Shilpa Medicare Ltd Directors Report.

To,

The Members,

Your Directors have pleasure in presenting herewith the 34th Annual Report on the business of your Company together with the Audited Standalone and Consolidated Accounts for the Financial Year ended 31 March, 2021.

FINANCIAL SUMMARY

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 prepared in accordance with Indian Accounting Standards (‘Ind AS) notified under the Companies (Indian Accounting Standards) Rules, 2015, as amended. Further, a statement containing the salient features of the Financial Statements of our subsidiaries pursuant to subsection 3 of Section 129 of the Companies Act, 2013 in the prescribed form AOC-1 is appended as Annexure 5 to the Boards Report. The Statement also provides the details of performance and financial position of each of the subsidiaries. During the year under review, the Company reported standalone operating revenues of Rs.83031.59 Lakhs as against Rs.80597.11 Lakhs and Total Comprehensive Income of

Rs.18440.97 Lakhs as against Rs.19251.65 Lakhs in the previous year, whereas consolidated gross revenues of Rs.90,113.01 Lakhs as against Rs.90,790.98 Lakhs and Total Comprehensive Income of Rs.14,805.11 Lakhs as against Rs.15,510.79 Lakhs in the previous year.

The Company registered a growth of over 6 % & decline of 5% on standalone basis and a growth of over 1 % & decline of 5% on consolidated basis in gross income and profit after tax, respectively With the new product-mix and product lines the Company was able to maintain margins though, there was a pressure on the margins due to shift in the demand of drugs on Covid-19 outburst. Over the period the managements concentration in developing new production technologies and continuous investment therein have slowly started yielding positive results. In view of prolonged regulatory certification issues effecting operational performance the management has actively been taking steps to expand the market to South American and other non-regulatory markets to neutralize the impact in the long-run

SHILPA MEDICARE API FACILITIES

Shilpa Medicare has two world class State-of-art API manufacturing facilities at Raichur, supported by strong & efficient team of R&D, IPM, Production, Engineering, Quality Control, Quality Assurance & regulatory functions with other supportive functions & well administered Human Resource management. The facilities are cGMP Complaint & approved by many national & international regulatory bodies like USFDA, EU, Cofepris- Mexico, PMDA-Japan, Korean FDA, TPD Canada & TGA-Australia.

The Company is having multiple APIs & intermediate manufacturing blocks with segregation of Oncology and Non-Oncology manufacturing facilities. Oncology products are manufactured & handled with highly prcised isolators & taking care of people & environment. Blocks designed to handle small scale, medium scale & high-volume scale to handle different levels of Batch size like 500 gm to 350 kg. The manufacturing facilities are certified by different bodies for management systems of Quality, Safety, Environment & Health like ISO 9001-2015 for Quality system, ISO 14001-2015 for Environment management system, OSHAS 18001-2007 for Occupational Health & Safety System & R&D is certified by DSIR, Govt. of India.

Shilpa is first Company to invest in India on containment technologies for the manufacturing of oncology drug substances in a contained environment & also latest technologies like Bipolar system from Japan to ensure the manufacturing process are sustainable with less consumption of natural resources & safe operations. These types of innovative technologies provide us the sustainable process which are validated & commercialized. This strength provides us the tremendous opportunities to enhance competitive to improve our positions in the market place & also to find the new market.

The company being environmentally conscious all the waste is treated in its ZERO discharge handling facility with all down line supported systems like Stripper, MEE, ATFD, Ficco Facco followed by Biological & RO systems to treat the waste & make it re-usable in applicable places. The company has positioned fractional distillation columns, where solvents from products which requires to purify & separate to get pure material which can be re used, with this all solvents are recycled.

The Company given high level safety importance & designed to train all the employees involved to make them aware about the risk involved, its consequences & mitigations required. All safety requirements of the facility are taken care in design where safety is built in system like Air handling units, rapture disc & safety vents, interlocks, alarms & firefighting systems.

The facility is designed to provide complete utility services & purified water systems. All utilities are designed to provide to support required to manufacture without any interruption. Well-designed coolers are used to support the systems like process cooling & HVAC and also compressed air & nitrogen facility.

Facility is having quality control unit with a capability of method development, method validation & testing of RM, IM & Finished products with all 21 CFR Part11 compliance sophisticated instruments like LCMS, GCMS, ICPMS, XRPD, PSD analyzer, HPLC, GC and 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 product called Tranexamic acid (Non-Oncology Product). Plant is modified & also expanded from 5.5 MT to 15 MT/month.

One of our another main non-Oncology Product called Ambroxol capacity expanded from 10.0MT -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 have multiple Products at a time with dedicated entry/exit. This increases block occupancy & productivity. Facility utilization is improved by providing Carbon Facility separately 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 API Facility like Peptide segment were R&D and manufacturing Block is made separately, Polymer R&D is scale up to the big facility & one GMP facility is created in facility.

SHILPA MEDICARE –R&D (API)

Shilpa Medicare views its R&D capabilities as a vital component of its business strategy that will provide a sustainable, long-term competitive advantage. Shilpa Medicare is among the few Indian pharmaceutical companies in India to have started its research program in support of its global ambitions. The R&D environment reflects its commitment to be a leader in the Oncology generics space. Our generics business helps to reduce drug costs for individuals and governments by bringing generic drugs to market as early as possible, and making them available to as many patients as possible. We supply pharmaceutical ingredients to pharmaceutical companies, which contributes to our goal of providing affordable medicine. We will continue to promote affordability in significant ways and work to expand our product offering of generics, focusing on increasing access to products with significant barriers to entry. We will continue to look for new opportunities to take generics to more patients, in collaboration with other companies.

Our research and development centre offers space for the development of generics meeting international development standards, including difficult to make complex API processes, such as those for Oncology/non-Oncology molecule.

The Shilpa Medicare R&D centre in Raichur has shown good progress in terms of new projects taken for development and the projects which were successfully transferred to plant. The Raichur API team has delivered 8 projects successfully and taken trial/validation at plant scale and taken up 25 new projects for process development of Oncology and non-Oncology molecule.

For environmental protection, we have introduced bipolar membrane technique to remove the ionic impurities from the drug substance during purification.

For further strength of our business strategy to depend less on external customers for supply of starting material and make them in-house to further reduce the cost of existing API to make more cost effective technology. For important projects starting material synthesis in-house initiated and taken some trial at plant/lab scale & some are the under lab development/ process optimization.

