Executive Summary:
This notification, issued by the Ministry of Environment, Forest and Climate Change, amends the Environment Impact Assessment Notification, 2006. It categorizes projects related to bulk drugs and intermediates for ailments like COVID-19 as Category B2 until September 30, 2020, to expedite environmental clearances and ensure drug availability during the pandemic. Any changes post this date will be considered as per existing provisions.
Key Points / Main Content:
* **Categorization of Projects:**
* Projects or activities related to bulk drugs and intermediates manufactured for addressing ailments such as Novel Corona Virus COVID19 and those with similar symptoms are categorized as B2.
* **Validity Period:**
* This categorization is an interim measure effective up to September 30, 2020.
* **Applicability:**
* Applies to proposals received up to September 30, 2020, for projects or activities in respect of Active Pharmaceutical Ingredients (API).
* **Post-September 30, 2020 Changes:**
* Any subsequent amendment, expansion, or change in product mix after September 30, 2020, will be considered as per the provisions in force at that time.
* **Legal Basis:**
* The notification is issued in exercise of powers conferred by subsection 1 and clause v of subsection 2 of section 3 of the Environment Protection Act, 1986, read with subrule 4 of rule 5 of the Environment Protection Rules, 1986.
Impact Analysis:
* **Bulk Drug and Intermediate Manufacturers:**
* Impact: Benefit from expedited environmental clearances for projects related to bulk drugs and intermediates for ailments like COVID-19.
* Action Required: Submit project proposals before September 30, 2020, to avail of the Category B2 appraisal. Be aware that any changes or expansions after this date will be subject to standard environmental regulations.
* **Ministry of Environment, Forest and Climate Change:**
* Impact: Required to appraise projects related to bulk drugs and intermediates for ailments like COVID-19 as Category B2 projects until September 30, 2020.
* Action Required: Implement the amended guidelines for environmental clearance and ensure appraisal processes are expedited for relevant projects.
Key Entities Referenced
Environment Protection Act, 1986: The Act under which the Ministry of Environment, Forest and Climate Change exercises its powers to issue notifications regarding environmental clearances.
Ministry of Environment, Forest and Climate Change: The Indian government ministry responsible for environmental regulation and protection. It issues the notification regarding environmental clearances.
Environment Impact Assessment Notification, 2006: Notification S.O.1533 E, dated the 14th September, 2006, which mandates prior environmental clearance for certain categories of projects. This notification is being amended.
New Delhi: The location where the notification was issued.
Novel Corona Virus COVID19: The specific outbreak cited as a reason for expediting environmental clearances for bulk drug and intermediate projects.
Active Pharmaceutical Ingredients API: Projects related to Active Pharmaceutical Ingredients are to be appraised as Category B2 projects
30th September 2020: The interim period until which bulk drug and intermediate projects are categorized as B2 for expedited environmental clearance.
Geeta Menon: The Joint Secretary of the Indian government who signed the notification.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. NO. D. L.-33004/99
सी.जी.-डी.एल.-अ.-28032020-218947
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CG-DL-E-28032020-218947
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असाधारण
EXTRAORDINARY
भाग II—खण् ड 3—उप-खण्ड (ii)
PART II—Section 3—Sub-section (ii)
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 1087] नई दिल्ली, िुिवार, माच ा27, 2020/चत्रै 7, 1942
No. 1087] NEW DELHI, FRIDAY, MARCH 27, 2020/CHAITRA 7, 1942
पर्ावा रण, वन और िलवार् ुपररवतना मत्रं ालर्
अजधसचू ना
नई दिल् ली, 27 माचा, 2020
का.आ.1223(अ).—केंद्रीर् सरकार, पर्ाावरण (संरक्षण) अजधजनर्म 1986 की धारा (3) की उपधारा (1) और
उपधारा (2) के खंड (v) के अधीन उसको प्रित् त िजिर्ों का प्रर्ोग करते हुए, तत् कालीन पर्ाावरण और वन मंत्रालर् में
पररर्ोिनाओं के कजतपर् प्रवगों के जलए पूवा पर्ाावरण अनापजि आज्ञापक बनाते हुए का. आ. 1533 (अ) तारीख 14 जसतंबर,
2006 द्वारा पर्ाावरणीर् समाघात जनधाारण अजधसूचना, 2006 प्रकाजित दकर्ा ह;ै
और पर्ाावरण, वन और िलवार्ु पररवतान मंत्रालर्, थोक औषजधर्ों और मध्र् व्तार्ों के बाबत पररर्ोिनाओं र्ा
दिर्ाकलापों के जलए पूवा पर्ाावरणीर् अनापजि में तेिी लाने के जलए आवश् र्क समझता ह।ै नोवेल कोरोना वार्रस (कोजवड -
19) के प्रकोप को कम करने के जलए व् र्ापक और मिबूत प्रणाली के एक भाग के रूप में, नोवेल कोरोना वार्रस (कोजवड -19) के
समाघात को कम करने के जलए औषजध की उपलब् धता र्ा उत् पािन को सुजनजित दकर्ा िाना ह।ै मंत्रालर् ने र्ह आवश् र्क समझा
