Express Pharma (Vol.12, No.17) July 1-15, 2017 by Indian Express

I understand FDD was a great success. Shall appreciate if you can let me know next time.I can support your activities as speaker

Ranjit Barshikar

Over a span of two years, Express Pharma and Ideal Cures were involved in joint discussions of having an independent platform dedicated for R&D scientists, to recognise their work and allow for much-needed deliberation and discussions to take place. Such an idea took me by awe and we decided to come together for the culmination of this platform. A brilliant inaugural session, FDD Conclave 2017 saw the gathering of top-notch industry leaders, insightful knowledge-sharing sessions and novel solutions that has encouraged an association of all leaders to work together towards a bigger and brighter tomorrow. A big thank you to all the R&D scientists for making it to the event and building a foundation for the upcoming FDD Conclaves.

Suresh Pareek Managing Director, Ideal Cures

QbD/ cGMP Consultant; Member of the Editorial Board at Journal of Generic Medicins â&#x20AC;&#x201C; England

I was awarded with Outstanding Achievement Award in Formulation Development at FDD conclave conducted by Express Pharma with Ideal Cures. I was very happy to receive this award along with eminent people especially the life achievement award winner and pioneer in formu lation development, Dr Himadri Sen

Dr Krishna Murthy Bhavanasi West Pharma partnered the first FDD Conclave in Hyderabad. It provided an excellent platform to showcase our solutions, share ideas & network with the leaders in formulation development as well as understand the emerging needs of the Indian formulation development scientists. We look forward to more events of this quality from the Express Pharma team.

Alagu Subramaniam Managing Director, India, West Pharma

GM-FR&D, Natco Pharma

The FDD conclave organized by Express Pharma was excellent in every sense. It provided a common platform for formulators from the industry, research academia and FDA regulators to have fruitful interaction and increased awareness about the latest regulations and trends in FDD and excipients. The conference was enriching and congratulations to the organisers for arranging such successful event. It was indeed a fruitful effort to bring all stakeholders on one platform and we look forward to such events in future The FDD conclave should be one on the calendar of every formulation scientist in years to come. A superb effort by Express Pharma team for organising the FDD Conclave. Excellent deliberations quality participation

Dr K D Yadav Senior VP (Technical), AAK KAMANI PVT LTD

Dr Sajeev Chandran Associate Director, Advanced Drug Delivery Systems Research, Pharmaceutical R&D, Lupin (Research Park)

I’d like to say thanks for the wonderfully organised FDD conclave. It was a great experience both in terms of technical sessions and networking opportunity. I could meet up with several old colleagues and friends after a long gap. Your initiative to institute FDD Leadership awards is another big milestone. I’m sure scientists from our fraternity will look forward to this event every year. Heartiest thanks to the Express Pharma team for the perfect arrangement and hospitality. Accept my heartiest congratulations and sincere appreciation for putting together a very successful inaugural FDD conclave. It was really a stupendous task to assemble major chunk of FDD leadership of today in the conclave. We all had a good time. There was so much positive energy over the two days. And I wish in the coming years the FDD conclave to become one of the very important yearly event for every formulation development scientist in India.

Manas Ranjan Sahoo Manager (R&D), Amrutanjan Health Care

Dr Sukhjeet Singh Senior Vice President – Pharma Research Panacea Biotec

I appreciate the FDD conclave event and initiative by Express pharma pulse. It’s very good initiative and will able to connect industries quiet well. Senior leadership presence from Pharma Industry will be the Key for future conclave. Happy to participate in second edition.

Krishnakant Tulsiram Gandhi

Makarand Avachat Senior VP, Pharma Research, Lupin

It was a perfect platform for initiating discussions and to trigger innovation in pharma formulation research and drug delivery projects. Further to interact with other scientist and leaders & policymakers of the pharma industries to get awareness on various current updates. We got many ideas on current brand tracking, identifying the new problems and issues, unmet needs to be looked upon, and various innovative drug delivery techs. My sincere thanks to the Express Pharma and team for organising such a fantastic conclave.

Director, Product Delivery Team, Dr Reddy's Laboratories

It was indeed a great and a maiden experience along with people from the back door of the industry and yet so very important for the survival and growth of the industry. Hearty congratulations to the Express Pharma team for organising this event.All these participants are going to reflect their experiences into their respective organisations.These individuals never got a platform earlier. I am sure this population will swell and these same participants will garner more participants from their faculty.Thank you for inviting me to this event. As for participants and delegates, they were bowled over.

SR Vaidya Director, Bliss GVS Pharma

CONTENTS Vol.12 No.17 July 1-15, 2017 Chairman of the Board Viveck Goenka

Gearing up for GST

MARKET

Sr Vice President-BPD Neil Viegas

‘30 PER CENT OF ANDAS APPROVED BY THE US FDA IN THE YEAR 2016 ARE FROM INDIA’

SECOND EDITION OF HEALTHCARE SENATE TO BE HELD IN HYDERABAD

ANALYTICA ANACON INDIA AND INDIA LAB EXPO TO BE HELD IN HYDERABAD

GST: USHERING NEW RULES TO THE GAME

Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das, Mansha Gagneja, Swati Rana New Delhi Prathiba Raju DESIGN

National Design Editor Bivash Barua

As corporate India gets ready for D day, how is the pharmaceutical sector coping so far? | P19

Asst. Art Director Pravin Temble Senior Designer Rekha Bisht Graphics Designer Gauri Deorukhkar Senior Artist Rakesh Sharma, Vivek Chitrakar

PHARMA ALLY

SPDS HOSTS DISSO INDIA-MUMBAI 2017

RESEARCH

Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Harit Mohanty - West Kailash Purohit – South Debnarayan Dutta - East

WERUM IT SOLUTIONS AND ON/OFF GROUP ENTER SERVICE PARTNERSHIP

NOVARTIS EYE DRUG WORKS WITH FEWER INJECTIONS

COMBO OF SLEEP APNEA AND INSOMNIA LINKED TO DEPRESSION IN MEN

Marketing Team Ajanta Sengupta Ambuj Kumar E Mujahid Mathen Mathew Nirav Mistry Rajesh Bhatkal PRODUCTION General Manager BR Tipnis Manager Bhadresh Valia Scheduling & Coordination Ashish Anchan CIRCULATION Circulation Team Mohan Varadkar

Express Pharma® Regd. With RNI No.MAHENG/2005/21398. Postal Regd.No.MCS/164/2016-18. Printed and Published by Vaidehi Thakar on behalf of The Indian Express (P) Limited and Printed at The Indian Express Press, Plot No.EL-208, TTC Industrial Area, Mahape, Navi Mumbai-400710 and Published at 2nd floor, Express Towers, Nariman Point, Mumbai 400021. Editor: Viveka Roychowdhury.* (Editorial & Administrative Offices: Express Towers, 1st floor, Nariman Point, Mumbai 400021) * Responsible for selection of news under the PRB Act. Copyright © 2017. The Indian Express (P) Ltd. All rights reserved throughout the world. Reproduction in any manner, electronic or otherwise, in whole or in part, without prior written permission is prohibited.

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July 1-15, 2017

EDITOR’S NOTE

Racing against the GST deadline

he May update on pharma channel sales was gloomy at best, according to AIOCD PharmaTrac. Unfortunately, sales in June, and possibly July too, are going to be as uncertain. With the Goods and Services Tax (GST) set to roll out by July 1, implementation is proving to be a bitter pill to swallow. But like most patients, the sector is hoping the bitter medicine will cure quite a few of its ills. An indicator that growth is taking a hit is the sharp dip in inventory days across individual companies. For instance, industry-wide averaged figures indicate that by April end, it was 41.3 days, which reduced only marginally by May-end to 40 inventory days. But the next 11 days, from June 1 to June 11, saw a drastic dip of 13 days, to 27 inventory days, by June 11. Some companies were more affected than others. For instance, Biocon's inventory days went from 55.3 (by end April), to 54.7 (end May) to 31.4 by June 11, a slash of 23.9 days. Clearly, chemists as well as stockists are wary of placing orders. Hence, primary sales (company to stockists) has already been hit. Secondary sales might have shown a slight rise as patients with chronic conditions like diabetes, etc. tried to buy medicines to last them for the next two months. Most chemists were stocking up only against firm customer demand and patients too had to wait for a couple of days till their ordered medicines arrived. Of course, pharma companies were anticipating this caution and there are reports that companies have tried to entice distributors to place orders by enhancing incentives. But, this might prove to be counterproductive, as their unsold stocks will be returned. AIOCD PharmaTrac's monthly reflects this uncertainty, with growth sliding from 8.3 per cent in April to just 7.2 per cent in May. The agency is not ruling out a further slide in June, due to lower pick-up by distributors. Hence, uncertainty will most likely reduce, or stability will return only around August. Till then, growth may remain uncertain, according to PharmaTrac. Pharma companies, at least the larger and more established ones, have anticipated this churn and have been working to ease this transition. The story, ‘Gearing up for GST’ in the July 1-15 issue of Express Pharma, charts out their strategies and the behindthe-scenes work done by consultancies like EY and KPMG as well as software vendors like Cygnet to prep up pharma companies. But, trade channels seem unprepared. QuintilesIMS conducted a survey with distributors and chemists across India and found the on-ground readiness of distributors and chemists to implement GST by July 1, 2017 below par and pharma companies will need to leverage cross-functional participation within the organisations to ensure

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According to QuintilesIMS survey,50 -70 per cent of stockists/ chemists aren’t clear and haven’t initiated implementation of GSTin their businesses

effective implementation. The survey is based on interviews with 25 distributors across key cities in India as well as 200 chemists. The chemist profile were 19 per cent across chain and 81 per cent independent pharmacies. Among chemists, 22 per cent were pharmacists, 42 per cent were pharmacy owners and 37 per cent were counter staff. According to the QuintilesIMS survey, 50 -70 per cent of stockists/chemists aren’t clear and haven’t initiated implementation of GST in their businesses; a significant number of distributors/ stockists are still to register themselves on the GST portal. The regulatory ambiguity regarding certain tactical aspects is expected to linger till July 1. For instance, one of the grey issues is that while a refund on tax for expired goods is permitted only up to six months, the average pharma product shelf life is 12 months. Similarly, there is lack of clarity around the accounting of inventory left on June 30. Other queries include working of the input tax credit process and processing of claims. For pharma companies, there is no doubt that after the painful initial months, the implementation of GST will bring significant operational efficiency within the supply chain as they rationalise their warehouses across states. The QuintilesIMS survey predicts that the reduction in logistics related complexities and cost will add to margins. The long term impact on drug pricing is expected to be neutral, with the net tax increase on most finished formulations to be approximately 1.8 per cent. Pharma companies are likely to absorb this additional burden, as drug prices are already controlled by the NPPA, points out the QuintilesIMS survey. But, even the best laid plans can go awry. To complicate matters, any shortage in medicines is bound to attract the ire of patients, consumer activists and the government. Hence, pharma companies cannot reduce production below a certain level. The next few months will be tough but hopes are high that the GST will be a temporary trough. To end on a much more positive note, Express Pharma's inaugural Formulation Development and Drug Delivery (FDD) Conclave, held from June 16-17 was a stupendous success. We were humbled by the humility of our 16 FDD Leadership Awardees; all stalwarts in their fields, who have steered their companies' formulation research and development activities over the last few decades. The Conclave was our sincere efforts to shine a light on the untiring efforts of these hidden gems and we hope to uncover many more in the next edition. For a complete report, see pages, 28-51 in the July 1-15 issue.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET LETTERS (FEEDBACK TO FDD CONCLAVE 2017 FROM PARTNERS AND DELEGATES) One-of-its-kind endeavour

A great networking opportunity

A successful event

t was a pleasure attending the FDD Conclave 2017. The conclave was different from the programmes I have attended so far and I liked it.

e were happy to see a gathering of such senior people from the pharma formulation segment gathered at at one point. The atmosphere and energy of the programme was very positive. More technical presentations or discussion topics on latest trends in FDD would be appreciated. It was an amazing opportunity for us to network with F&D heads of top 100 pharma companies. We look forward to our participation in the next edition as well. We took the opportunity to launch our new identity as HUGOPHARM TECHNOLOGIES PVT LTD. The industry gave us a positive response to the new launch.

Nidhi P Sapkal Project Research Co-ordinator, ZIM Laboratories

An excellent initiative t was an excellent initiative by Express Pharma. Despite being the inaugural event, it was well organised. It provided a good platform for a reunion of leading formulation scientists. Strong technical sessions on complex formulations (solid oral, injectable, topical delivery) would be appreciated from next time onwards.

Dr Harmik Sohi Associate Head - PDR (Formulations), JubilantGenerics , (Formerly Jubilant Life Sciences Division)

EXPRESS PHARMA

July 1-15, 2017

he FDD Conclave organised by Express Pharma was excellent in every sense. It provided a common platform for formulators from the industry, research academia and FDA regulators to have fruitful interactions and increased awareness about the latest regulations and trends in FDD and excipients. The conference was enriching and congratulations to the organisers for arranging such a successful event. It was indeed a fruitful effort to bring all stakeholders in one platform and we look forward to such events in future. Dr K D Yadav Senior VP (Technical), AAK KAMANI

Hiren Panchal Director, Hugopharm Technologies & Partner, SB Panchal & Company

Check out the online version of our magazine at: www.expresspharmaonline.com

MARKET I N T E R V I E W

‘30 per cent of ANDAs approved by the US FDA in the year 2016 are from India’ The Pharmaceuticals Export Promotion Council of India (Pharmexcil), is working on a zerodependent manufacturing mechanism to reduce dependence on imports.The Ministry of Commerce and Industry, through Pharmexcil, has formed a committee to identify drugs imported in huge volumes from other countries, says Ravi Uday Bhaskar, Director General, Pharmexcil, in an interaction with BV Mahalakshmi, on the sidelines of FDD Conclave 2017 held in Hyderabad What is Pharmexcil’s view on increasing pressure on the generic industry? The generic industry is robust and constitutes 28 per cent of the total pharma market and is growing at four to five per cent CAGR. In 2015, two blockbusters going off-patent has contributed to an increase in the size of the generic market in terms of volume and value. However, we may not see such blockbusters going off patent in the next two-three years. Additionally, we will face price controls in the US. However, governments across the world, especially in the regions of thickly populated Asia and Africa are making efforts to reach a larger percentage of population. This is likely to

increase the actual consumption of medicines by volumes. Besides, increased health coverage is being forecasted in the regions of CIS and LAC. Generics may see a flat performance in the developed regions of Western Europe and a very modest growth in North America. India, being a prime generic source and covering all Anatomical Therapeutic Chemical (ATC) therapies, may be able to balance its product portfolio across continents to achieve modest growth in the prevailing situation and hold on to its premium position. I see a positive trend in the coming years, particularly in the US, as 30 per cent of ANDAs approved by the US FDA in the year 2016

are from India and seven Indian pharma companies are among the top 20 global generic players. How to reduce import dependence and need for import restriction from China? Pharmexcil and the industry have combinedly highlighted to the government the need to revamp the capacities of our drugs, intermediates and key starting material industry. The Department of Commerce has also pitched in its support. It is quite possible. We are gearing up to kickstart the project. Pharmexcil has coordinated meetings between stakeholders of the industry and the government recently to focus

on some products initially and then expand the portfolio. A zero-dependant mechanism translates into not depending on raw materials from other countries. India imports drugs and pharma products from Europe and China in the form of raw materials as well as finished products for both, domestic consumption and exports. Imports form a big portion of many common drugs such as pain-killers like aspirin and paracetamol, first-line diabetes drug metformin and antibiotics such as erythromycin. What are the immediate plans to increase exports and the projected growth for the domestic industry?

