Express Pharma (Vol.14, No.3) December 01-15, 2018

CONTENTS Vol.14 No.3 December 1-15, 2018

Chairman of the Board Viveck Goenka

E-PHARMACIES: WAGING A BATTLE FOR 16 SURVIVAL

Sr. Vice President-BPD Neil Viegas Asst. Vice President-BPD Harit Mohanty Editor Viveka Roychowdhury* BUREAUS Mumbai Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das, Swati Rana, Tanuvi Joe

Pg

New Delhi Prathiba Raju DESIGN Asst. Art Director Pravin Temble

MARKET

MANAGEMENT

Chief Designer Prasad Tate Senior Designer Rekha Bisht

PHARMA ALLY

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EYEC LAUNCHES SOLUTIONS FOR TOBACCO PACKAGING

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CTI LAUNCHES HIGH-TECH INKS TO REDUCE PRODUCT TAMPERING AND COUNTERFEITING

Graphics Designer Gauri Deorukhkar Senior Artist Rakesh Sharma Digital Team Viraj Mehta (Head of Internet ) Photo Editor Sandeep Patil Marketing Team Rajesh Bhatkal Ambuj Kumar Debnarayan Dutta Ajanta Sengupta E Mujahid Nirav Mistry PRODUCTION General Manager BR Tipnis

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OGT EXPANDS GLOBAL DIRECT SALES INTO APAC REGION

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ION EXCHANGE INTRODUCES INDION LAB-Q SERIES OF PRODUCTS FOR HIGH PURITY WATER

PHARMA LIFE

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ONLINE REPORTING SYSTEM AS A PERFORMANCE ENHANCING TOOL

P10: INTERVIEW Luca Visini Managing Director, Eli Lilly and Company India

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BUILDING AN EFFECTIVE SALES PIPELINE

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VICE PRESIDENT OF INDIA TO MEET TOP 50 PHARMA CEOS AT 70TH IPC

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THE PILL HOUSE

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EDITOR’S NOTE

Achieving UNAIDS’ 90-90-90: A tall task

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his December 1 marks three decades since the first World AIDS Day. The theme of this year's World Aids Day campaign is ‘Know your status’, a challenge to focus attention on the need to test for the condition as early as possible.

The theme is to push forward on the 90–90–90 Targets, an ambitious treatment target set by the Joint United Nations Programme on HIV/AIDS (UNAIDS) in January 2017 to help end the AIDS epidemic. The target is that by 2020, 90 per cent of all people living with HIV will know their HIV status, 90 per cent of all people with diagnosed HIV infection will receive sustained antiretroviral (ARV) therapy and 90 per cent of all people receiving ARV therapy will have viral suppression.

We have a long way to go, because in September 2018, UNAIDS estimated that more than 9.4 million people living with HIV still did not know their status. This is clearly a call that needs to be heeded, by governments, public health workers as well as the general population across the world. The asymptomatic phase of HIV infection, when the virus is in gestation, but still transferable, is the reason why the spread continues undetected until too late.

How has India fared when it comes to tackling AIDS? Since 2010, new HIV infections have decreased by 46 per cent and AIDS-related deaths have decreased by 22 per cent. As per UNAIDS statistics, in 2016, India had 80000 new HIV infections and 62000 AIDS-related deaths. There were 2100000 people living with HIV in 2016, among whom 49 per cent were accessing antiretroviral therapy. The key populations most affected by HIV in India are people who inject drugs (with an HIV prevalence of 9.9 per cent), transgender people (7.2 per cent), gay men and other men who have sex with men (4.3 per cent), and sex workers (2.2 per cent).

Much of our future progress to contain HIV/AIDS depends on the efficient implementation of policies. On World AIDS Day last year, the National AIDS Control Organisation (NACO) launched the National Strategic Plan for HIV/AIDS and STI 2017 – 2024. Titled, Paving Way For An AIDS Free India, the document is prefaced by a

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Merely having an HIV/AIDS Act or NACO’s strategic plan will not help because as NACO’s Director Alok Saxena puts it, human behaviour is at the forefront of this epidemic

letter from Health Minister Jagat Prakash Nadda, who asks all States and Union Territories to ensure efficient implementation of the plan.

This was followed by the Human Immunodeficiency Virus and Acquired Immune Deficiency Syndrome (Prevention and Control) Act, 2017 which came into force from September 10 this year. At least on paper, the Act provides the legal framework for prevention and control of the spread of HIV and AIDS and for the protection of the rights of people living with HIV/AIDS as well as health providers associated with the disease.

Other laws too need to be changed to wipe out HIV/AIDS. For instance, the Supreme Court's decision to annul key provisions of Section 377 of the Indian Penal Code which criminalised sexual relations between lesbian, gay, bisexual, transgender and intersex (LGBTI) people, should hopefully go a long way towards encouraging this community to test earlier and seek treatment, without fear of discrimination.

But, merely having an HIV/AIDS Act or NACO’s strategic plan will not help because as NACO’s Director Alok Saxena puts it, human behaviour is at the forefront of this epidemic. As Joint Secretary in the Ministry of Health & Family Welfare looking after NACO as well as on the team implementing Ayushman Bharat-National Health Protection Mission (AB- NHPM), he has to ensure that the epidemic does not bounce back again in India. In his letter prefacing the National Strategic Plan for HIV/AIDS and STI 2017 – 2024, Saxena makes the point that India's epidemic has grown much more complex as HIV risk and vulnerabilities are rapidly changing. Thus, besides visible populations, we also need to bring into the fold populations who are hard-to-reach and invisible. He advocates a decentralised and bottom-up programming approach, development of localised differentiated prevention and care and treatment models, along with synergised and concerted efforts. Let us hope that these laws and plans translate from paper into action sooner rather than later.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

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MARKET I N T E R V I E W

‘Olumiant is already present in 50 countries around the world with more than 22,000 patients on it’ Eli Lilly and Company (India) recently announced the launch of Olumiant (baricitinib), marking the company’s entry into the autoimmune segment in India. Luca Visini, Managing Director, Eli Lilly and Company India, divulges more details about the once-daily oral medication for adult patients with moderate-to-severe active rheumatoid arthritis, it ability to provide relief to those who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs), his company’s plans for this segment, its larger vision for the Indian market and more, in an exclusive tete-a-tete with Lakshmipriya Nair

You have announced the company’s entry into the autoimmune segment in India? Tell us more about it.

It is a very exciting moment, part of that is also luck. This year we’re celebrating 25 years of Lilly’s presence in India. So, it’s a very symbolic time, marking a quartercentury. Today we’re specifically talking about one of those innovations that have characterised Lilly’s presence in India, and we’re talking about the autoimmune space.

This, for us, is an important news because it’s the first time that we are entering the autoimmune space for Eli Lilly and Company and we are talking about this at an auspicious time. Just a couple of days before the World Arthritis Day when we’re bringing in the market a therapy for rheumatoid arthritis.

Can you give us an overview on the problem posed by rheumatoid arthritis and the challenges in its management?

Talking about numbers, four

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to five million people in India are said to be suffering from rheumatoid arthritis. Women are three times more likely to develop rheumatoid arthritis than men and the age during which they are likely to develop rheumatoid arthritis is around 30 to 50 years. It’s a bit early in the lifecycle, and part of the challenge is that around 50 per cent of the people who have been treated with conventional drugs do not achieve remission, they do not feel better, or they feel better in the beginning and then they go back.

It’s not only about the mobility or the stiffnesses; it’s also the pain that comes with it, like holding a pen, getting a

cup of coffee or participating in social events. Thus, in rheumatoid arthritis, despite multiple options already in the market, multiple types of therapies, their problems are still huge.

Unfortunately, current treatments are still leaving a lot of unmet needs. So, that’s why we think that bringing a new therapy, oral, once a day that can help the doctor effectively prescribe for those patients who are not responding well to the current treatment. Now, we have a solution for those patients who are not any longer responding well to the conventional drugs. The solution is now getting to

Olumiant will work quickly on symptoms, pain, fatigue, stiffness and it will help in slowing damage that rheumatoid arthritis is bringing into the joint

India. It is present in other countries around the world.

Can you tell us more about the drug you are launching in this space?

Olumiant, our first in the autoimmune space is a oncedaily oral treatment indicated for moderate-to-severe rheumatoid arthritis, as indicated in adults and patients that either respond inadequately to the current treatment or are intolerant to the conventional treatment.

So basically, they need some more help. Talking about numbers, four to five million people in India are said to be suffering from rheumatoid arthritis. Women are three times more likely to develop rheumatoid arthritis than men and the age during which they are likely to develop rheumatoid arthritis is around 30 to 50 years. It’s a bit early in the life-cycle, and part of the challenge is that around 50 per cent of the people who have been treated with conventional drugs do not achieve remission, they do not feel better, or they feel better in the beginning and then they go back.

Now, we’ve Olumiant. The clinical trials for this drug have been done in 37 countries with 3500 patients.

India was included as well in the trials. They are proving that as a wrap-it-up set, as early as within week one, they start benefiting in a significant way on what we call patient-related outcomes through symptoms that are generally pain, fatigue and morning stiffness. The benefits are due to a oncedaily oral pill. Olumiant is already present in 50 countries around the world with more than 22,000 patients on it. So, it’s also very fairly used outside.

Why wasn’t it launched earlier in India or why is this the right time to launch it?

I like the question ‘Why is this the right time’. To me the right time is because we can.

So, responding to your

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question, we develop drugs generally on global clinical status. The moment we have those global clinical status we start the regulatory process in different countries in the world and according to the regulatory process, how things are structured, we

make it available. So, for India, last year we got the approval. The next steps, at the end of the year, regulatory-wise that we needed to go for, allowed us to launch it now. That’s why today and not last year or before.

So, how does this drug shorten the time of treatment or improve it?

Very good question. RA is chronic. It’s autoimmune.

When it starts, it’s chronic and what it does by the time you continue with it or it is not controlled is that it will

inflame the joints, it will damage the joints and the risk is that its restricting mobility and inducing disability. What Olumiant does is after the first line of treatment that is conventional, when they’re not working any more. It will help in working quickly on the

MARKET symptoms, pain, the fatigue, the stiffness and it will help slowing down the damage that rheumatoid arthritis is bringing into the joint. So basically, it will preserve the condition longer before it gets worse and worse. And today after the conventional, there are generally injectables that you go through. In this case, what works for patient compliance is that this is an oral drug. It is a once-daily oral drug. So, it will help the patient be more compliant to treatment.

Is there a way to find out whether we’re genetically predisposed or geographically or racially predisposed to the disease?

So, we know that there are factors that play into the likelihood of having it and genetics is one of that besides some behavioural factors.

Smoking and lifestyle behaviour are a part of it, but there is no definitive way to say yes someone will develop the disease, someone will not develop the disease. So, that is there and how we are styled.

The more we know about the human body, generally speaking, not talking about rheumatoid arthritis or autoimmune disease, the more we know what are the components that might be prone to develop it, the better, but we do not have a way to know if we will develop it.

How is this launch a part of your larger vision for this market?

India is clearly a country where we have a lot of interest, not only because we work here and this is basically our job, but in terms of our overall long-term strategy, when we talk about Lilly worldwide. When we talk about therapeutic areas where we are in, some of them are traditionally where Lilly has been, like diabetes and oncology, and there is the autoimmune space. Today is really the day we premier in the autoimmune and pain segments. So, what you can expect and what we all can expect is that for the years to come, in the world and across India, these four pillars, these

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therapeutic areas are where we’ll be launching drugs. So, our pipeline is mainly in these therapeutic areas.

I think earlier this year you had a tie up with Lupin for diabetes. Are you planning some kind of a tie-up for this space as well?

We did. It is correct. We’re in alliance with Lupin. We were already in alliance with Lupin with two products this year.

Even recently, in this month, Lupin announced a launch with us in diabetes.

