## Policy Analysis Report: New Drug Manufacturing and Stocking for COVID-19 (S.O. 553E)
**1. Executive Summary:**
This report analyzes Notification S.O. 553E, issued by the Ministry of Health and Family Welfare on February 9, 2022, concerning the manufacture and stocking of new drugs for COVID-19 treatment and related diseases. The core purpose of this notification is to expedite the availability of new drugs to address the emergency situation caused by the COVID-19 pandemic. Key findings include a streamlined process for manufacturers involving clinical trials and deferred requirements for prior permission to manufacture, aimed at quickly supplying needed drugs. The notification prioritizes public interest and overrides conflicting existing rules to meet the emergency.
**2. Introduction:**
This report provides an informative analysis of Notification S.O. 553E, as published in the Gazette of India on February 9, 2022. The analysis is based solely on the provided text of the notification and aims to inform affected parties regarding its provisions and implications.
**3. Policy Overview:**
This is a *new* policy enacted via notification.
* **Core Objective(s):** The core objective is to facilitate the rapid manufacture and stocking of new drugs for the treatment and management of COVID-19 and related diseases (such as Mucormycosis) in response to the COVID-19 pandemic. It aims to make suitable new drugs available to meet the requirements of this emergency, prioritizing public interest.
**4. Background and Rationale:**
As this is a new policy, the likely problem it addresses is the urgent need for new drugs to combat the COVID-19 pandemic and associated infections. The notification explicitly mentions the "outbreak of COVID19 pandemic throughout India, resulting into dangerous and opportunist infections, disease like Mucormycosis, etc." and the "emergency has arisen to make available new drugs for treatment or management of COVID19 and related diseases". This indicates a perceived shortage of effective treatments and a need to accelerate the drug development and distribution process.
**5. Key Provisions / Changes:**
The policy establishes the following provisions for manufacturers of new drugs for COVID-19:
* **Clinical Trial and Marketing Authorization:** A person intending to manufacture and stock a new drug for COVID-19 that is undergoing clinical trials for marketing authorization must:
* Obtain permission in Form CT06 to conduct a clinical trial.
* Upon successful completion of the clinical trial, obtain permission in Form CT23 from the Central Licensing Authority under the New Drugs and Clinical Trials Rules, 2019.
* Apply to the concerned Licensing Authority appointed by the State Government under rule 69, 70A, 75, or 75A of the Drugs Rules, 1945 for a license to manufacture and stock the drug for sale or distribution. This application must include the permission obtained for the clinical trial in Form CT06.
* **Deferred Prior Permission Requirement:** The requirement of prior permission from the Central Licensing Authority under rule 81 of the New Drugs and Clinical Trials Rules, 2019, to manufacture the new drug (as required under rule 83 of the said rules) is deferred to meet the emergent situation arising out of COVID-19. The notification states that such permission must be obtained *after* successful completion of the clinical trial and submission of the application with the necessary documentation and fees.
* **License Granting Condition:** The Central License Approving Authority or the State Licensing Authority, if satisfied with compliance with the Drugs and Cosmetics Act, 1940, the Drugs Rules, 1945, and the New Drugs and Clinical Trials Rules, 2019, may grant a license to manufacture and stock the new drug. However, the licensee is required to sell or distribute the new drug *only* after obtaining permission for such new drug in Form CT23 from the Central Licensing Authority under the New Drugs and Clinical Trials Rules, 2019.
* **Precedence Over Conflicting Rules:** In case of any inconsistency between the notification and any rule made under the Drugs and Cosmetics Act, 1940, the provisions of the notification will prevail to meet the emergency arising due to the COVID-19 pandemic.
**6. Target Audience and Stakeholders:**
The target audience and stakeholders directly affected by this policy include:
* Pharmaceutical manufacturers intending to develop, manufacture, and stock new drugs for COVID-19 treatment.
* Central Licensing Authority.
* State Licensing Authorities.
* Clinical trial organizers and participants.
* Patients and healthcare providers involved in COVID-19 treatment and management.
**7. Implementation Aspects (Inferred):**
* **Responsible Agency/Bodies:**
* Ministry of Health and Family Welfare (issuing authority)
* Central Licensing Authority (responsible for granting Form CT23 permission).
* State Licensing Authorities (responsible for granting manufacturing and stocking licenses).
