Express Pharma (Vol.13, No.11) April 1-15, 2018 by Indian Express

CONTENTS Vol.13 No.11 April 1-15, 2018 Chairman of the Board Viveck Goenka Sr Vice President-BPD Neil Viegas Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das, Mansha Gagneja, Swati Rana

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FAILURE OF THE ANTIMICROBIALS: A CRISIS AT THE DOOR-STEP

DR G RAMAKRISHNAN RECEIVES ISAS LIFETIME ACHIEVEMENT AWARD

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April 1-15, 2018

EDITOR’S NOTE

Yet another go at FDCs?

e seem to be slowly but surely moving towards the Centre’s goal of substituting branded medicines with generics. A Ministry of Health & Family Welfare notification dated March 13th mandates that the ‘proper name’ (read generic name) of the drug or fixed dose combination (FDC) drug needs to be printed at least two font sizes larger than the brand/trade name, or the brand/trade name should be written in brackets below or after the generic name. The notification also specifies that the brands can be substituted. The ruling is not applicable to FDCs of vitamins and FDCs containing three or more drugs. While it is true that there is no space on a medicine pack to print more than two or three generic names, isn’t this a loophole begging to be used? No doubt there are some FDCs which have proved their usefulness. Dr Nilima Kshirsagar, National Chair Clinical Pharmacology, ICMR, for instance points out that many anti-TB medicines contain more than three medicines. But could the exclusion indicate the regulator’s intention, over time, to weed out FDCs with more than three constituents? Replying in her personal capacity, Dr Kshirsagar is of the opinion that it would be very useful and important to also have information for patients to be put with the package. At present, the package insert contains information for prescribers. She is the chairperson of a sub committee appointed by the Drugs Technical Advisory Board (DTAB) to have a relook into these cases. As part of this review, a notice dated March 12 requested the All India Drugs Action Network (AIDAN) to revert with its recommendations by April 7, but this looks unlikely now, with the AIDAN asking for a month’s time to review the FDCs. This is understandable as the task involves gathering quite a lot of scientific data. The DTAB sub committee has specified that all information on composition/product details and its opinion on the therapeutic justification, safety, and efficacy for each ingredient of these FDCs should be part of the submission. All opinions have to be accompanied by a one page summary with supporting scientific evidence of a maximum of five relevant published articles. The submission needs to conclude with a recommendation if restriction or regulation instead of prohibition will be sufficient to control the manufacture and use of the FDCs under examination. Secondly, the AIDAN wants a reconstitution of the sub committee, saying that representatives of industry associations like the Indian Pharmaceutical Association and Indian Medical Association have a conflict of interest as many are affiliated to the pharma industry. Thus, while the wheels have been set into motion yet again, FDCs are too much part of

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While the wheels have been set into motion (yet again), FDCs are too much part of the pharma market in India to disappear with a single order

the pharma market in India to disappear with a single order. On a slightly more positive note, Dr Eswara Reddy’s first month as DCG(I) has seen not just the transfer of around 40 drug regulatory staff, but also a few key structural tweaks and outreach activities. The initiative to set up a public relation office (PRO) at the CDSCO headquarters at FDA Bhavan, New Delhi, headed by an assistant drug controller and supported by two drug inspectors, is a good move. As is the formation of the Indian Drug/Pharmaceuticals Association Forum, consisting of six industry bodies. Two high ranking representatives of each association will be invited each quarter for a discussion with the DCG(I) on issues related to CDSCO. While the list comprises Indian Pharmaceutical Alliance, Indian Drug Manufacturers Association, Bulk Drug Manufacturers Association, Federation of Pharma Enterpreneurs, Confederation of Indian Pharmaceutical Industry and Laghu Bhartiya Udyog (representing MSME pharma companies), the Organisation of Pharmaceutical Producers of India (OPPI), comprising the India-based subsidiaries of MNCs, is not part of this list. Maybe CDSCO felt that members of these six associations faced different issues and therefore intends to have separate meetings with OPPI. Kanchana TK, Director General, OPPI confirmed that they ‘have registered our disappointment with the relevant Ministries for not being included in the list of Associations identified for the constitution of Indian Drug/Pharmaceuticals Association Forum and have requested for a modified Office Order.’ But perhaps the most welcome step, with immediate benefits for pharma exporters, is the waiver of the no-objection certificate (NOC) in the shipping bills required at CDSCO’s port offices. The waiver is only for shipping bills filed by manufacturers with valid licenses and requires a copy of the license to be included in the export documents. While the NOC for pharma exports to major markets like the US, Canada, Japan, Australia and the EU was waived a couple of years back, the March 21 notification extends it to all other countries. This should go a long way towards easing India’s pharma exports. The safeguard to restrict the waiver to manufacturers is understandable given the concerns about quality. All these measures take forward the steps put in motion by the previous DCG(I), Dr GN Singh, to streamline processes in line with Prime Minister Modi’s mantra to increase the ease of doing business. There are good signs that this tempo will be maintained and we wish Dr Reddy all the best.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET I N T E R V I E W

Manufacturing of med tech products exclusively must be incentivised Analysing India's Medical Devices Rules which kicked in this January, Sundeep Shrivastava, Senior Director, Clinical Operations, Asia Pacific Medical Devices, IQVIA INDIA, tells Viveka Roychowdhury that we need an exclusive medical device sector policy, incentivised manufacturing of med tech products and more relaxed import duties on high risk product segments that still have a manufacturing lag in India India’s Medical Devices Rules have kicked in from January 2018. Are they at par with global regulations and do they give leeway to India's own socio-economic health requirements? India’s Medical Devices Rules are framed in line with the guidelines of the Global Harmonization Task force with salient features like clear mention of quality management systems; riskbased device classification, essential principles for safety and performance of medical devices in compliance with or at par with global regulations. Their implementation will provide the Indian medical device industry — both R&D and commercialisation — a boost and a level playing ground in the $390 billion global device market growing ~5 per cent annually. Have the Indian government and policy makers done enough to create an ecosystem conducive to innovative, affordable and quality medical devices? While we see a lot of innovations and high opportunity in India and device therapy looks promising, we need to evolve towards therapies that are more affordable and will allow a better quality of life and improved survival. There are many Indian companies who have excelled in developing world class devices and are recognised internationally

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as well. The Indian medical device industry in still in its nascence but the consultative and collaborative approach by the Government of India augurs well for the development of a conducive ecosystem for the industry. This is evidenced in what we are seeing around us with 100 per cent FDI permitted through the automatic route, academic researchers investing in tailored, affordable solutions for the Indian market, and incubation centres being set up to encourage research and innovation. Medical devices players will need to build collaborative relationships with key local and global stakeholders to ensure development and commercialisation strategies align with regulations, and market need and demands. What are the challenges that still exist and require policy

reform? India needs an exclusive medical device sector policy which covers all aspects and segments of the sector. We need to identify and prioritise specific medical devices to work on in collaboration with all the relevant stakeholders, including the regulators, industry and patient groups. ◗ The Medical Devices Rules which have been implemented from January 1, 2018 are still within the ambit of the Drugs and Cosmetics Act and there is a need for a separate set of rules for Medical Devices. ◗ Manufacturing of Med Tech products exclusively must be incentivised. “Cluster” status and benefits must be accorded to existing med tech manufacturing hubs in parallel with building new medical technology parks. ◗ For high-risk product segments that still have a manufacturing lag in India, a more relaxed approach should be adopted on import duties so that patients can benefit. Has India's indigenous medical devices industry invested enough in medical device research and innovation? Do we see enough alternatives to imported medical devices to support the Prime Minister's Make in India programme? The government’s initiatives to promote the medical devices sector are a step forward in making Make in India a reality

FOCALAREAS FOR MED DEVICE EXPORTS TO THE EU

for the sector. However, it will take time for the ecosystem to develop and for us to see a Make in India for medical devices that embraces both manufacturing and R&D. There will be a slow transition where indigenous and imports devices will have to be carefully balanced to meet the needs of the patient population. Policy makers recently changed the definition of medical devices to encourage FDI, in the hopes that global medical devices players would invest in manufacturing facilities in India. Will this work? This is a very positive move. Additionally, the implementation of the Medical Device Rules which makes India at par with other nations will boost FDI. Your views on the recently announced National Health Protection Scheme, i.e. Modicare announced as part of the Budget. Where are the challenges/gaps and how can they be resolved? What will it take in terms of resources (funding, manpower) to make this a viable plan? While this is a great initiative by the Government of India and a positive for the devices industry with the Government also becoming a large consumer/buyer in India, it is too premature to comment on the details. viveka.r@expressindia.com

Caroline Freeman, Principal Consultant, Consulting Services, IQVIA highlights four inter-linked focal areas that Indian device players looking to the EU regulated market should focus on

a) Good quality, wellordered technical documentation which demonstrates the safety profile of the device evidencing the compliance of the device with established international standards b) Robust clinical data to support the safety and performance of their devices. The Clinical Evaluation Report is a key element in technical documentation. c) Compliance with the ISO 13485:2016 quality system standard to show that high quality devices can be manufactured consistently. d) Thorough ongoing postmarket surveillance systems, including vigilance, to collect information from the use of the devices in the field.

I N T E R V I E W

â&#x20AC;&#x2DC;We are transforming business processes for the next phase of growthâ&#x20AC;&#x2122; After a stint lasting almost 25 years at Pepsico, Kanish Malik, President Operations, Glenmark Pharmaceuticals, joined Glenmark Pharma in August 2015. In an interaction with Usha Sharma, he talks about the demands and challenges of his role, corporate plans, other business mechanisms Before you joined Glenmark Pharma, you had a long innings with PepsiCo. What was your role during your tenure with PepsiCo? I joined PepsiCo in 1989 as a part of the start-up team.

Over the years, I had multiple assignments and roles within India and international business of PepsiCo, with the most recent being VicePresident Operations for Power of One (Po1), India

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Region. Prior to this, I was leading technical operations for North and South Asia business based out of Bangkok, Thailand. What made you switch from

FMCG to the pharma sector? Do you find any similarities between the sectors? PepsiCo is a great company to work for, where there is never a dull moment and my stint of almost 25 years at PepsiCo

was an exciting journey. Having done multiple leadership assignments across India and Asia Pacific Region, there was an urge to do something different while still staying connected to mass

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MARKET consumers. Pharma is another sector where one gets an opportunity to make a difference to the life of people through reliable and quality products and where product safety is paramount. The process rigour that goes behind development and manufacturing of products is non-negotiable. While every sector has its own nuances, there are subtle similarities between the two sectors. Both are regulated in their own ways by regulatory agencies and, specifically for generics businesses, which are getting commoditised, the lines are blurring on service expectations. Additionally, back-end investments are tied to product development and rigour behind process controls and quality standards is very similar even though some elements may be far more stringent for the pharma sector. You joined Glenmark in August 2015. How has the journey been so far? It has been a very exciting journey so far as we are transforming the business and its processes for the next phase of growth. With Glenn’s vision to move the business from ‘generics only’ to a balanced portfolio, including innovation drugs, adds a very different and exciting dimension to this journey. In Glenmark, you are overseeing the operations of 17 manufacturing facilities spread across four continents along with the global supply chain. Explain the challenges of this diverse role. Finding a time slot to get the entire team, across multiple time zones, on the same call is the most challenging part of the job! On a serious note, given the diversity of cultures, languages etc. one of the challenges of the role is to ensure that communication across teams is simple and sharp with no possibility of misinterpretation. Our markets are very diverse and at different levels of evolution. Hence, as a global function servicing these markets, it is extremely

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important to fully understand their needs and challenges. Fundamentally, regulations across all geographies to a great extent are similar i.e focussed on patient safety, which our internal processes are totally aligned to deliver. However, each market we service has its own specific need for documentation and lead time. Therefore, our back end supply function needs to be extremely nimble-footed, not only to plan for the future but also to be flexible to respond to changes in regulations or market requirements, if any. What are the factors obstructing growth of the Indian pharma industry? What are your recommendations to deal with them? Firstly, from pricing pressures driven by acute competition to enhanced expectations on patient safety - every pharma manufacturer is being tested, not only for the depth of technical understanding of their products but also for quality of infrastructure and robustness of process to ensure that they consistently deliver safe and affordable products to the consumer. Manufacturers are expected to have full control of the supply chain, all the way from sourcing of material to the endconsumer, so that these standards may be adequately implemented. In the interest of patient safety, governing bodies have been adopting clear expectations for risk assessment and quality standards that are processorientated, rather than just result-orientated. Therefore, solutions that utilise pure mechanisations or simple automations need a second look. Moreover, the challenges of running a complex, 24x7 process have redefined the meaning of ‘self-governance.’ Secondly, service expectation lines are blurring between pharma and other consumer industries, calling for value engineering and supply chain optimisation to enable faster response times. Any slip in meeting these expectations of supply reliability, cost efficiency and regulatory

discipline to walk them and deliver quality medicines with affordability built in. By definition, a generic has to be a copy of an innovation with proof of equivalence. However, any incremental innovation that helps compliance by the patient and makes his/her life easier is also an area that we continuously look at. As an example, it can be a novel way to drug delivery. Or, it may be making devices ergonomic to add to patient’s convenience etc. Few examples where we have been able to innovate – Digihaler, a device that indicates number of doses left, enabling patients to plan better, pocket nebuliser — a small version of nebuliser which is easy to carry, and many more.

