Your Directors have pleasure in presenting herewith the 34th Annual Reporton the business of your Company together with the Audited Standalone and ConsolidatedAccounts for the Financial Year ended 31 March 2021.
|Particulars || |
Financial Year 2020-21
Financial Year 2019-20
| ||Standalone ||Consolidated ||Standalone ||Consolidated |
|Operating revenue ||83031.59 ||90113.01 ||80597.12 ||90790.98 |
|Other Income ||3390.01 ||3014.16 ||1126.27 ||1693.94 |
|Profit before Interest Depreciation Tax and after exceptional Items from continuing operations ||31385.52 ||27263.31 ||25162.59 ||23673.76 |
|Interest ||1746.84 ||2186.87 ||432.89 ||455.76 |
|Depreciation ||4084.79 ||5397.67 ||3495.73 ||4377.68 |
|Net profit before tax ||25553.88 ||19678.77 ||21233.97 ||18840.32 |
|Provision for taxes || || || || |
|a. Current tax ||4469.86 ||4523.00 ||3909.38 ||3987.24 |
|b. Deferred Tax (Net of MAT Credit) ||2644.84 ||361.83 ||505.18 ||-638.06 |
|Profit after tax from continuing operations ||18439.17 ||14793.94 ||16819.41 ||15491.14 |
|Profit/(Loss) after tax from discontinued operations ||0 ||0.00 ||2552.41 ||0.00 |
|Share of profit/(Loss) in Associates/ Joint Ventures ||0 ||-173.58 ||0 ||-35.09 |
|Share of profit/(Loss) in Non-Controlling interest ||0 ||-157.67 ||0 ||-159.29 |
|Other comprehensive incomes (expenses) ||1.79 ||27.07 ||-120.16 ||-104.55 |
|Total Comprehensive Income ||18440.97 ||14805.11 ||19251.66 ||15510.79 |
REVIEW OF OPERATIONS:
STANDALONE AND CONSOLIDATED FINANCIAL STATEMENTS:
The Standalone and Consolidated Financial Statements of your Company have been preparedin accordance with Indian Accounting Standards (Ind AS') notified under theCompanies (Indian Accounting Standards) Rules 2015 as amended. Further a statementcontaining the salient features of the Financial Statements of our subsidiaries pursuantto subsection 3 of Section 129 of the Companies Act 2013 in the prescribed form AOC-1 isappended as Annexure 5 to the Board's Report. The Statement also provides the details ofperformance and financial position of each of the subsidiaries. During the year underreview the Company reported standalone operating revenues of Rs.83031.59 Lakhs as againstRs.80597.11 Lakhs and Total Comprehensive Income of
Rs.18440.97 Lakhs as against Rs.19251.65 Lakhs in the previous year whereasconsolidated gross revenues of Rs.90113.01 Lakhs as against Rs.90790.98 Lakhs and TotalComprehensive Income of Rs.14805.11 Lakhs as against Rs.15510.79 Lakhs in the previousyear.
The Company registered a growth of over 6 % & decline of 5% on standalone basis anda growth of over 1 % & decline of 5% on consolidated basis in gross income and profitafter tax respectively With the new product-mix and product lines the Company was able tomaintain margins though there was a pressure on the margins due to shift in the demand ofdrugs on Covid-19 outburst. Over the period the managements concentration in developingnew production technologies and continuous investment therein have slowly started yieldingpositive results. In view of prolonged regulatory certification issues effectingoperational performance the management has actively been taking steps to expand the marketto South American and other non-regulatory markets to neutralize the impact in thelong-run
SHILPA MEDICARE API FACILITIES
Shilpa Medicare has two world class State-of-art API manufacturing facilities atRaichur supported by strong & efficient team of R&D IPM ProductionEngineering Quality Control Quality Assurance & regulatory functions with othersupportive functions & well administered Human Resource management. The facilities arecGMP Complaint & approved by many national & international regulatory bodies likeUSFDA EU Cofepris- Mexico PMDA-Japan Korean FDA TPD Canada & TGA-Australia.
The Company is having multiple API's & intermediate manufacturing blocks withsegregation of Oncology and Non-Oncology manufacturing facilities. Oncology products aremanufactured & handled with highly prcised isolators & taking care of people& environment. Blocks designed to handle small scale medium scale & high-volumescale to handle different levels of Batch size like 500 gm to 350 kg. The manufacturingfacilities are certified by different bodies for management systems of Quality SafetyEnvironment & Health like ISO 9001-2015 for Quality system ISO 14001-2015 forEnvironment management system OSHAS 18001-2007 for Occupational Health & SafetySystem & R&D is certified by DSIR Govt. of India.
Shilpa is first Company to invest in India on containment technologies for themanufacturing of oncology drug substances in a contained environment & also latesttechnologies like Bipolar system from Japan to ensure the manufacturing process aresustainable with less consumption of natural resources & safe operations. These typesof innovative technologies provide us the sustainable process which are validated &commercialized. This strength provides us the tremendous opportunities to enhancecompetitive to improve our positions in the market place & also to find the newmarket.
The company being environmentally conscious all the waste is treated in its ZEROdischarge handling facility with all down line supported systems like Stripper MEE ATFDFicco Facco followed by Biological & RO systems to treat the waste & make itre-usable in applicable places. The company has positioned fractional distillationcolumns where solvents from products which requires to purify & separate to get purematerial which can be re used with this all solvents are recycled.
The Company given high level safety importance & designed to train all theemployees involved to make them aware about the risk involved its consequences &mitigations required. All safety requirements of the facility are taken care in designwhere safety is built in system like Air handling units rapture disc & safety ventsinterlocks alarms & firefighting systems.
The facility is designed to provide complete utility services & purified watersystems. All utilities are designed to provide to support required to manufacture withoutany interruption. Well-designed coolers are used to support the systems like processcooling & HVAC and also compressed air & nitrogen facility.
Facility is having quality control unit with a capability of method development methodvalidation & testing of RM IM & Finished products with all 21 CFR Part11compliance sophisticated instruments like LCMS GCMS ICPMS XRPD PSD analyzer HPLC GCand all other supportive instruments for testing products with well trained &qualified staff.
Shilpa taken up many expansions in last 1 year for one of our main and regular productcalled Tranexamic acid (Non-Oncology Product). Plant is modified & also expanded from5.5 MT to 15 MT/month.
One of our another main non-Oncology Product called Ambroxol capacity expanded from10.0MT -22.0 MT/month. Other than this Shilpa taken up debottlenecking of all the blocks& created double Bay/2 line in 2 manufacturing Onco Blocks which is helping to havemultiple Products at a time with dedicated entry/exit. This increases block occupancy& productivity. Facility utilization is improved by providing Carbon Facilityseparately where last stage can be handled with put linkage of intermediate block &same time we can take another Product. Shilpa brought up many other segments in APIFacility like Peptide segment were R&D and manufacturing Block is made separatelyPolymer R&D is scale up to the big facility & one GMP facility is created infacility.
SHILPA MEDICARE R&D (API)
Shilpa Medicare views its R&D capabilities as a vital component of its businessstrategy that will provide a sustainable long-term competitive advantage. Shilpa Medicareis among the few Indian pharmaceutical companies in India to have started its researchprogram in support of its global ambitions. The R&D environment reflects itscommitment to be a leader in the Oncology generics space. Our generics business helps toreduce drug costs for individuals and governments by bringing generic drugs to market asearly as possible and making them available to as many patients as possible. We supplypharmaceutical ingredients to pharmaceutical companies which contributes to our goal ofproviding affordable medicine. We will continue to promote affordability in significantways and work to expand our product offering of generics focusing on increasing access toproducts with significant barriers to entry. We will continue to look for newopportunities to take generics to more patients in collaboration with other companies.
Our research and development centre offers space for the development of genericsmeeting international development standards including difficult to make complex APIprocesses such as those for Oncology/non-Oncology molecule.
The Shilpa Medicare R&D centre in Raichur has shown good progress in terms of newprojects taken for development and the projects which were successfully transferred toplant. The Raichur API team has delivered 8 projects successfully and takentrial/validation at plant scale and taken up 25 new projects for process development ofOncology and non-Oncology molecule.
For environmental protection we have introduced bipolar membrane technique to removethe ionic impurities from the drug substance during purification.
For further strength of our business strategy to depend less on external customers forsupply of starting material and make them in-house to further reduce the cost of existingAPI to make more cost effective technology. For important projects starting materialsynthesis in-house initiated and taken some trial at plant/lab scale & some are theunder lab development/ process optimization.
