Pharma Bio World November 2017 by Pharma Bio World

www.pharmabioworld.com PHARMA BIO WORLD VOL 16 ISSUE 04 NOVEMBER 2017 MUMBAI TOTAL PAGES 60 ` 150

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4  November 2017

Pharma Bio World

INTERVIEW 08

“Indian API industry has to work more on R&D investments, patent registration, and advanced Supply Chain Management to expedite its growth in the international market” - Ashish Pruthi, Chairman Managing Director, Rajasthan Antibiotics Ltd (RAL) FEATURES

Contract Manufacturing - Saurabh Anand, Pranav Kumar Mysore

Improving Compliance Training through Progressive eLearning - Scott Barnard

The Role of Hands in Radiation Safety and Trends in Radiation Therapy - Satyaki Banerjee

NEWS FEATURE 24

Analysis on the issues raised by the regulatory authorities on Indian Pharmaceutical companies and inputs provided by them - Vidhyasagar L, D Naveen Kumar NEWS UPDATE

Press Release

Pharma News

Biotech News

Data Manupulation/Data integrity

CORPORATE AFFAIRS

35% Lack of data documentation discipline

Compliace

13%

8% Unhygiene

Lack of procedural awareness

18% 8%

Products

Events

Failure to Maintain Quality and Purity

BACKYARD

13% Inadequate investigation of critical deviations or a failure

Book Shelf

Ad Index

Next Issue Focus: Pharmaceutical Technology

6  November 2017

Pharma Bio World

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interview

“Indian API industry has to work more on R&D investments, patent registration, and advanced supply chain management to expedite its growth in the international market” Ashish Pruthi, Chairman Managing Director, Rajasthan Antibiotics L td ( RAL ) sh ares his v iew s on AP I market in India, grow t h pro s p ec ts , r e l eva n c e o f G ST i n p h a r m a i n d u s t r y a n d m u c h m o r e i n a n e m a i l

Ashish Pruthi

interaction with Mahes h Kallay il.

Could you please tell us about Rajasthan Antibiotics journey so far? Established in 1991, the pharmaceutical company Rajasthan Antibiotics Limited (RAL) has gone on to grow from strength to strength both in size and reputation in becoming the nation’s largest producer of injectable antibiotics. RAL, one of the fastest growing pharmaceutical companies in North India and having its corporate office based out of Delhi are always on the move to develop innovative products at very competitive prices. It is also very efficiently harnessing its funds for improving manufacturing facilities and upgrading the existing R&D department. The company has got a great clientele base not only in India but also in Europe and countries like China, Brazil, Indonesia, Bangladesh and UAE where it has already made its presence felt. The company also has set a vision for itself that it intends to generate revenue of INR 500 crores by 2020 as it continues to serve humanity chasing its endeavour of ranking right amongst the top pharmaceuticals company of the country.

8  November 2017

Please apprise us on Active Pharmaceutical Ingredients (API) market in India? The API industry in India is growing smoothly and as per the industry estimates; the sector is experiencing double-digit growth, i.e. - 10.76 per cent (CAGR). How supportive has the govt been to this sector? Pharmaceutical is one of the key sectors of the I n d i a n E c o n o m y, a n d i t ’s a m o n g t h e p r i o r i t y sectors for the Government. Both centre and state governments are supporting the industry through lenient and effective regulations, EXIM policies and trade laws. What according to you are the trends in this market? Compliance with current good manufacturing practices (cGMP) by USFDA, more investment on R&D activities, M&As, and getting benefits Pharma Bio World

CHEMICAL & PHARMA INDUSTRY

interview from the GST are the top trends in Indian pharma industry today.

motivate its team to deliver the best results

What all things Indian API market lack to achieve an envious growth?

May we have your take on GST in pharma industry?

Indian API industry is lacking in terms of R&D investments, Patent registration, and advanced Supply Chain Management. We have to work more in these three areas to expedite the growth of the industry in the international market. How do you plan to leverage on Make in India campaign? We primarily focus on our core competencies, in antibiotics, and we have expertise in it. Please tell us about antimicrobial resistance. Antibiotic resistance is the phenomenon in which antibiotics fail to resist or kill the growth rate of bacteria that cause infection and illness in human or animal body. Our body has trillions and trillions of bacteria i n s i d e u s . T h e s e b a c t e r i a ’s a r e v e r y helpful in some of the body’s important processes such as digestion and immunity. How do you perceive the booming export business in injectable antibiotics? How you plan to reap the benefit from it? RAL is the first company in India that has produced Ampicillin Sodium Sterile, RAL-Life also pioneered the manufacturing of Sterile Anti-Ulcer drugs namely Omeprazole Sodium Sterile and Pantaprazole Sodium Sterile for which it has won worldwide acceptance. RAL believes in time management, total quality m a n a g e m e n t a nd a b o ve a ll so lu t io n s development; simply these are the factors which differentiate RAL from others and 10  November 2017

Both consumers and industry players expect that GST will bring mutual benefits and with reduced complexities and an overall reduction in cost, GST translates to be a profitability and promising development. What are your policies to Compete with Competitors? We a r e l e a d e r s i n A m p i c i l l i n S o d i u m Sterile and Sterile Anti-Ulcer drugs, with our state-of-the-art infrastructure and R&D facilities, we are making substantial efforts to retain our leadership position. Availability of substandard lowquality substitutes is a main t h r e a t t o A P I m a r k e t . H o w, according to you, this can be curbed? Strict regulations and timely quality audits of the pharmaceutical companies this problem can be controlled to a greater extent.

It is out of the purview of our goals and scope. It’s the duty of police and investigation departments to take corrective actions. What are your future projects and plans? RAL intends to raise ` 25 crores in First Tranche through the route of PE / Venture Capital for its expansion plan by setting up a New Project in Cephalosporin Segment for domestic market & Upgrading the existing R&D facilities which are duly recognised by DSIR, Government of India. RAL is also adding 2 new Lyophilisers with higher capacities that will help in creating an additional capacity of 180 MT per annum and shall provide an incremental revenue of ` 60-70 crores p.a.The new Lyophilisers will augment the capacity by another 40-45 MT per annum. The 2 nd tranche of fundraising to the tune of ` 25 crores shall be utilised for setting up a new Oncology plant. We expect to achieve annual revenue of ` 500 Crores by 2022.

Requirement of microbiologists in India. Yes, to fill the gap we have to stop brain drain, and large pharma companies should also come forward to assist the education sector in terms of resource up-gradations and training of the microbiologists. How do you see the technological advancement in Injectable drug delivery? We need to work hard more to control cost. Could you give us an overview of antibiotics abuse in India and other countries? Pharma Bio World

Contract Manufacturing With the advent of multinational pharmaceutical organisations, and their rapidly growing presence in the country, the concept of contract manufacturing has steadily evolved and quickly adapted, so as to encompass services such as basic manufacturing of medicinal products, formulation development, stability studies, and various stages of clinical trials. This article look at the Indian scenario of pharmaceutical contract manufacturing, how the space has changed, upcoming trends, as well as what the industry will look like in the coming years.

Saurabh Anand Senior Associate K&S Partners

Pranav Kumar Mysore Senior Associate K&S Partners 12 ď&#x201A;&#x192; November 2017

ith snowballing growth of pharmaceutical industry in India, the concept and requirement of contract manufacturing is incessantly evolving. Now-a-days contract manufacturing has been extended to bring within its ambit various services, such as basic manufacturing of medicinal products, formulation development, stability studies and clinical trials. Off late, contract manufacturing is practiced in most of the industrial sectors, not limited to pharmaceutical sector alone. However, till date the concept of contract manufacturing has made significant impact in the pharmaceutical industry. Indian pharmaceutical sector has witnessed a strong hold in the processes of manufacturing/production due to the encouragement/recognition of process patent alone prior to 2005. Post 2005, an additional recognition in the form of product patents led to exponential growth in pharmaceutical sector. This led to an increase of manufacturing through contracts. This apart, Indiaâ&#x20AC;&#x2122;s allure as a viable outsourcing market lies in the fact of its resources including skilled labor, governmental incentives and WHO- GMP approved premises. In addition, contract manufacturing is expected to increase due to the fact that a number of patents over top-selling drugs are expected to expire, creating a profitable and differential opportunity to outsource to legally manufacture such drugs. As per the Draft Pharmaceutical Policy issued by the Department of Pharmaceuticals in August 2017, cost of the drugs in India are about 50% lesser as compared to Western nations. Indian companies have around 1300 WHO-GMP, 262 USFDA (outside USA) and 253 EDQM approved plants being operational and functional till date, making India a preferred and safe business haven for

contract manufacturing. Said policy further substantiate that the annual turnover of the Pharmaceutical Industry in India in 20152016 was around 30.76 billion dollars, out of which exports constituted around 15.38 billion dollars and the domestic consumption was 15.14 billion dollars, showcasing a brewing export in pharmaceutical sector. The advantages of contract manufacturing is not alien to us and the primary reason behind entering into a contract manufacturing is to have a sustainable growth. For instance, an entity which is primarily engaged in the business of R&D can invest on labor, materials and other expenses related to production by outsourcing the same to another organization which is primarily engaged in the business of manufacturing and supply. Roughly, a substantial 40%50% lower cost of operation and production is clearly operating as pulling-mechanism for multinationals to consider India for their outsourcing needs. Further, contract manufacturing helps an entity in spreading its arm in another market, rather than spending billions of dollars and time in setting up its operations in that country. By entering into alliances/ agreements with already established manufacturers in India, these outsourcing companies can have their expectations met at a cost which is dramatically lower than the cost of establishing itself in a new location. In addition to this, contract manufacturing allows for exploiting manufacturing counterpartsâ&#x20AC;&#x2122; pre-established marketing channels, which is a major consideration. Contract manufacturing as a business model is not only serving the purposes of the parties involved but has also prompted the growth of research and development in India. As one of the ground realities which is a prohibitory factor in conducting R&D in India, is paucity of funds. Hence, off late several Indian companies have Pharma Bio World

entered into research partnerships with multinationals, and have established R&D facilities as separate units in order to scale up resources and attract focused investments. Such strategies have two-fold benefits: increase in R&D activities and a constant financial support. The Government has encouraged such engagements by revising its FDI policy, which is effective from August 28, 2017, bringing significant changes in the amount of FDI allowed in the pharmaceutical sector. Where, under the erstwhile FDI policy, no FDI was permitted in brownfield pharmaceutical projects without government approval, the new policy allows 100% FDI in brownfield pharmaceutical projects, with up to 74% allowed in the automatic route and up to 74% allowed in the government approval route. However, entering into an arrangement for contract manufacturing not only requires compliance with the quality standards but also requires cross-jurisdictional regulatory compliances. There could be a situation where an US entity has entered into an agreement for manufacturing a product which might be prohibited for manufacturing/production in India. In such situations, both the entities have to be cautious of cross-jurisdictional regulatory requirements well in advance before entering into such transactions. One of the important aspects which entities should deliberate and negotiate beforehand, is the ownership and exploitation of IPRs generated thereunder, both in terms of the IP transferred and IP created during such process. It is inevitable that whenever an outsourcing company enters into a contract for manufacture with any manufacturer, there is an exchange of a large amount IP. The manufacturer is privy to information which is of a highly sensitive nature, the protection of which becomes extremely necessary, so that the outsourcing company does not lose its competitive edge. Thus, clear cut indication 14  November 2017

in the agreement that the information transferred to the manufacturer is “CONFIDENTIAL”, is imperative. However, mere indication that certain information is “CONFIDENTIAL” without giving any clarity on the consequences of its disclosure will dilute the agreement. These situations play a larger role in cross border arrangements. Regarding, ownership of IPRs, there could be several approaches to determine ownership of IP rights, namely ●●

●●

Solely owned – either by the outsourcing company or the manufacturer or Joint ownership – subject to mutually agreed terms.

However, such arrangements only serve to prompt more questions such as ownership of the IP created by an employee/ independent contractor, ownership over improvements and customizations, exploitation of jointly held IP, consequences of termination of contract on the outsourcing company’s IP, etc. Since a lot of the considerations stipulated hereinabove can only be decided upon negotiation, an IP due diligence, prior to execution becomes crucial. Trade Secrets form a major chunk of the exchange of IP under contract manufacturing. A trade secret, by its very nature, remains significant only until it is protected by secrecy and quickly becomes obsolete once disclosed. Thus, such disclosure can lead to disastrous consequences, such as, the usage of such information for the advantage of the manufacturer or transferring such information to the competitors of the outsourcing company. Unlike the USA, India does not have any codified legislation for protecting Trade Secrets. However, Trade Secrets in India can be protected under a contractual obligation. The Indian Judiciary has observed the importance of Trade Secrets in multiple occasions. For instance, the Hon’ble Delhi High Court in Telefonaktiebolaget LM Ericsson(Publ) vs. Xiaomi Technology & Ors; CS (COMM) 434/2016, on October 24, 2017, observed:

“The reason probably is in today’s world of globalization, where competition is at its peak, the organizations may not be inclined to disclose trade secrets/confidential agreements or its details, it had entered with different parties lest may cause serious prejudice to such parties because of competition involved. A trade secrets may make or break a company hence need to be protected. Once such disclosure is made or is misused by a competitor no order of the Court can save the company from loss or could retrieve it to its original position.” Thus, it is imperative to have express clauses for “Trade Secrets” in any contract of manufacturing especially in the absence of any existing legislation for the same in India. In the absence of a codified legislation for protecting Confidential Information and/or Trade Secrets, the concept of “Confidentiality Clubs” have been devised by the Indian judiciary. These “Confidentiality Clubs” are constituted on a case to case basis to deal with any instances of breach of confidentiality and/or disclosure of Trade Secrets. This positive approach by Indian Judicial System, by regulating the access of the parties through their representatives and preventing further unauthorized disclosures, is a positive sign in recognizing and protecting the rights over Confidential Information and/or Trade Secrets. As per recent reports, the contract manufacturing space in India is expected to grow around 20% on a compound annual growth rate. Thus, any entity should utilize this smart way of doing business but with water tight clauses. Such requirements are not only suggested to protect the interest of the parties involved but also to send a positive signal regarding the booming pharmaceutical sector in India.

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Improving Compliance Training through Progressive eLearning This article discusses the shift towards compliance training in an eLearning format and the six elements that can serve as a model for any organization that is developing compliance eLearning content.

