MANAGEMENT DISCUSSION AND ANALYSIS
Industry Structure & Developments
Global Vaccine Industry
Vaccines have emerged as one of the most attractive and fast growing sectors for thehealth care industry globally. The prevalence of infectious and non-infectious diseaseshas significantly risen worldwide, leading to a spur in healthcare expenditure of both thedeveloped and developing countries. Apart from the high disease prevalence, growingpopulation and emergence of new pandemics are important growth drivers of the globalvaccine market. The growth in the vaccine industry has been primarily driven by adultvaccines while the pediatric vaccines still continues to be one of the major contributors.
As per various industry estimates the overall global vaccines market was valued at US$28 billion in 2010 and is expected to reach US$ 56.7 billion by 2017 with a CAGR of 11.5%.The key growth drivers shall be growing public awareness about preventive healthcare,inclusion of vaccines in the Government immunisation programmes, introduction of newertherapeutic, prophylactic vaccines including combination vaccines and development ofvaccines for diseases like HIV, Malaria, Dengue, Cancer etc.
The major human vaccines markets include North America, Europe, Japan, Australia andNew Zealand. The US represents the largest market for prophylactic human vaccines,accounting for more than 50% of the global vaccines market. However, future growth isexpected to emanate mostly from the developing regions of Asia-Pacific, Latin America andthe Rest of World with Asia-Pacific being the fastest growing region. The emerging marketsare playing an increasingly significant role in the vaccines market as they industrialiseand generate additional national income and immunisation becomes their key priority area.The two other factors that are contributing to the globalisation of the vaccine market arethe efforts of the Gates Foundation and associated non-government organisations who arecontributing significant funding to the development and introduction of new vaccines intothe developing world. Additionally, there is real growth in the capabilities andaspirations of vaccine manufacturers located in the emerging markets such as India. Thesemanufacturers are now increasing their pipelines and products and have bigger aspirationsin terms of the market that they are targeting.
The pace of growth of vaccines business has become higher than the pharmaceuticalbusiness and major Pharma companies are eyeing the vaccine market as driver for theirgrowth. The classic examples are blockbuster launches of new generation vaccines globallywith revenue of more than $1bn immediately post its launch (Prevenar & Gardasil). Manymergers and acquisitions have taken place in this space. Major players like Sanofi, GSK,Novartis, Pfizer, J&J have laid strong foothold in vaccines. With companiesconsolidating, they can now emphasise better in the vaccine market through focused R&Dand new technology platforms. Morever, considering the growing competition and costs,heightened quality expectations and stricter safety enforcement, vaccine manufacturers arelooking to their suppliers not only for higher quality products, but for greater supportand closer collaboration at every stage of production in local manufacturing.
Indian Vaccine Market
India has made a significant contribution to the development of global vaccine industryby producing many critical vaccines in large volumes at affordable prices. The vaccinesmarket in India is vibrant with a strong global presence and is placed among the leadingones in the emerging markets. India's huge population and large birth cohort makes it anattractive market among the world's largest markets for all types of vaccines. The Indianvaccine market is getting boosted with the increasing penetration of existing vaccines,introduction of more and more vaccines in the national immunisation programme,introduction of innovative combination and novel vaccines by both Indian and multinationalcompanies in India.
The Indian vaccine market continued its growth trend and registered 22% growth in 2011with a market size of around US$ 350 million and is expected to reach around US$ 1.0billion by 2017 with a CAGR of approx. 20%. India produces 60 percent of the world'svaccines and account for 60-80 percent of annual UN vaccine purchases. Over 70% ofpatients from majority of the developing countries receive vaccines procured from India bythe UNICEF, International Dispensary Association, the Global Fund and Clinton Foundation.
With the concerted efforts of all stakeholders towards ensuring eradication/eliminationof diseases that can be prevented through vaccination, noteworthy improvement has happenedover these years in bringing down the number of cases reported earlier on MMR, HepatitisB, Diphtheria, Pertussis, Influenza and so on. India has shown tremendous commitmenttowards its fight against critical diseases which is evident from the fact that India hasnot only successfully reduced the polio cases to zero but also ensured non recurrence ofpolio cases since January 2011 resulting India getting out of WHO's Polio endemic list inFebruary 2012. This could be possible only through collaborative effort by the Government,both at Central and State Levels, Industry, multilateral agencies like Gates Foundation,Rotary and the mammoth role played by IAP and its members.
The key growth drivers for vaccine market in India are higher disease burden resultingin dire need to prevent it through vaccination, large unmet medical needs even for basicvaccines in rural India, commendable efforts by local governments to improve vaccinationthrough public infrastructure and increase in affordability leading to enhancedrequirements for new generation vaccines.
However, the Indian vaccine industry, due to its evolving nature and by virtue of itspresence in an imperfect emerging market, is faced with a number of challenges both at themicro unit level and at the macro level.
Global Pharmaceutical Market
The global pharmaceutical industry is witnessing transformation due to changingdemographic profile, epidemiological and economic shifts. With the growing and aging worldpopulation and changing lifestyle in the developing world, more and more new areas ofmedical need are emerging. These changes coupled with the large unmet medical need fortreatment of critical diseases are expected to generate significant opportunities forpharmaceutical companies across the globe.
During 2011, the global pharmaceutical market has grown by 5.1% to around US$ 956billion and is expected to grow at a CAGR of 3-6% to cross US$ 1.1 trillion by 2015. Themost significant feature is that more than 60% of this increase is expected to becontributed by the emerging markets, which is forecasted to grow at a remarkable CAGR of13-16% to reach around US$ 345 billion by 2015, while the developed markets are forecastedto grow at a much lower rate of less than 5% p.a.
Amidst all other good things, the global pharmaceutical industry continues to remainfragmented and fiercely competitive and faces increased genericisation. The genericsindustry on the other hand would be counting a lot due to generic competition in newmolecules arising out of patent expiries, alternative generic opportunities and increasedincentives for the usage of generics in many markets. The emerging pharma markets wouldtherefore look forward to capitalise on this opportunity.
The generics segment of the global pharmaceutical market has traversed a long way fromcontributing at around 28% in 2010 to reach at an expected landmark of 40% of the totalglobal pharma spending by 2015 growing with a CAGR of around 13%, as compared with a 1%CAGR in the patented branded market. This trend is visible not only in the emergingmarkets but also in the developed markets. The generics market is expected to expandfurther due to the increase in genericisation with US$140 billion drugs, now patented,going off patent by 2015, healthcare cost containment by governments/payers and relativelylow penetration in some major geographies etc. Contribution from the emerging pharmamarkets has gone up with China, India, Brazil, Turkey and Russia leading the way fromcontributing 19% in 2004, to contributing over 30% of the sales in the generics industry.
Total Unaudited and Audited Global Pharmaceutical Market, 2007-2011
|(*US$ in billions) ||2007 ||2008 ||2009 ||2010 ||2011 |
|Total World market ||729 ||800 ||833 ||881 ||956 |
|Total World market ("Constant US$) ||752 ||800 ||858 ||896 ||942 |
|Growth Over Previous year (**Constant US$ Growth) ||7.1% ||6.4% ||7.3% ||4.5% ||5.1% |
Source: IMS Health Market Prognosis, May 2012 | Includes IMS Audited and Unauditedmarkets | All Information current as of May 2012
*US$ uses actual quarterly exchange rates
**Constant $ uses Q4II average exchange rates
Indian Pharmaceutical Market
The Indian pharmaceutical market is currently valued at US$ 11 billion and has grownsteadily at a CAGR of 14-15% during the past five years and is expected to touch US$ 74billion by year 2020. Globally, India ranks third in terms of manufacturing pharmaproducts by volume. India, with a little over 10 % market share, ranks third in valueterms in Asia Pacific region. The strong growth has been driven by a confluence of factorsincluding growing Indian economy, rising disposable income, increasing healthcareexpenditure, increasing medical insurance coverage, increased lifestyle related diseases,improvement in healthcare infrastructure/delivery systems and rising penetration insmaller towns and rural areas. All these factors have led to the organic growth in theIndian market by expansion in volumes and new product introductions as against pricesincrease based growth. The Indian Pharma industry also holds immense potential as India ishome to approx. 1/6th of the world's population, and is expected to become the mostpopulous nation in the world by 2050.
Despite increasing consolidation, the market continues to remain highly fragmented withtop ten pharmaceutical companies accounting for 35-40% of the market. Leading playerscontinue to maintain their market share owing to their strong distribution reach, strongfield force and slew of new product launches.
The acute therapy segments dominate the Indian pharmaceutical market with a share of73% of the total market. However, with changing demographics and lifestyle patterns, thechronic segments such as cardiovascular, anti-diabetic, neurology, psychiatry have beengrowing at a faster pace and the market is gradually shifting towards chronics.
With the stabilisation of the patent regime in India and strong growth prospects infuture, the landscape for MNCs pharmaceutical companies is gradually changing and they arenow becoming increasingly aggressive in the Indian market as part of their focus onemerging markets.
India has over 120 USFDA approved plants, highest in any country outside USA, and 84 UKMHRA-approved manufacturing facilities. These facilities significantly contribute towardsexports and also support the companies involved in CRAMS. The collaborations and tie-upsbetween Indian and MNC pharma companies are increasing globally. While the Indiancompanies are focusing on de-risking their R&D and leveraging on marketing &distribution setup of MNCs through these collaborations, the MNCs are trying to leveragethe cost effective manufacturing and R&D capabilities of Indian companies.
Therapeutic wise market share in Indian Pharmaceutical Market
|THERAPIES ||VAL MAT JUN'12 (In Rs. billion) ||% SHARE ||VAL GROWTH |
|Indian Pharma Market ||569.0 ||100.0% ||14% |
|Anti-infectives ||91.5 ||16.1% ||10% |
|Cardiac ||66.6 ||11.7% ||17% |
|Gastro Intestinal ||60.8 ||10.7% ||13% |
|Respiratory ||48.7 ||8.6% ||13% |
|Pain / Analgesics ||48.0 ||8.4% ||12% |
|Vitamins / Minerals / Nutrients ||44.2 ||7.8% ||14% |
|Anti-Diabetic ||38.2 ||6.7% ||25% |
|Neuro / CNS ||34.3 ||6.0% ||17% |
|Derma ||32.4 ||5.7% ||17% |
|Gynaecology ||32.2 ||5.7% ||13% |
|Others ||13.0 ||2.3% ||12% |
As per IMS MAT June, 2012
Domestic Sales and Marketing
Panacea Biotec has pan India presence through a structure of domestic strategicbusiness units (SBUs) operating through a network of distributors, depots and field force.The Company focuses on niche therapeutic segments with several established brandsattaining the leadership position in the market.
