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                                                           w;s úfYI
    The Gazette of the Democratic Socialist Republic of Sri Lanka
                                                   EXTRAORDINARY
                             wxl 2277$55 - 2022 wfm%a,a ui 29 jeks isl=rdod - 2022'04'29
                                            No. 2277/55 - friday, April 29, 2022
                                                         (Published by Authority)
                             PART I : SECTION (I) — GENERAL
                                            Government Notifications
    L.D.B 9/2016 (III)
           THE NATIONAL MEDICINES REGULATORY AUTHORITY ACT, No. 5 OF 2015
REGULATIONS made by the Minister of Health under Section 142 of the National Medicines Regulatory Authority Act,
No. 5 of 2015.
	                                                                                            Prof. Channa Jayasumana,
                                                                                    	            Minister of Health.
Colombo,
28th April 2022.
                                                              Regulations
The Medicines (Ceiling on Prices) Regulations, 2019 published in the Gazette Extraordinary No. 2123/35 of May 15, 2019,
as amended by regulations published in Gazette Extraordinary No. 2241/43 of August 19, 2021 and regulations published
in Gazette Extraordinary No. 2271/23 of March 15, 2022 are hereby further amended as follows: -
(1) 	 by the repeal of regulation 6 thereof and the substitution therefor, of the following: -
	
           “6. (1) On the date of publication of these regulations, a manufacturer or importer who sells any Scheduled Medicine
     at a revised retail price under the Medicines (Ceiling on Prices) Regulations of 2019 published in Gazette Extraordinary
1A- G 36712 - 12 (04/2022)
This Gazette Extraordinary can be downloaded from www.documents.gov.lk
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          Part I : Sec. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 29.04.2022
     No. 2123/35 of May 15, 2019 as amended by the regulations published in Gazette Extraordinary No. 2241/43 of August
     19, 2021 and regulations published in Gazette Extraordinary No. 2271/23 of March 15, 2022 which is less than the
     maximum retail price specified in Column V of the Schedule to the Mediciness (Ceiling on Prices) Regulations of 2019
     published in Gazette Extraordinary No. 2123/35 of May 15, 2019 as amended may increase proportionately such revised
     retail price by a total forty per centum (40%).
          (2) Every trader, distributor, pharmacist, medical practitioner, dentist, veterinary surgeon, medical institution
     including a private medical institution, pharmacy or person who or which is in possession of the Scheduled Medicines
     for the purpose of sale shall maintain the price of the Scheduled Medicines at the maximum retail price or revised retail
     price whichever is less.”;
(2) by the repeal of the Schedule and the substitution therefor, of the following: -
                                                       “ SCHEDULE
                                                                                                              [Regulation 2]
                                   MAXIMUM RETAIL PRICES OF MEDICINES
 Column I                      Column II                            Column III           Column IV         Column V
                              Generic Name                           Route of             Strength       Maximum Retail
                                                                  Administration/                         Price Per unit
                                                                   Dosage forms                               (SLR)
      1                      ALBENDAZOLE                           Tablet/ capsule         400mg               70.94
      2           AMOXICILLIN+CLAVULANIC ACID                      Oral suspension      156mg/ 5ml             679.83
                  AMOXICILLIN+CLAVULANIC ACID                      Tablet/ capsule         375mg               83.71
                  AMOXICILLIN+CLAVULANIC ACID                      Tablet/ capsule         625mg               141.86
                  AMOXICILLIN+CLAVULANIC ACID                         Injection             1.2g              1492.06
      3                    CLARITHROMYCIN                          Tablet/ capsule         250mg               86.31
                           CLARITHROMYCIN                          Tablet/ capsule         500mg               174.99
                           CLARITHROMYCIN                          Oral suspension       125mg/5ml            1030.96
      4                      AZITHROMYCIN                          Tablet/ capsule         250 mg              88.91
                             AZITHROMYCIN                          Tablet/ capsule         500 mg              124.74
                             AZITHROMYCIN                          Oral suspension      200mg/ 5ml             413.78
      5                       CEFUROXIME                           Tablet/ capsule         250 mg              107.59
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Column I                     Column II                          Column III          Column IV        Column V
                            Generic Name                         Route of            Strength      Maximum Retail
                                                              Administration/                       Price Per unit
                                                               Dosage forms                             (SLR)
                           CEFUROXIME                          Tablet/ capsule        500 mg             171.65
   6                       DOXYCYCLIN                          Tablet/ capsule        100 mg             23.90
