Lok Sabha Question No. 82 (STARRED), answered on 2016-04-29
Subject: Ban of FDC Drugs
Ministry: HEALTH AND FAMILY WELFARE
Asked by: ASHOK SHANKARRAO CHAVAN, GEETHA KOTHAPALLI

## GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE DEPARTMENT OF HEALTH AND FAMILY WELFARE

## LOK SABHA STARRED QUESTION NO. 82 TO BE ANSWERED ON THE 29 TH APRIL , 2016 BAN OF FDC DRUGS

## *82. SHRI ASHOK SHANKARRAO CHAVAN: SHRIMATI KOTHAPALLI GEETHA:

Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:

- (a) whether the Government has tested more than 1200 Fixed Dose Combination drugs and prohibited the manufacture, sale and distribution of abou t 350 drugs, if so, the details of such drugs/ medicines and the reasons therefor;
- (b) whether the pharma companies have opposed the ban, if so, the reasons th the response of the Government thereto;
- (c)  whether  the  Government  has  taken  note of  side  effects  of  such  banned  FDC drugs/medicines  and  complaints  of  smuggling  of  contraband  drugs,  if  so,  th thereof; and
- (d) the corrective action taken by the Government to ensure safety of consumers a manufacture, sale and distribution of safe medicines having therapeutic justifi

## ANSWER THE MINISTER OF HEALTH AND FAMILY WELFARE (SHRI JAGAT PRAKASH NADDA)

- (a) to ( d):  A statement is laid on the Table of the House

## STATEMENT REFERRED TO IN REPLY TO LOK SABHA STARRED QUESTION NO. 82 * FOR 29 TH APRIL , 2016

(a)  The  Government vide Gazette  Notifications  S.O.  Nos.  705(E)  to  1048(E)  d 10.03.2016 prohibited the manufacture for sale, sale and distribution for hum FDCs with immediate effect in public interest as these FDCs were likely to inv human  beings  and  saf er  alternatives  were  available.  The  list  of  FDCs  prohib Annexed.

(b)  The  Pharma  companies  have  opposed  prohibition inter  alia on  the  following procedural grounds :

- (i). Government did not consult Drugs Technical Advisory Board (DTAB Drugs Consultati ve Committee (DCC).
- (ii). Opportunity was not given to the manufacturers.
- (iii).The  manufacturers  were  not  heard  after  they  replied  to  show notices.
- (iv). The  notification  is  vague  and  merely  says  there  is  no  ther justification and other safer alternatives are available.  It does not speci which are those alternatives.
- (v). The products are in the market for a long time and there are no reaction, etc.
- (vi). The manufacturers are having some kind of licence from State Lic Authority  before  September,    1988  o r  are  having  some  kind  of NOC/approval from the Drugs Contr oller General (India) [DCG(I)].
- (vii). Similar products are approved by DCG(I).
- (viii).Government  ban  will  make  the  stockists/  retailers,  etc.  li prosecution under section 18.
- (ix). The petitioners are having valid licenses from State Licensing Aut .

In the context of the foregoing, it needs to be noted that Fixed Dose C (FDCs) containing drugs combined together for the first time are treated as 'New Drugs'.

These, therefore, require permission from the DCG(I) before these could be licensed by t State Licensing Authorities (SLAs) for manufacture for sale in the country. had, despite not having the authority to grant licences for new FDCs, contin d to grant licences without approval of the DCG(I).  In order to address this issue, the Health and Family Welfare also issued statutory directions to the State/Uni Governments to instruct their respective drugs licensing authorit ies to refrain from grantin such licenses. However, the practice was still not discontinued by some SLAs. had also been considered by the Standing Committee of Parliament which had o that  Section  26A  of  the  Drugs  and  Cosmetics  Act,  1940 is  adequate  to  deal  with  th problem  of  irrational  and/or  FDCs  not  cleared  by  CDSCO.  Though,  the  l issued/obtained  were  without  jurisdiction  and  therefore  not  legal,  keeping public  health  and  safety  concerns,  on  the  direction  of  the  Gov ernment,  CDSCO  on 15.01.2013 , requested the State Regulators to ask the concerned manufacturers States to prove the safety and efficacy of such FDCs which had been license prior  to  01.10.2012  without  approval  of  DCG(I)  before  the  office of  DCG(I)  within  a period  of  18  months.  It  was  informed  that  in  the  event  of  failure  to  prov efficacy,  such  FDCs  would  be  considered  for  being  prohibited  for  manufac marketing in the country. This notice was also uploaded on the officia l website of CDSCO as an information and for necessary action. Subsequent to it, CDSCO also iss dated  05.07.2013  to  the  State  Drug  Controllers  asking  the  manufacturer applications as per the procedure defined in the letter for proving the safety and efficacy of these FDCs. In reply to above letter, CDSCO received approximately 6320 app from the manufacturers till 14 th July 2014. Keeping in view the fact that rationality drugs had not been proved, in the larger public i nterest, and to examine these applicati in a timely manner, the Ministry constituted a Committee under the Chairmanshi C. K. Kokate, Vice - Chancellor, KLE University, Belgaum, Karnataka on 16.09.2014.

The Chairman of the Committee along with the members presented the report befor the Ministry on 04.03.2015 wherein the Committee was requested to further exa elaborate the scientific reasons for each FDC considered as Irrational by th and submit the report accordingly. The Com mittee held a large number of FDCs to b rational  and  these  were  allowed  to  be  manufactured/marketed.  Further,  meetin Committee  took  place  on  07.04.2015  and  08.04.2015  and  Committee  gave  scie reasons in respect of each FDC/s held to be irrat ional. Thereafter, the final report o Committee was submitted to the Ministry on 16.4.2015.

After  examination  of  the  recommendations  of  the  Committee  in  case  of declared irrational, show cause notices were issued and opportunity was again ded to the applicants to respond within 30 days. However, on the request of the man further extension of 90 days was granted for submitting their replies. The re were  thereafter  examined  by  the  Expert  Committee  and  further  recommen dations  were given on 10.02.2016 after thorough examination of all replies. The experts in r also assisted the Committee in the evaluation process.

