Comment from Ipca Laboratories Limited
AnonymousSupportBusiness
Summary: Ipca Laboratories Ltd., a global pharmaceutical company, supports the FDA's initiative to develop guidance on using AI/ML in regulatory decision-making for drug and biological products. The company suggests that the FDA should specify minimum batch numbers for validation and clarify methodologies for mitigating model bias, while also advocating for streamlined post-approval monitoring and retraining of AI models.
Dear Madam/Sir,
Greetings from Ipca Laboratories Limited, Mumbai, India!
Ipca Laboratories Ltd., a consumer-led global pharmaceutical company, creating healthy doses of life since 1949. For more than 60 years, Ipca has been a crucial healthcare partner in over 120 countries across the 6 continents. We are a fully-integrated pharmaceutical company that manufactures over 350 formulations and 80 APIs for various therapeutic segments.
Ipca continues to develop a broad pipeline of biosimilar products and candidates that cover a spectrum of therapeutic areas including rheumatology, oncology, osteoporosis and inflammatory diseases.
We sincerely appreciate the initiative of the agency to have Industry comments/suggestions on the ‘Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products’, draft guideline published on Jan 2025. This opportunity will eventually encourage industries to more focused development of the therapeutic products for USFDA submission.
Attached are the few inputs to the agency based on our understanding and experience with Artificial Intelligence and Machine Learning (AI/ML).
Sincerely,
For Ipca Laboratories Ltd.,
Sanjeev Gupta, Ph.D.
Sr. Vice President - Advanced Biotech Lab
Ipca Laboratories Ltd., Mumbai, India
D: +91 22 6210 5820 | M: +91 9619730425
Email: sanjeev.gupta@ipca.com