NOVEMBER 2018
www.expresspharmaonline.com
Solutions from Research to Process
for Pharmaceutical Applications Demanding research needs all the support it can get. Cole-Parmer can support your complete discovery needs, scalable to production. • Trusted for over 60 years for bioprocessing and pharmaceutical solutions • Products designed to deliver uniform performance for high quality results, meeting regulatory requirements • Get the choice with the features you need from one source • Exceptional service along with technical and validation support
Peristaltic Pumps
Cleanroom consumables
Safety Products
Chromatography
Test & Measurement
Cell Culture
Electrochemistry
Lab Essentials
Need demo/samples? Contact us at:
022-6139-4444 / response@coleparmer.in
See product range at:
ColeParmer.in
FOREWORD Chairman of the Board Viveck Goenka Sr. Vice President-BPD Neil Viegas Asst. Vice President-BPD Harit Mohanty Editor Viveka Roychowdhury* BUREAUS Mumbai Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das, Swati Rana, Prabhat Prakash New Delhi Prathiba Raju DESIGN Asst. Art Director Pravin Temble
The success story of Goa's pharma sector
G
oa has emerged as a major pharma hub and is a preferred choice of overseas customers while sourcing medicines from India. It is home to more than 70 major pharma companies, which have significant investments in the state. Nestled on the shores of the Arabian Sea, the state has become a major tourist hub attracting both domestic and foreign tourists. The state has an area of
3,702 square kilometres and a population of 1.46 million. It has a well-developed social, physical Chief Designer Prasad Tate Senior Designer Rekha Bisht Graphics Designer Gauri Deorukhkar Senior Artist Rakesh Sharma Digital Team Viraj Mehta (Head of Internet )
and industrial infrastructure and virtual connectivity, including an international airport and significant ports. Industry-friendly policies with ease of doing business have attracted domestic and multinational pharma companies in the state. Armed with Goa Investment Policy 2014, the state has been able to create a conducive business environment and attract new industries to Goa. The government has ensured that companies adhere to strict environmental norms while manufacturing medicines. Goa Industrial Development Corporation has so far setup 16 industrial estates, constructed more than 600 industrial sheds and developed more than 1200 industrial plots. Creating new graduates and jobs is the motto of the government. Though there are tremendous opportunities for growth, however, challenges do linger. Express Pharma's Goa Pharma
Photo Editor Sandeep Patil
Summit will discuss ways on how more business conducive environment can be created. Industry leaders will discuss growth strategies for the next decade and will deliberate upon
Marketing Team Rajesh Bhatkal Ambuj Kumar Debnarayan Dutta Ajanta Sengupta E Mujahid Nirav Mistry
ways to make the state a business friendly destination. Under the theme, ‘Unlocking India Pharma Inc’s true potential,’ experts and veterans of the industry will gather at Goa Pharma Summit to analyse Goa's journey as a pharma hub in the last few years, how to meet the challenges and find solutions. We hope to understand the lessons learnt and therefore conclude the best way forward. Do join us in this journey to celebrate the success of Goa as a pharma hub.
PRODUCTION General Manager BR Tipnis Manager Bhadresh Valia Scheduling & Coordination Santosh Lokare CIRCULATION Circulation Team Mohan Varadkar
4
GOA PHARMA SUMMIT SPECIAL
November 2018
EXPRESS PHARMA
Goa, one of the smallest state in India, also happens to be a well known tourist destination. It has become a major pharma hub due to its user friendly policies where a number of pharma companies have set up their base. Goa Industrial Development Corporation (GIDC) has so far set up 16 industrial estates, constructed more than 600 industrial sheds and developed more than 1200 industrial plots. Industry stakeholders throw light on what makes Goa an ideal pharma hub
ROUNDTABLE
‘GOA IS AVIBRANT PHARMA MANUFACTURING HUB FORTIFIED WITH SOUND KNOWLEDGE BASED INSTITUTIONS AND SKILLED HUMAN RESOURCE AVAILABLE IN THE STATE’
G
oa has emerged as a major hub for the pharmaceutical industry with many MNCs as well as small and mid-scale pharma units making huge investments. In the last decade, Goa has slowly but surely metamorphosed from a tourist destination to an emerging pharma hub in India with not less than 80 registered pharma units in the state. The five-year tax holiday for Goa, announced in the Union Budget in 1993, which was further extended to 31-32004, as per section 80-IB (4) of the Income Tax Act, gave further impetus to the development of the pharma sector in Goa. Goa is a vibrant pharma manufacturing hub fortified with sound knowledge based institutions and skilled human resource available in the state. It provides innovative, quality and affordable healthcare solutions to the masses, generating more employment and elevating the quality of life in the state. The pharma industry in Goa has emerged as a major component in the industrial development of the state. The magnitude of the industry has catalysed a number of ancillary and service units in and around Goa. This eases the availability of most types of packaging materials, consumables and allied services necessary for the smooth running of the industry. Simultaneously, traders trading in a variety of raw materials, chemicals, packaging material and other consumables, which contribute to the productivity
EXPRESS PHARMA
PRAVEEN KHULLAR PRESIDENT GPMA & HEAD OF GLOBAL DEVELOPMENT CENTER, SANOFI GOA
The industry should also think on upgrading the syllabus and how it could be tailored to the meet the needs of the industry in order to build student capabilities and progress of the industry, have set up shop in Goa. All these activities are generating more employment, industrialisation and elevating the quality of life in Goa. Goa offers many advan-
tages other than having a major port in the state, such as IT infrastructure support for startups, abundance of skilled labour as well as a very efficient industry-academia connect with the establishment of
premier institutes such as IIT, NIT, BITS Pilani, Goa, and several pharmacy and engineering colleges. Besides, Goa also has the reputation in supplying high quality products to regulated markets such as the
US and Europe. This not only propels Goa as a destination of choice for further investments but also provides assurance of high quality products. The state is in the process of developing the logistics sector by forming a special logistics group and constructing several bridges to address the existing deficiency with regards to logistics and warehousing. Goa can turn into a haven for pharma industry with the government paying keen interest to provide key necessities such as uninterrupted supply of electricity, water and developing good infrastructure like roads and public transport. The government should also contemplate on announcing more incentives which in turn will provide rich economic returns to the state and its citizens. Taking cognizance of this great opportunity, the industry needs to be proactive and with industry associations such as the Goa Pharmaceuticals Manufacturers’ Association, it can serve as a scaffold for ushering in industry and academia collaboration to delve on multifarious issues such as skill building and industry readiness of students. The industry should also think on upgrading the syllabus and how it could be tailored to the meet the needs of the industry in order to build student capabilities, which in turn would provide them with a technically sound workforce. The pharma industry in Goa is raring to go and at this stage it is only the right impetus that can take it to the next stage of growth.
GOA PHARMA SUMMIT SPECIAL
7
November 2018
ROUNDTABLE
‘THE STATE’S EDUCATED WORKFORCE AND ITS PROXIMITY TO MUMBAI ALSO WORKS IN ITS FAVOUR’
T
he pharma industry in Goa has emerged as a major component in the industrial development of the state. The pharma industry flourished in Goa particularly in the last decade, which is home to as many as 80 big and medium sized pharma companies. This has also helped a number of allied ancillary and service units like packaging units in and around Goa to set up their base. Goa identifies the pharma industry as one of the major industry which is considered as the most environmentally friendly industry. This is in line with the state government’s industrial policy, which has improved the quality of life with pollution free natural environment. Indian and MNC formulations companies have already established their plants with various approvals from regulatory bodies worldwide. About 80 per cent of units export to the US, the EU and rest-of-theworld (ROW) markets. This is a
clean industry with a great deal of sophistication and state-ofthe-art plants and non-polluting as compared to other chemical or agrochemical industries. Goa is strategically located with good infrastructure facilities with airport, a seaport, connectivity by road network and other amenities. Further with efficient state government mechanism and support of central government and policies, it gives impetus to expand the pharma industry. Currently, Goa is already well placed on the network of pharma global supply map as exports from Goa comprise nearly 80 per cent of the state output. Major overseas customers prefer Goa as the first choice to source their products. Nearly the entire local industry is into overseas sales, their production facilities conform to the rigorous standards set by overseas US and European markets. Further, there is continuous investment in upgrading the
MAHESH GURNASINGHANI DIRECTOR MANUFACTURING & SCIENCE TECHNOLOGY, TEVA PHARMACEUTICAL
facilities to increase value addition and meet the demands of the export market requirements. The pharma industry being a knowledge-based industry and
Goa having sound knowledge based institutions with skilled human resource, is able to provide quality and affordable healthcare options to the common man. Goa has two pharmacy colleges, BITS, IIT, NIT, engineering and management colleges. Goa has numerous state-of-theart manufacturing and R&D facilities with latest technology available worldwide. It provides graduates from these institutions to get expertise and knowledge for the advancement in their career. The state’s educated workforce and its proximity to Mumbai, the business hub of the country also works in its favour. Goa has several advantages in its kitty when compared to other
states. It includes clean industrial environment due to the absence of polluting industry as well as good connectivity via road, rail and sea to the rest of world. The state needs to work on certain grey areas in infrastructure to remain major pharma destination. However, the good news is that the government is now emphasising on this by constructing bridges, roads and MOPA airport which will further provide the opportunities for the industry to expand. Moreover, most companies prefer and follow a policy of expanding in existing location and the presence of several players implies good amount of future investment to become Goa a vibrant manufacturing and research pharma supply chain destination. The pitch seems to be perfect for the next-phase of expansion for the state which can become the preferred global supply destination.
