To the Members
Directors have pleasure in presenting the 81st Annual Report together withthe Audited Accounts for the year ended 31st March 2021.
1. STANDALONE FINANCIAL RESULTS
(Rs. in Lakhs)
|Particulars ||2020-2021 ||2019-2020 |
|Revenue from Operations ||132544.91 ||133109.30 |
|Other income ||9714.59 ||8265.75 |
|Total Income ||142259.50 ||141375.05 |
|Profit (before finance costs and depreciation /amortisation) ||42147.58 ||36623.81 |
|Finance costs ||340.22 ||341.49 |
|Depreciation and amortisation ||3762.33 ||3736.33 |
|Profit before tax ||38045.03 ||32545.99 |
|Less: Taxation || || |
|- Current Tax ||8450.00 ||8280.00 |
|- Deferred Tax ||144.49 ||(411.87) |
|- Tax adjustments-earlier year ||1.58 ||- |
|Profit After Tax ||29448.96 ||24677.86 |
|Other Comprehensive Income/(Loss) for the year ||605.99 ||(355.63) |
|Total Comprehensive Income/(Loss) for the year ||30054.95 ||24322.23 |
|Earnings per equity share (Basic & Diluted) (Face value Re.1) ||17.32 ||14.34 |
2. BUYBACK OF SHARES
The Board of Directors at its meeting held on 07th August 2020 had approveda proposal of the Company to buy-back its 2163000 fully paid-up equity shares havingface value of Re. 1 each from the eligible equity shareholders of the company who havevalidly tendered their shares. The buy-back was offered to all eligible equityshareholders of the Company on proportionate basis through the "Tender offer"route in accordance with SEBI (Buy-back of Securities) Regulations 2018. The Buyback ofequity shares through the stock exchange commenced on 16th September 2020 andwas completed on 15th October 2020 and the Company bought back and extinguisheda total of 2163000 equity shares at a price of ' 450/- per equity share comprising of1.27% of pre-buyback paid up equity share capital of the Company. The buyback resulted ina cash outflow of ' 9733.50 Lakhs excluding transaction cost viz. brokerage applicabletaxes such as securities transaction tax service tax stamp duty etc. cost for theintermediaries appointed for the buyback and other incidental costs.
The Board of Directors of the Company after considering relevant circumstances inPharmaceutical Industry has decided that it would be prudent not to recommend anydividend for the year under review.
The Company has formulated Dividend Distribution Policy which is annexed as "AnnexureA" and it is also uploaded on the website of the Company i.e. www.fdcindia.com.
4. SHARE CAPITAL
During the year under review the paid up Equity Share Capital of the Company as on 31stMarch 2021 is as follows:
|Subscribed and Paid-up share capital : ||31st March 2021 ||31st March 2020 |
|168810084 (Previous year 170973084) Equity shares of Re. 1 each fully paid-up ||1688.10 ||1709.73 |
|Add: Nil (Previous year - 3145000) Equity shares forfeited || ||7.86 |
|Less: Nil (Previous year - 3145000) Equity shares forfeited Cancelled || ||(7.86) |
|Total ||1688.10 ||1709.73 |
5. MANAGEMENT DISCUSSION AND ANALYSIS REPORT
The Management of the Company presents the analysis of its performance for thefinancial year ended 31st March 2021 and its outlook for the future. Thisoutlook is based on assessment of the current business environment. It may vary due tofuture economic and other developments both in India and abroad.
GLOBAL PHARMACEUTICAL INDUSTRY
The global pharmaceutical industry is amongst the fastest growing industries globallyand one of the biggest contributors to the world economy. As per a research report fromthe IQVIA Institute for Human Data Science the global pharmaceutical industry isestimated to be at US$1228.45 billion in 2020.
In 2021 the global pharmaceuticals market is expected to grow by 1.8% to reachUS$1250.24 billion. The growth is likely to be mainly due to the companies rearrangingtheir operations and recovering from the COVID-19 impact which had earlier led torestrictive containment measures involving social distancing remote working and theclosure of commercial activities that resulted in operational challenges. The market isfurther expected to reach US$1700.97 billion in 2025 at a compounded annual growth rate(CAGR) of 8%. North America dominated the global pharmaceuticals market with 46% share in2020. Asia Pacific accounted for 26% while Africa was the least contributing region.
INDIAN PHARMACEUTICAL INDUSTRY
The Indian pharmaceuticals market (IPM) is dominated by generic drugs which constitutenearly 70% of the market whereas over the counter (OTC) medicines and patented drugs makeup to 21% and 9% respectively.
Due to COVID-19 impact as per IQVIA Report the Indian Pharmaceutical Market (IPM)grew in single digit at 4% with total sales reported at ' 156797 Crore in FY2020-21. IPM de-grew by 4% in the 1st Quarter (Q1) FY 2020-21 but maintainedpositive growth from second quarter onwards growing by 4% in Q2 and 9% in both Q3 and Q4of FY 2020-21. According to the Indian Economic Survey 2021 the domestic market isexpected to grow three times in the next decade. It is estimated at US$ 41 billion in2021 having grown 10 times in the last 2 decades and is likely to reach US$ 65 billionby 2024 and further expand to reach ~US$ 120-130 billion by 2030.
COVID-19 Impact fightback from the Indian Pharmaceutical Industry:
research & Development related to CoVID-19: On 14th July 2020Bharat Biotech started the first phase of human clinical trials for India's first COVID-19vaccine candidate COVAXIN. The drug was being developed by Bharat Biotech in collaborationwith Indian Council of Medical Research's Pune-based National Institute of Virology.
