Indoco Remedies Ltd Management Discussions.

a) Indian Pharmaceutical Industry

The pharmaceutical industry worldwide, along with all other industry sectors, has been impacted due to outbreak of the Covid-19 pandemic. This has led to material changes around consumer requirements and preferences accompanied by macroeconomic, microeconomic and structural changes. The ensuing global recession may have a long-term ramification on the economy and government policies. Slower or negative growth trends across most parts of the region, elevated political risks due to economic weakness and supply chain disruptions will have a major impact, especially on the developing countries. In the midst of the pandemic and a changed world, the pharmaceutical industry across the world has responded with agility. From the sequencing of the novel corona virus in January20, to vaccines being administered from December20, exceeded all expectations of governments and people across the world. Healthcare is likely to be on top of the strategic agenda across geographies. The pharma industry will be closely monitored by the government in all countries in times to come. It is imperative that India re-evaluates its current role within the global pharmaceutical industry, explores possibilities to consolidate and strengthen its position in light of geopolitical and economic shifts, with innovation as a guiding principle.

Indias domestic pharmaceutical market turnover reached Rs. 1.47 lakh crore (US$ 20.15 billion) in 2021. The Government of India unveiled ‘Pharma Vision 2020 to make India a global leader in end-to-end drug manufacturing. The approval time for new facilities has been reduced to boost investment. The government policy on PLI (Production Linked Incentive) scheme will also help the domestic pharma business to grow by reducing import dependence and developing export potential in the days to come, as most of the countries are looking at India for APIs (Active Pharmaceutical Ingredients) and KSMs (Key Starting Materials), in order to reduce dependence on China.

b) Opportunities & Threats:

Most of the Indian pharma companies are producing finished dosages as well as APIs. However, India does not produce all the APIs and intermediates it needs and whatever it produces is not enough. Therefore, India has to import APIs and intermediates from countries like China. Backward integration into API manufacturing and further increasing the existing capacity would be a major risk-mitigation tool for the Indian pharmaceutical companies and would help them maintain uninterrupted supplies and consistent growth.

Moreover, Indian pharmaceutical companies looking to export drugs and devices will need to both understand what is required for each target market and then follow through with development and manufacturing processes that meet global standards.

The year 2020-21 not only posed unexpected challenges, but also brought in new solutions and a newer perspective in business operations.

c) Financial Performance:

Net revenues for the year are at Rs. 1,217.38 crores, as against Rs. 1,079.39 crores last year. Other operating income in the current year is at Rs. 22.92 crores, as compared to Rs. 26.61 crores in the previous year. Material consumption to sales is 29.08 % at Rs. 354.07 crores, as compared to 30.61 % at Rs. 330.43 crores in the previous year. Staff cost to sales is 22.41 % at Rs. 272.88 crores, as compared to 23.65 % at Rs. 255.32 crores in the previous year. Recurring R&D expenses to net sales are 4.90 % at Rs. 59.70 crores, as compared to 4.60 % at Rs. 49.70 crores in the previous year. Other expenses to sales are at 27.11% at Rs. 330.08 crores, as compared to 32.17% at Rs. 347.21 crores in the previous year. Finance cost to sales is at 1.82 % at Rs. 22.22 crores, as compared to 2.43 % at Rs. 26.25 crores in the previous year. Operating profit is at Rs. 187.93 crores, compared to Rs. 75.98 crores in the previous year. Depreciation is at Rs. 73.12 crores, as against Rs. 70.81 crores in the previous year. Profit / (Loss) Before Tax is at Rs. 131.35 crores, as compared to Rs. 28.71 crores in the previous year. Profit / (Loss) After Tax is Rs. 92.39 crores, as against Rs. 24.25 crores in the previous year. Basic & Diluted Earnings Per Share (EPS) for the year is Rs. 10.03, as against Rs. 2.63 in the previous year (both after and before the extra-ordinary items). Outstanding long term debt as on March 31, 2021 was Rs. 96.94 crores, as compared to Rs. 96.93 crores in the previous year. Cash outflow on account of Capital Expenditure (CAPEX) during the year was Rs. 76.85 crores, as compared to Rs. 58.46 crores in the previous year. During the year, an amount of Rs. 20.00 crores was contributed to the national exchequer by way of payment of Income Tax and Rs. 41.61 crores by way of Goods & Services Tax (GST). Net worth of the Company as on March 31, 2021 is Rs. 768.93 crores, as against Rs. 680.16 crores in the previous year, on account of retained profits. Debt-equity ratio during the year was 0.18 as compared to 0.23 in the previous year.

