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1207 

GI/2016 (1)

 jftLVªh laö Mhö ,yö&33004@99  REGD. NO. D. L.-33004/99 

vlk/kj.k  EXTRAORDINARY 

Hkkx II— [k.M 3— mi&[k.M (ii) PART II—Section 3—Sub-section (ii)

 izkf/dkj ls izdkf'krPUBLISHED BY AUTHORITY 

 la- 608]  ubZ fnYyh] c`gLifrokj] ekpZ 10] 2016@iQkYxqu 20] 1937No. 608] NEW DELHI, THURSDAY, MARCH 10, 2016/ PHALGUNA 20, 1937  

 

   

 

   

 

   

 

   

 

 

   

 

   

 

   

  ण ि व भ ा ग  

ण ि व भ ा ग  ण ि व भ ा ग  

ण ि व भ ा ग

अ ि ध स ूच न ा 

अ ि ध स ूच न ा अ ि ध स ूच न ा 

अ ि ध स ूच ना

  , 1 0 , 2 0 1 6

क ा . आ  क ा . आ  क ा . आ  क ा . आ . 0 5  

. 0 5  . 0 5  

. 0 5 ( अ )  ( अ ) ( अ ) ( अ ) .  

.. 

.      

      फे न क

फे न क फे न क फे न क +  प ेरा ि स टा म ो ल

प ेरा ि स टा म ो ल प ेरा ि स टा म ो ल प ेरा ि स टा म ो ल + 

औ िष ध   ,  

औ िष ध

  औ ष ि ध के ब ा रे

  औ िष ध   ,   क र न ा

  क औ र स म ी च ी न है

अ त , अ ब ,   य स र क ा र , औ िष ध

  , 1 4 0 ( 1 4 0 क ा 2 3   2 6    ,  

   

  फे न क

फे न क फे न क

फे न क + 

प ेरा ि स टा म ो ल

प ेरा ि स टा म ो ल प ेरा ि स टा म ो ल

प ेरा ि स टा म ो ल +   

   

 ज ो ल

ज ो ल ज ो ल

ज ो ल औ िष ध   ,

फ ा .   - 1 1 0 3 5 / 5 3 / 2 0 1 4 -   स ी

  ,, ,,   स ि च व  

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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 10th March, 2016

S.O. 705(E).—Whereas, the Central Government is satisfied that the use of the drug fixed dose

combination of Aceclofenac + Paracetamol + Rabeprazole is likely to involve risk to human beingswhereas safer alternatives to the said drug are available;

And Whereas, the matter has been examined by an Expert Committee appointed by the Central

Government and the said Expert Committee recommended to the Central Government that the said drug is

found to have no therapeutic justification;

And Whereas on the basis of the recommendations of the said Expert Committee, the Central

Government is satisfied that it is necessary and expedient in public interest to regulate by way of prohibition

of manufacture for sale, sale and distribution for human use of the said drug in the country;

Now, therefore, on the basis of the recommendations of the said Expert Committee and in exercise of

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 drug fixed dose combination

of Aceclofenac + Paracetamol + Rabeprazole with immediate effect.

[F. No. X-11035/53/2014-DFQC]

K. L. SHARMA, Jt. Secy.

अ ि ध स ूच न ा 

अ ि ध स ूच न ा अ ि ध स ूच न ा 

अ ि ध स ूच ना

  , 1 0 , 2 0 1 6

क ा . आ  क ा . आ  क ा . आ  क ा . आ . 0 6  

. 0 6  . 0 6  

. 0 6 ( अ )  ( अ ) ( अ ) ( अ ) .  

.. 

.    

ल ा इ ड

ल ा इ ड ल ा इ ड ल ा इ ड +   

      फ े न ेक

फ े न ेकफ े न ेकफ े न ेक

स यंो ज न औ िष ध ,   औ िष ध  

औ र इ स

  औ िष ध  

 

औ िष ध   ,

  क औ र स म ी च ी न है

अ त , अ ब ,   य स र क ा र ,   औ िष ध

अ ि ध ि न य म , 1 4 0 ( 1 4 0 क ा 2 3   2 6    ,

ल ा इ ड

ल ा इ ड ल ा इ ड

ल ा इ ड +   

   

  फ े न ेक

फ े न ेकफ े न ेक

फ े न ेक

औ िष ध   ,   ल

फ ा .   - 1 1 0 3 5 / 5 3 / 2 0 1 4 -   स ी

  ,

, ,

,   स ि च व  

NOTIFICATION 

New Delhi, the 10th March, 2016

S.O. 706(E).— Whereas, the Central Government is satisfied that the use of the drug fixed dose

combination of Nimesulide + Diclofenac is likely to involve risk to human beings whereas safer alternatives

to the said drug are available;

And Whereas, the matter has been examined by an Expert Committee appointed by the CentralGovernment and the said Expert Committee recommended to the Central Government that the said drug is

found to have no therapeutic justification;

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¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 3

And Whereas on the basis of the recommendations of the said Expert Committee, the Central

Government is satisfied that it is necessary and expedient in public interest to regulate by way of prohibition

of manufacture for sale, sale and distribution for human use of the said drug in the country;

Now, therefore, on the basis of the recommendations of the said Expert Committee and in exercise of

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 drug fixed dose combination

of Nimesulide + Diclofenac with immediate effect.

[F. No. X-11035/53/2014-DFQC]

K. L. SHARMA, Jt. Secy.

अ ि ध स ूच न ा अ ि ध स ूच न ा अ ि ध स ूच न ा अ ि ध स ूच ना

  , 1 0 , 2 0 1 6

क ा . आ  

क ा . आ  क ा . आ  

क ा . आ . 0  

. 0  . 0  

. 0 ( अ )  

( अ ) ( अ ) 

( अ ) .  

.. 

.  

 

 

ल ा इ ड

ल ा इ ड ल ा इ ड

ल ा इ ड + 

+ 

ख रुा क स ं यो ज न औ िष ध   ह ै,   औ िष ध  

 

  औ िष ध  

 

औ िष ध   ,

  क औ र स म ी च ी न है

अ त , अ ब ,   य स र क ा र , औ िष ध

अ ि ध ि न य म , 1 4 0 ( 1 4 0 क ा 2 3   2 6    ,

ल ा इ ड

ल ा इ ड ल ा इ ड

ल ा इ ड + 

+ 

औ ष ि ध क ा   ,

फ ा .   - 1 1 0 3 5 / 5 3 / 2 0 1 4 -   स ी

  ,

, ,

,   स ि च व  

NOTIFICATION 

New Delhi, the 10th March, 2016

S.O. 707(E).—Whereas, the Central Government is satisfied that the use of the drug fixed dose

combination of Nimesulide + Cetirizine + Caffeine is likely to involve risk to human beings whereas safer

alternatives to the said drug are available;

And Whereas, the matter has been examined by an Expert Committee appointed by the Central

Government and the said Expert Committee recommended to the Central Government that the said drug isfound to have no therapeutic justification;

And Whereas on the basis of the recommendations of the said Expert Committee, the Central

Government is satisfied that it is necessary and expedient in public interest to regulate by way of prohibition

of manufacture for sale, sale and distribution for human use of the said drug in the country;

Now, therefore, on the basis of the recommendations of the said Expert Committee and in exercise of

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 drug fixed dose combination

of Nimesulide + Cetirizine + Caffeine with immediate effect.