SHILPA MEDICARE- FINISHED DOSAGE FORMULATION FACILITY

Shilpa Medicare Limited – Finished Dosage Formulation Facility is a state of the art manufacturing and testing facility, engaged in manufacturing and distribution of potent drugs- which includes liquid and lyophilized injectables in vials, Onco sterile dry powder 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 is designed for handling of potent Drug Products (including Oncology products or adjutant therapies) in a fully contained manner. Facility is designed to handle potent molecules upto 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 exempted three products from the Import Alert. Shilpa Medicare Unit 4 is distributing these three products (Azacitidine for Injection, Erlotinib Capsules and Cyclophosphamide Capsules), in the US market. Working with FDA to resolve the matter in timely manner. Remediation measures are going on. Working with three USFDA consultants. Supplies to Europe are going on uninterrupted!

This facility consists of Oral Solid Block with two commercial scale tablet manufacturing and one commercial scale capsule manufacturing line. There are two blister packing lines and one Bottle filling line.

Three separate Injectable blocks consists of commercial scale manufacturing lines for liquid-lyophilized- powder filled injections. Fully automatic packaging lines are available for Injectables. Facility for Safe packaging for Onco Injectables is also available. Serialization (Track and Trace) is in place and implemented for all commercial supplies.

Fully equipped Utility facility which is provided with water system (Pre-treatment and Post treatments for generation and distribution of Purified water/WFI/Pure steam), Chillers, Air compressors, Boilers, Diesel generators, HVAC etc.

All world class process equipments are provided with 21 CFR part 11 compliant SCADA systems.

Fully equipped chemical testing labs (2 nos.) and microbiology facility are operational with trained and qualified staff.

Commercial presence in regulated, semi regulated and domestic markets in various dosage forms.

Contract Manufacturing

Shilpa Medicare Limited manufactures many products in several types of dosage forms such as tablets, capsules, liquid injection (Aseptically and terminally sterilized), Lyophilized Injectable, Sterile Dry powder injectables. All products are manufactured under the same stringent quality standards for export to USA, EU, ROW and Domestic market.

Future Expansions

8 Acre Land available for further expansion. Building work is already completed.

FORMULATION R&D

Shilpa Medicare has commissioned the State of Art Centralized Finished Dosages R&D Centre at Dabaspet near Bangalore. The R&D Centre is involved in development of Oncology and Non–Oncology Injectable formulation and oral formulations. R&D also develops Transdermal patch and topical preparations Ophthalmic formulations and Orally Disintegrating Film formulation. R&D Centre is well equipped for development of novel formulations, Generics, Complex Generics and value added dosage forms involving Nano and Micro technologies like Liposomes, nano particles and specialty products. On Analytical front, the R&D is equipped with state of the art instruments to evaluate the all kinds of dosage forms. State of the Art infrastructure is built for Extractable & Leachable studies for relevant products. Facility is capable of carrying out analytical method validations for both in - house & customer products. Analytical R&D has capabilities of characterization of API, impurities, excipients and packing components.

The new Research and Development Centre is one point stop to customers for Product Development, can cater the product development along with analytical method development for finished product, analytical method validation, stability studies, characterization of impurities, evaluating extractable & leachable for packing components. Process Development Lab meeting the cGMP requirement for manufacture scale–up batches to optimize the process variables and to manufacture of clinical batches is in place and ready for execution. New Research and Development Centre can as CRO for Non–Onco products along with analytical support and for CRAMS for Oncology portfolio of customers.

INTELLECTUAL PROPERTY MANAGEMENT (IPM)

Shilpas success depends on the Companys ability to secure patents, protect the proprietary information and operate without infringing on the others intellectual property rights. Shilpa Medicare Limited Intellectual Property Management (IPM) team is responsible for building Shilpas global generic product pipeline and 505(b)2 NDA pipeline as well as creating, managing and protecting its high value patent estate. Shilpa has a dedicated IPM Team which provides stage wise IP-clearances during product/process development activities and also provides frequent updates and alerts on relevant IP (patent, trademark etc) to R&D scientists for products/process and suggests remedial measures to deal with IP issues. Shilpa IPM team is involved in product selection activity to ensure that right products are selected for development. Shilpas IPM team continues to build its future pipeline of complex products with an established robust portfolio selection process, providing early launch opportunities with intellectual property advantages.

Shilpas strengths, across various molecules including oral, Injectable and complex differentiated products, biologics, lie in developing intellectual property in non-infringing processes and resolving complex chemistry challenges. The API Process development is focused for developing and transferring commercially viable, non-infringing and patentable novel API technologies. The development grid selection for APIs is based on difficult-to-make API molecules and novel polymorphic forms of certain APIs for creating value addition. Shilpas IPM Team is involved in patenting of new products, processes, methods of use, drug delivery systems and medical devices in India, US, EU and other countries with significant market value.

Highlights FY 20-21:

In FY 20-21, Shilpa filed one NDA and settled the litigation. Shilpa settled one litigation during FY 20-21 and succeeded in litigation related Dimethyl fumarate DR capsules at District court of Delaware.

Shilpa is committed to enhance our product profile by strengthening our intellectual property. Our patent portfolio is testament to our commitment. In FY 20-21, Shilpa and its group companies have filed 56 patent applications taking the cumulative total to 413 patent applications in India and other countries. Shilpa received grants for 19 patents during 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 -

Formulation

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: Raichur Industrial Growth Centre, Chicksugur, Raichur, Karnataka, India, inspected by USFDA. EIR received on April 17, 2020.

Shilpa Medicare Limited, Bangalore (Unit-III & Unit-IV)

Transdermal Patches and Oral Film Manufacturing Plant (Unit VI) A transdermal patch is medicated adhesive patch that is placed on the skin to deliver a specific dose of medication through the skin and into the bloodstream. Transdermal patches have made their place in global market in past few decades as an alternative to conventional therapeutic for various disease indications. Transdermal patches are widely accepted among physicians and patients due to their non-invasive, pain free and easy administration. In recent years, the growth of transdermal patch market has increased and expected to increase significantly in coming years. Higher investments in research and development could be attributed to the success of transdermal patch market.

Similarly, the thin film drugs were recorded with high market acceptance due to its ease 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 drugs achieve the desired therapeutic results. Therefore, they have gained attention in the market as a potential treatment option. Looking to the market potential, facility is designed and build a state of art manufacturing facility of Transdermal Patch and Oral Films at Dobaspet, Bangalore. This facility shall cater to Domestic, Regulated and Non Regulated market. The lay outs confirming to cGMP requirements is finalized along with Utility, Administration and canteen building. The equipments are designed to cater both Transdermal Patch and Oral Film Products. A space for future expansion is allocated for capacity increment. Transdermal Patch and Oral Film Manufacturing Plant status highlights:

Transdermal Patch and Oral Film Manufacturing Facility Qualification activities completed and execution of filing batches is in the process.

