The bulk drug manufacturers of Gujarat have vehemently opposed the waste management guidelines proposed by the Central Pollution Control Board (CPCB).
Terming the guidelines as unrealistic, the manufacturers alleged that the report was prepared after consulting very few bulk drug units and had not considered the ground realities faced by the industry in the state. With the recently held CPCB-initiated discussions at Vadodara that ended in heated debates, the CPCB has asked the industry to come up with their written suggestions before month end to be considered for incorporation.
The draft guideline prepared with the help of National Productivity Council (NPC) has provided waste management options for 31 major bulk drugs including Paracetamol, Naproxen, Penicillin G, Loratadine, Sulbutamol Sulfate and ACME (Ramipril). While the CPCB was of the opinion that the document would streamline the regulatory measures adopted by the state pollution control boards thereby put an end to conflicting interpretations, the industry find the proposals as too costly to be implemented.
"We have several years of experience in treating hazardous wastes from bulk drug units. Our Common Waste Incinerator Unit was set up in 1998 and is functioning well. We could have offered our expertise to CPCB for a more effective and economical method of waste management. Nobody had consulted us, and now they have prepared a guideline which is much costlier to implement," complains Babubhai Patel, chairman, Nandawan Environment Control Limited, Baroda.
According to him, the CPCB guidelines came as a surprise to them as none of the member units in their industrial area (Nanda Industries Association) had prior knowledge about its contents. There are dozens of major and medium sized bulk drug units in the region.
"The CPCB guidelines, once finalized, would gradually become mandatory as it happened in the case of dyes and intermediates. If we are not able to point out the impractical provisions now, we may have to face the wrath of the officialdom once the rules are in force. This is forcing us to oppose the guidelines," Patel added.
The guidelines prepared by CPCB were the result of a study commissioned 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 is known to have prepared the document after conducting field visits to selected bulk drug units across the country. The industrialists feel that the laws should be framed after considering the national scenario and therefore the study team should have visited bulk drug units of all parts of the country before coming out with a set of guidelines applicable to all.
"The team should have studied the best options available in the country before making its observations. The CPCB says that the whole exercise was carried out with the cooperation of Bulk Drugs Manufacturers Association (BDMA). However, we have never been informed, neither by BDMA nor by CPCB about it," Patel says.
The CPCB sources, however, downplayed the whole issue by stating that they had not received any written representations / complaints from the industry after the meeting on January 5, 2005 at Vadodara. "We cannot delay the finalization of the report for long. We are giving them another two weeks time to make their representations," officials said. According to them, all issues discussed during the Vadodara meeting has been taken note of and possible changes are being incorporated in the final draft of the guideline.
The document has given waste management options for hazardous waste streams generated from manufacturing steps of a representative set of bulk drugs. These 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 is of the opinion that the industry specific guidance document will 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.
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.