From pricing pressures driven by acute competition to enhanced expectations on patient safety every pharma manufacturer is being tested to ensure that they deliver safe and affordable products compliance will be detrimental to the industry. How do you plan to encourage innovations in generics? In the generics space, business sustainability heavily depends on the ability to provide affordable solutions. Building affordability in a process calls for innovation, demanding continuous focus on productivity and efficiency to stay on the top. It takes a keen eye to find opportunities in the existing processes and a

What are your plans for the Indian market and how do you plan to execute it? Our primary objective has always been to strengthen our base in generics and create a roadmap for the company's evolution from a generics organisation to a fully integrated, globally commercialised, pharma company with innovative products. Glenmark has focussed on a long-term growth strategy while meeting the short-term growth objectives. As part of our strategy we have balanced our investment in various R&D projects (innovative and speciality) which have a very long gestation period. Apart from large investments, innovation demands, focus, persistence, and conviction as the business is fraught with many failures before a tiny drop of success is tasted, but it is the future we must build. At the same time, given the intense competition in generics space, it needs equal share of our focus. Apart from regular generic business, we have seven novel drugs and three specialty drugs in our research and development pipeline. And with our end-to-end capabilities from R&D to full-scale manufacturing (both in small molecules and novel biologics), we command a strong position

in IP leadership and global footprint for rapid market penetration. These intellectual assets are already producing results for us and we expect to launch speciality business in the US with our first FDA NDA approval in respiratory within three to five years. And on the domestic side, we are one of the fastest growing companies in India pharma market. Particularly in the last few years, we have had strong growth across derma, respiratory and cardio metabolic segments. Also, recently, we launched four key products in India. We introduced Nourkrin Women under an exclusive licensing agreement with Pharma Medico. Nourkrin Woman is a globally renowned, clinicallyproven proteoglycan replacement formula that normalises hair growth cycle in women. Second, Apremilast the breakthrough oral drug for the management of Psoriasis. Apremilast is a phosphodiesterase 4 (PDE4) inhibitor indicated for the treatment of moderate to severe Psoriasis and it is the first advanced oral systemic treatment for Psoriasis in India. Third, Kwitz, a nicotine replacement therapy (NRT) that helps reduce craving to smoke over three months. And, biosimilar of Adalimumab, launched under the brand name ADALY, indicated for the treatment of plaque psoriasis and rheumatoid arthritis. We presently have eight brands in the top 300 brands in the India pharma market and through innovation, we continue to strengthen our market share. As per IMS, between the period, MAT (Moving Annual Total) December 2016 to MAT December 2017, the cardiac segment market share increased to 4.22 per cent from 3.96 per cent; the respiratory segment market share rose from 4.68 per cent to 4.38per cent; and in the derma segment we have been able to maintain our leadership. We will continue to focus on these segments and have plans to launch a number of products. u.sharma@expressindia.com

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April 1-15, 2018

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MARKET Pharmaceutical Association, Gujarat State Branch and Partner, Apostle Remedies, Vadodara was the moderator for the session. The panelists who took part in the discussion were Jitendra Kumar Jain, AVP Quality, Amneal Pharmaceuticals; Dr Arvind Kukrety, Deputy Drugs Controller (I) Zonal Office, Ahmedabad; Dr Viranchi Shah, Chairman, Indian Drugs Manufacturers' Association, Gujarat and Chairman, Saga Laboratories; Dr HG Koshia, Commissioner, FDCA Gujarat; Gaurang Oza, Chief mentor and CEO, Vaibhav Analytical Services; Dr Anoop Kumar, Market Development Manager (L-R) Jitendra Kumar Jain, Dr Arvind Kukrety, Dr Viranchi Shah, Dr Jayant B Dave, Dr HG Koshia, Gaurang Oza, Dr Anoop Kumar, SG Belapure and Ramanuj Samal

Panelists look at different strategies to implement and ensure GMP practices in pharma facilities â&#x20AC;&#x201D; Pharma, Sciex, SG Belapure, MD, Zydus Hospira Oncology and Ramanuj Samal, Application Scientist, Beckman Coulter. In the opening remarks, Dr Dave highlighted that impurity tests and specifications as important determinants of product quality and GMP as a tool to evolve and maintain quality specifications. He briefly dwelt on scientific and regulatory importance of the same. Jitendra Kumar Jain talked about meeting the newer challenges in elemental impurities tests in view of newer specifications in USP. Gaurang Oza discussed issues related to practical problems faced by analysts in view of very unrealistic specifications of impurities. However, Ramanuj Samal mentioned that impurities at times also become triggers for development of new drug molecules. Dr Arvind Kukrety gave an in depth account of regulatory

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Dr HG Koshia

Ramanuj Samal

Dr Amitav Mohanty

Dr Anoop Kumar

MARKET norms in the country based on Impurities General Chapter in IP, Drug & Cosmetic Act, Sch V, Sch Y etc. He also conveyed that any new drug as defined in Drug & Cosmetic Rules has to meet with all quality and safety requirements including General Chapters on Impurities. Dr Anoop Kumar presented a technical account of mass spectrometry hyphenated techniques for enabling quantitative estimation of impurities at reporting threshold and characterisation at identification threshold. Dr Viranchi Shah talked about difficulties faced during dossier submission while securing product registration for exports and practical issues during manufacture to check the impurities. SG Belapure conveyed that the goal should be to establish as stringent standards as possible for impurities so that products can meet with expectations of several regulators; the specifications should be reviewed and revised from time to time based on product and process understanding. Dr HG Koshia, giving an idea about process impurities and degradation products, gave a brief account of the mechanism evolved by FDCA Gujarat, to constantly review the quality of products in the market and bring to light Not of Standard Quality products and remove them from distribution as a public health measure. In his concluding remarks, Dave said, “Much attention needs to be given to inner purity of one’s own self as we pay to the purity of molecules. Good science blended with ethics constitute a respected profession.” A presentation by Ramanuj Samal on 'Reducing the risk of product recall at reduced cost of ownership followed the panel discussion. The event concluded with a vote of thanks by Neeraj Khurana, Head Marketing, Beckman Coulter. The delegates also got an opportunity to interact with their peers at the networking dinner that followed the event. EP News Bureau

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IPM clocks ` 120788 cr in Feb 2018 Indian companies maintained their dominance in the IPM with a share of 79 per cent and grew combined at a strong 11 per cent growth rate THE INDIAN Pharmaceutical Market (IPM) clocked ` 120788 crores and grew at 6.3 per cent as of MAT February 2018 and was valued at ` 9992 crores for the month of February. The retail sector was valued at ` 102188 crores and showed a growth of 7.0 per cent. The growth for IPM was 10 per cent. Top 10 companies showed a double digit growth of 11 per cent over SPLY and clocked a combined revenue of ` 4319 crores with their share slight decreasing and coming down to 43 per cent in the IPM.

20 EXPRESS PHARMA April 1-15, 2018

Rank 4-7 set of top 10 companies grew in double digits with Mankind (21 per cent), Alkem (16 per cent), Macleods (14 per cent) and Lupin (11 per cent) being amongst companies with strong growths. Companies in 11-20 bracket grew even better at 13 per cent combined where Aristo (19 per cent) and Glenmark (13 per cent) were among the fastest growing companies. Top 10 brands in the IPM were valued at ` 322 crores combined and showed a growth of 9 per cent which

was slightly lesser than the IPM. 7 of the top 10 brands showed double digit growth with Clavam (26 per cent) and Thyronorm (23 per cent) leading the way for the month of February 2018. Only Novomix (-21 per cent) showed de-growth among top 10 brands. Brands ranked 1120 grew strongly at 18 per cent combined growth where Panderm+ (56 per cent) and Monocef (36 per cent) were amongst the fastest growing. These brands were valued at ` 231 crore for the month. Indian companies main-

tained their dominance in the IPM with a share of 79 per cent and grew combined at a strong 11 per cent growth rate. MNCs on the other hand continued to grow at single digits with a growth of 7 per cent and share of 21 per cent in the IPM. Five of the top 10 Indian companies registered a strong double digit growths. No. 1 Indian company Sun grew at 6 per cent while Mankind (21 per cent) was the fastest growing Indian company followed by Alkem (16 per cent) and Macleods (14 per cent). The top MNC Ab-

bott showed a strong growth of 9 per cent over SPLY. None of the top 10 MNCs showed double digit growth. Acute therapy with a growth of 11 per cent for the month of February â&#x20AC;&#x2122;18 continued its trend of last few months of growing better than chronic therapy which grew at 8 per cent. Acute therapy also increased its share by 1 per cent to 65 per cent in IPM as compared to Chronic coming down to 35 per cent share. Anti-infectives (16 per cent), Derma (10 per cent) and Respiratory (23

MARKET per cent) continued to be the growth driver for Acute Therapy. Comparatively subdued growths were registered by the top therapies cardiac (7 per cent) and antidiabetes (8 per cent) in chronic. Anti-infective therapy was valued at ` 1253 crores with a strong growth of 16 per cent. All of the Top 10 molecules grew in double digits with Amikacin (31 per cent), Cefpodoxime Solids (29 per cent) and Ceftriaxone Injectables (28 per cent) showing the fastest growths. Top molecule Amoxycillin and Clavulanic Acid Solids also showed a strong 21 per cent growth. Nine of the top 10 brands showed a strong double digit growth with the No. 1 brand Augmentin growing at 14 per cent over SPLY. Other Top 10 brands which showed a strong growth are Monocef (36 per cent), Moxikind-CV (31 per cent) Azithral (38 per cent) and Mikacin (51 per cent). Cardiac therapy continued to be the second largest therapy in IPM clocking a revenue of ` 1179 crores and a growth of 7 per cent on SPLY. While the top molecule Rosuvastatin (6 per cent) showed a decent growth, the No.2 molecule Atorvastatin (0 per cent) displayed no growth over SPLY. On the other hand molecules like Amlodipine + Telmisartan (11 per cent), Enoxaparin (13 per cent) and Cilnidipine (18 per cent) were those top 10 molecules which registered strong growths. Combinations (10 per cent) continued to show a better growth as compared to Plain molecules (6 per cent). While 7 of the Top 10 brands showed strong double digit growths with Cilacar (24 per cent) and Dytor (22 per cent) growing more than 20 per cent, brands like Nikoran (-14 per cent) continued to de-grow. Top brand Rosuvas grew at 5 per cent. Gastro intestinal therapy maintained its No. 3 rank in IPM with a value of ` 1032 crores for the month and a growth of 8 per cent which was slightly slower than the IPM. Only three of the top 10 molecules in the therapy reg-

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Anti-infective therapy was valued at ` 1253 crores with a strong growth of 16 per cent.Cardiac therapy continued to be the second largest therapy in IPM clocking a revenue of ` 1179 crores and a growth of 7 per cent on SPLY

istered a double digit growth with Oral Electrolytes (21 per cent) topping the chart in terms of growth. Ranitidine Oral Solids (-1 per cent) was the only molecule among top 10 to register degrowth. The top 2 molecules Pantoprazole + Domperidome (65 crores) and Rabeprazole + Domepridome (56 crores)

MARKET continued to growth at a slower pace of 3 per cent and 2 per cent respectively. Among top 25 molecules Bacillus Clausiiâ&#x20AC;&#x2122;s growths remained strong at 35 per cent whereas Esomeprazole + Domperidome also grew strog at 22 per cent. All the top 3 brands showed a strong double digit growth with No. 1 brand Spasmo-Proxyvon+ growing at 11 per cent while the newly crowned No.2 brand Electral showed a strong 22 per cent growth over SPLY. On the other hand PAN-D (-5 per cent) showed a negative growth for the month of February 2018. Anti-diabetics for the first time in many months lost its fourth positon to respiratory and moved one position down to become the fifth largest therapy in the IPM for the month of February 2018 clocking a revenue of ` 913 crores for the month with a growth of 8 per cent. While all the top 10 molecules grew positively, the No.1 molecule Glimepiride + Metformin showed a subdued growth of 3 per cent over SPLY. SGLT2 inhibitors however continued their progress clocking a growth of 49 per cent over SPLY. In DPP4 inhibitors molecules like Metformin + Sitagliptin (14 per cent) and Metformin + Teneligliptin (59 per cent) continued to grow strongly whereas Metformin + Vildagliptin (3 per cent) and Vildagliptin (-5 per cent) could not show a strong performance. Only 4 of the top 10 brands grew in double digits where Lantus (18 per cent), Janumet (13 per cent), Jalra (18 per cent) and Istamet (16 per cent) grew strongly. However 2 of the top 10 brands Novomix (-21 per cent) and Galvus (-3 per cent) also showed de-growth. Dermatology registered ` 728 crores of revenue with a growth of 10 per cent for the month of February 2018. This was a much slower growth registered by the therapy as compared to previous few months. Six of the top 10 molecules grew in double digits while the top category Emollients Protectives growing at 13 per cent for the month. The

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Antifungal category continued its progress with both top molecules Itraconazole (42 per cent) and Luliconazole (97 per cent) growing strongly. Also Clobetasole +

Ofloxacin + Ornidazole + Terbinafine with a growth of 49 per cent was another molecule which showed strong performance. Panderm+ continued to retain its top posi-

tion and grew at 56 per cent with the No.2 brand Betnovate-N also showing a strong growth of 17 per cent. Betadine (-2 per cent) and Skinlite (-3 per cent) were the only 2

brands among top 10 to show de-growth. Candiforce (37 per cent), T-Bact (17 per cent) and Lulifin (26 per cent) were some other brands among top 10 to perform strongly.

cover ) Three slalwarts, Ajit Singh & Jasjit Singh from ACG as well as Kairus Dadachanji from Schott Kaisha were honoured at PPL Conclave 2018 with citations for their tremendous contribution towards the pharma industry â&#x20AC;&#x2DC;s progress

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WHERE PACKAGING LEADERS MET... The thoughtleadership platform for packaging leaders witnessed meaningful dialogues and discourses on the current and future trends in the pharma packaging industry, as well as the growth drivers and challenges EXCLUSIVE COVERAGE

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April 1-15, 2018

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DAY 1 (15-3-2018)

INAUGURALCEREMONY

PPL CONCLAVE 2018 Welcome Address Lamp lighting ceremony Unveiling of PPL Leaders Handbook Keynote Address: Driving progress in pharma packaging Special Address: Pivotal role of pharma packaging High-speed integrated packaging line with 21 CFIR/EBMR PANEL DISCUSSION: Fostering an ecosystem for pharma packaging innovation Tea/Coffee Break Packaging solutions for generic injectables to regulated markets PANEL DISCUSSION: Putting India on the global map: Pharma packaging and labelling trends in the next decade Collaboration: Key to accelerated growth in pharma packaging PPL LEADERSHIP AWARDS NITE Welcome Address Address by Chief Guest Introduction to PPL Leadership Awards Presentation of Awards Vote of Thanks

26 EXPRESS PHARMA April 1-15, 2018

An auspicious beginning to PPL Conclave 2018 with a lamp lighting ceremony. Ajit Singh, Chairman, ACG, lights the lamp alongwith (from L-R) Alagu Subramaniam AR, MD, West Pharmaceutical Packaging India; Gautama Buddha, Packaging Consultant & Guest Faculty, IIP; Chakravarthi AVPS, Ambassador, World Packaging Organisation and Viveka Roychowdhury, Editor, Express Pharma

Usha Sharma, Principal Correspondent, Express Pharma welcomes all delegates at PPL Conclave 2018

he first edition of PPL Conclave kickstarted on an auspicious note with the ceremonial lamp lighting ceremony. Usha Sharma, Principal Correspondent, Express Pharma gave the Welcome Address. Speaking to the august audience, she said, “This event is an initiative to bring the leaders and experts of pharma packaging industry to discuss the trends, opportunities and challenges in this sector. It also aims to highlight the growing role of packaging

in ensuring quality, sustainability and regulatory compliance for pharma products. As a leading industry publication, we, Express Pharma also want to honour the innovators and game-changers of this sector.” She added, “We hope that the learnings gathered over the next two days, as we address crucial issues in pharma packaging and labelling, will help in fostering an ecosystem for pharma packaging innovation.”

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Launch of PPLLeaders Handbook

fter the lamp lighting ceremony, the dignitaries also unveiled the PPL Leadership Handbook. It features top leaders and game changers in pharma packaging, thereby ushering growth and excellence in this industry and partnering India Pharma Inc’s progress. The book provides valuable insights on the trends, opportunities and challenges in this fast evolving and rapidly growing sphere. It also highlights and acknowledges the pivotal role of packaging in pharma, be it ensuring highest drug quality and safety, enabling patient adherence or tackling counterfeiting. It is an endeavour to recognise the significant contributions of packaging heads within pharma organisations in making their companies and their products strong and credible brands.

