C-CAMP-WHO-BMGF India Workshop: “Global landscape for development & manufacturing of IVDs with regulatory requirements in India
Centre for Cellular and Molecular Platforms (C-CAMP)
Fostering deep science research and innovation for societal impact
Post-pandemic, India’s in vitro diagnostics or the IVD sector has positioned itself as a potential global leader, and therefore, a need has come up to develop and manufacture such kits that meet global standards. To address this, C-CAMP’s Indigenisation of Diagnostics (InDx) program, in collaboration with WHO India and the Bill & Melinda Gates Foundation, recently organized a 2-day workshop focusing on the global landscapes of In Vitro Diagnostics (IVDs) development and manufacturing.
According to WHO, IVDs are tests that can detect disease, conditions and infections, and may be done in laboratories, health care facilities or at home, using a variety of instruments ranging from small, handheld tests to complex laboratory instruments. The COVID-19 RATs and RT PCRs are quick examples of such kits. However, development of such kits is complex and require meticulous planning, validation and quality assessment to meet regulatory standards and ensure clinical efficacy.
Held for 30 cohort companies, this workshop, unmatched by any of its type in India before, focused on giving Indian IVD manufacturers national and international regulatory insights with tailored insights on
The workshop kicked off with Dr. Taslimarif Saiyed, C-CAMP’s Director-CEO, emphasising the eminence of the workshop in demystifying regulatory pathways for IVD developers in India for perhaps the first time at this depth.?
Technical Session 1: Global standards & Best practices for development & manufacturing of IVDs?
?“Do you know only 16 Indian IVDs have received the WHO PQ and no pre-qualified IVD for TB from India exists?” Dr. Madhur Gupta, Technical Officer- Pharmaceuticals at WHO India, stressed India's lag in WHO PQ for IVDs despite the country’s leadership in vaccines and medicines. “Hence, it is essential to foster local production and improve access to quality medical ancillary products that meet national and international demands,” she noted.
She highlighted the importance of WHO PQ, saying, “The objective of WHO PQ is to help countries ensure that only safe, affordable, efficacious and high-quality medical products are available to their populations. It is important for LMICs, which often have limited resources access such products.”
What are the requirements that must be met?
Dr. Reba Chhabra, Consultant, C-CAMP - Local Production of Diagnostics Initiative, explained the eligibility criteria for WHO PQ for IVDs, including disease necessity, suitability for resource-limited settings, and alignment with WHO guidelines.??
Sh. Pramod Meshram, Deputy Drugs Controller of India at the Central Drugs Standard Control Organisation (CDSCO), provided a comprehensive overview of the regulatory framework for medical devices in India. Meshram detailed the CDSCO's approval process and the regulatory requirements for clinical performance.
Defining the profile of your target product
Dr. Ravi Kumar Banda, MD at XCyton Diagnostics, elaborated on the criticality of Target Product Profile (TPP) for successful regulatory clearance of an IVD product.
The TPP should specify several critical elements such as the diseases targeted by the product and the organisms it aims to detect. It should also define the intended user demographic, and preferred performance characteristics like sensitivity, specificity, etc. He illustrated these points with three detailed case studies on meningitis.
Understanding QC versus QA
Dr. Rachana Tripathi, CEO of Huwel Lifesciences Pvt. Ltd., discussed Quality Control (QC) vis-a-vis Quality Assurance (QA) strategies in the development and manufacturing of IVDs.?
She explained that QA is designed to establish a controlled system of manufacturing that prevents errors proactively through continuous system monitoring and improvement, making it process-focused. In contrast, QC is more product-focused and deals with testing at critical manufacturing steps to identify and correct errors before the product reaches the market. She emphasized that maintaining high quality is the responsibility of every individual within the organization no matter the process or the strategy.?
Technical Session 2: Quality Management System for IVDs?
Dr. Chandranand, Consultant, C-CAMP-Local Production of Diagnostics Initiative, explained the Quality Management System (QMS) for IVDs focusing on Risk Management and Change Control. He highlighted the importance of starting risk assessments right from the supply chain to ensure cost reduction and robust product quality.?
Dr. Pramod Devanga, R&D Head, Medinno Technologies, continued the discussion on risk management, urging manufacturers to anticipate risks from all product development phases, starting from research and development.
领英推荐
He stressed the importance of a multidisciplinary team approach to evaluate risks and advocated for a well-documented change control process to minimise risks and promote continuous improvement.
Dr. Lakshmi Achuta, Strategic Advisor, AshRinBio spoke on the role of Current Good Manufacturing Practice (cGMP) in the Quality, Safety, and Effectiveness of IVDs. Dr. Lakshmi discussed the significance of cGMP in ensuring patient safety, data integrity, and compliance with standards.
