Shilpa Medicare Director Discussions


The Members,

Your Directors have pleasure in presenting their Report on the business and operations of the Company along with the Standalone and Consolidated Audited Financial Statements for the year ended March 31, 2023.

Financial Summary

(All figures are in Rupees in Lakhs)




Standalone Consolidated Standalone Consolidated

Continued operations :

Operating revenue 24,770.20 1,05,011.24 35,695.18 1,14,552.28
Other Income (Including Exceptional Item) 5,309.77 1,739.97 4,967.10 2,303.66

Profit before Interest, Depreciation, Tax and after exceptional Items from continuing operations

909.66 11,968.13 7,135.72 22,689.22
Interest 2,082.51 5,865.21 905.36 4,116.52
Depreciation 4,654.75 9,549.90 3,481.77 7,980.19
Net profit before tax from continued operations -5,827.60 -3,446.98 2,748.59 10,592.51
Provision for taxes
a. current tax -836.56 3,413.10 480.23 3,404.31
b. Deferred Tax (Net of MAT Credit) -42.74 -4,149.46 252.52 763.96

Profit after tax from continuing operations Discontinued operations :

-4,948.30 -2,710.62 - 2,015.84 - 6,424.24 -
Profit/ (loss) before tax from discontinued operation 7,095.22 - 16,540.71 -
Tax expense/(credit) of discontinued operation 3,572.38 - -4,457.74 -

Profit/(Loss) after tax from discontinued operations

10,667.60 - 12,082.97 -

Profit for the year from continued and discontinued operations

5,719.30 -2,710.62 14,098.81 6,424.24
Share of profit/(Loss) in Associates/ Joint Ventures - -380.97 - -366.03
Share of profit/(Loss) in Non-Controlling interest - -156.04 - -8.02

Other comprehensive incomes (expenses) (Continued and Discontinued operations)

-428.59 322.64 118.52 -136.33
Total Comprehensive Income 6,147.89 -2,924.99 13,980.29 5,929.90


During the year under review, the Company reported standalone operating revenues of 24770.20 Lakhs as against 35695.18 Lakhs and Total Comprehensive Income of 6147.89 Lakhs as against 13980.28 Lakhs in the previous year, whereas consolidated gross revenues of 105011.24 Lakhs as against 114552.28 Lakhs and Total Comprehensive Income of -2924.99 Lakhs as against 5929.90 Lakhs in the previous year.

Active Pharma Ingredients


(Wholly owned subsidary) API FACILITIES

Shilpa 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- Mexican, PMDA-Japan, Korean FDA, TPD Canada & TGA-Australia.

The company is having about 20 APIs & intermediate manufacturing blocks with segregation of Oncology and Non-Oncology manufacturing facilities. Oncology products are manufactured & handled with highly pr?cised isolators & taking care of people & environment. Oncology 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 India on containment technologies for the manufacturing of oncology drug substances in a contained environment.

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 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. Safety coordinators & safety squads are trained by expert to help industry in case of any issue & also neighbors. Emergency response team is in place to act in case of emergency. This Team is trained by Local fire authorities. They are actively involved in MOCK drills to Keep the system in always ready. 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.

All utility system performance is tracked & ensured that it is working at optimum level, Power consumption reductions are Placed in case of AHU 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 brought out the new block with about 65KL volume with higher size reactors to ensure the delivery of non-Onco products in market.

Polymer block and Peptide block is ready to start validation batches.


Shilpa Pharma views its R&D capabilities as a vital component of its business strategy that will provide a sustainable, long-term competitive advantage. Shilpa pharma 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.

Shilpa flow chemistry Team is in action & commercially demonstrated 2 products in Flow & expected to Demonstrate another 3-4 products in FY 23-24. This is really added Capability of close handling.

Shilpa started working on self-dependency on KSM & intermediate, in this context R&D started is work & completed 2 Products backward integration. Shilpa R&D continuously focusing on the process technology improvement activities of existing commercialized APIs to reduce the manufacturing cost to attain the global costing to sustain in the market continuously.


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, 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 up to OEL 4 level of containment. The facility is approved by various regulatory agencies including EUGMP- AGES-Austria, ANVISA, PERU, Argentina, South Africa & MEXICO COFEPRIS.

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.

Fully automatic packaging lines are available for Injectables in vial presentation and for Oral solid dosage forms in bottles and blister presentations. The Injectable Packaging lines are designed for safe packaging for Onco Injectables.

Serialization (Track and Trace) is in place and implemented as per market requirement for commercial supplies.

Fully equipped Utility Block is equipped 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 equipment are provided with 21 CFR part 11 compliant SCADA systems.

Fully equipped and approved chemical testing Laboratories and Microbiology laboratory are operational with trained and qualified staff.

Commercial presence in various regulated, emerging markets and domestic markets in injectable and oral solid dosage forms.


Inj. – between 1.5-3.0 Million vials depending on product cycle and vial size. OSD – about 15 - 20 Million units depending on product cycle.

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, etc for various reputed pharmaceutical organisations across the world.

All products are manufactured under the same stringent quality standards for export to USA, EU, EM and Domestic market.

