Lok Sabha Question No. 1431 (UNSTARRED), answered on 2020-09-20
Subject: Pharma Companies
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Anil Firojiya

## GOVERNMENT OF INDIA

## MINISTRY OF CHEMICALS & FERTILIZERS DEPARTMENT OF PHARMACEUTICALS

LOK SABHA UNSTARRED QUESTION NO. †1431

TO BE ANSWERED ON 20 th  September, 2020

## Pharma Companies

## †1431. SHRI ANIL FIROJIYA:

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

- (a) whether it has been assessed from Indian Pharma Companies that there is no shortage of medicines in the country;
- (b) if so, the details thereof and if not, the reasons therefor;
- (c)  whether  any  plan  has  been  formulated  to  tackle  the  environmental  challenges likely to be faced by the pharma industry; and
- (d) if so, the details thereof?

## ANSWER

## MINISTER IN THE MINISTRY OF CHEMICALS AND FERTILIZERS (SHRI D.V. SADANANDA GOWDA)

(a) & (b): The Department of Pharmaceuticals (DoP) played a crucial role in ensuring the  availability  of  essential  drugs  Generic  or  branded  at  reasonable  prices  before and  during  the  COVID-19  pandemic.  Timely  and  effective  steps  were  taken  to ensure no shortage of drugs during the lockdown period throughout the country. The National Pharmaceutical Pricing Authority (NPPA) under the DoP has taken various steps to ensure the availability of life saving essential drugs like Hydroxychloroquine, Paracetamol, Vaccines, Anti-Tuberculosis drugs, Anti-diabetic drugs, cardiac drugs, imported Anti-epileptic drugs and COVID-19 drugs like FDC Lopinovir & Ritonavir, Remdesivir, Favipiravir, Zinc Sulphate, Methylprednisolone, Enoxparin, Dexamethasone etc. Further, on the intervention of NPPA and DCG(I) manufacturers  of  Remdesivir  have  set  up  a  Helpline  to  make  available  the Remdesivir.  However,  both  these  drugs  are  not  part  of  Covid-19  Protocol  and continue as part of investigational therapy Drugs.

To ensure seamless availability of drugs, the NPPA set up a 'Control Room' with Helpline No. 1800111255 and issues like Non-availability of medicines, masks, gloves, hand sanitizers etc., and price violation of medicines, masks, gloves, hand sanitizers, etc., were resolved promptly. Also, a COVID-19 dashboard on the NPPA's website i.e.www.nppaindia.nic.in, having latest Office orders, circulars, helpline no., Email for sending grievances etc., was created for convenience of public and other stakeholders.

The NPPA ensured the availability of drugs by coordinating with State Health Authorities like SDCs and Central Govt. Authorities like the Central Drugs Standard Control Organisation (CDSCO), the Directorate General of Health Services

(DGHS), Department for Promotion of Industry and Internal Trade (DPIIT) etc. The NPPA also  collected  the  critical  information  from  drug  manufacturers  for  decision making to ensure drug availability.

The  NPPA  also  coordinated  issues  related  to  production  of  raw  material, medicines, medical devices, packaging material, etc. by manufacturers and movement of raw material, packing material, finished goods and manpower etc to ensure availability of life saving essential drugs during the lockdown.

The details of various steps taken by the NPPA are at Annexure 1.

(c) & (d):         The Ministry of Environment Forest and Climate Change  in consultation with the Central Pollution Control Board (CPCB) has notified discharge norms  for pharmaceutical industries in January 2020  under the Environment (Protection) Act, 1986, a copy of which is at Annexure 2. These norms are reviewed and revised periodically. The notified norms are enforced by State Pollution Control Boards (SPCB) / Pollution Control Committees in the consent order (CTO-Consent to operate) issued under the Air Act (PCP), 1981 and the Water Act, 1974. Further the  units  are  encouraged  to  reduce  their  waste  water  generation  by  technological advancement and reuse/recycle of wastewater.

All  highly  polluting  17  categories  of  industries,  including  bulk  drugs  and formulations (pharmaceutical) industry, have been directed to install online continuous  effluent/emission  monitoring  systems  (OCEMS).  These  OCEMS  are connected to CPCB & SPCB. Based upon the SMS alert, industries are selected for manual  monitoring.  The  CPCB,  time  to  time  carry  out  surprise  inspection  of  the industries  for  checking  performance  and  operational  status  of  pollution  control measures adopted by the industries. During the inspection/manual monitoring, if any industry  is  found  non-complying  the  norms,  then  closure  direction  is  issued  under section 5 of the Environment (Protection) Act, 1986 to the unit for rectification or upgradation of Effluent Treatment Plant (ETP)/ Air Pollution Control devices (APCDs).

## MEASURES TAKEN FOR ENSURING AVAILABILTY OF DRUGS

1. The  NPPA  vide  D.O.  letter  dated  20 th Feb,  2020  requested  all  Chief Secretaries of States/UTs      to      closely      monitor      the      production      and availability    ofActive Pharmaceutical Ingredients (APIs) and their formulations, and necessary action shouldbe taken under the provisions of the Drugs (Prices Control) Order, 2013 (DPCO, 2013) to ensure availability of life saving essential drugs to the consumers at all times.
2. In  order  to  address  the  issues  related  to  availability  and  pricing  of  critical Medical  Devices  such  as  Masks,  Sanitizers  and  Gloves  to  deal  effectively  with COVID-19  situation,  the  NPPA  vide  letter  dated  13 th March  2020  requested MoHFW  to  prepone  the  effective  date  of  consideration  of  Medical  Devices  as Drugs.
3. The NPPA vide order dated 13 th March, in exercise of powers under clause (l)  of  sub  section  (2)  of  section  10  of  the  Disaster  Management  Act  directed  all States/UTs  and  concerned  State  Authorities  to  take  necessary  steps  to  ensure sufficient availability of surgical and protective masks, hand sanitizers and gloves at prices not exceeding MRP printed on pack sizes. Ministry of Consumer Affairs had, issued order dated 13 th March 2020 to regulate the production, quality, distribution, logistics of masks and hand sanitizers.
4. In the effort of continuous monitoring, a letter dated 18 th March, 2020 was also issued to all State Drug Controllers (SDCs) directing them to take immediate action  through field  officers  to  restrain  acts  of  hoarding  of  surgical  and  protective masks, hand sanitizers and gloves and profiteering by manufacturers, distributors, stockists and  retailers  of  these  items  as  well  as  to  ensure  availability  and distribution of these items at prices not exceeding MRP.
5. In  its  effort  to  maintain  seamless  availability  of  critical  drugs  and  Medical Devices  related  to  COVID-19,  NPPA  vide  letter  dated  19 th March,  requested Secretary  (Textile)  to  put  temporary  Export  restrictions  on  critical  inputs  (PP MELTBLOWN Non Woven Fabric, the Nosewire  and  Loop  Elastic  non  latex)  for Masks. Further, at the intervention by NPPA,  DCGI vide Order dated 19 th March directed  all  Port  Offices  of  CDSCO  to  take  proactive  measures  for  clearance  of imported  stock  of  gloves  in  coordination  with  Customs  in  expedited  manner  in public interest.
6. The issue regarding availability of N95 Masks and PPE kits is entrusted to Empowered Group 3 and the issues of 2 ply/3 ply Masks and Hand Sanitizers is being  monitored  by  Ministry  of  Consumer  Affairs  and  Department  of  Food respectively. NPPA undertook database creation in respect of said Medical Devices and shared with concerned Authorities for effective monitoring.
7. The NPPA  made efforts to collect information regarding Domestic Manufacturers of Masks, Gloves, Hand Sanitizers, PPE Kits and Ventilators in the Country.  In  this  regard,  various  meetings  were  held  at  NPPA  as  well  as  through

Video  conferencing  with  the  stakeholders  including  industry  associations.  The compiled  information  was  placed  on  NPPA's  website  &  also  disseminated  to MoHFW and all States/UTs to assist in procurement of these devices required for treatment of COVID-19.