Indian Players Global exposure: In February 2021 the Russian Ministry of Healthallowed Glenmark Pharmaceuticals to market its novel fixed-dose combination nasal spray inRussia. In November 2020 Hetero Drugs a Hyderabad-based pharmaceutical company reachedan agreement with the Russian Direct Investment Fund (RDIF) to produce >100 milliondoses per year of the RDIF's Sputnik V COVID-19 vaccine in India.
technological Initiatives: On 15th October 2020 India and theNetherlands unveiled plans to collaborate with the aim of providing digital healthfacilities and security to all citizens. As a part of India's National Digital HealthMission (NDHM) through this cooperative initiative the two countries will work closelyto create capacities and put in place the requisite technology to enable this initiative.
The Indian pharmaceuticals market is the third largest in terms of volume and 13thlargest in terms of value. Indian drugs are exported to more than 200 countries in theworld with US being the key market. Generic drugs account for 20% of the global export interms of volume making the country the largest provider of generic medicines globally. Itis expected to expand even further in the coming years. The Indian pharmaceutical exportsincluding bulk drugs intermediates drug formulations biologicals Ayush and herbalproducts and surgical stood at US$ 20.14 billion in FY 2020-21 as compared to US$ 16.28billion in FY 2019-20. India has exported US$ 3.89 billion of bulk drugs & drugintermediates in FY 2019-20 and US$ 3.66 billion in FY 2020-21. India has one of thelowest manufacturing costs in the world. It is lower than that of USA and almost half ofEurope.
Source: Directorate General of Commercial Intelligence and Statistics. EXIM Analytics
Cost efficiency: Low cost of production and R&D boosts efficiency of Indianpharma companies leading to competitive exports. Indian pharma export reached US$ 16.28billion in FY 2019-20. As of 2019 India's cost of production is ~33% lower than that ofthe US. India's ability to manufacture high quality low priced medicines presents a hugebusiness opportunity for the domestic industry.
Economic Drivers: India is a fast-growing nation. The economic prosperity as aresult of it is likely to improve drug affordability. This will also contribute toincrease in penetration of health insurance which will drive expenditure on medicine.Further with the increasing penetration of pharmacies especially in rural India OTCdrugs will be readily available.
Policy Support: The Government's approval of Production-linked Incentive (PU)scheme for the pharmaceuticals sector from FY 2020-21 to FY 2028-29 is expected to attractinvestments of ' 15000 Crore (US$ 2.07 billion) into the sector. It is alsoexpected to lead to incremental sales of ' 294000 Crore (US$ 40.63 billion) andexports of ' 196000 Crore (US$ 40.63 billion) between FY 2022-23 and FY 2027-28.
Increasing Investments: The foreign direct investment (FDI) inflows in the Indiandrugs and pharmaceuticals sector stood at US$ 17.75 billion between April 2000 andDecember 2020.
Biosimilar: The Government's plans to allocate US$ 70 million for local players todevelop Biosimilar will boost the domestic market and it is expected to reach US$ 35billion by 2030.
Formulations: India is the largest exporter of formulations in terms of volumewith 14% market share and 12th in terms of export value. Double-digit growth isexpected over the next five years.
Source: RNCOS BMI Datamonitor Kemwell Biopharma Chemical Pharmaceutical GenericAssociation ICRA Report estimates pharmanewsprwire. com
Industry Growth Drivers
|DEMAND SIDE DRIVERS ||SUPPLY SIDE DRIVERS |
|ACCESSIBILITY: New business models are expected to penetrate tier-2 and 3 cities. Over 160000 hospital beds are expected to be added each year in the next decade. ||LAUNCH OF PATENTED DRUGS: Following the introduction of product patents several multinational companies are expected to launch patented drugs in India. Growth in the number of lifestyle diseases in India could boost the sale of such drugs. High Court has also allowed to export patented drugs to foreign players in the Indian market. |
|ACCEPTABILITY: Pharmaceuticals is likely to see increased acceptability with rising literacy increased propensity of patients to self-medicate which will boost the OTC market rising acceptance of biologics and preventive medicine and surge in medical tourism. ||MEDICAL INFRASTRUCTURE: Pharma companies have increased spending to tap rural markets and develop better medical infrastructure. Hospitals' market size is expected to increase by US$ 200 billion by 2024. |
| ||Medical devices industry in India has been growing 15.2% annually and was valued at US$ 5.2 billion in 2018 and is expected to reach US$ 50 billion by 2025. |
|PRADHAN MANTRI BHARTIYA JANAUSHADHI KENDRAS (PMBJK): Over 650 million people are expected to be covered by health insurance by 2020. The Government plans to provide free generic medicines to half the population at an estimated cost of US$ 5.4 billion. ||SCOPE IN GENERIC MARKET: India's generic drugs account for 20% of global exports in terms of volume making it the largest provider of generic medicines globally. The generics drug market accounts for around 70% of the India pharmaceutical industry and it is expected to reach US$ 27.9 billion by 2020. |
|Affordable medicines under PMBJK achieved an impressive sale of ' 100.40 Crore (US$ 14.24 million) in first two months of FY 2020-21. || |
|EPIDEMIOLOGICAL FACTORS: Patient pool is expected to increase over 20% in the next 10 years (until 2030) mainly due to rise in population new diseases and increasing prevalence of lifestyle diseases. ||OTC: India's OTC drugs market is estimated to have grown at a CAGR of 16.3% to US$ 6.6 billion over 2008-16 and is further expected to grow on the account of increased penetration of chemists especially in rural regions. The India OTC market was accounted at US$ 4.61 billion in 2018 and is expected to reach US$ 10.22 billion by 2024. |
| ||PATENT EXPIRY: About 120 drugs are expected to go off-patent over the next 10 years; with expected worldwide revenue between US$ 80 to US$ 250 billion. |
Source: BMI India Biz Nicholas Hall & Company IQVIA. ICRA Report on IndianPharmaceutical Sector Pharmaceutical Industry: Developments in India- Deloitte MckinseyPharma Report 2020
Opportunities in Healthcare
Clinical Trial Market: India is among the leaders in the clinical trial market. Dueto a genetically diverse population and availability of skilled doctors India has thepotential to attract huge investments to its clinical trial market.