ह ैदक नोवेल कोरोना वार्रस (कोजवड -19) िैसी बीमाररर्ों का पता लगाने के जलए थोक औषजधर्ों और मध्र् व्तार्ों की बाबत
जवजन्मता सभी पररर्ोिनाओं र्ा दिर्ाकलापों और इसी तरह के लक्षणों वाले रोगों को 30 जसतंबर, 2020 तक की अवजध के
जलए ‘बी2’ के रूप में वगीकृत दकर्ा ह।ै
अत:, अब, केन्द द्रीर् सरकार, पर्ाावरण (संरक्षण) जनर्म, 1986 के जनर्म 5 के उपजनर्म (4) के साथ परित पर्ाावरण
संरक्षण अजधजनर्म, 1986 (1986 का 29) की धारा 3 की उपधारा (1) और उपधारा (2) के खंड (v) द्वारा उसको प्रित् त
िजिर्ों का प्रर्ोग करते हुए, लोकजहत में, जनर्मों के जनर्म 5 के उप-जनर्म (3) के खंड (क) के अधीन सूचना की अपेक्षा स े
अजभमुजि के पश् चात्, इस अजधसूचना के रािपत्र में प्रकािन की तारीख से 30 जसतंबर, 2020 तक की अवजध के जलए भारत के
1622 GI/2020 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
रािपत्र, असाधारण, भाग II, खंड 3, उपखंड (ii) में सं. का. आ. 1533 (अ), तारीख 14 जसतंबर, 2006 द्वारा प्रकाजित भारत
सरकार के तत् कालीन पर्ाावरण और वन मंत्रालर् की उक् त अजधसूचना में जनम् नजलजखत और संिोधन करती है, अथाात् :-
उक् त अजधसूचना की अनुसूची म,ें स्ट् तंभ (5) के मि 5 (च) के सामने उससे संबंजधत प्रजवजिर्ों के पश् चात्, जनम् नजलजखत
प्रजवजिर्ां अंत:स्ट् थाजपत की िाएंगी, अथाात् :-
‘‘30 जसतंबर, 2020 तक प्राप् त एजक्िव फामाास्ट् र्ुरिकल इन्द रजे डएं स (एपीआई) की बाबत पररर्ोिनाओं र्ा
दिर्ाकलापों के सभी प्रस्ट् तावों को श्रेणी ‘बी2’ पररर्ोिनाओं के रूप में जनधााररत दकर्ा िाएगा, परन्द तु 30 जसतंबर, 2020 के
पश् चात् कोई पश् चात्वती संिोधन र्ा उत् पाि जमश्रण में जवस्ट्त ार र्ा पररवतान उस समर् तक प्रवृत् त उपबंधों के अनुसार माना
िाएगा।’’
[फा. सं. 19-21/2020 – आई ए. III]
गीता मेनन, संर्ुक्त सजचव
रिप्प ण : मूल अजधसूचना संख्र् ा का. आ. 1533 (अ) तारीख 14 जसतंबर, 2006 द्वारा भारत के रािपत्र, असाधारण, भाग II,
खंड 3, उप-खंड (ii) में प्रकाजित दकर्ा गर्ा था और अजधसूचना संख् र्ा का. आ. 751 (अ), तारीख 17 फरवरी, 2020
द्वारा अंजतम संिोधन दकर्ा गर्ा था।
MINISTRY OF ENVIRONMENT, FOREST AND CLIMATE CHANGE
NOTIFICATION
New Delhi, the 27th March, 2020
S.O. 1223(E).—WHEREAS, the Central Government in the erstwhile Ministry of Environment and
Forests, in exercise of its powers under sub-section (1) and clause (v) of sub-section (2) of section (3) of the
Environment (Protection) Act, 1986 has published the Environment Impact Assessment Notification, 2006 vide
number S.O.1533 (E), dated the 14th September, 2006, mandating prior environmental clearance for certain
category of projects;
AND WHEREAS, the Ministry of Environment, Forest and Climate Change deems it necessary to
expedite the prior Environmental Clearances to the projects or activities in respect of bulk drugs and
intermediates. As a part of comprehensive and robust system to handle the Novel Corona Virus (COVID-19)
outbreak, drug availability or production to reduce the impact of the Novel Corona Virus (COVID-19) are to be
ensured. The Ministry deems it necessary that all projects or activities in respect of bulk drugs and intermediates
manufactured for addressing ailments such as Novel Corona Virus (COVID-19) and those with similar
symptoms are categorized as ‘B2’ for a period up to the 30th September 2020, as an interim measure.
Now, therefore, in exercise of the powers conferred by sub-section (1) and clause (v) of sub-section (2)
of section 3 of the Environment (Protection) Act, 1986 (29 of 1986), read with sub-rule (4) of rule 5 of the
Environment (Protection) Rules, 1986, the Central Government, after having dispensed with the requirement of
notice under clause (a) of sub-rule (3) of the rule 5 of the rules in public interest hereby makes the following
further amendments in the said notification of the Government of India, in the erstwhile Ministry of
Environment and Forests published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (ii)
vide number S.O. 1533 (E), dated the 14th September, 2006, for a period up to 30th September 2020 from the
date of publication of this notification in the official Gazette, namely:-
In the said notification, in the Schedule, against the item 5(f), in the column (5), after entries relating
thereto the following entries shall be inserted, namely:-
“All proposals for projects or activities in respect of Active Pharmaceutical Ingredients (API),
received up to the 30th September 2020, shall be appraised, as Category ‘B2’ projects, provided that
any subsequent amendment or expansion or change in product mix, after the 30th September 2020,
shall be considered as per the provisions in force at that time.”.
[F.No. 19-21/2020-IA.III]
GEETA MENON, Jt. Secy.
Note: The principal notification was published in the Gazette of India, Extraordinary, Part II, Section 3,
Sub-section (ii) vide number S.O. 1533 (E), dated the 14th September, 2006 and was last amended vide
the notification number S.O. 751(E), dated the 17th February, 2020.
Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064
and Published by the Controller of Publications, Delhi-110054.