Future Expansions

8 Acre Land available for further expansion. Currently a greenfield project is partially erected for facility expansion of Injectables. REGULATORY FILINGS (API RAICHUR UNIT-1 & UNIT-2) FY- 2022-23



Filed in 2022-23 Cumulative Filed Status Planning to file in 2023-24 Remarks


No new DMFs Were Filed 45 DMF 25 DMF was Approved 3 DMF was under review 16 DMFs CA listed 8 DMFs -
CEP-EDQM 3 CEPs Were Filed 17 CEP 17 CEP Approved 4-CEPS -


3 ASMF were Filed 26 ASMF 6 CEPs under review 22 ASMF was Approved 4 ASMF under review -- -



Filed in FY 2022-23 Cumulative Filed Cumulative Status Planning to file in FY 2023-24 Remarks

Formulation US

No 29 13 - Final approvals 2 Pemetrexed Injection (Ready to


Submissions Submissions 3 - Tentative approvals 13 – Under assessment Use) NDA is approved.

EU Submissions

3 New Submissions 28 Submissions 20- Final approvals 8 – Under assessment 4

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.

Regulatory Inspections and approvals (Formulation unit). -Regulatory inspections:

(i) Russia Feb 2021 Approved
(ii) Kenya Nov 2021 Approved
(iii) Kazakhstan Mar 2022 Approved
(iv) Health Canada Sept 2022 Approved
(v) Australia (TGA) Sept 2022 responses submitted, outcome awaited


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 22-23:

Shilpa is committed to enhance our product profile by strengthening our intellectual property. Our patent portfolio is testament to our commitment. In FY 22-23, Shilpa and its group companies have filed 53 patent applications taking the cumulative total to 544 patent applications in India and other countries. Shilpa received grants for 7 patents during FY 22-23.


Transdermal Patches and Oral Film Manufacturing Plant (Unit VI) .

A transdermal patch is a 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 the global market in the 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 the transdermal patch market has increased and is expected to increase significantly in coming years. Higher investments in research and development could be attributed to the success of the transdermal patch market. Similarly, the oral 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 oral thin film drugs. The oral 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 Thin Films.

The layouts confirming cGMP requirements are finalized along with Utility, Administration, and canteen building. The equipments are designed to cater both Transdermal Patch and Oral Thin Film Products. Space for future expansion is allocated for capacity increment. The Facility comprises of below sections - Storage of incoming materials and finished products at controlled conditions. Transdermal System / Patch (TDS) and Oral Dispersible Film (ODF) Manufacturing Plant status highlights: Transdermal Patch and Oral Film Manufacturing Facility is a Qualified GMP facility to manufacture exhibit batches filling product filling and commercialized in Global market. This facility is approved by MHRA (UK) for ODF products.

We have completed execution of Exhibit/filing batches of Ten ODF products and one Transdermal product. We have filed an ODF product in UK MHRA which is expected to get approval in 2023. The rest of the products are under Clinical studies and stability studies and will be ready to file for different countries in the coming months.

We have got GMP certification program for Dietary Supplements (ODF) from

UL Verification Services Inc.; Pennsylvania 18106; United States of America.

We have ISO 5001:2018, ISO45001:2018 and ISO 14001:2015 Certification from AQC Middle East LLC, Noida, U.P. India and ISO / IEC 27001:2013 Certification from KVQA Certification Services Pvt Ltd Delhi, India We have Manufacturing Site Registration Certificate from

Ministry of Health, UAE.

We have COPP/WHO Licence to manufacture for sale (or for distribution of) drugs other than those specified in [Schedules C and C(l) and X]

US CDMO Business Plan Introduction

The global Contract Development and Manufacturing Organization (CDMO) outsourcing market size is projected to reach ~USD 160 billion by 2028, from USD 80 billion in 2021, at a CAGR of 10% during 2022-2028 (MarketWatch report, 2022). Small molecule API development and manufacturing for novel chemical entities (NCEs) are expected to be the dominant segments in the CDMO market with a revenue share of ~50% in 2018. Large molecules, such as biologics, biosimilars, cell and gene therapies, are expected to witness the fastest growth over the next 5 years and the global biologics CDMO Market is estimated to increase from ~USD 10 billion (2020) to ~USD 19 billion by 2026, registering a CAGR of 10.9%. Among global markets, North America will maintain the lead due to the presence of some of the largest industry players, focus on innovative R&D into new treatments, increasing aging population, prevalence of chronic conditions emergence of new diseases, as well as the relative abundance of funding from venture capital for undertaking the high-risk novel drug discovery research effort. High R&D costs, capacity and capability limitations and specialized expertise – all major constraints within pharma companies big and small - make CDMOs excellent external innovation partners to sponsors for expediting the drug manufacturing process while offering significant time, cost, and process efficiencies.

Shilpa Medicare Ltd. (SML) can expect rapid growth in the CDMO business due to its high-quality workforce, cost advantage in research and development (R&D) and manufacturing, and expertise across a range of industry verticals. In particular, SMLs capabilities in drug substance (small molecules and large molecules) development and manufacturing, and finished drug product development and manufacturing, as well as therapeutic peptides, polymer science and performance materials, makes a compelling case for the Company to become firmly entrenched as a partner of choice for a whole range of companies across pharma and non-pharma segments.