High-end Drugs: Due to increasing population and income levels demand for high-enddrugs is expected to rise. Growing demand could open up the market for production ofhigh-end drugs in India.
Penetration in Rural Market: With 70% of India's population residing in ruralareas pharma companies have immense opportunities to tap this market. Demand for genericmedicines in rural markets has seen a sharp growth. Various companies are investing in thedistribution network in rural areas.
CRAMS: The Contract Research and Manufacturing Services (CRAMS) industry -estimated at US$ 17.27 billion in FY 2017-18 is expected to reach US$ 20 billion by theend of 2020. The market has more than 1000 players.
Source: BMI Drug Controller General of India
Industry Risks and Outlook
The Indian pharmaceutical industry has been a world leader in generics both globallyand in domestic markets contributing significantly to the global demand for generics interms of volume. Made-in-India drugs supplied to the developed economies such as the USEU and Japan are known for their safety and quality. While in recent years the US markethad remained subdued for Indian pharmaceutical companies due to competitive intensity inthe generic space and consolidation of pharmaceutical distributors the situation has seenan improvement. Further Indian pharmaceutical players have steadily migrated up the valuechain to focus on value-added formulations with higher margins. India's ability tomanufacture high quality low priced medicines will continue to present a huge businessopportunity for the domestic industry.
In the domestic market medicine spending is projected to grow 9-12% over the next fiveyears leading India to become one of the top 10 countries in terms of medicine spending.Going forward better growth in domestic sales would also depend on the ability ofcompanies to align their product portfolio towards chronic therapies for anti-diabetesanti-depressants and anti-cancers segments which are on the rise.
The Government aims to increase healthcare spending to 3% of the Gross Domestic Product(GDP) by FY 2021-22. This will also drive the growth of the pharmaceutical market inIndia. Several steps are also being taken by the Government to reduce costs and bring downhealthcare expenses. Speedy introduction of generic drugs into the market has remained infocus and is expected to benefit the Indian pharmaceutical companies. Additionally thethrust on rural health programmes lifesaving drugs and preventive vaccines also augurswell for the pharmaceutical companies.
Finally the Indian pharmaceutical industry has been relatively resilient to theCOVID-19 disruption and is poised to gain from favourable currency tailwinds and stableoutlook for India and US business.
FINANCIAL PERFORMANCE AND OPERATIONS REVIEW
In FY 2020-21 the Company registered a standalone total income of ' 142259.50Lakhs compared to ' 141375.05 Lakhs in the previous year.
The Earnings before Interest and Depreciation amounted to ' 42147.58 Lakhs inFY 2020-21 as compared to ' 36623.81 Lakhs in the previous year. The Net Profitafter Taxation stood at ' 29948.96 Lakhs in FY 2020-21 as compared to '24677.86 Lakhs in the previous year.
On a consolidated basis the Company registered a total income of ' 143022.90Lakhs in FY 2020-21 as compared to ' 141308.88 Lakhs in the previous year therebyregistering a growth of 1.21%.
Financials Performance and Operations ratios are as follows:
| ||2019-20 ||2020-21 ||Diff ||% change |
|Debtors Turnover Ratio (days) ||34 ||30 ||(4) ||-14.59% |
|Inventory Turnover Ratio (days) ||58 ||59 ||1 ||2.30% |
|Interest Coverage Ratio (times) ||107 ||124 ||17 ||13.43% |
|Current Ratio ||3.77 ||4.57 ||1 ||17.48% |
|Debt Equity Ratio* ||0.01 ||0.00 ||(0) ||-53.59% |
|EBIDTA Margin (%) ||28% ||32% ||0 ||13.47% |
|Net profit Margin (%) ||19% ||22% ||0 ||16.56% |
*Due to repayment of loans and lease liabilities Debt equity ratio has changed morethan 25%.
SEGMENT WISE/ PRODUCT WISE PERFORMANCE
1st Quarter FY 2020-21: Due to COVID-19 pandemic and subsequent lockdownbeginning in the first quarter of FY 2020-21 the IPM has de-grown by 4% in FY 2020-21.The de-growth was sharper in April 2020 and May 2020 at 11.4% and 7.6% respectively.Except Cardio-Diabetic market rest all therapies de-grew by double digit. However fromJune 2020 onwards the IPM slowly paced growing at 6.3%.
Anti-viral Market: From June 2020 onwards the Anti-Viral market started pacing. Itgrew by more than 25% in June 2020 thereafter registering a triple digit growth in thebalance quarters. For FY 2020-21 the Anti-Viral market grew strongly at 161.2% largelyled by the new initiatives (growth of Remdesivir and Favipiravir which contributed 60% tothe total Anti-Viral Market. While the NI grew by 196.2% the volume and price de-grew by17.4% and 18.1% respectively.
As usual the top 10 therapies contributed 85% to total IPM growth of 3.2%. Cardiacled by volume and subsequently price growth and Vitamins/ Minerals/ Nutrients (Vits/Mins/ Nutri) led by price and NI growth segments grew in double digits.
Gastro-Intestinal Dermatology (Derma) Nuero/CNS and Gynaecology therapies grew bysingle digit due to price growth followed by NI growth. Except Neuro/CNS rest therapieswitnessed negative volume growth.
Source: IQVIA Secondary Sales Audit Mar' 21
Considering the pandemic scenario the Company launched selective molecules likeFavipiravir Hand Sanitiser Ivermectin Dexamethasone and Paracetamol during the year. Intotal the Company launched the following 13 brands in FY 2020-21:
99F ATA Favenza Piflu Ivsit Salmodil-DX Salmodil-LS Zifi-SB Trigaurd SanitiserUnox Cefponz Dexis and Zivas ASP.
During the year the Company's Gastro-Intestinal Derma Vits/ Mins/ Nutri and Cardiacsegments performed well registering growths of 5% 7% 3% and 10% respectively. In FY2020-21 incremental value measuredly came from Gastro-Intestinal and Anti-viral followedby Derma and Cardiac.
