The Institute of Chartered Accountants of India (ICAI) has released a Technical Guide on Internal Audit of Pharmaceutical Industry.
The Indian pharmaceutical industry holds a prominent position on the global stage, securing the third rank in pharmaceutical production by volume. Renowned for its production of generic medicines and affordable vaccines, the industry’s growth trajectory continues upward, promising abundant opportunities across key sectors within pharmaceuticals. These encompass areas such as Innovation and R&D, Healthcare Delivery, Manufacturing, and the Global Supply Chain.
However, amidst this growth, the industry grapples with the intricate challenge of managing diverse resources and navigating a complex external environment. Effectively addressing this challenge necessitates the optimization of resource utilization, establishing a robust support system to achieve strategic objectives, evaluating and enhancing existing controls and processes, and providing assurance and guidance concerning governance, risk appetite, risk and control culture.
Additionally, active engagement in consultative problem-solving activities is essential. In this context, Internal Audit emerges as a vital tool for steering the growth of the pharmaceutical industry. Chartered Accountants, recognized as world-class internal auditors, play a pivotal role in providing credible and unbiased insights. Internal Auditors adeptly assess the necessity for implementing best practices, recommend appropriate strategies, and actively contribute to their seamless implementation.
Keeping this in mind, the Board on Internal Audit and Management Accounting of ICAI issued this Technical Guide on Internal Audit of Pharmaceutical Industry to provide guidance to internal auditors in carrying out internal audits of companies operating in the pharmaceutical industry.
This Guide has been divided into various chapters that provide guidance on structure, history, regulatory framework, key drivers of this industry. This Guide, inter alia, provides guidance on aspects involved in various stages of the pharmaceutical industry and regulatory framework. This Guide also describes risks associated with the pharmaceutical industry and internal controls checklist for various processes. This Guide also contains an illustrative checklist for internal audit of major areas of the pharmaceutical industry.
“I congratulate CA. Rajendra Kumar P., Chairman, CA. Charanjot Singh Nanda, Vice Chairman and other members of Board of Internal Audit and Management Accounting for bringing out this publication “Technical Guide on Internal Audit of Pharmaceutical Industry”. This Technical Guide will provide the readers a crisp insight into various technicalities arising in the operations of pharmaceutical industry and covers the relevant issues which the internal auditors must be aware of. I am sure that this Technical Guide will assist the members in discharging their professional responsibilities efficiently.”, CA Aniket Sunil Talati, (President, ICAI) stated at New Delhi.
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