Panacea Biotec has seven SBUs in the domestic market catering to different focusedtherapeutic segments. Providing quality patient care in most of the major therapeuticsegments the company has allocated the SBUs into two broad categories - Super Specialtyand Acute & Chronic Care.
The Super Speciality business focuses on enhancing the quality of life of patients inneed of critical care with a range of formulations through 3 SBUs viz. Nephrology SBUfocusing on dialysis, Transplant SBU focusing on organ transplantation and OncoTrust SBUfocusing on oncology (cancer care).
The Acute & Chronic Care business focuses on multi-specialty therapies through 4SBUs viz. Diacar Alpha SBU focusing on diabetology, Diacar Delta SBU focusing on cardiaccare, Procare SBU focusing on gastroenterology, orthopedics and pain management andGrowcare SBU focusing on multiple specialties.
The aim of each SBU is to attain leadership position in its chosen markets andestablish brand equity in respective therapeutic segment by way of innovative products andscientific marketing approach. The SBUs promote a portfolio of brands with a special focuson Orthopaedicians, Cardiologists, Diabetologists, General Physicians, Nephrologists,Oncologists, Haematologists, Chest Physicians, Surgeons, Dentists, Consulting Physicians,Pediatricians and Gastroenterologists.
The Transplant SBU contributes in prolonging the life of organ transplant recipientsand is responsible for marketing of these immunosuppressive drugs in the therapy area ofpost multi-organ transplantation primarily kidney, liver, heart transplant etc. The SBUhas carved a niche in super - specialty segment and created a scientific image and hasachieved clear leadership in these segments.
Panacea Biotec started its journey in transplantation segment with the launch ofcyclosporine (Panimun Bioral) in 1994 as first generic brand and today Panimun Bioral is aflagship brand and has completed more than 17 years and continues to be the trusted andpreferred brand of Cyclosporine in the country. The commitment was further strengthenedwith the launch of Mycept (Mycophenolate Mofetil) which again was the first generic in thecountry and today is 2nd largest brand in its segment in India. The portfolio was furtherstrengthened by launching Mycept S (Mycophenolate sodium).
Again in the year 2004 Panacea Biotec was the first in the country to launch PanGraf(Tacrolimus), which is the largest and most preferred brand of Tacrolimus in India. Thelaunch of PanGraf along with the other brands lead Panacea Biotec towards leadershipposition in India and today PanGraf has attained leadership position in organtransplantation segment in India since 2007.
Being an innovative company amongst the many, the SBU was the first to launch PanGraf 2mg, Mycept 750 mg and Mycept S 540 mg which offered better dose titration, less pillburden for more compliance and better patient management by the physicians.
Our portfolio is completed in post-transplant immune-suppressive segment with additionof Imuza (Azathioprine). Besides there are Siropan (mTor Inhibitors Sirolimus) andrecently launched Evergraf (Everolimus) which have proved to be a right fit for long termgraft survival where there is CNI toxicity or other complications to patients.
Transplant SBU consolidated and strengthened its leadership status in organtransplantation in the year 2011-12 with entry into Anti-infective segment. Infectionmanagement amongst post-transplant patients is a critical success factor for longevity ofthe organ recipient. The SBU launched Vagacyte (Valganciclovir) for the prophylaxis ofcytomegalovirus amongst the recipients which is gaining fast acceptance amongst theTransplant physicians.
This SBU is planning to introduce many new products to ensure its commitment ofproviding an end-to-end solution for the organ transplant recipients.
Chronic kidney disease (CKD) is a worldwide public health problem and incidence rate ofkidney failure are rising. Often, chronic kidney disease is diagnosed as a result ofscreening of people known to be at risk of kidney problems, such as those with high bloodpressure or diabetes. Today in India the number of people suffering from diabetes andhypertension is on a high, leading to a rise in patients diagnosed with CKD. Dialysis isprimarily used as an optimal therapy to provide an artificial replacement for lost kidneyfunction in such patients.
The Nephrology SBU focuses on providing quality care to patients with Chronic KidneyDiseases or Dialysis. It offers a wide range of therapy starting from early stages in CKDto end stage renal disease. The SBU is focused on Renal Anemia Management, Hyperuricemia,Renal Nutrition and CKD-MBD (Mineral Bone Disorders) therapy areas being the key growthdrivers in the coming years. It currently has a brand portfolio of Epotrust(Erythropoietin), Overcom (Iron Sucrose), Alphadol (Alfacalcidol BP), SevBait (SevelamerCarbonate), Fosbait (Lanthanum Carbonate), Mimcipar (Cinacalcet Hydrochloride), K-bait(Calcium Polystyrene Sulphonate BP), Proseventy (Nutritional Protein Powder), Renhold(Protein for Dialysis Patients) and Febarto (Febuxostat).
The Anemia segment is the largest of the Nephrology SBU comprising of 46% of theNephrology business. Financial Year 2011-12 witnessed the SBU entering into a newtherapeutic segment with launch of Febarto (Febuxostat) in hyperuricemia segment andconsolidated its position in hyperphosphatemia segment with launch of SevBait. Epotrust isamongst the fastest growing brands in the erythropoietin market. Vials were launched toincrease the reach and penetration of Epotrust.
This SBU is planning to introduce many new products to ensure its commitment ofproviding an end-to-end solution for the Chronic Kidney Disease (CKD) patients which willadd to the extraordinary growth it is attaining in the segment taking fast growth path.
Cancer is the second leading cause of death worldwide. Like the western world, theperil of cancer has reached huge proportions in India with nearly 1 million new cancercases getting added every year to the existing cancer burden. The increasing cancerincidence has witnessed the Indian oncology community fighting this battle against cancerwith more dedication.
Oncotrust, the third Super Specialty SBU, one of the fastest growing in the Oncologysegment, is working with an object to make existing cancer treatment more affordable andalso to develop NDDS cytotoxic drugs that enable the patients to get high quality andaffordable medicine with improved efficacy and safety.
Being a part of this crusade against cancer and partner with the oncologists to fightthis dreaded disease, OncoTrust has completed five successful years in the market, gainingthe familiarity and wisdom to compete in the highly competitive oncology market of India.The position of OncoTrust as an ethical and scientific organisation has been cemented inthe oncology community with the several initiatives including entry into the NDDS segmentof chemotherapy.
Panacea Biotec has an offering of robust portfolio of targeted therapies, cytotoxic andsupportive care products that Oncologists can rely on to ensure a better quality of lifefor their patients.
The new product launch during the year, included, the Company's cost effective andNovel Drug Delivery nano-particle based albumin bound Product PacliALL (Paclitaxel), meantto be used as chemotherapeutic agent for the treatment of Breast Cancer. The product hasbeen a grand success and became No. 2 brand with
Market Share of >38% in volume and 26% in Value within the niche segment ofnab-Paclitaxel in the 1st year of launch.
The OncoTrust SBU has also achieved break even in FY12 and joined the profitable BUsegments of Panacea Biotec with a growth of 67% in the year under review. This SBU has 14products encompassing the major therapy area in cancer like Lung, Breast & ColorectalCancer, Gliomas, Haematology and Supportive care.
PacliALL has also received two prestigious awards in this year:
"Product of the Year award 2011" by BioSpectrum
"India Nanotech Innovation Award 2011" initiated by the Government ofKarnataka
Diacar Alpha and Diacar Delta SBUs
Today, India is the diabetes and hypertension capital of the world and Indians arefurther heading towards becoming the CAD (coronary artery disease) capital of the world.WHO further estimates that diabetes related mortality may increase upto 35% by 2015.Today, India is poised at the ascending limb of epidemic diabetes. By the end of year2025, 70 million will suffer from diabetes and associated complications. Similarly,cardiovascular segment is consistently showing high growth every year.
Diacar Alpha and Diacar Delta SBUs together are highest revenue contributing SBU of thecompany with dedicated marketing and sales infrastructure for Diabetes and Cardiovasculartherapy management.
Diacar focuses on Endocrinologists, Diabetologists, Cardiologists and Physicians in afiercely competitive scenario and have achieved significant leadership position in oralanti-diabetic segment. The SBU has now initiated an increase in focus on Nephrologists aswell. To tap the complete market potential, Diacar two strategic arms Diacar Alpha andDiacar Delta focusing on Diabetology and Cardiology respectively.
The flagship brand of Diacar Alpha is Glizid-M (Gliclazide + Metformin) which is theNo. 1 brand within the Company across all SBUs. The brand portfolio of Diacar Alpha andDiacar Delta includes:
Oral Hypoglycemic agents: Glizid, Glizid MR (Gliclazide modified release), Glizid-M OD(Gliclazide Modified release), Betaglim (Glimepiride), Betaglim M (Glimepiride +Metformin), Metlong and Metlong DS (Metformin), Pioryl (Pioglitazone + Glimepiride), Oglo(Pioglitazone), Gliben Total, Glizid Total and Glim Total (Glimepiride +Metformin +Pioglitazone). New product launches during the year include the most promising statinRosuvastatin under the brand name of Exeroz.
Cardiovascular agents: World's 1st Modified Release and patented Ramipril -RAMY24 (modified release Ramipril with double peaks) developed through in-house patentedtechnology, Lower A (Atorvastatin), Lower TG (Atorvastatin + Fenofibrate), OGLIBO(Voglibose), Teltor (Telmisartan), Teltor AM (Telmisartan + Amlodipine), Tecbeta(Metoprolol Succinate) and Tecbeta AM (Metoprolol Succinate + Amlodipine).
Co-prescriptives: In co-morbid conditions like Diabetic peripheral neuropathy DiacarAlpha has Myelogen Forte range which has gained wide spread usage and is fast growing.Brand was given an extension this year with Myelogen powder which is ideal supplement fordiabetics. Stamicar (L-Carnitine L-Tartrate) was launched in Diacar Delta which is gainingfast acceptance in the very first year.
Procare SBU of the Company caters to chronic care segment of Orthopedic andGastroenterology therapy through focus on specific disease management with deep rooting inpain management.