'25 YEARS OF INDUSTRIAL EVOLUTION IN THE STATE HAS HELPED INDUSTRY IN DEVELOPING AND NURTURING THE TALENT POOL'
G
oa started seeing its pharmaceutical boom in 1994, when the state offered tax incentives to companies for setting up their operations in Goa. Along the likes of Cipla, Glenmark, Sun (then Ranbaxy); Encube Ethicals also started its journey in Madkaim in 1998 and have grown to be one of the largest single site manufacturing facility in the world for topical dosage forms. We were able to do so primarily
8
due to the conducive environment – state has to offer on many variables like policies, support from FDA, availability of talent pool and many more. In the current Amazonian era, where customer requires everything 'Cheapest, Fastest and Best' – everything drills down to the one point – efficiency. And that’s where the local authority has been supportive and highly efficient in taking faster decisions, thereby sup-
GOA PHARMA SUMMIT SPECIAL
November 2018
MEHULSHAH MANAGING DIRECTOR, ENCUBE ETHICALS porting the industry to quickly respond to the growing patient needs. Also despite the fact that there are many pharma companies establishments in the vicinity, industry works in a very collaborative manner in terms of the talent retention. 25 years of industrial evolution
in the state has helped industry in developing and nurturing the talent pool, who forms the foundation of an organisation. Since the next level of growth of the industry would be derived from the newer technology in R&D as well as in operations, it is very important that state start thinking in up-scaling its digital landscape to ensure that industry is able to pace along with the fast changing IT landscape.
EXPRESS PHARMA
ROUNDTABLE
‘THE STATE HAS AWELLALIGNED, EFFICIENTAND COLLABORATIVE REGULATORYAGENCIES’
P
harma industry is gearing up for the future by making its commitment of proactively meeting the cGMP standards published by different regulatory agencies. The industry is also complying with the required regulations to provide quality medicines in the country. Maintenance of affordable cost of manufacturing medicines has forced pharma companies to
SANTOSH DESAI PLANT DIRECTOR – GOA, ABBOTT INDIA
The pharma industry in Goa has demonstrated over the years that they can proactively meet the expectations of the regulators in terms of quality come up with innovative way of manufacturing medicines. The industry is also adopting new technologies like ‘Track and Trace’ and serialisation to keep counterfeit medicines away from customers. Over the years, the pharma industry in Goa has demonstrated that they can meet customer expectations in terms of quality, cost and access without adding any environmental burden. Goa, a major tourist destinations in India, is also an ideal pharma hub today. Many factors have contributed in making Goa a most preferred destination for pharma companies. The policy set by the state government to allow electronics and non-polluting industries has helped the state to maintain the state as a tourist destination. The Goa government provides good infrastructure in the state like
EXPRESS PHARMA
electricity, water, transport connectivity and stable law and order situation. The state has a well aligned, efficient and collaborative regulatory agencies. There is availability of high skilled labourers from Goa andsurrounding states and well aligned worker unions. The pharma industry in Goa has demonstrated over the years that they can proactively meet the expectations of the regulators in terms of quality. The industry has come up with innovative ideas to cope with government expectations on selling prices for NLEM products in the domestic market. This can be done by increasing the volume base in domestic and help to increase the reach of medicines to the customers. Year-on-year, the pharma industry in Goa has met the demand in healthcare sector in domestic and international market.
GOA PHARMA SUMMIT SPECIAL
9
November 2018
ROUNDTABLE
‘THE STATE HAS EMERGED AS ‘THE INDUSTRIAL POLICY OF GOA GOVT IS FAVORABLE FOR PHARMA FORMULATION MAN- A PHARMA HUB DUE TO INVESTOR, ENVIRONMENT UFACTURING SET UP’ FRIENDLY POLICIES’ ANANT NAIK
T
he pharmaceutical industry is currently going through a phase wherein it is experiencing a stiff competition and high degree of compliance requirements. The growth in developed and emerging markets as well as the Indian market has the pharma industry on its toes to cater to this growing requirement. Hence the pharma industry is looking for strategically best places in the world to manufacture their products for the emerging Indian market, Asian market as well as developed markets. The core need for any pharma industry to set up its manufacturing plant today is to have a place wherein there is good infrastructure, political stability, clean unpolluted environment, quality culture, regulatory support and availability of skilled and unskilled manpower. Goa being a tourist destination is always a preferred place for business houses to set up the business. It is today a place where most people in the world would like to come and spend their time either for business or leisure or both. Current Goan socio-economic structure is able to cater to all economical classes of people. The basic necessities like roads, logistics and communication are well developed. All the industrial zones are equipped with basic amenities. Access to the airport, sea port, rail and road transport is easy and convenient. The new airport being developed in North Goa will be able to cater to growing needs of the industry. The industrial policy of the Goa government is favorable for pharma formulation manufacturing set up and is found to con-
10
GENERAL MANAGER QUALITY, UNICHEM LABORATORIES
stantly encourage the pharma industry due to its non-polluting nature. The policies of the government have been quite consistent for years which makes the environment very conducive for pharma formulation units. This is evident by the number of big pharma companies operating in such small state and support which it gets from government agencies. Most of the pharma formulation units in Goa are accredited with international regulatory approvals and are catering to the needs of both the Indian as well as international market. An important factor which matters to pharma formulation manufacturing plants is clean unpolluted air. When we see various industrial areas or cities throughout our country and compare it with Goa one is likely to fall in love at first sight for setting up a pharma unit. This is especially important when you have to host international customers or regulatory authori-
GOA PHARMA SUMMIT SPECIAL
November 2018
ties. These days we hear issues with regulatory compliance and consequently import alerts and warning letters grasping the pharma industry. All recent symposiums by regulatory agencies including CDSCO, MHRA and US FDA are stressing upon quality cultures in the companies. Cultures are built up over the years. Considering the high literacy levels and the culture in Goa it has been found easier to build quality cultures and to sustain them over time. One more important factor which is attracting the pharma industry in Goa is the drug regulatory authority in Goa. It has the legacy of industry-friendly approach. Goa FDA is in constant touch with industry associations like Goa Pharmaceutical Manufacturers’ Association (GPMA) for implementation of good practices and to resolve the industry issues. Goa has two pharmacy colleges with very good reputation, which provide required students with knowledge of pharma technology. Also, graduates from nearby states are very comfortable working in Goa. They impart training in engineering and non-engineering trades to fulfill industry requirements. Thus when we look at all the aspects needed by pharma industry to set up their formulation units, Goa is one of the best places on earth. The proof is in the pudding, with numerous pharma companies working in Goa and constantly expanding their manufacturing capacities.
W
ith a conducive environment, Goa has been able to attract many big multinational pharma companies as a destination to invest. Goa is a vibrant manufacturing hub with good knowledge and robust manpower. It has emerged as a hub for many small and big pharma industries having both investor friendly and environment friendly policies. It has a major component of its beauty and natural assets. It has
higher literacy rates compared to other states, which attracts skilled and genuine human resources. Having adequate supply of power with better road, rail and air infrastructure, Goa is going to become future ready. Despite inaccessibility of materials, limited technical support, lack of service units in and around Goa and other consumable services, the state has been able to succeed in smooth running of the industry.