[F. No. X-11035/53/2014-DFQC]

K. L. SHARMA, Jt. Secy.

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4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] 

अ ि ध स ूच न ा 

अ ि ध स ूच न ा अ ि ध स ूच न ा 

अ ि ध स ूच ना

  , 1 0 , 2 0 1 6

क ा . आ  

क ा . आ  क ा . आ  

क ा . आ . 0  

. 0  . 0  

. 0 ( अ )  

( अ ) ( अ ) 

( अ ) .  

.. 

.  

 

 

ल ा इ ड

ल ा इ ड ल ा इ ड

ल ा इ ड +  टा इ ज े ि न ड ा इ न  

टा इ ज े ि न ड ा इ न  टा इ ज े ि न ड ा इ न  

टा इ ज े ि न ड ा इ न  

स यंो ज न औ िष ध ,   औ िष ध  

  औ िष ध  

 

औ िष ध   ,

  क औ र स म ी च ी न है

अ त , अ ब ,   य स र क ा र , औ िष ध

अ ि ध ि न य म , 1 4 0 ( 1 4 0 क ा 2 3   2 6      ,

ल ा इ ड

ल ा इ ड ल ा इ ड

ल ा इ ड +  टा इ ज े ि न ड ा इ न  

टा इ ज े ि न ड ा इ न  टा इ ज े ि न ड ा इ न  

टा इ ज े ि न ड ा इ न  

औ िष ध   ,

फ ा .   - 1 1 0 3 5 / 5 3 / 2 0 1 4 -   स ी

  ,

, ,

,   स ि च व  

NOTIFICATION 

New Delhi, the 10th March, 2016

S.O. 708(E).— Whereas, the Central Government is satisfied that the use of the drug fixed dose

combination of Nimesulide + Tizanidine is likely to involve risk to human beings whereas safer alternatives

to the said drug are available;

And Whereas, the matter has been examined by an Expert Committee appointed by the CentralGovernment and the said Expert Committee recommended to the Central Government that the said drug is

found to have no therapeutic justification;

And Whereas on the basis of the recommendations of the said Expert Committee, the Central

Government is satisfied that it is necessary and expedient in public interest to regulate by way of prohibition

of manufacture for sale, sale and distribution for human use of the said drug in the country;

Now, therefore, on the basis of the recommendations of the said Expert Committee and in exercise of

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 drug fixed dose combination

of Nimesulide + Tizanidine with immediate effect.

[F. No. X-11035/53/2014-DFQC]

K. L. SHARMA, Jt. Secy.

अ ि ध स ूच न ा 

अ ि ध स ूच न ा अ ि ध स ूच न ा 

अ ि ध स ूच ना

  , 1 0 , 2 0 1 6

क ा . आ  

क ा . आ  क ा . आ  

क ा . आ . 0  

. 0  . 0  

. 0 ( अ )  

( अ ) ( अ ) 

( अ ) .  

.. 

.  

 

  प रेा ि स टा म ो ल

प ेरा ि स टा म ो ल प रेा ि स टा म ो ल

प ेरा ि स टा म ो ल + 

+ 

ख रुा क स ं यो ज न औ िष ध ,   औ िष ध  

  औ िष ध  

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¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 5

  य स र क ा र क ा य ह स म ा ध ा न ह ो ग य ा  

औ िष ध   ,

  क औ र स म ी च ी न है

अ त , अ ब ,   य स र क ा र , औ िष ध

अ ि ध ि न य म , 1 4 0 ( 1 4 0 क ा 2 3   2 6    , प ेरा ि स टा म ो ल

प ेरा ि स टा म ो ल प ेरा ि स टा म ो ल

प ेरा ि स टा म ो ल + 

+ 

औ िष ध   ,

फ ा .   - 1 1 0 3 5 / 5 3 / 2 0 1 4 -   स ी

  ,, ,,   स ि च व  

NOTIFICATION 

New Delhi, the 10th March, 2016

S.O. 709(E).—Whereas, the Central Government is satisfied that the use of the drug fixed dose

combination of Paracetamol + Cetirizine + Caffeine is likely to involve risk to human beings whereas safer

alternatives to the said drug are available;

And Whereas, the matter has been examined by an Expert Committee appointed by the CentralGovernment and the said Expert Committee recommended to the Central Government that the said drug is

found to have no therapeutic justification;

And Whereas on the basis of the recommendations of the said Expert Committee, the Central

Government is satisfied that it is necessary and expedient in public interest to regulate by way of prohibition

of manufacture for sale, sale and distribution for human use of the said drug in the country;

Now, therefore, on the basis of the recommendations of the said Expert Committee and in exercise of

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 drug fixed dose combination

of Paracetamol + Cetirizine + Caffeine with immediate effect.

[F. No. X-11035/53/2014-DFQC]K. L. SHARMA, Jt. Secy.

अ ि ध स ूच न ा 

अ ि ध स ूच न ा अ ि ध स ूच न ा 

अ ि ध स ूच ना

  , 1 0 , 2 0 1 6

क ा . आ  

क ा . आ  क ा . आ  

क ा . आ . 1 0  

. 1 0  . 1 0  

. 1 0 ( अ )  

( अ ) ( अ ) 

( अ ) .  

.. 

.  

 

   

   

  फ े न ेक

फ े न ेकफ े न ेक

फ े न ेक +

+   

   

 

   

  ज ो न

ज ो न ज ो न

ज ो न

औ िष ध , त औ िष ध

  औ िष ध   य औ   

 

औ िष ध   ,

  क औ र स म ी च ी न है

अ त , अ ब ,   य स र क ा र , औ िष ध

अ ि ध ि न य म , 1 4 0 ( 1 4 0 क ा 2 3   2 6    ,  

   

  फ े न ेक

फ े न ेकफ े न ेक

फ े न ेक +

+ 

 

   

 

   

  ज ो न

ज ो न ज ो न

ज ो न औ िष ध क ा म ा     ,

    - 1 1 0 3 5 / 5 3 / 2 0 1 4 -   स ी

  ,

, ,

,   स ि च व  

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6 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] 

NOTIFICATION 

New Delhi, 10th March, 2016

S.O. 710(E).— Whereas, the Central Government is satisfied that the use of the drug fixed dose

combination of Diclofenac + Tramadol + Chlorzoxazone is likely to involve risk to human beings whereas

safer alternatives to the said drug are available;

And Whereas, the matter has been examined by an Expert Committee appointed by the Central

Government and the said Expert Committee recommended to the Central Government that the said drug isfound to have no therapeutic justification;

And Whereas on the basis of the recommendations of the said Expert Committee, the Central

Government is satisfied that it is necessary and expedient in public interest to regulate by way of prohibition

of manufacture for sale, sale and distribution for human use of the said drug in the country;

Now, therefore, on the basis of the recommendations of the said Expert Committee and in exercise of

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 drug fixed dose combination

of Diclofenac + Tramadol + Chlorzoxazone with immediate effect.