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Pharmexcil coordinates with the industry and the government. All our activities are based on the advice of the industry and directions from the government. Hence, our activities are planned as per prevailing market situations. We are planning to explore potential markets like Central America. We are also trying to penetrate highly regulated and brand-oriented Japanese and Australian markets. We are focusing on AYUSH as well. During 2016-17, Indiaâ&#x20AC;&#x2122;s pharma exports stand at $16.83 billion. Pharmexcil does not make any projections. What is the outcome of the recent inter-ministerial committee meeting to reduce imports? Initiated by the Department of Commerce and Pharmexcil, a think tank was formed with the representatives from industry, CSIR-labs and other research institutions. The think tank identified largely imported /dependent key starting materials (KSMs), intermediates and APIs. It also identified the labs that can develop technology which is commercially viable. The recent inter-ministerial meeting decided to focus more on 60-70 largely imported /dependent products, where we can manufacture low hanging fruits. The Commerce Secretary requested Pharmexcil and CSIR to submit a detailed project report (DPR) to take the initiative further. What are the opportunities and challenges in the complex generics segment? The newer class of ARVs like Integrase strand transfer inhibitors, sophisticated dosage forms like pre-filled syringes, mostly used in management of diabetes but also being extended to antibiotics besides some steroids for intra-articular and intra-thecal use, as well as precise dosage delivery apparatus (inhalers) used mostly in respiratory management are some of the complex generics. These complex generics, on

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July 1-15, 2017

overcoming the challenges in developing them, offer good opportunities as there would be limited players in the market. Super generics was the buzz word in this category, four to five years ago but the time involved in developing these drugs and the difficulty

in obtaining market authorisation has dampened the interest in them to some extent. Indian players have representation in both the sections and are now keen on developing the former type. What is the impact of GST on

the domestic pharma industry? There will not be any serious impact on exports but there will be a slight increase in the price to the consumer. The higher rate of tax on beds, dental surgical chairs, operation theatre equipment and some

medical devices will add cost to patient bills. As of now, we feel it may not alter much as direct exports are not affected. Even products imported for exports are given the same benefit of reclaiming the IGST paid. bv.mahalakshmi@expressindia.com

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MARKET DEAL TRACKER

Pharma industry records 49 deals worth $16.7 billion in May 2017 One of the major transactions in May 2017 includes the proposed $7.4 bn combination of INC Research and inVentiv Health

THE M&A activity in the pharmaceutical and healthcare industry was focussed on the outsourcing service segment, which recorded $2 billion transactions. The industry recorded a total of 49 deals worth $16.7 billion in May 2017, as compared to 33 deals worth $14.7 billion in April 2017. One of the major transactions in May 2017 includes the proposed $7.4 billion combination of INC Research and inVentiv Health, which is expected to enhance the groupâ&#x20AC;&#x2122;s therapeutic expertise and suite of outsourced services across the drug development and commercialisation continuum. Following the closure of the transaction, INC Research shareholders are expected to own approximately 53 per cent and inVentiv shareholders are expected to own approximately 47 per cent of the combined company on a fully diluted basis. Advent International and Thomas H Lee Partners, both private equity firms and the current equal equity owners of inVentiv, will remain as investors in the combined company. Further, Thermo Fisher announced the acquisition of Patheon for $7.2 billion, the second major deal announced

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TOP M&A DEALS IN APRIL 2017 Deal Date

Acquirer (s)

Target

10-Apr-17

Bain Capital LLC; Cinven Partners LLP

Stada Arzneimittel AG (Germany)

24-Apr-17

Fresenius SE & Co KGaA (Germany)

Akorn Inc (US)

Source: GlobalData

May 2017 Charts

Source: GlobalData

MARKET Deal Date

Acquirer (s)

Target

Deal value (US$ m)

19-May-17

Advent Life Sciences LLP; Arix Bioscience PLC; Bay City Capital LLC; Canaan Partners; Domain Associates LLC; Frazier Healthcare Partners; New Leaf Venture Partners LLC; Pivotal bioVenture Partners LLC; Sofinnova Ventures Inc

Iterum Therapeutics Ltd (Ireland)

65.0

15-May-17

Edmond de Rothschild Investment Partners; F-Prime Capital Partners; Novo A/S; RiverVest Venture Partners LLC; TPG Biotech

Genoa Pharmaceuticals Inc (US)

62.0

02-May-17

Access Industries Inc; Atlas Venture Inc; Be The Match Foundation; Casdin Capital, LLC; Google Ventures; Partners Innovation Fund LLC; Third Rock Ventures LLC

Magenta Therapeutics Inc (US)

50.0

Source: GlobalData in May 2017. This transaction is expected to provide an opportunity to Thermo Fisher Scientific to enter into CDMO (contract development and manufacturing organisation) market and strengthen its position by adding complementary services. Goldman Sachs is financing the transaction, which is expected to close by the end of 2017.

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MARKET PRE EVENTS

Second edition of Healthcare Senate to be held in Hyderabad The theme for the second edition is ‘Building a future-ready healthcare sector for India’ AFTER THE success of the inaugural edition of Healthcare Senate last year, Express Healthcare is gearing to host the second edition of the event. This time, the theme is ‘Building a future-ready healthcare sector for India.’ The summit will be held at Novotel Airport, Hyderabad, from September 79, 2017. Thought leaders from the healthcare industry will congregate to exchange insights, share innovative ideas and build healthy connections. The event will address pivotal topics through panel discussions: They would include: ◗ Overcoming obstacles in business expansion: In this session, the panel will discuss strategies, infrastructure required and resource development needed for expansion of businesses. ◗ Healthcare policies: Are they making or breaking the sector?: Association heads of AIMED, NATHEALTH, NABH, AHPI, NPPA and gov-

The summit, to be held at Novotel Airport, Hyderabad, from September 7-9, 2017, will revolve around the theme ‘Building a future-ready healthcare sector for India.’Thought leaders from the healthcare industry will congregate to exchange insights, share innovative ideas and build healthy connections ernment officials will discuss the impact of pricing policies, quality codes etc., on the sector. The panel will also deliberate on the need for an Affordability Act in India. ◗ Fighting the antibiotic apocalypse: Infection control experts, hospital administrators, pharma companies, NABH representatives will discuss ways to control the increasing burden of antibiotic resistance ◗ Ensuring cost efficiencies

within capital intensive department: Radiology department heads of hospitals, imaging diagnostic promoters, Cath lab heads, OT heads and hospital CFOs will discuss how to reduce operating costs of these capital intensive departments to make the business profitable. ◗ People first: Hospital CEOs, promoters, nursing heads, HR heads, management consultants will discuss on building talent and capabilities

for the future. Revenue cycle transformation- A must for healthcare organisations: Hospital CAs, financial experts, healthcare CFOs, COOs or CEOs and PE investors will discuss on ways and means to increase their net revenue, accelerate cash flow, and reduce costs by addressing people, process, and technology components within their hospitals.

The other topics which

would be addressed at the event will be: ◗ Building an effective supply chain inventory management system ◗ Developing a physician leadership programme within hospitals ◗ Effective brand building for business success ◗ Understanding medical laws: a must for healthcare providers ◗ Medical tourism: An ocean of opportunities for India ◗ Evolving role of hospital pharmacies in India To register, click : http://healthcaresenate. financialexpress.com/registeration/ or Contact Vinita Hassija Mob: 9820590053 E-mail: vinitahassija@gmail.com

GIBS 2017 to be held in Mumbai The two-day comprehensive event will help gain new insights into IC/BPS GLOBAL INTERSTITIAL Cystitis Bladder Pain Society will organise second Global Interstitial Cystitis Bladder Pain Syndrome conference (GIBS 2017) in Mumbai from August 26-27. The two-day comprehensive event willhelp gain new insights into IC/BPS where eminent national and international faculties will take part in case-based panel dis-

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July 1-15, 2017

cussions, which will help every clinicians in managing such cases in the most refined way.

Discussions will be held on the following topics: ◗ BPS nomenclature and definitions ◗ Clinical presentation ◗ Investigations in a suspected case of IC/BPS ◗ Cystoscopy in a IC/BPS

◗ Intravesical instillation ◗ Pain management in IC/BPS ◗ Concurrent endometriosis with IC/BPS in chronic pelvic pain ◗ Assessing quality of life in bladder pain syndrome ◗ Chronic PID/Correlation between PID and IC ◗ Food allergy –Does it affect IC? ◗ Etio-pathogenesis of IC/BPS

◗ Clinical diffrentiation of various LUTS in women ◗ Bladder pain syndrome/IC: Should we recognise the pillar of conservative management? ◗ Challenges in diagnosis of IC ◗ Clinical examination in case of IC/BPS ◗ IC management using oral medications ◗ Current management of Hunner’s Lesion

◗ Intravesical cocktail instillation in BPS- our experience ◗ Managing patients of PBS/IC: Single center experience ◗ Efficacy of daily low-dose Tadalafil for treating interstitial cystitis: Initial results ◗ GIBS Clinical practices for treatment of IC /BPS EP News Bureau

MARKET

analytica Anacon India and India Lab Expo to be held in Hyderabad 250 plus exhibitors from 11 countries will take part in the event ANALYTICA ANACON India and India Lab Expo will be held in HITEX, Hyderabad from September 21-23, 20-17. It will bring together internationally renowned exhibitors, consultants, business experts and key government officials on one common platform to discuss global best practices and seek solutions to some of the most pressing challenges related to the industry. In 2017, the highlights of the vent are a sprawling exhibition space of 10,500 sq mtr, 250 plus exhibitors from 11 countries,

The event will discuss global best practices and seek solutions to pressing challenges 7,300 trade visitors, country pavilions from Germany and China and buyer seller meetings. analytica Anacon India and India Lab Expo will focus on innovative and applied product and system solutions for laboratories in the industrial, research and science sectors. Leading buyers, decision-makers, scientists and entrepreneurs from around the globe will be present to get relevant information about the latest developments during the three-day event. In 2016, analytica Anacon India and India Lab Expo highlighted the huge potential of the Indian laboratory technology, analysis and biotechnology market. The two trade fairs confirmed themselves as the leading industry platform on the Indian subcontinent. EP News Bureau

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MARKET EVENT BRIEF AUGUST TO SEPTEMBER-2017 3

PharmaTech Expo 2017

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Indian manufacturers and distributors. Decision makers from sectors like hospitals, diagnostic labs, oil and petroleum, chemical, cosmetics and government departments will meet at the tradeshow. The event will be supported by Ministry of Science & Technology, Government of India.

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egged as India's largest tax reform since Independence, the Goods and Services Tax (GST) system will finally roll out from July 1 this year. In preparation for this major milestone, the Goods and Services Tax Network (GSTN) has been created to provide IT infrastructure and services to central and state governments, taxpayers and other stakeholders to facilitate implementation of GST across the country. Another step towards smoothing the transition are GST Suvidha Providers (GSPs), which are identified private agencies who would fa-

Gearing up for GST As corporate India gets ready for D day, how is the pharmaceutical sector coping so far? By Swati Rana

cilitate taxpayers’ access to the GSTN. GSPs have a robust agreement with the GSTN and provide a tunnel to the taxpayer to submit their data to the GSTN. Explaining the role of a GSP, Suresh Nair, Partner – Indirect Tax, EY India said, “The companies have to submit transaction wise data of sales, stock transfers, and service provided which need to be submitted by July 10 (GSTR-1). Sales data uploaded by the suppliers will be available on July 11 and need to be confirmed and uploaded after doing reconciliation of mismatch, if any, such as mismatch in invoice number, in-

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voice date, invoice value, input tax, etc by July 15 (GSTR-2). The tax liability is to be calculated based on GSTR-1 and GSTR-2. GST is to be paid and uploaded by July 20 (GSTR-3) return (monthly return). For a taxpayer having a large volume of transaction level data required for return filing, accessing the return filing system of GSTN directly through the GST web portal could be a challenge. In such cases, the taxpayer can connect with the GSTN through third party service providers– commonly known as GSP.” “34 GSPs are approved and many more are likely to be approved in the days to come. GSPs have an agreement with the GSTN to provide support to the tax payer in submitting their data to the GSTN. While taxpayers can directly access the GSTN in the G2B mode, there are some limitations on the size of data that can be submitted to the GSTN. Interacting with GSTN through GSPs would be much more flexible as they would provide enriched experience of dealing with GSTN as it could be cus-

20 EXPRESS PHARMA July 1-15, 2017

GST tomised to client needs. There would be Application Service Providers (ASPs) who would provide value added services which would make return filing work much easier, will provide services like dashboards and MIS for management, off line reconciliation of data, automated communication with vendors’ data analytics etc. GSPs and ASPs will play an important role in the implementation of GST in the country as they will assist automation of the taxpayers compliance process and support the IT system or ERP that the taxpayer has,” informed Dr Waman Parkhi, Partner, Indirect Tax, KPMG in India.