Within Orthopedics, SBU's focus is on Osteoporosis, Osteoarthritis and RheumatoidArthritis Management and within the Gastroenterology focus is on Constipation, Anorectaldisorders and product range in liver disease management. This SBU promotes a portfolio ofbrands with special focus on Orthopaedicians, Surgeons and Gastroenterologists along withConsulting and General Physicians.
The brand portfolio of Procare includes:
Gastrointestinal: Sitcom (Euphorbia Prostrata) Tablets and Cream, Livoluk(Lactulose), Livoluk Fibre, Gush (Lactitol Monohydrate + Ispaghula Husk) & ODpep
Chronic liver diseases: Uciro (Ursodeo Xycholic Acid)
Anti-osteoporosis: Vacosteo (Zoledronic acid, 3rd generation injectablebisphosphonate), Alphadol-C (Alfacalcidol), Calcom & Monthiba (ibandronic Acid)
Anti-arthritis: Willgo, Kondro OD & Kondro Acute ((Glucosamine SulphatePotassium Chloride)
Pain Management: Nimulid, Nimulid SP, Nimulid MR, Nimulid HF, Dolzero, and newlylaunched Delupa (Aceclofenac)
Gout and Hyperuricemia: Febarto (Febuxostat) launched during the year
Sitcom has evolved as the first choice among anti-hemorrhoidals withinGastroenterologists and Surgeons. This success has motivated the SBU to launch innovativeformulations in the form of Sitcom Forte tablets and Sitcom LD cream for the first time inIndia in current financial year.
The future plans of the SBU include launching of high end molecules in the field oforthopedics (both osteoporosis and osteoarthritis), complete range of pain managementDelupa-P, Delupa-SP, Delupa-CR & Delupa-TH as well as gastroenterology and encash thebuilt up equity in both these segments. The SBU is fully geared for multiple launches inthis financial year with radical expansion plans in near future.
Growcare SBU focuses on Gastro-Intestinal (GI), Anti hemorrhoidal, Cough & Cold,Vitamins and Minerals and Pain Management therapies.
Committed to reduce the burden of these diseases, Growcare marks the Company's presencein therapy areas like Anorectal Disorders (Piles and Hemorrhoids), Gastro-Intestinal,Respiratory (Cough, Cold and Allergy), Anti-Infectives, Pain Relievers, Vitamins andMinerals. The different specialties serviced by Growcare SBU are General Physicians,Consulting Physicians, ENT Surgeons, Pediatricians and General Surgeons.
The brand portfolio of Growcare includes:
Anti hemorrhoidal: Thank OD & Thank OD Cream
Anti-infective: Ocimix (Ornidazole), ValueCef, ValueCef-O and ValueThral(Azithromycin Dihydrate)
Anti-Allergic: Zomont AL, Zomont AL Kid Tablet (Montelukast Sodium)
Cough, Cold and Fever: Cough syrups range Corton, Toff MD, Toff DC, Toff-lix& Toff expectorant, Orangemol Suspension. TECPara (technological advanced Paracetamol)an in house R&D patented product) is a new launch which is gaining acceptance
Pain Management: Nimulid & Nimulid MD (Mouth dissolving) tablets,Nimulid-ER, Nimulid Suspension and Nimulid Transgel
Gastro-Intestinal: EnBa, EnBa-Rab, FiberFOS, HiFibre and Livoluk kid
Vitamins & Minerals: Wholesum
Anti TB: Myser (Cycloserine) & Myobid (Ethionamide)
The plans are to launch during the year complete Tecpara range to strengthen PanaceaBiotec equity in fever and pain management.
Over the years, Panacea Biotec has established leading brands that enjoy top of themind recall by the medical fraternity. The Company's brands command excellent market sharein their therapeutic segments. According to ORG IMS (TSA MAT Jun'12) Sales value, PanaceaBiotec is among top 50 companies in the Indian Pharmaceutical Market with Nephrologists,Dentists, Orthopaedicians and Diabetologists giving the best support. As per StockistSecondary Audit of ORG IMS (MAT Jun'12), Glizid-M stands at 278th rank amongtop brands in the Indian Pharmaceutical market and retain number one position within itscategory.
The Company's key brands across therapeutic categories and their ranking/ market sharein India are:
Brand Standing and Market share
|Brands ||Market Share % ||Ranking |
|Diabetes and Cardiac Care: || || |
|Glizid M ||21.1 ||1 |
|Glizid 40mg ||29.0 ||1 |
|Glizid 80mg ||21.6 ||2 |
|Glizid MR 30mg ||13.5 ||2 |
|Glizid MR 60mg ||8.1 ||3 |
|Glizid Total ||24.4 ||2 |
|Pain Management: || || |
|Nimulid MD ||4.8 ||2 |
|Nimulid 100mg ||7.1 ||2 |
|Nimulid MR ||11.6 ||4 |
|Nimulid SP ||5.6 ||4 |
|Kondro OD ||16.3 ||3 |
|Kondro Acute ||6.5 ||4 |
|Vacosteo ||17.4 ||1 |
|Tuberculosis Management: || || |
|Myser ||7.2 ||3 |
|Myobid ||4.0 ||3 |
|Gastro-intestinal: || || |
|Livoluk ||5.8 ||4 |
|Anti-haemorroidal: || || |
|Sitcom Tabs ||7.0 ||4 |
|Thank OD Tabs ||6.4 ||5 |
|Penicillines: || || |
|Cilamin ||3.2 ||2 |
* Source: ORG IMS SSA audit JUN'12.
* Market Share and rank is calculated within its immediate operating market i.e. thestrength or the immediate market (wherever applicable).
Panimum Bioral, Mycept and PanGraf are also leading brands in the Organ Transplantationsegment but have a poor reflection in ORG IMS audit, as ORG IMS SSA audit does not trackinstitutional and hospital sales.
New Product Launches
Panacea Biotec continues to expand its product portfolio by launching new productsevery year. It launched new products in various therapeutic categories in FY 11-12including:
Tecbeta (Metoprolol), Tecbeta AM (Metoprolol+ Amlodipine), Exeroz F(Rosuvastatin+ Fenofibrate), Teltor (Telmisartan), Teltor AM (Telmisartan + Amlodipine) incardiology segment Tecpara (Paracetamol Oral Solids), Monthiba (Ibandronic Acid), DeLupaTH (Thiocolchicoside +Aceclofenac) and Febarto (Febuxostat) in Pain/Analgesics segment.
Myelogen Powder, Stamicar, Wholesum and Proseventy in the Vitamins/ Minerals/Nutrients segment
Valuecef O (Cefixime+ Ofloxacin) in Anti infectives segment
Uciro (Ursodeoxycholic acid) in the Hepatoprotectives segment
Enba Rab (Rabeprazole) for the Gastro segment Tofflix (Pholcodeine) in the Respiratorysegment Gliben Total P in anti-diabetic segment
Imuza (Azathioprine) in the immunosuppressive segment
International Pharmaceuticals Business
The year under review was a year of sustained growth and expansion for InternationalPharmaceuticals Business by strengthen the existing trade business in market place andventuring into new markets. During the year, the company's pharmaceutical formulationbusiness clocked export sales of Rs.753.6 million with a growth rate of 17%. In the year2011-12, the company has ventured into new markets of Latin America, CIS region, Asia andAfrica with products in various therapeutic areas like organ transplantation, painmanagement, nephrology, gastro-intestinal and anti-infectives.
The region wise sales for the year 2011-12 were as follows:
CIS Region Rs.369 million as compared to Rs.314.8 million in FY 2010-11
Latin America sales Rs.241.7 million as compared to Rs.220 million in FY 2010-11
Middle East sales Rs.62.9 million as compared to Rs.51 million in FY 2010-11
Asia Sales Rs.69.4 million as compared to Rs.55.6 million in FY 2010-11
The major achievements for international pharmaceutical formulation business during theyear have been:
Inclusion of Panimun Bioral and Mycept in Russia MOH Federal list
Increased acceptance and sole supplier of Tacrolimus 5mg to Brazil MOH.
Successful launch of Panolimus (Tacrolimus) in Serbia - 2nd European country to getTacrolimus registration clearance
The company has robust plans in place for coming years in terms of marketidentification, registration and commercializing a series of innovative products. Thefirst innovative product -RAMY 24 - Modified Release Ramipril, from our state of artR&D center GRAND is under registration in majority of our operating markets. Thecommercialisation of RAMY24 in select markets is expected by last quarter of 2012-13. Thecompany also has robust pipeline in speciality therapy areas like Oncology, Endocrinology,CNS and Urology and is at advanced stages in our R&D centers. The registration of theOncology products will commence in the second half of the year.
With this robust strategies and growth plans, the company is aiming to achieve shortterm growth of 40% and projected CAGR of 43% in international pharma business over next 5years.
The company is accelerating its movement towards promotional oriented approach from atrading business model across all markets.
The company is also in the process of formalizing in its own representative officeswith specialised personnel in various markets which will create a positive image of theCompany amongst customers in market place.
Immunisation being one of the most important & cost effective ways of reducingmorbidity and mortality, the Company has since inception adopted a long-term strategy ofdevelopment of newer vaccines.
The Company is the second largest vaccine producer in the country. Over the last 20years Panacea Biotec has created a strong portfolio of innovative vaccines againstcritical and life threatening diseases like Polio, Hepatitis B, Diphtheria, Tetanus,Pertussis, Haemophilus Influenza type B (Hib), pandemic flu (H1N1), etc. The Company hasdeveloped advanced fully-liquid combination vaccines; opening a whole new dimensiontowards protecting multiple diseases with a single vaccine.
Panacea Biotec has not only made significant contribution in the development of vaccinemarket but also in improving the life of millions of children by providing innovativevaccines at affordable prices across the globe. The Company is continuing with its effortsto strengthen its vaccines portfolio by adding more and more vaccines in future.
The Company had significant presence in both institutional and private vaccines marketsin India and international markets. Panacea Biotec has played a key role in polioeradication program by supplying more than 9 billion doses of Oral Polio Vaccines toGovernment of India and UNICEF.
In Indian private vaccines market, the Company is currently marketing its innovativepediatric vaccines through its joint venture company, viz. Chiron Panacea Vaccines Pvt.Ltd. The major brands in the vaccines business include Easyfive (DTwP-HepB-Hib), Easyfour(DTwP-Hib) and Polprotec (enhanced Injectable Polio Vaccine). The JV Company commands asignificant market share in the pediatric combination vaccines segment in India.
