CPhI Conferences India, a division of Informa Markets in India, is back with the most influential show, the West Parma presents 11th Annual InnoPack Pharma Confex slated for 9th and 10th June, 2022 in Mumbai. The show will offer exhibition floor, semi-scientific conferences and a spotlight for innovations allowing the pharma packaging fraternity to discover the latest trends and revolutionary technologies transforming the packaging industry.

India has multiple challenges and providing the best healthcare to a burgeoning population is one of the most critical factors. Despite improvements in the healthcare sector, chronic diseases are surging at a rapid pace. As per a World Health Organization (WHO) report, 20 per cent of the country’s population suffers from at least one non-communicable disease and the treatments are estimated to cost India $6.2 trillion till 2030. Research and development at pharma companies has driven the growth of the pharma packaging market in India.

The Innopack confex is a platform for exhibitors to demonstrate their latest developments in the fields of pharma packaging, labelling, drug delivery device design and engineering. It will also provide fledgling companies to discover whether their products can match market expectations. The confex also offers myriad content-driven sessions on the entire value chain for packaging of drugs and devices along with extensive networking opportunities and innovative crossover solutions to support capital investment decisions. It will also include packaging workshops, a packaging leaders Round Table (RT) session and the India Packaging Awards in its 6th edition. The event is expected to draw more than 50 exhibitors, 40 speakers and trainers and over 100 nominations for the awards.

Speaking on the announcement of the 11th Annual InnoPack Pharma Confex, Yogesh Mudras, Managing Director, Informa Markets, India, said, “We are pleased to announce that the InnoPack Pharma Confex will return to its flagship in-person format with a focus on the pharmaceutical packaging industry which will no doubt facilitate its growth to reach an estimated $3 billion by 2030, coupled with government incentives and rebate programmes. The Confex will provide the industry stakeholders a unique platform to see a comprehensive range of packaging and processing technologies while also affording them the scope for productive, in-depth discussions with vendors to solve pain points and address challenges.”

The government of India has introduced the Production Linked Incentive (PLI) scheme for encouraging domestic manufacturing and achieving an Aatmanirbhar Bharat. The adoption and compliance with regulatory norms in pharma packaging, along with standards about packaging recycling, has bolstered the growth of pharma packaging market in India. India’s pharma packaging market size was valued at $1434.1 million in 2020, and is projected to reach $3027.14 million by 2030 at a CAGR of 7.54 per cent from 2021 to 2030.

The event will witness the presence of various policy makers, industry captains from associations, participations of leaders from top pharma and biopharma companies. It has been well received by both MSMEs and large companies in form of participation and associations. Some of the key delegates include representations from companies such as Aurobindo, Dr Reddy’s, Zydus, Piramal, Wockhardt, Glenmark, Cipla, GSK, Alembic Pharma, Reliance Lifesciences, Macleods Pharma, Sanofi, Indoco Remedies and J&J, among others.

The sessions over the two-day conference will be delivered by Vishwanath Swarup, Chief Operating Officer, Bharat Serums and Vaccines; Dr Aravindan Raghavan, Corporate Head – Global Operational Excellence, Syngene International; Sriman Banerjee, Head, Packaging Development and CDE, R&D Pharma Sci, Takeda Pharma; Rajendra Vidwans, Biopharma Consultant, Ami Polymer; Ravi Kumar, Head, Supply Chain, and Johnson & Johnson Pharma (Janssen), amongst other key packaging experts.

Following the Confex, Informa Markets in India is all set to bring in the 7th edition of India Packaging Awards, and continue its legacy of honouring the leaders driving the industry, in the midst of a global audience.

The post 11th Annual InnoPack Pharma Confex to be held in Mumbai appeared first on Express Pharma.

Informa Pharma Intelligence announced the 2021 hybrid edition of CPhI and P-Mec conducted by CPhI Conference. The online conference and networking is being held between 15th and 30th Nov 2021, while the in-person event was held between 24th and 26th November, 2021 at India Expo Centre– Greater Noida, according to a statement by Informa Pharma Intelligence.

The statement said that in a bid to stay afloat towards increasing contemporary demand towards high-quality and low-cost pharma solutions, CPhI and P-Mec India has curated a platform through this event for a gateway to the latest trends and innovative solutions that the market has to offer. The event aims to build better pharma community engagements, network amongst the fraternity and source innovative solutions on-site from exhibitors who have footprints both domestically and globally and covering the entire pharma supply chain – from APIs, machinery, technology, packaging, outsourcing, finished products and biopharmaceuticals. The industry is anticipated to have a steady growth trajectory and the event organised by CPhI India has focussed on the key driving factors for the same. The expansion of medicine manufacturing pertaining to the evolving epidemiological profile of the country will be instrumental for India being the preferred drug-manufacturing destination on a global scale. Additionally, the event aims to encourage the development of the research-based pharma fraternity.

Speaking at the sidelines of the show, Yogesh Mudras, Managing Director, Informa Markets, India, said, “The Indian pharmaceutical industry has been growing at double digits year-on-year, and remains committed to not only providing solutions to the healthcare needs of the country, but also to the world. As the world is battling the pandemic at different levels, here, in India, we remain committed to ramping up production capabilities of some key medicines across infectious and non-infectious diseases to ensure their availability and accessibility to the country and the world. The CPhI and P-Mec India show is the single location for all pharmaceutical and allied companies to get together and share insights, techniques and technology that will help meet these demands.”

As a part of the management team of the CPhI and P-Mec 2021 event, Poornachandra Tejasvi, Senior Director, Emerging Markets, India, Informa Pharma Intelligence, said,” As a representative of the world’s leading pharmaceutical business intelligence provider, it’s heart-warming to be a part of the CPhI and P-Mec event where we get to share meaningful insights drawn from real-time news, trends, market analysis, special reports, to key pharmaceutical companies in the country and the world. Globally, we provide intelligence to over 10,000 customers and 3,000 of the top pharma, biotech and biosimilar companies with the collective support of more than 300 respected business intelligence subject matter analysts, editors and thought leaders located across countries. The 2021 CPhI and P-Mec event will be a great opportunity to reconnect with the stakeholders of the pharmaceutical world and provide them with any form of data intelligence and analysis as needed.”

