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In Conversation With 11

Special Focus 12

Roundtable 17

Facility Visit 18

S C Sehgal Chariman and Managing Director, Ozone Group of Companies

FDI in pharma retail Against all odds…

How can chemists integrate better with pharma companies?

ACG Pampac, Talegaon (Pune) Providing innovative packaging solutions

Intas plans to raise ` 1,000 crore by IPO Ahmedabad-based drug manufacturer, Intas Pharma has decided to raise around ` 1000 crore through its Initial Public Offer (IPO) plan. The company receives around 40 per cent of its sales from overseas and its gross revenues cross around ` 3,000 crore. Meanwhile bankers value this company to be more than ` 5,000 crore. The promoters currently hold around 85 per cent and Chrys Capital holds a stake of 15 per cent in Intas. Chrys Capital is a Private Equity (PE) firm, which had invested ` 300 crore last year before Intas had planned to hit the markets.

Glenmark recalls three drugs According to US FDA, Glenmark Pharmaceuticals subsidiary, Glenmark Generics, is recalling multiple lots of its three drugs from US market due to ‘odd smell’. A notification issued by US FDA said that the drug major has initiated voluntary recall of its Gabapentin tablets 600 mg, 500-count bottle and 800 mg, 500-count bottle; Pravastatin Sodium tablets 40 mg, 90-count bottle; and Topiramate tablets 200 mg, 60-count bottles from the US market following the identification of the problem. The recall was initiated under Class-III which FDA defined as ‘a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.’

US FDA imposes ‘import alert’ on Wockhardt Wockhardt is next in line to face the ire of US FDA. It imposed a ban on a plant operated by the generic drug maker at Aurangabad, Mahrashtra. In April, Wockhardt said that the FDA had carried out an inspection at its injectables plant in Aurangabad in Maharashtra, and had issued form 483s to the company. A form 483 is issued when inspectors see conditions that they believe may violate US rules, according to the FDA. An FDA import ban can be costly. The Wockhardt management, however, said it should be able to restore most of that ($ 100 million impact on revenues) within six to nine months by shifting production elsewhere. “That is a worst-case scenario,” said Habil Khorakiwala, Chairman, Wochkardt. The news has sent the price of the company shares to a 7-month low.

How will the Ranbaxy case affect Indian drug makers? Reputation built over the years does not take too long to destroy. With Ranbaxy recently pleading guilty, and agreeing to pay a whooping $ 500 million fine, as a part of drug safety settlement, the Indian pharma industry is abuzz with the impact that this case may have on the industry. The optimistic part of the industry believes that such cases do not badly deter the ‘Indian’ image as they are ‘one-odd’ cases occuring rarely. While the pessimists of the industry are holding their guns and believe that $ 500 million is a ‘kind’ fine for the impact that this will have on the Indian generics industry. Post the recent happenings, Arun Sawhney, CEO & Managing Director, Ranbaxy, stated that, “Ranbaxy is a different company today. The steps we have taken over the recent years reflect the wide-ranging efforts of the current board and management to address certain

conduct of the past and ensure that Ranbaxy moves forward with integrity and professionalism in everything we do. We are fully committed to upholding the high standards that patients, prescribers and all other stakeholders expect.” Time will only tell so as to how far will these steps and statements help in salvaging the industry and company image? MNCs have been attracted towards the Indian pharma market post the introduction of product patents in 2005, 100 per cent FDI in pharma in 2006 and the country’s strong growth prospects for generics and biosimilars. However, recent spate of issues in the form of Glivec disapproval, approval of Zita and Zita-met and other approvals of compulsory licences might make these companies wary of Indian laws and Indian companies.

The recent case has questions looming over the credibility of quality of Indian generics firms, the authority of independent auditing firms, the corporate integrity of Indian firms and it will be interesting to see how China takes advantage of the current situation and increases the lead it already has over the Indian generics market. Will the number of FDA-approved plants in India be affected in the long run? Will Japanese and other MNCs shy away from buying Indian firms? Will FDA get more stringent on granting approvals to Indian firms? There are many questions arising with this case. It will be worth noticing how well the Indian drug and policy makers move amid this scenario, because when they move global to do business their business practices will be under a big scanner. Parita Dholakia

DISSO INDIA begins with a focus on quality Every pharmaceutical product has to pass through dissolution testing process. This testing helps in classification of the product’s traits. The growing market demands for improved and better testing processes. Society for Pharmaceutical Dissolution Science (SPDS) has organised its 1st Annual International Symposium Conference, Disso India 2013 on May 3rd and 4th at The Lalit, Mumbai. The event is focussed on introduction of new technology, innovation and various issues faced related to ‘dissolution.’ Dissolution is vital as it is the predictable test for the effect of medicine in human body. This test is called in vitro test as it simulates the action of medicine in the body and is performed on a machine called dissolution tester. Before getting released in the market, 70 per cent of the global pharmaceutical medicines produced undergo dissolution testing. Vinod P Shah, Pharmaceutical Consultant, said, “No drug can pass without dissolution test. With the increasing variations of products

Delegates at the inauguration ceremony of the DISSO-2013

the types of processes is also increasing. In coming years, we are going to have dissolution testing for ointments.” Supporting the context, Dr L Ramaswamy, Managing Director, Sotax, said, “This was the first time that we arranged this conference. We are hoping for more such events and provide maximum information to the people from the industry.” Disso India 2013 event witnessed eminent professionals from the pharmaceutical industry. Disso India is being attended by the professionals from R&D, QA and QC as well as the Academia. As many as 300 delegates

registered and participated in the event, which is the first mega event focussing on dissolution. The event was organised under the Chairmanship of Dr Vinay G Nayak, President-Technical, Alembic Pharmaceuticals Ltd. Dr L Ramaswamy, Managing Director of Sotax India Pvt Ltd is the Organising Secretary of this event and the General Secretary of SPDS. The Scientific sessions were programmed and executed under the chairmanship of Dr Mangal Nagarsenker, HOD & Professor - Pharmaceutics, Bombay College of Pharmacy, Mumbai. Anubhav Sharma

Adaptive signs biomarker discovery collaboration agreement with Bristol-Myers Squibb Adaptive Biotechnologies recently announced that it has entered into a collaboration agreement with BristolMyers Squibb (BMS) for the discovery of immunological biomarkers in oncology. Under the collaboration, Adaptive will use its proprietary immune profiling assay, immunoSEQ, to identify potential biomarkers that may inform about drug response. The immunoSEQ assay uses high

throughput next-generation sequencing to characterise the repertoire of T and B cell receptors. Application of this technology is being explored in cells of cancer patients, to assess the impact of treatments on the immune system and evaluated as a tool to identify patient populations who might be more likely to respond to targeted therapies based on their immune status.

“We are delighted to collaborate with BMS to help uncover immunological biomarkers of response to cancer agents,” said Chad Robins, CEO and Founder, Adaptive Biotechnologies. “Collaborating with BMS is a real win for companies like ours that are committed to deepening the understanding of the interaction between the host immune system and the cancer cells themselves.”


CONTENTS In Conversation With


S C Sehgal Chariman and Managing Director, Ozone Group of Companies





Special Focus Pharma Retailing FDI in pharma retail Against all odds… OTC pharma retailing Factors governing product sales

12 14

Interface P B Ramamoorthy Jt CEO - Pharmacy Retail, Apollo Hospitals Group Hemanth Bothra Managing Director, Trust Pharmacy

15 16

Roundtable How can chemists integrate better with pharma companies?


Facility Visit ACG Pampac, Talegaon (Pune) Providing innovative packaging solutions

PRESIDENT & EDITORIAL DIRECTOR, TV 18 Senthil Chengalvarayan


DESIGN Varghees Tharakan

19 20

5 Editorial / Guest Editorial



Case Study: Single-use pumps Taking center stage Wallace Wittkoff, Hygienic Market Director-Americas, Pump Solutions Group (PSG®) and Ravi Prasad, Director - Sales, PSG India



EDITORIAL TEAM Parita Dholakia, Pallavi Mukhopadhyay, Anubhav Sharma, Rishab Kothari, Nikunj Sharma (Delhi), Hardik Ashar (Bengaluru)

Insight & Outlook Automation Trends: WirelessHART technology Process and asset monitoring simplified Jonas Berge, Level Application Manager Rosemount Business Unit, Emerson

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Time for proactive policy measures he last few days have not been so great for the country. No, I’m not referring to the spate of controversies surrounding cricket in IPL’s this season! It’s rather the Indian pharmaceutical industry that has been at the receiving end, going by several announcements made recently by the US Food and Drug Administration (US FDA). The US regulatory body has reportedly blocked import of all but one drug manufactured at the Aurangabad facility of Wockhardt, as a result of which the organisation is likely to suffer an annual financial impact of $ 100 million. Prior to this, another top pharma company from the subcontinent, Ranbaxy, had reportedly pleaded guilty and agreed to pay a fine to the tune of $ 500 million to the US government as a settlement of criminal and civil charges against it. Never heard of instances of such mega extent, this has become an eyesore for a country that is credited with having the world’s highest number of US FDAapproved pharmaceutical manufacturing units, outside the US. As the country gears up to meet the milestone of $ 20 billion in pharma exports by 2020, the moot question facing the Indian pharma sector today is about the next step of swift action to not only prevent in the future such major


Editorial Advisory Board Ajit Singh Chairman, ACG Worldwide & Head, ISPE

Dr Abraham Patani Past President, IDMA & CMD, Inga Laboratories

Dr Gopakumar G Nair IPR Consultant & Advisor

Dilip G Shah Chairman, IGPA & Secretary General, IPA

Daara Patel Secretary General, IDMA

deviations from the norm but also send out a clear and unified message to the whole world that few such instances do not necessarily make the entire Indian product basket look bad. In this direction, the jury is yet to be out on whether India’s drug regulators can take action by taking suo moto notice of safety alerts issued by foreign regulators on medicines manufactured by Indian companies. Technically, the applicable Indian law (Drugs and Cosmetics Act) does not have the power to take action in such cases involving foreign safety alerts. While it may be akin to jumping the gun if the Indian regulator takes punitive measures purely based on inputs from overseas, it will be the right time if the government puts in place clear policy guidelines based on which the regulator can take decisive action after assessing the GMP of erring Indian companies. After all, it is a matter of life and everyone who needs to take certain medications has to be assured of its safety and efficacy. It is time to act fast.

Manas R Bastia

Guest Editorial

Generic injectable drugs: Now is the time! ith the patent cliff nearing and the compounding problems of pharmaceutical industry such as not so healthy pipeline of new drugs, regulatory challenges and increasing prices are leading to an increasing focus towards generic injectables in emerging markets. A right mix of injectable products in the portfolio, along with appropriate manufacturing activities can add value to the overall growth of pharma companies at a time when the Indian pharmaceutical industry is at the threshold of becoming a major player. Stringent compliance with regard to manufacturing facilities has resulted in limited injectable manufacturing facilities globally. US FDA website statistics indicate the number of injectables falling under shortage list increased from 39 to 139 in 2011. These shortages involved cancer drugs, anaesthetics used for patients undergoing surgery, as well as drugs needed for emergency medicine, and electrolytes needed for patients on IV feeding. Discontinuations are another factor contributing to shortages. Sometimes older drugs are discontinued by companies in favour of newer, more profitable drugs. The list of injectable drugs going off patent in coming years is huge. Unlike oral drugs the cost of development is high for injectable drugs and also maintaining sterile facilities means stringent quality norms has to be followed and complied with.


It is known that India has maximum number of US-approved manufacturing plants outside of US. A large proportion of sales for Indian pharma companies is through exports. Due to high entry barriers with extended manufacturing and approval times and limited competition, this segment offers lucrative margins. Therefore, the opportunity is not only for domestic consumption but also for fulfilling the global market need. Several Indian companies are looking at biologics (bio similar & bio betters) where injectable therapy dominates the delivery route, due to the inherently unsuitable nature of protein molecules for oral administration. Given the high level of formulation/design skills, it is imperative for the industry to work on appropriate delivery technology/device to help in better usage of these therapies. While oral drug delivery (tablets, capsules, liquids) will continue to dominate as the primary treatment option, there will be increasing need for finding better options for drugs which pose unique clinical requirements or drug characteristics to enable full benefit of the drug to be realised. This is where injectable generic formulations will play a major role in providing a route of delivery, which offers fast and effective relief. Some drugs, which cannot be given by oral route, are best delivered through parenteral route. Affordable devices that enable improved compliance are needed; that can remind patients about dosage,

inform physician about patient progress, provide ongoing non-invasive monitoring of various conditions. Software and IT-enabled companies could work together with pharmaceutical industry to work on this area, which can be a key driver of adoption of these novel drugs on a mass scale. Increasingly device companies are working on making injectable route of drug administration safe, convenient and less painful. This is being achieved by better drug formulations, better devices such as auto disable syringes, shorter and sharper needles, needle shields for safety and prefilled syringes for dose precision, time saving and reduction of dose and medication errors. While for self-administration of injectable a lot of work is being done for making user friendly pens and auto injectors. As the industry is being challenged to offer innovative, safe and easy to use devices for efficient delivery of drugs into the body, the future will witness better and safer devices to be able to deliver commonly used generic drugs and more complex biotech molecules. Injectables will emerge as an important segment in delivering drugs safely and effectively with the help of new innovative devices. It is, however, to be seen if this space will see more consolidation to deliver consistent quality. Murli Sundrani Business Director, BD Medical - Pharmaceutical Systems



News, Views & Analysis

GE Healthcare hosts conference on C2C Bioprocessing Concerned DIPP wants to re-look at FDI policy at PM level The Department of Industrial Policy and Promotion (DDPI) has raised concerns over the FDI seeking to re-look the policy of the regulatory body at the Prime Minister’s level. The concern came over as the multinationals are seeking nod to acquire stake in Indian phamra firms despite government putting norms to check it. DPPI is understood to have raised concerns on the policy with as many as four applications for investments in drug firms came up for discussion in the Foreign Investment Promotion Board (FIPB). The proposals included two related to US-based Mylan Laboratories; Japanbased Terumo, and another of Medreich, a domestic firm. Interestingly, DIPP is raising concern again despite

comprehensive discussions at the PM level had led to a decision in December last year. Accordingly, all foreign investments in existing domestic pharma firms were allowed only after clearance by the FIPB. The decision was taken on the back of increasing concerns over availability of affordable essential drugs in the wake of multinationals acquiring local companies. DIPP had earlier pushed for only up to 49 per cent FDI in existing domestic pharma firms, which was turned down. Currently, India permits 100 per cent FDI in pharmaceutical sector through automatic approval route in the new projects but the foreign investment in the existing pharmaceutical companies were allowed only through FIPB’s approval.