In the international markets, the Company focuses on the emerging and ROW countries.Over the last couple of years strategic business partnerships have been initiated in morethan 50 countries with customised business models. Till date vaccines have been registeredin 11 countries with further registrations in around 20 countries expected in the nearfuture.
The Company has achieved an export turnover of Rs.2,641.5 million during the yearincluding deemed exports of Rs.38.5 million. During the year,Bangladesh, Uganda,Philippines and Peru were added as the new markets in addition to the existing markets ofChile, Nepal, Pakistan, Botswana and Swaziland etc.
Supply Chain Management & Logistics Network
Panacea Biotec has strong Supply Chain Management (SCM) systems designed for creatingend-to-end visibility and controls right from sourcing of materials till collection ofreceivables in both Pharmaceuticals and Vaccines segments. The objective has been toensure customer satisfaction by monitoring and improving delivery performance on variousparameters including Turn-around Time (TAT), On-time in Full (OTIF) and Error-freedelivery of products and promotional materials.
The Company has pan-India sales and marketing network covering approximately 600districts in India and targets more than 1.5 million customers through a field force ofover 1,400 trained marketing and sales professionals and 22 sales depots/carrying andforwarding agents all over India.
The Company has its Central Warehouse at Delhi and has expertise in cold chainmanagement for storage and distribution of Vaccines under monitored conditions using asystem of Vaccine Vial Monitors, Data Loggers, Ice Boxes, Coolant, Cold Rooms andRefrigerated Vehicles and Tyvek Sheet for sending temperature controlled productsoverseas. This ensures that the Vaccines remain safe and effective against changes in thevariant temperature conditions during transit.
The Company's manufacturing facilities for vaccines and pharmaceutical formulations aresituated in India in Delhi, at Lalru in Punjab,at Baddi in Himachal Pradesh and at NaviMumbai in Maharashtra. The Company also has state of the art integrated facility for bulkvaccines, antigens and biopharmaceuticals at Lalru in Punjab. The manufacturing facilitieshave been set up in compliance with international regulatory standards including WHO cGMPand European Union standards. The Company's manufacturing expertise lies in various solid,semi-solid & liquid oral dosage forms and vaccines such as:
Oral-solids - conventional tablets/capsules, controlled/ delayed release/entericcoated tablets and capsules, tablet in tablet, tablet in capsule, multi-layered capsules,hard gelatin/ soft gelatin capsules, mouth dissolving/chewable tablets, beadsencapsulation, coating (film, sugar & functional), taste masking and fast-dissolvingtablets
Semi-solids - ointments/creams/gels, transdermal drug delivery system
Liquids - suspensions/syrups/solutions
Vaccines - recombinant vaccines, combination vaccines, cell culture vaccines andlive vaccines
Anti-cancer - injectable
Pharmaceutical Formulations Facility at Baddi
The Company has its state-of-the-art pharmaceuticals formulations manufacturingfacility at Baddi, Himachal Pradesh. The facility has been built in compliance with cGMPstandards, received encouraging acclaim and numerous plant approvals from variousregulatory authorities. The facility has been approved by National Regulatory Authority ofIndia (NRA) and has also been audited and certified as cGMP compliant by variousregulatory agencies including the USFDA, German Regulatory Authority, TGA Australia andANVISA Brazil. The Company's soft gelatin manufacturing facility is also approved formarkets in European Union.
During the year under review, the Company has expanded this facility by setting upAnti-Cancer Formulation facility with two lines dedicated for liquid & lyophilizedvials as well as pilot scale up batches complying to USFDA, EU, ROW and cGMP norms with acapacity of 1.2 million vials per annum on three shift basis.
Manufacturing Facilities for Vaccine Antigens and biopharmaceuticals at Lalru
The Company has bulk vaccine manufacturing facilities at Lalru in Punjab with dedicatedblocks for manufacture of Recombinant,
Bacterial & Tetanus vaccine bulk & antigens and an integrated block for cellculture based vaccines and biopharmaceuticals. The integrated block comprises of threeindependent suites for manufacture of viral proteins/vaccines, non-viral recombinantbio-therapeutics (e.g. biosimilar molecules on cell culture in both conventional as wellas disposable formats), egg based viral vaccines and recombinant & conventionalvaccines in microbial cultures. All the blocks have been designed, constructed and adaptedfollowing current Good Manufacturing Practices (cGMP).
The facilities have been approved by NRA for manufacture of Diphtheria Toxoid, TetanusToxoid, whole cell Pertussis, Recombinant Hepatitis B surface antigen, Haemophilusinfluenzae type b conjugate bulk and Inactivated H1N1 split viron influenza vaccine bulk(by traditional egg based technology).
Vaccines Formulation Facility at Baddi
The Company's state-of-the-art vaccine formulation facility at Baddi in HimachalPradesh, located in a complex of 23 acres of land, comprises of two blocks. Thethree-storey main building consisting of production, quality control and quality assuranceis spread over approximately 2800 square meters construction area at each floor and afive-storey block of Warehouse-cum-Cold Storage facility is spread over approximately 2500square meters on each floor.
The facility has two filling lines complying with cGMP norms,one for filling ofinjectable liquid Vaccines in pre-filled syringe (PFS) and another switchable line forfilling of liquid & lyophilized Vaccines in vials. The total production capacity ofthis facility is 600 million doses per annum capable of being increased by addition ofthird line to one billion doses per annum.
The facility has been approved by National Regulatory Authority of India (NRA) formanufacturing of vaccines. The facility has recently undergone renovation and is undervalidation as per new Quality Management Systems in compliance with WHO pre-qualificationrequirements.
Vaccines Formulation Facility at New Delhi
The Company's vaccines formulation facility in New Delhi is a c-GMP compliant facilityfor Oral Polio Vaccines (tOPV, mOPV1, mOPV3 & bOPV) and also has been approved by NRA.The facility has built up area of more than 50,000 sq. ft. and has one vial filling linededicated to Oral Polio Vaccines. The total annual production capacity of the facility is800 million doses of Oral Polio vaccines in two shift operation.
Pharmaceutical Formulations Facility at New Delhi
The Company's pharmaceuticals formulation facility in New Delhi caters to therequirements of products for Emerging and ROW markets.
Manufacturing Facility for Anti-Cancer Products at Navi Mumbai
The Company has a manufacturing facility for manufacture of anti-cancer products(Injectables & Tablets) at Mahape, Navi Mumbai. This state-of-the-art containmentfacility (with isolator technology) is unique and capable of providing clinical supply andproduction of high value cytotoxic products. The Company is manufacturing its innovativeproduct in Oncology segment, viz. PacliALL in this facility.
Research & Development
Research & Development is one of the core strengths of Panacea Biotec. With itsfour highly sophisticated ultra-modern R&D centers manned with around 300 qualifiedand experienced scientists, the Company has built a strong R&D base over the lastdecade to support its business segments, vaccines, pharmaceutical formulations andbiopharmaceuticals. The key areas of research & development includes new vaccinedevelopment, biopharmaceuticals, proteins, peptides, monoclonal antibodies, Novel DrugDelivery Systems, Advanced Drug Delivery System and Drug Discovery (small molecules), incompliance with international regulatory standards. The Company's R&D Centers havebeen accorded registration by Department of Scientific and Industrial Research, Ministryof Science & Technology, New Delhi.
The Company also has a state-of-the-art animal house and facilities for carrying outpre-clinical research and for undertaking in-vitro and in-vivo microbiology, pharmacology,safety, efficacy, proof of concept and toxicology studies.
As a result of its research efforts, the Company has been granted more than 300 patentsin India and worldwide including in major countries like U.S., Europe, Australia, Canada,China, Japan, Russia etc.
The Company has been steadily increasing its expenditure on R&D, both revenue andcapital expenditure. During the year under review, the Company has made a totalexpenditure of Rs.1,026.5 million (14.9% of net turnover) on R&D as against Rs.849.6million during previous fiscal, an increase of 20.8% in value terms. The revenueexpenditure on R&D was Rs.872.2 million in fiscal 2012, as compared to Rs.594.5million in fiscal 2011, an increase of around 46.7% in value terms. The investment by wayof capital expenditure on R&D has been Rs.154.3 million in current fiscal as comparedto Rs.255.1 million in previous fiscal year. The Company is continuously strengthening itsR&D base to cater to increased healthcare needs and expanding niches in vaccines,pharmaceuticals formulations and biopharmaceutical segments, both in domestic as well asglobal markets.
LAKSH Drug Discovery R&D Center
The Company has its state-of-the-art research center LAKSH which is dedicated fordevelopment of New Chemical Entities (NCEs, small molecules) at Mohali, Punjab. The LAKSHis spread over an area of 70,000 sq. ft. with sophisticated laboratories equipped withmodern instruments to perform NCE research. The R&D center employs about 100 dedicatedscientists including 12 PhDs.
The focus of research is on development of NCEs for the treatment of diabetes, CentralNervous System (CNS) disorders and infectious diseases. This R&D center hassuccessfully delivered two Pre-Clinical Candidates (PCCs), one of which is currently underinvestigation for IND (Investigational New Drug) filing and the other one has recentlyentered phase I studies in India. Nine PCT applications and more than 50 patentapplications in national phases have been filed from this center.
Two grants amounting to Rs.37.8 million by DSIR (Department of Science & IndustrialResearch) and Rs.20 million by DST (Department of Science & Technology) have beensanctioned to partially fund both the projects for development and demonstration oftechnology.
SAMPANN Drug Delivery R&D Center
SAMPANN Drug Delivery Research and Development Centre, Lalru is a state-of-the-artresearch facility of Panacea Biotec with superior infrastructure, specialised machinery,adequate resources and highly qualified manpower.
Pharmaceutical research carried out using various innovative technologies like hydrogel based topical drug delivery system of peptides and herbal drugs, solid-soliddispersion for highly variable drugs, self emulsifying drug delivery system (SEDDS) andcontrolled release drug delivery systems in different therapeutic areas. Considering theneed to boost global marketing endeavors, various regulatory filings have been done in US& EU on immunosuppressant drugs. Apart from NDDS based products, several new moleculesare in the pipeline for development as generics for the ICH and ROW markets.
SAMPANN also has an excellent portfolio of innovative pediatricvaccines to protectchildren against dreadful diseases such as polio, hepatitis, diphtheria, tetanus, pertusisand haemophilus influenza.