Segment wise revenue contribution is as follows: d) Business Overview

Domestic Formulation Business:

Indocos Domestic Formulations Business has pan India presence and the Company ranks amongst the top 30 in the Indian Pharmaceutical Market (as per Sales Audit Report of All India Organization of Chemists and Druggists (AIOCD). The Company offers high quality medicines in multiple therapeutic categories, which include respiratory, stomatology, womens health, nutritional products, gastroenterology, cardiology, metabolic disorders and primary care medicines. The Company has a predominant presence in South (34%) and West (29%), followed by East (20%) and North (17%). The Company caters to multiple doctor specialties and generates more than 70 million prescriptions annually from over 3,00,000 doctors across India (as per SMSRC Prescription Data).

Performance of key therapy areas:

(Rs. In Lakhs)

Therapy

Cont %

2020-21

2019-20

Gw %

Stomatologicals 21.5 13242 12729 4.0
Respiratory 15.4 9479 11354 -16.5
Gastrointestinal 14.2 8730 9729 -10.3
Anti-Infectives 13.4 8229 10504 -21.7
Vitamins / Minerals / Nutrients 7.2 4457 4887 -8.8
Gynaecology 5.6 3425 3754 -8.8
Ophthal / Otologicals 4.9 3012 3998 -24.7
Dermatology 4.6 2838 2955 -3.9
Anti-Diabetic 4.6 2830 2780 1.8
Pain / Analgesics 4.0 2488 3337 -25.4
Urological 2.4 1479 1575 -6.1
Cardiac 2.0 1259 1299 -3.0

The Company enjoys a good position in the domestic market with 42 products ranking amongst the top 5 positions in their respective sub-segments:

Product

Rank

Broad Therapy

Market Share % (Respective Sub-Segments)

Sensodent-K 1 Stomatologicals 96.9
Karvol Plus 1 Respiratory 61.3
Sensoform Toothpaste 1 Stomatologicals 65.8
Cital UTI 1 Vitamins / Minerals / Nutrients 26.3
Kidodent 1 Stomatologicals 47.6
Cal Aid 1 Vitamins / Minerals / Nutrients 37.4
Rexidin M 1 Stomatologicals 45.2
Lignox A 1 Pain / Analgesics 90.6
Carmicide 1 Urology 67.0
Homide 1 Ophthal / Otologicals 88.8
Rexidin Plus 1 Stomatologicals 55.5
Renolen 1 Ophthal / Otologicals 63.2
Dexoren - S 1 Ophthal / Otologicals 83.7
Snowdent 1 Stomatologicals 39.7
Cyclopam 2 Gastrointestinal 9.8
Sensodent-KF 2 Stomatologicals 27.8
MCBM 69 2 Gynaecological 17.5
Dentogel 2 Stomatologicals 17.0
Sensoform Gum Paint 2 Stomatologicals 31.8
D Chiro 2 Gynaecological 21.7
Zincoren 2 Ophthal / Otologicals 18.6
Febrex Plus 3 Respiratory 13.6
ATM 3 Anti-Infectives 7.6
Cital 3 Urology 26.7
Cloben G 3 Derma 13.1
Methycal 3 Vitamins / Minerals / Nutrients 5.7
Scabex 3 Derma 15.0
Otorex 3 Ophthal / Otologicals 11.1
Rexidin SRS 3 Stomatologicals 8.5
RR Sensoform Dental 3 Stomatologicals 7.1
Carmicide 3 Gastrointestinal 9.6
Cyclomeff 3 Gastrointestinal 1.8
SM Fibro 4 Vitamins / Minerals / Nutrients 12.8
Hemsyl 4 Blood Related 11.6
Nosic 4 Gastrointestinal 3.3
Spear 4 Others (Anti-Haemorrhoidal) 8.3
Mofloren-D 4 Ophthal / Otologicals 7.0
Mofloren LP 4 Ophthal / Otologicals 6.1
MCBM DHA 5 Vitamins / Minerals / Nutrients 6.1
Apispur 5 Vitamins / Minerals / Nutrients 1.6
T-Lac 5 Pain / Analgesics 0.9
Tuspel 5 Respiratory 2.5

