Executive Summary:
This document, issued by the Ministry of Health and Family Welfare, prohibits the manufacture for sale, sale, and distribution for human use of several fixed-dose combination drugs in India. The decision follows recommendations from expert committees that these combinations lack therapeutic justification and may pose risks to public health. The prohibition is effective immediately, as of June 8, 2017.
Key Points / Main Content:
Prohibition of Fixed-Dose Combination Drugs:
* The Central Government prohibits the manufacture for sale, sale, and distribution for human use of the following fixed-dose combination drugs with immediate effect:
* Nimesulide Levocetrizine
* Ofloxacin Ornidazole injection
* Gemifloxacin Ambroxol
* Glucosamine Ibuprofen
* Etodolac Paracetamol
* The prohibition is enacted under Section 26A of the Drugs and Cosmetics Act, 1940.
* The decision is based on recommendations from Subject Expert Committees and the New Drugs Advisory Committee.
Justification for Prohibition:
* The expert committees determined that the specified fixed-dose combinations lack therapeutic justification.
* The committees cited potential for misuse, overuse, lack of added advantage, and potential risks to human health.
* The Central Government has determined that regulating these drugs through prohibition is necessary and expedient in the public interest.
Impact Analysis:
Manufacturers and Distributors of the Prohibited Drugs:
* Impact: Must immediately cease the manufacture, sale, and distribution of the specified fixed-dose combination drugs.
* Action Required: Ensure immediate compliance with the prohibition order.
Healthcare Professionals:
* Impact: Should discontinue prescribing the specified fixed-dose combination drugs.
* Action Required: Seek alternative treatment options for patients and be aware of the immediate prohibition.
Patients:
* Impact: May need to switch to alternative medications.
* Action Required: Consult with healthcare professionals regarding alternative treatment options.
Drug Regulatory Authorities:
* Impact: Enforce the prohibition on the manufacture, sale, and distribution of the specified drugs.
* Action Required: Monitor and ensure compliance with the order.
Key Entities Referenced
Drugs and Cosmetics Act, 1940: A law in India that regulates the import, manufacture, distribution and sale of drugs and cosmetics.
New Delhi: The capital of India, where the notification was issued.
Ministry of Health and Family Welfare: A ministry of the Government of India responsible for health policy.
Department of Health and Family Welfare: The department under the Ministry of Health and Family Welfare responsible for implementing health programs.
Central Government: The executive authority of India.
Subject Expert Committee: A committee constituted by the Central Government to examine the matter of drug combinations.
Nimesulide Levocetrizine: A fixed-dose drug combination that has been prohibited for manufacture, sale, and distribution.
Ofloxacin Ornidazole injection: A fixed-dose drug combination that has been prohibited for manufacture, sale, and distribution.