Further to broaden the existence of Panacea Biotec in the market, the SAMPANN isdeveloping the new generation vaccines like Pneumococcal Vaccine, Japanese encephalitisand Universal flu vaccine. High order combination vaccines like Easyfourpol and Easysixvaccines are currently in Phase III clinical trial. National Regulatory Authority (NRAs)approval has been obtained for manufacturing of DTwP vaccine, which are manufactured withindigenous developed drug substance. Successful dossier submission has been done withWorld Health Organisation (WHO) for obtaining the license for single dose InactivatedPolio Vaccine (IPV).
Significant number of projects have been developed and cleared for commercialisationand 16 International patent applications were filed during the year by SAMPANN.
One Stream Research Center
The confluence of two R&D centers (SAHA Vaccine and Biological Research Center andBiopharmaceutical Research Center) established the OneStream Research Center at New Delhi.The state-of-the-art OneStream facility is spread over 26,000 Sq. ft. area in three floorsand brings together rich experience of past so many years to develop novel, effective andaffordable vaccines and biopharmaceuticals for prevention against various epidemic/endemic life threatening diseases for global markets.
OneStream is backed by a team of 65 highly trained and skilled scientists including 8PhDs with excellent credentials working in divergent areas of biological sciencesincluding: molecular biology, cell biology, vaccine development, pharmacology, immunology& peptide biology.
OneStream is dedicated to carry out extensive research in vaccines and biologicalsusing genetic engineering, molecular biology, genomics tools, animal cell culture,fermentation, purification, formulation, Immunology and analytical testing techniques.OneStream has the infrastructure and expertise to take an idea through different stages ofproduct development towards a successful commercialisation. OneStream's focus is ondevelopment of novel preventive & therapeutic vaccines, novel therapeutic peptides andtherapeutic fully human monoclonal antibodies for treating infectious diseases and thelifestyle related disorders. OneStream is actively involved in developing differentbiosimilar products as well.
The Centre is involved in the development of following vaccines and bio therapeutics:
Vaccines: Cell culture based viral vaccine (dengue & japanese encephalitis virus(JEV), egg based viral vaccines (seasonal flu & yellow fever), recombinant viralvaccine (universal flu & respiratory syncytial virus), bacterial polysaccharidevaccine (pneumococcal, meningococcal), bacterial protein vaccine (acellular pertussis)& recombinant bacterial vaccine (anthrax).
Biotherapeutics: Biosimilars (Recombinant Darbepoetin, Trastuzumab, Bevacizumab,Etanercept, Omalizumab, Cetuximab, Rituximab) and Peptides (long acting GLP-1 analoguesand Hair Growth Peptide)
OneStream has dedicated classified areas to work with pathogenic bacteria, viruses,cell culture, clone development, peptides & cell based assays. The center haswell-established P3 facility to handle pathogenic viruses like H1N1, Seasonal flu & JEvirus. The Centre has indigenously developed and licensed Pandyflu against H1N1 virus(Swine flu). During the year under review, the focus of the center was development ofCompany's candidate vaccine for Pneumococcal disease which cleared safety evaluation toenter clinical trials and Vero cell based live attenuated tetravalent Dengue vaccine.
GRAND R&D Center
Global Research and Development (GRAND) Center at Mahape, Navi Mumbai is involved indevelopment of products for international as well as Indian market. Products developed areof highest quality with an innovative edge.
The primary objective of research & product development is to meet unmettherapeutic needs of the society, in the field of Oncology, Organ Transplantation, etc.and provide therapeutic advantage to the patients. The main focus of research is todevelop products using novel technologies like:
Gastro-retentive Spatially Programmed Orally Retentive Technology (SPORT) forbioavailability enhancement
Pulsatile Drug Delivery for bioavailability enhancement and better patientcompliance
Matrix controlled drug delivery for better patient compliance
Oral Fast Dissolving Films for better patient compliance
Microspheres for better patient compliance
Nanoparticles for improved safety and efficacy
Liposomes for better safety and efficacy
Over the years GRAND has emerged as a strong contributor to intellectual property ofPanacea Biotec.
Briefly, innovative product development at GRAND is categorised in followingsub-classes based on the route of drug administration:
Oral Drug Delivery:
Controlled and modified oral delivery of bioactives
Drug Delivery for Immunosuppressant drug
Parenteral Drug Delivery:
Nanoparticles: First indigeneously developed nanotechnology based parenteralproduct for delivery of Paclitaxel (PacliALL) has been launched in Indian Market. Productinvolves target oriented delivery of anticancer molecule leading to reduced side effectsand better patient compliance compared to conventional formulation.
Microparticles: Depot Injectable Formulations based on microparticles fordelivery of peptide/drugs are under development with an objective of controlled andsustained delivery of actives to provide improved therapeutic outcome with an addedadvantage of reduced dosing frequency.
Liposomes: Products are under development involving the concept of"Stealth" liposomes.
Quality is among the most important reasons to encourage a customer to buy a product.Total Quality Management has always been the foundation stone of the Company which hasresulted in achieving greater milestones in the past couple of years. At Panacea Biotec,quality is in-built in products & services and is integrated in each step of R&D,production, packaging, storage, marketing, sales & distribution. The Company iscommitted to adhere to the highest quality standards for products which are enabledthrough a highly qualified, techno-innovative & dedicated team.
Clinical Research plays a crucial role in the process of drug development. Clinicaldevelopment establishes the safety and efficacy of a new drug product involvingsignificant expertise, time and investment.
The year 2011-12 witnessed several milestone achievements in Clinical Research,including:
Investigational New Drug (IND) approval from USFDA for anti-diabetic newchemical entity (NCE)
Phase III trial of novel drug delivery antihypertensive
Phase III trial of novel drug delivery analgesic/antipyretic
WHO sponsored randomised controlled trial of mucosal immunity to polio virusesafter a supplemental dose of bOPV or IPV
Pre-IND meeting with USFDA and pre-submission meeting with European MedicinesAgency (EMA) for a novel drug delivery immunosuppressant
Scientific advice meeting with Federal Institute for Drugs and Medical Devices,Germany (BfArM) for a gastroesophageal reflux disease product
The Company has deployed the Argus safety database, a comprehensive adverse eventtracking and reporting system. This enables the company to provide a sustainable solutionaimed at managing our growing global pharmacovigilance compliance obligations.
This important project has long term goals of enhancing the Company's risk managementcapabilities, integration between critical business processes, 'value add' capability ofredefining business processes, enhanced compliance reporting features, and mostimportantly strategic advantage in the Global Safety Surveillance domain.
The Company has a full-fledged Intellectual Property Rights department which managesall the Intellectual Property related functions from inception to enforcement. The Companyhas been granted 33 product patents worldwide for different products/ technologies.
As at the end of the year under review, the Company has filed around 1,500 patentapplications worldwide including 194 Indian patent applications and 95 applications filedthrough the PCT (Patent Cooperation Treaty) route. Out of the total number of patentapplications filed, 413 patents had been granted / accepted for grant including in India.Apart from this, the Company had in-licensed several patent applications, some of whichare under process in different countries of the world.
During the year under review, 12 patents were granted in Algeria, Australia, Bulgaria,Eurasia, Ukraine, Singapore, Tunisia, USA and India.
So far the Company has filed over 835 domestic applications for registration of TradeMarks of which 433 have been registered including 49 trade mark applications registeredduring the year under review. In addition to this, the Company has filed during the year266
International Trade Mark Applications in various countries of which 97 have beengranted during the year under review.
Besides this, the Company had filed 209 applications for registration of Copyrights ofwhich 83 had been granted. The Company has till date also filed 4 Design Applications andall of them have already been registered.
The Company's Human Resource department has evolved over several years from being asupport function to be recognised as a business partner. It has seen a paradigm shift inthe approach adopted towards strategic human resource management and has taken aggressivesteps to make its functions absolutely process driven & at one click with minimumhuman intervention.
The systems and processes adopted by the company in the HR operations & statutorycompliances are absolutely well defined and are proven to be very helpful in driving theerror free operations of the business units.
Panacea Biotec has total manpower of around 3300 spread all over India and abroad inR&D Centres, Manufacturing facilities, Sales & Marketing offices and satellitepostings of the sales professionals. The talent pool has diversified expertise, skill setsand qualification which have resulted in a talent pool mix, enabling the organisation topropel towards being the most innovative and technologically advanced healthcare company.
Panacea Biotec ensures its core values are protected and nurtured and the same reflectsin the organisation demographics. The company believes in fostering the humane value andadopts the same in recruitments by hiring professionals in the industry and extends careeropportunity to all regardless of their castes, religions, races, gender etc. The Companyhas ensured that the right platform is provided to competent employees to visiblydemonstrate talent in the industry. By adopting a fair recruitment strategy, the Companydemonstrates its contribution to the social upliftment of the society and its socialresponsibility. It strongly focuses on empowering the human capital with the necessaryskills and knowledge which could be in the form of training events or workshops.
To bring in work life balance and celebrate festivals together, the Company conductedseveral employee engagement initiatives which observed encouraging participation.
The vision of the organisation and the deliverables of the employees are so wellconnected, that every employee right from their joining with the organisation has clarityabout the set expectations from him in driving the organisation to realise its vision byyear 2020.
Superannuation Celebration at Corporate Office: This year, the Company felicitatedaround 8 employees, who during their long tenure with the company had demonstratedoutstanding performance and were regarded as solid citizens of the organisation. Thesuperannuation of these employees was announced as they embark a new journey of theirlife.
Annual Day Celebration: The 17th Annual day at Panacea Biotec was celebratedacross the organisation in which employees gathered for a festive lunch post which themessage from the Directors desk was relayed across organisation through recorded videos onthe share portal/website.
In today's competitive market the companies are more dependent and relying oninformation technology to get more reliable and faster access to data for making businessdecision. The Information Technology works closely with the departments to support theirefforts to provide effective service and maintain efficient operations through theinnovative use of the information technology. The Information Technology not only simplyserves a company but has become a value proposition for the business. The increasinglyimportant role is transforming IT from being a simple support function within theorganisation to a key player of the organisation.