Pharma industry welcomes new drug policy The Indian pharma sector players welcome the new drug price control policy as it is likely to be a boon for consumers by putting an end to the ‘arbitrary’ pricing regime and will bring down medicine prices. Last week, the Department of Pharmaceuticals had notified the Drugs (Prices Control) Order 2013 under which prices of 348 medicines in the National List of Essential

Medicines (NLEM) have been brought under price control, thus replacing an earlier order of 1995 that regulated prices of only 74 bulk drugs. The DPCO proposes that retail price of 348 drugs will be fixed at the simple average price of brands that have more than 1 per cent market share. The scope of the NLEM Pricing Policy is likely to cover 18 per cent of the retail pharmaceutical market.

GE Healthcare Life Sciences recently hosted its thirds conference in the annual series of Quality by Design (QbD) Bioprocessing Workshops ‘C2C Bioprocessing’ on May 14-15, 2013 at The Leela Mumbai. C2C is the third conference in the annual series of Quality by Design (QbD) Bioprocessing Workshops by GE Healthcare Life Sciences India. The QbD workshop series was conceptualised for bringing into India latest technological advancements and scientific concepts used by the

global Biopharmaceutical industry. Key concerns of

Umay Saplakoglu , Global Fast Trak Leader, GE Healthcare Life

India Biopharma such as regulatory approvals and the hurdles in this, cost reduction in bringing out a drug (biosimilar), campaign production concepts etc are dealt with in this workshop. Actual case studies of how blockbusters are produced, the R&D involved, the regulatory rules that apply are shared with the audience. Speakers are senior industry consultants and also usually luminaries from the India Biopharma who have worked in MNC pharma abroad and bring back with them loads of real-life experience.

PharmaSecure’s lifesaving drug authentication solution crosses 50 crore mark PharmaSecure is a major provider of drug authentication solutions to empower the end customer to verify and authenticate the medicine through SMS, voice or web. Each medicine package coded by PharmaSecure has a unique, randomly generated alphanumeric code printed directly on the package. When a consumer sends this code by SMS (voice or web), a message comes back verifying the medicine is genuine. Within a span of 3 years, PharmaSecure has become a preferred protection partner for over 14 reputed pharmaceutical manufacturers in India. Today, PharmaSecure solutions have

been deployed for manufacturing lines in plants across 35 different geographical locations. PharmaSecure is known for its accuracy, speed and hassle-free integration that has taken the company to newer heights. Describing the innovative drug security solution and associated benefits offered by the company, Kishore Kar, VP, Sales and Marketing, informed,  “PharmaSecure’s mobile authentication technology empowers the end consumer to check and authenticate his own medicine at an affordable cost of an SMS, or through pharmaSecure portal/call center.  This service is easy for the consumer and


a simple, but effective solution for manufacturers. With increasing mobile use and growing consumer awareness levels, a solution such as mobile authentication has huge potential in India.”


News, Views & Analysis

Piramal Enterprises Ltd receives IND approval from the US FDA for its GPR40 agonist P11187 Piramal Enterprises Ltd (PEL) recently announced that it has received approval from the US FDA for its Investigational New Drug (IND) P11187. This approval will enable PEL to initiate a phase I clinical trial of P11187 in healthy volunteers in the US. P11187 is an orally active, small molecule New Chemical Entity (NCE), discovered and developed by the NCE Research Division of PEL. P11187 selectively acts on GPR40; a potential therapeutic target for Type 2 Diabetes Mellitus (T2DM). T2DM is an emerging

worldwide health crisis with an incidence rate of 300 million by 2025 as predicted by the WHO and accounts for about 90 per cent of the diabetic population. P11187 will be tested for safety and its glucose-lowering properties for the first time in humans; both properties having been well-established in our preclinical studies. Currently, the T2DM treatment space has limitations in terms of efficacy and adverse side-effect profiles. The advantage of P11187; as a GPR40 agonist, is the stimulation of insulin secretion in a glucose-dependent manner,

thus reducing the potential risk of excess insulin production. Dr Swati Piramal, Vice Chairperson, Piramal Enterprises Ltd, said, “The NCE Research division of PEL is dedicated to finding new cures for metabolic disorders. It focusses upon nurturing innovation and break-through thinking to impact the lives of millions of people. P11187’s IND approval by the US FDA; recognises our untiring efforts to identify candidates that would translate into more efficacious drugs for the effective management of diabetes.”

Agilent Technologies rolls out verified dissolution components for pharma applications Agilent Technologies Inc recently rolled out a new line of verified dissolution components for pharma applications, which includes molded vessels as well as basket and paddle shafts. Designed to ensure compliance with mechanical qualification guidelines, these components will be available from June 1 and offer verification that they conform to exact specifications. Speaking at the launch, Allan Little, Director - Marketing for dissolution systems, Agilent, said, “To better support the qualification needs of our

customers, it was critical for Agilent to offer improved options for component verification and traceability. Not only do we offer these new vessels and

shafts, but Agilent is leading the effort to educate pharmaceutical analysts on the importance of compliance with the developing qualification guidelines.” Prepared by using advanced manufacturing processes, these shafts are measured to exact

specifications and certified for traceability with an individual certificate of conformance. Qualification of dissolution apparatus in pharmaceutical laboratories involves performance verification testing, enhanced mechanical qualification, or a combination of the two procedures. With evolving guidance on qualification best practices, the adoption of verified components assists with longterm traceability and offers assurance that components meet tolerances set by the United States Pharmacopeia.

In Brief Wockhardt announces the appointment of V Suresh as President, Finance Pharmaceutical and biotechnology major, Wockhardt Ltd, recently announced the appointment of V Suresh as President, Finance. A Chartered Accountant and a Company Secretary, he brings with him more than three decades of qualitative and multi‐business experience at the highest level in the field of finance, accounting, strategy, projects, secretarial, business development, investment banking and consultancy and has handled comprehensive financial restructuring as well as internal financial management issues. With this appointment, Wockhardt has further strengthened its top management team adding depth to its finance department.

Canada strengthens drug safety with GMP for APIs In a bid to align with other industrialised nations, Canada has agreed to extend its GMP requirements for all APIs, according to a notice in the Canada Gazette . According to the new regulations, effective November this year, the country’s Establishing Licensing (EL) requirements will apply to all API manufacturers, packagers/labelers, testers, and importers. Further, the new regulations require record keeping that aims to improve the traceability of APIs from the original manufacturers to the dosage-form drug manufacturer. By this strategic move, the Canadian government expects to get a benefit of over $ 33.4 million over 10 years, which will primarily come from cost savings relate to the removal of poor quality drugs at the API stage. It will reduce the incidence of drug recalls.

Astellas submits marketing application of enzalutamide in Japan Astellas Pharma and Medivation have recently announced the submission of application for marketing approval of enzalutamide in Japan for the treatment of prostate cancer. The application was filed by Astellas with the Ministry of Health, Labour and Welfare in Japan. Oral androgen receptor inhibitor enzalutamide is designed to inhibit multiple steps in the androgen receptor signaling pathway, thereby decreasing the cancer cell growth and inducing induce cancer cell death (apoptosis). Results from the global Phase 3 trial (the AFFIRM trial) and a Phase 1-2 trial conducted in Japan were included in the application.




News, Views & Analysis

Novartis BioCamp will be held in Hyderabad in July Novartis India recently announced the next edition of the Novartis Biotechnology Leadership Camp (BioCamp) taking place in Hyderabad from July 8 to 10, 2013. BioCamp is a pioneering seminar organised by Novartis that brings talented students from diverse faculties and different universities closer to the pharmaceutical industry. Ranjit Shahani, Vice Chairman & Managing Director, Novartis India Ltd,

“BioCamp is a great platform for intelligent, young minds to interact with leaders in the pharmaceutical industry. This three day seminar provides students the opportunity to look closer at the pharmaceutical industry and helps them make career choices. Healthcare is a challenging area in our country and BioCamp reflects the Novartis commitment to furthering the cause of healthcare.”

Selected students will have the opportunity to learn from and network with leaders in the pharmaceutical and business sector as well as hone their team building skills. The top three students from the India BioCamp will represent India at the International BioCamp being held at Novartis global headquarters in Basel, Switzerland from August 25 to 29, 2013.

Mylan wins patent infringement case for Sunovion’s Brovana® product Mylan Inc recently announced that the Court of Appeals for the Federal Circuit has ruled in favor of Mylan Specialty L.P., f/k/a Dey Pharma, L.P. and has reversed the District Court’s decision invalidating five of Mylan’s patents related to Perforomist®. The Court’s reversal of the summary judgment decision reinstates Mylan Specialty’s patents

as valid and enforceable. Mylan previously announced a settlement agreement with Sunovion resolving the litigation relating to Sunovion’s Brovana® product, pending the outcome of the Federal Circuit appeal. Commenting on the development, Heather Bresch, CEO, Mylan, said, “We are pleased with the Court’s decision as it

confirms our original belief in the strength and validity of the intellectual property protecting Perforomist®, as well as our combination product for the treatment of Chronic Obstructive Pulmonary Disease (COPD), currently in development. We believe this decision by the Court only further supports the strength of our speciality franchise.”

Biogen Idec files BLA for approval of PLEGRIDY™ to FDA Biogen Idec filed Biologics License Application (BLA) to the USFDA for approval of its pegylated subcutaneous injectable candidate PLEGRIDY™ (peginterferon beta-1a) for treating relapsing forms of Multiple Sclerosis (RMS). This regulatory submission was based on the results from the first year of the two-year global Phase 3 advance study. The data demonstrated that PLEGRIDY met all primary and secondary endpoints by significantly reducing disease activity including relapses, disability progression and brain lesions compared to placebo, and showed favorable safety and tolerability profiles at one year. Douglas E Williams, PhD, Executive Vice President -

Research and Development, Biogen Idec, said, “This filing demonstrates our dedication to the treatment of MS, both through the discovery of new medications and the development of innovative solutions that enhance treatment for people living with this disease. We believe that based on the efficacy and safety PLEGRIDY has demonstrated, in addition to its less frequent dosing schedule, it has the potential to become a preferred interferon treatment option.” In addition to the BLA filing, the company also plans to submit a Marketing Authorisation Application (MAA) for PLEGRIDY to the European Medicines Agency (EMA) in the coming weeks.

Sanofi and Takeda ink co-promotion agreement to increase reach of Alogliptin in China Sanofi and Takeda recently inked co-promotion agreement to expand the reach of alogliptin in China to cure type 2 diabetes. Alogliptin is Takeda’s new type 2 diabetes therapy, which has been filed for marketing authorisation in China. It is a dipeptidyl peptidase-4 inhibitor (DPP-4i) that is designed to slow the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide). Subsequent to the deal, Takeda would provide exclusive right to Sanofi for jointly promoting co-promote alogliptin in China. Sanofi will utilise its commercial capabilities and experience to promote the product in defined territories in China. The commercial terms of the agreement were not disclosed. Commenting on the development, Haruhiko Hirate, Corporate Officer and Head of North Asia, Takeda, said, “Diabetes has become a major public health problem in China with a rapid increase in the prevalence over recent years. China is now the country with the largest number of people with diabetes. The collaboration will expand our reach to Chinese physicians treating patients with type 2 diabetes. Both Takeda and Sanofi have a long history and significant experience in diabetes and this makes for a win-win partnership, as we work together to advance patient care and help to meet the needs of this growing patient population.” Fabrice Baschiera, General Manager Pharmaceutical Operations, Sanofi China, informed, “We are pleased to announce the collaboration with Takeda. Alogliptin reinforces the strategic focus of Sanofi in the diabetes field. The new addition of alogliptin strengthens our offer of innovative diabetes treatment to Chinese patients, which includes best-in-class oral and insulin drugs. We look forward to working with Takeda to make alogliptin more widely available to patients with type 2 diabetes in China.”


News, Views & Analysis

Telezon ships another SoloFlow® batch to Serum Institute of India for use in vaccine kits Victoria-based medical device company Telezon Ltd announced the dispatch of second commercial shipment second batch of SoloFlow® to Serum Institute of India (SII), making up part of the 5,00,000 commercial order. Telezon’s SoloFlow needles are being used in SII’s vaccination kits for the world market. Following a shipment of 28,600 needles, SII has approved the company as an official vendor of the SoloFlow needle and ordered a further half a million units for their vaccination kits. The shipment is the

second of three with the remaining shipment scheduled for delivery in the next couple of months. The Board of Telezon was pleased that the Company is consistently achieving its commercial outcomes in global markets, and in turn, continuously creating value and awareness for its unique suite of medical device solutions. The company is currently pursuing capital investment to accelerate commercialisation of other world-patented products and technologies.

Bilcare extends future technology support to Biocon India’s leading packaging and technology solution company, Bilcare has been associated with Biocon, country’s largest biopharma company, to provide secure, non-clonable ‘Track & Trace technology’ for protection of Biocon’s exports across globe. Bilcare is providing endto-end holistic solutions to Biocon for Track & Trace and Authentication as per global standards. Bilcare will also build the ability to scale the service requirements to accommodate future needs. This association will bring multi-level

Multisorb to exhibit the StripPax and StabilOx systems at Pharmapack NA Multisorb Technologies recently announced that it will be exhibiting at Pharmapack North America. The technology-focussed conference is a leading educational and networking forum for top suppliers of innovative packaging and advanced drug delivery device technologies. The show is located at the Pennsylvania Convention Center in Philadelphia, Pennsylvania, June 18-19, 2013. Multisorb will feature its innovative StripPax® and StabilOx® Systems. The systems combine the StabilOx® packets or canister or StripPax® packets with its respective corresponding dispenser, providing unparalleled efficiency. StripPax packets have, for years, been relied on by pharmaceutical and device manufacturers to protect the integrity and stability of moisture sensitive products. StripPax packets take up little space in packaging yet have high moisture adsorption capacity. The packets are offered in a variety of sorbent blends and sizes to meet specific packaging needs. StabilOx packets and canisters effectively reduce package headspace oxygen levels while managing headspace moisture and drug product free moisture to reduce or eliminate oxidative degradation. Both StabilOx packets and canisters are uniquely designed to be run on their respective StabilOx dispensers as part of the StabilOx system. As part of the StripPax dystem, Multisorb will be demonstrating its APA2000 StripPax dispenser with an optional bottling line interface. The APA-2000 high-speed automated dispenser is capable of dispensing rates up to 300 packets per minute, giving it the ability to keep up with the fastest packaging line speeds. The dispensers are compatible with an array of packaging line configurations, including horizontal flow wrappers, VFFS, bottling lines, thermoformed pouching and other layouts. With optional splicing station cabinets, the APA dispenser will provide uninterrupted dispensing as an operator never has to stop the line to refill the sorbent packets.

benefits to Biocon including capability to deal with on-going changes in government mandates, reduced spend on IT assets & services, handle high volume (billions of records) serialised data and its retention and allowing the company to manage any country-specific additional data requirements. Bilcare’s nonClonable Track &Trace solution is secure, cost effective which facilitated Biocon to protect it exports brands and comply with Government’s DGFT mandate without hampering current productivity.