(Source : AWACS)

Domestic Marketing Divisions:

Indoco Pharma

Indoco Pharma division is the major domestic marketing division and enjoys a strong image amongst General Practitioners (GPs), Paediatricians, Gynaecologists and Consulting Physicians (CPs).

The division has acquired a prominent position within its covered market with market share of 5.3% as on March21. Brand management of legacy products like Cyclopam, Cital, Karvol Plus and Cloben G is carried out extensively and is evident in the form of good prescription growth for Jan-Feb21, over the previous period. Cital-UTI has also consolidated its leadership position in the covered market.

New launches like Poviclean Gargle and Fevindo 400 and 800 mg have helped the division to venture into the treatment of Covid-19 and offer comprehensive Covid care prevention range along with Karvol Plus and OHD3 capsules. The division will continue its emphasis on specialties like Pediatricians, Gynaecologists, CPs, ENTs, Chest Physicians and Urologists, without losing its focus on GPs with the objective to further increase its prescriber base. The division will be adding a new specialty like Chest Physician, while also increasing count of ENTs and Urologists.

Indoco Spade

Indoco Spade division, the second largest marketing division of Indoco, consists mainly of the Respiratory and Anti-infective portfolio. The major brands of the division are Febrex Plus, ATM and Bactogard. The division caters to ENT Surgeons, Paediatricians, GPs and CPs.

ATM, the leading anti- infective brand of the division performed well during the year. The division also introduced an immunity booster, Zmun CD with the concept of ‘Zmunity, meaning Zinc based Immunity. The launch of this brand has helped the division to make an entry into the sub-chronic segment. The division aims to create a strong foothold in the paediatric segment and also focus on creating higher market and prescription share for Febrex Plus.

Indoco Warren NxGen

Indoco Warren NxGen division caters to Dentists, ENTs, Pediatricians and GPs with products consisting of Sensodent KF, Rexidin, Kidodent, Lignox, SM Fibro, etc. The year has been very challenging, as the Dentists were at the highest risk of contracting Covid-19. Consequently, the dental treatments were restricted to emergency cases only, resulting in a drastic drop in the number of patients treated by dental professionals.

During the year, brands like Sensodent KF and Kidodent emerged as a silver lining for the division. Many prescription driven brands like SM Fibro, Rexidin SRS, Dentogel and Turbocort started showing progressive trends, as the lockdown was eased in a phased manner. Expanding presence in ENTs and Paediatricians also helped in gaining business. During the crisis, immediate assistance was provided to Dentists by providing PPE kits, sanitizers and educating patients about safety precautions. While many of the conventional ways of promotion got hampered, new ways were identified and executed in the most disciplined manner.

Indoco Warren ACE

Indoco Warren Ace division enjoys number 1 position in the Stomatological market with its legacy brands - Sensodent K and Sensoform toothpastes. These brands enjoy market leadership with 97% and 65% market share in respective segment. The divisions brands are available at nearly 250,000 Retailers (Chemists) across India. With pan India presence, the division caters to more than 45,000 dentists. Apart from Dental sensitivity management, the division focuses on pain management with brands like Acecloren and T-Lac. The division has expanded its product basket by building brands like Sensodent K Plus toothpaste, Rexidin Plus mouthwash, Sensoform gum paint, etc., which have excellent growth opportunities. With growing awareness on oral hygiene and preventive treatment, coupled with opportunities in the OTX segment, the division is ready to explore both Rx and OTX market opportunities with its ideal product mix.