Initial challenges Though the new tax regime is expected to transform the Indian economy in the medium to long term by simplifying and replacing the multiple taxes with a single tax in the country, pharma companies are still seeking many clarifi-

cations from the government. Pharma companies have been preparing for the change but are anticipating implementation challenges. As Jawed Zia, Country President, Novartis India puts it, “As a major indirect tax reform, smooth implementation of GST is the key to uninterrupted business operations across sectors. With digitisation of all compliances related to GST, it has become imperative for organisations to have the right systems in place. At Novartis India, we have partnered with domain leaders and made every effort to ensure that all systems have been updated, where required. Our internal team has been adequately trained to understand and comply with the new indirect taxation requirements. We are confident of our preparedness to meet the deadline of July 1 and are hopeful that all stakeholders of the pharma industry, including distributors, stockists and retailers, are equally prepared.”

For a taxpayer having a large volume of transaction level data required for return filing, accessing the return filing system of GSTN directly through the GST web portal could be a challenge Suresh Nair Partner – Indirect Tax, EY India

Pharma wholesalers too seem to welcome the move but express concerns on the initial stages of implementation. According to Dr Piyush Gupta, Associate Director, GNH India, “In the long term, it is a positive step as it will reduce the number of taxes and related compliance issues. But before we get there, there are some immediate challenges which are difficult to resolve. Many manufacturers have considerable stock manufactured during the excise and VAT regime and there is no clarity on how to invoice this from next month (July). Distributors too face the same difficulty regarding invoicing stock from July 1. In order to avoid too much confusion, we request the Central Board of Excise and Customs (CBEC) to open a live Q&A on the web to address these questions from businesses.” Taking a long term view, Amit Mookim, GM, South Asia, QuintilesIMS said, “GST is expected to significantly change the existing paradigm of business within the pharma industry. Consolidation of sup-

Our internal team has been adequately trained to understand and comply with the new indirect taxation requirements. We are confident of our preparedness to meet the deadline of July 1 and are hopeful that all stakeholders of the pharma industry, including distributors, stockists and retailers, are equally prepared Jawed Zia Country President, Novartis India

MARKET Overall increase in tax burden will get offset by the improved efficiencies; and pharma companies are likely to absorb the additional tax burden (an estimated net increase of about 1.8 per cent on finished formulations). While the long term outlook remains positive, managing the short term disruption will be critical Amit Mookim General Manager, South Asia, QuintilesIMS

ply chain will happen in an environment of tax neutral interstate transactions. Focus shifting from ‘tax advantage’ logistics planning to ‘strategic location of supply’ logistics planning will lead to higher operational efficiencies. New strategic geographic hubs of pharma manufacturing will emerge as the Central Sales Tax (CST) burden loses its relevance. Overall increase in tax burden will get offset by the improved efficiencies; and pharma companies are likely to absorb the additional tax burden (an estimated net increase of about 1.8 per cent on finished formulations). While the long term outlook remains positive, managing short-term disruption will be critical.” He supports his view by quoting from a survey conducted by QuintilesIMS with distributors and chemists across India to understand their preparedness for GST. “Based on our survey, the on-ground readiness of distributors and chemists to implement GST by July 1 unfortunately remains below par. Pharma companies will need to leverage cross functional participation within the organisation to ensure effective implementation.” According to Cygnet, reconciliation, distribution of data into respective section of GSTR 1 and GSTR 2 and vendor management are the major challenges faced by the pharma companies. Generally, pharma companies have lakhs of transactions a month. Companies have only five days for reconciliation between GSTR 2A and inward supply register, i.e. between 11- 15th of the month. By the 15th of each month, companies need to file GSTR 2 after taking appropriate action. Post July 1, the procedure to take appropriate action like accept/ reject/ modify/hold etc. has changed. Though the return is filed by the taxation department, the purchase department

needs to be consulted in order to decide what action needs to be taken. Each purchase department could have 10-15 different personnel, and identifying which difference belongs to which individual in the purchase department and then take appropriate action is a time consuming activity. It is obvious that this process will not be completed within five days if the number of transactions is huge.

Some solutions But one man's challenge is another man's opportunity. And solution providers like Cygnet ASP have attempted to ease some of these transition hurdles. As Niraj Hutheesingh, Founder Director, Cygnet explains, “The Cygnet ASP solution provides an option (for companies) to push data on GSTN on daily/ periodic basis. They need to request their vendor to also do the same. Once data is available from both ends, even before filing of return, reconciliation can be performed and one can have enough time to resolve differences not only by discussing with the purchase department but also with their vendors in advance.” Explaining further, he said, “Pharma companies have all type of transactions like B2B, B2C > 2.5 lakhs interstate, B2C other transactions, export, debit/credit notes, nil rated, exempted, non GST supply, advance received from customers etc. Slotting outward supply and inward supply data into the respective sections of GSTR 1 and GSTR 2 which consists of around 14 to 17 different sections, is a time consuming activity. Also if proper care is not taken, it may result in errors and amendments or mismatches. To avoid this, Cygnet has automised everything. Cygnet has developed a utility for SAP users through which data is fetched from SAP and pushed to respective section

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Multiple vendors and their GST readiness is a big question mark. Small vendors are yet to warm up to GST readiness Dr Waman Parkhi Partner, Indirect Tax, KPMG in India

of GSTR 1 and GSTR 2 in an automised manner. This not only saves time but also provides error-free data.” Under the GST regime, companies need to be very selective while finalising vendors because if the vendors are not GST-compliant i.e. not migrated into GST or not filing returns on time or not paying taxes on time, the organisation will not receive the input tax credit, which will greatly impact its working capital. Cygnet has two solution for vendor management as well. Firstly, to ensure that one’s vendors have migrated into the GST system, Cygnet has developed a utility through which one can send a link to their vendors. Vendors need to fill up necessary fields and upload the acknowledgment number. A report will be available to the organisation listing out vendors which have been migrated to GST. The second option is to send an email and SMS notification to vendors mentioning mismatches and the reason for the same. Companies can send emails and SMS notifications, either a standard or customised messages, mentioning

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July 1-15, 2017

the exact reason of mismatch, to their vendors when any mismatch is identified even before the filing of returns. This feature helps because while filing GSTR 1A by vendors, if they know reason for the action, both vendor and customer can be on the same page. According to Parkhi of KPMG In India, the readiness of IT systems is a major challenge as rules are yet to be finalised by the government and changes in IT system need finality to the structure. He said, “Multiple vendors and their GST readiness is a big question mark. Small vendors are yet to warm up to the GST readiness.” Nair of EY India believes the transition from the current norm to the GST is one major area of concern for the industry. He said, “We are working closely with our clients to help them navigate through this phase, guide on the transitional provisions and how to address the concerns of the trade during this transition. There would be a shift from the current tax positions for the loan license, area based exemption model and consignment sale operations. We are

supporting our clients to ensure that this crucial area of operations seamlessly change over to GST with maximum efficiency and ease in business for our clients.” The new law envisages a relook at all the tax positions for unique transactions of the pharma industry. EY India is providing detailed transaction by transaction tax positions to their clients helping them address specific areas such as write off, return of expired goods / near expiry goods, refund of accumulated credit under inverted duty structure, tax positions and credit related aspects for supply of physician samples, patient assist programmes, issuance of credit note, debit note, supplementary invoice etc. Similarly, solution / services provided by KPMG India range from computation of financial impact on the operation of the company, computing the impact on profits and on cash-flow; impact on the IT system or ERP of the company, identifying changes in the supply chain of the company (for e.g. reduction or increase of depots, business process re-engineering to re-

move processes added for the tax reasons in the past, brainstorming on new businesses and processes in light of the opportunities opened up by GST), listing all transactions typically entered by the company and documenting how these transactions would be viewed in GST and what impact they would have, re-engineer the way the transactions are done today so that these become easier from compliance perspective. KPMG India is also involved in the training of business and tax/ finance teams , training vendors, preparing SOPs for GST compliance, understanding vendor readiness for GST and helping them improve their readiness. Suggesting changes in contracts with customers and vendors is also part of their services.

Revamping ERP Enterprise Resource Planning (ERPs) are designed to meet the requirements of the current tax system. Under the GST, new data fields would be required e.g. place of supply, GSTIN etc. These need to be introduced in the system. The masters need to be updated.

In order to avoid too much confusion, we request the CBEC to open a live Q&A on the web to address these questions from businesses Dr Piyush Gupta Associate Director of GNH India

Reconciliation, distribution of data into GSTR 1, GSTR 2 & vendor management are the major challenges faced by pharma companies Niraj Hutheesingh Founder Director, Cygnet

MARKET Where ever the ERP service provider is not providing GST updates, the changes need to be carried out by the company themselves, ensure that the IT systems can provide data required for GST compliance and they are compatible with the ASP/ GSP selected by the company. The ERP systems would also need to find solutions to ensure compliance of tax positions under GST which was hitherto not applicable in the current indirect tax law. To cite some examples, GST is required to be paid on advances whether received for goods or for services (presently advances for services only were subject to GST), credit notes issued for discounts and other offers to customer needs to be

Under the GST regime, companies need to be selective while finalising vendors because if the vendors are not GST-compliant or not filing returns on time or not paying taxes on time, the organisation will not receive the input tax credit, which will greatly impact its working capital linked with original invoices for adjustment of GST. Also, GST is payable on reverse charge basis on all purchases from unregistered dealers, which is a new requirement under GST, said Nair. According to Hutheesingh, the shift will broadly involve

ERP updation of vendor/ customer master. For instance, currently, vendors and customers may have single registration. Under GST regime, if they opt for separate registration for each state, for each registration, the master should be updated in ERP.

The government is making continuous efforts to ensure smooth roll-out of GST. In the last meeting of the GST Council over May 18-19, 18 sectoral groups have been constituted representing various sectors of the economy. These 18 sectoral groups representing var-

ious sectors of the economy and containing senior officers of the centre and the states are being set up to ensure smooth implementation of GST by responding in time to the issues and problems of their respective sector(s). The Directorate General of Foreign Trade (DGFT) has also constituted a GST facilitation cell in the DGFT headquarters to assist and advice exporters, trade and industry for smooth transition from present regime to GST regime from July 1. Thus while there is a consensus that the GST is a step in the right direction, the coming quarters will be uncertain for all stakeholders in the pharma sector. swati.rana@expressindia.com

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GST: Ushering new rules to the game Goods and service tax (GST), to be rolled-out from July 1 this year, is expected to help bring in better efficiencies in the pharmaceutical industryâ&#x20AC;&#x2122;s supply chain management and reduce the cost of manufacturing pharmac products. A few industry players and service providers share their views on the impact of GST and getting ready for its roll-out By USHA SHARMA

'GSTwill act as a bridge to create a seamless connection between manufacturers, distributors, regulators and customers'

ST will have a positive impact on the pharmaceutical industry. It will lead to an increase in compliance and thereby enhanced transparency and better supply chain management which will not only be beneficial for the pharma industry but also for all the intermediaries in supply chain management and the customers.

RAVI KANT SHARMA FOUNDER AND CEO, SASTASUNDAR

Enhanced transparency in pharma distribution There may be issues during the initial phase of implementation of GST, the reason being in most of the states, medicines are currently being charged with VAT on MRP, i.e., single point taxation. It means the intermediaries involved in the distribution of medicines are not required to pay any VAT. In the current regime, maximum of intermediaries are not required to take any registration or pay VAT or file returns. But in the GST arena, there will be no concept of taxation on MRP. Rather, all the intermediaries will be required to take GST registration, pay monthly taxes and file three returns per month and in total, 37 returns annually. It will enhance compliance levels across the supply

24 EXPRESS PHARMA July 1-15, 2017

chain management by bringing in enhanced transparency to the system with complete tracking of movement of the product. It will be beneficial for all in the longer term. The country will have a major relief from the threat of fake or counterfeit medicines. We believe that GST will act as a bridge to create a seamless connection between the manufacturers, distributors, regulators and customers.

Innovative business models will come up The pharma distribution system will undergo a major transformation. There will be

no incentive for pharma companies to keep multiple warehouses across the country. The movement of goods from one state to the other will not attract any differential taxation and the pharma companies will rework on their distribution strategies. Eventually, it will result in the application of newer technologies in the supply chain management domain with better inventory planning and in turn, result in huge savings in the warehousing and logistics cost. We may see the emergence of innovative business models in near future in the pharma supply chain management domain.

We may see the emergence of innovative business models in near future in the pharma supply chain management domain

Shortage of medicines GST on most medicines have been kept at five per cent or 12 per cent and there will be no major impact on the price variation at all. However, due to concerns regarding the input tax credit of 40 per cent (allowed under the GST transition regime), realignment of production strategy by pharma companies due to changes in tax rates and other factors, there are fears related to medicine shortages during the tran-

sition phase. Recognising this threat and also our responsibility, we at SastaSundar have decided to rework on our procurement strategy so that during this transition phase, we can ensure the consistent availability of medicines.

Preparedness Regarding the preparedness for GST at Sastasundar, we have an efficient supply chain management model empowered with technology. We have already redesigned our system in compliance with GST and tested it as well. For a majority of the intermediaries in the pharma distribution, the GST regime will be a kind of transformation for their business models with enhanced compliance load but with the adoption of readily available technology, we believe that it can be managed. We understand that like us, all those associated with the supply chain management are also geared up for GST. GST is one of the biggest reforms in the country and we believe that the government's mission to ensure affordable healthcare to all Indians will get a major boost by the GST regime.

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'We need to embrace the new reality and move away from banal considerations'

ST is finally upon us. Enough has been spoken, and comprehensively so, about GST’s form, structure, benefits and pitfalls by consultants, specialists, analysts and pundits. However, the unanimous sentiment is that GST is an absolute game changer,

criticise or are negative about the developments and reforms pertaining to GST. While it’s true that these reforms have been designed by administrators and bureaucrats and not by businessmen, hence the flavour is more of compliance and regulation and not business friendliness,

GULSHAN BAKHTIANI DIRECTOR, WELLNESS FOREVER, WELLNESS

The undisputed consensus is that this is a move in the right direction for realising the vision of better governance not just for the pharma industry but for the country and its commerce as a whole. The undisputed consensus is that this is a move in the right direction for realising the vision of better governance. As responsible citizens and business leaders, it is not only expected of us but it’s also our responsibility to be active enablers for smooth implementation of the new GST reforms. Digitisation, automation and the resultant transparency is going to be a way of life rather than mere change management. Therefore, we need to embrace the new reality and move away from banal considerations such as impact on profit, deployment of additional resources for bookkeeping, document filing compliance. In fact, the focus should be on reshaping the organisation to become more compliant, efficient and, as a result, more scalable. I often meet leaders of small, medium and large businesses who partially owing to ‘change inertia’ and fear of the unknown and partially due to hearsay and incomplete information, indiscriminately

however, the bottom-line remains that legal compliance is the fundamental pre-requisite and should not be slotted as aspirational conformance. ‘What is inevitable, needs to be embraced’. With the roll-out of GST, two things will happen for sure: a) The manner in which business will be conducted will witness a paradigm shift from how it was conducted in the past. b) Boys will be separated from men Confusion with regards to GST taxation for online businesses will continue to prevail. The industry itself has given birth to myriad business models and it’s imperative that clear distinctions are made as to what constitutes online commerce. This in turn will lead to better clarity with respect to GST taxation for online businesses. Personally, I would like to believe that GST is a procedural, simple, tax-passing mechanism which is purely between businesses; the customer is merely the consumer of tax.