Market strategy

Shilpa Medicare is a fully integrated Company providing DS, DP development and cGMP manufacturing from USFDA,

Health Canada, EMA, PMDA, KFDA, Cofepris, and TGA accredited facilities. It is therefore well positioned to become a trusted and truly end-to-end solution provider given existing infrastructure and continuous capital-intensive investments. (1) specialization with a strong focus in the high growth oncology space (2) further strengthening of biologics capabilities and capacities, incl., vaccines (3) technology focus with addition of niche capabilities such as flow chemistry and AI-DD (4) planned introduction of new segments such as oligonucleotides As an external innovation partner to the innovator biopharma industry, the Company bring differentiation at several levels that sets it apart in the CDMO industry–(1) Early phase to late phase from AI/ML led discovery (target to hit, hit to lead and lead to NCE) to custom synthesis, scale up and clinical materials (for advanced intermediates, RSMs) (2) Commercial scale cGMP manufacturing with multi-metric ton capacities for final API

(3) Specialized capabilities such as oncology API, high potent (OEL Band 5) and cytotoxic compounds

(4) Flow technology with the ability to conduct asymmetric catalysis, fluorinations, nitrations and a range of hazardous/complex chemistries

(5) Process intensification using custom printed reactors that offer exceptional COGS benefits over commercial flow reactors

(6) AI/ML based process R&D that yields optimized ROS, higher selectivity and purity, and reduction of unwanted by-products and impurities (e.g., NDMA) In addition, Shilpa enjoys a unique position - on one hand - as a pharma Company first by combining both commercial and regulatory experience with successful registrations of >40 complex products globally incl., in the US and EU markets. On the services side on the other hand its experience in route scouting, synthetic chemistry, process and analytical development, ICH stability, product formulation, manufacturing, fill-finish, labeling and packaging offers customers a truly integrated approach to drug R&D. That combined with a structured program management approach assures customers of full support and high-quality execution from lab to clinic to market. We will follow a fundamentally partnership driven approach to the market with a focus on brand building, innovation, impeccable delivery, and long-term supply chain assurance as the key pillars of customer engagement and success. We will follow a Deep Science methodology based on deep knowhow of clients clinical pipelines, chemistry and biology that will position Shilpa as a research driven CDMO and facilitate the acquisition of net new logos. We will establish a Program Management approach to delivery that transitions clients from a PO based practice to a full ownership and full lifecycle model and assure Speed to Clinic and Speed to Market. We will create a Pharmaceutical Sciences Platform that offers clients a full-value chain solution incorporating integrated CMC and program delivery from lead selection to IND within 10-12 months where technical teams will work across functions to ensure knowledge retention from early to late phase incl., scale up, clinical trial materials and cGMP manufacturing. We will establish a Governance Framework to ensure tight integration with key stakeholders (client sponsors, technical, clinical, quality, regulatory, commercial heads) with the objective to evolve from a project-based into a long-term value-based partnership and ensuring consistent delivery. We will develop and execute consistent omnichannel (print and digital) marketing campaigns to evangelize Companys capabilities (website, email, print and video), incl., Japanese language messaging on LinkedIn and other social media channels. We will utilize sales automation and analytics to derive actionable intel and insights on markets and customers (e.g., dormant accounts, underserved territories, BD productivity metrics, win/loss stats, and so on).

Focus areas for the near-term (2023 – 2024)

(1) Small molecules: The US Food and Drug Administration (USFDA) approved 53 new molecular entities (NMEs) in 2020, of which 40, or 75%, were small molecules. Accordingly, a major focus for the Company will be to strengthen its position and penetration in this segment. Shilpa provides a fully integrated CDMO services covering drug substance, drug product development and cGMP manufacturing from our USFDA, Health Canada, EMA, PMDA and TGA accredited facilities. Our expertise covers custom synthesis, chemical development, clinical materials, scale-up and cGMP commercial scale production of advanced intermediates, RSMs and API, incl., high potency, oncology and cytotoxic compounds. As oncology specialists, we bring significant experience in the development and manufacturing of tyrosine kinase inhibitors such as Axitinib, Dasatinib, Erlotinib, Imatinib, Lenvatinib, Nilotinib, Pazopanib, Sorafenib, Sunitinib and others, and a portfolio of anti-cancer compounds (e.g., Bortezomib, Cabazitaxel, Capecitabine, Decitabine, Enzalutamide, Gemcitabine, Pomalidomide, Temozolomide, to name a few). With these unique capabilities, the CDMO business has picked up a number of innovator biopharma companies in its portfolio of clients and delivered successfully on complex programs.

36th Annual Report 2022-23 51

(2) Large molecules: Spending on biologics, and emerging modalities, such as cell and gene therapies, rose to $164 billion globally in 2020 at an average of 14.3% between 2015 – 2020 (IQVIA report, 2020). Shilpa Biologicals from its fully integrated facilities in Dharwad, Karnataka, India provides drug substance and drug product development and manufacturing for global markets. The facilities are fully equipped with state-of-the-art upstream and downstream processing for mammalian and microbial systemsformonoclonalantibodies(MAbs),fusionproteins as well as adenoviral and AAV based gene therapies and vaccine production. This includes mammalian cell culture capacities to 8000L (with associated downstream processing), three filling lines incl., a high throughput line with capacities of 300u/m liquid vial fill (for vaccines) is installed and will be commissioned in 2023. In microbial fermentation, we have 2000 liters, and are setting up a 150,000L facility with a downstream for microbials. We provide the full complement of services from cell line / clone development, and cGMP cell banking to manufacturing, fill/finish (in vials and PFS), packaging and labeling –

(1) CHO cells for MAbs, fusion proteins, glycoproteins and subunit vaccines

(2) HEK cells for adenoviruses and adeno-associated viruses

(3) Pichia pastoris for VLP, antigen and heterologous protein production


E. coli for DNA vaccines and high purity DNA plasmids (for mRNA vaccines) Our expertise stems from extensive hands-on development of molecules such as recombinant human albumin, an NBE, biosimilars such as adalimumab, etanercept, aflibercept and abatacept, as well as vaccine manufacturing (e.g., from HEK293 and

E. coli for Covid-19 and high purity DNA plasmids for mRNA vaccines). In addition, we have developed recombinant human albumin (rHA) in-house as a superior substitute as compared to what is available from natural sources such as plasma which carries risk of contamination from biological agents and pathogens. Several companies have shown interest in a strategic collaboration with us on rHA with immense commercial potential for the Company. An invited talk on Shilpas bioprocess expertise in the development of novel biologics was presented by Dr. Harshawardhan Bal, PhD, President of the CDMO business at the prestigious American Association of Pharmaceutical Scientists (AAPS) National Biotech Conference 2023 in Philadelphia in April 2023. The presentation received excellent reviews on social media (LinkedIn) and provided further exposure among the biopharma community as an innovator in the biologics space.

