Pharma Bio World December 2019

Vol 18 | Issue 05 | December 2019 | Mumbai | Total Pages 60 | Price ` 150

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PHARMA BIO WORLD Vol 18 Issue 05 December 2019 MUMBAI

Intellectual Property Rights

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4 ◄ December 2019

Pharma Bio World

Cover Story 08 IPR Regime for Indian Pharmaceuticals: The Legal Perspective

Shuchi Agarrwal, Founder and Managing Partner, IPNeeti

Shreeya Thakur, Associate, IPNeeti features

24

17 IPR Trends in Indian Pharma & Bio-Pharma Industry Manoj Poonia, Vice President – Operations, Effectual Services

21 IPR: The Concerns of Indian Pharma & Biopharma Industry

Dr Gopakumar G Nair, Gopakumar nair Associates

24 Employee Engagement in 2020

Sanjeev Himachali, Principal Consultant & Talent Strategist, Ecliptic HR Solutions Private Limited And Chief Curator, HRTales 28 The Internet of Things (IOT) and Pharma

Navin Parti, Vice President, Q3 Technologies 30 Techno-Healthcare: Impact of Technology on Healthcare Industry

Dr Dharminder Nagar, Managing Director, Paras Healthcare 32

34

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Continuing Innovation with Single-Use Technologies Mr Amit Chopra, Managing Director, India and Middle East, Thermo Fisher Scientific

Career in Pharmaceutical Management: More Promising than Ever Before Dr Ashok Peepliwal, Associate Professor, IIHMR University – Jaipur

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Transfer of Technology – An Indian Perspective Saurabh Anand, Senior Associate, K&S Partners

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Cover Story

IPR Regime for Indian Pharmaceuticals: The Legal Perspective In context of drug discovery process, Intellectual Property Rights (IPRs) is of immense significance, more so from the legal point-of-view. The author, here in this article, has put forth a very pertinent discussion about the same with the help of adequate country-wide statistics and also by citing a few business cases.

Shuchi Agarrwal

Founder and Managing Partner IPNeeti Email: Shuchi@ipneeti.com

Shreeya Thakur

Associate IPNeeti Email: Shreeya.Thakur@Ipneeti.com 8 ◄ December 2019

H

ard work that leads to an important discovery or invention needs to be given rightful recognition. The story about ‘Double Helix Structure of DNA’ believed to be studied by Rosalind Elsie Franklin much before Watson and Crick fetched the Nobel Prize for the same, pushing Franklin’s name in the background; and it is still an unsettled issue amongst the science enthusiasts.

However, in current times, individuals / companies are aware and prompt in claiming their innovations by way of patents with the same being the most important enforceable instruments presently. Patents are legislated social contracts to encourage, to foster, and to protect innovation. They not only grant complete ownership rights but also secure commercial interests of the inventors/ companies from unauthorized exploitation.

Further, patents ensure inventors’ monopoly in the market with respect to his/her product for a particular period of time.

Speaking of the pharmaceutical industry, the drug discovery process is long, laborious, and involves a sizeable expenditure. The risks are high and returns are uncertain. Intellectual property rights (IPRs), especially patents, help pharma companies make profits to recover the cost of drug discovery and also to plough back some money in the already ongoing research of other drugs. Plus, a sizeable IP portfolio is always a boon for a company.

Grasping the Background: India’s colonial status brought with it the patent legislation making India’s IP regime conform to the developed world status in terms of patent law 1. After independence, the Patents Act was passed in India in 1970, which came into force in 1972.

Before becoming a member of World Trade Organization (WTO) in 1995, India consciously chose to confine monopoly rights in the pharmaceutical industry by

granting ‘process patents’. It granted a lenient form of patent protection wherein only a specific process by which a substance was manufactured was protected. Thus pharmaceutical companies had the freedom to formulate a non-overlapping process to manufacture an already patented drug in India. Owning to this policy, the generic manufacturers had an advantage; between 1970 and 1993, the licensed drug manufacturers grew from about 2000 to 16,000, making India a net exporter of pharmaceutical products. 2 However, India underwent a major change with respect to IPRs when it shifted its attention from process patent to product patent regime. This change was in line with making the Indian industry more IPR compliant after India became a part of the TRIPS Agreement in 1995. India was given 10 years grace period to fully induct the changes in the patent regime and Indian industries had to rework on their IPR strategies to reap the maximum benefits of the new regime.

The legal position with respect to patents in India: The post-1995 changes helped India to gain access to the global market; but on the other hand, also incited discussions and debates at the international level, especially with regard to some contentious provisions. We touch upon some of the legal provisions that directly impact pharmaceutical companies.

Section 3 (d) of the Patents Act, 1970 – Taking a three-dimensional view of ‘Section 3d’ of the Indian Patent Act

Let us consider an interesting example of the popular HIV drug- azidothymidine (AZT) in the United States. Long before its use for the treatment of AIDS, AZT was actually synthesized as a drug to treat cancer.

However, later the researchers discovered that the drug could be used to fight viral Pharma Bio World

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Cover Story infections too. Hence, when the causative agent for AIDS was identified, many antiviral agents were screened among which AZT proved to be most effective in the clinical trials. This new use of AZT was quickly patented and it received USFDA approval in 1987. However, for India, the same scenario would be different as the ‘new use of a known substance’ comes under the nonpatentable blanket.

Delving into the detail, Chapter II of the Patents Act, 1970 on ‘Inventions not patentable’, section 3d reads as  ‘The mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance, or the mere discovery of any new property or new use for a known substance, or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.’

Explanation for the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations, and other derivatives of known substance shall be considered to be the same substance unless they differ significantly in properties with regard to efficacy.

From time to time, there has been a huge uproar and discomfort amongst the pharmaceutical industry on the application of the section. A case that has been widely discussed and in fact forms the basis of interpretation of the said section is the seven years long landmark case of Novartis versus Union of India and others 3.

To clear the confusion regarding the term ‘efficacy’ which was not clearly defined in the Act, the Supreme Court referred to the Oxford Dictionary definition and observed that ‘efficacy’ means “the ability to produce a desired or intended result”. The Supreme Court held that for medicines, the test of efficacy can only be “therapeutic efficacy”.

as most of the applications are filed at an early stage of drug discovery, it might be challenging for a patent applicant to satisfy the requirements of the patent examiners. It is only after conducting clinical trials that the applicant will be able to gather the required information regarding the therapeutic efficacy of the drug.

Out of the various affidavits, submitted by Novartis, which exhibited more beneficial flow properties, better thermodynamic stability, lower hygroscopicity, and 30 percent increase in bio-availability, the Honorable Supreme Court ruled that 30 percent increase in bioavailability could qualify as an increase in therapeutic efficacy under section-3(d) of Patent Act, 1970 if evidence is provided for the same. However, Novartis failed to furnish adequate research data leading to the rejection of its patent application.

It is important that for the sake of standardization, the Act clearly defines the following:

In the above case, the Honorable Supreme Court has defined the context of efficacy in drugs for future reference. But the terms such as ‘significant’, ‘known’, ‘enhancement’ in the given section still leave a scope of ambiguity. In fact, the phrase “enhancement of known efficacy” is a relative term.

Moreover, this judgment also suggests that the applicant is required to provide direct evidence and indirect or indirectly implied evidence would not be considered as a reflection of therapeutic efficacy. But precisely what would qualify as direct evidence is still subject to different interpretations. Also,

• Scope of therapeutic efficacy • Quantitative details of known efficacy • Percentage increase over the known efficacy • The minimum percentage increased required to be considered for crossing the bar of Section 3(d) • Permissible research data that qualify as direct evidence.

The above is important as an objective criterion is the need of the hour. For companies to invest in R&D of drugs especially lifesaving drugs, without a surety of patent protection due to a vague criterion of patentability assessment is not encouraging.

Current trends on the application of section 3d by the Patent Office indicate that the section has become a double-edged sword. As per statistics, out of every 100 pharmaceutical case rejections, 66 cases are rejected by the Patent Office under Section 3(d). An increase in this trend has been observed after the Novartis case.

Following graph 4 supports this observation:

Novartis had filed a patent application for an anti-cancer drug ‘Gleevec’, a beta crystalline form of imatinib mesylate. Imatinib was a drug that was earlier patented by Novartis in many countries. In India, the patent office rejected the application citing section 3d.

In return, Novartis went to the court to try to invalidate section 3(d) and argued that the provision was unconstitutionally vague.

10 ◄ December 2019

Pharma Bio World

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Cover Story If we look at the intent behind introduction of Section 3(d), India being a welfare state, intends to prevent ever-greening of patented products and in turn benefitting those who can’t afford the exorbitant prices of lifesaving medicines. It is thus be advisable that clarity on interpretation as well as application of the section is provided to eliminate the commotion around Section 3d balancing between award to the rightful inventions and availability of inexpensive drugs to people.

The

‘Inventive

Step’

conundrum:

Assessment of an inventive step in an invention is one of the essential patentability criteria to be considered. Section 2(1)(ja) of the Indian Patents Act defines an inventive step to be “a feature of an invention that involves a technical advancement as compared to the existing knowledge or having economic significance or both, and that makes the invention not obvious to a person skilled in the art”.

The Manual of the Patent Procedure and Practice 5 states  The following points need to be objectively judged to ascertain whether, looking at the invention as a whole, the invention does have an inventive step or not: • Identify the “person skilled in the art”, i.e. competent craftsman or engineer as distinguished from a mere artisan • Identify the relevant common general knowledge of that person at the priority date • Identify the inventive concept of the claim in question or if that cannot readily be done, construe it • Identify what, if any, differences exist between the matter cited as forming

part of the “state of the art” and the inventive concept of the claim or the claim as construed; • Viewed without any knowledge of the alleged invention as claimed, do those differences constitute steps which would have been obvious to the person skilled in the art or do they require any degree of inventive ingenuity?

The above criterion laid down by the Patent Office does seem reasonable in assessment of an invention step in an invention.

However, application of the same by the Patent Office is still questionable.

The Supreme Court in this landmark decision - Bishwanath Prasad Radhey Shyam v.

Hindustan Metal Industrie6 - had solved the mystery back in 1978. With respect to clarifying what would qualify as an inventive step, the Honorable Court mentioned, “for practical purposes, was it obvious to a skilled worker, in the field concerned, in the state of knowledge existing at the date of the patent to be found in the literature then available to him, that he would or should make the invention the subject of the claim concerned?

Largely, the guidelines detailed by the Patent Office follow the decade-old guidelines by the Honorable Court.

Pre-grant Opposition: a boon or a bane?

Section 25(1) of the Patents Act lists grounds on which a patent application can be opposed before the grant. A pregrant opposition can be filed any time after the publication of a patent application but before the grant of the patent. The grounds include among others invention wrongfully obtained, lack of novelty, inventive step, insufficiency of description, nondisclosure, and false claim to convention priority. Pre-grant opposition was devised

Unlike other sectors, pharmaceutical companies apply for patenting a new drug even before proceeding with the clinical trials. Because, the clinical phase takes a long time to complete and maintaining the secrecy of the drug is now next to impossible.

12 ◄ December 2019

to check ever-greening and filing of frivolous patents.

There is an assumption that pre-grant oppositions can be used as a tool to hamper patent grant procedure, sometimes even to the extent that negligible term remains after the grant of a patent. Further, more the number of pre-grant oppositions filed against a patent application, weaker is the chance for the patent to get the grant.

An interesting hypothetical example to depict this is as follows: Application filed

Jan 10, 2011

Application published

July 12, 2012

Issuance of examination report

April 10, 2014

1 st pre-grant opposition filed by company A

June 20, 2014

Hearing scheduled w.r.t 1 st pre-grant opposition

Aug 12, 2015

2 nd pre-grant opposition filed by company B

Aug 25, 2015

Hearing scheduled w.r.t 2 nd June 20, pre-grant opposition 2016 ---Decision The opponents may work in consonance with each other to plan the timelines of filing pre-grant oppositions as the Act provides a very open-ended time frame for filing of pre-grant oppositions – “Where an application for a patent has been published but a patent has not been granted…”

To curtail exploitation of the provision by competitors, it may be worthwhile that a time frame in terms of number of months or years be included for filing of a pre-grant opposition in the Act. More so because, if any genuine opposition is missed from filing, the opponent can avail the post-grant opposition mechanism provided by the Act in Section 25(2) which provides 12 months from the date of patent for filing of such opposition.

While pre-grant opposition is an effective mechanism in weeding out frivolous or nonPharma Bio World

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Cover Story patentable inventions, strategic use of the same can cause immense damage to an applicant.

Compulsory licensing – a blessing in disguise: While the Indian Patents Act honors granting of product and process patents relating to pharmaceutical innovations as per its international commitments, the Indian Patents Act equally balances its commitments with healthcare requirements of its State. In case of lifesaving drugs being patented in India but not reasonably available in India in quantity or price, the Act authorizes the Controller of the Patent Office to grant a compulsory license.

Definition of compulsory licensing in simple terms is the permission granted to a thirdparty by the Government to make, use or sell a specific product or process without the need of the authorization of the patent owner.

As per Section 84, at any time after the expiration of three years from the date of the grant of a patent, any person interested may make an application to the Controller for grant of a compulsory license on patent on any of the following grounds, viz: 1. The reasonable requirements of the public with respect to the patented invention have not been satisfied.

2. The patented invention is not available to the public at a reasonably affordable price.

3. The patented invention is not worked in the territory of India.

The historic Natco vs. Bayer 7 case is one of the most cited cases in relation to Compulsory Licensing. The case became

a matter of discussion at the global level and marked the start of an endless debate.

The Controller in an elaborate judgment considered all the facts of the case and issued a compulsory license to Natco for the manufacturing of anti-cancer drug Nexavar.

In the EU, for example, pharma companies are eligible to obtain Supplementary Protection Certificate (SPC) which grants them a five-year extension on their patent term so as to compensate for the lengthy procedural requisites of regulatory approval.

There have been a couple of more applications for compulsory licensing filed before the Patent Office. The most recent case was that of Lee Pharma versus AstraZeneca 8, where Lee Pharma filed a Compulsory Licensing application against the Diabetes Mellitus patented drug ‘Saxagliptin’. Lee Pharma argued that AstraZeneca had been importing the drug at a very cheap price but sold it for way higher value which is making the treatment expensive for Indian patients. They also alleged that AstraZeneca had also not made enough efforts to manufacture the drug in India. The Controller, however, rejected the application on the ground that a prima facie case could not be made for making an order under Section 84 of the Patents Act.

In the United States, there is a provision of patent term adjustment (PTA) which is intended to accommodate any delays caused in the prosecution of a patent application by the US patent office. This adjustment is an addition to the 20-year lifespan of a US patent.

Thus, there is an adequate check over the misuse of this provision and only applications with merits are considered.

Patent term extension – recouping the time lost: Patents are granted for a period of 20 years and during this period, companies enjoy a monopoly over their patented products. The patent clock starts ticking as soon as an applicant files the application for the innovation. However, due to some impediments at the Patent Office, many times, patent applications do not mature to respective patents in a reasonable time frame and take upwards of 10 years, leaving companies with lesser time to enjoy exclusive rights.

India being a welfare state, intends to prevent ever-greening of patented products and in turn benefitting those who can’t afford the exorbitant prices of lifesaving medicines. It is thus advisable that clarity on interpretation as well as application of the section be provided to eliminate any commotion by balancing between award to the rightful inventions and availability of inexpensive drugs to people.

14 ◄ December 2019

However, the Indian Patent System does not offer any term extension even if the lag is on the part of the Indian Patent Office. This not only dampens the spirit of innovation in the first place but also makes the applicants bear the brunt of delays caused during prosecution. The introduction of a provision for a patent term extension should be considered to compensate for the time lost.

Non-patent Exclusivity – an incentive to innovate: Unlike other sectors, pharmaceutical companies apply for patenting a new drug even before proceeding with the clinical trials. The reason is simple. The clinical phase takes a long time to complete, and maintaining the secrecy of the drug is now next to impossible.

Therefore, in some countries, non-patent exclusivity is granted to drug products to compensate for the amount of patentprotected time lost to gain approval to market the drug. This time period helps the company to enjoy a monopoly in the market with respect to a particular drug and recover the R&D cost even after the official term of patent protection has expired.

Countries such as the US and members of the EU let pharma companies enjoy an extended exclusivity period.

In the US, the Hatch-Waxman Act of 1984 grants non-patent exclusivity to pharma products that fulfill some prerequisites of the Act. During this period, the US drug regulatory Pharma Bio World

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Cover Story authority, FDA, can accept but not approve an Abbreviated New Drug Application (ANDA) on the same drug.

EU follows an ‘8+2+1 regime’ for data exclusivity. 8-year data exclusivity when no generic company’s application for marketing authorization is accepted, and additional 2 years of market exclusivity is given to the inventor company. No generic competitor is allowed for market authorization for the product with +1 year of market exclusivity extension. This extension may be granted if during the 8 year period of data exclusivity an additional authorization is taken for one or more new therapeutic indications.

The Indian Patents Act does not offer non-patent exclusivity. This is so as India being a developing country has a huge population to cater to which cannot afford expensive drugs or even basic healthcare.

Lack of the aforesaid provision directly promotes the burgeoning of generic drug manufactures who after the expiry of patent protection make pocket-friendly drugs easily accessible to people.

In fact, some of the statistics in this regard are interesting. India meets over 50 percent of global requirement for vaccines and about 25 percent of all medicines in UK9. In the US, there is a rise in Abbreviated New Drug Application (ANDA) approvals of Indian pharmaceutical companies from the USFDA. As per data, 2025 ANDAs were filed in the first half of 2019, of which 1374 were approved10.

There seems to be a rampant demand of generic medicines – not only in India but at the outside too. The sooner such medicines are provided to patients, the more lives are

saved. For now not providing extra time period to companies post term expiration may help India to cater to its population until the same tides over to a reasonable standard of living.

Patent incentives – the road ahead: Considering the disinterest issue for the orphan drug development in India, approximately 450 rare diseases have been identified in India; and statistically about 7,26,11,605 people in India are suffering from rare diseases and disorders 11. Drug discovery segment in India is still evolving and there is a holdup with respect to regulation and development in research related to orphan drugs for rare diseases.

There needs to be a strong evaluation of the burden of orphan diseases in India along with policies and initiatives from government and private institutions for orphan drug development. Taking the example of the US, orphan drug invention can be granted 7 years exclusivity to the companies in addition to tax benefits and research grants.

India has been taking steps to nurture the innovation culture in the country as its existing system which provided only front end incentive was not adequate to boost the patenting and innovations in India. In this regard, Section 115BBF of the Finance Bill, 201612 introduced the Patent Box Regime in India which is an effort that enables an inventor to benefit through tax concessions on the royalty income. This bill was passed in May 2016 and led to the insertion of a new Sec. 115BBF in the Income-tax Act, 1961.

India followed the lead of many countries across the globe that have initiated such tax incentive measures to promote research & new innovations, Ireland being the first country to do so. The patent box aims to

Patents are legislated to encourage, to foster, and to protect innovation. They not only grant complete ownership rights but also secure commercial interests of the inventors / companies from unauthorized exploitation.

16 ◄ December 2019

incentivize research and development.

However, India still has miles to go.

Conclusion: Keeping in view of the Indian Patent Regime, the above discussion highlights that India has a structured IP policy in place. However, the question that still persists is – whether India should make way for some changes in its Patent Policy for Pharma practices in the world market, or should it continue with the existing approach to allow maximum innovation and availability of life-saving drugs at affordable prices.