Source: IQVIA Secondary Sales Audit Mar' 21
Research and Development
The Research & Development (R&D) centres located at Kandivali (Mumbai) are dulyrecognised by the Indian Government's Department of Science and Technology (DST). TheCompany carries out its various R&D activities in the following areas:
The endeavour of the R&D Formulation team at FDC Limited is to develop qualityproducts at affordable prices. The team constantly innovates to develop top qualitypharmaceutical products for the domestic and global markets. The scientists are engaged indeveloping new products using innovative technologies and robust development strategies. Astimulating work environment provides the impetus to deliver the best. There is a constantthrust to address patient needs and efforts to develop products for their treatment areundertaken and delivered with utmost priority. The team has successfully developed andtransferred challenging complex products from the laboratory to the commercial level.
Some achievements of FY 2020-21 are as follows:
Ready for commercialisation of challenging MPSD (Multiparticulate PharmaceuticalSolid Dosage) technology-based products at plant
Development and successful transfer of technology of Pepcia D capsules andZipant D capsules for domestic market
Commercialisation of Preservative Free UV Lube
Ophthalmic solution to offer a better result for patients with dry eyes for domesticmarket
Abbreviated New Drug Application (ANDA) batches of Azelastine Oph 0.05% Solutionfor the US market
ANDA batches of Pilocarpine Oph Solution
1% for US market
Exhibit batches of Preservative Free Chloramphenicol Solution 0.5% for UK market
Filing of Ofloxacin Otic Solution 0.3% ANDA for the US market.
The Research and Development centre located at Kandivali (Mumbai) engages in processdevelopment of niche products particularly in area of Ophthalmic AntihypertensiveAntifungal Anti diabetic Antihistaminic Bronchodilator and Antibacterial New Chemicalentity (NCE). Currently it also focused on development of API for COVID-19; for exampleFavipiravir. The work on life cycle management of existing drug substances and synthesisof generic Peptide molecules for treatment of Leucoderma (skin Pigmentation) Obesity andAnti diabetic are also being carried out. These initiatives are aimed at costeffectiveness backward integration and meeting regulatory requirement to attainaccreditation from various World Drug Regulatory Authorities.
The other highlights of the process developments of generic drug molecules are:
Usage of environment friendly chemicals
Application of green chemistry principles for protection of environment and toreduce aqueous effluents
Development of desired polymorphs
Usage of classical chemistry for development of chiral drugs
Advanced state-of-the-art new flash and preparative chromatography technique forenhancing purity and yield on commercial scale
I implementation of electronic laboratory notebook software with 21 CFRcompliance for recording daily experiments. Moving towards state-of-the-art 21 CFRcompliant R&D center
Scale up and technology transfer activities ensuring overall chemical safety andprotection of inventions through intellectual property rights i.e. patents.
Nutraceuticals are products which other than nutrition are also used as medicine. Anutraceuticals product may be defined as a substance which has physiological benefits orprovides protection against chronic diseases. Nutraceuticals may be used to improvehealth delay the aging process prevent chronic diseases increase life expectancy orsupport the structure or function of the body.
The division works towards increasing its product categories of Infant Milk Substitute(IMS). It is working on advanced formulations on all four categories of IMS with someadded micro nutrients and beneficial ingredients Enerzal Fortification with addednutritional benefits development of new P2P and LL parties. With this the Company willbe ready to supply current market requirement by launching new range of products underNutraceuticals & Health Supplement category.
The achievements and quality enhancement for the year are as follow:
Sinnar facility successfully got ISO 22000:2018/HACCP and GMP certified by TUVlaboratory
New third parties developed for Tetrapak 200 ml to meet the market requirement
Enerzal Powder Orange Flavour alternate vendor developed and launched
Turmyl Immunity Milk product development completed and launch initiated
Developed new P2P for Enteroplus Probiotic supply in powder as well as capsuleformat
Many products under development such as Enerzal and Enerzal Zero FlavourEnerzal Plus Fortification Enerzal Zero Powder Enerzal Natural Colour IncorporationEnerzal Carbonation Protein Water etc.
a. G-CSF PROJECT:
As mentioned earlier the Company obtained Test license (Test license No: 201515686dated 31st March 2020 under Form 29 for manufacturing of clinical trial batchesof Filgrastim 300 gg/ml drug substance after the Joint inspection conducted by CDSCO (WestZone) and local FDA at its R&D bioprocess Jogeshwari facility.
Validation activity for Bioanalytical methods such as SDS PAGE to test in-processsamples of the clinical trial batches has been completed. Process validation documentationpreparation and Bioassay validation studies are in-process.
b. THIRD GENERATION THROMBOLYTE PROJECT:
The Company has tied up with third party for developing purification strategy forReteplase molecule.
The Company has successfully completed fermentation trials (10L capacity) anddownstream processing trial (lab scale) till refolding stage for Reteplase molecule.
c. MICROBIAL TESTING LAB:
R&D MTL lab has performed screening of the promising NCE's synthesised in largequantities (TNF-18 and
HY-27) to ensure that the efficacy observed in primary screening is consistent andreproducible.
These molecules have been handed over to R&D Formulation department in largequantities for further development. Based on the feedback from R&D Formulation &Medical department CROs shall be explored to test efficacy of developed formulation.
During FY 2020-21 the Company's annual export turnover of Finished Formulations hasgrown by 21% to ' 270 Crore from ' 223 Crore in FY 2019-20.
Major contribution was from revenue of the US and the UK markets which increased 37%from ' 155 Crore in FY 2019-20 to ' 213 Crore in FY 2020-21 helping theCompany to deliver even amidst challenges posed by COVID-19 outbreak.
The US pharmaceutical market is the second largest market for the Company. TheCompany's US business is riding high on the back of opportunities created in the marketplace on account of competitive environment. The Company has reached a critical size inthe US market and operate ' 184 Crore business with the commercialised portfolio.The Company holds leading position in several of them.