Shilpa Medicare Ltd, Biologics SBU

Background –

The past year witnessed a turmoil in the pharmaceutical markets globally on account of Covid related disruptions in raw materials and logistics. SBPL has largely remained unaffected thus far, owing to significant stocking up of raw materials prior to the disruptions and availability of raw materials from alternate sources. The biosimilar programs remain largely on track and our first biosimilar product is expected to be commercialized in the coming financial year.

The current ongoing Covid 19 crisis, while being a challenge in the near term for all businesses, is expected to contribute in a meaningful way to Shilpa Groups revenue in the coming Financial year with your company readying itself to manufacture at least one of the Covid vaccines that are likely to be commercialized in the near term. This vaccine is expected to contribute to the countrys fight against the virus in the latter half of this financial year.

While the sudden and sporadic nature of the pandemic makes it difficult to forecast the Covid vaccine opportunity in terms of duration and quantum of the revenues, the company views the recombinant vaccine opportunity as a strategic one, with the technology platforms outlasting the pandemic and being relevant over atleast the next 10 years. We intend to make significant investments in building up competencies in the technology platform areas, especially the viral vector platforms.

Opportunity and drivers -

Opportunity in regulated markets - Our single use manufacturing facility, coupled with very strong R&D backing in the area will help the company integrate vertically in biopharmaceuticals – conventional MAbs as well as in cell/gene therapies. Your company expects strong international partnerships in biologics over the next 1-2 years, to drive the business in regulated markets with the development and manufacturing from our site in Belur.

Opportunity in RoW markets – Your company is in the process of establishing partnerships with leading pharmaceutical players for Biosimilars across different geographies. Apart from this, your company is targeting co-development partnerships with global startups - which helps in expanding your companys footprint globally.

Your company is progressing one of its biologics into Human Clinical Trials designated as a New Biological Entity (NBE). This is expected to be major revenue driver from 2022-23 onwards – both, through direct sales and licensing opportunities for the company.

The same molecule is also being targeted at the excipient markets where test marketing of 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 is dominated by drugs catering to the autoimmune disorders and oncology segments, with 6 of the top 10 biologics in its pipeline. The remaining are niche, high margin opportunities catering to high unmet clinical needs. Your company is forging ahead with clinical trials on 1 nos MAb, 1 nos fusion protein and 1 nos NBE, while 3 others are expected to complete 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 Clinical trial pipeline, with market size of about $17 billion. The vaccine manufacturing opportunity helps us –

Meaningfully impact the countrys fight against Covid-19

With early revenue generation and helps us develop / enhance competence with novel platform technologies that have the potential to help us leapfrog competition in the emerging areas of gene and cell therapies. We look forward to a challenging, but exciting year ahead!

Contract development and manufacturing organisations (CDMOs) have established themselves as viable alternatives to the in-house development and manufacturing units of Pharmaceuticals and Biotech companies in recent decades. The increasing outsourcing trend in 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 vision to serve its Innovator and Generic customers from early development to cGMP manufacturing support, mainly to support new chemical entities development and cGMP supplies for clinical and commercial applications. SML possesses in-house credentials in HPAPI, Peptide, Polymers, Formulations (Oral, liquid, Parenteral, Topical etc.) and Biologics areas. SML HPAPI facility is a world-class one of the best developments and manufacturing facility for highly potent and such other niche molecules. It can handle molecules up to containment level five. The facility is audited and approved by various global regulatory agencies. SML integrated supply chain and in-house capabilities are well poised to solve toughest problems for Pharma, Bio-Pharma, Biotech and non-Pharma customers. Our expertise in complex Chemistry, High Potent API, Peptide, Polymer, Formulations, Biologics make us a partner of choice in CDMO market place. While market is expected to grow with double digit growth in niche CDMO space, SML aspire to register a very high growth in CDMO business, expected to grow with high double-digit growth.

SML has proven credentials in successful CDMO operations in past, supporting various global programs, in next 3 years time span, we aspire to establish SML as global CDMO brand for-

1. Integrated, one stop CMC solutions for preclinical, clinical and commercial outsourcing services of both Drug Substance and Drug Product for Small Molecules and Biologicals.

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 Solid phase 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 Novel therapeutics, 505(b)2, NDDS, Complex injectable, OSD, Transdermal and oral suspension areas.

6. Integrated, end to end solutions to Biologics Customers in Biosimilars, Novel Biologics, Vaccines, Gene and Cell therapies areas.

Domestic market overview:

Shilpa Medicare limited has entered in IPM in November 20 with a range of brands introduced in Gastrointestinal, Vitamins, Mineral, Nutrients, Gynaecology, orthopaedics, Urology, paediatrics segment etc. as first set of brands. Our aim is to provide unique ODF technology advantages to patients/consumers with an ease of administration and better patient compliance experience.

We have started our promotion to Doctors through a structured field force with promotion of products to Paediatrician, C. Phy, GP, family physician, Orthopaedics, Gynaecologist, Gastroenterologist, Urologist set of doctors 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 and injectable range as well as follow up with oral therapy after chemo is reduced considerable due to last year COVID pandemic which still is persisting at large thus market will take time to revive.

Branded domestic market in Acute segment is showing improve trend in last quarter of FY 2021.

IPM has witnessed recent surge in sales and demand in the segment specially GI overall oral and injectable antibiotics, Pain killers, Antipyretics, Multi vitamins, minerals, etc. and many more…

IPM has also witnessed slowdown of chronic care especially Diabetic, CV segment, Derma, Optho and Dental care section in specific We as an organization has a clear path and vision planned to penetrate in IPM market through exclusive Rx route and phase wise entry in OTX market with women care products and various other segment which we would like to share in 2nd quarter onwards as we add these products in our brand basket. we are sure to mark and make our presence felt in IPM through our unique delivery system technology called as MDF.

SUBSIDIARIES, ASSOCIATES & JOINT VENTURES

The Company has direct and step down subsidiaries in India and overseas. Consolidated financial statements have been prepared by the Company in accordance with the requirements of Ind AS 27 issued by Institute of Chartered Accountants of India (ICAI) and as per the provisions of the Companies Act, 2013 (“the Act”).