References: 1 http://www.iphandbook.org/handbook/ch03/ p03/ 2 h t t p s : / / w w w . t e c h d i r t . c o m / articles/20120312/02424818071/puttinglives-before-patents-india-says-priceypatented-cancer-drug-can-be-copied. shtml 3 Novartis Ag vs Union Of India & Ors on 1 April 2013 4 https://accessibsa.org/media/2017/12/ Rejected-in-India.pdf 5 http://www.ipindia.nic.in/writereaddata/ Portal/Images/pdf/Manual_for_Patent_ Office_Practice_and_Procedure_.pdf 6 Biswanath Prasad Radhey Shyam vs Hindustan Metal Industries on 13 December 1978 7 Bayer Corporation vs Union Of India on 15 July 2014 8 Lee Pharma Ltd. vs. AstraZeneca AB (C. L. A. No. 1 of 2015) 9 Press Information Bureau;

–"Affordable

Efficacious Medicines –All Roads Leads to India", 2013 report by IDMA; Brandindiapharma.in 10 h t t p s : / / w w w . s t a t i s t a . c o m / statistics/999240/india-anda-approvalsby-usfda/ 11 Mohanty R, Barick U, Gowda A, Nair A, Mittal S, Patil A. Scope of patient registries for rare diseases in India. Int J Med Res Health Sci. 2016;5:58-61.

12 https://www.indiabudget.gov.in/ub201617/fb/bill.pdf

Pharma Bio World

IPR Trends in Indian Pharma & Bio-Pharma Industry The author, in this article, orates the trending of Indian pharmaceutical industry with respect to intellectual property rights (IPR), with a special emphasis on Patent. He makes the entire journey more insightful through relatable brief business case citation.

T

he constant evolution in pharmaceutical and biopharmaceutical industry is very crucial for the well-being of the world.

India, being one of the largest provider of generic drugs worldwide, has a huge role to play in driving the pharma sector to its new zenith. With increased pharmaceutical exports valued at USD 19.14 billion in 2019, Indian pharma firms so far supplied 304 Abbreviated New Drug Application (ANDA) approvals from the US Food and Drug Administration (USFDA) in 2017, and over 80 percent of the drugs used globally to combat AIDS (Acquired Immune Deficiency Syndrome). The Indian pharma industry serves as a juggernaut with a reliable and promising revenue growth for the upcoming years. To add another jewel to the crown, MNC’s market share in the Indian Pharmaceutical Market in the domain has fallen from 75 percent in 1971 to around 35 percent, while the share of Indian companies has advanced from mere 20 percent in 1971 to nearly 65 percent as per present data. With the progression of this oneiric growth as being reveled by this innovation-driven industry, there is also a need for maturing recognition to ensure the protection of valuable investments in Research & Development (R&D). This is because the development and launch of a new drug into the market involves a substantial amount of investment – both in terms of time (5-6 years approx) and money (5-6 Billion USD approx). Along with this, the companies need a concrete assurance on the monetary returns for a solid protection against exploitation & duplicity, and also to keep themselves motivated to take the risk.

Patent laws in India: The PharmaIntellectual Shield Manoj Poonia Vice President – Operations Effectual Services Email: manoj.poonia@effectualservices.com Web: www.effectualservices.com Pharma Bio World

To provide this sense of security to the companies pursuing the Research & Development of new drugs and to promote innovation in the sphere, constant efforts are being made in India to curb problems of weak

intellectual property legislations, and the government is moving towards establishing a patent regime that is responsive to technological advancements and is helpful in staying at par with the fair and secure innovation environment guaranteed by the Intellectual property rights.

Initially, being a signatory member of the Patent Cooperation Treaty (1970) and the Paris Convention for the protection of industrial property (1883), India had a “product patent regime” under the Patents and Designs Act 1911 – essentially meaning that one could get a drug molecule (end product) patented. However, with the introduction of Indian Patent Act in 1970, the government excluded agrochemical and pharmaceutical products from eligibility for patents. This exclusion meant that India only allowed the “process” of manufacturing a drug to be patented and not the end product, thus allowing Indian generic manufacturers to manufacture the same end product (drug) by a different process.

The exclusion was made as a step towards breaking the country’s dependence on imported drugs and to provide a platform for the construction of a self-dependent local pharmaceutical industry. As a result of this provision, Indian pharmaceutical market grew rapidly, producing a cheaper version of the patented drugs for domestic markets and eventually stepped into the global market with generic drugs for which the patents had expired.

The product-patent regime made a reentry into the Indian market with India’s signing of the General Agreement on Tariffs and Trade (GATT) under the agreement on Trade-Related (Aspects of) Intellectual Property Rights (TRIPS) on 15 April 1994, making it obligatory to comply with the requirements of GATT. And as a result of which, India’s patent legislation had to include measures for availability of both product and process patents for pharmaceutical inventions and granting a minimum Patent life time of 20 years to December 2019 ► 17

any invention or products that fulfilled the mandated criteria. India got the benefit of being a developing country and was allowed time to introduce these terms in the form of a series of amendments: Patents Amendment Act 1999 (First Amendment), the Patents Amendment Act 2002 (Second Amendment), and Patents Amendment Act 2005 (Third Amendment). The third amendment being the one that finally introduced productpatents back into the country. However, Indian government took the advantage of the flexibilities offered by the TRIPS agreement and made amendments to the section 3(d) of the Indian Patent Act to prevent misuse of the product patent regime by the pharma giants, which stated that a mere discovery of a new form of a known substance which does not enhances the efficiency of the product will not be considered as an invention.

This provision of sector 3(d) in Indian Patent Act was introduced by the government to prevent the strategy of “Ever-greening” (term given to the strategy of large companies to extend the life of their patented products by patenting them again after making small changes to the structure of the drug for example, by using a different salt for the production). A famous example of this is the case of NOVARTIS, a Swiss

based pharmaceutical company which was rejected the grant of the patent for their drug GLIVEC by the Chennai Patent Office in 2006 under section 3d on the grounds that it lacked certain innovation over the already existing compound patented by the company.

Further, two petitions were filed by the company – One for dismissing the request, and another stating that Section 3 (d) of the Indian Patent act is not in accordance with the TRIPS and is arbitrary. However, after a 7-years long battle, the decision of the patent office was upheld by the Hon’ble Supreme court and was applauded in many countries as a strong message against “Ever-greening” in the domain.

TRIPS Agreement: The Aftermath

The growth of Indian pharmaceutical market post TRIPS amendment can be cited as one of the best examples of the importance of maintaining a patent regime in the pharma industry or in fact, in any industrial sphere.

Before TRIPS, the entire Indian pharmaceutical market was generic. The absence of any provisions for product protection led many MNC’s to limit their portfolio in the country.

While at the surface level, it served as an excellent step in making the Indian market self-dependant, which was evident from the recorded growth, it also discouraged the local companies from investing in R&D as they

feared about their innovation being reverseengineered and being sold at a cheaper price, eventually leading to lesser profits. The introduction of TRIPS in the Indian market initiated a transformation from imitation-driven market to innovation-driven market. Post TRIPS amendment, Indian companies were forced to invest in drug development, if they were not willing to take a license from foreign companies.

While the impact of TRIPS compliance on the domestic companies was feared during the initial stages, Indian companies rapidly adapted to this change and heavily invested in R&D in the following years, which is evident by the fact that a good portion of the leading companies in the domain today are Indian companies. Indian headquartered pharmaceutical companies that top the list of key assignees including Cadila Healthcare, Dr.Reddy’s, Wockhardt, Cipla, Sun Pharma, Aurobindo Pharma, Lupin, etc.

According to our research, we arrive at the following statistics: It is noteworthy that only 274 patent applications are attributed to these companies between 1995-2005; and on the other hand 933 (~240 percent increase) are attributed in the subsequent decade (20052015) post TRIPS compliance.

Patent publications Worldwide 180 160 140 20

100 80 60 40 0

68

20

120

20

42

60

2 1 2 18

14 5 2

12 10 3 30

20 12 10 21

12 7 9 30

8 9 13 28

10 11

11 28

15 3 16

18 34

42

15 4 17

51

34

58

13 40 10 3 23 41 20

8 4 7 11

31

10 5

50

28

27 37

27

32 41

20 21

17

9

36

24

38 26 30 28 1 1 23 23 23 22 20 6 18 4 16 13 13 13 4 12 12 6 2 12 7 2 6 11 5 4 4 3 2 2 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 CIPLA

DR. REDDY'S

LUPIN

NATCO

SUN PHARMA

Source: In-house research 18 ◄ December 2019

Pharma Bio World

Similar statistics are observed in ANDA filings:

ANDA approval Timeline Trend (1995-2019) 200 Sun Pharma

180

Dr Reddy

Lupin

Cipla

Natco 7

160

19

140 120

2

2

17

16

22

14

100 26

80

40

1 5 7

8 12

60

10

40

1

3

9

17

03

6 3

23

1 5 4

3 9

41 14

40

36

3 9 29

2 5

38

79

41

1 4 25

42 23

36

24

55 34

6

4 5

27

14

25

8 50

17

39

30

15 47

30

56

56

26

9

17

72

50

22

30 14

9 38

21

4 6

27

28

9

14

20 0

3 7

48

24

73

16

8 29

47

21

1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019

Source: In-house research

Evidently, the ANDA approvals are on rise with a maxima in 2019. Also, only 304 ANDA approvals were received by these companies during1995-2005, whereas 1129 (~270 percent increase) ANDA approvals were received in the subsequent decade (2006-2015), post TRIPS compliance.

The ingress of product patents further served as a boost for MNCs to invest in India with some of them entering the country directly by setting up subsidiaries (for example, Bristol Myers Squibb and Eisai) or indirectly through licensing arrangements with Indian companies for the marketing of their products and also opened the doors for contract-based researches in collaboration with Indian firms. MNCs have also started investing heavily in acquiring Indian companies, the famed example being the acquisition of Ranbaxy – one of India’s largest pharmaceutical companies – by the Japanese MNC, Daiichi Sankyo in June 2008 and its re-acquisition by Sun Pharma in 2014. Another notable acquisitions include Dabur Pharma (the pharma arm of Pharma Bio World

Dabur India) by Fresenius Matrix by Mylan, and Shantha Biotechnics by Sanofi-Aventis.

And, while the fate of bigger firms post TRIPS has generally been favourable, the market scenario for generic smaller and domestic market-oriented companies has been more of a mixed-bag with some of them continuing to manufacture generics for other markets like Africa and Latin America, some focusing on manufacturing drugs with expired patent protection and a smaller portion of them actually investing in the R&D of new drugs. A portion of these companies have also set up subsidiaries and acquired companies abroad in countries like Nepal to continue producing generic drugs (due to territorial nature of patent protection). These companies are also facing competition in the generics market from MNCs. Further, certain actions and policy initiatives at the behest of developed countries are also jeopardizing exports such as the seizure of several consignments of Indian exports meant for Africa and Latin America at European ports under allegations of violation of intellectual property rights.

Another arrow shot in the direction of the smaller units is the amendment of Schedule M of the Drugs and Cosmetics Act, 1940 to comply with the Good Manufacturing Practices (GMP) standards of the WHO. A large number of smaller units, operating on thin profit margins, which neither have the resources nor the incentives to upgrade their facilities in accordance with the new GMP standards have closed their shops and gone home.

One possibility for generic manufacturers to survive is to tie up with foreign companies to market and distribute their products which can be mutually profitable, like the in-licensing deals struck by Indian company Cadila Healthcare with Schering AG.

Indian Pharma-Intellectual pool: The success stories

Shedding light on the successful IP strategies of Indian pharma giants, the first corporate that stands apart is Biocon, owned by Kiran Mazumdar-Shaw, the Biotech Queen from Bangalore. The

December 2019 ► 19

company’s market strategy has been of using patent information as an integral tool to determine on which areas the company should focus for its R&D. An example of this is how the company used patent information to gain initial access to the field of human insulin production, and became a major player in the field. The company noticed that most of the patented processes used e-coli and baker’s yeast but as Biocon had expertise in another type of yeast (Pichia yeast) for which it had already licensed the intellectual property (IP) rights from a small company in the United States. This paved the way for their product Insugen which is used by one-fourth of the world’s population fighting with diabetes. Biocon filed a patent application for Insugen in 2004 with the Intellectual Property Office of India (IP India), which was granted in 2010. By that time, Biocon had filed over 900 patent applications worldwide, including over 100 PCT applications, with nearly 200 patents granted covering various technological areas. The company also registers trademarks for nearly all of its commercialized products and processes and also actively engages in partnerships for the development of new drugs.

The next company shining bright under the limelight is Dr Reddy’s Laboratories where IPR has played a significant role in the company’s market strategy. The company has more than sixty granted patents with Intellectual Property Office of India (IP India). Dr. Anji Reddy believes that smart companies know how to manage their intellectual capital and how they can use it to uncover the hidden value behind every transaction and every business relationship. Dr. Reddy’s Laboratories believes that fostering and protecting IP is one of the most important means through which India can emerge as a kernel of drug discovery. In line with this philosophy, Dr. Reddy’s and DRF (Dr. Reddy’s Research Foundation, an additional unit created to facilitate the company’s drug discovery program) protect nearly all of their developments with IPRs. The company’s first international patent was filed in 1995, and in 2004, DRF filed an international application for Balaglitazone. By 2010 20 ◄ December 2019

Dr. Reddy’s had alone filed 267 PCT applications, with DRF filing an additional 56 patent applications internationally, 43 of which were PCT filings. US represents one of the company’s largest export markets, and as such the company has filed around 100 patent applications with the United States Patent and Trademark Office (USPTO).

IPR in pharma industry: The barricades Just like every other thriving innovation environment, the patenting of products in the pharma industry has seen both enthusiasm and resistance and has been a heated matter of debate among those in favour of it and those calling themselves the defenders of the poor. While those benefiting from it argue that the presence of provisions for product patenting provides a sense of security to those taking the risk of developing new drugs and prevents low-cost replicas of their newly developed life-saving elixirs from entering the market, those against the notion argue that providing exclusiveness to a company over a certain drug creates their monopoly over the market and increases the prices of drugs as it prevents generic companies from bringing the low cost alternatives to the market, making the drugs inaccessible to the poor people in longer run.

This being said, we have examples such as Novartis being denied a patent to prevent “Ever-greening”. Another famous example is of the landmark decision made on 9th March 2012 in which the compulsory license was issued to Natco Pharma Ltd with respect to a patent granted to M/s.

Bayer Corporation with regard to the patent related to drug Sorafenib tosylate sold by Bayer under the brand name Nexavar. After getting this compulsory license, Natco is now free to manufacture and sell a generic version of Nexavar by paying a 6 percent royalty on the net sales to Bayer at the end of each quarter.

In light of the above examples, we can safely conclude that the policy makers and the machinery for IPR enforcement (Patent office, Hon’ble High Court and the Hon’ble Supreme Court) already has a cognizance of the fact and they are already doing

everything to prevent the possible misuse of the patent regimen.

Also, price control is not forbidden under TRIPS or any other agreement of the WTO. One prime distinction between price control measures and compulsory licensing is that, if properly implemented, the former makes drugs more affordable but that does not cut any slack to the generic companies.

The latter, however, not only makes the prices more affordable through competition but also ensures some room for generic companies.

Conclusion: The road ahead

The Indian patent law seems to have evolved into an excellent piece of patent legislation aimed at balancing the interests of both the common man and the inventors. When TRIPS was signed many apprehended that it would be detrimental for the growth of Indian Pharmaceutical Industry. The Indian companies, however, surprised the world by rising to the top and took the industry by storm. Intelligent investments in IPR and focus on building a strong patent portfolio has played a major role in making this innovation-driven industry one of the top money-spinners across the globe and will continue to do so as more and more companies have started becoming aware of the importance of carrying this intellectual shield to the pharmaceutical wars. Combined with the Government’s policies for promoting innovation by introducing research ecosystems with competitive tax breaks on R&D investments and simplifying regulatory framework, the roller coaster ride of Indian pharma companies appears to be reaching the smooth end of the tunnel paving the path for the small and middle-sized generic companies to make the transition from imitators to innovators. Further, the increasing number of tie-ups with MNCs as well as contract-based researches signifies that the world has started to realize that Indian pharmaceutical market is going to be the architect of the biggest drug store ministering life-saving elixirs to the world.

Pharma Bio World

IPR: The Concerns of Indian Pharma & Biopharma Industry In this article, the author narrates the IPR related concerns being faced by the Indian Pharma and Biopharma industry these days. The author also cites a few pertinent business cases briefly to exemplify.

T

he blossoming future of Intellectual Property is dynamic and even more challenging in terms of valuing intellectual assets and competing in the global marketplace. Therefore, in context of Indian pharmaceutical and biopharmaceutical industry, it is important to apply analytical intelligence in providing unique & outstanding solutions to the vexatious problems basis the clients’ challenging needs. With India becoming a member of the WTO and thus agreeing to the TRIPs provisions, the journey to comply with the requirements began in 1995.

Between 1995 and 2005, India introduced new statutes as well as amended existing ones such as the Patent Act. The Patent Act underwent three amendments – one each in 1999, 2002, and 2005.

IPR related Concerns in India: With the increasing awareness in the field of Intellectual property rights, it is time to acknowledge that intellectual property rights are of great importance to almost every sector and have become a pivotal factor for several industrial investment decisions. Intellectual Property Rights have become a significant factor in both creating and using ideas that are converted into inventions to promote innovation and economic growth. With the advent of an increasingly knowledgebased and creativity-based society, grant of intellectual property rights ensures that the innovators and creators have sufficient incentive to bring their work to the market and to build on the innovations & creations of others for the benefit of society.

Dr. Gopakumar G Nair

Gopakumar Nair Associates Email: gopanair@gnaipr.net Web: www.gnaipr.com Pharma Bio World

The UN Organization, called World Intellectual Property Organization (WIPO), is entrusted with the global management of IP. WIPO is based in Geneva. Global filing of Patent Applications can be done through the convention route or through

the PCT (Patent Cooperation Treaty) route. PCT related operations are also handled by WIPO. Global filing of Trade Mark Applications can also be done nation wise or through the Madrid Protocol.

There are nation wise or region wise IP/ TM/Patent Offices globally. Under these statutory bodies, inventions or other forms of IP may be secured in many countries under respective IP/TM/Patent Offices such as EU (European Union), ARIPO (African Regional Intellectual Property Organization), OAPI (Organisation Africaine de la Propriété Intellectuelle).

However, most countries, irrespective of whether they are members of regional treaties, provide their own registration individually. An attempt to have a single patent (world patent) under WIPO and PLT (Patent Law Treaty) did not receive needful support from countries like India.

However, under WIPO’s initiative, “Patent Prosecution Highway (PPH)” program has been initiated. India is yet to join PPH for which the Indian Patents Act, 1970, needs to be amended through the Parliament.

In India there are several statutes incorporated to encourage and protect the creation and innovation of IP. India is governed by the Patents Act 1970 and Patent Rules 2003, Trademarks Act 1999 and the Trademarks Rules 2002, Indian Copyrights Act 1957, Design Act 2000 and Rules 2001, the Geographical Indications of Goods (Registration & Protection) Act 1999, and the Geographical Indications of Goods (Registration & Protection) Rules 2002 with regard to the patents, trademarks, copyrights, designs and geographical indications, respectively. As mentioned before, India is compliant with the TRIPS Agreement, an international agreement administered by the World Trade Organization (WTO) that lays down minimal standards relating to several forms of Intellectual Property.