   7                         ACICLOVIR                         Tablet/ capsule        200 mg             87.46
   8                      CIPROFLOXACIN                        Tablet/ capsule        250 mg             13.59
                          CIPROFLOXACIN                        Tablet/ capsule        500 mg             20.10
   9                      LEVOFLOXACIN                         Tablet/ capsule        250 mg             57.22
                          LEVOFLOXACIN                         Tablet/ capsule        500 mg             94.58
   10                       CEPHALEXIN                         Tablet/ capsule        250 mg             19.38
                            CEPHALEXIN                         Tablet/ capsule        500 mg             35.49
                            CEPHALEXIN                         Oral suspension     125 mg/5 ml           626.61
   11                         CEFIXIME                         Tablet/ capsule        100 mg             54.38
                              CEFIXIME                         Tablet/ capsule        200 mg             100.97
                              CEFIXIME                         Oral suspension     100 mg/5 ml           815.55
   12                       AMLODIPINE                         Tablet/ capsule         5 mg              36.18
                            AMLODIPINE                         Tablet/ capsule        10 mg              50.37
   13                        DILTIAZEM                         Tablet/ capsule        30 mg               6.40
                             DILTIAZEM                         Tablet/ capsule        60 mg              21.06
                             DILTIAZEM                         Tablet/ capsule        90 mg              50.61
   14                 LOSARTAN POTASSIUM                       Tablet/ capsule        25 mg              17.37
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          Part I : Sec. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 29.04.2022
Column I                       Column II                           Column III         Column IV        Column V
                              Generic Name                          Route of           Strength      Maximum Retail
                                                                 Administration/                      Price Per unit
                                                                  Dosage forms                            (SLR)
                         LOSARTAN POTASSIUM                       Tablet/ capsule        50 mg              24.36
     15             LOSARTAN + Hydrochlorothiazide                Tablet/ capsule       62.5 mg             45.98
     16                        ENALAPRIL                          Tablet/ capsule        5 mg               14.18
                               ENALAPRIL                          Tablet/ capsule        10 mg              23.90
     17                         ATENOLOL                          Tablet/ capsule        25mg               7.08
                                ATENOLOL                          Tablet/ capsule        50 mg              10.40
                                ATENOLOL                          Tablet/ capsule       100 mg              30.74
     18               NIFEDIPINE – sustained release              Tablet/ capsule        20 mg              8.76
     19                       CLOPIDOGREL                         Tablet/ capsule        75 mg              41.40
     20                      ATORVASTATIN                         Tablet/ capsule         5mg               15.19
                             ATORVASTATIN                         Tablet/ capsule        10 mg              26.36
                             ATORVASTATIN                         Tablet/ capsule        20 mg              41.61
                             ATORVASTATIN                         Tablet/ capsule        40 mg              58.53
     21                      ROSUVASTATIN                         Tablet/ capsule        5 mg               50.83
                             ROSUVASTATIN                         Tablet/ capsule        10 mg              87.46
     22                       TELMISARTAN                         Tablet/ capsule        20 mg              24.11
                              TELMISARTAN                         Tablet/ capsule        40 mg              38.30
                              TELMISARTAN                         Tablet/ capsule        80mg               71.88
     23                          ASPIRIN                          Tablet/ capsule        75 mg              7.08
                                 ASPIRIN                          Tablet/ capsule       100 mg              12.53
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    Part I : Sec. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 29.04.2022
Column I                  Column II                          Column III          Column IV        Column V
                         Generic Name                         Route of            Strength      Maximum Retail
                                                           Administration/                       Price Per unit
                                                            Dosage forms                             (SLR)
   24                    METFORMIN                          Tablet/ capsule        500 mg              9.34
                 METFORMIN-sustained release                Tablet/ capsule        500 mg             18.20
                         METFORMIN                          Tablet/ capsule        850 mg             17.50
   25                 GLIBENCLAMIDE                         Tablet/ capsule         5 mg               5.18
   26                    GLICLAZIDE                         Tablet/ capsule         80mg              26.73
   27                    THYROXINE                          Tablet/ capsule        50 mcg             14.41