Well, when it comes to rheumatoid arthritis and when it comes to Olumiant, one other question we ask ourselves is can we launch on

of the Indian market?

That’s an interesting question because it is just part of my learning trajectory in the country. When we think about India clearly the size is impressive, because there is no other country apart from China that has this size. Now, with the size of the country also the size of the unmet needs is there. So, for Lilly, clearly our mission is that we make drugs to improve patient lives. Where there are unmet needs in therapeutic areas our goal is to make sure that we tackle that. Now, having said that, according to the type of country, according to the type of healthcare system, there are challenges

process and we keep ourselves informed about the same because it changes from time to time. Now, in India it changes; in Europe it changes; in the US it changes but with different frequencies.

You spoke of reaching out to the doctors across the country, do you have a strategy for doing it?

Today we are talking about rheumatology, so rheumatoid arthritis is a very difficult disease. The challenges for the disease are still high. The knowledge of the doctor prescribing the therapies or helping the patients with rheumatoid arthritis is very

In our pipeline, we have 22 in Phase 1, 10 in Phase 2 and seven in Phase 3.All the drugs we have are meant to be made available to countries around the world including India. Some of them are in the oncology space, some of them are in the diabetes space and some of them are in the autoimmune segment our own? Can we make available a drug for the Indian patient alone in an outstanding way and can we do that alone? If the answer is yes, then we go alone into the market and in this case, the answer has been yes. We can handle that directly and that’s why we’re handling it inhouse.

India is also a very costsensitive market. How affordable is this treatment -- this drug?

So, India is a price-sensitive market and we cannot avoid paying attention to that, so what we are doing is, we are launching the product and with Olumiant, there will be a patient-support programme to help patients who are struggling with access to the drug in terms of affordability.

The patient-support programme will help with this.

In comparison with other global markets, what are the unique characteristics

that arrive. In case of India for instance, India being an outof-pocket country -- as you said price is very sensitive.

So, our focus is, how do we make sure that affordability is there. Geography wise, you have countries like Switzerland that is basically a neighbourhood of Delhi or Mumbai literally in terms of people. So, here the challenge is that how do we make sure that we’re able to reach the doctors that are around India with our education, with our messages.

Regulatory wise, every country has its own focuses.

Our goal here is to make sure that we understand what the requests are and we’re ready to comply with those requests. You’re asking me the question today. Well, everywhere in the world what we do is work around the timelines to make the drugs available according to the local laws. India is not any different. Our attention is on making sure we know the

important. So, in our case, rheumatologists are the one who are allowed to prescribe it.

Our strategy is to make sure that we’re in front of those doctors and put in them the education they need. Now, when it comes to rheumatoid arthritis specifically, we know that we can do that. Doctors have more depth of understanding of autoimmune disease and then the patient of course partnering with them, will leverage the knowledge about the drug.

Now your focus is on autoimmune diseases, so rheumatoid arthritis is just one of them, which are the other diseases you’re looking at?

That’s a very good question.

When it comes to autoimmune, there are different series of specific diseases. Now, today is about rheumatoid arthritis. In our pipeline we have 22 in Phase 1, 10 in Phase 2 and 7 in Phase 3.

All the drugs we have are meant to be made available to countries around the world including India. Some of them are in the oncology space, some of them are in the diabetes space and some of them are in the autoimmune segment.

What are the major challenges in managing autoimmune diseases?

What we have learned is when it comes to autoimmune disease is that the challenge is big. We don’t know where they come from and there isn’t honestly a cure. So, our effort is how do we help the patients mitigate their symptoms and feel better and come back to life as normally as possible.

So, when we come to Olumiant today, to me the important piece is that we know for what the patient is indicating, so the one that does not respond well to conventional drugs receives help. The fact is that it is an oral therapy and is lasting.

The second part is the solid data. 37 countries and 3500 patients in the clinical studies prove that there is a quicker set and it is very important when you’re so frustrated about how your life is going on for the pain and it actually has a significant number of people suffering from it. Finally, it’s great that the availability is there and we’re happy that we have been able to make it available in India.

In the top 10 markets what is your focus area and where does India stand?

Okay. Well, as you may imagine, there is a lot of focus on the US, a lot of focus on Europe and in East Asia or Japan. For Southeast Asia, definitely for all diseases 100 per cent, but clearly India holds a very-very important piece in terms of the unmet needs. I come back to the point which is not by chance, because considering the size, considering the amount of the need for drugs in India, clearly as a company that wants to make drugs available, this is top priority for us. lakshmipriya.nair@expressindia.com

MARKET EVENT BRIEFS 12

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CPhI & P-MEC India

CPHI & P-MEC INDIA Date: December 12-14, 2018 Venue: India Expo Mart, Greater Noida, Delhi NCR Summary: UBM India is all set to bring in the third edition of India Pharma Week (IPW), a week-long celebration packed with avant-garde events alongside its flagship expo CPhI & P-MEC India.

This will enable all the key stakeholders and professionals of the pharma industry the convenience to congregate, network and celebrate the industry under one giant umbrella for an entire week.

Apart from India Pharma Week, the 2018 edition will also feature dynamic engagements such as the Pharma Leader’s Golf Pre-Connect Congress, plant visits, Women in Pharma – Power Breakfast, India Pharma Awards, Networking Evening, and a closed-door CEO Roundtable, amongst others.

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MARKET POST EVENT

Vice President of India to meet top th 50 pharma CEOs at 70 IPC 70th IPC LOC conducts final review meeting at PHD Chamber Usha Sharma New Delhi EXACTLY 40 days before the 70 th Indian Pharmaceutical Congress (IPC), the Local Or-

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ganizing Committee of IPC has conducted a review meeting of its 25 task committees on November 11, 2018 at the PHD Chamber of Commerce and Industry in New Delhi.

In his opening remarks, BR Sikri, LOC Chairman of 70 th IPC, updated the attendees about the last meeting held at Sun Pharma House on October 20 in Mumbai. He

also imparted the good news that Venkaiah Naidu, Vice President, India has agreed to be a part of the inaugural session of the 70th IPC. He further informed that LOC will

arrange to have a meeting of the top 50 pharma CEOs before the inauguration over breakfast at the venue of IPC itself. The LOC is also inviting Jagat Prakash Nadda Union

MARKET Minister of Health and Family Welfare, Suresh Prabhu, Commerce Minister, Arun Jaitley, Finance Minister, Dr Harsh Vardhan, S&T and Environmental and Forest Minister, and Chief Minister of Uttar Pradesh and looking forward to a positive response.

The LOC has already prepared a list of top 50 Indian pharma CEOs of which 7-10 CEOs category wise will be given a speaking slot of five to 10 minutes. He also informed that for the first time in the history of IPC, this year, the LOC of 70 th IPC is also going to invite key embassies with whom India has pharma business and representatives of industry associations like IDMA, BDMA, FOPE, CIPI, AIDCOC, etc. In addition to this, it is proposed to invite all

national level Apex bodies like FICCI, CII, Assocham, PHD etc. He hopes that the participation of these embassies and consulates will help enhance pharma business relationships with them. Key focus will be on China with whom India has huge business. In addition secretaries of MOH, DOP, S&T, Commerce, Biotechnology, Officers of NITI Ayog , ICMR, AIIMS, all state regulators etc, will also be invited.

Sikri thanked several individuals who have contributed significantly in ensuring the success of 70th IPC. He also extended his gratitude to Youth Wings for spreading the message of 70th IPC on various social media platforms.

The LOC has also adopted many new ideas in this year’s

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IPC. This year, there will be participation from not only manufacturers of plants and machineries but also from API and pharma manufacturing segments.

In support of the Swachh Bharat Abhiyan by the Government of India led by Narendra Modi, Prime Minister, India, a cleanliness campaign with nearly 500 people including all the task committee members volunteers, will be conducted on the morning of December 20, morning at 11 am in and around Amity Campus. It will be the first time in the history of IPC that such a positive move is being initiated by LOC. On the same day, there will be a press conference by the key members of 70th IPC between 2-4 pm at

Hotel Holiday Inn, followed by statutory meeting of governing body followed by dinner.

Another feature in the event is that first time spiritual master Anandmurti Gurumaa will be the Chief Guest for the valedictory session.

Her spiritual discourse are motivational particularly for youth and that is the reason that LOC has chosen a very dynamic and compassionate spiritual personality.

Taking over from Sikri, Atul Nasa, Organising Secretary, 70 th IPC, mentioned about the key challenges faced by registration and scientific committees. He informed that the student registration process is closed and asked the respective task committee heads to seek more registra-

tion from the industry. Recalling previous year’s registration, he informed that this year the number has almost doubled.

During the first week of December, the LOC will organise a ‘Bhoomi Poojan’ ceremony at the Amity University Campus for initiating IPC work.

To avoid any mishaps, the LOC has a stringent security mechanism in place and has decided to implement a barcode system at all halls. Besides this, there will be some value added services like body checkups.

All the committees are well prepared and gearing up themselves for the august gathering. u.sharma@expressindia.com

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cover )

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(

E-PHARMACIES:

WAGING A BATTLE FOR SURVIVAL

THE MAIN FOCUS

Across the globe, e-commerce entities have grown significantly over the last few years. E-pharmacies too have grown as a result of increasing incidence of chronic diseases, growing tech savviness, increasing demand for convenience, etc. Moreover, the significant discount provided by these entities are also a big lure. Till 2015, getting quality medicines at discounted rates was a dream, but, with the entry of online pharmacies in the Indian marketplace it has become a reality. However, its entry had significant impact on offline players’ business and it was strongly opposed by them. And several times, the apex body of chemists association The All India Organisation of Chemists and Druggists (AIOCD) had called up nationwide strikes against online pharmacies .

The war between online and offline pharmacies have been ongoing for some time and both have tried their best to turn the policy makers and regulators in their favour. In a recent development, the ongoing tussle between online pharmacies and offline pharmacies took a different route when Chennai-based Tamil Nadu Chemists & Druggists Association filed a plea to block links of websites selling medicines online. Their concern was that these sites may sell fake, expired, contaminated, unapproved drugs or otherwise unsafe products that are dangerous to patients and which might put a patient’s health at risk. This led to an interim ban on online pharmacies operating without a license. It has given rise to another dilemma — Are online pharmacies just mediators or full-fledged pharmacy stores?

In the midst of all these happenings, industry experts share their views on the recent developments and offer insights on the way forward for online pharmacies.

By Usha Sharma

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cover ) e-Pharmacy– Aconsumer perspective Anil Khanna, Partner, Wisdomsmith Advisors

T

here is a popular Chinese proverb, which goes as follows – “It is easy to get a thousand prescriptions, but hard to get one single remedy.”

This seems to be so true for the Indian e-pharmacy market, and all the debate centred around it. With all kind of expert opinions being propagated, and what’s the best way forward, what everyone seems to be missing one crucial point – “what does consumers want?”, “are consumers absolutely gung-ho about e-pharmacies?”

Are they going to junk their neighbourhood chemists overnight, and walk into the waiting arms of the e-pharmacies, all lock-stock and barrel?

Both offline and online pharmacies keep fighting and arguing among themselves, without a bother for the end consumer. Latest example being a judgement by Madras High Court, ordering interim ban on sale of medicines by online pharmacies, based on a petition by Tamil Nadu Chemists & Druggists Association (TNCDA).

And the usual reason given was ‘online pharmacies may sale fake medicines, which could be harmful for the patients’!

Though in reality TNCDA concern was not at all about consumers, but rather, it was only concerned about its member chemists, and their business. It can also be argued, even the judge who gave the order was also not fully concerned about the consumers, for if he was, he would have asked few penetrating questions on fake medicines being sold through offline chemists also. But he didn’t!

In this disproportionate focus on e-pharmacy regulation, AIOCD opposition to it, chemists strike, one person, who is the most critical in the entire scheme of things, is seldom mentioned – Consumer.

