## Policy Analysis Report: Amendment to Notification Regarding Fixed Dose Combinations of Corticosteroids
**1. Executive Summary:**
This report analyzes an amendment to a pre-existing policy regarding Fixed Dose Combinations (FDCs) of corticosteroids. The amendment, enacted through notification G.S.R. 255E, dated April 7, 2021, modifies notification G.S.R. 578E, dated July 23, 1983, as previously amended. The core purpose of the amendment is to exclude a specific FDC – Tamsulosin HCI 0.4 mg / Deflazacort 30 mg – from the general prohibition on corticosteroid FDCs for systemic use. Key findings indicate this decision was based on recommendations from the Prof. Kokate Committee and the Drugs Technical Advisory Board, following examinations of the safety and efficacy of this specific FDC.
**2. Introduction:**
The purpose of this report is to provide an informative analysis, based solely on the provided text of notification G.S.R. 255E, regarding the amendment to the existing policy concerning Fixed Dose Combinations (FDCs) of corticosteroids. This report will outline the context, rationale, specific changes, and likely impact of this amendment.
**3. Policy Overview:**
* This document is an amendment to notification G.S.R. 578E, dated July 23, 1983, which prohibited the manufacture and sale of FDCs of steroids for internal use (with some exceptions). This notification was previously amended by notification G.S.R. 738E, dated October 9, 2009.
* **Core Objective (inferred from text regarding the amendment):** To refine the existing prohibition on corticosteroid FDCs by excluding a specific combination deemed safe and effective for use: Tamsulosin HCI 0.4 mg / Deflazacort 30 mg.
**4. Background and Rationale:**
The amendment appears to address concerns about overly broad restrictions on corticosteroid FDCs. The original policy, aimed at mitigating risks associated with such combinations, seems to have been re-evaluated in light of new evidence regarding the safety and efficacy of Tamsulosin HCI 0.4 mg / Deflazacort 30 mg. The involvement of the Prof. Kokate Committee and the Drugs Technical Advisory Board suggests a rigorous review process preceded this amendment, likely triggered by industry advocacy or new scientific data. The text implies that this specific FDC provides a net benefit to patients, justifying its exclusion from the general prohibition.
**5. Key Provisions / Changes:**
* **Specific Part of Original Policy Changed:** Item 14 in the Table of notification G.S.R. 578E (as amended by G.S.R. 738E) is being substituted. This item pertains to "Fixed Dose combination of corticosteroid with any other drug for internal use except for preparations meant for meter dose inhalers and dry powder inhalers".
* **New Rule/Provision:** The substituted item 14 now reads: "Fixed Dose Combination of corticosteroid with any other drug excluding Fixed Dose Combination of Tamsulosin HCI 0.4 mg as film coated modified release tablet Deflazacort 30mg in hard gelatin capsule for internal use except for preparations meant for meter dose inhalers and dry powder inhalers."
* **Difference/Effect of Change:** The key effect of this amendment is to *remove* the prohibition on the manufacture and sale of the specific FDC, Tamsulosin HCI 0.4 mg / Deflazacort 30 mg. Previously, this FDC would have been subject to the general prohibition on corticosteroid FDCs for internal use. Now, it is explicitly excluded, as long as it is not administered via meter dose inhalers or dry powder inhalers.
**6. Target Audience and Stakeholders:**
* Pharmaceutical manufacturers who produce or intend to produce Tamsulosin HCI 0.4 mg / Deflazacort 30 mg in hard gelatin capsule.
* Patients who may benefit from this specific FDC.
* Healthcare professionals who prescribe or administer this FDC.
* The Drugs Technical Advisory Board, which was consulted regarding the amendment.
**7. Implementation Aspects (Inferred):**
* **Responsible Agency/Bodies:** The Central Government, specifically the Ministry of Health and Family Welfare (Department of Health and Family Welfare), is responsible for implementing this amendment. The Drugs Technical Advisory Board provides consultation.
* **Timelines/Procedures:** The amendment is effective as of the date of the notification (April 7, 2021). No specific implementation procedures or timelines are detailed within the provided text beyond the act of publication.
* **(Amendment-Specific Implementation):** Manufacturers of Tamsulosin HCI 0.4 mg / Deflazacort 30 mg no longer require special exemptions or approvals to manufacture and sell this product, unlike other corticosteroid FDCs, provided they meet all other regulatory requirements.