(L-R) Alagu Subramaniam AR, MD, West Pharmaceutical Packaging India; Gautama Buddha, Packaging Consultant & Guest Faculty, IIP; Ajit Singh, Chairman, ACG; Chakravarthi AVPS, Ambassador, World Packaging Organisation; SM Mudda, Director – Global Strategy (Technical) Micro Labs and Viveka Roychowdhury, Editor, Express Pharma

KEYNOTE ADDRESS: Driving progress in pharma packaging

n a hardhitting keynote address, Ajit Singh, Chairman, ACG gave an overview of the packaging industry. Highlighting various concerns in the path of the sector’s progress, he said, “It's really disturbing that hardly 1.2 per cent of our GDP is contributed by the government towards healthcare in general which includes medical and packaging. This 1.2 percent is spread among a huge number of people, the amount per head is hardly noticeable.” In his opinion, we have a healthcare system, which is neither healthy, nor caring, or a system. He raised very pertinent questions such as; ‘Can we be happy with the state affairs and the progress in healthcare, especially for medicine and pharma packaging?’ He also op-

Key takeaways ◗ A consortia of industry stakholders should be set-up to prepare white papers and persuade the government to make policies conducive for the growth of the industry ◗ Packaging should be sustainable, cost-effective, innovative and user friendly ◗ Improve safety in medicine by including track and trace elements in the packaging

Ajit Singh, Chairman, ACG

posed government’s price control measures in packaging. Further he gave a call to the industry to collbaorate and put forth thier recommendations and views to drive policy

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decisions. He said, “It is our job to help the government to get their priorities in order and then to ensure that they follow up with those priorities. Where is the representation that

we should be making to the government? By what means we are influencing the drugs technical advisory board, or the ministry of health, or the ministry of pharmaceuticals. There are individuals prepared to listen to us, but do we know who they are? Why are we not initiating parliamentary questions on such questions?” He also touched upon the subject of falsified medicines and ways to tackle this menace through effective packaging.

He pointed out that often cigarette packaging is superior to those of medicines and drugs. He also rooted for technology adoption for safety and quality. Concluding his address, he said, “In the last few years there have been tremendous progress in this area little in packaging material, little less in packaging machinery, but far more needs to be done and we are the people who need to do it.”

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cover ) Special Address: Pivotal Role of Pharma Packaging

e commenced his address by lauding Express Pharma for launching PPL Conclave. It called the right platform for leading pharma packaging professionals to congregate and discuss on issues crucial for the industry. He also predicted a very good future for the pharma industry despite the manifold challenges. Moving on to pharma packaging, he said that as the final contact between a drug and the users is packaging and hence, it has a very important role to play. He stressed that pharma packaging needs to be more patient-centric and asked the industry to adopt innovation to improve user convenience and patient-adherence. Acknowledging the challenges faced by

Key takeaways ◗ Pharma packaging needs to constantly evolve to remain relevant and and competitive ◗ Pharma packaging should balance user convenience with regulatory compliance ◗ The need of the hour is to develop and deliver innovative and tailor-made solutions to suit different requirements

Chakravarthi AVPS, Ambassador, World Packaging Organisation

packaging professionals, he admitted that they have the tall task of balancing cost, user preferences and regulatory norms.

Chakravarthi also spoke on how pharma packaging players should evolve with advances in the life sciences industry to remain competitive and stay

relevant. He elaborated on the various trends which are driving the industry and expounded on how different types of packaging have changed over time to suit the transformations in the pharma industry. He encouraged the pharma packaging industry to develop and deliver innovative solutions through R&D. Divulging that more people lose their lives due to counterfeit drugs than

terrorism, he pointed out the very pivotal role that packaging plays in fighting counterfeiting, a major menace. Changing demographics and serving the needs of different population are also a challenge that packaging should tackle. He ended with a message for pharma packaging professionals that they should be very proud of their work as they cover the globe's health!

High-speed integrated packaging line with 21 CFIR/EBMR

unil Nirmale, GM, ACG Engineering, in his technical topic, ‘Highspeed integrated packaging line with 21 CFIR/EBMR’, highlighted the needs of pharma packaging sector. He also highlighted different aspects such as the need for a high speed blister machine; fully integrated packaging lines; reduction in packaging cost; latest technology at competitive price; prompt and reliable service and support etc. Speaking on Blister X + Karton X, a product from ACG, he expounded on its salient features. He informed that the product has robotic transfer system and other suitable transfer systems to deal with high capacity and fast production. The product also has a single HMI for the complete line, and offers easy and quick access through tabs/phone as an option.

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There are various things that makes a machine, a high speed machine. Major features like large size roll; large format size, high speed feed rate, high sealing cycle; high speed punching as well as pick and place are a must

Sunil Nirmale, GM, ACG Engineering

He further explained the features of a high speed cartoning machine and the ways to make a high speed blister machine. Nirmale also touched on another important requirement of a high speed machine, and the

21 CFR PART 11 (title 21 of Food and Drugs, CFR-Code of Federal Regulations and part 11-electronic records; electronic signatures). He said, “The intended objective of part 11 is batch manufacturing records, standard operating procedure,

method of analysis, deviation and change control and stability studies, qualification of equipment, instrument and water system and process validation has been maintained by the company on paper in order to comply with FDA's cGMP.” The benefit to the user of the product is speed, audit ability and accountability; data

guarantee; traceability; online history; authenticity, data integrity, confidentiality of records; ease of keeping records, paperless with automation; fast information search with advanced searching capabilities; reduces the cost of record keeping, storage space; built in system for authentic report and signatures.

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Packaging solutions for generic injectables to regulated markets

lagu Subramaniam AR, MD, West Pharmaceutical Packaging India, spoke on ‘Packaging solutions for generic injectables to regulated markets’. In his presentation, he gave an overview on hi company’s offerings for the generic injectable markets globally such as the AceelTRA programme. He also spoke on West’s role in delivering medicines to patients for the last 90 years through its products like stoppers, seals, caps, syringe components, Daikyo CZ vials and syringes, reconstitution systems and self-injection devices. He also informed that the largest country consuming generic injectables is China. Its share of consumption amounts to 31 per cent of the total market. Next is North America with 19 per cent and then India

57 per cent is made up of generic injectables. The global market is growing for the past five years at a CAGR of 3.5 per cent

Alagu Subramaniam AR, Managing Director, West Pharmaceutical Packaging India

at around 10 per cent. Asia is 6 per cent, Western Europe is 11 per cent and rest of the world comprises 24 per cent of the injectables volume. He informed, “When we

look at the percentage of injectables, 57 per cent is made up of generic injectables. The global market is growing for the past five years at a compounded annual growth rate

of 3.5 per cent.” He also briefed the audience on the challenges and opportunities in injectables and on the impact of guidelines and regulations such as GDUFA I and GDUFAI II on the industry. He went on to elaborate about AccelTRA, reportedly the world's first generic rubber formulation and its uses. He also gave a rundown on the salient features of the product i.e speed, quality and

simplicity. With reference to its quality, he said that it meets the requirements of Global Compendia; it is available with Type V DMF; is Low Particulate and has Multi Puncture Design capability. The optimised lead times taken is one week trial and six weeks for commercial quantities. He also claimed that it is the single, next generation formulation 4031 which is globally available.

Collaboration: Keyto accelerated growth in pharma packaging

ohan Joshi, International Business Coach for Sales & Leadership was one of the speakers at the inaugural edition of PPL Conclave. In a very interesting and engaging session, he explored and examined the role and importance of purposeful partnerships in enabling growth for packaging professionals and organisations. He highlighted that the pharma industry has very acute specifications that need to be fulfilled to the last detail and hence, and hence a lot of hand-holding is involved, especially in packaging. He used existing, successful examples of partnerships which have enabled progress for the organisations involved and the industry as a whole. He present the case of the

The pharma industry has very acute specifications that need to be fulfilled to the last detail and hence a lot of hand-holding is involved, especially in packaging

Mohan Joshi, International Business Coach for Sales & Leadership

Matrix Alliance, a collaboration between pharma packaging leaders to help manufacturers speed breakthrough treatments to the market to state his point. SCHOTT AG, Vanrx and ARaymondlife are

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part of this alliance. Another of his examples was the partnership between Merck and Pfizer as well as the latter’s collaboration with Corning to modernise pharma glass packaging. He

also presented ACG's MoU with Applied DNA Sciences as a collaboration which is helping to thwart counterfeits through capsule authentication and traceability technology. He also pointed out that partnerships is key to creating strong and effective supply chain systems. He ended his session with a reiteration that collabora-

tion is the fuel and catalyst for continuous efficiency and for improving business results. Advocating that it is more fruitful and effective than competition as it yields better results, his advice to the pharma sector was to encourage collaboration and cooperation between employees and stakeholders to foster innovation and achieve business benefits.

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cover ) Fostering an ecosystem for pharma packaging innovation

(L-R) Prabir Das, VP – Packaging Development, Head, Pkgg. Tech. Services (OSD) – Mylan India; R Chandi Prasad, GM-Packaging Development, Aurobindo Pharma; Ayaz Kagzi, General Manager - Packaging Development, Cavinkare; P V Narayanan, Chairman, SIES School of Packaging; Gautama Buddha, Packaging Consultant & Guest Faculty, IIP (Moderator); Santanu Shome, GM - Procurement Direct Materials, Hospira Healthcare India (A Pfizer Company); and Jayanti Sawant, Consultant

PL Conclave 2018 comprised several insightful and interesting panel discussions. The first panel at the conclave focussed on the buzzword in every industry today – innovation. An eminent panel comprising Gautama Buddha, Packaging Consultant & Guest Faculty, IIP; Prof PV Narayanan, Chairman, SIES School of Packaging; R Chandi Prasad, GM-Packaging Development, Aurobindo Pharma; Santanu Shome, GM - Procurement Direct Materials, Hospira Healthcare India (A Pfizer Company); Jayanti Sawant, Consultant; Ayaz Kagzi, GM - Packaging Development, Cavinkare and Prabir Das, VP – Packaging Development, Head, Pkgg. Tech. Services (OSD) – Mylan India conversed and conferred on strategies needed to foster an ecosystem conducive for pharma packaging innovation.

30 EXPRESS PHARMA April 1-15, 2018

Buddha, as a veteran of this industry and the moderator for this panel, posed several pertinent questions to the panelists to drive meaningful dialogues and gain their insights. He questioned them on the prerequisites to create an ecosystem where innovation thrives, the role of academia in nurturing such an environment, role of important partnerships, so on and so forth. R Chandi Prasad opined that a constant flow of communication and interaction between different stakeholders is a must to encourage innovation in

pharma packaging. He recommended the academia, research organisations and user industries to collaborate and facilitate innovation. Prof Narayanan touched upon a variety of topics such as academia's role in furthering innovation, cost optimisation with packaging, its role in controlling the spread of spurious medicines etc. He spoke on the creation of pharma packaging exclusive approval centres as extensions of existing institutional facilities. He urged pharma packaging professionals to keep pace with changing

Key takeaways ◗ Academia, research institutes and user organisations should collaborate to drive innovation ◗ Every pharma company should create an innovation funnel, even in the packaging segment to drive growth ◗ Technology is a great enabler in fostering an ecosystem for innovation

regulatory requirements . Shome spoke on the benefits of building successful partnerships to develop a culture of innovation. He cited examples of Pfizer's efforts in this direction. He informed that the company has an innovation team for each function. Likewise, he also spoke on the company's partnership with Merck and Corning to drive innovative solutions. Das elaborated on the benefits of an ecosystem such as creating a unique identity, gaining a competitive edge, cost benefits and so on. He also cited examples to prove his point. For instance, a small design innovation helped his company to safeguard a product more effectively and, at the same time, save costs in the long run. Kagzi spoke on how the pharma industry should look at the measures taken by the rest of the sectors to learn, adapt

and adopt from them in a bid to provide more value through packaging. He also said that innovation should enhance the experience of the patient and these are things that the industry should work to develop. Sawant advocated the need for continuous review of packaging systems and processes to enhance their performance and plug the loopholes. She also said that people and processes, both have to be selected carefully to create an innovative ecosystem. The panel discussed on the newer methods of packaging and their ability to serve different needs and populations. They were unanimous in their view that each company should invest more in packaging R&D and create an innovation funnel to spur their growth trajectory. The panelists also reflected on the enormous potential of IT and ICT systems to drive innovation in this industry.

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Putting India on the global map: Pharma packaging and labelling trends in the next decade

(L-R) Prasad Satam, Head- Packaging Development, Aurobindo Pharma; Harpal Singh, Deputy General Manager - Packaging Development, Glenmark Pharmaceuticals, Shankar Gupta, COO, ACG Engineering; Avinash Kumar Talwar, Director - Supply Chain Management, Head – Global Sourcing (Strategic & Plant), Dr Reddy's Laboratories (Moderator), Santanu Chowdhury, Sr General Manager – Packaging Development, Sun Pharma; and Saravanan TJ, Senior Manager - Packaging Development, Biocon

PL Conclave 2018 witnessed a panel discussion on Putting India on the global map: Pharma packaging and labelling trends in the next decade. Eminent pharma packaging experts, Santanu Chowdhury, Sr GM – Packaging Development Sun Pharma, Saravanan TJ, Senior Manager - Packaging Development, Biocon, Harpal Singh, Deputy General Manager - Packaging Development, Glenmark Pharmaceuticals, Prasad Satam, Head- Packaging Development, Aurobindo Pharma and Shankar Gupta, COO, ACG Engineering, formed the panel for this discussion. The session was moderated by Avinash Kumar Talwar, Director Supply Chain Management, Head – Global Sourcing (Strategic & Plant), Dr Reddy's Laboratories. Talwar’s rundown on the

various projects at DRL to improve packaging and the need to develop patientfriendly pharma packaging set the context for further discussions. He also quizzed the panelists on different facets of pharma packaging and its correlation to India Pharma Inc’s growth trajectory. Singh briefed about some regulations which will shape the industry in the near future such as EU falsified medicine directive (EU FMD) and Drug Supply Chain Security Act (DSCSA). Besides, he spoke on some measures that Health

Canada has started enforcing. Satam spoke on the prospects for India to be a global leader in the life sciences sector, with an emphasis on opportunities for pharma packaging manufacturers. He also listed down the challenges faced by packaging players, especially in sourcing material for primary packaging. He also advised the players to expand their footprints from regulated and semi-regulated markets to explore other geographies as well. Chowdhury shared his views on how technology is

Key takeaways ◗ Indian pharma industry needs to gear themselves up for upcoming regulations to stay competitive and relevant ◗ Pharma companies are developing innovative labelling solutions for patient adherence ◗ Machinery manufacturers have to work with customers to deliver more innovative solutions

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changing the pharma packaging landscape. He drew inferences from the advancements in drug dispensing technologies with a growing emphasis on convenience and safety. He said that these changes are being driven by the paradigm shift happening across the healthcare system from cure to care. He elaborated on the importance of implementing QbD. He also touched upon topics such as balancing between, cost, innovation and convenience, patient adherence, regulatory compliance etc. Saravanan spoke on labelling and the role of fluids in enhancing its efficiency and efficacy. He detailed the various transformations and changes happening in the labelling sector. For instance, highlighting the role of labelling and packaging in patient adherence, he explained the value ad-

dition provided by time, temperature indicator labels on the product. The label has an active ingredient which changes colour when the products nears expiry. He informed that several such interesting and innovative features are coming up in the labelling sector. Gupta said that the packaging industry has to be ready to meet the challenges and opportunities in the pharma sector. As machinery and solutions providers, the challenge would be to remain cost-effective while embracing a culture of innovation. He also advised pharma packaging professionals to make strategic changes to their current systems to be at the top of the game. Panelists concluded that the pharma packaging industry is on the cusp of a major transformation and stakeholders need to collaborate to augment its advance and assuage concerns.