PAREEN DASHOTTAR VICE PRESIDENT & SITE HEAD - FORMULATION OPERATIONS, GLENMARK PHARMACEUTICALS
Compiled by Swati Rana, swati.rana@expressindia.com
EXPRESS PHARMA
INTERVIEW
‘Let’s keep up the good work’ Goa is one of the preferred destinations for many pharma companies. Currently the state has 70 pharma manufacturing sites and is gearing-up for more upcoming pharma projects in the state. Jyoti Sardesai, Director- Goa FDA, highlights the advantages that makes Goa an ideal pharma hub, in an interaction with Swati Rana You will be completing one year as the Director of Goa FDA in December, what are the major issues faced by you? Yes, on the 1st of December, I shall complete one year in this office. Since I have 25 years of service in the same department in various positions of Food & Drug regulation, I actually feel it is an extension of service with added responsibilities of Licensing and Controlling Authority. Having held the officiating charge on quite a few occasions in the last seven years, I have had my training and experience of the position. Brief us on the issues faced by the pharma industry in the state. What are the major changes that have been brought-in in the past year? As it is known, Goa, over the last several years, has been a preferred destination for pharma manufacturing activity, predominantly for exports to regulated and semiregulated markets all over the world. We have about 70 pharma manufacturing facilities, MNCs as well as leading Indian companies, majority of their facilities are approved by International regulatory authorities viz US FDA, UK MHRA, MCC, TGA, ENVISA, and even Japan. The rest of the facilities are certified under WHO-GMP scheme. Our department, over the years, has always been a facilitator to the industry and trade,rather than adopting a
EXPRESS PHARMA
with approx. 350 whole sellers and 800 retailers. There are three government blood banks and two in the private sector. There is also one public testing laboratory. Our department has a sanctioned strength of nine drug inspectors,three asst. drug controllers, two technical officers and two deputy directors. Besides, we have our own drug testing laboratory within our office campus, headed by senior scientific officer. The lab also has asst. chemists, chemists and Jr. scientific officers in the drug testing section. Our officers carry out regular inspections, investigations, joint inspections with Central Drug Regulatory Officers, participate as observers during overseas regulatory audits like UK MHRA, US FDA, and other overseas regulators. The manufacturing sites, as well as trading premises, are inspected all throughout the year. They also collect samples of the drugs routinely, and forward the same for testing in our lab.
strictly regulatory approach. We have always been proactive and receptive to the industry’s concerns and needs, and have played a positive role, through a speedy and transparent functioning. All that I had to do is to continue this fine tradition without making any significant changes.
Brief us on the number of inspections carried by Goa FDA in pharma companies annually. In addition to the 70 odd manufacturing sites, there are about 55 loan licensee manufacturers in Goa. We also have a very established pharma trading business in our state,
Goa is one of the states with a high number of pharma plants. What are the problems faced by FDA in carrying out inspection on a regular basis and does the state FDA have sufficient drug inspectors? Goa has an area of about 3500 sq km, and is divided into 12 talukas. In almost each taluka, there are industrial areas specially developed, which are
called industrial estates. Most of the pharma plants are located within these industrial estates, the most popular being Verna and Kundaim. Our main office is centrally located at Bambolim and all the industrial areas are easily accessible. We have not been facing any serious issues in carrying out regular inspection activities, both at the manufacturing sites as well as trading premises. We do have sufficient staff strength at present and we are in the process of filling up the vacancies created in the last one year. To improve accessibility of all the stakeholders, we shall be starting our District Office in South Goa, very shortly. How is Goa different from other states? What makes Goa an ideal pharma hub and how is it gearing to be future ready? Goa is a small state, progressive and with clear industrial policies . The state does not allow any pollution creating industries, while pharma manufacturing is one of the preferred activities. In addition, Goa has English literate workforce, sufficient availability of pharmacists graduating from the two pharmacy colleges in the state, good connectivity by road, rail, sea as well as air and encouraging government policies. Goa is one of the greenest states and is also very close to the commercial capital
GOA PHARMA SUMMIT SPECIAL
11
November 2018
INTERVIEW of India, i.e. Mumbai. Good educational institutions, residential options, good social life are some of the motivating factors for the senior management personnel to move to Goa. It has a good work culture and a clean environment. The accessibility and approach of State Drug Regulatory Authority as well as presence of Sub Zonal Office of CDSCO in the state are additional positive factors for the pharma industry. As one can see, Goa’s infrastructure, especially roads, bridges, airport and the
12
harbour are presently undergoing massive upgradation, with the upcoming Mopa International Airport being developed as a logistics hub. All these factors certainly make our state an ideal place for a clean industry such as pharma manufacturing. Goa, being famous the world over, as a popular tourist destination helps too. It is worthwhile to note that many companies, after setting their first plant and experiencing Goa, prefer to put up more plants here, besides expansion of the existing facilities.
GOA PHARMA SUMMIT SPECIAL
November 2018
The process is still on and we already have more pharma projects coming up in Goa. What are your plans for next year? Two of the major initiatives that are underway, and aimed to be completed by next year are up-gradation of our testing facilities with the aim of achieving NABL accreditation of our Food & Drugs Testing Laboratory and opening the branch office of our department in South Goa. Regular and periodic training for inspecting and testing personnel is an ongoing process
and we plan to intensify the same, for keeping them updated about the latest regulatory developments. It would also be our endeavour to increase the interaction and dialogue between our stakeholders and our office. What message would you like to give to the drug manufacturers in Goa for a better regulatory compliance? I am very proud of the fact that in my state, there is a compliant and quality culture in the pharma sector, both in manufacturing and trade, and
it has been so for a long time, even before the export oriented manufacturing units came up. Incidences of spurious and misbranded drugs are almost non-existent in Goa. Even the quantum of NSQ products is very small. The biggest contributor to this is the high level of regulatory and cGMP compliance by our manufacturers and the general awareness and compliant attitude of our pharma trade stakeholders. So the only message that I can give is to say:‘Let’s keep up the good work!' swati.rana@expressindia.com
EXPRESS PHARMA
INTERVIEW
'Globally, there is a growing respect for the quality of Indian product' Founded in 1996, Ami Polymer is a leading manufacturer of biopharmaceuticals grade elastomer tubings, reinforced hoses, gaskets as well as extrude, moulded components – supplying to industries as varied as pharmaceuticals, biotech, food processing, plastics, and medical industries, among others. In an interview with Express Pharma, Alpesh Gandhi, Managing Director, Ami Polymer, throws light on a wide range of matters that have defined the company’s growth including its emphasis on obtaining the best of global quality certifications, and the impact of the government policies. Excerpts from the interview
Please brief us about Ami Polymer's spread of operations. Our head office is in Mira Road, off Mumbai and our manufacturing site is at Silvassa, Gujarat. We have branch offices in Mumbai, Goa, Indore, Roorkee, Baddi, Sikkim, Baroda, Ahmedabad, Hyderabad, Vishakhapatnam, Bengaluru and Chennai. We also have an office in New York, US; and a direct presence in Bangladesh, Germany, Iran, Switzerland, Dubai, Slovenia, and Spain. Currently, our employee strength is more than 275. Which industries do you target with your products? Our products are specially made to suit the pharmaceuticals, biotech, food processing, plastics, and medical industries, though we also cater to a number of other sectors, such as steel, engineering, aerospace, textile, solar and steel. How have the policies of the present government impacted your business?