Sami Labs to focus on Indian market After noting 29 per cent rise in its 2012-13 turnover, nutraceuticals industry major Sami Labs Ltd has launched a holistic plan to further strengthen its foothold in India suggested top executives of the Bengaluru-based company. Currently, India business of the Sami Group contributes around 10 per cent of its global turnover. “We now intend to focus on indigenous market and targets 25 per cent growth,” said Dr Muhammed Majeed in an exclusive interview with Modern Dr Majeed Pharma  earlier this month. On the same line, Sami Labs is planning to sharpen and broaden its penetration in India by opening another regional office in Delhi. “We have an office in Mumbai, and sense the need for another such set-up in NCR region,” he added. “Of late, complimentary medicine is open and proactively inclined towards

nutritional and wellness products. The average Indian consumer wants to look fit, feel good and reduce the risks of lifestyle and hereditary disorders,” said V G Nair, CEO, Sami Labs. While company plans to continue with its B2B model, the company has moved up the value chain by launching Sami Direct. The 2011-founded company directly connects its offerings to the fitness-savvy consumer base of India, marked a growth of more than 600 per cent in 2012-13,” revealed Rajesh Kumar, CEO, Sami Direct. “Our current market share in India is 2 per cent. We plan to raise it to 10 per cent in the near future,” he added. Group has its major revenue coming from its US-arm, Sabinsa Corporation. Hardik Ashar




News, Views & Analysis

Marchesini introduces innovative ways for packing pre-filled syringes Marchesini Group recently presented a complete and innovative line for packaging pre-filled syringes, from assembly through to bundle overwrapping. The line handles a glass syringe with assembled needle, protected by a plastic tamper-evident cover. The needle is pre-assembled by machine model Corima APS2-Combi where the syringes received from the inspection machine are conveyed with a no-contact technology and loaded on the central carousel. The plunger is inserted and screwed in position. Afterwards the syringe is transferred to the next turntable to be inserted in a plastic cylinder that is pre-fed to the machine. In the station after that where the syringe is inserted in the cylinder, again on a star-wheel, the cap is inserted and pressed on. On the machine outlet, the syringe

is sealed inside its container and sent to the infeed of the Cartoning machine MA320. The infeed system consists of two units of Marchesini’s robotic solution ‘Robocombi’. The first Robocombi installed after Corima’s assembling machine picks up the cylinders with the syringes inside and places them on a positive-motion bucket conveyor belt, in alternated direction, namely with the caps turned by 180°. The second Robocombi installed downstream from the first one, at the end of the bucket chain, picks up several containers at a time and places them on the loading chain conveyor of the cartoning machine, which then places them inside a carton. A bundle overwrapping machine MF910MINI is installed at the outlet of the cartoning machine.

Automatic labelling machine BL400 VTETT is suitable for the application of the vignette label onto the main panel and of two self-adhesive Tamper Evident seals on the closure point of formed cartons. The machine is designed for carton ‘Track & Trace’ by means of 2D (Datamatrix) codes printing on line and subsequent verification with camera vision systems. It is an ergonomic balconydesign machine that offers full access to ensure cleaning and management comfort and to guarantee a full view of the entire production process. The labelling machine works by steps, consequently guaranteeing high precision in label application and the finished result. It is possible to install vignette thermal transfer printing systems, different ink-jet or laser printing systems for cartons and different vision systems for 2D code and human readable data verification.

Eppendorf India celebrates completion of 10 years Eppendorf India recently completed 10 years of direct operation in India. Launched in the year 2003 as a small organisation with 23 people has now grown to a company with 135 employees, and revenue in excess of Rs 100 crore. Today, it has branch offices in 9 locations and satellite operations in various cities in order to reach customers

nationwide. Adding another feather to the cap is the Pipette Calibration Centre in Chennai which received ISO 17025:2005 accreditation from National Accreditation Board for Testing and Calibration Laboratories. The growth of the organisation continued with the acquisitions of New Brunswick Scientific and DASGIP by Eppendorf AG.

Mylan introduces generic version of Tricor® tablets Mylan Pharmaceuticals, Inc recently received final approval from the USFDA for its Abbreviated New Drug Application (ANDA) related to generic version of Abbvie Inc’s Tricor® tablets. Fenofibrate tablets are indicated as adjunctive therapy to diet to reduce elevated lowdensity lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), Triglycerides and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDLC) in adult patients with primary

hypercholesterolemia or mixed dyslipidemia. Fenofibrate tablets also are indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridaemia. Fenofibrate at a dose equivalent to 145 mg has not been shown to reduce coronary heart disease morbidity and mortality in a controlled trial of patients with type 2 diabetes mellitus. Fenofibrate tablets, 48 mg and 145 mg, had US sales of approximately $1.2 billion for the 12 months ending March 31, 2013, according to IMS Health.

Pfizer discontinues Phase III study of inotuzumab ozogamicin in relapsed or refractory aggressive non-hodgkin lymphoma due to futility Pfizer has discontined Phase III randomised, open-label, two-arm study (B1931008) evaluating the safety and efficacy of the investigational compound inotuzumab ozogamicin in patients with relapsed or refractory CD22+ aggressive non-Hodgkin lymphoma (NHL) who are not candidates for intensive high-dose chemotherapy. In this study, inotuzumab ozogamicin was administered on a once-a-month schedule in combination with rituximab and compared with an active comparator arm (investigator’s choice of bendamustine plus rituximab or gemcitabine plus rituximab). During a scheduled interim analysis, an independent Data Monitoring Committee (DMC) concluded that in this study treatment with inotuzumab ozogamicin plus rituximab did not meet the primary objective of improving overall survival (OS) when compared to the comparator arm. No new or unexpected safety issues were identified. “We are working to better understand the findings from this review to determine if there are any patterns of outcome that may help us gain greater understanding of the potential effect of inotuzumab ozogamicin in specific patient subsets within the heterogeneous patient population enrolled in this trial,” said Dr Mace Rothenberg, Senior VP - Clinical Development and Medical Affairs, Pfizer Oncology Business Unit. “Haematologic cancers are a complex group of diseases, with more than 70 different types of lymphomas, leukaemias or myelomas that require unique treatment options. We remain committed to evaluating inotuzumab ozogamicin in patients with haematologic malignancies.” Pfizer has notified the study investigators and appropriate regulatory authorities of the decision to discontinue the study. Investigators will work with patients in the study on an individual basis to determine an appropriate course of action.


In Conversation With


The adventures of an entrepreneur are enjoyable Pallavi Mukhopadhyay pallavi.mukhopadhyay

Tell us about your journey as an entrepreneur. My journey has been full of thrills. The adventures of entrepreneur are enjoyable.  As an entrepreneur, I have come across different problems everyday and riding over them is challenging.  To a great extent, the success of an entrepreneur depends upon his strong will to succeed more than his wish to succeed and it is important to differentiate between a wish and will. Starting with a field strength of 40 in the year 1992 and achieving an annual turnover of 5 crore by 1995; how did you achieve this? It is difficult to make small big, but far easier to make big bigger. Initial challenges for an entrepreneur come in different types at different levels. During the journey, at every phase of the business, the way to succeed alters.  The fundamental principles employed to achieve a turnover of 1 crore is different than that when the business grows from 2 to 5 crore.  Similarly, the type of challenges that are faced for growth from 5 to 50 crore varies from that for growth from 50 to 100 crore. As the business grows substantially, it requires a different level of professionalism, insight, understanding and capability from its employees.  Thus, the style of functioning and in-house strategies need revamp, new areas of capabilities need to be worked as the company expands and professional help should be seeked. This process of learning all along has been very enjoyable and most certainly filled with many interesting challenges for me. What is your business model and what are the further expansion plans? An entrepreneur can grow the business personally upto a certain level.  Upto that level, he has to work as a CEO. For expanding the business further, there is a need to hire thorough professionals.  To make any business grow constantly, one should always work with individuals that have more talent than the entrepreneur. The entrepreneur must hire people who are sharper and more capable than him. We have gathered a team of professionals to help us grow at a steady pace, and achieve the goal of ` 1000 crore by 2015. How do you plan to achieve a turnover of ` 1000 crore by 2015? To witness radical growth, one has to do radical things. A competent management can bring about incremental growth but the rate of increment on a year to year basis would depend upon the extent of competence of every individual employee.  To achieve colossal growth, there has to be radical transformation and game changing decisions have to be taken in addition to professional competence. Innovation, clarity, ability to create new products and assuming new ventures can bring about radical transformation in volumes. We are constantly thinking, planning and trying to attain these objectives as a group. We are committed to continuous growth and take on all initiatives to make this happen.

…states S C Sehgal, Chairman and Managing Director, Ozone Group of Companies. A multi-talented strategist, a dreamer and an achiever, here he talks about his success story and what keeps him going during tough days. How are natural products faring against the synthetic product market today? Of late there is a high amount of realisation that being close to nature is always wiser than consuming artificial and chemical-based products in our day-to-day living. Nature is motherly and to be cared well, one has to be close to Mother. New products being introduced in the market are in sync with nature and are replacing synthetic and chemical based products on everyday basis. What is your message for budding entrepreneurs? The journey is tough. The type and the number of challenges are far more than what one can imagine. Young entrepreneurs must enjoy challenges and be ready to deal with different types of problems on a daily basis, with patience, passion and commitment. This

determines the success of an entrepreneur. Success for an entrepreneur can be satisfying but attainment of success is not easy. Therefore, all budding entrepreneurs should have patience, commitment, and understanding on many levels. What is your mantra for excellence? It is important to know what an individual can do and what he can do well. It is only few things which one can do well.  That is what an individual should attempt doing himself.  For attainment of success in different spheres of activity, an entrepreneur should depend upon the persons who have capability in these domains. It is very important to delegate and trust the employees. Awarding responsibility and authority to the employees will help them contribute and make their personal and professional life more satisfying, which in turn is important for the success of any enterprise.

How do you stay ahead in the market? Appetite for taking risks, institution and the courage to walk on un-walked grounds have been the factors that have helped me in my efforts to stay ahead in the market. I have tried to practice the dictum ‘Great men do not do different things but they do them differently.’



Special Focus

FDI in pharma retail

Against all odds… FDI in pharma retail is at a nascent stage in India. With strong opposition from the All India Association of Chemists and Druggists, structured entry of big multinational players could be a far-fetched reality. Although FDI in multi-brand retail would streamline operations and rake in good money in the government’s kitty, it is unlikely that promoters of Indian pharma are accepting this sea change in policies. This article takes a deeper look at the current mood of the industry.

Pallavi Mukhopadhyay pallavi.mukhopadhyay

oreign Direct Investment (FDI) has proven to be a high impact growth driver in developing countries. FDI to India has been on the rise in the last few years bringing in appreciable benefits to the local pharma market. While developing countries are exploiting the offerings of FDI in all sectors of pharma, the pharma retail sector is still at a nascent stage. With gradual entry of multinational players in the segment, over 95 per cent of the unorganised players and traditional pharma retailers could be forced to comply with stricter norms and professional ethics to stay ahead in the game.


is a much needed booster shot. The biggest beneficiary from this would be the middle-class Indian consumer, and the Apex Court emphasises that by saying ‘consumer is king and if that is the philosophy behind the policy then what is wrong.’ FDI in pharma retail will bring about modern business practices, upmarket store layouts, better supply chain and inventory management systems, use of cutting-edge technology, better systems for management of expiry date medicines and storage conditions, more competent pharmacists, economies of scale, ability to have a chain of

Growth potential Today, China is the largest recipient of FDI. While China is much ahead of India in terms of appropriate implementation of FDI, policy restrictions coupled with a non-liberal outlook has often shown to have hampered the success of FDI in the country in the past. In 2012, with the Government of India allowing 51 per cent FDI in multi-brand retail under which the pharmaceutical products fall, retail pharmacies of the world see a huge potential in the country. With the aim of eliminating middlemen and benefitting the customers by broadening their choice of purchase, the government is of the opinion that the retail sector is likely to grow in size and volume. The organised retail system will not only improve overall efficiency but will also give sizeable returns to the government in the form of timely taxes and duties. Anup P Shah, Partner, Pravin P Shah & Co, says, “The recent Supreme Court decision in the PIL filed by M L Sharma upholding FDI in retail trading

One of the biggest positives from FDI in retail has been the shrinkage of the distribution chain from the pharma companies to the consumers. Anup P Shah Partner, Pravin P Shah & Co

pharma stores, better quality and educated staff etc. Pharma franchise business models will be the next big thing with the entry of branded pharma retail chains. Internationally pharma stores are a part of a storewithin-store format or found in malls/ hyper marts/departmental stores, etc. This would be possible also once global brands, such as Walgreens, CVS, Rite Aid, Boots, etc, make their muscle felt in India. Moving up the value

Stop FD Pharm I In a Reta il

chain from being mere medicine vendors to wellness centres would be possible. Some chain pharmacy stores such as Apollo, MedPlus, Fortis Health World, Guardian Pharmacy, Viva Pharmacy, Dial for Health are already functioning better than individual owned pharmacies. While these are currently restricted to bigger cities, it may gradually move into smaller towns in the future. Shah states, “One of the biggest positives from FDI in retail has been the shrinkage of the distribution chain from the pharma companies to the consumers. This has led to lower overheads and better distribution strategies.” While India is a strong contender in CRAMS, its success ratio in the pharma retail segment at present is dismal. China is leaps and bounds ahead of India in this market. The main reason is the current absence of foreign players in the pharma retail business. Shah opines, “India is a large nation and traditional pharmacy can successfully co-exist with MNCs as there is enough room for all players. The main fear of mom-and-pop stores vanishing is a valid one. However, the BRICS nations have experienced good co-existence of traditional smaller shops with the larger chains.”