As per the provisions of Section 136 of the Act, separate audited financial statements of subsidiaries are placed by the Company on its website at www.vbshilpa.com . Statement containing the salient features of the financial statement of subsidiaries and associate company for the year ending March 31, 2021 in Form AOC-1 (Pursuant to first proviso to Sub-Section (3) of Section 129 read with Rule 5 of Companies (Accounts) Rules, 2014) is attached 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-III, Medchal-Malkajgiri District, Hyderabad, Telangana, India-500051, a progressive novel drug delivery company with an international outlook is dedicated to the development and commercialization of innovative and patient compliant novel drug delivery systems such as fast disintegrating oral strips. Shilpa Therapeutics Private Ltd. is the first company to commercialize prescription products as oral thin strips/films in India.

Management team with proven leadership and experience in pharmaceutical business., Shilpa Therapeutics is being lead and promoted by highly motivated professionals with extensive experience both in domestic and international pharmaceutical arena and highly qualified management professionals with a vision to develop and market innovative and patient compliant novel drug delivery systems.

Strong technical expertise to develop thin strips/films for oral/ sub-lingual/buccal delivery, As a result of continued efforts in the research and product development, Shilpa Therapeutics had developed the most sought after novel drug delivery dosage form– orally disintegrating strip/film and obtained the manufacturing and marketing licenses for this dosage form in India and abroad.

The orally disintegrating formulation resembling a postage stamp in size and shape is a taste masked, fast dissolving, convenient and potentially effective dosage form. The oral strip/film cannot be removed from the mouth upon application. The target patient population includes: One who cannot swallow e.g., Dysphagic & Odynophagia. One who does not want to swallow e.g., paediatric, geriatric and psychotic patients. Who should not swallow e.g., Dialysis patients (due to liquid intake restrictions) The oral strip/film is a convenient, discrete oral delivery form which when placed on the patient tongue is instantly wetted by saliva and then it rapidly disintegrates and dissolves within seconds to release the medication for its therapeutic benefits without the need of water.

The plant has recently Upgraded to carter Regulated Markets like ROW and European countries and the products are being updated to cater the registration requirements of the respective countries. Vertically integrated GMP facility from Research to Commercialization Shilpa Therapeutics facility is capable of meeting the regular commercial supply demand from manufacturing to secondary packing with its compliance to meet the latest Schedule ‘M, cGMP/WHO GMP compliant systems, procedures and practices.

The infrastructure includes major production equipment including formulation processing line with built-in high speed stirrers, homogenizers & de-aeration systems, layering and drying machinery, thermal heating systems, film slitting units and custom made pouch packing units.

Products available in the Domestic Market:

Shilpa Therapeutics had obtained manufacturing and marketing license from the Drugs Control General (India), New Delhi for the following products and these products have also been 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 Meniers 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 & Product Development 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 several patents on orally disintegrating strips A state-of-the-art R&D center for developing oral strips and sublingual film products, works in co-ordination with the Intellectual Property Management team to develop cost effective generics and novel patentable formulations.

In FY 2019-20, our patent filing grew further with 7 new patent filings including Indian and international filings. Since its inception, STPL has filed more than 25 patents across a wide global network.

The patent applications filed during FY 2019-20 includes novel pharmaceutical formulations, international filing of a unique formulation of green tea films.

STPL to continue aggressive patent filings and protection of IP in India and other important geographies of the world and plan to monetize the same.

STPL will continue to build its future pipeline of innovative and “first-time-in-the-world” fast dissolving films with Intellectual

Property (IP) advantages and we are con dent that the overall result of our initiatives will be evident in the coming years.

Regulatory Approvals

Shilpa Therapeutics Private Ltd has received approval for its oral disintegrating strip facility 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 are in verge of the products approval.

Business Scope

Shilpa Therapeutics holds bright prospects for its business scope. ODS products of Shilpa Therapeutics have already been launched in India under its own brand with Domestic Marketing Team formed under Shilpa Medicare Limited and also by other prominent pharma companies viz., Abbott India Limited, Delvin Formulations Private Ltd, Alkem Labs, Linux Laboratories etc. Shilpa Therapeutics has also extended its business to the external markets with its ODS products launched in Kenya and many other countries to follow.

Shilpa Therapeutics with its technical expertise, manufacturing capabilities and its finished products at various stages of registration in several countries is poised to attain 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 products using Nano technology. INM over the period has carried out research operations on various products and process in the fields of materials engineering / pharmaceutical technology and service in advanced technology and product development with scale up process for the developed micro / nanomaterials. INM has developed state-of-the-art facility for synthesis, characterization and analytical testing of nanotechnology based products and created various departments for the purpose of holding Company (i.e. Shilpa) involving major disciplines namely Biotechnology, Bio-Medical, Analytical and Pharmaceutical, Chemical, Polymer, Coatings, Electronics and Smart materials. INM Technologies R&D lab has been recognized by DSIR, New Delhi. INMT has filed patents on dental formulations namely: root canal sealant powder composites (Mineral Trioxide Aggregate) having nanostructured with nontoxic nature and highly biocompatible, Hemostatic gels based on Tranexamic acid and Tranexamic acid gingival based and Chitosan-Tranexamic acid loaded dicalcium silicate scaffold formulation for blood clotting and drug delivery. INMT has been working on Hydroxy apatite oral thin films for calcium supplement have been formulated and bio-studies are yet to be initiated. Paracetamol oral thin films have been initiated and have shown very interesting result in batch process.

In order to obtain advantage from the technologies, processes and resources developed by the INM Technologies Private Limited, Shilpa Medicare Limited has filed an application before National Company Law Tribunal, Bengaluru Bench for amalgamation of INM Technologies Private 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 to a wholly owned subsidiary company, INM Nuvent Paints Private Limited. Innovated nanostructured transparent coatings (6 Nos) namely: Hydrophillic, Hydrophobic, UV-absorbing, Heat Reflective, Fire retardant, multi protect 3 layer coating structures for SS surfaces are marketed through Nuvent. On the other hand, nanostructured paints (5 Nos) with enhanced performance have also been developed and under commercialization through Nuvent. These are anti-corrosion paint for MS surfaces, Heat Reflective paint for roof tops, High temperature (600oC) anticorrosion paint, fire retardant paint, Pigeon repellent paint. The developed paints are eco-friendly, low VOC, highly reliable and durable 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, Austria for 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 develop marketing network for the products of the Company in North American countries, particularly aimed at USA and also to co-ordinate with the USFDA authorities directly on a regular 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 drugs of 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, the products of the Company in Austria and adjacent countries.

