An Analytical Study of Selected Bulk Drug Manufacturers in Andhra Pradesh and Telangana: SEZ Status, Regulatory Framework, Compliance, Oversight, and Workforce Welfare and Safety
Abstract
Introduction: India’s bulk drug manufacturing industry has witnessed rapid growth over the past two decades, driven by supportive government policies, financial incentives, and regulatory reforms such as the Special Economic Zones (SEZ) Act 2005 and Rules 2006. Encouraged by these initiatives, several major pharmaceutical companies established manufacturing units across Andhra Pradesh and Telangana, particularly in industrial clusters and SEZs. Although this expansion significantly strengthened India’s pharmaceutical sector, it was also accompanied by multiple industrial accidents resulting in loss of lives and raising concerns about workplace safety and employee welfare.
Methods: This research paper evaluates ten selected bulk drug manufacturing companies using publicly available documents, regulatory reports, and media sources. The analysis is based on four key parameters: regulatory compliance, regulatory oversight, employee welfare, and workplace safety, along with a review of reported accidents.
Results and Discussion: The findings indicate that listed pharmaceutical companies generally perform better across all evaluated criteria. In contrast, certain SEZ-based unlisted companies, including Hetero SEZ Infrastructure and Escentia, appear to show weaker commitment toward employee welfare and occupational safety.
Summary: The study emphasizes the need for stricter regulatory enforcement, regular safety audits, greater transparency, and stronger accountability to ensure safer and more sustainable growth of the bulk drug manufacturing industry in India.
Conclusion: The review highlights the growth of India’s bulk drug industry and evaluates regulatory compliance, employee welfare, and workplace safety among selected companies. It emphasizes the need for stricter regulations, regular safety audits, transparency, and stronger accountability to ensure sustainable and safe industrial development.
Keywords:
Bulk drug manufacturers, SEZs, Regulations, Accidents, compliance, oversight, employee welfare, workplace safety
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Jayanti VR, Mandavilli SR, Battu H. An Analytical Study of Selected Bulk Drug Manufacturers in Andhra Pradesh and Telangana: SEZ Status, Regulatory Framework, Compliance, Oversight, and Workforce Welfare and Safety. Int J Drug Reg Affairs [Internet]. 2026Jun.15 [cited 2026Jun.20];14(2):60-5. Available from: https://www.ijdra.com/index.php/journal/article/view/906
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