The patented, wear-free punch brake magnets and hydraulic overpressure protection enable an even more reliable process. Thanks to its dedicated tooling and optimised product feeding system, the Kilian KTS 1000 compresses even sticky or poorly flowing powders efficiently.

For more information, please contact: The 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

Air Cleaner Catering to large indoor premises of up to 10,000 sq ft per unit, CC 6000 air cleaner is one stop solution for dusty environments and large indoor premises such as pharma facilities, food factories, heavy industry, warehouses, offices, supermarkets, etc. With flexible installation options for both mobile and stationary needs, the unit can also be ceiling mounted.

Designed and engineered in Sweden, the air cleaner is equipped with E11 filter upgradable to H13 HEPAcapable of removing the smallest and most dangerous particles from the air eliminating tobacco smoke, weld smoke, construction dust, asbestos and particles of all sizes down to ultrafine. CC6000 comes equipped with advanced molecular filtration capabilities that include activated and impregnated carbon filters for odour and gas phase contaminant removal. This helps in removing bad odours, smoke, and corrosive gases. Molecular filtration using adsorption techniques is the industry accepted method to remove the corrosive agents from the air. The air cleaner is even efficient in reducing the average temperature in high ceiling rooms, with carbon upgrade available to remove unwanted odours.

With an air flow capacity of up to 6000 mÂł/h, CC6000 adapts to specific needs and purification requirements with user-friendly control panels, premium efficient fans with adjustable airflow and Modbus connection, silencers for sound reduction, and easy change of front and back filters, significantly resulting in the reduction of dust particles from the air.

For more information, please contact: Camfil Air Filtration India Pvt Ltd 62 IDC, Mehrauli Road Gurgaon, Haryana 122 001 Tel: 0124-4874101 Fax: 91-0124-4082405 E-mail: pksv.sagar@camfil.com

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Separation for Wet/Dry Applications The high performance Russell Eco Separator is engineered to handle screening problems experienced by customers throughout the processing industries.

It accurately separates products into five fractions in one operation; increases productivity with higher capacities and provides complete material control to optimise separation quality. They are available in sizes 600, 750, 1,000, 1,200, 1,500 and 1,800 mm.

For more information, please contact: Russell Finex Pvt Ltd A-1201 Rustomjee Adarsh Regal Adarsh Vihar Complex Off Marve Road Malad (W) Mumbai 400 064 E-mail: sales.rfsf@russellfinex.com

Biophysical Characterisation Tool Malvern Viscosizer TD is an automated biophysical characterisation tool utilising Taylor Dispersion Analysis and providing ultra-low volume, solution-based molecular size and stability measurement capabilities, combined with Poiseuille flow for relative viscosity assessment. It offers biopharma researchers an orthogonal technique for conformational stability analysis and encompasses a critical size range from small molecules through to protein-based systems.

For more information, please contact: Aimil Ltd Naimex House A-8 Mohan Co-op Indl Estate Mathura Road New Delhi 110 044 Tel: 011-30810200 Fax: 91-011-26950011 E-mail: info@aimil.com

Centrifugal In-line Pumps The CR pump range from Grundfos is one of the most extensive in-line pumps on the market that can match all customer requirements. With many innovative features unique to Grundfos, CR pumps provide superior reliability and the lowest possible cost of ownership to customers.

By manufacturing their own motors, Grundfos ensures maximum performance in all its pumps. The Grundfos motor IE3 efficiency is extremely silent and resilient. They are also available in the self-regulating MGE configuration, featuring an integrated frequency converter meeting IE5 efficiency.

The pump houses a specially designed cartridge seal that increases reliability, ensures safe handling and enables easy service and access. Shaft seal solutions configurations come in a wide choice of materials which allows for a better temperature handling. The temperatures can range from -40°C to 180°C.Pump efficiency is maximized by stateof-the-art hydraulic design and carefully crafted production technology.