Many companies today have leveraged various technology to deliver compliance training to employees. Countless companies have cited evidence that eLearning delivers ROI. For example, managers at IBM were able to learn five times the amount of material via eLearning while devoting the same amount of time to training. Brandon Hall, the leading analyst for the eLearning industry, reported that eLearning requires from 40 per cent to 60 per cent less employee time than the same material delivered in a traditional classroom setting. 1 While many companies still conduct classroom and on-the-job training for most employees, adding eLearning enables training teams to reach more remote users at reduced costs. The advantage goes beyond dollars by addressing an evolution in training that can impact quality assurance by impacting employees’ dayto-day behavior. Many regulatory topics, which span different departments within a Life Science organization (as mandated by FDA, OIG, OSHA, EU, DOL, DOJ, etc.) are best conveyed first as “cold hard facts,” and then as compelling and realistic scenarios, to help learners understand how these regulations impact company policies as well as the employees’ activities.

Scott Barnard Market Strategy Director UL Compliance to Performance 16  November 2017

Conducting training via an eLearning model is a growing trend. A 2015 study from UK-based learning technology analyst Towards Maturity 2 showed that 98 per cent of companies implement an eLearning strategy to increase access and flexibility in providing staff training; 94 wanted to deliver greater value for

money; 88 percent needed a better way to prove compliance with new regulations and legal requirements, 88 per cent wanted to reduce training costs and 83 per cent wanted to extend learning to remote workers. Furthermore, this study noted that learning has been shifted towards a more personalized and continuous process that aligns to business goals, citing that in terms of business drivers for moving to an e-enabled learning strategy, 98 per cent of respondents wanted to improve the quality of learning delivered and 94 per cent needed to reduce time to competence. eLearning Elements In recent years, there has been a shift towards compliance training in an eLearning format. There are six essential elements that can serve as a model for any organization that is seeking to develop compliance content in an eLearning format. 1) Engaging Experts: When dealing with regulatory issues that pertain to the pharmaceutical industry, a company should leverage industry experts to serve as course authors. If the authors are not subject matter experts, such as individuals who are conducting consulting and training workshops, or speak regularly on the topics covered in courses, the learners will be left wanting. The content is complex and should represent thousands of hours of subject-matter expert input based on industry standards and practices. Training and learning is critical to all government regulatory bodies around the world; only the best, most salient and clear content produced by experts should be part of compliance training. Pharma Bio World

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2) A Mix of Learner Interactions: To make the learning and training interesting and engaging, it should be interactive as opposed to static. The best courses contain several interactive, scenariobased elements designed to truly enhance learning, as opposed to distracting from the purpose of the course. Such interactive exercises, or “interactions,” reinforce the information that is being presented. Interactivity can cue the learner’s mind on how best to process the information presented; in addition, content should be presented using interactive devices that “layer” the information, which has been proven to be an optimal way to build and reinforce knowledge, and change behavior in adult learners. 3) Assessments that Promote Retention: Interactive question and answer sets (Q&A’s) throughout the course will promote a deeper retention and comprehension of the material. This is a “master learning” approach in which learners must demonstrate proficiency in order to advance through the course and to be qualified on the course content. One way to ensure retention and compliance is to require that a final test be passed before the learner is deemed qualified. 4) Links to Resources and References: Learning should never be a once-anddone event. Effective learning should be constant and engaging. The best courses teach what is required then provide supplementary information to make the material more relevant to the learner. This adds value when the course is used as a “performance support” tool, in which the learner returns at a later date to confirm or validate a specific topic.

increase in smartphone and tablet use at the workplace for eLearning. In fact, when accessing digital media, the use of a mobile device is now significantly higher at 51 per cent compared to desktop at 42 per cent. 3 A mobile format can increase the accessibility and availability of anytime training that can take place even during off hours. Courses with actionable training programs within a graphic-rich, interactive format should be optimized for the mobile device experience, which can save an organization time, money and be much more efficient for learners and managers. 6) Keep Updated with Current Regulations: Regulations and laws are continuously being updated and changed. Organizations should consider subscribing to a course library that includes annual updates. This way, in-house compliance staff is not spending their time updating courses, but are focused on core competencies. Learning Management Systems Reduce Risk Compliance training affects every organization involved in pharmaceutical manufacturing. It can comprise anything from a review of the employee manual to training on critical life-or-death issues. Despite its importance, many organizations struggle to develop ways to make this training more engaging and strategic. By following these elements, it can help an organization achieve greater results.

5) Mobile-Ready Formats:

Whether the company develops its own courses or relies on outside experts to produce the content, research is clear that a learning management system (LMS) should be used to manage learning. However, an LMS is used to manage less than two-thirds of all compliance training.

In today’s world, most organizations are open to taking advantage of the

Brandon Hall Group’s research shows that nearly 25 per cent of all compliance

18  November 2017

training activities are manually managed. That means that many organizations track this incredibly critical piece of the business with spreadsheets, mail, and intranet sites. Companies that say their compliance efforts are not effective manually manage 36 per cent of compliance training; while companies that report effective compliance training—only 20 per cent manage it manually—80 per cent leverage an LMS. 4 When compliance and regulatory training is manually managed, tremendous risk enters the equation. The Brandon Hall Research showed that it is typically more challenging to keep these types of processes up to date to ensure that the right training reaches the right people and is properly recorded. Many companies do this manually because they have always done it that way and fear change will lead to even worse results. Compliance training that is created by experts and delivered in an e-learning environment though an LMS will help improve effectiveness and provide better outcomes. References: 1 Learning Magazine, eLearning Success- measuring the ROI impact and benefits, May 2013 2. Towards Maturity, Embracing Change: Improving Performance for Business, Individuals and the L&D Team, Nov. 5, 2015 3. Chaffey D. Mobile Marketing Statistics Compilation, Smart Insights, March 1, 2017, 4. Wentworth D. The Need To Reinvent Compliance Training, Training Magazine, Oct. 26, 2017

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The Role of Hands in Radiation Safety and Trends in Radiation Therapy This article talks on the safety of doctors from radiation emitted by the different medical equipmentâ&#x20AC;&#x2122;s, is of utmost importance as ensuring the safety of patients. It needs to be noted that most of our radiologists in our Indian hospitals are not armed with enough protection shields while conducting high-intense radiology tests and prone to higher risk of death from cancer than the general or therapeutic radiologist.

atient safety in radiation therapy is vital to limit damage to healthy tissues. Maximizing safety requires a team commitment and knowledge of the intricacies of advanced technologies. The safety of doctors and healthcare practitioners like radiologists, who are exposed to harmful radiation in laboratories and operating theatres is very important. Wearing the right protection apparel might not be enough since maximum exposure to harmful radiation is on their hands. Statistics reveal that such negligence by healthcare practitioners has resulted in the rise of deadly diseases like cancer among radiologists and doctors. One of the biggest challenges is awareness on the need of adequate radiation protection measures for healthcare professionals. This can be resolved through concerted efforts between regulatory agencies, medical institutions and key opinion leaders in conjunction with industry to educate medical professionals across the country on the deterministic and stochastic effects of radiation exposure. There is adequate requirement of radiation protection to prevent severe health problems for both patients and medical professionals as any exposure to ionizing radiation carries a risk of causing cancer and affects the tissues which lead to erythema, hair loss and cataracts. For most common radiographic exposures, this risk is extremely small. However, as the risk is proportional to the level of exposure, it is important to ensure exposures are kept as low as possible.

Satyaki Banerjee President Kiran Labsystems 20 ď&#x201A;&#x192; November 2017

The radiation resistant gloves are effective in counterbalancing the risk of scatter beam radiation exposure during

lab procedures like fluoroscopy, cardiac cath lab and electrophysiology. Every time an image is captured, the x-ray actions its movements through the body making contact with internal structures. Hence, multiple images are necessary to ensure the success of these procedures. However the negative effects of scatter beam radiation exposure to the physicians and assistants can be offset by use of radiation protection gloves. These gloves are specially designed to allow the maintenance of dexterity during surgical procedures. These radiation gloves are offered sterile, by the pair in a full range of sizes, including half-sizes. The greatest source of radiation exposure to the operator and staff is scattered radiation from the patient. Normally, controlling the patient dose also reduces the scatter and limits operator dose. However, chronic radiation exposure in the work place mandates the use of protective tools in order to limit occupational radiation dose to an acceptable level. The purpose of radiation protection tools is to improve operator and staff safety without impeding the procedure of patientâ&#x20AC;&#x2122;s safety. The current radiotherapy innovations have led to increase in the precision of treatments allowing improved outcomes and reduced treatment-related side effects. Noteworthy developments are in the areas of Intensity Modulated Radiotherapy (IMRT), Stereotactic Body Radiation Therapy (SBRT), 4D imaging, particle therapy and nanotechnology. Advancement in imaging technology are further enhancing the target of radiotherapy treatment. An essential development is the introduction of adaptive treatments which can be adjusted as tumour Pharma Bio World

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where patient characteristics change throughout the course of radiotherapy. Adaptive treatments improve patient outcomes (for example, the reduction of radiotherapy related side effects for bladder cancer) but often require considerable investment of time by the whole radiation oncology team. The on-going improvements in techniques/ technologies are increasing the precision and accuracy of radiotherapy which allows treatments to minimize the impact on healthy tissue and reduce treatment related morbidity. These advances are mediated through increased complexity of treatments and are relatively more resource-intensive in the short term, but leads to long term saving. Radiotherapy has always been a personalized treatment as every patient’s plan is unique and tailored to their particular clinical circumstances. It is expected that the introduction of tumour marker testing and molecular and biological imaging techniques

will enable the already personalized radiotherapy treatments to be even more targeted.

in their clinical circumstances which are again causing quite a lot of issues to the patients.

Radiation oncology uses some of the most highly developed information technology infrastructure in the healthcare system to support its data and imaging needs. The need to use telemedicine in patient management will increase significantly as the number of cancer centres increases, particularly in regional areas. Technological solutions to expedite the transfer of relevant imaging and previous radiotherapy treatment details to the treating radiotherapy centre will be imperative.

There are several ways to stay protected from scattered radiation. Minimizing the duration of contact with radiation, keeping a standard distance from the source, wearing radiation protection apparels like gloves are a few steps to protect any individual from the harmful effects of radiation.

In all, consumer awareness of radiation oncology has been always low. Increased access to information via the Internet is changing things. The lack of a current centralized patient information resource for radiation oncology means that sometimes the information accessed by consumers is inappropriate or not relevant

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Pharmaceutical Technology deals with the discovery, production, processing, and safe and effective delivery of medications to patients. Technologies involved include computer modeling for research, bioengineering for research instrumentation, processes and methods for increasing production, and computing technology and biosystematics for the management and analysis of data. In the December issue of Pharma Bio World, we intent to cover a wide range of important topics on today’s pharmaceutical technology, such as in vitro drug release and controlled drug delivery, the use of nanotechnology in pharmaceuticals, quantum dot imaging, assessment and efficacy of pharmaceuticals, and much more To ensure Pharma Bio World continues to meet your needs, we would appreciate your feedback. Please feel free to write to us at mahesh_kallayil@jasubhai.com if you think we can serve you better.

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news features

Analysis on the issues raised by the regulatory authorities on Indian Pharmaceutical companies and inputs provided by them

With all the aforesaid accolades it behooves that the Indian Pharmaceutical industry observe the stringent regulatory norms suiting to both domestic and international standards. However, lately, it has been noted that there has been a spurt in the issuance of the import alerts and warning letters for domestic manufacturing facilities significantly over the past years following USFDA’s increasing focus on compliance of guidelines of cGMP. This restricts the manufacturing units to supply drugs to the US market from that facility resulting in the decline of revenue for the companies particularly to US market and also from other markets subsequently if the issues are not closed out to the earliest.

24  November 2017

Sequence observed by regulatory enforcement:

USFDA

USFDA’s Office of Regulatory Affairs (ORA) is the lead office for all the field activities, including inspections and enforcement, which carries out the inspections of the manufacturing facilities approved by them in regular intervals. At the completion of inspection a report is prepared by the agency and is termed as ‘Establishment Inspection Report’ which details inspectional findings. During an inspection, if investigators do not observe any objectionable conditions

at the plant site, the said manufacturing unit (which is outside USA) can continue to export to USA, however if any objectionable conditions are observed then based on the investigator’s judgement, ‘ FDA Form 483’ is issued to the manufacturer. Thereafter the companies are fostered to respond to the ‘FDA Form 483’ in writing with respective corrective action plan and subsequently implement the plan expeditiously. If the response to ‘FDA Form 483’ submitted by the company deemed insufficient, a warning letter may be issued by US FDA to the respective firm. FDA then checks back

USFDA carries out the inspection

YES

Plant can continue to export

ith market size of around $ 33 bn in FY2017, Indian pharmaceutical industry is ranked third globally in terms of volume and thirteenth in terms of value. Indian pharmaceutical companies, over decades of arduous efforts, have gradually developed the necessary technology, capacities and capabilities to meet the demand and explore the opportunities provided by global regulated markets; and currently, United States of America (USA) contributes about one third of the total Indian pharmaceutical exports. Furthermore, Indian pharmaceutical manufacturing companies accounted for 34% of the total Abbreviated New Drug Application (ANDA) approvals by USA in 2016 as compared with 30% in 2015; the total number of ANDA approvals has increased from 167 to 201 during the same period. India has second highest number of USFDA (United States Food and Drug Administration) approved manufacturing plants i.e. about 700 units with 2,633 FDA-approved drug products.

The company needs to implement appropriate remediations process

Observations

YES Whether satisfied with revert?

USFDA issues Form 483 immediately

USFDA can issue Warning letter and gives time line of 15 working days to revert

USFDA can issue import alert with immediate effect followed by warning letter

Chart illustrating the steps observed by USFDA Source: Compiled by CARE Ratings Ltd

Pharma Bio World

news features Categories of inspections carried out in India

Total number of inspections in India 185

140 120

118

100

119

2011

2012

20 0

36 17 2013

111

101

45 29

14 2014

No action indicated

2015

17 0 2016

2011

Voluntary action indicated

to ensure that the corrections taken by the company are adequate. And in case they find the explanations or corrective measures taken by the company is inadequate then they would issue alert. All the inspections carried out USFDA are categorized in three buckets: No Action Indicated (NAI), Voluntary Action Indicated (VAI) and Official Action Indicated (OAI) (See Chart 1). NAI = No Action Indicated, meaning no objectionable conditions or practices were found during the inspection (or the significance of the documented objectionable conditions found does not justify further action).