The opposition clout Experts argue that bigoted and archaic policies followed by

the promoters of the industry are hugely hampering the growth of the sector. All India Association of Chemists and Druggists (AIOCD) are currently protesting against the

Although the potential for retail pharmacy as a business is unquestionable, not many leading global pharmaceutical retailers would enter India in the near future. Rajendra Pratap Gupta Retail pharmacy expert and Former COO & Board Member, Medicine Shoppe International Inc, India Ops

Central Government’s policies of the compulsory presence of a pharmacist at the drug store and introduction of FDI in retail pharma. Rajendra Pratap Gupta, Retail pharmacy expert and Former COO & Board Member, Medicine Shoppe International Inc, India Ops, says, “As of now, the retail pharmacy chain business in India has been a ‘miserable failure’ due to myopic policies

followed by the promoters. Even the retail pharmacy venture initiated AIOCD has failed to take off despite trying for over six years and similar to the fate of the Government’s Jan Aushadhi venture. Although the potential for retail pharmacy as a business is unquestionable, not many leading global pharmaceutical retailers would enter India in the near future.” Thus, although FDI could positively impact the retail industry and bring about better user experience, the industry is trurning its back on any new initiatives at the moment. It is yet to be seen what course this war eventually takes.

Overall impact of FDI in pharma FDI in pharma may be the right decision for short-term growth but could have negative implications in the long term. FDI is instrumental to a certain extent in reversing the growth of small players in the market and thwart the independence of Indian pharma companies. Takeovers, control over the Indian firms by the MNCs could be another roadblock for the domestic players. For any industry to thrive, it is a given that innovation and stronger imposition of intellectual property rights is a must. The current need is that of a national R&D policy. Being a world leader in generics, India does not need technology in formulations today. Thus, the big question still remains to be answered. While FDI can definitely kickoff the economy of a country, can it sustain it in the long term?



Special Focus

OTC pharma retailing

Factors governing product sales Anubhav Sharma anubhav.sharma

ccording to several reports, in 2008, the Indian OTC market was about ` 7,434 crore ($ 1.8 billion). Segments such as cough & cold preparations, analgesics, vitamins & minerals and indigestion preparations account for a little over ` 2,700 crore. The Indian pharma market in comparison is valued at about $ 10.4 billion in 2012. It grew at about 12 per cent CAGR from 2004 to 2012 while it is expected to reach $ 20 billion by 2015 (CAGR of 16 per cent from 2009 to 2015), as per ORG IMS estimates. Traditional medicine (Ayurvedic) accounts for approximately ` 1,600 crore, while other segments such as medicated skin products, topical OTC medicines, plasters and bandages, anti-smoking aids, etc collectively account for over `3,000 crore. Indian OTC market ranks eleventh in global OTC market and is expected to grow in coming five years. It may happen as Indian population is getting more concerned about their wellness than illness. This can be the major factor behind the growth. A pharmacist can sell drugs mentioned in Schedule H and X of the Drug and Cosmetic Rule as ‘Household Remedies’ but only in those places where population is below 1,000 plus under certain conditions. Consumer products or OTC product category is the third most lucrative healthcare business after pharmaceuticals & medical devices/diagnostics with an average operating margin of 25-30 per cent. For instance, some big Indian pharmaceutical manufacturers such as Piramal retained its OTC brands but sold off its pharma business to Abbott. As there is increased self-medication and consumer awareness towards wellness focussed OTC products, the sale of OTC products is projected to be higher than prescription products. In the Indian market, with the changing lifestyle and increasing awareness about being healthy, several health and wellness products have seen a surge in sales. A lucrative growth of 14 per cent is projected for the Indian OTC market making India one of the fastest growing market globally.


Described in detail below are some of these factors. Awareness among the population In recent years, masses became more concerned about their wellness rather than illness. As a

Over the past few years, OTC retailing has seen a good growth and the future remains optimistic. With such a boom, it is vital to understand the factors that are promoting the growth of this field. Let us understand these… result, they are opting for more of preventive measures drugs, such as nutritional supplements than the prescribed drugs. This concern about the healthy lifestyle plays a major role in growth of the OTC market in India. “In the Indian market, optimum performance at work and job security are now more important to consumers which means that use of preventive remedies, wellness products, convenience OTCs, energy

In the Indian market, optimum performance at work and job security are important, which means that use of preventive remedies, wellness products, etc is on the rise. Manish Singh National Purchase Manager, Religare Wellness

boosters, brain-boosting supplements and formulations for sight and hearing provide growth opportunities, along with contraceptives for women who want to work longer before having children, are on a rise” says Manish Singh, National Purchase Manager, Religare Wellness

Economic factor The manufacturers are aware about the growth of the OTC pharma and thus provide variety of options to consumers who are looking for better drugs at reasonable price. Furthermore, the insurance companies are also keeping a close eye on the market and offering reimbursement facilities on OTC drugs. These reimbursements allow consumers to use those drugs easily and without any hesitation. Pharma companies are sensitising the public regarding the benefits of certain OTC products, and thus helping to grow the industry faster. Also, with the increasing income in the urban and tier I and tier II population, people are ready to spend more on wellness products. Easy services Increasing growth of the OTC drug market is also demanding innovations in the service sector, which is the backbone of the pharma industry. Thus, the service sector is also moving at par with the growing OTC market. Dr Sanjeev Sood, Hospital Administrator and NABH Assessor, explains, “The services in pharma retailing have also become more convenient and patient friendly with innovations such as doorstep delivery, home care, on line sales of OTC drugs and widespread use of software such as first-in and first-out (FIFO) that ensures no expired drug is ever dispensed to the patient.” Increasing disease burden Increasing population and deteriorating living conditions are major factors for the increasing disease burden in India. In the recent years,

many people are affected by small ailments, which lead to an increase in the sale of OTC drugs. Sood says “Sales of OTC medicines have increased over the last few years due to increasing episodes of minor ailments such as cold and cough, backache and toothache and skin allergies for which patients and chemists prefer and encourage self-medication.” Increasing focus on healthcare Due to the increase in

Sales of OTC medicines have increased over the last few years due to increasing episodes of minor ailments for which patients and chemists prefer and encourage self-medication. Dr Sanjeev Sood Hospital Administrator and NABH Assessor

awareness created by the government, people are being conscious about wellness and want to live a healthy lifestyle, even if it means consuming various health supplements. Further, the spread of health awareness in the rural population too has resulted in the rising sale of OTC products.

Rising disposable income India’s GDP has increased a lot in the recent years. With this increased disposable income and spending capacity, consumers have more purchasing power and thus do not hesitate in purchasing OTC medicines. Moreover, OTC drugs are reasonable due to the tough competition in this field. Service sector innovation Latest developments in the field allow consumers to get better products at a better price. Also, in order to sustain in the competitive market, companies rely on proper marketing strategies which in turn attracts masses towards its products. Another reason is the boom in investment by MNCs in Indian firms that provides variety in OTC drugs. Ayurvedic medicine Indian OTC pharma is majorly driven by Ayurvedic medicines. Since they have herbal ingredients, it makes it easy for the pharmacists to sell these medicines without any issues. These drugs are monitored by a manufacturing licence issued by the Ayurvedic State Licensing Authorities. Moreover, these drugs do not require any sale license so can be sold freely by non-chemists.

From here… OTC retailing exists in the market since several years. As figures speak, the growth is continuous. Apart from the mentioned factors, there are several others which regulate the product sales. It is important to have an authoritative governing body that can look after the OTC market closely to ensure that customers are not being affected negatively. (Inputs from Pallavi Mukopadhayay)


Special Focus: Interface


Retail pharmacy has witnessed several regularisation initiatives in the past decade from policymakers and organised private players Nikunj Sharma

How do you see the revolution as brought by the pharmacy chains in India? Pharmacy retail chains have brought some drastic changes in the pharma retailing practices in India. The organised players made their presence felt to the customers by providing a vast range of Stock Keeping Units (SKUs), better customer orientation services, improved ambience, customer loyalty schemes etc. Future expansion plans of Apollo Pharmacy… Today, we operate from 1500+ outlets with the count growing day by day. We have presence in 600+ cities and towns from tier I and tier II categories. We have built a rock strong network predominantly in the South wherein we are present in tier 3 towns too. We also have our outlet rollout planned to cover tier 3 towns across the country in coming years.

Every percentage increase of organised retail share would lead to uniformity in terms of pricing, flow of branded drugs in the market, awareness about right medication methods to customers etc. How is the response to ‘24-hour open pharmacy’ concept by the customers? Is it a cost-effective model? Apollo’s concerted effort is to provide medicines to the customers at the time of need and the customers appreciate our round the clock service. Our aim is to redesign our model and ensure to have at least one 24 hour pharmacy in each cluster, which facilitates all the needs during night. As on today, one-third of our total outlet services are round the clock. With several players joining the retail chains, how will the market shape from here in terms of competitive aspects? As this industry is predominantly covered by unorganised players and government being favourable towards FDI in retail, many more players will participate from within the country as well as from other countries. This would enable all the customers in almost all the towns and cities an equal opportunity of getting the right kind of drugs at an affordable price. Every percentage increase of organised retail share would lead to uniformity in terms of pricing, flow of branded drugs in the market, awareness about right medication methods to customers etc. Have you taken any initiative to ensure quality drug delivery in the country? Medicines are sourced only from the

…says P B Ramamoorthy, Jt CEO - Pharmacy Retail, Apollo Hospitals Group. Here, he discusses about the transformation, vision and future prospects of organised retail pharma sector in India. authorised vendors and vendor analysis takes place on a yearly basis. We have our own centralised distribution centres in almost all the major cities which service close to 200 outlets in their surroundings. We also ensure that every drug is maintained under respective temperature conditions throughout all the stages of supply chain starting from manufacturer to customer. Is generics sales taking over the original versions in India? Generics being the most cost-effective products for the consumer and also being popularised by many state

governments, we are always positive about selling generics. At present, not all original versions have generic equivalents in the market and there are only certain categories of drugs wherein generics are taking over original versions. How do you manage to stay ahead? Our strong network, changing formats, periodical health awareness camps, increasing range of private label, our tailor-made corporate tieups, prescription refill reminder and special offers to loyal customers in FMCG category sets us apart from the competition.



Special Focus: Interface

FDI in pharma retail is required to make the sector more organised Anubhav Sharma anubhav.sharma

…says Hemanth Bothra, Managing Director, Trust Pharmacy. In this conversation, he talks about how pharma retail can be improved and be made more customer centric.

Is the unorganisation in the pharma retailing sector affecting consumers? The unorganised pharma retail sector is affecting the consumer in a major way. It is a fact that right medicines need to be consumed at the right time. Unorganised pharma retailing resorts to selling of medicines without a bill, substituting of prescription, storing the medicines in an improper manner etc, which ultimately affects the consumer.

Selling of medicines requires more care compared to other retail businesses. The customers need to be aware of the basic rights while buying the medicines and this can be overcome by proper campaigning.

Briefly explain the effect of FDI in pharma retail sector. FDI in pharma retail is required to

make the sector more organised. Large investments are required to improve the service quality, proper

storage conditions in order to retain the potency of the drugs and availability of right drugs. FDI would play a vital role in bringing in better technology to this sector. Is the new policy by the central government of having a stationed pharmacist at every pharmacy store going to negatively impact the industry? The policy of having a stationed pharmacist needs to be clearly defined. It is always advisable to have a pharmacist at the outlets and it will have a positive impact on increasing the confidence level of the customers. The pharma industry is growing at a fast pace. How can the pharma retail sector keep up with the ever changing demands? Change is inevitable. The complete air conditioning of outlets is an example, as it is implemented by the government of Gujarat and Rajasthan for new stores. The pharma retail sector needs to follow proper guidelines while opening the outlets and the ever changing demands of the customers and policymakers need to be seriously looked into.

Segments benefited Bulk-drugs Domestic formulations Exports to non-regulated markets Contract research and manufacturing services Exports of generics to regulated markets NCE research for global pharmaceutical companies What challenges does the Indian Pharma retail sector currently face and how can one overcome those? The main problem this sector is witnessing is the quality of service and supply chain. Selling of medicines requires more care compared to other retail businesses. The customers need to be aware of the basic rights while buying the medicines and this can be overcome by proper campaigning. The supply chain needs to be more professionally run instead of being guided by an association. The storage system and the transportation of medicines need to be improved right from the manufacturer to the retailer. Where do you see the Indian pharma retail sector 5 years down the line? The will be an exponential growth in this sector and it will be a customercentric growth. All outlets will gear up to the healthy competition from the organised retail chain. We want the ‘king’ (ie, customer) to enjoy his/her rights.


Special Focus: Roundtable


How can pharma companies integrate better with chemists? Pallavi Mukhopadhyay pallavi.mukhopadhyay

Dr Sanjeev Sood

Neeraj Vashisht

Hospital Administrator and NABH Assessor

Senior Principal Consulting, IMS Health India

It is important for pharma retailers or chemists to be effectively integrated with pharma companies as a part of a secure supply chain. Ensuring that their supply chain is secure is just one way by which companies can reduce the risk of counterfeit drugs entering the industry. This is a universal problem that needs global solutions. The pharma products should not be allowed to be ‘re-boxed, re-labelled or over-stickered’ at the retailer end, which can lead to the damage of identification numbers, make it difficult to identify counterfeit drugs. Improvements to the track and trace technology are another way in which the pharmaceutical industry is looking to clamp down on the trade of counterfeit medicines. Today, there are systems using a Changing times call two-dimensional code mark, which for changing measures. There is can be as small as 2 mm by 2 mm, increasing awareness among pharma enabling it to be printed on the retail segment to understand end-to-end surface of capsules or coated tablets. The code, which can contain as many drug distribution and healthcare management as 10 billion numbers, when scanned processes. System integration coupled with links to a database containing detailed data upgradation and management in cohesion information on the raw materials used with pharma companies is the next step for and the time of manufacture. This database could be accessed online to Indian pharma. This would aid in streamlining verify the information and in many cases operations, reducing circulation of spurious the codes can be read using a picture drugs and regulating the supply chain. from a camera phone. The DGCI’s Experts elaborate on the integration recommended mandatory barcoding on drugs is another step in this direction and process and its benefits. should be properly implemented. Further, inadequate infrastructure has lead to haphazard quality compliance in many cases. Thus, integration should be done through medical councils such that both chemists and manufacturers become an integral part of the healthcare ecosystem. Proper norms must guide chemists, doctors and manufacturers and all the parties should be held equally responsible for their services. Better integration shall also ensure better forecasting of drug demand and prevent unforeseen shortages in the market.

Dr Ruchi Dass Founder, HealthCursor Consulting Group In today’s world, it has become imperative that pharma companies keep their momentum intact by connecting directly with their business spokes. For better supply chain management, patient awareness and follow-up, several models have come up. Mobile health brings several successful models related to advance care, counterfeit management and drug distribution analytic  that have helped several efforts to react in time. IDart, Sproxil, mpedigree are such business models to learn from. A simple service such as pill reminder on a mobile phone for the chronic patients can pull in data which is worth millions. A patient like this observed for 12 months would produce insights regarding availability or drugs,  adherence and compliance statistics, consumer behaviour and so on. This will help build a bridge between chemists, pharma companies and the patient. Many companies are piloting this idea to gather data-related compliance, refills, referrals made by doctors and supply chain management. This will in turn help pharma companies forecast trends, have better knowledge about drug action and device better ways to foray into specific market segments.