* **Timelines/Procedures:**
* The policy came into effect on February 9, 2022, the date of its publication in the Official Gazette.
* Manufacturers must first obtain Form CT06 permission for clinical trials.
* Upon successful completion of the clinical trial and after getting Form CT23, manufacturers then apply for the manufacturing and stocking license to the State Licensing Authority.
* Prior permission under rule 81 and 83 is deferred until after successful completion of clinical trials and submission of an application.
**8. Expected Outcomes / Impact of Changes:**
The likely intended outcomes of this policy are:
* **Increased Availability of New Drugs:** The streamlined approval process and deferred requirements for prior permission are intended to accelerate the manufacturing and stocking of new drugs for COVID-19.
* **Faster Access to Treatment:** By expediting drug availability, the policy aims to provide faster access to potentially life-saving treatments for COVID-19 patients.
* **Effective Pandemic Response:** The policy is designed to enhance the government's ability to respond effectively to the COVID-19 pandemic by ensuring an adequate supply of essential medications.
**9. Conclusion:**
Notification S.O. 553E represents a significant policy intervention designed to address the urgent need for new drugs in the context of the COVID-19 pandemic. By streamlining the approval process and deferring certain regulatory requirements, the policy aims to facilitate the rapid manufacture and distribution of essential medications, ultimately contributing to a more effective pandemic response. This notification is significant because it temporarily prioritizes speed of drug production over standard regulatory hurdles, with the understanding that these hurdles will be addressed after the initial emergency response.
Key Entities Referenced
COVID19: Coronavirus disease 2019 pandemic affecting India.
Mucormycosis: A dangerous opportunistic infection/disease associated with COVID19.
Drugs Rules, 1945: Indian regulations pertaining to drugs manufacture, sale and distribution.
New Drugs and Clinical Trials Rules, 2019: Indian regulations concerning new drugs and clinical trials.
Drugs and Cosmetics Act, 1940: Indian legislation related to drugs and cosmetics, specifically section 26B.
Form CT06: Form for obtaining permission to conduct clinical trials of new drugs.
Form CT23: Form for obtaining permission from the Central Licensing Authority under the New Drugs and Clinical Trials Rules, 2019.
Central Licensing Authority: Authority responsible for granting permission in Form CT23 under the New Drugs and Clinical Trials Rules, 2019.
State Government: Refers to the government of individual states within India, responsible for appointing Licensing Authorities.
State Licensing Authority: Licensing authority appointed by the State Government.
Central License Approving Authority: Authority that grants licenses in accordance with the provisions of the Drugs Rules, 1945 to manufacture and stock the new drug.
Dr. MANDEEP K BHANDARI: Jt. Secy.
New Delhi: The location of the Ministry of Health and Family Welfare and where the notification was issued.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-10022022-233278
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CG-DL-E-10022022-233278
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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.ं 534] नई दिल्ली, बुधवार, फरवरी 9, 2022/माघ 20, 1943
No. 534] NEW DELHI, WEDNESDAY, FEBRUARY 9, 2022/MAGHA 20, 1943
स्ट्व ास्ट्् य और पररवार कल्य ाण मत्रं ालय
(स्ट्व ास्ट्् य और पररवार कल्य ाण जव भाग)