This is actually the reality, and

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hence the tragedy, of any discussion related to pharma / healthcare industry. While everyone pushes their point-of-view in the garb of ‘representing consumer benefit’, what they essentially pushing is their own agenda. So is the case with e-pharmacy related debate Just a small mickey-mouse, random check in your neighbourhood (large metro city, and cosmopolitan) will reveal a sobering truth. First port-of-call for medicine is the corner pharmacy, almost always. Why only medicine? In large number of cases, even for medical advice.

You probe further, with sufficient nudge towards e-pharmacies, all that one hears - “yaah!

They provide big discounts!”

With no spontaneous recall of any single e-pharmacy brand, even ‘aided recall’ is also very low.

This despite the fact that large amount of dollar has been spent by e-pharmacies in TV campaigns – be it Netmed’s - India Ka Khayal Rakhe, India Ki Pharmacy! Or Medlife's – LafadduMatBano campaigns. They just talk about the discount What does it reveal? The answer is one small, though very critical fact – consumer focus or lack of it.

In the summer of 2017, Google launched a TV ad titled 'Pharmacy Near Me'. The ad

focused on their app which helps in immediately pulling up the nearest pharmacy listed, with contact details and ends with the home delivery of something as simple as bandages.

Google won’t do anything just for the fun. Whatever, their plans may be, but they got fundamental consumer truth, absolutely bang-on. That neighbourhood pharmacy matters.

That even after being in operation for nearly 5 years, combined gross sales of e-pharmacies is just about Rs. 1,000 crores! That too, with discounts being offered ranging from 2050%. The reason is simple – in India for large number of people, a chemist not only dispenses

THE NUMBERS WILL PROVE SIMPLE TRUTH

medicines, but he also dispenses medical advice. In a large-scale chemist’s survey conducted by the author sometime back, it was revealed that more than 35% consumers come to a chemist with their symptoms and seek his advice on the medication. So, a visit to a neighbourhood chemist, helps consumer also save on doctor’s fee.

Another important reason is the trust. Since an online pharmacy is a distant entity, consumers don’t know who is the face behind them – an important consideration, especially when it comes to healthcare (including medicine). Consumers, if a survey is done, may overtly say that they would like to buy medicine online, but the reality is there is a certain degree of comfort with physical chemists. In fact, in a very recent chemist conversations, we figured out that outside of Mumbai / Bangalore, in any other metro, there was hardly any impact of online pharmacies on the sale of offline chemists.

Another reason for low online medicine sales is that, out of 280+ e-pharmacies operating in India, most, may be around 90% are operating illegally, or may be violating law of the land flagrantly. That’s a different problem altogether, for which both the law as well as its implementation needs to be strengthened.

So, while, experts will focus on law should have such and such provisions, it should lead to ease of business and so and so forth. But ultimately, what matters is ‘what consumer wants?

Online pharmacies need to evolve With GoI releasing draft guidelines for e-pharmacies and seeking stakeholders’ feedback, regulation for the online pharmacies will eventually fall in place in near future. While clarity on the regulation would be quite desirable and will remove ambiguity, ultimately e-pharmacies would need to become customer centric. They will have to move beyond focusing only on discounts.

Going forward, multi-format pharmacy groupings will be the future. They will create brands, which are meaningful to consumers, leverage marketing clout, generate multi-channel shopping experiences through e-commerce, home delivery and loyalty schemes linked to store cards and mobile technology applications – m-commerce. Such multi-format chains will exert buyer power on a national/regional basis to maximise market share forcing further consolidation in the supply chain to match the demands of pharmacy groups in terms of prices, cost of goods, promotional spend and services. There could be segmentation, with some focused on discounts and other targeting premium opportunities (in Russia major chains run two brands). This will inevitably lead to creation of ‘private label’ pharma brands. So, what’s that one remedy, instead of thousands of prescriptions? – Consumer Connect. And consumers want the flexibility of both online and offline worlds.

This is a space that’s been crying out for consumer focused rationalisation. Alas, no online player is focused on it.

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THE MAIN FOCUS

Taking the tech route to improve healthcare Pradeep Dadha, Founder and CEO, Netmeds.com

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e were pleased with the outcome of the recent hearing at the Madras High Court, which reiterated its earlier observation on Nov 1, 2018, that it will not restrain licensed online pharmacies from selling medicines through their platforms. As a fully licensed pharmacy, Netmeds.com is committed to adhering to all the guidelines and rules under the D&C act.

It’s often said, “all good things come to those who wait,” and it seems now that a very good thing may be coming to those of us, both businesses and consumers alike, who have for more than three years awaited clarity on the status of online pharmacies.

Although not finalised, all indications are pointing toward a positive outcome and the ratification of the recently released Draft Rules that will once and for all legitimise and regulate online pharmacies.

For many of us, this landmark event will signal both the successful culmination of a hardfought battle as well as the beginning of a new chapter in the ever-evolving history of our company and the online pharma industry. Founding Netmeds.com was one of the most exciting and challenging

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cover ) things I’ve undertaken to date, and it may be of interest to understand my motivations in doing so.

There was initial resistance from some of the stakeholders in the pharmaceutical distribution ecosystem due to the lack of clarity on the regulatory aspects. However, the realisation is quickly dawning within the corridors of power, that to fulfil the basic fundamental right of every citizen’s access basic healthcare services – going online is the solution. Whether it is to help old patients who lack access to offline pharmacies or to reach remote areas where essential prescription drugs and medicines are not easily available, e-pharmacies can ensure that patients’ needs are addressed on time. DCGI is already reviewing a study and setting up a registry of le-

gitimate online pharmacies that will ensure compliance and patient safety while ensuring such entities work within a legal framework. The validation from the government of India is the outcome of the hard work we have put in and the results are there for all to see. For a country like India, where a big part of the rural population is underserved, online pharmacies have ensured that people who don’t have access to a chemist or a hospital, can get life-saving drugs delivered to their door steps.

We did face challenges in bringing about that mind-set shift from the conventional practice of visiting the nearby pharmacy, to come online to meet your medicinal needs. It involved educating consumers about the benefits e- pharmacies can bring to them. Basic

things like the importance of consulting a doctor in case of illness and having a prescription, rather than ‘self-medicating’ is a concept that we have helped to inculcate. Further, such customers to be brought online needs a collective effort from all industry stakeholders.

Another challenge we have faced is misinformation regarding ‘fake’ medicines. A common concern raised about online pharmacies is regarding the quality of medicine sold. There is a tendency to raise the spectre of counterfeit or expired medicine, as if purchasing medicine online might somehow increase the chances of getting spurious medicine.

It’s an ironic reference because in reality, getting medicines from an established, licensed online pharmacy

actually negates the possibility of getting anything but 100 per cent authentic medicines and branded OTC products.

Large and reputed online pharmacies insist on up-todate prescriptions which are linked to manufacturers’ batch numbers and expirations dates. We also deal either directly with manufacturers or with very established and trust-worthy master distributors. The supply chain is much more secured, organised and regulated, virtually ruling out the possibility of fakes or expired drugs entering the system. As a great side-benefit to this new approach, we are also able to amass a very accurate database, all of which is linked back to manufacturers’ batch numbers, providing invaluable data to all healthcare stakeholders.

For any e-commerce company, addressing the issue of logistics to cover the vast country like India in itself is a challenge. Timely sourcing of the prescription medicines and Over-The-Counter (OTC) products in one basket, as the typical chronic patient may be taking as many as six different medicines a month, sometimes more. And we have to get the orders delivered quickly. To this end we are excited about developing and implementing AI to ensure on-time and flawless delivery.

To sum up, the use of technology to overcome challenges and give people a better quality of life will eventually improve the health of the nation. And to contribute to a strong and healthy nation is the dream we are working towards.

An easyand effective wayto manage chronic problems Man Mohan Gupta, Co Founder, Mymedicinebox.in

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libaba, the Chinese e-commerce giant, on 11.11.2017 sold goods worth $25.4 billion, smashing its own record of 2016. Ecommerce is now a thriving industry in India. Home-grown Indian companies like Flipkart, Snapdeal and Paytm have redefined customer experience and breaking online shopping inertia.

However, ePharmacy still remains widely untapped with tremendous potential in the future. The market growth is fuelled by the rise of lifestyle disorders and large number of people are suffering from chronic diseases like diabetes, hypertension, asthma and obesity, leading to an increased requirement of therapeutics.

Unfortunately, the ePharmacy business in India is viewed with suspicion by the regulatory authorities even though it had clarified that there was no restriction on online sale of drugs

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till it complied with the existing FDA regulations.

It is a known fact that most of medical stores sell medicines without prescriptions and do not abide by the regulations. Most of the time, patients are forced to buy alternatives and substitutes on recommendations of pharmacists selling at stores.

Whereas epharmacies are trustworthy and always sell medicines as per prescriptions.

In the last three years at MyMedicineBox, no medicine was sold without a genuine bill and always procured from renowned distributors of respective companies and are 100 per cent authentic. More than 50000 customers buy with full confidence. The Indian Pharmacy business is governed by number of acts and notifications.

It is mandatory to sell medicines on valid prescription issued by the registered practitioners while there is no mechanism and

coordination between the laws which govern doctors and medical stores. It is the need of hour that there should be only one Indian medical code which covers entire healthcare. One nation One Medical Code.

Recently, draft rules are framed to regulate the sale of medicines online and to avoid present ambiguity and uncertainty.

India is a country of youngsters and yong India is spending time using their smartphones and surfing online so purchasing online will not be an issue. I am a

member of FICCI committee helping in framing guidelines. I am confident the proposed regulations will regulate the online selling of medicines effectively and will prevent misuse and pave the way for transparent competition to benefit patients at large. It will also benefit people living even in small towns.

Infact, ePharmacies have created challanges for brick and mortar medical stores. ePharmacies has educated the masses about buying right medicines at best prices.

Technology is helping ePharmacies to scale up the business and offering more transparency and patients are well informed .ePharmacies are still at a very nascent stage in India. ePharmacies and healthcare is an important segment in the Indian E commerce industry, it is anticipated to grow at a CAGR of over 20 per cent, crossing the $ 3 billion mark by 2024.

We see great opportunities in the Indian ePharmacy market as it opens employment opportunities at large. MyMedicineBox tag line is Accessibility – Availability – Affordability – Alacrity. ePharmacies will create opportunity to improve the overall healthcare quality in India and will support E-Healthcare & Digital India Initiatives by the government at large.

It is important to mention that the government has shown some initiative to encourage Epharmacies. The Department of Pharmaceuticals, Government of India has formulated the "Draft Pharmaceutical Policy 2017", wherein it has recommended that E-pharmacies should be encouraged in the interest of consumers. This policy also envisages detailed guidelines for E-pharmacies in addition to recognising the potential for foreign direct investment in this sector.

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THE MAIN FOCUS

There is a need for more clarityon e-pharmacies Sripal Bachawat, Director, C-Square

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ndian government is very pro online pharmacies.

While it has several good aspects of online pharmacie there are few grey areas which needs a clarification. Either they have thought about it but we could not interpret it or it’s a real grey area.

Current challenges on draft rules 1. Doing online business can be done by a regular pharmacy by taking license but the law expects 12 hours for all seven days for support and that too by a registered pharmacist. Does it

mean extra burden for small pharmacies?

2. How will the market place work and who is responsible for the customer? The physical pharmacy license holder or epharmacy license holder?

3. Does it mean providing home delivery by physical pharmacy will also require to apply for e-pharmacy license ?

4. As per law customer information should not be revealed to any other person.

Does it mean courier by third party is not allowed?

e-pharmacy

Benefit to consumers by

E-pharmacy is inevitable. With digital adoption, customers’

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busy schedule, traffic and parking issues in cities - Buying medicine is no longer an easy task and online is solving the purpose. This business will consumers in a big way if: 1. Discount war is avoided The draw back of discount war is that it will force low capital holders to opt for buying from unreliable sources for the sake of better margin and consumers health may be compromised. Recently a big consignment got caught which was spurious in nature.