During the year under review the Company has successfully re-implemented SAP's newversion, SAP ECC 6 after conducting business process re-engineering (BPR) exercise. Withthe help of BPR, the Company has been able to optimise the business processes to furtherimprove the productivity & quality and reduce the costs in operations. With theimplementation of SAP ECC 6.0, the company has engulfed automation of several criticalbusiness functions to cater with a capability of the organisation to provide a businessintelligence report to the leaders.
As planned the company has also started the implementation of business intelligenceover and above the SAP system to provide business insights to the management leading tobetter, faster and more relevant decisions. Apart from this IT has also adopted thevirtualisation concepts in the data center to reduce the inventory and cost of handlingthe data center, and also able to increase/ optimise the performance of Hardware andapplication.
Internal Audit & Control System
Panacea Biotec has a comprehensive internal control system that commensurate with itssize and nature of operations. These cover all manufacturing and research &development facilities, warehouses and sales offices besides corporate office.
The internal controls have been developed and implemented at each business processlevel across the Company. The user level responsibilities are constantly shared with keyusers for their implementation and compliance. The internal control systems are furthertested on a sample basis by internal auditors every quarter and also by competentpersonnel of the Company and are reviewed by the Management to ensure that processes andcontrols are in place and working as intended in achieving efficiency of operations,customer focus, financial reporting and compliances of applicable contracts, laws, rulesand regulations. The Company controls its revenue and capital expenditure budgets throughan effective SAP fund management module.
Further, internal audits are conducted periodically by independent Chartered Accountantfirms appointed by the Audit Committee of the Board of Directors. The Audit Committeecomprising of independent directors actively reviews the adequacy and effectiveness ofinternal controls, internal audit systems and advises improvements as may be required. Anymaterial change in the business process or outlook is reported to the Audit Committee andthe Board of Directors. Post audit follow-ups are carried out to ensure identified risksare addressed and recommendations of the Audit Committee are implemented.
Subsidiaries, Joint Ventures, Collaborations & Tie-ups
The Company continues to nurture and expand its relations with its collaborationpartners. The Company has several collaborations & tie-ups directly as well as throughits direct/indirect subsidiaries including the following:
Best On Health Ltd.: The Company's wholly-owned subsidiary (WOS) namely Best On HealthLtd. ("BOH"), which owns a prime immovable property being used by the Company asits Corporate Office, has diversified in related health management space as part of itsfuture growth plans. BOH holds a substantial piece of land on its own and through its fourwholly owned subsidiaries for setting up sector-specific biotech Special Economic Zonelocated at Pataudi Road, Gurgaon, Haryana. BOH has got the formal approval for setting upsector specific biotech SEZ.
BOH has 6 wholly owned subsidiaries (WOS), viz. Radicura & Co. Ltd., PanaceaHospitality Services Pvt. Ltd., Sunanda Steel Company Ltd., Panacea Educational InstitutePvt. Ltd., Best on Health Foods Ltd. and Nirmala Organic Farms & Resorts Pvt. Ltd.Nirmala Organic Farms and Resorts Pvt. Ltd.owns land in Rajasthan as part of its plan tocarry out the business of agriculture farming, cultivation setting up motels, touristresorts etc.
Lakshmi & Manager Holdings Ltd.: Lakshmi & Manager Holdings Ltd., an erstwhileassociate company involved into carrying the business of trading in securities of thecompanies, became the wholly owned subsidiary of the Company w.e.f. 24thNovember, 2011. This company has a WOS Trinidhi Finance Pvt. Ltd., which possess NBFClicense from RBI and is involved in carrying out the business of non-banking financingactivity.
NewRise Healthcare Pvt. Ltd.: The Company's subsidiary NewRise Healthcare Pvt. Ltd. issetting up a 225 bedded, state-of-the-art multi super-specialty hospital at Gurgaon,Haryana with an investment of around Rs.1400 million. The construction work is progressingin full swing and the hospital is set to commence its operations during the currentfinancial year.
Panacea Biotec (International) SA: The Company's indirect WOS in Switzerland hascommenced operations during the year under review through in-licensing of certainpharmaceutical products and is currently marketing products in Australia and New Zealandthrough strategic collaborations. The Company achieved a turnover of CHF 689,823 duringthe financial year 2011-12.
Panacea Biotec Germany GmbH: The Company's indirect WOS in Germany has got registrationof products in Germany and has successfully launched the first product TACPAN"(Tacrolimus) in Germany during the second half of fiscal 2012. It has also launched anin-licensed product MOWEL" (Meropenem) in the German Markets. The Companyachieved a turnover of Euro 66,138.46 during the financial year 2011-12.
Joint Ventures & Associates
Chiron Panacea Vaccines Pvt. Ltd.: The Company's joint venture company Chiron PanaceaVaccines Pvt. Ltd. (CPV) is marketing vaccines in the domestic private market. CPV hasgrown its business in DTwP based pediatric combination vaccines by 3% and Polio (IPV &OPV) by 21% over previous year. CPV has a significant market share in the DTwP basedpediatric combination vaccines, with Easyfour at 62% and Easyfive at 43%, as per the March2012 report of Multi Client Study conducted by Frost & Sullivan.
The Company achieved a turnover of Rs.531.82 million during the financial year 2011-12.Further, Polprotec (IPV) vaccine has a market share of 43% and Agrippal S1 flu vaccinehave a market share of 17% as per the said report.
CPV also led a nationwide mass awareness program with the pediatricians on the WorldPolio Day through various activities across the country like CME's synergetic role ofIPV+OPV in polio eradication, vaccination camp, with a drive to protect maximum childrenagainst Polio.
PanEra Biotec Pvt. Ltd.: The Company's associate Company, PanEra Biotec Pvt. Ltd.(PanEra) is continuing to meet the Company's requirement of bulk vaccines and antigens formanufacture of Hepatitis B and Combination Vaccines & H1N1 Vaccine by the Company.PanEra has become a specialised company focused on bulk manufacture of vaccines. TheCompany achieved a net turnover of Rs.274.38 million during the financial year 2011-12.
Adveta Power Pvt. Ltd.: Adveta Power has been set-up as a 50:50 joint venture companywith PanEra Biotec Pvt. Ltd. for the purpose of generation of electricity with a focus onrenewable energy.
Collaborations and Tie-ups
Panacea Biotec has important business relationships with various research institutes,academic universities & commercial corporations, including:
The National Institute for Public Health and the Environment (RIVM), The Netherlands:The Company is one of the two companies shortlisted by WHO globally for developing thesabin based injectable polio vaccine (sIPV) and has entered into an agreement with RIVMfor in-licensing of proprietary know-how for production of sIPV vaccine and relatedquality control testing for commercialisation in India and other international markets.
Binnopharm, Russia: The Company has recently entered into a multi-phase supply andtechnology transfer agreement with Binnopharm for supply of Company's finished product,viz. Hib Conjugate Vaccine and for transfer of technology thereof, for commercialisationin Russian Federation.
National Institute of Immunology, India: The Company has an exclusive ten-year licenseagreement with National Institute of Immunology, India for in-licensing of technology andprocesses for production of tissue culture derived formalin inactivated,Japaneseencephalitis vaccine. The technology has been further modified significantly at ourresearch center to yield a commercially viable and safer vaccine.
Biotech Consortium India Ltd.: The Company has a ten-year in-licensing arrangement withBiotech Consortium India Ltd. for the development, manufacture and marketing of anthraxvaccine developed by Jawahar Lal Nehru University, India. Phase I/IIa of human trials havebeen successfully completed, the Company has plans to submit an IND application to USFDAfor performing Phase IIb clinical trial in India. After successful Phase II b trials inIndia, the Company plans to perform Phase III clinical trials in US for supplying theanthrax vaccine to the U.S. Government under Emergency Use Authorisation.
National Institutes of Health (NIH), U.S.: The Company has an in-licensing arrangementwith NIH, USA, for use of a peptide-based product for generation of hair follicles, hairgrowth for alopecia (hair loss) management and recombinant dengue vaccine.
Dr. Reddy's Laboratories Ltd.: The Company has a License and Supply Agreement with Dr.Reddy's for the supply of its patented product, Nimesulide Injection, for marketing inIndia. The Company has another License and Supply Agreement with Dr. Reddy's for anotherpatented product, Nimesulide Transdermal Gel, for marketing, distribution and sale inRussian Federation.
National Research Development Corporation (NRDC), India: The Company has in-licensingarrangement with NRDC for manufacturing the Foot and Mouth Disease (FMD) Vaccine developedby Indian Veterinary Research Institute (IVRI).
PT BioFarma, Indonesia: The Company has an agreement with PT BioFarma, to manufacture& market the measles vaccine and plans to supply the vaccine to UNICEF, PAHO and CIS,African, LATAM and Asian Countries in furtherance to Global Measles Reduction Strategy ofWHO and UNICEF.
Punjab University, Chandigarh: The Company has a MoU with Punjab University, Chandigarhfor a Drug Discovery Project to identify lead molecules with an aim to bring a newchemical entity (NCE) superior to existing marketed products in the therapeutic area ofPsychiatric Disorders. Panacea Biotec will undertake their preclinical and clinicaldevelopment leading to their launch worldwide.
Kremers Urban Pharmaceuticals Inc. (UCB Group): The Company has entered into a firmlong term contract with Kremers Urban for the distribution of some of its products in US.Panacea Biotec's ANDA for one of the products is under advanced stage of review with FDAand the approval is expected during this fiscal. Under the terms of the agreement PanaceaBiotec would be responsible for development, registration and commercial supplies of theproducts while Kremers Urban would be responsible for marketing, sales and distribution.
Summarised Balance Sheet
| || ||(Rs. in million) |
|Particulars ||As at March 31, 2012 ||As at March 31,2011 |
|Sources of Funds: || || |
|Shareholders' Funds ||8,120.4 ||6,368.1 |
|FCMITDA* ||20.5 ||- |
|Non-current liabilities ||5,055.9 ||5,017.4 |
|Current liabilities ||5,332.0 ||5,792.4 |
|Total Liabilities ||18,528.8 ||17,177.9 |
|Application of Funds: || || |
|Fixed assets ||10,483.7 ||6,523.6 |
|Non-current investments ||2,584.7 ||2,329.4 |
|Long-term loans and advances ||821.7 ||1,046.5 |
|Other non-current assets ||1.2 ||0.9 |
|Current assets ||4,637.5 ||7,277.5 |
|Total Assets ||18,528.8 ||17,177.9 |
*Foreign Currency Monetary Item Translation Difference Account
Net Worth: The net worth of Company has increased to Rs.8,120.4 million during the yearunder review from Rs.6,367.8 million as at the end of previous year registering anincrease of 27.5% mainly on account of fair valuation of land & building amounting toRs.3,830.2 million (net of depreciation).