2012

2014

Official action indicated

VAI = Voluntary Action Indicated, meaning objectionable conditions were found and documented but the agency is not prepared to take or recommend regulatory action. OAI = Official Action Indicated, meaning objectionable conditions were found and regulatory action should be recommended. Out of the total inspections carried out during CY11 and CY12 only about 5% of cases were categorized under Official action indicated, however during CY13 and CY14 there was sudden surge in this category to 15% and 27% respectively, which subsequently were converted into warning letters and alerts. Further during CY15 the total number of cases falling under OAI has

No of warning letters issued by USFDA across globe vis-Ă -vis India

2013

2015

2016

Chart 1 Source: USFDA

reduced to about 7.5%, post to which India having experienced the headwinds from the heightening regulatory requirements, have improved their processes leading to nil inspections falling under OAI category during CY16. A warning letter restricts the ability of that manufacturing unit to supply new drugs to the US from that facility. The company in that case needs to appoint Source: USFDA consultants to advice on corrective actions and also monitor implementation of the same. After this, the company approaches the FDA and makes a request for re-inspection. If the regulator is satisfied with the corrective measures, it can issue a close-out letter.

No of import alerts and WL

12 9

15 12 6

Total

2017

2013

2016

2012

Data Manipulation/Data integrity

2015

Classification of Warning letters

2011

26 ď&#x201A;&#x192; November 2017

2014

Chart 2Source: Source:USFDA USFDA

Pharma Bio World

Failure to Maintain Quality and Purity

Inadequate investigation of critical deviations or a failure

Lack of procedural awareness

Total

2015

Lack of data documentation discipline

Unhygiene

Compliance

Grand Total

However FDA can also choose to issue Import Alerts immediately whenever it determines that it already has sufficient evidence to conclude that the products manufactured from a specific unit appear to be adulterated, misbranded, or unapproved, and has made serious deviations from cGMP, then they may be refused from importing. In such cases warning letter would follow the issue of import alerts (See Chart 2). The basic purpose of import alert is to prevent voilative products from being circulated in United States; provide uniform coverage across country; and place the responsibility back on the importer to ensure that the products being imported into the United States are in compliance with FDA laws and regulations. Post to issue of import alert the company needs to implement appropriate remediations process religiously. Once the company is confident about its processes, it can invite USFDA to carry out the inspection post to implementation. Once the FDA finds that all the process are in place then unit can restart the export of the drugs to US. Pharma Bio World

Table 1 and Graph 1 delineates upon the entire classification of observations mentioned in warning letters received from USFDA into various categories and it can be inferred that that about 50% of the warning letters issued to the Indian Pharma companies pertain to Data manipulation, data integrity and lack of data documentation discipline. Following are some of the inputs provided by the regulatory authorizes and consultancies in order to avoid the observations and incorporate systems in place: ●

●

To maintain strong systems in place with proper qualified and designated personal to handle the data in order to prevent unauthorized access or changes to data, and to provide adequate controls to prevent omission of data. As about 50% of the observations pertain to data integrity, manipulation and/or discipline, USFDA necessitates that a pharmaceutical manufacturing company approved by it to observe standard operating procedures meticulously.

2017

2014

Classification of Warning letters

2016

2013

Data Manipulation/Data integrity

Sourc

2012

2011

news features

7 36

172

Further those SOPs have to clearly written, modified, and maintained in a consistent and timely manner, and be centrally accessible. Problems and accidents generally take place if the employees do not have current written instructions for their tasks or if they do not observe written instructions in toto. ●

●

To maintain complete data derived from all testing, and to ensure compliance with established specifications and standards as many data integrity observations fall under the category “Failure to provide records required to be readily available for authorized inspection”. To maintain the buildings used in the manufacturing, processing of a drug product in a clean and sanitary condition and keep them free of infestation by rodents, birds, insects, and other vermin. While addressing the observations made by the regulatory authority, the company needs to take case that every observation should have a thorough November 2017  27

news features Data Manupulation/Data integrity

35% Lack of data documentation discipline

Compliace

13%

8% Unhygiene

18% 8%

Lack of procedural awareness

Failure to Maintain Quality and Purity

13% Inadequate investigation of critical deviations or a failure

Graph 1 Source: Compiled by CARE Ratings Ltd

●

root cause analysis performed and, if necessary present, one or more corrective and preventive actions identified very clearly with specific timelines of implementation. It is in the benefit of the company to peruse to obtain closeout letter at the earliest for which the remediation process should start right from the day of receipt of Form 483 or a warning letter. USFDA generally looks for a response to most of its compliance notices within 15 business days. The USFDA, although doesn’t confirm to the company’s response immediately but it would be appropriate to contact the agency and confirm receipt.

for minimizing the human errors is to establish a system where each step has to be followed by implementing an enterprise quality management software system. The plausible and best-practice features include prompting users with selected data which is just need to be accessed or entered by the specific task performer. This would significantly reduce data entry related errors and avoid mistakes common in manual document management and data entry. Apart from above the implementation of aforementioned systems would also take care the procedural errors.

Authors’ Details

Vidhyasagar L Associate Director Corporate Ratings

Conclusion: As majority (about 50%) of the observations fall under data integrity, manipulations and discipline category the best approach 28  November 2017

D Naveen Kumar Senior Manager Corporate Ratings Pharma Bio World

marketing initiative

Automation partner for pharma industry to build smart machines B&R displaying automation & Industrial IoT solutions at P-MEC 2017

n order to comply with their system. Machine builders and factory regulations, pharmaceutical operators benefit from maximum industries must take on the challenge security without altering anything in of guaranteeing product safety while the control system. With B&R solutions, improving efficiency and productivity machine builders achieve accelerated at the same time. This yearâ&#x20AC;&#x2122;s P-MEC development and reduce investment will take place from November 28- risk for applications subject to the FDAâ&#x20AC;&#x2122;s 30. In Hall 6, Booth H66, B&R will be Title 21 CFR Part 11 requirements. The highlighting various automation and ability to retrace actions performed on Industrial IoT solutions for building a machine can also be of great service smart machines along with its modular, to its manufacturer in the event of flexible hardware and software warranty claims. solutions for pharmaceutical industry. HMI design has never been so easy Audit trails made easy mapp View, which offers access to web The food and pharmaceutical industries technology, will be another highlight need to log operations performed by at the exhibition. It allows developers users without the risk of them being to create powerful web-based user tampered with. B&R mapp Technology interfaces right from the engineering provides a quick and easy way to environment without any knowledge of implement and customize audit trails. web technology. mapp View relies 100% Machine builders thus obtain various on web standards to ensure that content benefits and achieve compliance with can be viewed optimally on any output FDA CFR 21 Part 11 using a controller device or even customized for specific instead of using a dedicated SCADA users or user groups.

Figure 1:Orange Box: achieving greenfield benefits at brownfields Pharma Bio World

Industrial IoT ready Whether visitors are starting a greenfield project or considering a brownfield upgrade, they will find a smart manufacturing solution that perfectly fits their needs at the B&R booth. To remain competitive in era of IoT, implementation of digital transformation is necessary. B&R offers complete hardware and software solutions, comprehensive service and expertise in automation, and the digitalization of machinery and equipment. With dedicated technology and global communication standards like OPC UA, B&R is the right partner for implementing Industrial IoT solutions in both new and legacy equipment.

For details contact www.br-automation.com.

Figure 1:Achieve compliance with FDA CFR 21 Part 11 using a controller instead of using a dedicated SCADA system November 2017 ď&#x201A;&#x201E; 29

marketing initiative

“Our aim is to provide Import substitute quality products with economical prices” Alpesh Gandhi Managing Director Ami Polymer Pvt Ltd

Tell us about the performance of Ami Polymer over the past years and the growth drivers for the company?

●●

Ami Polymer Pvt. Ltd. started its operation in 1996 to manufacture a wide range of silicone rubber products for intricate applications in the field of food & beverage, pharmaceutical, medical & heavy engineering in India as well as overseas market. There are following milestones achieved by Ami Polymer Pvt. Ltd.

30  November 2017

●●

We have achieved Excellence Award among Top 50 fastest growing Indian companies by ASSOCHAM. 1 st Indian Silicone Product manufacturing company to build Clean room Class 10000. 1 st Indian Silicone product manufacturing company to Register Silicone products in USFDA and having DMF as #26201. 1 st Indian Silicone product manufacturing to have TOXIKON LAB USA Based E & L Studies on Platinum cured silicone products.

●●

TOXIKON is renowned name in worldwide lab testing agencies based at USA. 1 st Indian Silicone product manufacturing company to register silicone Resins in NSF -51, USA. NSF-51 is food safety mark on product.

Could you please brief us on Ami Polymer’s vision and mission? ● ● Our Vision: To be global Leader in Inflatable Seals, Pharma Tubing and Silicone rubber implants.

Pharma Bio World

marketing initiative Polymer Tubings

Polymer Hoses

Imapure™ - Platinum silicone Tube I m a f i t ™ - P o l y e s t e r for Regulatory market Silicone Hose

braided

Imatech™ - Platinum Silicone Tube Imavac™ - SS 316 L Spiral reinforced for Non regulatory market Silicone hose for vacuum application Imapex™ - Peroxide silicone tube for Imavacfit® - SS 316 L Spiral & Polyester Non critical/engineering applications braid Reinforced Silicone hose Imawrap® - 2-4 Polyester ply Imaprene™ - TPE tubings for dynamic wrapping reinforced Silicone hose application for steam transfer Imaweld® - TPE tubing for biotech Imaflexxie™ - PTFE lined Hose with industry SS 304 Reinforcement for Corrosive Imachemton™ - Viton tubing for hot chemical transfer corrosive material transfer application

Pharma Bio World

●●

Table 1 ● ● Our Mission: To become a 155 Crore company by the end of March 2021 by providing excellence in service and quality to our customer. In the process, we are committed to delight and respect our customer, employees, vendors and communities.

What are the key thrust areas for Ami Polymer? How has the technology changed in this fields in the in the last few years? ● ● Ami Polymer highly believes and committed to provide world class quality product for various industries like food, pharma and engineering. We never compromised in our quality and that made us top in the list of all Silicone Product suppliers.

Currently Ami Polymer is leader as high quality inflatable seals and Pharma tubing in India. Our aim to be leader in global level. We are in process to launch clean room facility for Silicone Catheter manufacturing

●●

Awareness of quality products have been increased in last few years and it had shifted choice of purchasing peroxide silicones to platinum silicones. Platinum catalysed silicones are superior in terms of purity and shelf life compared to Peroxide silicones. Pharma indus tries h a v e s ta r te d prac tic ing Single us e c o n s u mp tio n ins tead of multiple us e s o f s a me produc ts after repetitiv e s te r iliz in g , whic h has led to main ta in r is k fr e e applic ation of drug p r o c e s s in g and deliv ery .

November 2017  31

marketing initiative

Which sectors do you cater to? We are dealing in Rubber products for Food, pharmaceutical, Biopharmaceutical, Medical, electrical, and Heavy engineering industries. What

are

you

pharmaceutical

offering

sector?

Please apprise us the market opportunities of these products/ services in India? We are pioneer in tubing, hoses and gaskets which are highly consumable in pharmaceutical industry. We have a vast list of registered brands in tubing and hose (please refer table 1). These products are in high demand and 32  November 2017

level of consumption is expected to rise exponentially in future. What are the initiatives that you are undertaking currently to sustain the frontier position you have in the Indian market? Are there any marketing initiatives being planned? ●● Food, pharma and biopharma sectors have been growing with huge demand of critical products. Currently Indian clients are dependent on overseas based vendors to fulfil their quality requirement of world class standards. ●● Our aim is to develop and supply World class Quality Import Substitute Rubber products to provide our client maximum advantage of high quality goods with fastest delivery and economical rates.

●●

For new product development and to promote existing silicone products, we will target injectable and biotech industries. What are the key successful factors of your company?

What are the key successful factors of your company? ●● World class silicone product manufacturing clean room of class 10000 facility to manufacture tubing, hoses and gaskets for pharma industry. ●● More than 12 Polymer technologists dedicatedly continuously working on new developments ●● World class certification of food, pharma and biocompatibility compliances ●● Quick delivery with economical prices as compare to global suppliers Pharma Bio World

marketing initiative

●●

therapeutics segments really encourages polymer industries for their bright perspective of business. Indian medical industries are consuming catheters on huge level. Introduction of Foley catheters made in India will promote use of import substitute products. We can forecast tough and healthy competition with Global silicone product manufacturing companies among Current Indian Pharma industries.

What are your future plans? R&D (Research & Development) plays a very important role in the success of a business. R&D contributes to sustainability of business. It is the R&D function that provides a platform for creativity and innovation to flourish in an organization. Innovative breakthroughs have happened only because of painstaking efforts of the R&D function. It helps a business to have a competitive edge over its competitors. ●●

●●

Good documentation and certification support to handle pre-audit and post audit queries of clients. Latest Processing machineries and automatic inspection system of extrusion of pharma tubing. Trust of more than 3000 pharma clients on our quality and certification.

What are the new challenges for Ami Polymer? ●● Our aim is to provide Import substitute quality products with economical prices. In international market, day by day Raw material’s prices are increasing. To maintain economical prices for critical products without compromising quality is really challenging and to avoid such discrepancies, we have designed some solutions. Pharma Bio World

●●

Now consumption of tubing, hose and gaskets are increasing significantly. To fulfill the rising demand, we have planned to expand our manufacturing facility and to provide delivery on urgent basis we are planning to establish stock points among various locations in India. To explore the product at global level, stringent food and pharma studies on product are required. We have planned technical validation of critical products through world’s renowned labs like TOXIKON and Namsa lab USA.

What kind of growth are you looking at in the Indian market? ●● Indian pharmaceutical and Biopharmaceutical market is exploring exponentially. Kind of growth observed in Oncological, ophthalmic, Nasal,

●●

Currently, we have a team of 12 polymer technologist working in R & D lab well equipped with latest machineries for continuous development. We will focus on new developments and to achieve our goals we will recruit more polymer technologist in company. Soon we will launch our clean room facility of class 5 to manufacture foley catheters. To create integrated management system of ISO 9001, ISO 14001 and OHSAS 18001to be certified by TUV. To expand distribution network in overseas like ASIA, UK and USA. Launch variety of new pharma tubing and Hoses.