As per the statement, The P-Mec event is the single destination in the country today for all things associated with the latest innovative pharma solutions that the world has to offer. The venue also hosted the latest types of equipment associated with research and development and analytical solutions followed by cleanroom engineering design, certifications and the latest types of air-purification solutions. The packaging technology on display included a comprehensive range of glass, pouches, bottles, caps, tubes and plastic packages as well as printing and trademark solutions.

The post CPhI partners with Informa Pharma Intelligence to present 2021 hybrid edition of CPhI and P-Mec Expo in NCR appeared first on Express Pharma.

The 14th edition of South Asia’s biggest pharma event CPhI & P-Mec India expo opened yesterday at the India Expo Centre, Greater Noida, Delhi-NCR. The three-day expo is set to witness over 534 exhibitors from 16 countries and over 20,000 visitors.

The expo was inaugurated by Guests of Honour Ravi Uday Bhaskar, Director General, Pharmexcil; Bodh Raj Sikri, Co-Chairperson, Federation of Pharma Entrepreneurs; Dr Viranchi Shah, Senior Vice President and National President (Elect), Indian Drug Manufacturers Association; AVPS Chakravarthy, Ambassador, World Packaging Organization and Board Member of Pharmexcil; Yogesh Mudras, Managing Director, Informa Markets, India and Rahul Deshpande, Group Director, Informa Markets, India, amidst an august industry presence.

With a focus on building new business partnerships and announcements, the three-day expo intends to deliver and discuss new trends in the industry to grow the economy. The event is hosting a line-up of conferences by addressing the challenges and focussing on future opportunities of the pharmaceutical industry in India while adapting and thriving in this ever-changing industry.

The expo is supported by participants from various pharmaceutical companies (generic finished products), API producers, distributors, pharmaceutical companies (innovator finished products), intermediates manufacturers, engineering and contract manufacturers, ingredients distributors/buyers, consultancies and packaging materials companies. The expo is well received by the industry and associations such as –  Pharmexcil, CIPI, IDMA, ASPA, IPA, IPEC and KDPMA.

The expo, which is a part of the India Pharma Week, culminated with sessions on Day 1 under The Pharma Connect Conference that addressed ‘Policy Trigger and National Commitment to Nurturing Resilient Pharma Value Chain,’ ‘Leverage Digitalisation to Enhance Existing Pharmaceutical Manufacturing Plants,’ ‘Understanding the Criticality of Catalyst Development through Case Studies’ and ‘Global Pharma Opportunity and Expanding Indian Footprint.’

The CEO Roundtable, which was a closed-door strategic gathering of CEOs of leading pharma and biopharma companies, deep-dived into thought-provoking discussions on pharma developments in India which was chaired by KG Ananthakrishnan, Director-General, OPPI and co-chaired by Sriram Shrinivasan, Consulting CHS Leader, EY India. The roundtable witnessed the presence of leaders such as Anandram Narasimhan, Managing Director, Merck Specialities; Suresh Patatthil, General Manager, Abbvie India; BR Sikri, Co-Chairman, Federation of Pharma Entrepreneurs (FOPE); Dr Viranchi Shah, Director, Saga Laboratories; Franck Toussaint, Executive Director and Co-founder, BSMA Europe; Sanjit Singh Lamba, CEO, Valence to name a few.

Speaking at the inauguration of the 14th edition of CPhI & P-Mec India Expo, Yogesh Mudras, Managing Director, Informa Markets, India, said, “The past 13 editions of the CPhI & P-Mec India expo have paved the way for advancement in the pharma space. It is always a pleasure for us to provide a forum to the industry leaders to present their contributions to the industry, and at the same time, witness those of their peers. The overwhelming response from the exhibitors and the discussions at the conference will provide great insight into the industry. The aim is to capture new market trends, innovate, adapt and seek newer opportunities, in this dynamic global market. On this note, we look forward to a great show, and we wish all our guests a safe and productive experience at the India Pharma Week.”

The India Pharma Awards (IPA) and Networking Night: A part of the Recognition and Networking stream of the IPW, the 8th edition of the India Pharma Awards will bring together industry champions, stalwarts, visionaries and organisations from the pharma universe. The India Pharma Awards is one of the most transparent and process-driven awards. It is conducted professionally as well as methodically to draw out the best in the industry. This is done with a neutral jury panel representing various segments of the industry in a two-round process of sifting through the nominations. This year, the IPA received 159 nominations with categories such as excellence in R&D, excellence in brand/product management, excellence in marketing communications, excellence in CSR and excellence in response to COVID-19, among many others.

The post 14th CPhI & P-Mec India Expo opens in Delhi-NCR appeared first on Express Pharma.

Give us an overview of Freudenberg Medical’s presence and growth in India over the years. Where does India fit into the company’s global strategy for the future?

Freudenberg Medical has been serving biopharma customers directly, and with the help of a few distributors in India for the past few years, supplying standard and custom silicone tubings and fluid-handling products from our dedicated manufacturing sites in Germany and the US. In 2020, Freudenberg added a support team in India to meet the growing sales and service needs of biopharma customers in the region. Freudenberg Medical’s parent company, the Freudenberg Group, has held business ties with customers in India since 1920. Freudenberg Medical also manufactures products for medical device customers in India with custom tubing for oxygenators, ventilators, catheters and other medical devices.

With the explosive growth in global biologics production, which includes vaccines and cell and gene therapy, Freudenberg is able to support customers worldwide from two like for like manufacturing sites outfitted with the same top of the line-manufacturing equipment, software and quality systems.

The COVID-19 pandemic has brought about significant shifts across businesses. What were the major transformations that Freudenberg Medical witnessed?

Freudenberg saw a surge of demand of silicone tubing and single-use custom assemblies and the challenges for suppliers, like us, to meet the demand in a reasonable timeframe.