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'GST is going to promote fair play in business'

n the dusty lanes and bylanes of each and every town in the Indian subcontinent, one trade which is visible is a medical store or a pharmacy. Such is the reach of over seven lakh pharmacies in India. The pharmacist is often the most trusted trader and is the distributor of good advice along with the medicines required by the customer. The brand driven by the Indian formulation market and the low brand loyalty of the prescriber has put a large amount of pressure on the trader. Compliance to the laws of the land in terms of tax returns and documentation is often the loser. The success of the GST programme is going to be more in its execution and implementation by all the stakeholders. The GST programme will bring in clarity in the documentation and also drive total compliance. Traders will be forced to select suppliers who are not only GST compliant but also financially stable.

SRIPAL BACHAWAT DIRECTOR, C-SQUARE INFO SOLUTIONS

SAJITH THATALATH DIRECTOR AND CEO, C-SQUARE INFO SOLUTIONS

For eg: A trader cannot claim input credit under GST unless and until the supplier has uploaded his GSTR-1. GST is also going to promote fair play in business. Section (2) of Section 16 talks of additional interest payable to the government if the input tax is not paid for more than 180 days. GST’s approach is bringing in the much-needed transparency and holistic approach to plug the loop holes

in tax structure compliance. Traders who buy from noncomplaint suppliers under Section 9(4) have to pay the entire GST. From a solution perspective, we feel that the adoption of strong POS software becomes a boon and in many instances a necessity. Adoption would help in correct and effective documentation. The GST for the pharma industry has multiple tax slabs and

given the plethora of brands, an automated solution is essential to file in the returns required by the new GST laws. C Square with its large installed base of solutions in the pharma retail space have GST ready versions of our products which will help the retailer become GST compliant in an easy adoption curve. Automated purchases and auto ordering and other tools

present in our solutions will help pharma retailers become a model citizen. Sajith T, Technical Director, C Square, has built a workflow into the solutions which will reduce human intervention in the filing of the various returns. He says that “Automation is the key to becoming an organised trader and unless you are organised, GST adoption is going to difficult and arduous.”

'There is teething problems that need to be solved related to implementation'

he current indirect tax regime in India provides for a complex tax environment due to multiplicity of taxes, tax cascading and elaborate compliance obligations. Under the proposed GST regime, various indirect taxes would be subsumed (except for few taxes such as stamp duty), and hence it is expected that it would result in a simpler tax regime, especially for industries like the pharma industry. The pharma industry has been representing to address the present inverted tax structure in GST and also for a lower GST rate for pharma products. GST would have an impact on the pricing, working capital, contracts with vendors and cus-

26 EXPRESS PHARMA July 1-15, 2017

DR DHAVAL SHAH CO- FOUNDER PHARMEASY

tomers, ERP systems, processes, internal control and accounting. Another important impact of GST on pharma companies would be

the opportunity to review the supply chain and move to a supply chain based on business parameters. Hence, GST would impact every aspect of

the business. There has been significant progress on the GST front recently. With the release of the draft model GST Law on 14 June 2016, a major milestone has been achieved, and we have certainly moved a step closer to GST. It is expected that the government would push for passage of the GST Constitution Amendment Bill during the upcoming Monsoon Session. India finally seems to be on the cusp of implementing this much awaited tax regime. Our stand to be simple - we think it's great. This will benefit the industry and everyone. However, currently there is teething problems that need to be solved related to implementation. There may be a

temporary shortage of medicines, but we are doing our best to ensure that the customer is not taking the hit. We’ve already alerted our customers about the possible shortage and send across messages requesting them to stock up their medicines well in advance by providing a valid prescription for the same. We see long-term benefits will outweigh certain current problems by a distance. These mainly include interstate transport, availability in rural India, hassle-free returns and doctor’s ability to prescribe treatment therapies without thinking about availability in a new state or city. u.sharma@expressindia.com

cover )

28 EXPRESS PHARMA July 1-15, 2017

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FDD Conclave 2017

A congregation of R&D leaders In an endeavour to encourage research and innovation in the rapidly evolving field of formulation development and drug delivery, Express Pharma and The Indian Express Group hosted the inaugural edition of FDD Conclave at Novotel Airport, Hyderabad. Held on 16-17 June, 2017, it saw attendance from over 100 leading scientists and R&D heads representing prominent pharma organisation and top biotech companies

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cover ) DAY 1 16 JUNE , 2017

FDD CONCLAVE 2017

INAUGURALCEREMONY

L-R: Viveka Roychowdhury, Editor, Express Pharma; Suresh Pareek, MD, Ideal Cures; Pramod Pimplikar, Managing Director, Shalina Laboratories; Seetaraju Gembali, Director, GSR Pharma Research and Ravi Uday Bhaskar, Director General, Pharmexcil at the lamp lighting ceremony of FDD Conclave 2017

◗ Welcome Address ◗ Lighting of Lamp ◗ Release of the FDD Leaders Handbook ◗ Address by Chief Guest ◗ Special Address: Formulating a program for formulation development of complex products ◗ Q&A with Dr Hussain ◗ Advances in film coating technology ◗ Advances in the world of probiotics ◗ Networking tea break ◗ PANEL DISCUSSION: Expanding India's talent pool in formulation development and drug delivery: Innovative approaches ◗ Networking lunch ◗ FDD LEADERSHIP AWARDS NITE ◗ Welcome Address ◗ Introduction to FDD Leadership Awards 2017 ◗ Presentation of Awards ◗ Vote of Thanks ◗ Gala Dinner

30 EXPRESS PHARMA July 1-15, 2017

Unveiling of the FDD Leaders Handbook

he first edition of FDD Conclave kickstarted on an auspicious note with the ceremonial lamp lighting ceremony. Viveka Roychowdhury, Editor, Express Pharma gave the Welcome Address. Speaking to the august audience, she said, “It is my honour to welcome all the stalwarts and champions in pharma research to the inaugural edition of FDD Conclave. Express Pharma has partnered the pharma sector lived through it many phases of evolution. Today, it is common knowledge that the sector,

both globally and in the country, face myriad pressures. Escalating R&D expenses. Government push to reduce prices. An increase in patient demand and expectations. I could go on, but then, every challenge is also an opportunity. We believe that the journey that we start today, with the inaugural edition of the FDD Conclave, will put us firmly on the path to winning this race.” The FDD Leaders Handbook, featuring over 40 leading scientists in the field, was also unveiled at the event.

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Chief Guest's Address Ravi Uday Bhaskar, Director General, Pharmexcil

he Chief Guest, Ravi Uday Bhaskar, Director General, Pharmexcil, lauded Express Pharma for creating such a platform and and spoke on the need for it to drive progress in formulation development and drug delivery. He went to speak on his long tenure in drugs control administration, and then his shift to the Pharmaceutical Export Promotion Council (Pharmexcil), a completely different ball game. He gave insights on the focus areas of Pharmexcil and how it assists in tackling the issues faced by the Indian pharma industry globally. He also spoke on the evolution of the formulation development and drug delivery segment in India. Recalling some

major achievements since his college days, he marvelled at how far we have come in terms of developing novel drug delivery systems. Speaking on Express Pharmaâ&#x20AC;&#x2122;s long association with the industry, Bhaskar recalled the time when All India Drugs Control Officers' Confederation (AIDCOC ) was formed in 1995 and the news was carried in the Express Pharma (then Pharma Pulse). He lauded Express Pharma for reporting exclusive, high quality, news and chronicling all the major happenings in the pharma industry for over two decades. He also said that Pharmexcil would like to collaborate with Express Pharma in organising events to promote pharma exports as well.

Special address: Formulating a programme for formulation development of complexproducts Dr AjazHussain Former Deputy Director, Office of Pharmaceutical Science,US FDA; Founder of Insight, Advice & Solutions, US and President, National Institute for Pharmaceutical Technology and Education, US

r Ajaz S Hussain, Former Deputy Director of Pharmaceutical Science, US FDA, gave a special address at the FDD Conclave 2017 through a video presentation on, â&#x20AC;&#x2DC;Formulating a programme for formulation development of complex products'. His detailed and in-depth presentation addressed various pertinent aspects of product development and ensuring regulatory compliance while thriving in a complex environment. He also spoke on the meas-

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ures needed to drive continuous product value and functionality. He examined strategies to cope with design complexities in pharma formulations while maintaining time to market and profitability. He gave a rundown on the importance of quality by design in dealing with complexities and how formulation development will evolve in times to come. He explained the good practices in formulation development and stressed on the need for their adoption to ensure regulatory compliance. He also pointed out

that the companies need to anticipate how to stay pertinent in a dynamic environment and emphasised on the need to invest in R&D of complex products to do so. He said that investing $10 in R&D of complex products would give $150 in terms of revenue. Dr Hussain also interacted with the audience over Skype to answer their queries on the changing regulatory scenario in formulation development and the steps needed to stay updated and relevant in these times.

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Advances in film coating technology Mike Easterbrook Chief Technical Officer, Ideal Cures

ike Easterbrook, CTO, Ideal Cures took stage to give insights on the advances in film coating technology. He spoke on current industry requirements which needs Employment of innovative technologies to improve product quality and process efficiency and retention or enhancement of product safety and efficacy within commercially acceptable cost constraints. Then, he elucidated on Ideal Cures' efforts towards development of products and systems meeting the above

requirements which includes very high solids/ low viscosity coatings offering time savings combined with excellent uniformity and smoothness and innovative film systems mimicking sugar coat appearance but with more economical process times and opportunities for automation. He also gave a detailed presentation on InstaCoat 4G, an offering from Ideal Cures, and elaborated on its advantages which include dry powder system for aqueous reconstitution, high solids capability, high pro-

ductivity, high adhesion, ideal for friable cores, enhanced bulk tablet flow properties, demonstrated performance in all types of conventional, side-vented and continuous coating equipment etc. He used real case studies to demonstrate the actual benefits accrued through the product for its users. He spoke on the need to stay at par with the advancements in the dynamic segment of formulation development and drug delivery and assured that Ideal Cures can prove to be a good partner in this journey.

Advances in the world of probiotics Dr Hongwei Wang Applied Nutrition Manager, DuPont Nutrition & Health

ongwei Wang, Applied Nutrition Manager, DuPont Nutrition & Health talked about the 'Advances in the world of Probiotics'. He provided a brief on DuPont Nutrition & Health and the services the company offers. he said that the company has indepth knowledge of food and nutrition with current research and expert science to deliver unmatched value to the food, beverage and dietary supplement industries. He also said that they draw on deep consumer insights and a

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broad product portfolio to help their customers turn challenges into high value business opportunities. He also touched upon different topics like gastrointestinal microbiota in health and disease, introduction to probiotics and their characteristics, reported clinical benefits and proposed mechanisms, manufacturing of probiotics and DuPont Danisco range of probiotic strains and delivery formats at the FDD Conclave . Wang's detailed presentation enlightened the audience

about the different levels of action of probiotics and the effects of probiotics in maintaining good health. He also drew inferences from a study conducted by DuPont in Hyderabad to understand the effect of probiotics on diarrhea affected kids. The objective was to understand whether it can help reduce incidence of diarrhea or improve their health status. Summing up, Wang said that probiotics can help in improving the immune system and help improve resistance to infectious diseases.

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Panel discussion: Expanding India’s talent pool in formulation development and drug delivery: Innovative approaches

(L-R) Dr Pawan Bhat, Executive Vice President, Technical Operations- R&D, Natco Pharma; Jaya Abraham, Head - NCE,NDDS, Generic Formulation, Packaging, IP Development, Torrent Pharmaceuticals; Dr Himadri Sen, Chairman, STEERLife India (Moderator); Vinod Kumar Arora, Principal Advisor, IGMPI; Dr Mahesh Burande, Director, Skill Development and Professor, RMDIPER

he first panel discussion of the FDD Conclave 2017 revolved around a critical issue — ‘Expanding India’s talent pool in formulation development and drug delivery: Innovative approaches’. In this session, an expert panel comprising Dr Himadri Sen, Chairman, STEERLife India as the moderator; Vinod Kumar Arora, Principal Advisor, IGMPI; Dr Pawan Bhat, Executive Vice President, Technical Operations-R&D, Natco Pharma; Jaya Abraham, Head - NCE, NDDS, Generic Formulation, Packaging, IP Development, Torrent Pharmaceuticals; and Dr Mahesh Burande, Director, Skill Development and Professor, RMDIPER, highlighted various challenges faced by the sector due to qualitative and quantitative paucity of talent. Dr Sen initiated the discus-

sion by examining the current scenario and raising several relevant questions for the panelists to deliberate upon. One such query was where are gaps in talent management and which are the major focus areas? Do we need the talent in drug discovery development, new formulations, new generics, drug delivery system, innovative dosage forms or complex generics? He also raised a query on the role of academic institutions and how they are poised to create better talent in terms of quality and quantity. Arora highlighted three vital points — lack of industry readiness in the students and the gap between academia and the industry. Secondly, he suggested that we look into novel drug delivery systems along with product development of generics as the cost benefits are marginal. He further

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recommended initiation of continuing education programmes (CMEs) which will give hands on training to students for better understanding of the industry. Abraham also agreed that the current syllabus needs to be revamped to create better talent in formulation development and briefed on the need for critical thinking, data analysis, interpretation, logical conclusion and designing experiments. She also stressed on application-oriented knowledge to be imparted by the institutes. Bhat elaborated on the subject of education and said that there is need to have different approaches to deal with talent at different levels. He elaborated on the need to revise the syllabus to bridge the gap between the freshers calibre and índustry's expectations. He also opined that mushrooming

of institutes without proper emphasis on quality could be the reason for dilution of standards in talent creation. He also addressed issues such as lack of knowledge in graduates about compliance, regulations, IP etc. Burande, quoted from a report that revealed investments in R&D by pharma companies have substantially increased from ` 2000 crores in 2010 to ` 8000 crores in 2017. He informed that the Indian pharma industry holds the third position in the world in terms of volume but when it comes to value, we lag behind. Despite, 1300 degree pharmacy colleges along with 800900 post graduate courses run in most of these institutes, he reiterated the fact that the quality of talent is deteriorating as against quantity, which is increasing. He mentioned lack of proper emphasis on skill development as a reason

for the lag. Urging the experts to come up with a platform which involves academicians as well in creating adequate solutions, he referred to examples of various developed countries like South Korea, Japan, Germany who work towards skill development and ushered the industry to take lessons from these nations. He added that a provision needs to be devised for applicationbased training of the teachers by industry experts to bridge the gaps in skill development. The expert panel also recommended measures like finishing schools, better industry – academia collaborations, reform in educational curriculum to improve talent management in this evolving segment. An interactive audience also share their views and recommendations which made the panel discussion even more interesting.