SHILPA MEDICARE- FINISHED DOSAGE FORMULATION FACILITY
Shilpa Medicare Limited Finished Dosage Formulation Facility is a state ofthe art manufacturing and testing facility engaged in manufacturing and distribution ofpotent drugs- which includes liquid and lyophilized injectables in vials Onco sterile drypowder injectables in vials oral solid dosage form (Tablets and hard gelatine capsules)into various regulated and rest of the world markets including US and EU. The facility isdesigned for handling of potent Drug Products (including Oncology products or adjutanttherapies) in a fully contained manner. Facility is designed to handle potent moleculesupto OEL 4 level of containment.
The facility is approved by various regulatory agencies including EUGMP-AGES-Austria ANVISA PERU Argentina South Africa & MEXICO COFEPRIS Russia.
For USFDA currently the facility is under Import Alert however USFDA has exemptedthree products from the Import Alert. Shilpa Medicare Unit 4 is distributing these threeproducts (Azacitidine for Injection Erlotinib Capsules and Cyclophosphamide Capsules) inthe US market. Working with FDA to resolve the matter in timely manner. Remediationmeasures are going on. Working with three USFDA consultants. Supplies to Europe are goingon uninterrupted!
This facility consists of Oral Solid Block with two commercial scale tabletmanufacturing and one commercial scale capsule manufacturing line. There are two blisterpacking lines and one Bottle filling line.
Three separate Injectable blocks consists of commercial scale manufacturing lines forliquid-lyophilized- powder filled injections. Fully automatic packaging lines areavailable for Injectables. Facility for Safe packaging for Onco Injectables is alsoavailable. Serialization (Track and Trace) is in place and implemented for all commercialsupplies.
Fully equipped Utility facility which is provided with water system (Pre-treatment andPost treatments for generation and distribution of Purified water/WFI/Pure steam)Chillers Air compressors Boilers Diesel generators HVAC etc.
All world class process equipment's are provided with 21 CFR part 11 compliant SCADAsystems.
Fully equipped chemical testing labs (2 nos.) and microbiology facility are operationalwith trained and qualified staff.
Commercial presence in regulated semi regulated and domestic markets in various dosageforms.
Shilpa Medicare Limited manufactures many products in several types of dosage formssuch as tablets capsules liquid injection (Aseptically and terminally sterilized)Lyophilized Injectable Sterile Dry powder injectables. All products are manufacturedunder the same stringent quality standards for export to USA EU ROW and Domestic market.
8 Acre Land available for further expansion. Building work is already completed.
Shilpa Medicare has commissioned the State of Art Centralized Finished Dosages R&DCentre at Dabaspet near Bangalore. The R&D Centre is involved in development ofOncology and NonOncology Injectable formulation and oral formulations. R&D alsodevelops Transdermal patch and topical preparations Ophthalmic formulations and OrallyDisintegrating Film formulation. R&D Centre is well equipped for development of novelformulations Generics Complex Generics and value added dosage forms involving Nano andMicro technologies like Liposomes nano particles and specialty products. On Analyticalfront the R&D is equipped with state of the art instruments to evaluate the all kindsof dosage forms. State of the Art infrastructure is built for Extractable & Leachablestudies for relevant products. Facility is capable of carrying out analytical methodvalidations for both in - house & customer products. Analytical R&D hascapabilities of characterization of API impurities excipients and packing components.
The new Research and Development Centre is one point stop to customers for ProductDevelopment can cater the product development along with analytical method developmentfor finished product analytical method validation stability studies characterization ofimpurities evaluating extractable & leachable for packing components. ProcessDevelopment Lab meeting the cGMP requirement for manufacture scaleup batches tooptimize the process variables and to manufacture of clinical batches is in place andready for execution. New Research and Development Centre can as CRO for NonOncoproducts along with analytical support and for CRAMS for Oncology portfolio of customers.
INTELLECTUAL PROPERTY MANAGEMENT (IPM)
Shilpa's success depends on the Company's ability to secure patents protect theproprietary information and operate without infringing on the others' intellectualproperty rights. Shilpa Medicare Limited Intellectual Property Management (IPM) team isresponsible for building Shilpa's global generic product pipeline and 505(b)2 NDA pipelineas well as creating managing and protecting its high value patent estate. Shilpa has adedicated IPM Team which provides stage wise IP-clearances during product/processdevelopment activities and also provides frequent updates and alerts on relevant IP(patent trademark etc) to R&D scientists for products/process and suggests remedialmeasures to deal with IP issues. Shilpa IPM team is involved in product selection activityto ensure that right products are selected for development. Shilpa's IPM team continues tobuild its future pipeline of complex products with an established robust portfolioselection process providing early launch opportunities with intellectual propertyadvantages.
Shilpa's strengths across various molecules including oral Injectable and complexdifferentiated products biologics lie in developing intellectual property innon-infringing processes and resolving complex chemistry challenges. The API Processdevelopment is focused for developing and transferring commercially viable non-infringingand patentable novel API technologies. The development grid selection for API's is basedon difficult-to-make API molecules and novel polymorphic forms of certain API's forcreating value addition. Shilpa's IPM Team is involved in patenting of new productsprocesses methods of use drug delivery systems and medical devices in India US EU andother countries with significant market value.
Highlights FY 20-21:
In FY 20-21 Shilpa filed one NDA and settled the litigation. Shilpa settled onelitigation during FY 20-21 and succeeded in litigation related Dimethyl fumarate DRcapsules at District court of Delaware.
Shilpa is committed to enhance our product profile by strengthening our intellectualproperty. Our patent portfolio is testament to our commitment. In FY 20-21 Shilpa and itsgroup companies have filed 56 patent applications taking the cumulative total to 413patent applications in India and other countries. Shilpa received grants for 19 patentsduring FY 20-21. Additionally 49 patent applications have been acquired from FTF Pharma.
REGULATORY FILINGS SUMMARY
|API Particulars ||Filed in 2020-21 ||Cumulative Filed ||Status ||Planning to file in 2021-22 ||Remarks |
|US DMF CEP-EDQM ||4 Numbers No new CEPs Were Filed in FY 2020-21 ||40 Numbers 16 Numbers ||All CA listed 13 CEP Approved 3 CEPs under review ||3 Numbers 2 Numbers ||- - |
|EDMF ||12 Numbers ||- ||All procedures are under review ||5 Numbers ||- |
|Particulars ||Filed in 2020-21 ||Cumulative Filed ||Status ||Planning to file In 2021-22 ||Remarks |
|US Submissions ||1 New Submission 3 transfers to Shilpa ||25 Submissions ||10 - Final approvals 3 - Tentative approvals 12 Under assessment ||8 Submissions ||Apremilast Tablets 10 mg 20 mg and 30 mg - Tentative approval Pemetrexed Injection (Ready to Use) New NDA submission. Docetaxel Injection (non-alcohol formula) approved NDA transfer to Shilpa. |
|EU ||03 New ||20 ||15 - Final approvals ||19 Submissions ||New submissions: |
|Submissions ||Submission ||Submissions ||05 Under assessment || ||Sunitinib Capsules; Pemetrexed Injection (Ready to Use); Thalidomide Capsules. |
Regulatory Inspections and approvals (API units).
In February 2020 two API facilities located at Raichur Karnataka i.e. Unit-1:Deosugur Industrial Area Deosugur Raichur Karnataka India and Unit-2: RaichurIndustrial Growth Centre Chicksugur Raichur Karnataka India inspected by USFDA. EIRreceived on April 17 2020.
Shilpa Medicare Limited Bangalore (Unit-III & Unit-IV)
Transdermal Patches and Oral Film Manufacturing Plant (Unit VI) A transdermal patch ismedicated adhesive patch that is placed on the skin to deliver a specific dose ofmedication through the skin and into the bloodstream. Transdermal patches have made theirplace in global market in past few decades as an alternative to conventional therapeuticfor various disease indications. Transdermal patches are widely accepted among physiciansand patients due to their non-invasive pain free and easy administration. In recentyears the growth of transdermal patch market has increased and expected to increasesignificantly in coming years. Higher investments in research and development could beattributed to the success of transdermal patch market.
Similarly the thin film drugs were recorded with high market acceptance due to itsease of application and high effectiveness. Moreover developed economies such as the U.S.and countries in Europe recorded significant sale of thin film drugs. Thin film drugsachieve the desired therapeutic results. Therefore they have gained attention in themarket as a potential treatment option. Looking to the market potential facility isdesigned and build a state of art manufacturing facility of Transdermal Patch and OralFilms at Dobaspet Bangalore. This facility shall cater to Domestic Regulated and NonRegulated market. The lay outs confirming to cGMP requirements is finalized along withUtility Administration and canteen building. The equipment's are designed to cater bothTransdermal Patch and Oral Film Products. A space for future expansion is allocated forcapacity increment. Transdermal Patch and Oral Film Manufacturing Plant status highlights:
Transdermal Patch and Oral Film Manufacturing Facility Qualification activitiescompleted and execution of filing batches is in the process.
