| File Note: |
The report/ recommendations of RO in the matter has been examined and it was noted as under:
BRIEF BACKGROUND:
• Earlier, the industry had applied for obtaining renewal ‘consent to operate’ under the Water (Prevention & Control of Pollution) Act, 1974 and Air (Prevention & Control of Pollution) Act, 1981. Accordingly, due to violation observed during the visit, the industry was issued notice for was issued notice for refusal of ‘consent to operate’ under the Water (Prevention & Control of Pollution) Act), 1974 and Air (Prevention & Control of Pollution) Act, 1981, alongwith an opportunity of personal hearing before the Chairman of the Board on 20.11.2023 in the said hearing, it was decided as under:
1. The ‘consent to operate’ applied under the Water (Prevention & Control of Pollution) Act, 1974 and Air (Prevention & Control of Pollution) Act, 1981.
2. PSPCL authorities be directed u/s 33-A of the Water (Prevention & Control of Pollution) Act, 1974 to disconnect the electric supply available to the industry with immediate effect.
3. Two bank guarantees amounting to Rs. 5 lakhs each submitted by the industry be encashed.
4. Explanation of PSPCL authorities be called as to why they have failed to comply with the directions issued by the Board u/s 33-A of the Water (Prevention & Control of Pollution) Act, 1974 and electric connection had not been disconnected after 16.10.2023.
• Further, the application of the industry for obtaining ‘Consent to Operate’ under the Water (Prevention & Control of Pollution) Act, 1974 and under the Air (Prevention & Control of Pollution) Act, 1981, was refused on 20.11.2023.
• Accordingly, the industry was issued following directions u/s 33-A of the Water (Prevention & Control of Pollution) Act, 1974 vide PPCB letter no. 8857 dated 20.11.2023 following directions:
1. The industry shall take all necessary steps to close down its operations and stop forthwith discharging any effluents/ wastewater into sewer/ into storm water drain/ inland surface water/ onto land for stagnation/ irrigation or through any mode.
2. The industry shall stop forthwith discharging any effluent/ emissions from its industrial premises or through any mode.
3. The industry will immediately stop its manufacturing activities and will not restart the same unless all necessary water and air pollution control measures are taken and it obtains valid consents to operate of the Board as required under the provisions of the Water (Prevention & Control of Pollution) Act 1974.
4. The Punjab State Power Corporation Ltd. authorities shall be directed to disconnect the supply of electricity available to the industry.
• In compliance to decision no. 4 above, PSPCL vide disconnection order dated 22.11.2023 had disconnected the electric supply available to the industry.
• Thereafter, the industry had submitted request letters dated 21.11.2023 and 23.11.2023 to Hon’ble Chairman of the Board, requesting to release the electric connection of the unit. Taking into consideration the compliances made by the industry and considering the request, the Competent Authority of the Board decided to temporarily restoration the electric connection for a period of 03 months vide Board’s letter no. 9132—33 dated 30.11.2023, i.e. upto 29.02.2024.
• Afterwards, the electric connection has been temporarily restored for six months period till date and lastly the same has been restored upto 31.12.2025 vide letter no. 3977-78 dated 27.08.2025.
• Further, the industry had been accorded CTOs under the Water Act, 1974 and Air Act, 1981 for short term periods.
• Lastly, the industry was granted consents to operate under the provisions of Water (Prevention & Control of Pollution) Act, 1974 and the Air (Prevention & Control of Pollution) Act, 1974 on 27.08.2025, which was valid till 31.12.2025, for production for various Bulk Drugs/ APIs subject to certain conditions as mentioned therein.
NGT MATTER:
• It is submitted that earlier O.A no. 105/2023 titled as M.L Dhiman v/s State of Punjab was disposed of by Hon’ble National Green Tribunal vide order dated 16.03.2023.
• Thereafter, Hon’ble National Green Tribunal has admitted miscellaneous application, M.A no. 70/2023 in the matter.