For details contact Email : mktg@amipolymer.com Website: www.amipolymer.com Ph: +91-22-28555107 / 631 / 914 November 2017  33

marketing initiative

HRS showcases comprehensive food & beverage processing technology at Gulfood Manufacturing Dubai 2017

une, Nov 2, 2017: HRS Process Systems Ltd. (HRS PSL), part of HRS Group, UK, one of India’s leading heat transfer specialists participated in Gulfood Manufacturing Dubai 2017, one of the prominent event for the food & beverage processing industry. The expo was held at Dubai World Trade Centre 31st October to 2nd November 2017. At this event, HRS PSL exhibitied their energy efficient range of heat exchangers and systems: ECOFLUX* Corrugated Tube Heat Exchanger, HRS Funke Plate Heat Exchangers, Unicus Scraped Surface Heat Exchanger and a wide range of heat exchanger based systems applied for range of processes throughout the industry sectors. HRS showcased advanced systems like the HRS Monobloc Aseptic Steriliser

cum Filler, single and multiple effect Evaporation systems for the fruit pulp and juice processing industry. These systems have enabled processing in a way that has almost doubled the shelf life at the same time retention of nutritive value of end product. Our innovative systems such as Unicus Scraped Surface Heat Exchanger and HRS ParaDice* with Hygienic Piston Pump ensure processing of viscous and particulate foods, ready-to-eat foods without damage to the foods. Our customers in processing industry are adapting to the demands of end consumers for fortified, processed, hygienic and nutritious foods, have shown a good deal of interest for our UHT processing, nutraceutical and infant food processing pilot and turnkey systems.

At Gulfood Manufacturing Dubai, HRS’ showcased comprehensive turnkey beverage processing lines which are especially of interest to large beverage producers, many of whom are huge conglomerates in the market or processors assisting the integration to fulfill high production capacity demands. These systems are integrated to process single or multi-fruit processing lines and are installed at some of the esteemed companies in India and international geographies. Recently, some of the Mega Food Parks, under the ‘Make In India’ initiative of the Government of India have entrusted HRS for their fruit/food processing technology requirements. Speaking on the company’s first time participation in Gulfood Manufacturing Dubai 2017, Mr. V Gokuldas, MD, HRS Process Systems Ltd. said: “HRS is one of the leading technology providers to the food sector with focus on fruit, beverage, milk and allied segments. Our heat transfer solutions have enabled efficient thermal processing including aseptic processing, in fruit pulp, beverage, dairy and special sectors such as ready-to-eat, nutraceuticals. Gulfood Manufacturing Dubai 2017 has provided us with a good platform to connect with companies in West Asia and Africa. Our application engineering and solutions have been well appreciated by Customers. We are committed to our Customers for quality product, performance satisfaction and efficient service.” This edition of Gulfood Manufacturing Dubai saw companies from African continent, Dubai Sharjah in UAE, India,

34  November 2017

Pharma Bio World

marketing initiative

Pakistan, Europe and many more attending the event. Many leading multinational companies have shown keen interest in HRS’ processing lines. About HRS PSL: H R S P ro c e s s S y st e m s L t d . , (H R S ) p a rt o f U K b a s e d H RS Gro u p , is o n e o f t h e l e a d i n g h e a t t ra n sf e r sp e cia list t h a t o p e ra t e s a t t h e f o re f ro n t o f t h e rm a l p ro c e s s i n g t e ch n o lo g y. E st a b lish e d i n 2 0 0 3 , w i t h h e a d q u a rt e rs in Pu n e , H R S h a s m a rke t in g o f f ice s sp re a d a c ro s s m a j o r m e t ro cit ie s o f I n d ia a l o n g w i t h t h e g ro u p co m p a n ie s in U K , S p a i n , U SA, M a la ysia , Au st ra lia and New Zealand. HRS offers effective heat transfer solutions for an extensive range of processing applications across a spectrum of industry sectors like Oil & Pharma Bio World

Fats, Food & Beverage, Nutraceuticals, Dairy, Sugar, Breweries and Distilleries, Pharmaceuticals, Chemical, Oil & Fats, Fertilizer, Cement, Steel, Power, Agro Chemical,

OEM

(Original

Equipment

Manufacturers), Paint, Paper & Pulp, Textile, Automotive, Food & Beverage,

HRS is ISO 9001:2008 certified along with ASME ‘U’ (The American Society of Mechanical Engineers), NBBI (The National Board of Boiler & Pressure Vessel Inspectors), HTRI (Heat Transfer Research, Inc.) and NSIC-CRISIL accreditations.

Sugar, Breweries and Distilleries, are among others. Pioneers in the revolutionary corrugated tube technology for the process industry, HRS offers innovative technology of international global standard for thermal processing like corrugated tube heat exchangers, plate heat exchangers, hot water systems Heat exchangers based systems, evaporators, systems for food/ fruit/beverage

processing,

along

with

various food processing systems, CIP systems, aseptic processing and filling technologies.

For details contact HRS Process Systems Ltd 201/202 Karan Selene 851 Bhandarkar Instt Rd, Pune - 411004. Tel: 020 25663581/82/ 66047894 Email: info@hrsasia.co.in Web: www.hrsasia.co.in November 2017  35

marketing initiative

KSB’s Energy Pumps Division received ISO 9001:2015 certification in a record time

naugurated on 28th April 2017, Energy Pumps Division of KSB in India received an ISO 9001:2015, ISO 14001:2015 & OHSAS 18001:2007 certification from TUV Rheinland.

An ISO audit was conducted in September – Federal Republic of Germany in Mumbai). 2017 i.e. just 3 months after the plant In a record time, IMS team carried out this was inaugurated at the hands of Mr. U. C. herculean task of demonstration of IMS Muktibodh (Director Technical – NPCIL) system implementation and maintenance. and Dr. Jürgen Morhard (Consulate General Energy Pumps Division, a new facility of KSB Pumps Limited is housed in an overall plot area admeasuring 100,000 sq. meters. This division is dedicated to manufacturing of high pressure multistage pumps, barrel casing pumps, vertical condensate pumpsets meant for supercritical power plants. About KSB Pumps Ltd. KSB Pumps Ltd. Founded in 1960 in India is a part of KSB AG., - one of the world’s leading suppliers of pumps, valves and systems. Combining innovative technology and excellent service to provide intelligent solutions, the company has been offering innovative and sturdy solutions to cater to the myriad needs of the Indian Customer may it be in power, oil, building services, process engineering, water treatment, water transport, etc. The activities of KSB’s in-house research centre focus on the areas of hydraulics, sealing technology, materials, production technology and automation. Today the KSB group has a presence on all the continents with its own sales and marketing companies, manufacturing facilities and service operations. More than 14,500 employees generate annual consolidated sales revenue of over Two billion Euros. For details contact Raveendra Savadikar General Manager (Integrated Management) KSB Pumps Ltd. Mumbai-Pune Road, Pimpri, Pune 411 018 Tel. : +91 20 2710 1000 email : Raveendra.savadikar@ksb.com

36  November 2017

Pharma Bio World

marketing initiative

Hydroprokav Pumps (India)Pvt ltd

ydroprokav Pumps (India)Pvt ltd .Explosives, Pharma ,Food Processing, Bio one of the Leading Manufacturers Gas, etc. of Progressive Cavity Pumps used in Various types of Industries like Edible This Pumps are designed for handling high Oil, Sugar, Paper , Chemical, Paint ,STP, Viscus & High Consistency Fluids Transfer Waster Water, Oil & Gas, Mines & Minerals Applications .

We are exporting our Pumps to more than 48 Countries from our Indian Plant and maximum exports goes to USA & CANADA.

Pumping Solution For All Industrial Needs

For details contact Srinivasa Sridhar General Manager-Marketing SF No.170/2 & 170/3, Private Industrial Estate, SIDCO, Coimbatore – 641 021, Tamilnadu, INDIA Phone No: 91 - 422 - 2679624, 3242220 Fax No: 91 - 422 – 2679476,2672102. E.mail: hydroprokav@vsnl.net Pharma Bio World

November 2017  37

marketing initiative

Bilcare saves chiller opex with HMX-PCU-F with 26,000 CFM and the other with 13,000 CFM.

Company Background Bilcare is an innovation-led solutions provider that is a global leader in the field of pharmaceutical packaging. Bilcare uses a range of specialty polymer films and aluminum foils to devise solid dosage pharmaceutical packaging materials. Bilcare operates out of nine different locations and has five R&D centres spread across Asia, Europe and USA. The company has a strong base of 2,500 customers across 50 countries.

During the summer months the fresh air coming into the chilled water AHUs was at 40-45°C. This led to high TR load on the chillers, resulting in high operating expenditure for these chillers. To reduce the operating cost of chillers, it was necessary to bring down the temperature of fresh air coming to the chiller. Solution

Challenge

Bilcare discussed the problem at length The Rajgurunagar plant of Bilcare with the HMX team. On the basis of had set up a new triplex laminating the weather data available and the line with a raw material storage area. TR load installed, HMX worked out a As per the process requirement, the feasible solution for the company. It was temperature inside the laminator plant suggested that two fresh air pre-cooling room was to be maintained at 26 ± units HMX- PCU-F without blowers 0°C throughout the year with a RH should be installed for the two chilled level of 55 ± 5%.To achieve this, 3 water AHUs. This would help in bringing x 100 TR water cooled screw chillers down subtantially the temperature of the are used with two Air Handling Units fresh air being taken in, thus reducing (AHUs) with chilled water coils, one the TR load on the chilled water coils, Calculation of TR savings based on temperature readings taken at the exit of the HMX-PCU-F units:

CFM

WBD °C

Ambient

After HE1

DB T (°C )

Cooling Sensibl e

Power consumption/T R

Powe r save d

Monetar y savings

kW/T R

kW/h

Rs/h @ Rs 7/kW

26,000

33. 0

24. 0

136.50

1. 2

46.8

327. 6

13,000

33. 0

23. 5

68.25

1. 2

23.4

163. 8

According to Mr. C.R. Raghu, Head – Maintenance & S.H.E “The management is happy and is looking at the possibility of using the HMX units at other locations in the same factory.”

38  November 2017

which would in turn lower the operational expenditure of the air conditioning system installed. Based on the recommendations, Bilcare opted for two HMX-PCU-F, which were installed and commissioned in September 2013. Result Temperature readings recorded at the exit of both the HMX-PCU-F units clearly establish a signiﬁcant and consistent reduction in the TR load on the chiller system.

For details contact A.T.E. ENTERPRISES PRIVATE LIMITED (Business Unit: HMX) T +91 - 80 - 2372 1065 / 2372 2325 ambiator@hmx.co.in W www.hmx.co.in Pharma Bio World

marketing initiative

Summits Hygronics

ummits Hygronics an ISO: 90012008 Company offers a complete range of products and solutions for Compressed air purification, Gas generation and purification and Industrial cooling systems.

Few of the companies are listed below.

The company has full in-house capabilities to produce all the equipments which includes latest state of art fabrication facilities, CNC machining centres, test facilities, etc housed in an area of 9880 m2. The company caters to many public and private sector industries in India, UK, Europe, Far East, Middle East and African Countries. The Company also manufactures and supplies custom made products to many original equipment manufacturers.

The core strength of Summits relies on technology development Innovative and Qualified design engineers strive to invent and upgrade the technical know-how in the field of compressed air and gas purification.

Vision: Summits has a strong global vision. Summits strives to supply reliable and advance technology compressed air purification, gas generation and purification products to customer focused market in all the five continents by 2020.

Summits partners with Siemens and uses Solid Edge software & analysis tools for designing the entire products & component

Mission: Becoming a significant global company in the field of compressed air & gas purification and generation relying on its core technological advancement. Quality Quality is vigorously persuaded from the design stage through manufacturing till customer service by the entire organization. Summits is also one of the very few Indian Air dryer manufacturing companies equipped with ASME U, S & R certified shop floor. Summits can also supply equipment in compliance with CE, DOSH and other International certificate requirements. Download ASME Certificate here

R&D Infrastructure

The feedbacks from customers are heard with great care to enhance continuous product improvement. The technology development department has sophisticated tools like 3D modeling software, analysis software, test rigs etc.

Energy Saving & Clean Environment The main ideology of Summits is to implement technologies to reduce energy consumption in every product and keep the environment clean. Summits refrigeration dryers use most advanced technology heat exchangers and energy efficient compressors to reduce energy. Summits only uses eco-friendly refrigerants to save environment. Summits desiccant dryers use optimum regeneration principles to reduce energy the dryers and filters are designed for a very minimum pressure drop to reduce energy. Customer Care Summits believes in retaining customers by professional relationship & providing excellent aftermarket support Customer care team practices 8D & FMEA process that use a combination of effective techniques and tools assisted by a cross functional team.

Summits is equipped with sophisticated testing facilities which include (but not limited to) dewpoint measurement, filtration particle measurement, flow and velocity measurement etc.

Trusted Manufacturer of Compressed Air Dryers, Nitrogen Generators and Oxygen Generators

Many Project consultants, Turnkey Project Companies, Inspection agencies have approved Summits as a preferred vendor for the products manufactured by Summits.