अजधसचू ना
नई दिल्ली, 9 फरवरी, 2022
का.आ. 553(अ).—संपूणण भारत म ें कोजवड-19 महामारी का प्रकोप ह,ै जिसके पररणामस्ट्वरूप खतरनाक और
अवसरवािी संक्रमण, म्यूकोर्मणकोजसस िैसी बीमारी आदि होती ह,ै जिसके कारण कोजवड-19 और संबंजधत रोगों के उपचार
या प्रबंधन के जलए नई औषजध उपलब्ध करान े के जलए आपात जस्ट्िजत उत्पन्न हो गई ह;ै
केन्द रीय सरकार को यह समाधान हो गया ह ै दक कोजवड-19 महामारी के कारण उत् पन्द न हुई आपात जस्ट्िजत की
आवश् यकतां को पूरा करन े के जलए नए औषजध की उपलब् धता अजनवाय ण ह,ै और कोजवड-19 संक्रमण की रोकिाम,
उपचार के जलए औषजध की जब क्री या जवतरण के जलए जव जनमाणण और भडं ारण को जवजनयजमत करना िनजहत म ें आवश् यक
और प्रासंजगक ह;ै
अतः अब, केन्द रीय सरकार औषजध और प्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23) की धारा 26ख द्वारा
प्रित् त िजियों का प्रयोग करते हुए, औषजध जनयम, 1945 और नए औषजध और नैिाजनक परीक्षण जनयम, 2019 म ें
अंतर्वणष्ट दकसी बात के होते हुए भी, कोजवड-19 के कारण उत्पन्न आपात जस्ट्िजत की अपेक्षां को पूरा करन े के जलए उपयुि
औषजध उपलब्ध कराए िाने के प्रयोिन स े जनम्नजलजखत अजधसचू ना िारी करती ह,ै अिाणत:—
(क) यदि कोई व् यजि, कोजवड-19 के जलए दकसी औषजध, िो जबक्री या जवतरण के जलए जवपणन प्राजधकार हते ु
नैिाजनक परीक्षण के अधीन ह,ै के जवजनमाणण एव ं भंडारण का इच्छ ुक ह ै तो वह उस औषजध के नैिाजनक
परीक्षण के जलए प्ररूप सीटी-06 के रूप म ें अनुमजत ल े चुका होगा और निै ाजनक परीक्षण के सफल समापन
के बाि और नए औषजध और नैिाजनक परीक्षण जनयम, 2019 के अंतगणत केन्द रीय अनुज्ञापन प्राजधकारी स े
878 GI/2022 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
प्ररूप सीटी-23 म ें अनुमजत प्राप्त करन े के बाि वह औषजध और प्रसाधन सामग्री अजधजनयम, 1940 (1940
का 23) (जिसे इसम ें इसके पश्चात ् उि अजधजनयम कहा गया ह)ै और उसके तहत बनाए गए जनयमों के
उपबंधों के अंतगणत ऐसी जबक्री एव ं जवतरण हते ु औषजध के जवजनमाणण एव ं भडं ार के जलए अनुज्ञजि प्रिान दकए
िाने के जलए औषजध जनयम, 1945 के जनयम 69 या जनयम 70क या जनयम 75 या जनयम 75क के अंतगणत,
िैसा भी मामला हो, नए औषजध और नैिाजनक परीक्षण जनयम, 2019, के अंतगणत प्ररूप सीटी-06 म ें
नैिाजनक परीक्षण करने के जलए प्राि अनुमजत के साि आवेिन करेगा।
परंत ु दक नए औषजध और निै ाजनक परीक्षण जनयम, 2019 के जनयम 81 के अंतगणत अनुज्ञापन
प्राजधकारी स े नए औषजध के जवजनमाणण की पूवण-अनुमजत की आवश् यकता, िैसा दक उि जनयमों के जनयम 83
के तहत अपेजक्षत ह,ै कोजवड-19 स े उत्पन्न आपात जस्ट्िजत स े जनपटन े के जलए िनजहत म,ें आस्ट् िजगत होगी
और व् यजि, नैिाजनक परीक्षण के सफल समापन और नए औषजध और नैिाजनक परीक्षण जनयम, 2019 के
उपबंधों के अनुसार िल्ु क और डेटा तिा जववरणों के साि आवेिन प्रस्ट्त ुत करने के बाि उक्त अनुमजत प्राप्त
करेगा।
(ख) केन्द रीय अनज्ञु ापन अनुमोिन प्राजधकारी या राज्य अनज्ञु ापन प्राजधकारी, िैसा भी मामला हो, को यदि यह
समाधान हो िाता ह ै दक उि अजधजनयम और औषजध जनयम, 1945 तिा नए औषजध और नैिाजनक
परीक्षण जनयम, 2019 के अंतगणत जन धाणररत उपबंधों के अनुसार, अपेक्षां का अनपु ालन दकया गया ह ै तो
औषजध जनयम, 1945 के उपबधं ों के अनुसार नए औषजध के जवजनमाणण और भडं ारण के जलए इस ित ण के
अधीन अनुज्ञजि प्रिान कर सकता ह ै दक उक्त औषजध के संबंध म ें नए औषजध और नैिाजनक परीक्षण जनयम,
2019 के अतं गतण केन्द रीय अनज्ञु ापन प्राजधकारी स े प्ररूप सीटी-23 म ें अनुमजत प्राप् त करने के बाि ही
अनुज्ञजिधारी द्वारा नए औषजध की जबक्री और जवतरण दकया िायेगा।
2. इस अजधसूचना और उि अजधजनयम के अधीन बनाय े गय े दकसी जनयम के बीच कोई असंगजत होने के
मामले म,ें कोजवड-19 महामारी के कारण उत्पन्न आपात जस्ट्िजत स े जनपटने के जलए िनजहत में, ऐसे जनयम के स्ट् िान पर इस
अजधसूचना के उपबंध प्रभावी होंगे।
3. यह आििे रािपत्र म ें प्रकािन की तारीख से प्रवृत होगा।
[फा. स.ं एक् स-11014/02/2020-डीआरएस]
डॉ. मनिीप के. भण्डारी, संयुक् त सजचव
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 9th February, 2022
S.O. 553(E).—Whereas, there is an outbreak of COVID-19 pandemic throughout India, resulting into