**8. Expected Outcomes / Impact of Changes:**
* The intended outcome is likely to make Tamsulosin HCI 0.4 mg / Deflazacort 30 mg more readily available to patients who require it.
* The amendment may encourage further research and development into other FDCs, potentially leading to the exclusion of additional combinations from the general prohibition, provided they meet stringent safety and efficacy standards.
* The amendment clarifies the regulatory landscape for manufacturers and healthcare providers regarding this specific FDC.
**9. Conclusion:**
The amendment to notification G.S.R. 578E, as detailed in notification G.S.R. 255E, represents a refinement of the policy regarding corticosteroid FDCs. By excluding Tamsulosin HCI 0.4 mg / Deflazacort 30 mg from the general prohibition, the amendment aims to balance the need for patient access to beneficial medications with the need to mitigate risks associated with corticosteroid combinations. This change highlights the importance of ongoing evaluation and adaptation of regulations in light of new scientific evidence and expert recommendations. The decision to exclude this specific FDC underscores the commitment to evidence-based policy and suggests a willingness to consider the benefits of certain combinations when their safety and efficacy are demonstrably proven.
Key Entities Referenced
New Delhi: Location of the notification, likely referring to New Delhi, Delhi, India.
Ministry of Health and Family Welfare: The Indian government ministry responsible for health policy.
Department of Health and Family Welfare: A department within the Ministry of Health and Family Welfare.
Central Government: The government of India.
Fixed Dose Combination: A pharmaceutical term for a combination of two or more active drugs in a single dosage form (FDC).
G.S.R. 578E: A notification number related to prohibition of manufacture and sale of FDCs of Steroids, dated the 23rd July, 1983.
G.S.R. 738E: A notification number that further amended G.S.R. 578E, dated the 9th October, 2009.
Tamsulosin HCI 0.4 mg as film coated modified release tablet Deflazacort 30 mg hard gelatin capsule: A specific Fixed Dose Combination (FDC) drug that is being examined and excluded from prohibition.
Prof. Kokate Committee: A committee constituted by the Central Government to examine the safety and efficacy of FDCs.
Central Licensing Authority: Licensing authority for drugs.
Drugs Technical Advisory Board: An advisory board related to drugs and pharmaceuticals.
Drugs and Cosmetics Act, 1940: An act of the Parliament of India which regulates the import, manufacture, distribution and sale of drugs and cosmetics.
DR. MANDEEP K BHANDARI: Jt. Secy. , likely a Joint Secretary in the government, responsible for the notification.
Gazette of India: The official journal of the Government of India.
रजजस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
xxxGIDHxxx
सी.जी.-डी.एxलxx.-GअID.-E1x0x0x 42021-226478
CG-DL-E-10042021-226478
ऄसाधारण
EXTRAORDINARY
भाग II—खण् ड 3—ईप-खण्ड (i)
PART II—Section 3—Sub-section (i)
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 204] नइ दद्ली, िुक्रवार, ऄप्रलै 9, 2021/चत्रै 19, 1943
No. 204] NEW DELHI, FRIDAY, APRIL 9, 2021/CHAITRA 19, 1943
स्ट्व ास्ट्् य रर पिरवार क्य ाण मत्रं ालय
