bilcare Management discussions

Industry Outlook

India is the largest provider of generic drugs globally and is known for its affordable vaccines and generic medications. The Indian Pharmaceutical industry is currently ranked third in pharmaceutical production by volume after evolving over time into a thriving industry growing at a CAGR of 9.43% since the past nine years. Generic drugs, over-the-counter medications, bulk drugs, vaccines, contract research & manufacturing, biosimilars, and biologics are some of the major segments of the Indian pharma industry. India has the most number of pharmaceutical manufacturing facilities that are in compliance with the US Food and Drug Administration (USFDA) and has 500 API producers that make for around 8% of the worldwide API market.

Indian pharmaceutical sector supplies over 50% of global demand for various vaccines, 40% of generic demand in the US and 25% of all medicine in the UK. The domestic pharmaceutical industry includes a network of 3,000 drug companies and ~10,500 manufacturing units. India enjoys an important position in the global pharmaceuticals sector.

Global clinical trial supplies market expected to generate revenue of around USD 2,092.5 million by end of 2024, growing at a CAGR of around 7.20% between 2018 and 2024. The clinical trial supplies market is segmented on the basis of product / services into manufacturing, packaging and labelling, and storage and distribution.

Opportunities, Threats & Outlook

While leading pharmaceutical contract manufacturers in India are focusing on ensuring innovative products. To meet sustainability objectives, several manufacturers are also implementing innovative and environmental-friendly packaging. Packaging plays a crucial role in the pharma industry, where its function extends beyond serving as a branding aid and providing barrier protection to products for the shelf-life period. It is increasingly playing a vital role in ensuring overall patient safety by carrying key information pertaining to the product, ensuring tamper-evidence and traceability of products. The growing population, rising health awareness, and increasing life expectancy can be attributed to the growth of the pharmaceutical packaging industry.

The Comparator Sourcing is a fast-growing industry within clinical trials that has doubled within the last three years. A recent report published by the Institute for Healthcare Informatics forecasts that the surge in cancer drug innovation is projected to continue over the next five years, with oncology currently already making up 25% of the global late-stage pipeline. As the majority of drug candidates are being studied against the existing standard of care, the need for secure and transparent sourcing of comparator drugs and non- investigational medicinal products (NIMPs) on a global scale is likely to rise significantly. Sourcing optimization is by and large achieved via gradual transition from centralized to local comparator suppliers. Global sourcing companies are beginning to assess local market capabilities for availability of quality certificates and actively export drugs for QP release.

Business Performance

In the current year, Bilcare handled Primary and secondary packaging with various innovative blinding techniques, IWRS, Storage at variable temperatures along with distribution on global depots/ sites with equivalent capabilities to facilitate storage and distribution, handling of returns and destruction.

Services of in respect of IMPs (Investigational Medicinal Products):

• Comparator Procurement

• Primary and Secondary Packaging

• Storage at Ambient and Controlled Temperatures

• Logistics

• Analytical & Regulatory

• Manufacturing

• IVRS and IWRS

Considering the growing market demand in the CTMS Market, Bilcare GCS has already aligned its resources.

During the year Bilcare s key achievements have been - We supported Pharma companies and CROS in USFDA audit; by successfully attending the Investigator Meets; Expanded global depot partners to cover most of the locations in the world. With this, Bilcare GCS is poised to regain its market share and looks forward to maximize profits by providing innovative, compliant and faster services to its clients.

The Comparator Sourcing is a fast-growing industry within clinical trials that has doubled within the last three years. Global sourcing companies are beginning to assess local market capabilities for availability of quality certificates and actively export drugs for QP release. Bilcare is becoming formidable player in this market as well.

Bilcare has well-placed Standard Operating Procedures (SOPs) and adequate Internal Checks and Controls, which ensures best Procedures followed globally in the Industry. This is also witnessed by, the Company undergoing and completing all major Customer / Clients audits without any Critical Audit Observations. Very soon we will be expanding our services for our own Manufacturing set up to cater to the need of Clinical Trial Industry and thus provide full solutions to Industry and Clients under one umbrella and one stop shop.

Internal Control System and Adequacy

The Company has a well-placed and adequate Internal Financial Control system, which ensures that all the transactions are authorized, recorded and reported correctly as well as is compliant with the Companys policies and Standard Operating Procedures (SOPs). The Internal Auditors independently evaluate the adequacy of the internal controls and report to the Audit Committee of any major deviations.

Financial Performance

The Company has been through a restructuring phase over the last few years. As on March 27, 2023 the Company sold its PPI division to its subsidiary Caprihans India Limited on a slump sale basis. Thus the financial performance reflected is only the GCS division and not comparable to the previous years. However, with the bank debt fully repaid, the Company expects the growth trend to increase manifold.

Key Change in Financial Ratios

Effective the slump sale, the ratios are not comparable with the previous years figures.

Risks and Concern

The Company is subjected mainly to currency fluctuation risks.

Cautionary Statement

Statements in this Management Discussion and Analysis describing the Companys objective, projection, estimates, and expectations may be ‘forward looking statements within the meaning of applicable laws and regulations. Actual outcome may differ substantially or materially from those expressed or implied. Important developments that could affect the Companys operation include significant changes in the political and economic environment in India or overseas in key markets, applicable statues, litigation, labor relations, exchange rate fluctuation, interest and other costs.