[F. No. X-11035/53/2014-DFQC]

K. L. SHARMA, Jt. Secy.

अ ि ध स ूच न ा 

अ ि ध स ूच न ा अ ि ध स ूच न ा 

अ ि ध स ूच ना

  , 1 0 , 2 0 1 6

क ा . आ  क ा . आ  क ा . आ  क ा . आ . 1 1  

. 1 1  . 1 1  

. 1 1 ( अ )  ( अ ) ( अ ) ( अ ) .  

.. 

.      

      म ा इ न

म ा इ न म ा इ न म ा इ न +  प ैर ा 

प ैर ा प ैर ा प ैरा ि स टा म ो ल

ि स टा म ो ल ि स टा म ो ल ि स टा म ो ल + 

औ िष ध ,   औ िष ध

  न े

  औ िष ध  

 

औ ष ि ध के म ा न व उ प य ो ग के ि ल ए   ,

  क औ र स म ी च ी न है

अ त , अ ब ,   य स र क ा र , औ िष ध

अ ि ध ि न य म , 1 4 0 ( 1 4 0 क ा 2 3   2 6    ,  

   

  म ा इ न

म ा इ न म ा इ न

म ा इ न +  प ैरा ि स टा म ो ल

प ैरा ि स टा म ो ल प ैरा ि स टा म ो ल

प ैरा ि स टा म ो ल

+ 

औ िष ध   ,   ल

फ ा .   - 1 1 0 3 5 / 5 3 / 2 0 1 4 -   स ी

  , 

,, 

,   स ि च व  

NOTIFICATION 

New Delhi, 10th March, 2016

S.O. 711(E).— Whereas, the Central Government is satisfied that the use of the drug fixed dose

combination of Dicyclomine + Paracetamol + Domperidone is likely to involve risk to human beings

whereas safer alternatives to the said drug are available;

And Whereas, the matter has been examined by an Expert Committee appointed by the Central

Government and the said Expert Committee recommended to the Central Government that the said drug is

found to have no therapeutic justification;

And Whereas on the basis of the recommendations of the said Expert Committee, the Central

Government is satisfied that it is necessary and expedient in public interest to regulate by way of prohibition

of manufacture for sale, sale and distribution for human use of the said drug in the country;

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¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 7

Now, therefore, on the basis of the recommendations of the said Expert Committee and in exercise of

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 drug fixed dose combination

of Dicyclomine + Paracetamol + Domperidone with immediate effect.

[F. No. X-11035/53/2014-DFQC]

K. L. SHARMA, Jt. Secy.

अ ि ध स ूच न ा 

अ ि ध स ूच न ा अ ि ध स ूच न ा 

अ ि ध स ूच ना

  , 1 0 , 2 0 1 6

क ा . आ  

क ा . आ  क ा . आ  

क ा . आ . 1 2  

. 1 2  . 1 2  

. 1 2 ( अ )  

( अ ) ( अ ) 

( अ ) .  

.. 

.  

 

 

ल ा इ ड

ल ा इ ड ल ा इ ड

ल ा इ ड +  प रेा ि स टा म ो ल घ ु ल न ी य टे ब ल े ट 

प ेरा ि स टा म ो ल घ ु ल न ी य टे ब ल े ट प रेा ि स टा म ो ल घ ु ल न ी य टे ब ल े ट 

प ेरा ि स टा म ो ल घ ु ल न ी य टे ब ल े ट 

औ िष ध ,   औ िष ध

 

  औ िष ध  

 

औ िष ध   ,

  क औ र स म ी च ी न है

अ त , अ ब ,   य स र क ा र ,   ि व श षे  औ िष ध

अ ि ध ि न य म , 1 4 0 ( 1 4 0 क ा 2 3   2 6    ,

ल ा इ ड

ल ा इ ड ल ा इ ड

ल ा इ ड +  प ेरा ि स टा म ो ल

प रेा ि स टा म ो ल प ेरा ि स टा म ो ल

प रेा ि स टा म ो ल

घ ुल न ी य टे ब ल े ट 

घ ुल न ी य टे ब ल े ट घ ुल न ी य टे ब ल े ट 

घ ुल न ी य टे ब ल े ट  औ िष ध   ,   ल

फ ा .   - 1 1 0 3 5 / 5 3 / 2 0 1 4 -   स ी

  ,

, ,

,   स ि च व  

NOTIFICATION 

New Delhi, 10th March, 2016

S.O. 712(E).— Whereas, the Central Government is satisfied that the use of the drug fixed dose

combination of Nimesulide + Paracetamol dispersible tablets  is likely to involve risk to human beings

whereas safer alternatives to the said drug are available;

And Whereas, the matter has been examined by an Expert Committee appointed by the Central

Government and the said Expert Committee recommended to the Central Government that the said drug is

found to have no therapeutic justification;

And Whereas on the basis of the recommendations of the said Expert Committee, the Central

Government is satisfied that it is necessary and expedient in public interest to regulate by way of prohibitionof manufacture for sale, sale and distribution for human use of the said drug in the country;

Now, therefore, on the basis of the recommendations of the said Expert Committee and in exercise of

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 drug fixed dose combination

of Nimesulide + Paracetamol dispersible tablets with immediate effect.

[F. No. X-11035/53/2014-DFQC]

K. L. SHARMA, Jt. Secy.

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8 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] 

अ ि ध स ूच न ा 

अ ि ध स ूच न ा अ ि ध स ूच न ा 

अ ि ध स ूच ना

  , 1 0 , 2 0 1 6

क ा . आ  

क ा . आ  क ा . आ  

क ा . आ . 1 3  

. 1 3  . 1 3  

. 1 3 ( अ )  

( अ ) ( अ ) 

( अ ) .  

.. 

.  

 

  प ेरा ि स टा म ो ल

प ेरा ि स टा म ो ल प ेरा ि स टा म ो ल

प ेरा ि स टा म ो ल + 

+   

   

 

ि न य त ख रुा क स ं यो ज न औ िष ध ,   औ िष ध

  य स र क ा र क ो य     औ िष ध  

 

औ िष ध   ,

  क औ र स म ी च ी न है

अ त , अ ब ,   य स र क ा र , औ िष ध

अ ि ध ि न य म , 1 4 0 ( 1 4 0 क ा 2 3   2 6    , प रेा ि स टा म ो ल

प ेरा ि स टा म ो ल प रेा ि स टा म ो ल

प ेरा ि स टा म ो ल + 

+ 

औ िष ध   ,

फ ा .   - 1 1 0 3 5 / 5 3 / 2 0 1 4 -   स ी

  ,

, ,

,   स ि च व  

NOTIFICATION 

New Delhi, 10th March, 2016

S.O. 713(E).— Whereas, the Central Government is satisfied that the use of the drug fixed dose

combination of Paracetamol + Phenylephrine + Caffeine is likely to involve risk to human beings whereas

safer alternatives to the said drug are available;

And Whereas, the matter has been examined by an Expert Committee appointed by the CentralGovernment and the said Expert Committee recommended to the Central Government that the said drug is

found to have no therapeutic justification;

And Whereas on the basis of the recommendations of the said Expert Committee, the Central

Government is satisfied that it is necessary and expedient in public interest to regulate by way of prohibition

of manufacture for sale, sale and distribution for human use of the said drug in the country;

Now, therefore, on the basis of the recommendations of the said Expert Committee and in exercise of

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 drug fixed dose combination

of Paracetamol + Phenylephrine + Caffeine with immediate effect.