EXPRESS PHARMA
We have seen a huge growth thanks to the pro-business policies of the Narendra Modi government, especially in the exports segment. That’s because the government has taken plenty of initiatives to promote exports. The Skill India scheme
has also benefited us immensely. We generally undertake campus recruitment from the ITIs (Indian Technical Institutes). Previously, we rarely used to get good technically skilled people from these institutes, but today there is an abundance
of job aspirants who are appropriately skilled. This is a result of close association between the institutes and the industry. The government has been proactive in supporting the formation of committees, comprising representatives of both the industry and the
institutes, for developing course curricula. These committees fine-tune courseware according to the needs of the industry, and this is what helps us to recruit people with the right skills. How has the Goods and
GOA PHARMA SUMMIT SPECIAL
13
November 2018
INTERVIEW Services Tax (GST) affected your business? It’s a great relief for those having pan-India operations to treat all regions across India as a single market, and not having to pay taxes separately for different regions. It’s a boon for those doing legitimate business, as transactions have become easier. GST has not only emboldened those who are doing legitimate business, but has also helped increase their number, because only those coming under the GST bracket, are entitled to get credit for business transactions. Manipulations have come down drastically. How do you manage to cope with the ever-changing and demanding customer expectations? Since we are increasing our focus on the export market, we are trying to win customers who will go only for world-class products. So we keep enhancing the quality of our products, and this is possible by upgrading our manufacturing equipment consistently with the latest technology enhancements happening globally. The other way to ensure
14
the quality that customer demands, is to obtain the best of global quality certifications, which we have been managing quite successfully and consistently. Our certifications include DMF #26201 (Drug Master File) for manufacturing silicon tubes and hoses accredited by US FDA; Clean Room of Class 10000 Certified Facility; NSF-51 Certification on platinum cured silicone resin; TUV Nord Certified ISO 9001:2015, ISO 14001:2015, OHSAS 18001:2007; and TOXICON Lab (USA) based E&L Study, USP Class 87, ISO 10993 biocompatibility studies on products. In the recent past, there have been cases where Indian companies had got into trouble over certification issues denting the image of our country abroad. How does the world look at the quality of the products leaving Indian shores? The world today looks at India in a very positive way. There is a growing respect for Indian products in the US and the other parts of the world. Indian companies have worked hard to earn
GOA PHARMA SUMMIT SPECIAL
November 2018
this respect. For instance, India has the highest number of US FDA-compliant plants today. What are your expectations from the Indian market, at a time when a series of elections, including the Lok Sabha elections are round the corner? It all depends on the policies of the government, like the GST, which have been a boon to those doing legitimate business. We hope such probusiness policies will continue, and we will get consistently motivated. What was your revenue for the last financial year, and how much growth do you expect this year? In the last financial year, we achieved a ? 36-crore revenue, and we are targeting to achieve a revenue of ? 155 crore by the year 2022. What’s your share of business from the exports and domestic markets? Presently, exports account for only about 15 per cent of our business, and we hope to increase this percentage to about 50 per cent within the
next five years. Focusing on exports, what are the key demand drivers for your products? Our product and plant certifications. In the export market, buyers are much more stringent with quality parameters of the product they intend to buy. Which new regions are you eyeing in the export market? While we look forward to consolidating our position in the markets that we are already present, we are looking at new regions like East Asia, Russia and China. Won’t language be a barrier in the East Asian countries? Also, what’s your modus operandi for starting off your business in new regions? Language barriers are taken care of by English translators. In newer regions, we generally start by appointing local agencies who help us choose local channel partners after which our people visit the region. If the progress is good in a particular region, then we set up our offices and employ staff for these offices.
How big is the role of IT systems in your business operations? One of the major reasons for our growth is that we have been using the best of IT solutions, and keep upgrading them. Since long, we have been using Microsoft Dynamics NAV ERP solution for operations, and SAP for Customer Relationship Management (CRM), The processes are getting faster, hassle-free. How much do you focus on R&D for product quality enhancements? We have a full-fledged R&D team that indulge in a lot of reverse engineering and develop applications after understanding customer requirements and demands perfectly, before developing the product. The R&D team has also been instrumental in developing a number of import substitutes. This way, we save on import duties; are able to do customisation faster, and remain costcompetitive. Our emphasis on R&D also ensures that we don’t have to keep inventories for long, and our products are always of international standards. -EP News Bureau
EXPRESS PHARMA
BUSINESS AVENUES
EXPRESS PHARMA
GOA PHARMA SUMMIT SPECIAL
November 2018
15
BUSINESS AVENUES
GOA PHARMA SUMMIT SPECIAL
LABORATORY EQUIPMENTS SANITARY HOSES & FITTINGS Performance matched to your production needs
Lab Stirrers Hot Plate Magnetic Stirrers
Walk-in chamber
Refrigerated Centrifuge Deep freezer
Single Door Refrigerator
Laboratory Centrifuge
Cyclomixer
Mini Rotary Shakers
REMI SALES & ENGINEERING LTD. Remi House, 3rd Floor, 11 Cama Industrial Estate, Walbhat Road, Goregaon (East), Mumbai - 400 063. India Tel: +91 22 4058 9888 / 2685 1998 Fax: +91 22 4058 9890 E-mail: sales@remilabworld.com l Website: ww.remilabword.com
16
November 2018
Industries Served
Pharma Biotech Food & Beverage Chemical and Petrochemical Incubator Shaker
Shah Brothers Email:priyanka@shahbros.com
EXPRESS PHARMA
VALUE ADD
Anew perspective on flow enhancement in solid oral dosage formulation – advantages of an unique glidant material TRI-CAFOS 200-7 Daniel Zakowiecki, Innovation and Application Development Manager, Marek Lachmann, Innovation and Application Development Manager and Tobias Hess, Head of Innovation and Application Development, Budenheim, give a new perspective on flow enhancement in solid oral dosage formulation
T
he handling of solid materials is involved in almost every pharmaceutical production process even though the final product might be liquid or semi-solid. Materials are conveyed through hoppers, pipes feeding shoes, dozing nozzles and other pieces of equipment. Therefore the necessity of sufficient powder flow in solid handling cannot be overemphasised [1]. Poor powder flow cannot only lead to processing problems (e.g. uneven die feeding, air entrapment) but more importantly also to batch rejections of the dosage form due to compromised dosage uniformity [2]. The problem of flow regulation is becoming more and more significant because the majority of already existing as well as newly developed APIs (Active Pharmaceutical Ingredients) show poor flow properties. Moreover, it is desirable to improve their flowability to enable more cost-effective tablet production via direct compression. Many glidant materials such as talc, hydrophilic colloidal silicon dioxide or magnesium oxide, are widely available [3] whilst tribasic calcium phosphate (hydroxyapatite) is less well known as a glidant. Budenheim offers the glidant material TRICAFOS 2007 which offers a
EXPRESS PHARMA
Daniel Zakowiecki
Marek Lachmann
Fig. 1. SEM picture of TRI-CAFOSÂŽ 200-7 under magnification of 11 kX
Tobias Hess
number of significant advantages. Apart from regulation of a flow it offers substantially reduced dust formation as well as decreased exposition of operator to dust. Furthermore the material helps to de-agglomerate lumpy substances more efficiently while aggregating to a lesser content itself. TRI-CAFOS 200-7 fulfils the monograph for tribasic calcium phosphate of the United States Pharmacopoeia (USP/NF) and the monograph for calcium phosphate (tricalcii phosphas) of the European Pharmacopoeia (Ph.Eur.). The material consists of agglomerates having a particle size around four micrometers (Fig. 1). However, during mixing the agglomerates break up into smaller primary particles which cover crystals of host particles and govern flowability of powder mixtures [4]. The bulk density of 200 g/l is significantly higher than for most commonly used glidants. Decreased dust formation and general handling advantages are the result of the increased bulk density. The experiments described in the first part of this article outline the performance of the material with respect to flow enhancement as well as impact on tableting performance of direct compression mixtures.
GOA PHARMA SUMMIT SPECIAL
17
November 2018
VALUE ADD Improvement of powder flow Ibuprofen 38 (BASF, Ludwigshafen, Germany) and sodium metamizole monohydrate (Shangdong Xinhua Pharmaceutical Company, Shangdong, China) were used as model substances. The APIs were mixed with the glidants in a Turbula mixer (Willy A Bachofen, Muttenz, Switzerland) at a rotational speed of 32 rpm for five minutes to yield mixtures containing 0.5 per cent or 1.5 per cent of either hydrophilic silicon dioxide (SiO2) or tribasic calcium phosphate (TRICAFOS 200-7) respectively. The glidant performance was assessed using standard compendial method such as measurement of an angle of repose (Fig.2) and flow through an orifice (in this case an 8 mm funnel) (Fig.3). Both drug substances showed poor flow properties according to the classification system of the pharmacopoeias. Addition of glidant materials helped to improve the flowability significantly. Blending of the substances with TRI-CAFOS 200-7 gave a powder mixture of significantly improved flow properties. It can be observed that the results obtained with the tribasic calcium phosphate glidant indicate slightly better flow than the ones obtained by the addition of hydrophilic colloidal silicon dioxide. A concentration of 0.5 per cent of the glidant was sufficient to achieve optimal results and addition of more glidant did not help to significantly improve flowability of both drug substances.