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Express Pharma hosts first ever PPLLeadership Awards It recognises excellence in pharma packaging and acknowledges the role of pharma packaging professionals in driving life sciences industry’s progress

xpress Pharma, the leading industry publication from The Indian Express Group, recently hosted the first ever PPL Leadership Awards. It acknowledged and honoured pharma packaging professionals who have been the innovators and game changers in the life sciences sector with their significant contributions. ACG was the Presenting Partner for the awards. Held concurrently with the first edition of Pharma Packaging and Labelling (PPL) Conclave, on March 15, 2018, at Novotel Airport, Hyderabad, the awards night began with an address by Viveka Roychowdhury, Editor, Express Pharma, who welcomed the delegates and explained the rationale behind the initiative. She explained that the awards were a recognition of the winners’ individual contribution to the pharma packaging industry, thereby making it one-of-its-kind. Next, Madan Mohan Reddy, Chairman, Pharmexcil & Wholetime Director, Aurobindo Pharma, who was also the Chief Guest on this occasion, addressed the audience. He lauded Express Pharma for launching this initiative. He also highlighted the various challenges faced by the Indian pharma industry and emphasised on the need of strong collaborations in the industry to overcome them. He also spoke on spurring innovation across various segments of the pharma industry and creating a very conducive eco-system for growth. The next speaker, Chakravarthi AVPS, Ambassador, World Packaging Organisation, and Chairperson of PPL Conclave’s Advisory Board,

32 EXPRESS PHARMA April 1-15, 2018

Stalwarts, Jury members along with PPL Leadership Award Winners

Madan Mohan Reddy, Chairman, Pharmexcil & Wholetime Director, Aurobindo Pharma as Chief Guest at PPL Leadership Awards Nite

explained and elaborated on the methodology of the PPL Leadership Awards and the process of choosing the deserving winners. He also assured that this platform is set to become bigger in the following years to ensure that pharma packaging professionals receive their due respect and acknowledgment

for their contributions to the life sciences industry. Subsequently, Roychowdhury, alongwith Reddy gave away the awards. Shankar Gupta, COO, ACG and members of PPL Conclave’s Advisory Board, Chakravarthi AVPS, Ambassador – World Packaging Organisation; Gautama

Buddha, Packaging Consultant & Guest Faculty, IIP and S M Mudda, Director – Global Strategy (Technical) Micro Labs, joined them in presenting the awards to the winners. 17 leading professionals received the PPL Leadership Award for Outstanding Achievement in Pharma

Packaging. Two emerging leaders were also recognised at PPL Awards as ‘Rising Stars in Pharma Packaging’. Express Pharma, also honoured three stalwarts of India’s pharma packaging industry with special citations. The citations acknowledged them as pioneers and leading lights of the pharma packaging services industry and recognised that have been instrumental in introducing several technological advances, thereby accelerating the progress of the life sciences sector. Today, their organisations are global players of great repute. The Advisory Members of PPL Conclave and Awards were also felicitated for their invaluable insights and constant guidance in making the inaugural PPL conclave a successful endeavour. The winners were exultant and elated at receiving the awards. The evening ended with a gala dinner which gave the delegates to interact and network with their peers in the industry.

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CITATIONS TO STALWARTS

Ajit Singh, Chairman, ACG

Jasjit Singh, Vice Chairman ACG

Ajit Singh,Jasjit Singh and Kairus Dadachanji were awarded for their tremendous contribution and exemplary work towards driving progress in India's pharma packaging sector Video message by Kairus Dadchanji, MD, Schott Kaisha

OUTSTANDING ACHIEVEMENT IN PHARMA PACKAGING

Ajay Bapat, Head Packaging Development, Emcure Pharmaceuticals

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Avinash Talwar, Director - Supply Chain Management, Head – Global Sourcing (Strategic & Plant), Dr Reddy’s Laboratories

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R Chandi Prasad, GM-Packaging Development, Aurbindo Pharma

Shantanu Shome,GM - Procurement Direct Materials, Hospira Healthcare India (A Pfizer Company)

Dr. Srinivas Arutla, Head (VP) Product Development, Apotex Research

Manoj Teluguntla, Sr GM-Packaging Development, Cadila Healthcare

Srinivas Naidu, Sr GM, Sun Pharma

TJ Saravanan, Associate Director, Packaging DevelopmentQuality, Biocon

Narlanka Praveen Kumar, Deputy GM, Aurobindo Pharma

Sriman Banerjee, Head of Packaging- Respiratory Category, Glaxosmithkline Consumer Healthcare

Tripti Nakhare, Sr GM, FDC

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Prabir Das, VP – Packaging Devp, Head, Pkgg. Tech. Services (OSD) – Mylan India

Rajendra Suthar, Additional Director (Head Packaging, Packaging Development & Consignment Dispatch), Serum Institute of India

Munindra Roy, Sr Manager, Gland Pharma

Rahul Bhargava, AVP, Sun Pharma

Reetika Prashar, Packaging lead, Merck Consumer Health

Rajshri Chetan Pardeshi, Head- Packaging Development & Labelling (ANDA), Unosource Pharma

Rajesh Kumar Mishra, Associate Director- Packaging Development, Abbott Healthcare

Santanu Chowdhury, Sr GM, Packaging Development, Sun Pharma

Chief Guest Felicitating Advisory Board & Jury Members

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DAY 2 (16-3-2018)

Role of regulations: Assuring quality,safety,compliance and success with pharma packaging

(L-R) SM Mudda, Director – Global Strategy (Technical) Micro Labs (Moderator); Tripti Nakhare, Senior GM, Regulatory Affairs and Packaging Development, FDC; Pradeep Dhargalkar, Head Packaging, Unichem; Rajesh Mishra, Associate Director- Packaging Development and Dr Srinivas Arutla Head (VP), Production Development, Apotex Research

PPL CONCLAVE 2018 PANEL DISCUSSION: Role of regulations: Assuring quality, safety, compliance and success with pharma packaging Trends in Barrier Packaging Pharma Packaging & Labelling – Importance & Effectiveness, Challenges & Opportunities Introduction to Pharma Packaging PANEL DISCUSSION: Packaging in Parenterals: Challenges and opportunities Networking Tea Break The way forward, what pharma packaging professionals need do to take it to the next level Vote of Thanks

36 EXPRESS PHARMA April 1-15, 2018

he second day of the PPL Conclave began with an interesting panel discussion on Role of regulations: Assuring quality, safety, compliance and success with pharma packaging. The panel was moderator by SM Mudda, Director – Global Strategy (Technical) Micro Labs. Tripti Nakhare, Senior General Manager, Regulatory Affairs and Packaging Development, FDC; Pradeep Dhargalkar,Head Packaging, Unichem; Rajesh Mishra, Associate Director- Packaging Development and Dr Srinivas Arutla Head, VP-Production Development, Apotex Research were the panelists. Before beginning the panel discussion, Mudda briefed the audience on the evolution and importance of choosing the right packaging material. He said, “Development in packaging has helped us in achieving operational excellence, cost reduction, patent compliance and globalisation. We cannot undermine the importance of packaging in product design and delivery either. It is the representative of the company. The company first speaks to its patients through its pack. So, it has significant importance in building the brand and image of the company.” He asked Nakhare to throw some light on the regulatory requirements in packaging. Nakhare informed that the regulations are across the packaging line. She said, “When it co mes to regulation and its impact on packaging, I would like to break it into three segments i.e. regulation on the production packaging, regulation on the material and regulation on labelling. Production packaging has many guidelines like the orange book in Europe which describes what is expected on the packaging line, WHO NX 9, and Schedule M of Drugs and Cosmetic Act. More or less they all talk the same language. In the current scenario we are facing a lot of audit issues, the equipment or packaging machinery needs

Key takeaways ◗ Packaging helps achieving operational excellence, cost reduction, patent compliance and globalisation ◗ In any product which is being developed, QbD needs to be considered. ◗ Packaging has significant importance in building the brand and image of the company

to be upgraded with time. Today, we cannot have PLCs or any software which has windows XP, it’s not accepted by FDA any longer. So, these are aspects that need to be kept in mind.” Answering Mudda's next question on new standards and industry’s methods to cope with it, Dhargalkar said that packaging technology as a whole has to assist in meeting quality standards before they change their standard of rating procedures. Dr Arutla emphasised on QbD and its benefits to the product. He said, “In any product which is being developed, QbD needs to be considered. When we develop a product we focus more on primary packaging and formulation development. QbD is a systematic approach of product development keeping the end objective in mind with knowledge about the product and the process.” Mishra pointed out that while designing packaging, the patients, manufacturing ability and cost effectiveness should be kept in mind. He advised that just as we invest a lot in beautifying our packaging, a significant amount should be invested in innovation. The panelists also informed about advancements in

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Introduction to Pharma Packaging

anoj Mishra, AVPSales & Marketing, UNIWORTH Enterprises LLP gave a presentation on ‘Introduction to pharma packaging’, wherein he spoke on his company’s offerings for the pharma sector. He also informed the audience that UNIWORTH has technical expertise in handling Rigid PVC films and catering to international standards. He informed that in 2017, UNIWORTH forayed into pharma packaging with a manufacturing plant in Ahmedabad. The manufacturing area is 29000 sq m with a built up area of 6000 sq m. The company has installed an Indian origin coater and laminator machine. The calender unit has 600 tonnes capacity per month. The PVDC coating has a capacity of 250 tonnes per

UNIWORTH has technical expertise in handling Rigid PVC films and catering to international standards

Manoj Mishra, AVP- Sales & Marketing, UNIWORTH Enterprises LLP

month. The laminator capacity is 300 tonnes per month. The manufacturing facility has a slitting machine with an online vision inspection system ensures the quality parameters required by the packaging seg-

ment. He further highlighted the company’s manufacturing capabilities which include isolated clean room production area; PVC wider range capabilities from 60 microns to 700

microns; calender with online thickness guage system; online vision inspection system; non traditional inverted 'L' five roll calendar; coating with four stations and lamination with adhesion uniformity. He also briefed the audience on UNIWORTH’s product range which includes PVDC and laminates. In PVC the company gives 60 microns to 300 microns clear and colour films for all packaging requirement. The company also manufactures CFB (cold form blis-

ters), commonly known as ALU-ALU with an in-house capabilities of 60 microns PVC, ensuring lamination with metal as well as OPA. He also spoke on the evolving requirements of the industry and the ompnay’s ability to meet them. He also informed that the company adheres to international quality standards, has ISO certification and US FDA, DMF No. for all the products The company is globally present in Turkey, South Africa and the US.

Pharma Packaging & Labelling – Importance,Effectiveness, Challenges & Opportunities

rabir Das gave a presentation on Pharma Packaging & Labelling- Importance and Effectiveness Challenges and Opportunities. He informed the audience that pharma products, without labelling on its packaging, act no less than a poison. He said, that packaging not only protects and preserves the product, but also ensures safe and secure delivery of the product to the customer. Labelling on the packaging establishes communication with the user about the product, and complies to all statutory requirements. It also helps in identifying and tracking the product from shop floor, till its consumption. He further explained that every product needs packaging for protection from external en-

Every product needs packaging for protection from external environment and needs labelling to communicate with the external world

Prabir Kumar Das – Head, Pkgg. Tech. Services (OSD) – Mylan, India

vironment and needs labelling to communicate with the external world. He also informed that packaging and abelling complement each other. He also briefed on the

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precautions needed for safe and secure delivery on the product such as appropriate positioning for clean visibility and clear legibility; instructions and pictogram for ease in handling and

storage; use of different font, calligraphy, colour for special attention; use of protective layer to avoid label defacing/damages; use of anti-counterfeit and tamper evident features; use of security features to reduce chances of theft and backward integration – confidentiality agreement. Packaging also plays an important role in track and trace systems. Apart from India (DGFT), US (DSCSA) and

Europe (FMD), many more countries across the world have specific guidelines on Track & Trace or Authentication system, to optimise effectiveness and efficiency of drug distribution system. He informed that countries like Argentina, Brazil, China, Japan, Korea, Nigeria, Saudi Arabia, Turkey, Costa Rica, Canada, Mexico, etc. have either adopted or are working on its implementation.

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cover ) Trends in barrier packaging

eelam Lalwani, Global Quality Head,ACG Films & Foils, ACGs spoke on Trends in barrier Packaging. She said that as India gets into complex generics, reverse engineering for innovative products is not the only solution. A lot more understanding is required for developing apt solutions. She also gave a brief presentation on ACG's recent acquisition, which helped them in expanding their global footprints. Stressing on the company's product portfolio and its relevance in today's time, she informed that the company has a whole basket of conventional films in pharma packaging which are still relevant. Recalling discussions from

Companies need to invest and avoid legal hassles in the market through solutions which are available in the market

Neelam Lalwani, Global Quality Head,ACG Films & Foils, ACG

the Day 1 of PPL conclave which highlighted the importance of research and innovations, she stressed that it can lead to the next level of growth for the company. She shared an example of Aclar which was a research molecule and later got transferred

into packaging with zero barrier properties. She also informed about the availablity of a wide range of Aclar films in various thicknesses and combinations to suit both, the needs of water vapour transmissions rate and oxygen barrier.

Moving forward, she informed about the company's ultra safe high barrier properties of Polyvinylidene Chloride (PVDC ), and its ability to provide customised solutions based on API requirements, excipients, and drug products â&#x20AC;&#x2DC; moisture sensitivity. Referring to the counterfeit menace and its impact on companies' brands, she suggested that companies need

to invest in avoiding legal hassles through solutions which are available in the market. She informed that besides oral dosages the company also offers a complete range of solutions for suppositories and unique dosage. She shared the company's latest innovations and how they are customising them to any product as per the requirements.

The wayforward for pharma packaging professionals

eetika Prashar, Packaging lead, Merck Consumer Health gave a very interesting and engaging presentation on 'The way forward, what pharma packaging professionals need do to take it to the next level'. She began her presentation by lauding Express Pharma for creating this platform for packaging leaders. She went to give some very relevant examples of superior and interesting examples of packaging from different industries. She stated that packaging has immense potential to bring explosive business growth to companies. However, she recommended the adoption of innovative packaging materials to drive progress. She also put forth how packaging could be a very good tool to build a brand and communi-

38 EXPRESS PHARMA April 1-15, 2018

Packaging has immense potential to bring explosive business growth to companies. Adoption of innovative packaging materials drive progress.

Reetika Prashar, Packaging lead, Merck Consumer Health

cate effectively with its consumers. Her examples included brands like Parchute, Catch and Paper Boat. She spoke on how each of these

products/brands have effectively utilised packaging to become household names. For instance paper Boat has built itself as a brand which evokes memories of a happier times.

Catch has managed to convert a kitchen product like salt into something which is displayed on the dining table. Prashar advised the pharma industry to take a cue from other industries and utilise packaging in a more optimal manner. She admitted that the industry has started doing it to a certain extent. For instance, glucometers, nebuliser have become household products, thanks to good packaging

and communication. She also pointed out the other benefits that packaging can ensure for the industry such as patient adherence and regulatory compliance. She ended her presentation with some clips from a recently released film, PADMAN to remind the industry about how important it is to be innovative and think out-of-the-box solutions to bring down packaging costs.