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EXTRAORDINARY
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PART II—Section 3—Sub-section (ii)
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PUBLISHED BY AUTHORITY
la- 1644] ubZ fnYyh] c`gLifrokj] twu 8] 2017@T;s"B 18] 1939
No. 1644] NEW DELHI, THURSDAY, JUNE 8, 2017/JYAISTHA 18, 1939
(cid:7021)(cid:7021)(cid:7021)(cid:7021)वव वव ाााा(cid:7021)(cid:7021)(cid:7021)(cid:7021)(cid:7005)(cid:7005) (cid:7005)(cid:7005) यय यय औऔऔऔरररर पपपप(cid:7407)(cid:7407)(cid:7407)(cid:7407)ररररववववाााारररर कककक(cid:7016)(cid:7016)(cid:7016)(cid:7016)यय यय ााााणणणण मममम(cid:7074)(cid:7074)ंं(cid:7074)(cid:7074)ंं ााााललललयययय
(((((cid:7021)(cid:7021)(cid:7021)(cid:7021)वव वव ाााा(cid:7021)(cid:7021)(cid:7021)(cid:7021)(cid:7005)(cid:7005) (cid:7005)(cid:7005) यय यय औऔऔऔरररर पपपप(cid:7407)(cid:7407)(cid:7407)(cid:7407)ररररववववाााारररर कककक(cid:7016)(cid:7016)(cid:7016)(cid:7016)यय यय ााााणणणण मममम(cid:7074)(cid:7074)ंं(cid:7074)(cid:7074)ंं ााााललललयययय ििििववववभभभभाााागगगग))))
अअअअििििधधधधससससचचूूचचूू ननननाााा
नई (cid:7408)द(cid:7016) ली, 8 जून, 2017
ककककाााा....आआआआ.... 1111888855551111((((अअअअ))))....————के(cid:7008) (cid:7076)ीय सरकार के (cid:7007) यान म(cid:7286) यह बात लाई गई थी (cid:7408)क ननननीीीीममममससेेससेे ुलुलुलुलााााइइइइडडडड ++++ ललललेवेवेवेवोोोोसससस(cid:7069)(cid:7069)ेे(cid:7069)(cid:7069)ेे ीीीीििििजजजजनननन कककक(cid:7409)(cid:7409)(cid:7409)(cid:7409) ििििननननययययतततत खखखखुरुरुरुरााााकककक
ससससययंंययंं ोोोोजजजजनननन ओओओओषषषषििििधधधध का (cid:7079)योग युि(cid:7334)सगं त नह(cid:7277) है;
और के(cid:7008) (cid:7076)ीय सरकार (cid:7367)ारा ग(cid:7407)ठत इस िवषय से संबंिधत िवशेष(cid:6980) सिमित (cid:7367)ारा इस िवषय क(cid:7409) परी(cid:6979)ा क(cid:7409) गई ह ैऔर उ(cid:6989) त सिमित
ने के(cid:7008) (cid:7076)ीय सरकार को यह िसफा(cid:7407)रश क(cid:7409) है (cid:7408)क उ(cid:6989) त िनयत खुराक संयोजन का कोई िच(cid:7408)क(cid:7004) सीय औिच(cid:7004) य नह(cid:7277) और ऐसे मामल(cid:7298) म(cid:7286) जहां
एकल ओषिध क(cid:7409) आव(cid:7019) यकता ह ैवहां इस ओषिध का द(cid:7272)ु पयोग और अ(cid:7004) यिधक उपयोग हो सकता है;
और उपयु(cid:6981)(cid:6989) त सिमित क(cid:7409) िसफा(cid:7407)रश(cid:7298) क(cid:7409) परी(cid:6979)ा करने के प(cid:7019) चात् के(cid:7008) (cid:7076)ीय सरकार का यह समाधान हो गया ह ै (cid:7408)क दशे म(cid:7286) उ(cid:6989) त
ओषिध के मानव उपयोग के िलए िव(cid:7059)याथ(cid:6981) िविनमा(cid:6981)ण, िव(cid:7059)य और िवतरण को (cid:7079)ितिष(cid:7373) करके िविनयिमत करना लोकिहत म(cid:7286) आव(cid:7019) यक
और समीचीन ह;ै
अत:, अब, के(cid:7008) (cid:7076)ीय सरकार, ओषिध और (cid:7079)साधन साम(cid:7061)ी अिधिनयम, 1940 (1940 का 23) क(cid:7409) धारा 26क (cid:7367)ारा (cid:7079)द(cid:7004) त
शि(cid:7334)य(cid:7298) का (cid:7079)योग करते (cid:7263)ए, ननननीीीीममममससेेससेे ललुुललुु ााााइइइइडडडड ++++ ललललेवेवेवेवोोोोसससस(cid:7069)(cid:7069)ेे(cid:7069)(cid:7069)ेे ीीीीििििजजजजनननन कककक(cid:7409)(cid:7409)(cid:7409)(cid:7409) ििििननननययययतततत खखखखररुुररुु ााााकककक ससससययंंययंं ोोोोजजजजनननन ओओओओषषषषििििधधधध का मानव उपयोग के िलए िव(cid:7059)याथ(cid:6981)
िविनमाण(cid:6981) , िव(cid:7059)य और िवतरण त(cid:7004) काल (cid:7079)भाव से (cid:7079)ितिष(cid:7373) करती ह।ै
[फा. सं. ए(cid:6989) स.11014/12/2017-डीआरएस]