Shilpa Medicare Ltd Biologics SBU
The past year witnessed a turmoil in the pharmaceutical markets globally on account ofCovid related disruptions in raw materials and logistics. SBPL has largely remainedunaffected thus far owing to significant stocking up of raw materials prior to thedisruptions and availability of raw materials from alternate sources. The biosimilarprograms remain largely on track and our first biosimilar product is expected to becommercialized in the coming financial year.
The current ongoing Covid 19 crisis while being a challenge in the near term for allbusinesses is expected to contribute in a meaningful way to Shilpa Group's revenue in thecoming Financial year with your company readying itself to manufacture at least one of theCovid vaccines that are likely to be commercialized in the near term. This vaccine isexpected to contribute to the country's fight against the virus in the latter half of thisfinancial year.
While the sudden and sporadic nature of the pandemic makes it difficult to forecast theCovid vaccine opportunity in terms of duration and quantum of the revenues the companyviews the recombinant vaccine opportunity as a strategic one with the technologyplatforms outlasting the pandemic and being relevant over atleast the next 10 years. Weintend to make significant investments in building up competencies in the technologyplatform areas especially the viral vector platforms.
Opportunity and drivers -
Opportunity in regulated markets - Our single use manufacturing facility coupledwith very strong R&D backing in the area will help the company integrate vertically inbiopharmaceuticals conventional MAbs as well as in cell/gene therapies. Yourcompany expects strong international partnerships in biologics over the next 1-2 years todrive the business in regulated markets with the development and manufacturing from oursite in Belur.
Opportunity in RoW markets Your company is in the process of establishingpartnerships with leading pharmaceutical players for Biosimilars across differentgeographies. Apart from this your company is targeting co-development partnerships withglobal startups - which helps in expanding your company's footprint globally.
Your company is progressing one of its biologics into Human Clinical Trialsdesignated as a New Biological Entity (NBE). This is expected to be major revenue driverfrom 2022-23 onwards both through direct sales and licensing opportunities for thecompany.
The same molecule is also being targeted at the excipient markets where test marketingof the molecule has commenced and expected to see fruition in 2021-22.
SBPL now has 8 Biosimilars and one New Biological Entity in its pipeline and isdominated by drugs catering to the autoimmune disorders and oncology segments with 6 ofthe top 10 biologics in its pipeline. The remaining are niche high margin opportunitiescatering to high unmet clinical needs. Your company is forging ahead with clinical trialson 1 no's MAb 1 no's fusion protein and 1 no's NBE while 3 others are expected tocomplete preclinical studies. The combined market size of these three drugs today is about$30 billion. 2 more are expected to be added in the next financial year to the Clinicaltrial pipeline with market size of about $17 billion. The vaccine manufacturingopportunity helps us
Meaningfully impact the country's fight against Covid-19
With early revenue generation and helps us develop / enhance competence with novelplatform technologies that have the potential to help us leapfrog competition in theemerging areas of gene and cell therapies. We look forward to a challenging but excitingyear ahead!
Contract development and manufacturing organisations (CDMOs) have establishedthemselves as viable alternatives to the in-house development and manufacturing units ofPharmaceuticals and Biotech companies in recent decades. The increasing outsourcing trendin pharmaceutical and Biotech Industry demonstrate the success of this business model.CDMOs are increasingly becoming the integral part of Pharma value chain. SML has a visionto serve it's Innovator and Generic customers from early development to cGMP manufacturingsupport mainly to support new chemical entities development and cGMP supplies forclinical and commercial applications. SML possesses in-house credentials in HPAPIPeptide Polymers Formulations (Oral liquid Parenteral Topical etc.) and Biologicsareas. SML HPAPI facility is a world-class one of the best developments and manufacturingfacility for highly potent and such other niche molecules. It can handle molecules up tocontainment level five. The facility is audited and approved by various global regulatoryagencies. SML integrated supply chain and in-house capabilities are well poised to solvetoughest problems for Pharma Bio-Pharma Biotech and non-Pharma customers. Our expertisein complex Chemistry High Potent API Peptide Polymer Formulations Biologics make us apartner of choice in CDMO market place. While market is expected to grow with double digitgrowth in niche CDMO space SML aspire to register a very high growth in CDMO businessexpected to grow with high double-digit growth.
SML has proven credentials in successful CDMO operations in past supporting variousglobal programs in next 3 years' time span we aspire to establish SML as global CDMObrand for-
1. Integrated one stop CMC solutions for preclinical clinical and commercialoutsourcing services of both Drug Substance and Drug Product for Small Molecules andBiologicals.
2. Complex API and high potent API solutions to Innovator Pharma and Biotech companies.
3. Specialized Chemistry one stop solutions from development to cGMP supplies for Solidphase peptide synthesis Polymers Flow Chemistry.
4. Integrated and standalone services to ADC and Pegylation customers for Chemistry(payload linker Bio-conjugation) Biology and Formulations.
5. Standalone Formulation solutions to Innovators and Generic Pharma in Noveltherapeutics 505(b)2 NDDS Complex injectable OSD Transdermal and oral suspensionareas.
6. Integrated end to end solutions to Biologics Customers in Biosimilars NovelBiologics Vaccines Gene and Cell therapies areas.
Domestic market overview:
Shilpa Medicare limited has entered in IPM in November 20 with a range of brandsintroduced in Gastrointestinal Vitamins Mineral Nutrients Gynaecology orthopaedicsUrology paediatrics segment etc. as first set of brands. Our aim is to provide unique ODFtechnology advantages to patients/consumers with an ease of administration and betterpatient compliance experience.
We have started our promotion to Doctor's through a structured field force withpromotion of products to Paediatrician C. Phy GP family physician OrthopaedicsGynaecologist Gastroenterologist Urologist set of doctor's in major cities of India.
As an organization we would like to introduce many new products in coming month in F.Y.2022 and so on. The Oncology segment is current in stress due to almost nil IPD andinjectable range as well as follow up with oral therapy after chemo is reducedconsiderable due to last year COVID pandemic which still is persisting at large thusmarket will take time to revive.
Branded domestic market in Acute segment is showing improve trend in last quarter of FY2021.
IPM has witnessed recent surge in sales and demand in the segment specially GI overalloral and injectable antibiotics Pain killers Antipyretics Multi vitamins mineralsetc. and many more
IPM has also witnessed slowdown of chronic care especially Diabetic CV segment DermaOptho and Dental care section in specific We as an organization has a clear path andvision planned to penetrate in IPM market through exclusive Rx route and phase wise entryin OTX market with women care products and various other segment which we would like toshare in 2nd quarter onwards as we add these products in our brand basket. we are sure tomark and make our presence felt in IPM through our unique delivery system technologycalled as MDF.
SUBSIDIARIES ASSOCIATES & JOINT VENTURES
The Company has direct and step down subsidiaries in India and overseas. Consolidatedfinancial statements have been prepared by the Company in accordance with the requirementsof Ind AS 27 issued by Institute of Chartered Accountants of India (ICAI) and as per theprovisions of the Companies Act 2013 (the Act).
As per the provisions of Section 136 of the Act separate audited financial statementsof subsidiaries are placed by the Company on its website at www.vbshilpa.com . Statementcontaining the salient features of the financial statement of subsidiaries and associatecompany for the year ending March 31 2021 in Form AOC-1 (Pursuant to first proviso toSub-Section (3) of Section 129 read with Rule 5 of Companies (Accounts) Rules 2014) isattached at the end of the notes to Accounts to Financial Statements.
SHILPA THERAPEUTICS PRIVATE LIMITED (STPL) (WHOLLY OWNED SUBSIDIARY)
Shilpa Therapeutics Private Ltd. situated at Cherlapally IDA Phase-IIIMedchal-Malkajgiri District Hyderabad Telangana India-500051 a progressive novel drugdelivery company with an international outlook is dedicated to the development andcommercialization of innovative and patient compliant novel drug delivery systems such asfast disintegrating oral strips. Shilpa Therapeutics Private Ltd. is the first company tocommercialize prescription products as oral thin strips/films in India.
Management team with proven leadership and experience in pharmaceutical business. ShilpaTherapeutics is being lead and promoted by highly motivated professionals withextensive experience both in domestic and international pharmaceutical arena and highlyqualified management professionals with a vision to develop and market innovative andpatient compliant novel drug delivery systems.