[F. No. X-11035/53/2014-DFQC]

K. L. SHARMA, Jt. Secy.

अ ि ध स ूच न ा 

अ ि ध स ूच न ा अ ि ध स ूच न ा 

अ ि ध स ूच ना

  , 1 0 , 2 0 1 6

क ा . आ  

क ा . आ  क ा . आ  

क ा . आ . 1 4  

. 1 4  . 1 4  

. 1 4 ( अ )  

( अ ) ( अ ) 

( अ ) .  

.. 

.  

 

   

   

  फे न क

फे न क फे न क

फे न क + 

+  प ैरा ि स टा म ो ल

प ैरा ि स टा म ो ल प ैरा ि स टा म ो ल

प ैरा ि स टा म ो ल

ि न य त ख रुा क स ं यो ज न औ िष ध ,   औ िष ध

  य स र क ा र

  औ िष ध  

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¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 9

 

औ िष ध   ,

  क औ र स म ी च ी न है

अ त , अ ब ,   य स र क ा र , औ िष ध

अ ि ध ि न य म , 1 4 0 ( 1 4 0 क ा 2 3   2 6    ,  

   

  फे न क

फे न क फे न क

फे न क + 

+ 

प ैरा ि स टा म ो ल

प ैरा ि स टा म ो ल प ैरा ि स टा म ो ल

प ैरा ि स टा म ो ल औ िष ध   ,   ल

फ ा .   - 1 1 0 3 5 / 5 3 / 2 0 1 4 -   स ी

  ,, ,,   स ि च व  

NOTIFICATION 

New Delhi, 10th March, 2016

S.O. 714(E).— Whereas, the Central Government is satisfied that the use of the drug fixed dose

combination of Diclofenac + Tramadol + Paracetamol is likely to involve risk to human beings whereas

safer alternatives to the said drug are available;

And Whereas, the matter has been examined by an Expert Committee appointed by the CentralGovernment and the said Expert Committee recommended to the Central Government that the said drug is

found to have no therapeutic justification;

And Whereas on the basis of the recommendations of the said Expert Committee, the Central

Government is satisfied that it is necessary and expedient in public interest to regulate by way of prohibition

of manufacture for sale, sale and distribution for human use of the said drug in the country;

Now, therefore, on the basis of the recommendations of the said Expert Committee and in exercise of

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 drug fixed dose combination

of Diclofenac + Tramadol + Paracetamol with immediate effect.

[F. No. X-11035/53/2014-DFQC]K. L. SHARMA, Jt. Secy.

अ ि ध स ूच न ा 

अ ि ध स ूच न ा अ ि ध स ूच न ा 

अ ि ध स ूच ना

  , 1 0 , 2 0 1 6

क ा . आ  

क ा . आ  क ा . आ  

क ा . आ . 1 5  

. 1 5  . 1 5  

. 1 5 ( अ )  

( अ ) ( अ ) 

( अ ) .  

.. 

.  

 

   

   

  फे न क

फे न क फे न क

फे न क +  प ैरा ि स टा म ो ल

प ैरा ि स टा म ो ल प ैरा ि स टा म ो ल

प ैरा ि स टा म ो ल + 

       

      ज ो न

ज ो न ज ो न ज ो न +   

      औ िष ध ,

  औ िष ध

  औ ष ि ध के ब ा    

 

औ िष ध   ,

  क औ र स म ी च ी न है

अ त , अ ब ,   य स र क ा र , औ िष ध

अ ि ध ि न य म , 1 4 0 ( 1 4 0 क ा 2 3   2 6    ,  

   

  फे न क

फे न क फे न क

फे न क +  प ैरा ि स टा म ो ल

प ैरा ि स टा म ो ल प ैरा ि स टा म ो ल

प ैरा ि स टा म ो ल

+   

   

 

   

  ज ो न

ज ो न ज ो न

ज ो न +   

   

  औ िष ध   ,

फ ा .   - 1 1 0 3 5 / 5 3 / 2 0 1 4 -   स ी

  ,

, ,

,   स ि च व  

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10 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] 

NOTIFICATION 

New Delhi, 10th March, 2016

S.O. 715(E).— Whereas, the Central Government is satisfied that the use of the drug fixed dose

combination of Diclofenac + Paracetamol + Chlorzoxazone + Famotidine  is likely to involve risk to

human beings whereas safer alternatives to the said drug are available;

And Whereas, the matter has been examined by an Expert Committee appointed by the Central

Government and the said Expert Committee recommended to the Central Government that the said drug isfound to have no therapeutic justification;

And Whereas on the basis of the recommendations of the said Expert Committee, the Central

Government is satisfied that it is necessary and expedient in public interest to regulate by way of prohibition

of manufacture for sale, sale and distribution for human use of the said drug in the country;

Now, therefore, on the basis of the recommendations of the said Expert Committee and in exercise of

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 drug fixed dose combination

of Diclofenac + Paracetamol + Chlorzoxazone + Famotidine  with immediate effect.

[F. No. X-11035/53/2014-DFQC]

K. L. SHARMA, Jt. Secy.

अ ि ध स ूच न ा 

अ ि ध स ूच न ा अ ि ध स ूच न ा 

अ ि ध स ूच ना

  , 1 0 , 2 0 1 6

क ा . आ  क ा . आ  क ा . आ  क ा . आ . 1 6  

. 1 6  . 1 6  

. 1 6 ( अ )  ( अ ) ( अ ) ( अ ) .  

.. 

.      

      न

न नन +  प ैरा ि स टा म ो ल

प रैा ि स टा म ो ल प ैरा ि स टा म ो ल प रैा ि स टा म ो ल

स यंो ज न औ िष ध ,   औ िष ध  

  औ िष ध  

 

औ िष ध   ,

  क औ र स म ी च ी न है

अ त , अ ब ,   य स र क ा र ,   प र औ र औ िष ध

अ ि ध ि न य म , 1 4 0 ( 1 4 0 क ा 2 3   2 6    ,  

   

  न

न न

न +  प ैरा ि स टा म ो ल

प ैरा ि स टा म ो ल प ैरा ि स टा म ो ल

प ैरा ि स टा म ो ल

ि न य त ख रुा क स ं यो ज न औ िष ध   ,

क र त ी ह ै ।

फ ा .   - 1 1 0 3 5 / 5 3 / 2 0 1 4 -   स ी

  ,

, ,

,   स ि च व  

NOTIFICATION 

New Delhi, the 10th March, 2016

S.O. 716(E).—Whereas, the Central Government is satisfied that the use of the drug fixed dose

combination of Naproxen + Paracetamol is likely to involve risk to human beings whereas safer alternatives

to the said drug are available;

And Whereas, the matter has been examined by an Expert Committee appointed by the Central

Government and the said Expert Committee recommended to the Central Government that the said drug is

found to have no therapeutic justification;

And Whereas on the basis of the recommendations of the said Expert Committee, the Central

Government is satisfied that it is necessary and expedient in public interest to regulate by way of prohibition

of manufacture for sale, sale and distribution for human use of the said drug in the country;

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¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 11

Now, therefore, on the basis of the recommendations of the said Expert Committee and in exercise of

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 drug fixed dose combination

of Naproxen + Paracetamol with immediate effect.