What are the revenue targets, growth targets for the lifesciences business in Freudenberg Medical in India and what are the strategies to achieve these targets?

We cannot share specific details but we are constantly strengthening our presence in India to achieve our growth objectives through a combination of distribution partners, OEMs and end users of biopharma industry

What are the major lessons your organisation learnt from this health crisis and its management? How will it impact your future offerings and capabilities development for the life sciences sector?

Like all major organisations, one of the major learnings is about sustainability and security of supply of critical components and ingredients required to manufacture life-saving drugs and vaccines. We will further nourish and scale up our strategy of offering various products and technology solutions through our dedicated manufacturing and R&D sites.

What will be the next frontiers for Freudenberg Medical? What is the blueprint to achieve them? 

Freudenberg is planning to introduce several new products in 2022 focussed on the fluid-handling space for biopharma. These include extensions of our current PharmaFocus product line plus a new product line. Stay tuned or further announcements in upcoming months.

What are you showcasing at CPhI this year, and what are your expectations from the event?

Freudenberg will be presenting the PharmaFocus Premium brand of silicone tubing which are extractables tested with a full validation package, perfect for demanding biopharmaceutical applications with standard, braid reinforced and peristaltic pump tubing. Also on display, the HelixMark brand of fluid handling products for medical device and pharmaceutical applications. This product line is available off the shelf in a wide array of product types and sizes, including a choice of silicone raw materials from all the major manufacturers.

At CPhI, we plan to meet with current customers as well as introduce our product offerings and innovations to the ever-evolving Indian pharma and biopharma industry.

The post Freudenberg to introduce products in 2022 focussed on fluid-handling space for biopharma appeared first on Express Pharma.

CPhI & P-mec India – organised by Informa Markets – is set to welcome attendees and exhibitors from around the world, both online and in-person, as new CPhI analysis points to sustained pharma growth in India, with an improving outlook for finished dosage, API and biologics.

The India-specific findings of the CPhI Annual Report survey conducted among 350 executives point to a significant jump in the country’s global reputation with India widely perceived to be benefitting from post-pandemic macro-economic and supply chain changes.

The 14th Annual CPhI & P-mec India will run in a hybrid form, with an online conference and networking from 15-30 November alongside an in-person event in New Delhi from 24-26 November.

“There is a tremendous need for new manufacturing partners and as shown in the report – Indian manufacturers, in particular, are in high demand. By delivering a hybrid event and offering a platform where international and national buyers and suppliers can profile themselves, we are facilitating a greater opportunity for future partnerships,” commented Silvia Forroova, Brand Director, Informa.

India’s single biggest metric improvement in the CPhI data was in the perceived quality of ‘finished dose manufacturing,’ where the country surged 13 per cent in year, adding to the four per cent rise in 2020, while it also jointly topped the prestigious ‘growth potential’ category with the US for the first time.

In fact, across all Indian manufacturing, there has been tremendous growth in the last year.

Sriram Shrinivasan, Consulting CHS Leader, Ernst & Young India, commented, “Indian contract manufacturing exported goods worth around $10 billion in 2020, and is expected to reach $27-28 billion by 2026, which equates to a fantastic 18-20 per cent CAGR during this period. Also, there is a lot more focus on outsourcing, resourcing and manufacturing into India. This trend is fuelled by India’s reputation for quality, infrastructure, growing innovation ecosystem and its skilled workforce – one of the largest pool of STEM graduates globally.”

India also saw its reputation for API manufacturing improve by seven per cent year-on-year. Emphasising this shift in perspectives, in 2021, there has been a five-fold increase in private equity investments [totalling $1.5billion] into API companies across the country. In fact, to help attendees explore this burgeoning sector further, the second day of CPhI & P-mec India’s online conference will feature a live panel discussion on API & Next Gen Labs. The session will offer foresight into the emerging possibilities for automation and robotics in pharmaceutical manufacturing as well as evaluating the complexity of the global API supply chain.

In another boon to Indian manufacturing, the country showed the largest gains in terms of ‘growth potential for biologics manufacturing’ of any country – including traditional biologics powerhouses France, the US, Singapore and the UK – perhaps helped by the Serum Institute of India’s well-documented supply of COVID vaccines. Highlighting this issue’s current prominence in India, a panel of experts, moderated by Duncan Emerton, Executive Director, Custom Intelligence and Analytics, Informa Pharma Intelligence, will also explore the opportunities and challenges for biologics and biosimilars.

To enhance networking and deal-making at the event, the online event platform will open more than a week before the beginning of the in-person event, empowering the industry to maximise the value they get from the in-person CPhI & P-mec India. This enables companies to identify more partners in advance and pre-qualify their leads. The online platform will also play host to some 30 sessions spanning four tracks – Drug Development and Delivery, API & Next Gen Labs, Biosimilars & mAbs and Digitization. Running alongside the event is India Pharma week which will host the ‘Women in Pharma’ roundtable as well as the eighth annual India Pharma Awards.

Forroova added, “It is such an exciting time with a multitude of new opportunities emerging out of India, which is why we are really looking forward to hosting the hybrid CPhI & P-mec India. With so many opportunities to network over the course of the fortnight, I would encourage everyone to take advantage of the online platform to not only set up virtual meetings, but to also pre-qualify leads ahead of the in-person event.”

The post India sees sizeable improvement in finished dosage reputation and growth ahead of CPhI India 2021 appeared first on Express Pharma.

Nick Mitchell, Managing Director, Phenomenex India, opines that the pharma and biotech industry within India, need to develop a series of short-term goals and targets to accelerate progress

2015 marks the mid-point of the second decade of the 21st century. A good time for reflection and critical analysis of what has been accomplished, and what has yet to be done. Prime Minister Narendra Modi summarises one of our toughest moments, on July 27th this year, “India mourns the loss of a great scientist, a wonderful President and above all an inspiring individual. RIP Dr APJ Abdul Kalam”. And in his death we should recall some of his incredibly forward-looking works, written and published before we even crossed into the new millennium, challenging all of us to think about India – 2020.

