The Central Pollution Control Board (CPCB), set up by the ministry of environment and forests, is planning to come out with specific guidelines for the control and management of hazardous wastes produced by the bulk pharmaceutical sector in the country.
The CPCB has prepared the draft guideline for waste management of 31 major bulk drugs with the help of National Productivity Council (NPC) and is in the process of finalising it. The guideline is to provide waste management options for bulk drugs like Paracetamol, Naproxen, Penicillin G, Loratadine, Sulbutamol Sulfate and ACME (Ramipril).
The document is to put an end to the conflicting interpretations of the 'Hazardous Wastes (Management and Handling) Rules' by various state pollution control boards (SPCBS), thereby saving the bulk drug industry from one of its biggest present-day headaches.
The CPCB is of the opinion that the industry specific guidance document would help both the bulk drug sector as well as the SPCBS to properly identify and quantify the waste, including recovery and recycling different types of wastes and their management in an environmentally safe manner. Such documents have already been prepared by CPCB for petrochemical, pesticide and Dyes and Dye intermediate sectors.
The document was prepared after CPCB commissioned a study to the NPC on "Identification of hazardous waste streams, their characterization and waste minimisation (recovery / recycle) options in bulk drugs and pharmaceutical sector." The NPC has submitted its report recently and the CPCB is in the process of finalising the report, it is learnt.
The NPC study has given waste management options for hazardous waste streams generated from manufacturing steps of a representative set of bulk drugs. This include Paracetamol, Naproxen, Penicillin G, Erythromycin Thiocyanate, Amoxycillin Trihydrate, Cloxacillin Sodium, ADCA, Cephalexin Monohydrate, 7-ACCA, Cefaclor, Cefuroxime Axetil, Clarithromycin, Cefpodoxime Proxetil, Ethambutol HCI, Ranitidine HCI, N-Methyl-4-Piperidone, 4-Hydroxy-N-Methylpiperidine, 4-Chloro-N-Methylpiperidine, N-Carboethoxy-4-Piperidone, 4-Amino 1,2,4 Triazole, Ciprofloxacin, Glibenclamide, Fluoxetine HCI, Veniafaxine HCI, Loratadine, Loratadine (U-04), Pheniramine Maleate, Sulbutamol Sulfate (Intermediate-5), ACME (Ramipril), lassamide and finasteride Int 6.
The CPCB has called for a meeting of the bulk drug industry representatives in Vadodara later this month to discuss the draft report prepared by NPC before finalising the document. According to bulk drug manufacturers, the report is a welcome move as it would be a solution to most of the PCB related problems faced by the bulk drug sector in Andhra Pradesh and Gujarat. However, they wanted the list to be expanded by including all bulk drugs in future. The industry also welcomed the CPCB decision to invite the stakeholders for a discussion before finalising the document.
Management of hazardous waste has become important as improper disposal can cause serious damages to environment and health. The environment ministry has promulgated Hazardous Wastes (Management & Handling) Rules in 1989 and amended in 2000 under the Environment Protection (Act), 1986. These rules were further amended in 2003. In these rules, various professional / industrial sectors with waste streams and regulatory concentration limits for various constituents have been listed in Schedule 1 and Schedule 2 respectively. However, a need was felt to prepare industry specific guideline document to help the industries and SPCBs to properly identify and quantify the waste including recovery & recycling different types of wastes and their management in an environmentally safe manner.
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