Lok Sabha Question No. 733 (UNSTARRED), answered on 2024-07-26
Subject: Pharmaceutical Waste Management
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Shri Maddila Gurumoorthy

## GOVERNMENT OF INDIA MINISTRY OF CHEMICALS AND FERTILIZERS DEPARTMENT OF PHARMACEUTICALS

LOK SABHA UNSTARRED QUESTION No. 733 TO BE ANSWERED ON THE 26 th  JULY, 2024

## Pharmaceutical Waste Management

## 733 Shri Maddila Gurumoorthy:

Will the Minister of CHEMICALS AND FERTILIZERS be pleased to state:

- (a) whether  the Government  has  taken/proposes  to take any steps to ensure better pharmaceutical  waste  management, especially  at  the  production  level  and  if  so,  the  details thereof;
- (b)  whether  the  Government  is  aware  that  currently,  only  38  percent  of  the  pharma  sector companies have been publishing sustainability reports in the country;
- (c) if so, whether the Government has any plan to mandate all pharma sector companies to publish similar reports, if so, the details thereof; and
- (d) whether the Government intends to mandate all major pharma manufacturing units to adopt sustainable  practices  like  committing  to  reducing  their  carbon  footprint,  increasing  water neutrality and reducing waste created during and after the manufacturing process, and if so, the details thereof?

## ANSWER

## MINISTER OF STATE IN THE MINISTRY OF CHEMICALS & FERTILIZERS (MS. ANUPRIYA PATEL)

(a):    The  Ministry  of  Environment,  Forests  and  Climate  Change  (MoEF&CC) has  notified effluent  and  emission  discharge  standards  for  pharmaceutical  industry.  The  standards  are implemented  by  State  Pollution  Control  Boards  (SPCBs)  /  Pollution  Control  Committees (PCCs) through consent mechanism i.e. notified standards are enforced by SPCBs/PCCs in the consent order issued under the Water Act or the Air Act or authorization under the Hazardous and Other Wastes (Management and Transboundary Movement) Rules.

Vide GSR 541(E) dated 6th August, 2021, the MoEF&CC notified standards for Bulk Drug  and  Formulation  (Pharmaceutical)  Industry  in  exercise  of  the  powers  conferred  by Section 6 and 25 of the Environment (Protection) Act, 1986. These standards aim to regulate and  mitigate  the  environmental  impact  caused  by  pharmaceutical  manufacturing  activities, ensuring compliance with environmental norms and promoting sustainable practices within the industry. This notification represents a significant step towards environmental protection and management in the pharmaceutical sector.

The Notification stipulates that:

(i) Chemical  and  Biological  sludge  or  any  residue,  reject,  concentrate  generated  from wastewater treatment or its management facility at Industry or Common Effluent Treatment Plants (CETP) catering to industries engaged in manufacturing of bulk drug formulations of pharmaceuticals,  has  been  classified  as  Hazardous  Waste  as  per  the  provisions  of  the

Hazardous Waste and Other Wastes (Management and Transboundary Movement) Rules, 2016 and shall be managed in environmentally sound manner in accordance with these rules.

- (ii)   SPCBs/PCCs shall prescribe additional relevant parameters as given in para A (ii) of this notification  as  per  needs  and  discharge  potential  of  member  industries  and  specify  the frequency of monitoring considering the receiving environment conditions.
- (iii)     Expired  or  Discarded  Medicines shall be treated and disposed of in accordance with Schedule I, and in compliance with the standards provided in Schedule-II of the Bio-medical Waste Management Rules, 2016 (BMW Rules) by the health care facilities and common biomedical waste treatment facility.
- (iv)    Date-expired products generated from production/formulation of drugs /pharmaceutical and health care is categorized as hazardous waste as category 28.5 of Schedule I of Hazardous & Other Wastes (Management and Trans-Boundary Movement) Rules, 2016 and the occupier / manufacturer is required to follow procedures for environmentally sound management and safe disposal as per responsibilities of the occupier stipulated under the rules.
- (v)         Guidelines  on  Monitoring  Mechanism  for  Active  Pharmaceutical  Ingredient  (API) residue' has been prepared by Central Pollution Control Board (CPCB) and circulated to all SPCBs/ PCCs in compliance of Hon'ble NGT order of Principal Bench, New Delhi in the matter of Original Application No. 136/2020.
- (vi)       To reduce antibiotic residues from effluent sources, industry is adopting reduce, recycle and reuse of treated effluent to maximum extent or Zero Liquid Discharge (ZLD) to minimize risk of Pharmaceutical Compounds' residues.
- (b) to (c):   The business responsibility and sustainability reporting by listed entities in terms of Securities and  Exchange  Board  of India  (SEBI)  circular  -  SEBI/HO/CFD/CMD2/P/CIR/2021/562,  dated  10.05.2021  is  mandatory  for  the  top  1000  listed  companies  (by market capitalization).
- (d):    The manufacturing of bulk drugs and intermediates is listed at S.N. 5(f) of schedule of Environment Impact Assessment (EIA) Notification, 2006 and requires prior environmental clearance  from  Ministry  of  Environment,  Forest  and  Climate  Change  or  respective  State Environment Impact Assessment Authority (SEIAA) based on proposals falling under category 'A' or 'B' in the schedule. While granting environmental clearance, Ministry of Environment, Forest  and  Climate  Change stipulates  the  specific  and  general  conditions  as  environmental safeguards.  It  is  mandatory  for  Pharmaceutical  industries  to  operate  only  after  obtaining Consent to Operate from respective SPCBs/PCCs.  It is mandatory for all the industries to have Effluent Treatment Plant and Air Pollution Control System and to comply with the prescribed effluent and emission discharge standards. Further, CPCB has directed all 17 categories of high pollution potential industries, Grossly Polluting Industries of Ganga basin and common waste treatment  facilities  to  install  Online  Continuous  Effluent/  Emission  Monitoring  Systems (OCEMS) for strengthening monitoring mechanism and effective compliance through selfregulatory mechanism and constant vigil on pollution levels. Real-time values of environmental  pollutants  of  trade  effluent  and  emissions  generated  through  OCEMS  are transmitted  online  to  CPCB  and  concerned  SPCB/PCC  on  24x7  basis.  Central  software processes the data and in case of value of pollutant parameter exceeds prescribed environmental norms, an automatic SMS alert is generated and sent to industrial unit, SPCB and CPCB, so that corrective measures can be taken by the industry immediately and appropriate action can be taken by concerned SPCB/PCC/CPCB.