In the early 1990’s, Kalam offered India a SWOT (Strengths, Weaknesses, Opportunities, and Threats) analysis for the nation and a strategic vision looking over 20 years into the future. One example was recognising India’s incredible agriculture production potential, but identifying the weaknesses such as cold storage solutions, lack of roadways, and rapid transportation from rural areas to the heavily populated metros across the country.

In the pharmaceutical and biotech industry within India, now might be an opportune time to develop a series of goals and targets that we can work toward over the next five years, the decade which will take us to 2025, or perhaps as far out as 2030. For those of you responsible for goal-setting within your organisations, we all know that mid and long-term goals can be very challenging to set and might only be achieved with a strong focus on clearly defined short-term goals.

A recent meeting in September of a number of UN-member nations in New York, brought government leaders together for an exercise to develop a series of global goals, across number of categories. The meeting concluded with the finalisation of seventeen global goals. These goals have short-term metrics, and will drive the stakeholder nations to achieve the objectives.

If world leaders can come together and develop a set of goals with such tremendous scope, then surely we in the Indian pharma, biotech and life sciences space can take inspiration and challenge ourselves to do something similar in our niche arena, wouldn’t you agree?

To further the parallel of this analysis, let’s go back to 1990 and review the progress made on one of the UN’s Millennium Development Goals. In 1990, the percentage of the global population below the poverty line was 36 per cent. The goal was to reduce this number by 50 per cent by 2015. By 2010 (five years early), the percentage was decreased by half (18 per cent), and by 2015 this number has reached 12 per cent (http://www.bbc.com/ news/business-32082968). It’s interesting to note that the establishment of the original goal was coincidentally incredibly close to India’s economic liberalisation which officially began in 1991.

Let’s consider India’s pharma market development over the same time frame. Although the industry began as early as the 1950’s and 1960’s, there was incredible momentum created during the economic liberalisation of the early 1990’s. This development, coupled with India’s unique position on intellectual property considerations during this same time period, fuelled the rapid growth of the active pharmaceutical ingredient (API) and generic drug manufacturing within the country.

Transitioning to a world class research and development nation within the fields of pharma and biotech pharma requires a conscientious decision on all stakeholders. It requires a commitment from the academic institutions to develop educational models that are focused on delivering the latest content, and delivered by leading academics publishing research in the most reputable journals worldwide. It requires a commitment from industry to invest in the latest analytical technology platforms to perform their testing protocols, and the leaders of these organisations must recognise that the increase in expense of these platforms is a long-term investment to increase the quality of testing results across the entire spectrum. And ultimately, an increased risk tolerance has to be accepted by those that develop the financial models to support these development objectives.

The short-term impetus to moving in this direction is very clear, it is re-establishing India’s place at the front of generic pharma manufacturing market; head to head with our immediate rival, China. As a nation we must regain the trust of the international community, specifically the regulated markets of the West, by agreeing to accept this initiative and not falter on 100 per cent compliance. The mid to long-term position will be to effectively move into the rapidly developing bioequivalents and biosimilars market.

The Make in India initiative is establishing a communication platform to bring industry stakeholders together in early January 2016 (http://makeinindia.com/sector/ pharmaceuticals/). If the homework is done now, this meeting could act as a catalyst for the change that the industry must undergo. With this forum as a backdrop, there needs to be a coordination between policy makers and players across the value chain for meaningful change to take place.

The suggestion of a plan for migration further up the value chain with a fifteen year timeline between 2015 and 2030 is more than reasonable. It will afford ample time to drive all stakeholders to comply. It also offers the opportunity for those organisations that are already serving the Western markets to re-affirm their position, as well as offer their support to those companies which are currently struggling. Finally, it would permit a timeline toward a zero tolerance initiative that the Indian pharma community must accept as they integrate into the global community and recognise a single global standard.

India is an emerging market, and emerging markets are very cost conscious. However, low cost products are not the panacea to all of the dilemmas we are facing within our sector today. On the contrary, the commitment to significant investments are required across the sector to increase the level of quality as well as to confirm the quality of the processes and their final products that the Indian pharma and biopharma companies are manufacturing.

A final thought to borrow from another vertical in India that has done very well over the last two decades, namely business process outsourcing and IT consulting. In this space, there have been incredibly strong training programmes for the graduates of India’s strongest engineering schools. Companies like Infosys, Wipro, and Tech Mahindra to name a few, have training programmes that can last anywhere from four to six weeks, six months, or even a full year. These programmes take the brightest of students and put them through rigorous sets of protocols, where deviance cannot be accepted, else dismissal is the end game. Ironically enough in visiting a few of these institutions over my years of living in India, I have never heard of “jugaad IT innovation”. There cannot be cutting corners, there is a compliance to “off’s” and “on’s” (“0’s and 1’s”). And it is this compliance, and the respect of this compliance that has turned this industry into a multi-billion dollar one across India. I think our pharma and biopharma companies can learn a lot from the companies in a high technology industry right next door to ours’.

Over the last month of 2015, take the time to consider, how will I do my part to take my organisation to the pinnacle of success globally? Phenomenex India is so interested in supporting our clients globally that strive to reach new heights. Our products and services are recognised by the US-FDA, the European Pharmacopeia, and are in hundreds of validated methods around the world. We manufacture all our products under the strictest of ISO guidelines, and we are always deeply committed to reach positive resolutions to all of your chromatographic challenges. We take this opportunity to wish you a strong finish to 2015, and best wishes for a fantastic 2016, during which we will celebrate our official “Five Years in India” at the end of April 2016. We look forward to you sharing in our celebrations. And lastly, thank you to all of our customers that have worked closely with us toward advancing the frontiers of separation science, here in India and across the globe. We sincerely appreciate your support and we look forward to working more closely with you in 2016 and the years ahead.

The post 2016: Onward and Upward, India! appeared first on Express Pharma.