[F. No. X-11035/53/2014-DFQC]

K. L. SHARMA, Jt. Secy.

अ ि ध स ूच न ा 

अ ि ध स ूच न ा अ ि ध स ूच न ा 

अ ि ध स ूच ना

  , 1 0 , 2 0 1 6

क ा . आ  क ा . आ  क ा . आ  क ा . आ . 1  

. 1  . 1  

. 1 ( अ )  ( अ ) ( अ ) ( अ ) .  

.. 

.    

ल ा इ ड

ल ा इ ड ल ा इ ड ल ा इ ड +   

      ड े स

ड े स ड े स ड े स

ख रुा क स ं यो ज न औ िष ध ,   औ िष ध  

  औ िष ध  

 

औ िष ध   ,

  क औ र स म ी च ी न है

अ त , अ ब ,   य स र क ा र , औ िष ध

अ ि ध ि न य म , 1 4 0 ( 1 4 0 क ा 2 3   2 6    ,

ल ा इ ड

ल ा इ ड ल ा इ ड

ल ा इ ड + 

 

   

  ड से 

ड से ड से 

ड से  औ ष ि ध क ा म ा न व उ प य ो ग के ि ल ए   ,

फ ा .   - 1 1 0 3 5 / 5 3 / 2 0 1 4 -   स ी

  ,

, ,

,   स ि च व  

NOTIFICATION 

New Delhi, the 10th March, 2016

S.O. 717(E).— Whereas, the Central Government is satisfied that the use of the drug fixed dose

combination of Nimesulide + Serratiopeptidase is likely to involve risk to human beings whereas safer

alternatives to the said drug are available;

And Whereas, the matter has been examined by an Expert Committee appointed by the Central

Government and the said Expert Committee recommended to the Central Government that the said drug is

found to have no therapeutic justification;

And Whereas on the basis of the recommendations of the said Expert Committee, the Central

Government is satisfied that it is necessary and expedient in public interest to regulate by way of prohibition

of manufacture for sale, sale and distribution for human use of the said drug in the country;

Now, therefore, on the basis of the recommendations of the said Expert Committee and in exercise of

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 drug fixed dose combination

of Nimesulide + Serratiopeptidase with immediate effect.

[F. No. X-11035/53/2014-DFQC]

K. L. SHARMA, Jt. Secy.

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12 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] 

अ ि ध स ूच न ा 

अ ि ध स ूच न ा अ ि ध स ूच न ा 

अ ि ध स ूच ना

  , 1 0 , 2 0 1 6

क ा . आ  

क ा . आ  क ा . आ  

क ा . आ . 1  

. 1  . 1  

. 1 ( अ )  

( अ ) ( अ ) 

( अ ) .  

.. 

.  

 

  प ेरा ि स टा म ो ल

प ेरा ि स टा म ो ल प ेरा ि स टा म ो ल

प ेरा ि स टा म ो ल +   

   

  फे न क

फे न क फे न क

फे न क +

  ि न य त

ख रुा क स ं यो ज न औ िष ध ,   औ िष ध  

  य स र क ा र क ो   औ िष ध  

 

औ िष ध   , ि व  

  क औ र स म ी च ी न है

अ त , अ ब ,   य स र क ा र , औ िष ध

अ ि ध ि न य म , 1 4 0 ( 1 4 0 क ा 2 3   2 6    , प ेरा ि स टा म ो ल

प ेरा ि स टा म ो ल प ेरा ि स टा म ो ल

प ेरा ि स टा म ो ल +   

   

  फे न क

फे न क फे न क

फे न क

+

औ िष ध   ,   ल

फ ा .   - 1 1 0 3 5 / 5 3 / 2 0 1 4 -   स ी

  ,

, ,

,   स ि च व  

NOTIFICATION 

New Delhi, the 10th March, 2016

S.O. 718(E).—Whereas, the Central Government is satisfied that the use of the drug fixed dose

combination of Paracetamol + Diclofenac + Famotidine is likely to involve risk to human beings whereas

safer alternatives to the said drug are available;

And Whereas, the matter has been examined by an Expert Committee appointed by the CentralGovernment and the said Expert Committee recommended to the Central Government that the said drug is

found to have no therapeutic justification;

And Whereas on the basis of the recommendations of the said Expert Committee, the Central

Government is satisfied that it is necessary and expedient in public interest to regulate by way of prohibition

of manufacture for sale, sale and distribution for human use of the said drug in the country;

Now, therefore, on the basis of the recommendations of the said Expert Committee and in exercise of

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 drug fixed dose combination

of Paracetamol + Diclofenac + Famotidine with immediate effect.

[F. No. X-11035/53/2014-DFQC]

K. L. SHARMA, Jt. Secy.

अ ि ध स ूच न ा 

अ ि ध स ूच न ा अ ि ध स ूच न ा 

अ ि ध स ूच ना

  , 1 0 , 2 0 1 6

क ा . आ  

क ा . आ  क ा . आ  

क ा . आ . 1  

. 1  . 1  

. 1 ( अ )  

( अ ) ( अ ) 

( अ ) .  

.. 

.  

 

 

ल ा इ ड

ल ा इ ड ल ा इ ड

ल ा इ ड +  ि प ट ो फ े न ो न

ि प ट ो फ े न ो न ि प ट ो फ े न ो न

ि प ट ो फ े न ो न + 

+   

   

  ह ल

ह लह ल

ह ल औ िष ध ,  

औ िष ध

औ 

  औ िष ध  

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¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 13

   

औ िष ध   ,

  क औ र स म ी च ी न है

अ त , अ ब ,   य स र क ा र ,   औ िष ध

अ ि ध ि न य म , 1 4 0 ( 1 4 0 क ा 2 3   2 6    ,

ल ा इ ड

ल ा इ ड ल ा इ ड

ल ा इ ड +  ि प ट ो फ े न ो न

ि प ट ो फ े न ो न ि प ट ो फ े न ो न

ि प ट ो फ े न ो न + 

+   

   

  ह ल 

ह ल ह ल 

ह ल  औ िष ध   ,

फ ा .   - 1 1 0 3 5 / 5 3 / 2 0 1 4 -   स ी

  ,, ,,   स ि च व  

NOTIFICATION 

New Delhi, the 10th March, 2016

S.O. 719(E).— Whereas, the Central Government is satisfied that the use of the drug  fixed dose

combination of Nimesulide + Pitofenone + Fenpiverinium + Benzyl Alcohol  is likely to involve risk to

human beings whereas safer alternatives to the said drug are available;

And Whereas, the matter has been examined by an Expert Committee appointed by the CentralGovernment and the said Expert Committee recommended to the Central Government that the said drug is

found to have no therapeutic justification;

And Whereas on the basis of the recommendations of the said Expert Committee, the Central

Government is satisfied that it is necessary and expedient in public interest to regulate by way of prohibition

of manufacture for sale, sale and distribution for human use of the said drug in the country;

Now, therefore, on the basis of the recommendations of the said Expert Committee and in exercise of

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 drug fixed dose combination

of Nimesulide + Pitofenone + Fenpiverinium + Benzyl Alcohol with immediate effect.