Koanaa, Austria has now changed its strategy from direct marketing of products in Europe to out licensing model. This strategy could remain in force for few years for now till 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 only focus on Out-Licensing of products and thus it is responsible to sell their products through 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 partners to 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 brand “Austrian Quality”. The products will prove highest standards and quality and Koanaa, Austria will stand for Deliverability and Service for Patients and Physicians through its partners and distributors.

In terms of geographical presence Koanaa, Austria is based in Austria (Fischamend) near Vienna and is offering products released from Austria for now to all its customers going forward.

Koanaa, Austria has already got the approval from the AGES inspection (Austrian pharmaceutical authority) as a wholesaler with the official right to sell pharmaceutical products. Imatinib was the first product which was launched in the highly competitive market in Germany and Austria in April/ May 2017, later it was launched in Sweden, Finland and UK.

New territories such as CZECH and Romania have been also identified for launch. Though we have received the approval for Bortezomib and Pemetrexed, the same is still not launched as there is patent restriction.

The vision of Koanaa, Austria is to develop as a successful and reliable partner within the pharmaceutical domain.

KOANAA HEALTHCARE CANADA INC (Wholly Owned Subsidiary) Koanaa Healthcare Canada Inc was incorporated on April-24th-2020. Currently, there are two executives (President and VP of Regulatory 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 pharmaceutical industry. Koanaa was audited by Health Canada agency and received its compliance rating and drug establishment license on October 28th, 2020. Right after this important milestone, 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-licensing products to partners). This business model can be managed by both employees. The company has already secured business deals with partners and currently there are five dossiers under review and expect to receive approval in the second half of the year. One dossier is approved, and the head office plans to manufacture and dispatch the products in April or May. This will be the first recorded commercial sales in the territory. Koanaa Canada is under negotiations with additional partners and plans to make more business deals this year.

INDO BIOTECH SDN.BHD (Wholly Owned Subsidiary)

Indo Biotech SDN BHD is a Malaysian based company which is located in MALAYSIA The company has been formed for the primary purpose of marketing, manufacturing and distributing while performing other financial, business development, regulatory and general 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, to compete with both domestic manufacturers and imports. Generic pharmaceutical products are bio equivalent and therapeutic equivalent alternatives to branded drugs that have lost market exclusivity of patent protection.

Indo Biotech SDN BHD will be a wellspring of discovery and a catalyst for change in healthcare& pharmaceutical. We are committed to push the frontiers of discovery in order to improve health and well-being.

We believe connections make everything possible. Therefore, we want to be Malaysias leading health provider, we are working towards to strive to provide the right services to help you enjoy life to the fullest. From the way we operate to what we intend to accomplish both on the local and international front, we apply and hold close a vision of excellence created towards making ones life better.

At Indo Biotech SDN BHD, excel through high-quality innovative products and services to continuously bring value through commitment, respects, integrity and professionalism.

KOANAA HEALTHCARE SPAIN (Wholly Owned Subsidiary) S.L., Headquarters of Shilpa B2B Europe, became active in April 2020.

Currently, there are three executives (Vice President, and recently incorporated, Head of Business Development and Head of Regulatory Affairs), employed and located near Barcelona, Spain.

The main business model for Europe is a B2B License and Supply model, in which we out-license our high-quality Dossiers to European end customers who will market the products, supplied by Shilpa, under their own brand name. During the financial year 2019-2020 Shilpa, very successfully launched Azacitidine, covering the majority of European countries. Our aim is to become the preferred partner of choice, by providing a high-level quality of service and information, combined with a continuously growing strong, competitive and innovative portfolio.

KOANAA INTERNATIONAL FZ-LLC

Koanaa International FZ-LLC is a Rakez Free Zone Limited Liability Company FZ-LLC in United Arab Emirates. Koanaa International is offering its services to Africa and Middle East where they provide sales and marketing information. The Company also offers analytical data in pharmaceutical for Africa and Middle East countries. Koanaa International offers its best consultancy services in Food products, OTC, Pharmaceutical and healthcare products. The Company also manage the healthcare Companies specific project like sales and distribution channel, Pharmaceutical Research and development, supply chain management and all the Pharmaceutical companies related project. The company also offers the consultancy services for appointing distributor channel and poestablishing a company sales 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 a marketing 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 and Business Development. The Market Access planning has structured into formidable projects and would like to report each vertical as under:

a. Dosage Form:

As a strategy we have positioned in the Emerging Market by formalizing a supply consortium supporting Reva. The module has been successful and Tender supply of medicine for MOH (Afghanistan) was awarded to Reva. The supply was scheduled for Q4 2019-20, but due to COVID-19, it was shipped by May/June 2020. We plan to extend the strategy for market of Vietnam which still holds opportunity for new drugs and the registration timeline is short.

Licensing as a vertical was structured last year and success has been achieved in the markets of Europe, US & China.

b. API (Generic)

The business has progressed with commercial supplies of Oncology, Anti-Infective and Cardio into markets of Japan, Korea, Europe and Emerging Nations.

The Company has made Japan as its key market and build in-roads with main Industry Associations namely; (KPIA – Kansai Pharmaceutical Industries Association) and (JPMA – Japan Pharmaceutical Manufacturer Association). Reva Medicare is a joint venture between 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 year with operations of its Research

& Development Labs in Rajajinagar, Bengaluru-560010. We have completed key activities 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 model is taking advance and availing 5 years of royalty revenue on successful completion and implementation of the projects.

3) Delivered one complete “Conceptual Engineering Package to Customer” and they are in the process of procuring equipment for building the plants.

4) Completed more than 5 projects successfully and delivered some of them to customers and those projects are in different stages. Some of the technologies are developed by Sravathi on its own where we will be giving multiple licenses on non-exclusive basis in coming financial year.

5) Generated first revenues in this year through projects. Understood market “potential for our flow chemistry” which is significantly high.

6) Obtained approvals for selected API from “Drug control authority” during this year.

7) Hired number of skilled people – present team strength is ~50 people.

8) Established some capabilities, including new “Sravathi own designs” of flow 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, some disturbance for operations during April & May months of this financial year. However, overall 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 , & is establishing a state of art Manufacturing Facility for Recombinent Human Albumin manufacturing. This Product is developed by Shilpa Biologicals as a novel biological entity – a program part funded by the Department of Biotechnology, GoI, through its BIRAC arm. The program was also recognized as amongst the most innovative by DBT in 2012 and again in 2014/15. While the estimated Global demand is 1000 MT per annum for Albumin, hardly a fifth of this requirement is being catered to currently. The current market for Albumin is $1 billion based on the current supply condition having recognised this as a important potential business opportunity, The Company has invested in developing a synthetic route for generation of Human Albumin (outside of the human body) and came up with a technology that has been scaled up.