                         THYROXINE                          Tablet/ capsule       100 mcg             21.53
   28                      GLIPIZIDE                        Tablet/ capsule         5 mg              18.69
   29                     IBUPROFEN                         Tablet/ capsule        200 mg              2.60
                          IBUPROFEN                         Tablet/ capsule        400mg               8.76
   30               DICLOFENAC SODIUM                       Tablet/ capsule        50 mg              30.74
                    DICLOFENAC SODIUM                       Tablet/ capsule        100 mg             35.70
   31             DICLOFENAC POTASSIUM                      Tablet/ capsule        50 mg              25.90
   32                   PARACETAMOL                         Tablet/ capsule        500 mg              4.16
   33               SODIUM VALPROATE                        Tablet/ capsule        200 mg             21.28
   34                    RISPERIDONE                        Tablet/ capsule         1 mg              18.69
                         RISPERIDONE                        Tablet/ capsule         2 mg              21.85
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          Part I : Sec. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 29.04.2022
Column I                       Column II                           Column III         Column IV        Column V
                              Generic Name                          Route of           Strength      Maximum Retail
                                                                 Administration/                      Price Per unit
                                                                  Dosage forms                            (SLR)
     35                       OLANZAPINE                          Tablet/ capsule        5 mg               23.65
                              OLANZAPINE                          Tablet/ capsule        10 mg              49.15
     36                     CARBAMAZEPINE                         Tablet/ capsule       200 mg              28.35
     37                       ALPRAZOLAM                          Tablet/ capsule       0.25 mg             15.37
                              ALPRAZOLAM                          Tablet/ capsule        0.5 mg             23.42
     38                       FLUOXETINE                          Tablet/ capsule        20 mg              26.01
     39                       GABAPENTIN                          Tablet/ capsule       100 mg              39.61
                              GABAPENTIN                          Tablet/ capsule       300 mg              78.39
     40                   BECLOMETHASONE                           DP capsule           200 mcg             14.18
                                                                   (inhalation)
                          BECLOMETHASONE                           DP capsule           400 mcg             16.07
                                                                   (inhalation)
                          BECLOMETHASONE                       Metered dose inhaler     100 mcg           1,200.04
                                                                   (200 doses)
                          BECLOMETHASONE                       Metered dose inhaler     250 mcg           1,326.53
                                                                   (200 doses)
     41                       SALBUTAMOL                           DP capsule           200 mcg             9.45
                                                                   (inhalation)
                              SALBUTAMOL                           DP capsule           400 mcg             13.01
                                                                   (inhalation)
                              SALBUTAMOL                       Metered dose inhaler     100 mcg            733.03
                                                                   (200 doses)
     42                METHYL PREDNISOLONE                        Tablet/ capsule        4 mg               28.01
                       METHYL PREDNISOLONE                        Tablet/ capsule        16mg               96.95
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    Part I : Sec. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 29.04.2022
Column I                  Column II                          Column III          Column IV        Column V
                         Generic Name                         Route of            Strength      Maximum Retail
                                                           Administration/                       Price Per unit
                                                            Dosage forms                             (SLR)
   43                   OMEPRAZOLE                          Tablet/ capsule        20 mg              10.64
   44                  PANTOPRAZOLE                         Tablet/ capsule        20 mg              40.18
                       PANTOPRAZOLE                         Tablet/ capsule        40 mg              66.19
   45                  ESOMEPRAZOLE                         Tablet/ capsule        20 mg              47.75
                       ESOMEPRAZOLE                         Tablet/ capsule        40 mg              90.80
   46                   DOMPERIDONE                         Tablet/ capsule        10 mg              12.77
   47                   RABEPRAZOLE                         Tablet/ capsule        10 mg              26.73
                        RABEPRAZOLE                         Tablet/ capsule        20 mg              50.96
   48                ALENDRONIC ACID                        Tablet/ capsule        70 mg              239.76
   49                   CEFTAZIDIME                          INJECTION             500 mg            1080.97