Summits Hygronics offers products, services and complete systems for the treatment of compressed air and gases. Treatment of compressed air is vital. Compressed Air

Pharma Bio World

and Gas Institute (cagi.org) has released an important article on the importance of compressed air dryers and the needs. Summits manufactures wide range of Compressed Air purification, Gas generation and purification products since 1996 confirming to Indian and International standards. The innovative products and services are of outstanding quality which delivers optimum performance for a very long duration to the complete satisfaction of the user. The flexibility structure of the company allows customizing the products to the needs of the user. Summits also capture the ever-growing market requirements and continuously develop new products and technologies to sustain in the marketplace. Products Compressed Air Purification Refrigeration Air Dryer Heatless Air Dryer Compact Heatless Air Dryer Heat of Compression Air Dryer Blower Reactivated Air Dryer No loss Split Flow Air Dryer Heated Purge Air Dryer High Pressure Air Dryer Compressed Air Filters Automatic Drain Valves Pressure Vessels

●●

Gas Generation & Purification Natural Gas Dryer Gas Filters Nitrogen Generators Oxygen Generators

●●

For details contact HO: +91 96009 10165 North : +91 93116 1 0165 West: +91 9665062435 East : +91 93303 20002 South : +91 96009 10165 Spare Parts: +91 9600910180 Email : cc@airdryer.in November 2017  39

marketing initiative

ABEX Engineering is ISO 9001:2015 certified company providing high quality Evaporation, Drying and Extraction Systems worldwide. Our success is based on our wide range of products, technical expertise, and close working relationships with our customers. This combination allows us to provide solutions based on the unique needs of each customer. Our Products ● ● ● ● ● ● ● ● ● ● ●

Rising Film Evaporators Falling Film Evaporators Agitated Thin Film Evaporator Agitated Thin Film Dryer Annular Centrifugal Extractor Liquid – Liquid Extractor (RDC) Zero Discharge Systems Micro Reactors Loop Reactors Steam Under Vacuum Thermal Fluid Heaters

We focus in development, production, installation, operation and maintenance

of plants and equipment for thermal separation. We have our In-House PILOT TEST PLANT FACILITY in order to help our potential customers experience the efficiency or our POCESS EQUIQMENTS. Pilot trials are the best way to make correct investment choices. Our Team members handle every aspect of the business — initial assessment, product testing, scale-up, quotations, project management, commissioning, and post-sale support. The FABEX team can provide technology for all applications from laboratory scale to production, as individual components or full-scale systems. Our Capabilities DESIGN ENGINEERING : We design 3D custom made systems as per customer minimum space layouts.

●

We design using latest Software’s like Auto Cad, Solid Works, Bentley,

STADD & PROSTEEL. We have successfully solved complex fluid flow structure problem using CFD software’s.

●

MANUFACTURING FACILITIES : We have more than 20,000 sq.fts Integrated Manufacturing Facility in Nasik.

●

We can Manufacture Rotary Equipment up to 30 M2 surface area. All are equipment are always made as per ASME standards.

SKID MANUFACTURING FACILITY: ● We provide SKID Systems which makes our equipment installations faster at clients end by integrating all essentials from our end itself. ●

We provide Modular skid units, which are easily assembled & thus saves lots of time & money.

Pilot Plant Equipment

       Sales Team W-45 MIDC, Ambad Nashik- 422010, Maharashtra, India Phone No. : 0253-6600170 / +91-9762638952 Email: sales@fabex.co.in

LABSPDU 40  November 2017

LABATFE

LABATFD

For Pilot trails appointment: Email: pilotplant@fabex.co.in Pharma Bio World

press release Bristol-Myers Squibb and Syngene Expand Ongoing Research Collaboration Syngene International, India’s largest contract research organization, has expanded its ongoing collaboration with BristolMyers Squibb. The next phase of the partnership will see the addition of a new facility to support future Bristol-Myers Squibb research and development operations, an expansion of the team and the extension of the existing agreement through 2026. The expansion will enable the two companies to undertake a greater range of scientific research and development for pharmaceuticals across a broader range of activities. Syngene and Bristol-Myers Squibb have worked together since 1998. The research campus, known as Biocon BMS Research Center (BBRC), Syngene’s first dedicated R&D Center, was established in 2007, which was subsequently renewed through 2020 and now has been further extended through 2026. It is the largest research and development facility for Bristol-Myers Squibb outside of the United States and plays an integral part within their global research and development network. Since its inception, BBRC has contributed to the discovery and pre-clinical development of numerous drug candidates for further study, as well as generated data that has led to multiple patent filings around the world. It has also played a key role in reducing the time and costs associated with advancing new compounds to first-in-human studies for Bristol-Myers Squibb. As part of the expansion, Syngene will set up a new dedicated facility spread across 25,000 sq. ft. of laboratory and office space for Bristol-Myers Squibb. This facility will house an additional team of 75 Syngene scientists who will work exclusively in support of Bristol-Myers Squibb. BBRC provides integrated services supporting Discovery, Translational Sciences and Product Development functions for Bristol-Myers Squibb.

Piramal Wins ‘Industry Partner of the Year’ at the Global Generics & Biosimilars Awards 2017

Every award effectively underscores the efforts made by the global generics and biosimilars sectors to make affordable medicines available to more people across the globe. These are among the most coveted recognitions in the pharmaceutical industry. Piramal Pharma Solutions is a global leader in pharmaceutical manufacturing, with a large portfolio of APIs, intermediates & formulations. Since its inception in 1995, Piramal’s Generic API business has been the preferred partner of customers for providing a wide range of quality APIs. The Generic API business has grown consistently over the years based on strong customer relationships, a stand out quality record, an emphasis on innovation, and a stellar reputation on time delivery and customer centricity. Piramal holds a successful performance record of over 20 years of supplying API to US and European markets from facilities located in India and the UK. All the facilities meet global regulatory requirements, cGMP compliance standards and are FDA inspected and approved.

Roche Appoints Lara Bezerra as MD, Roche Pharma India Roche has announced the appointment of Lara Bezerra as Managing Director for Roche Products (India) Pvt. Ltd. She succeeds Maturin Tchoumi who has now moved to Roche Finland in a new role. Lara has held various positions of leadership across geographies, including Europe and Latin America. With over 24 years of experience in the pharmaceutical industry, Lara comes to India after a successful assignment as the General Manager of Roche Venezuela. Her tenure in Venezuela was among the most turbulent times in the country’s history, and her leadership was critical in navigating that period. In 2016, Roche was named among the Top 20 Places to Work in Venezuela. “We are delighted to have Lara Bezerra join Roche India from Venezuela,” says Dr. Christiane Hamacher, Region head of Roche Pharmaceutical Asia Pacific. “With her strong business acumen and unique, people-centric leadership approach, Lara is ideally positioned to drive Roche’s efforts to bring our innovative treatments to patients in India.”

Piramal Pharma Solutions (PPS) is pleased to announce that it was recognised as the ‘Industry Partner of the Year’ at the recently held Global Generics & Biosimilars Awards 2017, in Frankfurt, Germany. It competed with several global peers in this category and emerged as the winner.

“I am excited to join the India team that has already made significant strides in bringing innovative healthcare solutions here,” says Lara Bezerra. “I look forward to building on this foundation by bringing our transformational medicines to the country, being a strong healthcare partner and making a meaningful difference for patients in India.”

The Global Generics & Biosimilars Awards 2017 rewards ‘best practice’ in two sectors, while at the same time encouraging improvements in every aspect of the way business is conducted.

Lara has a degree in Business Administration from the Fundacao Getulio Vargas (FGV) University, Sao Paulo, Brazil.

Pharma Bio World

November 2017  41

press release UE LifeSciences Inks Distribution Pact with GE Healthcare USA-India based med-tech startup UE LifeSciences Inc has announced a distribution partnership with GE Healthcare to commercialize its iBreastExam (iBE) in countries across South Asia and Africa. The partnership brings together UE LifeSciences\’ skills to design and develop mobile health innovations, and GE Healthcare\’s sales, marketing and distribution expertise in these markets to enable early detection of breast cancer in the developing world, the company officials said. UE LifeSciences, Founder and CEO, Mihir Shah had expressed that the iBreastExam can create access where none exists right now across its partnership geography. This partnership will provide a significant opportunity to commercially scale-up iBE across India, South Asia, Africa and South-East Asia and also work towards improving breast cancer related outcomes in these regions, said GE Healthcare Sustainable Healthcare Solutions President and CEO, Terri Bresenham. BE is a Made in India device developed by a team of 20-plus scientists, engineers and clinicians with USD 1.3 million in grant funding from Pennsylvania Department of Health (CURE Grant), University City Science Center (QED & DHA), Drexel University (Coulter Programme) and Unitus Seed Fund (StartHealth grant). It is currently commercially available in India, Myanmar and Botswana The project has been mentored and invested by Dr Kiran Mazumdar-Shaw of Biocon, Dr Ranjan Pai of Manipal Education and Medical Group and Unitus Seed Fund, a social impact investor in affordable healthcare innovations.

Glenmark Launches Apremilast Glenmark Pharmaceuticals Limited, a research-led global integrated pharmaceutical company, announced the launch of Apremilast in India. Apremilast is the first advanced Oral Systemic treatment for Psoriasis in India. Apremilast is a phosphodiesterase 4 (PDE4) inhibitor which is indicated for the treatment of moderate to severe Psoriasis. The launch of Apremilast will revolutionize the treatment of Psoriasis impacting close to 33 million Indians suffering from the condition. Apremilast is an advanced oral treatment for Psoriasis which addresses the limitations of the current available therapies in India. It acts in a targeted manner at an early stage of the disease progression. Also, it is an immunomodulator whereas the other available drugs in the country are immunosuppressant including biologics and are mostly indicated for the treatment of oncological conditions. Immunosuppressants suppress the immune system thereby making the body susceptible to various infections. Apremilast being an immunomodulator does not suppress the immune system and treats the condition of psoriasis at an intracellular level which will benefit psoriasis patients across the country. 42  November 2017

Apremilast is an oral therapy which can be self-administered unlike some of the currently available injectable therapy which have to be administered by paramedics. Further, Apremilast is a safer drug having no effects on other organs like the liver and kidney and does not require routine laboratory diagnostic tests like CBC, liver & Kidney test or TB screening as required in the case of other therapies used currently. Glenmark has launched Apremilast under the brand name ‘Aprezo’ indicated for the treatment of Psoriasis. Glenmark received approval from DCGI for Apremilast after conducting clinical trials on the molecule as per the regulatory requirements. Globally, about 3% of the world population has some form of Psoriasis. Another study reveals that the prevalence of psoriasis in countries ranges between 0.09% and 11.43%, making psoriasis as one of the serious issues. India has now become one of the largest patient pool in the world and is estimated to have around 33 million psoriasis patients. As per a study on psoriasis in India, based on data collected across various medical colleges located in Lucknow, Dibrugarh, Calcutta, Patna, Darbhanga, New Delhi and Amritsar, it was found that the incidence of psoriasis among total skin patients ranged between 0.44 and 2.2%. It was also found that the ratio of male to female (2.46:1) was very high and the highest incidence was noted in the age group of 20-39 years. Apremilast will revolutionize the treatment for 33 million psoriasis patients in the country. Apremilast is the first oral treatment in India specific for psoriasis treatment; it is convenient to administer, it is safer compared to existing therapies and will transform the psoriasis treatment regime in the country.

Mylan Introduces DURART R 450 Mylan Pharmaceuticals Private Limited, a leading global pharmaceutical company, has launched DURART R 450, a FixedDose Combination (FDC) drug comprising of Darunavir/Ritonavir 400/50mg for treatment experienced adults and adolescents weighing more than 40kg with HIV-1 in India. This is the first FDC drug available to patients in India. Alternative treatments require patients to take two drugs separately from two different bottles. Darunavir and Ritonavir are HIV protease inhibitors and can be used in combination for patients failing first and second-line regimens during the management of HIV-1 infection. Darunavir is currently available in India in 600 mg and 800 mg dose forms and Ritonavir is available in the 100 mg and 50 mg dose forms. Globally, Mylan supplies life-saving antiretroviral (ARV) medicines to nearly 50% of the men, women and children living with HIV in more than 100 developing countries. The company’s comprehensive ARV portfolio includes 14 APIs and 50 finished dosage forms in first-line, second-line and pediatric formulations. Pharma Bio World

press release A g i l e n t T h o u g h t L e a d e r Aw a r d Presented to Professor Jiandong Jiang Agilent Technologies Inc has announced that Professor Jiandong Jiang has received an Agilent Thought Leader Award in support of his studies on cancer stem cells differentiation induced by natural products. “Cancer is a chronic disease generated by multiple factors. Our research is focused on the treatment of cancers with new concepts or principles, using cutting-edge techniques,” said Professor Jiang. Professor Jiang is director of the Institute of Materia Medica (IMM), Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC) in Beijing, China. He is also the vice chairman of the China Pharmaceutical Innovation and Research Development Association (PhIRDA). Professor Jiang’s research focuses on antimicrobial drugs, including viruses and bacteria, anticancer drugs, and the development of treatments for metabolic syndrome. The Agilent Thought Leader Award will enable Professor Jiang’s team to implement metabolite flux analyses, metabolism analyses, and integrated biology approaches to characterize the anti-tumor activity of natural products. In addition to Agilent mass spectrometry solutions, Professor Jiang’s lab will also make extensive use of Agilent Seahorse XF technology, and Agilent MassHunter and VistaFlux software. The project will also include a collaboration with Professor Wenbin Li from the Beijing Shijitan Hospital, Capital Medical University to perform clinical related research. The IMM supports research and discovery of innovative drugs useful in treating or preventing human diseases. This work is done via creative multidisciplinary research based on Chinese herbal medicine and natural product research, along with the adoption of modern medical, and pharmaceutical theories and technologies.

Clariant Healthcare Packaging Site in Cuddalore, India Now Operational Clariant, a world leader in specialty chemicals, announces that its new Clariant Healthcare Packaging production facility in Cuddalore, Tamil Nadu, India is now operational. The new site is capable of producing Clariant’s line of Sorb-it, Tri-Sorb, 2-in-1 Can, and Getter Can sorbent canisters for the growing Indian and Asia-Pacific pharmaceutical packaging markets. “The new site has been validated as scheduled, and we look forward to serving customers with Clariant desiccants directly from Cuddalore,” says Matthias Brommer, Head – Clariant Healthcare Packaging business line. “By manufacturing regionally, we will be able to provide improved supply and service to our significant customer base in India while further addressing important and emerging markets in Greater China, the rest of Asia and Australia.” Pharma Bio World

The Cuddalore site is already certified ISO 9001, with ISO 14001, 18001, and 15378 certifications intended to be obtained by the end of the year, the latter of which will add Cuddalore to Clariant Healthcare Packaging’s network of GMP-certified production facilities. Cuddalore is equipped with an ISO Class 8 clean room, and products produced at the site meet the relevant US FDA, USP and EU standards for use in pharmaceutical applications. “Clariant canisters are among the most widely used pharmaceutical desiccants by generic manufacturers in India,” says Ketan Premani, Head – Healthcare Packaging India. “Thanks to the latest manufacturing equipment and product design, customers can expect the highest level of quality, and now with improved customer service.” Not only does the new Cuddalore site augment Clariant’s production capacity for desiccant canisters, it also adds to Clariant’s ability to meet BCP (Business Continuity Planning) requirements of global customers by producing identical products at multiple sites worldwide. Furthermore, Clariant continues to offer the Indian market a full range of controlled atmosphere packaging solutions from its global production sites, and it can help customers determine the ideal packaging configuration via its Stablus™ program.