The    above  findings  of  the  Expert  Committee  were inter  alia based  on  various parameters such as patient safety, drug toxicity/adverse effect, misuse of drug/pr error, abuse potential, pharmacokinetic and pharmacodynamic interaction/compa dosage compatibilities of FDCs vis - à- vis that of single ingredients, issue of antimi drug  resistance,  latest  standard  treatment  guidelines  (STG),  risk/benefit  r compliance, international status, etc. The matter was, thereafter ,further examined by the Government  and  the  FDCs  found  to  be  irrational  were  prohibited.  Thus,  the rt Committee  has  carried  out  an  elaborate  exercise  based  on  contemporary  s knowledge  before  finalising  its  recommendations.  Adequate  opportunity  ha provided  to  the  manufacturers  to  place  their  position  before  the  Committe Government.

(c) All facts related to these FDCs were duly considered by the Government bef a decision.

(d) While, the FDCs have been prohibited, a large number of cases have been fi Pharmaceutical Manufacturers in Delhi, Chennai, Himachal Pra desh and Karnatka.   Delhi and Karnatka High Courts have granted stay in cases filed in these courts and currently sub - judice.

|       | List of FDCs prohibited                               | GSR NO.      |
|-------|-------------------------------------------------------|--------------|
| S.No. | Name of FDC                                           |              |
| 1     | Aceclofenac + Paracetamol + Rabeprazole               | S.O. 705 (E) |
| 2     | Nimesulide + Diclofenac                               | S.O. 706 (E) |
| 3     | Nimesulide + Cetirizine +Caffeine                     | S.O. 707 (E) |
| 4     | Nimesulide +Tizanidine                                | S.O. 708 (E) |
| 5     | Paracetamol + cetrizine + caffeine                    | S.O. 709 (E) |
| 6     | Diclofenac + Tramadol + Chlorzoxazone                 | S.O. 710 (E) |
| 7     | Dicyclomine +Paracetamol +Domperidone                 | S.O. 711 (E) |
| 8     | Nimesulide +Paracetamol dispesible tablets            | S.O. 712 (E) |
| 9     | Paracetamol + Phenylephrine + Caffeine                | S.O. 713 (E) |
| 10    | Diclofenac +Tramadol +Paracetamol                     | S.O. 714 (E) |
| 11    | Diclofenac + paracetamol + chlorzoxazone + famotidine | S.O. 715 (E) |
| 12    | Naproxen+Paracetamol                                  | S.O. 716 (E) |
| 13    | Nimesulide + serratiopeptidase                        | S.O. 717 (E) |

|   14 | Paracetamol +Diclofenac +Famotidine                                               | S.O. 718 (E)              |
|------|-----------------------------------------------------------------------------------|---------------------------|
|   15 | Nimesulide + Pitofenone + Fenpiverinium + benzyl alcohol                          | S.O. 719 (E)              |
|   16 | Omeprazole + Paracetamol + Diclofenac                                             | S.O. 720 (E)              |
|   17 | Nimesulide + Paracetamol injection                                                | S.O. 721 (E)              |
|   18 | Tamsulosin + diclofenac                                                           | S.O. 722 (E)              |
|   19 | Paracetamol +Phenylephirine +Chlorpheniramine +Dextromethorphan                   | +Caffeine S.O. 723 (E)    |
|   20 | Diclofenac +Zinc Carnosine                                                        | S.O. 724 (E)              |
|   21 | Diclofenac + paracetamol+ chlorpheniramine maleate + magnesium                    | trisillicate S.O. 725 (E) |
|   22 | Paracetamol + pseudoephdrine + cetrizine                                          | S.O. 726 (E)              |
|   23 | Phenylbutazone+Sodium Salicylate                                                  | S.O. 727 (E)              |
|   24 | Lornoxicam+Paracetamol+Trypsin                                                    | S.O. 728 (E)              |
|   25 | Paracetamol +Mefenamic Acid +Ranitidine +Dicyclomine                              | S.O. 729 (E)              |
|   26 | Nimesulide + Dicyclomine                                                          | S.O. 730 (E)              |
|   27 | Heparin +Diclofenac                                                               | S.O. 731 (E)              |
|   28 | Glucosamine +Methyl Sulfonyl Methane+Vitamin D3 + Manganese + Boron+ Copper +Zinc | S.O. 732 (E)              |

|   29 | Paracetamol +Tapentadol                                                                                      | S.O. 733 (E)   |
|------|--------------------------------------------------------------------------------------------------------------|----------------|
|   30 | Tranexamic Acid + Proanthocyanidin                                                                           | S.O. 734 (E)   |
|   31 | Benzoxonium Chloride+Lidocaine                                                                               | S.O. 735 (E)   |
|   32 | Lornoxicam +Paracetamol +Tramadol                                                                            | S.O. 736 (E)   |
|   33 | Lornoxicam +Paracetamol +Serratiopeptidase                                                                   | S.O. 737 (E)   |
|   34 | Diclofenac +Paracetamol +Magnesium trisilicate                                                               | S.O. 738 (E)   |
|   35 | Paracetamol +Domperidone +Caffeine                                                                           | S.O. 739 (E)   |
|   36 | Ammonium Chloride +Sodium Citrate +Chlorpheniramine Maleate +Menthol                                         | S.O. 740 (E)   |
|   37 | Paracetamol +Prochlorperazine Maleate                                                                        | S.O. 741 (E)   |
|   38 | Combikit of 3 tablets of Serratiopeptidase (enteric coated 20000 units) Potassium & 2 tablets of Doxycycline | + S.O. 742 (E) |
|   39 | Nimesulide +Paracetamol suspension                                                                           | S.O. 743 (E)   |
|   40 | Aceclofenac +Paracetamol +Famotidine                                                                         | S.O. 744 (E)   |
|   41 | Aceclofenac + Zinc Carnosine                                                                                 | S.O. 745 (E)   |
|   42 | Paracetamol + disodium Hydrogen Citrate + Caffeine                                                           | S.O. 746 (E)   |
|   43 | Paracetamol + DL Methionine                                                                                  | S.O. 747 (E)   |