[F. No. X-11035/53/2014-DFQC]K. L. SHARMA, Jt. Secy.

अ ि ध स ूच न ा 

अ ि ध स ूच न ा अ ि ध स ूच न ा 

अ ि ध स ूच ना

  , 1 0 , 2 0 1 6

क ा . आ  

क ा . आ  क ा . आ  

क ा . आ . 2 0  

. 2 0  . 2 0  

. 2 0 ( अ )  

( अ ) ( अ ) 

( अ ) .  

.. 

.  

 

  ओ ि म 

ओ ि म ओ ि म 

ओ ि म 

+  प ेरा ि स टा म ो ल

प ेरा ि स टा म ो ल प ेरा ि स टा म ो ल

प ेरा ि स टा म ो ल +   

   

  फ े न क  

फ े न क  फ े न क  

फ े न क  

औ िष ध ,   औ िष ध

 

  औ िष ध  

 

औ ष ि ध के म ा न     ,

  क औ र स म ी च ी न है

अ त , अ ब ,   य स र क ा र , औ िष ध

अ ि ध ि न य म ,   ,

+  प ेरा ि स टा म ो ल

प ेरा ि स टा म ो ल प ेरा ि स टा म ो ल

प ेरा ि स टा म ो ल + 

 

   

  फे न क

फे न क फे न क

फे न क औ िष ध   ,

फ ा .   - 1 1 0 3 5 / 5 3 / 2 0 1 4 -   स ी

  ,

, ,

,   स ि च व  

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14 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] 

NOTIFICATION 

New Delhi, the 10th March, 2016

S.O. 720(E).— Whereas, the Central Government is satisfied that the use of the drug fixed dose

combination of Omeprazole + Paracetamol + Diclofenac is likely to involve risk to human beings whereas

safer alternatives to the said drug are available;

And Whereas, the matter has been examined by an Expert Committee appointed by the Central

Government and the said Expert Committee recommended to the Central Government that the said drug isfound to have no therapeutic justification;

And Whereas on the basis of the recommendations of the said Expert Committee, the Central

Government is satisfied that it is necessary and expedient in public interest to regulate by way of prohibition

of manufacture for sale, sale and distribution for human use of the said drug in the country;

Now, therefore, on the basis of the recommendations of the said Expert Committee and in exercise of

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 drug fixed dose combination

of Omeprazole + Paracetamol + Diclofenac with immediate effect.

[F. No. X-11035/53/2014-DFQC]

K. L. SHARMA, Jt. Secy.

अ ि ध स ूच न ा 

अ ि ध स ूच न ा अ ि ध स ूच न ा 

अ ि ध स ूच ना

  , 1 0 , 2 0 1 6

क ा . आ  क ा . आ  क ा . आ  क ा . आ . 2 1  

. 2 1  . 2 1  

. 2 1 ( अ )  ( अ ) ( अ ) ( अ ) .  

.. 

.    

ल ा इ ड

ल ा इ ड ल ा इ ड ल ा इ ड +   

      न 

नन न 

ि न य त ख रुा क स ं यो ज न औ िष ध ,   औ िष ध  

  औ िष ध  

औ   

औ िष ध   ,

  क औ र स म ी च ी न है

अ त , अ ब ,   य स र क ा र , औ िष ध

अ ि ध ि न य म , 1 4 0 ( 1 4 0 क ा 2 3   2 6    ,

ल ा इ ड

ल ा इ ड ल ा इ ड

ल ा इ ड +  प ेरा ि स टा म ो ल

प रेा ि स टा म ो ल प ेरा ि स टा म ो ल

प रेा ि स टा म ो ल

 

   

  न 

नन 

न  औ िष ध   ,

फ ा .   - 1 1 0 3 5 / 5 3 / 2 0 1 4 -   स ी

  ,

, ,

,   स ि च व  

NOTIFICATION 

New Delhi, the 10th March, 2016

S.O. 721(E).— Whereas, the Central Government is satisfied that the use of the drug fixed dose

combination of Nimesulide + Paracetamol injection is likely to involve risk to human beings whereas safer

alternatives to the said drug are available;

And Whereas, the matter has been examined by an Expert Committee appointed by the Central

Government and the said Expert Committee recommended to the Central Government that the said drug is

found to have no therapeutic justification;

And Whereas on the basis of the recommendations of the said Expert Committee, the Central

Government is satisfied that it is necessary and expedient in public interest to regulate by way of prohibition

of manufacture for sale, sale and distribution for human use of the said drug in the country;

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¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 15

Now, therefore, on the basis of the recommendations of the said Expert Committee and in exercise of

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 drug fixed dose combination

of Nimesulide + Paracetamol injection with immediate effect.

[F. No. X-11035/53/2014-DFQC]

K. L. SHARMA, Jt. Secy.

अ ि ध स ूच न ा 

अ ि ध स ूच न ा अ ि ध स ूच न ा 

अ ि ध स ूच ना

  , 1 0 , 2 0 1 6

क ा . आ  

क ा . आ  क ा . आ  

क ा . आ . 2 2  

. 2 2  . 2 2  

. 2 2 ( अ )  

( अ ) ( अ ) 

( अ ) .  

.. 

.  

 

 

ल ो ि स न

ल ो ि स न ल ो ि स न

ल ो ि स न +   

   

  फे न क

फे न क फे न क

फे न क  

स यंो ज न औ िष ध ,   औ िष ध  

 

  औ िष ध  

 

औ िष ध   ,

  क औ र स म ी च ी न है

अ त , अ ब ,   य स र क ा र , औ िष ध

अ ि ध ि न य म , 1 4 0 ( 1 4 0 क ा 2 3   2 6    , ट मे 

ट मे ट मे 

ट मे 

ल ो ि स न

ल ो ि स न ल ो ि स न

ल ो ि स न +   

   

  फे न क

फे न क फे न क

फे न क

औ िष ध   ,

फ ा .   - 1 1 0 3 5 / 5 3 / 2 0 1 4 -   स ी

  ,, ,,   स ि च व  

NOTIFICATION 

New Delhi, the 10th March, 2016

S.O. 722(E).— Whereas, the Central Government is satisfied that the use of the drug fixed dose

combination of Tamsulosin + Diclofenac is likely to involve risk to human beings whereas safer alternatives

to the said drug are available;

And Whereas, the matter has been examined by an Expert Committee appointed by the Central

Government and the said Expert Committee recommended to the Central Government that the said drug isfound to have no therapeutic justification;

And Whereas on the basis of the recommendations of the said Expert Committee, the Central

Government is satisfied that it is necessary and expedient in public interest to regulate by way of prohibition

of manufacture for sale, sale and distribution for human use of the said drug in the country;

Now, therefore, on the basis of the recommendations of the said Expert Committee and in

exercise of 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 drug fixed dose

combination of Tamsulosin + Diclofenac with immediate effect.