India is a leading country engaged in production of cost effective and quality generic drugs. Many countries, in developed and developing world, are dependent on India for their generic drug requirement. One of the main advantages which India currently enjoys is the exceptional cost competitiveness. Same is true in the field of vaccines, Indian manufacturers are able to manufacture quality vaccines at a lower cost. In the last decade, several Indian manufacturers have been prequalified by WHO for supply of vaccines to UNICEF, Pan American Health Organization (PAHO) other international agencies engaged in public health and immunisation.

Growing global demand for quality drugs that are competitively priced has resulted in big opportunity for Indian pharma manufacturers who have manufacturing capability to produce quality products meeting international standards. Large and successful Indian enterprises focus on supplying drug products primarily to the US markets. In the recent past, some Indian manufacturers have suffered setbacks due to issues related to non-conformance to cGMP and data integrity. This has brought focus to practices adapted by Indian manufacturers and resulted in lingering doubt in the mind of international community about quality of Indian drugs. This situation was the result of poor implementation of quality systems in true spirit by some of the companies despite having a robust regulatory guidelines. This has led to increased vigil by USFDA and Indian regulators and situation need to be redeemed at the earliest in order to stay competitive. China, our most fierce competitor is a good example in this regard.

Good manufacturing practices is an essential cornerstone of pharma manufacturing in order to maintain consistent quality of drug products. There are several GMP guidelines national (Schedule M) and international (US FDA, WHO, PIC/s, PDA) covering almost all the aspects of manufacturing right from the facility, raw materials, equipment, manpower, process, quality testing and final product. These guidelines are a live document and are subject to change with time, hence GMP is always termed as current good manufacturing practices (cGMP).

GMP comes at a cost; apart from investment in building a modern facility, maintenance of the facility on a consistent basis requires substantial expenditure, and includes periodical calibration of instruments and validation of equipment and facility.

Most significant of all is manpower which needs to be qualified and regularly trained, not only in core technical skills but also in cGMP and regulatory aspects. Skilled and conscientious manpower is vital in ushering a GMP culture. A sizeable portion of expenditure of all successful enterprises need to be earmarked for acquiring, training and retaining manpower.

There are some aspects to be looked into with an objective to bridge the gap between increasing expectations and present state of affairs.

A significant share of capital is used in construction of the facility. A no-frills manufacturing facility with a simple design and a focus on proper layout for men and material movement as well as process requirement is the basic criteria. We also need to focus on energy efficient construction, which is the need of hour. A large clean room facility requires enormous energy to run and maintain. Let us look at three major components: heating ventilation and air conditioning (HVAC), process and utility equipment and lighting; HVAC consumes approximately 60 per cent of total electricity, lighting accounts for approximately 10 per cent and balance is used by equipment. Hence, it is a must to assess the facility layout design with this perspective, selecting the right clean room grade for a particular activity/ operation, apart from selection of energy efficient equipment.

Worldover, pharma industry has understood the significance of energy efficiency built in the design and operating system. In an increasingly competitive world, to deliver consistent quality and be cost-effective for sustainability of the business, Indian manufacturers cannot ignore this critical aspect of facility design. Moreover, to meet increasingly stringent guidelines and deliver consistently good product quality at a lower production cost, one needs to be mindful of selecting energy efficient technology and practices. A multi-product facility, where some of the support services viz. cleaning and sterilisation, media and solution preparation is common between different products can also reduce installation and operating cost without compromising quality of operation and product/s.

Another critical aspect is water, pharma manufacturers consistently require large quantity of high quality water for manufacturing. Water is a scarce resource and it is the biggest challenge that the industry is going to face in the coming years. Water is used for different purposes in pharma manufacturing operations viz. cleaning and rinsing, media and buffer preparation and formulation apart from running utility services. Quality of water is paramount for all these activities and does have a direct impact on the quality of the product. Design of a water system is a critical aspect as it has high energy need like a WFI generation and distribution system that needs to be maintained at 800 C with continuous recirculation at a flow rate where biofilms are not formed inside the loop over a period of time. Input quality of water is a crucial factor to be considered while designing a water purification system. While modern purification technology can efficiently address organic and chemical impurity, elimination of microbial contamination require greater effort in terms of design and operation. Like electricity, water is required 24×7 and its availability is of great concern, hence design of process, equipment and facility should also be vetted against the quantity of water requirement. In order to reduce consumption of water, manufacturers of biologicals and vaccines are exploring the possibility of single use multi-product facility, where need of water for cleaning during process changeover is obliterated.

Consistent product quality demands a robust manufacturing process which delivers drug substance or drug product batch after batch within the requisite quality specification. Robustness of a process is not only evaluated by quality of the end product but also by the consistency of the process parameters, defined as critical process attributes established during product development and verified during process validation studies. Quality by design (QbD) is a scientific, risk-based approach for product development which helps in complete understanding of critical process parameters and its impact on product quality and performance. From the perspective of a manufacturer engaged in production of biologicals and vaccines for several years, one can simply state that biological manufacturing processes are infinitely more complex than synthetic chemical processes. There are numerous variables in bacterial fermentation and viral culture which need to be continuously monitored and controlled to deliver a good quality antigen. Biological processes are more challenging to control and difficult to reproduce with the same result, batch after batch. Hence, there is a need for exhaustive study of all possible process variables of a manufacturing process during development and the importance of a complete and robust process validation study can’t be understated. It is key to maintain consistent quality. It is mandatory as a part of regulatory compliance to document all out of specification (OOS) results, deviations and changes in the annual product quality review (APQR). This enables the manufacturer to assess, analyse and evaluate the process for its robustness and helps in giving a fillip to consistent quality improvement.

A quality assurance system is the framework under which all manufacturing activities are carried out, right from the receipt of raw materials to dispatch of the finished product. Quality assurance is responsible for overseeing the end-to-end manufacturing process including testing, procurement and dispatch. The role and responsibility of quality assurance is well defined in several guidelines pertaining to pharma products. Validation of process, analytical methods and equipment, audits, in-process quality checks, documentation and batch release is some of the key functions. It is pertinent to point out that documentation is also a very critical component of quality assurance which needs to be clear, correct and reliable. Quality assurance is a most vital element to ensure and assure product quality and its role is ever evolving. Nowadays, pharma companies engaged in research and development (R&D) have a dedicated quality assurance team for supervision which is responsible for evaluating the product and process from a very early stage. This brings efficiency, removes bottlenecks and considerably reduces the time from lab to market. The team engaged in assuring product quality should have varied skills and experience which not only includes sound knowledge of basic science, emerging technology and regulatory guidelines but also possess good analytical abilities and problem solving skills.