Strong technical expertise to develop thin strips/films for oral/ sub-lingual/buccaldelivery As a result of continued efforts in the research and product development ShilpaTherapeutics had developed the most sought after novel drug delivery dosage formorally disintegrating strip/film and obtained the manufacturing and marketing licenses forthis dosage form in India and abroad.
The orally disintegrating formulation resembling a postage stamp in size and shape is ataste masked fast dissolving convenient and potentially effective dosage form. The oralstrip/film cannot be removed from the mouth upon application. The target patientpopulation includes: One who cannot swallow e.g. Dysphagic & Odynophagia. One whodoes not want to swallow e.g. paediatric geriatric and psychotic patients. Who shouldnot swallow e.g. Dialysis patients (due to liquid intake restrictions) The oralstrip/film is a convenient discrete oral delivery form which when placed on the patienttongue is instantly wetted by saliva and then it rapidly disintegrates and dissolveswithin seconds to release the medication for its therapeutic benefits without the need ofwater.
The plant has recently Upgraded to carter Regulated Markets like ROW and Europeancountries and the products are being updated to cater the registration requirements of therespective countries. Vertically integrated GMP facility from Research toCommercialization Shilpa Therapeutics facility is capable of meeting the regularcommercial supply demand from manufacturing to secondary packing with its compliance tomeet the latest Schedule M' cGMP/WHO GMP compliant systems procedures andpractices.
The infrastructure includes major production equipment including formulation processingline with built-in high speed stirrers homogenizers & de-aeration systems layeringand drying machinery thermal heating systems film slitting units and custom made pouchpacking units.
Products available in the Domestic Market:
Shilpa Therapeutics had obtained manufacturing and marketing license from the DrugsControl General (India) New Delhi for the following products and these products have alsobeen launched in India by well-established national pharmaceutical companies.
|Molecule ||Category |
|Ondansetron Hydrochloride 2mg 4mg & 8mg Orally Disintegrating Strips Simethicone 62.5mg Orally ||For the prevention of chemotherapy induced nausea and vomiting (CINV) Anti-Flatulent. |
|Disintegrating Strips Sildenafil Citrate 25mg & 50mg Orally Disintegrating Strips ||For the treatment of erectile dysfunction (ED) |
|Tadalafil 5 mg 10mg & 20mg Orally Disintegrating Strips Methylcobalamin 1500 mcg Orally Disintegrating Strips ||For the treatment of erectile dysfunction (ED) For the treatment of Diabetic Neuropathy and Peripheral Neuropathy |
|Montelukast Sodium 4 mg 5 mg & 10 mg Orally Disintegrating Strips Vitamin D3 2000 IU Orally Disintegrating Strips ||For the Prophylaxis and Chronic Asthama Vitamin D3 Supplement |
|Betahistine Dihydrochloride 16mg & 24 mg ||For the treatment of Menier's syndrome characterised by unilateral or bilateral Vertigo sensorineural hearing loss |
|Green Tea Film (FSSAI) ||For Household drink for therapeutic benefits |
|Menthol Mouth Freshener in different flavor ||Mouth Fresheners |
|Paracetamol 60 mg & 120 mg ODS ||For Paediatric Pain Reliever and a Fever Reducer. |
Products in the Pipeline
The following formulations are under various stages of Research & ProductDevelopment along with several others in the initiation phase.
|Molecule ||Category |
|Rizatriptan 10 mg Orally Disintegrating Strips ||For Treatment of Migraine |
|Methylcobalamin 1500 mcg + Pregablin 75 mg Orally Disintegrating Strips ||For Treatment of Pain and for Diabetic and Peripheral Neuropathy |
|Prucalopride 1mg & 2 mg ODS ||For Treatment of Chronic Constipation |
|Risperidone 1mg 2mg 3mg & 4mg ODS ||Anti Psychotic |
|Pregabalin 25 mg/ 50 mg/ 75 mg ODS ||For Treatment of Pain |
|Ketorolac Tromethamine 10mg ODS ||Anti Inflammatory |
Strong Intellectual Property Management Team/Profile
Shilpa Therapeutics has a strong IP profile. The company has been granted severalpatents on orally disintegrating strips A state-of-the-art R&D center for developingoral strips and sublingual film products works in co-ordination with the IntellectualProperty Management team to develop cost effective generics and novel patentableformulations.
In FY 2019-20 our patent filing grew further with 7 new patent filings includingIndian and international filings. Since its inception STPL has filed more than 25 patentsacross a wide global network.
The patent applications filed during FY 2019-20 includes novel pharmaceuticalformulations international filing of a unique formulation of green tea films.
STPL to continue aggressive patent filings and protection of IP in India and otherimportant geographies of the world and plan to monetize the same.
STPL will continue to build its future pipeline of innovative andfirst-time-in-the-world fast dissolving films with Intellectual
Property (IP) advantages and we are con dent that the overall result of our initiativeswill be evident in the coming years.
Shilpa Therapeutics Private Ltd has received approval for its oral disintegrating stripfacility from following regulatory authorities:
National Pharmaceutical Regulatory Agency (NPRA)
Malaysia which is an PIC/S member (Pharmaceutical Inspection Co-operation Scheme)
Ministry of Health Thailand
Pharmacy Poison Board Kenya
National Drug Authority Uganda
Regulatory Authority of DR Congo
Supreme Board of Yemen
Many of the products are under screening process in above Ministries of Health and arein verge of the products approval.
Shilpa Therapeutics holds bright prospects for its business scope. ODS products ofShilpa Therapeutics have already been launched in India under its own brand with DomesticMarketing Team formed under Shilpa Medicare Limited and also by other prominent pharmacompanies viz. Abbott India Limited Delvin Formulations Private Ltd Alkem Labs LinuxLaboratories etc. Shilpa Therapeutics has also extended its business to the externalmarkets with its ODS products launched in Kenya and many other countries to follow.
Shilpa Therapeutics with its technical expertise manufacturing capabilities and itsfinished products at various stages of registration in several countries is poised toattain promising business results in the very near future.
INM TECHNOLOGIES PRIVATE LIMITED (INMT) (Wholly Owned Subsidiary)
INMT has been promoted as a joint venture company with a vision to develop productsusing Nano technology. INM over the period has carried out research operations on variousproducts and process in the fields of materials engineering / pharmaceutical technologyand service in advanced technology and product development with scale up process for thedeveloped micro / nanomaterials. INM has developed state-of-the-art facility forsynthesis characterization and analytical testing of nanotechnology based products andcreated various departments for the purpose of holding Company (i.e. Shilpa) involvingmajor disciplines namely Biotechnology Bio-Medical Analytical and PharmaceuticalChemical Polymer Coatings Electronics and Smart materials. INM Technologies R&D labhas been recognized by DSIR New Delhi. INMT has filed patents on dental formulationsnamely: root canal sealant powder composites (Mineral Trioxide Aggregate) havingnanostructured with nontoxic nature and highly biocompatible Hemostatic gels based onTranexamic acid and Tranexamic acid gingival based and Chitosan-Tranexamic acid loadeddicalcium silicate scaffold formulation for blood clotting and drug delivery. INMT hasbeen working on Hydroxy apatite oral thin films for calcium supplement have beenformulated and bio-studies are yet to be initiated. Paracetamol oral thin films have beeninitiated and have shown very interesting result in batch process.
In order to obtain advantage from the technologies processes and resources developedby the INM Technologies Private Limited Shilpa Medicare Limited has filed an applicationbefore National Company Law Tribunal Bengaluru Bench for amalgamation of INM TechnologiesPrivate Limited.
INM NUVENT PAINTS PRIVATE LIMITED (NUVENT) (Step down Subsidiary)
All the coatings and paints developed in the department has been spin off from INMT toa wholly owned subsidiary company INM Nuvent Paints Private Limited. Innovatednanostructured transparent coatings (6 Nos) namely: Hydrophillic HydrophobicUV-absorbing Heat Reflective Fire retardant multi protect 3 layer coating structuresfor SS surfaces are marketed through Nuvent. On the other hand nanostructured paints (5Nos) with enhanced performance have also been developed and under commercializationthrough Nuvent. These are anti-corrosion paint for MS surfaces Heat Reflective paint forroof tops High temperature (600oC) anticorrosion paint fire retardant paint Pigeonrepellent paint. The developed paints are eco-friendly low VOC highly reliable anddurable and cost effective.
LOBA FEINCHEMIE GmbH AUSTRIA (LOBA) (Step down Subsidiary)
As on 31st March 2021 Loba Feinchemie GMBH was sold to ZR Pharma & GMBH Austriafor a sale consideration of 3.3 Million Euros.
SHILPA PHARMA INC. USA (Wholly Owned Subsidiary)
Shilpa Pharma Inc has been promoted with the vision to register create and developmarketing network for the products of the Company in North American countriesparticularly aimed at USA and also to co-ordinate with the USFDA authorities directly on aregular basis for obtaining approvals.
KOANAA HEALTHCARE LIMITED UK (KOANAA UK) (WHOLLY OWNED SUBSIDIARY)
Koanaa UK has been formed for the purpose of registration and vmarketing of the drugsof the Company in European market.
KOANAA HEALTHCARE GmbH AUSTRIA (KOANAA AUSTRIA) (Wholly owned subsidiary)
Koanaa Healthcare GmbH has been founded to register and develop the market for theproducts of the Company in Austria and adjacent countries.
Koanaa Austria has now changed its strategy from direct marketing of products inEurope to out licensing model. This strategy could remain in force for few years for nowtill Koanaa Austria does not have a size chunk of products in its basket going forward.Koanaa Austria therefore decided to surrender its GMP license to GDP as it will onlyfocus on Out-Licensing of products and thus it is responsible to sell their productsthrough partners and distributor rather than directly marketing the products on their own.With the change in the focus Koanaa Austria has started focusing on identifying partnersto whom the products could be out licensed. The basic essence of Koanaa Austria to be[positioned as European Player in the field of oncology with the brandAustrian Quality. The products will prove highest standards and quality andKoanaa Austria will stand for Deliverability and Service for Patients and Physiciansthrough its partners and distributors.
In terms of geographical presence Koanaa Austria is based in Austria (Fischamend) nearVienna and is offering products released from Austria for now to all its customers goingforward.
Koanaa Austria has already got the approval from the AGES inspection (Austrianpharmaceutical authority) as a wholesaler with the official right to sell pharmaceuticalproducts. Imatinib was the first product which was launched in the highly competitivemarket in Germany and Austria in April/ May 2017 later it was launched in Sweden Finlandand UK.
New territories such as CZECH and Romania have been also identified for launch. Thoughwe have received the approval for Bortezomib and Pemetrexed the same is still notlaunched as there is patent restriction.
The vision of Koanaa Austria is to develop as a successful and reliable partner withinthe pharmaceutical domain.
KOANAA HEALTHCARE CANADA INC (Wholly Owned Subsidiary) Koanaa Healthcare Canada Inc wasincorporated on April-24th-2020. Currently there are two executives (President and VP ofRegulatory Affairs/Quality) that are employed and located in Montreal Quebec Canada.Both employees have over 25 years of experience and are well known in the pharmaceuticalindustry. Koanaa was audited by Health Canada agency and received its compliance ratingand drug establishment license on October 28th 2020. Right after this importantmilestone the company immediately filed its first dossier and plans to file more in 2021.The senior management have decided to implement the B2B strategy model (out-licensingproducts to partners). This business model can be managed by both employees. The companyhas already secured business deals with partners and currently there are five dossiersunder review and expect to receive approval in the second half of the year. One dossier isapproved and the head office plans to manufacture and dispatch the products in April orMay. This will be the first recorded commercial sales in the territory. Koanaa Canada isunder negotiations with additional partners and plans to make more business deals thisyear.
INDO BIOTECH SDN.BHD (Wholly Owned Subsidiary)
Indo Biotech SDN BHD is a Malaysian based company which is located in MALAYSIA Thecompany has been formed for the primary purpose of marketing manufacturing anddistributing while performing other financial business development regulatory andgeneral administrative functions of Health care and General pharma products.
Indo Biotech SDN BHD is fully capable of offering formulation in Research &Development manufacturing of both pilot and commercial batches Warehousing &Distribution and Sales & Marketing of health care Pharmaceutical and allied Products.Indo Biotech SDN BHD is capable of offering pharmaceutical products cost-effectively tocompete with both domestic manufacturers and imports. Generic pharmaceutical products arebio equivalent and therapeutic equivalent alternatives to branded drugs that have lostmarket exclusivity of patent protection.
Indo Biotech SDN BHD will be a wellspring of discovery and a catalyst for change inhealthcare& pharmaceutical. We are committed to push the frontiers of discovery inorder to improve health and well-being.
We believe connections make everything possible. Therefore we want to be Malaysia'sleading health provider we are working towards to strive to provide the right services tohelp you enjoy life to the fullest. From the way we operate to what we intend toaccomplish both on the local and international front we apply and hold close a vision ofexcellence created towards making one's life better.
At Indo Biotech SDN BHD excel through high-quality innovative products and services tocontinuously bring value through commitment respects integrity and professionalism.
KOANAA HEALTHCARE SPAIN (Wholly Owned Subsidiary) S.L. Headquarters of Shilpa B2BEurope became active in April 2020.
Currently there are three executives (Vice President and recently incorporated Headof Business Development and Head of Regulatory Affairs) employed and located nearBarcelona Spain.
The main business model for Europe is a B2B License and Supply model in which weout-license our high-quality Dossiers to European end customers who will market theproducts supplied by Shilpa under their own brand name. During the financial year2019-2020 Shilpa very successfully launched Azacitidine covering the majority ofEuropean countries. Our aim is to become the preferred partner of choice by providing ahigh-level quality of service and information combined with a continuously growingstrong competitive and innovative portfolio.
KOANAA INTERNATIONAL FZ-LLC
Koanaa International FZ-LLC is a Rakez Free Zone Limited Liability Company FZ-LLC inUnited Arab Emirates. Koanaa International is offering its services to Africa and MiddleEast where they provide sales and marketing information. The Company also offersanalytical data in pharmaceutical for Africa and Middle East countries. KoanaaInternational offers its best consultancy services in Food products OTC Pharmaceuticaland healthcare products. The Company also manage the healthcare Companies specific projectlike sales and distribution channel Pharmaceutical Research and development supply chainmanagement and all the Pharmaceutical companies related project. The company also offersthe consultancy services for appointing distributor channel and poestablishing a companysales and distribution in Africa and Middle East
REVA PHARMACHEM PRIVATE LIMITED (RPPL) (Associate)
The Company holds 33.33% shareholding in RPPL a joint venture company formed with amarketing expert to market the drugs of the company in regulated markets.
REVA MEDICARE PRIVATE LIMITED (RVMPL) (Joint Venture)
The Company achieved higher than its target goals for the financial year on Sales andBusiness Development. The Market Access planning has structured into formidable projectsand would like to report each vertical as under:
a. Dosage Form:
As a strategy we have positioned in the Emerging Market by formalizing a supplyconsortium supporting Reva. The module has been successful and Tender supply of medicinefor MOH (Afghanistan) was awarded to Reva. The supply was scheduled for Q4 2019-20 butdue to COVID-19 it was shipped by May/June 2020. We plan to extend the strategy formarket of Vietnam which still holds opportunity for new drugs and the registrationtimeline is short.
Licensing as a vertical was structured last year and success has been achieved in themarkets of Europe US & China.
b. API (Generic)
The business has progressed with commercial supplies of Oncology Anti-Infective andCardio into markets of Japan Korea Europe and Emerging Nations.
The Company has made Japan as its key market and build in-roads with main IndustryAssociations namely; (KPIA Kansai Pharmaceutical Industries Association) and (JPMA Japan Pharmaceutical Manufacturer Association). Reva Medicare is a joint venturebetween Shilpa Medicare Ltd and Akira Pharma (P) Ltd.
SRAVATHI ADVANCE PROCESS TECHNOLOGIES PRIVATE LIMITED (Joint Venture)
Sravathi Advance Process Technologies Private Ltd is completed one full financial yearwith operations of its Research
& Development Labs in Rajajinagar Bengaluru-560010. We have completed keyactivities during this year which are listed below.
1) Signed confidential agreements with >10 customers.
2) Signed 6 Project development agreements for different projects. Our business modelis taking advance and availing 5 years of royalty revenue on successful completion andimplementation of the projects.
3) Delivered one complete Conceptual Engineering Package to Customer andthey are in the process of procuring equipment for building the plants.
4) Completed more than 5 projects successfully and delivered some of them to customersand those projects are in different stages. Some of the technologies are developed bySravathi on its own where we will be giving multiple licenses on non-exclusive basis incoming financial year.
5) Generated first revenues in this year through projects. Understood marketpotential for our flow chemistry which is significantly high.
6) Obtained approvals for selected API from Drug control authority duringthis year.