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Express Pharma honours leading formulation scientists in India Organised by Express Pharma and presented by Ideal Cures, FDD Leadership Awards recognised the stellar achievements of these scientists in furthering research and innovation in formulation development and drug delivery

Winners of the FDD Leadership Awards 2017

xpress Pharma hosted the first ever FDD Leadership Awards to recognise the stellar achievements of Indian scientists and R&D heads of reputed institutions and organisations for outstanding research and innovation in the field of formulation development and drug delivery. Ideal Cures was the Presenting Partner for the awards. Held concurrently with the FDD Conclave, on June 16, 2017, at Novotel Airport, Hyderabad, the awards night began with an address by Viveka Roychowdhury, Editor, Express Pharma, who welcomed the delegates, explained the rationale behind the initiative and elaborated on the methodology of the awards. Subsequently, Roychowdhury, alongwith Ravi Uday Bhaskar, Director General, Pharmexcil and Suresh Pareek, MD, Ideal Cures, alongwith the eminent jury of FDD Leadership Awards

34 EXPRESS PHARMA July 1-15, 2017

2017 â&#x20AC;&#x201C; Vinod Kumar Arora, Principal Advisor, Institute of Good Manufacturing Practices India; Dr Girish Jain, President, Research and Development, Alkem Laboratories; Seetaraju Gembali, Director, GSR Pharma Research and Pramod Pimplikar, Managing Director, Shalina Laboratories, presented the awards to the winners. 15 leading professionals received the FDD Leadership Award for Outstanding Achievement in Formulation Development and Drug Delivery. The Lifetime Achievement Award was also presented to an industry veteran who has traced a glorious career in this field. The jury members were also felicitated by Express Pharma and Ideal Cures to appreciate thir invaluable efforts in helping choose the deserving winners. The events night came to close on a celebratory note and ended with a gala dinner.

The eminent jury of FDD Leadership Awards 2017 felicitated at the event

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The winners of FDD Leadership Awards 2017 share their vision to make India a hub for formulation development and drug delivery â&#x2013; Lifetime Achivement Award

Dr Himadri Sen Chairman STEERLife India

We need to expand our current talent pool for the next generation of scientists and technologists,to sustain our leadership position in generics.We also need major thrust and focus on drug delivery and creation of innovative platforms

â&#x2013; Outstanding Achivement in

Formulation Development and Drug Delivery

Arun Kumar Pandey Senior Vice President Alkem Laboratories

Nurturing talent and targeting unclassified therapeutic segments to serve the society at affordable costs will make India a global hub for formulation development and drug delivery To subscribe: bpd.subscription@expressindia.com

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July 1-15, 2017

cover ) DAY 1 â&#x2013; Outstanding Achivement in

Formulation Development and Drug Delivery

Ashish Gogia Executive Vice President, R&D, Medreich

Demonstrate speed in developing advanced formulations technology and regulatory approvals for differentiated products.New ITsoftware systems should be implemented in formulation development for online experiments,data recording and acquisition

â&#x2013; Outstanding Achivement in

Formulation Development and Drug Delivery

Geena Malhotra Global Head of Integrated Product Development Cipla

By promoting entrepreneurship, incubation,Intellectual Property Rights (IPRs) and technology transfer,we can make India a hub for formulation development and drug delivery

36 EXPRESS PHARMA July 1-15, 2017

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■ Outstanding Achivement in

Formulation Development and Drug Delivery

Dr Jayant Karajgi Chief Scientific Officer Wockhardt

R&D is a unique function wherein diverse and completely different skills like formulation,analytical, packaging,bioequivalence and regulatory etc.have to work in isolation in their respective expertise areas,but at the same time be in tandem to create a unique product – the Dossier!

■ Outstanding Achivement in

Formulation Development and Drug Delivery

Jaya Abraham Head – Formulation/Biopharmaceutics/ Reverse Engineering Analytics, IPR Landscaping and Strategy design, Packaging Torrent Pharma

India’s young talent pool should have their own approaches for innovation,patient engagement,data and proof of value.We need to be openminded,inquisitive and mentally prepared for a rigorous grind with patience and perseverance to get maximum mileage of the winds of change To subscribe: bpd.subscription@expressindia.com

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Formulation Development and Drug Delivery

Dr Krishna Murthy Bhavanasi General Manager-Formulation R&D Natco Pharma

We need to focus on niche technologies,invest on development of differentiated products and delivery systems like noninvasive technologies,ease of administer dosage forms like subcutaneous dosage forms and patches

â&#x2013; Outstanding Achivement in

Formulation Development and Drug Delivery

Makarand Avachat Senior Vice President Pharma Research, Lupin

Continued supply of talent with enhanced capabilities to handle future challenges of complexities with respect to molecules and dosage forms would help India become a FDD hub

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■ Outstanding Achivement in

Formulation Development and Drug Delivery

Rajesh Kshirsagar Chief Technical Officer Microlabs

The industry and academics should concentrate on innovation-driven developments.The industry should concentrate and invest more on latest drug delivery technologies rather than vanilla generic developments

■ Outstanding Achivement in

Formulation Development and Drug Delivery

Ravinder K Senior Director, Head of PSAI Formulations Dr Reddy’s Laboratories

We need to seriously work around creating a talent pool,establishing a conducive industrial research environment to encourage innovation,and encourage practical models for effective industry-academia collaboration with active engagement from Government of India

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EXPRESS PHARMA

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Formulation Development and Drug Delivery

Dr Shirish Kulkarni Senior Vice President R&D, Sun Pharma. India

Focussed efforts with a long-term vision will create enough opportunities to attract or generate talent pool.The industry needs to take a lead on training new graduates as well as visiting faculties from academia,as it will be mutually beneficial.

â&#x2013; Outstanding Achivement in

Formulation Development and Drug Delivery

Srikant Pimple Head- Formulation Development Unichem Laboratories

We have to enter into collaborative R&D arrangements with brand and generic companies to supplement their R&D productivity.There is a need to control R&D operating costs,formulation development costs,packaging costs and reduce cost of existing formulations to increase profitability

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■ Outstanding Achivement in

Formulation Development and Drug Delivery

Dr Sukhjeet Singh Senior Vice President – Pharma Research Panacea Biotec

We can surely leverage the infrastructure built by the generic industry to make the leap forward into drug delivery.The ecosystem which is required to make India a hub of drug delivery includes universities and research centres which not only provide talent pool but also serve as nurseries of innovation

■ Outstanding Achivement in

Formulation Development and Drug Delivery

Sushrut Kulkarni Senior Vice President & Head Pharmaceutical Technology Center Zydus Cadila

Industry leaders need to help academics to generate high quality applied research results in the field of formulation and clinical research

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EXPRESS PHARMA

July 1-15, 2017

cover ) DAY 1 ■ Outstanding Achivement in

Formulation Development and Drug Delivery

Ulhas R Dhuppad Executive Vice President (CMC) Glenmark Pharmaceuticals

During the last 20 years,Indian pharma has grown significantly and become one of the major exporters to US and other markets.It will be good if we work in alliance and market our skill sets to the pharma companies who are looking for it

■ Outstanding Achivement in

Formulation Development and Drug Delivery

Dr VijaySinh Chauhan Senior Vice President – Research and Development (Formulation Finish Products) Intas Pharma

The industry should tie up with universities or institutes for research-based programmes with sponsorship.Research needs to be encouraged through good government policies. Institutes should also get into semester exchange programmes with foreign universities

42 EXPRESS PHARMA July 1-15, 2017

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DAY 2 17 JUNE , 2017

FDD CONCLAVE 2017

Keynote address: Changing the waywe make and take medicines

◗ Changing the way we make and take medicines ◗ Excipients in pharmaceutical formulations - A regulatory perspective ◗ Lipids as pharmaceutical excipients in drug formulations - Challenges and opportunities ◗ The journey of Ideal Cures ◗ PANEL DISCUSSION: FDD strategies to increase compliance in special population segments ◗ Trends in injectable packaging ◗ Keeping up with evolving regulations ◗ Superior polymer technologies to meet emerging drug delivery demands: Dry enteric coatings ◗ Role of high resolution mass spectrometry in peptide impurity characterisation ◗ Improve coating efficiency and yield by using best technology ◗ PANEL DISCUSSION: The way forward in FDD ◗ Vote of thanks

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Dr Himadri Sen, Chairman, STEERLife

he second day of the FDD Conclave 2017 commenced with a key note address from none other than Dr Himadri Sen, Chairman, STEERLife, the doyen of formulation scientists in India. He drew from his commendable experience spanning over four decades to share learnings to create an effective synergy between engineering sciences and pharma applications to change the way we make and take medicines. Detailing the inefficacies and inefficiencies in the current batch manufacturing processes which include time consuming sample collection and testing processes, suboptimal yield and inconsistent quality, Dr Sen recommended the adoption of cleaner, flexible, more efficient continuous manufacturing processes. He outlined the manifold benefits and advantages of continuous manufacturing process and underlined how it can have significant impact on the growth of the industry. He also said

that it is time we moved completely from quality by testing to quality by design. Dr Sen opined that it is high time we changed the way we looked at process R&D and unlearnt some of current ways to make a significant difference. He gave examples of misuse of antibiotics and its pitfalls to state his point. Dr Sen also elaborated on the next-gen technologies which would usher an era of change in formulation development and drug delivery. For instance, novel hot melt extrusion (B2C –E) replacing conventional hot melt extrusion; hot melt fragmentation* (B2C- F) replacing spray drying and spray congealing; activated granulation (B2C –G) instead of conventional wet, dry and melt granulation. The session ended with the audience interacting with Dr Sen to gain more insights on this topic and clarify their doubts.

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Excipients in pharmaceutical formulations – a regulatory perspective SR Salunkhe Assistant Commissioner, FDA, Maharashtra

R Salunkhe, Former Assistant Commissioner, FDA Maharashtra, gave an insight from a regulatory perspective on the use of excipients is pharma formulations. Highlighting the need to produce, safe, effective and quality drugs, he pointed out that the current quality mechanisms often fail on safety and efficacy fronts. He also drew attention to the fact that this negligence has often caused several serious mishaps in the past and how good manufacturing practices (GMP) were put into place to avoid them. Giving a rundown on excipi-

ents, Salunkhe elaborated on their functionality and role in enhancing product identity, safety and efficacy. He explained how the physio-chemical and biological properties of the drug excipients influences the drug's product stability, bioavailability and manufacturability. He also spoke on various laws which govern the use of excipients in pharma processes. Salunkhe then detailed on the differences between commercial and pharmacopoeial excipients and how it is important to use the right excipient to get optimum results. He also pointed out that testing the quality of excipients only in fin-

ished products would not suffice and that it needs to be done at various levels of the manufacturing process. He explained various complexities and considerations involved in the use of excipients and threw light on the standards that need to be maintained to add them to pharma formulations. He pointed out that as per International Pharmaceutical Excipients Council (IPEC) standards, the material used in the pharma drug product is required to be manufactured under appropriate GMP and it is not appropriate to use a non-pharma grade excipients as a drug component.

Lipids as pharmaceutical excipients in drug formulations Challenges and opportunities KD Yadav Senior VP (Technical), AAK Kamani

n this session, KD Yadav, Senior VP (Technical), AAK Kamani elucidated the importance of lipids as excipients in drug formulations for the pharma industry. Reiterating Dr Himadri Sen’s view on how quality is not defined by testing, but by design, he highlighted why they are integral to formulations as well as active drugs which are oil solubles. He also elaborated on various kinds of lipids available in the market, such as fatty acids, natural

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oils and fats, mono, di, and triglycerides (e.g GMS, GMO), polyethylene glycol (PEG) derivatives of glycerides and fatty acids, polyglyceryl fatty acid esters, phospholipids etc. Explaining the functionality of lipids in detail, he said that they are required to make a stable emulsion when there is a need to improve shelf life. Dr Yadav also briefed the audience on the rich history of his company and the milestones it has achieved in a

journey spanning six decades. He also briefed about AAK Kamani's offerings to pharma as well as veterinary industry and the myriad applications of these offerings in these industries. He also spoke on the company’s manufacturing facilities and capabilities. Giving a rundown on the various kind of oils used in the pharma industry, he also pointed out the importance of right processing of oils to improve their effectiveness and efficacy.

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The Journeyof Ideal Cures Suresh Pareek Managing Director, Ideal Cures

n a very interesting session, Suresh Pareek, thanked the audience for being a part of the FDD Conclave, as it was the first of its kind event for scientists and R&D heads. He went on to congratulate all the winners of the FDD Leadership Awards. Then, he spoke on a his entreprenurial journey and narrated the story of how it all began. From resigning a plum job to venture into the unknown terrain of entrepreneurship, to the myriad challenges he had to overcome to hold his own in a competitve industry, he went on to nar-

rate several interesting incidents from his life’s journey. He also informed that Ideal Cures was not his first foray into entrepreneurship, he had pursued other avenues without noticeable success. Then, Pareek decided to enter the film coating industry, a new ball game as his experience was in the paint industry. he had to compete with already established players and bring in significant value additions to make a mark for himself. Pareek also narrated incidents of dealing with obstacles on the personal front such as health issues while

trying to build a flourishing business. However, he persisted and his perseverance paid off. In 2003, he set-up his first GMP facility in Vasai and later on set up plants in Jammu and Sikkim. The company today has offices in Milan, Italy and a second office in Israel to work with Teva. At present, the company has four plants. Thus, Ideal Cures is a renowned name in the industry today. Pareek ended his inspirational session by saying “Only you can empower yourself to walk on the path you want.”

Trends in Injectable Packaging Siva Prasad Reddy Technical Support Engineer – India, West Pharma

DD Conclave 2017 had a session by Siva Prasad Reddy, Technical Support Engineer India, West Pharma who gave a presentation on trends in injectable packaging. He spoke on the challenges in injectable packaging. Reddy informed the audience about the growing demands for parental drugs but also highlighted the growing challenges in terms of increased regulatory scrutiny; more complex devices and combination products; higher focus on quality risk management; more advanced and rigorous testing and inspec-

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tion of final drug products; etc. Reddy went on explain the risks in container closures and the need for increased scrutiny by regulatory agencies to enable better preservation of drugs or biologics, which comprise various factors such as chemical compatibility and leachables formation; variability in quality at particle levels and visual defects; reliability with device delivery in terms of dimensional control and functionality; sterile component equivalency, consistency in bulk, nest and port bags etc.

Talking about major concerns with glass containers across the world, Reddy highlighted pain points such as interaction with sensitive biologics; breakage; dimensional variation; variable silicone distribution; amount of silicone coverage and quality etc. Further, he briefed the audience on the various products offered by his company to serve the changing requirements of the pharma industry. He also informed that West Pharma is among the top 25 companies and 35 injectable biologics and they have customers across the world.

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Panel discussion: FDD strategies to increase compliance in special population segments

(L-R) Anwar Daud, Managing Director, Zim Laboratories; Dr Bharani Sanjay Sogali, Professor & Head, Department of Pharmaceutics, Krupanidhi College of Pharmacy; Seetaraju Gembali, Managing Director, GSR Pharma (Moderator) and SR Vaidya, Director, Bliss GVS Pharma

he two-day FDD Conclave 2017 saw several insightful sessions addressing myriad critical aspects of formulation development and drug delivery. The panel discussion on â&#x20AC;&#x2DC;FDD strategies to increase compliance in special population segmentsâ&#x20AC;&#x2122; held on the second day of the event was one of them. Prominent representatives of the industry and academia comprising Seetaraju Gembali, Managing Director, GSR Pharma (Moderator); SR Vaidya, Director, Bliss GVS Pharma; Anwar Daud, Managing Director, Zim Laboratories; Dr Bharani Sanjay Sogali, Professor & Head, Department of Pharmaceutics, Krupanidhi Col-

46 EXPRESS PHARMA July 1-15, 2017

lege of Pharmacy came together to discuss this important issue and deliberate on various considerations to take into account while developing formulations for special populations. The session covers three variant formulations developed inline to meet the need of special population segment requirements. Setting the stage for the discussion, Gembali, the moderator of this session, briefed the audience about special populations and informed that they comprise paediatric and geriatric population, people suffering from dysphasia and those who are mentally challenged. He highlighted the importance of focussing on this population as it is in-

creasing each day. For instance, he pointed out that of the total world population, eight per cent population is geriatric. By 2050, this will increase to 16 per cent which comes to 1.5 billion people. Hence, it is essential to prepare drug formulations keeping this special population in mind so that we are geared for the future. Then, each panelist gave a short presentation on the upcoming trends, opportunities and challenges in this sphere. They spoke on suppositories and pessaries, orally soluble dissolving films, inhalation therapy, transdermal patches etc. in connection with the topic. Vaidya talked about the importance and benefits of

pessaries and suppositories over traditional formulations. He also explained how conventional drugs can have side effects which can be mitigated if we opt for better formulations. He cited several examples to prove his point. Daud presented on oral thin films as an effective option for formulations to cater to the special population segment. He elaborated on their myriad benefits and their relevance to the special population and highlighted the challenges in developing these formulations. He also spoke on future technologies and their role in creating effective strategies to deliver innovative approaches to formulation development which would offer significant bene-

fits to the patients. Dr Sogali gave a presentation on inhalation therapy and informed that it can be used widely for paediatric as well as geriatric population. She also gave a rundown on the challenges and potential of inhalation therapy and emphasised on the important parameters to be considered while developing inhalation therapies. She also explained the different applications of nanotechnology for inhalation and how to improve patient compliance using inhalation applications. The audience also got a chance to interact with the panelists and understand more on the subject, thereby making it a very informative session.

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Superior polymer technologies to meet emerging drug delivery demands: Dryenteric coatings Nitin Bhusane Director, Shin-Etsu Chemical Tylose India

nother technical session at FDD Conclave 2017, covered the topic of dry enteric powder coating and demonstrated how it is one of the superior polymer technologies to meet emerging drug delivery demands. Nitin Bhusane, Director, Shin Etsu Chemical Tylose India, he speaker in this session, gave in-depth information about the use of coating technologies, their need and role in improving the efficacy of the formulations. He also drew a comparative analysis between conventional coating systems

and dry enteric coatings. He highlighted the advantages and disadvantages of different technologies. He also gave details on the application of these technologies in various pharma formulations. Bhusane drew attention to the disadvantages of conventional methods which include low productivity, low polymer concentration, long coating time, difficult to apply to water sensitive drugs and environment pollution. Speaking on the advantage sof dry powder coating, Bhusane said that dry powder coating is high in productivity and solid

content. It will consume less time in comparison to conventional methods. It is easily applicable to water sensitive drugs and there is no harm to the environment in using dry powder coating. Bhusane also gave a detailed pictorial presentation on the right way to apply dry enteric coatings to achieve best results. He further said that his company recommends for dry powder coating to the industry. However, he pointed out that his company has other offerings in the form of powder mixtures and liquid mixtures as well.

Keeping up with evolving regulations Dr BobbyGeorge Vice President & Head Regulatory Affairs, Reliance Life Sciences

r Bobby George, VP & Head Regulatory Affairs, Reliance Life Sciences, in his session, addressed a vital topic, keeping up with evolving regulations. He also threw light on the government's mandate which involves removing regulatory bottlenecks, enhancing ease of doing business, successfully engaging with stakeholders, etc. Giving a rundown on the current regulatory scenario and the challenges faced by companies in ensuring compliance, Dr George also spoke on

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the measures taken by the government to enable a more effective and transparent regulatory system across pivotal areas such as clinical studies, manufacturing, e-governance, evolving regulations, pharmacovigilance etc. He also examined the effectiveness and efficacy of some significant measures like tightening the noose around irrational FDCs; New Medical Device Rules, 2017; audio video recording of consent, manufacturing test license validity, annual joint inspections of facility, risk-based inspections, establishing and em-

powering Life Science Skill Development Council, reporting of adverse drug reporting (ADRs) for marketed drugs, National Regulatory Assessment by WHO etc. He also analysed the potential of some of the steps on the anvil which includes regulation of online pharmacies; streamlining the process for handling of NSQ samples; amendment of Schedule H list; separate set of rules for New drugs and CTs; setting up mini drug testing labs at port offices etc., to bring in a positive change and create a more efficient ecosystem.

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Role of high resolution mass spectrometryin peptide impurity characterisation Dr Annu Uppal Global Demo Lead and Manager Application Support for Biopharma Applications, Sciex

he FDD Conclave 2017 witnessed several technical sessions which are of importance to the formulation development and drug delivery industry. In one such session, the focus was on the importance of identifying impurities in the development process of drugs. Dr Annu Uppal, Global Demo Lead and Manager Application Support for Biopharma Applications, Sciex, spoke on the role of high resolution mass spectrometry in peptide impurity characterisation. She also informed the audience that impurities and

the amount in which they exist can be deterrents in the efficacy of peptide-based drugs. So, Sciex has developed a software named Metabolite Pilot to ensure accurate identification of impurities. Talking about the advantages of the software, Dr Uppal highlighted that Metabolite Pilot is an all-in-one integrated software tool for ID confirmation, structure elucidation and correlation. It has advanced peak finding algorithms optimised for Sciex accurate mass platforms. It consists of known transformation database for related impurities identification and also correlates with an

analog database for related impurities identification. It assists in integrated MS/MS fragment interpretation, structural assignment, high throughput batch analysis and sample to sample correlation. Dr Uppal also spoke on how one can leverage high resolution mass spectrometry for characterisation of these impurities . She emphasised on the importance of identifying, characterising and quantifying the impurities in API and pharma products as these impurities can lead to the side effect, toxicity and impact the drug activity.

Improve coating efficiencyand yield byusing best technology Devendra Chaudhari Marketing Head, Anish Pharma Equipment

nother technical session at the FDD Conclave was on improving coating efficiency and yield by using best technology. The speaker, Devendra Chaudhari, Marketing Head, Anish Pharma Equipment, gave detailed insights to the audience on the latest coating technology available in the market and the his companyâ&#x20AC;&#x2122;s offerings in this sphere. Giving an overview on the companyâ&#x20AC;&#x2122;s history, he informed that the group was founded in 1992 to manufacture some semisolid equipment. At present, it has six manufacturing facilities at Nashik, with a total area of 50,000 sq ft. and a dedicated fat

48 EXPRESS PHARMA July 1-15, 2017

facility. Currently, there are 150 plus professionals working at Anish Pharma to provide support to the customer. Chuadhari also spoke about their seamless process development facility which boasts of the latest equipment for manufacturing oral solid dosages. He informed that the facility is well equipped with all the accessories and controls like steam, chiller, humidifier, instrumentation, latest offerings in process technology etc. It allows the company to manufacture batches from 100 gm to 60 kg at Nashik. Chaudhari also briefed the audience on the advantages, capacity and features of the equip-

ment available with Anish Pharma such as APCG 175C, APCG 300C, APCG 450C, Extruder Spheronizer etc. Chaudhari also highlighted the advantages of a conical machine offered by his company, in the manufacturing of MUPS. he pointed out the advantages of the machine in maintaining superior and consistent quality products with the help of the conical machine. He assures that the conical series machine will give high efficiency and higher spray rate with less electrostatic charge. Thus, he spoke on his companyâ&#x20AC;&#x2122;s capability to partner progress in formulation development and drug delivery.

(

THE MAIN FOCUS

Panel Discussion: The wayforward in FDD

(L-R) Seetaraju Gembali, Managing Director, GSR Pharma Research; Vinod Arora, Principal Advisor, IGMPI (Moderator); Dr Girish Jain, President, Research & Development, Alkem Laboratories and Pramod Pimplikar, Managing Director, Shalina Laboratories

he last panel discussion of the FDD Conclave 2017 ensured a befitting finale to the two-day event which saw attendance from leading formulation scientists and R&D heads of renowned pharma companies. Titled, 'The Way Forward in FDD', it saw an interesting exchange of views on the paths that professionals in FDD need to tread to encourage and drive innovation in the formulation development and drug delivery sector of India. The session comprised an eminent panel of Vinod Arora, Principal Advisor, IGMPI (Moderator), Dr Girish Jain, President, Research & Development, Alkem Laboratories, Seetaraju Gembali, Managing Director, GSR Pharma Re-

search and Pramod Pimplikar, Managing Director, Shalina Laboratories. Arora, the moderator of the session, set the stage by giving an overview on the current scenario in FDD and said that India is at crossroads. Now, it has to take some crucial decisions and choose between continuing with vanilla generics or moving to super generics or super super generics. He also pointed out the opportunities for growth in these emerging areas and explained that they can help meet India's huge unmet medical needs. Arora also opined that this move would be more affordable than getting into new chemical entities (NCEs) which require huge investments. Dr Jain reiterated these

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views and said that NCEs don't always guarantee returns on investment. It might be a better bet for India to go the complex generics route to sustain its growth momentum in the pharma industry. He urged the industry to encourage innovation in formulation development of super generics or complex generics and administer them through novel drug delivery systems to gain profits and emerge as a leader in the pharma industry. Gembali offered a counterview and said that India should not completely disregard development of NCEs. On the contrary, India should look at developing NCEs in a big way as it would usher more innovation in the sector and if successful, reap huge financial returns.

However, he also admitted that there are bottlenecks that need to be cleared before India can grow as a major hub for NCE development. He said that this would take our achievements to the next level and help us gain more recognition in the global arena while making the industry more profitable as well. Nevertheless, he agreed that super generics and complex generics offer great growth avenues as well. Pimplikar gave a rundown of the opportunities and challenges in the formulation development and drug delivery sector of India in the current scenario. He said that while India has sufficient talent and brain power to become a pharma powerhouse, challenges like funding, data secu-

rity, etc are hampering the industry's progress. He also spoke on the need to be more capable to deal with competition from countries like China. He also urged India to focus more on innovation to drive growth. Pimplikar was also of the opinion that getting into NCEs would require more deeper pockets and at this point of time, India might not be equipped to engage in these activities. But, with the right measures, soon India can look at extending its focus areas and leveraging opportunities which has not been tapped yet. The panelists also interacted with the audience and there was knowledgesharing galore at the second panel discussion of FDD Conclave 2017.

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cover ) DAY 2

FDD Conclave hosts power discussion on future of film coating

enior formulation scientists and R&D heads discussed the need to look beyond obvious and simple solutions as the level of complexity in the pharma industry would only increase in the coming days. This was the consensus of a power discussion on â&#x20AC;&#x2DC;The Future of Film Coatingâ&#x20AC;&#x2122;, held on the second day of the FDD Conclave. The hour long brainstorming session saw formulation scientists, R&D heads and members of the jury for the FDD Leadership Awards, discuss how regulations in various markets were set to change the film coating industry. They exhorted technology solution providers to look beyond the obvious simple solutions, which

50 EXPRESS PHARMA July 1-15, 2017

could be easily replicated. They emphasised that as the issues would only get more complicated, the solutions too needed to be of a higher degree of complexity. While the initial investment in researching such solutions would be considerable, this complexity could ultimately give far sighted technology providers an edge over their competitors as well as endear them to current and prospective pharma customers. Suresh Pareek, MD, Ideal Cures; Girish Kumar Jain, President, Research & Development, Alkem Laboratories; Vinod Arora, Principal Advisor, IGMPI; Seetaraju Gembali, MD, GSR Pharma Research; Pramod Pimplikar, MD, Shalina

Laboratories; Shirish Kulkarni, Senior VP- Formulation Development, Sun Pharma; Makarand Avachat, Senior VP- Pharma R&D, Lupin; Krishnakant Gandhi, Director, Delivery Manager-Generics Product Delivery Team, Dr Reddy's Laboratories and few others were the part of the power discussion. The discussion began with a brief note by Pareek who opened the discussion by asking participants to discuss trends and issues faced by formulation scientists, their expectations from technology providers in terms of new techniques, technologies and the future of film coating. One of the jury members suggested that there should be some mechanism to control the

initial release. The present requirement is of sustained release. He further explained the difficulties of replicating the same standards between batches and pointed out that if a vendor could come out with that kind of mechanism, it would herald a new generation in film coating. Such a solution would also be more convenient for the formulation scientist to use as the current practice involves changing the composition of the formulation and also tweaking the composition of the coating mix. The film coating industry provides coating substances in a particular pattern leaving the formulation scientist to play a role only in the composition of the formulation itself.