|   44 | Disodium Hydrogen citrate +Paracetamol                            | S.O. 748 (E)   |
|------|-------------------------------------------------------------------|----------------|
|   45 | Paracetamol +Di - Sodium Hydrogen Citrate (Duplicate Entry of 44) |                |
|   46 | Paracetamol + Caffeine + Codeine Phosphate                        | S.O. 749 (E)   |
|   47 | Aceclofenac (SR) + Paracetamol                                    | S.O. 750 (E)   |
|   48 | Diclofenac + Paracetamol injection                                | S.O. 751 (E)   |
|   49 | Azithromycin+Cefixime                                             | S.O. 752 (E)   |
|   50 | Amoxicillin +Dicloxacillin                                        | S.O. 753 (E)   |
|   51 | Amoxicillin 250 mg+Potassium Clavulanate Diluted 62.5 mg          | S.O. 754 (E)   |
|   52 | Azithromycin + Levofloxacin                                       | S.O. 755 (E)   |
|   53 | Cefixime +Linezolid                                               | S.O. 756 (E)   |
|   54 | Amoxicillin +Cefixime +Potassium Clavulanic Acid                  | S.O. 757 (E)   |
|   55 | Ofloxacin +Nitazoxanide                                           | S.O. 758 (E)   |
|   56 | Cefpodoxime Proxetil +Levofloxacin                                | S.O. 759 (E)   |
|   57 | Combikit of Azithromycin dihydrate, secnidazole and fluconazole   | S.O. 760 (E)   |
|   58 | Levofloxacin +Ornidazole +Alpha Tocopherol Acetate                | S.O. 761 (E)   |

|   59 | Nimorazole+Ofloxacin                                               | S.O. 762 (E)         |
|------|--------------------------------------------------------------------|----------------------|
|   60 | Azithromycin + ofloxacin                                           | S.O. 763 (E)         |
|   61 | amoxycillin + tinidazole                                           | S.O. 764 (E)         |
|   62 | Doxycycline +Serratiopeptidase                                     | S.O. 765 (E)         |
|   63 | Cefixime +levofloxacin                                             | S.O. 766 (E)         |
|   64 | Ofloxacin +Metronidazole +Zinc Acetate                             | S.O. 767 (E)         |
|   65 | Diphenoxylate +Atropine +Furazolidone                              | S.O. 768 (E)         |
|   66 | Combikit of Fluconazole Tablet, Azithromycin Tablet and Ornidazole | Tablets S.O. 769 (E) |
|   67 | Ciprofloxacin +Phenazopyridine                                     | S.O. 770 (E)         |
|   68 | Amoxycillin +Dicloxacillin +Serratiopeptidase                      | S.O. 771 (E)         |
|   69 | Azithromycin +Cefpodoxime                                          | S.O. 772 (E)         |
|   70 | Lignocaine+Clotrimazole+Ofloxacin+Beclomethasone                   | S.O. 773 (E)         |
|   71 | Cafuroxime +Linezolid                                              | S.O. 774 (E)         |
|   72 | Ofloxacin +Ornidazole +Zinc bisglycinate                           | S.O. 775 (E)         |
|   73 | Metronidazole +Norfloxacin                                         | S.O. 776 (E)         |

|   74 | Amoxicillin+Bromhexine                                     | S.O. 777 (E)   |
|------|------------------------------------------------------------|----------------|
|   75 | Ciprofloxacin +Fluticasone +Clotrimazole +Neomycin         | S.O. 778 (E)   |
|   76 | Metronidazole +Tetracycline                                | S.O. 779 (E)   |
|   77 | Cephalexin + Neomycin +Prednisolone                        | S.O. 780 (E)   |
|   78 | Azithromycin + Ambroxol                                    | S.O. 781 (E)   |
|   79 | cilnidipine + metroprolol succinate + metroprolol tartrate | S.O. 782 (E)   |
|   80 | L-Arginine +Sildenafil                                     | S.O. 783 (E)   |
|   81 | atorvastatin + vitamin D3 + folic acid + vitamin B12 +     | S.O. 784 (E)   |
|   82 | Metformin+Atorvastatin                                     | S.O. 785 (E)   |
|   83 | Clindamycin+Telmisartan                                    | S.O. 786 (E)   |
|   84 | Olmesartan+Hydrochlorothiazide +Chlorthalidone             | S.O. 787 (E)   |
|   85 | L-5- Methylterahydrofolate calcium + Escitalopram          | S.O. 788 (E)   |
|   86 | pholcodine +Promethazine                                   | S.O. 789 (E)   |
|   87 | Paracetamol +Promethazine                                  | S.O. 790 (E)   |
|   88 | Betahistine +Ginkgo Biloba Extract+Vinpocetine+Piracetam   | S.O. 791 (E)   |

|   89 | Cetirizine Dihydrochloride +Diethyl Carbamazine                           | S.O. 792 (E)             |
|------|---------------------------------------------------------------------------|--------------------------|
|   90 | Doxylamine +Pyridoxine +Mefenamic Acid+Paracetamol                        | S.O. 793 (E)             |
|   91 | Drotaverine + Clidinium + Chlordiazepoxide                                | S.O. 794 (E)             |
|   92 | Imipramine + Diazepam                                                     | S.O. 795 (E)             |
|   93 | Flupentixol +Escitalopram                                                 | S.O. 796 (E)             |
|   94 | Paracetamol + Prochloperazine                                             | S.O. 797 (E)             |
|   95 | Gabapentin +Mecobalamin +Pyridoxine +Thiamine                             | S.O. 798 (E)             |
|   96 | Imipramine +Chlordiazepoxide +Trifluoperazine +Trihexyphenidyl            | S.O. 799 (E)             |
|   97 | Chlorpromazine +Trihexyphenidyl                                           | S.O. 800 (E)             |
|   98 | Chlopromazine +Trihexyphenidyl (Duplicate Entry of 97)                    |                          |
|   99 | Ursodeoxycholic Acid + Silymarine                                         | S.O. 801 (E)             |
|  100 | Metformin 1000/1000/500/500mg +Pioglitazone 7.5/7.5/7.5/7.5mg + 1/2/1/2mg | Glimepiride S.O. 802 (E) |
|  101 | Gliclazide 80 mg + metformin 325 mg                                       | S.O. 803 (E)             |
|  102 | Voglibose+ Metformin + Chromium Picolinate                                | S.O. 804 (E)             |
|  103 | Pioglitazone 7.5/7.5mg+Metformin 500/1000mg                               | S.O. 805 (E)             |