With increasing awareness about environment, any responsible pharma manufacturing company needs to assess its products, processes and practices from the perspective of safety to environment which also include people, both operators and customers. In the field of biological manufacturing, processes are evaluated on the basis of risks to operator and environment and classified accordingly, thereby enabling the manufacturer to design and build a safe facility. Manufacturing processes and practices also need to be designed and adapted with the safety of people, product and environment in mind. How we treat our solid and liquid waste in an energy efficient manner is as important as the manufacturing process.

A sustainable business is one which adapts to change in its environment with speed. Indian pharma manufacturers also need to accept, evolve and adapt to global regulatory demands and customer needs. The cornerstone of such change is efficiency.

The post Pharma manufacturing – Improving quality, cost and efficiency appeared first on Express Pharma.

Nilesh Nayak, Global Head – Business Development, VerGo Pharma Research, says CROs can no longer sustain only on the service model and need to have a relook at their strategies

Contract Research Organisations’ (CROs) have always been the back stage boys in the Indian pharmaceutical industry. The silent operators have been away from the limelight but their contribution to the growth of the industry can never be underestimated. Being majorly privately owned, the total size and reach of this integral part of the pharma world is very difficult to estimate. But going by the number of new units and service providers mushrooming in the country we have all the reasons to believe that this sector is doing well and has reached the critical mass from where it can and will jump and leap frog into the next orbit of growth. The regulatory clogs and business uncertainties in the growing economies of the world have made the growth story a bit difficult for these companies. It’s an industry which is easy to enter but to grow and to sustain is a different ball game all together. Too many service providers in the same area juggling for limited space have forced the companies to rethink their strategies. It’s time for these innovation focused companies to reinvent themselves and have a closer look on the road ahead. They are at crossroads of growth and sustainability and it’s a tough decision to make.

CRO: Explaining the term

The abbreviation CRO is used for both ‘Clinical Research Organisation’ and ‘Contract Research Organisation.’ The former includes only the clinical research companies which can be subdivided into two categories:

• Clinical research organisations offering phase I to phase IV clinical trials
• Bioequivalence centres offering BA/ BE studies

For the sake of this article, we will be focusing on only the latter, ‘Contract Research Organisations’ which includes product development and custom organic synthesis companies assisting the big pharma innovator and global generic companies in formulation development, chemistry processes and other areas like stability studies and scale ups. The Contract Manufacturing Organisations (CMOs) have been kept out of the gamut of discussion here.

CRO business in India

Historically, India was always considered as a powerhouse for chemistry-based research. Our expertise in reverse engineering for synthesis of active pharmaceutical ingredients, process optimisation for bringing down the cost of synthesis, solvent recovery, synthesis of different salts and later different isomers gave India an unprecedented identity as a partner for chemistry research. As the companies started getting a foothold in the API market, the focus slowly started to move towards the next step in the value chain — formulations. Within no time the formulations market started growing and along with it, India’s expertise in the formulation research also started to take shape. The earlier patent regime giving Indian producers the liberty of not aligning towards product patents and only respecting process patents made us experts in process research and we found innovative ways for circumventing patents and bringing the latest products out in Indian markets. This helped the collective innovative thinking in the country to grow and our scientists became experts in generic product development, thereby gaining a grip on the generic industry.

The outsourcing or contract research industry is an off shoot of this development and many scientists with global development expertise started becoming technocrats and set up small chemistry and formulation development laboratories to service the global pharma industry. Indian CROs became extended arms for global generic companies and were seen as a reliable and cheaper source of development compared to in-house development in the bigger pharma companies. More and more companies started outsourcing their chemistry and formulation requirements to India and the market which was not existent till the late 90’s now suddenly became very attractive. The main factors which drew the global companies for outsourcing to India were:

• Scientific acumen and understanding
• Low cost for research
• IP understanding
• Respect for confidentiality
• Documentation skills because of language proficiency
• Professional approach and adherence to regulatory requirements

What started as a trickle in the 90’s with only a few companies providing these services soon became a steady flow of new companies entering this arena because of less entry barrier in form of investments needed and a big gap between outsourcing needs (demand) of pharma companies and the capacity of CROs (supply) to meet these needs.

CRO business model: Evolving with time

The CROs operated in multiple business models and the most common amongst those were:

• FTE-based model: Full Time Equivalent or FTE as its popularly called was one of the first models chosen by sponsor companies outsourcing their chemistry programmes to Indian CROs. This was a simple risk free model wherein the sponsor pays the CRO a fixed amount of money for a fixed amount of period depending on the number of scientists they engage for the project. This was very popular with the innovator and drug discovery companies who used to engage a fixed amount of scientists for their research work and CRO was paid a fixed amount of money per scientist engaged. In some cases there was a success-based incentive for the CRO in case of positive outcome to the research work. This model was similar to the working of the BPOs but because of the knowledge quotient involved the industry was also referred to as the KPO (Knowledge Process Outsourcing) Industry. The FTE model was generally favored for long-term engagements between the sponsor and CROs and relationships spread across multiple projects and assignments.
• Fee for service model: The FTE model was not suitable for the outsourcing of smaller projects particularly in the areas of formulation development wherein the projects were distributed by the sponsor across multiple CROs and the sponsors didn’t want to get tied up to one CRO for all their projects. The fee for service model worked on milestone- based payments to the CRO which were pre decided and time bound. Various factors like API availability / CMO availability / bio study failure etc throws the project out of time lines and both the sponsor and CRO are adversely affected with the CROs cash flows getting affected and the sponsors’ projects getting stuck and not moving ahead. The risks associated with the fee for service model are high and there is practically nothing that both the sponsor and CRO can do to mitigate the risks. The carrot and stick approach in form of success fees and penalties respectively are not known to have any positive outcome on the timelines and project deliverables.
• Co-development/ Outlicensing model: As the CROs began to mature and started having a surplus cash flow they started investing in their own in house developments. The strategy was simple. Select products that would be attractive to generic sellers and with minimum players in market, develop the products till proof of concept (positive stability and pilot biostudy) and then scout for partners for investing in the manufacturing of the exhibit batches and pivotal biostudy which make up for substantial part of the development cost. The CROs can aim for better revenues in this model as they share the risk of development with the sponsor and can offer more definite timelines thereby improving their time to market for the products. The co-development model is becoming very common even in custom chemistry synthesis areas.