2. Level playing field for existing stores - Most of the Indian

pharmacy are bread winners for their family. More than 20 lakh families are directly dependent on this business. If same margins are not available to small ones then they will die due to non-profit generation from this business.

3. All physical stores to be technologically uplifted. Currently, they run away because of lack of knowledge.

How e-pharmacy business will be sustainable.

1. Today, in India, a pharma distributor serves the retailer with an average bill value of `1200 -

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cover ) 1800. Retailer is given a trade margin of 20 per cent on MRP. Apart from this distributor passes on 2-5 per cent cash discount for retailer to pay within 715 days. Distributor travels 1-20 km to deliver at retailers doorstep.

2. E-Pharmacy average bill value is also around `1200-1800.

E-Pharmacy also passes 20 per cent to consumer. Consumer pays instantly. E-pharmacy travels 1-10 km for delivery.

3. With above two examples If E-pharmacy practices model of distributors and not retailers, they will become profitable in less time. Current challenge or marketing spend will be only to

acquire customers.

4. If E-pharmacy joins hands with existing physical stores then they can supply in less than 90 minutes to customers. This will give double benefit - It will be an inclusive affair (including existing pharmacy) and the second customer will get both convenience and speed of deliv-

ery (very useful for acute medicines).

However, E-pharmacies are again getting trapped with lack of clarity. Recent ruling from Madras court has put all portals in dilemma. It says that any license holder can continue to operate. As far as e-pharmacy licenses are concerned, law is yet

to be passed for a separate license. On the other hand, if it is mentioning about drug license, most of the e-pharmacies are working like aggregators and using local pharmacy as a point of sale. It is evident that e-pharmacy business will need another year or so to get a clarity on their do’s and dont’s.

e-pharmacies offer useful health info on websites Dr Sujit Paul, MD, StayHappi Pharmacy

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n the US, big pharmacy retailers such as Walgreens and CVS have been focused on the ‘online space’ for a while, whilst we have seen the traction coming in India off late. Not only does online pharmacy miss out on that face-to-face contact but there is also the huge expense of delivery. The idea that it’s more efficient is not yet proven, hence I always recommend all the current players to keep a close eye on the supply chain and fulfilment cost. Abroad local drug stores have websites; you may be able to use one to fill or renew a prescription. You will recognise their names: CVS, Walgreens, Rite Aid, or dozens of others. Unless you have questions about your local pharmacy's reputation, there should be no problem purchasing drugs from their websites. I have seen companies mushrooming in online pharma selling over the

22 EXPRESS PHARMA December 1-15, 2018

last one year, however once regulated with enough checks and balances, e-pharmacy would enable consumer to order medicines in a convenient manner, from their mobile or computer.

This will significantly help patients who are already sick and not in a condition to go out to find a pharmacy. However the three major steps to effectively integrate online pharmacy in Indian healthcare would be to link the below: 1. To offer high quality generic drugs — With differences in patent concerns, and that we have patients with wide income strata online pharmacies based need to offer a much more extensive selection of generic equivalents of brand name drugs, and true generic medicines with molecule names, which Stayhappi intends to do in the online space as well, so as to ensure that High Quality Medi-

cine reaches to the end consumer at an affordable price.

Easy access to additional medical information — A particular benefit of many online pharmacies is the inclusion of useful health information on the site itself. Information regarding

the medicines themselves, potential harmful interactions, and links to other resources such as university research, governmental agencies and regulations, and established medical associations are often provided on the better pharma sites. As with all other forms of health information presented online, one should evaluate such information carefully and critically. I strongly recommend this, as I believe that patients need to be educated and they should not only be dependent on their clinician for knowledge. In our health system a better integration could happen , if the online pharmacy feeds the patient with the desired information of his need and offers true value.

Ability to purchase without prescription — Be it good or be it bad, many online pharma sites that have recently started marketing themselves do not ask for

100 per cent prescription as what I have seen in India. This allows for an individual to obtain medicines without the expensive and often times embarrassing visit to a doctor. This, however, removes a layer of protection provided by consultation with and diagnosis by a trained medical professional, though I never recommend self medication personally and purchase of controlled substances without an appropriate prescription may involve serious health risks as well.

There are multiple lobbying against online pharmacies that have been going on, which is but obvious, thereby a structured approach move towards the space, will really diminish the share of brick and mortar, as we have already understood the Indian mindset of online purchasing, right from pin to house, and so would it be in medicines soon.

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THE MAIN FOCUS

Digital renaissance: The e-pharmacy conundrum Tabish Sangra, Co-Founder & Chief Information Officer (CIO), Aiolos Solutions

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isruption is passé, the age of digital transformation (DT) is upon us. Every sector is facing the full brunt of this tectonic shift that has challenged our understanding of markets, customer service and business models. Healthcare has traditionally been a laggard in technology adoption; the technology debt has always been off the charts. It’s no surprise then that there is massive resistance to change across the board and digital transformation has been slow and deliberate. Having helped several Fortune500 companies, including marquee healthcare leaders design, plan and navigate through their Digital Transformation transitions, I’ve crystallised these transformation endeavours into four distinct stages–I&3R–Inertia, Resistance, Revolt & Renaissance.

The Indian pharmacy retail market is pegged at $6 Billion, growing at a steady clip of 18 per cent annually. Of an estimated 900,000 pharmacies that serve the neighbourhoods of a rapidly urbanising India, only 6 per cent constitute organised retail; little wonder then that the ‘mom n pop’ stores account for 45 per cent of the market revenue and consequently, have huge ‘Inertia’ to any change.

Organised pharmacy retail is thriving too, growing at an average of 25 per cent and is expected to blow up to 35-40 per cent over the next couple of years. Piece this together with the Indian e-comm juggernaut that’s estimated to grow at a CAGR of 35 per cent (till 2020) and you’ll see why there are now 300+ Indian e-pharmacy startups, 25 of which have already raised in excess

of $200 million in funding.

The pie is big, however the threat is real and the traditional incumbents feel threatened, hence the ‘resistance’ – unorganised vs organised and offline vs online.

The ‘revolt’ manifested itself in the many bandhs organised by offline pharmacy retail associations against epharmacies and the attempts to formalise them as a legal sales channel. That the epharmacies account for a meagre 2-3 per cent of total drug sales in India seems to have no bearing on this opposition. The most recent bandh organized by the All India Organization of Chemists and Druggists (AIOCD) was in September and was widely viewed to be in protest of the draft guidelines on online sale of drugs released by the Union Health Ministry in the

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same month.

There are quite a few issues plaguing offline pharma retail. Incidents of sale of counterfeit medicines, medicine sale without prescription, mass dispensation of habit-forming, prescription drugs are rampant and wellknown here too. Moreover, most pharmacies are low-tech and have sub-optimal supply chain management which results in loss in revenue. According to recent estimates, retail pharmacies are able to service only 60 per cent of the medicine consumption demand; we are far behind our goal of providing inclusive, affordable and universal healthcare.

The above scenario sets the stage for the ‘Renaissance’. No individual or corporation has monopoly over E-commerce or digital as a

sales channel. That e-comm businesses have gone on to become monopolies leveraging network effects is a different study, however, digital is a free for all, level playing field; therein lies the real opportunity. In my view, e-pharmacies are an eventuality and medicine e-comm makes a strong case given the hyper change in user behaviour among centennials. The market presents a golden opportunity for unorganised retail to embrace digital transformation and make the transition from unorganised to omni-channel retail. If this mass exodus comes into effect, it’ll positively send metrics of revenue, margins, medicine availability & affordability and customer service into orbit! Like I said earlier, digital transformation of healthcare is already upon us and it’s imperative that we en-

sure that all stakeholders are equal participants of this paradigm shift. Unorganised retail is also a great avenue of entrepreneurship and employment to thousands of Indian families and we need to look at how we can integrate them into the post-modern healthcare ecosystem.

The government is already thinking in the right direction and enablers are being mooted and refined. For instance, let’s look at a tenet of the e-pharmacy framework proposed by the government: as per the latest draft rules, e-pharmacies need to apply to Central Drugs Standard Control Organisation (CDSCO) to obtain a license for selling medicines online. The fees for the license is ` 50,000, valid for a period of three years and renewable subject to timely inspections and approvals. It’s also instructed that the e-pharmacy run a pharmacist customer support center and that the epharmacy cannot sell narcotic or psychotropic drugs online.

These steps and more, are great moves and certainly dispel the ambiguity around doing business online and proprietor owned, unorganised pharmacies can effect a significant revenue upheaval by playing smart.

The e-pharmacy association and owners have written to the High Court seeking further clarification. Again, a classic case of Inertia->Resistance->Revolt.

The Healthcare Ministry is making the right moves, consumer demand is growing and the tail winds are telling.

Now it’s up to the entrepreneurs of India to leapfrog into Digital Bharat and usher India into a digital era of healthcare services. u.sharma@expressindia.com

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MANAGEMENT

Building an effective sales pipeline Mohan G Joshi, International Business Coach and Former President, SCHOTT Glass India outlines the importance of measuring the effectiveness of your pipeline to help understand sales graph, assess the gaps, fill them up and move ahead to a sterling performance

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pipeline is undoubtedly a revealing tool in the sales process. What construes your pipeline, how you read it and how you make the most of it, speaks volumes about your sales effectiveness.

Pipeline as a term is core to sales; however, it has been used quite randomly without much thought. It pays for every sales person to invest time in understanding how you can build a pipeline in the new age and how you can make it work for you.

What is a pipeline and what it is not?

A pipeline is a specific set of actions in a sequence taken by the seller to move the prospect to the next stage – from the entry to conversion. It has specifics about every prospect, shows the value of every deal at every stage. Sales pipelines help sales persons understand how their sales are looking, whether they have enough leads and deals, how these are distributed across each stage and whether this will help them achieve their sales targets for that period.

A sales pipeline and a sales funnel are often considered as synonyms; but one would be wrong in doing so. A sales funnel gives a quick conversion report; it deals with an overview of figures and shows the conversions at every stage. A sales funnel looks like a funnel, broad at the top and narrow at the bottom, showing the dropouts at every stage. A sales pipeline is more detailed and helps in a qualitative analysis of your prospect movement across the buying journey. Together, a sales funnel and a sales pipeline can help in predictive analysis and

24 EXPRESS PHARMA December 1-15, 2018

be. Solve that problem and ensure smoother flows to the conversion stage. d) Conversion rate: It all boils down to results and conversion. Sales, at the end of the day is the closures achieved, contracts won and deals cracked. Keeping a close watch on your conversion rates (leads to conversions ratio) becomes key to your sales process.

can help formulate a sales strategy that results in successful selling.

The classic pipeline and its stages A pipeline has typically four to five stages, through which your prospect will move.

1) Making the initial contact (buyer-seller or seller-buyer) 2) Qualifying the contact 3) Meeting 4) Sharing a proposal 5) Closing However, a little flexibility in setting the stages as per industry buying patterns is a good practice. There are buying patterns specific to every industry. For example, the cement industry buyer displays a certain buying pattern in his/her buying journey. The pharma industry may have different stages; and the food industry may have its own stages. Then again, there is a lateral influence to be considered while stage setting, considering the influencers in the industry (the pharma industry has doctors as major influencers in the buying pattern) It is best to consider the gatekeepers, the influencers, the decision makers and the buyers as key parts of the ‘buying process’, while setting the stages in your sales pipeline.

How do you come up with these buying stages for your industry?

The key here is to study your buyers’ buying journey. You need to simulate patterns from earlier buyers to arrive at your stages. While defining the stages, you need to have clear entry and exit point for every stage. Remember that the idea is to deliver value to your prospect at every stage. Exam-

Turning the pipeline into gold

ple, if downloading a certain brochure from your website is earmarked as one stage in your buyer’s journey, you need to assess if that plays an important part in the buying process. You also need to check if there is value for your buyer from the ‘brochure download’ to take him further to the next stage.

