Shilpa Medicare Ltd.

Hyderabad: As drug manufacturers in India embrace the revised Schedule M mandate—aligned with the World Health Organization (WHO) and PIC/S (Pharmaceutical Inspection Co-operation Scheme) standards—the revised norms place a sharp focus on product quality assurance, data integrity, and manufacturing consistency. The shift signals a pivotal moment for companies, compelling them to adopt advanced technologies for better process monitoring and control, with newer advancements in technology, the transition offers numerous opportunities, supported by extensive global evidence. However, with nearly 80 per cent of the entities falling in the small and mid-sized part —those with an annual turnover of or less than ₹250 crore—the multifaceted overhaul has remained a challenging task, linked with resource crunch, capex constraints and skill shortage. While, on the back of extensions, subsidies, and constant guidance from regulators, firms have initiated actions, the pace of adoption has been a major cause for concern for the government. Delving into this critical issue the second edition of ETPharma Tech Innovate Conclave, convened a panel discussion to explore, “Are Mid and Small-Sized Pharma Players Ready to Embrace Technology Transformation?” Representing the industry at the discussion, the panel featured R.K. Agarwal, National President, Bulk Drug Manufacturers Association; S.M. Mudda, Managing Director, Misom Labs Limited, Chairman IDMA, Regulatory Affairs, Chief Technical Advisor- Encube Ethicals, Mumbai; Dr. Pavan Bhat, CEO, Inventia Healthcare; and Dr. Jayant Karajgi, CEO of Formulation Unit, Shilpa Medicare The discussion was moderated by Vikas Dandekar, Editor- ET Pharma, The Economic Times Context and Variations “In India, GMP norms aligned with the WHO guidelines of 2000 have been in place. However, implementation was previously relaxed, and many units took for granted that this was the standard way of manufacturing,” said R. K. Agarwal, National President of the Bulk Drug Manufacturers Association IDMA Chairman S. M. Mudda highlighted, earlier companies were required to comply with guidelines prescribed by the regulator. However, the revised standards focus on treating quality differently and aim to build a system that ensures traceability across the entire value chain. “The revised norms are requiring small drugmakers to shift their mindset and adopt a quality management system approach that encompasses development, stability, and quality review,” he added. According to Agarwal, the division of responsibilities—norm-setting by the Centre and execution by the states—is creating inconsistencies in how the rules are being adopted across the country. Cost Conundrum Dr. Karajgi, CEO of Shilpa Medicare’s Formulation Unit, outlined that “compliance involves cost, and smaller companies may initially be hesitant. However, elements like Quality Management Systems and Annual Product Quality Reviews (APQR) can be effectively implemented through the right systems. “It’s important to accept that deviations may occur in an APQR, and there may be batches that don’t meet intended outcomes — but these can be justified,” he noted. Commenting on the required capital expenditure Agarwal said, “only those units which were operating on earlier benchmarks would require a complete overhaul whereas for manufacturers who are at the current benchmark level are required to spend a reasonable cost. The majority of companies, including larger ones, tend to be reactive rather than proactive,” said Dr. Bhat. He further added, “Investments in automation and other quality controls are merely supportive tools—the real issue lies in the industry's mindset, which is often lacking when it comes to implementing these practices on the shop floor, but making it a non-negotiable condition gives a quantum leap in quality. Strategies to succeed Manufacturers should adopt a uniform approach and investing in quality management systems helps to make compliance sustainable and scalable, Muda said. To address the cost challenge, Dr. Karajgi suggested that companies should categorize their upgradation plans and explore innovative models for expenditures like training of staff with cost-effective solutions. On part of digitization, Dr Bhat said, “integrating advancements like e-log books, warehouse management system will help to eliminate human intervention, avoid errors, however shifting directly to Manufacturing Execution System–a system which tracks and documents the entire process–, going completely paperless is not required. For legacy products that lack modern-day controls, Dr. Bhat stressed, “regulators can initiate a renewal registration process, allowing companies to re-register their products with updated data, methods, and process validations that will help separate the wheat from the chaff in the industry.” By Prathiba Raju & Abhijeet Singh ,