Bottlenecks for growth

As the CRO industry progressed from one business model to another, the more competent and ambitious one’s graduated to different levels of services and entered into the next areas in the value chain by offering manufacturing services and sometimes also offering complete dossiers with market authorisations.

The investments of the CRO have increased considerably with now private investors and venture capitalists entering into the fray. The mom-and-pop shops have metamorphosed into professionally run corporate houses with management coming from the bigger generic and innovator companies. Most of the CROs are still privately-owned and stand alone businesses making them vulnerable to changing market dynamics. The slowdown in the EU markets and stiff price wars in the US generic industry had an adverse effect on the CRO’s with flow of projects slowing down and sponsors negotiating heavily on pricing of the projects. The increase in competition and smaller players entering the fray further worsened things and many of the CRO’s are fighting for survival.

The stage is set for the industry to try something new to grow and sustain the business in future. CROs can no longer sustain only on the service model and need to have a re-look at their strategies. With the flow of projects not guaranteed and limited investment possibilities in own projects the CROs are at crossroads and need to take a decision of whether to remain independent and continue to provide services or to align themselves with their sponsors by providing the sponsors a stake in the company and becoming their integral part. This will provide the sponsor better control over the CRO and they could get their projects prioritised and for the CRO there will be better sustainability with a bigger sponsor acting as their guardian angel. The BA/ BE industry had seen this kind of alignment happening in the past and it’s a model which has worked for them. Whether the contract research companies will also take this plunge and join hands with bigger companies is an inevitability waiting to happen?

The post At ‘CRO’ssroads appeared first on Express Pharma.

CPhI India and its co-located events are the largest and most comprehensive pharmaceutical industry events in South Asia. CPhI India will be held along with P-MEC, which will take place at Bombay Convention and Exhibition Centre, Mumbai, from December 1-3, 2015.

Visitors will be able to meet with key decision makers in the pharma industry from 92 countries, including India, China, the US, the UK, France, Italy.

Technical seminars will be held during the event. CPhI India Pharma Awards will be given out to recognise and appreciate the contribution and efforts of the Indian pharma industry.

Exhibitor profile includes, active pharma ingredients, alkaloids, amino acids, antibiotics, antibodies, antimicrobial preservatives, antioxidants, biocatalysts, biotechnology, capsules/ encapsulation, chemical synthesis/ analysis, chira intermediates, coating agents, colour and dispersions, custom manufacturing, cytokines, emulsifying/ solubilising agents, enzymes, excipients and drug formulation, fine chemicals, flavours and perfumes, glidants, herbal teas, hormones and synthetic substances, immunochemistry, intermediates, medicinal plants, microencapsulation, ointments bases, peptides, phospholipids, plant/animal extracts, prostaglandins, publisher, purification and separation techniques, regulatory affairs, sera and vaccines, solvents, stiffening agents, stiffening bases, suppository bases, suspending/ viscosity, increasing agents, sweetening agents, synthetic organic chemistry, tablet binders, tablet disintegrants, tablet filler-binders, tablet lubricants, tissue culture medias, wetting/ solubilising agents.

EP News Bureau – Mumbai

The post CPhI India to be held in Mumbai from Dec 1-3, 2015 appeared first on Express Pharma.

Chemicals are inevitable constituents of almost all drugs. Though these chemicals are regularly checked for their controlled side effects on the human body, their adverse effects on the environment perhaps never get the due attention. Scientifically and technically strong pharma operators know this fact very well. However, things are taking time to change, sometimes due to compulsions of the business and sometimes due to lack of alternatives.

Role of catalysts

Use of a catalyst is considered unavoidable in the drug manufacturing process. However, catalysts like palladium are not only expensive for the company but also harmful for the environment. So, is there a need to find an alternative to catalysts as a step towards making drug development eco-friendly? According to experts, contrary to popular belief, catalysts are not polluting agents apart from few exceptions. In fact, catalysts can aid in reducing environment pollution.

Pravin Herlekar, Chairman, Omkar Chemicals, says, “Use of catalysts is a must in many drug manufacturing processes. There are alternate processes without the use of a catalyst. However, they would lead to more complex issues related to effluents. Catalysts are primarily used to improvise on the yields of the desired product, minimise by-products, expedite kinetics of the reactions and minimise effluents. There are new generation catalysts such as chiral catalysts and nanotech-based catalysts which make use of common metals such as cobalt, nickel, copper, etc. as against costly materials like palladium. However, they are process specific and cannot be applied in general. But one must say that use of a catalyst helps in reducing environmental issues.”

A chemical research scientist, speaking in his personal capacity, echoes Herlekar’s views. According to him use of catalysts is a must. He says, “As of now catalysts are unavoidable. Catalysts avoid all routes that other chemicals would take as reagents. Use of a proper catalyst is very important. Different types of catalysts can be used for one reaction. However, yield and selectivity of the desired product will change with the catalyst. Catalyst with the best yield and selectivity must be used. Next step is the optimisation of process parameters. In the pharma industry, optimisation is mostly avoided due to urgency or lack of time in product development, very rapid product changes, unawareness or negligence. Catalysts are unavoidable, but must be used wisely. I do not think there is any research to avoid catalyst. In fact, catalysts are the best candidates to do the job with maximum yield selectivity and minimal waste.”