The purpose of a sales pipeline is to keep your sales organised and delivering value to you at every juncture. It may be best to keep your stages at an optimal number all the time.

Does your pipeline measure up?

Having a pipeline is not enough.

It needs to measure up to certain benchmarks if you wish it to be effective. Measuring the effectiveness of your pipeline helps you understand your sales graph, assess the gaps, fill them up and move ahead to a sterling performance.

How do you measure your pipeline performance? a) Deal size: Find out your average deal size. Is it a high value or high volume one? With high value, you can achieve your sales targets with lesser numbers. The question to ask yourself is – ‘How do I convert my deals into high value ones?’ b) Pipeline coverage stats: Look at your pipeline (a CRM can be a handy tool if used effectively). See if you have enough leads at the entry point; monitor your growth rate. If you have a growing number of leads entering, you stand a good chance to achieve your targeted sales quota. c) Pipeline length performance: This is the average time that a lead takes to move from the entry to the final stage of the pipeline. Monitor the transition rate to the next stage. If you spot bottlenecks, understand what the reasons could

Making the most out of your pipeline is the task on hand.

Here’s how you can focus on getting gold out of the pipeline.

Automating without losing out on personalising: There are some buying patterns that can be capitalised on by automating, yet maintaining a personalised feel to it. There are a lot of tech tools to do this and save your valuable time.

Maintaining uniformity of stage definitions across your sales team: Define each stage in detail and communicate. This way, there is no room for confusion and chaos.

Profiling the prospect in greater detail: This will help in optimising the available prospect data and turning it into an opportunity for conversion at every stage. This way, you can tailor your pitch to align with prospect expectations.

Using a CRM: This may help in monitoring how far your lead has travelled along the pipeline.

Stepping back: Assessing and analysing the process regularly - to ensure the conversion rate is improving.

Your sales pipeline shows the vital stats of your business at a glance. Check regularly if you are ‘pipelining’ the right way.

MANAGEMENT

The Pill House Pill House or the pharmacy forms an integral part of the healthcare system.

Pharmacies with well-organised practice can go a long way to ensure quality healthcare for the patient. In the fourth of a series of six articles, Organisation of Pharmaceutical Producers of India (OPPI) reveals more

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n most of the household in India, it is common to order the groceries from our trusted kirana store. The youngsters of the household shop online and order from their trusted shopping site.

Medicines are no different. It is not uncommon to have the elders of the house order their medicines from their trusted neighbourhood pharmacy. This makes the Pill House or the pharmacy an integral part of the healthcare system. Pharmacies with well-organised practice can go a long way to ensure quality healthcare for the patient.

Good Pharmacy Practice Guidelines 2002 proposed to establish standards for practice of pharmacy as a profession in India. It proposes standard guidelines that cover the premises and facilities, systems and processes, pharmacovigilance, and practices such as inventory management, prescription handling, and much more. These practices become increasingly relevant as the Pill House dispenses medicine to the ultimate consumer- the patient, most often.

Storage of pills and storage management becomes critical.

The products storage area, in pharmacies, should be protected from exposure to excessive light and heat. Ambient temperature in the pharmacy should be maintained within the stipulated range to prevent deterioration of medicines. The refrigerated storage facilities should be inspected regularly for products at cold temperature.

Pharmacies are meant to have neat, catalogued and labeled shelves for storing medicines systematically. Adequate provisions should be available

26 EXPRESS PHARMA December 1-15, 2018

for storing various medicines at prescribed temperature conditions. Prescription drugs should be kept out of reach of the customer. Drug and dosage form that require special care while dispensing (e.g. drugs specified under the schedule X, Narcotic drug and Psychotropic Substances Act and some other CNS drug etc.) should be kept under lock and key. Shelves should be checked at a predetermined periodicity to ensure that expired drugs are not dispensed to patients and are kept out of reach. Expired drugs should be returned to the supplier or destroyed as per in-house procedure, at the earliest.

Health authorities like the NHS in the UK have laid down clear guidelines on these points, including what should be done when an error is discovered. A March 2017 NHS

document mentions that a separate refrigerator should be used for medicines and food.

Pathological test specimens should never be stored in the same place. Besides, maximum and minimum temperatures in the fridge and in the storage, should be recorded once daily, since medicines intended to be

kept cool should not be frozen.

Likewise, the medicines labeled as inflammable should be kept away from open flames such as cookers and burners and any equipment that may emit electrical sparks.

Another important factor is child-proofing. Medicines intended for adult use, particularly prescription drugs and controlled substances should be kept away from children, in tightly screwed bottles.

Medical gases such as oxygen cylinders (even found in people’s homes these days) always require staff with special training to handle them. The cylinders must be properly secured so that they don’t topple over and sustain damage. Special records need to be kept about the storage and administration of Controlled Substances, including narcotics and some varieties of pain med-

ication.

Today’s pharmacists are supported by powerful, userfriendly pharmacy management systems that can navigate the complexities of dispensing, inventory management, and point-of-sale functions. The Pill House is the last leg of the journey that a medicinal product follows from the factory floor to the patient for whom it is intended. Of the several stages in this journey, each is equally important – as management gurus are fond of saying, “a chain is only as strong as its weakest link.” It is only when the entire chain is completed that the real purpose of the pharmaceutical industry is served.

Issued in public interest by OPPI Watch this space for the last in the KYP series- The Rotten Pill

PHARMA ALLY VENDOR NEWS

EyeC launches solutions for tobacco packaging Comprehensive quality check including the health warnings conformity

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AMBURG, NOVEMBER 8, 2018. EyeC, manufacturer of print inspection systems, has launched new solutions for a quick and automated inspection of cigarette and tobacco packs.

Strict regulations on cigarette and tobacco packaging has been forcing manufacturers to strengthen their quality controls. One of their main challenges is to ensure the quality and conformity of health warnings. Thanks to EyeC inspection systems, they can now perform quality checks at each of the

Thanks to EyeC inspection systems, quality checks can be performed at each of the production stages easily production stages easily and make sure that their cigarette and tobacco packs are in full compliance with legal requirements.

One of the key components of EyeC’s new solutions is the EyeC Health Warning Inspection Tool. Using the EyeC HWIT, users quickly and easily

create a merged file that contains all compliant health warnings and will serve as a reference during inspections. The main advantage of this software, is that it enables users to assign and combine health warnings coming directly from Health Warning Document Libraries — such as general warnings, addi-

tional warnings, and side information messages — to their artwork files automatically.

With the help of this secured reference file and EyeC inspection systems, users can perform a comprehensive inspection. At pre-press, they can use the EyeC Proofiler Graphic to check print files (one-up or step-

and-repeat files) automatically.

During and after printing, they can use the EyeC Proofilerto control printed samples quickly.

EyeC systems detect all items automatically and inspect the complete content of files or printed samples. Text, graphics, 1D and 2D codes as well as health warnings and their rotations are checked in a single inspection cycle. All deviations are displayed clearly, so that users detect any quality issues immediately.

EP News Bureau

MULTIUSE SOLUTIONS FOR PHARMA EXPERTS Vials, pre-filled syringes, and cartridges can be processed in one machine: At p-mec India, Optima Pharma will present the MultiUse Filler as the ideal solution for small batch sizes and different container types. This type of machine can be used for production in a laboratory for up to medium-sized batches. The MultiUse Filler is fully automated and highly flexible. It can be adjusted quickly for different format sizes and container types.

See for yourself at p-mec!

p-mec, India 2018 December 12 - 14, 2018 India Expo Centre, Greater Noida, Delhi NCR Stand No: Hall 11 / Stand D07

OPTIMA pharma GmbH | 74523 Schwaebisch Hall | Germany | www.optima-packaging.com/pharma OPTIMA India Packaging Machines Pvt. Ltd. | Bangalore - 560 013 | India | info-in@optima-packaging.com

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December 1-15, 2018

PHARMA ALLY

CTI Launches high-tech inks to reduce product tampering and counterfeiting New ‘Tamper Heat’ and ‘Tamper Freeze’ inks combat thieves’ efforts to use extreme heat or cold to alter packaging THE BLINDSPOTZ technology of CTI (Chromatic Technologies) is helping stop product tampering by inventing the first dual-indicator to detect product tampering from heat and freezing. The use of extreme temperatures (especially sub-zero temperatures) to circumvent traditional security measures on packaging has increased substantially among criminals in recent years, with no effective deterrent until now.

To date, most tamper indicators only reveal heat tampering (such as using a heat gun to melt glue on packaging tape). BlindSpotz ‘Tamper Freeze’ and ‘Tamper Heat’ inks show colour and messaging when thieves use heat OR cold to tamper with packages.

The ‘Tamper Heat and Tamper Freeze’ ink technologies from CTI are designed to protect documents, seals, tape, labels or various packag-

ing substrates.

‘Tamper Freeze’ inks turn from clear to blue when exposed to temperatures below -10° C while ‘Tamper Heat’ turns from gray to orange (or gray to pink) if exposed to heat greater than 65° C. The longtime industry standard has been a ‘high-heat’ tamper indicator that changes colour, but now there’s a tool to fight bad actors who use cold spray, freezing or liquid nitrogen to (1) pull apart a money or document bag and (2) remove and replace an expired label or bypass security tape–treated, high-heat irreversible inks.

Lyle Small, Founder, CTI said, “Criminals have figured out that the way to get around high-heat tampering indicators is to ‘go cold’ by exposing packaging to very low temperatures. This can ‘delaminate’ many adhesives without activating a tamper-heat indica-

tor. “The BlindSpotz ‘Tamper Heat and Tamper Freeze’ inks eliminate both threats,” Small continued. CTI’s ‘Tamper Freeze’ ink is the only tamperevident product on the market to identify sub-freezing tampering.

Additionally, the ‘Tamper Heat’ ink offers multiple advantages compared to existing high-heat tamper evident inks: (1) they maintain colour if exposed to very high temperatures (greater than 100°C for instance), (2) Tamper Heat/ Tamper Freeze technology activates within a 5° C window, (3) can be printed with adhesives and over-print varnishes and (4) will last much longer on the shelf than existing “heat irreversible” systems, in both wet and printed states.

The ‘Tamper Heat and Tamper Freeze’ inks are part of the BlindSpotz technology portfolio from CTI developed to print sensors on-

pack to measure temperature compliance, confirm high pressure processing (HPP) pasteurisation and detect tampering or water damage.

The ‘Tamper Heat-Freeze’ ink is available in UV Flexo and Water-based inks systems.

With a history dating back to the late 1890s, the effects of product tampering have been staggering. The most infamous case of product tampering is the Tylenol crisis of 1982, in which seven Chicago-area people died after taking what they thought was extrastrength Tylenol but was in fact potassium cyanide. The case is still unsolved. One man was later convicted of extortion, but no one was convicted of the murders. This event led to new requirements for tamper-evident seals on overthe-counter medications and changes in US tampering laws. Sadly, product tamper-

ing worldwide has continued: in September 2018, sewing needles were found inside strawberries in six of Australia’s seven states. In January 2018, metal pins were found in grocery store food in Offenburg, Germany, and in September 2017, jars of baby food in Friedrichshafen, Germany, were laced with ethylene glycol (the sweet-tasting compound used in antifreeze).

The year 2016 saw deadly baked sweets containing a potent pesticide kill more than 30 people in Pakistan’s Punjab province following a family argument. And in 2003, Italian supermarkets were on high alert for several months when “The Aquabomber” used a syringe to contaminate water bottles with bleach and acetone. Over a dozen people became sick after drinking the tainted water.

EP News Bureau

OGT expands global direct sales into APAC region Following successful European rollout, more customers to benefit from enhanced local sales and support services OXFORD GENE Technology (OGT), the molecular genetics company, has expanded its direct sales of Cytocell Fluorescence In Situ Hybridisation (FISH) products to include the Asia-Pacific (APAC) region.