Non-Current Liabilities: Non-current liabilities include long term borrowings, deferredtax liabilities and long term provisions. The long term borrowings as at 31st March, 2012,have increased to Rs.4830.3 million as against Rs.4237.2 million as at 31stMarch,2011, mainly on account of availment of foreign currency term loan from Bank ofIndia amounting to Rs.1,272 million. The deferred tax liability has decreased to Rs.205.0million as at the end of fiscal 2012 as compared to Rs.756.6 million as at the end of theprevious year. The long term provision has decreased to Rs.20.6 million as at the end offiscal 2012 as compared to Rs.23.6 million as at the end of the previous year.
Current Liabilities: Current liabilities include short term borrowings, trade payables,other current liabilities and short term provisions. The short term borrowings as at 31stMarch, 2012, has decreased to Rs.2,693.4 million as against Rs.3824.4 million mainly onaccount of repayment of working capital term loan & buyers' credit. The trade payableshave increased to Rs.1,181.4 million as at the end of fiscal 2012 as compared to Rs.826.9million as at the end of the previous year. The other current liabilities have increasedto Rs.1,363.6 million as at the end of fiscal 2012 as compared to Rs.1,010.0 million as atthe end of the previous year mainly on account of availment of foreign currency term loanfrom SBI. The short term provisions have decreased to Rs.93.6 million as at the end offiscal 2012 as compared to Rs.131.1 million as at the end of the previous year.
Fixed Assets: The net fixed assets increased to Rs.10,483.7 million as againstRs.6,523.6 million as at the end of the previous year on account of fair valuation of Land& Building, capital expenditure on ongoing expansion/new projects and capitalisationof forex exchange gains as per option given by the Companies (Accounting Standards)Amendment Rules, 2009.
Non-current investments: The non-current investments increased to Rs.2,584.7 millionfrom Rs.2,329.4 million as at the end of the previous year on account of investment innon-cumulative redeemable preference shares of Rs.172.5 million in its subsidiary Best OnHealth Ltd. and investment of Rs.14.2 million in its subsidiary Lakshmi& Manager Holdings Ltd.
Long-term loans and advances: The long term loans & advances decreased to Rs.821.7million as against Rs.1,046.5 million as at the end of the previous year on account ofprovision made during the current year in respect to loan given to the overseas WOS ReesInvestments Ltd.
Other non-current assets: The Other non-current assets have increased to Rs.1.2 millionas at the end of fiscal 2012 as compared to Rs.0.9 million as at the end of the previousyear.
Current Assets: Current Assets include trade receivables, inventories, cash & bankbalances, short term loans & advances and other current assets. The trade receivableshave decreased to Rs.664.5 million as at the end of fiscal 2012 as compared to Rs.2,788.4million as at the end of the previous year. The inventories have decreased to Rs.3,397.3million as at the end of fiscal 2012 as compared to Rs.3,680.2 million as at the end ofthe previous year. The cash and bank balances have come down to Rs.113.3 million as at theend of fiscal 2012 as compared to Rs.393.8 million as at the end of the previous year. Theshort term loan & advances have increased to Rs.411.7 million as at the end of fiscal2012 as compared to Rs.334.8 million as at the end of the previous year. The other currentassets have decreased to Rs.50.7 million as at the end of fiscal 2012 as compared toRs.80.3 million as at the end of the previous year.
Summarised Profit & Loss Account
| || ||(Rs. in million] |
|Particulars || |
For the year ended
| ||31.03.2012 ||31.03.2011 |
|Net Turnover ||6,883.8 ||11,304.6 |
|Other Operating Income ||122.0 ||193.7 |
|Revenue from operations (net) ||7,005.8 ||11,498.3 |
|Materials & Finished Goods ||3,472.0 ||5,307.0 |
|Purchases || || |
|Employee benefits expense ||1,504.5 ||1,543.1 |
|Other expenses ||2,968.4 ||1,959.1 |
|Earnings Before Interest, ||(939.1) ||2,689.1 |
|Depreciation, Taxes & || || |
|Amortisation (EBITDA) || || |
|Other Income ||74.6 ||156.8 |
|Finance costs ||1,011.1 ||557.5 |
|Depreciation and amortisation expense ||753.9 ||731.1 |
|Profit/ (Loss) Before Tax (PBT) ||(2,629.5) ||1,554.9 |
|Provision for Taxes (including deferred tax) ||(551.6) ||204.4 |
|Profit/(Loss) After Tax (PAT) ||(2,077.9) ||1,350.5 |
Segment-wise Net Turnover
|Fiscal || |
| ||Rs. Million ||% ||Rs. Million ||% |
|Vaccines ||3,579.5 ||52.0 ||8,332.3 ||73.7 |
|Pharmaceutical Formulations ||3,304.3 ||48.0 ||2,972.3 ||26.3 |
|Total ||6,883.8 ||100.0 ||11,304.6 ||100.0 |
Vaccines: In fiscal 2012, the Vaccines segment's turnover declined by 57.0% andcontributed Rs.3579.5 million or 52.0% of net turnover, as compared to Rs.8,332.3 or 73.7%of net turnover for fiscal 2011 due to decline in the institutional vaccine business whichcontributed Rs.3,275.1 million as against Rs.8,036.6 million during the fiscal 2011,registering a degrowth of 59.3%. The decline in institutional business was primarily onaccount of delisting of the Company's pentavalent and oral polio vaccines from the WHO'slist of pre-qualified vaccines. The Vaccine sales to CPV for domestic market marginallyincreased toRs.304.4 million during fiscal 2012 from Rs.296.2 million during fiscal 2011.
Pharmaceutical formulations: The pharmaceutical formulations segment's turnover grew by11.1% and contributed Rs.3,304.3 million or 48.0% of net turnover during fiscal 2012, ascompared to Rs.2,972.3 million or 26.3% of the net turnover for fiscal 2011.
Materials & Finished Goods purchases: The raw and packing materials and finishedgoods purchases during the year under review has decreased by 34.6% at Rs.3,472.0 millionas against Rs.5,307.0 million during the previous financial year due to decline in the netturnover.
Employee benefits expense: The employee benefits expenses decreased by 2.5% toRs.1,504.5 million for fiscal 2012 from Rs.1,543.1 million for fiscal 2011.
Other Expenses: The other expenses increased by 51.5% to Rs.2,968.4 million for fiscal2012 from Rs.1,959.1 million for fiscal 2011 mainly on account of increase in operationalcosts like power & fuel, repair & maintenance and also due to higher provisioningfor doubtful debts & advances, loss on sales /discard of fixed assets and adverseexchange fluctuations.
Finance costs: Finance cost increased significantly to Rs.1,011.1 million during fiscal2012 as against Rs.557.5 million during fiscal 2011. The increase in interest charges isattributable to higher utilisation of borrowed funds for meeting funds requirement forcapital as well revenue expenditure on expansion /upgradation/ modification facilitiespost delisting of the Company's vaccines, higher interest rates leading to higher interestcost and adverse exchange fluctuations.
Depreciation and amortisation expenses: Depreciation has increased marginally by 3.1%to Rs.753.9 million as compared to Rs.731.1 million during fiscal 2011.
Earnings Before Interest, Tax, Depreciation & Amortisations (EBITDA): The Companyregistered negative EBITDA of Rs.939.1 million for fiscal 2012 as compared to positiveEBITDA of Rs.2,689.1 million for fiscal 2011 due to reasons explained above.
Profit/(Loss) Before Tax (PBT): The Company incurred a loss before tax of Rs.2,629.5million for fiscal 2012 as against PBT of Rs.1,554.9.0 million for fiscal 2011 due toreasons explained above.
Profit/(Loss) After Tax (PAT): The loss after tax was Rs.2077.9 million for fiscal year2012 against PAT of Rs.1,350.5 million for fiscal 2011 due to reasons explained above.
Earning per Share (EPS): The basic and diluted EPS stood negative at Rs.33.92 per shareas compared to positive EPS of Rs.21.4 per share for the fiscal 2011 due to reasonsexplained above.
Cash Flow Statement
The following table summarises our cash flows from various activities:
| || ||(Rs. in million) |
|Cash Flows from: ||Fiscal 2012 ||Fiscal 2011 |
|Operating Activities ||2,552.4 ||929.5 |
|Investing Activities ||(1,217.1) ||(226.2) |
|Financing Activities ||(1,613.7) ||(670.6) |
|Net Cash Flows ||(278.4) ||32.7 |
Cash Flow from Operating Activities: The net cash flows from operating activitiesduring fiscal 2012 was Rs.2,552.4 million as compared to Rs.929.5 million during fiscal2011 registering an increase of 174.6% during fiscal 2012 primarily on account of decreasein inventories and other receivables and increase in trade payables and other currentliabilities.
Cash Flow from Investing Activities: Net cash used in investing activities amounted toRs.1,217.1 million as primarily on account of investment in setting up of oncologyfacility at Baddi, Himachal Pradesh, addition of fixed assets for various ongoingexpansion and long term investments.
Cash Flow from Financing Activities: Net cash used in Financing Activities amounted toRs.1,613.7 million as primarily used for the repayment of borrowings.
Consolidated Financial Statements:
The consolidated net revenue from operations of the group has decreased to Rs.7,100.9million during financial year 2011-12 as compared to Rs.11,678.8 million during financialyear 2010-11,primarily on account of reasons explained above. Accordingly the consolidatedEBITDA was negative at Rs.863.1 million for fiscal 2012 as compared to positive EBITDA ofRs.2,684.1 million for fiscal 2011. On consolidated basis, group has incurred loss beforetax of Rs.2,553.2 million for fiscal 2012 as against profit before tax of Rs.1,543.7million for fiscal 2011. The consolidated loss after tax was Rs.2,056.6 million for fiscalyear 2012 against PAT of Rs.1,446.7 million for fiscal 2011.
Opportunities and Outlook
Indian pharmaceutical industry is one of the largest and most advanced pharmaindustries in the developing world. India has the highest number of U.S. FDA approvedplants outside the U.S. and accounts for around 20% of all the Abbreviated New DrugApplications (ANDAs) filed with USFDA. The expertise of Indian pharma companies inmanufacturing low cost qualitative products and research & development offers a hugeopportunity due to multi-billion drugs going off patent in the next couple of years as itis going to expand the potential in the generic industry in the regulated markets ofworld.