Indoco Spera

Indoco Spera division caters to womens health and covers Gynaecologists. The product mix includes, nutraceutical brands for pregnancy care and lifestyle management products. Scientific activities like, Round Table Meets (RTMs) and Continuing Medical Education (CMEs) have helped to increase the prescriber base of Gynaecologists. Customer centric approach through patient awareness activities and patient camps, viz., Synergy camps and STAR Hb camps has helped the division to garner attention of the Key Opinion Leaders (KOLs). Participation in All India Gynaecology Conference (AICOG) and other state conferences has also strengthened the divisions presence in the market.

Indoco Excel and Vision

Indoco Excel and Vision division caters to a niche segment of Ophthalmology with a wider therapeutic range. Due to Covid-19 lockdown amongst all specialties in pharma, ophthalmology has suffered the most because of the nature of treatment. The divisions wide range of products extends from tear substitutes, anti-infectives, anti-oxidants, nonsteroidal anti-inflammatory drugs (NSAIDs), anti glaucoma and anti-allergic. The division sees an overall improvement in the core brands, like Irivisc, Mofloren and PGVISC.

On the prescription front, the division has shown significant revival, as overall Rx response for the division appears to be gaining momentum. It is encouraging to note that, the boost in PGVSIC Rxns during Nov-Feb21 has made the brand attain the no. 1 position in the market. Mofloren eye drop has also shown good revival in prescriptions.

The division took significant efforts in creating a strong foothold in the digital space during year 20-21 by conducting 12 national / regional webinars between Apr-Dec 2020 with renowned KOLs, reaching around 5000 Doctors across India.

Indoco Focus

Indoco Focus division is strengthening its foothold among the Endocrinologist, Diabetologist and CPs. The division offers a wide range to provide ‘Care at every stage of Diabetes with brands like Aloja, Aloja M, Aloja M Forte, Depaja, Glychek, Zilenta, Metchek, Praztac, Trucharge and Durashape to meet the requirement of every Diabetic patient. The division has conducted 14 advisory scientific sessions with the industry KOLs on Alogliptin. The division has also conducted more than 80 plus CME programs pan India to build Doctors confidence in Aloja (Alogliptin). Indoco Focus further strengthened its relation with 150 Doctors through "For Your FOCUS Cares" campaign. The division is in process of strengthening its portfolio as per the needs of Diabetes practitioners.

Indoco CND

Indoco CND division caters to super-specialists like cardiologists, diabetologists and CPs. The division aims to make strong inroads in the cardiology market. Creation of sizeable prescriber base within cardiologists by the division denotes success in terms of its penetration in the cardiology market. Introduction of newer brands like Rosuchek Gold and Telmichek CT will further help the division to establish itself in the cardiology segment. The division has an encouraging prescription trend for its key cardio-diabetic brands like, Prichek M, J-Ring M and Telmichek. Scientific and clinical customer engagement activities have helped the division to get closer to realization of its set objectives, one being due recognition of the divisions product range by cardiologists and other specialities.

Institution

Institution division covers most of the Central, State Government and Public Sector Undertakings, including TNMSC, ESIC, Indian Railways, Armed Forces Medical Depots, Directorate of Health Services, BHEL, BEML, HAL, ONGC and Port Trusts. Indoco is registered with most of these government institutions and participates in annual rate contracts and local tenders for branded and proprietary products. The division aims to get the products registered and adding proprietary products in formularies of prestigious government institutions. The division has a good range of anti-diabetic, analgesics, anti-hypertensive and calcium preparation.

New Product Launches:

Looking into the pandemic situation and the market demands, Indoco launched few products, majority of them pertaining to the Covid portfolio - Fevindo tablets, Poviclean Gargle and Zmun CD tablets.

The introduction of Telmichek CT, Depaja and Aloja M and Aloja M Forte in the chronic segment strengthened the Companys cardio-diabeto portfolio, taking the total new product launches to nine during the year.