OGT will provide customers in Singapore, Malaysia, Vietnam, Australia, and New Zealand with enhanced local sales and support services via established affiliates of Sysmex Corporation, as well as via continued collaboration with existing distributors. The move follows the successful in-

28 EXPRESS PHARMA December 1-15, 2018

troduction of selling via a number of European Sysmex affiliates earlier this year.

OGT’s Cytocell brand is well-known for providing the widest range of high-quality, reliable, and cost-effective FISH probes on the market, as well as excellent customer support, service, and expertise. To grow and maintain its renowned exceptional customer support services on a global scale, OGT is also delivering extensive training programmes across the portfolio for Sysmex staff in EMEA and

APAC. In addition to the expansion into APAC, OGT is increasing its global logistics cooperation with Sysmex, providing customers with extra levels of support and convenience. The company has recently opened a new Cytocell customer service and distribution centre, initially for customers in the US, located in Lincolnshire, IL, at the Sysmex America, Inc. (SAI) Headquarters. By working closely with SAI, OGT will be able to deliver extended order-

ing and shipping hours, and plans to establish a Singapore distribution centre to serve customers in APAC in the future.

Spencer Howell, Executive VP Sales at OGT, remarked, “Building on the successes of previous initiatives to establish direct sales through Sysmex affiliates, which have provided many benefits to customers in Poland, Czechia, Slovakia, France, Belgium, Switzerland and Luxembourg, we are now focussing on APAC where we see enormous

growth potential. With increased local support and activity, backed by larger Sysmex affiliate organisations, we will increase our visibility, deliver growth, and be able to better realise the opportunities. The expanding cooperation with Sysmex delivers the benefits of being part of a larger organisation to our customers, providing them with enhanced local service and support, something we are committed to continue developing.”

EP News Bureau

PHARMA ALLY

GROUP

Innovation is life

Control Moisture

PRODUCTS

Ion Exchange introduces INDION LAB-Q series of products for high purity water

ter, waste water management, solid waste management and now waste to energy.

Tap water has many contaminants and should not be used directly in laboratories or for scientific purposes. Impurities, elements or compounds in amounts as small as one part per trillion, can significantly influence results in many clinical research experiments. Heavy metals and dissolved organics, commonly found in tap water, are particularly damaging to the results in life science research. Some analytical techniques such as HPLC (High Performance Liquid Chromatography) which use detector base lines for calibration require ultra pure water completely free of any impurity so that the results remain uninfluenced. The water must especially be free of any elements that are being measured.

INDION LAB-Q units are compatible with multiple clinical analysers with different water dispensing capacities. The products are developed by blending highly advanced technologies (RO, UV, UF & DI) and are manufactured in India while

Diagnostic Kits Ensure accurate test results

maintaining international standards.

INDION LAB-Q series is available in the following variants: ◗ INDION LAB-Q ULTRA – Type I Water Maker: LAB-Q ULTRA is a multipurpose water purification unit which can produce Ultrapure Type I and Type II water directly from tap water. LAB-Q ULTRA produces pyrogen and DNAse-RNase free water with very low Total Organic Carbon (TOC) content thus meeting the requirements of liquid chromatography and all spectroscopy methods, in addition to microbiological and molecular biology applications. ◗ INDION LAB-Q SMART - Type II Water Maker: Pure water produced by LABQ SMART complies with the requirements of ISO 3686 and corrosponding ASTM standards. LAB-Q SMART produces water with very low organic carbon content. This Type II water can be used as feed for Type I water, clinical analysers, flame spectrometry electrochemistry, sample dilution, media – buffer preparation and radioimmunoassay. ◗ INDION LAB-Q Water Maker - Type III Water Maker: Lab Q water maker provides cost-effective continuous uninterrupted water supply for clinical analysers.

Analysers are traditionally fed by water stills or bottled water. LAB-Q Water Maker provides a fit and forget solution reducing energy consumption and providing ease of logistics.

Different standards of purity are required for different applications. The LAB-Q series of products provide unmatched superior quality water that perfectly complements the requisite laboratory procedure or appliance.

Contact details Ion Exchange (India) A: Ion House, Dr E Moses Road, Mahalaxmi, Mumbai - 400 011 B: +91 22 3989 0909 D: +91 22 3047 2048 M: +91 97697 57642 .F: +91 22 2493 8737

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December 1-15, 2018

lower humidity level to below 15% RH to protect diagnostic kits from degradation Protect your product... and your reputation Components of diagnostic kits are highly hygroscopic.

They react with moisture and get degraded rapidly, unless they are made and packaged in a dry environment.

Bry-Air is the trusted choice of Pharma industry worldwide to control moisture effectively and economically.

Helps meet

GMP

Standards Backed by

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TM

ECODRY Desiccant Wheel At the heart of it all

Contact today

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21C, Sector-18, Gurugram 122015, Haryana, India Phone: +91-124-4091111 • E-mail: bryairmarketing@pahwa.com www.bryair.com

Leaders in Dehumidification . . . Worldwide

RB/BA/1834HVCA1R1

ION EXCHANGE (India) has introduced INDION LAB-Q Water maker series of products that provide high purity water for multiple diagnostic applications in line with CLRW (Clinical Laboratory Reagent Water) and ASTM (American Society for Testing and Materials) standards. Ion Exchange, a pioneer of water treatment in India, with a legacy spanning over five decades offers complete solutions for wa-

during manufacture, storage and packaging of

PHARMA ALLY

Metal detectable silicone rubber- Aunique solution to multiple industries Nikunj Thakkar, Asst Manager – R&D, Ami Polymer, gives an insight on the advantage of metal detectable silicone which has become a unique solution to avoid contamination in production line PRODUCT QUALITY is a matter of bigger concern in pharmaceutical, food and beverage industry. Major processing steps involve the dynamic movement of silicone rubber parts.

Silicone is most preferred choice for sealing application in food and pharma industry.

There was a risk of silicone rubber particles getting mixed into the products during the production process, due to natural wear and tear. This kind of contamination can cause serious quality problems during the production and it may affect the reputation of the company.

Scope of metal detectable silicone rubber To ensure that the product is free from contamination, the idea of metal detectable silicone arose. As the name suggests, metal detectable silicone rubber is a unique solution to avoid contamination in production line. Metal detector devices can detect silicone-based products made from this unique formulation. During mass production, if the device generates any signal of metal presence in product due to failure of seal or abrasion of gaskets, the line can be stopped immediately. Due to the safety and cost-effective solution, metal detector silicone rubber products are becoming the best solution for pharma, food and beverage industry.

FDA approved metal detectable silicone rubber: A challenge Designing formulation as per food and pharma regulatory compliances is really a challenging task for rubber formulators. To maintain food properties along with metal detectable formula is a matter of expertise, which is required to be placed for balancing both properties. Few silicone products are used in food and pharma product contact applications with the following required compliance:

30 EXPRESS PHARMA December 1-15, 2018

FDA approved metal detectable silicone rubber and its applications The above mentioned products can be traceable through X ray devices. Any small segment of rubber contamination with drug products can be traced through devices and defected products can be separated due to this innovation. The market of metal detectable silicone is growing and many industries are waiting to taste fruits of this development. Polymer industries are developing multiple application of this formulation and we expect that conventional silicones will be soon replaced with metal detectable silicones.

Contact details Ami Polymer # +91 82389 22236 research@amipolymer.com

Silicone Diaphragms FOOD/PHARMA grade, platinum cured silicone is widely accepted in pharmaceutical and biotech applications and is often used throughout the plant. Like all of our diaphragm materials, our silicone diaphragms meet USP Class VI and FDA 21 CFR 177.2600 standards.

Features and benefits ◗ All diaphragms meet USP VI standard and are FDA CFR 177.2600 compliant ◗ Meets the standards for quality, purity, lack of toxicity, strength and consistency ◗ Suitable for biomedical/pharma application

PHARMA ALLY

Clean room high speed doors a necessity BUSINESS ENTITY requires a designated area for clean manufacturing.

Gandhi Automations offers a variety of energy efficient clean room high speed doors. These are suitable for even busy openings in a controlled environment with a guarantee to protect from airborne contaminants.

Cleanroom space is a worthwhile investment for your firm as it assures improved quality in production which interprets to a better financial yield. High speed doors for such rooms have multiple benefits such as stabilising the pressure levels as well as reducing air leakage out of the room. This feature has been revolutionary in the industrial process finding

once opened. The objective here is to isolate the external environment to avoid entry of dust, humidity and altering the internal temperature of your cleanroom.

The door then has to be designed to facilitate high speed opening and closure to serve the stated function. The doors meet unmatched quality standards both in the local and international market hence providing and sustaining a controlled environment in any given clean room.

application in production of medical equipment and its packaging, pharmaceutical industry, manufacture of computers and electronics, food processing and even in the manufacture of military technology.

◗ Special side guides to tightly integrate the curtain ◗ High leak tightness due to the close filling curtain in the guide rails ◗ High door efficiency with and low permeability values, EN 12426 EN 12427: < 12 m3/m2 h Δ 50 PA. ◗ Control device enclosure in Stainless Steel SS 316 Contact details Gandhi Automations Chawda Commercial Centre Link Road, Malad (W) Mumbai – 400064 Off : +91 22 66720200 / 66720300(200 Lines), Fax : +91 22 66720201 Email : sales@geapl.co.in Website : www.geapl.co.in

Best choice of clean room high speed doors Once the nature of production is understood one will need an experienced partner to guide in making an informed choice of high speed clean room doors. Gandhi Automations provides esteemed clients top priority, walking them through different products in order to pick out clean room doors that will serve them better.

One of the key considerations to make is the overall time the door will take to close

Top features of high speed clean room doors Gandhi Automations carefully designs its doors incorporating emerging technological trends in order to give a superior high speed door that will have extended durability once installed. Such features entail: ◗ Concept of low air permeability in pressurised rooms with positive and negative air pressure ◗ Designed to fit inside the columns ◗ Self-supporting construction ◗ Minimises air leakage ◗ Can be equipped with transparent PVC horizontal sections or vision windows

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December 1-15, 2018

PHARMA ALLY

B&R presents fully integrated cameras at SPS IPC Drives B&Râ&#x20AC;&#x2122;S ENTRY into the machine vision market is led by two camera variants: Smart Sensor and Smart Camera. Since the hardware is fully integrated in the automation system, the cameras can be synchronised to machine functions with microsecond precision.

The Smart Sensor is designed to implement a single machine vision functionality, such as QR code reading or position detection. Unlike many other devices in its class, there is no need to install dedicated hardware for each function. Instead, the user simply configures the desired Smart Sensor function in the Automation Studio development environment. OEMs only have to stock a single camera type and are nevertheless able to support a wide range of applications.

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EXPRESS PHARMA

December 1-15, 2018

erful Smart Camera. The existing application software, parameters and models can continue to be used. Whichever camera type is selected, installation could hardly be easier: Simply hook the camera up to the machine network, and it automatically obtains all the settings it needs from the controller.

Optimum image quality

Scalable hardware In cases where more than one

functionality is required, it is easy to switch to the more pow-

Smart Sensor and Smart Camera can each be equipped with one of three image sensors, ranging from 1.3 to 5 megapixels.

All three sensors are characterised by their large pixel size, high light sensitivity and low noise. This guarantees optimum image quality â&#x20AC;&#x201C; even in highspeed applications. Lighting can be implemented in the form of integrated LEDs or external

barlights and backlights.

Housing variants are available with either an integrated lens or a standard C mount. The integrated lenses have electronic focus adjustment and are available in focal lengths from 4.6 to 25 mm. All B&R lenses are specially optimised for the image sensors used to achieve maximum sharpness and optimal imaging performance.