(

THE MAIN FOCUS

Packaging in Parenterals: Challenges and opportunities

(L-R) Prof M S Sarveswara Rao, Strategic Advisor, GreatFour Systems & Adjunct Faculty, SVCP (Moderator); Prasad Satam, Head- Packaging Development, Aurobindo Pharma; Santanu Shome, General Manager - Procurement Direct Materials, Hospira Healthcare India (A Pfizer Company); Soumyanath Mishra, Head & DGM, Packaging Development-F&D, Mankind Research Centre; Munindra Roy, Head - Packaging Development, Gland Pharma; and Ajay Bapat, Head Packaging, Emcure

he PPL Conclave’s final panel discussion was on, ‘Packaging in Parenterals: Challenges and Opportunities’. The panelists were Prof MS Sarveswara Rao, Strategic Advisor, GreatFour Systems & Adjunct Faculty, SVCP (Moderator); Soumyanath Mishra, Head & DGM, Packaging Development-F&D, Mankind Research Centre; Munindra Roy, Head Packaging Development, Gland Pharma; Santanu Shome, GM - Procurement Direct Materials, Hospira Healthcare India (A Pfizer Company); Prasad Satam, Head- Packaging Development, Aurobindo Pharma and Ajay Bapat, Head Packaging, Emcure. Rao, the moderator for this session, gave an overview on parenterals as a dosage form and elaborated on its unique features and benefit. He also highlghted the huge growth po-

tential in this segment, especially for India. He explained that in case of parenterals, the packaging is often also the drug delivery system and hence the challenges are also manifold. Giving a rundown on the packaging challenges in parenterals, he emphasised on inter-departmental collaboration as a measure to tackle them effectively. Roy, at the behest of the moderator, expounded on the differences between parenterals and other dosage forms and spoke on primary packaging challenges in this segment. He

pointed out that product-package compatibility, transportation, regulatory compliance etc. are some of the factors that need to be taken into consideration while implementing packaging solutions for this segment. He recommended packaging professionals to consider these factors in the design stage itself to avoid hassles in the long run and prevent product recalls, a major problem for the pharma industry in the recent times. Bapat expounded on secondary and tertiary packaging challenges and his emphasis was on

Key takeaways ◗ Packaging comes with its unique set of opportunities and challenges. Increase R&D in this segment to come up with apt solutions. ◗ Adopting QbD is one of the most effective ways to mitigate risks through packaging ◗ Partnerships can be pivotal in developing innovative and out-ofthe-box solutions for parenteral packaging.

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child-resistant and elderlyfriendly packaging. He said that in times of self-medication, packaging has to do its best to enable safety, ensure quality and provide convenience to the users. He also spoke on developing parenterals for oncology and how packaging needs to be designed with utmost care for complex therapeutic areas. Satam was quizzed by the moderator on the design aspects of packaging solutions for parenterals. He spoke on risk mitigation through quality by design (QbD) in packaging. He further informed about the importance of choosing the vials, stoppers, tubes etc. for parenterals to strike the right balance between cost, quality and efficacy of the product. He advised his peers and colleagues to pay attention to even the smallest detail when it comes to parenteral packaging. Mishra drew parallels

between different packaging materials for parenteral packaging and examined their pros and cons. He compared glass and plastic containers and explored the advantages and disadvantages of each material when it comes to packaging of products with complex molecules. Shome explained about concepts such as zero-defect supplies and quality control through such methods. He also elaborated on the role of good partnerships in fostering a culture of innovation in pharma companies. He presented the examples of his company’s various partnerships to come up with both, pertinent and out-ofthe-box solutions. He recommended increasing research in packaging to come up with apt solutions. The panel also reiterated that parenterals as a segment is poised to grow in future.

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cover ) GLIMPSES OF PPL CONCLAVE 2018

40 EXPRESS PHARMA April 1-15, 2018

MANAGEMENT REPORTS

IoTsoftware and services in pharma sector to be worth $2.4 billion by 2020 The Asia-Pacific region’s robust IoT software and services growth in the pharma sector is primarily driven by the large number of upcoming pharma manufacturing organisations

nternet of Things (IoT) is transforming the pharmaceutical industry at a rapid pace. IoT has the potential to enhance almost all the processes of the pharma industry ranging from clinical trials, drug disclosure, manufacturing, and supply chain to remote patient monitoring, according to GlobalData, a leading data and analytics company. IoT software and services in the pharma industry is expected to grow from $420 million in 2015 to $2,486 million by

Middle East & Africa will deliver the fastest overall growth in IoT spending with a five-year CAGR of 49.9 per cent

2020, at a Compound Annual Growth Rate (CAGR) of 42.7 per cent from 2016 to 2020. Alok Singh, Senior Technology Analyst, GlobalData, comments, “IoT software and services effortlessly connect and create the base upon which IoT applications and use cases can be realised to develop a comprehensive solution that will benefit organisations to reduce response times, enhance product quality, security, and boost

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performance. IoT software and services spending is driven by the large adoption of cloud platform as a service (PaaS) along with advanced data analytics, new application, and use cases, which transforms data into substantial information and eventually into the activity that will boost business productivity, or better customer service.” GlobalData’s pharma IoT software and services revenue forecast depicts significant

growth in the Asia Pacific region, to reach a value of $655 million by 2020, growing almost fivefold against the 2015 baseline. The Asia-Pacific region’s robust IoT software and services growth in the pharma sector is primarily driven by the large number of upcoming pharma manufacturing organisations, increasing expenditure, high Internet penetration rates, government investment policies, demand for quality

treatment, and rising adoption of new technologies like cloud computing, big data, and artificial intelligence (AI). Moreover, it is interesting to note that Middle East & Africa (MEA) will deliver the fastest overall growth in IoT spending with a five-year CAGR of 49.9 per cent, but from a far smaller base. Meanwhile, North America and Europe are the largest regions in terms of investment at the beginning of the forecast

period and combined represent a $1.5 billion market by 2020. Singh concludes, “IoT will revolutionise the way pharma organisation will operate and do business. IoT software and services can help pharma organisations to digitise and connect critical actions, increase efficiencies, compliance, and persuade product quality that will benefit organisations to achieve a faster time to value.” EP News Bureau

Pharma firms ramp up investment in security products to secure critical data Pharma companies are also deploying some form of backup and archiving, and content and web filtering solutions to store as well as preserve their online information PHARMACEUTICAL companies require efficient technologies such as Internet of Things (IoT), cloud computing, artificial intelligence and big data to manage information that is vital to the development and production of successful drugs. As a result, pharma firms are increasing their investment on various security products to prevent breaches, protect patient data and secure sensitive information, according to GlobalData, a leading data and analytics company. According to GlobalData’s survey, 79 per cent of pharma companies are currently making in-

vestments in identity and access management (IAM) solutions and 72 per cent of companies are considering investment in the solutions over the next two years. Siddharth Kumar Tiwari, Technology Analyst at GlobalData, explains, “Investments in IAM solutions among pharma companies are driven by the need to manage electronic user identities and ensure data privacy while avoiding any misuse of critical business information.” The survey further reveals that an equal proportion (75 per cent) of pharma companies are currently deploying some form

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of backup and archiving, and content and web filtering solutions to store as well as preserve their online information. Furthermore, organisations are striving to deploy IoT to minimise human intervention and achieve enhanced quality control. Tiwari concludes, “Although the pharma sector lags behind in implementing cyber security, prevalence of data sharing is compelling companies to look for vendors that can provide integrated security operations and analytics to tackle anomalous behaviour.” EP News Bureau

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April 1-15, 2018

RESEARCH

Failure of the antimicrobials: Acrisis at the door-step MK Chattopadhyay, Retired Senior Principal Scientist, Centre for Cellular and Molecular Biology (CSIR), talks about the urgent need for new antibiotics which will be effective against resistant organisms

uring the past few decades, world-wide emergence of microbial strains, resistant to various therapeutically useful antibiotics, has assumed the role of a major crisis. Discussion in this article is confined into the antibacterial antibiotics for convenience. However, similar type of problems is encountered in the management of infections caused by the other types of microorganisms (fungus, mycoplasma, virus) also.

Achievements of antibiotics Though there are ample evidences of use of several types of antibacterials by people in the ancient civilisations, the modern era of antibiotics started with the discovery of penicillin in 1928 by Alexander Fleming. The sulfur drugs were introduced into the clinical practice during the 1930s. Penicillin, which was superior to the sulfur drugs in various ways, appeared to be a magic bullet against bacterial infections. The average life-span of people in the developed and developing countries alike was substantially enhanced following introduction of antibiotics in the clinical practice. Discovery of a number of other antibacterial antibiotics during the 1940s allured many people to believe (including some scientists) that bacterial infections of any type could be subdued using antibiotics and hence there was nothing to worry about them. The idea appeared to be justified since a number of life-threatening infectious diseases could be successfully cured, risks associated with surgical operations could be substantially reduced and quality of life was significantly improved by the use of antibiotics.

Failure of the life-saving drugs The chink in the armor was evidenced within a few years follow-

44 EXPRESS PHARMA April 1-15, 2018

ing introduction of the antibiotics in the clinical practice. It was found that a subpopulation of the bacteria, which were susceptible earlier to certain antibiotics, was no longer responding to the same antibiotics. By this time, organisms resistant to all the therapeutically useful antibiotics have been detected. So the existing antibiotics are turning ineffective. Widespread emergence of methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant Enterococci (VRE) reveals the dimension of the crisis. Detection of a bacterial enzyme called New Delhi Metallo-ß-lactamase (NDM-1), which inactivates a wide-range of antibacterial drugs, makes it evident that no antibiotic is infallible. The worldwide practice of adding antibiotics to the feed of farm animals and poultry is believed to significantly contribute to the problem. If the situation is left as such, it was estimated by a British survey (2014) that by 2050, 10 million people will die each year of infections caused by the antibiotic-resistant bacteria. Although the prediction is disputed, the gruesome dimension of the crisis is not denied by anybody. In a ministerial conference, held in June 2014, Margaret Chain, the then Director –General of the World Health Organization (WHO), commented “Antibiotic resistance is not a future threat looming on the horizon. It is here, right now, and the consequences are devastating.” Quite reasonably, an urgent need for new antibiotics, which will be effective against the resistant organisms, is appreciated by everybody.

Genetic basis of antibiotic resistance Antibiotic resistance emerges in antibiotic-susceptible bacteria by a process called spontaneous mutation. The resistance-conferring genes are copied and

sistance-conferring genes evolved long before antibiotics were introduced into the clinical practice. So simply by avoiding use of antibiotics, we cannot bypass the problem of resistance.

Problems associated in getting effective antibiotics

transferred to antibiotic-sensitive organisms by the resistant organisms. Horizontal gene transfer is a process by which even unrelated bacteria can disseminate resistance-conferring genes among themselves. Genes that confer antibiotic-resistance most often co-occur with genes that confer resistance to toxic metals (mercury, copper, nickel, zinc) which are present in many articles of our everyday use. Thus antibiotic-resistant bacteria are selected to grow in natural environments polluted with heavy metals even in absence of antibiotics.

The double whammy Professor Stuart B Levy, a researcher and physician at the Tufts University (US), is untiringly advocating for rational use of antibiotics. According to his ‘Antibiotic Paradox’ theory, the possibility of emergence of bacterial strains resistant to an antibiotic, is substantially increased with the use of that antibiotic (more use, more resistance). While available evidences speak volumes in support of this theory, it is also a fact that antibiotic resistance is an outcome of evolution and emergence of resistance does not require exposure to antibiotics. Antibiotic resistance is found to occur even in bacteria which were never exposed to antibiotics. As a matter of fact antibiotic biosynthetic genes and re-

Antibiotics are generally extracted from the soil bacteria belonging to the genus Actinomycetes. The drugs belong to different types of chemical categories e.g, the penicillins, the tetracyclines, the aminoglycosides and some others types. So if the same source is tapped again in search of new drugs, we are likely to get a new penicillin-type of antibiotic or a new tetracycline-type of antibiotic or a new aminoglycoside-type of antibiotic. But bacteria have already evolved with the capacity to bypass these categories of antibiotics. So the efficacy of the newly-discovered drugs will be short-lived.

Some new antibiotics from the soil bacteria However, scientists have not given up search for new drugs from the soil bacteria. Recently, researchers working at the Rutgers University, New Brunswick (Canada), the Italian biotechnological company NAICONS Sri and some other organisations, have been successful in isolating a microorganism from a soil sample, collected from Italy. It produces a new antibiotic pseudouridimycin, which is found to be effective against a wide range of antibiotic-sensitive and antibiotic-resistant bacteria. This new drug has been obtained from an organism, which can be grown in the laboratory. Unfortunately most of the naturally occurring bacteria do not offer such advantage to the scientists. They cannot be cultured in the laboratory. In 2015, a collaborative work involving four institutes in the US and

Germany and two pharma companies, led to the isolation of a new bacterium from a soil sample obtained from Maime (UK), using an improved device of growing soil organisms called isolation chip or ichip. The bacterium was observed to produce an antibiotic named teixobactin, which binds to the lipid components of bacterial cell-wall and thus kills the organism. No resistance was found to develop in the target bacteria. Scientists are also trying to get new antibiotics using recombinant-DNA technology and by chemical synthesis of new compounds in a very large scale by a process called Combinatorial Chemistry. It is indicated from the whole genome sequence of some antibiotic- producing organisms belonging to the genus Streptomyces, that it might be possible to get some novel antibiotics from them.

Antibiotics from novel organisms Scientists are also attempting to use organisms not used earlier for antibiotic production. These new candidates include bacteria obtained from the rain forests, the Arctic and Antarctic regions. They are also tapping marine sediments to get novel antibiotic-producers. A couple of years ago, three research teams from the University of Tehran and two other research institutes of Iran, reported isolation of antibiotic-producing bacteria from the sediments obtained from the Caspian Sea. Antibiotic-producers have also been detected in marine sediments collected in British Columbia, Canada. They are found to occur also in marine sediments collected near the Andaman and Nicobar islands by two groups working at the Andhra University, India. The desperate attempt of the scientists to get new antibiotics is evidenced by the unusual and bizarre nature of some sources tapped by them.

Antimicrobial substances with improved spectrum of efficacy are reported to occur in the extract of crushed cockroach, extract of the brain of locust, secretion of catfish, proteins extracted of the white blood cells of alligator, skin of frog, blood of panda, leaf-cutter ants of South America and also some other sources which as such are not believed to provide any life-saving drug.