कुंदन लाल शमा(cid:6981), संयु(cid:6989) त सिचव
3645 GI/2017 (1)(cid:32)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 8th June, 2017.
S.O. 1851(E).—Whereas it had been brought to the notice of the Central Government that the use of
the drug fixed dose combination of Nimesulide + Levocetrizine is not rational;
And, whereas, the matter has been examined by the Subject Expert Committee constituted by the
Central Government and the said Committee has recommended to the Central Government that the said fixed
dose combination does not have therapeutic justification and the drug could be its misused and overuse in
cases where a single drug is required;
And, whereas, after examination of the recommendations of the aforesaid Committee, the Central
Government is satisfied that it is necessary and expedient in public interest to regulate by way of prohibition,
the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of the powers conferred by section 26A of the Drugs and Cosmetics Act,
1940 (23 of 1940), the Central Government, hereby prohibits the manufacture for sale, sale and distribution
for human use of the drug fixed dose combination of Nimesulide + Levocetrizine with immediate effect.
[F. No. X.11014/12/2017-DRS]
K. L. SHARMA, Jt Secy.
अअअअििििधधधधससससचचूूचचूू ननननाााा
नई (cid:7408)द(cid:7016) ली, 8 जून, 2017
ककककाााा....आआआआ.... 1111888855552222((((अअअअ))))....————के(cid:7008) (cid:7076)ीय सरकार के (cid:7007) यान म(cid:7286) यह बात लाई गई थी (cid:7408)क ऑऑऑऑ(cid:7010)(cid:7010)(cid:7010)(cid:7010)ललललोोोो(cid:6989)(cid:6989)(cid:6989)(cid:6989)सस सस ााााििििससससनननन ++++ ओओओओररररििििननननडडडडााााज़ज़ज़ज़ोोोोलललल इइइइंंंंजजजज(cid:6989)(cid:6989)ेे(cid:6989)(cid:6989)ेे शश श शनननन कककक(cid:7409)(cid:7409)(cid:7409)(cid:7409) ििििननननययययतततत
खखखखुरुरुरुरााााकककक ससससययंंययंं ोोोोजजजजनननन ओओओओषषषषििििधधधध का (cid:7079)योग युि(cid:7334)संगत नह(cid:7277) है;
और के(cid:7008) (cid:7076)ीय सरकार (cid:7367)ारा ग(cid:7407)ठत नई ओषिध सलाहकार सिमित (cid:7367)ारा इस िवषय क(cid:7409) परी(cid:6979)ा क(cid:7409) गई ह ै और उ(cid:6989) त सिमित ने
के(cid:7008) (cid:7076)ीय सरकार को यह िसफा(cid:7407)रश क(cid:7409) ह ै (cid:7408)क उ(cid:6989) त िनयत खुराक संयोजन युि(cid:7334)संगत नह(cid:7277) ह ै और दोनो ओषिधय(cid:7298) को एक साथ आं(cid:7074)ेतर (cid:7272)प
म(cid:7286) दने े का कोई िविन(cid:7416)द(cid:7020) ट लाभ नह(cid:7277) ह ैऔर इस (cid:7079)कार इस ओषिध के िवपणन को जारी रखने का कोई िच(cid:7408)क(cid:7004) सीय औिच(cid:7004) य नह(cid:7277) ह;ै
और उपयु(cid:6981)(cid:6989) त सिमित क(cid:7409) िसफा(cid:7407)रश(cid:7298) क(cid:7409) परी(cid:6979)ा करने के प(cid:7019) चात् के(cid:7008) (cid:7076)ीय सरकार का यह समाधान हो गया ह ै (cid:7408)क दशे म(cid:7286) उ(cid:6989) त
ओषिध के मानव उपयोग के िलए िव(cid:7059)याथ(cid:6981) िविनमा(cid:6981)ण, िव(cid:7059)य और िवतरण को (cid:7079)ितिष(cid:7373) करके िविनयिमत करना लोकिहत म(cid:7286) आव(cid:7019) यक
और समीचीन ह;ै