(3) Drug Product Development: The Company brings decades of experience developing a wide range of finished dose formulations, e.g., orals, injectables (fill finish in vials and pre-filled syringes), ophthalmics, suspensions, topicals, extended-release formats such as oral thin films and transdermal systems as well as nanoparticle, liposomal and lyophilized preparations. This includes extensive experience in developing value-added clinically differentiated 505(b)(2) products across therapy areas that enhance the patient experience. We have successfully registered >50 products globally incl., in the US and EU markets and bring together synthetic chemistry, process development, manufacturing and regulatory expertise assisted with AI/ML enabled discovery and development for a uniquely integrated CMC approach to drug R&D. The Company has successfully delivered on drug substance and drug product programs under its CDMO business for US based biotech companies following this approach.

(4) Specialty Chemicals: The Company brings extensive infrastructure for the manufacturing of both cGMP and non-GMP materials for use across multiple industry segments, both pharmaceutical and non-pharmaceutical. This includes high value, low volume and high-volume commodity chemicals. This business will leverage the Companys existing chemical development and manufacturing expertise and provide excellent cash flow to the CDMO business.

(5) Therapeutic peptides: The global peptide CDMO market was valued at ~USD 2.0 billion in 2021, and is expected to double by 2030, with a CAGR of 9.0% during this period (InsightAce Analytic Pvt. Ltd., 2022). Peptide therapeutics play an essential role in addressing unmet medical needs and several peptide drugs have reached the market for diseases such as cancer, multiple sclerosis, diabetes, osteoporosis, chronic pain, and HIV infection. This is a high growth market due to advancements in peptide design technologies, incl., use of bioinformatics and systematic biological approaches, rising R&D investments in peptide-based therapies, and inherent favorable properties such as high specificity and tolerability. Shilpa is extremely well positioned in this space given our proven expertise in development, synthesis, incl., advanced technologies such as

microwave synthesis, and formulation of peptide products. The Company recently completed a program for involving complex macrocyclic peptides.

(6) Polymers and performance materials: Shilpa brings specialized expertise in specialty polymers from custom synthesis through a range of mechanisms, such as free radical polymerization, ring-opening polymerization, anionic and cationic polymerization, ATRP polymerization, RAFT polymerization, and condensation polymerization. We bring specialized expertise in PEGylation chemistry

(incl., high MW pegylations),applicationof poly(butadiene)-b-poly(ethylene oxide) for controlled drug release as well as a range of capabilities in development of derivatives (e.g., functionalization of polybutadienes, and other polymers) and can deliver high quality and cost-effective products at any commercial scale from our USFDA approved facilities. The polymer division has won a number of programs and enjoys long-term relationships with several marquee customers in the polymer space.

(7) Vaccines: The COVID-19 pandemic has brought pharma companies face to face with unprecedented challenges in the development of safe and effective therapies under stringent timelines, especially, in vaccines. Contract manufacturers have worked side by side with vaccine producers to meet the tremendous demand and has validated the Companys ability to jump into action and leverage its expertise to supply vaccine APIs to several pharmaceutical companies such as Zydus, Dr Reddys and the Serum Institute, thereby playing an important role in Indias public health efforts against the spread of the virus. This achievement highlights a key aspect of the Companys culture – the ability to provide purpose-built and customized solutions for a client introducing a new product with unique characteristics and regulatory requirements. The global vaccine market has undergone a radical transformation as a result of the pandemic. There were 394 COVID-19 vaccines in development between discovery and Phase III in 2020 (GlobalData report, 2020). The vaccine market value is estimated to reach $57 billion in 2025, expanding at a CAGR of 7.4% between 2020 and 2025 (IMARC Group, 2020). Currently representing less than 5% of the vaccines market, the contract manufacturing sector has significant room for expansion and biomanufacturing is a thrust area for the Company that will continue to see significant traction and revenues from India and regulated markets.

(8) Antibody-drug conjugates (ADCs): An increasing number of ADCs are entering clinical trials and our experience with handling cytotoxic payloads, linker technologies, bioconjugation reactions and antibody development, as well as large in-house manufacturing capacity and the required containment and engineering controls-allunderoneroof-meanswecanquicklyemerge as a front runner in this space. Given their complexity, more than 70% of ADC projects are outsourced to CDMOs and this is therefore another thrust area for the Company. Analysis of companies going public or raising fresh capital indicates nearly 50% of the companies have small-molecule pipelines while 20% are focused on monoclonal antibodies and recombinant proteins and 20% are developing cell and gene therapies. So, while the focus will be on small and large molecules, a future proof strategy will include forward investments into new capabilities in gene and cellular therapies.