[F. No. X-11035/53/2014-DFQC]

K. L. SHARMA, Jt. Secy.

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16 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] 

अ ि ध स ूच न ा 

अ ि ध स ूच न ा अ ि ध स ूच न ा 

अ ि ध स ूच ना

  , 1 0 , 2 0 1 6

क ा . आ  

क ा . आ  क ा . आ  

क ा . आ . 2 3  

. 2 3  . 2 3  

. 2 3 ( अ )  

( अ ) ( अ ) 

( अ ) .  

.. 

.  

 

    य स र का र क ा य ह स म ा   प ेरा ि स टा म ो ल

प ेरा ि स टा म ो ल प ेरा ि स टा म ो ल

प ेरा ि स टा म ो ल +  फ े न ा इ ल फ े री न

फ े न ा इ ल फ े री न फ े न ा इ ल फ े री न

फ े न ा इ ल फ े री न + 

        र फ े न ा इ रे म ा इ न म े ल टे

र फ े न ा इ रे म ा इ न म े ल ेटर फ े न ा इ रे म ा इ न म े ल टेर फ े न ा इ रे म ा इ न म े ल ेट +   

   

+ 

औ िष ध

,   औ िष ध

  य स र क ा र

  औ िष ध  

 

औ िष ध   ,

  क औ र स म ी च ी न है

अ त , अ ब ,   य स र क ा र , औ िष ध

अ ि ध ि न य म , 1 4 0 ( 1 4 0 क ा 2 3   2 6    , प ेरा ि स टा म ो ल

प ेरा ि स टा म ो ल प ेरा ि स टा म ो ल

प ेरा ि स टा म ो ल +  फ े न ा इ ल फ े री न

फ े न ा इ ल फ े री न फ े न ा इ ल फ े री न

फ े न ा इ ल फ े री न

+   

   

  र फ े न ा इ रे म ा इ न म े ल ेट

र फ े न ा इ रे म ा इ न म े ल ेटर फ े न ा इ रे म ा इ न म े ल ेट

र फ े न ा इ रे म ा इ न म े ल ेट +   

   

+ 

औ ष ि ध क ा म ा न व उ प य ो ग के ि ल ए

  ,

फ ा .   - 1 1 0 3 5 / 5 3 / 2 0 1 4 -   स ी

  ,

, ,

,   स ि च व  

NOTIFICATION 

New Delhi, the 10th March, 2016

S.O. 723(E).— Whereas, the Central Government is satisfied that the use of the drug fixed dose

combination of Paracetamol + Phenylephrine + Chlorpheniramine + Dextromethorphan + Caffeine is

likely to involve risk to human beings whereas safer alternatives to the said drug are available;And Whereas, the matter has been examined by an Expert Committee appointed by the Central

Government and the said Expert Committee recommended to the Central Government that the said drug is

found to have no therapeutic justification;

And Whereas on the basis of the recommendations of the said Expert Committee, the Central

Government is satisfied that it is necessary and expedient in public interest to regulate by way of prohibition

of manufacture for sale, sale and distribution for human use of the said drug in the country;

Now, therefore, on the basis of the recommendations of the said Expert Committee and in exercise of

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 drug fixed dose combination

of Paracetamol + Phenylephrine + Chlorpheniramine + Dextromethorphan + Caffeine with immediate

effect.

[F. No. X-11035/53/2014-DFQC]

K. L. SHARMA, Jt. Secy.

अ ि ध स ूच न ा अ ि ध स ूच न ा अ ि ध स ूच न ा अ ि ध स ूच ना

  , 1 0 , 2 0 1 6

क ा . आ  

क ा . आ  क ा . आ  

क ा . आ . 2 4  

. 2 4  . 2 4  

. 2 4 ( अ )  

( अ ) ( अ ) 

( अ ) .  

.. 

.  

 

    य स र    

   

  फ े न ेक

फ े न ेकफ े न ेक

फ े न ेक + 

ख रुा क स ं यो ज न औ िष ध ,   औ िष ध  

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¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 17

 

  औ िष ध  

 

औ िष ध   ,

  क औ र स म ी च ी न है

अ त , अ ब ,   य स र क ा र , औ िष ध

अ ि ध ि न य म , 1 4 0 ( 1 4 0 क ा 2 3   2 6    ,  

   

  फ े न ेक

फ े न ेकफ े न ेक

फ े न ेक + 

क ा र न ो स ा इ न  

क ा र न ो स ा इ न  क ा र न ो स ा इ न  

क ा र न ो स ा इ न   औ िष ध   ,   ल

फ ा .   - 1 1 0 3 5 / 5 3 / 2 0 1 4 -   स ी

  ,

, ,

,   स ि च व  

NOTIFICATION 

New Delhi, the 10th March, 2016

S.O. 724(E).— Whereas, the Central Government is satisfied that the use of the drug fixed dose

combination of Diclofenac + Zinc Carnosine  is likely to involve risk to human beings whereas safer

alternatives to the said drug are available;

And Whereas, the matter has been examined by an Expert Committee appointed by the Central

Government and the said Expert Committee recommended to the Central Government that the said drug is

found to have no therapeutic justification;

And Whereas on the basis of the recommendations of the said Expert Committee, the Central

Government is satisfied that it is necessary and expedient in public interest to regulate by way of prohibition

of manufacture for sale, sale and distribution for human use of the said drug in the country;

Now, therefore, on the basis of the recommendations of the said Expert Committee and in exercise of

powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Governmenthereby prohibits the manufacture for sale, sale and distribution for human use of drug fixed dose combination

of Diclofenac + Zinc Carnosine with immediate effect.

[F. No. X-11035/53/2014-DFQC]

K. L. SHARMA, Jt. Secy.

अ ि ध स ूच न ा 

अ ि ध स ूच न ा अ ि ध स ूच न ा 

अ ि ध स ूच ना

  , 1 0 , 2 0 1 6

क ा . आ  

क ा . आ  क ा . आ  

क ा . आ . 2 5  

. 2 5  . 2 5  

. 2 5 ( अ )  

( अ ) ( अ ) 

( अ ) .  

.. 

.  