Wellthy Therapeutics Conducts First Made-in-India ‘Digital Pill’ Clinical Trial Wellthy Therapeutics a digital therapeutics company that uses artificial intelligence (AI) and patient centric design to improve patient outcomes is now conducting the first made-in-India ‘digital pill’ clinical trial for diabetes. The #WeDiDiT (Wellthy Digital Diabetes Therapy) trial is all set to prove the efficacy of its 16-week structured diabetes management programme delivered through a mobile app. The trial was launched by, Dr. Sarita Bajaj, past president, Research Society for the Study of Diabetes in India (RSSDI), at the RSSDI Annual Conference in Bhubaneswar in the first week of November. The outcome of this multi-center randomized control trial will be measured by the HbA1C levels of patients before and after the trial. As part of the programme, personalized diabetes self-management education and real time coaching will be offered through dedicated health coaches and an artificial intelligence powered chat bot, to engage and improve the health of patients with type 2 diabetes by facilitating behavior change. According to Dr. Rajeev Chawla, Current President Elect, RSSDI, the need for digital interventions in diabetes care is more now than ever, especially in India. The Wellthy Diabetes intervention is an innovation born out of India, for Indians and South Asians. November 2017  43

press release To r r e n t P h a r m a ’s P r o j e c t G e t s Centre Nod The Centre gave green nod to Torrent Pharmaceuticals’ proposal to establish a bulk drug manufacturing unit in Gujarat with an investment of Rs 300 crore, as per an official document. The Union Environment Ministry issued the environment clearance certificate for the proposed project saying that the approval has been given with certain riders. The Ahmedabad-based firm’s unit will cover 57,737 sq mt area in Kalol taluk. It would have a production capacity of 21,415 tonnes per annum.

technology and scientific knowledge and look to partner with specialized solutions providers to manage their safety data. In addition, well-established companies are looking to increase efficiencies and compliance in the area of post-marketing surveillance. Many of these companies address this by turning to service providers who offer end-to-end solutions so they can focus on their core competencies of developing medicinal products.

It has also been told to ensure storage of raw materials does not exceed three days at any point of time, it added. Torrent Pharma has strong presence in cardiovascular, dialectology, pain management, gastro-intestinal segments, dermatology, among other healthcare products.

In Pharmacovigilance (PV), Sciformix provides adverse event processing services such as safety case intake, medical review of adverse events, regulatory reporting and proactive risk management. Sciformix offers these services leveraging the Argus platform for both customers who utilize its PV services, and companies engaging their own PV delivery model. This offering includes technology infrastructure, user services, application services, regulatory reporting and data analytics. The Argus suite of software solutions enable compliance with E2B exchange standards for expedited reporting, allowing users to conduct global case processing that can scale up to many thousands of annual cases, while also improving reporting capabilities. This comprehensive services offering improves operational efficiencies through individual and bulk case processing, built in audit trails validation, instant scalability, and business agility to meet changing needs, while embracing innovation and reducing IT costs.

Sciformix Corporation Collaborates with Oracle Health Sciences

The Oracle Argus Platform offered through Sciformix enables companies to increase their visibility into their entire risk and safety continuum, including signal management, adverse drug event (ADE) trends, and performance analytics.

The project is estimated to cost about Rs 300 crore and is expected to provide employment to 100 persons, as per the document. The ministry has asked the company to take necessary permissions from the state pollution control board, ensure zero liquid discharge and take waste minimisation measures. The company has been asked to plant 25,000 trees per year for next five years.

Sciformix Corporation, a leading scientific knowledge-based organization, is proud to announce its adoption of Oracle Argus Enterprise Edition platform to offer superior value to their customers in the Life Science industry. Through its collaboration with Oracle Health Sciences, Sciformix is able to offer its customers a fully automated and integrated safety database solution, allowing easy reporting and analytics for improving the quality and efficiency of drug safety operations. With headquarters in the United States and operations in the United Kingdom, Romania, India and the Philippines, Sciformix partners with Life Sciences clients to provide a full range of services including safety and risk management, clinical development, real world evidence and market research, scientific writing, regulatory affairs and technology services. The Life Science industry is facing ongoing change with mergers, acquisitions, and increasingly complex regulations, along with the pressure of doing more with less. As a result, organizations have to develop strategies to manage divergent priorities in order to implement cost-saving measures while keeping a keen eye on innovative technology solutions that address growing compliance and data analytics needs. Rapidly growing organizations, with complex safety needs for clinical trials, often lack the necessary 44  November 2017

Dr. Reddy’s Launches Generic Azacitidine Dr. Reddy’s Laboratories Ltd is pleased to announce that generic Azacitidine for injection 100 mg/vial, a bioequivalent generic version of VIDAZA (azacitidine for injection), is approved by Health Canada. “Bringing Azacitidine for Injection to the Canadian market at this time is very important for us, as well as for our customers and their patients,” says Alok Sonig, Executive Vice President and Head of the North America Generics business at Dr. Reddy’s. “This launch represents Dr. Reddy’s commitment to make affordable injectable drugs available in Canada.” Dr. Reddy’s is first to market with this Azacitidine for injection in Canada. Vinod Ramachandran, Ph.D., Country Manager, Dr. Reddy’s Canada says that “The approval and launch of Azacitidine for injection is an important milestone for Dr. Reddy’s in Canada. The launch of first generic Azacitidine for injection is another step in our long-term commitment to bring more cost-effective options to Canadian patients.” Pharma Bio World

Pharma News Cipla Gets US FDA Nod for Generic Pulmicort Respules Cipla Ltd, a global pharmaceutical company, has received final approval for its Abbreviated New Drug Application (ANDA) for budesonide inhalation suspension, 0.25mg/2mL, 0.5mg/2mL, and 1mg/2mL from the United States Food and Drug Administration (FDA) to market a generic version of Astrazeneca’s Pulmicort Respules. Cipla’s budesonide inhalation suspension, 0.25mg/2mL, 0.5mg/2mL, and 1mg/2mL, are AN-rated generic equivalents of Astrazeneca’s Pulmicort Respules and are indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. The product is available for shipping immediately. Pulmicort Respules and generic equivalents had US sales of approximately USD 825 million for the 12-month period ending September 2017, as reported by IMS Health

wiring boards (PWB business). On August 2, 2017, Taiyo Holdings set up a wholly owned subsidiary engaged in the pharmaceutical business towards the transfer of the Products. Taiyo Holdings is determined to take this opportunity and make a full-scale entry into the pharmaceutical business. The 13 products covered by the agreement will continue to be marketed under the Chugai brand to ensure uninterrupted supply during the handover period. The marketing and manufacturing rights will be transferred to Taiyo Pharma on a step-by-step basis, starting from April 2018. Taiyo Holdings, Taiyo Pharma, and Chugai will cooperate closely to achieve a smooth transfer of marketing authorization and marketing activities regarding the Products. Until completion of the transfer, Taiyo Pharma and Chugai will work together and engage in activities aimed at the provision of information suitable for the treatment of diseases, and the promotion of proper use.

Chugai to Sell Production Right of 13 Ast raZ enec a R ec eives U S F D A Approval for Faslodex Medication to Taiyo Pharma Chugai Pharmaceutical Co and Taiyo Holdings Co have announced that they have entered into an agreement, under which Chugai and F. Hoffmann-La Roche, Ltd. will transfer the marketing authorizations, including marketing and manufacturing rights, of 13 long-term listed products manufactured and marketed in Japan by Chugai to Taiyo Pharma Co., Ltd., a wholly owned subsidiary of Taiyo Holdings. Chugai aims to contribute to patients and the medical community through the creation of innovative medical products and services based on its business philosophy, “Innovation all for the patients.” The decision to transfer these long-term listed products was taken to reinforce Chugai’s focus on creating innovation, supporting the goal of ensuring sustainable growth by optimizing investment in business segments and products with potential to enhance the company’s competitive advantage. As described in the mid-term business plan “Next Stage 2020” announced on June 7, 2017, Taiyo Holdings has conducted feasibility studies and examinations over years, intending to make an entry into the medical and pharmaceutical business, an area that Taiyo Holdings deemed to be promising as a new wing of business or a growth driver to lessen its considerable dependence on the existing business in materials for printed Pharma Bio World

AstraZeneca has announced that the US Food and Drug Administration (FDA) has approved a new indication for Faslodex (fulvestrant), expanding the indication to include use with abemaciclib, a CDK4/6 inhibitor, for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer (MBC) in women with disease progression after endocrine therapy. The FDA approv al is bas ed on data from th e p h a s e III MO NARCH 2 trial, whic h met the s tud y ’s p r ima r y endpoint of PFS. The trial included 669 women with HR+, HER2- advanced breast cancer. The results showed a statistically significant increase in investigator-assessed median PFS of 7.1 months (16.4 months vs 9.3 months) in patients who received Faslodex 500 mg and abemaciclib 150 mg over Faslodex and placebo (HR: 0.553; 95% CI: 0.449-0.681; p<0.0001). This expanded indication for Faslodex is the second FDA approval for Faslodex in combination with a CDK4/6 inhibitor. Faslodex has been licensed in the US since 2016 for use with the CDK4/6 inhibitor, palbociclib, for the treatment of women with HR+, HER2-negative MBC, whose cancer has progressed after endocrine therapy. November 2017  45

Pharma News DCGI Approves Hetero’s Generic FDC Drug ‘Darunavir + Ritonavir’ Hetero, one of India’s leading generic pharmaceutical companies and the largest producer of anti-retroviral drugs, has received the approval from Drug Controller General of India (DCGI) to launch the first-ever generic fixed-dose combination (FDC) drug ‘Darunavir + Ritonavir’ in India. The product will be marketed and distributed under the brand name ‘Danavir-R’ in India by Hetero Healthcare Ltd. It will be made available in three strengths - 800/100mg, 600/100mg and 400/50mg. The FDC drug ‘Darunavir+Ritonavir’ is an anti-retroviral medication indicated for the treatment of human immunodeficiency virus (HIV-1) in treatment-experienced adult patients. This first-ever drug combination, a once-daily dose, simplifies the patient’s treatment with one tablet taken every day along with other anti-retroviral agents, ensuring that the drugs are taken in correct proportions. This ‘2-in-1’ combination therapy improves the patient’s adherence to treatment, while improving the quality of life. In line with Hetero’s commitment in making HIV/AIDS drugs affordable and accessible to patients globally, the company also looks forward to make this product available in other countries, subject to approvals from respective regulatory authorities.

Novartis Join Hands with ASCP & ACS to Fight Cancer in Sub-Saharan Africa Novartis, the American Society for Clinical Pathology (ASCP) and the American Cancer Society (ACS), announced they will work together to devise a common approach to improve access to cancer treatment in Sub-Saharan Africa. Each partner brings unique expertise in cancer diagnosis and treatment. This complements the work the Clinton Health Access Initiative (CHAI) is doing to improve access to affordable, quality-approved oncology medicines in the region. ASCP will build healthcare capacity for immuno-histochemistry (IHC) analysis in two hospital laboratories in Ethiopia and Tanzania. ACS will support training of healthcare professionals in Ethiopia, Tanzania and Uganda to ensure quality processes in the transportation of biopsy samples and in the administration 46  November 2017

of chemotherapy. Novartis will provide funding to support the technical work. This initiative will serve as a pilot for the future roll-out of similar activities to other countries. Cancer is on the rise in Sub-Saharan Africa. Approximately 650,000 people in Africa develop cancer annually, and about 510,000 cancer deaths occur annually due to limited treatment. More than one third of cancer deaths in Africa are from cancers that are easily preventable and/or treatable, if detected early.

Sawai Forms Strategic Alliance with Sumitomo Corporation Upsher-Smith Laboratories, LLC (Upsher-Smith) reported that its parent company, Japan-based Sawai Pharmaceutical Co., Ltd. (Sawai) will sell a 20 per cent stake in its US subsidiary (Sawai America Inc) to Sumitomo Corporation of Americas (SCOA), a subsidiary of Sumitomo Corporation, one of Japan’s leading general trading houses. Under the terms of the agreement, SCOA will acquire the stake for consideration of $211 million. The transaction is expected to close by the end of March 2018. Sumitomo Corporation is a major organizer of multinational projects, an expediter of ideas, an important international investor and financier, and a powerful force for distribution of products and global communications through a network of offices worldwide. Its core business units include Tubular Products, Environment and Infrastructure, Steel and NonFerrous Metals, Transportation and Construction Systems, Chemicals and Electronics, Media and IOT Applications, Real Estate, Mineral Resources and Energy, and Food. “Sumitomo’s investment in our US subsidiary and its management participation in Upsher-Smith will allow us to benefit from its experience, knowledge and network in the global business arena in areas such as sourcing of active pharmaceutical ingredients (APIs) and product introduction,” said Mitsuo Sawai, President of Sawai. “By leveraging the unique strengths of the three companies, namely Sawai, Upsher-Smith and Sumitomo Corporation, we will continue to enhance our global presence, including the US business, to accelerate growth with the goal of becoming ‘a Globally Recognized Generics Company’.” Added Rusty Field, President and CEO of Upsher-Smith, “We are excited by the potential of this partnership and look forward to increasing our capacity for acquisition and discovering broader strategic growth opportunities.” Pharma Bio World

Biotech News US FDA Accepts Ascentage's IND Application for APG-1387 Ascentage Pharma, a global clinical-stage biopharmaceutical company dedicated to developing apoptosis-targeted therapies, announced that the US Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application for APG-1387, a novel small molecule IAP inhibitor for the treatment of advanced solid tumors and hematologic malignancies. Inhibitors of apoptosis (IAPs) are a group of proteins that act on the intrinsic pathway that blocks programmed cell death or apoptosis. High expression of IAP proteins has been linked to several cancers, including lung, head and neck, breast, gastrointestinal, and melanoma and multiple myeloma. APG1387 is designed to bind to IAP protein monomers and dimers, unlike other IAP inhibitors in development which bind only to monomers. The Company believes that this dual inhibition may improve its effectiveness for more cancers. Ascentage has previously completed Phase 1 dose escalation studies with APG-1387 in China and Australia.