• The matter was lastly listed in the Hon'ble National Green Tribunal on 15.10.2024. In the hearing held on 15.10.2024, Hon'ble NGT has disposed off the case and has passed order, the relevant para of the orders is reproduced as under:
"7. On the perusal of the report of the Joint Committee, we find that there is some anomaly in respect of the compliance in the norms of ZLD by Respondent No. 3. The steps which have been initiated by Respondent No. 3 for compliance of the suggestions given by the Joint Committee are also required to be monitored and ascertained that the suggestions are fully complied with. Hence, we dispose of the M.A. directing the State PCB to inspect the Respondent No. 3 unit in the Month of March 2025 and submit the Report before the Registrar General of the Tribunal by 30th April, 2025 disclosing the compliance of the suggestions given by the joint Committee and the status of ZLD in the unit."
• In compliance to the orders of Hon'ble NGT, the industry had submitted the compliance report vide letter dated 31.03.2025 and the same was submitted to Hon'ble NGT vide dated 01.09.2025.
• Thereafter, the applicant had filed Misc Application in disposed of cases no. 123/2025 In Misc Application in disposed of cases no. 70/2023 titled as ML Dhiman vs Union of India & Ors. The case was heard on 28.10.2025 and it was decided as under:
Status report on behalf of Punjab State Pollution Control Board (PSPCB) dated 01.09.2025 has been filed.
2. List for hearing on 28.01.2026.
PRESENT CASE:
• Now, the industry has applied for obtaining renewal of consent to operate under the provisions of Water (Prevention & Control of Pollution) Act, 1974 and Air (Prevention & Control of Pollution) Act, 1981 for production for various Bulk Drugs/ APIs.
• The industry has also submitted written request letter dated 13.10.2025 for restoration of permanent electricity connection as the industry is complying with the directions issued u/s 33-A of the Water (Prevention & control of Pollution) Act, 1974.
• The project proponent has already obtained Environmental Clearance vide no. EC22B058PB186332 dated 25.04.2022 for manufacturing of 32 API products.
• The industry was visited by the officer of the Board on 03.10.2025 and noted as under:
The industry as well as the ETP (followed by RO), MEE & ATFD, STP were found in operation.
The OCEMS installed on the RO Permeate line was operational.
The industry is reusing RO permeate as cooling tower makeup and boiler feed in its premise and RO reject is being sent to MEE for treatment along with HTDS.
The industry is using treated domestic effluent after STP onto land for plantation developed within its premises.
During visit the office collected effluent samples from the RO Permeate/ Feed/ Reject lines and MEE Feed/ Condensate lines. The analysis results of RO Permeate showed concentration of pH as 9.1, TSS<5 mg/l, TDS 2446 mg/l, COD 120 mg/l, BOD 20 mg/l.
The industry has installed OCEMS at RO permeate line and the same was in operation and reading were shown as BOD @ 18 mg/ltr, COD 78 mg/ltr, pH 8.54, TSS 40 mg/ltr.
The industry has installed 2 no. boiler of capacity 6 TPH (rice husk fired having Trema cyclone followed by bag filter house as APCD) and 3 TPH (biomass bricket fired having mechanical dust collector followed by bag filter house as APCD). The industry has provided common stack with these boilers and emission sample was collected from the stack and the results are within the prescribed limit of the Board.
Incinerator installed by the industry was not in operation.
The industry has installed one SRP unit and has installed VOC and TOC analyzer with the same.
The RO brought out in its report that the Board has issued directions vide dated 20.11.2023 to disconnect the electricity connection. Thereafter, the industry was visited by the officers of the Board on 07.12.2023, 06.06.2024, 04.11.2024, 10.12.2024, 16.04.2025, 19.06.2025, 03.10.2025 was found complying.
• The RO concluded in its report that the industry is complying with the provisions of the Water (Prevention & Control of Pollution) Act, 1974 and Air (Prevention & Control of Pollution) Act, 1981; and recommended that varied ‘Consent to operate’ under the Water (Prevention & Control of Pollution) Act, 1974 and Air (Prevention & Control of Pollution) Act, 1981 upto 30.06.2029 and PSPCL may be directed to permanently restore the electricity connection available to industry
The report/ recommendations of RO in the matter were examined in detail at ZO level and the following discrepancies were noted for which the application was sent back to RO for clarification and the RO has replied with the following clarifications; the Remarks on the clarification given by RO are also given in the following table:
Sr. No. Observations Raised to RO Clarification given by RO Remarks
1. The RO collected samples from the RO Permeate/Feed/Reject lines and the MEE Feed/Condensate lines. As per the analysis, the RO Permeate exhibited a pH of 9.1, TSS < 5 mg/l, TDS 2446 mg/l, COD 120 mg/l, and BOD 20 mg/l. These results clearly show non-compliance, as the pH exceeds the permissible limit of 8.5 and the TDS is significantly above the general standard of 2100 mg/l. Despite this, the RO has not provided any comments on these exceedances and has recommended grant of CTOs. The RO is required to comment on the same and clarify why it did not flag these deviations before recommending approval. The industry has adopted ZLD and entire treated effluent is being reused back into process. No effluent was discharged by the project proponent. The MoEF&CC has notified effluent standards for bulk drugs and formulation (Pharmaceutical) vide dated 06.08.2021 (G.S.R.541 (E). These effluent standards are applicable to all discharge to land and surface water bodies including use of treated wastewater for horticulture or irrigation purposes. These standards are not applicable on the unit being ZLD. There is no outlet of the industry being ZLD and in such type of unit only general parameters have been tested. As per the analysis, the RO Permeate exhibited a pH of 9.1, TSS < 5 mg/l, TDS 2446 mg/l, COD 120 mg/l, and BOD 20 mg/l, the value of pH is slightly above the range prescribed in general standards (6.5 – 9.0), no standard has been prescribed for TDS in general standards. The major parameters like BOD, COD are in the prescribed range.
It is further pointed out that the value of TDS in RO feed, RO reject and RO permeate is 2428, 4989 & 2446, which is practically not possible that the value of RO permeate is more than the RO feed, when the RO reject is of higher value than that of RO feed. The reply submitted by the RO is not acceptable. Even for ZLD units, the quality of treated effluent must meet the prescribed standards, especially when the treated water is being reused within the premises. The ETP, RO, MEE and other treatment systems are specifically designed to achieve the notified discharge standards. Any failure to achieve these standards comprises non-compliance with environmental norms.
In the present case, the RO permeate shows pH of 9.1, which is beyond the permissible range, and TDS of 2446 mg/l, which is also higher than general norms. Instead of recording these exceedances as non-compliance, the RO has attempted to justify them. The RO was required to clearly highlight the deviations and recommend corrective action.
2. It is further observed that the RO did not collect samples from the final outlet (RO Permeate line) for the full set of parameters mandated under GSR 541(E) dated 06.08.2021. Only pH, TSS, TDS, COD, and BOD have been analysed, whereas several critical prescribed parameters—such as Ammoniacal Nitrogen, Oil & Grease, Bioassay Test, Phosphates (as P), Sulphides (as S), Phenolic Compounds, Zinc, Copper, Total Chromium, Hexavalent Chromium (Cr⁶⁺), Cyanide (as HCN), Arsenic, Mercury, Lead, etc.—were not collected or analysed. As a result, the adequacy of the treatment system cannot be assessed. The RO is required to clarify as to why it had omitted these mandatory parameters or did not ensure complete sampling as required under the notification. The reply of above observation is already given in reply of the observation 1. The clarification given by the RO is not satisfactory. As per GSR 541(E) dated 06.08.2021, pharmaceutical units are required to meet specific effluent standards for several critical parameters such as Ammonical Nitrogen, Oil & Grease, Phenolic Compounds, Cyanide, Heavy Metals, Bioassay, etc.
The RO has monitored only basic parameters like pH, TSS, TDS, BOD, and COD and without analysing the full set of prescribed parameters, the actual performance of the treatment system cannot be assessed.
It is pertinent to mention here that the CPCB had issued Draft Guidelines for the Pharmaceutical Industry in India, which clearly state that even in ZLD systems, the industry must operate its ETP, RO, MEE and other treatment units in such a manner that the treated effluent meets the prescribed effluent standards. The objective of ZLD is to promote reuse and recycling of wastewater, not to dilute or bypass compliance with environmental norms.
The draft guidelines specifically emphasize that treated effluent reused for irrigation, horticulture, cooling, or process purposes must conform to the prevailing effluent standards, including limits for TDS, pH, BOD, COD and other notified parameters. Therefore, failure to achieve the prescribed standards, even in a ZLD setup, amounts to non-compliance and cannot be justified merely on the ground of “no discharge.” These guidelines have not been notified yet but clarifies the stance of CPCB for achieving prescribed standards even by ZLD units.
Accordingly, the RO was required to assess compliance strictly against the notified standards and CPCB guidelines, which has not been adequately done in the present case.
It is brought out that team of officers of Zonal Office headed by SEE, ZP-1 for quarterly monitoring protocol had visited the unit on 26.12.2025 and collected samples from the ETP inlet & RO Permeate for full set of prescribed parameters as per GSR 541(E) dated 06.08.2021 alongwith samples from MEE Feed/Condensate/Concentrate lines & STP outlet. The analysis results are awaited.
3. The RO is required to clarify regarding the violations pursuant to which the Board had originally issued directions for disconnection of electricity supply to the unit and clearly comment if it is complying with the said violation(s). The industry was afforded opportunity of personal hearing before the Chairman of the Board on 13.03.2023 wherein the representative of the industry ensure that they will make compliance of all short comings informed during the visit dated 10.03.2023 as well as during the hearing by 31.03.2023. They will also apply consent to operate under the Water (Prevention & control of Pollution) Act, 1974 and Air (Prevention & Control of Pollution) Act, 198. After hearing it was decided as under:
1. The industry shall stop the production/ operation of the industry immediately, upto 31/3/2023. If the industry is found in operation in this period i.e. upto 31/3/2023, then directions u/s 33-A of the Water (Prevention and Control of Pollution) Act, 1974 be confirmed without any further opportunity/ notice.
2. They industry shall apply for consent to operate of the Board required under the Water (Prevention and Control of Pollution) Act, 1974 and the Air (Prevention and Control of Pollution) Act, 1981, immediately.
3. The Environmental Engineer, Punjab Pollution Control Board, RO, SAS Nagr shall keep a vigil on the operation of the industry, during the period upto 31/3/2023, if the industry is found in operation, then sent the report immediately.
The site was visited by the officer of the above on 28/3/2023 and observed that the industry was in operation and manufacturing of proxetil and axetil was being done. The industry has failed to comply with the decision no. 1 of the hearing as mentioned above.
The industry was continuously violating the provisions of the Water (Prevention and Control of Pollution) Act, 1974 and environmental laws. After, considering all the aspects of the case, the Competent Authority of the Board is of the view that it is a fit case to issue directions by invoking the provisions of Section 33-A of the Water (Prevention & Control of Pollution) Act, 1974 and direction for disconnection of electricity connection and sealing of DG set was issued vide dated 21.04.2023.
Thereafter, the industry was granted consent to operate under the Water (Prevention & Control of Pollution) Act, 1974 vide no. CTOW/Fresh/PBIP/SAS/2023/2304888552 dated 16/6/2023 and the Air (Prevention & Control of Pollution) Act, 1981 vide no. CTOA/Fresh/PBIP/SAS/2023/ 2304917502 dated 16/6/2023, valid upto 16/10/2023 for production of Cefepime Hydrochloride @30 Kgs/day, Cefrozil @ 20 Kgs/day, Cefpodoxim e Proxetil @ 100 Kgs/day, Ceftiaxone Sodium @ 100 Kgs/day, Cefixime @ 80 Kgs/day, Cefdinir @ 10 Kgs/day, Cefuroxime Axetil Amorphous @ 126.67 Kgs/day, with certain conditions mentioned therein.
