• Prathmesh Sangale
• Mr. Shravan J. Somani
• Mr. Akshay S. Jadhav
• Mr. Abhijit R. Rode

The pharmaceutical industry has always established keep intent to produce drug products with enhanced quality for meeting the patient requirement. The consistent invention of drug products with the desired quality traits, however, has been an arduous challenge owing to the prevalence of high degree of unpredictability in active pharmaceutical ingredients, raw materials, and/or processes. In an endeavor to address such crucial issues, the pharma houses have lately been undergoing transformation by adopting systematic approach for developing drug product with enhanced quality, robustness and resource-economics. Robust regulatory arrangement provides the foundation for a national method of medicine safety, and for public self-assurance in medicines. This article focuses on the need to sharpen the regulatory requirement for pharmacovigilance in India. To be operative the responsibility of drug regulatory authorities needs to go further than the approval of new medicines, to encompass a wider range of issues related to the safety of medicine. In order to achieve their respective objective pharmacovigilance program and drug regulatory authorities must be mutually supporting. Quality risk management (QRM) is one of the most important tasks when it comes to the pharmaceutical industry. It is because the industry produces medicines, whose quality is directly related to the patient’s health. The International Conference on Harmonization (ICH) has developed various guidelines to guard the quality of medicines along with its safety and efficacy. QRM is currently approaching to be a required practice in industries.

"A Brief Review on Regulatory Approaches of Pharma Industry", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.10, Issue 5, page no.a229-a245, May-2023, Available :http://www.jetir.org/papers/JETIR2305033.pdf

"A Brief Review on Regulatory Approaches of Pharma Industry", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.10, Issue 5, page no. ppa229-a245, May-2023, Available at : http://www.jetir.org/papers/JETIR2305033.pdf