Bayer, PeptiDream Ink Global Drug Discovery Pact Bayer and PeptiDream, a public Japanese biopharmaceutical company, have entered into a global drug discovery collaboration across multiple therapeutic areas and target classes. Under the agreement, Bayer and PeptiDream will work to identify new compounds for difficult-to-address drug targets by using PeptiDream’s proprietary Peptide Discovery Platform System (PDPS) technology. The aim of the collaboration is to discover novel lead structures in areas of high unmet medical need across Bayer’s strategic research areas such as oncology or cardiology. Finding new lead structures is one of the major challenges in drug discovery. PeptiDream has developed a novel peptidebased hit-finding technology which offers starting points for lead-discovery projects for difficult-to-address targets based on the great magnitude of the libraries. The multi-year collaboration will complement Bayer’s internal lead discovery capabilities and represents a strategic extension of Bayer’s in-house technology portfolio. Under the terms of this agreement, PeptiDream will receive an up-front payment as well as success-based milestone payments. Pharma Bio World

Bayer owns the rights to novel lead structures generated in the course of the collaboration and obtains a license under PeptiDream’s PDPS technology to the extent necessary for human therapeutic use (excluding peptide-drug conjugates) of those novel structures. PeptiDream will also receive royalties on successfully commercialized drugs that result from a collaboration program.

G V K B I O C o m p l e t e s 1 0 Ye a r Collaboration with Nuevolution GVK BIO, leading Contract Research & Development (R&D) Organization that services the global biopharma industry, known for its customer focus , has completed 10 years of research and development collaboration with Denmark-based Nuevolution. Over last 10 years, GVK BIO and Nuevolution have collaborated on projects that pan across integrated discovery and development. The collaboration journey with Nuevolution has witnessed enhanced productivity metrics, problem solving, innovation and more timely completion of projects by supporting the discovery pipeline of Nuevolution. Another dimension of scientific contribution was ability to handle complex projects, leveraging problem solving capabilities while keeping a focus on customer requirements.

GNA Biosolutions to Introduce Pharos V8 for In Vitro Research Use GNA Biosolutions GmbH, a molecular technology company based in Martinsried, Germany, announced the launch of Pharos V8, the world’s first Laser PCR platform. Pharos V8, an ultrafast PCR instrument for in vitro research use, will be showcased at the Medica Trade Fair from November 13-16. The patented technology behind the Pharos V8 platform is Laser PCR. Laser PCR operates on the same principles as conventional nucleic acid amplification with PCR (Polymerase Chain Reaction). However, Laser PCR uses nanomaterials to control temperature cycles at the nano scale, accelerating PCR reaction times by a factor of ten and opening the door for applications in multiple time-sensitive settings. The Pharos V8 is the company’s first platform to come on the market, with additional product launches planned over the next two years. November 2017  47

Particle Size Analyser

Miniature Float Switch

Through innovative use of laser diffraction technology, the Mastersizer has become the worldâ&#x20AC;&#x2122;s preferred particle size analyser in the laboratory. It offers practical, proven solution to the particle sizing needs of industry, capable of accurately characterizing emulsions, suspension and dry powders. Incorporating Standard Operating Procedures (SOPs), it has set the benchmark for measurement reproducibility and ease of operation. Particles over a wide size range, from submicron to a few millimetres are measured accurately and non-destructively.

For more information, please contact: Aimil Ltd Naimex House A-8 Mohan Co-op Indl Estate Mathura Road New Delhi 110 044 Tel: 011-30810200 Fax: 91-011-26950011 E-mail: info@aimil.com

Miniature float switch is suitable for single level sensing. It consists of a reed switch housed inside the SS housing and a permanent magnet inside the float assembly. The float moving with the liquid level makes (NC) and breaks (NO) the reed switch contact. It is used for sensing low, high or point level in tank. The counting is through a M10 male thread.It finds application in hydraulic oil, water boilers, chemical and pharma industries.

For more information, please contact:

Filpro Sensors Pvt Ltd No: 130, 10 th Cross Petechennappa Indl Estate Kamakshipalya Magadi Main Road Bengaluru, Karnataka 560 079 Tel: 080-23286463 E-mail: sales@filprosensors.com

VOC Sensors Alphasense offers a new sensor for the measurement of VOCs (volatile organic compounds). The new p-type metal oxide sensor is a broadband total VOC detector with a range of 0 to 100 ppm (isobutylene) and 10-50 ppb detection limit, depending on the VOC. The new VOC sensor will be of particular interest to manufacturers and developers of instruments and monitoring systems for applications such as process monitoring, occupational safety, leak detection and environmental monitoring. Typical VOCs measured by the sensor include solvents, sterilants and petrochemicals.

For more information, please contact: Alphasense Ltd Sensor Technology House 300 Avenue West Skyline 120, Great Notley Essex CM77 7AA, U.K. Tel: +44 (0) 1376 556 700 Fax: +44 (0) 1376 335 899 E-mail: sensors@alphasense.com

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Revolving Check Weigher Check weigher RCW100 uses the state-of-the-art technology weigh cell (EMFC) to achieve greater accuracy in dynamic weighing for aerosol, cans, vials, etc. The system provides 100 per cent online weighing, ensuring compliance with international standards of pharma, food, chemical and cosmetic industries. Check weigher RCW100 also improves production line profitability through significant reduction in product give away. The entire system is made from SS and designed for easy removal for cleaning purposes.

For more information, please contact:

Technofour Electronics Pvt Ltd Gat No: 3 (PT), 5 (PT), 243 (PT), Kasurdi (Kheba) Khed Shivapur-Saswad Road Post: Khed Shivapur, Tal: Bhor, Dist: Pune, Maharashtra 412 205 Tel: 02113-305200, 305246, Fax: 91-02113-305250 E-mail: pcssales@tepl.co.in / teplinbox@gmail.com

Air Cleaner Camfil offers a new range of energy efficient, versatile air cleaners - CC2500 and CC1700. This new range comes with molecular filtration aimed at providing solutions for improved indoor air quality (IAQ) in offices, factories, clinics, hotels, data centers and control rooms. Designed for large area ranging from 6,000 to 8,000 sq ft, it is an India first innovation by Camfil Group. The sound and versatile CC2500 is specially designed to provide solutions in corrosion control, healthcare and comfort segments. Only 550-mm deep, the elegant new compact design fits in seamlessly in areas having space constraints. Perfect with retrofit and with outstanding performance, features and flexibility, CC2500 provides an impressive solution in areas that require super indoor air quality. The all-round acoustic insulation of 25-40 mm, makes it a silent performer. With a variety of options and combinations, issues related to particles, VOCs, formaldehyde, ozone, and acids can be resolved with CC2500. The air flow outlets can be configured in two different ways, by the side windows or just through the top. In addition to the upward airflow, the flexible design of these air cleaners can also be reversed to be used as a pressurization unit. The motor produces efficient and even air flow distribution, while also achieving a higher air flow. Backed by Camfil state-of-the-art filtration technology, CC1700 is a mobile and autonomous solution that eliminates particulate and gaseous contaminants. The air cleaner is best suited for areas that may contain corrosive gases, especially in paper mills, petrochemical plants, but can also be installed in libraries, museums, etc. The new range is equipped with HEPA and molecular filters bringing several unique advantages, such as low pressure drop and low energy consumption, a unique media combination and an optimized product life cycle. Both CC1700 and CC2500 offer unique benefits to the customers including low energy consumption, optimized product lifetime and high filtration efficiency. Placed in PSSA boxes, robust and perfectly sealed, they ensure optimal protection of sensitive industrial equipment and processes. For more information, please contact:

Camfil Air Filtration India Pvt Ltd 62, IDC, Mehrauli Road, Gurgaon, Haryana 122 001 Tel: 0124-4874101 Fax: 91-0124-4082405 E-mail: pksv.sagar@camfil.com

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Metal Detector + Checkweigher Metal detector + checkweigher is useful in food industry for detection of the metal contamination and weight checking on single platform. Metal detector checks for the metal contamination and checkweigher checks and classifies for weight variation in packed product. It finds application in pharma â&#x20AC;&#x201C; bottle line before sealing and capping; food for non-metalised packing of snack food, pulses, spices, flour, ready to eat, sugar, pulp and ketchup, chopped vegetables, glass/HDPE bottle, etc.

For more information, please contact:

Technofour Electronics Pvt Ltd Gat No: 3 (PT), 5 (PT), 243 (PT), Kasurdi (Kheba) Khed Shivapur-Saswad Road Post: Khed Shivapur, Tal: Bhor Dist: Pune, Maharashtra 412 205 Tel: 02113-305200, 305246 Fax: 91-02113-305250 E-mail: pcssales@tepl.co.in / teplinbox@gmail.com

Capping Machine This is a single head automatic cap sealing-filling machine with cap orientation unit. The cap orientation unit and sealing unit mounted on table-top with height adjustment system. It is GMP compliant with hard chrome-plated for corrosionfree and OHNS sealing rollers for trouble-free long life of rollers. It is easy to operate and variation of drive speed to align with filling machine. Output up to 2,400 to 3,600 containers per hour depends on bottle sizes.

For more information, please contact: Pharma Chem Machineries 311/2484 Motilal Nagar No: 2 M G Road, Goregaon (W) Mumbai 400 090 Telefax: 91-022-28735321 E-mail: pharmach@gmail.com pharmachem79@gmail.com

The Vial and Bottle Labeller Based on the expertise of many years of cooperation with customers in the pharmaceutical industry, the Vial and Bottle Labeller from LSS has been designed with a primary focus on user friendliness. LSS customers confirm that the machine fulfils the unique requirements of the pharmaceutical industry. The LSS Vial and Bottle Labeller is specified for vials and bottles made of glass or plastic with a product diameter between 14 and 35 mm and a minimum height of 30 mm. The machine labels up to 250 vials or bottles per minute. The LSS Vial and Bottle Labeller is available both as an off-line or in-line unit. Due to its small footprint and modular design it can be easily integrated into existing production environments.The labeller achieves maximum efficiency not only during the period of time when the machine is running but also by enabling quick and safe batch start / stop, format changes, line clearance, cleaning, maintenance and service. For more information, please contact: LSS Etikettering A/S Labelling Systems Scandinavia Normansvej 8 DK-8920 Randers NV Denmark Tel: +45 7020 2500 E-mail: pbh@lss-dk.com

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Automatic Powder Filling Machine This sturdy compact clean, elegant and easy to operate machine is suitable for powder, talcum and spices. Capable of filling 3 bottles at a time – auto, no bottle no filling arrangement with suck back facility. The machine provides easy changeover and is flexible for powders of different nature. Semi-automatic single, double, triple head powder filling. For more information, please contact: Pharma Chem Machineries 311/2484 Motilal Nagar No: 2, M G Road Goregaon (W) Mumbai 400 090 Telefax: 91-022-28735321 E-mail: pharmach@gmail.com pharmachem79@gmail.com

Steam Emulating Indicator The steam emulating indicator is the most critical chemical indicator, designed to evaluate the sterilisation parameters on the location and to give instant readout. The steam emulating indicator complies with EN-ISO 11140-1 Type (6).

For more information, please contact:

Yogi Kripa Medi Chem Pvt Ltd Ujagar Chambers, Unit No: 4 & 5, Plot 2E, Sundar Baug Off Sion Trombay Road, Next to Deonar Bus Depot Deonar, Mumbai 400 088 Tel: 022-61365400 Fax: 91-022-61365499 E-mail: info@yogikripa.com

Sifter Sieves A sieve or sifter is a device for separating wanted elements from unwanted material or for characterizing the particle size distribution of a sample, typically using a woven screen such as a mesh. Sifting is mainly used in two areas, Check screening of raw material to remove extraneous material and sizing to sort, segregate or control the particle size distribution of powders and granules. Sifting is mainly achieved by use of vibratory, rotary and centrifugal screeners. Sieves have to be specially designed to resist the high tensile stress generated. Since particle size distributions plays a vital part in drug dissolutions, maintaining the accuracy of the sieves apertures is an essential part of sieves manufacturing. Proper thickness of wire, accurate nominal apertures, high tensile strength and toughness of the sieves are essential part of sieve for high sifting performance.Material of construction SS-316 and 316L, and aperture sizes 4075 to 70 microns or mesh sizes 4# to 200# with ASTM standard being certified 90X microscope.Sieves are available in various sizes from 4” to 30” dia. The most common size used 20” (550 mm) and 30” (750 mm) dia. The silicone is food grade material, transparent in appearance. Non-toxic and moulded on the stainless steel ring. It finds application in chemical, pharma and food industries and are used in vibro-shifter machine.