The pharma-chemist relationship in India has evolved over the years. Pharma companies are increasingly seeing value in engaging more with this last mile of the retail healthcare value chain. Indeed, pharma companies have a lot at stake at this last mile. Smart companies are not just taking a tactical perspective to this relationship (eg, ensuring SKU stocking or running channel related deals) but also are viewing this channel strategically (eg open new avenues of growth for their flagship products). In one case example, using a set of observation studies and mystery shopping frameworks IMS observed a company could leverage the strength of its prescription brand to grow its share at the retail level despite heavy promotional activity by local, cheaper brands in a category that was increasingly moving OTC. In another example, a company was surprised to find fairly significant switching in a category that is not traditionally viewed susceptible to switching behaviors. In this case, the company profiled the retailers likely to exhibit this behaviour and take steps in educating and protecting its share. Bottom line is that the pharma-chemist relationship is full of challenges and opportunities. Not all chemists are the same, nor are the chemists likely to behave identically across categories. Pharma companies need to understand this channel, how their brands and the categories flow through the channel, what challenges must be addressed and what opportunities should be pursued. This would be the right basis to integrate better with this important channel.

Vikram Gupta Founder & Managing Partner, IvyCap Ventures

Pharma manufacturing and pharma retailing are two different kinds of businesses. The pharma retail chain is a dynamic business and sales largely depend on the location and format of the outlet. Business is also charted by the ratio of prescription drugs to OTC drugs the outlet sells thus clearly defining profit margins. For pharma companies already selling generics through distributors and intermediaries, moving into the retail sector would not serve as a big advantage as companies are not allowed to push their own products. Products are sold depending on their affordability, brand presence and efficacy. However, conversely, if a chemist integrates with multiple pharma companies, they would stand to be gained. This integration would work well if a product stock was moving fast. With the integration of IT systems within the supply chain, drugs can be tracked, customer’s buying behaviour monitored and better forecasting ensured. Inventory management would thus streamline operations for both the chemist as well as the manufacturer. Study of these trends would help devise new marketing strategies for pharma companies. Further, integration would also facilitate seamless and transparent stock movement and ensure reduction in sales of spurious drugs. Integration of chemists and pharma companies could act as a long-term solution to the spurious drugs menace.

Editorial take Regulated distribution of drugs is the backbone of any healthcare industry. All measures must be taken to smoothly facilitate this process. Further, integration of pharma companies and chemists would not only improve the industry’s credibility as a whole but would also improve patient care and disease management.



Facility Visit

ACG Pampac, Talegaon (Pune)

Providing innovative packaging solutions Pallavi Mukhopadhyay pallavi.mukhopadhyay

ocated in quiet bylanes of the picturesque town of Talegaon, about 100 miles from Mumbai, ACG Pampac’s seven acre state-of-the-art packaging machinery manufacturing plant, manufactures futuristic and efficient machinery for the world. ACG Pampac, a group company of ACG Worldwide, is a celebrated name famed for manufacturing a wide range of machinery used for primary, secondary and tertiary packaging. Today, in addition to serving a core pharma client base, ACG Pampac is also addressing the needs of non-pharma clients.

As the pharma packaging market evolves and expectations escalate, streamlining operations, bringing in innovation and broadening product ranges is the need of the hour. Keeping pace with this change is ACG Pampac, a fast-growing company specialising in packaging machinery. We take a look at the inside story behind the rise of the company.

Photo: Joshua Navalkar


Manufacturing unit at the plant

Early days ACG Pampac started in mid-1987 as a Joint Venture with Germany’s IWK, a manufacturer of premium range of packaging machines. This association lasted till early 2006. Post 2006, ACG Pampac began manufacturing and selling its own machines. Today, ACG Pampac’s innovative design and fabrication allows pharma companies to pack its tablets, capsules, oral solid dosage products into blisters and cartons. In addition, many highprofile non-pharma companies use ACG Pampac’s machines to pack their products.

CEO, ACG Pampac says, “In the last 4-5 years, we have been focusing on serving the pharma segment but have also extended our machinery portfolio for non pharma segment as well. Currently, around 15-20 per cent of our machinery is targeted towards non-pharma clients. Going forward, this will balance out as growth will propel a wider range of product offerings. Currently, we are in the process of developing machines for case packing and stretch banding.”

While the company manufactures sophisticated machinery, there still lies immense scope of improvement as the European machines have higher levels of reliability and aesthetics. In a bid to ramp up its already existing product range, ACG Pampac is taking measures to ensure higher productivity

Inside the mind of ACG Pampac Latest machinery ACG Pampac offers hi-tech blister packing and carton packing machines. In the past it offered rotary-forming rotarysealing blister packaging machines. In 2000, it launched a high-speed flatforming flat-sealing machine, BQS. Its latest offering, developed in 2010, is the flat-forming and rotary-sealing blister packaging machine - B45. Until 2010, ACG Pampac manufactured continuous-motion cartoning machines. Lately, the company introduced an intermittent-motion cartoning machine - K120i - having a simple design and higher efficiency levels. By the end of 2013, ACG Pampac aims to launch more continuous-motion highspeed cartoning machines. ACG Pampac has won numerous awards for its new machine designs, not just in India but also overseas. Its K120i and SLV machines have won the IPMMIIMDIR award for machinery design and development and innovation. The company also bagged Pacmachine Award for its B45 machine in January 2013. Commenting on the latest developments, Shriram Parameswaran,

Blister strip mould

ACG Pampac, ISO 9001:2008 certified, currently boasts of a dedicated R&D setup which is instrumental in the ideation of new designs and concepts. ACG Pampac’s main aim is to create a range of high-technology products to cater to the Indian and overseas market. A collaborative research effort between ACG Worldwide’s SciTech Centre in Jogeshwari, Mumbai, and the company has played a contributory role in the development of ACG Pampac’s host of new advanced machinery. Innovative product development and expansion of the already existing product range is a focus area for the company as it grows in size and revenue and continues to cater to multiple segments. While 60 per cent of its machinery is sold in the domestic market, 40 per cent is sold in the overseas market. Growing expectations in the European market have propelled ACG Pampac to innovate and upgrade its operations. The company currently supplies its machinery to all pharma companies in India and many large pharma players worldwide. It is a clear that ACG Pampac’s key competition is the European manufacturers.

Incorporating high-precision technology within the machine to make the design foolproof and safe to use is going to be the next step. Shriram Parameswaran CEO

and quality. Parmeshwarm elucidates, “We are constantly trying to ensure higher reliability and durability levels in our machines. Along with that, we are making efforts at improving the aesthetics of the machines. Every machine must have excellent form and functionality. We are investing heavily in industrial design to make the machines more ergonomic, safer to operate and intelligent. Incorporating high-precision technology within the machine to make the design foolproof and safe to use is going to be the next step. Moreover, making the machine versatile and reducing the time taken for changeover processes will add tremendous value to customers. Appropriate training for both operators and maintenance crew is another essential we invest in.” As clients are increasingly demanding a more compact and more versatile machine to reduce its energy footprint, ACG Pampac is ensuring production of sleeker and compact machines.

While ACG Pampac is focussing on streamlining its existing operations, it is also ensuring a sustainable growth of over 20 per cent CAGR. Revamping operations will play a major role in achieving this target. Apart from core machinery manufacturing, format parts are also a high growth business for the company. Shriram adds, “We are following a phasegated approach for product development. Our objective is to streamline this operation such that product development can be completed within to 9-12 months. Packaging needs of pharma keeps changing from time to time. Currently, India is a high growth market as the Indian pharma customers are establishing capabilities to serve the international market. With many formulations going off-patent globally, the generic pharma majors in India and overseas are investing in expansion and newer products to cater to the tremendous demand for medicines and ensure that all parts of the world have access to cost-effective therapies. Thus, we too are focussing on ramping our capabilities and facilities.”

After sales services Pampac also offers a range of services after selling the machines. This ranges from installation & commissioning, technical assistance, training, format parts, validation and calibration. The company offers technical assistance through the entire life cycle of the machine. The team consists of trained engineers who are updated with latest technology. Training is also offered at the customer site for handling the machines. Special attention is given to critical stations of the machine. The customer is trained to address troubleshooting procedures and efficiently maintain the machine. Onsite validation service documents are also offered to the clients tailor-made to suit their specific needs. ACG Pampac also designs and delivers a wide range of format parts for different types of products on the machines. Thus, ACG Pampac is evolving as a formidable and trusted player in the packaging market, continually recording steady growth since its inception. ACG Pampac’s earnest pursuit in strengthening quality while maintaining affordability is going to be the key to its success.


Insight & Outlook: Automation Trends


WirelessHART technology

Over the past few years, WirelessHART transmitters have been used in process and asset monitoring tasks that previously were too risky or impractical to automate by laying cables in an operating plant. But what important characteristics of the WirelessHART technology make it so uniquely adept for process applications? Read on…


ndustrial wireless sensor networks have existed for more than ten years. However, the first generation of wireless sensors was impractical because every manufacturer had a different proprietary protocol. Products from different suppliers did not work together. Multiple gateways and configuration software were required to use different kinds of sensors. This mirrors the early days of ‘smart’ protocols for 4-20 mA transmitters. DCS manufacturers used different protocol that only supported their own devices. Multiple handheld terminals were required. Eventually, the HART protocol prevailed, and thanks to 4-20 mA/HART, most DCS can now communicate with any 4-20 mA device, and only a single field communicator is required. WirelessHART is doing the same for wireless. IEC 62591 is the only international standard for wireless in process applications. It was originally developed by the HART Communication Foundation (HCF), released in 2007, and subsequently approved as an international standard in April 2010. Standard WirelessHART products are available, thus there is no need to buy proprietary or ‘standards-ready’ wireless products now, and later worry about how to upgrade. The same common handheld field communicators and laptop software that plants already have for configuring 4-20 mA/HART devices can also be used to securely commission WirelessHART devices, regardless of manufacturer or type before it joins the WirelessHART network. WirelessHART security measures include encryption, authentication, verification, key rotation, sequence number etc, but if not enabled it would be useless. For this reason, WirelessHART security cannot be turned off, ensuring these security measures are constantly active.

Meeting process users’ needs WirelessHART was developed to meet the requirements of process industry users. In the early phase of development, the HCF collected wireless requirements from endusers in the process industries. Users demanded coexistence, reliability, long battery life, security, multivendor interoperability – all that plants need to solve process problems – and end-users are experts on their process. However, end-users are not necessarily experts on Radio Frequency (RF) design or communication protocol stacks, so HCF member companies sent their experts on RF and digital communication to design the WirelessHART technology to meet these process requirements.

Wireless plant network WirelessHART is a wireless level 1 network for sensors and actuators that complements the existing level 2 industrial protocols that may use Wi-Fi (wireless Ethernet) such as Modbus/ TCP, EtherNet/IP, FOUNDATION fieldbus HSE, and PROFINET, etc, as well as level 3 and 4 standard protocols for web browsing, email, file transfer, voice, video, etc. It is not a good idea to put all eggs in one basket, so a single wireless network covering the entire plant may not be ideal. A practical solution would be having one network per plant area, just like plants have one DCS controller per plant area. It fits in with the DCS architecture in most plants and the division of job responsibilities within the plant. WirelessHART supports this architecture. It is even possible for the same area to have different gateways for process automation and asset optimisation if preferred, but usually a single gateway is used. Data from gateways in different plant areas is backhauled over Ethernet or Wi-Fi using the HART-IP protocol, Modbus, etc. WirelessHART fits well with existing plant philosophies. Because WirelessHART requirements were collected from end-users only in the process industries, not from factory automation, building automation, or power grid, the protocol is optimised for process application. An advantage of this application optimisation is that a multitude of communication options need not be set at commissioning. This prevents errors and reduces delays.

A true standard Over the past few years, WirelessHART devices have made their way into all kinds of plants in every industry around the world. A vast majority of these devices in operation are so called native devices meaning the radio, antenna, and power module (battery pack) are built into the device as a single integrated unit such as a pressure or temperature transmitter. The other solution is wireless adapters that are mounted on conventional 4-20 mA/ HART devices and tap into the digital HART communication, tunneling the device set-up information and diagnostics to intelligent device management software. Such tunneling is only required for the HART protocol, and it is useful because more than 90 per cent of the 4-20 mA/HART devices installed are not digitally integrated; they use 4-20 mA to the DCS. The HART communication is only used with a handheld field communicator at commissioning. A WirelessHART adapter is an easy way to add HART capability to an old DCS. However, FOUNDATION fieldbus, PROFIBUS,

and Modbus, etc, have no 4-20 mA, they are all purely digital, and therefore, already digitally integrated with the DCS. Therefore, there is no need for wireless adapter or tunneling for those protocols; tunneling HART is sufficient. By using a single standard protocol, WirelessHART avoids the problem of multiple protocols such as multiple gateways, numerous drivers, and different ways of mapping the process variable (PV) to the system database. A single protocol avoids multiple ways to configure, calibrate, and diagnose/ troubleshoot device problems. The WirelessHART approach is to use a single common protocol for all wireless devices regardless of manufacturer and type. Moreover, native integration of the DCS with the gateway or wireless I/O card is possible without drivers and data mapping. A single common protocol is the only way to true interoperability.

WirelessHART uses a unique full mesh topology as many as seven hops deep, providing an important advantage. It does not need a costly infrastructure of multiple backbone routers to be installed throughout the plant within range of every wireless device. Technology ready for control when you are WirelessHART operates in the same license-free 2.4 GHz ISMband as Wi-Fi and other wireless technologies, but since it uses channel hopping and channel black listing, WirelessHART is able to coexist with these technologies. WirelessHART transmitters are predominantly used for process and asset monitoring. However, the technology is ready for control when you are. The technology is time synchronised and scheduled with a precisely periodic macrocycle (called superframe), and makes use of publisher/subscriber (called burst mode and catch) communication similar to FOUNDATION fieldbus. The result is deterministic communication.