Antibiotics with new targets The antibiotics that we are using at present work by various mechanisms. Some of them inhibit synthesis bacterial cellwall, some inhibit bacterial protein synthesis, some inhibit synthesis of folic acid in bacteria, some others inhibit synthesis of bacterial DNA and RNA. Pathogenic bacteria have already been evolved with capacity to escape these modes of actions. Hence, scientists are looking for compounds which target bacterial molecules not targeted earlier by the existing antibiotics. For example, cytoskeleton is a complex network of filaments, essential for cell division, maintenance of the structure and shape of the cell and also for the protection of the cell from damage. The bacterial cytoskeletal protein FtsZ is essential for cell-division. Some inhibitors of this protein like 3methoxybenzamide derivatives are found to inhibit the growth of several pathogenic bacteria including the antibiotic-resistant strains. A couple of years back, a group of scientists led by Professor Neil Stokes at the Biota Europe Limited, Oxfordshire (UK), developed such a derivative, which was active against some multidrug-resistant organisms. Some other derivatives are also reported with similar efficacy. DNA topoisomerase II is a bacterial enzyme that is essential for bacteria but absent in higher eukaryotes. Hence it offers a novel target for the development of new antibiotics. Menaquinones are chemical substances present in the cytoplasmic membrane of bacteria. They are involved in a number of crucially important biochemical and physiological processes. Hence, inhibitors of

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menaquinone biosynthesis appear to be useful in controlling bacterial infections. Recently a team of researchers, led by Dr David Alland (Rutgers University, New Jersey Medical School, USA), reported the isolation of a novel biphenylamide (designated as DG 70), which was

found to inhibit the growth of both drug-resistant and drugsusceptible form of Mycobacterium tuberculosis, by inhibiting menaquinone biosynthesis. Anti-tubercular drugs generally used in therapeutics do not work against non-dividing cells. But inhibitors of menaquinone

biosynthesis are active even against the cells which are not dividing. A study made in 2008 revealed that out of 167 new antibiotics in the pipeline, only 15 had a new mechanism of action. Hence a lot of impetus is the need of the hour to boost devel-

opment of antibiotics with novel mechanism of action.

Reversal of resistance As mentioned earlier, number of therapeutically useful antibiotics is decreasing because of rapid development of antibiotic-resistance in pathogenic bacteria. So

RESEARCH while searching for new sources of antibiotics or trying to develop new antibiotics with improved efficacy, scientists are also trying to foil the various mechanisms of antibiotic-resistance in bacteria and restore their sensitivity to the existing antibiotics. Some resistant bacteria chemically modify antibiotics with the help of some substances produced by them. The modified substances do not possess any antibiotic- activity. For example, penicillin-resistant bacteria produce an enzyme, beta-lactamase, which catalyses conversion of penicillin into penicilloic acid. It has no antibiotic property. In 1974-75, scientists working at the British company Beecham isolated a compound which they named clavulanic acid from a bacterial culture. It was found to bind to the enzyme beta-lactamase and inactivate it. Thus when clavulanic acid was added to a formulation of amoxicillin , a penicillin-group antibiotic, the bacterial enzyme could not alter the antibiotic . So it remained active. The combination called augmentin is now widely used for the clinical management of infections caused by penicillin-resistant bacteria. Bacteria in natural environments always live in consortium with other organisms. When their number reaches a certain level, they start producing an organic polymer. The process is known as Quorum Sensing. Organisms get embedded into the polymer and form a conglomerate called biofilm. Bacterial biofilm is formed on mast of the ships, within the pipeline meant for water supply, within the aircondition machine and even on the pacemaker and urinary catheters placed inside the body of the patients. Biofim is like a fort which protects bacteria from several types of adverse conditions. Bacteria in biofilm show remarkable resistance to antibiotics. If the process of biofilm formation could be disrupted, they become antibioticsensitive. Quorum sensing is essential for biofilm formation. Scientists are trying to interfere with the process of Quorum Sensing. They are trying to inhibit the process by the addition of several types of chemical substances called the Quorum

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Some resistant bacteria chemically modify antibiotics with the help of some substances produced by them. The modified substances do not possess any antibiotic- activity. For example, penicillin-resistant bacteria produce an enzyme, beta-lactamase, which catalyses conversion of penicillin into penicilloic acid Quenchers (QQs). If the QQs are used as antibiotic supplement, they are likely to inhibit biofilm formation and thus antibiotic-resistance will not be developed in bacteria. Gram-negative bacteria and also some gram-positive bacteria release nano-sized bag-like structures in the environment called Outer Membrane Vesicles (OMVs). Besides helping bacteria in cell-to cell communication, secretion, acquisition of nutrients and self-defence, OMVs also foster antibiotic-resistance in various ways. Hence, inhibitors of vesicle formation bear the potential to be used as antibiotic adjuncts which counteract antibiotic-resistance. These approaches are beset with limitations. The beta- lactamase enzyme produced by some bacteria, is not inhibited by clavulanic acid. Some bacteria are found to produce inhibitors of QQs. So the strategies are not infallible.

Problems in the development of new antibiotics Development of a new antibiotic takes a very long time and huge amount of investment. After it comes to the market, doctors hesitate to prescribe it in a wide scale apprehending emergence of resistant strains. The case of bedaquiline presents a revealing example in this context. It is an anti-tubercular antibiotic with a novel mechanism of action (inhibition of mycobacterial ATP synthase) approved for clinical use by the Food and Drug Administration (US) after 40 years for the treatment of multidrug-resistant TB (MDR-TB). A 18-yearold girl, suffering from MDR-TB, was admitted to a Delhi Hospital. But doctors were reluctant to prescribe bedaquiline to her. Her father approached Delhi

High Court and ultimately got approval of the National Institute of Tuberculosis and Respiratory Diseases (Delhi) for the use of drug to treat her daughter. The hesitation of the doctors to prescribe the newly-developed antibiotics, though rational, impacts the market. The investors do not get quick return from the new drugs which they develop incurring a huge expenditure. Antibiotics, as such, are not expected to give a lot of profit within a short time. Unlike the anti-diabetic drugs or cholesterol-lowering drugs, which are prescribed for life-long use, antibiotics are generally recommended for short-term use. Moreover, restricted use of the new antibiotics by the doctors, adversely affects the commercial prospect of the new products. Quite reasonably, the entrepreneurs do not feel encouraged to invest money for the development of new antibiotics. Thus we see that microbial strains resistant to the existing antibiotics are emerging rapidly, leading to a decrease in the number of usable antibiotics. On the other hand, new antibiotics are coming to the market in trickles. While more than 20 classes of new antibiotics were marketed during the middle of the last century, only 2 classes of new antibiotics appeared in the market since the 1960s. The situation has raised an alarm among the visionaries. “There is an urgent need for more investment in research and development for antibiotic-resistant infections including TB,” feels Dr Tedros Adhanom Ghebreyesus, Director-General of WHO, “otherwise we will be forced back to a time when people feared common infections and risked their lives from minor surgery.” In an interview with a corre-

spondent of Scientific American, the Nobel-laureate US scientist of Indian origin Professor Venkatraman Ramakrishnan opined “They (the governments) have to think of this as something generally good for society, the same reason that governments fund education, roads, police, defence and so on. This is one case where governments need to act”. The importance of his suggestion needs hardly to be over-emphasised.

Judicious use the only means The untiring endeavour of the scientists to maintain the supply of life-saving drugs is promising no doubt. But we must try our best to keep the existing antibiotics active by restraining their use. We must remember that more is the use, more is the chance of development of resistance. We must not forget that antibiotics can be used, changed, or their course can be stopped only when advised by a medical practitioner. In this country, antibiotics are freely available without any prescription. But the liberty contributes to the crisis and threatens to invite a dooms day when no antibiotic will be available for the management of life-threatening infections. Judicious use of antibiotics is the only way we could keep such a devastating situation at bay. Simultaneously we should practice and promote our ageold practices (personal cleanliness, hand washing) which minimize the chance of infections. Role of Pharmacists Scientists, medical practitioners and health workers must initiate all out effort to raise awareness among the common people about the crisis, of which most of us remain blissfully ignorant. Pharmacists working in hospi-

tals can assume important role in monitoring the process of hand-washing, sterilisation, preparation of the antibiotic -resistant profile of organisms isolated from the different areas of the hospitals and antibiotic stewardship (suggestion given to the doctors in avoiding unnecessary use of antibiotics and choosing the right antibiotic). They could also assume an important role in counseling the patients regarding the appropriate use of antibiotics. Needless to say, effort made by them will not be paid any importance in the beginning. But they have to resort to untiring canvassing to make the authority convinced of the importance of their endeavor. For this purpose they have to keep themselves abreast of the recent development in the relevant area.

Suggested for further reading 1) Levy SB (2002) The 2000 Garrod Lecture : factors impacting the problem of antibiotic resistance: Journal of Antimicrobial Chemotherapy, 49 : 25-30 2) Sengupta S, Chattopadhyay MK, Grossart H-P (2013) The multifaceted role of antibiotic and antibiotic-resistance in nature: Frontiers in Microbiology March 12;4:47. doi: 10.3389/fmicb.2013.00047. eCollection 2013 3) Chattopadhyay MK (2014) Use of antibiotics as feed additives : a burning question Frontiers in Microbioogy, July 2;5:334. doi: 10.3389/ fmicb.2014.00334. eCollection 2014. 4) Stokes NR et al (2013) An improved small-molecule Inhibitor of FtsZ with superior in vitro potency, drug-like properties, and in vivo efficacy. Antimicrobial Agents and Chemotherapy; 57 : 317-325. 5) Sukheja P et al (2017) A novel small-molecule inhibitor of the Mycobacterium tuberculosis Demethylmenaquinone Methyltransferase MenG is bactericidal to both growing and nutritionally deprived persister cells. mBio. 2017 Jan-Feb; 8(1): p ii e02022-16. 6) Bhardwaj AK (2013) Bacterial quorum sensing inhibitors: attractive alternatives for control of infectious pathogens showing multiple drug resistance; Recent Patents in Anti-infect Drug Discovery. 8 (1) : :68-83.

IT @ PHARMA

Boosting the productivity of medical reps A low-code rapid mobile application development platform (RMAD) can help business heads in pharma companies to quickly build small mobile apps and improve productivity of medical representatives. Jinen Dedhia, Co-Founder & MD, DronaHQ gives an insight about these fast solutions

medical representative (MR) plays a unique role. Unlike field executives in other industries, an MR’s target audience is not drug buyers but the doctors who prescribe these. His job covers a gamut of activities including maintaining relationships with doctors and hospitals, identifying new business opportunities, collecting relevant groundlevel facts (research), and representing the company at trade shows—besides maintaining an accurate record of visits, meetings, and discussion points. A medical rep, in short, is the pivot around which the entire pharma business revolves.

Automation for MRs: The story so far Given the critical importance of MRs, their productivity is the primary concern of all pharma companies. The automation efforts in this sector traditionally involved installation of large sales automation applications—branded or custom-made. On top of these, pharma companies invested in business intelligence and dashboards for pattern analysis and reporting.

These enterprise applications, while improved productivity to a great extent, required MRs to ‘return-to-base’ for feedback, call-logs, and documentation after every few days. In short, it consumed one extra half-day (or full day) of an MR just for data entry and office meetings.

Enterprise mobility: A few ground realities Pharma companies have been looking at building mobile apps to further improve the MR function. The development and deployment of apps, however, are seldom free of difficulties. The common challenges encountered include lacklustre user adoption, long development times, rollout delays, and steep costs involved in the internal marketing of apps—besides the app development expenses. The companies also have to find specialised app development resources— internal or external—to do this job. Untimely exits of team members augment the problems faced by pharma CIOs in this scenario.

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April 1-15, 2018

IT @ PHARMA A fresh, new perspective Over the past eighteen months, a new breed of enterprise mobility tools has emerged in the market. Gartner terms these as lowcode rapid application development platforms (RMAD). Combined with a mobile container app approach, these tools can comprehensively address all the issues that pharmaceutical organisations face with respect to MR productivity. Typically, a low-code rapid mobile application development platform (RMAD) facilitates building small apps that automate individual tasks. Its lowcode nature ensures that organisations can use their existing resources with basic HTML knowledge to build these apps (or micro-apps). The RMAD tools with a MicroService architecture for backend as well as front-end can help build mobile apps at speed with minimal DevOps hassles.

Low-code RMAD: A productivity panacea There are several MR team management and productivity challenges that a pharmaceutical organisation faces. A lowcode RMAD tool can resolve these issues satisfactorily. Let’s explore these advantages one by one. ◗ MR team engagement: As medical representatives spend their time mostly on the field,

A container app is the only app that a medical representative has to download and install. It houses all the apps inside the container and every new app introduced gets automatically added to an MR’s container their supervisors and senior managers rarely get adequate time to engage with them on a regular basis. A small app developed using low-code RMAD platform can help managers to stay in touch and communicate with their MR teams without asking them to visit the office. ◗ Motivation: Considering the tough job that the MR road warriors perform, keeping them motivated is the biggest responsibility of area managers, territory managers, and the likes. Using a low-code RMAD platform, pharma business teams can quickly develop a small app to incorporate and conduct quizzes, contests, assign targets, allocate KRAs, and provide incentives— thus, keeping their MR teams motivated. These apps can leverage the native features of smartphones and tablets. For example, the best performing MR can quickly take his own photo and publish it through the app for the entire organisation to view. Similarly, the

achieved targets can be captured, highlighted and incentives delivered on-the-fly. ◗ Intelligence gathering: A medical rep spends a great deal of time waiting at doctors’ clinics and hospitals. He is required to collect information such as potential and available spots to place display advertisements at these locations. Usually, medical reps feed-in all such information only upon returning to their office-locations. A small app can help an MR to use these wait-times to click photos of potential display slots (for educational material) and share it with the back-office teams instantaneously. The app can use the native features such as geo-tagging/maps to identify the exact location of the clinic (or hospital) at which the photo is clicked. Moreover, if a medical practitioner permits, he can record and instantly share with his supervisor a few minutes of audio capturing the specific queries raised by the practi-

tioner. This way, the organisation can save precious time of the MR while collecting deep market insights, simultaneously. ◗ Daily call logs: A mobile app can streamline the maintenance of call logs for MRs. With the help of an app, MRs can simply take a photo of the clinic's nameplate and/or doctor's business card to log a call. The app can interpret the image and also identify the location automatically, freeing up the MR from the mundane task of keying in the details after every meeting. ◗ Meeting schedules: Field supervisors can take a bird’s eye view of the clinics visited (and not visited) and assign appointment-targets to their juniors in near real time. The area or zonal managers can even develop a customised micro-app to automate such tasks using a lowcode RMAD platform on their own. When viewed on a regionwide or nation-wide scale, the same app can display the breadth and depth of the com-

pany’s market coverage at a glance. ◗ Education and training: A mobile app can streamline the training activity by making specific modules available for medical representatives for any-time, any-place learning. This includes information about new drugs, effects of drugs, precautions for patients, info on diseases, common doubts raised by doctors, and so on.

For that extra mile Lastly, while a low-code platform can help in quickly building micro-apps, it can work wonders when deployed along with a container app tool. A container app can help a pharmaceutical company to comprehensively address the user adoption challenge that organisations face. A container app is the only app that a medical representative has to download and install. It houses all the apps inside the container and every new app introduced gets automatically added to an MR’s container. Thus, an MR does not have to find, download, or install every app that the organisation introduces. By combining these cuttingedge technologies, pharma CIOs can speed-boost their enterprise mobility programmes and accomplish tremendous productivity gains for medical representatives in a very short time.

CONTRIBUTOR’S CHECKLIST ❒ Express Pharma accepts editorial material for

❒ We welcome information on new products and

regular columns and from pre-approved contributors / columnists. ❒ Express Pharma has a strict non-tolerance policy of plagiarism and will blacklist all authors found to have used/refered to previously published material in any form, without giving due credit in the industryaccepted format. All authors have to declare that the article/column is an original piece of work and if not, they will bear the onus of taking permission for re-publishing in Express Pharma. ❒ Express Pharma's prime audience is senior management and pharma professionals in the industry. Editorial material addressing this audience would be given preference. ❒ The articles should cover technology and policy trends and business related discussions. ❒ Articles for columns should talk about concepts or trends without being too company or product specific. ❒ Article length for regular columns: Between 1200 1500 words. These should be accompanied by diagrams, illustrations, tables and photographs, wherever relevant.

services introduced by your organisation for our various sections: Pharma Ally (News, Products, Value Add), Pharma Packaging and Pharma Technology Review sections. Related photographs and brochures must accompany the information. ❒ Besides the regular columns, each issue will have a special focus on a specific topic of relevance to the Indian market. ❒ In e-mail communications, avoid large document attachments (above 1MB) as far as possible. ❒ Articles may be edited for brevity, style, and relevance. ❒ Do specify name, designation, company name, department and e-mail address for feedback, in the article. ❒ We encourage authors to send their photograph. Preferably in colour, postcard size and with a good contrast.