dangerous and opportunist infections, disease like Mucormycosis, etc., due to which emergency has arisen to make
available new drugs for treatment or management of COVID-19 and related diseases;
Whereas, the Central Government is satisfied that making available suitable new drugs is essential to meet
the requirements of emergency arising due to pandemic COVID-19, and in public interest it is necessary and
expedient to regulate the manufacture and stock for sale or distribution of such new drugs for prevention and treatment
of COVID-19 and associated infection;
Now, therefore, notwithstanding anything contained in the Drugs Rules, 1945 and New Drugs and Clinical
Trials Rules, 2019, for the purposes of making available suitable drugs to meet the requirements of emergency arising
due to COVID-19, in exercise of the powers conferred by section 26B of the Drugs and Cosmetics Act, 1940 (23 of
1940), the Central Government, hereby notifies the following, namely:―
(a) In case a person intends to manufacture and stock a new drug for COVID-19, which is under clinical
trial for marketing authorisation for sale or distribution, then, such person shall have to obtain
permission in Form CT-06 to conduct clinical trial of such drug and on successful completion of the
clinical trial and after obtaining permission in Form CT-23 from the Central Licensing Authority under
the New Drugs and Clinical Trials Rules, 2019, he shall make an application under rule 69 or rule 70A[भाग II—खण् ड 3(ii)] भारत का रािपत्र : असाधारण 3
or rule 75 or rule 75A of the Drugs Rules, 1945, as the case may be, to the concerned Licensing
Authority appointed by the State Government along with the permission obtained for conducting
clinical trial in Form CT-06 under the New Drugs and Clinical Trials Rules, 2019, for grant of license
to manufacture and stock the drug for sale or distribution under the provisions of the Drugs and
Cosmetics Act, 1940 (23 of 1940) (hereinafter referred to as the said Act) and the rules made
thereunder:
Provided that the requirement of prior permission from the Central Licensing Authority under
rule 81 of the New Drugs and Clinical Trials Rules, 2019 to manufacture the new drug as required
under rule 83 of the said rules shall be deferred in public interest to meet the emergent situation arisen
out of COVID-19 and such person shall obtain the said permission after successful completion of the
clinical trial and submission of application along with fees, data and particulars in accordance with the
provisions of the New Drugs and Clinical Trials Rules, 2019.
(b) The Central License Approving Authority or the State Licensing Authority, as the case may be, if
satisfied that requirements under the provisions of the said Act and the Drugs Rules, 1945 and the New
Drugs and Clinical Trials Rules, 2019 have been complied with, grant License in accordance with the
provisions of the Drugs Rules, 1945 to manufacture and stock the new drug subject to the condition
that the licensee shall sell or distribute the new drug only after obtaining permission for such new drug
in Form CT-23 from the Central Licensing Authority under the New Drugs and Clinical Trials Rules,
2019.
2. In case of any inconsistency between this notification and any rule made under the said Act, the
provisions of this notification shall prevail over such rule in public interest so as to meet the emergency which has
arisen due to COVID-19 pandemic.
3. This order shall come into force on the date of its publication in the Official Gazette.
[F. No. X.11014/02/2020-DRS]
Dr. MANDEEP K BHANDARI, Jt. Secy.
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.