Fevindo 400/800 mg Tablets

Fevindo was launched in the peak of the Covid-19 pandemic by Indoco Pharma division to cater to patients with mild to moderate symptoms. Fevindo contains Favipiravir, the most recent anti-viral therapy in the management of mild to moderate Covid-19 patients. Due to oral route, it is patient compliant and is prescribed to patients not requiring hospitalization.

Poviclean Gargle

Poviclean Gargle is another product in the basket of the Covid segment launched by the Pharma division. Poviclean Gargle contains Povidone-iodine, a broad-spectrum antiseptic with no known resistance, that has been listed by the World Health Organization as an essential medicine. Poviclean Gargle plays a significant role in reducing Covid-19 transmission by decreasing viral load during the first phase of infection.

Zmun CD Tablets

Zmun CD is an immunity booster, which was launched during the pandemic by the Indoco Spade division. Zmun CD tablets contain Vitamin C, Vitamin D and Zinc. These are safe, low-cost, and effective nutraceuticals to help the immune system to fight off Covid-19 and other acute respiratory tract diseases.

Telmichek –CT Tablets

Telmichek CT is a fixed dose combination of Telmisartan and Chlorthalidone, prescribed for the management of hypertension and launched by the Indoco CND division in the chronic segment.

Aloja M and Aloja M Forte Tablets

Aloja M and Aloja M Forte, fixed dose combinations of Alogliptin and Metformin were launched for management of non-insulin-dependent diabetes mellitus (NIDDM). These are DCGI approved products launched by the Company for the first time in India.

Depaja 5 mg / 10 mg Tablets

Depaja 5 mg / 10 mg tablets contain Dapagliflozin, which belongs to the class of SGLT2 inhibitor. This product was launched by Indoco Focus division to strengthen its existing anti diabetic portfolio. The product is indicated for management of non-insulin-dependent diabetes mellitus (NIDDM) and is indicated to reduce hospitalization, risk of heart failure in adults with Type 2 Diabetes Mellitus and multiple cardiovascular (CV) risk factors. It is also used to reduce the risk of sustained worsening of renal function, progression to end-stage kidney disease, and death from renal or cardiovascular causes.

International Business:

The Indian pharmaceutical exports have registered a record growth of 18 % during the pandemic year FY 20-21, with exports of USD 24.44 billion. In spite of a sluggish growth in the global pharma market, there has been a big surge in demand for India made generics, owing to its quality and affordability. US, South Africa, UK, Russia, Germany, Nigeria, Brazil, Canada, France and the Netherlands have been Indias biggest customers for pharmaceuticals during the year. United States of America continues to be the largest market with the size of USD 523 billion (IMS

MAT Sep20). This is equivalent to 46 % of the global pharmaceutical market, which stands at USD 1.14 trillion. Out of the 1287 drug manufacturing facilities approved by the USFDA, 327 were from India. Out of the 751 ANDA approvals granted by USFDA in the year 2020, 352 approvals were to Indian firms accounting to 46 % of the total ANDA approvals. The pharmaceutical market size in Canada is USD 23 billion with growth of 5.4%.

Following trends were observed in the US and Canada Market during the pandemic:

Expedited review of dossiers and speedy approval.

Exponential market demand for products used in the treatment of Covid-19.

Increased demand for pre-filled syringes and unit dose formulations.

Pharma Digitization: Virtual audits of facilities by regulatory agencies.

Supply interruptions due to shortages of RM/PM.

Delays of product approvals for non-Covid related products.

Logistic challenges and increased freight cost.

North America Business

Indocos North America business has witnessed a robust growth during the year. Indoco was successful in launching 11 products in USA through its partners. Indoco launched an ophthalmic suspension product in the US market, which is the first and only generic. The Company has also received an expedited approval for one injectable product, which is used in the treatment of Covid.

Country Wise / Region Wise Sales Contribution.