Dr. Malay Kataria, R&D Head, Trivitron Healthcare explained the Qualification of Facility, Equipment & Personnel in Manufacturing of IVDs. Dr. Kataria detailed the standards for facility setup, equipment, and personnel qualification to maintain a controlled manufacturing environment.
The second day of the workshop transitioned into more nuanced aspects of IVD development such as enhancing manufacturing and post-market surveillance.
Mr. Siddharth Daftary, Co- CEO, of Advy Chemicals Pvt. Ltd., spoke on the crucial phases of raw material control and process validation, stressing the importance of establishing strong Standard Operating Procedures and learning from manufacturing errors.
In parallel, Mr. Dipan Shelat, Lead IVD Team, TüV-SüD South Asia Pvt. Ltd., discussed the critical role of audits and inspections, for the manufacturing of IVDs. Dr. V. Kalaiselvan, Senior Principal Scientific Officer, Indian Pharmacopoeia Commission (IPC), continued the discussion highlighting the role of the IPC in monitoring adverse events and ensuring product safety.
PANEL DISCUSSION - Challenges and Opportunities in Indigenisation of In-Vitro Diagnostics and getting WHO-Pre qualification mark
Dr. Unnikrishnan, Head MHD, Bureau of Indian Standards (BIS) and Dr. Nagavarshini Mayakkannan , Scientist at BIS discussed the BIS's role in setting standards for IVDs, including formulating product-specific standards and ensuring compliance with quality and risk management.
Dipan Shelat, Lead IVD Team, TüV-SüD South Asia Pvt. Ltd, addressed the role of Notified Bodies, outlining steps manufacturers should take in case of non-conformity with compliance standards. He also highlighted the importance of staying updated with national and international cybersecurity standards and applying for various certifications.
Companies with WHO PQ approvals shared their experiences. Dr. Bhaumik Dave, Additional General Manager R&D, Meril Diagnostics highlighted patient safety, stressing the importance of thorough documentation and adherence to guidelines.?
Siddharth Daftary, Co-CEO, Advy Chemicals emphasized the critical aspects of health management and risk management, particularly focusing on the training of new personnel. He noted the lengthy process for WHO PQ and stressed the importance of managing risks to prevent major non-conformances at the later stages of product development.?
Dr. Dr. Maulik Rachh chh, General Manager, Arkray Healthcare discussed strategies for accessing clinical samples, personal experiences in dossier submission, and the importance of thinking beyond India acknowledging that various geographies have their own standards for testing samples.
Dr. Pazhanimuthu Annamalai Ph.D , Managing Director, AURA Biotechnologies wrapped up the session by highlighting the vision for WHO PQ and how it can promote health equity specifically in LMICs.
Technical Session 3: Assay Design, Optimisation & Validation of IVDs
Dr. Mitali Samaddar, Science and Technology Lead, C-CAMP InDx Program discussed the structured "Stage-gate" process in IVD development, split into three main phases:
This was followed by detailed discussions on assay design, optimisation, the necessity of rigorous validation processes and the importance of stability studies by Dr. Surakasi Venkata Prasad, Managing Director, Progenics Laboratories, Bhaumik Dave, Dr. Maulik Rachh, General Manager, R&D, Arkray Healthcare and Dr. Ashwani Kumar Mishra, MD, DNA Xperts.?The technical session covered test method validation, critical analysis of sensitivity and specificity, minimizing false positives and ensuring accurate diagnosis under all performing conditions.
Technical Session 4: Clinical Validation of IVDs
The workshop concluded with a focus on clinical validation where Dr. Ravi V , Head of R&D at Tata MD and Dr. Anita Shete, Scientist E at the Indian Council of Medical Research, National Institute of Virology, outlining the regulatory and documentation challenges and strategies for clinical validation of IVDs. Their talks underscored the complexity of clinical studies, which are essential for ensuring that IVDs perform reliably under varied real-world conditions.
The Step Forward in Diagnostic Excellence
The two-day intense workshop highlighted the technical and regulatory challenges faced by IVD manufacturers and paved the way for more transparency by regulatory bodies towards helping manufacturers overcome these obstacles.?
The key points in each session underlined that advancing the IVD industry requires a multidisciplinary approach involving rigorous regulatory frameworks, robust quality management systems, and continuous improvement through global partnerships.?
This C-CAMP-WHO-BMGF co-hosted workshop has laid the foundations for India to become the diagnostics capital of the world.?
Good work