(9) Artificial Intelligence and Machine Learning (AIML) in biopharma discovery and development: Shilpa added another feather in its cap through the investment in Sravathi Artificial Intelligence Technology. Artificial intelligence (AI) and machine learning (ML) are bringing about a paradigm shift in drug discovery R&D and are being adopted by pharma companies to enhance R&D productivity and speed market. The global healthcare AI market is estimated to grow from ~USD 5 billion in 2020 to USD45 billion by 2026 (Markets and Markets, 2020). Applications of AI are being integrated into drug discovery processes with 40% of start-ups exploiting AI to identify new drug candidates, 28% to identify new targets, and 17% for de novo drug design. Shilpa/Sravathi AI brings the ability to combine deep learning algorithms and domain expertise and the opportunity to position itself as a highly differentiated CDMO to big pharma customers. With its AI-DD technology, the Company now provides significant predictive utility, incl., forecasting novel lead molecules with high affinity to the target of interest with enhanced drug like properties and tox profiles, thereby enhancing quality of compounds that go into the discovery funnel, faster time to selection of lead compounds and reducing probability of failures. Our validated AI-led discovery methodology leads to new molecules in <3 months with predicted tox profiles and high affinity to defined targets and we can synthesize compounds from mg to kg to multi-metric ton cGMP commercial scale from our API manufacturing sites.

(10) FlowChemistry:SravathisAdvanceProcessTechnologies arm brings in AI-enabled process intensification and flow chemistry that affords immense value to process R&D, e.g., optimized synthetic route, reaction conditions, controlled heat and mass transfer leading to higher selectivity, purity, and reduction of unwanted by-products. Sravathis specialized capabilities spanning asymmetric catalysis, fluorinations, nitrations and other complex chemistries with custom printed reactors offer exceptional COGS benefits over commercial flow reactors.

SML is extremely well positioned because of these superlative and full value chain capabilities to become a strong contender for innovative solutioning across modalities to the biopharma, polymer and chemicals industry community globally.

Customer segmentation: Large pharmaceutical companies are consolidating their supplier base to minimize overheads and the complexities of dealing with multiple outsourcing partners. Small and medium-sized biotech and biopharma companies are increasingly introducing products into the market on their own and account for a significant proportion of R&D innovation. In 2017, for example, they made up 51% of USFDA market approvals, a trend that is expected to rise in the coming years as they gain experience and successfully bring products to market. Additionally, small, and medium-sized biotech companies do not invest in developing expensive cGMP production facilities in house and makes this the top focus market for us. Big pharma companies were the originators in 28% of USFDA approvals and remain a very attractive market due to the sheer size of their developmental pipelines. Our major focus will together be on the growing segment of small and medium-sized (smid) and specialty biopharma companies. The buying criteria for big pharma are different than those of the smid pharma incl., for example, access to technology not available in-house in early phase, access to manufacturing capacity and price rationalization for established or mature products, on the other end of the spectrum. We will continue to engage with big pharma along both these lines. Biopharma companies raised $88 billion in new equity in 2020, including sources such as venture capital, initial public offerings (IPOs), and secondary offerings by publicly listed companies (Jefferies report, 2020). This is a 76% increase in the amount raised over the previous year with most of the capital flowing into emerging biopharma companies. In turn, this will fuel growth of CDMOs and clinical contract research organizations (CROs) for pharmaceutical and clinical development of pipeline candidates.

Marketing: The Company attended several major industry events such as American Peptide Society (Whistler, British Columbia, June 2022), ChemOutsourcing 2022 (New Jersey), CPhI 2022 (Frankfurt), AAPS 2023 (Philadelphia), Drug, Chemical & Associated Technologies Association (DCAT) 2022 and DCAT 2023 (New York City), and others, incl., representing the Company at booths for one-on-one interactions with prospective customers as well as invited talks. Separately, the Company undertook digital campaigns to advance the Companys brand as a science-driven CDMO on LinkedIn which garnered excellent response from the industry across key biopharma hubs. The Company will undertake a significant amount of dedicated and week on week marketing effort to establish its presence in the CDMO market.


At Shilpa Medicare Ltd Our key expertise lies in the oncology formulation. Fiscal Year 2022–2023, we have started a brand-new voyage! Embarked our journey to reach out to all the cancer treatment facilities nationwide with the primary goal of offering World-Class drugs at competitive pricing.

By hiring the best field teams with the best skills and educating them with the best scientific information on treatments and Products. In the year 2022–2023, we have expanded our reach. To guarantee that the most recent scientific advancements may be disseminated to all Stakeholders, particularly the medical community and caregivers, a medico-marketing department was established.

Capebel 1000 mg dispersible Tablet (Capecitabine 1000 mg tablet) is an excellent example. Capebel 1000 mg dispersible tablets enable doctors to provide recommended dosages with more compliance and, as a result, a more powerful outcome.

Current market trends:

In the 75th year of Independence, the pharma sector has put India on the global map. Globally, today India is one of the largest sources of Pharmaceuticals.

In India, an estimated 1.32 million new cancer cases are diagnosed each year with 0.9 million deaths annually, Since the last decade, the cancer burden has more than doubled in India. Breast, Lip, Oral and Cervical Cancer account for 1/3rd of cancer cases in India. 5-year prevalence is estimated to be around 2.7 million Patients The domestic oncology market is valued at 4500 Cr and expanding at an 18% rate across a range of medicines including hematology and solid tumors. Immunotherapies and Targeted MABs are therapeutic oncology subspecialties that are expanding quickly. Additionally, the new molecular pipeline into the domestic market offers doctors additional possibilities for interventional therapy as well as new paths for patients in need of treatment assistance.

Oncology has a huge demand for treatments, thus improving formulation with a patient-centric perspective is even more essential. Shilpa Medicare Ltd is therefore obligated to offer such Thoughtful Innovations for Powerful Outcomes.