## MEASURES TAKEN FOR ENSURING AFFORDABILITY OF N-95 MASKS

1. In  order  to  ensure  availability  of  N95  mask  at  affordable  prices  in  the Country, NPPA vide O.M dated 21.05.2020, directed Manufacturers/ Importers/Suppliers  of  N95  Mask  to maintain parity in prices for non-government procurements  and  to  make  available  the  same  at  reasonable  prices  and  any violation of the same would invite action under Essential Commodities Act, 1955.
2. After  issuing  such  an  Advisory,  major  manufacturers/importers  of  N-95 Masks have reduced their prices significantly up to 67%. Further, a Press Release in  this  regard  was  released  on  25.05.2020  for  dissemination  of  information  to general public.

## NPPA's CONTROL ROOM AND HELPLINE

1. As a measure to deal with the emerging situation arising due to outbreak of COVID-  19,  to  ensure  seamless  availability  of  drugs  including  masks,  hand sanitizers  and  gloves,  the  NPPA  set  up  a  'Control  Room'  with  Helpline  No. 1800111255  and  e-mail  ID  monitoring-  nppa@gov.in  on  20th  March  2020.  The Control Room has attended 1867 calls and addressed all types of the complaints in coordination  with  the  State  Drug  Control  Departments,  AIDCD,  Aimed  etc.till 31.08.2020.
2. The NPPA's Control Room team worked vigorously on 24 x 7 basis, in 3 shifts,  on  virtual  basis  through  remote  locations  and  has  made  serious  efforts,  in coordination  with  O/o  Chief  Secretaries  of  States/UTs,  SDCs,  District/  State Administration  and  other  State  Authorities,  for  prompt  resolution  of  number  of issues.  The  summary of  the  issues  resolved  through  the  NPPA Control  Room  is given below:

|   Sl. | Issues                                                                                                                           |
|-------|----------------------------------------------------------------------------------------------------------------------------------|
|     1 | Non-availability of medicines, masks, gloves, hand sanitizers, etc.                                                              |
|     2 | High price of medicines, masks, gloves, hand sanitizers, etc.                                                                    |
|     3 | Coordination in permission for production of raw material, medicines, medical devices, packaging material, etc. by manufacturers |
|     4 | Coordination in movement of raw material, packing material, finished goods and manpower.                                         |

## MEASURES FOR LOGISTIC MANGEMENT FOR AVAILABILTY OF DRUGS

1. NPPA associated with Empowered Group 5 headed by Shri ParameswaranIyer, Secretary, DWS, regarding 'Facilitating supply chain & Logistics Management  for  availability of necessary items such as  Food  &

Medicines'  to  flag  the  logistics  issues  of  Pharmaceutical  Industry  to  ensure  the seamless availability of drugs across the Country.

2. In lockdown period which also includes sealing of State borders at various places,  Pharmaceutical  sector  faced  serious  challenges  relating  to  logistics  raw materials and manpower in an effort to provide seamless availability of drugs and medical  devices  across  country.  In  this  regard,  NPPA  took  many  initiatives  in management of logistic disruption faced by the Pharmaceutical Industry which has led to increased availability of Medicines and Medical Devices across the Country.
3. The NPPA took measures for availability of Drugs for COVID-19 and other Essential  Drugs  including  HCQ,  Paracetamol,  Vaccines,  TB,  Insulin  and  other cardiac drugs. NPPA is also dealing with issues related to sub optimal production, logistics, MIS, shortages and exports.
4. The shortage  of  imported  Anti-epileptic  drugs  (particularlySabril  500)  was reported by  MoHFW  and  some  NGO  groups.  NPPA  immediately took  necessary action and the issue was addressed promptly. Similarly, the issue of availability of imported drug Acterma of COVID treatment, was facilitated through discussion with Cipla, the importer.
5. NPPA vide  D.O.  letter  No.  37001/2020/Div.-III/NPPA/Part  dated  25 th April, 2020  to  Administrator,  Daman  &  Diu  and  Chief  Secretary  Maharashtra,  has requested to take immediate necessary action in respect of resolution of bottlenecks to mitigate the risk of shortage of Anti-TB medicines in the country .
6. Further,  based  on  communication  dated  21 st April, 2020  from Joint Secretary  (RCH)  referring  to  the  letter  dated  14 th April  2020  of  the  Secretary (Health), requesting to address transportation issues due to nationwide lockdown to ensure seamlessavailability of vaccines required to successfully conduct Universal Immunization Programme (UIP), NPPA vide letter dated 21 st April, 2020 requested Ministry  of  Civil  Aviation,  GoI  to  take  immediate  steps  regarding  airlifting  of necessary  supplies  of  vaccines,  at  the  earliest,  as  it  is  critical  for  the  smooth operation of UIP.
7. The grievances received at micro and macro level from individuals as well as from Associations/ Industry and Institutions/ Departments were taken care of to address all issues. During the lockdown, complaints were received regarding non access to critical medicines. These were got home delivered through coordination with SDCs.
8. On 26 th March, 2020, NPPA requested all States/UTs to ensure unobstructed movement of Raw material, packing material, finished products and manpower related to manufacturing and distribution of drugs and medical devices.

## CREATION OF DASHBOARD FOR COVID-19

NPPA created  a  COVID-19  dashboard  on  its  website  having  latest  Office orders, circulars, helpline no., Email for sending grievances etc. for convenience of public and  other stakeholders. Link: http://www.nppaindia.nic.in/en/whats-newabout-coronavirus/.

## CREATION OF COVID AND COVID PLUS DRUGS DATABASE

NPPA in  coordination  with  DCGIdeveloped  a  comprehensive  database  for COVID & COVID plus (55+97) drugs as a measure of preventive preparedness for fighting  COVID-19.  This  will  be  immensely  useful  in  current  scenario  as  well  as future  needs  of  the  organization.  DCGI  has  been  directed  to  create  a  state  wise mechanism  to  obtain  timely  alerts  (ring  the  bell)  in  case  of  shortages  to  take remedial action.

## MEASURES TAKEN TO ENSURE AVAIALBILITY OF MEDICAL OXYGEN

NPPA  also  coordinated  the  issue  of  availability  of  Medical  Oxygen.  The Empowered Group of Secretaries Group-3 (EGoS) considered the representation of All India Industrial Gas Manufacturer Association (AIIGMA) regarding cost impact of production of medical oxygen by the major manufacturers on 27th May, 2020. Tariff Commission was asked to examine the claim.

NPPA  coordinated  the  data  for  medical  oxygen  from  companies  to  Tariff Commission  and  ensured  that  examination  of  claim  is  done  timely.  In  its  report, Tariff Commission has mentioned that the claim of AIIGMA relies mainly on venting of  various  gases  on  account  of  production  of  oxygen  and  increase  in  electricity consumption cost. However both grounds are prima facie not substantiated based on data provided by AIIGMA / manufactures and reject the price increase claim.