|   104 | Glimepiride 1mg/2mg/3mg+Pioglitazone 15mg/15mg/15mg+Metformin 1000mg/1000mg/1000mg   | S.O. 806 (E)                |
|-------|--------------------------------------------------------------------------------------|-----------------------------|
|   105 | glimepiride 1mg/2mg+ pioglitazone 15mg/15mg + metformin 850mg/850mg                  | S.O. 807 (E)                |
|   106 | Metformin 850mg+Pioglitazone 7.5 mg+Glimepiride 2mg                                  | S.O. 808 (E)                |
|   107 | Metformin 850mg+Pioglitazone 7.5 mg+Glimepiride 1mg                                  | S.O. 809 (E)                |
|   108 | Metformin 500mg/500mg+Gliclazide SR 30mg/60mg+Pioglitazone 7.5mg/7.5mg               | S.O. 810 (E)                |
|   109 | Voglibose+Pioglitazone+Metformin                                                     | S.O. 811 (E)                |
|   110 | Metformin +bromocriptine                                                             | S.O. 812 (E)                |
|   111 | Metformin +Glimepiride +Methylcobalamin                                              | S.O. 813 (E)                |
|   112 | Pioglitazone 30 mg+Metformin 500mg                                                   | S.O. 814 (E)                |
|   113 | Glimepiride +Pioglitazone +Metformin                                                 | S.O. 815 (E)                |
|   114 | Glipizide 2.5mg+Metformin 400mg                                                      | S.O. 816 (E)                |
|   115 | Pioglitazone 15mg+Metformin 850 mg                                                   | S.O. 817 (E)                |
|   116 | Metformin ER+Gliclazide MR+Voglibose                                                 | S.O. 818 (E)                |
|   117 | Chromium Polynicotinate+Metformin Hydrochloride                                      | S.O. 819 (E)                |
|   118 | Metformin Hydrochlopride +Gliclazide +Piogllitazone +Chromium                        | Polynicotinate S.O. 820 (E) |

|   119 | Metformin +Gliclazide +Chromium Polynicotinate                             | S.O. 821 (E)        |
|-------|----------------------------------------------------------------------------|---------------------|
|   120 | Glibenclamide + Metformin (SR)+ Pioglitazone                               | S.O. 822 (E)        |
|   121 | Metformin (sustainded release) 500mg+Pioglitazone 15 mg+Glimepride         | 3mg S.O. 823 (E)    |
|   122 | Metformin (SR) 500mg+Pioglitazone 5mg                                      | S.O. 824 (E)        |
|   123 | Chloramphenicol +Beclomethasone +Clomitrimazole +Lignocaine                | S.O. 825 (E)        |
|   124 | Clotrimazole + Ofloxaxin + Lignocaine + glycerine and propylene            | glycol S.O. 826 (E) |
|   125 | Chloramphennicol+Lignocain+Betamethasone+Clotrimazole+Ofloxacin+Antipyrine | S.O. 827 (E)        |
|   126 | Ofloxacin +Clotrimazole +Betamethasone +Lignocaine                         | S.O. 828 (E)        |
|   127 | Gentamicin Sulphate +Clotrimazole +Betamethasone +Lignocaine               | S.O. 829 (E)        |
|   128 | Clotrimazole +Beclomethasone +Ofloxacin +Lignocaine                        | S.O. 830 (E)        |
|   129 | Becloemthasone +Clotrimazole+Chloramphenicol+Gentamycin +Lignocaine drops  | Ear S.O. 831 (E)    |
|   130 | Flunarizine + Paracetamole+ Domperidone                                    | S.O. 832 (E)        |
|   131 | Rabeprazole +Zinc carnosine                                                | S.O. 833 (E)        |
|   132 | magaldrate + famotidine + simethicone                                      | S.O. 834 (E)        |
|   133 | cyproheptadine + thiamine                                                  | S.O. 835 (E)        |

|   134 | Magaldrate +Ranitidine +Pancreatin +Domperidone                               | S.O. 836 (E)          |
|-------|-------------------------------------------------------------------------------|-----------------------|
|   135 | Ranitidine +Magaldrate +simethicone                                           | S.O. 837 (E)          |
|   136 | magaldrate + papain+ fungul diastase + simethicone                            | S.O. 838 (E)          |
|   137 | Rabeprazole + zinc + domperidone                                              | S.O. 839 (E)          |
|   138 | Famotidine + oxytacaine + Magaldrate                                          | S.O. 840 (E)          |
|   139 | Ranitidine+Domperidone+Semithicone                                            | S.O. 841 (E)          |
|   140 | Alginic Acid+Sodium Bicarbonate+Dried Aluminium Hydroxide+Magnesium Hydroxide | S.O. 842 (E)          |
|   141 | Clidinium +Paracetamol +Dicyclomine +Activated Dimethicone                    | S.O. 843 (E)          |
|   142 | Furazolidone +Metronidazole +Loperamide                                       | S.O. 844 (E)          |
|   143 | Rabeprazole +Diclofenac +Paracetamol                                          | S.O. 845 (E)          |
|   144 | Ranitidine +Magaldrate                                                        | S.O. 846 (E)          |
|   145 | Norfloxacin+ Metronidazole + zinc Acetate                                     | S.O. 847 (E)          |
|   146 | Zinc Carnosine+Oxetacaine                                                     | S.O. 848 (E)          |
|   147 | Oxetacaine +Magaldrate +Famotidine                                            | S.O. 849 (E)          |
|   148 | Pantoprazole (as Enteric Coated Tablet)+Zinc Carnosine (as Film Coated        | Tablets) S.O. 850 (E) |