 

   

   

  फ े न ेक

फ े न ेकफ े न ेक

फ े न ेक +  प ेरा ि स टा म ो ल

प ेरा ि स टा म ो ल प ेरा ि स टा म ो ल

प ेरा ि स टा म ो ल + 

 

   

  र फ े न ा इ रे म ा इ न म े ल ेट

र फ े न ा इ रे म ा इ न म े ल ेटर फ े न ा इ रे म ा इ न म े ल ेट

र फ े न ा इ रे म ा इ न म े ल ेट + 

औ िष ध

ह ै,   औ िष ध

  औ िष ध    

 

औ िष ध   ,

  क औ र स म ी च ी न है

अ त , अ ब ,   य स र क ा र , औ िष ध

अ ि ध ि न य म , 1 4 0 ( 1 4 0 क ा 2 3   2 6    ,  

   

  फ े न ेक

फ े न ेकफ े न ेक

फ े न ेक +  प ेरा ि स टा म ो ल

प ेरा ि स टा म ो ल प ेरा ि स टा म ो ल

प ेरा ि स टा म ो ल

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18 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] 

+   

   

  र फ े न ा इ रे म ा इ न म े ल ेट

र फ े न ा इ रे म ा इ न म े ल ेटर फ े न ा इ रे म ा इ न म े ल ेट

र फ े न ा इ रे म ा इ न म े ल ेट + 

 

   

  औ ष ि ध क ा म ा न व उ प य ो ग के ि ल ए

  ,

फ ा .   - 1 1 0 3 5 / 5 3 / 2 0 1 4 -   स ी

  ,, ,,   स ि च व  

NOTIFICATION 

New Delhi, the 10th March, 2016

S.O. 725(E).—Whereas, the Central Government is satisfied that the use of the drug fixed dose

combination of Diclofenac + Paracetamol + Chlorpheniramine Maleate + Magnesium Trisillicate   is

likely to involve risk to human beings whereas safer alternatives to the said drug are available;

And Whereas, the matter has been examined by an Expert Committee appointed by the Central

Government and the said Expert Committee recommended to the Central Government that the said drug is

found to have no therapeutic justification;

And Whereas on the basis of the recommendations of the said Expert Committee, the Central

Government is satisfied that it is necessary and expedient in public interest to regulate by way of prohibition

of manufacture for sale, sale and distribution for human use of the said drug in the country;

Now, therefore, on the basis of the recommendations of the said Expert Committee and in exercise of

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 drug fixed dose combination

of Diclofenac Sodium + Paracetamol + Chlorpheniramine Maleate + Magnesium Trisillicate  with

immediate effect.

[F. No. X-11035/53/2014-DFQC]

K. L. SHARMA, Jt. Secy.

अ ि ध स ूच न ा 

अ ि ध स ूच न ा अ ि ध स ूच न ा 

अ ि ध स ूच ना

  , 1 0 , 2 0 1 6

क ा . आ  

क ा . आ  क ा . आ  

क ा . आ . 2 6  

. 2 6  . 2 6  

. 2 6 ( अ )  

( अ ) ( अ ) 

( अ ) .  

.. 

.  

 

  प ेरा ि स टा  

प ेरा ि स टा  प ेरा ि स टा  

प ेिरा स टा म ो ल

म ो ल म ो ल

म ो ल + 

+ 

ि न य त ख रुा क स ं यो ज न औ िष ध ,   औ िष ध

  औ िष ध  

 

औ िष ध   ,

  क औ र स म ी च ी न है

अ त , अ ब ,   य स र क ा र , औ िष ध

अ ि ध ि न य म , 1 4 0 ( 1 4 0 क ा 2 3   2 6    , प ेरा ि स टा  

प रेा ि स टा  प ेरा ि स टा  

प िेरा स ट ा म ो ल

म ो ल म ो ल

म ो ल + 

+ 

औ िष ध   ,   ल

फ ा .   - 1 1 0 3 5 / 5 3 / 2 0 1 4 -   स ी

  ,

, ,

,   स ि च व  

NOTIFICATION 

New Delhi, the 10th March, 2016

S.O. 726(E).— Whereas, the Central Government is satisfied that the use of the drug fixed dose

combination of Paracetamol + Pseudoephedrine + Cetrizine is likely to involve risk to human beings

whereas safer alternatives to the said drug are available;

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¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 19

And Whereas, the matter has been examined by an Expert Committee appointed by the Central

Government and the said Expert Committee recommended to the Central Government that the said drug is

found to have no therapeutic justification;

And Whereas on the basis of the recommendations of the said Expert Committee, the Central

Government is satisfied that it is necessary and expedient in public interest to regulate by way of prohibition

of manufacture for sale, sale and distribution for human use of the said drug in the country;

Now, therefore, on the basis of the recommendations of the said Expert Committee and in exercise of

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 drug fixed dose combination

of Paracetamol + Pseudoephedrine + Cetrizine with immediate effect.

[F. No. X-11035/53/2014-DFQC]

K. L. SHARMA, Jt. Secy.

अ ि ध स ूच न ा 

अ ि ध स ूच न ा अ ि ध स ूच न ा 

अ ि ध स ूच ना

  , 1 0 , 2 0 1 6

क ा . आ  

क ा . आ  क ा . आ  

क ा . आ . 2  

. 2  . 2  

. 2 ( अ )  

( अ ) ( अ ) 

( अ ) .  

.. 

.  

 

  फे न ा इ ल ब ु टा ज ो न

फे न ा इ ल ब ु टा ज ो न फे न ा इ ल ब ु टा ज ो न

फे न ा इ ल ब ु टा ज ो न +  स ो ि ड य म स ि ल क ा इ ल ेट 

स ो ि ड य म स ि ल क ा इ ल ेट स ो ि ड य म स ि ल क ा इ ल ेट 

स ो ि ड य म स ि ल क ा इ ल ेट 

ि न य त ख रुा क स ं यो ज न औ िष ध ,   औ िष ध

    औ िष ध  

 

औ िष ध   ,  

  क औ र स म ी च ी न है

अ त , अ ब ,   य स र क ा र , औ िष ध

अ ि ध ि न य म , 1 4 0 ( 1 4 0 क ा 2 3   2 6    , फ े न ा इ  

फ े न ा इ  फ े न ा इ  

फे न ा इ ल ब ु टा ज ो न

ल ब ुटा ज ो न ल ब ुटा ज ो न

ल ब ुटा ज ो न +  स ो ि ड य म

स ो ि ड य म स ो ि ड य म

स ो ि ड य म

स ि ल क ा इ ल ेट 

स ि ल क ा इ ल ेट स ि ल क ा इ ल ेट 

स ि ल क ा इ ल ेट  औ िष ध   ,   ल

फ ा .   - 1 1 0 3 5 / 5 3 / 2 0 1 4 -   स ी

  ,

, ,

,   स ि च व  

NOTIFICATION 

New Delhi, the 10th March, 2016

S.O. 727(E).— Whereas, the Central Government is satisfied that the use of the drug fixed dose

combination of Phenylbutazone + Sodium Salicylate is likely to involve risk to human beings whereas safer

alternatives to the said drug are available;And Whereas, the matter has been examined by an Expert Committee appointed by the Central

Government and the said Expert Committee recommended to the Central Government that the said drug is

found to have no therapeutic justification;

And Whereas on the basis of the recommendations of the said Expert Committee, the Central

Government is satisfied that it is necessary and expedient in public interest to regulate by way of prohibition

of manufacture for sale, sale and distribution for human use of the said drug in the country;

Now, therefore, on the basis of the recommendations of the said Expert Committee and in exercise of

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 drug Phenylbutazone +

Sodium Salicylate with immediate effect.

[F. No. X-11035/53/2014-DFQC]

K. L. SHARMA, Jt. Secy.

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20 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC