Show ApplicationProcessingDetails

Id:

22138113

Approve:

false

Approve Note:

Clarification:

false

Clarification Note:

Date Created:

2023-05-22 13:03:27.689

File Note:

RECOMMENDATIONS:                             It is intimated that the said firm has proposed to set up new formulation unit for manufacturing of medicines in form Tablets @ 150000 Numbers/Day & Syrup @ 50 Liter/day using Paracetamol @ 60 Kgs/day, Starch @ 20 Kgs/day, Omeprazole @ 4 Kgs/day & Diclofienac sodium @ 5 Kgs/day as raw material.                             The Industry has submitted a copy of CLU from Department of Town & Country Planning, Punjab vide Memo No. 6050 dated 06/12/2016 for establishment of an industrial unit to manufacture Medicines. So as to certify, whether the said CLU is still valid even after 7 years, the industry has got latest clarification vide DTP, Sangrur letter no. 695 dated 18/05/2023, mentioning that the site now falls in Tehsil Ahmedgarh, District Malerkotla for which Master Plan is yet to finalize. It is further intimated that during the preparation of Master Plan, Ahmedgarh, the site may fall under Industrial Zone.  And as per Zoning Regulation clause 2.7 of 2018, "The site on which various projects have been approved or whose change of Land Use has already been permitted by the competent Authority/Govt., inform the final Notification of the Master Plan, such sites shall be deemed to be adjusted as sanctioned/ permitted. Hence, as per the DTP letter, the CLU is valid for establishment of the proposed unit.                             Accordingly, the industry has now applied for obtaining ‘NOC' consent to establish' for establishment of formulation unit to manufacture medicines in form Tablets @ 150000 Numbers/Day & Syrup @ 50 Liter/day using Paracetamol @ 60 Kgs/day, Starch @ 20 Kgs/day, Omeprazole @ 4 Kgs/day & Diclofienac sodium @ 5 Kgs/day as raw material under the Water Act, 1974 and Air Act, 1981 with requisite documents. The industry has deposited NOC fee of Rs. 3600/- as mentioned at sr. no. vii against the total project cost of Rs. 75.00 lacs as per the project report submitted by the industry, which is adequate for one year as per the policy of the Board dated 29/10/2018.                                As per the proposal, the details manufacturing process, type of pollution involved with the process and its control measures to be taken. Water consumption and wastewater generation: a)           Washing of mixing vessels: There will be a generation of very small quantity of waste water during CIP. The industry has proposed to provide forced Pan Evaporator for treatment of the same. b)           Wastewater generation from lab: The waste water discharged from the lab will also be treated using forced Pan Evaporator. c)           Domestic requirement: There will be requirement of around 1.0 KLD of fresh water for domestic purpose. The domestic effluent @ 0.6 KLD will be disposed onto land for plantation after passing through septic tanks.   Air pollution and its control <span lang="EN-US" style="font-size: 10.0pt; line-height: 150%; font-family: 'Tahoma','sans-serif'; mso-fareast-font-family: Tahoma; mso-font-width: 96%; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA;">(a)                 There will be no source of process emissions, as no process of color coating on tablets will be done in the unit. Hence, No APCD is required. <span lang="EN-US" style="font-size: 10.0pt; line-height: 150%; font-family: 'Tahoma','sans-serif'; mso-fareast-font-family: Tahoma; mso-font-width: 96%; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA;">(b)                To trap the raw material during mixing process, industry has provided air handling units to collect and recover its raw material. Hazardous waste and its disposal:                          There will be generation of hazardous waste pertaining to category 5.1- (Used or spent oil) and 35.1-(Exhaust air and gas cleaning residue). The waste will be sent to authorized recycling units in accordance with the provisions stipulated in Hazardous & Other Wastes (Management and Transboundary Movement) Rules, 2016.     Accordingly, the site was visited by the undersigned on 05/05/2023 and following observations were observed:- 1.          During visit, it was observed that the site of the industry is situated on Right Side of Ludhiana to Malerkotla Road, while going towards Village Rohira. 2.          The Project Proponent has constructed its complete proposed building and installation of Plant & machinery for formulation of Tablets & syrup was under progress. 3.          