The status of ANDAs as on March 31, 2021 stands as below:

Particulars

Own Filings

Through Partners

Total

Approvals till date 10 13 23
Filed but, pending approval 13 18 31
Total 23 31 54

Europe

Europe is the second largest market in the world. The total EU market size is USD 268 billion with generics contribution of USD 70 billion. In the European region, Germany is the largest market with market size of Euro 48 billion, followed by France, Italy, United Kingdom and Spain. Germany is 100% tender market, of which 70 % is government and 30 % is private insurance. Major tenders in Germany are AOK, BARMER, TKK and DAK. United Kingdom is 80 % retail market with over 12000 pharmacies. Europe is now the largest revenue contributor in the Companys overall turnover. UK and Germany remain the top revenue generators from the region, followed by Spain and Eastern Europe. Own product launches in Germany will ensure further growth to the revenues and improved margins. The Company managed to fulfill the requirements of Paracetamol tablets for the UK government during the pandemic by airlifting the shipment through chartered flight from Goa. During the year, multiple new products were launched in the UK. Increase in demand due to the Covid-19 pandemic for analgesics and anti-diabetics drugs has been adding to the revenues of the Company. Focus on niche products, right product mix and direct to market approach will further boost the revenues from EU region.

South Africa, Australia and New Zealand

Indoco progressed well with its remediation process related to GMP issues with SAHPRA and TGA. Indoco received GMP approval from SAHPRA for all three GOA facilities in March 2021. TGA has also accepted Indocos responses and is expected to inspect Indocos Goa facilities through virtual inspection. With SAHPRA accreditation to its facilities, Indoco plans to resume commercial supplies to private and tender markets. During the year, Indoco filed a record 22 dossiers under SAHPRAs resubmission programme for product registrations. In New Zealand, Indoco won the tender for Allopurinol 100 and 300 mg tablets for supplies till June 30, 2023. Indoco has filed 4 dossiers in New Zealand, out of which 3 are in Indocos ownership. With necessary accreditations in place and strong market potential for Ophthalmics, the Company plans to increase the number of dossier filings and intends to be a strong player in New Zealand.

Emerging Markets

The Companys major business comes from geographies where brands are promoted by the Companys sales teams. Since the working of team members in the field was disrupted during the year, the Company devised various digital means to promote brands to remain on top of the mind of its customers. Indocos teams in the field made all efforts to brave the challenges all through the year. This collective effort helped to register a double digit growth during the year.

Two of the Companys strong markets, French West Africa and Sri Lanka grew at a rate of 30% and 44% respectively. Other geographies that grew at a double digit rate include, Tanzania, Zambia, Botswana, Swaziland, Mauritius, Zimbabwe, Malaysia and Qatar.

ABZ, Nosic, ATMax, Febrex-TM, Cital and Viscid are the Companys major brands and continue to remain on top promotion. The Company received 16 new product registrations during the year.

API Business:

Unlike other pharma companies, Indoco entered into API manufacturing, after firmly establishing itself in the domestic formulation business. After foraying into international business, Indoco realized that backward integration is a key to success. Accordingly, a new API facility at Patalganga was acquired to ensure that the majority of the Companys ANDAs / Dossier filings are backed by own APIs. The objective is to make APIs available for own use and offer remaining capacity to meet the market demand. Though API contribution to overall business is not sizable, its importance from the strategic perspective is high. Considering the growing demand, both for captive as well as external sales, the capacity was expanded recently by commissioning of a new state-of-the-art API manufacturing facility at Patalganga. The new facility is equipped with an automated solvent dispensing system, efficient recovery system to control the cost of manufacturing and adequate safety by installing modern equipments. The facility is USFDA approved.

In addition to Patalganga, the Company has two more sites at Rabale, viz., Kilo Lab facility which is USFDA approved and an intermediates manufacturing facility, which supplies intermediates to both the Kilo Lab and Patalganga plants.

With a good product mix of APIs in ophthalmics, anti-diabetic, anti-gout and other therapeutic categories, backed by DMFs and Certificates of Suitability (CEPs), the API division is well positioned to register an impressive growth in the coming years.

Research and Development:

‘Research and Development is an expression of Indocos commitment towards excellence through innovation. R&D is imperative for any pharmaceutical companys future. The Companys focus is to develop differentiated generics & innovative specialty products for strengthening its global specialty product pipeline. Indocos R&D Centre, located at Rabale, Navi Mumbai has a highly skilled team of around 300 scientists engaged in the research and development of Active Pharmaceutical Ingredients (API), as well as, Finished Dosage Forms (F&D). The Chemical Research Department (CRD) works on chemical synthesis, process chemistry, designing of non-infringing processes and scale up of APIs. The Finished Dosages (F&D) research develops various dosage forms like, immediate release tablets, capsules, multi unit Pellet Systems (MUPS), Pulsatile drug delivery systems, Sterile Ophthalmic Ointments, Ophthalmic Gels, Suspensions and Solutions, Extended release tablets with matrix technology, complex ophthalmic products like emulsions and nano suspensions as well as a range of injectable solutions, suspensions and depot based long acting injectables.

With a strong technical team in place, Indoco is a partner-of-choice for several large pharmaceutical companies across the globe for in-licensing, co-development and site transfer projects of ophthalmic, injectable, solid and liquid dosages.

Regulatory Affairs:

Indocos Regulatory team comprises of 40 team members, who are engaged in the submission of Dossiers to Regulatory Authorities in regulated and emerging markets. Over 730 product registrations have been achieved across more than 50 countries. In addition, Indoco regulatory has submitted Drug Master Files for 24 Active Pharmaceuticals (APIs). The regulatory function is equipped with eCTD software to support submissions in all advanced countries and a software for Structured Product Labelling (SPL) to support US applications. Electronic submissions of DMFs and Dossiers are done through the Electronic Submission Gateway (ESG) to USFDA and through the Common European Submission Platform (CESP) to EDQM and other European National Competent Authorities (NCA) and through specific National Portal of MHRA for submissions to UK.

AnaCipher CRO, Hyderabad :

The AnaCipher CRO offers a complete range of BA/BE services, such as, bio-availability, bio-equivalence, pharmacokinetics, steady state studies, food effect studies, taste evaluation formulation studies, single and multiple dose studies.

The CRO is equipped with 98-beds, monitoring stations, phlebotomy stations, four-bed ICU, state-of-the-art Bio-analytical lab and capabilities of eCTD (Electronic Common Technical Document) submission. It has a database of more than 18,000 healthy human volunteers and has tied up for the implementation of a ‘Common Volunteer Database Management System to track the volunteers cross participation across all the CROs in Hyderabad. The state-of-the-art-facility is spread over 30,000 sq. ft. area and is located in Hyderabad, India. Anacipher CRO has been successfully audited by the USFDA with Zero 483s for the last 5 inspections. Anacipher has also undergone desktop assessment by the prequalification team of WHO. Product based approvals have been received from Europe (Germany, Italy, Spain and UK) without carrying out an on-site inspection.

Indoco Analytical Solutions (IAS), Rabale

Indoco houses a separate public testing Lab at its R&D Centre at Rabale. The state-of-the-art infrastructure is equipped with latest and sophisticated analytical instrumentation and software. Several studies on Extractable and Leachable for injectables as well as for ophthalmics are undertaken in this facility. Studies on Elemental impurities, as per ICH Q3D, which is now mandatory for regulatory submissions are also performed using advanced instruments. Identification of unknown impurities and its characterization is also routinely performed in the analytical laboratory.

Intellectual Property Rights (IPR):

The Company has from time to time added to its kitty of Intellectual Property by obtaining patents for its innovative manufacturing processes. The IPR Cell is actively involved in filing and prosecution of Patent applications in different territories. It is well equipped with different patent search tools and has access to various scientific journals. The patent applications are filed in respective countries based on the market potential. Status of patent applications filed:

Patent Applications

India

PCT

Europe

USA

Japan

Total

APIs 42 18 5 4 1 70
FDFs 29 3 2 2 - 36
Total 71 21 7 6 1 106

Out of the 70 API patent applications filed, 25 applications are accepted and patents granted. Out of the 36 patent applications filed, 17 applications are granted patents for Finished Dosage Forms (FDFs).

e) Human Resources:

Human Resource Management functions as a strategic partner in the growth of the business contributing positively to the quality of life of Indocoites. It firmly believes that people are the Companys greatest asset and adopt best practices to ensure healthy employee relations, employee growth and development. During these challenging times, various Training Programs and Employee Welfare initiatives continued online.