Discussing the requirements and expectations of pharma manufacturers from coating providers, participants explained the need to reduce the use of solvents, as the industry is moving away from solvents to aqueous. The next phase would be the move from aqueous to deposition of powder but that would be another 10 to 15 years away from now. The participants also shared their views on technical issues faced by the coating manufacturer in coming up with the dry powder coating. They also touched on evolving regulations and how these were influencing trends in the coating industry in both domestic and global markets.

RESEARCH UPDATES

Novartis eye drug works with fewer injections than rival Cutting the frequency of injections could also give RTH258 an edge over Lucentis, an eye drug that Roche sells in the US and Novartis sells elsewhere

Novartis drug to treat a leading cause of vision loss in people over 65 does not need to be injected as frequently as a rival medicine from Regeneron Pharmaceuticals to be effective, clinical trials showed recently. Novartis said the trials showed its RTH258 drug would reduce the injection burden for patients with neovascular age-related macular degeneration (nAMD). Head-to-head late-stage trials showed RTH258, which goes by the generic name brolucizumab, worked as well as Regeneron's Eylea, with just over half the patients needing doses every 12 weeks, rather than every eight weeks for Eylea. Leerink Partners analyst Geoffrey Porges said the data removes an uncertainly for Regeneron investors who had been on the sidelines and were now looking to take advantage of the positive sales trajectory of Dupixent, the company's recently approved treatment for severe atopic dermatitis. He added that it appeared the potential negative impact of Novartis data was already fully priced into the Regeneron stock. Still, analysts at Jefferies called the trial result "a significant differentiator and competitive advantage for RTH258." Cutting the frequency of injections could also give RTH258 an edge over Lucentis, a best-selling eye drug that Roche sells in the US and

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2016 for Roche and Novartis. Regeneron is betting on Dupixent and its also just approved Kevzara for rheumatoid arthritis, both with blockbuster potential, to reduce its reliance on Eylea, which accounts for nearly 70 per cent of its revenue. Competition for nAMD patients is likely to grow even more intense, with data from trials on Abicipar, an investigational medicine being developed by Allergan (AGN.N) and Switzerland's Molecular Partners, set for release in 2018. Allergan is also banking on reduced injection frequency compared to Lucentis and Eylea to win over eye doctors and patients, should its drug win approval.

SCIENTISTS HAVE developed a new three-in-one blood test that has the potential to turn AstraZeneca's drug Lynparza into a precision medicine for prostate cancer. Lynparza, which is already approved for ovarian and recently produced good results in breast cancer, is currently in clinical development against prostate tumours. Researchers at the Institute of Cancer Research (ICR) in London said their new test was able to pick out which men with advanced disease were likely to benefit from the drug, while also checking that those taking it were responding. In addition, the test can quickly detect if prostate cancer is evolving genetically and might be becoming drug-resistant. The development of the new test, details of which were reported in the medical journal Cancer Discovery, marks a step forward for so-called liquid biopsies, which involve simple blood sampling as opposed to an invasive tissue biopsy. AstraZeneca's drug, also known as olaparib, is the first in a new class of anti-cancer agents called PARP inhibitors that block enzymes involved in repairing damaged DNA, thereby helping to kill cancer cells. Lynparza - abandoned at one stage by AstraZeneca but revived by CEO Pascal Soriot when he took over in 2012 - became the first PARP drug to reach the market when it won US approval for ovarian cancer at the end of 2014.

Reuters

Cutting the frequency of injections could also give RTH258 an edge over Lucentis, a best-selling eye drug that Roche sells in the US and Novartis sells elsewhere

Novartis sells elsewhere. Lucentis patients generally receive doses every four weeks. "It exceeds our expectations and we're looking forward to filing in 2018" for regulatory approval, Vas Narasimhan, Drug Development Chief, Novartis, said in an interview. "We had hoped to see 40 per cent or greater" of patients responding positively to injections every 12 weeks, he said. "Now that we see it well into the 52 to 57 percent range, we feel very good about

the result." Novartis expects eventual annual sales to top $1 billion. Zuercher Kantonalbank analyst Michael Nawrath said the data should help Novartis win back share in a highly lucrative market of 20 million to 25 million patients. Eylea, which was developed with Bayer, has powered much of Regeneron's growth since late 2011. However, the drug's sales growth has slowed, mainly due to competition from Lucentis. Lucentis topped $3.2 billion in sales in

Newtest may turn AZâ&#x20AC;&#x2122;s Lynparza into precision drug for prostate cancer

Combo of sleep apnea and insomnia linked to depression in men Sleep deprivation, which may occur in chronic insomnia, is known to adversely affect muscles involved in breathing and may contribute to the propensity and severity of sleep apnea MEN WITH both obstructive sleep apnea and insomnia are much more likely to have depression symptoms compared to men with either sleep disorder alone, suggests a recent Australian study. The depression symptoms also seem to be worse for men who have both apnea and insomnia compared to men with depression but without this combination of sleep problems, the authors report in the journal Respirology. “Obstructive sleep apnea and insomnia are the two most common sleep disorders and can occur together in the same individual,” lead author Dr Carol Lang, a researcher at the Basil Hetzel Institute at the University of Adelaide Queen Elizabeth Hospital Campus. “We know that each of

these disorders is individually associated with poor physical and mental health outcomes in patients. However, we don’t know very much about if, or how, the two disorders interact with each other and the health outcomes when they coexist in the same individual,” Lang said in an email. A person with obstructive sleep apnea has their breathing interrupted multiple times during sleep by narrowed or blocked airways. The condition is often treated by wearing a continuous positive airway pressure, or CPAP, mask to keep the airway open. Insomnia was defined in this study as the inability to fall or stay asleep together with feeling fatigued during the day. Lang and her colleagues enrolled 700 mostly middle

Researchers found that more than half of the men had undiagnosed obstructive sleep apnea aged men in Adelaide with no diagnosis of obstructive sleep apnea. All of them underwent at-home sleep monitoring known as polysomnography and answered questions about their sleep habits, health conditions and possible depression symptoms. Researchers found that more than half of the men had

undiagnosed obstructive sleep apnea. In the entire group, 323 men had sleep apnea only, 37 had insomnia only and 47 had both conditions. Of the men with both sleep apnea and insomnia, 43 per cent also had depression, compared with 22 per cent of the men who had insomnia alone and 8 per cent of the men who had sleep apnea alone. Sleep deprivation, which may occur in chronic insomnia, is known to adversely affect muscles involved in breathing and may contribute to the propensity and severity of sleep apnea, Lang noted. “There are also many biochemical signaling pathways in the body through which sleep apnea, insomnia, and depression may interact with each other,” she said.

If one of the sleep disorders is suspected, primary care providers should consider the possibility of co-existing sleep apnea and insomnia as well as their patient’s mental health, said Lang. “Since some hypnotic medications could potentially be counter-productive, patients should be referred to sleep clinics, and if necessary mental health clinics, for further investigation so that the most appropriate treatment strategy can be implemented for them as an individual,” she said. Our sleep is important for our physical and mental health, Lang added, and a person who experiences sleep problems should talk to a medical practitioner to see if further investigation is necessary. Reuters

Shire wins US approval for long-acting ADHD drug Shire plans to launch Mydayis in the third quarter of 2017 SHIRE HAS won US approval for a long-acting attention deficit drug aimed at adolescents and adults, boosting its stock of medicines for the cognitive condition that affects millions of children and is being diagnosed more in older people. The US Food and Drug Administration (FDA) green light for Mydayis follows good results for Shire's new hereditary angioedema drug and helps offset the setback of early generic competition to a Shire drug for ulcerative colitis. The new drug Mydayis, previously known as SHP465, contains the same active ingredient as Shire's widely used

attention deficit hyperactivity disorder (ADHD) treatment Adderall XR but is formulated to last up to 16 hours. Adderall XR, which is also available in generic forms, manages symptoms for up to 12 hours. "It's obviously not a new molecule but it does extend delivery," said Gregory Mattingly, who has been a study investigator in multiple Shire ADHD drug trials. Shire, whose ADHD drugs Adderall XR and Vyvanse generated close to $2.4 billion in sales last year, plans to launch Mydayis in the third quarter of 2017.

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The company has said Mydayis could have annual sales of $500 million by 2020, well above the $294 million consensus figure. Jefferies analysts noted that every ADHD drug launched by Shire has significantly exceeded initial market projections. While Shire was once bestknown for its ADHD medicines, analysts now view the business as essentially a cashgenerating machine to help the company repay debt and fund investment in its large portfolio of drugs for rare diseases. Mydayis is designed to help those patients, many of them college students or adults, who

now take two doses of various ADHD treatments to control their symptoms throughout the day. The drug cannot be used by children aged 12 years or younger. Shire first filed an application to market Mydayis in 2006 but faced multiple setbacks, including a requirement for additional studies to satisfy the FDA. ADHD is characterised by inattention and/or hyperactivity-impulsivity that affects development. Estimates vary but recent data show up to 11 per cent of American children are afflicted and more than half continue to suffer as adults.

Both Mydayis and Adderall XR contain amphetamine, a stimulant that elevates levels of dopamine - a neurotransmitter associated with motivation, attention and movement. As a stimulant, such drugs carry a risk of abuse, can be poorly tolerated, and even be fatal in rare cases. Non-stimulant ADHD treatments have fewer side-effects but are typically less effective. Other ADHD drug developers include Neos Theraputics, Alcobra, Aevi Genomic Medicine and privately held NLS Pharma. Reuters

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PHARMA ALLY VENDOR NEWS

SPDS hosts Disso India-Mumbai 2017 The convention witnessed the presence of professionals from Pharma R&D, QA, QC and academia to discuss developments related to dissolution science and its applications

he Society for Pharmaceutical Dissolution Science (SPDS) organised its 5th Annual International Convention Disso IndiaMumbai 2017. The convention aimed to promote introduction of new technology, innovation in the field of dissolution testing. Disso India-Mumbai 2017 witnessed eminent professionals from the pharmaceutical industry and was attended by professionals from R&D, QA and QC as well as the academia and had deliberations on various issues related to Dissolution Science and its applications. This event was organised under the chairmanship of Dr K Bangarurajan, Deputy Drugs Controller, DDC (India), Central Drugs Standard Control Organization, West Zone, India and the organising secretary, Dr L Ramaswamy, MD, SOTAX India. The scientific sessions were programmed and executed under the chairmanship of Prof Padma V Devarajan, Professor in Pharmacy, Department of Pharmaceutical Sciences and Technology, Institute of Chemical Technology and Dr Vinod P Shah, Ex US FDA, Pharmaceutical Consultant, USA. The event had plenary lectures, panel discussions, exhibits and poster sessions. Disso India 2017 had global speakers such as Dr Roger Willam, EX-CEO USP, Ex US FDA, USA, who shared an insight on regulation science: the paradigm of dissolution. Dr Vinod P Shah, Ex. US FDA, Pharmaceutical Consultant, USA, who explained the novel science-based approach for Topical drug Classification (TCS) and covered the topic

54 EXPRESS PHARMA July 1-15, 2017

(L-R) Vijay Kshirsagar, President SPDS, Dr K Bangarurajan-Chairman, Disso India Mumbai 2017, Dy Drugs Controller (India) CDSCO West Zone Mumbai, Chief Guest Ajit Singh; Dr Vinod P Shah, Scientific Co Chair â&#x20AC;&#x201C; Disso India Mumbai 2017 and Dr L Ramaswamy, Organising Secretary Disso India Mumbai 2017. Prof Padma Devarajan, Scientific Chair-Disso India Mumbai 2017 is seen addressing the gathering

The scientific sessions were programmed and executed under the chairmanship of Prof Padma V Devarajan, Professor in Pharmacy, Department of Pharmaceutical Sciences and Technology, Institute of Chemical Technology and Dr Vinod P Shah, Ex US FDA, Pharmaceutical Consultant, USA of scientific basis for topical drug classification system (TCS). Prof Dr Jennifer Dressman, Institute of Pharmaceutical Technology, Biocenter, Johann Wolfgang Goethe University, Germany spoke on Gastrointestinal I physiology and need for selective dissolution media and also presented the advantages and impact of biorelevant dis-

solution media. The event had few technical sessions such as Quality by Design ( QbD) implementation in Dissolution Studies - Case studies by Vijay Kshirsagar, Director and CEO, TRAC Pharma Consulting, Mumbai, India & President -SPDS; and patentability of a product based on dissolution data and data integrity issues in disso-

lution based factors affecting bioavailability by Prof Dr Umesh Banakar, Professor and President, Banakar Consulting Services, USA; quality metrics for better compliance by Prof Dr Raghunandan HV, Deputy Director- Academics, JSS University, Mysore; automation in dissolution testing by Michel Magnier, Product Manager and Application spe-

cialist, SOTAX, Switzerland; Complexity of invitro drug release measurements for ophthalmic drug products by Dr Chetan Pujara, Vice President, Small Molecule Product Development, Allergan, USA; drug dissolution: excipient vs excipient by Dr Abhijit V Gothoskar, Technical Advisor, Anshul Life Sciences, India; risk assessment of analytical methods w.r.t dissolution testing by Manu Grover, Waters India; incorporating physiologically based pharmacokinetic (PBPK) modelling to assist with dissolution method development, IVIVC and successful biowaivers by Dr Parizad A Elchidana, GMP Scientific and In vitro dissolution testing for nano formulations by Prof Dr Padma V Devarajan, Institute of Chemical technology, (ICT), Mumbai. EP News Bureau

Werum ITSolutions and on/off group enter service partnership Werum customers to benefit from scalable and supplementary services during implementation of their PAS-X MES for DACH region and Europe WERUM IT Solutions has extended its range of services: The on/off group has been successfully certified as 'PAS-X Endorsed Service Partner' for the DACH region and Europe. This qualifies on/off to support pharma and biotech manufacturers during the implementation phase of Werum’s Manufacturing Execution System (MES) PAS-X at production sites all over Europe. The on/off group is a leading engineering service provider for process automation and information technologies with headquarters in Germany. “With the help of the on/off group, we can support our customers in Europe and especially in the DACH region even more effectively,” said Torsten Isenberg, Senior Director Services, Werum IT Solutions. “As PAS-X Endorsed Service Partner, on/off takes on typical, easily

