Regulatory Compliance Motivated Manufacturing Issues In Indian Small & Medium Scale Pharmaceutical Enterprises

Abstract

In the past few decades, there has been increased attention and concern towards the potential damaging effects of industrial pollutants on the global eco-system. To combat these effects, countries have enacted their own environmental regulatory laws and standards.  However removal of the pollutants at the source and keeping the product standards according to the regulatory compliance level becomes a major concern for the manufacturing sector, particularly to Small and Medium Scale Enterprises (SMEs). Focus of this study is on Indian Pharmaceutical Small and Medium Scale Enterprises (PSMEs), aimed at identifying and prioritizing the reasons, nature and magnitude of vulnerable regulatory issues to environmental compliance.  Stratified random sampling design is adopted for data and prioritization of the issues arising out of compliance measure is done using Analytical Hierarchy Process (AHP). The study and related reviews brings out the relevance of strategic interventions from government, regulatory organizations and industry associations for improving the sustainable business environment of SMEs.