|   149 | Zinc Carnosine+MagnesiumHydroxide +Dried Aluminium Hydroxide +Simethicone                                                              | S.O. 851 (E)            |
|-------|----------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
|   150 | Zinc Carnosine+Sucralfate                                                                                                              | S.O. 852 (E)            |
|   151 | Mebeverine Hydrochloride & Inner HPMC capsule (Streptococcus +Clostridium butyricum +Bacillus mesentricus+Lactic Acid Bacillus)        | Faecalis S.O. 853 (E)   |
|   152 | Clindamycin +Clotrimazole +Lactic Acid Bacillus                                                                                        | S.O. 854 (E)            |
|   153 | Sildenafil +Estradiol Valerate                                                                                                         | S.O. 855 (E)            |
|   154 | Clomifene Citrate +Ubidecarenone +Zinc +Folic Acid +Methylcobalamin +Pyridoxine +Lycopene +Selenium+Levocarnitine Tartrate+L -Arginine | S.O. 856 (E)            |
|   155 | Thyroxine + Pyridoxine + Folic Acid                                                                                                    | S.O. 857 (E)            |
|   156 | Gentamycin+Dexamethasone+Chloramphenicol+Tobramycin+Ofloxacin                                                                          | S.O. 858 (E)            |
|   157 | Dextromethorphan + Levocetirizine +Phenylephrine +Zinc                                                                                 | S.O. 859 (E)            |
|   158 | Nimesulide +Loratadine +Phenylephrine +Ambroxol                                                                                        | S.O. 860 (E)            |
|   159 | Bromhexine +Phenylephrine +Chlorepheniramine Maleate                                                                                   | S.O. 861 (E)            |
|   160 | Dextromethorphan + bromhexine +Guaiphenesin                                                                                            | S.O. 862 (E)            |
|   161 | Paracetamol + Loratadine + phenylephrine + Dextromethorphan                                                                            | + caffeine S.O. 863 (E) |
|   162 | Nimesulide + Phenylephrine + Ceffeine+ levocetirizine                                                                                  | S.O. 864 (E)            |
|   163 | Azithromycin + acebrophyline                                                                                                           | S.O. 865 (E)            |

|   164 | Diphenhydramine +Terpine +Ammonium Chloride +Sodium Chloride +Menthol                                | S.O. 866 (E)          |
|-------|------------------------------------------------------------------------------------------------------|-----------------------|
|   165 | Nimesulide+Paracetamol+Cetrizine +Phenylephrine                                                      | S.O. 867 (E)          |
|   166 | paracetamol+ loratadine + dextromethophan + pseudoepheridine +                                       | caffeine S.O. 868 (E) |
|   167 | chlorpheniramine maleate+ dextromethophan+ dextromethophan + guaiphenesin ammonium chloride+ menthol | S.O. 869 (E)          |
|   168 | Chlorpheniramine Maleate+Ammonium Chloride+Sodium Citrate                                            | S.O. 870 (E)          |
|   169 | Cetirizine +Phenylephrine +Paracetamol +Zinc Gluconate                                               | S.O. 871 (E)          |
|   170 | Ambroxol +Guaiphenesin +Ammonium Chloride +Phenylephrine +Chlorpheniramine Maleate +Menthol          | S.O. 872 (E)          |
|   171 | dextromethophen + bromhexine + chlorpheniramine maleate + guaiphenesin                               | S.O. 873 (E)          |
|   172 | levocetirizine + ambroxol + phenylephrine +gu aiphenesin                                             | S.O. 874 (E)          |
|   173 | dextromethorphan + chlorpheniramine + chlorpheniramine maleate                                       | S.O. 875 (E)          |
|   174 | cetirizine + ambroxol + Guaiphenesin + ammonium chloride+ phenylephrine+ menthol                     | S.O. 876 (E)          |
|   175 | chlorpheniramine + phenylephrine + caffiene                                                          | S.O. 877 (E)          |
|   176 | dextromethorphan + triprolidine + phenylephrine                                                      | S.O. 878 (E)          |
|   177 | Terpinhydrate+ dextromethorphan + menthol                                                            | S.O. 879 (E)          |
|   178 | dextromethorphan + phenylephrine + zinc gluconate+ menthol                                           | S.O. 880 (E)          |

|   179 | chlorpheniramine + codeine + sodium citarte + menthol syrup              | S.O. 881 (E)              |
|-------|--------------------------------------------------------------------------|---------------------------|
|   180 | Enrofloxacin + bromhexin                                                 | S.O. 882 (E)              |
|   181 | Bromhexine +Dextromethorphan +Phenylephrine +Menthol                     | S.O. 883 (E)              |
|   182 | Levofloxacin +Bromhexine                                                 | S.O. 884 (E)              |
|   183 | Levocetirizine +Ranitidine                                               | S.O. 885 (E)              |
|   184 | Levocetirizine +Phenylephrine +Ambroxol +Guaiphenesin +Paracetamol       | S.O. 886 (E)              |
|   185 | cetirizine + dextromethorphan + phenylephrine + zinc gluconate + menthol | paracetamol+ S.O. 887 (E) |
|   186 | paracetamol+ pseudoephedrine + dextromethorphan + cetirizine             | S.O. 888 (E)              |
|   187 | diphenhydamine + guaiphenesin + ammonium chloride + bromhexine           | S.O. 889 (E)              |
|   188 | Chlorpheniramine +Dextromethorphan +Phenylephrine +Paracetamol           | S.O. 890 (E)              |
|   189 | Dextromethorphen +Promethazine                                           | S.O. 891 (E)              |
|   190 | Diethylcabamazine +Cetrizine +Guaiphenesin                               | S.O. 892 (E)              |
|   191 | Pseudoephedrine+Dextromethorphan +Cetirizine                             | S.O. 893 (E)              |
|   192 | Chlorpheniramine +Phenylephrine +Dextromethophan +Menthol                | S.O. 894 (E)              |
|   193 | Ambroxol + Terbutaline + Dextromethorphan                                | S.O. 895 (E)              |

|   194 | Dextromethorphan +Chlorpheniramine +Guaiphenesin                             | S.O. 896 (E)           |
|-------|------------------------------------------------------------------------------|------------------------|
|   195 | Terbutaline +Bromhexine +Guaiphenesin+Dextromethorphan                       | S.O. 897 (E)           |
|   196 | Dextromethorphan +Tripolidine +Phenylephirine                                | S.O. 898 (E)           |
|   197 | Paracetamol +Dextromethorphan +Chlorpheniramine                              | S.O. 899 (E)           |
|   198 | Pholcodine+Phenylephrine +Promethazine                                       | S.O. 900 (E)           |
|   199 | codeine + levocetirizine + menthol                                           | S.O. 901 (E)           |
|   200 | dextromethorphan + ambroxol + guaifenesin + phenylephrine + chlorpheniramine | S.O. 902 (E)           |
|   201 | Cetirizine +Phenylephrine + Dextromethorphan + Menthol                       | S.O. 903 (E)           |
|   202 | Roxithromycin + Serratiopeptidase                                            | S.O. 904 (E)           |
|   203 | Paracetamol +Phenylephrine +Triprolidine                                     | S.O. 905 (E)           |
|   204 | Acetaminophen+Loratadine+ambroxol +Phenylephrine                             | S.O. 906 (E)           |
|   205 | Cetirizine +Acetaminophen+Dextromethorphan +Phenyephrine +Zinc               | gluconate S.O. 907 (E) |
|   206 | Diphenhydramine +Guaifenesin +Bromhexine +Ammonium Chloride +Menthol         | S.O. 908 (E)           |
|   207 | Chlopheniramine Maleate +Codeine syrup                                       | S.O. 909 (E)           |
|   208 | Cetirizine +Dextromethorphan +Zinc Gluconate +Menthol                        | S.O. 910 (E)           |