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

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Single-sided Rotary Press The KTP 590X is an extremely versatile single-sided rotary press from Romaco Kilian which can be used to manufacture both mono-layer and bi-layer tablet formats. It can be switched between mono-layer and bi-layer mode without any modifications to the compression units. Bi-layer tablets can be compressed at any time on the version with three compression rollers. The tablet press is equipped for this purpose with two standard fill shoe modules, which distribute the powder absolutely uniformly in the die. Thanks to the optimised paddle design, even poorly flowing or sticky powders can be processed efficiently and compressed homogeneously. With its three separate compression stations, the Kilian KTP 590X is equally suited for manufacturing effervescent tablets. The powder is simply tamped initially to prevent air pockets and capping, then pre-compressed and finally converted into finished tablets in the main compression unit. The dwell time is significantly longer owing to the use of Kilian 28/41 tooling, meaning harder tablets can be made. All in all, the Romaco Kilian KTP 590X single-sided rotary press boasts a max output of up to 510,000 tablets per hour, even in bi-layer mode. Low process temperatures, efficient cleaning and retooling and a mature hygiene concept – the KTP 590X single-sided rotary press; too, conforms to the design principles of Romaco Kilian’s successful KTP Series: Cool, Fast & Clean. This product will be on display at P-MEC (Bombay Exhibition Centre, Mumbai, Stand D40) from November 28 to 30, 2017. For more information, please contact: The Romaco Group Am Heegwald 11, 76227 Karlsruhe Germany Tel: +49 (0)721 4804 0 Fax: +49 (0)721 4804 225 E-mail: susanne.silva@romaco.com

Drum Pumps Shanbhag & Associates is the authorised, national distributor for the entire range of Lutz products. Lutz Pumpen GmbH & Co KG, Germany is the premier manufacturer of electric and pneumatic drum/container pumps in the world. The Lutz concept allows the complete pump (drive motor and pump tube) to be used in different containers and liquids as long as components in the pump tube are approved for use in the liquids. Lutz drum pumps can handle liquids which are aggressive, flammable, thin, viscous, hot or cold, hazardous to ground water and the environment, and vary with respect to their density. Liquids up to 100,000 cp can be unloaded from drums or IBCs. The wide variety of liquids and container types/dimensions necessitates an extensive range of drum pump models. They are available in a variety of materials, equipped with electric/air motors adapted to the output requirements, for different voltages (AC/DC), explosion-proof for hazardous applications, pneumatically operated, with the required delivery rate and a suitable sealing system. Added to this are pump tubes in varying lengths and a wide range of accessories permitting, eg, adaptation to problematic containers or operating conditions. Pump tubes are available with centrifugal impeller or in eccentric screw principle constructions. Tube materials are in PP/PVDF/Alu/SS-316 (Ti) / Hast-C. Tube drivers are available in electric (Flp/Non-Flp) and pneumatic options. Drum pumps can be offered in sanitary and nonsanitary constructions including 3A certified construction. For more information, please contact:

Shanbhag & Associates B-50 Nandbhuvan Indl Estate, Mahakali Caves Road Andheri (E), Mumbai 400 093 Tel: 022-40365700, 40365711 Fax: 91-022-40365712 E-mail: info@shanbhags.com

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Pharma Bio World

Tableting Robot In the newest generation of Romaco Kilian’s STYL’ONE Evolution single-stroke press, the compression cycles have been speeded up by more than 60 per cent and the max compression force increased to 50 kN. The technology is thus ideal for simulating high speed presses like the Romaco Kilian KTP 420X at up to 104 revolutions per minute. The compression force profiles of all standard rotary presses are stored in ANALIS, the intelligent PAT software, and can be accessed easily when needed. Furthermore, depending on the test set-up, the compression processes can be either based on compression force or displacement controlled. The ROCO Pack software additionally simulates the operation of granulating mills on request. This extreme versatility is a hallmark of the STYL’ONE Evolution tableting robot. The remarkable precision of the test batches means powder properties can be analysed very realistically, for instance. By the same token, scale-ups or test series to optimise existing processes or troubleshoot errors can be performed on the laboratory press. The new models also have an interchangeable process worktable, which is an advantage if the products in question are highly abrasive. The STYL’ONE Evolution is capable of compressing up to 1,750 tablets per hour in configurations for mono-layer, multilayer or core tablets.The product will be on display at P-MEC (Bombay Exhibition Centre, Mumbai, Stand D40) from November 28 to 30, 2017. For more information, please contact: The Romaco Group Am Heegwald 11, 76227 Karlsruhe Germany Tel: +49 (0)721 4804 0 Fax: +49 (0)721 4804 225 E-mail: susanne.silva@romaco.com

AODD Pumps Shanbhag & Associates is the authorised national distributor for the entire range of Dellmeco Products with an all India sales and service network. The range of Dellmeco Pumps includes solid block AODD pumps in PE, PTFE - in conductive and non-conductive housings from 1/4” to 3”; SS, CI - PTFE coated and aluminium housing AODD pumps from 3/4” to 3”; hygienic, zero hold-up SS-316L AODD pumps from 1/2” to 2.5”; jacketed and high-pressure AODD pumps for applications such as filter press and AODD pumps for powder transfer. The pumps internals are available in EPDM or with chemically bonded PTFE diaphragms and ball valves. Dellmeco AODD pumps are absolutely lube-free; non-stalling in operation and corrosion-free. Air valve body is available in corrosion-free engineered plastic. There are fewer moving parts and commonly used spares across models and sizes compared to moulded AODD pumps. Dellmeco pumps find applications in industries such as pharma, paint, chemical, clay and ceramics, electroplating/surface treatment, food, dairy and beverages, automotive, glass and fibreglass, oil and gas, marine/shipbuilding, metal and steel treatment, effluenttreatment, aircraft, etc.

For more information, please contact:

Shanbhag & Associates B-50 Nandbhuvan Indl Estate, Mahakali Caves Road Andheri (E), Mumbai 400 093 Tel: 022-40365700, 40365711 Fax: 91-022-40365712 E-mail: info@shanbhags.com

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November 2017  53

Seal-less, Magnetic Driven Pumps Shanbhag and Associates is the sole, authorised, national distributor for M Pumps - an Italian manufacturer of seal-less, magnetic driven pumps. M Pumps is a unit of the Mischiatti Group and has been manufacturing magnetic driven pumps for over 30 years now. The seal-less, magnetic driven pumps are offered in centrifugal, peripheral, sliding vane, self-priming, centre-line mounted, inline and vertical pump versions. M Pumps manufactures these pumps in metallic, non-metallic and lined constructions. M Pumps is an ISO 9001 and ISO 14001 certified company manufacturing to API 610 and 685 as well as non-API pump standards. To safeguard the pumps we also offer dry-running protectors, temperature monitors on rear casing and ATEX certification as options for many models as optional features. Contact Shanbhag with fluid details and your pump requirements. Their national sales and service network will application engineer your pump requirements. M Pumps can offer a good quality pump at a competitive price for your difficult applications. Our pumps find applications in oil and gas, chemical, pharmaceutical, industrial refrigeration, offshore platform, electronic and galvanising and nuclear plant areas amongst others. For more information, please contact: Shanbhag & Associates B-50 Nandbhuvan Indl Estate Mahakali Caves Road Andheri (E), Mumbai400 093 Tel: 022-40365700, 40365711 Fax: 91-022-40365712 E-mail: info@shanbhags.com

Walk-in Humidity Chamber M a ck Ph a rm a t e ch P vt Ltd offers walk -in humidity c hamber in the temperature rang e o f 2 0 ° C to 6 0 °C ; h u m id it y ra n g e 40%RH to 95%RH; ac c urac y ±0.2°C and ±2.0% RH; unifor mity ±1 .0 ° C a n d ± 3 . 0 %R H . Test is suitable for 25°C and 60%RH, 30°C and 65%RH, 40°C and 75%RH; and 30°C and 75%RH. Features PLC-based control system; 21 CFR software; HMI (touch screen display); standby refrigeration system; standby humidity system; imported Hygroflex sensor; 8+8 scanner; GSM technology; hooter system; full view glass door and GMP mode.

For more information, please contact: Mack Pharmatech Pvt Ltd B-48 Malegaon MIDC, Sinnar Dist: Nashik, Maharashtra 422 113 Fax: 91-02551-230877 E-mail: sales@mackpharmatech.com

54  November 2017

Pharma Bio World

Intermittent Motion Cartoner In the high-speed version, the Promatic P 91S intermittent motion cartoner achieves a max output of 140 cartons a minute. This compact machine has a small footprint which makes it perfect for many pharma applications and line configurations. The cartoner’s cGMP compliant balcony architecture affords a better view of the process and reduces the risk of cross-contamination. All line clearance measures can be completed in a very short time. The optimal access to all components and the retractable carton magazine simplify cleaning and enable faster product and format changes. The operator simultaneously profits from the cartoner’s lower noise level and ergonomic working height. The use of servo technology and Venturi vacuum systems not only reduces noise emissions; it also ensures reproducible processes and gentle handling of the products and packaging. What’s more, the intuitive HMI terminal of the P 91S intermittent motion cartoner from Romaco Promatic provides max ease of use. The product will be on display at P-MEC (Bombay Exhibition Centre, Mumbai, Stand D40) from November 28 to 30, 2017 For more information, please contact: The Romaco Group Am Heegwald 11, 76227 Karlsruhe Germany Tel: +49 (0)721 4804 0 Fax: +49 (0)721 4804 225 E-mail: susanne.silva@romaco.com

Motorised Double Diaphragm Pumps The DELLMECO DME Series is an electro-mechanical double diaphragm pump which is highly energy-efficient. Instead of running the double diaphragm pumps on compressed air or Ni gas which is the most expensive plant utility, Dellmeco offers energy efficient, electric geared motor as the driver for the double diaphragm pumps.The pump technology is especially designed for universal applications which require low pressure - up to 6 bar. Its compact, special design does not require hydraulic fluid, and preventive maintenance is easy to carry out.The DELLMECO DME unique design concept and low energy consumption enable us to combine high-tech with proven reliability and quality for the most demanding of customers. DME Series pump housings are machined from conductive PE and PTFE blocks and also in aluminium, cast iron, AISI 316 industrial and AISI 316 L hygienic combinations. The pumps can withstand temperatures up to 120°C; are self-priming, capable of dry-running, low shear, versatile fluid handling capability; smooth product transfer; low operating costs through highly efficient electric drive. They deliver constant flow rate against variable pressure and viscosity; withstand highly corrosive chemicals; with long life fully enclosed diaphragms; abrasion resistant with their robust design; capacity up to 650 l/min without variable frequency drive (VFD) flow control; optional VFD flow control for process performance (from 35 to 70 Hz) with wide range of optional accessories available. Compact design means less space required compared to ecc screw and peristaltic pumps. For more information, please contact:

Shanbhag & Associates B-50 Nandbhuvan Indl Estate, Mahakali Caves Road Andheri (E), Mumbai 400 093 Tel: 022-40365711 Fax: 91-022-40365712 E-mail: info@shanbhags.com

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events diary                                                       Date: 07 - 09 , December 2017 Venue: Madrid, Spain th

This event is platform to discuss various disciplines involved in the Pharmaceutical Biotechnology, conduct of Novel Approaches in biopharmaceuticss which will educate Biotechnology in Health Care researchers about design, Formulation of Biotech Products, Advances in Biotech Manufacturing, Regulatory issues and drug approval which promotes better understanding by Pharmacokinetics and Pharmacodynamics of Biotech Drugs for general public about the importance of Current researches in Nano Technology by using Biopharmaceutical Engineering Methods. PharmaBiotech 2017 Conference conduct presentations, distribute information, throughout the world where we can meet with current and potential professors, researches, scientists, make a splash with new developments of biotech pharmaceuticals.

   Date: 22 nd - 24 th December 2017 Venue: Chitkara University, Punjab Indian Pharmaceutical Congress Association (IPA) is the apex body representing the Indian Pharmacists working in various capacities, viz, Community Pharmacists, Hospital Pharmacists, in Industry (in Production, R&D, Quality Assurance Marketing, Regulatory Affairs) Academics and other disciplines and areas of work. IPC (Indian Pharmaceutical Congress) 2017 is organised by IPCA every year. IPC includes Lectures, Expo, Poster Presentation, Paper Presentation, Discussion on current developments in Pharmaceutical Sciences. Contact: Dr Sandeep Arora Email: sandeep.arora@chitkara.edu.in

Contact: Radha Gokul Tel: (702) 508-5200 Ext: 8028 Email: pharmabiotech@pharmaceuticalconferences.org

        

       

Date : 17 th December 2017 Venue: Grand Hyatt, Mumbai

Date : 17 th February 2018 Venue: The Oberoi Dubai, The Oberoi Centre, Al A'amal Street, Dubai

ICMBPS' main objective is to promote scientific and educational activities towards the advancement of common man's life by improving the theory and practice of various disciplines and sectors of Medicine, Life-Sciences, Medical-Pharmacy. ICMBPS-17 will provide an excellent international forum for sharing knowledge and results in Health, Medical ethics, Medicine and Medical Science, Public Health, Biology, Pharmacists Role in Patient Safety ,Clinical Pharmacy and Its Key Role in Treatment ,Clinical Pharmacy Activities and Prescriptions. The aim of the Conference is to provide a platform to the researchers and practitioners from both academia as well as industry to meet the share cutting-edge development in the field.

International Conference on Drug Discovery & Development (ICDDD-18) is a globally recognized, highly appreciated platform globally with the richness of abundance. To be held on 17 th February, 2018 at Dubai, this event is sure to repeat its history again. Encapsulating with it the different domains of people, researchers, thought leaders, speakers and unique visitors, International Conference on Drug Discovery & Development (ICDDD-18) brings out the best of the best to the world.

Contact: Conference Coordinator Ph: +91-8882620621( press 1 for conference Enquiry) Email: info@itar.in

56  November 2017

      

Pharma Bio World

bookshelf Plasmid Biopharmaceuticals: Basics, Applications, and Manufacturing (Hardcover) Author: Duarte Miguel F Prazeres Price: USD 58.47 No of pages: 616 pages The book addresses the basics, applications, and manufacturing of plasmid biopharmaceuticals. The survey of the most relevant characteristics of plasmids provides the basics for designing plasmid products (applications) and processes (manufacturing). Key features that the authors include in the book are: i) consistency and clear line of direction, ii) an extensive use of crossreferencing between the individual chapters, iii) a rational integration of chapters, iv) appellative figures, tables and schemes, and v) an updated, but selected choice of references, with a focus on key papers.

The Strategic Pricing of Pharmaceuticals (Paperback) Author: E M (Mick) Kolassa Price: USD 46.29 No of pages: 292 pages The Strategic Pricing of Pharmaceuticals explains how pharmaceutical prices are, and should be set, in the US and international markets. The book discusses how pharmaceuticals are different from other products in terms of value and why typical assumptions and approaches to pricing fail to consider the true nature of pharmaceuticals or to capture their value. This book provides pharmaceutical marketers with needed guidance through the use of in-depth discussions and analyses of the factors that should be considered when setting and managing pharmaceutical prices.

Pharmaceutical Marketing (Paperback) Authors: Brent L Rollins, Matthew Perri Price: USD 90.22 No of pages: 282 pages Pharmaceutical Marketing will provide students and new industry professionals with a thorough overview of the general principles of marketing including marketing as a process, marketing effectives in the pharmaceutical environment, and coverage of marketing brand and generic drugs with special emphasis on direct-to-consumer advertising and the impact of social media and technology. Two unique chapters of the text are Chapter 10 Social Media, which addresses exactly what Social Media is, how it is currently being used within the industry, and how it should be used from the manufacturer’s perspective; and Chapter The New 4 P’s of Pharmaceutical Marketing takes a unique look at how the Internet and mobile technology has shaped the pharmaceutical industry and shifted the promotion paradigm to these current “P’s” - Predictive modeling/analysis, Personalization, Peer-to-peer networking and Participation. Pharma Bio World

November 2017  57

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