Full mesh topology Although opinions of wireless experts differ on many points, there is consensus on at least one point: that selforganising mesh topology is the most robust. This is because devices establish multiple paths among themselves, routing messages at device level, in a mesh. If one of the paths is disrupted, the network automatically switches to another path, thus maintaining a

Photo courtesy: Emerson Process Management

Process and asset monitoring simplified

reliable connection. That is, redundant data pathways eliminate single points of failure. Actual installations consistently demonstrate more than 99 per cent data reliability. Mesh topology is therefore the best practice. Star topology is typically not used although supported by the technology. WirelessHART uses a unique full mesh topology as many as seven hops deep, providing an important advantage. It does not need a costly infrastructure of multiple backbone routers to be installed throughout the plant within range of every wireless device. Running costly hazardous area power supply to backbone routers is therefore not required. Mesh topology is truly wireless and with low risk. The ability to self-organise is critical in a plant environment with intermittent sources of noise and temporary obstructions. With sources of noise ranging from motors and pumps starting and stopping to walkie-talkies, the RFI environment is constantly changing. But a selforganising network can easily adapt and maintain high data reliability. It also makes adding and removing devices easy as manual configuration is not required.

Deploying wireless After thousands of installations in industries globally, users have found that choosing their wireless network can be simple with a few thumb rules to follow. Choose a wireless technology, which is an international standard supported by one’s preferred transmitter suppliers, and has all the device types required for one’s current and future applications. Narrow it down to a single protocol that ensures ease of deployment and long-term device maintenance, and which makes use of your existing commissioning tools and requires less training. Make sure to use a self-organising mesh topology for maximum robustness and ease of management. One common protocol customised for process automation users eliminates the need for superfluous configuration. Last but not the least, security that cannot be turned off greatly reduces cyber security risks. Many believe that the question is not if they will use wireless, it is merely a question of when. By choosing the wireless network wisely, the investment will be repaid not only on the first application, but for every additional application that is added to the same network in the future. Jonas Berge Level Application Manager - Rosemount Business Unit, Emerson



Insight & Outlook: Case study

Single-use pumps

Taking centre stage Single-use pumps, such as those using disposable pump chambers, feature replaceable wetted parts, meaning that no cleaning and validation process is needed during a product-development process that can require multiple trials. And single-use quaternary diaphragm pump technology from Quattroflow™ meets the speed-to-market challenges of biologic-based drug manufacturing. Studying the case in detail.


n the multi-billion-dollar global biopharmaceutical industry, a further emphasis is being placed on the development and manufacture of advanced biologically derived drugs (termed here as biologics). These biologics offer exciting potential for the development of blockbuster drugs that can provide as-yet-unknown treatments for a wide array of diseases. The development of new biologically derived drugs, however, is just one opportunity for manufacturers. Another equally important goal is to commercialise these products as early as possible in the typical 20-year patent window. Patent submission needs to occur during the drug-development process. Following a patent filing, much occurs, including further product development, toxicity checks and clinical trials. Hopefully, FDA approval also occurs during this period. Following FDA approval, the developers need to take all the necessary steps to properly produce the product in commercial scale and execute the market– introduction plan. If the drug’s development takes additional time after patent approval, the patent may run through a good portion of its window of protection before the drug has a chance to be commercialised. In some cases, there are only about seven years left on the patent for the product when it goes to market. From a process-equipment standpoint, permanent and single-use quaternary diaphragm pumps, such as Quattroflow™ pumps, represent a growing technology that both helps enable the efficient development of new biologic drugs and then facilitates the speed to market of the end-product. Single-use pumps are a great advantage for drug manufacturers who are looking to maximise their production operations through the implementation of cuttingedge pumping technology. The critical issue in these targetcomponent extraction techniques is that biologics are extremely sensitive to change or damage from outside influences, such as shear, temperature changes and light. That means the extraction process that these target components are subjected to requires a type of pump that can reliably deliver desired operational characteristics. This study illustrates how one type of pump technology—positive displacement quaternary diaphragm— has become one of the preferred pumps to incorporate in critical biologicshandling applications.

The challenge The harvesting and purification of biologic target materials is accomplished using separation and filtering processes. There are generally three purification processes (that can also be used in combination) as follows: Tangential Flow Filtration (TFF): Also known as cross-flow filtration. For this process the biologic feed stream flows horizontally with positive pressure

across the filter membrane. As it passes across the membrane, the portion of the feed stream that is smaller than the membrane’s pore size passes through the membrane. This mode of operation means that a TFF process can operate continuously with relatively high solids loads without fouling of the filter, which is also known as filter blinding. The quaternary diaphragm Chromatography columns: A typical chromatography column is a glass, steel or plastic tube that is filled with resins that are compressed in a certain format through which a feed stream product flows to either capture or purify this feed stream. These chromatography columns contain filter media that need careful handling. In this application, a quaternary diaphragm Quattroflow pump can be used to pack the resin into the chromatography column and then pump the biologic material through the column. Centrifuges: A centrifuge, really a separator and not a filter, consists of an elaborate vessel that can be fed with a biologic substance and spun around a central axis in order to separate the materials according to their different specific gravities/weights, or to separate particles that are suspended in the liquid. The biologic’s target product can be the high, intermediate or low specificgravity substance that is spun out of the centrifuge.

One key manufacturing trend that can reduce development cost and increase speed-to-market is the adoption of single-use technologies.

In all three processes that are used for target feed stream purification, the requirements of the pump are precise: constant, low-slip, low-shear, low-pulsing flow. Over the years, several different types of pump technologies have been used/tested for these processes, and while there are applications that they are best suited for, they have been found to be deficient in the purification processes described above:

Single-use pumps needed One key manufacturing trend that can reduce development cost and increase speed-to-market is the adoption of single-use technologies. In certain cases, permanent stainless-steel process lines are very costly to set up, lack the production flexibility in biologic development, and have complex and time-consuming cleaning and validation requirements. Therefore, much expense and time can be saved by simply starting each trial process with a fresh, sterile set of single-use process-equipment components. These components can consist of bags instead of stainlesssteel vessels, special agitators instead

Pump technology like that found in single-use quaternary diaphragm models from Quattroflow® are able to satisfy the product containment and speed-to-market requirements that are paramount in these types of operations.

of stainless-steel shaft agitators, singleuse tubing, coupling and valves instead of their stainless-steel equivalents, and filter systems, many of which are single-use by their very nature. Prior to Quattroflow, single-use low-pulsation positive displacement pump options were not suitable for many needed biologics production processes.

The solution For a growing number, the solution to the strict single-use pumping requirements that are demanded in the biologics-filtering process can be found in the positive displacement quaternary diaphragm technology that has been developed by the German company, Quattroflow™, which also introduced to the market the singleuse configuration for use in critical product-handling applications in the pharmaceutical and biotech industries. In January 2012, Quattroflow was acquired by the Pump Solutions Group (PSG®), which is a conglomeration of several of the world’s leading pump manufacturers that operates within the Dover Corporation’s Dover Energy™ business platform. PSG has integrated the manufacture of Quattroflow pumps into the operations of its Almatec® subsidiary, which is headquartered in Kamp-Lintfort, Germany. The main advantage of Quattroflow pumps used in biologics-handling applications is its unique form of operation: The quaternary diaphragms are driven one after another by a connector plate, which moves back and forth out of its central position in a stroke that is generated by an eccentric shaft, with the length of the stroke determined by the angle of the eccentricity. In other words, the Quattroflow technology has been modeled on the operation of the human heart—which is eminently capable of pumping whole human blood, one of the most shear-sensitive products around—with its four pumping Wallace Wittkoff Hygienic Market Director-Americas, Pump Solutions Group (PSG®)

chambers and check valves keeping product flow constantly moving forward. Single-use pumps that are made from FDA/USP class VI conforming/approved materials also have a lower cost compared to their stainless-steel counterparts. The total cost of using a single-use pump is less because the cost to replace the head may pale in comparison to the cost of validating the cleaning (which can run in the tens of thousands/millions of dollars), plus the entire cost to install a permanent stainless-steel process line. A common notion in this industry is that the cost of the paper backing up the equipment used is higher than the equipment itself. The Quattroflow, by using a standardised and documented single-use variation, reduces that paper and cost. For cases where the total cost of a permanent stainless-steel process line is more attractive, the Quattroflow pump head can be converted to a stainlesssteel head with the same controlled flow, low-shear, low-slip and high-purity operation, with the addition of desirable high-cleanability attributes.

Conclusion Advances in the ability to produce and use biologically derived drugs has created an exciting opportunity for manufacturers in the biopharmaceutical market. However, while this continuing trend is packed with possibilities, they can only be realised if the development and manufacturing processes for these products are optimised, both in regards to speed-to-market considerations and contaminant-free production requirements. Quattroflow has identified the challenges in this process and has responded with a pump style— single-use positive displacement quaternary diaphragm pumps—that dependably meets challenges and allows biopharmaceutical manufacturers to confidently meet many of their most crucial biologic-handling and manufacturing needs.

Ravi Prasad Director - Sales, PSG India




New projects and expansion activities are the barometers of industrial growth. These also present business opportunities to service providers like consultants, contractors, plant & equipment suppliers and others down the value chain. This feature will keep you updated with vital information regarding new projects and capacity expansions being planned by companies in the pharma/lifesceinces industry. Installation and commissioning of ultrasound machine with high frequency probe Project type: New facility Project news: Institute Of Liver & Biliary Sciences is planning to install & commission ultrasound machine with high frequency probe. Project location: Delhi Project cost: NA Implementation stage: Planning Contact details: Institute Of Liver & Biliary Sciences D-1, Vasant Kunj, New Delhi-110070 Tel: 46300000 Extn. 5042 Fax: 46300010 Email : Installation and commissioning of whole slide imaging system (slide scanner) Project ty pe: New facility

Project news: Institute Of Liver & Biliary Sciences is planning to install & commissioning of whole slide imaging system (slide scanner). Project location: Delhi Project cost: NA Implementation stage: Planning Contact details: Institute Of Liver & Biliary Sciences D-1, Vasant Kunj, New Delhi-110070 Tel: 46300000 Extn. 5042 Fax: 46300010 Email : Installation & commissioning of deep freezer -20 Deg C Project type: New facility Project news: Institute Of Liver & Biliary Sciences is planning to install and commissioning of deep freezer -20 deg C Project location: Delhi


Project cost: NA Implementation stage: Planning

Project news: Institute Of Liver & Biliary Sciences is planning to install and commissioning of High Dose rate (HDR) brachy - therapy system

Contact details: Institute Of Liver & Biliary Sciences D-1, Vasant Kunj, New Delhi-110070 Tel: 46300000 Extn. 5042 Fax: 46300010 Email :

Project location: Delhi Project cost: NA Implementation stage: Planning

Installation and commissioning of ultrasound machine with probe Project type: New facility Project news: Institute Of Liver & Biliary Sciences is planning to install and commission ultrasound machine with probe. Project location: Delhi Project cost: NA Implementation stage: Planning Contact details: Institute Of Liver & Biliary Sciences D-1, Vasant Kunj, New Delhi-110070 Tel: 46300000 Extn. 5042 Fax: 46300010 Email : Installation and commissioning of High Dose rate (HDR) brachy - therapy system Project type: New facility

Information courtesy: 1, Arch Gold, Next to MTNL Exchange, Poisar, S V Road, Kandivali (W), Mumbai - 400 067, Maharashtra, India t5FMt'BYt&NBJMQBSNFFUE!UFOEFSTJOGPDPN

Contact details: Institute Of Liver & Biliary Sciences D-1, Vasant Kunj, New Delhi-110070 Tel: 46300000 Extn. 5042 Fax: 46300010 Email: Installation and commissioning of advanced digital linear accelerator Project type: New facility Project news: Institute Of Liver & Biliary Sciences is planning to install and commissioning of advanced digital linear accelerator. Project location: Delhi Project cost: NA Implementation stage: Planning Contact details: Institute Of Liver & Biliary Sciences D-1, Vasant Kunj, New Delhi-110070 Tel: 46300000 Extn. 5042 Fax: 46300010 Email :




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1, Arch Gold, Next to MTNL Exchange, Poisar, S.V. Road, Kandivali (W), Mumbai - 400067 Maharashtra, India Tel: tFax: tEmail:


invite that

rewards as well... Dear Reader, ‘Modern Pharma’ solicits original, well-written, application-oriented, unpublished articles that reflect your valuable experience and expertise in the pharmaceutical industry.

16-31 May 2013 I Vol 1 I No 22 I `100


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You can send us Technical Articles, Case Studies and Product Write-ups. The length of the article should not exceed 1,200 words, while that of a product write-up should not exceed 100 words.

Policies & Regul ations

rma exports

in 2013

The articles should preferably reach us in soft copy (either E-mail or a CD). The text should be in MS Word format and images in 300 DPI resolution & JPG format. The final decision regarding the selection and publication of the articles shall rest solely with ‘Modern Pharma’. Authors whose articles are published will be sent a complimentary copy of that particular edition. Published by Network18 Media & Investments Ltd, ‘Modern Pharma’ is one of the leading fortnightly magazines exclusively meant for producers and user fraternities of the pharmaceutical industry. Well supported by a national readership of over 80,000 and our strong network of 26 branch offices across India, this magazine reaches out to key decision makers among the Indian manufacturers of pharma products, machinery and allied sectors. Brought out in association with Hong Kong-based Ringier Trade Media Ltd (one of the world’s largest trade publishing houses with more than 200 special interest titles and offices in every major country), it ensures that advertisers are able to promote their products and services across the globe at no extra cost. So get going and rush your articles, write-ups, etc‌ Thanking you, Yours sincerely,