|   209 | Paracetamol +Phenylephrine +Desloratadine+Zinc Gluconate +Ambroxol     | S.O. 911 (E)   |
|-------|------------------------------------------------------------------------|----------------|
|   210 | levocetirizine + montelukast + acebrophylline                          | S.O. 912 (E)   |
|   211 | dextromethorphan + phenylephrine + ammonium chloride + menthol         | S.O. 913 (E)   |
|   212 | Dextromethorphan +bromhexine +Guaiphenesin+menthol                     | S.O. 914 (E)   |
|   213 | Acrivastine+ Paracetamol + Caffeine + Phenylephrine                    | S.O. 915 (E)   |
|   214 | Naphazoline +carboxy Methyl cellulose +Menthol +Camphor +Phenylephrine | S.O. 916 (E)   |
|   215 | Dextromethorphan +Cetirizine                                           | S.O. 917 (E)   |
|   216 | nimesulide + paracetamol + levocetirizine + phenylephrine + caffeine   | S.O. 918 (E)   |
|   217 | Terbutaline +Ambroxol +Guaiphenesin+Zinc+Menthol                       | S.O. 919 (E)   |
|   218 | Codeine +Chlorpheniramine +Alcohol syrup                               | S.O. 920 (E)   |
|   219 | Dextromethorphan +Phenylephrine +Guaifenesin+Triprolidine              | S.O. 921 (E)   |
|   220 | Ammomium Chloride+Bromhexine +Dextromethorphan                         | S.O. 922 (E)   |
|   221 | Diethylcarbamazine +Cetirizine +Ambroxol                               | S.O. 923 (E)   |
|   222 | Ethylmorphine + Noscapine + Chlorpheniramine Maleate                   | S.O. 924 (E)   |
|   223 | Cetirizine +Dextromethorphan +Ambroxol                                 | S.O. 925 (E)   |

|   224 | Bromhexine +Dextromethorphan +Ammonium Chloride +Menthol                  | S.O. 926 (E)   |
|-------|---------------------------------------------------------------------------|----------------|
|   225 | Ambroxol + Guaifenesin + Phenylephrine + Chlorpheniramine                 | S.O. 827 (E)   |
|   226 | Paracetamol +Phenylephrine +Chlorpheniramine +Zinc Gluconate              | S.O. 928 (E)   |
|   227 | Dextromethorphan +Phenylephrine +Cetirizine +Paracetamol +Caffeine        | S.O. 929 (E)   |
|   228 | Dextromethophan +Chlorpheniramine +Guaifenesin +Ammonium Chloride         | S.O. 930 (E)   |
|   229 | Levocetirizine +Dextromethorphan +Zinc                                    | S.O. 931 (E)   |
|   230 | Paracetamol +Phenylephrine +Levocetirizine +Caffeine                      | S.O. 932 (E)   |
|   231 | Chlorpheniramine +Ammonium Chloride +Sodium Chloride                      | S.O. 933 (E)   |
|   232 | Paracetamol +Dextromethorphan +Bromhexine +Phenylephrine +Diphenhydramine | S.O. 934 (E)   |
|   233 | Salbutamol +Bromhexine +Guaiphenesin +Menthol                             | S.O. 935 (E)   |
|   234 | Chlorpheniramine +Ammonium Chloride +Noscapine +Sodium Citrate            | S.O. 936 (E)   |
|   235 | Cetirizine +Dextromethorphan +Bromhexine +Guaifenesin                     | S.O. 937 (E)   |
|   236 | Diethyl Carbamazine +Chlorpheniramine +Guaifenesin                        | S.O. 938 (E)   |
|   237 | Ketotifen +Cetirizine                                                     | S.O. 939 (E)   |
|   238 | Terbutaline +Bromhexine +Etofylline                                       | S.O. 940 (E)   |

|   239 | Ketotifen +Theophylline                                      | S.O. 941 (E)   |
|-------|--------------------------------------------------------------|----------------|
|   240 | Ambroxol +Salbutamol +Theophylline                           | S.O. 942 (E)   |
|   241 | Cetirizine +Nimesulide +Phenylephrine                        | S.O. 943 (E)   |
|   242 | Chloropheniramine +Phenylephrine+Paracetamol+Zinc Gluconate  | S.O. 944 (E)   |
|   243 | Acetaminophen+Guaifenesin+Dextromethorphan +Chlorpheniramine | S.O. 945 (E)   |
|   244 | Cetirizine +Dextromethorphan +Phenylephrine +Tulsi           | S.O. 946 (E)   |
|   245 | Cetirizine +Phenylephrine +Paracetamol+Ambroxol +Caffeine    | S.O. 947 (E)   |
|   246 | Guaifenesin+Dextromethorphan                                 | S.O. 948 (E)   |
|   247 | Levocetirizine +Paracetamol +Phenylephirine +Caffeine        | S.O. 949 (E)   |
|   248 | Caffeine +Paracetamol +Phenylephrine + Chlorpheniramine      | S.O. 950 (E)   |
|   249 | Ketotifen +Levocetrizine                                     | S.O. 951 (E)   |
|   250 | Paracetamol +Levocetirizine +Phenylephirine +Zinc Gluconate  | S.O. 952 (E)   |
|   251 | Paracetamol +Phenylephrine +Triprolidine +Caffeine           | S.O. 953 (E)   |
|   252 | Caffeine +Paracetamol +Phenylephrine +Cetirizine             | S.O. 954 (E)   |
|   253 | Dextromethorphan +Phenylephirine +Guaifenesin                | S.O. 955 (E)   |