The CR is available in four different materials: titanium, stainless steel AISI 316 and stainless steel AISI 304, and AISI 304/cast iron.

For more information, please contact: Grundfos Pumps India Pvt Ltd 118 Rajiv Gandhi Salai Thoraipakkam Chennai 600 097 Tel: 044-45966800 Fax: 91-044-45966969

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August 2018 ► 49

Pails with Clamping Ring Lids Vinisa E I Pvt Ltd offers space saving pails - tapered bodies with stacking beads, wide beads or jumbo beads. Various types of closures: clamping ring with toggle latch suitable for tamper-evident sealing, jet-ring closure for fully automatic drum closing, also available as pharma version.

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

GPC/SEC System Malvern’s OMNISEC is a Gel Permeation Chromatography/Size Exclusion Chromatography (GPC/ SEC) system for the measurement of absolute molecular weight, molecular size, intrinsic viscosity, branching and other parameters. It includes OMNISEC RESOLVE, the integrated GPC/SEC modules, OMNISEC REVEAL, the integrated multi-detector module and OMNISEC software for the characterisation of synthetic and natural polymers and proteins.

For more information, please contact: Aimil Ltd Naimex House, A-8 Mohan Co-op Indl Estate Mathura Road, New Delhi 110 044 Tel: 011-30810200 Fax: 91-011-26950011 E-mail: info@aimil.com

Heavy Duty Screw and Vane Pumps Within the SPX FLOW business, the breadth and depth of pumping knowledge is based on decades of pump development and experience. From its Plenty brand, comes a wide range of vane and screw pumps which are widely used for the pumping of heavy viscous fluids across industries such as oil and gas, power generation and naval, and are ideal for forced lubrication of rotating machinery and fuel transfer processes. Plenty Triro triple screw pumps provide reliable, quiet, pulse and vibration-free operation. The clever design of these compact pumps with just three moving parts, increases pump reliability, reduces noise pollution and minimizes impact on other downstream equipment. They deliver a stable flow of fuel and oil and offer better efficiency than equivalent centrifugal pump models. Well proven within the oil and petrochemical industries, the Plenty Twinro two screw pumps offer an ideal solution for heavy duty fuel transfer in accordance with API specifications.

The pumps can handle most bulk liquid transfer duties, and are used extensively in bulk loading and unloading applications. Each rotor is a precisely machined piece; the accurate screw profile ensures volumetric efficiency, accuracy, low running costs and reduced deflection even at high pressure discharge.The unique SPX FLOW Plenty vane pump offers advantages over conventional vane pump technology with gentle, low shear pumping action; low rate of wear; lower running costs, and variable flow without the need for variable speed drive systems. The pump incorporates a rotor between the vane tips and the stationary body core with two sets of parallel flats machined on the inside surface against which the vanes run. The ends of the vanes are angled to give a component of force to drive the rotor around and creating the same action as traditional vane pump designs, the shaft and rotor centrelines are eccentric and form expanding and contracting cavities as the shaft rotates. Precision engineering, heavy blades and high quality manufacturing ensure the Vane pumps offer long life and exceptional performance. SPX FLOW’s experience with refinery and oil and gas specifications means that customers are assured of compliant solutions with all necessary documentation. The understanding of international specifications is supported by innate industry expertise and the ability to customize and package a pump to meet the most exacting of requirements.

For more information, please contact: SPX International Ltd Lodge Park House, Kettering Parkway Kettering Venture Park, Kettering NN15 6XU, U.K. Tel: +44 (0)1604 889921 E-mail: Maryanne.Johnson@spxflow.com

50 ◄ August 2018

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Pharma Bio World

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events diary        Date: 19 September 2018 Venue: Kohinoor Continental, Mumbai

    Date: 20 th – 23 rd February 2019 Venue: Bombay Exhibition Center, Mumbai

Virtue Insight 40 Alwarthirunagar 2nd Street, Lakshmi Nagar Chennai

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

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



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

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

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

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

Also it can help you control your product’s lifecycle, your patient’s trust, and your revenue. Hence, this conference will provide an important platform for pharmacovigilance stakeholders to discuss and share best practices in expediting PV development.