Molecules like Capecitabine Dispersible Tablets.

ToeffectivelymaximizethebenefitsofThoughtfulInnovations for Powerful Outcomes, frequent communication aids and performing RTM and CME with doctors and emerging experts are required in order to effectively reach this communication with the Care Givers, and our field force is fully equipped in this front.

Recent Trends including pricing in Oncology and Approach:

In the oncology market, new molecules are introduced quickly due to patent expirations. Prices are extremely volatile because of the constant introductions of the same molecules by different companies, but special dosage forms like Capecitabine dispersible tablets must be developed with the patient in mind.

Decreasing medicine wastage by developing Multidose Ready to Use [RTU] formulations, especially injectables. Effectively communicating the same with regular communications aids and conducting RTM and CME with Doctors and emerging specialists.

Strong Growth in Biologic & Biosimilars Drugs in Domestic Market: -

The Indian Biosimilars market was worth around 300 million in 2015 and is expected to reach 40 billion by 2030.

Looking into the attractiveness of Biologicals, Shilpa has introduced a separate entity Shilpa Biologics Pvt. Ltd. Shilpa Biosciences division of SBPL will focus on the core segment Orthopedics & Rheumatology segment. Looking into the high prevalence of Autoimmune diseases SBPL is planning to introduce the brand Oriadali (Adalimumab 40mg/0.4ml concentration). It will be manufactured in the SBPL Dharwad facility. The current domestic market is 87 Cr which is growing at a CAGR of 21% (source AIOCD). In FY 23-24, Shilpa Biosciences aims to achieve

a 5% Market Share.

With the launch of SBPL, we are spreading our reach to newer therapeutic areas like Rheumatoid Arthritis, Orthopedics, Gastroenterology, and Dermatology. At SBPL we have identified these therapeutics areas to enter into INR. 650 Crores represented the market. With a goal to attain 7 % market share within first three years of its launch. In a nutshell, Biologics is the future of Indian Pharmaceuticals and SBPL will have a strong presence in the coming days.

Shilpa Biologicals Pvt Ltd

Shilpa Biologicals Pvt Ltds core expertise lies in the development of biologics and has mainly focused this year on the approvals and market authorizations of internal projects and expansion of CDMO capabilities. With strong emphasis on quality control and assurance throughout its manufacturing processes, the company is confident of obtaining certifications from different regulatory authorities. Shilpa Biologicals biosimilar programs for Adalimumab, Aflibercept and Abatacept are progressing well towards approvals from different regulatory authorities. Focusing on obtaining approvals from different markets worldwide is a strategic move for Shilpa Biologicals. In line with this strategy, our RA, BD and marketing teams are working towards filing in different ROW markets. This will allow the company to expand its market reach beyond India and cater to patients in various regions.

The anticipated launch of our biosimilar to Humira, Oriadali?, in India during the 2nd quarter of 2023-2024 is a significant milestone for the organization. SBPLs Adalimumab is the biosimilar version of innovators high concentration product (100mg/mL). By developing a biosimilar version, Shilpa Biologicals can provide a more cost-effective alternative to patients without compromising on quality or efficacy. Due to this advantage over other biosimilar versions of Adalimumab, revenue generation is expected post-products launch from direct sales, partnering and out-licensing opportunities across the India and RoW markets.

SBPL has received phase III clinical trial approval for our biosimilar to Eylea (Aflibercept) in India, which is another significant milestone during this financial year. Aflibercept is a complex molecule in terms of process development and SBPL has developed a perfusion process to achieve biosimilarity for this molecule. Material generation for Clinical trials for the molecule is completed and process validation is ongoing. The progress made with Aflibercept signifies the companys dedication to innovation and improving patient outcomes in the field of ophthalmology. Additionally, three other pipeline drugs are expected to complete preclinical studies indicates that SPBL is continuously expanding its portfolio and investing in research and development. The joint inspections and clearance from the Central Drugs Standard Control Organization (CDSCO) for Bioanalytical Laboratory and for marketing authorization of our Biosimilar to Humira are significant achievements. The approval received for Bioanalytical Laboratory will fasten the clinical trials programs of our Biosimilar programs and also opens up new area for revenue generation through CRO activities.

Its positive to note that multiple customers have approached Shilpa Biologicals for CDMO activities in FY2022-23, indicating an increasing demand for the companys services. The fact that Shilpa Biologicals underwent audits from various prominent organizations of India and successfully cleared them, highlights the companys commitment of maintaining high quality and meeting regulatory standards. The combined market size of the two drugs currently in clinical trials, estimated at around $30 billion, signifies the potential commercial value of these products. This demonstrates SPBLs focus on developing drugs targeting therapeutic areas with significant market demand. Furthermore, the anticipation of adding two more drugs to the clinical trial pipeline in the next financial year, with an estimated market size of approximately $17 billion, highlights SPBLs commitment to further expansion and capturing additional market opportunities.

Opportunity and drivers - a) Opportunity in RoW markets – Our company is in the process of establishing partnerships with leading pharmaceutical players for biosimilars across different geographies as a strategic approach to expand its presence in these markets. Due diligence of our Dossier of our Biosimilar Adalimumab and Aflibercept is completed in different RoW markets, and we expect successful collaborations in the coming year. In addition, we have signed an out-licensing deal with one of the Russian organizations for Aflibercept. These partnerships can lead to increased market penetration, accelerated product adoption, and mutually beneficial growth opportunities.