The Company continues to work on filing additional ANDAs in the US market to supportexisting basket of ophthalmic products.
With a strong presence in some of the major and most regulated pharma markets acrossthe world the Company has also widened its global presence by entering the emergingeconomies. The Company has marked its presence in a number of other countries of AsiaPacific CIS Africa Middle East and LATAM.
FY 2020-21 saw most regions delivering solid performance. The CIS region supported witha significant growth of 134% and Uzbekistan market was started successfully with receiptof 2 ophthalmic product registrations and their first Launch Purchase Order in thefinancial year.
LATAM region has grown by 63% Africa region by 68% and Australasia by 40%.
Products of the Company are now exported to more than 35 countries across the globe.
To augment the growth in these markets the Company is focusing on introducing newproducts and growing the share in existing products through strategic partnershipagreements for product out-licensing.
Active Pharmaceutical Ingredients
In FY 2020-21 the Company's annual export business of Active PharmaceuticalIngredients
has grown by 24% to ' 61 Crore as compared to ' 49 Crore in FY 2019-20.
Top 10 countries that contributed an appreciation of 75% to the API revenue for the FY2020-21 are USA Germany Taiwan Pakistan Turkey South Korea Bangladesh Japan UAEand France whose revenues grew to ' 46 Crore as compared to ' 27 Crore in FY2019-20.
The Company's Top 10 markets of API export are:
The Company is exporting its API range of products to more than 50 countries across theglobe and its major revenue of the API business comes from Asia at ' 30 Crorefollowed by Europe at ' 17 Crore and America (USA Canada and Latin America) at '10 Crore. The Company is progressively committed to introducing new range of product mixto its API portfolio and also continues to focus on the existing business as it gears upfor FY 2021-22 for new opportunities.
As regulatory initiative the Company continues to file several new as well asmaintain the existing registrations and accreditations. Its team has successfullycompleted 10 CEP applications which include new as well as the updated existingapplications. 17 New API DMF applications for Ophthalmic range were filed in AsiaSouth-East Asia CIS Europe Africa and Latin America markets. Whereas 4 DMFs wereupdated as a complete DMF in 'Base line' format submission with the USFDA.
With determined companionship the Company is also pivoting to introduce its ophthalmicrange of APIs as its core products to new and emerging markets. The Company hassuccessfully partnered with a few customers in the Asia region for its Ophthalmic APIs andhas also exported some of its ophthalmic products to these countries.
The Company continues to work in line with its strategic plan and road map to obtain asubstantial share in the international market for its API business.
A. Internal Financial Controls and their Adequacy
The Company has in place a robust Internal Financial Control commensurate with thesize scale and complexity of its operations. These controls ensure that the transactionsare recorded and reported diligently adhere to the Company's policies & systemssafeguard the assets prevent and detect the frauds and errors accuracy and completenessof the accounting records and timely preparation of reliable financial information.
The Company has an internal audit department which carries out audits throughout theyear and appropriate actions are taken by the management based on their recommendations.
B. Human Resources
The Company believes that the employees are the most valuable assets and key drivers ofbusiness success and sustained growth. The Human Resource (HR) policies and practices arewell aligned to meet business objectives.
As the Company operates in a highly competitive environment the HR function attractsand retains the best talent for its operations across all locations. The Companyencourages and provides the platform for individuals to excel in their professional andpersonal goals along with the focus on a healthy work life balance. Several initiativeswere carried out through the year to serve employees including fitness programmes.
Being future-ready is one of the key processes for sustainable growth; the Company istherefore building synergy and cultural integration through coherent leadership programmesfor top leaders as a part of its core initiative. The Company has an in-house Training andDevelopment team to help the sales team on products scientific knowledge and sellingtechniques. The Company also conducts various programmes on managerial effectiveness toimprove individual competencies and leadership abilities for sales leadership.Understanding the importance of newer training techniques the Company would be migratingfrom classroom training to an e-learning platform for its sales team in the next financialyear. The web-based training will provide self-paced learning using interactive methods.
In line with the requirement of SEBI listing regulations Company has adopted a"Code of Conduct and Work Ethics Policy and Whistle Blower Policy". The policyon Whistle Blower are uploaded on the Company's website .i.e. www.fdcindia.com.
C. Cautionary Statement
Certain statements in respect to Management Discussion and Analysis Report may beforward-looking and are stated as required by the applicable laws and regulations. Thefuture results of the Company may be affected by many factors which could be differentfrom what the Directors' envisage in the terms of future performance and outlook.
6. MATERIAL CHANGES AND COMMITMENTS AFTER THE END OF THE FINANCIAL YEAR
No material changes and commitments affecting the financial position of the Companyhave occurred between the end of the financial year to which financial statements in thisreport relates and the date of this report.
7. COVID 19 PANDEMIC IMPACT
The Company acted promptly to mitigate the impact of COVID -19 Pandemic and the Countrywide Lockdown. There has been short term disruption in the Operations of the Company dueto the reason of COVID 19 and Countrywide lockdown. However the overall financial impactis not material for the Company.
The Company being in Pharmaceutical business was allowed to operate during theCountrywide lockdown subject to compliance to the Orders and Guidelines issued by theGovernment and various Authorities from time to time. At initial stages itself FDCresponded to the rapid challenges arisen from disruption in operations supply chainsrestrictions on imports/ exports difficulties in Procurement of Raw materials and PackingMaterials.
Further there has been no material impact on the capital and financial resourcesprofitability liquidity position assets internal financial reporting and controlsupply chain demand for its products/services or fulfilling of any obligation.
As protective steps for all its employees the Company has implemented various StandardOperating Procedures in line with Government's guidelines/ directives issued from time totime for the smooth functioning of business activity. Further with respect to the PlantsCorporate office Depots and R & D Centers The Company have taken proactive measuresto avoid spread of COVID 19. The Company has provided work from home facility to itsemployees in significant ways.