अत:, अब, के(cid:7008) (cid:7076)ीय सरकार, ओषिध और (cid:7079)साधन साम(cid:7061)ी अिधिनयम, 1940 (1940 का 23) क(cid:7409) धारा 26क (cid:7367)ारा (cid:7079)द(cid:7004) त
शि(cid:7334)य(cid:7298) का (cid:7079)योग करते (cid:7263)ए, ऑऑऑऑ(cid:7010)(cid:7010)(cid:7010)(cid:7010)ललललोोोो(cid:6989)(cid:6989)(cid:6989)(cid:6989)सस सस ााााििििससससनननन ++++ ओओओओररररििििननननडडडडााााज़ज़ज़ज़ोोोोलललल इइइइंंंंजजजजे(cid:6989)े(cid:6989)े(cid:6989)े(cid:6989)शश शश नननन कककक(cid:7409)(cid:7409)(cid:7409)(cid:7409) ििििननननययययतततत खखखखररुुररुु ााााकककक ससससययंंययंं ोोोोजजजजनननन ओओओओषषषषििििधधधध का मानव उपयोग के िलए
िव(cid:7059)याथ(cid:6981) िविनमा(cid:6981)ण, िव(cid:7059)य और िवतरण त(cid:7004) काल (cid:7079)भाव से (cid:7079)ितिष(cid:7373) करती है।
[फा. सं. ए(cid:6989) स.11014/12/2017-डीआरएस]
कुंदन लाल शमा(cid:6981), संयु(cid:6989) त सिचव
NOTIFICATION
New Delhi, the 8th June, 2017
S.O. 1852(E).—Whereas it had been brought to the notice of the Central Government that the use of
the drug fixed dose combination of Ofloxacin + Ornidazole injection is not rational;¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 3
And, whereas, the matter has been examined by the New Drugs Advisory Committee constituted by
the Central Government and the said Committee has recommended to the Central Government that the said
fixed dose combination is not rational and there is no specific advantage an administering both drugs together
in parental form and as such there is no therapeutic justification for the continued marketing of this drug;
And, whereas, after examination of the recommendations of the aforesaid Committee, the Central
Government is satisfied that it is necessary and expedient in public interest to regulate by way of prohibition,
the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of the powers conferred by section 26A of the Drugs and Cosmetics Act,
1940 (23 of 1940), the Central Government, hereby prohibits the manufacture for sale, sale and distribution
for human use of the drug fixed dose combination of Ofloxacin + Ornidazole injection with immediate
effect.
[F. No. X.11014/12/2017-DRS]
K. L. SHARMA, Jt Secy.
अअअअििििधधधधससससचचूूचचूू ननननाााा
नई (cid:7408)द(cid:7016) ली, 8 जून, 2017
ककककाााा....आआआआ.... 1111888855553333((((अअअअ))))....————के(cid:7008) (cid:7076)ीय सरकार के (cid:7007) यान म(cid:7286) यह बात लाई गई थी (cid:7408)क जजजजममेेममेे ीीीी(cid:7010)(cid:7010)(cid:7010)(cid:7010)ललललोोोो(cid:6989)(cid:6989)(cid:6989)(cid:6989)सस सस ााााििििससससनननन ++++ एएएएमममम(cid:7081)(cid:7081)(cid:7081)(cid:7081)ोोोो(cid:6989)(cid:6989)(cid:6989)(cid:6989)सस सस ोोोोलललल कककक(cid:7409)(cid:7409)(cid:7409)(cid:7409) ििििननननययययतततत खखखखररुुररुु ााााकककक
ससससययंंययंं ोोोोजजजजनननन ओओओओषषषषििििधधधध का (cid:7079)योग युि(cid:7334)सगं त नह(cid:7277) ह ैऔर इससे मानव जीवन को खतरा होने क(cid:7409) संभावना है;
और के(cid:7008) (cid:7076)ीय सरकार (cid:7367)ारा ग(cid:7407)ठत इस िवषय से संबंिधत िवशेष(cid:6980) सिमित (cid:7367)ारा इस िवषय क(cid:7409) परी(cid:6979)ा क(cid:7409) गई ह ैऔर उ(cid:6989) त सिमित
ने के(cid:7008) (cid:7076)ीय सरकार को यह िसफा(cid:7407)रश क(cid:7409) ह ै (cid:7408)क उ(cid:6989) त ओषिध म(cid:7286) पया(cid:6981)(cid:7009) त िच(cid:7408)क(cid:7004) सीय औिच(cid:7004) य नह(cid:7277) ह ै (cid:6989) यो(cid:7408)क एम(cid:7081)ो(cid:6989) सोल ओषिध का
(cid:7079)ितसू(cid:7023) मजीवी स(cid:7408)(cid:7059)यता म(cid:7286) कोई अित(cid:7407)र(cid:6989) त फायदा नह(cid:7277) है;
और उपयु(cid:6981)(cid:6989) त सिमित क(cid:7409) िसफा(cid:7407)रश(cid:7298) क(cid:7409) परी(cid:6979)ा करने के प(cid:7019) चात् के(cid:7008) (cid:7076)ीय सरकार का यह समाधान हो गया ह ै (cid:7408)क दशे म(cid:7286) उ(cid:6989) त
ओषिध के मानव उपयोग के िलए िव(cid:7059)याथ(cid:6981) िविनमा(cid:6981)ण, िव(cid:7059)य और िवतरण को (cid:7079)ितिष(cid:7373) करके िविनयिमत करना लोकिहत म(cid:7286) आव(cid:7019) यक
और समीचीन ह;ै
अत:, अब, के(cid:7008) (cid:7076)ीय सरकार, ओषिध और (cid:7079)साधन साम(cid:7061)ी अिधिनयम, 1940 (1940 का 23) क(cid:7409) धारा 26क (cid:7367)ारा (cid:7079)द(cid:7004) त
शि(cid:7334)य(cid:7298) का (cid:7079)योग करते (cid:7263)ए, जजजजममेेममेे ीीीी(cid:7010)(cid:7010)(cid:7010)(cid:7010)ललललोोोो(cid:6989)(cid:6989)(cid:6989)(cid:6989)सस सस ााााििििससससनननन ++++ एएएएमममम(cid:7081)(cid:7081)(cid:7081)(cid:7081)ोोोो(cid:6989)(cid:6989)(cid:6989)(cid:6989)सस सस ोोोोलललल कककक(cid:7409)(cid:7409)(cid:7409)(cid:7409) ििििननननययययतततत खखखखररुुररुु ााााकककक ससससययंंययंं ोोोोजजजजनननन ओओओओषषषषििििधधधध का मानव उपयोग के िलए िव(cid:7059)याथ(cid:6981)
िविनमाण(cid:6981) , िव(cid:7059)य और िवतरण त(cid:7004) काल (cid:7079)भाव से (cid:7079)ितिष(cid:7373) करती ह।ै
[फा. सं. ए(cid:6989) स.11014/12/2017-डीआरएस]
कुंदन लाल शमा(cid:6981), संयु(cid:6989) त सिचव
NOTIFICATION
New Delhi, the 8th June, 2017
S.O. 1853(E).—Whereas it had been brought to the notice of the Central Government i that the use of the
drug fixed dose combination of Gemifloxacin + Ambroxol is not rational and is likely involve risk to human beings;
And, whereas, the matter has been examined by Subject Expert Committee constituted by the Central
Government and the said Committee recommended to the Central Government that the said drug does not have sufficient
therapeutic justification as the drug Ambroxol does not have any added advantage in antimicrobial activity;
And, whereas, after examination of the recommendations of the aforesaid Committee, the Central Government
is satisfied that it is necessary and expedient in public interest to regulate by way of prohibition, the manufacture for sale,
sale and distribution for human use of the said drug in the country;4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
Now, therefore, in exercise of the powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23
of 1940), the Central Government, hereby prohibits the manufacture for sale, sale and distribution for human use of the
drug fixed dose combination of Gemifloxacin + Ambroxol with immediate effect.
[F. No. X.11014/12/2017-DRS]
K. L. SHARMA, Jt Secy.
अअअअििििधधधधससससचचूूचचूू ननननाााा
नई (cid:7408)द(cid:7016) ली, 8 जून, 2017
ककककाााा....आआआआ.... 1111888855554444((((अअअअ))))....————के(cid:7008) (cid:7076)ीय सरकार के (cid:7007) यान म(cid:7286) यह बात लाई गई थी (cid:7408)क (cid:6991)(cid:6991)(cid:6991)(cid:6991) लल ल लककुुककुु ोोोोससससााााममममााााइइइइनननन ++++ इइइइबबबबु(cid:7079)ु(cid:7079)ु(cid:7079)ु(cid:7079)ोोोोफफफफेेेेनननन कककक(cid:7409)(cid:7409)(cid:7409)(cid:7409) ििििननननययययतततत खखखखररुुररुु ााााकककक ससससययंंययंं ोोोोजजजजनननन
ओओओओषषषषििििधधधध का (cid:7079)योग युि(cid:7334)संगत नह(cid:7277) ह;ै
और के(cid:7008) (cid:7076)ीय सरकार (cid:7367)ारा ग(cid:7407)ठत इस िवषय से संबंिधत िवशेष(cid:6980) सिमित (cid:7367)ारा इस िवषय क(cid:7409) परी(cid:6979)ा क(cid:7409) गई ह ैऔर उ(cid:6989) त सिमित
ने के(cid:7008) (cid:7076)ीय सरकार को यह िसफा(cid:7407)रश क(cid:7409) ह ै(cid:7408)क उ(cid:6989) त ओषिध म(cid:7286) युि(cid:7334)संगतता और िच(cid:7408)क(cid:7004) सीय औिच(cid:7004) य नह(cid:7277) है;
और उपयु(cid:6981)(cid:6989) त सिमित क(cid:7409) िसफा(cid:7407)रश(cid:7298) क(cid:7409) परी(cid:6979)ा करने के प(cid:7019) चात् के(cid:7008) (cid:7076)ीय सरकार का यह समाधान हो गया ह ै (cid:7408)क दशे म(cid:7286) उ(cid:6989) त
ओषिध के मानव उपयोग के िलए िव(cid:7059)याथ(cid:6981) िविनमा(cid:6981)ण, िव(cid:7059)य और िवतरण को (cid:7079)ितिष(cid:7373) करके िविनयिमत करना लोकिहत म(cid:7286) आव(cid:7019) यक
और समीचीन ह;ै
अत:, अब, के(cid:7008) (cid:7076)ीय सरकार, ओषिध और (cid:7079)साधन साम(cid:7061)ी अिधिनयम, 1940 (1940 का 23) क(cid:7409) धारा 26क (cid:7367)ारा (cid:7079)द(cid:7004) त
शि(cid:7334)य(cid:7298) का (cid:7079)योग करते (cid:7263)ए, (cid:6991)(cid:6991)(cid:6991)(cid:6991)लल लल ककुुुककु ोोोोससससााााममममााााइइइइनननन ++++ इइइइबबबब(cid:7079)(cid:7079)ुु(cid:7079)(cid:7079)ुु ोोोोफफफफेेेेनननन कककक(cid:7409)(cid:7409)(cid:7409)(cid:7409) ििििननननययययतततत खखखखररुुररुु ााााकककक ससससययंंययंं ोोोोजजजजनननन ओओओओषषषषििििधधधध का मानव उपयोग के िलए िव(cid:7059)याथ(cid:6981)
िविनमाण(cid:6981) , िव(cid:7059)य और िवतरण त(cid:7004) काल (cid:7079)भाव से (cid:7079)ितिष(cid:7373) करती ह।ै
[फा. सं. ए(cid:6989) स.11014/12/2017-डीआरएस]
कुंदन लाल शमा(cid:6981), संयु(cid:6989) त सिचव
NOTIFICATION
New Delhi, the 8th June, 2017.
S.O. 1854(E).—Whereas it had been brought to the notice of the Central Government that the use of
the drug fixed dose combination of Glucosamine + Ibuprofen is not rational;
And, whereas, the matter has been examined by the Subject Expert Committee constituted by the
Central Government and the said Committee recommended to the Central Government that the said drug lacks
rationality and therapeutic justification;
And, whereas, after examination of the recommendations of the aforesaid Committee, the Central
Government is satisfied that it is necessary and expedient in public interest to regulate by way of prohibition,
the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of the powers conferred by section 26A of the Drugs and Cosmetics Act,
1940 (23 of 1940), the Central Government, hereby prohibits the manufacture for sale, sale and distribution
for human use of the drug fixed dose combination of Glucosamine + Ibuprofen with immediate effect.