48 EXPRESS PHARMA April 1-15, 2018

Email your contribution to: The Editor, Express Pharma, Business Publications Division,

The Indian Express (P) Ltd, 1st Floor, Express Towers, Nariman Point, Mumbai - 400 021. Tel: 91-22-2202 2627 / 2285 1964/ 6744 0000 Fax: 91-22-2288 5831 viveka.r@expressindia.com

PHARMA ALLY PRODUCTS

nice Neotech Medical Systems launches unique features and benefits nice Neotech has launched the following products: Respiratory Humidifier

tilation, Infant Bubble CPAP, resuscitation, and oxygen therapy.

(nice 8010) ◗ Capable of operating in non-invasive control mode with low, medium and high temperature setting. ◗ It can be used for invasive ventilation, non invasive ventilation and oxygen therapy.

Reusable Adult Humidifier Chamber ◗ Autoclavable humidifying chamber with peak flow bypass. ◗ Chamber compressible Volume for high flow 700ml. ◗ Maximum water capacity 280 ml. ◗ 360 deg viewable water line for ease to monitor the water level from all angles. ◗ Highly durable intended for multiple usages. ◗ Gas sterilisation up to 218º C. ◗ Water fill port for refilling wa-

Infant care ◗ Capable of operating in non invasive control mode with low, medium & High temperature setting. ◗ It can be used for Infant Bubble CPAP, Resuscitation, and oxygen therapy. Reusable Paediatric/Neonatal Humidifier Chamber ◗ Autoclavable low compressible volume humidifying chamber. ◗ Chamber compressible Volume for high flow 360 ml. ◗ Maximum water capacity 230 ml. ◗ 360 deg viewable water line for ease to monitor the water level from all angles. ◗ Highly durable intended for multiple usages. ◗ Gas Sterilisation up to 218ºC. ◗ Water fill port for refilling water during operation. ◗ Bio-compatible material minimises risk on patient with safer material. ◗ Burn-free design minimises risk of accidental burn.

nice 8050 Servo Control Respiratory Humidifier Adult Care ◗ Capable of operating in either invasive or non-invasive control mode with flow detection. ◗ It can be used for invasive ventilation, non-invasive ventilation and oxygen therapy. Infant Care ◗ Capable of operating in either invasive and non-invasive control mode with flow detection. ◗ It can be used for invasive ven-

continues to warm during delivery. Rain-out and waste are reduced, while the need for circuit change is minimised. ◗ Comprehensive audible and visual alarm constantly protects against potential problems. The nice 8050 will alert at variations of set temperature Vs actual. ◗ The design of nice 8050 and nice 8010 makes it the ideal humidification system for Adult Ventilator, Infant Ventilator, NCPAP, Bubble CPAP, Infant Resuscitator & Oxygen Therapy for Adult, Paediatric & Neonatal care. The nice 8050 & nice 8010 accommodates both high and

nice 8010

nice 8050

ter during operation. ◗ Bio-compatible material minimises risk on patient with safer material. ◗ Burn-free design minimises risk of accidental burn.

low flow ventilation therapies, as well as heated and non-heated wire breathing system. The nice 8050 and 8010 delivers precise, reliable performance. An advanced microprocessor controller assures the control of the system. The system responds immediately to any change in settings, and constant self diagnostic verify proper operation every second of use. High and low temperature protection is assured through out operation, including warmup and setting changes. if the delivery temperature exceed 41°C independent circuitry shutdown all heating elements.

Features: ◗ Designed for use in hospital environment wherever medical gas is being supplied to patients, nice 8050 and nice 8010 heated wire humidifier incorporates latest technology that provides physiological level of humidity at body temperature. ◗ The nice 8050 features dual servo control feedback system, incorporates to constant monitoring and control chamber and proximal temperatures in the airway line. As a result high temperature gases cannot exist anywhere in the system. When use a heated wire breathing system from nice 8050, ventilated gas

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Provides essential equipment for safe and easy delivery of Neonatal CPAP Optimise lung protection and breathing support Continuous Positive Air- way

Pressure (CPAP) supports infant breathing by providing respiratory support throughout the respiratory cycle. OxyPAP maintains the infant's functional residual capacity by helping to prevent airway closure. CPAP promotes gas exchange in the alveoli, which acts to enhance airway patency, improve lung volume recruitment and maintain infant energy reserves, without the complications associated with endotracheal intubation. Optimal humidity (37°c, 44mg/L) with CPAP is vital to support an infant's breathing and protect its developing lungs. Optimal humidity protects the lungs to optimise outcomes for the infant by minimising airway drying, improving secretion clearance, reduce airway constriction. Features: ◗ Safe and reliable The Unique Bubble CPAP generators provides consistent and accurate delivery of CPAP. The Reusable Pressure Manifold with pressure relief valve for infant safety. The manometer is provided to ensure the delivery of accurate PEEP. Rotating PEEP adjustment knob to prevent the use error of setting the PEEP. Servo control humidifier with temperature indication with heater wire for humidity of delivered gas. ◗ Easy to use Easy to adjust the PEEP setting on the Bubble CPAP generator. Easy to set modes of humidifier. Easy to fix the nasal prong with the neonates.

OxyPAP nice 5060 Bubble CPAP ◗ Optimum humidification The Bubble CPAP system provides respiratory supports with body temperature saturated gas to the infant. Optimal humidity promotes mucociliary clearance and reduces the work

OxyPAP nice 5060 Bubble CPAP

of breathing. ◗ Infant nasal prongs Contoured nasal prongs made from non-reactive silicone along with a unique cannula body provides stability during therapy. The integrated pressure monitoring line allows the monitoring of nasal prong pressure without having lines near the infant's face. Offered in seven different sizes, it can be used on a wide range of patients from premature to new born baby. ◗ Bubble generator Bubble generator provides a convenient means to apply positive airway pressure, freeing the clinician to focus on patient care, not the device. This design delivers accuracy and stability throughout the course of therapy. The ergonomic design allows airways pressure to be easily set without the cumbersome time consuming tasks normally associated with bubble devices. Water feeding port allows water to be added or removed by disconnecting the expiratory circuit. Minimum and maximum lines clearly visible in highly transparent jar with overflow container. Contact details nice Neotech Medical Systems No: 85, Krishna Industrial Estate, Mettukuppam, Vannagaram, Chennai-600 095 Tamil Nadu Tel: +91 44 2476 2594 / 2476 4608 M: +91 98408 73602 / 98408 74902 Web: www.niceneotech.com

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April 1-15, 2018

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Gandhi Automations’high speed doors ideal for medium and large entrances GANDHI AUTOMATIONS, India’s No.1 entrance automation and loading bay equipment company offers high speed doors. High speed doors designed and manufactured by Gandhi Automations are sturdy, dependable and are the ideal solution for medium and large entrances. The doors are manufactured with European collaboration and technology with innovative and creative engineering. Fast moving functional and reliable doors are needed in industrial and commercial contexts. Gandhi Automations’ designed and manufactured high speed doors are versatile and solid ensuring long-lasting reliability. The modular structure of the curtains, assembled and joined by anodised aluminium extrusions, provides for a wide range of polyester sections available in a variety of colours. Wide, full-width window panels ensure a safer traffic and allow more light in. Their fast and easy replacement, in case of accidental tearing, saves money and time. The alternating metal tubular structure there inserted ensures high wind-resistance. Prime high speed doors are the ideal solution for internal and external entrances and effectively operate in any situation, even when strong winds are blowing and in rooms with high volume traffic. Sturdy and dependable, Prime is the intelligent door for medium and large entrances. High speed doors for external entrance are equipped with spring steel wind lock in curtain pocket that ensures silent door travel, higher wind loads and curtain stability. Contact details Gandhi Automations Chawda Commercial Centre Link Road, Malad (W) Mumbai – 400064 Off: +91 22 66720200 / 66720300(200 Lines) Fax: +91 22 66720201 Email: sales@geapl.co.in Website: www.geapl.co.in

50 EXPRESS PHARMA April 1-15, 2018

PHARMA ALLY VALUE ADD

Caramelisation or darkening in the colour of autoclaved liquid BI ampoules Russ Nyberg, Director of Manufacturing and Production, Mesa Labs, explains glucose and other sugars that may be present in the media slightly darken and the overall appearance of the media will look more of a dark honey or light brown colour. The shear presence of the additional purple pH indicator used in these ampoules make the colour look even darker than media would without the pH indicator WHEN AUTOCLAVING liquid agar or tryptic soy broth, many times the sterilised media takes on a darker than expected colour due to the sterilisation and resulting exposure to heat. This presents a concern when working with sealed glass ampoule type biological indicators (BI) that contain tryptic soy broth (TSB). With most ampoule type self-contained biological indicators, the bacterial spores are contained in the ampoule as a suspension of spores and TSB. Once the ampoule BI has been autoclaved in a typical cycle being monitored, the ampoule is then incubated to see if all the spores are dead or if some survived the cycle. This growth/no growth testing is evaluated by looking at the colour and clarity of the TSB within the ampoule. The ampoules also contain a pH indicator that gives the TSB a purple colour. Upon incubation, if the spores were not killed in the cycle they will germinate to vegetative cells, metabolise the TSB and begin to grow. As part of the metabolism of the sugars present in the TSB, acidic waste products are released and the colour of the ampoule changes from purple towards a yellow colour as a result of a lowering of pH. When one is using the self-contained ampoule the question arises as to whether the normal darkening of colour that occurs when ampoules are exposed

to extended or high temperature cycles will still promote growth and detect any badly damaged spores that may have survived the cycle. This is mainly being questioned since some individuals have stated that the darker colour ampoules are caramelised and will no longer function due to an inability to promote growth. Other than heat sensitive selective media, most other media, when sterilised according to manufacturer’s directions, are to be sterilised at 121°C for 15 minutes. This time and temperature parameter for sterilisation is made very clear in USP 1 to mean ‘time at temperature of media’. Thus 15 minutes at 121°C means that the media is held at 121°C for a full 15 minutes. Considering that a come-up time could be 20 minutes for the media flask to reach temperature, the entire cycle would be set at 35 minutes: 20 minutes for come-up and an additional 15 minutes at 121°C.

Director of Manufacturing and Production, Mesa Labs

Longer or extended cycles along with cycles that are run at higher temperatures beyond the specified 15 minutes at 121°C are likely to some degree or another cause a natural darkening or a brown colour caramelisation of the media. This is an occurrence simply due to the exposure of the media to extended or higher heat cycles other than specified by the manufacturer and by the physical presence of a purple coloured pH

indicator. During caramelisation the glucose and other sugars that may be present in the media slightly darken and the overall appearance of the media will look more of a dark honey or light brown colour. Along with the media itself darkening, the shear presence of the additional purple pH indicator used in these ampoules make the colour look even darker than media would without the pH indicator. Caramelisation is a major concern with most users of self-contained sealed glass ampoule type biological indicators such as ProSpore Ampoule or MagnaAmp. Typically when these biological indicators are used in various situations where the ampoules are exposed to extended cycles or higher temperature cycles rather than just 15 minutes at 121°C, the colour of the media tends to darken. Both of these types of BIs have bacterial spores suspended in an ampoule of TSB

During caramelisation the glucose and other sugars that may be present in the media slightly darken and the overall appearance of the media will look more of a dark honey or light brown colour.Along with the media itself darkening, the shear presence of the additional purple pH indicator used in these ampoules make the colour look even darker than media would without the pH indicator

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which contains sugar. The ampoules also contain a purple pH indicator for user ease in determining growth within the ampoule. If the BI was not killed in the sterilisation cycle, upon incubation the surviving spores metabolise the sugars, release acid waste and when the pH goes down as a result, the pH indicator changes the ampoule colour from purple to yellow. If slight caramelisation occurs while autoclaving these ampoules, due to the sugar presence along with the physical presence of a purple coloured pH indicator, the ampoule will seem darker in colour than would be expected and darker when compared to an unprocessed ampoule. This is why a negative control ampoule should be used for a visual processed ampoule colour. The negative control ampoule is run along with the test ampoules and can be used as a future colour reference of what a normal ‘processed’ ampoule colour will be when it is removed from the autoclave. Upon incubation, an ampoule that is demonstrating growth will change further in colour to or towards a honey or yellow colour and will exhibit turbidity. This additional colour change can easily be noted when it is compared to the colour of a processed control ampoule. A potential problem can occur when one person removes the ampoule from the autoclave after a cycle has been run and places

EXPRESS PHARMA

April 1-15, 2018

PHARMA ALLY the ampoule in an incubator without noting or taking notice that the ampoule colour has already changed from its initial bright purple colour. After 48 hours of incubation the ampoule is removed from the incubator by someone else who is unaware of the normal colour change of the processed ampoule and thinks the colour change of the ampoule being removed resulted from being incubated and records the colour change as a positive test. This is a situation that can be avoided by keeping a processed ampoule as your colour guide for a normal colour change and as a colour example for a negative growth ampoule test.

Ampoules with growth (right) and without

Will the caramelisation compromise the media’s ability to promote growth? In an attempt to determine if caramelised TSB that is used in an ampoule BI will still promote growth, a study was done in 2009 by personnel at Mesa Labs’ Omaha Manufacturing Facility2.Raven Labs in Omaha Nebraska, a division of Mesa Labs. In this study,

numerous test ampoules and control ampoules were autoclaved in an extended time and high temperature cycle. These ampoules were run in the autoclave for 2 hours at a temperature of 132°C. When removed, the ampoules were very dark in colour. The growth promotion ability of the sterilised media was then tested by aseptically breaking the tops off the ampoules and inoculating each ampoule with Geobacillus stearothermophilus spores. This bacterial spore was chosen since it is the species initially present in the BI ampoules for testing. All ampoules were then incubated at 55 to 60°C for 48 hours. All 20 of the sterilised ampoules that were inoculated with viable spores showed signs of growth by turning the media colour toward yellow within 48 hours of incubation. Thus the media’s darkening or caramelisation during exposure did not compromise the media’s ability to promote growth and provide useful sterilisation test data. It should be noted that some caramelisation with various media types may not

promote the growth of other bacterial species if one is using bacterial species other than those used in ampoule BIs. Additional testing would need to be done with that media and/or those organisms. However, for the BI indicator organism Geobacillus stearothermophilus used in spore ampoules, the darkening and caramelisation of the media will not affect the growth promotion ability of the media or the function of the BI. Will the BI still function when the media is so dark? YES How can I tell a positive ampoule when the media is so dark? Compare the exposed and incubated test ampoule to the exposed and incubated negative control ampoule for determination of colour change.