The Company has also implemented various safety measures along with social distancingtransport and food facility etc for its employees in line with the guidelines of theGovernment. The Company also has in place the mediclaim insurance for all its employees totake care of any health issues. The senior management team is constantly in touch with allthe employees and gives regular instructions to the employees to face this Pandemicthrough advisory emails.
8. AUDITOR'S REPORT
The report given by BSR & Co. HP Statutory Auditors on the Financial Statement ofthe Company for the year ended 31st March 2021 is a part of the Annual Report.There has been no qualification reservation or adverse remark or disclaimer in the saidaudit Report.
9. CONSOLIDATED FINANCIAL STATEMENT
The Consolidated Financial Statement of the Company form part of this Annual Report.This statement has been prepared on the basis of Audited Financial Statement received fromthe subsidiary companies as approved by their respective Board of Directors.
10. SUBSIDIARIES AND THEIR OPERATIONS
The Company has 2 (Two) wholly owned Subsidiaries namely FDC Inc. USA and FDCInternational ltd UK and 1 (One) Subsidiary namely Fair Deal Corporation PharmaceuticalSA (Pty) ltd. at South Africa. The Financials of the Subsidiary Companies are disclosed inthe Consolidated Financial Statements which forms a part of this Annual Report.
A statement containing salient features of the Financial Statements of SubsidiaryCompanies is annexed to this Report as "Annexure B" pursuant to theprovisions of Section 129 of the Companies Act 2013 and the Rules made thereunder in theprescribed Form No. AOC-1 and hence the same is not repeated for the sake of brevity.
In accordance with the provisions of Section 136 (1) of the Companies Act 2013 thefollowing information has been uploaded on the website of the Company i.e.www.fdcindia.com
(a) Annual Report of the Company containing therein its Standalone and theConsolidated Financial Statement; and
(b) Audited Financial Statement pertaining to the Subsidiary Companies.
During the year under review the Company acquired an additional stake of 44% in FairDeal Corporation Pharmaceutical SA (Pty) Ltd pursuant to which it became a SubsidiaryCompany as the stake holding raised to 93% after acquisition.
11. BUSINESS RESPONSIBILITY REPORT
As per Regulation 34 of the SEBI (listing Obligations and Disclosure Requirements)Regulations 201 5 the Business Responsibility Report is annexed as "AnnexureC".
12. DIRECTORS' RESPONSIBILITY STATEMENT
Pursuant to Section 134(3)(c) of the Companies Act 2013 your Directors state that:
(a) In the preparation of Annual Accounts for the year ended 31st March2021 the applicable Accounting Standards have been followed along with properexplanations relating to material departures if any;
(b) They have selected such accounting policies and applied them consistently and madejudgments and estimates that are reasonable and prudent so as to give a true and fair viewof the state of affairs of the Company as on 31st March 2021 and of the profitof the Company for the year ended on that date;
(c) They have taken proper and sufficient care for the maintenance of adequateaccounting records in accordance with the provisions of the Companies Act 2013 forsafeguarding the assets of the Company and for preventing and detecting fraud and otherirregularities;
(d) They have prepared the annual accounts on a going concern basis;
(e) They have laid down proper Internal Financial Controls to be followed by theCompany and they were adequate and operating effectively; and
(f) They have devised proper systems to ensure compliance with the provisions of allapplicable laws and such systems were adequate and operating effectively.
13. PARTICULARS OF LOANS GUARANTEES AND INVESTMENTS
Details of Loans Guarantees and Investments made by the Company are given in the notesto the Financial Statement.
Your Company has not given any Loans or Guarantees or Investments in contravention ofthe provisions of Section 186 of the Companies Act 2013.
14. PUBLIC DEPOSITS
During the year under review your Company has not accepted any deposits from thePublic and as such no amount of principal or interest on deposits from Public wasoutstanding as on the date of the Balance Sheet.
15. ENERGY CONSERVATION TECHNOLOGY ABSORPTION FOREIGN EXCHANGE EARNINGS AND OUTGO
The information relating to energy conservation technology absorption foreignexchange earnings and outgo pursuant to Section 134 of the Companies Act 2013 and theRules made thereunder is annexed as ''Annexure D" to this Report.
16. DIRECTORS AND KEY MANAGERIAL PERSONNEL:
During the year under review there were no appointments/ resignations of any BoardMembers of the Company.
Re-appointment of Directors:
The Shareholders in the Annual General Meeting held on 30th September 2020had approved re-appointment of Mr. Ashok A. Chandavarkar as the Executive Director of theCompany for a period of 5 (Five) years with effect from 01st March 2021.
The Board of Directors on recommendation of the Nomination and Remuneration Committeehave approved re-appointment of CA. Uday Kumar Gurkar as an Independent Director of theCompany for a period of five years with effect from 01st April 2021 subject tothe approval of the shareholders at the ensuing Annual General Meeting of the Company.Further he shall continue to act as a Chairman of the Board.
Appointment and Resignation of Directors:
During the year under review there were no new Appointments or Resignation ofDirectors.
Retirement by Rotation:
In accordance with provisions of the Companies Act 2013 and the Articles ofAssociation of the Company Mr. Ameya A. Chandavarkar CEO- International Business &Executive Director retires by rotation at the 81st Annual General Meeting andbeing eligible has offered himself for re-appointment. The Profile of Director seekingreappointment pursuant to Regulation 36 of the SEBI (Listing Obligations and DisclosureRequirements) Regulations 2015 is included in the Notice of the 81st AnnualGeneral Meeting and the statement annexed thereto.
Key Managerial Personnel:
I n terms of Section 203 of the Act the following are the Key Managerial Personnel(KMP) of the Company as on 31st March 2021:
1. Mr. Mohan A. Chandavarkar Managing Director
2. Mr. Sanjay B. Jain Chief Financial Officer
3. Ms. Varsharani Katre Company Secretary
During the year no KMP has been appointed or has retired or resigned.