SWOT Analysis Strengths:
Indigenous capabilities of developing first in class and best in class NCEs,NBEs and patented drug delivery systems
Strong manufacturing capabilities
Cost competitiveness with quality products
One of the largest English speaking scientific and technical manpower in theworld
Established marketing and distribution network and presence in major markets
Relatively low investments in R&D
Price Control Regulations: strict monitoring by government through price controlof several products
Patent regime still not as strong as in developed markets.
Significant export potential in regulated markets on account of large number ofdrugs going off patent from 2012 onwards.
Increasing opportunities in other pharmerging markets across the globe
Emerging opportunities in Biotechnology and Biosimilars
Increasing coverage of vaccines under National Immunisation
Large population base, increasing lifestyle related diseases and increasinghealthcare expenditure offer significant future opportunities
Contract research & manufacturing services opportunities.
Collaborative alliances with MNCs for production, sales and distribution ofproducts in India and abroad
Threats, Risks and Concerns:
Risks, challenges and threats are inherent in any type of industry and needs to bemitigated through well planned strategies. The major risks/concerns associated to theindustry as a whole are as under:
Increasing timelines in obtaining regulatory approvals in key markets
Increasing regulatory requirements for conducting large and complexclinical trials
Pricing pressure across the globe
High volatility in currency exchange rates affects the industry adversely
Increasing competition from developing countries due to lower manufacturingcost
Increasing pressure from government to bring more and more products underprice control
Rising costs of regulatory compliance in the form of audit burdens,inspections and fines
Strong lobbying by MNC players having increased business interests inIndia
Risk of Product failure - a risk of all R&D initiatives not leading tocommercially viable and successful products
Risk of IPR challenges
Besides above, there are a few risk factors that are applicable to the Company'soperations and business. While the effective measures are taken by the Company to minimiseor eliminate the impact of these risks on its business performance, they nonethelessexist. Some such risks, challenges or threats are outlined below:
Cost and time overrun issues with several projects in the past.
High attrition in sales and marketing
Significant dependence over tender based institutional business
Revenue contribution highly skewed towards few products.
Adverse developments at JV/Collaboration partners may impact the future ofsuch JVs/Collaborations
Future Growth Drivers
During the year under review, the Company has faced many business challenges and is inprocess of implementing several corrective and preventive measures to overcome thesechallenges. With these measures, the Company's existing capabilities will get furtherstrengthen thereby ensuring that the Company is strategically positioned against itscompetitors. The Company has well laid strategy for its future growth with clearlyidentified growth drivers to ensure it derives sustainable revenues and profits in future.
The Company's key future growth drivers are as under:
Launch of several difficult to develop generic and innovative products inICH regions and other key pharmerging markets through partnership/out-licensing tostrategic partners
Launch of DTwP and IPV based combination pediatric vaccines
Launch of new IPV & acellular pertussis based combination Vaccinescurrently under development for pediatric age group
Launch of critical vaccines like Pneumococcal conjugate vaccine, JapaneseEncephalitis vaccine, Dengue Vaccine etc.
Global launch of Biosimilars
Strengthening product portfolio through internal development and/or in-licensing ofproduct/technologies.
Diversification in related healthcare segment
In addition to above identified growth factors, the Company will continue to explorefurther opportunities to fasten its growth strategy.
Corporate Social Responsibility
Panacea Biotec recognises Corporate Social Responsibility as one of its core values.
Safety, Health and Environment Protection
The Company is privileged to be working in the healthcare industry in which it has theopportunity to contribute towards improving the health of patients. The Company undertakesall its operations with a high concern and sincerity for environment and its surroundingsas well as the safety and health of people. The Company has dedicated Environment &Occupational Health and Safety (EOHS) Protection department and also engages the servicesof outside consultant for independent evaluation of EOHS activities.
The Company has made substantial investments in setting up Effluent Treatment Plants,Air pollution control devices and in developing "Green Belt" and greenlandscaping at the manufacturing sites at Baddi to prevent possible adverse environmentalimpact on the community. All type of wastes, i.e. non-hazardous, hazardous &bio-wastes generated are managed separately and adequately as per the norms, these dataare maintained on line in pollution control board's web site. All personnel working invaccine plant are vaccinated as per the Vaccination Policy. Manufacturing and virushandling areas are provided with cascaded negative pressure differentials with respect toair locks and corridors respectively. The air exhaust (AHU) from all process areas passthrough HEPA systems (HEPA filters) with attached viral burning unit before going to outeratmosphere. It has dedicated decontamination autoclave for removal of biohazardous wastematerial
The Company has installed Modern Fire fighting facility e.g. Hydrant System, smoke /heat detection & sensing devices at its all major facilities, for an early detectionand extinguishing of accidental fire. The fire suppression systems also include fireresistant compartmentation, fire detection system and fire extinguishers at allfacilities. The company has trained Emergency Management Teams at all locations to controlemergency situations, if any. Different mock drills / fire-fighting drills are conductedto create awareness amongst the employees during emergency situation. Regular safetytraining is also provided to the employees about the importance of safety in day-to-daylife in general and work in particular. The integration of environment friendly measuresand cleaner production practices in the business process has resulted in better efficiencyof operations.
The company celebrated "National Safety Week" in March by conducting varioussafety programs and prize distribution ceremony.
Panacea Biotec has continued its efforts in making a difference to the lives of people.It works closely towards the development of society, in line with its philosophy ofcreating happier and healthier society. Health, education, disaster relief and patientawareness have been identified as the areas of priority. The Company's emphasis has beenon providing assistance on a need basis, and that too, assistance at a local level. TheCompany also regularly provides financial assistance or sponsorship for pursuing postgraduates/doctorate studies and carrying out research projects being undertaken byResearch Associates in various Institutes & Universities.
The Company's commitment and actions towards making affordable vaccines for masspopulation across the globe as part of social responsibility were well appreciated andvalued by GAVI alliance and Bill & Melinda Gates Foundation at pledge conference atLondon in June 2011. Mr. Bill Gates has himself cherished the efforts taken by Dr. RajeshJain's towards this noble act.
The Company regularly takes initiatives towards fulfilling its corporate socialresponsibility including:
SURAKSHA: Detection and Awareness Camps on Diabetes & Complications wereorganised wherein blood sugar was screened along with neuropathy & nephropathy, thetwo most common complications of diabetes
PREVENT: Diabetes & Complications Management Guidelines from IndianPerspectives. For the 1st time in India, the Company initiated this uniqueproject PREVENT to help Indian clinicians at primary care set-ups diagnose and managediabetes and complications. The Company also came out with a book PREVENT
PANDEPTH: Under this program, the Company initiated the awareness program forchecking heart problems while checking diabetes for the patients to help early screeningof heart problems in diabetes. Incidentally, heart disease is the leading cause of deathin diabetics
PANCHECK, DDC & HbA1c Camps: These camps were organised for creatingawareness in the society with regard to Diabetes & its complications. In PANCHECK -patients Triglyceride & Total Cholesterol levels are screened. In DDC & HbAlcpatients' random sugar levels and their HbA1c levels are detected
DHRUVARSITY: In this activity, the company is conducting workshops inCardiology for medical students in which they are guided by the profound FacultyCardiologists, DM/ DNB panelists. This serves guidance for upcoming young cardiologists inthe society
CONTROL: Dyslipidemia - Recommendations in Management of Indian Patients- For the 1st time in India, the Company initiated this unique project "CONTROL"a book created by 11 Panelists chaired by Dr. Jamshed Dalal, to help Indian cliniciansproviding immense use to practicing Physicians, Endocrinologists & Cardiologistsmanaging Dyslipidemia in Asian Indians in India & abroad
Winners of Life: "Breast Cancer Survivors Meets" were organised atvarious places across India as a part of International Breast Cancer Awareness Month inOctober to enhance the confidence and motivation of the patients as well as the medicalfraternity to fight against Breast Cancer.
No Tobacco Campaign: Organised on 31st May across India, whereby awarenesswas created amongst the masses towards the ill effects of tobacco via posters, patienteducation pamphlets, etc
Lung Cancer Awareness Month: Organised in the month of November wherein GreyRibbon badges were distributed amongst the masses and Lung Models depicting cancer weredisplayed for showing concern in eradicating the dreaded disease
Support to National Brain Tumor Association: The Company regularlypurchases greeting cards from this Association who generates money which is used for thepatients suffering from Brain Tumour
Lighthouse: The Company has taken up the major initiative of supporting thelaunch of a patient counseling helpline namely "Lighthouse" for organ transplantrecipients
Transplant Fortnite: A patient education campaign was organised by theCompany for providing information and sharing of experience amongst transplant recipientsand their loved ones
Soft Skill Training: Various skill workshops are organised for the medicaland para-medical staff and other people connected with the health care delivery profession
Renal Fortnight: a special Patient-Doctor interaction program to createawareness amongst the mass done at more than 75 major Nephrology Centers across thecountry
World Environment Day: The Company also celebrates "World EnvironmentDay" (5th June) by conducting social activity in nearby villages andplantation through employees to motivate and aware the employees as well as surroundingcommunity every year
Tree Plantation of about 500 plants was conducted at Lalru site and at linkroad ex Lalru to Choundheri
Donation of life saving drugs to Charitable Dispensaries, Institutions,Research Projects and hospitals as per their needs and free medicines to various Dental/Medical Colleges for conducting trials
Various other programs were organised on Constipation Management, PilesAwareness and Osteoporosis awareness.
Piles detection camps were organised at different public locations for thebenefit of employees of public municipal transport and police department
Contribution to several NGOs for supporting their efforts and contributionfor social cause in the field of medicine, education and culture etc
Contribution to Blood donation camp by providing blood donors continuouslyon regular basis
Contribution in eye camp, orgnised by Bharat Vikas Prishad Lalru, with thehelp of doctors (Eye Specialists)
Launch of website www.ckdmbd.org by Nephrology SBU ,as India's first onlineresource as an educational initiative, This website elucidates information extending frombiochemical bone and vascular derangements associated with CKD MBD for practicingNephrologists as well as patients
Note: As a result of rounding off adjustments, the figures/ percentages in a columnin various sections in the Annual Report may not add up to the total for such column.