December 2019 ► 21

In India, the appellate body in relation to the Intellectual Property Rights is the Intellectual Property Appellate Board (IPAB). It has the jurisdiction to hear appeals dealing with disputes falling under the above mentioned statutes. In spite of the effective provisions for protecting and grant of IPR, there have been lapses and latches in related tribunals and their functioning. The IPAB has become nonfunctional due to the frivolous but serious reason that the posts of the judicial and technical members as well as the chairman and vice-chairman of IPAB are not being filled. As a result of this, it is highly unfortunate that a large number of appeals have been left unheard by the IPAB since last few years. It is imperative that the government must immediately put the IPAB functional.

Landmark Business Case on Patent:

India is well-known globally for the “Gleevec Case” which was eventually decided by the Supreme Court on April 01, 2013. The litigation in Gleevec case started in early 2006, when Gnanlex Associates LLP, on behalf of the globally reputed Indian pharmaceutical company CIPLA, filed one of the earliest Pre-Grant Oppositions against Patent Application No. 1602/MAS/1998, relating to Beta crystalline salt of Imatinib Mesylate (Gleevec) against Novartis. CIPLA won and the Patent Application for Gleevec was rejected.

The litigation, consequent to challenge of the rejection at the patent office, went for nearly 10 years, culminating in the now famous Supreme Court Order.

An area of concern: Another area, adversely affecting the reputation of the Indian Pharma and Bio-Pharma Industry

in the complex problem of SSFFC (Substantial, Spurious, Falsely Labelled, Falsified, and Counterfeit) which is practiced by unlicensed manufacturers or lower strata of licensed manufacturers in backward areas or states, where regulators such as CDSCO or state FDAs are weak or unable to reach out for further enforcement. This is also often associated with falsified and tall (often bordering on criminal) claims on the website of some of the unscrupulous companies. Such practices are often conducted by unscrupulous traders acting or camouflaging themselves as manufacturers, claims to process GMP certification, R&D approvals, and Patents. There is a need for search/ research into these nefarious activities to nip them in the bud, so that the global reputation of Indian Pharma-Bio-Device industry is not adversely affected or imperiled.

Compulsory Licenses (CL): Significant potential has also been observed for pursuing voluntary as well as compulsory licenses. While there are various grounds for obtaining compulsory licenses such as under Section 84, Section 92 (Health Emergency), Section 92A (Exports), Section 100 (Government Use), – Section 84 of the Patents Act 1970 is one of the interest to the industry. Though a few Compulsory License (CL) applications have been filed, till now only one CL has been granted (Nexavar) in India. Currently, the Government of India, Department for Promotion of Industry and Internal Trade (DPIIT) and Patent office do not favour grant of CL, especially since when USA has voiced their concerns through Super 301 Report and India-US Trade Forum.

However, it is pertinent to note that USA

With the advent of an increasingly knowledge-based and creativitybased society, grant of intellectual property rights ensures that the innovators and creators have sufficient incentive to bring their work to the market and to build on the innovations & creations of others for the benefit of society.

22 ◄ December 2019

grants CLs for Government use under USC 1498, liberally.

Patents vs Patients: Post WTO/TRIPs, India has rightly chosen the middle path of balancing effectively between the rights of patients (public) vis-á-vis the right patentees. This balance of rights and obligations is the key highlight of India’s IP policy for which India has received global acclaim. However countries like USA, where the balance is heavily tilted in favour of patentees, have tick-marked India and has been pressing India to continue to pursue the “affordable access of life-saving medicines and medical devices” policy.

This has been leading to wide global acclaim as well as strong criticism from countries like USA. Therefore, it is the time for the companies to proceed appropriately in this regime for processing through the IP minefields, and also for planning, strategizing, & collaborating in their IP programs and policies.

CIPROM (Centre for Intellectual Property Management) : In a country like India, there is acute scarcity of social and community oriented IP practitioners for providing IP policy suggestions and proposals for improvement in IP related programs and procedures. With the objective of filling a void in the field, CIPROM (Centre for Intellectual Property Management) has been set up under the initiative of Dr. Gopakumar Nair.

Eminent IP Lawyers, educationists, and IP practitioners have been associated with CIPROM.

Trade Marks – Recent Developments: In recent times, the increasing number of brands and the need to secure their rights have enhanced the load on Trademark protection and enforcement backed by the ubiquitous influence of IPR protection under the new TRIPs regime. Consequently, there has been an increased reliance on protected Trademarks in the aggressive competition which further leads to conscious and deliberate manipulation by third parties to Pharma Bio World

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Article 51A (Fundamental Duties-Directive Principles) states that “it shall be the duty of every citizen of India to develop the scientific temper, humanism and the spirit of inquiry”. However, the spirit of innovation in scientific research in India is not receiving adequate attention it deserves. Indian Pharma-Bio needs to urgently build up the innovation culture from grass roots to move up the value chain from “generic capital” to “innovative capital” of the world. Generating ideas through creativity and protecting the intellectual properties for value addition is the road map for future global leadership for India in the field of Pharma-Bio and Medical Devices.

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your reach through

Further, there are increasing trends to appropriate well-known marks having high elements of goodwill to register such well-known brands as internet domains to gain the profits out of the goodwill of the said brands. Hence, the trademark holders need to be careful, alert, and vigilant about such cyber extortionists. It is essential that the well-known marks, brand names, and house names are also protected early through related domain registrations, even on defensive basis in multiple domain extensions.

APRIL-MAY 2019

With increasing awareness of the need and benefits of trademark protection the filing of TM applications and their related proceedings in the TM Office has gone up.

One of the consequences of such vibrancy in TM field is the proliferation of TM oppositions. Often, these oppositions are more to frustrate the competitor rather than to emphasis on the descriptive character of the TM or on its deceptive similarity. In spite of there being barely any similarity in the disputed trademarks, these are

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With the emphasis on protection of marks and the associated value/IP asset creation, the tendency to misappropriate the goodwill associated with such wellknown marks has also gone up, in recent times. One of the remarkable cases, in which well-known mark was protected under the common law principles of passing off, is the case of Daimler Benz Aktiegesellschaft & Anr v. Hybo Hindustan. In this case, the Plaintiff – the manufacturer of Mercedes Benz cars – alleged ‘Defendant’ of using its mark BENZ for selling its undergarments. The Court restrained the Defendant from using the impugned mark and stated that “there’s no valid reason as to why any trader in India should adopt the name “Benz”, which is associated with one of the finest engineered cars in the world, and use the same name with respect to ordinary goods, in this case undergarments, particularly underwear.”

attempts at intentional manipulation and obfuscation by the third party.

VOL. 38 NO. 1

misuse the goodwill and reputation of the renowned and well-known brand names and logos. Such other companies are popularly known as tapping competitors who intentionally exploit the opportunity of the rightful proprietor to register its brand name or logo to fulfill their malicious intentions. However, these are not as widely practiced as “Patent Trolls”.

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December 2019 ► 23

Employee Engagement in 2020 In 21st century and going forward, employee engagement has become a crucial quotient for business success in terms of company bottom line.

Pharmaceutical industry, being an important contributor to Indian economy, does also have no escape from employee engagement to foster their business success. Author, here in this article, narrates the nook and cranny of the same in a comprehensive manner.

I

Sanjeev Himachali

Principal Consultant & Talent Strategist Ecliptic HR Solutions Private Limited And Chief Curator, HRTales Email: sanjeev.himachali@ecliptichr.com 24 ◄ December 2019

n recent years, employee engagement has emerged as competitive human capital management and business strategy, because – it has a direct impact on employee productivity, employee turnover, and company bottom line. According to the Hay Group study titling ‘The New Rules of Employee Engagement’, companies with engaged workforce achieve 2.5X the revenue growth as compared to others with low engagement. Gallup’s metaanalysis study revealed that organizations with higher engagement witness a rise of 21 percent in productivity, 22 percent in profitability, and a decline of 25 percent in employee turnover. Higher employee engagement also has a positive domino effect on the personal development of employees, team dynamics, customer service, company culture, and innovation.

While organizations do acknowledge that employee engagement brings strategic

benefits, most of them still struggle to get the expected results. A survey titling ‘State of the Global Workplace’ conducted

by Gallup revealed that only 15 percent of employees are engaged in the workplace.

This means that a staggering 85 percent of employees have some negative perceptions about their organizations.

According to ‘The 2019 Employee Engagement Report’ based on a global survey by TINYpulse, employee loyalty has decreased – 43 percent of employees would be willing to quit the company for even a 10 percent salary increase due to lack of strong company culture, career advancement opportunities, recognition, and support of managers.

Employee engagement has been with a strong focus on HR leaders in the last few years, and it will keep its relevance in 2020 as well. In fact, it is now being viewed as an obvious business goal for 2020 and succeeding years.

Pharma Bio World

– emotionally committed, passionateabout-work, innovative, productive, profitable, consistent performer, or whatever business outcomes that are expected.

In simple and basic terms, employee engagement refers to a workplace approach that gets people to show up at the office, and bring their minds & hearts into work every day.

Key Employee Engagement Trends 2020 • Organizational culture rules the roost – it is still the greatest differentiator in employee engagement. Employees will value culture over monetary incentives.

• Technology will be instrumental in driving employee engagement to deliver opportunities and benefits related to telecommute / flexible work options (work-life balance), collaborative working, smart work environment, learning and development, and performance management.

• Employee experience will become an important non-monetary engagement strategy. Organizations will have to create deeper employee experiences through a combination of culture, physical, and technological environments.

• Employee wellness programs will move beyond physical health – organizations will also focus on the mental and financial well-being of employees.

• Organizations will become more active in their inclusion and diversity practices to create trust and equal opportunities among employees, irrespective of their demographics. When employees feel welcome, appreciated, valued, safe, and cared for – they feel more connected and engaged in their work.

In order to keep their workforce engaged, organizations need to work on two fronts: firstly, to dig deeper into the definition of employee engagement, and then to implement effective employee engagement strategies.

Understanding Employee Engagement – Clarity is Everything: Some of the terms that are associated with employee engagement are – happy, motivated, enthusiastic, experienced, satisfied-with-the-work, etc. From the organization’s perspective, the words that define employee engagement are

“Fresh approaches to employee engagement are critical to sustain high organizational performance. It’s a challenging task. But failure is not an option, because the ability to attract and retain talent will either be a competitive advantage or a fatal flaw”, says Gary Short, Senior Consultant, Talent Management, Kimberly-Clark.

Pharma Bio World

Now, what important to understand here is: the engagement drivers differ from employee to employee, something similar on the lines of ‘Maslow’s Hierarchy of Needs’ pyramid. Every employee moves through different stages of engagement based on their motivational needs such as money, promotion, recognition, learning and development opportunities, job security, and workplace camaraderie.

Employee engagement is also about fostering positive emotions in the workplace. According to a Dale Carnegie Training white paper, there are four emotional drivers for employee engagement – Enthusiasm, Inspiration, Empowerment, and Confidence. 95 percent of employees, who feel at least three of these positive emotions, are found engaged at their work.

The point that is being driven home here is: employee engagement framework should be built around these needs and emotions so as to drive both financial and emotional commitment from employees. Employees should be emotionally invested enough in work to be a significant part in achieving organizational goals and the requisite business outcome.

Effective Employee Engagement Strategies:

Before putting any employee engagement strategy in place, it would make sense to understand the present level of engagement in the organization. An internal employee survey could give you December 2019 ► 25

some useful insights into the needs and emotions of your employees.

1. Leaders and HR should work hand-in-hand Both top management / leadership team and HR should share the onus to drive employee engagement. Leaders should identify the barriers of engagement, define the roles and responsibilities clearly, tie employee engagement with performance goals, and give autonomy to employees.

When leaders set the tone of engagement, HR can build a robust framework of good & sustainable practices and execute it across the organization.

2. Build a Culture of Trust and Transparency

Strong and open workplace culture will attract and retain the 2020 global workforce which is predicted to be

dominated by millennials (35 percent) and Gen X (35 percent). Some of the ways organizations can create a culture of trust and transparency are: • Weave the trust and transparency in day-to-day interactions • Walk the talk – leaders should lead by example.

• Share the company’s progress and business priorities with employees through regular meetings or emails.

• Keep an open-book or open-door policy – employees should be able to give their feedback or express their opinions without any hesitation.

• Encourage meaningful conversations between manager and employees in one-to-one sessions.

According to the Hay Group study titling ‘The New Rules of Employee Engagement’, companies with engaged workforce achieve 2.5X the revenue growth as compared to others with low engagement.

26 ◄ December 2019

3. Provide Opportunities for Professional Growth The 2019 Employee Engagement Report based on a global survey by TINYpulse highlighted that 54 percent of employees are unclear about their promotion and career path, while 44 percent feel that they don’t have sufficient professional growth opportunities in their current positions. This can be a major barrier to employee engagement. Organizations can create these opportunities by taking the following actions:

• Ask questions to employees about their professional aspirations and interests.

• Provide job-specific training.

• Conduct skill-development workshops.

• Sponsor or reimburse the fee of professional certifications that employees want to complete.

• Connect employees with mentors from the organization or industry.

• Encourage employees to share their ideas – this will also lead to the culture of innovation in the organization.

Pharma Bio World

• Bring Your Own Device (BYOD) policy (with security reinforcements) to give work autonomy to employees.

• Implementation of Social, Mobile, Analytics, and Cloud (SMAC) technologies for digital transformation.

• Social intranet software where employees can informally interact with co-workers.

7. Wellness Programs

4. Give Rewards and Recognition

Money is indeed a prime motivator, but employees also need psychological motivation. It is a basic human tendency to seek validation or affirmation, and that’s why rewards and recognition play an important role in employee engagement. The rewards and recognition program should cover a broad range of programs because needs and emotions vary from one employee to another.

Public recognition at a company event, peer to peer recognition, surprise treats, sponsored vacations, flexible work hours, and exclusive perks are some of the ideas to engage employees through rewards and recognition. Inviting families for company’s gatherings, picnics and events also give a feel-good factor to employees.

5. Invest in Workplace Design

Believe it or not, the physical elements of the workplace can have a considerable impact on employee engagement. The workplace design should be such that it fosters collaboration and open communication.

Even the lighting, temperature, ventilation, and furniture ergonomics can optimize employee engagement. Organizations should also have quiet spaces or zones where employees can have privacy to relax or to concentrate.

6. Leverage the Technology

The millennial workforce is extremely tech-savvy and expects digital workplaces from employers. From the organization’s perspective, technology can not only increase employee engagement, but also unify communication, increase productivity, and build transparency & accountability. Organizations can leverage technology to boost employee engagement in various ways: • Collaborative tools for video conferencing, instant messaging, manage schedules / project timelines, document work in a single place, track progress, etc.

• Gamification of learning development programs.

and

Gallup’s meta-analysis study revealed that organizations with higher engagement witness a rise of 21 percent in productivity, 22 percent in profitability, and a decline of 25 percent in employee turnover.

Pharma Bio World

If people are stressed out or if they experience burn out at work, it affects their productivity and engagement levels.

So, organizations must take care of employees’ physical, mental, and financial health through wellness programs such as fitness trackers, health wear-ables, health insurance policies, mental health counsellor meets, gyms on work premises, rest lounges, personal wealth advisory, spa coupons, sabbaticals, etc.

8. Measure Effectiveness of Employee Engagement Practices

Every employee engagement practice must have KPIs and metrics such as absenteeism rate, turnover/retention, profitability, productivity, and employee Net Promoter Score (eNPS). Employee suggestion boxes, exit interviews, and pulse surveys are also useful tools to measure employee engagement. The results should be followed by analysis and improvisation of weak spots, relaunching initiatives, and then again measuring the effectiveness. It should be a continuous process.

Conclusion: Employee engagement is fundamental to the organization’s sustainable success and employee’s happiness at work. It is also a critical measure of an organization’s culture and health. If organizations want to remain competitive in the market, they must harness the power and potential of employee engagement.

December 2019 ► 27

The Internet of Things (IOT) and Pharma Journey of drug and medical equipment starts from its manufacturing to its consumption by the patients and hospitals. Use of IOT in pharmaceutical industry is not only limited to collection of data using fitness wearables, but the sensors are also being used in drug manufacturing plants to monitor the different parameters like temperature and humidity, required to meet the regulatory compliance for drug manufacturing. Sensors are being used in the manufacturing plants to monitor the performance of machineries and predict any failures. Sensors are also going to play a vital role in Logistics and supply chain of these drugs where these sensors can be used to monitor the movement of the drugs from manufacturing units to their desired destinations.

G

artner, Inc. forecasts that 8.4 billion connected things will be in use worldwide in 2017, up 31 percent from 2016, and will reach 20.4 billion by 2020. The total spending on endpoints and services will reach almost USD 2 trillion in 2017. With growing footprints of digital transformation across different industries and verticals, digitalization is not only limited to becoming paperless, but it has moved a step ahead, where data from different sources are helping organizations in their growth. Q3 feels this is where IOT is going to be one of the key contributors. In fact, McKinsey estimates the potential economic impact of IOT applications to exceed USD 11.1 trillion per annum by 2025.

As we all know, Internet of Things or IOT is about building a network of physical objects.

The world has moved from a network of interconnected computers to a network of interconnected everything. Increased usage of linked devices, faster cloud adoption, growth of high-speed networking systems have motivated every industry to embrace IOT solutions to augment their infrastructure.

Wi-Fi, Bluetooth, NFC, RFID, and QR codes are the widely used technologies to enable IOT ecosystems.

With IOT, intelligently linked devices embedded with sensors are able to communicate and exchange data. Any device fitted with sensors and actuators gains the ability to produce, transmit and process data. The data generated is not being used to its full potential and serves around 2 per cent of what it is capable of.

Right now, the focus of using IOT is mainly on

Navin Parti Vice President Q3 Technologies 28 â—„ December 2019

abnormality detection, control mechanisms or for instructional purposes. IOT data for optimization and predictive analysis is yet to be fully exploited and tapped.

IOT in Pharma The journey of drug and medical equipment starts from manufacturing to its consumption by the patients and hospitals. IOT in pharma Industry can be used in the following stages of a drug/equipment lifecycle: Manufacturing - Drug manufacturing and production units are using IOT to automate their maintenance processes. Sensors attached to their production units regularly send data against different parameters to assess the performance of machineries and predict any possible failures. Similarly, various assets and raw materials required in these industries are being monitored through sensors which will send notifications before any actual shortage of raw material happens. Industrial Internet of Things (IIOT) could add USD 14.2 trillion to the global economy by 2030. Moreover, investment in IIOT is expected to exceed USD 60 trillion in the next 15 years.

Drug Compliance / Quality Control Several predefined parameters needs to be monitored while manufacturing any drug.

These predefined parameters if violated can lead to disqualification of the whole batch of drug leading to a production loss. Sensors can be used to monitor such parameters in real time during manufacturing and raising proper alarms if any of such parameter is expected to go beyond the set values.

“With IOT, intelligently linked devices embedded with sensors are able to communicate and exchange data. Any device fitted with sensors and actuators gains the ability to produce, transmit and process data.�

Pharma Bio World

Supply chain/Logistics - Drugs and Medical equipment once manufactured, need proper storage and transportation in a controlled environment. IOT sensors can be used to monitor such controlled environment so that one can track the drugs while in transit.

this data to draw meaningful insights etc.

The ability of IOT systems to function effectively in an organization requires interoperability between these systems.

This interoperability is required for 40-60 percent of the implementation.

Implementing IOT

Conclusion

The implementation of an IOT ecosystem in an organization requires a change in the business model. Technical as well as governance obstacles need to be overcome for an organization to set up an effective, value driven IOT ecosystem. Creative business models equip organizations to position their products as services. Small business cases that churn out a quick ROI while addressing minor pain points with IOT devices and networks can be a good start.

The real value-add of IOT depends on the data that these devices generate.

Industries can improve operations and plan future roadmaps by analyzing this data.