Manas R. Bastia Senior Editor Modern Pharma

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Foreign Corrup t Practices Act Understanding business objectiv es and complia nce

eneca Pharm A better glass aceuticals will provid AB ea the medicine container can safegua to ` 140 crore financial grant of up rd for a longer to This is what period of time. the next three the Indian firm over the Schott’s Fiolax Academ discussed AstraZ eneca years. “The promoter, in detail y in a conducted Sweden has Pharmaceuticals AB for the SMEs. recent even the leading Schott, one non-repayabl decided a voluntary manufactures of e financial which is used of glass tube nearly $ 22.5 grant of million to by the pharmato made containers 26.5 million over the industry, conduc used three years open Fiolax Academ (FY14-FY16) under a ted an subvention y to on quality agreement,� AstraZeneca of glass used educate SMEs Pharm in contain making a India stated ers. This in a filing of the to the The Lalit, Mumbconference took place AstraZ eneca BSE. at ai, on April Pharm aceuti The main Participants 26. AB would purpose of at the Schott cals provid was to provide the Fiolax Academ of $ 14 million e the first tranch adequate knowleconference pharm y, Mumbai e (` 74 crore) the quality a industry dge about Indian firm of the glass is growing to the rate. We are in and to educate at a fast on the fact year, it added. the current financial just that glass can pharma industr industry enough trying to educate deteriorating contribute ies from the about so that in interna the conditi that region the quality on of the The confere tional standar it could meet the difference Suven Life drug. we nce produce and ds. Further are one the Boltres, Produc was led by the Dr Bettine more, as what they get. in what we patents for Sciences receives was positive The field, we try oldest manufacturer Tubing Produc t Manager, Pharmaceutic and that motiva response and Canadathree NCEs in Eurasia al the smaller to pass on the knowle in the move further t ted us to Services, Schott. Management & Scientif .� dge compan to ies by arrangi ic kinds Apart from of Academ type of glass She explained about what ng these Suven having the y. conference and Li The journey � to make contain tubes should be and semina Academy Sciences receivefe of used Schott’s arrang rs, Schott Fiolex Academ started some es several the drug for ers in order to safegua product patent s lecture two years y pharm rd confere a longer period ago. The initial aceutical college s to various Dr Boltres nce was a for its NCEs,s of includ ing time. said, closed s so and that studen one where invited certain factories two pharmaceutic “It is important for ts they the one in Eurasi in Canad a and companies the the event. al field can be and the persons on a. These that not only industry to unders It was arrange to be a part of of aware about meant to NCEs tand the the are the d part of the cure neurod in rubber cap quality the contain nation, Delhi. the northern making glass that is being but also disorders egenerative er can used reason, Sundee and patent Elaborating Both are equally affect the drug badly. the Academ of the containers. Schott’ in the s are valid till 2028. p Prabhu, important and - Sales &Mark Vice Preside s The grante y should pay a compan nt nations is being carried out Fiolax of the patent d claims eting, Pharm attention to in many across the s include them. With y Tubing, Schott, conference, aceutical of selecti globe with the class said, this place we are trying motive of ve 5-HT the sole creating the answer their where there “Delhi is the one our best to compounds discovered awareness the glass queries are tubes are by Suven about tubing. For Georg Sparsch .� and are being easily availab various cheap plans developed future plans, uh, Preside le. There many compan as present at it were users, to have a conference nt, Schott, and are useful therapeutic agents ies who were the event, for the tubes such as doctor selling these said, “The in the treatm cognit ive s, and educat end Indian importunder our name. Consid regarding ent of impair ment e them the ering ance, better quality we chose this the with neurod associated containers. place to educate egenerative like Alzhei mer’s disease disorders Deficient Anubhav Sharma , Hyperactivit Attention India pharm (ADH D), y a industry Hunti ngton’ Disorder around $ that exports Parkinson s diseas e, 10 billion and Schizo The country pharmaceutic worth of phreni Speaki ng al produc plus pharma has exported $ 10 billion on the develo a. ts per expects cent Venkat Jasti, ceuticals in growth in issues faced pment, 22 include 2012, the current related to dissolut CEO, Suven, “India is the “We are year. and s 90 per cent share of formulawhich Indian pharma said, ion, he said. frontrunner pleased by 10 per cent firms manufa pharmaceutica in export of tions quality the grant these patent ls including of standard medicin cturing global manufacturing of APIs. More than s for our and active formulations 180 and molecu les pipeline of plants are approve es, are way pharmaceutic today one tablet in FDA in India, ahead d by US (APIs) in al ingredient out of four consum being develo CNS arena that are which is the in US or the highest numbe outside US. ped for Europe is ed per cent export world. We expect India’s share disord ers r a local cognit ive 22 market growth in pharma companmanufactured by of the generic with high is year,� told medical need y. unmet L Ramaswamy, the current contrib about to 35 per cent. Hence, Society ution of the Director, the Science for Pharmaceutical Dissolu potential globallwith huge marke Indian Sotax India Managing industr t (SPDS) is tion y.� y for the growth pharmaceutical sidelines of on workin further the a g towards of generic drugs the world improving pharma conven ‘Disso India 2013’ – the quality a pharma is high, Ramaswamy said. in production and tion. of industry needs export, and The achieve trying to new technol innovation ogy, consum the target of every and needs to third tablet sort out various ed globally should be India, he said. made in

T +91 22 3024 5000 D +91 22 3003 4669 F +91 22 3003 4499 E W



Event List

N AT I O N A L E V E N T S PHARMAbiotika


Pharmabiotika 2013 is an exhibition with an in built buyer and seller meet which will help one in networking with 10000+ business visitors, 600 delegates and 400+ exhibitors, attending the global exhibition. There are around 30+ thought leaders from across the world sharing their valuable experiential learning in the 3 days conference. The event will help in meeting the potential customer requirements mapping for developing new trade leads and analysing the exhibiting plan and execute trade objectives; September 16-18, 2013, Mahatma Mandir Convention & Exhibition Center, Gandhinagar

Some of the primary highlights of this conference will be interactive session, papers, abstracts and programs. Masses from all over the world are welcomed to be the parts of this conference. Topics that will be discussed in Asia Arvo are genetics of AMD, understanding AMD, reprogramming and regeneration, gene therapy, small molecule screening and drug discovery, model organisms, gene regulation during development and disease, eye development inherited eye diseases, diabetic retinopathy, common eye diseases, signaling pathways, angiogenesis, crystallins, chaperons and heat shock proteins, oxidative stress, aging and eye disease; October 28-31, 2013, Ashok Convention Centre, New Delhi

For details contact: Human Crayon Management Services Pvt Ltd Tel: +91- 120 – 6528801 Email: Website:

Indian Pharma Expo The Indian Pharma Expo 2013 will serve as a perfect platform for pharma entrepreneurs andinvestors, eager to be a part of the pharmaceutical business through franchisee and distributorship opportunities in the India pharma market. The two-day expo will bring together drug manufacturers, pharma companies and suppliers and distributors of pharma products under one roof to exchange ideas; September 20-21, 2013, Pragati Maidan, New Delhi For details contact: UBM Medica India Pvt Ltd Tel: +91-22-66122600 / 66122673 Fax: +91-22-66122626 Email: Website:

For details contact: The Association for Research in Vision and Ophthalmology Tel: +12402212900 Fax: +12402210370 Website:

CPhI India CPhI India will bring pharma professionals from all over the world to Mumbai and facilitate, initiate and close business deals. It will be a great opportunity for the industry to showcase their products and services while enhancing their brand at South Asia’s leading pharma industry event. Exhibitors will include manufacturers of Active Pharmaceutical Ingredients, Alkaloids, Amino acids, Antibiotics, Antibodies, Antimicrobial preservatives, Antioxidants, Biocatalysts, Biotechnology, Capsules/ encapsulation, Chemical synthesis/analysis, Chira intermediates and lots more;


Andhra Pradesh, May 31- June 3, 2013 India’s premier industrial trade fair on products and technologies related to Machine Tools, Hydraulics & Pneumatics, Process Machinery & Equipment, Automation Instrumentation, Packaging & Auxiliaries, IT Products, Electrical & Electronics, Material Handling and Safety Equipment.

For details Network18 Media & Investments Ltd

Ruby House, 1st Floor, J K Sawant Marg, Dadar (W), Mumbai 400 028. R5&95fhh5iffi5jlkg5R5295fhh5iffi5jjoo5R5'#&95(!2*)H(.1),%gn*/&#-"#(!8)'

December 3-5, 2013, Bombay Exhibition Centre, Mumbai

December 3-5, 2013, Bombay Exhibition Centre, Mumbai

For details contact: International UBM Live Tel: +31 (0) 20 40 99 524 Fax: +31 (0) 20 36 32 616 Email: Website:

For details contact: International UBM Live Tel: +31 (0) 20 40 99 524 Fax: +31 (0) 20 36 32 616 Email: Website:

P-MEC India

34th International Conference on Bioscience, Biochemical and Pharmaceutical Engineering

With India’s pharmaceutical machinery and equipment market growing, decision makers from all over the world are increasingly looking at India for sourcing pharmaceutical machinery and equipment. At P-MEC India, visitors will have the unique opportunity to showcase their products in front a large audience, building brand awareness and gaining new leads from over 85 countries. P-MEC India is co-located with CPhI India, a sister brand of CPhI Worldwide - the “must attend� event in the international pharmaceutical industry. It is a great platform for visitors to showcase high-quality pharma machinery and equipment, meet with key decision makers in pharmaceutical industry from countries, including India, China, US, UK, France, Italy, etc and network and build the brand in one of the world’s fastest growing pharmaceutical markets;

The main focus of this conference is to bring scientists, researchers and scholars together to exchange and share experiences and research results about bioscience, biochemical and pharmaceutical engineering, and discuss the practical challenges encountered and the solutions adopted. The conference will deal with topics such as bioscience, biochemical and pharmaceutical engineering, affective neuroscience, astrobiology; December 5-6, 2013, Sheraton, Bengaluru For details contact: World Academy of Science Engineering and Technology Tel: +44-782-4879405 Website: conferences/2013/bangalore/icbbpe/

I N T E R N AT I O N A L E V E N T S 2nd International Conference on Bioinformatics and Biomedical Science The objective of the 2013 2nd International Conference on Bioinformatics and Biomedical Science (ICBBS) is to provide a platform for researchers, engineers, academicians as well as industrial professionals from all over the world to present their research results and development activities in Bioinformatics and Biomedical Science; June 8-9, 2013 Concorde Inn Kuala Lumpur International Airport, Kuala Lumpur, Malaysia For details contact: Asia-Pacific Chemical, Biological & Environmental Engineering Society (APCBEES) Tel: +86-28-86528465 Email: Website:

The Clinical Genome Conference Bio-IT World and Cambridge Healthtech Institute will host the 2nd Annual TCGC: The Clinical Genome Conference is inviting stakeholders from all arenas impacting clinical genomics to share new findings and solutions for advancing the application of clinical genome sequencing. The conference will bring together many constituencies for frank and vital discussion of the applications,

questions and solutions surrounding clinical genome analysis, including scientists, physicians, diagnosticians, genetic counselors, bioinformaticists, ethicists, regulators, insurers, lawyers, and administrators; June 25-28, Hotel Kabuki, San Fransisco, CA For details contact: Cambridge Healthtech Institute Tel: 781.972.5400 Fax: 781.972.5425 Email: Website:

International Congress of Toxicology 2013 The theme for the conference is ‘From Basic Science to Clinical and Environmental Outcomes’. This conference encompasses novel approaches and technologies being used to properly assess the safety, toxicity, and risk for human health. The scientific programme will consist of keynote/distinguished lectures, symposia, workshops, round table discussions, debate and poster sessions. This meeting will provide attendees with ample opportunities to exchange the ideas and to launch collaborations; June 30 - July 4, 2013, Coex, Seoul, Korea For details contact: ICT XIII Secretariat Tel: +82-2-557-8422

Fax: +82-2-566-6084 Email: Website:

Pharma Trials World Korea 2013 Pharma Trials World Korea 2013 is where pharma companies, trial sponsors, regional and international CROs and clinical trial sites gather to strategise in accelerating clinical development, accessing emerging markets, enhancing clinical operations through effective offshoring and outsourcing in Korea; July 8-11, 2013, Korea For details contact: Terrapinn Pvt Ltd Tel: +65 6222 8550 Fax: +65 6226 3264 Email: Website:

3rd International Conference on Environmental, Biomedical and Biotechnology 3 rd International Conference on Environmental, Biomedical and Biotechnology is sponsored by the Asia-Pacific Chemical, Biological & Environmental Engineering Society. It is one of the leading international conferences for presenting novel and fundamental advances in the fields of environmental, biomedical and biotechnology. It also serves to foster communication among researchers and

practitioners working in a wide variety of scientific areas with a common interest in improving environmental, biomedical and biotechnology-related techniques; August 24-25, 2013, Royal Hotel, Singapore For details contact: Asia-Pacific Chemical, Biological & Environmental Engineering Society Tel: +86-28-86528465 (China Branch) Email: Website:

5th Pan Arab Human Genetics Conference The conference will focus on topics ranging from cancer genomics and NexGen sequencing to molecular profiling and pharmacogenomics. International and regional experts will take to the platform to deliver their lectures on these topics. Researchers will be encouraged to submit their abstracts for oral or poster presentation at the conference. Also, a special feature of the conference will be a workshop on rare disorders; November 17-19, 2013, Al Bustan Rotana, Dubai-UAE For details contact: Meeting Minds Experts Tel +971.4.4270492 Fax +971.4.4270493 Email Website:

The information published in this section is as per the details furnished by the respective organiser. In any case, it does not represent the views of Modern Pharma.


Book Review Global Approach in Safety Testing: ICH Guidelines explained The International Conference On Harmonisation of technical requirements for registration of pharmaceuticals for human use (ICH) formed in the early 90s, brings together experts and policymakers from the three pharma major areas of the US, Europe and Japan. It aims to do away with the local and individual differences in the process of new drug approval among the major markets so as to improve international trade and healthcare. The book is an ICH safety guideline document which gives a clear and in-depth look into the various factors and players involved in the industry. The initial chapters deal with the history, necessity and major impacts of the ICH. Two chapters also give a European and Japanese perspective of the ICS. The majority of the text is devoted to various aspects of safety testing of new pharmaceuticals. The chapters individually describing carcinogenicity testing, genotoxicity testing, toxicokinetics, duration of testing, and reproductive toxicity, give a detailed ICH guideline view of the same. Every detail is explained with supportive evidence and potential benefits of the same. The book concludes with chapters dedicated to biotechnology-derived products, non-clinical evaluation of anti-cancer drugs and non-clinical safety studies. The book has a straight guideline based language, interspersed with relevant flowcharts and diagrams to drive the point. A great compendium to anyone interested in international drug development and regulatory requirements.