7) Hired number of skilled people present team strength is ~50 people.
8) Established some capabilities including new Sravathi own designs offlow reactors.
9) Filed one patent application during this year by Sravathi.
10) Established all HR processes and implemented them during this year.
11) Due to pandemic situation in Bangalore where company R&D is located somedisturbance for operations during April & May months of this financial year. Howeveroverall able to manage operations with all required COVID-19 protocols.
SHILPA BIOCARE PRIVATE LIMITED.
Shilpa Biocare Private Limited is a 100% subsidiary of Shilpa Medicare Ltd & isestablishing a state of art Manufacturing Facility for Recombinent Human Albuminmanufacturing. This Product is developed by Shilpa Biologicals as a novel biologicalentity a program part funded by the Department of Biotechnology GoI through itsBIRAC arm. The program was also recognized as amongst the most innovative by DBT in 2012and again in 2014/15. While the estimated Global demand is 1000 MT per annum for Albuminhardly a fifth of this requirement is being catered to currently. The current market forAlbumin is $1 billion based on the current supply condition having recognised this as aimportant potential business opportunity The Company has invested in developing asynthetic route for generation of Human Albumin (outside of the human body) and came upwith a technology that has been scaled up.
The company has global patent granted for this technology and intends to pursue thisvigorously.
The company with permission from the RCGM (regulatory body) and DCGI is conductingthe clinical studies on the said Product . The European Union has also waived off a partof the clinical trials required to release the protein on the market after having gonethrough the data generated so far. Hence the company is setting up a large scaleproduction unit for its recombinant Human Albumin at Kadechur Industrial Area. Theclinical studies data & approval will be obtained in the 01st quarter of 2022. Thereafter the company will cater to global demand for Albumin from this site thuskeeping Shilpa Biocare on the Global Biotechnology map
SHILPA CORPORATE HOLDINGS PRIVATE LIMITED (SCHL) (A WHOLLY OWNED SUBSIDIARY)
Shilpa Corporate Holdings Private Limited a wholly owned subsidiary company has beenformed to invest and hold the investments in group companies.
SRAVATHI AI TECHNOLOGY PRIVATE LIMITED:
Sravathi AI Technology Pvt Ltd is established its Research & Development facilityin Rajajinagar Bengaluru-10 in the month of August 2020. We have leased facility andestablished facilities for doing research in the area of Artificial Intelligence inchemistry. Established server and required high computing facilities for doingArtificial Intelligence work which includes many GPUs and CPUs. We have hiredrequired technical talent which comprise of Data scientists Molecular modelingexperts Biochemistry medicinal chemistry Bioinformatics etc. and operations team now presently ~20+ people are onboard. We have established and developed DrugDiscovery platform with variety of predicting models for generating new moleculesand predicting biological properties. We have also established new capabilities fordeveloping new molecules generation Reaction platform and formulation platform. We havecompleted two Drug Discovery projects of In-silico (one program is related toDrugs for COVID-19 and another one related to Immuno-oncology and presently workingon synthesis of promising molecules. We have also established Bioavailabilityplatform and completed one project and given for testing. We have received all requiredapprovals/ certificates like MSME GST IEC PF PT etc. We have signed NDAs with ~4 CROcompanies for biological testing of new molecules for Drug discovery.
FTF PHARMA PRIVATE LIMITED (Wholly Owned subsidiary)
FTF Pharma has started operation in mid-2013 and completed successful 8 years ofoperation with global footprint. FTF has created a brand image in the industry as anexperienced capable and profitable company having vast experience and expertise in drugformulation development. It attracted competent and experienced technical manpower fromlarge pharmaceutical companies to cater to its growth. FTF Pharma is working on flexiblebusiness model as per the market dynamics to cater to its growth and has de risking policyto manage its resources profitably. The different business models are:
1. Contract development model
2. Collaborative development and
3. Own development followed by out licensing with profit share for 5-10 years. Therevenue generated is ploughed back into the company to generate IP and to create state ofthe art modern R&D infrastructure and creating enough R&D space for futurebusiness growth.
The company is engaged in pharmaceutical dosage form development of oral solids(sustained and immediate release) Oral Liquid (solution and suspension) Parenteral(solution and Lyo) and topical products. As the name suggests FTF business model wasbased on the concept of First to File ANDA in USA to get 6 months exclusivity formarketing generating more profit for the client and more value to our IP and 505b2projects.
In this process we grew from strength to strength between 2014- 2018 as first to fileopportunity was considered a value proposition for all major generic companies in USA. Wechanged our business model from licensing to contract development making a whole lot ofnew customers between 2018-2021 depending less on licensing revenue from FTF projectswhich is cyclical in nature and market dynamic change for First to File model changedmaking it unviable.
AUXILLA PHARMACEUTICALS AND RESEARCH LLP (Investment Entity) AUXILLA PHARMACEUTICALSAND RESEARCH LLP is R&D centre based at Ahmedabad focused on development of505(b)(2) and complex generics. This business is of product development for national andinternational clients based on fee for service type as well asco-development/collaboration of in-house projects. Our innovative product developmentbusiness helps to address reduction in product pricing and burden on healthcarepractitioners/nurses.
We will continue to expand our clientele globally and develop differentiated productsfocusing on increasing access to products with significant barriers to entry. In firstyear after inception we have shown good progress in terms of new projects taken fordevelopment and out-licensed as well. There are more than 25 projects in pipeline fordevelopment and 10 of them will be taken for trial/validation at plant scale. We have alsosigned agreement for two complex generic injectable projects and one peptide basedinjectable product in this year.
In terms of patents three Indian patents are filed and another seven patents are underfiling on liquid orals and injectables. We have developed one injectable platform forwater sensitive molecules keeping low production cost in mind and another injectableplatform technology for long-acting depot which can enhance patient adherence towardscritical chronic diseases.
VEGIL LABS PRIVATE LIMITED
Your company has formed wholly owned subsidiary Vegil Labs Private Limited (VLPL) forthe Business purposes of the Company.
SHILPA LIFESCIENCES PRIVATE LIMITED.
Your company has formed a wholly owned subsidiary Shilpa Lifesciences Private Limited(SLPL) to transfer Active Pharmaceutical Ingredients (API) Business of the Company on aslump sale basis such transfer will create API Business into separate entity which willinteralia benefit the whole Shilpa group.
CHANGE IN THE NATURE OF BUSINESS
During the year under review there was no change in the nature of business carried outby your Company.
Your Directors recommended a dividend of i.e Rs.1.10 Per Equity Share of Rs.1 /- each(i.e 110) FY 2020-21 absorbing an amount of Rs.896.79 Lakhs from the profits of FY2020-21. The Dividend Distribution Policy of the Company is set out as Annexure-10and the same is uploaded on the Company's website athttps://www.vbshilpa.com/pdf/Dividend-Distribution-Policy.pdf
The paid up share capital of your Company is Rs.81526898/- (Rupees Eight CroreFifteen Lakh Twenty Six Thousand Eight hundred and Ninety Eight) divided into 81526898equity shares of Rs.1/- each. There was no change in the share capital structure duringthe period under review.
Pursuant to the provisions of section 124 (5) of the Companies Act 2013 read with theIEPF Rules the Company has transferred 12000 shares belonging to the shareholders whodid not continuously claim dividend for seven years from the financial year 2012- 13 toIEPF Account the details of which are placed on the website of the Company.
LISTING OF EQUITY SHARES:
The securities of the Company are listed on National Stock Exchange of India Limited(NSE) and BSE Limited (BSE). Further the Company has no equity shares carryingdifferential rights.
TRANSFER TO RESERVES:
During the financial year under review your Company has not transferred any amount tothe general reserve.
DIRECTORS OR KEY MANAGERIAL PERSONNEL:
Mr. Naresh Patwari (DIN No. 03319397) Non-Executive Director will retire by rotationat the ensuing Annual General Meeting and being eligible offers himself forre-appointment. Mr. Amit Chander (DIN: 02406965) Ceased to be director of the Company witheffect from 02nd October 2020 due to change in his professional priorities.Further Mr. Sushil Bajaj Chief Financial Officer of the Company has resigned and ceasedto be as such w.e.f 19th January 2021. Mr. Alpesh Dalal was appointed as ChiefFinancial Officer of the Company w.e.f 31st May 2021.