17. PARTICULARS OF EMPLOYEES AND RELATED DISCLOSURES
Information pursuant to Rule 5(1) (2) and (3) of the Companies (Appointment andRemuneration of Managerial Personnel) Rules 2014 is annexed to this report as "AnnexureE".
18. CORPORATE GOVERNANCE
In terms of Regulation 34 of the SEBI (Listing Obligations and Disclosure Requirements)Regulations 2015 a Report on Corporate Governance along with a Compliance Certificateissued by the Statutory Auditors of the Company forms part of the Annual Report.
19. RISK MANAGEMENT
The Risk Management Committee identifies and evaluates the business risks in additionto overseeing the Risk Management Policy of the Company from time to time. The details ofthe Risk Management Committee are included in the Corporate Governance Report.
The Risk Management Policy is placed on the website of the Company on web linkhttp://www.fdcindia.com/admin/ images/Risk_Management_Policy.pdf
20. NOMINATION AND REMUNERATION POLICY
Your Company has in place a Nomination and Remuneration Policy for selectionappointment and remuneration of Directors Key Managerial Personnel and Senior ManagementTeam.
The details of this Policy are provided in the Corporate Governance Report and the sameis also available on the website of the Company on web link http://www.fdcindia.com/admin/images/Nomination_&_Remuneration_Policy.pdf
21. MEETINGS OF THE BOARD AND COMMITTEES THEREOF
The information has been furnished in the Corporate Governance Report.
22. AUDIT COMMITTEE
The Audit committee reviews all the information that is required to be mandatorilyreviewed by it under the Corporate Governance and other matters as per terms of referenceto Audit Committee inter-alia covers all the matters specified under Section 177 of theCompanies Act 2013 and also all the matters listed under Part C of Schedule II of SEBI(Listing Obligations and Disclosure Requirements) Regulations 2015.
The Audit Committee of the Board as on 31st March 2021 comprises of 2 (Two)Non- Executive Independent Directors and 1 (One) Executive Director. CA. Swati S. Mayekaris the Chairperson of the Committee. CA. Uday Kumar Gurkar and Mr. Mohan A. Chandavarkarare the other members of the committee. The Company Secretary acts as the Secretary to theCommittee. The CFO is the permanent invitee to the Committee meeting. The Internal Auditorand the concerned partners/ authorised representatives of Statutory Auditors are regularinvitees of the Committee meetings.
The Powers and Role of the Audit Committee are provided in the Corporate GovernanceReport. All recommendations made by the Audit Committee were accepted by the Board ofDirectors during the period under review.
23. BOARD & DIRECTORS EVALUATION
Pursuant to the provisions of the Companies Act 2013 and SEBI (Listing Obligations andDisclosure Requirements) Regulations 2015 the Board has carried out the AnnualPerformance Evaluation of its own performance the Directors individually as well as theevaluation of the working of its Audit Nomination and Remuneration and ComplianceCommittees based on the evaluation parameters formulated by the Nomination andRemuneration Committee. The manner in which the evaluation was carried out has beenexplained in the Corporate Governance Report.
24. FAMILIARISATION PROGRAM FOR INDEPENDENT DIRECTORS
The Independent Directors are familiarised with their roles rights responsibilitiesof the Company the business model of the Company etc. through various programmes on acontinuous basis. Details of the familiarisation program of Independent Directors aredisclosed on the website of the Company i.e https://www.fdcindia.com/familiarisation-programme.php
25. VIGIL MECHANISM/ WHISTLE BLOWER POLICY
The Company has in place a Whistle Blower Policy for reporting genuine concerns orgrievances on fraud and mismanagement. The said Policy is explained in detail in theCorporate Governance Report.
The Company has not denied any person from accessing the Audit Committee. There were noallegations/ disclosures/ concerns received during the year under review. The said Policyis also uploaded on the website of the Company:http://www.fdcindia.com/admin/images/Whistler_ Blower_Policy.pdf
26. CODE OF CONDUCT
The Company has in place a Code of Conduct for Board Members and Senior ManagementPersonnel of the Company. The Code of Conduct lays down the standard of conduct which isexpected to be followed by the Directors and the Senior Management Personnel and theduties of Independent Directors towards the Company.
The Directors and Senior Management Personnel have affirmed compliance with the Code ofConduct applicable to them during the year ended 31st March 2021. ACertificate duly signed by the Managing Director and Mr. Ashok A. Chandavarkar ExecutiveDirector on the compliance with the Code of Conduct is given in the Corporate Governance
Report. The said Code is available on the website of the company i.e.
27. PREVENTION OF INSIDER TRADING
The Company has in place a Policy on the Code of Conduct for Prevention of InsiderTrading with a view to regulate the trading in securities by the Promoters Directors andthe Designated Employees of the Company.
The same has also been uploaded on the website of the Company i.e.http://www.fdcindia.com/admin/images/Code_of_Conduct_for_Prevention_of_Insider_Trading.pdf
The Promoters Directors and the Designated Employees have affirmed compliance with theCompany's Code of Conduct for Prevention of Insider Trading.
28. RELATED PARTY TRANSACTIONS
During the year under review all Related Party Transactions entered into by theCompany were on an arm's length basis and in the ordinary course of business. Your Companyhas not entered into any contract arrangement or transaction with any Related Party whichwould be considered as the material under SEBI (Listing Obligations and DisclosureRequirements) Regulations 2015.
The Board has also approved a policy on Related Party Transactions and the same hasbeen uploaded on the Website of the Company i.e. http://www.fdcindia.com/admin/images/Policy_on_Related_Party_Transactions.pdf
A statement giving details of all Related Party Transactions is placed before the AuditCommittee and the Board on a quarterly basis. Omnibus prior approval was also obtainedfrom the Audit Committee and the Board on an annual basis for transactions recurring innature.
The Related Party Transactions as required under Accounting Standard are reported inthe notes to financial statement The particulars as required under Section 134(3)(h) ofthe Companies Act 2013 are furnished as "Annexure - F" to this report.