Shilpa Biologicals Pvt Ltd has a robust pipeline comprising of 11 biosimilars which cater to different therapeutic areas like autoimmune disorders, ophthalmics, and cancer. By diversifying their pipeline with a combination of established biologics and niche opportunities, Shilpa Biologicals demonstrate a comprehensive approach to product development. This strategy allows SBPL to leverage their expertise in biopharmaceuticals while targeting a wide range of therapeutic areas and patient needs.

FTF Pharma (P) Ltd.

Almost a 10 years old company, FTF Pharma is the trusted and a well-known name amid various big and medium sized pharmaceutical players across the globe as a reputed CDO & CDMO. Employing about 70 highly skilled professionals, FTF Pharma owns a state-of-the-art R&D center in Ahmedabad, Gujarat (India) that is spread into 55,000 square feet area with dedicated FnD labs, AR&D labs and facility for handling highly potent drugs, all equipped fully with modern equipment & sophisticated instruments. As a CDO, FTF focuses on the development of high valued first-to-file generic products under ANDA regulatory pathway, complex generic products & innovative new drug products covered by 505b2 NDA applications. FTFs interest lies predominantly in the development of products comprising small molecules & peptide molecules. Since its inception, FTF has developed & collaborated more than 100 products for major regulated markets & RoW markets. FTFs front-end generic development partners from all over the world makes FTF globally a leading CDO and partner of choice. FTFs thirst for innovation is evident by its patent filing numbers. So far, FTF has filed more than 75 patent applications in different jurisdictions including USA, Europe/UK, Canada, China, and India and awarded 5 US patents & 2 Indian patents covering FTFs 505b2 oral & parenteral technologies. Having its expertise in the development of different types of solid, liquid, lyophilized & topical dosage forms, FTF is also working on new-edge technologies such as Nano-emulsions, SMEDDS, micellar formulations and lipid nanoparticles. FTF is expert in developing tablets, hard gel capsules, low & high volume parenterals (ready-to-use/dilute solutions, suspensions), lyophilized solids, oral thin films, strips, patches, prefilled syringes, ophthalmic solution & drops, coated/ uncoated/sugar coated/film coated pellets/beads in capsules, matrix dosage forms, orally disintegrating tablets, IR/ER/PR/ SR/DR/MR dosage forms, bi-layered tablets, and combination products.

FTFs product development expertise is further evident by the fact that some of the products developed & collaborated by FTF are now approved in US. These products include first to file generics of Opsumit? and Otezla?; 505b2 oral liquids Norliqva? (amlodipine oral solution), Tadliq? (tadalafil oral suspension), Zonisade? (zonisamide oral suspension), Liqrev? (sildenafil oral suspension) and Atorvaliq? (atorvastatin oral suspension).

Continuously striving towards its vision & mission, through all these years, FTF has been successfully offering Research and Formulation Development services, Technology Transfer

& Contract Manufacturing services, Non-infringing/Design-around strategies, Regulatory filing strategies, and BA/BE & clinical support services. Under the leadership of Shilpa Medicare Ltd. (SML), FTF is achieving new milestones in its growth journey and is increasing its footprints in US, Europe, Canada, China and other emerging markets. After its acquisition by SML, FTF has considerably added good numbers of clients to its clientele list. FTF visions to become one of the TOP GLOBAL CROs by 2025 and FTF is moving towards its vision firmly & positively.


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 to the Boards Report. The Statement also provides the details of performance and financial position of each of the subsidiaries.


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 Statement containing the salient features of the financial statement of subsidiaries and associate company for the year ending March 31, 2023 in Form AOC-1


During the year under review, there was no change in the nature of business carried out by your Company. Further, it is to be noted that consequent to the approval of members of the Company vide postal ballot dated 20 July 2021 & 08 February 2022, The API business was transferred to Shilpa Pharma Lifesciences Limited (A wholly owned Subsidiary Company) via Slump sale. The said transaction was complete and effective from 01 July 2022.


In pursuance to the Dividend Distribution policy of the Company, your Directors do not recommend any dividend for the year. The Dividend Distribution Policy of the Company is set out as Annexure-2 and the same is uploaded on the Companys website at Dividend%20Distribution%20Policy_Update.pdf


The paid up share capital of your Company is 8,68,01,898/- (Rupees Eight Crore Sixty Eight Lakhs One Thousand Eight hundred and Ninety Eight) divided into 8,68,01,898 equity shares of 1/- each.

Pursuant to the provisions of section 124 (5) of the Companies Act, 2013 read with the IEPF Rules, the Company has transferred 251 shares, belonging to the shareholders who did not continuously claim dividend for seven years from the financial year 2014- 15 to IEPF Account, the details of which are placed on the website of the Company.


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.


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


Mr. Om Prakash Inani (DIN No.01301385), Non-Executive Director will retire by rotation at the ensuing Annual General Meeting and being eligible, offers himself for re-appointment.


During the year Ms. Sirisha Chintapalli - Independent Director of the Company ceased from the office of Directorship w.e.f 28 September 2022 due to completion of her tenure. In place of the retiring Director Dr. Anita Bandyopadhyay was appointed as Independent Director a period of 3 years. Further, Dr. Kamal K Sharma was appointed as Independent Director for a period of 3 years. Their appointments were approved by members of the Company at the Annual general meeting held on 28 September 2022.


During the year Ms. Ritu Tiwary was appointed as Company Secretary & Compliance officer w.e.f 23 May 2022. Following are the key managerial personnels of the Company: Mr. Vishnukant C Bhutada – Managing Director Mr. Kalakota Sharath Reddy – Whole-time Director Mr. Alpesh M Dalal – Chief Financial Officer Mrs. Ritu Tiwary – Company Secretary & Compliance Officer


During the financial year, Five 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:

1. 23 May 2022

2. 11 August 2022

3. 11 November 2022

4. 04 February 2023

5. 14 February 2023


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.