The success of any IOT project primarily depends on the predictive/prescriptive analytics done using the data generated.

Data generated from IOT devices, when used for optimization and predictive analysis, creates maximum value for both the stakeholders and consumers of the organization. Use of IOT in pharmaceutical industry is not only limited to collection of data using fitness wearables, but sensors are also being used in drug manufacturing

Implementing IOT is not just about installing sensors, it involves lot of other activities like receiving data from sensors, processing Pharma Bio World

plants to monitor the different parameters like temperature and humidity, required to meet the regulatory compliance for drug manufacturing. Sensors are being used in the manufacturing plants to monitor the performance of machineries and predict any failures. Sensors are also going to play a vital role in Logistics and supply chain of these drugs where these sensors can be used to monitor the movement of the drugs from manufacturing units to their desired destinations. We believe that implementing IOT would test conventional business models and would generate maximum worth through interoperability, optimization and analytics.

December 2019 â–ş 29

Techno-Healthcare: Impact of Technology on Healthcare Industry From improved operational efficiency to standards in patient care, the healthcare transformation has enhanced the entire experience for both patients and medical professionals. This article discusses the healthcare industry trends and innovations that are revolutionising the field.

I

n today’s world, technology plays a crucial role in the functioning of every industry and has made our lives totally different than before. Out of all the industries, technology plays one of the most dynamic roles in healthcare industry. The advent of techno-healthcare, promises to improve and save countless lives all around the world. Techno-healthcare is a broad field where innovation plays a crucial role in sustaining health. Areas like biotechnology, pharmaceuticals and information technology along with the development of medical devices and equipment have made significant contributions to the healthcare industry.

From development of adhesive bandages and ankle braces to complex more innovations like MRI machines, robotic prosthetic limbs and artificial organs, technology has made a remarkable impact on healthcare. Doctors are able to carry out better diagnosis, surgical procedures, and improved patient care due to technology.

The change is palpable with the way doctors and patients interact with each other nowadays. Doctors are increasingly adopting technology like using notepads to take down and save patients’ history.

Mobility

Dr Dharminder Nagar Managing Director Paras Healthcare 30 â—„ December 2019

With doctors and hospitals incorporating technology in their systems, more and more fuctions are carried out effortlessly and efficiently. Physicians have been given the gift of mobility. Doctors now have access to all kind of information required, be it drug information, research or studies, patient history or records and much more, within mere seconds. With the ability to effortlessly carry mobile devices around throughout the day, information is never too far from them. Devices that aid

in identifying potential health threats and examining digital information like x-rays machines and CT scan machines also contribute to the benefits that information technology brings to healthcare.

Analytics Predictive algorithms hold immense potential in solving some of the acute problems faced by the healthcare system and delivery in India. With this technological development, doctors are able to diagnose their patients more precisely. Analytics are being applied in other countries for diagnosis and the same technology can be adopted in India. This helps the doctors in discovery of a new source of data which helps them draw the complete picture about the diseases of the patients. This also makes possible the complete analysis of a medical problem like diabetes or any other problem and then find a revolutionary solution.

Digital The push towards digitization augers well for the healthcare industry. Digitization is helping in conversion of patient records from paper driven to electronic storage systems. This is resulting in more efficient delivery of healthcare to the patients as their medical history and even treatment is no longer tied to one location and can be sent for reference and cross checking to any part of the world in no time. With Aadhar number linkage of the health records of the patients, there will be further simplification of the process of getting OPD appointments in hospitals. Patients need not stand in long queues and just need to mention their Aadhar numbers and forego the process of registration at hospital counters.

Pharma Bio World

Patient Care Another key area that has benefited from techno-healthcare is patient care.

The use of information technology has made patient care much more reliable at hospitals. Nurses and doctors working at the frontline now regularly use hand-held computers to record important real-time patient data and then share it instantly within their updated medical history. It is an excellent contribution of technology to health care industry. Being able to store lab results and other crucial patient data at one centralized area has altered the level of care and efficiency a patient can expect to receive when they enter the hospital.

Medical Research An improved level of efficacy in data collection means that an immense pool of patient history and case studies is now available to scientists online, who

can easily study extensive patient case studies and make medical breakthroughs at a faster rate. Scientists and physicians are persistently conducting research and finding new procedures to prevent, diagnose and cure diseases in a more efficient way and develop new drugs and medicines that can reduce the symptoms or treat ailments in a quicker way.

Vaccines Through the use of technology in medical research, scientists have also been able to study and examine diseases on a cellular level and produce vaccines against them. These antibodies against life-threatening diseases like malaria, polio, MMR, etc, prevent the onset of diseases and save millions of lives all around the planet. In fact, according to World Health Organization estimates, vaccines save about 3 million lives each

year and prevent million others from contracting deadly viruses and diseases.

Advancements in technology have rendered an extraordinary impact on the healthcare industry and dealing with medical problems has never been easier.

Physicians are able to better diagnose and treat their patients, ever since the beginning of the professional practice of medicine. Scientists and researchers are able to formulate better medicines and vaccines, thanks to the resources made available by technology. Countless lives have been saved and the overall quality of life continues to improve over time owing to the growing scale and size of technohealthcare industry.

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You are most welcome to share editorial content with us such as technical articles, case studies and product writeups. The length of the article should not exceed 1500 words with maximum three illustrations, images, graphs, charts etc. All the images should be high-resolution (300 DPI) and attached separately in JPEG or JPG format. Have a look at our editorial calendar on our website www.pharmabioworld.com.

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December 2019 â–ş 31

Transfer of Technology - An Indian Perspective Technology transfer is the process of transferring scientific findings, knowledge, technologies, processes etc. from one organization to another for the purpose of further development and commercialization. This article discusses the Indian scenario concerning transfer of technology.

Saurabh Anand Senior Associate K&S Partners 32 ◄ December 2019

O

ne of the most acceptable and unambiguous definitions of “Technology Transfer” or in other words “Transfer of Technology” is the process by which “commercial technology” is disseminated from one industry to another, and/or among different economies. In common parlance, the said terms are often misconstrued to be limited only to the transfer of a patent with respect to a particular product, which is patented. Meaning thereby, the product of the technology is often fused with the technology itself.

However, in actual commercial terms, technology is often considered to be a blueprint, which once obtained would promise better commercial output and it largely depends upon the industry. For instance, in mechanical industries, transfer of technology might include transfer of an end product, involving multiple IP rights.

However, for pharmaceutical industries, transfer of technology might include transfer of know-how of a process to obtain a product, which will not always be a fullfledged transfer of IP rights, as certain IP rights will be developed upon development of that particular product. Thus, getting a patent is not always a pre-requisite for initiating or rather indulging in a “Technology Transfer” arrangement. This dynamic model often creates multiple hurdles for a transferor to enter into such transactions, due to the vulnerability of the “technology” at the whims and fancies of the transferee.

This is often observed in cases of transborder transactions, wherein the transferor who wishes to expand its footprint in a particular country, is hesitant to enter into such kind of arrangements due to the lack of confidence in the laws governing the importing country. However, at the same time such transfer of technology is often required to give a technological as well as economical boost to the importing country in an era wherein technology is changing

overnight and the thrust of adopting to changing technologies is also increasing at the same pace.

At this juncture, the laws of the importing country play a vital role in preparing a ground to facilitate such transactions.

Undoubtedly, strong IP laws play a crucial role for any transferor to prefer a particular jurisdiction over another, but simultaneously enforcement of such laws in order to protect the IP becomes the game changer. For instance, mere mention of provisions for remedies in cases of infringement would no doubt portray a positive image of the importing country and at the same time if such statutory provisions have actually been implemented by way of granting injunction or directing to pay for damages and so on, it definitely acts as a springboard for the transferor to actually start investing in such importing countries. Section 83 of the Indian Patents Act, 1970 which is in consonance with Article 7 of the TRIPS Agreement recognises this concept as under: General principles applicable to working of patented inventions. – Without prejudice to the other provisions contained in this Act, in exercising the powers conferred by this Chapter, regard shall be had to the following general considerations, namely:• that patents are granted to encourage inventions and to secure that the inventions are worked in India on a commercial scale and to the fullest extent that is reasonably practicable without undue delay; • that they are not granted merely to enable patentees to enjoy a monopoly for the importation of the patented article; • that the protection and enforcement of patent rights contribute to the promotion of technological innovation Pharma Bio World

and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations; Thus, the Indian Patents Act, recognises the twin-benefit of Technology Transfer, that is, encouragement of innovation as well as protection and enforcement of patent rights. In addition to IP laws, the strength of ancillary laws like contractual laws, regulatory laws and so on, play a critical role in aiding such transactions.

Further, various Government initiatives like FDI, tax exemptions, fast approvals, digitalization and the like are other factors which provides the impetus for Transfer to Technology. For instance, the pharmaceutical sector is one of the key 25 sectors identified by the Government of India under the ambitious ‘Make in India’ initiative, which is likely to provide the necessary momentum to the sector in order to achieve its true potential. Following this, is the nod by the Union Cabinet for FDI up to 100 percent under the automatic route sector for manufacturing of medical devices subject to certain conditions. Further, the implementation of the Goods and Services Tax (GST) is expected to be a gamechanger for the Indian Pharmaceuticals industry as it will lead to tax-neutral interstate transactions.

Till date, the Government of India has undoubtedly taken multiples initiatives towards improvements in the pharmaceutical sector however, they are mainly restricted to just that and do not focus on the concept of technology transfer to reduce the amount of input in such an industry. For instance, in the Union Budget 2017-18, the Department of Biotechnology (DBT) received Rs. 2,222.11 crore, an increase of 22 per cent, to continue implementing the Department’s National Biotech Strategy. Later on, in an attempt to revive the active pharmaceutical ingredient (API) and the bulk drug market in India, the Government of India has proposed peak Pharma Bio World

customs duty on the importing of APIs and also plans to establish mega drug parks to promote domestic production. It has also unveiled ‘Pharma Vision 2020’ aimed at making India a global leader in end-to-end drug manufacture. Approval time for new facilities has been reduced simultaneously to boost investments. The Government has also introduced systems such as the Drug Price Control Order and the National Pharmaceutical Pricing Authority in order to deal with the issue of affordability and availability of medicines. Against this backdrop, it is imperative to note that the concept of technology transfer can greatly help in reducing the cost of R&D in this sector if the government also provides incentives for the same especially since there has been a six-fold increase in the cost of R&D in this sector since 2010.

The high cost of development and rapid obsolescence may prevent the transfer of technology and the patent holder may prefer direct exploitation or import of products over transferring the technology or know-how. Fear of competition also dissuades the transfer of technology or demands a high royalty for the transfer, but huge royalties may have a negative impact on the expenditure on R&D. In the case of India in the pre’70s era, technology transfer by the big MNCs did not support indigenous technological abilities, although post ‘70s, a large number of small and medium size firms have also been transferring their drug technologies to India, thus encouraging an atmosphere of competition in technology transfer.

The Ministry of Science and Technology has issued the guidelines “Instructions for Technology Transfer and Intellectual Property Rights”, which would help in enhancing the motivation of scientists, research institutions and universities in projects funded by the Department of Science and Technology, Department of Biotechnology, Department of Scientific and Industrial Research and Department of Ocean Development. The salient features of the guidelines are limited to ownership,

commercial exploitation, royalty, norms for private industry, royalty free licenses for the government as well as patent facilitating funds.

India at this point has an immense potential for becoming a booming ground to facilitate and nurture the benefits of technology transfer. However, there exists a dire need to address this with guidelines to govern the same. The goals of technology transfer will only truly be met and be expected to cater to the needs of the public if there is a greater involvement of the Government.

Despite the above, Government of India is on the verge of opening Technology Transfer Offices, universities, institutions that will be funded by the Central Government and will act as mechanisms for transferring or exporting the research conducted and its outcome to the desired place. It is pertinent to note that some Indian institutes such as the National Chemical Laboratory, Pune, CSIR-CDRI, have already been commercializing their research and have been successful in entering into technology transfer agreements vide which they have been licensed as technologies to industry.

It is only with adequate legal framework, guidelines and an increase of awareness that the issues of technology transfer can be encouraged. Although a number of Indian firms have been the receivers, a greater need of boosting this within the domestic markets is the need of the hour.

References: Rosegger. G “The Economics of Production and Innovation: An Industrial Perspective” (Oxford: Butterworth-Heinemann Ltd), 1996, p. 155-156 h t t p s : / / w w w. i b e f . o r g / i n d u s t r y / pharmaceutical-india.aspx http://www.pfc.org.in/info/tt_ipr.htm December 2019 ► 33

Continuing Innovation with Single-Use Technologies Adoption of single-use equipment has been increasing at a rapid pace. Users started to embrace the available technologies over 10 years ago to reduce the cost in pre-clinical drug product manufacturing and clinical testing of new therapeutics and vaccines. Today, single-use equipment such as single use bioreactors are being adopted in cGMP suites and entire facilities are being converted to single use. The article addresses how the successful suppliers are responding to the need to provide higher quality product while continuing to innovate and produce approved molecules to meet the market demand.

A

lthough biopharmaceutical manufacturing has been pursued for just a handful of decades, bioprocess technologies have evolved dramatically. Optimization of cell-culture media and cell clones has led to dramatic increases in productivity. Manufacturing footprints have declined significantly; 20,000-L bioreactors (scale-up approach) have been replaced with 2000-L or multiple 2000-L single use bioreactors (scale-out approach).

with improvements in film robustness, were achieved.

These developments have enabled the adoption of single-use (SU) technologies across all scales, from research and development to clinical and commercial manufacturing. SU storage containers and mixers for non-critical applications have been in use for approximately 20 years. Their adoption in critical applications began a decade ago once drug manufacturers realized the myriad benefits afforded by SU technologies and equipment suppliers began to address concerns about waste management, extractables and leachables (E&Ls), and reliability of supply.

Stirred-tanks SUBs are proven to operate with the same mixing principles found in traditional stainless-steel reactors. With the broad adoption of SUT, users today are looking to optimize performance and reduce the footprint on cell-culture processes. One approach is to improve the performance of stirred-tanks SUBs through implementation of a higher 5:1 turndown ratio. Doing so allows users to eliminate equipment and consumables in their seed trains and thus achieve greater efficiency and cost savings.

The benefits of single-use bioprocessing include both cost and time savings.

Because SU systems come presterilized, there is no need for cleaning, sterilization and related validation (or associated consumables for utilities and equipment) between runs, reducing setup and switchover times. Risk of crosscontamination in multi-product facilities is also minimized.

Advances in SU Bioreactor Technology

Mr Amit Chopra Managing Director India and Middle East Thermo Fisher Scientific 34 â—„ December 2019

Development of single-use bioreactors (SUBs) that are well-suited for commercial biopharmaceutical manufacturing was an initial focus of SU suppliers.

Vendors collaborated closely with drug manufacturers to establish a range of bioreactors designs. Ease of use, power generation, and effective mixing, along

Today, single-use BioProcess Containers (BPCs) employed with SUBs are manufactured using specialty films engineered for bioprocessing in configurations to fit different frame designs for rocker and stirred tank bioreactors.

SUB vessels are functionalized to enable mixing, venting, sparging, monitoring/ sensing, sampling, and liquid transfer.

In 2017, Thermo Fisher Scientific developed a novel cross flow sparger technology that makes it possible to achieve similar cell-culture performance whether running a bioreactor at 20% or 100% working volume. The bioreactor design is scalable for use in process development, clinical and cGMP manufacturing. Use of this 5:1 turndown ratio bioreactor allows employment of intensified seed trains with fewer vessels, reducing capital and operating expenses and accelerating development and scale up.

The Story of Single-Use Sensors In addition to advances in bioreactor design, SU vendors have responded to the demand for single-use sensing technologies. Control of important process parameters, such as temperature, pH, Pharma Bio World

Figure 1: Equivalent performance of the new 5:1 turndown ratio SUB at different working volumes dissolved oxygen (DO), and mass transfer, is essential during cell culture to achieve the desired cell density, viability and expression rates.

Approximately five years ago, single use pH and DO sensors were introduced to the market. Since then additional SU sensors for measurement of pressure, cell density and cell (bio) mass, concentrations of cell culture metabolites, and glucose have also been developed. The performance of these devices has improved over time, but further developments are needed to achieve more robust and reliable SU sensing technologies, particularly for determination of pH and metabolites. Single-use equipment manufacturers continue to work diligently to develop.

Expansion across the Process Flow Chain The benefits of single-use technology are not restricted to upstream operations, and today a variety of SU solutions are available for downstream processing.

In fact, most upstream and downstream unit operations in a biopharmaceutical plant can be performed reliably and costPharma Bio World

effectively in SU equipment. The “factory of the future� concept is based on the use of SU technologies across the process flow chain, including media preparation and storage, cell culture, harvesting, buffer preparation and storage, intermediate drug storage, viral inactivation, and final formulation and product storage. Advances continue to be made in the development of cost-effective SU solutions for inline buffer dilution systems, chromatography and ultrafilitration/diafilitration.

Automation Improvements Another area of focus for SU vendors has been the development of effective control and automation systems for use with their SU technologies. Vendors have worked closely with software developers and device manufacturers to design robust and cost-effective solutions that provide ease of use combined with reliable operation.

Different solutions have been developed for automation and control of non-GMP R&D and process development activities and clinical and commercial manufacturing, which require strict compliance with cGMP

guidelines. Different software platforms (Delta V, PLC, and others) have also been adopted by the industry.

Automation and control systems are also elevating the cGMP manufacture of SU-systems to meet the demands of the biopharmaceutical industry.

Implementation of semi-automated / automated manufacturing lines using HEPA-filtration has enabled the reduction of particulates during the production of SUTs. Standardization of BPC manufacturing with complete traceability has further ensured compliance with the highest quality levels expected.

Vendors are currently challenged to expand automation and control systems beyond SU bioreactors to all upstream and downstream operations. Many biopharmaceutical manufacturers desire to implement manufacturing execution systems (MESs) such as SmartFactory that integrate all upstream and downstream unit operations and their associated automation systems. At present, however, there are only a limited number of players that can support the MES level of automation in the biopharmaceutical arena.

December 2019 â–ş 35

Making Modular Moves

Addressing Challenges

The needs of biopharmaceutical manufacturers today include reducing time to market, risk, and investment in infrastructure for clinical manufacturing while also producing their products locally. Smaller, flexible, multi-product manufacturing plants that can be replicated in multiple locations around the world are therefore needed.

Initial concerns about E&Ls have been addressed through the development of high-performance, engineered films for the production of biocontainers, tubing, connectors, and other SU components.

Modular facilities with single-use technologies are increasingly seen as the answer. It takes as little as 50% of the time to build a modular vs. a traditional stainless-steel plant depending on the size and specifications.4 Modular facilities would not, however, offer the time and cost benefits they do without the deployment of single-use technologies.

Facilitating Continuous Manufacturing Like modular facilities, continuous bioprocessing is viewed as a way to increase the efficiency and reduce the cost of biopharmaceutical manufacturing.

It can also result in quality improvements and reduced environmental impacts, which has led FDA to strongly encourage its implementation.5 There is growing interest in the biopharmaceutical industry, and a number of products are under development that will be produced in the next 3-5 years using continuous processing.

This move is challenging SU suppliers.

Continuous bioprocesses can operate for weeks or months, and the product contact time with the SU biocontainer film increases significantly. There is a need for highly reliable and robust SU systems with long-term acceptable E&L profiles. Furthermore, because realtime process control and monitoring are crucial to achieving consistent steadystate conditions, there is greater pressure on SU suppliers to develop robust and reliable SU sensor solutions for the measurement of process parameters.