Editors: A Hamid Mollah, Mike Long, Harold S Baseman Price: ` 7,200

Publisher: Wiley Distributor: Wisdom Book Distributors, Hornby Building, 1st Floor, 174, D N Road, Mumbai 400 001, Tel: 022 2207 4484/6631 8958, Telefax: 022-2203 4058 Email:

Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing Over the past decade, regulators of the pharmaceutical industry have become more stringent and are constantly upgrading their policies. In these days of widespread international pharmaceutical trade, compliance with regulations and reducing the risk of compliance-related issues is on the forefront of all industry players. The initial chapters give a brief insight into the need of risk management and the different methods of the same. The first half of the book also gives a regulator’s perspective of risk in pharmaceutical manufacturing, especially an organisational view. The second half of the book breaks the drug manufacturing process into components where risk management becomes a priority and devotes considerable text to each section. Starting with manufacturing facilities, equipment, setting up and scaling, process development and actual product manufacture all are described from a potential risk management perspective. Hazard Analysis and Critical Control Point (HACCP)-based risk management approach in product manufacture has been described in details and serves as a good tool to understand every step, which has a potential risk of interfering with existing regulations. The book describes in considerable detail the risks involved in aseptic processing technology and management principles for the same. The text is complemented with fish diagrams, flow charts, illustrations and pictures to put due emphasis on the risk management strategy. A great book for all stakeholders of the industry especially the chemists, engineers, entrepreneurs and the regulators. Reviewer: Dr Mandar Kubal, Director, Infectious Diseases & Pulmonary Care Pvt Ltd


Editors: Jan Willem van der Laan & Joseph J DeGeorge Price: ` 10,500

Publisher: AAPS Press Distributor: Wisdom Book Distributors, Hornby Building, 1st Floor, 174, D N Road, Mumbai 400 001, Tel: 022 2207 4484/6631 8958, Telefax: 022-2203 4058 Email:




Looking For A Specific Product? Searching and sourcing products were never so easy. Just type MPH (space) Product Name and send it to 51818 eg, MPH Laboratory software and send it to 51818

Automatic ampoule loader It has electrical rating of 0.5 HP. The power characteristics are 415 Volts, 3 Phase, 4 Wire system, 50 cycles/sec. It features a S.S. finish / body painted in nickle-gray colour with size 890mm (L) x 1170mm (W) x 1270 mm (H) and 350 kg weight. Approximate output/hour is 9000 ampoules. Ampoules size is 1ml to 5 ml. The machine is time saving due to automatic loading of ampoules in combi trays of multijet washing machines. Tailor-made machine is possible to make compatible with your multijet washing machine.

A.H Industries Ahmedabad – Gujarat Tel: 079 - 22744728 Fax: 079 22747093 Email: Website:

GSM alarm system GSM/GPRS SMS alarm system is known as EnviroGSM system. This system is a useful tool to remotely monitor critical systems like industrial automation, remote security and environmental monitoring. EnviroGSM has up to 8 input and 8 potential free alarm outputs, which can be connected to buzzer, CCTV,

flood lights and willkie-talkie. It ensures the adoption of advanced end to end monitoring system and is used to monitor critical process control parameter like temperature, pressure, humidity and will generate SMS alerts if parameter crosses predefined levels and security team can then achieve central monitoring by wiring the audio alarm circuits to the security never center. By communicating in a low voltage condition at a particular zone, EnviroGSM can send SMS alert to mobile phones anywhere in the world, including one to security control room.

Walk-in humidity chamber Walk-in humidity chamber is specially designed chamber for low humidity conditions such as 25°C & 40%RH, 40°C & 25%RH, 30°C & 35%RH. The temperature range is from 20°C - 60 °C and humidity range from 40%RH - 95%RH with accuracy +0.2 °C / +2.0 % RH and uniformity +1.0 °C / +3.0 % RH. It is test suitable for 25°C & 60%RH, 30°C & 65%RH and 40°C & 75%RH, 30°C & 75%RH. Optional features include GSM technology, hooter system and extra tray.

Enviro Technologies Thane - Maharashtra Tel: 022 - 64646500 Email: Website:

Mack Pharmatech Pvt Ltd Nashik - Maharashtra Tel: 2551 230877 Fax: 2551 230877 Email: Website:

Octagonal blender Octagonal blender features discharge output via. butterfly valve, safety guards provided with limit switch interlocked to motor to ensure safe operation, bump- less rotation. All contact parts are made of SS 316 as per GMP standard. It has zero retention design. Internal finish conforms 220 grits to 320 grits, outside mat finish180 grits. Charging drum arrangement with mechanical / hydraulic trolley is provided. Other features include safe earthing systems, optional accessories/ attachments, flame proof construction, PLC with MMI and VFD. Applications include blending of dried granules for tablets and blending of dry powders for capsules. Documentation like DQ, IQ, OQ and FAT is provided with the machine. Jay Pharma Equipments Mumbai - Maharashtra Tel: 022 - 32155790 Email: Website:

Rigid tube packaging machine Automatic rigid tubes filling and closing machine is suitable to count and introduce positively, tablets in plastic or metallic rigid tubes, cylindricalshape. It has a final tube closure with



pressure cap and discharge of the tubes is correctly filled on a bucket conveyor at machine outfeed, with cap facing the operator side, extremely compact tube feeding; tube transport carried out through bushes that proceed with synchro-dynamic movements. The tablet insertion is made with a system that moves them in a positive way by means of a pick & place system. The machine is manufactured in strict compliance with GMP norms. It is made of steel and aluminium with AISI304 stainless steel panels and operating parts are constructed with materials suitable to operate at direct contact with product. Jay Pharma Equipments Mumbai - Maharashtra Tel: 022 - 32155790 Email: Website:

jet mill glove box isolators feature total containment gloveboxes/ isolators while milling compounds along with a controlled and safe environment. All equipment can be purged with nitrogen to prevent dust explosions and can achieve less than 1% oxygen. Safety review includes nitrogen protection system for dust explosion risks, sampling methods include integration of online particle size analysers, 3D models and full scale mock-ups are available and it has assured containment to nanogram levels. PSL India Mumbai – Maharashtra Tel: 022 - 28908232 Email: Website:

Silicone transparent braided hose

Mills and microniser PSL’s contained microniser mill/air jet mill glove box isolators are innovatively designed by expert process engineers for size reduction of active ingredients. Total mill adaptation can be provided within the glovebox isolator solutions. PSL’s contained microniser mill/air

Silicone transparent braided hose conforms to USP Class VI requirement & FDA 21 CFR 177.2600. This braided hose is made from 100% pure silicone rubber by using fully automatic state-of-

the- art machineries and technologies. The medical grade braided hose is manufactured under stringent quality control. The braided hose is temperature resistant from -80°C to 250°C (-110°F to 480°F), non-reactive to body tissue and fluid and has non-adherence to tissue. It is unaffected by most water soluble materials and is sterilisable by steam, dry heat, ethylene oxide (ET) and gamma radiation. It resists oxidation, ozone and radiation and has an indefinite shelf life. Available size is from 6 mm ID to 60 mm ID. AMI Polymers Pvt Ltd Thane - Maharashtra Tel: 022-28555107/631 Mob: 09223290931 Fax: 022-28555378 Website: www.

Track and trace system Track and trace system is powered to create a complete identification and data verification solution for labels on pharmaceutical medical device packaging and healthcare serialisation. It reads 2-D and 1-D barcodes: Data Matrix, GS1-128, GS1 dataBar, securPharm and Pharmacode. It can verify correct ID code contents, including compliance with the GS1 Healthcare data standard, supports FDA 21 CFR Part 11 validation compliance


with change tracking, double blind and secondary authentication, provides data matrix mark quality assessment during production to detect changes in print quality, verify the accuracy of printed text & skew, detect label misalignment & skew and supports bundle aggregation. Cognex Sensors India Pvt Ltd Pune - Maharashtra Tel: 020- 40147840 Fax: 020-66280011 Email: Website:

V blender V blender is an ideal mixer for cream, ointment and paste. All parts are made of stainless steel and are highly polished. The blender can produce a homogeneous mixture. Technical specifications are 43 Kg weight, 68 kg gross weight, 660mm x 482mm x 630mm dimension and electrical specifications 0.25HP, AC, 230V, 50Hz, 3Ph. Cronimach Machinery Ahmedabad - Gujarat Tel: 079 – 25861418 Email: Website:




Multi-channel scanner The Enviro scanner is fully valid table and designed for regulated industries. The specification incorporated serves every simple and critical process control applications of the industry. It is known as an e-scan system which is suitable for continuous monitoring and recording of temperature or humidity at 16 different locations, eliminating the need for number of individual temperature or process indicators in turn saving the cost. The temperature is indicated within the accuracy +/-0.15°C and humidity better than +/-2% RH. A graphical display screen reads and displays the data at respective channel. This scanner is designed to monitor and display up to 16 channel for each of temperature, humidity, RTD, thermocouple as well as any digital inputs. A graphical display is provided to indicate the current process value of temperature and humidity. Enviro Technologies Thane - Maharashtra Tel: 022 - 64646500 Email: Website:

Silicone transparent tubing

AMI Polymers Pvt Ltd Thane - Maharashtra Tel: 022-28555107/631 Mob: 09223290931 Fax: 022-28555378 Website: www.

Wet granulator These transparent tubings are made from 100% pure silicone rubber by using fully automatic state-of-the art machineries and technologies. Silicone transparent tubings are manufactured under stringent quality control and has the several distinguished features. It is made form medical grade silicone rubber which complies with USP Class VI requirement & FDA 21 CFR 177.2600, temperature resistant from -80°C to 250°C (-110°F to 480°F), non reactive to body tissue and fluid, non-adherence to tissue. It remains unaffected by most water soluble materials and is sterilisable by steam, dry heat, ethylene oxide (ET) and gamma radiation which resists oxidation, ozone and radiation. It has an indefinite shelf life. Silicone sleeves are also manufactured. It finds application in food, pharma, chemical, medical, heavy engineering, thermal power stations and PSUs.

Wet granulator is suitable to manufacture wet granules of various granule sizes. Parts are made of stainless steel and each apparatus is supplied with one sieve. It has a working capacity of 25-30 kg/hr, net weight 18 kg, gross weight 40 kg, dimension 38cm x 35cm x 60 cm. Power requirements are 230 V 0.15 HP 1phase. Cronimach Machinery Ahmedabad - Gujarat Tel: 079 – 25861418 Email: Website:

Spray dryer and encapsulator S p r a y drying and encapsulation are attractive technologies f o r production of nano and microparticles of different substances and polymers. The technology allows fast processing times with small batches at high yield. Spray dryer allows a visible process from the nozzle outlet to the powder collection. It indicates the drying properties and behaviour of the sample in aqueous or organic solvents. Similarly, the encapsulator also allows visible process from the nozzle outlet to the bead collection. Two models of spray dryer and two models of encapsulation are available to produce particles from 300 nanometers up to 2000 microns. It is useful in scenarios like solubilisation of new molecules in nano scale, microparticles for research on inhalers and parenteral, encapsulated beads for taste masking, targeted and sustained release and odorless products. Buchi India Pvt Ltd Mumbai - Maharashtra Tel: 022-66775400 Fax: 022-66718986 Email: Website:

Syringe filling machine

This machine is equipped with a stoppering system that completely eliminates any air left between the product and the stopper. The typical balcony-design structure and the oval shape of the machine guarantees better access to the inside, clearly separating the mechanical drives from the filling area as well as simplifying the use of typical protection systems (laminar flow): all these specifications meet the clean concept requirements of this industry. The syringes are loaded semi-automatically and a pick and place system loads the empty syringes in the relative puck. The filling unit, which utilises three brushless tracking motors, dispenses the exact amount of product and ensures maximum precision for liquids but also for viscous solutions. The machine is equipped with a station that ejects non-compliant syringes and a pair of gloves on the front protection panel so that operators can intervene without having to open them. Marchesini Group India Pvt Ltd Mumbai – Maharashtra Tel: 022 67082755/64 Fax: 022 67082761 Email: Website:

The information published in this section is as per the details furnished by the respective manufacturer/distributor. In any case, it does not represent the views of

Modern Pharma




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30 List of Products & Advertisers Looking For A Specific Product? Searching and sourcing products were never so easy. Just type MPH (space) Product Name and send it to 51818 eg, MPH Laboratory software and send it to 51818 Product

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Access control ....................................................... 29

Content uniformity testing .......................................... 7

HVAC & MEP................................................................ 3

Rigid tubes packaging machine ................................. 26

Acoustic enclosure ..................................................21,27

Contrast /colour scanner ............................................ 25

Inductive switch ................................................... 25

Roots blower ...........................................................21,27

Air circuit breaker......................................................BIC

Cylindrical sensor ........................................................ 25

Label ....................................................................... 29

Servos ...................................................................BIC

Air shower controller .................................................. 29

Dissolution testing ................................................. 7

Laminar air flow unit................................................FIC

Silicone transparent braided hose ............................. 27

Air sterilisation............................................................... 3

Door interlock system................................................. 29

Loniser .........................................................................BC

Silicone transparent tubing ........................................ 28

Ambient air monitor-envirotrack and sampler......... 6

Double sheet monitoring ........................................... 25

LVS ..............................................................................BIC

Spray dryer and encapsulator .................................... 28

Automatic ampoule loader......................................... 26


Measuring sensor ................................................. 25

Syringe filling machine ............................................... 28

Barcode patient ID band ..................................... 29

Dry van pump ........................................................21,27

Metal doorset .............................................................FIC

Tefzel HHS isotactic P.P material......................... 8

Bearing .......................................................................... 16

Dry screw vacumm ..................................................... 15

Mills and microniser ................................................... 27

Three parameter display ............................................. 29

Blower ........................................................................... 15

Dynamic pass box .....................................................FIC

Mini sensor................................................................... 25

Track and trace system ............................................... 27

Blow-fill seal machine ................................................... 9

Electric actuator and gripper.............................BC

Modular clean room .................................................FIC

Turnkey solutions for biotech and pharma industry 3

Cable carrier ......................................................... 16

Electronic gas monitor.................................................. 6

Mrfrs of thermoplastic valves and piping system from

Twin-screw co-rotating extruder ............................... 11

Cable connector ........................................................... 16

Exhibiiton - Plastivision 2013 .................................... 26

polypropylene ................................................................ 8

Twin-screw element .................................................... 11

Calibration.................................................................... 10

Fibre optic amplifier ............................................ 25

Multi channel scanner ................................................ 26

Twin-screw extruder ................................................... 11

Chain............................................................................. 16

Fire alarm ..................................................................... 29

Octagonal blender ................................................ 26

Ultrasonic sensor ................................................. 25

Chemical gas detector ................................................... 6

Fire resistant door......................................................FIC

Pass box inter lock system .................................. 29

V blender ............................................................... 27

Clean room door .......................................................FIC

Forked photoelectric sensor ....................................... 25

Physical testing............................................................... 7

Vacuum booster pump ..........................................21,27

Cleanroom equipment and accessories .................... 23

Gas blower............................................................. 15

PLC ..............................................................................BIC

Vacuum system .......................................................21,27

COD analyser and digester .......................................... 6

GSM alarm system ...................................................... 26

Printer ........................................................................... 29

Validations and temperature / RH mapping ........... 10

Compact pneumatic cylinder ...................................BC

Guided compact pneumatic cylinder ......................BC


Walk-in humidity chamber ................................ 28

Connector..................................................................... 16

Heart valve frame ................................................. 11

Rapid endotoxin detection system..................... 29

Water ring vaccum pump .......................................... 29

Contactor and motor starter....................................BIC


Refrigrated compressed air dryer .............................BC

Wet granulator ............................................................. 28

Container sterilisation................................................... 3

Human-machine interface .......................................BIC

Reverse laminar air flow ...........................................FIC

Xray inspection system ....................................... 13

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