TABLE 1: COMPOSITION OF TABLETS Ingredient
Percentage [%]
Flow enhanced API (ibuprofen or metamizole sodium mixed with TRI-CAFOSÂŽ 200-7or SiO2)
80.0
DI-CAFOSÂŽ A150 (anhydrous dibasic calcium phosphate)
10.0
Microcrystalline Cellulose Type 102
7.0
Croscarmellose Sodium
2.0
Magnesium Stearate
1.0
Fig. 2. Impact of different glidants on angle of repose of ibuprofen and metamizole sodium
Fig. 3. Flow through an orifice of ibuprofen and metamizole sodium mixed with different glidants
The flow enhanced APIs were blended with excipients such as anhydrous dibasic calcium phosphate, microcrystalline cellulose, croscarmellose sodium and magnesium stearate to obtain the tableting mixture for di-
rect compression. The detailed composition of the tablets is given in the Table 1. Tableting mixtures were compressed into tablets on a Fette 102i press (Fette Com-
GOA PHARMA SUMMIT SPECIAL
November 2018
Breaking force of tablets (hardness) Tablets made with metamizole sodium monohydrate showed a higher tablet breaking force (hardness) than tablets with ibuprofen. Partially this is due to the higher compaction force chosen for this material (Fig. 4). Depending on the active substance being tested and the glidant material used, the hardness of tablets varied slightly. However, these differences were not significant and practically within the error range. Iburprofen tablets with hydrophilic silicone dioxide appear to have a somewhat higher hardness compared to tablets with tribasic calcium phosphate. For tablets with metamizole sodium the opposite trend can be observed: a significant decrease in tablet breaking force can be observed for the formulation containing hydrophilic silicon dioxide. TRI-CAFOS 200-7 yielded tablets of improved hardness.
Tablet friability
Impact on tablets prepared by the direct compression
18
compression force Tableting mixtures comprising the same ingredients but without glidant were prepared for comparison. However, owing to very poor flowability they had to be filled into the dies by hand just before compression.
paction, Schwarzenbek, Germany) rotary press at 62.5 rpm using flat faced punches of 8 mm diameter. Feeding was accomplished using the Fill-o-Matic feeding shoe. Compaction force
was 32 kN (equivalent to 640 MPa) for metamizole sodium tablets and 27 kN (equivalent to 540 MPa) for ibuprofen tablets. Pre-compression force was adjusted to 10 per cent of the main
All tablets containing glidant materials showed an acceptably low friability, below 0.5 per cent. An improvement of the friability by the glidant addition can be also observed (Fig. 5). For tablets containing ibuprofen the effect seems to be slightly higher with SiO2 than for the tribasic calcium phosphate. However, all values are very close in the range between 0.4 per cent and 0.5 per cent. Tablets containing metamizole sodium monohydrate showed a lower friability even without the addition of glidant due to the higher tablet hardness. For both glidant materials the performance of the lower concentration
EXPRESS PHARMA
VALUE ADD (0.5 per cent) yielded in better results than the higher concentration of 1.5 per cent.
Disintegration time of tablets The disintegration time of all tested formulations did not exceed 160 seconds regardless of the glidant used (Fig. 6). It should be noted that the effect of the glidant on the disintegration time is strongly dependent on the nature of the drug substance itself. In the case of tablets containing ibuprofen, the addition of hydrophilic silicon dioxide or TRICAFOS 200-7 caused a prolongation of disintegration time, whereas it had no significant effect on the formulation with sodium metamizole.
Fig. 4. Impact of glidant material on breaking force of tablets with ibuprofen and metamizole sodium monohydrate
References [1] Howard SA, Lai JW. Flow properties of solids. In: Encyclopaedia of Pharmaceutical Technology (edited by Swarbrick J). Informa Health Care, New York 2007, p. 3275-96
Summary In the presented study TRICAFOS 200-7 showed an equal or better performance in flow enhancement than most commonly used glidant of the hydrophilic silicon dioxide type. Concentrations of 0.5 per cent to 1.5 per cent are usually sufficient to achieve sufficient powder flow of poorly flowing APIs to enable tablet production by direct compression. The concentration required to achieve optimal flow enhancement depends on the particle size and surface area of the host particles (API particles in this case). Mostly a mixing time of five minutes is sufficient to reach near optimal flow enhancement. Tablet production via direct compression after the flow enhancement with TRI-CAFOS 200-7 does not have negative effects on the measured critical quality attributes of the tablet formulations. In some cases (metamizole sodium monohydrate) the hardness of the tablets can be improved while no relevant decrease can be seen for tablets containing ibuprofen. Glidant materials can help to reduce the friability of tablets
EXPRESS PHARMA
and the performance of TRICAFOS 200-7 is equivalent to that of the most often used type of colloidal silicon dioxide. Furthermore, the disintegration time of tablets can be positively influenced. In the series of experiments presented here a special mixing regimen was implemented. The API substance was blended with the glidant before the other components for direct compression were added to the blend. This method was reported to be favourable by various authors [5,6] and their findings were confirmed during the experimental work for this study.
[2] Staniforth J. Powder Flow, in: Pharmaceutics, the Science of Dosage Form Design, 2nd ed. (edited by Aulton ME). Churchill Livingstone, London 2001, p. 197-210
Fig. 5. Impact of glidant material on friability of tablets with ibuprofen and metamizole sodium monohydrate
[3] Rowe RC, et al. Handbook of Pharmaceutical Excipients, 6th ed. (edited Quinn RS). Pharmaceutical Press, London 2009 [4] Hess T, et al. Flow enhancement of poorly flowable APIs using a novel tricalcium phosphate based glidant. Poster presented at AAPS Annual Meeting and Exposition, 2016 November 13-17; Denver, CO, USA [5] Pingali K, et al. Mixing of glidant and lubricant - influence on powder and tablet properties. International Journal of Pharmaceutics 2011, 409, p. 269-277
Fig. 6. Impact of glidant material on disintegration time of tablets with ibuprofen and metamizole sodium monohydrate
[6] Abe H, et al. Improving powder flow properties of a direct compression formulation using a two-step glidant mixing process, Chem. Pharm. Bull. 2009, 57 (7), p. 647-652
GOA PHARMA SUMMIT SPECIAL
19
November 2018
Cole Parmer: Preferred partner to scientific and engineering community since 2006 in India
W
ith over 60 years in the industry, ColeParmer is a leading manufacturer and supplier of fluid handling, environmental testing, electrochemistry, general laboratory equipment and consumable supplies. The company’s close association with the pharmaceutical industry has enabled them to develop products and solutions to meet industry’s stringent requirements for testing and manufacturing. Their application knowledge and expertise combined with in-depth understanding of customers’ needs enables them to provide integrated solutions that address their customer’s requirements. Cole-Parmer today is seen as a substantial, superior value, one-stop package of innovative products, quality service and technical support. Cole-Parmer has established a strong presence in the last 12 years in the Indian pharma and biotech markets. For biopharma product development, Cole-Parmer is proficient in providing custom solutions and scale-up assistance from R&D to pilot and to manufacturing. Carrying on the strong foundation, the company aims at continuous growth and therefore is meticulously investing in enhancing its product portfolio. It has added many renowned brands in the last three years to strengthen it’s Pharma portfolio – Techne, Jenway, Stuart, Electrothermal, Argos Technologies, Kinesis, Vaplock, Traceable, and Ismatec to name a few. Cole-Parmer offers complete solution from research to process applications. Whether
it’s a lab set-up or scale-up, the company has wide range of products and services to offer. In the bioprocess research and manufacturing space, ColeParmer is the most trusted choice for their Masterflex Peristaltic Pumps and fully validated pharma tubing. Other key application areas, in which end-to-end customised solutions are most looked for are aseptic fluid transfer, including a wide range of single-use products such as bioprocess bags and liners, manifolds, and EZ Top container closures. The company has also very rapidly expanded its offerings in safety and cleanroom con-
20 GOA PHARMA SUMMIT SPECIAL November 2018
sumables. Cole-Parmer is amongst very few companies who manufacture pharma latex gloves, specifically made for pharma applications addressing related stringent regulatory concerns. The company today has an extensive range of latex and nitrile gloves for various pharma applications like research, cleanroom, oncology, chemical handling, and delicate object handling etc., provided with complete validation support including factory audit, making it a reliable choice for the customers. Cleanroom range also includes apparels, microfiber wipers, goggles, chairs, shoes,
and cleanroom supplies like mats, paper, mops, rollers, and swabs etc, meeting requirements of cleanroom environment. Range of plasticware and labware is also added to the consumables portfolio, for customers to get complete solution for their cell culture and research applications. Another recent addition to the portfolio is chromatography end-to-end solutions, which includes HPLC and GC columns, protein separation columns, fittings, Vaplock solvent delivery and waste systems, SGE micro syringes, D2 & HC lamps and vast range of AccuStandard standards. The
company is also known for vast range of lab equipment and essentials, which include stirrers and mixers, baths and circulators, melting point apparatus, spectrophotometers, reaction stations, cell culture solutions, temperature products, and data loggers, to name a few. In addition to ColeParmer's portfolio of proprietary and industry-leading brands, the company is renowned for offering exceptional service and technical support. Customers rely on the company's team of trained and experienced application experts for help in selecting the right product for their application, troubleshooting existing equipment, and solving regulatory compliance issues. It all adds up to a promise that ColeParmer as ‘Scientific Experts’ works to fulfil every day: delivering solutions customers trust and therefore is considered as preferred partner for end-toend solution to the scientific community. For more details ColeParmer.in, or contact at 022-6139-4444 / response@coleparmer.in