## MEASURES TAKEN TO ENSURE AVAIALBILTY OF DRUGS UNDER EXPORT RESTRICTION

1. Paracetamol  and  Hydroxychloroquine  along  with  other  drugs  were  put under export prohibition to ensure drug security in the country.NPPA made all out efforts  to  collect  data  regarding  manufacturing  capacity,  domestic  requirement, current  stock,  procurement  orders  of  APIs/KSMs/Intermediates  in  respect  these drugs under Export restriction.
2. Based  on  detailed examination of the stock position, manufacturing capacity  and  domestic  requirement  of  Paracetamol,  DoP/NPPA  vide  letter  dated 15th May,2020 recommended to DGFT for lifting of ban on Export of Paracetamol API  with  the  condition  for  Major  Manufacturers  to  maintain  supply  of  equivalent quantity in the domestic market. NPPA is regularly monitoring the details regarding manufacturing, stock position and supplies of Paracetamol API made to domestic market by major manufacturers.
3. Further,  also  vide  dated  11.06.2020  recommended  to  DGFT  for  lifting  of ban on Export of Hydroxychloroquine API and Formulations with the condition for Major Manufacturers to maintain sufficient availability in the domestic market .
4. The  NPPA  is  regularly  monitoring  the  details  regarding  manufacturing, stock  position  and  supplies  of  Hydroxychloroquine  made  to  various  authorities/ agencies  by  major  manufacturers . Further,  NPPA  is  submitting  a  daily  report  to Cabinet Minister, MoC&F regarding Hydroxychloroquine based on reports received from the concerned major manufacturers of the drugs.

## MONITORING THROGH SURVEY

The availability of key medicines is also monitored through CDSCO chemist level surveys, AIOCD surveys and Pharmatrac reports.

## MEASURES TAKEN TO ENSURE AVAIALBILTY OF OTHER COVID-19 DRUGS

1. As  and  when  any  drug  (e.g.  FDC  Lopinovir&  Ritonavir,  Remidesivir, Favipiravir, Zinc Sulphate, Mythyleprednisolone, Enoxparin, Dexamethasone etc)come into consideration for treatment protocol of COVID-19, NPPA pro-actively initiated  task  of  collection  of  information  to  assess  availability  situation  in  the Country.
2. NPPA, on receiving of estimated quantity required from MoHFW, vide letter dated 03.07.2020 and 16.07.2020 directed Major manufactures of Mythyleprednisolone,  Enoxparin,  Dexamethasoneto  ensure  sufficient  production and availability of these drugs across the country .

## MEASURES TAKEN TO COORDINATE WITH SDCs

NPPA conducts regular meeting through VC with SDCs and Drug Manufacturers to monitor the availability of drugs and takes appropriate action.  NPPA  also coordinates with SDCs through WhatsApp group.

## MEASURES TAKEN TO ENSURE AVAIALBILTY OF HEPARIN:

NPPA  received  representations  from  several  manufacturers  for  upward revision of ceiling prices of Heparin Injection 5000IU/ ml which has been considered as  an  essential  COVID  plus  medicine  by  Ministry  of  Health  &Family  Welfare.  To ensure the availability, NPPA increased the ceiling price of Heparin for a period of six month.

## MEASURES TAKEN TO STOP PRICE RISE OF DRUGS

1. National Pharmaceutical Pricing Authority (NPPA) issued necessary instructions  to  DCGI,  States/  UTs  to  ensure  adequate  supply  of  APIs  and formulations including surgical and protective masks, hand sanitizers and gloves at affordable prices in the market and to prevent black marketing and hoarding which could create artificial shortages in the country.
2. NPPA took cognizance of reports of black marketing of  Remedesvir and Toclizumab  and  directed  DCGI  to  issue  necessary  instruction  to  SDCs  to  take appropriate action in this respect.
3. Several requests from State Governments, NGOs and general public were received regarding fixation of prices for N-5 Masks as the same were available in the market at exorbitant and differential prices. In order to ensure availability of N95 mask  at  affordable  prices  in  the  Country,  NPPA  vide  O.M  dated  21.05.2020, directed  Manufacturers/  Importers/Suppliers  of  N95  Mask  to  maintain  parity  in prices  for  non-government  procurements  and  to  make  available  the  same  at reasonable prices and any violation of the same would invite action under Essential

Commodities Act, 1955.

4. After  issuing  such  an  Advisory,  major  manufacturers/importers  of  N-95 Masks have reduced their prices significantly up to 67%. Further, a Press Release in  this  regard  was  released  on  25.05.2020  for  dissemination  of  information  to general public.
5. The  NPPA  also  took  cognizance  of  complaints  of  black  marketing  and hoarding of N- 95 Masks and directed SDC Maharashtra to take necessary action. SDC conducted raid on the company doing black marketing and hoardingof N-95 Masks.

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## असाधारण

EXTRAORDINARY

भाग II -खण्  ड 3-उप-खण्  ड (i )

PART II-Section 3-Sub-section (i)

प्राजधकार से प्रकाजित

PUBLISHED BY AUTHORITY

नई दिल्ली, बृहस्ट्  पजतवार, िनवरी 23, 2020 /माघ 3, 1941

NEW DELHI, THURSDAY, JANUARY 23, 2020/MAGHA 03, 1941

## पर्ाावरण, वन और िलवार्ु पररवतान मंत्रालर्

## अजधसूचना

नई दिल्  ली, 23 िनवरी, 2020

सा. का. जन. 44(अ).-अजधसूचना, जिसे क े न्द  रीर् सरकार, पर्ाावरण (संरक्षण) अजधजनर्म, 1986 (1986 का 29) की धारा 6 और धारा 25 में प्रित्  त िजिर्ों का प्रर्ोग करते हुए िारी करने का प्रस्ट्  ताव करती है, का जनम्  नजलजखत प्रारूप पर्ाावरण (संरक्षण) जनर्म, 1986 के जनर्म 5 के  उपजनर्म (3) की अपेक्षानुसार, िनसाधारण जिनक े  उसक े  द्वारा प्रभाजवत होने की संभावना है, की िानकारी क े जलए, एततद्वारा प्रकाजित दकर्ा िाता है; और एततद्वारा सूचना िी िाती है दक उक्  त प्रारूप अजधसूचना पर उस तारीख से, जिसको भारत के  रािपत्र की प्रजतर्ां, जिसमें र्ह अजधसूचना अंतर्ववष्  ट है, िनसाधारण को उपलब्  ध करा िी िाती है, साठ दिन की अवजध की समाजि पर र्ा उसके  पश्  चात जवचार दकर्ा िाएगा।

ऐसा कोई व्  र्जि, िो प्रारूप अजधसूचना में अंतर्ववष्  ट प्रस्ट्  तावों पर कोई आपजि र्ा सुझाव िेने में जहतबद्ध है, इस प्रकार ऊपर जवजनर्दिष्  ट  की  गई  अवजध  क े   भीतर,  क े न्द  रीर्  सरकार  द्वारा  जवचार  दकए  िाने  क े   जलए,  आपजि  र्ा  सुझाव  सजचव,  पर्ाावरण,  वन  और िलवार्ु पररवतान मंत्रालर्, इंदिरा पर्ाावरण  भवन,  िोर  बाग  रोड, नई  दिल्  ली -110003  को  र्ा  ई-मेल पते अर्ाात mscb.cpcb@nic.in और h.kharkwal@nic.in पर सिस्ट्  र् सजचव, क े न्द  रीर् प्रिूषण जनर्ंत्रण बोडा और मंत्रालर् क े  वैज्ञाजनक 'ई' को जलजखत रूप में भेि सक े गा।

## प्रारूप अजधसूचना

के न्द  रीर् सरकार, पर्ाावरण (संरक्षण) अजधजनर्म, 1986 में और अजधक संिोधन करने क े  जलए एततद्वारा जनम्  नजलजखत जनर्म बनाती है, अर्ाात्-

सं. 41]

No. 41]

- 1 संजक्षप्  त िीषाक और प्रारम्  भ-(1) इन जनर्मों को पर्ाावरण (संरक्षण) संिोधन जनर्म, 2019 कहा िाएगा। (2) र्े आजधकाररक रािपत्र में उनक े  अंजतम प्रकािन की तारीख से लागू होंगे।
2. पर्ाावरण (संरक्षण) अजधजनर्म, 1986 में, अनुसूची-। में क्रम संख्  र्ा 73 और उससे संबंजधत प्रजवजिर्ों क े  जलए जनम्  नजलजखत क्रम संख्  र्ा और प्रजवजिर्ां प्रजतस्ट्  र्ाजपत की िाएगी अर्ाात:-

| क्रम सं.   | उद्योग                                | पैरामीटर                          | मानक                                                                                        |
|------------|---------------------------------------|-----------------------------------|---------------------------------------------------------------------------------------------|
| 1          | 2                                     | 3                                 | 4                                                                                           |
| ' 73       | र्ोक िवा और जनमााण )फामाास्ट्र्ुरटकल( | क. बजहस्राव मानक                  | क. बजहस्राव मानक                                                                            |
|            |                                       |                                   | ईटीपी का अंजतम आउटलेट सांरण के जलए सीजमत मान) पीएच और िैव परख को छोड़कर जमलीग्राम / एल में( |
|            |                                       | i) अजनवार्ा पैरामीटर              | i) अजनवार्ा पैरामीटर                                                                        |
|            |                                       | पीएच                              | 6.0 -8.5                                                                                    |
|            |                                       | बीओडी) 3 दिन 27 जडग्री सेजल्सर्स( | 30                                                                                          |
|            |                                       | सीओडी                             | 250                                                                                         |
|            |                                       | टीएसएस                            | 100                                                                                         |
|            |                                       | टीडीएस                            | 2100                                                                                        |
|            |                                       | तेल और जचकनाई (ग्रीि)             | 10                                                                                          |
|            |                                       | िैव - परख परीक्षण**               | 100% बजहस्राव में पहले 96 घंटों के बाि मछली की 90% उत्तरिीजवता                              |
|            |                                       | ii) अजतररि पैरामीटर               | ii) अजतररि पैरामीटर                                                                         |
|            |                                       | अमोजनकल नाइरोिन                   | 50                                                                                          |
|            |                                       | नाइरेट नाइरोिन                    | 10                                                                                          |
|            |                                       | *** बेंिीन                        | 0.05                                                                                        |
|            |                                       | *** टाजल्वन                       | 0.05                                                                                        |
|            |                                       | *** जाइलीन                        | 0.06                                                                                        |
|            |                                       | ***मीर्ाइलीन क्लोराइड             | 0.9                                                                                         |
|            |                                       | फॉस्ट्फ ेट पी के रूप में          | 5                                                                                           |
|            |                                       | क्लोराइड                          | 1000                                                                                        |
|            |                                       | सल्फ ेट SO 4 के रूप में           | 1000                                                                                        |
|            |                                       | फ्लोराइड                          | 2                                                                                           |
|            |                                       | एस के रूप में सल्फाइड             | 2                                                                                           |
|            |                                       | फेनोजलक र्ौजगक                    | 1                                                                                           |
|            |                                       | कुल अवजिि क्लोरीन                 | 1                                                                                           |
|            |                                       | िस्ट्ता                           | 5                                                                                           |
|            |                                       | लोहा                              | 3                                                                                           |
|            |                                       | तांबा                             | 3                                                                                           |
|            |                                       | कुल क्रोजमर्म                     | 2                                                                                           |
|            |                                       | हेक्सावलेंट क्रोजमर्म) Cr 6+ )    | 0.1                                                                                         |

| साइनाइड                        |   0.1 |
|--------------------------------|-------|
| आसेजनक                         |  0.2  |
| पारा                           |  0.01 |
| लेड                            |  0.1  |
| **** सदक्रर् िवा संघटक) एपीआई( |  0.05 |

## iii) साझा बजहस्राव िोधन संर्ंत्र में जनस्ट्  साररत कर रहे उद्योगों क े  अंजतम आउटलेट क े  जलए

दिनांक  1  िनवरी,  2016 की अजधसूचना का के   अनुसार  प्रत्र्ेक  (अ) 4  .आ.साझा बजहस्राव िोधन संर्ंत्र )  सीईटीपी)  क े   जलए,  राज्र्  बोडा  साझा  बजहस्राव  िोधन  संर्ंत्र )  सीईटीपी)  क े   जडिाइन  और स्ट्र्ानीर् िरूरतों और जस्ट्र्जतर्ों क े  अनुसार सामान्दर् मापिंडों, अमोजनर्म नाइरोिन और हैवी मेटल्स के  जलए इनलेट क्वाजलटी स्ट्टैंडर्डसा जनधााररत करेगा ।

## रटप्  पणी:

िेडएलडी= र्ोक िवा और जनमााण उद्योग में िून्दर् तरल जनस्ट्  सारण प्रणाली पर जवचार दकर्ा िाता है, िब अजनवार्ा पैरामीटरों क े  जलए जनधााररत की गई सीमाओं को पूरा करते है। िोजधत बजहस्रावों को प्रदक्रर्ा  अर्वा उपर्ोजगताओं क े प्रर्ोग में  लार्ा िाएगा।  (कू आलग टॉवरो आदि/बॉर्लर) बागवानी / बागवानी में िोजधत अपजिि के  पुन :उपर्ोग को र्ोक िवा और जनमााण उद्योगों में िेडएलडी नहीं माना िाएगा।

- ** िैव परख परीक्षण आईएस :6582-1971 के अनुसार आर्ोजित दकर्ा िाएगा
- "अजतररि पैरामीटर "क े  रूप में सूचीबद्ध पैरामीटर प्रदक्रर्ा और उत्पाि क े  आधार पर जनधााररत दकए िाएंगे।
- *** र्े सीमाएं  उन  उद्योगों  पर  लागू  होंगी  िो  बेंिीन, टाजल्वन,  जाइलीन,  जमर्ाइलीन  क्लोराइड, क्लोरोबेंिीन का उपर्ोग कर रहे हैं ।
- *** * एपीआई सीमाएं एंटीबार्ोरटक िवाओं क े  अलावा एपीआई बनाने वाली इकाइर्ों क े  जलए लागू होगी।

## ख प्रदक्रर्ा .ररएक्टर वेंटस / टैंक फामा वेंटस से उत्  सिान मानक

| पैरामीटर                  |   सांरण के जलए सीजमत मान )जमलीग्राम/एनएम 3 ) |
|---------------------------|----------------------------------------------|
| क्लोरीन                   |                                           15 |
| हाइड्रोक्लोररक एजसड वाष्प |                                           35 |
| अमोजनर्ा                  |                                           30 |
| बेंिीन                    |                                            5 |
| टाजल्वन                   |                                          100 |
| ऐजसटोनाईराईल              |                                         1000 |
| जडकलोरोमीर्ेन             |                                          200 |
| जाइलीन                    |                                          100 |
| एसीटोन                    |                                         2000 |

ग जवलार्क का क ु ल .नुकसान, उपभोग दकए गए जवलार्क के   3 % से अजधक नहीं होना चाजहए।

## घ. र्ोक िवा और जनमााण उद्योग में िोजधत बजहस्राव में एंटोबार्ोरटक अवजिष्  ट और र्ोक िवा और जनमााण इकाइर्ों की सिस्ट्  र्ता सजहत सीईटीपी।

पृर्क एंटीबार्ोरटक अवजिष्  ट नीचे ताजलका में दिए गए मानों क े  बराबर र्ा उससे कम होंगे।

| पैरामीटर   |   सांरण के जलए सीजमत मान) u/g / l) |
|------------|------------------------------------|
| i.एजमकाजसन |                                6.4 |

| ii.एमोजक्सजसजलन          |   0.10 |
|--------------------------|--------|
| iii.एम्फोटेररजसन बी      |   0.01 |
| iv.एम्पीजसलीन            |   0.1  |
| v.एनीड्यूलाफ ंजगन        |   0.01 |
| vi.एजवलामाईजसन           |   3.2  |
| vii.एजिथ्रोमाईजसन        |   0.01 |
| viii.एिररर्ोनाम          |   0.2  |
| ix.बेजसरेजसन             |   3.2  |
| x.बेडादक्वजलन            |   0.03 |
| xi.बेन्दजाइलपेजन्दसलीन   |   0.1  |
| xii.क जप्रर्ोमाईजसन      |   0.8  |
| xiii.सेफ ेकलोर           |   0.2  |
| xiv.सेफाड्रोजक्सल        |   0.8  |
| xv.सेफालोजनर्म           |   8.4  |
| xvi.सेफालोररडीन          |   1.6  |
| xvii.सेफालोजर्न          |   0.8  |
| xviii.सेफािोजलन          |   0.4  |
| xix.सेफजडजनर             |   0.1  |
| xx.सेफ ेपाईम             |   0.2  |
| xxi.सेफीिाईम             |   0.02 |
| xxii.सेफोपेरािोन         |   0.2  |
| xxiii.सेफोटेजक्सम        |   0.04 |
| xxiv.सेफोऐजक्सरटन        |   3.2  |
| xxv.सेफजपरोम             |   0.02 |
| xxvi.सेफपोडोजक्सन        |   0.1  |
| xxvii.सेफदक्वनोम         |   0.64 |
| xxviii.सेफटेरोजलन        |   0.02 |
| xxix.सेफटाजिजडम          |   0.2  |
| xxx.सेफटीब्र्ूटेन        |   0.1  |
| xxxi.सेफटीओफर            |   0.02 |
| xxxii.सेफटोजबप्रोल       |   0.09 |
| xxxiii.सेफटोलोिेन        |   0.76 |
| xxxiv.सेफाररर्ोक्सन      |   0.01 |
| xxxv.सेफ रोजक्सम         |   0.2  |
| xxxvi.सेफालेजक्सन        |   0.03 |
| xxxvii.क्लोरामफ ेजनकोल   |   3.2  |
| xxxviii.जसपरोफ्लोक्साआसन |   0.02 |
| xxxix.क्लेररथ्रोमाईजसन   |   0.03 |

| xli.जक्लनाफ्लोक्साजसन    |   0.20 |
|--------------------------|--------|
| xlii.जक्लन्दडामाईजसन     |  0.04  |
| xliii.क्लोक्साजसलीन      |  0.05  |
| xliv.कोजलजस्ट्टन         |  0.8   |
| xlv.डेपटोमाईजसन          |  0.4   |
| xlvi.डेलमाजनड            |  0.02  |
| xlvii.डोरीपेनेम          |  0.04  |
| xlviii.डॉक्सीसाइजक्लन    |  0.8   |
| xlix.एनरामाईजसन          |  1.92  |
| l.एनरोफ्लोक्सजसन         |  0.02  |
| li.एरटापेनेम             |  0.05  |
| lii.एररथ्रोमाईजसन        |  0.2   |
| liii.एर्ामब्र्ुटोल       |  0.8   |
| liv.फ रोपेनेम            |  0.01  |
| lv.दफडाएक्सोमाईजसन       |  0.01  |
| lvi.फ्लोरफ ेजनकोल        |  0.8   |
| lvii.फ्लूकोनेजोल         |  0.1   |
| lviii.फ्लुमेदक्वन        |  0.1   |
| lix.फॉस्ट्फोमाईजसन       |  0.8   |
| lx.फ्र्ुसीजडक एजसड       |  0.2   |
| lxi.सेटीफ्लोक्साजसन      |  0.05  |
| lxii.िेमीफलोक्साजसन      |  0.02  |
| lxiii.िेंटामाईजसन        |  0.08  |
| lxiv.इनीपेनेम            |  0.05  |
| lxv.आइसोजनर्ाजिड         |  0.05  |
| lxvi.इराकोनेिोल          |  0.004 |
| lxvii.कानामाईजसन         |  0.44  |
| lxviii.लेवोफ्लोक्साजसन   |  0.1   |
| lxix.आलकोमाईजसन          |  0.72  |
| lxx.लाईनजोजलड            |  2.68  |
| lxxi.लोराकारबेफ          |  0.8   |
| lxxii.मेजसजलनेम          |  0.4   |
| lxxiii.मेरोपेनेम         |  0.02  |
| lxxiv.मेरोजनडेिोल        |  0.05  |
| lxxv.माइनोसाइजक्लन       |  0.4   |
| lxxvi.मॉक्सीफ्लोजक्सन    |  0.05  |
| lxxvii.म्र्ुरीरोजसन      |  0.1   |
| lxxviii.नेलीजडजक्सक एजसड |  6.4   |

| lxxx.जनर्ोमाईजसन                 |   0.01 |
|----------------------------------|--------|
| lxxxi.नेटीलजमजसन                 |   0.2  |
| lxxxii.जनरोफ्र्ूरेनटोएन          |  25.6  |
| lxxxiii.नॉरफ्लोजक्सन             |   0.2  |
| lxxxiv.ऑफ्लोजक्सन                |   0.2  |
| lxxxv.ऑक्साजसजलन                 |   0.4  |
| lxxxvi.ऑक्सीटेरासाइजक्लन         |   0.2  |
| lxxxvii.पेफक्लोजसन               |   3.2  |
| lxxxviii. फे नक्सीमेजर्लपेनजसजलन |   0.02 |
| lxxxix.जपपेराजसजलन               |   0.2  |
| xc.पॉलीजमजक्सन                   |   0.8  |
| xci.रेटापाम्र्ुजलन               |   0.02 |
| xcii.ररफाम्पजसन                  |   0.02 |
| xciii.रॉक्सीथ्रोमाईजसन           |   0.4  |
| xciv.सेक्नीडेिोल                 |   0.4  |
| xcv.स्ट्पाराफ्लोजक्सन            |   0.02 |
| xcvi.स्ट्पेक्टीनोमाईजसन          |  12.8  |
| xcvii.जस्ट्परामाईजसन             |   0.2  |
| xcviii.स्ट्रेप्टोमाइजसन          |   6.4  |
| xcix.सल्बेक्टम                   |   6.4  |
| c.सल्फाजडर्ाजिन                  | 288    |
| ci.सल्फाजडजमजर्र्ोजिन            |  20    |
| cii.सल्फाडॉजक्सन                 |   0.24 |
| ciii.सल्फामेर्ोक्सािोल           |   0.24 |
| civ.टेिोबेक्टम                   |  17.6  |
| cv.टेडीिोजलड                     |   3.92 |
| cvi.टेईकोप्लाजनन                 |   0.2  |
| cvii.टेलीथ्रोमाईजसन              |   0.02 |
| cviii.टेरासाइजक्लन               |   0.4  |
| cix.जर्र्ाम्फ ेनीकोल             |   0.4  |
| cx.रटर्ाम्र्ुजलन                 |   0.4  |
| cxi.रटकार्वसजलन                  |   3.2  |
| cxii.रटगेसाइजक्लन                |   0.4  |
| cxiii.रटल्डीपीरोजसन              |   0.17 |
| cxiv.रटल्मीकोजसन                 |   0.4  |
| cxv.टोबरामाईजसन                  |   0.4  |
| cxvi.ररमेर्ोजप्रम                |   0.2  |
| cxvii.रोवाफ्लोक्साजसन            |   0.01 |

| cxix.बेंकोमाईजसन       | 3.20     |
|------------------------|----------|
| cxx.जवर्ोमाईजसन        | 0.80     |
| cxxi.जवर्विजनर्ामाईजसन | 0.80. '. |

रटप्  पणी: - एंटीबार्ोरटक अवजिष्  ट र्ुि गाि को िलाकर राख दकर्ा िाएगा और साझा खतरनाक अपजिि भस्ट्मक अर्वा उद्योग जवजिि भस्ट्मक क े  जलए अजधसूजचत दकए गए भस्ट्मक का मानक लागू होगा।

[फा.सं.क्  र्ू.-15017/12/2018-सीपीडब्ल्र्ू] जिगमेत टक्पा, संर्ुि सजचव

रटप्  पणी: मूल जनर्म भारत के  रािपत्र असाधारण, भाग- II, खंड 3, उप-खंड (i) में दिनांक 19 नवम्  बर, 1986 को संख्  र्ा का.आ. 844 (अ) द्वारा प्रकाजित दकए गए र्े और उन्द  हें अंजतम बार दिनांक 26 दिसम्  बर, 2019 को सा.का.जन. 952 (अ) की अजधसूचना द्वारा संिोजधत दकर्ा गर्ा र्ा।

## MINISTRY OF ENVIRONMENT, FOREST AND CLIMATE CHANGE NOTIFICATION

New Delhi , the 23rd January, 2020

G.S.R. 44(E).The following draft of the notification, which the Central Government proposes to issue in exercise of the powers conferred by sections 6 and 25 of the Environment (Protection) Act, 1986 (29 of 1986) is hereby published, as required under sub-rule (3) of rule 5 of the Environment (Protection) Rules, 1986, for the information of the public likely to be affected thereby; and notice is hereby given that the said draft notification shall be taken into consideration on or after the expiry of a period of sixty days from the date on which copies of the Gazette containing this notification are made available to the public.

Any  person  interested  in  making  any  objections  or  suggestions  on  the  proposals  contained  in  the  draft notification may forward the same in writing, for consideration of the Central Government within the period specified above to the Secretary, Ministry of Environment, Forest and Climate Change, Indira Paryavaran Bhawan, Jor Bagh Road, New Delhi-110003, or send it to Member Secretary, CPCB and Scientist 'E' Ministry at the e-mail address i.e. mscb.cpcb@nic.in and h.kharkwal@nic.in.

## Draft Notification

The Central  Government  hereby  makes  the  following  rules  further  to  amend  the  Environment  (Protection) Rules, 1986, namely:-

1. Short title and commencement(1) These rules may be called the Environment (Protection) Amendment Rules, 2019.
- (2) They shall come into force on the date of their final publication in the Official Gazette.
2. In the Environment (Protection) Rules, 1986, in Schedule-l,  for serial number 73 and the entries relating thereto, the following serial number and entries shall be substituted, namely:-

| Sl. No.   | Industry                                    | Parameters    | Standard                                                                                       |
|-----------|---------------------------------------------|---------------|------------------------------------------------------------------------------------------------|
| 1         | 2                                           | 3             | 4                                                                                              |
| '73       | Bulk Drug and Formulation (Pharmaceuti cal) |               | A. EFFLUENT STANDARDS                                                                          |
| '73       | Bulk Drug and Formulation (Pharmaceuti cal) | i) Compulsory | For final outlet of ETP Limiting value for concentration (in mg/l except for pH and Bio assay) |
| '73       | Bulk Drug and Formulation (Pharmaceuti cal) | Parameters    |                                                                                                |
| '73       | Bulk Drug and Formulation (Pharmaceuti cal) | pH            | 6.0 -8.5                                                                                       |

| BOD (3 days 27°C)                          | 30                                                         |
|--------------------------------------------|------------------------------------------------------------|
| COD                                        | 250                                                        |
| TSS                                        | 100                                                        |
| TDS                                        | 2100                                                       |
| Oil &Grease                                | 10                                                         |
| Bio - Assay Test**                         | 90% Survival of Fish after first 96 hours in 100% effluent |
| ii) Additional Parameters                  |                                                            |
| Ammonical Nitrogen                         | 50                                                         |
| Nitrate Nitrogen                           | 10                                                         |
| ***Benzene                                 | 0.05                                                       |
| ***Toluene                                 | 0.05                                                       |
| ***Xylene                                  | 0.06                                                       |
| ***Methylene Chloride                      | 0.9                                                        |
| Phosphates as P                            | 5                                                          |
| Chlorides                                  | 1000                                                       |
| Sulphates as SO 4                          | 1000                                                       |
| Fluoride                                   | 2                                                          |
| Sulphides as S                             | 2                                                          |
| Phenolic Compounds                         | 1                                                          |
| Total Residual Chlorine                    | 1                                                          |
| Zinc                                       | 5                                                          |
| Iron                                       | 3                                                          |
| Copper                                     | 3                                                          |
| Total Chromium                             | 2                                                          |
| Hexavalent Chromium (Cr 6+ )               | 0.1                                                        |
| Cyanide                                    | 0.1                                                        |
| Arsenic                                    | 0.2                                                        |
| Mercury                                    | 0.01                                                       |
| Lead                                       | 0.1                                                        |
| ****Active Pharmaceutical Ingredient (API) | 0.05                                                       |

## iii) for final outlet of Industries discharging to CETP

For each Common Effluent Treatment Plant(CETP), the state Board will prescribe inlet quality Standards for general parameters, Ammonical Nitrogen and Heavy Metals as per the  design  of  the  Common  Effluent  Treatment  Plant(CETP)  and  local  needs  and conditions. As per notification S.O. 4 (E) dated 1 st January, 2016

## Note:

- ZLD =  Zero  Liquid  Discharge  system  in Bulk  Drug  and  formulation industry  is considered when treated effluent meeting the limits prescribed for compulsory parameters shall be used in Process or Utilities (boiler/ Cooling tower etc.). The reuse of treated effluent in gardening/ horticulture shall not be considered as ZLD in Bulk Drug and formulation industries.
- ** The Bio assay test shall be conducted as per IS : 6582-1971

Parameters listed as 'Additional Parameters' shall  be  prescribed depending upon the process and product.

- *** Limits shall be applicable to industries those are using Benzene, Toluene, Xylene, Methylene Chloride, Chlorobenzene.
- ****API limits shall be applicable for units manufacturing API other than antibiotics.

| B. EMISSION STANDARDS from Process Reactor Vents/ Tank farm Vents   | B. EMISSION STANDARDS from Process Reactor Vents/ Tank farm Vents   |
|---------------------------------------------------------------------|---------------------------------------------------------------------|
| Parameter                                                           | Limiting value for concentration (mg/Nm 3 )                         |
| Chlorine                                                            | 15                                                                  |
| Hydrochloric acid vapour                                            | 35                                                                  |
| Ammonia                                                             | 30                                                                  |
| Benzene                                                             | 5                                                                   |
| Toluene                                                             | 100                                                                 |
| Acetonitrile                                                        | 1000                                                                |
| Dichloromethane                                                     | 200                                                                 |

| Xylene                                                                                                                                                                                                                                             |                                                                                                                                                                                                                                                    | 100                                                                                                                                                                                                                                                | 100                                                                                                                                                                                                                                                |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Acetone 2000 C. The total losses of solvent should not be more than 3% of the solvent consumed.                                                                                                                                                    | Acetone 2000 C. The total losses of solvent should not be more than 3% of the solvent consumed.                                                                                                                                                    | Acetone 2000 C. The total losses of solvent should not be more than 3% of the solvent consumed.                                                                                                                                                    | Acetone 2000 C. The total losses of solvent should not be more than 3% of the solvent consumed.                                                                                                                                                    |
| D. Antibiotic Residues in the treated effluent of Bulk Drug and Formulation Industry and CETP with membership of Bulk Drug and formulation Units Individual antibiotic residues will be equal to or less than the values given in the below table. | D. Antibiotic Residues in the treated effluent of Bulk Drug and Formulation Industry and CETP with membership of Bulk Drug and formulation Units Individual antibiotic residues will be equal to or less than the values given in the below table. | D. Antibiotic Residues in the treated effluent of Bulk Drug and Formulation Industry and CETP with membership of Bulk Drug and formulation Units Individual antibiotic residues will be equal to or less than the values given in the below table. | D. Antibiotic Residues in the treated effluent of Bulk Drug and Formulation Industry and CETP with membership of Bulk Drug and formulation Units Individual antibiotic residues will be equal to or less than the values given in the below table. |
| Parameter Limiting value for concentration (µg/l)                                                                                                                                                                                                  | Parameter Limiting value for concentration (µg/l)                                                                                                                                                                                                  | Parameter Limiting value for concentration (µg/l)                                                                                                                                                                                                  | Parameter Limiting value for concentration (µg/l)                                                                                                                                                                                                  |
| i.                                                                                                                                                                                                                                                 | Amikacin                                                                                                                                                                                                                                           |                                                                                                                                                                                                                                                    | 6.40                                                                                                                                                                                                                                               |
| ii.                                                                                                                                                                                                                                                | Amoxicillin                                                                                                                                                                                                                                        |                                                                                                                                                                                                                                                    | 0.10                                                                                                                                                                                                                                               |
| iii.                                                                                                                                                                                                                                               | Amphotericin B                                                                                                                                                                                                                                     |                                                                                                                                                                                                                                                    | 0.01                                                                                                                                                                                                                                               |
| iv.                                                                                                                                                                                                                                                | Ampicillin                                                                                                                                                                                                                                         |                                                                                                                                                                                                                                                    | 0.10                                                                                                                                                                                                                                               |
| v.                                                                                                                                                                                                                                                 | Anidulafungin                                                                                                                                                                                                                                      |                                                                                                                                                                                                                                                    | 0.01                                                                                                                                                                                                                                               |
| vi.                                                                                                                                                                                                                                                | Avilamycin                                                                                                                                                                                                                                         |                                                                                                                                                                                                                                                    | 3.20                                                                                                                                                                                                                                               |
| vii.                                                                                                                                                                                                                                               | Azithromycin                                                                                                                                                                                                                                       |                                                                                                                                                                                                                                                    | 0.01                                                                                                                                                                                                                                               |
| viii.                                                                                                                                                                                                                                              | Aztreonam                                                                                                                                                                                                                                          |                                                                                                                                                                                                                                                    | 0.20                                                                                                                                                                                                                                               |
| ix.                                                                                                                                                                                                                                                | Bacitracin                                                                                                                                                                                                                                         |                                                                                                                                                                                                                                                    | 3.20                                                                                                                                                                                                                                               |
| x.                                                                                                                                                                                                                                                 | Bedaquiline                                                                                                                                                                                                                                        |                                                                                                                                                                                                                                                    | 0.03                                                                                                                                                                                                                                               |
| xi.                                                                                                                                                                                                                                                | Benzylpenicillin                                                                                                                                                                                                                                   |                                                                                                                                                                                                                                                    | 0.10                                                                                                                                                                                                                                               |
| xii.                                                                                                                                                                                                                                               | Capreomycin                                                                                                                                                                                                                                        |                                                                                                                                                                                                                                                    | 0.80                                                                                                                                                                                                                                               |
| xiii.                                                                                                                                                                                                                                              | Cefaclor                                                                                                                                                                                                                                           |                                                                                                                                                                                                                                                    | 0.20                                                                                                                                                                                                                                               |
| xiv.                                                                                                                                                                                                                                               | Cefadroxil                                                                                                                                                                                                                                         |                                                                                                                                                                                                                                                    | 0.80                                                                                                                                                                                                                                               |
| xv.                                                                                                                                                                                                                                                | Cefalonium                                                                                                                                                                                                                                         |                                                                                                                                                                                                                                                    | 8.40                                                                                                                                                                                                                                               |
| xvi.                                                                                                                                                                                                                                               | Cefaloridine                                                                                                                                                                                                                                       |                                                                                                                                                                                                                                                    | 1.60                                                                                                                                                                                                                                               |
| xvii.                                                                                                                                                                                                                                              | Cefalothin                                                                                                                                                                                                                                         |                                                                                                                                                                                                                                                    | 0.80                                                                                                                                                                                                                                               |
| xviii.                                                                                                                                                                                                                                             | Cefazolin                                                                                                                                                                                                                                          |                                                                                                                                                                                                                                                    | 0.40                                                                                                                                                                                                                                               |
| xix.                                                                                                                                                                                                                                               | Cefdinir                                                                                                                                                                                                                                           |                                                                                                                                                                                                                                                    | 0.10                                                                                                                                                                                                                                               |
| xx.                                                                                                                                                                                                                                                | Cefepime                                                                                                                                                                                                                                           |                                                                                                                                                                                                                                                    | 0.20                                                                                                                                                                                                                                               |
| xxi.                                                                                                                                                                                                                                               | Cefixime                                                                                                                                                                                                                                           |                                                                                                                                                                                                                                                    | 0.02                                                                                                                                                                                                                                               |
| xxii.                                                                                                                                                                                                                                              | Cefoperazone                                                                                                                                                                                                                                       |                                                                                                                                                                                                                                                    | 0.20                                                                                                                                                                                                                                               |
| xxiii.                                                                                                                                                                                                                                             | Cefotaxime                                                                                                                                                                                                                                         |                                                                                                                                                                                                                                                    | 0.04                                                                                                                                                                                                                                               |
| xxiv.                                                                                                                                                                                                                                              | Cefoxitin                                                                                                                                                                                                                                          |                                                                                                                                                                                                                                                    | 3.20                                                                                                                                                                                                                                               |
| xxv.                                                                                                                                                                                                                                               | Cefpirome Cefpodoxime                                                                                                                                                                                                                              |                                                                                                                                                                                                                                                    | 0.02 0.10                                                                                                                                                                                                                                          |
| xxvi.                                                                                                                                                                                                                                              | Cefquinome                                                                                                                                                                                                                                         |                                                                                                                                                                                                                                                    | 0.64                                                                                                                                                                                                                                               |
| xxvii. xxviii.                                                                                                                                                                                                                                     | Ceftaroline                                                                                                                                                                                                                                        |                                                                                                                                                                                                                                                    | 0.02                                                                                                                                                                                                                                               |
| xxix.                                                                                                                                                                                                                                              | Ceftazidime                                                                                                                                                                                                                                        |                                                                                                                                                                                                                                                    | 0.20                                                                                                                                                                                                                                               |
| xxx.                                                                                                                                                                                                                                               | Ceftibuten                                                                                                                                                                                                                                         |                                                                                                                                                                                                                                                    | 0.10                                                                                                                                                                                                                                               |
| xxxi.                                                                                                                                                                                                                                              | Ceftiofur                                                                                                                                                                                                                                          |                                                                                                                                                                                                                                                    | 0.02                                                                                                                                                                                                                                               |
| xxxii.                                                                                                                                                                                                                                             | Ceftobiprole                                                                                                                                                                                                                                       |                                                                                                                                                                                                                                                    | 0.09                                                                                                                                                                                                                                               |
| xxxiii.                                                                                                                                                                                                                                            | Ceftolozane                                                                                                                                                                                                                                        |                                                                                                                                                                                                                                                    | 0.76                                                                                                                                                                                                                                               |
| xxxiv.                                                                                                                                                                                                                                             | Ceftriaxone                                                                                                                                                                                                                                        |                                                                                                                                                                                                                                                    | 0.01                                                                                                                                                                                                                                               |
| xxxv.                                                                                                                                                                                                                                              | Cefuroxime                                                                                                                                                                                                                                         |                                                                                                                                                                                                                                                    | 0.20                                                                                                                                                                                                                                               |
| xxxvi.                                                                                                                                                                                                                                             | Cephalexin                                                                                                                                                                                                                                         |                                                                                                                                                                                                                                                    | 0.03                                                                                                                                                                                                                                               |
| xxxvii.                                                                                                                                                                                                                                            | Chloramphenicol                                                                                                                                                                                                                                    |                                                                                                                                                                                                                                                    | 3.20                                                                                                                                                                                                                                               |
| xxxviii.                                                                                                                                                                                                                                           | Ciprofloxacin                                                                                                                                                                                                                                      |                                                                                                                                                                                                                                                    | 0.02                                                                                                                                                                                                                                               |
| xxxix.                                                                                                                                                                                                                                             | Clarithromycin                                                                                                                                                                                                                                     |                                                                                                                                                                                                                                                    | 0.03                                                                                                                                                                                                                                               |
| xl.                                                                                                                                                                                                                                                | Clavulanic Acid                                                                                                                                                                                                                                    |                                                                                                                                                                                                                                                    | 22.40                                                                                                                                                                                                                                              |
| xli.                                                                                                                                                                                                                                               | Clinafloxacin                                                                                                                                                                                                                                      |                                                                                                                                                                                                                                                    | 0.20                                                                                                                                                                                                                                               |
| xlii.                                                                                                                                                                                                                                              | Clindamycin                                                                                                                                                                                                                                        |                                                                                                                                                                                                                                                    | 0.04                                                                                                                                                                                                                                               |
| xliii.                                                                                                                                                                                                                                             | Cloxacillin                                                                                                                                                                                                                                        |                                                                                                                                                                                                                                                    | 0.05                                                                                                                                                                                                                                               |
| xliv.                                                                                                                                                                                                                                              | Colistin                                                                                                                                                                                                                                           |                                                                                                                                                                                                                                                    | 0.80                                                                                                                                                                                                                                               |
| xlv.                                                                                                                                                                                                                                               | Daptomycin                                                                                                                                                                                                                                         |                                                                                                                                                                                                                                                    | 0.40                                                                                                                                                                                                                                               |
| xlvi.                                                                                                                                                                                                                                              | Delamanid                                                                                                                                                                                                                                          |                                                                                                                                                                                                                                                    | 0.02                                                                                                                                                                                                                                               |
| xlvii.                                                                                                                                                                                                                                             | Doripenem                                                                                                                                                                                                                                          |                                                                                                                                                                                                                                                    | 0.04                                                                                                                                                                                                                                               |
| xlviii. xlix.                                                                                                                                                                                                                                      | Doxycycline Enramycin                                                                                                                                                                                                                              |                                                                                                                                                                                                                                                    | 0.80 1.92                                                                                                                                                                                                                                          |
| l.                                                                                                                                                                                                                                                 | Enrofloxacin                                                                                                                                                                                                                                       |                                                                                                                                                                                                                                                    | 0.02                                                                                                                                                                                                                                               |

| li.              | Ertapenem                | 0.05       |
|------------------|--------------------------|------------|
| lii.             | Erythromycin             | 0.20       |
| liii.            | Ethambutol               | 0.80       |
| liv.             | Faropenem                | 0.01       |
| lv.              | Fidaxomicin              | 0.01       |
| lvi.             | Florfenicol              | 0.80       |
| lvii.            | Fluconazole              | 0.10       |
| lviii.           | Flumequine               | 0.10       |
| lix.             | Fosfomycin               | 0.80       |
| lx.              | Fusidic acid             | 0.20       |
| lxi.             | Gatifloxacin             | 0.05       |
| lxii.            | Gemifloxacin             | 0.02       |
| lxiii.           | Gentamicin               | 0.08       |
| lxiv.            | Imipenem                 | 0.05       |
| lxv.             | Isoniazid                | 0.05       |
| lxvi.            | Itraconazole             | 0.004      |
| lxvii.           | Kanamycin                | 0.44       |
| lxviii.          | Levofloxacin             | 0.10       |
| lxix.            | Lincomycin               | 0.72       |
| lxx.             | Linezolid                | 2.68       |
| lxxi.            | Loracarbef               | 0.80       |
| lxxii.           | Mecillinam               | 0.40       |
| lxxiii.          | Meropenem                | 0.02       |
| lxxiv.           | Metronidazole            | 0.05       |
| lxxv.            | Minocycline              | 0.40       |
| lxxvi.           | Moxifloxacin             | 0.05       |
| lxxvii.          | Mupirocin                | 0.10       |
| lxxviii. lxxix.  | Nalidixic acid Narasin   | 6.40 0.20  |
| lxxx.            | Neomycin                 | 0.01       |
| lxxxi.           | Netilmicin               | 0.20       |
|                  | Nitrofurantoin           | 25.60      |
| lxxxii. lxxxiii. | Norfloxacin              | 0.20       |
| lxxxiv.          | Ofloxacin                | 0.20       |
| lxxxv.           | Oxacillin                | 0.40       |
| lxxxvi.          | Oxytetracycline          | 0.20       |
| lxxxvii.         | Pefloxacin               | 3.20       |
| lxxxviii.        | Phenoxymethylp enicillin | 0.02       |
| lxxxix.          | Piperacillin             | 0.20       |
| xc.              | Polymixin                | 0.80       |
| xci.             | Retapamulin              | 0.02       |
| xcii.            | Rifampicin               | 0.02       |
| xciii.           | Roxithromycin            | 0.40       |
| xciv.            | Secnidazole              | 0.40       |
| xcv.             | Sparfloxacin             | 0.02       |
| xcvi.            | Spectinomycin            | 12.80      |
| xcvii.           | Spiramycin               | 0.20       |
| xcviii.          | Streptomycin             | 6.40       |
| c.               | Sulfadiazine             | 288.00     |
| ci.              | Sulfadimethoxin          |            |
|                  | Sulfadoxine              | 0.24       |
| cii.             |                          |            |
| ciii.            | Sulfamethoxazol e        | 0.24       |
| civ. cv.         | Tazobactam Tedizolid     | 17.60 3.92 |
| cvi.             | Teicoplanin              | 0.20       |
| cvii.            | Telithromycin            | 0.02       |

| cviii.   | Tetracycline   | 0.40    |
|----------|----------------|---------|
| cix.     | Thiamphenicol  | 0.40    |
| cx.      | Tiamulin       | 0.40    |
| cxi.     | Ticarcillin    | 3.20    |
| cxii.    | Tigecycline    | 0.40    |
| cxiii.   | Tildipirosin   | 0.17    |
| cxiv.    | Tilmicosin     | 0.40    |
| cxv.     | Tobramycin     | 0.40    |
| cxvi.    | Trimethoprim   | 0.20    |
| cxvii.   | Trovafloxacin  | 0.01    |
| cxviii.  | Tylosin        | 0.33    |
| cxix.    | Vancomycin     | 3.20    |
| cxx.     | Viomycin       | 0.80    |
| cxxi.    | Virginiamycin  | 0.80.'. |

Note:The  sludge  containing  antibiotic  residues  shall  be  incinerated  and  the  standard  of  incinerator  notified  for common hazardous waste incinerator or industry specific incinerator shall be applicable.

[F.No. Q-15017/12/2018-CPW] JIGMET TAKPA, Jt. Secy.

Note: The principal rules were published in the Gazette of India, Extraordinary, Part II, Section 3,Sub-section (i) vide number  S.O.  844  (E),  dated  the  19th  November,  1986  and  last  amended  vide  notification  number  G.S.R. 952(E), dated the 26th December, 2019.