The company has global patent granted for this technology and intends to pursue this vigorously.

The company with permission from the RCGM (regulatory body) and DCGI , is conducting the clinical studies on the said Product . The European Union has also waived off a part of the clinical trials required to release the protein on the market after having gone through the data generated so far. Hence the company is setting up a large scale production unit for its recombinant Human Albumin at Kadechur Industrial Area. The clinical studies data & approval will be obtained in the 01st quarter of 2022. There after the company will cater to global demand for Albumin from this site – thus keeping 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 been formed to invest and hold the investments in group companies.

SRAVATHI AI TECHNOLOGY PRIVATE LIMITED:

Sravathi AI Technology Pvt Ltd is established its Research & Development facility in Rajajinagar, Bengaluru-10 in the month of August 2020. We have leased facility and established facilities for doing research in the area of “Artificial Intelligence in chemistry”. Established server and required high computing facilities for doing “Artificial Intelligence” work, which includes many GPUs and CPUs. We have hired required technical talent which comprise of “Data scientists, Molecular modeling experts, Biochemistry, medicinal chemistry, Bioinformatics etc. and operations team – now presently ~20+ people are onboard. We have established and developed “Drug Discovery platform” with variety of predicting models for generating new molecules and predicting biological properties. We have also established new capabilities for developing new molecules generation, Reaction platform and formulation platform. We have completed two “Drug Discovery” projects of In-silico (one program is related to Drugs for COVID-19 and another one related to Immuno-oncology” and presently working on synthesis of promising molecules. We have also established “Bioavailability” platform and completed one project and given for testing. We have received all required approvals/ certificates like MSME, GST, IEC, PF, PT etc. We have signed NDAs with ~4 CRO companies 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 of operation with global footprint. FTF has created a brand image in the industry as an experienced, capable and profitable company having vast experience and expertise in drug formulation development. It attracted competent and experienced technical manpower from large pharmaceutical companies to cater to its growth. FTF Pharma is working on flexible business model as per the market dynamics to cater to its growth and has de risking policy to 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. The revenue generated is ploughed back into the company to generate IP and to create state of the art modern R&D infrastructure and creating enough R&D space for future business 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 was based on the concept of First to File ANDA in USA to get 6 months exclusivity for marketing generating more profit for the client and more value to our IP and 505b2 projects.

In this process, we grew from strength to strength between 2014- 2018 as first to file opportunity was considered a value proposition for all major generic companies in USA. We changed our business model from licensing to contract development making a whole lot of new customers between 2018-2021 depending less on licensing revenue from FTF projects which is cyclical in nature and market dynamic change for First to File model changed making it unviable.

AUXILLA PHARMACEUTICALS AND RESEARCH LLP (Investment Entity) AUXILLA PHARMACEUTICALS AND RESEARCH LLP is R&D centre based at Ahmedabad focused on development of 505(b)(2) and complex generics. This business is of product development for national and international clients based on fee for service type as well as co-development/collaboration of in-house projects. Our innovative product development business helps to address reduction in product pricing and burden on healthcare practitioners/nurses.

We will continue to expand our clientele globally and develop differentiated products, focusing on increasing access to products with significant barriers to entry. In first year after inception, we have shown good progress in terms of new projects taken for development and out-licensed as well. There are more than 25 projects in pipeline for development and 10 of them will be taken for trial/validation at plant scale. We have also signed agreement for two complex generic injectable projects and one peptide based injectable product in this year.

In terms of patents three Indian patents are filed and another seven patents are under filing on liquid orals and injectables. We have developed one injectable platform for water sensitive molecules keeping low production cost in mind and another injectable platform technology for long-acting depot, which can enhance patient adherence towards critical chronic diseases.

VEGIL LABS PRIVATE LIMITED

Your company has formed wholly owned subsidiary, Vegil Labs Private Limited (VLPL) for the 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 a slump sale basis, such transfer will create API Business into separate entity which will interalia 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 out by your Company.

DIVIDEND:

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 FY 2020-21. The Dividend Distribution Policy of the Company is set out as Annexure-10 and the same is uploaded on the Companys website at https://www.vbshilpa.com/pdf/Dividend-Distribution-Policy.pdf

SHARE CAPITAL:

The paid up share capital of your Company is Rs.8,15,26,898/- (Rupees Eight Crore Fifteen Lakh Twenty Six Thousand Eight hundred and Ninety Eight) divided into 8,15,26,898 equity shares of Rs.1/- each. There was no change in the share capital structure during the period under review.

Pursuant to the provisions of section 124 (5) of the Companies Act, 2013 read with the IEPF Rules, the Company has transferred 12,000 shares belonging to the shareholders who did not continuously claim dividend for seven years from the financial year 2012- 13 to IEPF 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 carrying differential rights.

TRANSFER TO RESERVES:

During the financial year under review, your Company has not transferred any amount to the general reserve.

DIRECTORS OR KEY MANAGERIAL PERSONNEL:

Mr. Naresh Patwari (DIN No. 03319397), Non-Executive Director will retire by rotation at the ensuing Annual General Meeting and being eligible, offers himself for re-appointment. Mr. Amit Chander (DIN: 02406965) Ceased to be director of the Company with effect from 02nd October, 2020 due to change in his professional priorities. Further Mr. Sushil Bajaj, Chief Financial Officer of the Company has resigned and ceased to be as such w.e.f 19th January, 2021. Mr. Alpesh Dalal was appointed as Chief Financial 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 in compliance with the provisions of the Companies Act, 2013, the Listing Regulations and Secretarial Standards on Board meeting: a. 05th May, 2020 b. 15th June, 2020 c. 08th August, 2020 d. 09th September, 2020 e. 18th September, 2020 f. 02nd November, 2020 g. 22nd January, 2021 h. 13th February, 2021 i. 05th March, 2021 j. 31st March, 2021

STATEMENT OF DECLARATION GIVEN BY INDEPENDENT DIRECTORS UNDER SUB-SECTION (6) OF SECTION 149:

The Independent Directors have submitted their declaration of Independence, as required under Section 149(7) of the Companies Act, 2013 stating that they meet the criteria of independence as provided in Section 149(6) and Regulation 25 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.

AUDITORS:

Statutory Auditors:

M/s. Brahmayya & Co., Chartered Accountants (Firm Registration No. 000513S), were appointed at the 30th Annual General Meeting as the Statutory Auditors of the Company for a term of five years to hold office till the conclusion of the 35th Annual 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.

