IN THE HIGH COURT OF KERALA AT ERNAKULAM PRESENT : THE HONOURABLE MR. JUSTICE S.SIRI JAGAN MONDAY, THE 19TH DECEMBER 2011 / 28TH AGRAHAYANA 1933 WP(C).No. 21342 of 2006(N) ------------------------------------ PETITIONER(S): ----------------------- SREE SUDHEENDRA MEDICAL MISSION CHITTOOR ROAD, COCHIN-18, REPRESENTED BY ITS SECRETARY. BY ADVS. SRI.P.SANJAY SRI. A.PARVATHI MENON RESPONDENT(S): ------------------------- 1. UNION OF INDIA REPRESENTED BY SECRETARY, MINISTRY OF ENVIRONMENT & FORESTS, PARYAVARAN BHAVAN, NEW DELHI. 2. CENTRAL POLLUTION CONTROL BOARD, PARIVESH BHAVAN, EAST ARJUN NAGAR, DELHI-110 032, REPRESENTED BY ITS CHAIRMAN. 3. THE KERALA STATE POLLUTION CONTROL BOARD PLAMOODU JUNCTION, PATTOM PALACE, THIRUVANANTHAPURAM. 4. STATE OF KERALA, REPRESENTED BY SECRETARY, DEPARTMENT OF HEALTH, SECRETARIAT, THIRUVANANTHAPURAM. 5. THE SCHOOL OF ENVIRONMENTAL STUDIES COCHIN UNIVERSITY OF SCIENCE & TECHNOLOGY, KALAMASSERY, KOCHI REPRESENTED BY ITS DIRECTOR. * ADDITIONAL R6 IMPLEADED R6 INDIAN MEDICAL ASSOCIATION, KERALA STATE BRANCH REPRESENTED BY ITS STATE SECRETARY, DR. R. RAMESH S/O RAYRU K.M., AGED 44 YEARS, RESIDING AT DEEPANJALI, THIRUVANGAD P.O., THALASSERY 670 103. (ADDITIONAL R6 IMPLEADED AS PER THE ORDER DATED 19/12/2011 OF 1.A. NO. 998 OF 2007) DCS WP(C).No. 21342 of 2006(N) R1 BY ADV. SRI.V.E.ABDUL GAFOOR, ADDL.CGSC R2 & R3 BY ADV. SRI.BABU JOSEPH KURUVATHAZHA,SC,POLU.C. R3 BY ADV. SRI.M.K.CHANDRA MOHANDAS,SC,POLL.C.BOARD R5 BY DR.K.P.SATHEESAN, SC COCHIN UNIVERSITY SRI.S.P.ARAVINDAKSHAN PILLAI,SC,COCHIN UNIVERSITY SRI.P.CHANDRASEKHAR,SC,CUSAT,COCHIN UNIVERSITY R6 BY ADV. SRI.JACOB SEBASTIAN THIS WRIT PETITION (CIVIL) HAVING BEEN FINALLY HEARD ON 19/12/2011, ALONG WITH WPC NO. 35951 OF 2007 THE COURT ON THE SAME DAY DELIVERED THE FOLLOWING: APPENDIX PETITIONER'S EXHIBITS:- EXT. P1 : COPY OF THE MEDICINE COVER AND EXTRACT OF MONTHLY INDEX OF MEDICAL SPECIALITIES EXT. P2 : COPY OF THE NOTICE DATED 16.01.2006 FILE NO. PCB/6MV/GEN/106/2005 EXT. P3 : COPY OF THE REPRESENTATION MADE BY THE PETITIONER DATED 14.06.2006 RESPONDENT'S EXHIBITS:- EXT. R3 (1) : COPY OF THE RULES AMENDED UPTO 2000 NOTIFICATION DATED 20.07.1998 EXT. R3 (2) : COPY OF THE REPORT OF CUSAT WASTE MANAGEMENT EXT. R3 (3) : COPY OF THE DIRECTION TO STOP USE OF PAB/BPAB REACTORS DATED 01.08.2005 EXT. R3 (4) : COPY OF THE LETTER OF THE BOARD ADDRESSED TO QPMPA DATED 16.01.2006 EXT. R3(5) : COPY OF THE LETTER DATED 16.01.2006 EXT. R3(6) : COPY OF THE ORDER DATED 16.01.2006 IN WP(C) 29579/2005 EXT. R3 (7): COPY OF THE MINUTES OF THE HEARING CONDUCTED BY THE CENTRAL POLLUTION CONTROL BOARD DATED 08.03.2006 /TRUE COPY/ P.A. TO JUDGE DCS S. SIRI JAGAN, J. ------------------------------------------- W.P.(C) Nos.21342 of 2006 & 35951 of 2007 ---------------------------------------------- Dated this the 19th day of December, 2011 JUDGMENT The petitioners are running hospitals. In their hospital, they have established a Placenta Anaerobic Bio-Reactor and Body Parts Anaerobic Bio-Reactor that process Bio- Medical materials into non-polluting form. Bio- Medical materials like Placenta, human anatomical materials, organs, body parts etc. generated in the course of treatment in the hospitals are being disposed of using the said process. According to them, this is a process now widely accepted in other countries and the Cochin University of Science and Technology has, after elaborate scientific investigation, recommended use of that process for disposal of Bio- Medical waste in hospitals. But, by Ext.P2 in both writ petitions, the Kerala State Pollution Control Board has informed the petitioners that the said process is not approved as per the Bio-Medical Waste (Management & Handling) Rules 1998, which recognises only the technology prescribed in Schedule 1 to the W.P.