Simultaneously, the Board directed to PSPCL authorities to restore the the electric connection of the industry temporarily upto 16/10/2023 vide no. Board's 3540 dated 17/5/2023.
The industry had applied for renewal of consent to operate under the Water (Prevention & Control of Pollution) Act, 1974 and the Air (Prevention & Control of Pollution) Act, 1981 with same products alongwith requisite documents.
The site of the industry was visited by officer of the Board on 6/11/2023 and it was observed that the industry is not complying with the provisions of the Water (Prevention & Control of Pollution) Act, 1974 and the Air (Prevention & Control of Pollution) Act, 1981 as well as not complied with the conditions mentioned in the consent to operate earlier granted to it under the Water (Prevention & Control of Pollution) Act, 1974 and the Air (Prevention & Control of Pollution) Act, 1981. Thus, the industry is violating the provisions of the Water (Prevention & Control of Pollution) Act, 1974 and the Air (Prevention & Control of Pollution) Act, 1981 Acts, intentionally and deliberately.
Therefore, the industry was served show cause notice for refusal of consent to operate applied under the Water (Prevention & Control of Pollution) Act, 1974 and the Air (Prevention & Control of Pollution) Act, 1981 vide Board's letter no. 8734-35 dated 14/11/2023 alongwith an opportunity of personal hearing before the Chairman of the Board on 20/11/2023.
The representatives of the industry attended the hearing and submitted its written reply, which was taken on record. During hearing, they failed to give any satisfactory reply of the show cause notice issued to the industry.
Also, the unit is being operated inspite of temporarily restoration of electric connection available to the industry upto 16/10/2023. After hearing the officers of the Board, the representatives of the industry and going through the material facts on the record, the Chairman of the Board decided as under:
1. The consent to operate applied under the Water (Prevention and Control of Pollution) Act, 1974 and the Air (Prevention and Control of Pollution) Act, 1981 may be refused.
2. PSPCL authorities be directed u/s 33-A of the Water (Prevention and Control of Pollution) Act, 1974 to disconnect the electric supply available to the industry with immediate effect.
3. Two bank guarantees amounting to Rs. 5 Lakhs each submitted by the industry be encashed.
4. Explanation of PSPCL authorities be called as to why they have failed to comply with the directions issued by the Board u/s 33-A of the Water (Prevention and Control of Pollution) Act, 1974 and electric connection had not been disconnected after 16/10/2023.
Thereafter, the industry was visited by the officers of the Board on 07.12.2023, 06.06.2024, 04.11.2024, 10.12.2024, 16.04.2025, 19.06.2025, 03.10.2025 was found complying and consent to operate were extended with temporary restoration. The RO has clearly brought out that the electricity connection of the industry was disconnected earlier and directions under Section 33-A were issued because the unit had failed to comply with Decision No. 1 of the hearing dated 13.03.2023 and continued its operations in violation of the Board’s directions.
Subsequently, the industry obtained Consent to Operate for the production of Proxetil and Axetil products, subject to specific conditions. As per the RO’s reports, the unit has since been inspected on multiple occasions, i.e., on 07.12.2023, 06.06.2024, 04.11.2024, 10.12.2024, 16.04.2025, 19.06.2025, and 03.10.2025, and was found complying during these visits.
Therefore, it is noted that although the industry had serious non-compliances in the past, it has subsequently taken corrective measures and has been reported as compliant in recent inspections by the RO.
4. Also, to comment if the unit is eligible for permanent restoration of electricity supply as per Board's latest orders/ guidelines for processing applications/ requests for permanent restoration of electricity supply. In consideration of the above. As per Office Memorandum no. 428 dated 23.09.2025 regarding procedure for processing cases for restoration of power supply and release of bank guarantee submitted by the entrepreneur as an assurance to comply with the Environmental laws-
"B. Procedural violation apart from failure of samples or non-submission of certain document(s)
a. The bank guarantee be returned and/or permanent restoration be allowed on compliance of specified violation or submission of necessary document based on single site visit subject to decision of Competent Authority."