(L-R) Torsten Isenberg, Senior Director Services, Werum IT Solutions and Björn Müller, MD, on/off it-solutions, closing the agreement

scalable implementation services such as master data parameterisation, MBR development, validation and on-

site go-live support.” “Through the combination of Werum IT Solutions' and on/off's expertise, our cus-

tomers will benefit from the long-term, complementary experience of both companies. This partnership is a

landmark and future-oriented decision for on/off as well as for Werum. We look forward to an exciting cooperation,” says Björn Müller, MD, on/off it-solutions. PAS-X Endorsed Service Partners meet all requirements of Werum IT Solutions' PAS-X service partner programme. The main objective of the programme is to offer the same quality and competence of services to Werum customers all over the world – through reliable, experienced and certified partners. The service partners need to have comprehensive PAS-X knowledge, participate at PAS-X trainings on a regular basis, possess experience in the regulated industries and use a quality management system. The certification has to be renewed on a regular basis. EP News Bureau

Dr Markus Wyss, CEO, Camag, Switzerland gives insight on HPTLC products Visits Ahmedabad and Chandigarh explaining the potential of HPTLC analysis, in every kind of organic analysis DR MARKUS WYSS, CEO, Camag, Switzerland recently visited India to speak about latest developments in High Performance Thin Layer Chromatography (HPTLC) products and methodology. He addressed analysts in Ahmedabad and Chandigarh explain-

ing the potential of HPTLC analysis, in every kind of organic analysis, using cannabis as an example. He commented that India has a lot of HPTLC equipment and the need of the hour is to perform HPTLC as per the USP’s SOP, which requires a

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change in methodology and not additional equipment. Three instruments were on demo-cum display. The patented 'TLC-MS interface' is an accessory to LCMS or GC-MS to record MS of HPTLC bands of interest. The patented 'Derivatiser' that re-

quires only 2ml of reagent for spraying on chromatographed HPTLC plates. Last but the most important from regulatory point of view, automated development chamber which offers a closed system with extremely controlled parameters for very reproducible results.

All the three instruments represent giant steps in HPTLC. Dr Wyss appreciated the use of instrumental TLC so widely used in India for research and quality control and happy that most will shift to HPTLC. EP News Bureau

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PHARMA ALLY

Honeywell to acquire industrial cyber security software leader Nextnine Broadens industrial cyber security offerings to meet increasing threat to industrial facilities and critical infrastructure HONEYWELL SIGNED a definitive agreement to purchase Nextnine, a privately held provider of security management solutions and technologies for industrial cyber security. The addition of Nextnine’s industry-leading security solutions and secure remote service capabilities will enhance the company’s existing range of innovative cyber security technologies and significantly increase Honeywell’s Connected Plant cyber security customer base. Nextnine’s flagship technology, ICS Shield, protects industrial sites from cyber security attacks and enables remote monitoring of assets. It complements Honeywell’s extensive cyber security portfolio with a solution that is used at more than 6,200 sites glob-

ally across the oil and gas, utility, chemical, mining and manufacturing sectors. Previously, ICS Shield had to be deployed separately for each control system vendor, resulting in multiple and separate installations at a single customer site. With this acquisition, customers will be able to deploy and operate a single system, thereby simplifying and better securing their entire site with Honeywell’s proven capability to provide multi-vendor solutions. Founded in 1998, Nextnine has been backed to date by Infinity VC, XT Hi-Tech and several other prominent investors. “Each day, the number of attempted cyber-attacks on industrial facilities and critical infrastructure around the world increases,” said Vimal Kapur, President, Honeywell

Process Solutions. “This acquisition shows our ongoing commitment to providing our customers with a comprehensive portfolio of cyber security solutions to protect and defend their industrial control systems and process control networks. Honeywell’s extensive global reach will increase Nextnine’s availability to a broader range of customers.” Nextnine’s security solutions also will be a key enabler of Honeywell Connected Plant, which combines Honeywell’s unmatched industrial expertise, software and digital technologies to make its customers’ operations more reliable, profitable and secure than ever before possible. Cyber security is a critical part of that programme. EP News Bureau

5th edition of India Chem Gujarat 2017 to be held in Gandhinagar The event to be held from September 21-22, 2017, aims to showcase the potential of the Indian chemicals sector and allied industry A CURTAIN raiser of ‘India Chem Gujarat 2017’, the 5th edition of the international exhibition and conference of the chemicals industry in India was presided over by Mansukh L Mandaviya, Minister of State for Road Transport & Highways, Shipping, Chemical & Fertilizers, Govt of India, in Mumbai in the presence of Samir Kumar Biswas, Joint Secretary, Chemicals, Dept of Chemicals & Petrochemicals, Ministry of Chemicals & Fertilizers, Govt of India. The biennial event, will be jointly organised by the Federation of Indian Chambers of Commerce and Industry (FICCI), Department of Chemicals and Fertilizers, Govt of India, Govt of Gujarat, and iNDEXTb. While speaking at the curtain raiser Mandaviya said, “Mandaviya added, “Make in India initiative will provide necessary support to companies for investment in the sector which is likely

to grow by 9 per cent p.a. to reach $226 billion by 2020.” With structured buyer-seller meet, 150 exhibitors and more than 7000 business visitors are expected to make their presence at the event. The endeavour is to bring out winning strategies for building and strengthening the awareness of emerging new application of specialty chemicals sector and allied industry and highlight the application technologies to enhance productivity. The event will witness the presence of industry CEOs, engineers, technocrats and scientists; marketing heads, purchase heads, professionals and consultants; policy makers and foreign commercials corps; head R&D, regulatory affairs and quality managers; industry associations and international trade delegations; manufactures, entrepreneurs, owners, end users etc. EP News Bureau

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PHARMA ALLY PRODUCTS

Gandhi Automations launches quality engineered rolling shutters GANDHI AUTOMATIONS, India’s well known entrance automation and loading bay equipment company, is the only manufacturer of rolling shutters and is ISO 9001 – 2008 certified. This has resulted in the implementation of continuous improvement in personnel training, production, inspection, equipment calibration, machinery maintenance, logistics and customer relations. The product engineering team uses the latest software combined with technologically advanced machinery to offer to the customer a well-engineered product. Over years of meticulously working on the design, fabrication and installation, Gandhi Automations has developed technical expertise in manufacturing various kinds of automated rolling shutters. The R&D team with

The rolling shutters are ideal for situations where side room is at a premium and security is required. They require little headroom above the structural opening To subscribe: bpd.subscription@expressindia.com

its extensive know-how and experience are able to produce specific types of rolling shutters unique to certain sites and client requirements. A consistent quality product has thus become the hallmark of Gandhi Automations' manufacturing process right through installation to after sales service. Gandhi Rolling Shutters are ideal for situations where side room is at a premium and security is required. The rolling shutters require very little headroom above the structural opening. They combine strength with elegance along with durability and are designed for both external and internal applications. The products are fabricated of interlocking galvanised insulated and non-insulated, stainless steel, patented aluminum or polycarbonate profiles and patented MS rolling grills. Each of the rolling shutters are designed to client specifications conforming to IS 6248 and solidly constructed to promote trouble-free operation and long life. Gandhi Rolling Shutters fit openings to a maximum width of 30,000 mm and height of 40,000 mm with an endless array of options to satisfy both aesthetic considerations as well as working requirement. Contact details Gandhi Automations Chawda Commercial Centre Link Road, Malad (W) Mumbai – 400064, India Off : +91 22 66720200 / 66720300(200 lines) Fax : +91 22 66720201 Email : sales@geapl.co.in Website: www.geapl.co.in

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PHARMA ALLY

Phenomenex expands Lux chiral LC/SFC column family PHENOMENEX, A global leader in the research and manufacture of advanced technologies for the separation sciences, has expanded its Lux chiral LC/SFC column family with new immobilised Lux 5μm i-Amylose-1 and Lux 3μm i-Amylose-1 media. During the manufacturing of Lux immobilised media, a chemical crosslinking is formed between the polysaccharide and silica support, resulting in a robust column that can withstand a wide range of strong solvents including DMSO, THF, Ethyl Acetate and DCM. This robustness allows for potential increases in enantioselectivity as new strong solvent systems can provide more mobile phase options during method development. It also allows scientists to keep samples dissolved

in strong solvents like DMSO/DCM. With the addition of the new Lux i-Amylose-1 and previously introduced i-Cellulose5 media, Phenomenex now offers two immobilised polysaccharide chiral stationary phases (CSP) in analytical and preparative formats.

These two robust chiral options combine with six Lux coated chiral stationary phases (Amylose-1, Amylose-2, Cellulose-1, Cellulose-2, Cellulose-3 and Cellulose-4) to deliver a wide and complementary range of enantioselectivity for even the most difficult chiral separation projects under nor-

mal-phase, reversed-phase, polar-organic or SFC separation modes. The new Lux 3μm i-Amylose-1 is ideal for LC/SFC analytical work and chiral screening, while the larger diameter Lux 5μm i-Amylose-1 can be used for analytical and purification work as it is available in pre-packed Phenomenex Axia preparative columns. Primary applications for this new phase include small molecule pharmaceuticals and their impurities as well as chiral pesticides in the environmental and agricultural markets. Phenomenex continues to expand its Lux chiral media offering, which now contains eight different Lux medias, to meet these needs. The company also offers free chiral screening services with greater than 90 per

cent success rates from its PhenoLogix application development group, along with over 2,000 chiral applications online that are easily searchable by compound structure or name at www.phenomenex.com/tools. Contact details Raj Kiran Ch Marcom Operations Specialist Phenomenex India Laxmi Cyber City, Ground Floor B Block, Survey no: 10 Kondapur, Hyderabad - 500 084 Tel: 040-3012 2400 Fax: 040-3012 2411 Email: Rajk@phenomenex.com Website: http://www.phenomenex.com

Camag introduces automated development in HPTLC MODERN INSTRUMENTAL quantitative analysis by HPTLC is popular these days. The products have the following characteristic features: They are visual chromatogram, simple, multiple sample handling in parallel, low analysis and maintenance costs, negligible sample clean - up, derivatisation, hyphenation with MS etc. However, the glass chamber with manual handling, a carry – over from TLC, resulted in the development of Achille’s heel. This is now a history with the availability of Camag, Switzerland, which has developed automatic development chamber – 2. It is a completely ‘closed’ development chamber. Automated Development Chamber ADC-2 from Camag, Switzerland retains the 20 x 10 cm twin trough glass chamber for development. This eliminates absolutely genius design eliminating the need to revalidate older methods. Moreover, the ADC-2 enables a control over the humidity content of

58 EXPRESS PHARMA July 1-15, 2017

the layer ensuring universal reproducibility of chromatographic conditions. The new regulatory HPTLC SOP ( effective August 2015) is optimally performed with help of this instrument. The SOP for using ADC – 2 is extremely simple. The plate (with samples applied) in ADC- 2 needs to be hanged and pre-loaded method recalled followed by pouring the mobile for saturation and for development and ultimately pressing the start button. After the audio signal, chromatographed and dried plate should be removed. HPTLC today is fully automated but in individual steps. Sample application as bands and evaluation by scanner or image visualiser are fully automated and well accepted to HPTLC. The ADC- 2 adds cGLP compliance to HPTLC. Contact details Anchrom Enterprises (I) 101, A Wing, Aniket Apartment, Navghar Road, Mulund (E),

Mumbai - 400 081, India. Tel.: 091 22 21639928 -

31/7506792122 Fax: 091 22 21639927

E-mail : hptlc@anchrom.in Web : www.anchrom.in

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HVAC System Modular Clean Room PUF/EPS WALL/CEILING Partitions-Thickness Range : 50-200 mm.

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Air Showers

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The leading air management solution provider... Airtech is a customized air solutions provider. Since its inception in 1992, Airtech has cultivated an in-depth understanding and expertise of executing turnkey HVAC & Clean Room Projects. Airtech undertakes complete project management comprisig of design, supply, installation & commissioning and validation of HVAC and Clean Room Systems. Airtech’s Clean Room system provides an ultra-clean environment ranging from Class 100 to Class 100000 with effective control of Air flow, Pressure, temperature, Relative humidity and Filteration suitable for Clan room applications. EXPERTS IN HVAC & CLEAN ROOM SOLUTIONS 502 & 503, 5th Floor, Satellite Silver, Andheri - Kurla Road, Marol Naka, Andheri (East), Mumbai – 400 059. Tel:+91 9322218023 / +91 9324644630 /+91 9699626434 /+912228592275 E-mail : sales@airtechsys.in, sunil.airtech@gmail.com • Website : www.airtechsys.in

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s which lidation service Airtech offers Va otocols pr PQ & , IQ, OQ comply with DQ ational rn te llowing In conforming to fo cts) : oje Pr ld Fie en re Standards (G

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LABORATORY EQUIPMENTS

OSMOMETER 3250

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Walk-in chamber

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REMI SALES & ENGINEERING LTD. 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

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

Wiper Type Sight Glass

DIN 100 Light Glass LED

Swastik Associates Shed No. 1, 2 & 3, Sr. No. 30/7, Behind Dran Company, Dhayari-Pune 411041 Phone : 020 24690268 / 24690041, 9923124949 / 9028716622, 9028716222 Email : sale1swastik@gmail.com swastikpune1@gmail.com

www.kesarcontrol.com

Our other product details

Humidity Chamber

Cold Chamber

SS Fittings

SS Valves Manual & Pneumatic

SS Filters

SS Pumps: Centrifugal, Self Priming & Shear Pump

SS Powder Blender

SS Steam & Water Mixing Station

Drain Trap

Manhole Round Dia 450

Sight Glass Flange with LED

LED Bush

4W / 15W / 20W / 24W

Manhole Pressure Type

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Service Network all over INDIA Mfg. Unit : B/8, Karma Industrial Estate, Nr. Trikampura Patiya, Vatva, Ahmedabad - 382445. Gujarat, INDIA. Tele : 079 - 25890727

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Sterile IPA & Related Product Autoclavable Spray Bottle u

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Autoclavable Spray Bottle For Sterile IPA/ Disinfectant By Harada / Furupla - Japan Improved Design For 70 Cycle Autoclaving All Component Are Heat Resistance & Autoclavable

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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