NUMBER OF MEETINGS OF THE BOARD:
During the financial year Ten Board Meetings were held as detailed below which are incompliance with the provisions of the Companies Act 2013 the Listing Regulations andSecretarial Standards on Board meeting: a. 05th May 2020 b. 15thJune 2020 c. 08th August 2020 d. 09th September 2020 e. 18thSeptember 2020 f. 02nd November 2020 g. 22nd January 2021 h. 13thFebruary 2021 i. 05th March 2021 j. 31st March 2021
STATEMENT OF DECLARATION GIVEN BY INDEPENDENT DIRECTORS UNDER SUB-SECTION (6) OFSECTION 149:
The Independent Directors have submitted their declaration of Independence as requiredunder Section 149(7) of the Companies Act 2013 stating that they meet the criteria ofindependence as provided in Section 149(6) and Regulation 25 of SEBI (Listing Obligationsand Disclosure Requirements) Regulations 2015.
M/s. Brahmayya & Co. Chartered Accountants (Firm Registration No. 000513S) wereappointed at the 30th Annual General Meeting as the Statutory Auditors of theCompany for a term of five years to hold office till the conclusion of the 35thAnnual General Meeting of the Company. They have confirmed their eligibility for the F.Y.2021-22 under Section 141 of the Companies Act 2013 and the Rules framed thereunder.
The Board on the recommendation of the Audit Committee has appointed M/s. V.J. Talati& Co. Cost Accountants for conducting the audit of cost records of various segmentsof the Company for the financial year 2021-22. As required under Section 148 of theCompanies Act 2013 and Rule 14 of the Companies (Audit and Auditors) Rules 2014 aresolution is being placed at the ensuing AGM for ratification of remuneration payable tothe said Cost Auditors.
M/s. P.S. Rao & Associates Practicing Company Secretaries were appointed toconduct the Secretarial Audit of the Company for the financial year 2021-22 as requiredunder Section 204 of the Companies Act 2013 and Rule 9 framed thereunder. The SecretarialAudit Report in form MR-3 for the financial year 2020-21 forms part of this Report as Annexure- 9.
The Board has appointed M/s P.S. Rao & Associates Practicing Company Secretariesas Secretarial Auditors of the Company for the financial year 2021-22.
M/s M. Bhasakara Rao and Co. Chartered Accountants were appointed in the Boardmeeting held on 31st May 2021 as recommended by the Audit Committee toconduct the Internal Audit of the Company for the financial year 2021-22 as required undersection 138 of the Companies Act 2013 and rules made thereunder.
COMMENTS BY THE BOARD ON EVERY QUALIFICATION RESERVATION OR ADVERSE REMARK ORDISCLAIMERS: Statutory Auditors:
As there is no qualification reservation or adverse remark in the reports given by theStatutory Auditors your directors need not provide any clarification on the same.
As there is no qualification reservation or adverse remark in the reports given by theSecretarial Auditors your directors need not provide any clarification on the same.
CONSERVATION OF ENERGY TECHNOLOGY ABSORPTION FOREIGN EXCHANGE OUTGO:
Information required under section 134(3)(m) of the Companies Act 2013 read with Rule8 of the Companies (Accounts) Rules 2014 is enclosed herewith as Annexure8.RISK MANAGEMENT POLICY:
Pursuant to Regulation 21(4) of SEBI (LODR) Regulations 2015 the Board of Directorshas formulated and implemented a
Risk Management Policy which identifies various elements of risks which in itsopinion may threaten the existence of the Company and contains measures to mitigate thesame. The Risk Management Policy of the Company is posted on the Company's website:www.vbshilpa.com.
A Risk Management Committee has been constituted as per the terms of Regulation 21 ofSEBI (LODR) Regulations 2015 to monitor and review the major risks faced by and the riskmanagement plan of the Company periodically.
In accordance with the provisions of Section 129 (3) of the Companies Act 2013 theStandalone and Consolidated Financial Statements drawn up in accordance with theapplicable Accounting Standards form part of this Annual Report.
In accordance with Rule 8 (1) of Companies (Accounts) Rules 2014 the highlights ofperformance of the Subsidiaries Associates and Joint Ventures and their contribution tothe overall performance of the Company have been detailed in Annexure - 5 enclosedto this report. Further the annual accounts of all the subsidiary companies are availableon the Company's website www.vbshilpa.com. Annual accounts of the SubsidiaryCompanies and related detailed information will be available for inspection by themembers at the registered office of the Company and will also be made available to themembers upon request.
ADEQUACY OF INTERNAL FINANCIAL CONTROLS WITH REFERENCE TO THE FINANCIAL STATEMENTS:
The Company has Internal Control Systems commensurate with the size scale andcomplexity of its operations. Various Audit systems in the Company monitor and evaluatethe efficacy and adequacy of the internal control systems of the Company its compliancewith operating systems accounting procedures and policies at all locations of theCompany. Based on the audit reports the concerned department/ unit undertakes correctiveaction in the respective areas and strengthens the controls. Significant auditobservations and corrective actions thereon are presented to the Audit Committee of theBoard periodically.
The Board of Directors of the Company has adopted various policies like Related PartyTransactions Policy Whistle Blower Policy Policy to determine Material SubsidiariesCode of Conduct for Regulating Monitoring and Reporting Insider Trading and such otherprocedures for ensuring orderly and efficient conduct of its business for safeguarding itsassets prevention and detection of frauds and errors accuracy and completeness of theaccounting records and timely preparation of reliable financial information.
DETAILS OF THE COMPANIES WHICH HAVE BECOME OR CEASED TO BE SUBSIDIARIES JOINT VENTURESOR ASSOCIATE COMPANIES DURING THE YEAR UNDER REVIEW:
The following instances took place during the year under review which need to bereported in accordance with Rule 8(5) (iv) of Companies (Accounts) Rules 2014: a. Duringthe year under review Shilpa Corporate holdings Private Limited an investment company toinvest in the group companies has been formed as a wholly owned subsidiary and acquired100% stake in FTF Pharma Private Limited an Indian company Koanaa Healthcare CanadaKoanaa International FZ LLC (Dubai) Indo Biotech SDN. BHD Malaysia so that all thesecompanies have become as wholly Owned Subsidiaries.
Further the Company also acquired balance 25% equity shares of INM TechnologiesPrivate Limited and made a wholly owned subsidiary. b. Your company has acquiredcontribution in Auxilla Pharmaceuticals And Research LLP c. INM Technologies PrivateLimited which is the wholly owned subsidiary of the Company holds 25 percentage of itsstake in INM Nuvent Paints Private Limited. d. The Company had disposed off the totalstake in its Step Down Subsidiary named Loba Feinchemie GMBH Austria. The proceeds havebeen realized in the month of April 2021.
CORPORATE SOCIAL RESPONSIBILITY (CSR):
In terms of the provisions of Section 135 read with Schedule VII to the Companies Act2013 and the Companies (Corporate Social Responsibility Policy) Rules 2014 a CorporateSocial Responsibility Policy (CSR Policy) indicating the activities to be undertaken bythe Company as framed by the Corporate Social Responsibility Committee (CSR Committee)has been adopted by the Board of Directors. Accordingly the Company has provided the CSRamount to Shilpa Foundation' a public charitable trust taking up various socialpublic causes of the society in and around Raichur Karnataka and the activities of thesaid trust are covered under the Schedule VII of the Companies Act 2013. A report on theCSR activities as required under Rule 8 of the Companies (Corporate SocialResponsibility) Rules 2014 is enclosed herewith as Annexure 4.
The CSR Policy of the Company and other details as required is are placed on theCompany's website at https://vbshilpa.com/ pdf/CSR_Policy.pdf
NOMINATION AND REMUNERATION POLICY:
A Committee of the Board named as Nomination and
Remuneration Committee has been constituted to comply with the provisions ofSection 178 Schedule IV of the Companies Act and Regulation 19 of SEBI (LODR)Regulations 2015. It has been entrusted with the task to recommend to the Company theprospective directors and KMP who possess the requisite skills and positive attributes asspecified in the Nomination and Remuneration Policy.
The Nomination and Remuneration Committee has formulated a Nomination and RemunerationPolicy which recommends the guidelines based on which the annual performance of theIndependent Directors Board and Individual Directors is carried out by the Board.
The Nomination and Remuneration Policy of the Company is placed on the Company'swebsite at https://vbshilpa.com/pdf/ NominationRemunerationPolicy.pdf
FORMAL ANNUAL EVALUATION MADE BY THE BOARD OF ITS OWN PERFORMANCE AND OF ITS COMMITTEESAND INDIVIDUAL DIRECTORS:
The Board of Directors have carried out an annual evaluation of its own performance aswell as that of its Committees and individual directors pursuant to the provisions of theSections 134 and 178 read with Schedule IV to the Companies Act 2013. A structuredquestionnaire was prepared after taking into consideration inputs received from theDirectors covering various aspects of the Board's functioning such as adequacy of thecomposition of the Board and its Committees execution and performance of specific dutiesby the Board of Directors independence governance ethics and values attendance andcontribution at meetings etc.