One cable is all you need The camera only needs a single cable. The camera is integrated into the machine network via an M12 hybrid connector which also supplies the necessary 24 VDC power. A second hybrid connection enables easy daisychain cabling with additional cameras or B&R lighting elements.

PHARMA ALLY

B&R presents powerful Edge Controller at Hannover Messe A SINGLE device to acquire data, evaluate it and send it to the cloud – that'’s now possible with B&R's Edge Controller. The powerful industrial PC can even be used for big data analysis and machine learning, while at the same time serving as a full-fledged industrial controller.

B&R’s Edge Controller is based on the robust Automation PC 910, whose high-performance variant is equipped with an Intel XEON processor able to handle resourceintensive tasks like machine learning. The Edge Controller runs a hardened operating system – a commercial Linux variant with guaranteed long-term support.

Cloud transmission occurs via MQTT.

Full-fledged industry controller B&R Hypervisor makes it possible to simultaneously run a real-time operating system on the Edge Controller. That turns the edge device into a full-fledged industrial controller with cycle times in the sub-millisecond range.

An unlimited number of I/O modules or controllers can be connected via the POWERLINK Industrial Ethernet protocol, OPC UA or other fieldbus systems. With the Edge Controller, this will soon also be possible with OPC UA TSN.

B&R cloud application powered byABB Ability opens new opportunities for OEMs ASSET PERFORMANCE Monitor is B&R’s first cloud application based on ABB AbilityTM, ABB’s unified, cross-industry offering of digital solutions. By giving OEMs a reliable overview of all their machines in the field, it allows them to identify potential improvements, take service operations to the next level and unlock new business models and revenue streams.

Around the clock, Asset Performance Monitor delivers data about production rate, energy consumption and temperature. Users can define which information is required, and the application automatically calculates key performance indicators (KPIs) such as overall equipment effectiveness and provides opportunities for improvement.

Asset Performance Monitor prepares the data and displays it in a clearly organised dashboard. OEMs can then use

this data to implement welltargeted machine upgrades and offer their customers next-level service.

Open architecture An edge device is installed on site to collect data from a machine or production line. It receives data from the machine controller via OPC UA and passes it on to the cloud using the MQTT protocol.

The edge device automatically establishes a connection to the ABB Ability cloud and installs the necessary software. Simply logging in with a username and password gives the OEM access to Asset Performance Monitor and all the features it has to offer.

ABB Ability platform B&R’s cloud applications run on ABB Ability. Security and data integrity are guaranteed by state-of-the-art security standards and transfer protocols. The Microsoft Azure infrastructure ensures reli-

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able access to ABB Ability services all around the world, which includes all the prerequisites for future cloud applications featuring artificial intelligence and machine learning.

Contact details B&R India Headquarters: Pune 8 Tara Heights Mumbai - Pune Road Wakdewadi 411003 Pune

India Phone: +91 20 4147 8999 Fax: +91 20 4147 8998 Mail: office.in@brautomation.com

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PHARMA ALLY VALUE ADD

Glimpse into the world of lactose Geetanjali Laghate, Radhika Thakkar and Dr Heeshma Shah, Technical Services Department, Signet Chemical Corporation, give an overview of lactose grades and the selection criteria to suit various formulation needs

A ROBUST formulation is one that should be able to accommodate typical variability in API, excipients, and processes. The choice of excipients is hence of utmost importance. An excipient is chosen based on its functionality as well as chemical compatibility with the drug substance.

In the pharmaceutical industry, lactose is one of the oldest and still widely used filler and diluent in tablets and capsules. The reason for its popularity is attributed to its properties like low hygroscopicity, water solubility, compatibility with active ingredients and other excipients, excellent physical and chemical stability. Depending on the manufacturing process, different types of lactose are formed having application in varied processes like wet granulation, direct compression, roller compaction, fluid bed processing, etc. Apart from oral delivery, it also finds application in parenteral formulations and dry powder inhalers. The additional advantage of lactose over other range of excipients is its availability and cost effectiveness.

Lactose is a naturally occurring disaccharide derived from the condensation of ß-Dgalactose and a-D-glucose, which form a ß-1,4-glycosidic linkage as seen in Figure 1.

Lactose exists in two isomeric forms viz. a and ß lactose respectively. The difference in these two forms is due to the position of the hydrogen atom and hydroxyl group on carbon atom no. 1 of the glucose moiety. Interestingly, alpha and beta-lactose morph back and forth into one another due to a phenomenon

34 EXPRESS PHARMA December 1-15, 2018

Figure 1: Structure of Lactose

TABLE 1: LACTOSE FORMS AND CHARACTERISTICS Sr. No.

Forms of Lactose

Characteristics

Condition of Production

1

Crystalline Lactose

1a.

a-lactose monohydrate

Stable, non-hygroscopic

By crystallization of saturated lactose solution at room temperature below 93°C

1b.

Anhydrous ß-lactose

Relatively low hygroscopicity and good storage stability

By crystallization of saturated lactose solution at temperature above 93°C by roller drying

2

Amorphous lactose

Tends to absorb moisture to form crystalline lactose

By quick drying of lactose solution (either by spray drying or freeze drying)

called mutarotation. The rate of mutarotation is influenced by a number of conditions including the concentration of lactose, the temperature and the acidity, or pH, of the milk.

At room temperature, the ratio of isomers is about 40 per cent alpha to 60 per cent beta lactose.

Lactose is available in two states i.e. crystalline and amorphous. Crystalline lactose is widely used in pharmaceutical industry and can majorly exist in the form of a-lactose monohydrate and anhydrous-ß lactose which are elaborated in Table 1: Meggle Wasserburg GmbH & Co. KG, headquartered in

the Bavarian city of Wasserburg (Germany), has been servicing the pharmaceutical industry for the last 60 years with its broad lactose product portfolio. With intelligent innovations and exceptional product quality, MEGGLE took a leading role in the global business of pharmaceutical excipients. It is GMP and GDP certified according to EXCiPACT standard for the manufacturing, testing, storage and distribution of lactose and co-processed grades used as pharmaceutical excipient.

Lactose grades offered by Meggle meet all the pharmacopoeial requirements of USP/NF, Ph. Eur. and JP

monographs. It is GRAS listed and well supported by complete set of regulatory documentation.

This results in formation of tomahawk shaped crystals.

Narrow fractionation of these randomly sized lactose crystals results in coarse sieved grades (Figure 2). Meggle’s sieved alpha-lactose monohydrate (listed below) are inherently free flowing in nature which is evident from their low Carr’s and flowability index. Hence these grades are recommended for capsule, sachet filling and powder triturates.

Grades: PrismaLac 40, CapsuLac 60, SacheLac 80, SpheroLac 100 2. MILLED LACTOSE The tomahawk shaped crystals of lactose when milled, results in the formation of finer sharper-edged particles (Figure 3) called milled lactose. These grades (listed below) have poor flow but show good binding and compaction properties due to their small particle size and high specific surface area.

Therefore they are are especially useful in wet and dry granulation and pelletisation.

Grades: GranuLac 70, GranuLac 140, GranuLac 200, GranuLac 230, SorboLac 400

Types of Lactose Meggle’s lactose range comprises of different product groups with more than 20 specialty grades, covering all areas from solid dosage forms, dry powder inhalations and parenteral dosage forms.

These grades along with their applications are elaborated below in detail.

1. SIEVED LACTOSE Alpha lactose monohydrate is derived from re-crystallization of lactose solution.

3. DIRECTLY COMPRESSIBLE LACTOSE: a. Spray Dried Lactose: When lactose is spraydried, rapid water evaporation causes the formation of 10-15 per cent amorphous lactose depending on the solids content and process conditions. Unlike alpha-lactose monohydrate which is known to exhibit brittle fracture during compaction, amorphous lactose deforms plastically.

Due to the synergistic plastic

PHARMA ALLY and brittle nature of spraydried lactose, it exhibits superior compactability. As can be seen in Figure 4, the spherical nature of Meggle’s FlowLac is attributed to spray-drying of fine milled alpha-lactose monohydrate suspension.

This morphology along with the particle size distribution makes FlowLac the best flowable lactose amongst all the grades.

The amorphous lactose content in spray-dried grades ensures low friction with the die wall, preventing capping behavior as well. Spray-dried lactose also shows superior binding properties resulting in hard tablets.

Anhydrous beta lactose is more brittle as compared to alpha lactose monohydrate and hence is well suited for direct compression and roller compaction. Moreover, exposure to such high temperature during manufacturing causes removal of crystal water resulting only in non-hygroscopic anhydrous form which is well suited for moisture sensitive actives.

On compaction, DuraLac H fragments and exposes clean surfaces with numerous binding sites. This gives rise to robust tablets in DC process as well as cohesive plugs in capsule manufacturing. DuraLac H is also recommended for dry granulation since it retains its compactibility after the initial slugging step.

Figure 2: SEM images of sieved lactose grades

Figure 3: SEM images of milled lactose grades

Grades: FlowLac 100, FlowLac 90 FlowLac 100 is the standard grade of spray-dried lactose, providing excellent flowability and extraordinary compactability. FlowLac 90 is the superior grade developed by optimizing the amorphous lactose content to provide greater compactability compared to FlowLac 100. In addition, its particle size distribution makes FlowLac 90 virtually dust-free. b. Agglomerated Lactose: Agglomerated lactose is developed by combining the good flow of coarse lactose and good compactibility of fine powder grade. This grade is manufactured by wet granulation process by spraying water on fluidized fine particles of lactose monohydrate. This creates liquid bridges which bring the particles together.

Upon drying, the excess water is evaporated and the bridges are maintained resulting in a very stable, non-hygroscopic alpha lactose monohydrate with no amorphous lactose.

Meggle’s agglomerated lactose grades come under the name ‘Tablettose’.

Grades: Tablettose 70, Tablettose 80, Tablettose 100 As seen in Figure 5, Tablettose grades have a rough surface and a ‘blackberry’ or ‘popcorn’ like shape due to which they flow well. This morphology also provides sta-

Meggle’s lactose range comprises of different product groups with more than 20 specialty grades

Figure 4: SEM images of spray-dried lactose

Figure 5: SEM images of agglomerated lactose grades

ble, homogenous mixtures and is well suited especially for low dose actives.

Tablettose 80 is the standard grade in this series, which is suitable for direct compression. Tablettose 70 has a narrow particle size distribution, which reduces dust while Tablettose 100 is the finest of the three exhibiting superior compactibility. This could be attributed to the fact that it is prepared from

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smaller starting particle size lactose, which increases its binding capacity. Additionally, due to their morphology they are well suited for formulation of low dose actives. c. Anhydrous Lactose: Roller / Drum drying of concentrated lactose solution above 93.5°C results in the formation of anhydrous lactose in the ratio of 80 per cent beta and 20 per cent alpha form.

Figure 6: SEM image of anhydrous lactose

4. LACTOSE MONOHYDRATE FOR INJECTIONS: Lactose is widely used in lyophilized injectable formulations as a stabilizer and to increase the solid content of the plug. It is also used in IV, IM, SC ready to use injections. Meggle offers Lactose Monohydrate, Low Endotoxin grade with a BET limit of NMT 5 EU/g.

5. Lactose Monohydrate for Inhalation: Dry powder inhalers (DPI) are widely used in pulmonary drug delivery due to their ease of handling, portability, small size and no requirement of breath-actuation co-ordination.

The carrier used in DPI formulations not only acts as a filler but also plays an important role in deposition of drug into the lungs. Lactose is one of the most widely used carriers in DPIs owing to the fact that it is inert, has a well-established safety profile and is accepted by regulatory and medical authorities. Meggle offers inhalation grade lactose under the brand name of InhaLac. These grades are manufactured by a two-step crystallization process to give preliminary lactose monohydrate with stringent microbial limits and endotoxin limit of less than 5 IU/g. The lactose is then either sieved, milled or micronized to give different InhaLac grades to cater to specific customer needs.