(C)No.21342/06 & Con.case 2 said Rules and since the Central Pollution Control Board has not granted approval for the said process and the said process is not one included in the Schedule 1 of the rules, the technology was found unsuitable for the purpose. It is challenging Ext.P2, the petitioners have filed these writ petitions seeking the following reliefs; W.P.(C)No.21342/06 “(i) Call for the records leading to the issuance of Ext p-2 and peruse the same; (ii) Issue a Writ of Certiorari or any other Writ and quash Ext P-2 since the petitioner is not handling or treating Bio medical Waste; (iii) Declare that PAB reactors dealing with or treating Bio-medical materials do not attract the provisions of Biomedical Waste Management and Handling Rules. (iv) Declare that petitioner is entitled to continue the sue of PAB reactors since they do not deal with Bio-medical waste but with Bio-medical materials.” W.P.(C) No.35951/07 “(i) Call for the records leading to the issuance of Ext P-1 and P-2 and peruse the same; (ii) Issue a Writ of Certiorari or any other Writ and quash Ext P-1 and P-2 since the petitioner is not handling or treating Bio medical Waste; (iii) Declare that PAB reactors dealing with or treating Bio-medical materials do not attract the provisions of Biomedical Waste Management and Handling Rules. (iv) Declare that petitioner is entitled to continue the use of PAB reactors since they do not deal with Bio-medical waste but with Bio-medical materials.” W.P.(C)No.21342/06 & Con.case 3 2. The first contention raised by the petitioners is that materials like placenta, human anatomical materials, organs, body parts etc., by themselves are not waste or polluting materials until discarded or decomposed. Since the petitioners are converting those parts into liquid non-polluting form, immediately, after the same is removed in the course of treatment, it does not become Bio-medical waste is the contention raised. It is also submitted that placenta is being validly used for manufacturing life saving drugs. Therefore, according to the petitioners, the stand of the Kerala State Pollution Control Board is clearly arbitrary and unsustainable. 3. A counter affidavit has been filed by the Kerala State Pollution Control Board controverting the contentions. 4. I have heard the parties. 5. In the light of the pleadings in these cases, what I have to consider is whether Ext.P2 in both writ petitions are sustainable or not. It is not sustainable, if the contention of petitioners that placenta, human anatomical materials, organs, body parts etc removed from the body parts in the course of W.P.(C)No.21342/06 & Con.case 4 treatment are not Bio-medical waste. I am of opinion that I cannot hold that it is not waste. Of course, if placenta is being removed for manufacture of life saving drugs, it is a different question. But, admittedly, the petitioners are processing these body parts by using a new process for converting it into non- polluting liquid form. Therefore, evidently going by the averments of the petitioners themselves, the same is a waste. Rule 5 of the Rules reads thus: “5. TREATMENT AND DISPOSAL (1) Bio-medical waste shall be treated and disposed of in accordance with Schedule I, and in compliance with the standards prescribed in Schedule V. (2) Every occupier, where required, shall set up in accordance with the time-schedule in Schedule VI, requisite bio-medical waste treatment facilities like incinerator, autoclave, microwave system for the treatment of waste, or, ensure requisite treatment of waste at a common waste treatment facility or any other waste treatment facility.” Schedule 1 reads thus: “SCHEDULE I CATEGORIES OF BIO-MEDICAL WASTE ---------------------------------------------------------- Option Waste Category ---------------------------------------------------------- Category No.1 Human Anatomical Waste (human tissues, organs, body parts) Category No.2 Animal Waste (animal tissues, organs, body W.P.