FORMULATION AND ISSUES IN THE IMPLEMENTATION OF DISPOSABLE STANDARDS FOR ANAEROBICALLY TRANSFORMED INTERMEDIATES OF ANTIBIOTIC PHARMACEUTICAL INDUSTRY – A CASE STUDY

The formulation and implementation of regulatory standards for the ultimate disposal and reuse of transformed products of antibiotic drugs and solvents have been a pending issue in the waste management of pharmaceutical industries especially in the developing countries like India. A case study has been identified and the current issues in one of the major pharmaceutical industry (manufacturing cephalosporin drugs) located in Chennai, India, has been discussed for the possible implementation of transformed intermediate products. The objective of the study were to discuss the issues in the implementation of the disposal standards for effective waste management in pharmaceutical industries. Cephalosporins are widely manufactured and used for the therapy of acute pneumonia and infections of respiratory tract, skin and soft tissues, bones and joints, urinary tract and blood stream (Goodman, 1980). Cephalosporin is a common name refers to cephradine (C16H19N3O4S) and cephalexin (C16H17N3O4S.H2O) (British Pharmacopoeia, 1980). Based on the critical examination of results the industry is looking for the alternatives of either direct disposal of 7-amino-3-deacetoxycephalosporanic acid (7-ADCA) and Phenyl acetic acid or for further degradation and disposal, which will essentially require additional cost and maintenance. The present regulatory standard implemented in India does not envisage such disposal alternatives and hence this would invite suggestions and recommendations of the expertise for the possible implementation on the pending issue in the antibiotic based pharmaceutical industries. The presence of cephalosporin increases total strength (Chemical Oxygen Demand) of the effluent and indirectly increases the cost of the treatment. Hence the biotransformation of cephalosporin either alone or in combination with other energetic compounds, offers the potential for an economical and environmentally friendly disposal alternative.