ICAI Technical Guide on Internal Audit of Pharmaceutical Industry

ICAI issue Technical Guide on Internal Audit of Pharmaceutical Industry

the Indian pharmaceutical industry is the world’s 13th largest by value and third largest in the world by volume. The pharmaceutical industry in India was valued at an estimated US $42 billion in 2021 and is estimated to reach $.130 billion by 2030.  India is the world’s largest provider of generic medicines by volume, with a 20% share of total global pharmaceutical exports. It is also the largest vaccine supplier in the world by volume, accounting for more than 60% of all vaccines manufactured in the world. Indian pharmaceutical products are exported to various regulated markets including the US, UK, European Union and Canada.

In view of the role and importance of the pharmaceutical industry, the ICAI has issued a Technical Guide on Internal Audit of Pharmaceutical Industry to provide guidance to internal auditors in carrying out internal audit of companies operating in pharmaceutical industry.

This Guide has been divided into ten chapters i.e. regulatory framework, key drivers of this industry, technical aspects, R&D, Risk Assessment, internal audit etc.

This technical guide aims to provide comprehensive information and guidance to internal auditors working in the domestic pharmaceutical industry. It aims to equip internal auditors with the knowledge necessary to effectively assess and evaluate the risk management and internal control systems, management processes and compliance frameworks specific to the pharmaceutical sector.

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• Audit Fee to be received only by digital modes/banking channels -ICAI revises Ethics
• Demand set aside as assessee for period covered had discharged tax liability under SVLDRS
• No addition u/s 68 when there is no fresh receipt of unsecured loans during the year
• Taxes on sales comprising in turnover to be excluded for estimating net profit
• Capital contribution deposited in assessee’s bank not partnership firm – Addition 69A upheld