|   254 | Ambroxol + Levocetirizine + Phenylephrine + Guaiphenesin + Menthol                             | S.O. 956 (E)   |
|-------|------------------------------------------------------------------------------------------------|----------------|
|   255 | Pseudoephedrine +Cetirizine                                                                    | S.O. 957 (E)   |
|   256 | Dextromethorphan +Chlorpheniramine +Ammonium Chloride +Menthol                                 | S.O. 958 (E)   |
|   257 | Paracetamol +Caffeine +Phenylephrine +Chlorpheniramine                                         | S.O. 959 (E)   |
|   258 | Salbutamol +Aminophylline +Guaifenesin                                                         | S.O. 960 (E)   |
|   259 | Salbutamol +Thoephylline +Bromhexine                                                           | S.O. 961 (E)   |
|   260 | Chlorpheniramine +Dextromethorphan +Guaifenesin +Phenylephrine                                 | S.O. 962 (E)   |
|   261 | Caffeine + Paracetamol+ Chlorpheniramine                                                       | S.O. 963 (E)   |
|   262 | Ammonium Chloride+Dextromethophan+Cetirizine +Menthol                                          | S.O. 964 (E)   |
|   263 | Dextromethorphan +Paracetamol+Cetirizine +Phenylephrine                                        | S.O. 965 (E)   |
|   264 | Chlorpheniramine +Terpin +Antimony Potassium Tartrate+Ammonium chloride+Sodium Citrate+Menthol | S.O. 966 (E)   |
|   265 | Terbutaline Sulphate+Etofylline+Ambroxol                                                       | S.O. 967 (E)   |
|   266 | Paracetamol +Codeine +Chlorpheniramine                                                         | S.O. 968 (E)   |
|   267 | Paracetamol +Pseudoephedrine +Cetirizine +Caffeine                                             | S.O. 969 (E)   |
|   268 | Chlorpheniramine +Ammonium Chloride +Menthol                                                   | S.O. 970 (E)   |

|   269 | N -Acetyl Cysteine + Ambroxol + Phenylephrine + Levocetirizine                  | S.O. 971 (E)          |
|-------|---------------------------------------------------------------------------------|-----------------------|
|   270 | Dextromethorphan +Phenylephrine +Tripolidine +Menthol                           | S.O. 972 (E)          |
|   271 | Salbutamol +Cetirizine +Ambroxol                                                | S.O. 973 (E)          |
|   272 | Dextromethorphan +Phenylephrine +Bromhexine +Guaifenesin+ Chlorpheniramine      | S.O. 974 (E)          |
|   273 | Nimesulide +Cetirizine +Phenylephrine                                           | S.O. 975 (E)          |
|   274 | Naphazoline +Chlorpheniramine +Zinc Sulphate +Boric Acid Ip+Sodium +chlorobutol | chloride S.O. 976 (E) |
|   275 | Paracetamol+Bromhexine +Phenylephrine +Chlorpheniramine +Guaifenesin            | S.O. 977 (E)          |
|   276 | Salbutamoll+Bromhexine                                                          | S.O. 978 (E)          |
|   277 | Dextromethorphan +Phenylephrine +Guaifenesin +Cetirizine +Acetaminophen         | S.O. 979 (E)          |
|   278 | Guaifenesin+ Bromhexine + Chlorpheniramine + Paracetamol                        | S.O. 980 (E)          |
|   279 | Chlorpheniramine +Ammonium Chloride +Chloroform +Menthol                        | S.O. 981 (E)          |
|   280 | Salbutamol +Choline Theophylinate +Ambroxol                                     | S.O. 982 (E)          |
|   281 | Salbutamol +Choline Theophylinate +Ambroxol (Duplicate entry of 280)            |                       |
|   282 | Chlorpheniramine +Codeine phosphate +Menthol syrup                              | S.O. 983 (E)          |
|   283 | Pseudoephedrine +Bromhexine                                                     | S.O. 984 (E)          |

|   284 | Cetirizine +Phenylephrine +Paracetamol +Caffeine +Nimesulide             | S.O. 985 (E)         |
|-------|--------------------------------------------------------------------------|----------------------|
|   285 | Dextromethorphan +Cetirizine +Guaifenesin +Ammonium Chloride             | S.O. 986 (E)         |
|   286 | Ambroxol + Salbutamol + Choline Theophyllinate + Menthol                 | S.O. 987 (E)         |
|   287 | Paracetamol +Chlorpheniramine +Ambroxol +Guaifenesin +Phenylephrine      | S.O. 988 (E)         |
|   288 | Chlorpheniramine +Vasaka +Tolubalsm +Ammonium Chloride +Sodium +Menthol  | Citrate S.O. 989 (E) |
|   289 | Bromhexine +Cetrizine +Phenylephrine +Guaifenesin +Menthol               | S.O. 990 (E)         |
|   290 | Dextromethorphan +Ambroxol +Ammonium Chloride +Chlorpheniramine +Menthol | S.O. 991 (E)         |
|   291 | Dextromethorphan +Phenylephrine +Cetirizine +Zinc +Menthol               | S.O. 992 (E)         |
|   292 | Terbutaline + N -Acetyl L -Cysteine + Guaifenesin                        | S.O. 993 (E)         |
|   293 | Calcium Gluconate +Levocetirizine                                        | S.O. 994 (E)         |
|   294 | Paracetamol +Levocetirizine+Pseudoephedrine                              | S.O. 995 (E)         |
|   295 | Salbutamol +Choline Theophylinate +Carbocisteine                         | S.O. 996 (E)         |
|   296 | Chlorpheniramine +Vitamin C                                              | S.O. 997 (E)         |
|   297 | Calcium Gluconate +Chlorpheniramine +Vitamin C                           | S.O. 998 (E)         |
|   298 | Chlorpheniramine+Paracetamol +Pseudoephedrine +Caffeine                  | S.O. 999 (E)         |