EXPRESS PHARMA
PRODUCTS
Refrigerated warehouse makes every doorway count New facility’s doors separate ambient, refrigerated and freezer storage to reduce energy consumption while optimising uptime. An insight by Gandhi Automations
G
andhi Automations is one of the leading diversified suppliers to the pharma sector, serving pan India customer accounts in more than 23 cities. Clean room doors (Prime Clean Reset) are designed for inside applications requiring limitation of leak flow. The perfect sealing properties of Prime Clean Reset provide environmental control and protect the inside environment against draughts, dust and dirt. Clean room doors provided by us also has self- repairing system. One of the most imperative aspects of clean rooms is the door you choose for clean room facility. Time for which door is open will play a critical factor in avoiding dirt, temperature, humidity etc. Opening and closure of door has to quick enough to isolate the two areas. At Gandhi Automations, we provide clean room high speed doors specifically designed for above purpose. Our clean room high speed doors are best suited for pharma industries where you need to have controlled environment. The opening and closing of door is fast enough to separate two areas. In the high-volume, 24/7 facility, turns in the cooler happen twice a day and, in the freezer, inventory turns occur every day and a half. With traffic streaming in and out of the building through 47 dock doors, losing a single high-traffic door could severely jeopardize deliveries. Prime Freeze High Speed Doors are a perfect solution where cold storage with negative temperatures to as low as
EXPRESS PHARMA
We provide clean room high speed doors specifically designed for above purpose – 22°F is required. The curtain is made of reinforced PVC vinyl with heated side guides. Optionally a special and innovative insulated flexible curtain is also available. High Speed Freezer Doors are the solution when temperature control is critical and where forklift traffic is high.
“If a cooler door is down, that could be detrimental to our operation,” says warehouse manager, who notes that a single inoperable door could cost 30 per cent of shipping capacity. “We cannot afford to lose an opening. We are hard on things, and that’s why we need durable doors.” High-speed freezer duo not only helps maintain temperature but also in human safety. high-speed freezer doors have a revolutionary soft bottom edge and sensor combine to ensure operator safety at all times. High-speed freezer duo doors curated by Gandhi Automations are sturdy, dependable and an ideal fit for maintaining temperature control. To prevent ice formation during intensive cooling, the highspeed freezer duo doors have a functionality of partial and full opening. Its intelligent dual curtain technology - simultaneous open-and-close operation has blower/dryer to maintain temperature balance. Fast door speed also reduces the likelihood of panel collisions with tall-mast forklifts. In the event of a collision, the self-repairing system automatically resets the panel back into its guide without human intervention. To avoid accidental contact with door panels, an LED safety light system along the door columns warns employees when the door is about to close and when it is actually closing. Two photo eyes, (cells) a dual-pneumatic reversing edge and threshold warning lights will reverse the descending door panel if an employee is in the doorway.
GOA PHARMA SUMMIT SPECIAL
21
November 2018
PRODUCTS
Clean room high speed doors a necessity
I
f your business entity requires a designated area for clean manufacturing, Gandhi Automations offers a variety of energy efficient clean room high speed doors. These are suitable for even busy openings in a controlled environment with a guarantee to protect from airborne contaminants. Cleanroom space is a worthwhile investment for your firm as it assures improved quality in production which interprets to a better financial yield. High speed doors for such rooms have multiple benefits such as stabilising the pressure levels as well as reducing air leakage out of the room. This feature has been revolutionary in the industrial process finding application in production of medical equipment and its packaging, pharmaceutical industry, manufacture of computers and electronics, food processing and even in the manufacture of military technology.
Best choice of clean room high speed doors Once you have understood the nature of production for your product you will need an experienced partner to guide you in making an informed choice of high speed clean room doors. At Gandhi Automations we give our esteemed clients top priority, walking them through our different products in order to pick out clean room doors that will serve them better. One of the key considerations to make is the overall time the door will take to close once opened. The objective here is to isolate the external environment to avoid entry of dust, humidity and altering the internal temperature of your cleanroom. The
22
GOA PHARMA SUMMIT SPECIAL
November 2018
door then has to be designed to facilitate high speed opening and closure to serve the stated function. Our doors meet unmatched quality standards both in the local and international market hence providing and sustaining a controlled environment in any given clean room.
Top features of our high speed clean room doors Gandhi Automations carefully designs its doors incorporating emerging technological trends in order to give a superior high speed door that will have extended durability once installed. Such features entail: ◗ Concept of low air permeability in pressurized rooms with positive and negative air pressure ◗ Designed to fit inside the columns ◗ Self-supporting construction ◗ Minimises air leakage ◗ Can be equipped with transparent PVC horizontal sections or vision windows ◗ Special side guides to tightly integrate the curtain ◗ High leak tightness due to the close filling curtain in the guide rails ◗ High door efficiency with and low permeability values, EN 12426 EN 12427: < 12 m3/m2 h Δ 50 PA . ◗ Control device enclosure in Stainless Steel SS 316 Contact details Gandhi Automations Chawda Commercial Centre Link Road, Malad (W) Mumbai – 400064, India Off : +91 22 66720200 / 66720300(200 Lines) Fax : +91 22 66720201 Email : sales@geapl.co.in Website : www.geapl.co.in
EXPRESS PHARMA
COMPANY PROFILE
Anton Paar: Great people,great instruments Progress and A innovation,
nton Paar develops, produces and distributes highly accurate laboratory instruments and process measuring systems, and provides custom-tailored automation and robotic solutions. It is the world leader in the measurement of density, concentration and CO2 and in the field of rheometry. Anton Paar is owned by the charitable Santner Foundation. Progress and innovation, high-precision craft and the passion for research – these define Anton Paar. The measuring instruments reflect thoughts and actions: Components produced with the highest precision, innovative measuring principles and well-designed user interfaces represent the understanding of quality. The products are created in
high-precision craft and the passion for research – these define Anton Paar a dialog with customers and integrate seamlessly into their working environment. The products exactly meet customers' requirements and are the solutions for the challenges being faced.
Svam Packaging: Blending ideas & technology S
vam Packaging industries, a 30-year-old organisation aims to serve the packaging requirements of the growing Indian pharma industry. Svam is prepared to cater to the international market with its quality products and services. The company's continuous research and development programmes has allowed Svam to become the first and the largest producers of pharma flexibles, especially cold form laminates in India. The team of R&D is continuously monitoring and developing new features within existing packaging to ensure anti-counterfeiting features as well as ensuring development of new cost effective laminates to ensure finest packaging for the pharma industry. To gain
EXPRESS PHARMA
new heights and enhance the scope of supplies, anti-counterfeits and technologies, SVAM is open for joint ventures and partnerships with its vendors, customers and other associates which brings value to the market. From coding to printing or blister packing machines to blister packing materials, the team is equipped with strong technical know how of the product and deep product knowledge. The technologists are trained by the OEM’s of the blister packaging machine to serve its customers. Best of ideas and a blend of advanced technology drives the company to become one of the top notch pharma packaging companies in the market. Svam believes that in
pharma, the value of the product is the life of someone, and due to this belief the team has taken utmost care and protection to ensure one of the finest grade of packaging materials for pharma. A dedicated team and infrastructure regularly monitors the quality for each and every batch of raw materials, semi-finished or finished materials. The production or processing machines are equipped with special features from Germany, Switzerland and USA to ensure consistency in the quality of lamination and ensuring no compromise in the quality of the laminate. The quality control lab comprises all the latest machines for testing the laminates and even a blister packing machine with different
shapes of tools/cavities for regular testing the performance of laminates produced by the company. Each and every batch produced by the company is tested on this blister machine. Svam are the first producers of cold form laminates in India producing one of the finest quality of the same. The company's non stop research and development are focussed in a direction to offer anti-counterfeiting solutions as well as cost effective packaging solutions to the pharma industry. Its experts are well trained on the blister packaging machines as well as consumables, which gives Svam an edge over others to offer its clients with a complete detailed study about their packaging requirements.