Cost Auditors:

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 segments of the Company for the financial year 2021-22. As required under Section 148 of the Companies Act, 2013 and Rule 14 of the Companies (Audit and Auditors) Rules, 2014, a resolution is being placed at the ensuing AGM for ratification of remuneration payable to the said Cost Auditors.

Secretarial Auditors:

M/s. P.S. Rao & Associates, Practicing Company Secretaries were appointed to conduct the Secretarial Audit of the Company for the financial year 2021-22, as required under Section 204 of the Companies Act, 2013 and Rule 9 framed thereunder. The Secretarial Audit 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 Secretaries, as Secretarial Auditors of the Company for the financial year 2021-22.

Internal Auditor:

M/s M. Bhasakara Rao and Co., Chartered Accountants, were appointed in the Board meeting held on 31st May , 2021 as recommended by the Audit Committee, to conduct the Internal Audit of the Company for the financial year 2021-22 as required under section 138 of the Companies Act, 2013 and rules made thereunder.

COMMENTS BY THE BOARD ON EVERY QUALIFICATION, RESERVATION OR ADVERSE REMARK OR DISCLAIMERS: Statutory Auditors:

As there is no qualification, reservation or adverse remark in the reports given by the Statutory Auditors, your directors need not provide any clarification on the same.

Secretarial Auditors:

As there is no qualification, reservation or adverse remark in the reports given by the Secretarial 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 Rule 8 of the Companies (Accounts) Rules, 2014, is enclosed herewith as Annexure–8. RISK MANAGEMENT POLICY:

Pursuant to Regulation 21(4) of SEBI (LODR) Regulations, 2015, the Board of Directors has formulated and implemented a

Risk Management Policy which identifies various elements of risks, which, in its opinion, may threaten the existence of the Company and contains measures to mitigate the same. The Risk Management Policy of the Company is posted on the Companys website: www.vbshilpa.com.

A Risk Management Committee has been constituted as per the terms of Regulation 21 of SEBI (LODR) Regulations, 2015 to monitor and review the major risks faced by and the risk management plan of the Company periodically.

FINANCIAL STATEMENTS:

In accordance with the provisions of Section 129 (3) of the Companies Act, 2013, the Standalone and Consolidated Financial Statements, drawn up in accordance with the applicable Accounting Standards, form part of this Annual Report.

In accordance with Rule 8 (1) of Companies (Accounts) Rules 2014, the highlights of performance of the Subsidiaries, Associates and Joint Ventures and their contribution to the overall performance of the Company have been detailed in Annexure - 5 enclosed to this report. Further, the annual accounts of all the subsidiary companies are available on the Companys website – www.vbshilpa.com. Annual accounts of the Subsidiary Companies and related detailed information will be available for inspection by the members, at the registered office of the Company and will also be made available to the members upon request.

ADEQUACY OF INTERNAL FINANCIAL CONTROLS WITH REFERENCE TO THE FINANCIAL STATEMENTS:

The Company has Internal Control Systems, commensurate with the size, scale and complexity of its operations. Various Audit systems in the Company monitor and evaluate the efficacy and adequacy of the internal control systems of the Company, its compliance with operating systems, accounting procedures and policies at all locations of the Company. Based on the audit reports, the concerned department/ unit undertakes corrective action in the respective areas and strengthens the controls. Significant audit observations and corrective actions thereon are presented to the Audit Committee of the Board periodically.

The Board of Directors of the Company has adopted various policies like Related Party Transactions Policy, Whistle Blower Policy, Policy to determine Material Subsidiaries, Code of Conduct for Regulating, Monitoring and Reporting Insider Trading and such other procedures for ensuring orderly and efficient conduct of its business for safeguarding its assets, prevention and detection of frauds and errors, accuracy and completeness of the accounting records and timely preparation of reliable financial information.

DETAILS OF THE COMPANIES WHICH HAVE BECOME OR CEASED TO BE SUBSIDIARIES, JOINT VENTURES OR ASSOCIATE COMPANIES DURING THE YEAR UNDER REVIEW:

The following instances took place during the year under review which need to be reported in accordance with Rule 8(5) (iv) of Companies (Accounts) Rules, 2014: a. During the year under review Shilpa Corporate holdings Private Limited an investment company to invest in the group companies, has been formed as a wholly owned subsidiary and acquired 100% stake in FTF Pharma Private Limited an Indian company, Koanaa Healthcare Canada, Koanaa International FZ LLC (Dubai), Indo Biotech SDN. BHD Malaysia, so that all these companies have become as wholly Owned Subsidiaries.

Further, the Company also acquired balance 25% equity shares of INM Technologies Private Limited and made a wholly owned subsidiary. b. Your company has acquired contribution in Auxilla Pharmaceuticals And Research LLP c. INM Technologies Private Limited which is the wholly owned subsidiary of the Company holds 25 percentage of its stake in INM Nuvent Paints Private Limited. d. The Company had disposed off the total stake in its Step Down Subsidiary named Loba Feinchemie GMBH, Austria. The proceeds have been 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 Act, 2013 and the Companies (Corporate Social Responsibility Policy) Rules, 2014, a Corporate Social Responsibility Policy (CSR Policy), indicating the activities to be undertaken by the 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 CSR amount to ‘Shilpa Foundation, a public charitable trust taking up various social public causes of the society in and around Raichur, Karnataka and the activities of the said trust are covered under the Schedule VII of the Companies Act, 2013. A report on the CSR activities, as required under Rule 8 of the Companies (Corporate Social Responsibility) Rules, 2014, is enclosed herewith as Annexure – 4.

The CSR Policy of the Company and other details as required is are placed on the Companys 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 of Section 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 the prospective directors and KMP who possess the requisite skills and positive attributes as specified in the Nomination and Remuneration Policy.

The Nomination and Remuneration Committee has formulated a Nomination and Remuneration Policy which recommends the guidelines based on which the annual performance of the Independent Directors, Board and Individual Directors is carried out by the Board.

The Nomination and Remuneration Policy of the Company is placed on the Companys website at https://vbshilpa.com/pdf/ NominationRemunerationPolicy.pdf

FORMAL ANNUAL EVALUATION MADE BY THE BOARD OF ITS OWN PERFORMANCE AND OF ITS COMMITTEES AND INDIVIDUAL DIRECTORS:

The Board of Directors have carried out an annual evaluation of its own performance, as well as that of its Committees and individual directors pursuant to the provisions of the Sections 134 and 178 read with Schedule IV to the Companies Act, 2013. A structured questionnaire was prepared after taking into consideration inputs received from the Directors, covering various aspects of the Boards functioning such as adequacy of the composition of the Board and its Committees, execution and performance of specific duties by the Board of Directors, independence governance, ethics and values, attendance and contribution at meetings etc.