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

The goal of the conference is to uncover the insights of the most emerging best practices and industry expertise in the field of packaging and labelling in the pharma sector. This conference attracts packaging, labelling, serialization, track and trace and artwork experts from across big and small pharma, who come together to share case studies, discuss the current challenges and find solutions.

This year we will be exploring topics, which affect both commercial labelling and packaging teams across small, medium and large pharma. We will have a co-presentation looking at the industries endto-end labelling strategy to ensure companies are inspection ready while harnessing branding as a storytelling tool to remain relevant to your consumers, old and new. Coupled with this we aim to show ways through which the operational challenges of serialization can be overcome and improved to ensure you are meeting compliance standards. 

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

 Virtue Insight 40 Alwarthirunagar, 2 nd Street, Lakshmi Nagar Chennai

52 ◄ August 2018

Pharma Bio World

bookshelf Research Handbook on Intellectual Property and Creative Industries

Authors, Editors: Abbe E L Brown and Charlotte Waelde Price: $264.75 No of pages: 424 pages (Hardcover) Publisher: Edward Elgar Pub About the book: The creative industries are becoming of increasing important from economic, cultural and social perspectives. This Handbook explores the relationship, whether positive or negative, between creative industries and intellectual property (IP) rights.

Distinguished international contributors reflect on the diverse policy approaches from across the world, taking into consideration a broad spectrum of economic and philosophical stances. In doing so, the topical chapters offer a global exploration of a wide breadth of issues, including sector-specific examples ranging from museums to traditional knowledge and artificial intelligence to enforcement and new business models. Intriguingly, this Handbook also looks forward to future challenges and developments regarding the role of IP in creative industries.

Delivering fresh and challenging perspectives on the rich and important relationship between IP and the creative industries, this Handbook will be vital reading for scholars of IP. It will also be an important reference for advisors to, policymakers for, and funders of the creative industries, as well as activists challenging the power of IP.

Understanding Clinical Papers

Authors: David Bowers, Allan House, David H Owens and Bridgette Bewick Price: $45.21 No of pages: 258 pages (Paperback) Publisher: Wiley-Blackwell (3 rd Edition) About the book: This book explains important research-related topics using actual papers from clinical journals to illustrate how to understand and evaluate published research. The authors use an imaginative pictorial approach for an enjoyable and informative read.

This new edition has been fully revised and expanded to include several new chapters on qualitative and mixed methods research, as well as new quantitative material. With updated examples drawn from current research, Understanding Clinical Papers remains a valuable resource for all healthcare professionals.

Patent Litigation Primer

Author: Robert A Klinck Price: $24.99 No of pages: 206 pages (Paperback) Publisher: CreateSpace Independent Publishing Platform (1st Edition) About the book: Patent litigation can be a dizzying maze for the uninitiated. The substantive law, procedures, lingo and various quirks inherent in this type of lawsuit can appear extremely complex - even mysterious - for those not intimately familiar with the process.

In Patent Litigation Primer, author Robert A Klinck helps to demystify the patent lawsuit procedure for the inventors, business owners, investors and other participants who might be new to the arena.

This eye-opening book is designed to provide readers with a working knowledge of the relevant, essential issues by breaking them down into informative yet accessible sections. Divided into five parts that provide material on basic framework, fundamental legal issues, the litigation process, mechanisms for obtaining patent office review and frequently asked questions, Patent Litigation Primer proves itself equally useful and readable for lawyers and laypeople.

Providing an educational yet reasonable overview of this difficult subject matter, Klinck offers an essential resource for anyone interested in developing a basic understanding of patent litigation.

Pharma Bio World

August 2018 â–ş 53

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