|   299 | Guaifenesin +Bromhexine +Chlorpheniramine +Phenylephrine +Paracetamol +Serratiopeptidase (as enteric coated granules)10000 SP Units   | S.O. 1000 (E)               |
|-------|---------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
|   300 | Paracetamol +Pheniramine                                                                                                              | S.O. 1001 (E)               |
|   301 | Betamethasone +Fusidic Acid+Gentamycin +Tolnaftate+Iodochlorhydroxyquinoline(ICHQ)                                                    | S.O. 1002 (E)               |
|   302 | Clobetasol +Ofloxacin+Miconazole +Zinc Sulphate                                                                                       | S.O. 1003 (E)               |
|   303 | Clobetasole +Gentamicin +Miconazole +Zinc Sulphate                                                                                    | S.O. 1004 (E)               |
|   304 | levocetirizine + ambroxol + phenylephrine + paracetamol                                                                               | S.O. 1005 (E)               |
|   305 | Permethrin + Cetrimide + Menthol                                                                                                      | S.O. 1006 (E)               |
|   306 | beclomethasone + clotimazole + neomycin + iodochlorohydroxyquinone                                                                    | S.O. 1007 (E)               |
|   307 | Neomycin + Doxycycline                                                                                                                | S.O. 1008 (E)               |
|   308 | Ciprofloxacin + Fluocinolone + Clotrimazole + Neomycin + Chlorocresol                                                                 | S.O. 1009 (E)               |
|   309 | Clobetasol + Ofloxacin + Ketoconazole + Zinc Sulphate                                                                                 | S.O. 1010 (E)               |
|   310 | Betamethasone +Gentamicin +Tolnaftate +Iodochlorhydroxyquinoline                                                                      | S.O. 1011 (E)               |
|   311 | Clobetasol +Gentamicin +Tolnaftate +Idochlorhydroxyquinone                                                                            | +Ketoconazole S.O. 1012 (E) |
|   312 | Allantoin+Dimethieone+Urea+Propylene+Glycerin+Liquid paraffin                                                                         | S.O. 1013 (E)               |
|   313 | Acriflavine +Thymol+Cetrimide                                                                                                         | S.O. 1014 (E)               |

|   314 | Betamethasone +Neomycin +Tolnaftate +Iodo Chloro Hydroxy Quinoline +Cholorocresol   | S.O. 1015 (E)              |
|-------|-------------------------------------------------------------------------------------|----------------------------|
|   315 | clobetasol +Neomycin +Miconazole +Clotrimazole                                      | S.O. 1016 (E)              |
|   316 | Ketoconazole+Tea Tree oil+Allantion+zinc Oxide+Aloe Vera+Jojoba oil+Soap noodles    | oil+Lavander S.O. 1017 (E) |
|   317 | Clobetasol +Ofloxacin +Ornidazole +Terbinafine                                      | S.O. 1018 (E)              |
|   318 | Clobetasol +Neomycin +Miconazole +Zinc Sulphate                                     | S.O. 1019 (E)              |
|   319 | Beclomethasone +Neomycin +Tolnaftate +Iodochlorhydroxyquinoline +Chlorocresol       | S.O. 1020 (E)              |
|   320 | Betamethasone +Gentamycin +Zinc Sulphate +Clotrimazole +Chlorocresol                | S.O. 1021 (E)              |
|   321 | Borax +Boric acid +Naphazoline +Menthol +Camphor + methyl hydroxy                   | benzoate S.O. 1022 (E)     |
|   322 | Bromhexine +Dextromethorphan                                                        | S.O. 1023 (E)              |
|   323 | Dextromethophan +Chlopheniramine +Bromhexine                                        | S.O. 1024 (E)              |
|   324 | Menthol +Anesthetic Ether                                                           | S.O. 1025 (E)              |
|   325 | Dextrometharphan +Chlopheniramine +Ammonium Chloride +Sodium Citrate +Menthol       | S.O. 1026 (E)              |
|   326 | Ergotamine Tartrate +Belladona dry extract +Caffeine +Paracetamol                   | S.O. 1027 (E)              |
|   327 | Phenytoin +Phenobarbitone sodium                                                    | S.O. 1028 (E)              |
|   328 | Gliclazide 40mg+Metformin 400mg                                                     | S.O. 1029 (E)              |

|   329 | Paracetamol + Ambroxol + Phenylephrine +Chlorpheniramine             | S.O. 1030 (E)   |
|-------|----------------------------------------------------------------------|-----------------|
|   330 | Oflaxacin + Ornidazole suspension                                    | S.O. 1031 (E)   |
|   331 | Albuterol + Etofylline + Bromhexine + Menthol                        | S.O. 1032 (E)   |
|   332 | Albuterol + Bromhexine + Theophylline                                | S.O. 1033 (E)   |
|   333 | Salbutamol + Hydroxyethyltheophylline (Etofylline)+ Bromhexine       | S.O. 1034 (E)   |
|   334 | Paracetamol +Phenylephrine +Levocetirizine +Sodium Citrate           | S.O. 1035 (E)   |
|   335 | Paracetamol +Propyphenazone +Caffeine                                | S.O. 1036 (E)   |
|   336 | Guaifenesin +Diphenhydramine +Bromhexine +Phenylephrine              | S.O. 1037 (E)   |
|   337 | Dried Alumnium Hydroxide Gel +Propantheline Bromide +Diazepam        | S.O. 1038 (E)   |
|   338 | Bromhexine +Phenylephrine +Chlorpheniramine +Paracetamol             | S.O. 1039 (E)   |
|   339 | Beclomethasone +Clotrimazole+Gentamicin+Iodo - Chlorhydroxyquinoline | S.O. 1040 (E)   |
|   340 | Telmisartan + Metformin                                              | S.O. 1041 (E)   |
|   341 | Ammonium Citrate+Vitamin B 12+Folic Acid+Zinc Sulphate               | S.O. 1042 (E)   |
|   342 | levothyroxine pyridoxine+ nicotinamide                               | S.O. 1043 (E)   |
|   343 | benfotiamine+ metformin                                              | S.O. 1044 (E)   |

|   344 | Thyroid +Thiamine + Riboflavin + Pyridoxine + Calcium Pantothenate Tocopheryl Acetate +Nicotinamide              | + S.O. 1045 (E)      |
|-------|------------------------------------------------------------------------------------------------------------------|----------------------|
|   345 | Ascorbic Acid + Manadione Sodium Bisulphate+ Rutin + Dibasic Calcium Phosphate + Adrenochrome Mono Semicarbazone | S.O. 1046 (E)        |
|   346 | Phenylephrine +Chlorpheniramine +Paracetamol +Bromhexine +Caffeine                                               | S.O. 1047 (E)        |
|   347 | Clotrimazole +Beclomethasone +Lignocaine +Ofloxacin +Acetic Acid + Methyl Paraben +Propyl Paraben                | Sodium S.O. 1048 (E) |

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