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PHARMA ALLY Grades: Sieved – InhaLac 70, InhaLac 120, InhaLac 160, InhaLac 230, InhaLac 251 Milled – InhaLac 400 Micronized – InhaLac 500 Sieved, milled and micronized InhaLac grades show different morphology. Sieved ones contain partly tomahawk shaped crystals, which can occur as single or agglomerated particles. In contrast to sieved grades, milled and micronized grades consist of fine lactose particles. Their disrupted and sharp-edged appearance derives from a defined milling process.

All InhaLac grades are BET tested and have stricter or even additional microbial limits compared to the current pharmacopoeia. This provides the highest security for use of InhaLac grades in DPI formulations.

Figure 7: SEM image of inhalation lactose grades Table 2: Product Decision Matrix

QUICK GLANCE AT MEGGLE’s LACTOSE PORTFOLIO Meggle offers a broad array of lactose grades with solutions for any formulation requirement. Table 2 outlines applications and properties, helping you decide the perfect grade of lactose for your formulation needs.

CONCLUSION Lactose is a widely accepted filler of choice for varied applications from solid dosage forms to dry powder inhalations. Selecting the right grade of lactose should involve wise consideration of physicochemical properties like particle size distribution and surface morphology. It is known to be a versatile excipient due to its properties like compressibility, compactability, flowability, etc. and hence an in-depth understanding can certainly facilitate designing of formulation. Thus, lactose is and will continue to remain a popular choice in pharmaceutical industry.

For additional information about Meggle’s Lactose, kindly refer to https://www.megglepharma.com or www.signetchem.com

36 EXPRESS PHARMA December 1-15, 2018

+++++ : Excellent ++++ : Very good +++ : Good ++ : Satisfactory + : Sufficient - : Insufficient / Not advised

BUSINESS AVENUES

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EXPRESS PHARMA

December 1-15, 2018

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BUSINESS AVENUES

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December 1-15, 2018

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PVC RIGID FILM FOR BLISTER FORMING

TRIPLEX LAMINATE

US FDA Type III DMF: 032495

US FDA Type III DMF: 032497

ALU ALU LAMINATE

PVdC COATED PVC FILM

US FDA Type III DMF: 032494

US FDA Type III DMF: 032496

EMERGING AS THE MOST PREFERRED PRIMARY PACKAGING SOLUTIONS PROVIDER FOR THE PHARMA INDUSTRY. CALENDER

Uniworth Enterprises LLP with it's location at Ahmedabad, INDIA, is ideally suited to cater efficiently to the Indian market and with ICD facility and excellent connectivity by road to Nhava Sheva port, Mumbai, can also service the export market with minimum time lag between production and export.

Ÿ Dust Free & Fully Air Conditioned Factory Ÿ Fully Equipped Analytical Lab

SLITTER COATING LINE

Ÿ Producing 60 Micron PVC Film by Direct

Calendering without Stretching. Ÿ ISO 9001:2015 & ISO 15378:2017

Manufacturing site Ÿ 29000 Sq. Mtr. of Manufacturing Area

LAMINATOR

Ÿ 6000 Sq. Mtr. Built-up Area

WE PACKAGE GOOD HEALTH. Corp. Off: 804, Siddhi Vinayak Tower B off. S.G. Highway, Makarba, Ahmedabad -380051 Factory: Chharodi - Sanand (Gujarat) +91 -9726430369 / 7433966038 info@uniworthllp.com • www.uniworthllp.com EXPRESS PHARMA

December 1-15, 2018

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OSMOMETER 3250

Milk Cryoscopes Available

127, Bussa Udyog Bhavan, Tokershi Jivraj Road,Sewri, Mumbai - 400015. India

Tel: +91-22-24166630 Fax: +91-22-2662776 E-mail: support@rosalina.in Web: www.rosalina.in

JOINPURE® L-HPC (Low-Substituted Hydroxypropyl Cellulose)

Physical Properties Real specic gravity: 1.46 Apparent density: 0.45~0.70g/mL (tapped) Solubility: L-HPC does not dissolve in water but swells. It neither dissolves nor swells in ordinary organic solvents, but dissolves in a 10% NaOH solution to give a viscous solution.

The key benets of L-HPC :

Ξ

Excellent compatibility with active ingredients

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Disintegration into smaller particles leading to better dissolution

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Anti-capping effect for tableting process

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Suitable for pellet extrusion as well as tableting

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A variety of grades are available depending on application

One of the benets of L-HPC is to resolve “capping,” which is a typical problem in the tableting process. Several reports have highlighted that capping is caused by a high residual die-wall pressure during the tableting process. L-HPC reduces the residual die-wall force and ejection force during the tableting process.

angwal 40

December 1-15, 2018

®

Package and Storage Pack in drums, net weight 20kg per drum.

Store in sealed container, keep away from sunlight & moisture.

Contact for more information Gangwal Chemicals Pvt. Ltd. :

706-707, Quantum Tower, Rambagh Lane, Behind State Bank Of India, Malad (west), Mumbai - 400064 Tel.: +91 22 2888 9000, Fax: +91 22 2883 5347, Email: info@gangwalchem.com, Web.: www.gangwalchem.com

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BCAP

Autoclavable & Sterile Disposable Goggles

LABORATORY EQUIPMENTS

Clear view Autoclavable Panoramic Thermoplastic Rubber Body Goggles With 40 Autoclave Cycles, Can Be Worn Over Eyeglass With Grid For Marking Autoclaving Goggles

BCAH

Lab Stirrers

Cleaview Autoclavable GogglesWith 40 Autoclave With Grid For Marking Autoclaving Goggles

Grid For Marking Autoclaving

Refrigerated Centrifuge Deep freezer

Laboratory Centrifuge

BVGS

Single Use Gamma Sterile Anti Fog Goggle

Grid

Hot Plate Magnetic Stirrers

Walk-in chamber

11X14EPAd05

BCAG

Clearview Autoclavable Silicon Rubber Goggles With 40 Autoclave Cycle, Can Be Worn Over Eyeglass

June Range of Products for free download look for JUNE4GMP

Single Door Refrigerator

Cyclomixer

Mini Rotary Shakers

Incubator Shaker

REMI SALES & ENGINEERING LTD.

June Enterprises Pvt. Ltd. | www.june4gmp.com info@june4gmp.com | +91 9930359528

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Remi House, 3rd Floor, 11 Cama Industrial Estate, Walbhat Road, Goregaon (East), Mumbai - 400 063. India Tel: +91 22 4058 9888 / 2685 1998 Fax: +91 22 4058 9890 E-mail: sales@remilabworld.com l Website: ww.remilabword.com

ISO 9001 - 2015 Certied

To Advertise in

Business Avenues Please Contact: ■ Mumbai: Rajesh Bhatkal 09821313017 ■ Ahmedabad: Nirav Mistry 09586424033 ■ Delhi: Ambuj Kumar 09999070900 ■ Chennai ■ Bangalore: Rajesh Bhatkal 09821313017 ■ Hyderabad: Mujahid 09849039936 ■ Kolkata: Ajanta 09831182580

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December 1-15, 2018

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SANITARY HOSES & FITTINGS Performance matched to your production needs

Industries Served

Pharma Biotech Food & Beverage Chemical and Petrochemical Shah Brothers Email:priyanka@shahbros.com

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December 1-15, 2018

EXPRESS PHARMA

PHARMA LIFE

Online reporting system as a performance enhancing tool Srinivasan V, pharma consultant elaborates how an online reporting system can help field personnel understand and analyse their performance, improve it consistently, earn the best increments year after year and reach for the stars in their career

T

here was a time when field force in ethical pharma marketing companies used to send their Daily Call Reports – DCRs – using a post card. Then, printed DCR format were given to fill up and send by post till the advent of computers.

Any analytical work like Field Work Analysis, Sales Performance Analysis, etc. used to be done manually which took time, and also there was no guarantee for accuracy.

Today almost all pharma companies, irrespective of size, have invested heavily into ‘online reporting system’ with following inbuilt conveniences: Once the day’s work is over, one can log in, enter details of work done for the day, and at the click of a button, submit the report, which can be accessed immediately by all his superiors, from the first line manager to National Sales Manager. They can go through the reports and send their feedback on the quality and quantity of work done immediately for correction and implementation from the very next day wherever required.

No paper work is required now as everything is online.

Saves on stationery items like paper, therefore lot of trees, and pen.

No need to send reports by post or courier, hence saves on postage/courier expenses.

Very easy, and doesn’t take much time to fill up and send the reports, hence saves the precious working time of field personnel.

No need to carry a lot of manual files related to work,

Communication to field personnel, newsletters, internal magazines, etc can be sent through this platform and reach the field force immediately, thus saves on postage/courier, and transit time as well sales performance details etc. for discussion with superiors.

The laptop containing all the details is more than adequate for meaningful participation in any meeting. Thus saves extra baggage/load and precious meeting hours. Ensures paperless and files less office envi-

To subscribe: bpd.subscription@expressindia.com

ronment.

Communication to field personnel, newsletters, internal magazines, etc can be sent through this platform and reach the field force immediately, thus saves on postage/courier, and transit time as well.

Very importantly, the online reporting system has empowered the field force to do lot of important analytics relating to quantity and quality of field work, overall Sales performance overall as well as Product-wise month-wise, Stockistwise Product- wise Secondary sales vis-à-vis Primary sales, Customer wise Product wise Sales performance, etc. can all be done just at the click of a button. Accuracy is guaranteed though it depends upon the accuracy of the input data keyed in.

Many pharma companies have also been using this platform to update product knowledge and for conducting tests for field personnel to evaluate their understanding of product knowledge.

Many pharma companies have also included ‘performance evaluation’ for annual increment in the online reporting system, as to ensure transparency, and also to avoid subjectivity. The parameters for evaluation along with the weightage for each parameter is loaded in the system at the beginning of the year, and then at the end of every month, it shows the points scored against each parameter based on actual performance of the field force for the month, as well as cumulatively till date.

This enables the field force to understand where they stand now, and under which parameter they need to improve upon in the coming months to post the best overall score before the year end.

Thus the online reporting system acts as a mirror which always shows the real picture

to the field personnel to understand and analyse their performance, and act upon immediately where required, thus improve performance consistently, earn the best increments year after year and reach for the stars in their career.

Unfortunately, a majority of the field personnel uses the online reporting system as a tool to send Daily Call Reports and also to send and receive inter office memos/communication only. Any field force, who is keen on doing well and succeed, should regularly use the platform for other important activities like various analytics, as discussed above in detail, to brush up products knowledge, see how he has fared in the performance evaluation parameters, and then take corrective measures where required immediately either on his/her own or in consultation with the superiors. Chances are more for such field personnel to deliver consistently and succeed in their career. Therefore, I would prefer to call this platform as a performance enhancing tool rather than a simple online reporting system.

The challenge in front of pharma companies and its line managers is how to impress upon all their field personnel to use this performance enhancing tool in the most ideal manner, as discussed in detail in the previous paragraph, so as to improve the performance of individuals, all teams, consistently, and therefore the organisation as a whole. Line managers, are you up for the challenge?

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December 1-15, 2018

REGD.WITH RNI NO. MAHENG/2005/21398, POSTAL REGD. NO. MCS/164/2016 – 18, PUBLISHED ON 5TH / 20TH EVERY FORTNIGHT, POSTED ON 5TH, 6TH, 7TH & 20TH, 21ST, 22ND OF EVERY FORTNIGHT POSTED AT MUMBAI PATRIKA CHANNEL SORTING OFFICE, MUMBAI – 400001

Ideal Cures launches

A film-coating that ruptures in 5 - 10 seconds and helps in faster disintegration

Product Applications: • Quick disintegrating coating for Pharmaceutical and Nutraceutical applications • Recommended where drug release related issues occur due to the interaction between film coating formulation and API • Suitable for drug layering applications

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