(स्ट्वास्ट््य रर पिरवार क्याण जवभाग)
ऄजधसचू ना
नइ दद् ली, 7 ऄप्रैल, 2021
सा.का.जन. 255(ऄ).—जबदक, केंद्रीय सरकार न े आसस े समाधान होन े पर दक कोर्टिकोस्ट्िेरॉयड के जनयत खुराक
सजममश्रण (आसम ें आसके पश्चात ् एफडीसी कहा गया ह)ै के दकसी ऄन्य रषजध के साथ सवागां ी ईपयोग से मानवीय जीवन
खतरे म ें पड़ सकता ह,ै तारीख 23 जुलाइ, 1983 की ऄपनी ऄजधसूचना संख्या सा.का.जन. 578 (ऄ) के माध्यम स,े ऄन्य
बातों के साथ-साथ स्ट्िेरॉआड्स के एफडीसी के जवजनमााण रर जबक्री को, ऄस्ट्थमा के ईपचार के जलए, ऄन्य रषजधयों के साथ
स्ट्िेरॉआड्स के सजममश्रण को छोड़कर, अंतिरक ईपयोग के जलए जनजषद्ध कर ददया ह;ै
रर जबदक, केंद्रीय सरकार ने तारीख 9 ऄक्तूबर, 2009 की ऄजधसूचना संख्या सा.का.जन. 738(ऄ) के माध्यम स े
तारीख 23 जुलाइ, 1983 की ईक्त ऄजधसूचना संख्या सा.का.जन. 578(ऄ) म ें पनु ः संिोधन दकया था तथा मद 14 रर
ईससे संबंजधत प्रजवजियों को "मीिर डोज़ आन्हले स ा रर ड्राइ पाईडर आनहले सा के जलए जवजनर्ममजतयों के जसवाय अंतिरक
ईपयोग के जलए दकसी ऄन्य रषजध के साथ कॉर्टिकोस्ट्िेरॉआड का जनयत खुराक सजममश्रण" प्रजवजि स े प्रजतस्ट्थाजपत दकया था;
रर जबदक, तमसुलोजसन हाआड्रोक्लोराआड 0.4 एमजी (दफ्म कोिेड मोजडफाआड िरलीज़ िेबलेि के रूप म)ें +
डेफ्लाजाकोिा 30 एमजी हाडा जजलेििन कैप्सूल की एफडीसी की केंद्रीय ऄनुज्ञापन प्राजधकरण की जबना पूवा ऄनुमोदन के 1
ऄक्तूबर, 2012 स े पूवा ऄनुज्ञजि जारी दकए गए थ,े की सुरक्षा रर प्रभावोत्पादकता की जांच करने के जलए केंद्रीय सरकार
2127 GI/2021 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
द्वारा गिित प्रोफेसर कोकािे सजमजत द्वारा जांच की गइ थी रर आसीजलए, प्रोफेसर कोकािे सजमजत न े ईपलब्ध दस्ट्तावेजों
रर वैज्ञाजनक दस्ट्तावेजों के अधार पर वतामान पिरदश्ृ य म ें ईक्त एफडीसी की जांच की थी तथा आस एफडीसी को
युजक्तसंगत माना था तथा तदनसु ार, तमसुलोजसन हाआड्रोक्लोराआड 0.4 एमजी (दफ्म कोिेड मोजडफाआड िरलीज़ िेबलेि के
रूप म)ें + डेफ्लाजाकोि ा 30 एमजी हाडा जजलेििन कैप्सूल को ऄनुमोददत कर ददया गया था;
रर जबदक, तमसुलोजसन हाआड्रोक्लोराआड 0.4 एमजी (दफ्म कोिेड मोजडफाआड िरलीज़ िेबलेि के रूप म)ें +
डेफ्लाजाकोिा 30 एमजी हाडा जजलेििन कैप्सूल के एफडीसी को भी रषजध तकनीकी सलाहकार बोडा को भेजा गया था तथा
ईसकी जांच करने के ईपरांत रषजध तकनीकी सलाहकार बोडा न े तमसुलोजसन हाआड्रोक्लोराआड 0.4 एमजी (दफ्म कोिेड
मोजडफाआड िरलीज़ िेबलेि के रूप में)+ डेफ्लाजाकोि ा 30 एमजी हाड ा जजलेििन कैप्सूल के एफडीसी को तारीख 9 ऄक्तूबर,
2009 को ऄजधसूचना संख्या सा.का.जन. 738 (ऄ) के माध्यम स े दकए गए जनषेध स े ऄलग करने की जसफािरि की थी।
ऄतः ऄब, केंद्रीय सरकार रषजध रर प्रसाधन सामग्री ऄजधजनयम, 1940 (1940 का 23) की धारा 26क द्वारा
प्रदत्त िजक्तयों का प्रयोग करत े हुए, रषजध तकनीकी सलाहकार बोड ा स े परामि ा के पश्चात ् एतद ् द्वारा तारीख 23 जलु ाइ,
1983 की ऄजधसूचना संख्या सा.का.जन. 578 (ऄ) म ेंरर संिोधन करने के जलए जनम्नजलजखत संिोधन करती ह,ै ऄथाात:—
ऄजधसूचना म,ें सारणी म,ें मद 14 रर ईससे संबंजधत प्रजवजियों के स्ट्थान पर, जनम्नजलजखत मद रर प्रजवजियां
रखी जाएंगी, ऄथाात:—
"कोर्टिकोस्ट्िेरॉआड का जसवाय मीिडा डोज आनहले सा तथा ड्राइ पाईडर आनहले सा के जलए जवजनर्ममजतयों के अंतिरक
ईपयोग हते ु तमसलु ोजसन हाआड्रोक्लोराआड 0.4 एमजी (दफ्म कोिेड मोजडफाआड िरलीज़ िेबलेि के रूप में)+ हाडा जजलेििन
कैप्सूल म ेंडेफ्लाजाकोि ा 30 एमजी को छोड़कर ऄन्य दकसी रषजध के साथ जनयत खुराक सजममश्रण । "।
[फा. स.ं एक्स.11014/8/2020-डीअर]
डॉ. मनदीप के भण्ड ारी, सयं क्ु त सजचव
ििप्पणी: मूल ऄजधसूचना ऄजधसूचना संख्या सा.का.जन. 578(ऄ) तारीख 23 जुलाइ, 1983 के द्वारा भारत के राजपत्र,
ऄसाधारण, भाग-II, खंड-3, ईप-खंड (i) म ें प्रकाजित की गइ थी तथा आसम ें ऄजधसूचना संख्या सा.का.जन.