Statutory Auditors:

Members of the Company at the Annual General Meeting held on 28 September 2022 approved the appointment of M/s. Bohara Bhandari Bung & Associates LLP, Chartered Accountants, Raichur FRN:008127S/S200013, as the new statutory auditors of the Company to hold office for one term of 5 years commencing from conclusion of the ensuing 35th Annual General Meeting up to the 40th Annual General Meeting of the Company.

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 2023-24. 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 Annual General Meeting for ratification of remuneration payable to the said Cost Auditors.

Secretarial Auditors:

Mr. D.S. Rao, Practicing Company Secretary was appointed to conduct the Secretarial Audit of the Company for the financial year 2022-23, 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 2022-23 forms part of this Report as Annexure - 3.

The Board on the recommendation of the Audit Committee has appointed Mr. D S Rao, Practicing Company Secretaries, as Secretarial Auditors of the Company for the financial year 2023-24.

Internal Auditor:

Pursuant to the provisions of section 138 of the Companies Act, 2013 and rules made thereunder, the Board on the recommendation of the Audit Committee has appointed M/s BDO India LLP as Internal Auditors of the Company for the financial year 2023-24.


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.


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 – 4 RISK MANAGEMENT POLICY:

Pursuant to Regulation 21(4) of SEBI (LODR) Regulations, 2015, the Board of Directors have 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 hosted on the Companys website:

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.

During the year two Risk Management Committee meetings were held on 24 September 2022 & 17 March 2023.


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 transferred 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 – 5.

The Company has constituted the CSR Committee for monitoring the activities undertaken by the Company in this regard. The CSR Policy of the Company and other details as required is are placed on the Companys website at https://


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://www.vbshilpa. com/pdf/NominationRemunerationPolicy.pdf


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.


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 - 1 enclosed to this report.

Further, the annual accounts of all the subsidiary companies are available on the Companys website 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.


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 have 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.


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: During the year, no new Companies have become Subsidiaries/ Joint ventures/ Associate Companies of Shilpa Medicare Limited Your Company has filed a Second Stage petition with National Company Law Tribunal for effecting the amalgamation with INM Technologies Private Limited being the wholly owned subsidiary, The Company is awaiting for the final order of the Honble tribunal in this regard.

Zatortia Holdings Limited a wholly owned Subsidiary Company of Shilpa Medicare Limited was closed during the year.


Pursuant to Section 134 (5) of the Companies Act, 2013 Your Directors confirm that: Applicable accounting standards have been followed in the preparation of the annual accounts and that no material departures have been made from the same; Accounting policies have been selected and applied consistently. Judgments and estimates made are reasonable and prudent, so as to give a true and fair view of the state of affairs of the Company at the end of the FY2023 and of the profit of the Company for that period; Proper and sufficient care has been taken to maintain adequate accounting records in accordance with the provisions of the Act for safeguarding the assets of the Company and for preventing and detecting fraud and other irregularities; Annual accounts have been prepared on a going concern basis Adequate internal financial controls for the Company to follow have been laid down and these are operating effectively; and Proper and adequate systems have been devised to ensure compliance with the provisions of all applicable laws and these systems are operating effectively


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 has been placed on the Website of the Company at www.

OTHER DISCLOSURES: Committees of Board:

Your Company has the following committees, namely: Audit Committee Nomination and Remuneration Committee Stakeholders Relationship Committee 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.


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- 6.


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.


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 safeguard against victimization of director(s) or employee(s) or any other person who avail the mechanism and allow direct access to the Chairman of the Audit Committee in exceptional cases. Your Company adheres to uncompromising integrity in conduct of its business and strictly abides by well-accepted norms of ethical, lawful and moral conduct. It has zero tolerance for any form of unethical conduct or behaviour. Directors and employees are at liberty to report unethical practices.


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-7.


Statement of employees as required under Rule 5(2) of the Companies (Appointment and Remuneration of Managerial Personnel) Rules, 2014, is enclosed as Annexure – 8 to the Boards Report.


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.


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. 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.


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.


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 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 - 9.

Related Party disclosures as per Schedule V of SEBI (LODR) Regulations, 2015 are enclosed I

The policy on Related Party Transactions, as approved by the Board may be accessed on the Companys website https:// party policy.pdf


The SEBI vide its circular dated 10 May 2021 made Business Responsibility & Sustainability (BRSR) Mandatory for top 1000 Listed Companies (by Market Capitalization) from the FY 2023, while disclosure was voluntary for the FY 2022.

Pursuant to Clause 34(2)(f) of the SEBI (LODR) Regulations, 2015 Business Responsibility & Sustainability Report, being applicable to the Company, forms part of the Board Report as Annexure-10


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 to which the financial statements relate and the date of the report.

No applications were filed before or any proceedings pending under the Insolvency and Bankruptcy Code, 2016

The details of Difference between valuation done at the time of one time settlement and the valuation done while taking loan from the banks and financial institutions along with the reason thereof - Not Applicable.

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.

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 wholehearted support. Further, Your Directors would like to express the appreciation to all the employees of your Company for their continued dedication, significant contributions, hard work and commitment towards achieving the objects of the Company.

For and on behalf of the Board of Directors Shilpa Medicare Limited

Omprakash Inani
DIN: 01301385

Place: Raichur

Date: 01 September 2023