29. DISCLOSURE UNDER THE SEXUAL HARASSMENT OF WOMEN OF WORKPLACE (PREVENTIONPROHIBITION AND REDRESSAL) ACT 2013
The Company has in place a Policy on the Prevention Prohibition and Redressal ofSexual harassment at workplace in line with the requirements of The Sexual Harassment ofWomen of Workplace (Prevention Prohibition and Redressal) Act 2013.
The said Policy is available on the website of the Company.
i.e. http://www.fdcindia.com/admin/images/Sexual_Harassment_ Policy.pdf
An internal Sexual Harassment Committee has also been set up to redress the complaintsreceived regarding sexual harassment. The Company has not received any complaints duringthe year under review.
30. AUDITORS AND AUDIT REPORTS
a. STATUTORY AUDITORS
Auditor's report for the year under review does not contain any qualificationsreservations or adverse remarks.
b. COST AUDITORS
Pursuant to Section 148 of the Companies Act 2013 read with Companies (Cost Recordsand Audits) Rules 2014 the Board of Directors on the recommendation of the AuditCommittee have re-appointed M/s. Sevekari Khare & Associates (Firm Registration No.000084) Cost Accountants Mumbai as Cost Auditors of the Company to carry out the auditof cost records of the Company. The said Auditors confirmed their eligibility forappointment as Cost Auditors.
As required under the Companies Act 2013 and Rules made thereunder the requisiteresolution for ratification of remuneration of Cost Auditors by the Members has been setout in the Notice of the 81st Annual General Meeting of the Company.
The Cost Audit Report for the year ended 31st March 2020 was filed with theMinistry of Corporate Affairs within the prescribed time.
c. SECRETARIAL AUDITORS
Pursuant to the provisions of Section 204 of the Companies Act 2013 and the Rules madethereunder the Company had appointed M/s. Sanjay Dholakia and Associates (PCS No. 1798)Company Secretaries in Practice to undertake the Secretarial Audit of the Company for theyear ended 31st March 2021. The Secretarial Audit Report is annexed as "AnnexureG" to this Report. There is no qualification reservation adverse remark ordisclaimer in the said Report.
31. COMPLIANCE WITH SECRETARIAL STANDARD ON BOARD AND GENERAL MEETINGS
The Company has complied with Secretarial Standards issued by the Institute of CompanySecretaries of India (ICSI) on Board and General Meetings.
32. DETAILS OF FRAUD REPORTED BY THE AUDITORS
During the year under review the Statutory Auditors Secretarial Auditors and CostAuditors have not reported any instances of fraud committed in the Company by its officersor employees to the Audit Committee under section 143(12) and Rule 13 of the Companies(Audit and Auditors) Rules 2014 of the Companies Act 2013.
33. CORPORATE SOCIAL RESPONSIBILITY (CSR)
The Company has always been a socially responsible corporate citizen who is well awareand sensitive to the needs of the underprivileged people around it. During the year underreview the Company has undertaken various socio-economic activities such as organisingNutritional Programmes environmental awareness improving water resources/ structure inthe villages surrounding Plant sites Constructing Toilets at Schools/Backward regionsetc. directly as well as through Trust and Non-Governmental Organisation.
Your Company is doing its best to undertake various needs based activities incompliance with Schedule VII to the Companies Act 2013.
The CSR policy is available on the website of the Company
i.e. http://www.fdcindia.com/admin/images/Corporate_ Social_Responsibility.pdf
In accordance with the provisions of Section 135 of the Companies Act 2013 anabstract on the Company's CSR activities is appended as "Annexure H" tothis report.
34. EXTRACT OF ANNUAL RETURN
Pursuant to the provisions of Section 92 of the Companies Act 2013 and the amendmentmade thereunder Form MGT-7 is available on the web-link i.e.http://www.fdcindia.com/news-content.php?year=2021
35. TRANSFER OF UNPAID AND UNCLAIMED DIVIDEND AMOUNTS AND SHARES TO INVESTOR EDUCATIONAND PROTECTION FUND (IEPF)
The Company has been sending reminders to those Members having unpaid/unclaimeddividends before transfer of such dividend(s) to IEPF. Details of the unpaid/ unclaimeddividend are also uploaded on the Company's website i.e. www.fdcindia.com.
The Members who have not encashed their dividend pertaining to Final Dividend2013-2014 and onwards are advised to write to the Company immediately for claimingdividends declared by the Company.
a. 1232 shares on which dividend for the FY 2012-13 remained unclaimed for 7 (Seven)consecutive years were transferred to IEPF account in the FY 2020-21. Your Company hasuploaded the details of such Shareholders whose shares are transferred to IEPF account onthe website of the Company i.e. www.fdcindia.com. The procedure to claim the sharestransferred to IEPF account has also been uploaded on the website.
36. ENVIRONMENT HEALTH AND SAFETY
The Environment Health and Safety are a part of the Management responsibilities andconcerns. The Company has been providing various kinds of medical assistance to theemployees and their families. Periodic health checkups are carried out for all theemployees. Employees are also educated on safety and precautionary measures to beundertaken on their job.
37. SIGNIFICANT AND MATERIAL ORDERS PASSED BY THE REGULATORS OR COURTS
There are no significant or material orders passed by any regulatory tribunal or courtthat would impact the going concern status of the Company and its future operations.
Your Directors would like to express and place on record their sincere appreciation forthe continued co-operation and support received from the Medical fraternity GovernmentAuthorities and Agencies Stock Exchanges Financial Institutions Investors BankersConsumers Vendors and Members during the year under review. Your Directors also place onrecord their appreciation for the hard work and contribution of all the employees of theCompany.
| ||For and on behalf of the Board || |
| ||Sd/- ||Sd/- |
|Place: Mumbai ||Mohan A. Chandavarkar ||Ashok A. Chandavarkar |
|Date: 26th May 2021 ||Managing Director ||Executive Director |