738(ऄ), तारीख 9 ऄक्तूबर, 2009 के द्वारा ऄंजतम बार संिोधन दकया गया था।
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 7th April, 2021
G.S.R. 255(E).—Whereas the Central Government, on being satisfied that the Fixed Dose Combination
(hereinafter referred as the FDC) of corticosteroid with any other drug for systemic use is likely to involve certain risk
to human beings, vide its notification number G.S.R. 578(E), dated the 23rd July, 1983, inter alia prohibited the
manufacture and sale of FDCs of Steroids for internal use except combination of Steroids with other drugs for the
treatment of Asthma;
And whereas, the Central Government vide notification number G.S.R. 738(E), dated the 9th October, 2009
further amended the said notification number G.S.R. 578(E), dated the 23rd July, 1983 and substituted item 14 and the
entries relating thereto with the entry "Fixed Dose combination of corticosteroid with any other drug for internal use
except for preparations meant for meter dose inhalers and dry powder inhalers";
And whereas, FDC of Tamsulosin HCI 0.4 mg (as film coated modified release tablet) + Deflazacort 30 mg
hard gelatin capsule was examined by Prof. Kokate Committee constituted by the Central Government for examining
the safety and efficacy of FDCs which were licensed prior to 1st October, 2012 without prior approval of the Central
Licensing Authority and therefore, Prof. Kokate committee examined the said FDC in current scenario based on the[भाग II—खण् ड 3(i)] भारत का राजपत्र : ऄसाधारण 3
available documents and scientific literature and considered this FDC as rational and accordingly, the FDC of
Tamsulosin HCI 0.4mg (as film coated modified release tablet) + Deflazacort 30 mg hard gelatin capsule was
approved;
And whereas, FDC of Tamsulosin HCI 0.4 mg (as film coated modified release tablet) + Deflazacort 30 mg
hard gelatin capsule was also referred to Drugs Technical Advisory Board and upon examination, the Drugs Technical
Advisory Board had now recommended to exclude the FDC of Tamsulosin HCI 0.4 mg (as film coated modified
release tablet) + Deflazacort 30 mg hard gelatin capsule from the prohibition made vide notification number G.S.R.
738(E), dated the 9th October, 2009.
Now therefore, in exercise of the powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23
of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board, hereby makes the
following amendments further to amend the notification number G.S.R. 578(E), dated the 23rd July, 1983, namely:—
In the notification, in the Table, for item 14 and the entries relating thereto, the following item and entries
shall be substituted, namely:—
"14. Fixed Dose Combination of corticosteroid with any other drug [excluding Fixed Dose Combination of
Tamsulosin HCI 0.4 mg (as film coated modified release tablet) + Deflazacort 30mg in hard gelatin capsule] for
internal use except for preparations meant for meter dose inhalers and dry powder inhalers.".
[F. No. X.11014/8/2020-DR]
DR. MANDEEP K BHANDARI, Jt. Secy.
Note: The principal notification was published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-
section (i) vide notification number G.S.R. 578(E), dated the 23rd July, 1983 and lastly amended vide
notification number G.S.R. 738(E), dated the 9th October, 2009.
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.