Amneal Pharmaceuticals and Shilpa Medicare have announced the US launch of BORUZU™, a new presentation of bortezomib for ready-to-use subcutaneous administration or intravenous (IV) administration. This new ready-to-use oncology product reduces the compounding preparation steps typically required with administration. BORUZU™ (bortezomib injection), a proteasome inhibitor, is used for the treatment of multiple myeloma and mantle cell lymphoma. This product references the branded product Velcade®, a lyophilized powder requiring reconstitution before use. Shilpa developed the molecule and Amneal will manufacture and commercialize the product. BORUZU has a unique J-code. "As we advance our broader strategy to build a leading injectables portfolio with durable, high-impact complex products, we are excited to announce the U.S. launch of BORUZU™ in our oncology portfolio. This ready-to-use injectable marks a significant innovation for our customers by streamlining pharmacy preparation steps for clinicians while now carrying a unique J-code to facilitate reimbursement. Our commitment remains steadfast in delivering differentiated oncology products that enhance patient care and access," said Sean McGowan, Senior Vice President, Biosimilars and Branded Oncology. “This second NDA product being launched in the US market from our novel injectable portfolio demonstrates our capabilities and commitment to introduce pharmacy efficient solutions that enhance compliance and have the potential to reduce patient wait times. This development exemplifies Shilpa’s constant endeavor to work towards introducing novel first of its kind pharmaceutical products that help improve the healthcare requirements of a large patient pool,” said Vishnukant Bhutada, Managing Director of Shilpa Medicare. The most commonly reported adverse reactions for BORUZU™ in clinical studies include asthenic conditions, diarrhea, nausea, constipation, peripheral neuropathy, vomiting, pyrexia, thrombocytopenia, psychiatric disorders, anorexia and decreased appetite, neutropenia, neuralgia, leukopenia and anemia.

Boruzu is the first ready-to-use bortezomib injection for multiple myeloma and mantle cell lymphoma. Credit: SmartPhotoLab/Shutterstock. Amneal Pharmaceuticals and Shilpa Medicare have launched the new presentation of bortezomib, Boruzu, for subcutaneous or intravenous administration, offering a ready-to-use option for patients with multiple myeloma and mantle cell lymphoma in the US. Boruzu is the first ready-to-use bortezomib injection for multiple myeloma and mantle cell lymphoma , and lowers the compounding preparation process needed for administration. A proteasome inhibitor, Boruzu references branded Velcade, a lyophilised powder that needs reconstitution before usage. Shilpa has created the molecule, while Amneal will handle the manufacturing and commercialisation of the product. The most commonly reported adverse events for Boruzu in clinical studies have been anaemia, anorexia, asthenic conditions, diarrhoea, euralgia, gastrointestinal issues, leukopenia, neutropenia, peripheral neuropathy, psychiatric disorders, pyrexia, reduced appetite and thrombocytopenia. Amneal pharmaceutical biosimilars and branded oncology senior vice-president Sean McGowan stated: “As we advance our broader strategy to build a leading injectables portfolio with durable, high-impact complex products, we are excited to announce the US launch of Boruzu in our oncology portfolio. “This ready-to-use injectable marks a significant innovation for our customers by streamlining pharmacy preparation steps for clinicians while now carrying a unique J-code to facilitate reimbursement.” Amneal is a biopharmaceutical company based in Bridgewater, US. Through its affordable medicines segment, the company focuses on widening complex product categories as well as therapeutic areas, which include biosimilars and injectables. In its speciality segment, Amneal has a branded pharmaceutical portfolio focusing mainly on endocrine and central nervous system disorders. The company distributes pharmaceuticals and other products to the federal government of the US, as well as to institutional and retail markets, via its AvKARE segment. An integrated pharmaceutical group, Shilpa has business interests in peptides, oncology and non-oncology active pharmaceutical ingredients, differentiated finished dosage formulations and polymers. It also offers contract development and manufacturing organisation services to pharmaceutical firms, supported by research and development and manufacturing capabilities. In August 2024, the US Food and Drug Administration (FDA) approved Amneal’s Crexont extended-release capsules for treating Parkinson’s disease.