There is no Lal Lakir/Phirni within 100 mtr radius of site. However, there are few shops and houses just in front side of the site of industry. 4.          There will be no source of process emissions, as no process of color coating on tablets will be done in the unit. Hence, No APCD is required. 5.          To trap the raw material during mixing process, industry has provided air handling units to collect and recover its raw material. 6.          There will be a generation of very small quantity of waste water during CIP as well from lab. The industry has proposed to provide forced Pan Evaporator for treatment of the same. 7.          There will be generation of only domestic effluent which will be utilized onto land for plantation after passing through septic tanks. It is pertinent to mention here that no specific sitting guidelines have been issued by the Board for establishment of such type of units and only general sitting guidelines are applicable. And to verify the number of residential houses within 100 mtr radius of the site, the industry has submitted a copy of report dated 16/05/2022, Copy pasted in the agenda note attached   In addition to this, the industry has also submitted an undertaking in form of affidavit to the effect that there are only 4 no. oh residential houses in 100 mtr radius of the building of industry where plant & machinery has been installed. Copy pasted in the agenda note attached                           Further, to regulate the extraction of ground water, Moreover, the Board vide Head Office letter no. 768-97 dated 13/01/2021, decided as under:             “The Board shall continue to grant consent to establish/consent to operate to the industries with the advisory to obtain necessary clearance for abstraction of ground water from the Punjab Water Regulation and Development Authority (PWRDA)”   Moreover, as per the guidelines issued by PWRDA, the units abstracting not more than 300 KLM of ground water are exempted from taking NOC from PWRDA. In this case the industry has proposed to abstract only 34.2 KL of water per month. Hence no permission is required.   <span lang="EN-US" style="font-size: 10.0pt; line-height: 150%; font-family: 'Bookman Old Style','serif'; mso-fareast-font-family: Calibri; mso-bidi-font-family: Tahoma; color: black; mso-bidi-language: PA;">Site Suitability<span lang="EN-US" style="font-size: 10.0pt; line-height: 150%; font-family: 'Bookman Old Style','serif'; mso-fareast-font-family: Calibri; mso-bidi-font-family: Tahoma; color: black; mso-bidi-language: PA;">:- <span lang="EN-US" style="font-size: 10.0pt; line-height: 150%; font-family: 'Bookman Old Style','serif'; mso-fareast-font-family: Calibri; mso-bidi-font-family: Tahoma; color: black; mso-bidi-language: PA;">The Industry has already obtained CLU from Department of Town & Country Planning, Punjab vide Memo No. 6050 dated 06/12/2016 for establishment of an industrial unit to manufacture Medicines. Hence suitable. Applicability of EIA notification dated 14/9/2006:- No, the industry is a formulation unit and is not covered under EIA notification dated 14/9/2006. Applicability of first schedule of Factories Act: - Pharmaceuticals and drugs are mentioned in the list of industries require permission under First Schedule of factories Act, 1948. However, in this case the industry is a formulation unit and no air pollution is involved in the process and there will be a generation of very small quantity of waste water during CIP& lab, which will be treated using Pan Evaporator. Hence, the process does not seem to be covered under the First Schedule of Factories Act, 1948 and therefore industry has not obtained clearance of site from SAC. Moreover, as per the prevailing policy of the Board, other such units have already been granted consent by the Board without SAC. Applicability of Press Note-17 (1984 series):- No, the industry is a formulation unit and is not covered under the press note 17 (1984-series).                         In view of the above mentioned facts, May if approved, the case of the industry for obtaining "Consent to establish” (NOC) under the Water Act, 1974 and Air Act, 1981 for establishment of formulation unit to manufacture medicines in form Tablets @ 150000 Numbers/Day & Syrup @ 50 Liter/day using Paracetamol @ 60 Kgs/day, Starch @ 20 Kgs/day, Omeprazole @ 4 Kgs/day & Diclofienac sodium @ 5 Kgs/day as raw material in the revenue estate of Village Rohira, Tehsil Ahmedgarh & District Malerkotla be kindly be considered for grant of NOC and as per the prevailing policy of the Board for such type of units. Competency- SEE, ZO-II, Patiala

Inspection:

false

Inspection Note:

Officer:

PPCB143

Reject:

false

Reject Note:

Role:

RO AEE Mohit Singla