Under ‘IMPACT (Indocos Management Program for Achieving Competitive Talent), various informative sessions were conducted on ‘The New Normal for different departments and locations. These soft skill-training programs helped to create a healthy and stress-free environment during the ongoing pandemic, thereby creating a positivity amongst the work force.

Various online training sessions were conducted under the CLIMB (Cluster of Learning for Mutual Benefit) initiative by renowned professionals. A series of sessions on ‘Financial Awareness and Wealth Management were conducted with special focus on Savings and Investment, Insurance, Loans and Retirement Planning. The series also added a session on New Tax Regime to keep employees updated on the new tax saving options. Session on Innovations through Digitization gave a deep insight on the new techniques and strategies for business development.

HR conducted Me2We online sessions by introduction of concepts like competitions, debates, recipe corner, witty tips for health and exercise and brainy quiz. The initiative was successful in bringing together and strengthening different departments and helped in bonding and team building. The HR Team continued to conduct Employee Engagement Activities like Dussehra Pooja, Navratri, Diwali Fusion, Indocos Annual Day (INSPIRA and UDAAN) and Foundation Day through live podcast and webinars.

Various Staff Welfare Programs were conducted during the year. Birthday celebrations and retirement felicitation functions were held online. Employees completing 25 years of service and children of Indocoites with outstanding performance in Std. X examination were felicitated. Childrens Day and Womens Day were also celebrated across locations. Online sessions were held for all Indocoites on interesting topics such as ‘Financial Empowerment, ‘Management Lessons from Bollywood, series on ‘Health & Ayurveda, session on ‘Oncology, ‘Yoga for Wellness and ‘Mediclaim. The Company celebrated the ‘Safety Week and ‘Earth Day to bring in safety and environmental awareness. An information session on POSH (The Sexual Harassment of Women at Workplace (Prevention, Prohibition and Redressal) Act, 2013 was conducted by professionals educating women of their right to protection and equality creating a stress-free working environment. The entire globe is undergoing medical emergency due to the surge in Covid-19 cases and India is no exception. The Pharmaceutical industry was classified under essential services and allowed to manufacture so that the supply of essential medicines was uninterrupted. As the permission for operating the manufacturing sites was given, Indoco adhered to the strict guidelines to maintain safety, hygiene and social distancing norms while travelling and also within the premises. HRs contribution has been significant in developing and strengthening the culture of the organization.

f) Future Outlook:

The Companys Domestic business continues to focus on brand building, thrust on chronic and sub-chronic segment as well as penetration in the North and East Region. The Company will selectively launch new products in the specialty segment to boost growth. Well-known legacy brands, Doctors loyalty over 7 decades, highly motivated field force, distribution network across India and presence in growing segments, including Stomatologicals and Ophthalmology will help the Domestic business to grow on sustainable basis.

On the International front, the Companys US business is expected to grow as ANDAs are being commercialized at regular intervals and USFDA approvals have started flowing in. Reinstatement of the EU-GMP compliance certificate for Goa Plant-I and the EU-GMP approval of solid dosages manufacturing facility at Baddi (Plant-III) will boost the EU business, with availability of larger manufacturing capacity. Indoco is also consolidating its position in the Emerging Markets through active brand promotion in select markets. Robust pipeline in specialty dosages, viz., Ophthalmics and Injectables, will enable the Company to have an upper edge over its competitors in the International business.

The capacity expansion at the Companys API manufacturing facility at Patalganga will augment the captive requirements and boost external sale of APIs.

Expertise in Research and Development, backward integration with own APIs, a full-fledged CRO set-up, excellence in finished dosages manufacturing and a strong customer base makes the Company, a preferred partner, offering complete solutions to its customers worldwide.