36 â—„ December 2019

Initial guidelines on E&Ls were introduced by the single-use suppliers and biological manufacturers group BPSA (Bio-Process Systems Alliance). A group representing biopharmaceutical manufacturers (BPOG, the BioPhorum Operations Group) and the American Society of Mechanical Engineers (ASME) have since introduced their own guidance materials. Additional guidelines on single-use processing are expected to be released by the US Pharmacopoeia and ASTM International.

Due to the lack of a unified approach, SU suppliers are expected to comply with all of these varying regulations and guidelines.

The testing required is expensive, and it remains questionable as to who will fund the testing required to comply with these regulations.

Similarly, standardization is needed for both biological manufacturing processes and SU solutions on the supplier side.

BPOG and BPSA have initiated efforts in this direction, but much remains to be achieved in the next three to five years. Every bioprocess is unique with unique requirements. One standard set of equipment will therefore be insufficient, and customization will always be necessary. Intellectual property concerns must also be addressed.

or manufacturing facilities of the same supplier with no overlap in their supply chains that offer equivalent materials with respect to both their physicochemical properties and their functional performance. Few SU suppliers at this point have elected to invest in redundant manufacturing facilities to provide the desired level of assurance of supply.

Moving forward on this issue requires sharing of all stakeholder perspectives and will be a slow process.

Innovation is No Longer an Option The numerous benefits realized with the implementation of SU technologies clearly outweigh the challenges associated with their use. SU systems have been adopted in every area of biopharmaceutical manufacturing: r-protein and monoclonal antibodies, vaccines, human/animal blood products, cell- and gene-therapies, and personalized medicines.

SU technologies will in fact be essential to the successful commercialization of nextgeneration treatments. As the demand for SU technologies increases with time, suppliers of single-use technologies must continue to innovate to expand the applicability of SU systems across all bioprocessing unit operations – batch and continuous and improve the performance of their products, while also investing to enhance the assurance of supply.

BPOG and BPSA are also working to alleviate concerns regarding the need for the dual supply of SU technologies.

Due to the widespread use of SU technologies in both upstream and downstream bioprocessing, SU systems have become critical components of biomanufacturing. SU suppliers need to mitigate the risk associated with this aspect of the supply chain.

Dual sourcing requires the identification of two completely independent suppliers Pharma Bio World

Career in Pharmaceutical Management: More Promising than Ever Before Pharmaceutical Management is one of the fastest growing and rewarding field of Management Courses. The author here discusses the various career choices one can make in the Pharma field.

W

ith the Pharmaceutical industry growing in double digits every year, there is plethora of career opportunities in the country. Few other sectors today are more lucrative and promising than the pharma sector which has witnessed over 17 percent annual growth from 2005 to 2016. The size of the industry is expected to be robust Rs 40,000 crore by 2020.

With such fast growth of the industry, there is be equally fast growth in career avenues in the sector and youngsters with specialized education and training in the field can chart good growth for themselves in a relatively short span of time.

A focused masters programme in pharmaceutical management, like MBA In Pharmaceutical Management is a course that deals with health, management and chemical sciences. MBA graduates in pharma work with these disciplines to ensure the safe and secure use of pharmaceutical drugs.

Roles in Pharma Companies

Dr Ashok Peepliwal Associate Professor IIHMR University, Jaipur (WHO collaborative center for District Health System based in Primary Health Care) Pharma Bio World

Those who wish to start their career after MBA in Pharmaceutical Management can join pharmaceutical companies in diverse roles like pharmaceutical sales, R&D, marketing, management, and related fields in capacity of Quality Assurance Manager, Drug Distribution Manager, Business Development Manager, Sales Manager, Marketing Research Analyst, or Marketing Manager etc. Experienced MBA graduates can get into post of Deputy General Manager or Regional Manager in reputed public sector pharmaceutical companies.

Those who wish to study after an MBA degree can opt for higher studies

like doctoral level courses in field of Pharmaceutical Economics, Health Systems, Pharmacy Management etc.

Starting Salaries The starting salary for MBA graduates in pharmaceuticals has gone up sharply in the past. The starting salary for an MBA (Pharmaceutical Management) is around Rs 4.5 to 10 lakh per annum but not restricted to that for good candidates. Good experience in this field can easily lead to a highly-paid job. It is important to note that those who start with high packages do not necessarily draw proportionately high salaries ten years later but if the selection of career path is right at the start, with a company of the right profile, then one can attain the satisfaction, good package and a senior position in the industry within short span of time.

It is thus advisable that students give attention to the company profile, company’s good-will, its market value and also their own long-term career plans. It is important to match the long term plans with the priorities of the company. There are a lot of opportunities for overseas placement also after completion of the course. The demand for Indian professional in the field in other countries because of various reasons like cost effective labour etc.

Eligibility for MBA in Pharmaceutical Management The eligibility for the programme is basic graduation degree in Pharma or Science or Life Sciences. The admission process is quite rigorous for MBA programs of top universities. Numerous national December 2019 â–ş 37

level exams are conducted in various universities like Pharma MAT by IIHMR University, CMAT (Common Management Admission Test), GMAT, NMAT (Narsee Monjee Aptitude test).

The entrance test is followed by group discussion and personal interview.

The qualities that are judged through group discussion and interview are candidate’s ideas, expression ability, aptitude, attitude, decision making and critical thinking.

There many colleges and universities which offer MBA program in pharmaceutical management.

The prominent ones are the Indian Institute of Health Management and Research (IIHMR University), Jaipur, Narsee Monjee Institute of Management Studies (NMiMS University), Mumbai, Punjab, Indian Institute of Pharmaceutical Marketing, Lucknow, Jamia Hamdard University, New Delhi, Indian Institute of Management, Ahmedabad, National 38 ◄ December 2019

Institute of Pharmaceutical Education, and Research (NIPER), Indian Institute of Commerce and Trade, Lucknow etc.

The sector is expected to grow faster with new policies and regulatory framework work. More and more international pharma companies are coming to India which further opens up avenues for these professionals. India has also started exports of pharma products to various countries and the list of such countries is only increasing. With more export opportunities for Indian pharma companies, there are even more options for a career in this field.

Signs of Maturity by Indian Pharma Companies

bulk drugs, formulations and other products. As these companies will grow and mature, there will be need for professional management and hence youngsters can look at vast opportunities even in distant future.

It is a matter of paramount importance to select the right avenue at the right time to make a successful professional career. Presently, the pharma-industry is in need of highly qualified technical, researchers, highly skilled, dynamic, effective managers who can take the company’s challenges forward by taking the complex decisions for the success and growth.

The pharma companies in India are showing signs of maturity and even new and patented drugs are being manufactured in the country. India is increasingly establishing itself as cost-effective manufacturing base for Pharma Bio World

marketing initiatives

Three Must-have Features to Ensure Your Pharmaceutical Metal Detector is Best-in-Show

F

ew industries are as heavily regulated as the pharmaceutical industry. Manufacturers must do all they can to protect customers by ensuring that the products contain what they stipulate on the label and that they’re free-from metal contaminants.

The repercussions of a product recall due to fragments of broken sieve wire found in medicine can be catastrophic. As well as impacting profit margins in the short term, a recall can damage consumers’ trust in the product, hitting sales and market share in the long term.

Gravity Fall Pharma GF-PRO system for free-falling powdered and granular materials that have been designed and built to address the challenges of an increasingly demanding and regulationdriven market.

When searching for metal detection machinery for their lines, pharmaceutical companies should look out for a number of design features to ensure equipment meets safety requirements. These features can mean the difference between a product inspection system that offers ‘best practice’ and one that simply meets Quality control is vital on pharmaceutical minimum standards. Below is a list of production lines to safeguard against features pharmaceutical manufacturers contamination. Companies can use a should consider to guarantee their product number of strict safety standards to set the inspection processes and products are framework for manufacturing processes. best-in-show.

These include the US Food and Drug Administration’s (FDA) Process about Best Practice 1: Generating Records Analytical Technology (PAT) guidance – a In compliance with Section 2.1 of mechanism to design, analyse, and control the proposed updates to World Health Organisation (WHO) GMP for pharmaceutical manufacture, and Good Pharmaceutical Products: Main Principles Manufacturing Practice (GMP) – which from January 2013, records have to be is aimed primarily at reducing the risks made, either manually or using automated inherent in pharmaceutical production, technology, during the manufacturing including metal contamination. process to provide proof of compliance.

Manufacturers must also keep To comply with these best practice comprehensive data on batch history and guidelines, pharmaceutical manufacturers distribution in a readily accessible form to require reliable product inspection optimise traceability and, in the event of a technology, such as metal detectors, product recall, to enable the source of any specially developed for pharmaceutical quality issue to be identified. lines. Equipment such as Mettler-Toledo Safeline Metal Detection’s Tablex Metal detectors that have been designed and integrated metal detector and high-speed built to comply with FDA and GMP standards rejection system for inline tablet & capsule can satisfy pharmaceutical industry demands inspection, and the Pharmaceutical for data monitoring and traceability. Those Pharma Bio World

developed specifically for pharmaceutical applications can arrive on the production line ready for connection to manufacturers’ data collection devices, ensuring full compliance with industry regulations.

Mettler-Toledo Safeline Metal Detection’s Tablex-PRO pharmaceutical metal detectors, for example, incorporate a data storage function that’s easy for machine operatives to set up, due to a colour touchscreen and Windows-style icon-driven Human Machine Interface (HMI). This helps to reduce unnecessary downtime

by

making

it

simple

for

operatives to navigate the machine’s set up options with minimal training. On-screen histograms (graphical representations of the distribution of product inspection data) provide an easy-to-understand visual breakdown of performance and historical inspection records. Moreover, for multinational manufacturers, flexible connectivity interfaces simplify integration with external data collection systems, enabling the company’s entire production process to be monitored.

Best Practice 2: Cleaning Up To meet GMP requirements, the highest hygiene standards must be upheld on pharmaceutical production lines. To facilitate this, production line machinery designs must – wherever possible – avoid ledges, corners and flat surfaces that can act as dirt traps where excess layers of dust can accumulate. In addition, systems must be easy to clean, with modules that can be dismantled efficiently without the need for tools. At the same time, they must be made December 2019 ► 39

marketing initiatives of robust materials, such as stainless steel, capable of withstanding harsh and repeated washdowns without succumbing to corrosion.

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In addition, advanced metal detectors with built-in performance validation software indicate to operatives when scheduled testing is due and guide them through step-by-step test routines. This ensures that product inspection performance monitoring takes place as often as required by GMP Best Practice guidelines and to the standard expected.

Lab Equipment

MUMBAI

Pharmaceutical metal detectors incorporating advanced HMIs with icondriven displays help manufacturers ensure that their product inspection system’s data collection process is easy to navigate with minimal training. This not only saves time during product changeover, and boosting productivity, but also reduces the risk of human error affecting data monitoring.

www.pharmabioworld.com

JUNE 2019

To guarantee Best Practice, simply integrating data monitoring technologies, or easy-clean machines isn’t sufficient.

Machine operatives on pharmaceutical production lines must also be properly trained to ensure comprehensive data monitoring and timely cleaning. Such procedures are documented correctly.

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Best Practice 3: Operator Training

INSIGHT INTO THE PHARMACEUTICAL AND BIOTECH INDUSTRIES

PHARMA BIO WORLD

Compact metal detectors, with rounded corners and curved surfaces can streamline the cleaning process, enabling pharmaceutical manufacturers to comply with PAT and GMP standards.

Technologies, such as the Tablex-PRO, can be easily dismantled and reassembled without the need for tools or small parts, facilitating regular hygiene inspections of every aspect of the machine. With the electrical components removed, the fully waterproof modules, made from mirror-finish stainless steel, can be fully submersed in water for optimal cleaning.

Better Than Best Complying with regulatory and industry standards for quality, traceability, and safety is paramount to ensure product safety, as well as to retain access to lucrative international markets.

By following the three best practice guidelines in this article, pharmaceutical manufacturers can ensure that they select metal detection systems that not only meet, but exceed GMP and PAT standards, achieving best practice on their lines whilst maximising the wellbeing of consumers.

About Mettler-Toledo Safeline Metal Detection Mettler-Toledo Safeline is the world’s leading supplier of metal detection and x-ray inspection solutions for the food and pharmaceutical industries. Together with Garvens Checkweighing, CI-Vision, and Pharmacontrol Electronic GmbH (PCE), Mettler-Toledo Safeline forms the Product Inspection division of Mettler-Toledo.

BioPharma World Expo 2021 BioPharma World Expo 2019 24-27 February 2021 4-6 December 2019 ,/d y džŚŝďŝƟ ŽŶ ĞŶƚĞƌ͕ dƌĂĚĞ &Ăŝƌ Kĸ ĐĞ ƵŝůĚŝŶŐ ŽŵďĂLJ džŚŝďŝƟ ŽŶ ĞŶƚĞƌ 'ŽƌĞŐĂŽŶ ; ĂƐƚͿ͕ DƵŵďĂŝ͕ /ŶĚŝĂ /njnjĂƚ EĂŐĂƌ͕ <ŽŶĚĂƉƵƌ WK͕ ,LJĚĞƌĂďĂĚ͕ /ŶĚŝĂ

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For more information: General information about Mettler-Toledo Safeline, visit: http://www.mt.com/pi http://www.mt.com/safelinemetaldetection Due diligence or any aspect of metal detection procedures and technology: Please write to us at sales.mtin@mt.com Or, Contact Us on 1800 228884 / 1800 1028460 (Toll-Free).

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press release Clarivate Analytics Highlighted India as an Emerging Hub for Biologics and Biosimilars New Delhi, India: Clarivate Analytics plc, a global leader in providing trusted insights and analytics to accelerate the pace of innovation, has released a new report together with the Department of Biotechnology (DBT), Biotechnology Industry Research Assistance Council (BIRAC) and ABLE (Association of Biotechnology Led Enterprises). Entitled ‘India: The emerging hub for biologics and biosimilars’, the report features analysis based on insights from Cortellis Deals Intelligence™ and Cortellis Competitive Intelligence™, and it can be downloaded.

The report examines the transformation of the pharmaceutical/ biotech industry from small molecule therapeutics to biotherapeutics (biologics and biosimilars), driven by unmet clinical needs, the inherent advantages of biotherapeutics, and commercial potential.

Of the top 10 blockbuster molecules in 2018, only two were small molecule therapeutics and eight were biological therapeutics.

The report was released at the Global Bio-India 2019 in New Delhi

by Dr. Harsh Vardhan, Union Minister for Science and Technology, Earth Sciences, and Health and Family Welfare, Shri. Dharmendra Pradhan, Minister for Petroleum & Natural Gas and Steel, Dr. Renu Swarup, Secretary, DBT and other luminaries including Prof.

Vinod K. Paul, Member NITI Aayog and Dr. Kiran Mazumdar Shaw, Chairperson and Managing Director, Biocon Limited.

Dr. Renu Swarup, Secretary, Department of Biotechnology said, “India has 95 approved biosimilars in the domestic market, more than any other country, and market penetration, which is currently relatively low and expected to increase quickly in coming years with the increase in demand by middle class patients.”

The Indian pharmaceutical/biotech industry is well placed to capitalize on the substantial opportunity offered by biotherapeutics and includes companies with an extensive pipeline of biosimilars under active development.

Kiran Mazumdar, Chairperson and Managing Director, Biocon Limited, said, “Technological innovation, coupled with economies of scale, are driving India’s emergence as a global hub for biologics and biosimilars. In enabling affordable access to high quality biosimilars worldwide, India’s biopharma sector can emulate the global leadership achieved in generic drugs and vaccines.” Dr. Cyrus S. Poonawalla, Chairman and Managing Director, Serum Institute of India, said, “India’s contribution and heft in the health sector is growing through novel technologies and innovative science, supported by economies of scale and cutting-edge manufacturing infrastructure to drive new frontiers in health science.”

So far, Indian pharmaceutical companies have launched 123 biosimilars and currently have 201 active biosimilars covering multiple indications in the development pipeline. It is likely that drug development will continue to accelerate thanks to the steps taken by the government of India to support the biopharmaceutical industry with the necessary infrastructure, funding, global collaborations to bridge the technical knowledge gap, and further development of regulatory guidelines.

Pharma Bio World

“Efforts by industry and the government will help position India as a leader in biotechnology-based research and a hub for biotech innovation and commercialization,” concluded Arvind Pachhapur, Vice President, Clarivate Analytics.

Kilitch Drugs to Set-Up Second Green Field Project in Ethiopia at an Investment of USD 5 Mn Mumbai, India: Government of Ethiopia in its endeavor to become

self-sufficient has invited Kilitch to explore supply of Liquid injectables.

Kilitch Drugs, is setting up its second green field project in Ethiopia to manufacture liquid injectables and at a capital investment of USD 5 million. In this regard, the Company has accepted the request of Ethiopian government for one hector land near Addis Ababa.

Commenting on the company’s project status, Mr. Bhavin Mehta, Whole time Director of Kilitch Drugs said, “We are happy to announce our second manufacturing venture in Ethiopia as also for the maiden unit which is now at a very critical stage of our project implementation cycle. Once the validation process is satisfactorily done, Kilitch Drugs plans to commence operations at the first unit in the first quarter of FY2020-21. We are confident that manufacturing base in Ethiopia will strengthen our presence in the African continent.”

At the same time, the Company’s first manufacturing plant has also reached a decisive stage of the completion process. Kilitch Drugs has begun installing machinery at the first Addis Ababa manufacturing unit and is all scheduled to commence the validation process in December. Process validation being an important tool in quality management of pharmaceuticals is a significant parameter of GMPs. Kilitch Drugs has registered over 300 products in key African countries and another 250+ products are under registration. It has been having a presence in Africa for over three decades now and during this period has gained a strong advantage. The company’s hopes to replicate its Ethiopian business model to the rest of Africa, going forward.

Eris Lifesciences Acquired Zomelis from Novartis Mumbai, India: Eris Lifesciences has announced the acquisition of

the trademark Zomelis and its associated trademarks from Novartis AG, Switzerland for a consideration of USD 13 million. Zomelis is used in the treatment of type 2 diabetes and comes under a new class of anti-diabetic drugs known as DPP 4 inhibitors. Amit Bakshi, Chairman and Managing Director, Eris Lifesciences, said, “The acquisition of Zomelis will help us strengthen our position in the diabetes care market in India. Zomelis is a strong brand amongst the super speciality prescriptions and has been promoted for close to 10 years. Our inorganic growth strategy continues as we explore good opportunities to strengthen our product offering for patients.”

December 2019 ► 41

press release Siddharth Mittal Took Over as CEO and Joint Managing Director of Biocon Limited

Bengaluru, India: Biocon Ltd an innovation-led global biopharmaceuticals company, announced that Siddharth Mittal has taken over as Chief Executive Officer & Joint Managing Director of the Company starting December 1, 2019. Mr. Mittal has been serving as Biocon’s Chief Financial Officer (CFO) since August 2014.

Welcoming Mr. Mittal, Kiran Mazumdar-Shaw, CMD, Biocon, said, “I am very pleased to welcome Siddharth as CEO & Joint MD of Biocon. Siddharth’s strong leadership qualities, comprehensive understanding of various aspects of the business, deep financial insights and robust operational experience make him an excellent fit for the role of CEO to lead Biocon through its next phase of growth. I am confident that in this new role he will build immense value for Biocon and its stakeholders.” Mr. Mittal takes over from Dr. Arun Chandavarkar who retired as Chief Executive Officer & Joint Managing Director of Biocon on November 30, 2019, after 29 years of outstanding contribution to the evolution and success of Biocon.