(C)No.21342/06 & Con.case 5 parts carcasses, bleeding parts,fluid blood and experimental animals used in research, waste generated by veterinary hospitals colleges, discharge from hospitals, animal houses) Category No.3 Microbiology & Biotechnology waste (wastes from laboratory cultures, stocks or specimens of micro-organisms live or attenuated vaccines, human and animal cell culture used in research and infectious agents from research and industrial laboratories, wastes from production of biologicals, toxins, dishes and devices used for transfer of cultures) Category No.4 Waste sharps (needles, syringes, scalpels, blades, glass etc. that may cause puncture and cuts. This includes both used and unused sharps) Category No.5 Discarded Medicines and Cytotoxic drugs (wastes comprising of outdated, contaminated and discarded medicines) Category No.6 Solid Waste (Items contaminated with blood, and body fluids including cotton, dressings, soiled plaster casts, lines, beddings, other material contaminated with blood) Category No.7 Solid Waste (wastes generated from disposable items other than W.P.(C)No.21342/06 & Con.case 6 the waste shaprs such as tubings, catheters, intravenous sets etc.) Category No.8 Liquid Waste (waste generated from laboratory and washing, cleaning, house-keeping and disinfecting activities) Category No.9 Incineration Ash (ash from incineration of any bio- medical waste) Category No.10 Chemical Waste (chemicals used in production of biologicals, chemicals used in disinfection, as insecticides, etc.) ------------------------------------------------- @@ Chemicals treatment using at least 1% hypochlorite solution or any other equivalent chemical reagent. It must be ensured that chemical treatment ensures disinfection.” Going by Rule 5 read with Schedule 1, there cannot be any doubt that use of Placenta Anaerobic Bio-Reactor and Body Parts Bio-Reactor are not methods approved by the rules for disposal of such bio-medical waste. But, that does not mean that the process adopted by the petitioners have to be straightaway discarded as unacceptable methods especially in view of the studies by the Cochin University of Science and Technology relied upon by the petitioners. New methods developed are certainly worth looking into for acceptance, if W.P.(C)No.21342/06 & Con.case 7 they are in fact acceptable methods of disposing of bio-medical waste. But, of course, for that, the rules have to be appropriately amended. The learned counsel for the petitioners submits that the Central Government is in the process of amending the rules and it is likely to be amended shortly. I am of opinion that the process put forward by the petitioners for disposing of bio-medical waste is worth looking into for inclusion in the Rules. In any event, since the Central Government is considering amendment of the rules, it is only appropriate that the Central Government considers this aspect also. 6. In the above circumstances, the writ petition is disposed of with the following directions: The petitioners shall file a suitable representation before the Central Government and the Central Government Pollution Control Board with appropriate materials in support of their contentions. The Central Government and the Pollution Control Board shall consider the same also while considering the amendment to the rules. The petitioner shall apply to the W.P.(C)No.21342/06 & Con.case 8 2nd respondent for continuation of the present process until a final decision is taken. The same shall be considered by the 2nd respondent and appropriate orders passed, within one month from the date of receipt of a copy of this judgment along with an application as directed above. Till then, interim orders dated 10.8.2006 and 5.12.2007 directing status quo passed in these two cases shall continue to be in force. S. SIRI JAGAN, JUDGE acd W.P.(C)No.21342/06 & Con.case 9 W.P.(C)No.21342/06 & Con.case 10