Focusing on pharma, the company's state-of-the-art facility comprises lamination, printing, coating and slitting machines with advanced features and major equipment that are imported from specialised manufacturers of the equipment, enabling Svam to produce consistent quality of the product and maintain a clean atmosphere inside the plant. The quality lab comprises nearly all the necessary equipments required for testing of each and every raw material as well as finished products. It also has a blister packaging machine with different change parts/cavities design made for different forming ratios to test formability of its laminate as well as testing delamination.
GOA PHARMA SUMMIT SPECIAL
23
November 2018
COMPANY PROFILE
Beckman Coulter: Focussed on innovation A dvancing research and discovery is our foundation, built on an 80-year legacy of innovation. At Beckman Coulter, we are dedicated to advancing and optimising the laboratory. For more than 80 years, we have been a trusted partner for laboratory professionals, helping to advance scientific research and patient care. We have a vital role: our focus on innovation, reliability and efficiency has led us to become the partner of choice for clinical, research and industrial customers around the globe. In the life sciences, researchers use Beckman Coulter’s precision instruments to study complex biological
problems, including causes of disease and potential new treatments. Our team of experts dedicates the time and energy to understand the complexity of research for laboratory customers in a wide variety of settings: universities, government, biotechnology and pharmaceutical companies, hospitals, and commercial laboratories. By innovating new processes and technologies, we’re challenging conventional wisdom; our goal is to develop the best, most widely trusted laboratory solutions available on the market today. Spotlight on today’s discussion shall be online analysis of pharma waters, facility monitoring and
particle characterisation in formulations. Manufacturers of injectable products are required by local and international regulators to ensure that the water that they use in their manufacturing process meets certain quality attributes. TOC analysers play a vi-
tal role in ensuring the quality of purified water and water for injection used in the pharma and biopharma manufacturing process meets the required national and international regulatory standards. By attending this seminar, you will learn how Anatel online TOC analysers
Propix: Enabling technical excellence P
ropix manufactures fast and accurate, vision based inspection solutions to help the industry match the desired quality standards while maintaining the pace of the packaging process. With rapid industrial growth and increasing speeds in packaging lines, vision inspection systems are considered to be of utmost importance in the crucial stage of production called quality control. The vision of the company is to attain technical excellence by identifying 'unthought-of' solutions that delights its customers and its mission is to provide unparalleled solutions and state-ofthe-art technology, with emphasis on quality control and production continuity, in
keeping with the increasing demands of production and current validation standards. Propix specialises in innovation-based, vision inspection systems for diverse industrial applications across pharma, food and beverage, FMCG and printing industries. Since its inception in 2004, the company has grown to prominence, delivering well-designed camera based inspection systems and related services to customers across India. The turnkey vision inspection systems meet manufacturer quality assurance requirements across multiple market segments and product packaging types. These easyto-use camera based inspection systems can accurately inspect products at high speeds, protecting the manu-
24 GOA PHARMA SUMMIT SPECIAL November 2018
facturer's brand image without reducing throughput. Propix concentrates on devising effective and efficient technology solutions that inspect and weed out errors at all crucial stages of production as well as packaging. It invests heavily in R&D to ensure that products and services aid its customers in producing end products that surpass industry standards. The objective is to attain the apex position in the customers' minds whenever they think of vision inspection solutions. The company takes pride in its ability to provide customised solutions to serve the complex needs of the various industries that it caters to. Propix believes in creating long-lasting business relationships through continual sup-
port and correspondence, beyond installation and sales. It values customers' time, appreciate their specific requirements and respect deadlines. The team of technocrats comprises software engineers, design engineers, support engineers and production specialists who pride themselves in providing ingenious, automated inspection solutions to cater to the specific needs of clients across various industries. This team, of highly qualified and skilled professionals, possesses the domain knowledge and the experience to understand the vision inspection needs of various industries. It possesses the capability to deliver customised, camera-based inspection solutions to every industry that Propix caters to.
can help you improve compliance, get better data integrity and reduce your operating costs whilst assuring your water quality. During the seminar, you will learn where and why TOC analysers are used in water systems, what the regulatory requirements are, how TOC analysers work, and how the Anatel PAT700 can reduce your operating costs while increasing your compliance and data integrity. Anyone working in biopharma or pharma manufacturing processes, using WFI or PW will benefit from attending. Additionally there will be the opportunity to interact and discuss your requirements with Beckman Coulter experts.
The company's state-ofthe-art research facility and in-house mechanical tool room enable the veteran brain power to continually develop the technically sound and advanced vision inspection solutions to offer their clients across various industries. Propix believes in creating long-lasting business relationships through continual support and correspondence. Hence, its team also comprises dedicated sales and marketing staff, who provide time-critical support, beyond installation and sales. Its extensive network covers every corner of the country, helping Propix serve its clients better. It utilises the company's strong global presence to bring clients the best industry solutions and practices.
EXPRESS PHARMA
STORY
Reforming Public Health:Lessons From India Pharma Inc The pharma industry, one of the key stakeholders of public health, have a huge responsibility to ‘do good’ and ‘be part of the solution’ By Lakshmipriya Nair mproving public health is a development priority for India, but while the country has made some noteworthy advances in this sphere, mammoth challenges remain to be conquered. And, it is growingly evident that only a strong and sustainable partnership across the entire health value chain can be the solution to tackle them. Therefore, as India’s focus on health intensifies and the government drafts ambitious plans to make its population healthy, we would also have to take the pharma sector’s perspective to ensure access and quality in public health. Hence, one of the major discussions at the 4th edition of Healthcare Sabha - The National Thought Leadership Forum on Public Health was on ‘The Path Ahead in Public Health – A Pharma Perspective’. An eminent panel comprising Viveka Roychowdhury, Editor, Express Healthcare and Express Pharma (Moderator); N Rajaram, MD, Sanofi India; Umang Vohra, MD and Global CEO, Cipla; Anuja Kadian, Head, Government Affairs, AstraZeneca Pharma India; AG Prasad, VP - Cluster Head, Sales & Marketing, Glenmark Pharmaceuticals, came together to highlight several pertinent factors such as access to medicines, drug pricing, patents and intellectual property, government policies and means to achieve UHC. Roychowdhury steered the discussion through the companies’ latest initiatives on increasing access, affordability and quality of medicines, healthcare in India; the panelists’ views on Ayushman Bharat and measures to make it successful, and the role of the pharma sector in
resources to train them to think differently. India’s public healthcare can take a leaf out of these measures and ramp up investment in research and infrastructure creation to strengthen its current capacities and build more capabilities.
I
EXPRESS PHARMA
We have to aim for Universal Care Coverage Umang Vohra
Ayushman Bharat and other government initiatives. Let’s examine a few of the most important insights shared by them and how can they be applied effectively to transform our public health system for the better.