Mr. Mittal has been a core member of the leadership team at Biocon since May 2013 and has played an instrumental role in the biosimilars success story so far including restructuring of the biosimilars business into Biocon Biologics with an objective to unlock value for Biocon’s shareholders. He also played a pivotal role in managing global collaborations. As the CFO, he has successfully created a compelling Shareholder Value Proposition for Biocon over the last 6 years, including value unlocking of Syngene which was listed on the Indian capital markets in 2015.

Siddharth Mittal, CEO & Joint Managing Director, Biocon, said, “I am honoured to take over as the CEO & Joint MD of Biocon, which has a strong legacy as an innovation-led biopharmaceuticals company. It is at an inflection point where it is well positioned to create value for its shareholders by unlocking the potential of various business segments. I now look forward to generating value for our stakeholders by focusing on our Small Molecules business with an aim to further strengthen our portfolio of complex APIs and Generic Formulations in key global markets.”

Piramal Pharma Solutions Announced Collaboration with BerGenBio

Mumbai, India: Piramal Enterprises Limited’s Pharma Solutions business, a leading Contract Development and Manufacturing Organization (CDMO) announced that the company will be partnering with BerGenBio ASA on the development of bemcentinib for the treatment of elderly patients with relapsed Acute Myeloid Leukemia (AML). Bemcentinib was recently designated as a Fast Track drug by the U.S. Food and Drug Administration (FDA), as there are currently no marketed drugs specifically approved for relapsed AML patients, representing a significant unmet medical need.

42 ◄ December 2019

According to Peter DeYoung, CEO, Piramal Pharma Solutions, “BerGenBio’s decision to partner with us is a validation of our integrated business model. The breadth and scale of our assets and our expertise as a leading CDMO allow us to customize services according to their needs and deliver solutions that benefit the patients.”

To accelerate the timelines required for Fast Track development, PPS will be developing the drug leveraging its Xcelerate Integrated Solutions™ platform that delivers speed, flexibility and versatility to the drug development process. The Xcelerate platform, which addresses the industry’s growing need for preferred partner relationships, has been successfully applied to more than eighty programs.

Richard Godfrey, Chief Executive Officer of BerGenBio, stated that “Outsourcing of development and manufacturing services is a requirement for us, and we were rigorous in our due diligence of potential partners. Piramal Pharma Solutions’ capabilities – especially the Xcelerate Integrated Solutions platform – represent an ideal solution for BerGenBio.” The bemcentinib development program encompasses a fully integrated program of PPS resources that includes intermediates sourced from India, pilot process development and API validation in North America and formulation development in Europe. As part of the partnership agreement, PPS is also expected to provide commercial manufacturing of the final drug product.

Granules India Limited to Divest its Stake in its Joint Venture Located in China Hyderabad, India: Granules India Limited announced its intention

to divest its entire equity shareholding in Granules Biocause Pharmaceuticals Co. Ltd. by selling its stake to joint venture partner.

Granules Biocause Pharmaceuticals Co. Ltd. is an equal joint venture between Granules India Limited and Hubei Biocause Heilen Pharmaceutical Co. Ltd. The manufacturing facility of the joint venture is in Jingmen, China.

Granules formed the JV in 2007 to ensure a regular supply of Ibuprofen API to support its requirements for manufacturing Pharmaceutical Formulation Intermediates and Finished Dosages. Granules cited the environmental issues as one of the key reason for exiting the JV. Environmental issues have created an atmosphere of business uncertainty in China. To comply with regulatory issues on pollution, Granules Biocause Pharmaceuticals’ production facility had invested and will continue to invest substantial capex, which is contrary to Granules India’s strategy of reducing Capex outflow and Free Cash Flow generation. Also several existing Ibuprofen API manufacturers have expanded capacity or stated their intention to increase capacity.

In addition, several companies have announced their intention to enter the Ibuprofen API market. Granules believes the additional API supply will enable it to have more supply options and having a JV is not necessary to ensure Ibuprofen API continuity. Granules India’s decision to dilute the stake will not impact its commitment of achieving the profitability target provided for the year even without any additional JV’s contribution in the consolidated Net Profit.

Pharma Bio World

press release Biocon and Mylan Launched Trastuzumab Sweden Announced Launch of India-Sweden Healthcare Innovation Centre in India Biosimilar, Ogivri™ in the U.S. Bengaluru, India: Biocon Ltd. announced the U.S. launch of Ogivri™ (trastuzumab-dkst), a biosimilar to Herceptin® (trastuzumab). This FDA-approved product, co-developed by Biocon Biologics and Mylan, was unanimously recommended by the FDA Oncologic Drugs Advisory Committee. Mylan to offer Ogivri in both the 420mg and 150mg strengths, increasing access to treatment for thousands of HER2-positive breast and gastric cancer patients.

Dr Christiane Hamacher, CEO, Biocon Biologics, said: “The U.S. launch of Ogivri marks a significant milestone in our biosimilars journey. It is an important endorsement of our science, development and manufacturing capabilities in the area of monoclonal antibodies. The introduction of both 420mg multiuse vials and 150mg single-use vials of a high quality biosimilar trastuzumab with robust long-term efficacy and safety data will offer greater choice and value to patients, prescribers and payors in the U.S. Ogivri is the second biosimilar from our partnered portfolio being commercialized by Mylan in the U.S. Last year, through the launch of Fulphila we helped in expanding patient access to biosimilar Pegfilgrastim”. FDA approval of Ogivri was based on robust data demonstrating that Ogivri is highly similar to Herceptin and no clinically meaningful differences exist between the biosimilar product and Herceptin in terms of safety, purity and potency.

Ogivri was the first biosimilar trastuzumab approved by the U.S. Food and Drug Administration (FDA) and unanimously recommended by the FDA Oncologic Drugs Advisory Committee (ODAC). Ogivri is approved for all indications of Herceptin including for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma). Trastuzumab and biosimilar trastuzumab products contain a Boxed Warning for cardiomyopathy, infusion reactions, pulmonary toxicity and embryo-fetal toxicity.

Two supplemental Biologics License Applications were recently approved by the FDA, expanding the manufacturing capability for Ogivri, as well as Mylan and Biocon’s first U.S. biosimilar, Fulphila®, a biosimilar to Neulasta®. Mylan and Biocon Biologics have sufficient manufacturing capacity to fulfil demand in the U.S. and global markets for both products. Mylan President Rajiv Malik added, “As one of the largest suppliers of oncology medicines in the U.S., we are proud to offer Ogivri, and help increase more affordable access to this important treatment option for breast and gastric cancer patients. With Ogivri, Fulphila and our generic oncology portfolio, Mylan is uniquely positioned to provide a broad range of treatment options for oncology patients.”

Pharma Bio World

New Delhi, India: The Swedish Trade Commissioner’s Office in collaboration with the All India Institute of Medical Sciences, New Delhi (AIIMS, New Delhi) and All India Institute of Medical Sciences, Jodhpur (AIIMS, Jodhpur) announced the launch of India-Sweden Healthcare Innovation Centre in India at the India- Sweden Business Summit Inauguration held recently.

The announcement was made in the presence of His Majesties King Carl XVI Gustaf of Sweden and in the presence of the Ministers Nirmala Sitharaman, Finance, Government of India and Ibrahim Baylan, Ministry of Enterprise and Innovation, Government of Sweden. The knowledge partner was represented by Mr. Leif Johansson, Chairman of the Board, AstraZeneca who reinforced the importance of innovation to achieve the ambition of providing affordable and accessible healthcare to all in the country.

The signing of the Memorandum of Intent (MoI) took place at the event that marked the 10 years of India Sweden health cooperation in the presence of Dr. Harsh Vardhan, Union Minister of Health and Family Welfare and Dr. Maja Fjaestad, State Secretary, Ministry of Health and Social Affairs, Government of Sweden.

AIIMS Delhi was represented by Dr. Randeep Guleria, Director and AIIMS Jodhpur by Dr. Sanjeev Misra, Director and Swedish Trade Commissioner’s Office by Anders Wickberg, Swedish Trade Commissioner to India.

Sanofi Acquired Synthorx for USD 2.5 Billion Parish, France: Sanofi announced that it will acquire Synthorx,

a clinical-stage biotechnology company headquartered in La Jolla, CA, for $68 per share in cash, totaling to approximately $2.5 billion. Through the agreement, Sanofi will obtain all outstanding shares of Synthorx common stock for $68 per share, which represents a 172 percent premium to Synthorx’s closing price, according to a Sanofi press release. The transaction is expected to be completed in the first quarter of 2020.

The acquisition will give Sanofi access to Synthorx’s lead immuno-oncology product candidate, THOR-707, a variant of interleukin-2 (IL-2), which is currently in clinical development in solid tumor types as a single agent and in combination with immune checkpoint inhibitors. Additionally, Synthorx’s Expanded Genetic Alphabet platform will work in conjunction with Sanofi’s Nanobody technology and other existing platforms to expand Sanofi’s novel biologics, protein fusions, and multispecific biologics.

“Synthorx’s exceptionally novel discovery platform has already produced a molecule that has the potential to become a foundation of the next generation of immuno-oncology combination therapies,” said John Reed, MD, PhD, global head of Research and Development at Sanofi, in the press release.

December 2019 ► 43

press release ZETA Engineering for LONZA's Mega Project IbexTM Solutions

in increased issuance of warning letters/import alerts. The pricing pressure led by consolidation of supply chain in US market and faster ANDA approvals is abating and is expected to remain in mid-single digit in FY2020 compared to low teens in FY2018.

in its biopark in Visp, Switzerland. This expansion of IbexTMSolutions makes it possible to manage the entire production cycle at one site. ZETA is providing the detailed layout for the single-use plant in which upstream, midstream and downstream processes are integrated in a single module. The complex multi-purpose plant is designed for the utmost flexibility to map a wide range of processes at different scales. Based on the R&Is, a 3D model was designed in the shortest possible time that ensures space-saving design to meet the requirements of the limited package space.

ICRA expects the industry profitability to remain healthy supported by cost optimization undertaken by several players though variables such as increased regulatory compliance costs, R&D costs for commercialising specialty product pipeline and currency volatility related challenges in emerging markets (EM)s may have an adverse impact. Overall, company specific factors would continue to play a pivotal role with quality of product pipeline (i.e. higher share of limited competition launches in the U.S.) being the single most differentiating factor. Companies with growing portfolio comprising of niche/complex products in regulated markets, diversified geographic-mix and established brands in EMs would be better placed to manage some of the headwinds.

Homer Glen, USA: Lonza is investing400 million Swiss francs

ICRA Maintained Stable Outlook for Indian Pharma Companies

Gurugram, India: ICRA has maintained a stable outlook on the Indian pharmaceutical industry. The abating headwinds from pricing pressure in largest regulated markets USA, stable growth for the Indian market driven by increasing healthcare spend and better accessibility are likely to drive healthy growth for the Indian Pharma companies, coupled with comfortable balance sheet structure. However increased cost related to regulatory compliances especially for US market, price controls across markets and mandatory genericisation for Indian market remains key risks. The domestic pharmaceutical industry has gained adequate scale and generic drug development capabilities over a decade of growth which will keep them in good stead to capture bigger opportunities especially in the Specialty/niche segments in the regulated market. The FY2019-2022 CAGR is expected to be around 10-12percent for domestic Pharmaceutical companies.

The credit metrics of leading pharma companies are likely to remain stable in view of steady growth prospects in regulated markets and limited dependence of Indian pharmaceutical companies on bank borrowings.

The OPBITDA/Interest and TD/OPBITDA for ICRA set of 21 entities in Indian pharmaceutical industry has been healthy at 10.0x and 2.1x for FY2019. They are expected to remain in similar range in medium term despite some pressure on profitability and marginal rise in debt levels, given inorganic investments. The key sensitivity to our outlook remains productivity of R&D expenditure, operational risk related to increased level of due diligence by regulatory agencies and price controls.

The growth from US picked up in FY2019 to 12.1 percent after seeing a decline of -13.1 percent in FY2018. The growth was supported by higher market share for Indian players as several generic MNC players optimised product portfolios along with new product launches. While the US growth is expected to remain at high single digit to low double digit, it will face headwinds given the relatively moderate proportion of large size drugs going off patent, generic adoption reaching saturation levels in the US market and increased regulatory scrutiny as reflected 44 ◄ December 2019

With R&D optimization efforts underway to counter US pricing pressure, we expect aggregate R&D spend to maintain at current levels despite requirements arising from expanding presence in complex therapy segment such as injectables, inhalers, dermatology, controlled-release substances and even biosimilars. Companies will opt for co-development of biosimilars that need expensive clinical trials to diversify their risk across portfolio of such products while benefitting from commercial and marketing prowess of their JV partners.

Panacea Biotec Announced the Launch of Diabetes Drug in India

New Delhi, India: Panacea Biotec is pleased to announce launch of

brand ViLACT in India. ViLACT is used in the treatment of Uncontrolled Type 2 Diabetes Mellitus patients with HbA1c >6.5 percent. The total market size of this molecule and its combination is ` 969 Crore as per AIOCD MAT October ‘2019 and is growing at the rate of 4 percent.

Vildagliptin product patent (IN 212815) in India has expired on 09th December ‘2019. Vildagliptin is a new oral antidiabetic agent that enhances pancreatic islet cell responsiveness to glucose, is an incretin enhancer, a potent and selective inhibitor of dipeptidyl peptidase-4 (DPP-4), the enzyme responsible for the rapid degradation of the incretin hormones glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP). This activity increases levels of active incretins and enhances pancreatic islet α- and β-cell responsiveness to glucose, thus improving insulin secretion and reducing inappropriate glucagon production, improving insulin sensitivity, improving postprandial lipid and lipoprotein metabolism, and reducing fasting and prandial glucose and HbA1c.

Susheel Umesh, Chief Executive, Domestic Formulation said the VilACT brand will be an affordable, high quality medicine in the armamentarium of a physician treating patients with Diabetes. The patients have always been and will continue to be the center of our business. The Physician needs a lot of options to bring down the burden of Diabetes and we with the VilACT range will continue to support the patient and physician in this journey.”

Pharma Bio World

press release HRS PSL Exhibited Energy Efficient Heat Transfer Solutions for Pharmaceutical Industry at P-mec /CPHI 2019

limited, Sun Pharma, Lupin, Biocon, Aurobindo, Divis, Baxter, Cadila healthcare limited, Rakshit Drugs, Sriram, Neclife, Suven Life Sciences, Pharmazail and many more have visited the stall and shown great deal of interest in our energy efficient range of heat exchanger for pharmaceutical industry.

Arctoris Ltd Successfully Moved into Its New Global Headquarter in Oxford, UK Oxford, UK: Arctoris Ltd, the developer of the world’s first fully

automated drug discovery platform, has recently opened the doors to its new global headquarters and state-of-the-art research and development (R&D) facility in Oxford, UK. Housing the company’s proprietary technology and providing space for its rapidly growing commercial and scientific teams, the facility will enable Arctoris to continue to support its research partners around the world with its structured, automated approach to drug discovery.

Pune, India: HRS PSL has recently participated at P-mec/ CPHI

2019, organized by Informa Markets at India Expo Centre, Greater Noida, Delhi NCR, held from 26th – 28th November 2019. This was Asia’s biggest exhibition and conference held for sharing latest information and developments in pharma processing technology and ingredients industries.

HRS presented its flagship ECOFLUX* corrugated tube heat exchangers (CTHE), in the exhibition. ECOCLUX* is one of the most trusted heat exchangers in the process industry today, having a track record of over 2 decades in service. Also exhibited the energy efficient HRS FUNKE plate heat exchangers (PHE) and range of heat exchanger based systems to enable customers to achieve better productivity and efficiency in process plants.

Many visitors from pharma, healthcare and allied industries have visited our stall to understand the heat transfer solutions from HRS for pharmaceutical industry. In an interview with Informa Markets, Mr. Naresh Agarwal (Vice President - Heat Exchangers BU, HRS PSL) explained role of advanced Heat Transfer technology to achieve better productivity. He also emphasized HRS’ expertise to design and manufacture heat exchangers in exotic material like AL6XN, C22, C276, C2000, Titanium, Tantalum, Duplex, Super Duplex, Alloy 20, Copper, Cu-Ni, alloys, Inconel, Monel, SMO grades of SS which are increasingly proving beneficial for critical applications for the pharmaceutical industry.

It is a great opportunity to interact with many of our partners in the pharmaceutical industry. An opportune event to show case the company, meet new clients and generate business opportunities. Our esteemed customers like Cipla, Teva, Emcure, Biocon, Aurobindo, Jubilant Life Sciences, Dr. Reddy, Deccan, Granules, Sartorius, Mylan, Hetero, Unichem Laboratories Pharma Bio World

At the heart of the new scientific facility is the next-generation, fully automated platform developed by the drug discovery experts, engineers and roboticists at Arctoris. The platform efficiently generates reproducible data from biochemical, cellbased and molecular biology assays. The rapid turnaround enables shorter cycle times – and therefore more design-maketest-analyse iterations – for their drug discovery partners. This end-to-end robotic platform provides biotechnology companies, pharmaceutical corporations and academic centres with costeffective and reproducible drug discovery data – all through an online portal that streamlines experiment planning, ordering, tracking and data analysis.

Martin-Immanuel Bittner MD DPhil, Chief Executive Officer and CoFounder of Arctoris, said, "Investing in new global headquarters and greatly enhanced R&D facility in our home city of Oxford, UK, an internationally-renowned centre of scientific excellence, demonstrates our continued commitment to delivering the highest standards of data available to our partners. This state-of-the-art home for our next-generation robotic platform enables our growing team of experts to provide scientists across the globe with access to reproducible data through a rapid and fully-validated approach to drug discovery."

Having settled into its new headquarters, Arctoris will continue delivering high quality, reproducible drug discovery data to its customers through access to a library of validated drug discovery protocols designed to support hit-to-lead analysis, lead optimisation, mechanistic profiling and additional preclinical studies. This will enable scientists to make rapid, informed decision-making in basic biology, target validation, toxicology and phenotypic screening for drug characterisation, optimisation and selection.

December 2019 ► 45

press release OneLife – Live It Right, Raised Pre-Series A Funding of INR 50 Mn from High Networth Individuals (HNIs)

causes 60 percent of companies to experience a project delay or failure due to formulation challenges. In response to this situation, CAS has invested millions of dollars over the past 3 years and conducted over 500 research sessions with formulation scientists in order to develop this tool.

Mumbai, India: Onelife Nutriscience Pvt. Ltd. (”Onelife”) which owns the consumer healthcare brand “Onelife – Live it right” has raised Pre-Series A funding of INR 50 Mn from a group of HNIs from Pharma / Healthcare & Chemicals Industry. Onelife has over 100 products in the nutrition, wellness and beauty space with presence in more than 15 cities across West and North India. Onelife is geared up for its next level of growth post this round of capital. It will leverage the infused funds for geographical expansion, online & offline expansion, marketing and team building.

The Company is founded by Gaurav Aggarwal who has over 20 years of experience in the Nutrition Industry. Hailing from a family who has been one of the leading producers of Vitamin B3 in the World, this is a natural progression for Gaurav to leverage his extensive experience and network to develop a promising B2C Healthcare Brand.

Speaking about the launch, Molly Strausbaugh, Assistant Director, CAS, said: “The new CAS collection of formulations has been curated from information found by hundreds of scientists from numerous sources. This data clearly identifies formulation ingredients and their roles and provides users with critical insights, decreasing development time. By speeding up this process, formulators are able to receive reliable information more quickly, allowing them more time to spend on the real-world challenges they’re trying to solve.”