The performances of the Independent Directors were evaluated by the Board after seeking inputs from all the directors on the effectiveness and contribution of the Independent Directors.

The performance of the Committees was evaluated by the Board after seeking inputs from the Committee members based on the criteria such as the composition of Committees, effectiveness of Committee Meetings, etc.

The Board reviewed the performance of the individual directors on the basis of criteria such as the contribution of the individual director to the Board and Committee Meetings, like preparedness on the issues to be discussed, meaningful and constructive contribution and inputs in Meetings, etc. In addition, the Chairman was also evaluated on the key aspects of his role.

In a separate meeting of Independent Directors, performance of the Non-Independent Directors, performance of the Board as a whole and performance of the Chairman was evaluated, taking into account the views of Executive Directors and Non-Executive Directors. The Independent Directors also assessed the quality, quantity and timeliness of flow of information between the Board and the management that is necessary for the Board to perform its functions reasonably and effectively. The same was discussed in the Board Meeting 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 the applicable Accounting Standards have been followed along with proper explanation relating to material departures;

The Directors have selected such accounting policies and applied them consistently and made judgments and estimates that are reasonable and prudent so as to give true and fair view of the state of affairs of the Company at the end of the financial year ended 31st March, 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 adequate accounting records in accordance with the provisions of the Companies Act for safeguarding the 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 Company and that such internal financial controls are adequate and were operating effectively; and

The Directors had devised proper systems to ensure compliance with the provisions of all 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 (Management and Administration) Rules, 2014 (as amended), a copy of the Annual Return of the Company shall be placed on the Website of the Company at https:// www.vbshilpa.com

OTHER DISCLOSURES:

Committees of Board:

Your Company has the following committees, namely:

Audit Committee;

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 Act, 2013 and SEBI (LODR) Regulations, 2015. The details of the constitution are mentioned in Corporate 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 as such the details as specified in Schedule V(C) of SEBI (LODR) Regulations, 2015, with regard to Corporate Governance Report including Practicing Company Secretarys Certificate on compliance with the conditions of Corporate Governance specified in Schedule V(E) of SEBI (LODR) Regulations, 2015 as well as a certificate as specified in Schedule V(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 stipulated under Regulation 34 read with Schedule V (B) to the SEBI (LODR) Regulations, 2015 is annexed hereto and forms part of this Annual Report.

Vigil Mechanism:

In pursuance to the provisions of Section 177(9) & (10) of the Companies Act, 2013 and Regulation 22 of SEBI (LODR) Regulations, 2015, a vigil mechanism for directors and employees to report genuine concerns has been established. The Policy on vigil mechanism i.e. Whistle Blower Policy may be accessed on the Companys website at https://www.vbshilpa. com/. The policy provides for a framework and process for the employees and directors to report genuine concerns or grievances about leak of Un-published Price Sensitive Information (UPSI) and illegal or unethical behavior to the Chairman of the Audit Committee.

Remuneration ratio of the Directors/Key Managerial Personnel/Employees:

Statement showing disclosures pertaining to remuneration and other details as required under 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 as Annexure-2.

Particulars of Employees:

Statement of employees as required under Rule 5(2) of the Companies (Appointment and Remuneration of Managerial Personnel) Rules, 2014, is enclosed as Annexure – 3 to the Boards Report.

COST RECORDS AND COST ACCOUNTS:

The Company is maintaining cost records and accounts as specified by the Central Government under subsection (1) of section 148 of the Companies Act, 2013.

DISCLOSURE UNDER SEXUAL HARASSMENT OF WOMEN AT WORKPLACE (PREVENTION, PROHIBITION, AND REDRESSAL) ACT, 2013:

Your Company has always provided a safe and harassment free workplace to every individual working in its premises through various policies and practices. Your Company always endeavors to create an environment that is free from discrimination and harassment, including sexual harassment. Your Company has been actively involved in ensuring that the clients and all the employees are aware of the provisions of the POSH Act, 2013 and the rights available to them there under.

Your Company has in place an Anti-Sexual Harassment Policy in line with the requirements of the Sexual Harassment of Women at workplace (Prevention, Prohibition and Redressal) Act, 2013. An Internal Complaints Committee has been set up to redress the complaints received regarding sexual harassment. Your Company did not receive any complaints during the period under review.

PARTICULARS OF LOANS, GUARANTEES OR INVESTMENTS:

Details of the loans granted, guarantees given, securities provided and investments made during the year under review, as covered under Section 186 of the Companies Act, 2013, are detailed in the notes to the financial statements which may be read as a part of this Report.

DEPOSITS:

During the year under review, your Company has not accepted any deposits within the meaning of Section 73 of the Companies Act, 2013 read with the Companies (Acceptance of Deposits) Rules, 2014.

RELATED PARTY TRANSACTIONS:

Related Party Transactions entered into during the financial year under review are disclosed in Note No. 45 to the Financial Statements. These transactions were at an arms length basis and in the ordinary course of business. There were no materially significant Related Party Transactions with the Companys promoters, directors, management or their relatives 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 enclosed herewith as Annexure - 6.

Related Party disclosures as per Schedule V of SEBI (LODR) Regulations, 2015 are enclosed herewith as Annexure - 7. The policy on Related Party Transactions, as approved by the Board may be accessed on the Companys websitehttps:// www. vbshilpa.com/pdf/related_party_policy.pdf

BUSINESS RESPONSIBILITY REPORT:

Pursuant to Clause 34(2)(f) of the SEBI (LODR) Regulations, 2015 Business Responsibility 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 the following 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 any scheme.

Neither the Managing Director nor the Whole-time

Director of the Company received any remuneration or commission from any of its subsidiaries.

No significant or material orders were passed by the

Regulators or Courts or Tribunals which impact the going concern status and Companys operations 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 the Company occurred between the end of the financial year of the Company to which the financial statements relate and the date of the report.

The Company has complied with Secretarial Standards, i.e. SS-1, and SS-2 relating to Meetings of the Board of Directors and General Meetings respectively, issued by the Institute of Company Secretaries of India and notified by the Ministry of Corporate Affairs.

ACKNOWLEDGEMENT:

Your Directors wish to express their gratitude to the Central and State Governments, investors, analysts, financial institutions, banks, business associates and customers, the medical profession, distributors and suppliers for their whole- hearted support. Your Directors commend all the employees of your Company for their continued dedication, significant 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