The industry was visited by the officers of the Board on 07.12.2023, 06.06.2024, 04.11.2024, 10.12.2024, 16.04.2025, 19.06.2025, 03.10.2025 after issuance of directions and was found complying and consent to operate were extended with temporary restoration. Thus, the electric connection of the industry may be permanently restored.
In view of above, it is recommended that the industry may be granted varied 'Consent to operate' under the Water (Prevention & Control of Pollution) Act, 1974 and Air (Prevention & Control of Pollution) Act, 1981 upto 30.06.2029 along with direction to PSPCL authority for permanent restoration of electricity connection available to industry. As per Office Memorandum No. 428 dated 23.09.2025, permanent restoration of electricity supply may be considered in cases of procedural violations once the specified shortcomings are rectified and compliance is verified through site inspection.
In the present case, the RO has reported that the industry was inspected on multiple occasions after issuance of directions and was found complying during these visits. The RO has also recommended permanent restoration of electricity supply based on the observed compliance and extension of CTOs with temporary restoration.
In consideration of the above facts; if approved, the competent authority be recommended as under:
A. The industry may be granted varied 'Consent to operate' under the Water (Prevention & Control of Pollution) Act, 1974 and Air (Prevention & Control of Pollution) Act, 1981 for short term, i.e. six months, subject to suitable conditions and following additional conditions:
a. The industry shall operate and maintain its STP, ETP, MEE and ATFD properly, at the times.
b. The industry shall reuse the entire RO Permeate back into its process and shall adhere to ZLD, at all times. Further to ensure to achieve the prescribe standards issued by MoEF&CC for such units vide GSR 541(E) dated 06.08.2021.
c. The industry shall use only treated domestic effluent after STP, onto land for plantation within its premises.
d. The industry shall ensure that no problem related to air and water pollution is being caused by the unit due to its operation.
e. The industry shall not discharge any effluent at any unauthorized place by any unauthorized means i.e. shall not discharge any wastewater outside its premises orin any drain/inland surface waters /drain/choe/nallah/onto land for stagnation or outside its premises, at any time, under any circumstances.
f. The industry has been approved by the Board from pollution angle and the industry shall obtain the statutory clearances / permissions from all other concerned departments.
g. The adequacy/efficacy of the pollution control arrangements shall be the sole responsibility of the industry and the industry shall be bound to implement/upgrade its pollution control arrangements as per the discretion of the Board to achieve the prescribed emission/effluent standards, as amended from time to time.
h. The industry shall ensure the compliance of provisions of the Water (Prevention & Control of Pollution) Act, 1974, Air (Prevention & Control of Pollution) Act, 1981, Environment (Protection) Act, 1986 and/or any other environmental law applicable to him and Rules, Circulars &Directions issued by the Board from time to time.
i. The 'consent to operate' is being issued to the project proponent based upon the documents/ information submitted by it along with the online application form. The Board would be at liberty to take penal action against the industry/project proponent and its responsible/concerned person(s) in case information/document is detected incorrect/false/misleading at any point of time, without any opportunity of Personal Hearing. as
j. In case the project proponent fails to comply with the provisions of the Water (Prevention& Control of Pollution) Act, 1974, Air (Prevention& Control of Pollution) Act, 1981, Environment (Protection) Act, 1986 and/or any other environmental law applicable to the project and Rules, Circulars &Directions issued by the Board from time to time, action as deemed fit shall be taken against the project proponent.
B. Amended directions be issued to the PSPCL authorities to permanently restore the electricity connection available to industry.
C. In view of the incomplete monitoring of prescribed effluent parameters, incorrect interpretation of the applicability of notified standards for ZLD units, and failure to appropriately flag observed non-compliances, the Regional Office be issued notice for explanation and direction to ensure strict adherence to statutory monitoring requirements, CPCB/MoEF&CC guidelines, and due diligence in future processing of consent and compliance cases.
Comp.: Hon’ble Chairperson
*Report attached as PDF for reference. |