Commenting on the capital raised, Gaurav Aggarwal, Founder, Onelife said, “We are very happy to have experienced an early acceptance of our products from the customers at a time when the Nutraceuticals Industry is looking at an exponential growth. The funds raised will help us strengthen our product range, expand geographies, increase online & offline presence, invest in marketing & brand building and add further talent. We are targeting to achieve 3x growth over next 18 months from our current levels.”

Mumbai based Nyuleaf Advisors were the exclusive advisors on this transaction.

CAS Launched Formulus®: Largest Collection of Formulations Data in India Mumbai, India: CAS, a division of the American Chemical Society

that specializes in scientific information solutions, has recently launched Formulus® in India, the world's largest collection of formulations sourced from journals, patents and product inserts.

Formulus is the new one-stop shop for research scientists looking to search through millions of formulations quickly and efficiently. This product can be a potential gamechanger for India’s pharmaceutical and agrochemical sector because it streamlines and simplifies the time-consuming process of formulating new products and can help new innovations get to market faster. CAS will be holding workshops this week in Mumbai, Hyderabad and Bangalore to demonstrate its capabilities for formulators and researchers.

Formulation is a critical component of drug or product development.

However, current formulation resources and solutions are lacking, data sources are disparate and existing libraries are small. This

46 ◄ December 2019

Over 70 percent of formulators that tested Formulus confirmed that it helped them narrow focus more quickly and 73 percent of formulators agreed that it helped them get up to speed about a new product. CAS formulations content can also be licensed for in-house projects and applications. Formulus is integrated with CAS substance collection, detailed supplier specifications and regulatory resources and the data is also being made available in leading CAS solutions STNext® and SciFindern.

Abzena Showcased Discovery and Developability Services at PEGS Europe 2019 Cambridge, UK: Abzena has recently showcased its discovery and

developability Services, enabling biopharmaceutical companies to generate high affinity antibodies and select lead candidates with the highest chances of clinical success at the 11th Annual Protein & Antibody Engineering Summit (PEGS Europe) being held 18–22 November, on Booth #121 at the Lisbon Congress Centre, Lisbon, Portugal.

Abzena offers a Discovery Service that harnesses murine immunisation to generate antibodies with high affinity and desired functional properties. This is integrated with full Developability Services to assesses the fundamental characteristics of drug design – specificity, functionality, safety and manufacturability – to ensure the probability of identifying antibodies with appropriate therapeutic utility and maximise the chances of clinical success.

Campbell Bunce PhD, Chief Scientific Officer at Abzena, commented: "The development of biologics takes time, is expensive and subject to safety, functionality, stability and scalability liabilities. Having worked with hundreds of drug candidates, Abzena’s Discovery and Developability Services offer a defined approach that applies our expertise to guide the discovery and selection of the best drug candidates and reduce the risks that can significantly impact the time and cost typically associated with biopharmaceutical R&D." "Maximising the chances of therapeutic utility and clinical success drives our Discovery and Developability Services: from providing custom strategies for generating high affinity antibodies, to our Developability Service for selecting lead candidates and identifying measures that will mitigate risks," added Rob Holgate PhD, Senior Director of Protein Engineering at Abzena.

Pharma Bio World

press release SCHOTT Inaugurated New Production Facility at Its Gujarat Plant, Production Capacity to Increase by 50 percent

India. With its expanded operations in the country, it is catering to the needs of the Indian health industry and contributing to the Indian government’s initiatives such as Make in India and Pharma Vision 2020.”

in pharmaceutical glass manufacturing, has recently inaugurated its new glass tank facility in Jambusar, Gujarat following an investment of €21 million last year. The company forecasts a rapid growth trend for high quality glass material in the pharma industry, and has thus committed additional investments of €26 million for yet another tank facility in 2020.

SCHOTT’s India plant functions as a production hub for SCHOTT pharmaceutical tubing in Asia and produces the branded FIOLAX® pharmaceutical tubing. FIOLAX® glass exists since 1911 and provides an unprecedented quality standard in the industry through SCHOTT’s perfeXion® process since 2017. perfeXion® stands for the transition from statistical quality control to 100 percent automated inspection of each individual FIOLAX® tube – based on big data. Hence, it is introducing Germany’s Industry 4.0 to its Indian factory in the most effective manner.

Each of the new production facilities with a combined investment of €47 million, will double the capacity of SCHOTT Glass India’s manufacturing plant, allowing the group to produce its highly specialised FIOLAX® tubing material for both domestic and export demands.

Texila American University Announced Scholarship for PG Medical Aspirants

Mainz, Germany; Jambusar, India: SCHOTT AG, a global leader

SCHOTT began the construction of its first new facility last year on the occasion of completing two decades of operations in India.

The facility finished construction within a record time of one year, enabling employment of another 100 skilled local workforce. The new set-up brings together SCHOTT’s state-of-the-art technology and Indian ingenuity together to produce pharmaceutical packaging and tubing equipment in line with ‘Industry 4.0’ standards.

Talking about SCHOTT Glass India’s future plans, Managing Director, Georg Sparschuh shared, “While domestic market remains our key focus, our India plant also caters to the Asian market, thereby contributing to pharmaceutical industry exports and the Indian government’s vision of becoming a global pharmaceutical hub. SCHOTT also takes cognizance of the Indian Health Ministry’s initiative to provide affordable and accessible healthcare to its citizens. In this regard, we wish to be part of such initiatives by contributing to the pharmaceutical value chains and by providing high-quality glass products for pharma packaging, ensuring highest global safety standards.”

SCHOTT’s success story runs parallel to India’s phenomenal performance in the World Bank’s Ease of Doing Business Rankings, where India jumped 14 places this year to be ranked 63rd out of 190 countries. “We are among the benefactors of the efforts made by the Government of India in creating an environment conducive for international businesses to invest and set up manufacturing facilities. We plan to continue investing in India as a part of Make in India, as we believe there is great potential in our Indian facilities becoming the hub for providing pharmaceutical equipment for global pharmaceutical supply chains as well.

SCHOTT is also collaborating with Indian universities and training institutes to focus on skilling, preparing trainees to match the demands of future industry 4.0 requirements,” said Dr Patrick Markschläger, Executive Vice President, SCHOTT AG, Business Unit Tubing.

Dignitaries from the German Consulate, Mumbai, key partners and industry associations such as the CII also graced the inauguration of the new facility.

On the occasion, Marja Einig - Deputy German Counsel commended the efforts and said, “SCHOTT is playing a pivotal role in giving a fillip to our efforts in strengthening the Indo- German partnership. Time and again, SCHOTT has showcased its commitment towards Pharma Bio World

New Delhi, India: Texila American University (TAU) has announced a scholarship program for post-graduation (PG) medical aspirants for the year 2020. Students can register for any TAU’s PG program on or before December 31, 2019, and avail 10% scholarship on their first-year tuition fees. TAU offers an opportunity for students to upgrade their qualifications without disturbing their clinical practice.

The shortage of skilled doctors and specialists continues to be a pressing issue across the globe, especially in developing countries like India. An extreme shortage of specialist doctors in India poses a serious threat to the nation’s health sector. Shortage prevails in almost all disciplines. India demands 230,000 pediatricians, whereas it has only 23,000. Besides, we have only 650 specialists in endocrinology to treat 70 million diabetic patients. The demand for specialized doctors is growing at a faster pace, whereas the supply cannot meet the demand.

Upon understanding the demand, TAU, in association with Universidad Central de Nicaragua (UCN), offers a range of PG fellowship, PG upgradation, and research programs for medical professionals. These programs will help students to upgrade their knowledge and skills in their respective fields.

TAU offers a few PG programs for working professionals to get specialized in the area of interest without compromising clinical commitments. One of them, Fellowship (MMSc) that offers specializations ranging from Critical Care, Endocrinology, Diabetology, Preventive Cardiology, Family Medicine, Oncology, Nuclear Medicine, Cosmetology, to Reproductive Health.

Other one is Master of Medicine/Master of Surgery that provides a premier learning experience, both in theoretical and clinical aspects.

It enables to learn unique skills, get trained, and gain extensive knowledge. They can also upgrade on General Surgery, Orthopaedics, Obstetrics and Gynaecology, Dermatology, Paediatrics, Internal Medicine, Anaesthesia, Pathology, ENT, and so on.

Ph.D. in Medical Science program is designed for individuals who want to do extensive research on their specialized studies and enhance their academic career without leaving their job.

December 2019 ► 47

Vacuum Leak Tester An economical model vacuum leak tester is a consistent tool to check the seal integrity, pressure decay, seal performance of specimen like foiled cups, gels, pouches, pharma pouches, sealed tubes, food pouches, etc.

A defined vacuum is generated in the chamber to measure integrity for the evaluation of the leak-proof of the foil packaging to assure that the seals are intact. It is primarily used as the last before storage and warehousing.

For more information, please contact:

Presto Stantest Pvt Ltd I042 DLF Indl Area, Phase I, Delhi Mathura Road Faridabad, Haryana 121 003 Tel: 0129-4272727 E-mail: info@prestogroup.com

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

The condensor has been standardised with 1.5-m², 3-m² and 6-m² cooling surface area. The material of construction can be given in Mild Steel/SS-304/SS316 for Shell and Copper/Cu Nickel/SS-304/SS-316 for the cooling coil.

For more information, please contact:

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

Mass Spectrometer AMETEK Process Instruments has broadened its line of process mass spectrometers to include the StreamPro, a field-proven system for critical process analysis and control applications. Because mass spectrometry is a very rapid analytical method that allows for the analysis of multiple components in seconds, the StreamPro quickly provides the user with actionable data.

Applications for the StreamPro include monitoring for any number of analytes (C1-C8, H 2, N2, CO2, CO, O 2, VOCs, and other components m/z 1-200 amu) in a broad range of markets: pharma, hydrocarbon processing, research and design, and process development.

Real-time process monitoring of multiple components is straightforward with the StreamPro’s Process 2000 software. Complex overlapping spectra are handled automatically, with data output provided directly in concentration units. Different calibration and analysis methods can be assigned to each sample port. The software also provides an easy setup and operation, with advanced alarm and automation capabilities.

Autocalibration maintains the performance and accuracy of the system for quantitative analysis. The on-board computer activates the auto-start to prevent data loss or process interruption during a power failure. The analyzer has a streamlined, economical footprint, simplifying the installation.

With the StreamPro, there is no need for expensive service contracts that are typical with most process mass spectrometers. The system’s self-diagnostics and modular design ensure ease of maintenance by on-site personnel for servicing or replacing key components, with remote support available for additional factory diagnosis and troubleshooting.

For more information, please contact: AMETEK Process Instruments 150 Freeport Road Pittsburgh, PA 15238, U.S.A. Tel: 412-828-9040 Fax: 412-826-0399 E-mail: sales.ametekpi@ametek.com

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Oil-lubricated Vacuum Pumps Toshniwal supplies oil-lubricated vacuum pumps.

These oil-lubricated vacuum pumps of the TMS Series are single stage, oil-lubricated rotary vane vacuum pumps with oil re-circulation system. The lubricant system is rated for continuous operation of high intake pressures so that the pump may be used in a versatile manner in most rough vacuum applications. The pumps are used for suction of air also in presence of water vapour and for continuous industrial use. TMS Series pumps are made from high quality materials, has economical features which matches together to achieve high pumping speed over the range of absolute pressure 1,000 mbar-0.5 mbar; high water vapour tolerance and low noise level; no pollution; air-cooled: built-in anti-suck back system. The pumping capacities available are 17-m3/hr, 35-m3/hr, 65-m3/hr, 100-m3/hr and 150-m3/hr.

For more information, please contact:

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

Liquid Ring Vacuum Pump P O M P E T R AVA I N I is one of the world’s leading manufacturers of liquid ring vacuum pumps with singlestage (TRS) and twostage (TRH) pump series.

With the experience acquired through decades of engineering research, continual investments in the latest technological advanced machinery and sound mechanical know-how, Pompetravaini’s product is today synonymous with high quality, high efficiency, robust construction and maximum reliability.

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

For more information, please contact:

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

Industrial Vacuum Cleaners Dustcontrol UK offers its upgraded range of powerful Tromb vacuum cleaners. The trio of new additions to the Tromb family include the DC Tromb 400 dust extractor, DCF Tromb pre-separator and the combined DC Tromb twin dust extractor and pre-separator.

The remodeled versions of the Tromb range meet modern safety requirements while offering ergonomic and modular functions. One of the major updates is that the new DC Tromb Twin Model is separable, meaning the dust extractor and pre-separator are easily detached and re-assembled from each other to make transport simple. Other updates to the new range include a simpler filter change system and a motor package that is easier to remove. In addition, improved motors and a sturdier chassis have seen the Tromb family go through a significant expansion and upgrade.

The new range is not just powerful, robust and effective but also versatile and can handle all kinds of fine dusts and materials on a construction site, created from cutting concrete, sanding, grinding or drilling floors or walls, as well as dust from many other industrial factory processes. Ultimately, the new range ensures those working in industries where hazardous dust is prevalent, will be able to carry out their jobs in a safe and healthy environment.

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

Pharma Bio World

December 2019 ► 49

NSP Series Solenoid Pumps & NXP Series Stepper Motor-driven Pumps Neptune, part of PSG, a Dover company offers its new NSP Series Solenoid Metering Pumps and NXP Series Stepper Motor-driven Metering Pumps for chemical applications that require reliable and accurate dosing.

Featuring a durable, low-maintenance solenoid drive equipped with double-ball valves, the NSP Series from Neptune ensures consistent and precise dosing of a variety of chemicals, including acids, alkalis, coagulants and flocculants. The compact design and easy-to-use control of the NSP Series provide more efficient operation and shorter setup times for the operator. The small footprint allows it to easily integrate into dosing systems with limited space. The NSP Series is available in manually-, analog- and pulse-controlled models.

Thanks to its compact design and intelligent-drive concept, the Neptune NXP Series combines the advantages of a solenoid-driven pump with the precision of a motor-driven pump. This makes it an ideal solution to safely feed chemicals in highly accurate, reproducible applications. The NXP Series is fully adjustable to produce a constant supply stream during low-pulsation dosing, and the stepper motor with its wear-free tooth belt drive ensures a homogeneous and gentle dosing process. Available in six sizes, the NXP Series is plug-and-play and includes a universal power supply unit.

For more information, please contact:

Dover India Pvt Ltd No: 33, NH-4, Pazhanchur Mevalurkuppam, Chennai 600 123 Tel: 044-67193000 E-mail: rajesh.shankar@psgdover.com / ravi.prasad@psgdover.com

GNX Series Pumps with 3- and 4-inch Models Blackmer, part of PSG, a Dover company announce that its GNX Series Sliding Vane Pumps are now available in 3- and 4-inch models. The market’s only alignment-free reduced-speed positive displacement pumps, the Blackmer GNX Series have been designed to optimize the transfer of noncorrosive, non-abrasive industrial and petroleum products for both portable and stationary applications.

Originally launched in 2- and 2.5-inch models, Blackmer GNX Series heavy-duty sliding vane pumps include the proven features of Blackmer legacy GX Series pumps but take them to the next level with the incorporation of a commercial-grade, single-stage gearbox, motor and baseplate. This innovative new gearbox fits between the motor and pump and is held in place by a permanent dowelled connection that creates a structural link between the high-speed and low-speed sides of the system. This results in a pump that will not need to be realigned either at initial installation or following a maintenance procedure, resulting in improved peace of mind for the operator. The 2- and 2.5-inch models have aluminum gearboxes while the new 3- and 4-inch models feature cast iron gearboxes.

GNX Series pumps provide flow capacities ranging from 7 to 500 gpm (25 to 1,893 L/min) at working pressures up to 175 psi (12.1 bar).

They are also available with optional steel and composite baseplates. The pre-grouted composite baseplate adds additional value to the pump, gearbox and motor setup by providing unmatched surface flatness, significant vibration damping and reduced installation costs.

GNX Series pumps have a 90° porting orientation and GNXH Series pumps have a 180° porting orientation. These pumps are available in a full range of motors from 1 to 50 HP. For more information, please contact:

Dover India Pvt Ltd No: 33, NH-4, Pazhanchur Mevalurkuppam, Chennai 600 123 Tel: 044-67193000 E-mail: rajesh.shankar@psgdover.com / ravi.prasad@psgdover.com

50 ◄ December 2019

Pharma Bio World

Heat Sealable Thermoplastic Elastomer Tube Imaweld is thermoplastic elastomer opaque tubing designed for fluid transfer in pharma and biotech applications. Imaweld is specially formulated, which meets the requirement of pharma industries with superiority compared to PVC and silicone.

Imaweld complies with FDA 21 CFR 177.2600, USP Class VI and ISO 10993. It is manufactured and packaged under GMP guidelines in dust-free area of ISO 9001 QMS, ISO 14001 and OHSAS 18001 Certified facility. It is heat sealable and weldable. It can be laser etched for traceability. It has excellent flexibility and flex crack resistance. It also has excellent acid and alkali resistance. Its smooth bore surface eliminates particle entrapment. It has superior chemical resistance compared to silicone. It is sterilizable by steam, gamma radiation and ethylene oxide. It has custom dimension and available in length size. It is also available in transparent colour.

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

Intelligent LC/MS System for Chromatographers Agilent Technologies Inc offers a new, self-aware mass detector into their comprehensive LC/MS portfolio for the Indian market. The new Agilent InfinityLab LC/MSD iQ System incorporates ‘designed-in’ smart features, software, and hardware developed specifically for chemists and chromatographers who will benefit from the intuitive design and greater level of detail generated by a mass selective detector. The InfinityLab LC/MSD iQ incorporates intelligent instrument health monitoring, which is integrated into the system. Embedded sensors gather and display data allowing a quick assessment of the system’s readiness, status, and configuration. The instrument includes features such as a system suitability check that uses a test mixture designed to permit an overall assessment of the whole liquid chromatographymass spectrometry (LC/MS) system before the collection of data. An early maintenance feedback feature allows lab managers to plan routine maintenance on the lab’s schedule resulting in a focus on overall productivity. The InfinityLab LC/MSD iQ system is designed to sit beneath a stack of Agilent’s InfinityLab HPLC instruments, saving valuable lab space. It is designed to be serviced without dismantling the stack, ensuring that instrument maintenance and parts exchange is fast and simple. To accommodate changing space and layout requirements, lab managers will be able to utilize the new Agilent InfinityLab Flex Bench MS, to enable mobility, modular mounting of all system components, and easy access to all system areas. The Flex Bench MS also improves lab environments with an integrated solution for waste management, as well as system noise reduction. Routine operation of the InfinityLab LC/MSD iQ utilizing Agilent’s OpenLab CDS Software provides the most efficient and reliable method for data collection, analysis, and reporting, developed with a focus on ease-of-use and data integrity all in one system. The InfinityLab LC/MSD iQ eliminates the complexity of MS data acquisition with new features such as the auto-acquire mode that makes method setup even easier.

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

Pharma Bio World

December 2019 ► 51

Vacuum Leak Tester

Vacuum Leak Tester

The Presto leak detector machine is a high quality packaging seal integrity tester that adds quality control measures to your packaging applications. Regardless of contents, the vacuum seal integrity test will help ensure that your packaged product is sealed to your specifications. Benefits of will be realised by many industries from package manufacturers and converters to end-user packagers in the packaging of coffee, foiled cups, gels, pouches, grains, cereal, bakery, namkeen, chips, etc.

For more information, please contact:

Presto Stantest Pvt Ltd I042 DLF Indl Area, Phase I, Delhi Mathura Road Faridabad, Haryana 121 003 Tel: 0129-4272727 E-mail: info@prestogroup.com

The Presto leak detector machine is a high quality packaging seal integrity tester that adds quality control measures to your packaging applications.