The performances of the Independent Directors were evaluated by the Board after seekinginputs from all the directors on the effectiveness and contribution of the IndependentDirectors.
The performance of the Committees was evaluated by the Board after seeking inputs fromthe Committee members based on the criteria such as the composition of Committeeseffectiveness of Committee Meetings etc.
The Board reviewed the performance of the individual directors on the basis of criteriasuch as the contribution of the individual director to the Board and Committee Meetingslike preparedness on the issues to be discussed meaningful and constructive contributionand inputs in Meetings etc. In addition the Chairman was also evaluated on the keyaspects of his role.
In a separate meeting of Independent Directors performance of the Non-IndependentDirectors performance of the Board as a whole and performance of the Chairman wasevaluated taking into account the views of Executive Directors and Non-ExecutiveDirectors. The Independent Directors also assessed the quality quantity and timeliness offlow of information between the Board and the management that is necessary for the Boardto perform its functions reasonably and effectively. The same was discussed in the BoardMeeting that followed the meeting of the Independent Directors.
DIRECTORS' RESPONSIBILITY STATEMENT:
Pursuant to Section 134 (5) of the Companies Act 2013 Your Directors' confirm that:
In preparation of annual accounts for the financial year ended 31st March 2021 theapplicable Accounting Standards have been followed along with proper explanation relatingto material departures;
The Directors have selected such accounting policies and applied them consistently andmade judgments and estimates that are reasonable and prudent so as to give true and fairview of the state of affairs of the Company at the end of the financial year ended 31stMarch 2021 and of the profit and loss of the Company for the year;
The Directors have taken proper and sufficient care for their maintenance of adequateaccounting records in accordance with the provisions of the Companies Act for safeguardingthe assets of the Company and for preventing and detecting fraud and other irregularities;
The Directors had prepared the annual accounts on a
going concern' basis;
The Directors had laid down internal financial controls to be followed by the Companyand that such internal financial controls are adequate and were operating effectively; and
The Directors had devised proper systems to ensure compliance with the provisions ofall applicable laws and that such systems were adequate and operating effectively.
EXTRACT OF ANNUAL RETURN:
In accordance with Section 92(3) of the Act and rule 12(1) of the Companies (Managementand Administration) Rules 2014 (as amended) a copy of the Annual Return of the Companyshall be placed on the Website of the Company at https:// www.vbshilpa.com
Committees of Board:
Your Company has the following committees namely:
Nomination and Remuneration Committee;
Stakeholders Relationship Committee and
Corporate Social Responsibility Committee
Risk Management Committee
The constitutions of all the committees are as per the provisions of the Companies Act2013 and SEBI (LODR) Regulations 2015. The details of the constitution are mentioned inCorporate Governance Report which forms part of this Annual Report.
Corporate Governance Report:
Regulation 15 of SEBI (LODR) Regulations 2015 is applicable to your Company and assuch the details as specified in Schedule V(C) of SEBI (LODR) Regulations 2015 withregard to Corporate Governance Report including Practicing Company Secretary's Certificateon compliance with the conditions of Corporate Governance specified in Schedule V(E) ofSEBI (LODR) Regulations 2015 as well as a certificate as specified in ScheduleV(C)(10)(i) of SEBI (LODR) 2015 forms part of the Annual report as Annexure- 11.
Management Discussion and Analysis:
The Management Discussion and Analysis Report for the year under review as stipulatedunder Regulation 34 read with Schedule V (B) to the SEBI (LODR) Regulations 2015 isannexed hereto and forms part of this Annual Report.
In pursuance to the provisions of Section 177(9) & (10) of the Companies Act 2013and Regulation 22 of SEBI (LODR) Regulations 2015 a vigil mechanism for directors andemployees to report genuine concerns has been established. The Policy on vigil mechanismi.e. Whistle Blower Policy may be accessed on the Company's website athttps://www.vbshilpa. com/. The policy provides for a framework and process for theemployees and directors to report genuine concerns or grievances about leak ofUn-published Price Sensitive Information (UPSI) and illegal or unethical behavior to theChairman of the Audit Committee.
Remuneration ratio of the Directors/Key Managerial Personnel/Employees:
Statement showing disclosures pertaining to remuneration and other details as requiredunder Section 197(12) of the Companies Act 2013 read with Rule 5(1) of the Companies(Appointment and Remuneration of Managerial Personnel) Rules 2014 is enclosed herewith asAnnexure-2.
Particulars of Employees:
Statement of employees as required under Rule 5(2) of the Companies (Appointment andRemuneration of Managerial Personnel) Rules 2014 is enclosed as Annexure 3to the Board's Report.
COST RECORDS AND COST ACCOUNTS:
The Company is maintaining cost records and accounts as specified by the CentralGovernment under subsection (1) of section 148 of the Companies Act 2013.
DISCLOSURE UNDER SEXUAL HARASSMENT OF WOMEN AT WORKPLACE (PREVENTION PROHIBITION ANDREDRESSAL) ACT 2013:
Your Company has always provided a safe and harassment free workplace to everyindividual working in its premises through various policies and practices. Your Companyalways endeavors to create an environment that is free from discrimination and harassmentincluding sexual harassment. Your Company has been actively involved in ensuring that theclients and all the employees are aware of the provisions of the POSH Act 2013 and therights available to them there under.
Your Company has in place an Anti-Sexual Harassment Policy in line with therequirements of the Sexual Harassment of Women at workplace (Prevention Prohibition andRedressal) Act 2013. An Internal Complaints Committee has been set up to redress thecomplaints received regarding sexual harassment. Your Company did not receive anycomplaints during the period under review.
PARTICULARS OF LOANS GUARANTEES OR INVESTMENTS:
Details of the loans granted guarantees given securities provided and investmentsmade during the year under review as covered under Section 186 of the Companies Act2013 are detailed in the notes to the financial statements which may be read as a part ofthis Report.
During the year under review your Company has not accepted any deposits within themeaning of Section 73 of the Companies Act 2013 read with the Companies (Acceptance ofDeposits) Rules 2014.
RELATED PARTY TRANSACTIONS:
Related Party Transactions entered into during the financial year under review aredisclosed in Note No. 45 to the Financial Statements. These transactions were at an arm'slength basis and in the ordinary course of business. There were no materially significantRelated Party Transactions with the Company's promoters directors management or theirrelatives which could have had a potential conflict with the interests of the Company.Form AOC-2 containing a note on the aforesaid Related Party Transactions is enclosedherewith as Annexure - 6.
Related Party disclosures as per Schedule V of SEBI (LODR) Regulations 2015 areenclosed herewith as Annexure - 7. The policy on Related Party Transactions asapproved by the Board may be accessed on the Company's websitehttps:// www.vbshilpa.com/pdf/related_party_policy.pdf
BUSINESS RESPONSIBILITY REPORT:
Pursuant to Clause 34(2)(f) of the SEBI (LODR) Regulations 2015 BusinessResponsibility Report being applicable to the Company forms part of the Board Report as Annexure- 1. GENERAL:
Your Directors state that no disclosure or reporting is required in respect of thefollowing items as there were no transactions on these items during the year under review:
Issue of equity shares with differential rights as to dividend voting or otherwise.
Issue of shares (including sweat equity shares) to employees of the Company under anyscheme.
Neither the Managing Director nor the Whole-time
Director of the Company received any remuneration or commission from any of itssubsidiaries.
No significant or material orders were passed by the
Regulators or Courts or Tribunals which impact the going concern status and Company'soperations in future.
No frauds were reported by the auditors during the year under review.
There are no material changes and commitments affecting the financial position of theCompany occurred between the end of the financial year of the Company to which thefinancial statements relate and the date of the report.
The Company has complied with Secretarial Standards i.e. SS-1 and SS-2 relating toMeetings of the Board of Directors and General Meetings respectively issued by theInstitute of Company Secretaries of India and notified by the Ministry of CorporateAffairs.
Your Directors wish to express their gratitude to the Central and State Governmentsinvestors analysts financial institutions banks business associates and customers themedical profession distributors and suppliers for their whole- hearted support. YourDirectors commend all the employees of your Company for their continued dedicationsignificant contributions hard work and commitment.
| ||For and on behalf of the Board of Directors |
| ||Shilpa Medicare Limited. |
| ||Omprakash Inani |
|Place: Raichur ||Chairman |
|Date: 02nd September 2021 ||DIN: 01301385 |