Strategic investments are key to improve public health – N Rajaram Rajaram was a very strong advocate for investments which would make medicines affordable without compromising on quality, for instance manufacturing technology. He informed that as a company which has been manufacturing in India over several years, Sanofi has invested over `5000 crores in upgrading their existing facilities or acquiring new ones. Hence, falsifying the general belief that MNCs only manufacture expensive medicines, 25 per cent of Sanofi’s portfolio today is priced between `1 to `5. Thus, a therapy or fiveyear treatment for a patient can
be between `5 to `25. However to do that, he stressed on the need to build expertise for developing products at an affordable price without compromising on the quality. And, this can only be done with a capacity for large scale manufacturing. He also laid emphasis on investments in innovating as well. He explained that it is important to develop solutions and encourage incremental innovations which would bring value to the Indian market. He cited the example of disposable insulin pens which is used all over the world. However, they are priced at `2000 and above and moreover it generates a lot of plastic. Therefore for India, Sanofi developed reusable pens which are priced at 1/10th of disposable ones. This instance is an example of how incremental innovation and out-ofthe box thinking is crucial to serve the health needs of the Indian population. However, it also highlights the importance of investing in innovation and human
Vohra underlined the role of pharma companies in enabling access to medicines and informed that Cipla has always endeavoured and stood for access. He accentuated that enabling access to quality medicines in India was the vision of its Founder KA Hamied and till today, Cipla continues to be driven by this vision. However, he also stressed that now it looks at access differently and believes it to be more than just that affordability. He states that access is more about creating an ecosystem which enables and empowers the citizens to avail good quality healthcare conveniently and affordably. He advocates that the policymakers and public health sector too should realise this and work towards for a more comprehensive strategy towards expanding healthcare access. Putting it in the context of Ayushman Bharat, Vohra lauded it as a very bold and worthy initiative but he also opined that this should only be a step towards achieving Universal Care Coverage and not just Universal Health Coverage. Outlining some measures which could help in achieving this larger and more effective outcome, he said that Cipla, in its bid to expand access and its generics business, has ventured
into most of the tier II-III areas of India and has realised that the community health centres (CHCs) and primary health centres (PHCs) in these areas could be mobilised in a better manner to enable and expand the reach of quality medicines and healthcare to these regions. He spoke on how right diagnosis and training is essential to make ambitious endeavours such as Ayushman Bharat successful. Vohra also emphasised on the inclusion of diagnostics in the whole scheme, thus making it more than just about medicines and hospitalisation. He advocated looking beyond just costs and making Ayushman Bharat more outcomes-driven to make it effective and successful. The public health sector should heed this timely and pertinent insight to create a 360o approach towards serving the needs of its citizens.
Government schemes should be formed in concurrence with all stakeholders - AG Prasad AG Prasad spoke at length about the importance of assuring quality of medicines to build a sustainable and effective public health system. He informed that Glenmark looks at quality at different levels and includes patient safety, environment safety and pharmacovigilance and is not only concerned about the potency of product. He informed that the company also ensures that its raw materials are sourced only from high quality manufacturers. Mirroring this practice, our public health system too needs to assure quality at each level to fortify it and strengthen it from within.
GOA PHARMA SUMMIT SPECIAL
25
November 2018
STORY
Dr S Eswara Reddy, DCG(I)
N Rajaram, MD, Sanofi India
AG Prasad, VP- Cluster Head, Sales & Marketing, Glenmark Pharma
Umang Vohra, MD & Global CEO, Cipla
Anuja Kadian, Head, Government Affairs, AstraZeneca Pharma India
Another point highlighted is that while the government develops public health schemes it should be done with inputs from all stakeholders. He said that often good schemes do not take off and perform as expected due to lack of adequate stakeholder participation. For instance, Jan Aushadhi is a very good initiative taken by the Government of India but the project has not taken up the way it is expected to, primarily, because it has failed to attract reputed pharma companies. Prasad also pointed out that often lack of clarity and tediousness in government procedures like tendering and procurement dissuade big companies from participating in these schemes. At the same time, he also lauded AMRIT stores, run through HLL which is very successful. He cited it as an example of good partnership between private and public institutions, wherein AMRIT stores source branded products from reputed companies with 30-40 per cent discount and offers 20-30 per cent discount to customers. CGHS and many other government sector institutions also prefer procurement through Amrit stores of HLL. He advised applying these learnings while implementing Ayushman Bharat, an insurance and assurance scheme, as its success is dependant on the quality of execution. As public private partnerships (PPP) would be crucial to success for Ayushman Bharat and all other
large scale public health schemes, the government should take the views of all stakeholders involved to create a win-win situation for all.
But, the most important takeaway from her was how the use of digital technologies can help reform and improve public health. She spoke on how it is gradually being implemented in the pharma sector to come up with products and processes which are more efficient and efficacious and recommended using these technologies on a large scale to make public health schemes like Ayushman Bharat more successful. She opined that robust monitoring systems, gap analysis, creating data sets etc are essential to make an ambitious public health plans successful, including Ayushman Bharat. Through effective use and application of digital technologies and ICT technologies, it is possible to gather valuable data sets which would enable us to gather empirical evidences about the public health priorities for the country as well as important clusters of population that need to be served. This, in turn, would help develop targeted interventions and schemes which would get the desired outcomes.
explained that the access puzzle can be resolved only through a mix of measures which would be dependent on medical expertise and good governance as well as efficient healthcare and supply systems. And, the role of the regulator in ensuring all these and helping the pharma industry live up to its potential in an ethical manner is paramount. Hence, Healthcare Sabha had also invited the Eswara Reddy, DCG(I) to present his vision and objective for the pharma industry and augment its role in ensuring an effective public health system. He informed that as the DCG(I), one of his major objectives is to build trust and confidence in the public mind about the quality of medicines that are manufactured, distributed, sold and exported from India. The second objective is to work towards building a positive image of the Indian drug regulator in the public mind. He also spoke about the measures introduced to ensure quality of the products and to make drug regulators accessible. He further stated that they have a public relations office where manufacturers, start-ups and innovators can visit or call to clarify doubts, get information and resolve their problems. Measures are also being into place to assure quality, fight counterfeits and make our systems more transparent. He said, “We are going to make a very comfortable environment for the innovators and manufacturers to carry out
their business in India. We are taking several measures to improve ease of doing business in India, be it clinical research or manufacturing in India. We are also open for any national and international audits to ensure that we are fully compliant with the Drug & Cosmetics Act. ”
Digital technology can make public health schemes effective - Anuja Kadian As a representative of AstraZeneca she spoke on the Anglo-Swedish company’s 40 years of presence in India and its focus areas. She informed that sustainability is inherent for their global strategy and access to healthcare is key to their sustainability strategy. Their major endeavours include measures for disease prevention, capacity building and access to medicines. She also spoke on how spreading healthcare awareness is paramount. She stressed on the importance of not only looking at curing diseases but also encouraging healthy living and elaborated on strategies such as CSR funds effectively to expand access to medicines and healthcare. Throwing more light on AstraZeneca’s efforts in this direction, she spoke on their young health programme which focusses on spreading awareness. She revealed that till date they have reached 2.5 lakh adolescents directly and intend to set up several centres of excellence to spread access. They also promote healthy living as part of their access programmes.
26 GOA PHARMA SUMMIT SPECIAL November 2018
Role of the regulator Thus, each one of the panelists reiterated and underlined the endeavours of their organisation in creation of value to improve patients’ well-being, and contribute significantly to the quality and protection of life. At the same time, their insights also carried a lot of learnings to improve public health. They also
Going forward In the past 60 years, innovation and technology have driven huge improvements in global health. However, be it for research and training personnel or reevaluating our health policies and effective reallocation of resources at national and local levels, multi-stakeholder approaches will be pivotal to build an effective public health system which can serve our present and future needs. And, the pharma industry, generally acknowledged to be one of the most powerful economic sectors across the globe, is also one of the key stakeholders of public health with a very significant role to play alongside governments, international organisations, (NGOs) and others. So, the companies themselves also have a huge responsibility to ‘do good’ and ‘be part of the solution.’ This would mean putting systems in place to enable compliance to national laws, protecting the environment, monitor performance, encourage transparent communication and enhance accountability. lakshmipriya.nair@expressindia.com
EXPRESS PHARMA
Superior excipients meeting your formulation challenges
DI- CAFOS® TRI-CAFOS® Budenheim offers a comprehensive range of superior phosphate products ... covering liquid and solid dosage forms and a wide range of functionalities for pharmaceutical companies. All DI-CAFOS® and TRI-CAFOS® grades for direct compression offer several advantages which include excellent flow properties, high tablet hardness and high content uniformity which are essential for high speed tablet manufacturing.
... and extensive global services, including technical and regulatory support completes the offer to our customers and has made Budenheim a leading player in this segment. Our Tabletting Competence Center enables us to run trials under real production conditions, helps us to understand the requirements of the market and to develop customized solutions for you.
Chemische Fabrik Budenheim KG Business Unit Performance Materials | 55257 Budenheim | Germany | Phone + 49(0)6139 89 –0 | pharma@budenheim.com | www.budenheim.com