Replacing stoichiometric methods with catalyst would be a good eco-friendly option, opines a spokesperson from BASF. “The key to more eco-friendly processes in fine chemicals manufacturing is the substitution of classical organic syntheses employing stoichiometric amounts of inorganic reagents with cleaner, catalytic alternatives. The E factors (by waste per kg product) of chemical processes increase dramatically on going downstream from bulk to fine chemicals and pharma products, mainly owing to the use of stoichiometric methods,” informs BASF’s spokesperson. He adds, “The concept of atom efficiency is a useful tool for rapid evaluation of the amount of waste generated by alternative processes. To make processes more atom-efficient and decrease the E factor, catalysts are key to success. For example, the Presidential Green Chemistry Awards show examples of catalysts being used for making processes more eco-friendly. A good starting point for the use and impact of E-factor calculations and the role catalysts can make in this is: Pure and Applied Chemistry, 2009, 72 (7), p.1233-1246 by R.A. Sheldon.”

Drug design

Though changing drug design is an option mulled over by scientists, developing ‘benign by design’ drug is hardly possible. Understandably, why would a company think about sacrificing drug qualities that keep it active and stable for the sake of environment?

BASF spokesperson says, “If this is referring to the production process of a specific drug we can state the following: a trend is observed towards replacing stoichiometric reagents by catalysts to make processes more cost efficient and eco-friendly. If the statement is referring to changing the chemical structure of a pharma compound, making a statement by BASF is more difficult and better answered by pharma companies. However, it is known that changing the design of a pharma compound has an impact on the pharmacological effect and typically cannot be considered for existing pharma products.”

Herlekar opines, “The drug required for a particular disease is designed after considering its efficacy, extent of side effects, affordability, etc. Once the drug is designed, we have to select the most cost effective process for manufacturing the same. This can be done by adopting the best available processes of synthesis, while keeping in mind the final targeted cost of drug. A suitable route of synthesis should be chosen to address the issues relating to the environment.”

Dealing with effluents

Water is the largest receptor of pharma effluents. Drug residues excreted by the pharma manufacturing plants linger in water bodies for months or even years. The challenging part is that the effects of these residues are hard to isolate and sometimes poorly understood. According to reports, anti-depressants like Prozac might disrupt frog development. Consumption of fish containing harmful chemical may prove fatal to human life as well. So effluents remain one of the biggest hurdles in making drugs eco-friendly.

Vijay Ramanavarapu, Corporate Development, General Manager, Granules India, says, “Companies can treat effluents more effectively to ensure that they are properly disposed of. Proactive companies can install zero-liquid discharge (ZLD) systems to ensure that all water is treated on-site and can be safely used for other applications such as garden water. While many Indian companies aren’t being proactive right now, we feel that in the future, successful companies will focus on how to minimise their environmental impact due to increasing emphasis on sustainability. Many companies, in particular, Western-based customers, are increasingly using environmental sustainability as a selection criteria when picking a new supplier.” He adds, “While researching new methodologies, pharma companies need to ensure the end product is still the same and the impurity profile of the product doesn’t change. Any major changes including different raw materials will require regulatory approvals from agencies such as the US FDA which will take time for a company to receive. At Granules India, our R&D has actively been working on green technologies that will reduce our carbon footprint. We believe this will not only give us a cost advantage but also improve our overall sustainability efforts.”

While developing pharma processes, chemists hardly make prior discussions with chemical engineers, complains a chemical engineering expert. He explains, “Chemist’s target is to get the product, yield does not matter to them. Process engineering and intensification must be done. The use of statistical techniques like design of experiments in process development and optimisation is also lacking. Effluents will be produced, but E-factor can be very low if process (reaction and workup) is well optimised.”

The most cost effective processes may lead to serious environmental issues while the most eco-friendly processes may lead to high cost of production. “We have to strike a balance wherein we optimise both these factors,” stresses Herlekar.

He adds, “Pharma effluents may certainly be chemical-free and there are ways and means to do so. Such effluents can be treated by making them neutral, followed by adjusting their levels of biological oxygen demand (BOD), chemical oxygen demand (COD), etc. They can be further processed in multiple effect evaporators, RO plants, incinerators, etc. and the water obtained can be recycled back into the process. However, all these operations add to the cost of the product and the market must accept and sustain the same.”

There are many research activities which are still at the conceptual stages. For e.g. Developing drugs with photodegradable properties. These drugs would be light sensitive and would decompose once exposed to light in the waste treatment plant. Possibilities of adding temporary stabilisers to the drug which would break off only after arriving inside the body are also being explored.

Financial hurdles

As mentioned earlier, becoming eco-friendly is an expensive option and pharma companies would require a hefty balance sheet to invest in the same. Under tight market conditions, raising additional money is seen as a business eroding step by the pharma industry. Unless going green coincides with some other profit-making measures, convincing drug manufacturers to implement eco-friendly methods looks difficult.

“In India, most the drug manufacturing is being done in the SME sector and these units do not have the requisite financial strength as well as the space required for exhaustive treatment facilities. One way to come out of this situation is to have government support in promoting larger CETPs in the industrial areas wherein the government can subsidise the cost of processing effluents,” says Herlekar.

Becoming eco-friendly should be the joint venture between the pharma industry and the government. Financially strong MNCs can afford to invest extra money for new developments, however, for majority of the Indian drug manufacturers, government’s subsidy would prove helpful. Subsidy could be on buying machinery to treat effluents or to provide lands for effluent treatment at nominal costs. Government can also reward a company with the most eco-friendly record.

The way forward

Eco-friendly drugs is a possible yet difficult to achieve dream. Any successful drug is a result of years of effort, research and investment. Changing these drugs, their manufacturing/research set up overnight, is obviously not very practical for pharma companies as they offer solutions that suits their financial requirements. Moreover, treating human beings first gains priority over caring for the environment. However, both humans and the eco-system are part of a cycle where they are interdependent. Damage to one of the entities would surely affect the other.

sachin.jagdale@expressindia.com

The post Eco-Friendly Drugs: Difficult, yet possible appeared first on Express Pharma.