[F. No. X.11014/12/2017-DRS]
K. L. SHARMA, Jt Secy.
अअअअििििधधधधससससचचूूचचूू ननननाााा
नई (cid:7408)द(cid:7016) ली, 8 जून, 2017
ककककाााा....आआआआ.... 1111888855555555((((अअअअ))))....————के(cid:7008) (cid:7076)ीय सरकार के (cid:7007) यान म(cid:7286) यह बात लाई गई थी (cid:7408)क इइइइटटटटोोोोडडडडोोोोललललकककक ++++ पपपपैरैरैरैरााााससससटटेेटटेे ााााममममोोोोलललल कककक(cid:7409)(cid:7409)(cid:7409)(cid:7409) ििििननननययययतततत खखखखररुुररुु ााााकककक ससससययंंययंं ोोोोजजजजनननन
ओओओओषषषषििििधधधध का (cid:7079)योग युि(cid:7334)संगत नह(cid:7277) ह;ै¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 5
और के(cid:7008) (cid:7076)ीय सरकार (cid:7367)ारा ग(cid:7407)ठत नई ओषिध सलाहकार सिमित (cid:7367)ारा इस िवषय क(cid:7409) परी(cid:6979)ा क(cid:7409) गई ह ै और उ(cid:6989) त सिमित ने
के(cid:7008) (cid:7076)ीय सरकार को यह िसफा(cid:7407)रश क(cid:7409) ह ै (cid:7408)क उ(cid:6989) त िनयत खुराक संयोजन का कोई िच(cid:7408)क(cid:7004) सीय औिच(cid:7004) य नह(cid:7277) और दोन(cid:7298) ओषिधय(cid:7298) को
‘यथापेि(cid:6979)त’ आधार पर पृथक-पृथक दने ा सव(cid:7299)(cid:7004) तम ह;ै
और उपयु(cid:6981)(cid:6989) त सिमित क(cid:7409) िसफा(cid:7407)रश(cid:7298) क(cid:7409) परी(cid:6979)ा करने के प(cid:7019) चात् के(cid:7008) (cid:7076)ीय सरकार का यह समाधान हो गया ह ै (cid:7408)क दशे म(cid:7286) उ(cid:6989) त
ओषिध के मानव उपयोग के िलए िव(cid:7059)याथ(cid:6981) िविनमा(cid:6981)ण, िव(cid:7059)य और िवतरण को (cid:7079)ितिष(cid:7373) करके िविनयिमत करना लोकिहत म(cid:7286) आव(cid:7019) यक
और समीचीन ह;ै
अत:, अब, के(cid:7008) (cid:7076)ीय सरकार, ओषिध और (cid:7079)साधन साम(cid:7061)ी अिधिनयम, 1940 (1940 का 23) क(cid:7409) धारा 26क (cid:7367)ारा
(cid:7079)द(cid:7004) त शि(cid:7334)य(cid:7298) का (cid:7079)योग करते (cid:7263)ए, इइइइटटटटोोोोडडडडोोोोललललकककक ++++ पपपपैरैरैरैरााााससससटटेेटटेे ााााममममोोोोलललल कककक(cid:7409)(cid:7409)(cid:7409)(cid:7409) ििििननननययययतततत खखखखररुुररुु ााााकककक ससससययंंययंं ोोोोजजजजनननन ओओओओषषषषििििधधधध का मानव उपयोग के िलए िव(cid:7059)याथ (cid:6981)
िविनमाण(cid:6981) , िव(cid:7059)य और िवतरण त(cid:7004) काल (cid:7079)भाव से (cid:7079)ितिष(cid:7373) करती ह।ै
[फा. सं. ए(cid:6989) स.11014/12/2017-डीआरएस]
कुंदन लाल शमा(cid:6981), संयु(cid:6989) त सिचव
NOTIFICATION
New Delhi, the 8th June, 2017
S.O. 1855(E).—Whereas it had been brought to the notice of the Central Government that the use of the drug
fixed dose combination of Etodolac + Paracetamol is not rational;
And, whereas, the matter has been examined by the New Drugs Advisory Committee constituted by the Central
Government and the said Committee has recommended to the Central Government that the said fixed dose combination
drug does not have therapeutic justification and the two drugs are best administered separately on as required basis;
And, whereas, after examination of the recommendations of the aforesaid Committee, the Central Government
is satisfied that it is necessary and expedient in public interest to regulate by way of prohibition, the manufacture for sale,
sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of the powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23
of 1940), the Central Government, hereby prohibits the manufacture for sale, sale and distribution for human use of the
drug fixed dose combination of Etodolac + Paracetamol with immediate effect.
[F. No. X.11014/12/2017-DRS]
K. L. SHARMA, Jt Secy.
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