Regardless of contents, the vacuum seal integrity test will help ensure that your packaged product is sealed to your specifications. Benefits of will be realised by many industries from package manufacturers and converters to end-user packagers in the packaging of coffee, foiled cups, gels, pouches, grains, cereal, bakery, namkeen, chips, etc.

For more information, please contact:

Presto Stantest Pvt Ltd I042 DLF Indl Area, Phase I, Delhi Mathura Road Faridabad, Haryana 121 003 Tel: 0129-4272727 E-mail: info@prestogroup.com

pH Meter & Conductivity Meter Cole-Parmer offers the new additions in the Oakton family of water testing and analysis products. The new additions in the Oakton family are compactly designed and economical meters for benchtop pH and conductivity measurement. These small meters provide precise measurement of pH and conductivity, offering highquality at a low price, without compromise. The meters have IP54-rated housing which is dust- and spill-proof, whilst connectors are protected by silicone seal caps. Both meters have the capacity to automatically recognize NIST and USA calibration solutions and can store and recall up to 50 groups of data. Whatâ&#x20AC;&#x2122;s more, these meters have a warranty of up to 3 years.

The PH 550 benchtop pH meter features a microprocessor chip which provides automatic temperature compensation, data storage, parameter setup, and Max/Min reading display. The meter offers a pH range from 0 to 14 and a three-point automatic calibration. The advanced digital processing technology improves meter response time and measuring accuracy. A stable reading display icon appears when the measuring value is stable. The 3-in-1 combination pH electrode measures pH and temperature simultaneously. The compact meter includes a detachable electrode holder and three bottles of pH buffer solution.

The CON 550 benchtop conductivity meter features a microprocessor chip which provides automatic calibration, automatic temperature compensation, data storage, parameter setup, and Max/Min reading display. The meter reads 0 to 200 mS/cm across four ranges and the four-point conductivity calibration. The advanced digital processing technology improves meter response time and measuring accuracy.

A stable reading display icon appears when the measuring value is stable. A conductivity electrode with temperature sensor measures conductivity and temperature simultaneously and allows for automatic temperature compensation. The compact meter includes a detachable electrode holder and three bottles of conductivity calibration solution.

For more information, please contact:

Cole-Parmer India 403, A-Wing, Delphi, Hiranandani Business Park Powai, Mumbai 400 076 Tel: 022-61394444, 61394410, Fax: 91-022-61394422 E-mail: response@coleparmer.in

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Pharma Bio World

Helical Ribbon Impellers

Impellers

Helical ribbon impellers are designed for axial and overall mixing in laminar flow.

Such an impeller can be designed with an additional inner helix or auger used to pumping in the opposite direction. These are needed for the mixing of high viscosity materials. These impellers can also have one or two start helix. The quality of the final mixed product in these applications is very critical. Wall scrapers can be mounted on the impeller blades to improve heat transfer and homogeneity in sticky products.

For more information, please contact:

FEDA Inc B-37 Maruti Indl Estate Plot No: 59/1/2/3, Phase 1, GIDC, Vatva Ahmedabad, Gujarat 382 445 E-mail: ashok@fedainc.com / reena@fedainc.com

Anchors/Gate Type impellers are close-clearance impellers that fit the contour of the vessel. These impellers provide adequate mixing under the laminar flow conditions encountered in high viscosity applications for heat transfer. There are many applications that other types of impellers are integrated with the anchor. These impellers sweep the whole wall surface of the vessel and agitate most of the fluid bath through physical contact. Anchor impellers are used for liquid viscosities between 5,000 amd 60,000 cP. When reaction/mixing homogeneity is required, other types of impellers are recommended.

For more information, please contact:

FEDA Inc B-37 Maruti Indl Estate Plot No: 59/1/2/3, Phase 1, GIDC, Vatva Ahmedabad, Gujarat 382 445 E-mail: ashok@fedainc.com / reena@fedainc.com

Customizable Hotplate Stirrers For the very first-time, and with the use of an online configurator, customers can customize their own colorful, sleek and technology rich Stuart Hotplate Stirrer. ColeParmer, a leading manufacturer and supplier of laboratory and industrial products, instrumentation, and supplies offers their newest Stuart customizable hotplate stirrers. Individuals can select from a variety of parameters including model type, interface, surface and colour. Each unit can be designed to unique specifications, built for its specific application and is personal to the owner.

The range comprises three versions: hotplate, stirrer or hotplate stirrer, and three interfaces to choose from analog, digital and premium, with the latter boasting enhanced versatility. The former two are available in white, black and blue, while the premium is supplied in an additional five colours: pink, avocado, tangerine, red and ultraviolet. All three versions offer minimal storage and footprint, accommodation for a retort stand to receive an external temperature probe, while an independent hot light LED clearly shows when instrument temperature is over 50 oC, making it safe even when the unit is unplugged. These latest additions mean researchers have even greater control over their experiments and processes, while making their lab safer. Each unit is robust and has a host of user-friendly features that will keep individuals safe including chemically toughened glass interface, glass ceramic or ceramic-coated aluminium hotplate, and an independent hot-warning light. They also have temperature sensor compatibility, programming with built-in timer (Premium version only) and 50 to 2000 rpm.

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

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December 2019 â&#x2013;ş 53

events diary India Diagnostic Expo Date: 04-Jan-2020 to 06-Jan-2020 Venue: Hitex Exhibition Center, Hyderabad, India About the Event: India Diagnostic Expo is providing the only platform in the Diagnostic Sector with enhanced business opportunities in Hyderabad. The diagnostic services market is expected to continue growing at 27.5 percent for next five years. In terms of services, the market is dominated by pathology services, which account for approximately 70 percent of the market. India Diagnostic Expo networking platform is something that can help to reach more clients, knowledge, and eventually attain business growth and increase the profits.

Fair Profile: In-vitro Kits l Clinical Diagnostic l Homeostasis Test Systems l Cleaning Kits l Diagnostic Reagents & Equipments, l Clinical Microbiology l Blood Cell Counters l Blood Bank Centrifuges l Equipment & Devices l Rapid Test systems l OEM Products l Diagnostic Imaging & Equipments l Diagnostic Test Systems l Collection Devices l Laboratory Softwares l BioMedical Equipments l Immunoassays l Turbidometry l Seroloogy l Laboratory Analyzers l Laboratory Chemicals & Reagents l Molecular Diagnostic For More Information: https://www.indiadiagnosticexpo.com

Indian Society of Chemists & Biologists (ISCB) International Conference Date: 22-Jan-2020 to 24-Jan-2020 Venue: Nirma University, Ahmedabad, India About the Event: ISCB conference has prime objective to provide an opportunity for a close interaction of scientists with varied interests in diverse fields of the research. Conference will also provide common platform and more opportunities to the researchers in the areas of chemical sciences and biological sciences and other related areas to interact with each other. ISCBC will also provide a forum for indepth assessment of the challenges involved in the dynamic and fast moving field of Drug research. It will bring together leading Chemists, medicinal chemists, pharmacologists, biotechnologists, and other allied professionals to discuss and present the latest important developments in drug discovery and therapeutics. It is expected that approximately thousand delegates will participate coming from different part of India and abroad. A large number of pharmaceutical and biotechnology industry professionals will join us for this event, share ideas, and built networks.

Fair Profile: Theme: Integrating Chemical, Biological, and Pharmaceutical sciences for innovations in health care Main Tracks and Sub-Tracks of Conference: Pharmaceutics and Pharmaceutical Technologies, Pharmaceutical Chemistry, Pharmacology / Biology, Pharmaceutical Analysis and Quality Assurance, Pharmacognosy and Natural Products, and Regulatory Affairs & Global Scenario For More Information: http://www.iscbconference.com 54 ◄ December 2019

Indian Society for Clinical Research (ISCR) Conference Date: 23-Jan-2020 to 25-Jan-2020 Venue: Taj Lands End, Mumbai About the Event: Indian Society for Clinical Research Conference brings together all those who are engaged in clinical research activities in India and provides a forum for the exchange of information and learning. ISCR aims to build awareness of clinical research as a specialty in India and to facilitate its growth in the country while helping to evolve the highest standards of quality and ethics.

Highlights: • Multiple tracks • Four power packed Pre-Conference workshops • Over 550+ delegates • Prof. Ranjit Roy Choudhury oration • Session for and by Patients who have been clinical research participants • Regulatory- Industry captain’s exchange • Oral and Poster sessions with attractive prizes and certificates • Newer horizons in Clinical Research session (Technology meets Research) Fair Profile: The 2020 edition aims to bring the clinical research community together to learn, connect, and explore opportunities to drive excellence in clinical research. The 2020 conference program of the Indian Society for Clinical Research has been crafted to focus on various clinical trial reforms towards building future research enterprise as well as discussions on emerging research opportunities in India.

It is the ideal venue for learning the best practices, creative solutions and “learning through doing” by participating in our workshops and conference sessions on what can be done more for patient safety and data quality and improves the overall research enterprise.

The conference will be attended by over 500 delegates from medical institutions, ethics committees, biopharmaceutical industry, government, patient organizations, and clinical research organizations.

For More Information: https://www.iscr.org

Conference of the Indian Radiological and Imaging Association Date: 23-Jan-2020 to 26-Jan-2020 Venue: MMCC, Gandhinagar, Gujarat About the Event: IRIA proclaims to be the largest radiology conference of India. By organizing its 73rd annual conference in 2020, Indian Radiological and Imaging Association (IRIA) is moving towards its next era of achievement. In the quickly advancing field of radiology, the conference is meant to take into account the requirements of the occupant and also the rehearsing radiologist. Thereby, the program exercises will be driven by specialists and recognized speakers from various driving institutions around the world.

Fair Profile: The imminent group of onlookers incorporates doctors, therapeutic physicists, clinical researchers, technologists and other radiological experts and delegates. The conference assures the great learning experience along with warm hospitality.

For More Information: https://www.iria2020.org/ Pharma Bio World

bookshelf India and the Patent Wars

Author: Murphy Halliburton Publication: ILR Press, An Imprint of Cornell University Press, Ithaca and London No. of Pages: 187 Price: ` 1155.00

About the Book: India and the Patent Wars explains an international debate over the costs of medicine and restrictions on access under stringent patent laws showing how activists and drug companies in low-income countries seize agency and exert influence over these processes. Murphy Halliburton throws an analytical insight on globalization within the fields of anthropology, sociology, law, and public health by drawing on interviews and ethnographic work with Indian and UK pharmaceutical producers. India has been at the center of emerging controversies around patent rights related to pharmaceutical production and local medical knowledge. The author shows here that Big Pharma is not all-powerful, and that local activists and practitioners of Ayurveda – India’s largest indigenous medical system – have been able to undermine the aspirations of multinational companies and the WTO. The author traces how key drug prices have gone down, not up, in low-income countries under the new patent regime through partnerships between US- and India-based companies, but warns us to be aware of access to essential medicines in lowand middle-income countries going forward.

Medical Monopoly – Intellectual Property Rights and the Origins of the Modern Pharmaceutical Industry (Synthesis) Author: Joseph M. Gabriel Publication: The University of Chicago Press No. of Pages: 334 Price: ` 3286.00 About the book: With the changing requirements of making intellectual property rights in drug manufacturing legitimate, both scientifically and ethically, complex changes have been introduced in patent and trademark law in the decades following the civil war. By World War I, patented and trademarked drugs had become essential to the practice of good medicine, aiding in the rise of the American pharmaceutical industry and forever altering the course of medicine. Drawing on a wealth of previously unused archival material, Medical Monopoly combines legal, medical, and business history to offer a sweeping new interpretation of the origins of the complex and often troubling relationship between the pharmaceutical industry and medical practice today. Joseph M. Gabriel provides the first detailed history of patent and trademark law as it relates to the nineteenth-century pharmaceutical industry as well as a unique interpretation of medical ethics, therapeutic reform, and the efforts to regulate the market in pharmaceuticals before World War I. His book will be of interest not only to historians of medicine and science and intellectual property scholars, but also to anyone following contemporary debates about the pharmaceutical industry, the patenting of scientific discoveries, and the role of advertising in the marketplace.

Boosting Pharmaceutical Innovation in the Post-TRIPS Era: Real Life Lessons for the Developing World.

Author: Burcu Kilic Publication: Edward Elgar Publishing Limited No of Pages: 271 Price: ` 8964.00 About the book: The author in this book explains the concept of innovation and illustrates the crucial role that patent strategies play within processes of pharmaceutical innovation. Drawing on extensive country and company case studies, the book mentions the key issues relevant to the revival of local pharmaceutical industries. The book is based on the case studies of national innovation strategies. It specifically addresses an important question - to what extent can lessons from national experiences be transferred to current policy developments for innovation in the pharmaceutical industry in a developing country context? The book also recommends a number of choices through which this achievement is possible.

It suggests that it can be done in relation to the key development objectives of promoting the technological and scientific advancement of the country, enhancing local pharmaceutical innovation capacities, adapting patent law to own local realities, providing wide access to medicines and knowledge, safeguarding public health interests, and fostering innovation. Practitioners and policy planners within the pharmaceutical industry will deem this book invaluable as it addresses a number of practical implications for the promotion of the pharmaceutical industry. It will also be of enormous interest to students, researchers, and academics specializing in intellectual property law and policy, science and technology, and the management of technology and innovation.

Pharma Bio World

December 2019 ► 55

CEW Interview

interview

Cadila’s Vision is to Make Affordable & Quality Medicine for Common Man Mahidhwaj Sisodia, in an exclusive interaction with P h a r m a B i o Wo r l d , t a l k s a b o u t C a d i l a ’ s fo ot p r i n t , competitive position in global formulations market, global expansion strategy, changing consumer trend & its impact, cross border business & the associated legal implications, and many other aspects.

Mahidhwaj Sisodia Head of International Formulations Business Cadila Pharmaceuticals Limited Please acquaint our readers with Cadila’s footprint in international markets. How does the company contribute to Indian pharma industry, both in terms of revenue as well as value addition?

Cadila started with a simple vision of making affordable, quality medicine for the common man. This vision still drives all the decisions we take, and this is the value that we bring. This was the vision of our founder chairman and we continue this. This vision has enabled us to establish our presence in more than 100 countries. Our international business has shown tremendous growth over the past years and the journey for me has been really exciting.

been experiencing good growth in the global formulation markets. We are proud of our achievements including 1400+ product registrations and globally accredited plants complying with European Union, etc including almost all health authorities around the world giving us an edge in the global market.

What strategy has been adopted by Cadila for global expansion? What sort of competition and challenges does the company face?

How do you describe Cadila’s competitive position in global formulation market compared to its contemporaries?

Every market is different and you need different strategies to tackle the challenges in each country. Our strategies have mostly been to gain competitive advantage through partnerships and joint ventures. We have also been investing in building our product pipeline and manufacturing capabilities.

We are one of the largest privately owned pharmaceutical companies, probably one of the oldest India based pharma players.

We started in 1951, and have been fulfilling our promise for almost 7 decades. We have

Technology is changing the pharma industry every second. It is very important for any pharma company to keep themselves in the loop so as not to get outdated. From customer centric healthcare to e-pharmacies,

56 ◄ December 2019

the future is very dynamic. In such a scenario, we try to adapt to the changing market which sometimes can be a challenge.

Please walk us through the changing consumer trends and its impact on the formulation market.

With the advent of digital marketing, the consumer is more aware than ever today and more involved in the decision making.

Everything is now a google search away. It has become more important for brands to enter the consumer journey early in the decision making process to establish better brand recall. Pharma marketing is not only about reaching out to the doctors, but also about reaching out to patients. As patients are also participating in the discussions about their health, Pharma Companies have to build brand presence in front of the consumers.

Thanks to the various communication media, companies can talk about the value they bring, thus adding much more touch-points to the consumer journey. This comes with added responsibility as now companies have to be doubly sure about the message they send out.

Pharma Bio World

interview While making a foreign entry, how does Cadila manage the cross-border entry?

How does it prefer its operation: through joint-ventures or through wholly-ownedsubsidiaries?

Cadila has had a long history of global presence in most of the international markets. This has been built by nurturing long term relationships with various stake holders such as trade players, medical professionals, and hospitals. Cadila has their own professionals in various countries providing us with valuable insights such as local sensitivity, culture, etc. This eases the process of entering the newer markets.

How does Cadila manage its legal implications for doing overseas business and what’s the policy perspective?

Each country has a very different set of laws. We have been able to manage our presence across the countries by having key people in the country who understand the regulations and plan ahead. Most of our international initiatives are planned at least a year ahead. This is of course done keeping in mind the laws of all the regions.

Our dedicated medical, regulatory, and legal teams also play a huge role in ensuring that no regulations are overlooked by helping our teams in all policy related matters.

What sort of tactical changes are needed in operational ground for doing international business?

The biggest tactical adjustment an organisation has to generally make is: planning and forecasting the way ahead. Our supply chain team, for international orders, has to take into account the time it takes to process the order, for regulatory clearances and delivery time. This sometimes means planning for several months ahead including the time for manufacturing of the drug.

With respect to global expansion and operation, how does Cadila balance between the mark-up of centralized and decentralized decision making?

This is a suitable combination. A mix of decisions made at the Head Office as well as ground zero make the system nimble and agile. Surely, most of the strategic and financial approvals are centralized. The execution is decentralised. Our support team coordinates the activities between the Head office & region-specific teams, and also supports the region-specific teams to execute the marketing and sales activities.

What strategy has been adopted by the company to manage various cross-border cultures?

One of the most important steps we have taken is to have the people who understand the culture and have them at the right places. Our teams at the head office have regular interactions with our outstation teams and make sure that there is no gap in communication. We encourage the team to identify with the global organization instead of the local office. We regularly hold interactive sessions with our leaders talking about global expansions encouraging the teams to think of a global career with the organization. At the same time, we believe in nurturing local talent and creating a right work ecosystem for them to flourish. We can proudly say that almost all employees in our Ethiopia manufacturing plant are local.

What sort of skill-sets do you look for, in employees, in sync with Company’s global expansion strategy? What initiatives does Cadila take for its employees’ capability development?

While our experienced team brings unique skill sets with them, we try to enhance the same by providing a conducive environment

Biosimilars are also changing the shape of the industry. According to reports, biosimilars might grow to capture 20 percent of the market in the coming few years.

Pharma Bio World

to experiment with various opportunities given that there exists a massive potential in various geographies. One of the most important things we look for in talent today is: fungibility, that is – how changeable my resource is. Can I choose someone who has been doing great in domestic market and put him as a country lead in international formulations, and how can I make sure they excel in it. Today it’s easier to find talent, but it’s difficult to find a fungible talent. A few aspects that we look into mobility, specifically in formulations, are - cultural mobility, skill mobility, practice mobility, and also geographical mobility to make them more confident.

• Skill mobility – Everybody brings with them their own set of skills, but I want to give them a new bag of skills so that our talent can climb up the career ladder.

• Cultural mobility – When people from different backgrounds collaborate, the organization gets a broader and newer perspective due to the diversity of opinions.

• Technology/Digital mobility – It provides a sense of comfort with mobility but as an organization we can help them to develop it further.

Message to pharmaceutical industry w.r.t leveraging international business opportunity.

My only message would be to embrace the change and appreciate the difference in cultures of various countries. The regulations are changing rapidly in the market; consumers are investing more in their healthcare decisions; and newer platforms & business models for the industry are coming up. In such a scenario, it is important for any established company to keep revamping their working models and to keep investing in newer technologies. Only such an approach will help them to thrive in international markets and will make able to emerge as market leaders.

Moderator: Jayati Mukherjee December 2019 ► 57

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