References 1 USP 31, Pg. 3804,General Information, Media Preparation and Quality Control 2 Robert Bradley, ProSpore Media Integrity Study, Nov. 2, 2009, www.MesaLabs.com, Technical Papers

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Digitalisation is changing the future of Pharma Pooja Patil, Corporate Communication, B&R Industrial Automation, talks about B&R’s versatile industrial transport systems, SuperTrak and ACOPOStrak for the pharma industry, which can achieve the increased market demand effectively and efficiently

DIGITAL REVOLUTION is bringing remarkable changes in all business models. Pharmaceutical manufacturing companies are no exception to this. They have started adopting advanced automation technologies in their manufacturing plants to achieve optimisation and improve efficiency of their machines and factories. Manufacturers need to take full advantage of these technologies to compete effectively in the ever-changing global marketplace. In the era of digitalisation, IT and automation are converging with data management, connectivity, supply chain, finance, sales, inventory and much more at the core. Thus, today, automation is not only limited to industrial manufacturing and shop floors, but its expanding to higher levels, IT, suppliers and laboratories too. Growth of the pharma market is leading to new products as well as the need for factories to handle increased volume. To minimise workload and maintain high levels of accuracy, automation has become a significant part of pharma manufacturing. It increases efficiency, avoids human error and contamination. In addition, with the use of robots, the pharma industry is ramping up. Pharma packaging machine builders are adopting off the shelf and customised robots, subsequently pushing other suppliers to embrace robotic solutions.

tors and consumers. Current machine designs are unable to fulfil these demands and in order to fulfill this demand- supply ratio, pharma machine builders are turning to efficient industrial transport technology over conventional transport and conveyor systems. This technology helps in product transport as well as is able to handle delicate products efficiently. This technology is appropriate for the pharma sector, where profitability is heavily influenced by the performance of the production lines. B&R’s versatile industrial transport systems, SuperTrak and ACOPOStrak are the answer to market demands to achieve the increased demand effectively and efficiently. Based on long-stator linear motors, B&R’s next-generation

Pooja Patil, Corporate Communication, B&R Industrial Automation

industrial transport systems are constructed with IP65 dust and water protection and smooth surfaces that are easy to clean. The hygienic design certifies operation in food grade environment. The industrial-grade design ensures high availability and reliability with 24/7 operation. Dependable, precise and remarkably low maintenance –ACOPOStrak melds seamlessly with robotics and CNC systems to create integrated production lines. The flexible tracks used in the system make production more efficient, simultaneously improving product quality. This helps in making the production and packaging lines economical and effective at any volume from mass production down to batch size one. By eliminating the need for buffer zones, they allow for a substantial reduction in track length

compared to conventional belt conveyors. They also make much more efficient use of the remaining space by utilising curve sections and incorporating reverse movements. Products can be transported flexibly and independently and then grouped together at a station to be processed as a batch. Overall, the production process can be accelerated by up to 50 per cent for a significant boost in productivity. B&R’s smart-factory motion control used in the transport technology helps to achieve key advantages as maximum availability, high-speed transport and positioning, rapid changeover and fault-tolerant high quality. ACOPOStrak boosts the overall equipment effectiveness (OEE), multiplies return on investment (ROI) and accelerates the time to market (TTM).

Transport technology to achieve efficiency The growing market demand is continuously driving a proliferation of new products and hence new packaging formats tailored to complex preferences from retailers, distribu-

B&R makes it easy to synchronise robots and conveyor belts

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PHARMA ALLY Build it with digital twin Digital twin allow companies to have a complete digital footprint of their machines from design and development to the end of product life cycle. B&R helps machine builders to virtually develop their machines without the need of actual mechanics and electronics. Virtualisation allows descriptive models to be constructed in order to simulate the behaviour of the motion control system or control loops even without the electronics or mechanics. This allows future design challenges, complexities and errors if any to be identified early. A Digital Twin can have several benefits including the ability to run in-line with the real machine to enable rapid task-planning, early detection of potential problems and cost reduction during development and product machining. Digital twin of a machine with ACOPOStrak is a virtual copy of the machine, which can be simulated for observing the behaviour of the system without actually building it. Digital twins allows to perform software-inthe-loop testing to validate and optimise the work early on – without the risk and expense of real hardware. Digital twins ensure superior machine design, streamlined commissioning and smooth operation – while substantially reducing the time it takes to engineer new machinery or implement new products on existing machines. With B&R, such virtualised concepts via MapleSim, Mathworks or industrialPhysics can be easily converted to a source code at the single click of a button for deployment in a controller. In this way, by integrating a Digital Twin of the machine design on a real-time platform, the virtual machine can be configured and tested even before the real machine is built, accelerating the commissioning process, reduce risks and decrease costs.

Seamless integration of robots Keeping in mind, the rigorous operational demands, pharma factory operators are demanding more flexible packaging machines. Machine builders and automation vendors are responding with systems that

54 EXPRESS PHARMA April 1-15, 2018

3D simulation shows the behaviour of all shuttles in combination with synchronised subsystems like robotics and CNC

The pharma industry understands the value and the potential of digital transformation, which has opened the door for significant step change improvements. The companies who seize this initiative can give themselves a sustainable competitive advantage; operate with greater agility, cost-efficiency, and control; and ultimately provide better care for patients promise less complexity, less engineering and programming time with less expense and higher productivity. Today, pharma packaging machine builders are actively deploying robots, increasing productivity, ensuring safe operations and reducing machine footprint. This eventually gives rise to a lean manufacturing line with increased efficiency and safety. B&R technology removes the boundaries between machines and robots. B&R offers the most advanced form of integration with robots incorporated seamlessly into the ma-

chine control logic. Whether it’s a press brake, packaging line or injection molding system, the machinery and robots utilise the same processor, memory and timing. Ethernet POWERLINK helps in synchronisation of robot and machine with a cycle time of 100µs and a low jitter. The common DC bus enables maximum energy efficiency. openROBOTICS has opened up new dimensions of robotics integration for machinery and production lines. With completely uniform programming for every component in the line — including robotics — B&R

customers around the world gain full benefit of holistic approaches to operation, diagnostics and maintenance. openROBOTICS, provides an option for total integration with a possibility of a single controller from B&R for robot as well as machine control and programming. These systems run on open source, vendor independent, high-speed, real-time network Ethernet POWERLINK coupled with a fieldbus independent, open source, TÜV certified safety openSAFETY. B&R has already a successful implementation for a human

robot collaboration application where the robot is not bounded by cage and works together with humans satisfying entire safety requirement.

A step towards digital manufacturing with B&R The pharma industry understands the value and the potential of digital transformation, which has opened the door for significant step change improvements. The companies who seize this initiative can give themselves a sustainable competitive advantage; operate with greater agility, cost-efficiency, and control; and ultimately provide better care for patients. B&R is a global automation provider with groundbreaking motion control, machine operation and control solutions for pharma processes. From blister packaging to fillers and cappers, from cartoning to case packers or palletisers and robotics with integrated vision inspection systems, remote diagnostics and maintenance, secure and real time connectivity, LLM technology and much more – B&R provides the best automation solutions for pharma machines and plants.

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April 1-15, 2018

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S. P. PRODUCTS

PHARMA EQUIPMENTS AT IT'S BEST

S.S. MULTIPURPOSE TROLLEY

S.S. VIAL / AMPOULE BOX

S.S. CAGE TROLLEY

S.S. TROLLEY FOR STD WEIGHT / STORAGE

S.S. CONTAINER (5LTR - 500LTR)

S.S. STEP OVER BENCH WITH SHOE RACK

S.S. HELMET STAND

S.S. CHEMIST TABLE.

S.S. STERILE CABINET WITH UV LIGHT

S.S. SIEVES FOR SIFTER / MULTIMILL / CADMILL

S.S. CROSS OVER BENCH 'L TYPE & 'C TYPE

SS INPROCESS CONTAINER

S.S. DRAIN TRAP (SINGLE / DOUBLE SEAL)

S.S. PADDLE / TILTING DUSTBIN

S.S. KEY BOX

S.S. SIEVES TROLLEY

S.S. TRAY

S.S. SPOON / MEASURING JAR / SCOOPS

S.S. STERILLIUM STAND

S.S. STEP LADDER

S.S. PERFORATED / PLAIN TABLE

S.S. PASS BOX

S.S. CABINET FOR FBD BAGS STORAGE

S.S. TROLLEY FOR HAND DISINFECTANT / HAND GLOVES / MASK /ROLLER

S.S. STREET SHOE RACK

S.S. PALLET

S.S. ANTIVIBRATION TABLE S.S. FIX / REV STOOL / CHAIR TM

S.S. CABINET FOR BLISTER S.S. LOCKER S.S. VISITOR CHANGE PART / STRIP CH PART / FOR KEEPING APPRON CABINET POLYBAG STREET GARMENT

• All products are custom made & available in 304, 316 & 316L Quality with optional Matt & Mirror finish. • We undertake the side work of Cladding of Machinery & others.

April 1-15, 2018

S.S. CABINET FOR MULTIMILL SIEVES

S.S. WRITING DESK WITH DRAWERS

S.S. II CHANGE CROSS OVER BENCH

Contact: Mr. Kiran Shah / Mr. Chirag Shah

S.S. DIES & PUNCHES CABINET

OFFICE: F-823, VEENA SANTOOR BLDG., NEAR PAWANDHAM, BEHIND 'D' MART, MAHAVIR NAGAR EXTN. ROAD, BORIVALI (W), MUMBAI-400092. TELEFAX: 28197068 / 3082 MOBILE: 98200 54453. Email: info@pharmaequipments.com URL: www.pharmaequipments.com WORKS: W6, OM SAI COMMERCIAL COMPLEX, GODDEO ROAD, NEAR EKVIRA GAS GODOWN, BHAYENDER (EAST), THANE - 401 105 TEL: 2819 3082

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PVC RIGID FILM FOR BLISTER FORMING

TRIPLEX LAMINATE

US FDA Type III DMF: 032495

US FDA Type III DMF: 032497

ALU ALU LAMINATE

PVdC COATED PVC FILM

US FDA Type III DMF: 032494

US FDA Type III DMF: 032496

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

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

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

SLITTER COATING LINE

Ÿ Producing 60 Micron PVC Film by Direct

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

Manufacturing site Ÿ 29000 Sq. Mtr. of Manufacturing Area

LAMINATOR

Ÿ 6000 Sq. Mtr. Built-up Area

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

April 1-15, 2018

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ATCC Culture ®

• Atcc Derivatives

• Quantitative & Qualitative With

Certification To Usage And Handling • Available vailable In 1st, 2nd & 4th • Easy To Passage, assage, Kwik Stik / Kwik Stik • Biochemical TTest est Report Report Is Provided Provided Plus & CRM Along With Every COA Of Culture • Lyophilized yophilized Cultures

ISO 9001 - 2015 Certiﬁed Company

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

OSMOMETER 3250 www.kesarcontrol.com

www.kesarcontrol.com

Humidity Chamber

Cold Chamber

Service Network all over INDIA Milk Cryoscopes Available

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

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

Mobile : 09427613646 Email : service@kesarcontrol.com

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

April 1-15, 2018

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introduce

An Enterprise Providing Professional Value of Optimized Technology Name Source : Advantage + Technology + Praxis + Practice

From Technique for Humanity

From Zero Base to Innovation

Breakthrough the existing frame, users-centered and innovative new product

Optimized Technology

Tablet Press

Capsule Filling F Series

P Series

Sejong Coater

Sejong FBD

C Series

D Series

Source Genuine Sejong Spares from Allpharm Alone Save your high tech machines from Non OEM, Spurious parts

A 404, Rajeshri Accord, Teli Galli Cross Lane, Andheri (East), Mumbai - 400 069 Tel: +91 97691 99633 Email: mail@allpharm.in Web: www.allpharm.in

April 1-15, 2018

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BI For Silicon / Flexible Tube Validation Is Silicon / Flexible Tubing Sterilisation Validation Is Cumbersome ? • Easy To Use • Easy To Install • No Destruction Of Tube

*Check The Efcacy Or Validation Of H2O2 / VHP Process*

S S Carrier Designed for use With Isolator / Filling Line With ATCC - 7953 / 12980

• Apex Discs • Apex Ribbons • Tri-Scale Bioligical Indicator

June Product Catalogue for free download look for JUNE4GMP

11X14EPAd02

For Hydrogen Peroxide

June Enterprises Pvt. Ltd. | www.june4gmp.com quality@june4gmp.com | 022-27787913 ISO 9001 - 2015 Certified Company

LABORATORY EQUIPMENTS

Lab Stirrers Hot Plate Magnetic Stirrers

Walk-in chamber

Refrigerated Centrifuge Deep freezer

Single Door Refrigerator

Laboratory Centrifuge

Cyclomixer

Mini Rotary Shakers

Incubator Shaker

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

April 1-15, 2018

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To Advertise in

Business Avenues Please Contact: ■ Mumbai: Rajesh Bhatkal 09821313017 ■ Ahmedabad: Nirav Mistry 09586424033 ■ Delhi: Ambuj Kumar 09999070900 ■ Chennai ■ Bangalore: Kailash Purohit +91 9552537922 ■ Hyderabad: Mujahid 09849039936 ■ Kolkata: Ajanta 09831182580

We care for your health DIGESTIVE AIDS ü Alpha amylase / fungal diastase / fungal amylase ü Alpha galactosidase ü Bacterial alpha amylase ü Bromelain ü Hemicellulase ü Lactase ü Lipase ü Ox bile ü Papain ü Pepsin ü Pancreatin ü Protease (acid / alkali)

ANTI-INFLAMMATORY ENZYMES ü Serratiopeptidase ü Peptizyme (enteric coated serratiopeptidase granules) ü Trypsin Chymotrypsin mix (6:1)

PROBIOTICS ü Saccharomyces boulardii ü Lactic acid bacillus ü Bacillus Subtilis ü Lactobacillus Plantarum.

CIRCULATORY HEALTH ü Nattokinase

BIOCATALYSTS ü Addzyme Liquid ü Addzyme Powder ü Addzyme Immobilized

ADVANCED ENZYME TECHNOLOGIES LTD. Sun-Magnetica, ‘A’ Wing, 5th Floor, LIC Service Road, Louiswadi, Thane (W) 400 604 Tel: +91-22-4170 3200 | Fax: +91-22-2583 5159 Email: info@advancedenzymes.com | www.advancedenzymes.com

April 1-15, 2018

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PHARMA LIFE

Dr G Ramakrishnan receives ISAS Lifetime Achievement Award Dr G Ramakrishnan received the award for promoting advancement of science and technology, especially in the area of education in chromatography and spectroscopy through Chromatographic Society of India

r G Ramakrishnan, President, Chromatographic Society of India & Honorary Director, SIES Institute of Chromatography and Spectroscopy recently received Indian Society of Analytical Scientists (ISAS) Lifetime Achievement Award during the Indian Analytical Science Congress-2018. The event was held at Kumarakom, Kerala. The award was handed over by Dr U Kamachi Mudali, Chairman and CEO, Heavy Water Board, Department of Atomic Energy, Government of India. Dr Ramakrishnan said, â&#x20AC;&#x153;This award was meant for my contributions in promoting advancement of science and technology, especially in the area of education in chromatography and spectroscopy through Chromatographic Society of India and SIES Institute of Chromatography and Spectroscopy over the past several years.â&#x20AC;? EP News Bureau

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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

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