                        CEFTAZIDIME                          INJECTION               1g              1801.62
   50                   CEFTRIAXONE                          INJECTION             250 mg             540.18
                        CEFTRIAXONE                          INJECTION             500 mg            1013.40
                        CEFTRIAXONE                          INJECTION               1g              1576.40
   51                    CEFOTAXIME                          INJECTION             500 mg             506.72
                         CEFOTAXIME                          INJECTION               1g               844.51
   52                   FLUCONAZOLE                         Tablet/ capsule        50 mg              56.29
                        FLUCONAZOLE                         Tablet/ capsule        150 mg             101.33
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          Part I : Sec. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 29.04.2022
Column I                       Column II                           Column III         Column IV        Column V
                              Generic Name                          Route of           Strength      Maximum Retail
                                                                 Administration/                      Price Per unit
                                                                  Dosage forms                            (SLR)
     53               INSULIN SOLUBLE HUMAN                        INJECTION         100 IU/1ml           2702.41
                                                                                     (10 ml vial)
                      INSULIN SOLUBLE HUMAN                        INJECTION          100 IU/1ml          1351.21
                                                                                         (3ml
                                                                                       cartridge)
                     INSULIN ISOPHANE HUMAN                        INJECTION         100 IU/1ml           2702.41
                                                                                     (10ml vial)
                     INSULIN ISOPHANE HUMAN                        INJECTION          100 IU/1ml          1351.21
                                                                                         (3ml
                                                                                       cartridge)
                        BIPHASIC ISOPHANE                                            100 IU/1ml           2702.41
                       INSULIN (AS INSULIN                         INJECTION         (10 ml vial)
                     SOLUBLE HUMAN 30IU/1ml,
                INSULIN ISOPHANE HUMAN 70IU /1ml)
                         BIPHASIC ISOPHANE                                            100 IU/1ml          1351.21
                    INSULIN (AS INSULIN SOLUBLE                                          (3 ml
                          HUMAN 30IU/1ml,                          INJECTION           cartridge)
                      INSULIN ISOPHANE HUMAN
                              70IU /1ml)
     54                       GLIMEPIRIDE                           TABLET               1 mg               16.11
                              GLIMEPIRIDE                           TABLET               2 mg               22.85
                              GLIMEPIRIDE                           TABLET               3 mg               38.29
                              GLIMEPIRIDE                           TABLET               4 mg               41.65
     55                        SITAGLIPTIN                          TABLET               25 mg              33.77
                               SITAGLIPTIN                          TABLET               50 mg              64.16
                               SITAGLIPTIN                          TABLET              100 mg             109.21
     56                       TAMSULOSIN                          Tablet/ capsule       0.40 mg             47.28
     57                      MONTELUKAST                            TABLET               4 mg               27.03
                             MONTELUKAST                            TABLET               5 mg               33.77
                             MONTELUKAST                            TABLET               10 mg              47.28
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     Part I : Sec. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 29.04.2022
 Column I                  Column II                          Column III          Column IV        Column V
                          Generic Name                         Route of            Strength      Maximum Retail
                                                            Administration/                       Price Per unit
                                                             Dosage forms                             (SLR)
    58                    PREGABALIN                         Tablet/ capsule         50 mg             27.58
                          PREGABALIN                         Tablet/ capsule         75 mg             34.92
                          PREGABALIN                         Tablet/ capsule        100 mg             43.34
                          PREGABALIN                         Tablet/ capsule        150 mg             54.05
                          PREGABALIN                         Tablet/ capsule        300 mg             88.97
    59                    TOPIRAMATE                         Tablet/ capsule         25 mg             45.04
                          TOPIRAMATE                         Tablet/ capsule         50 mg             72.06
                          TOPIRAMATE                         Tablet/ capsule        100 mg             117.10
    60                   LAMOTRIGINE                            TABLET               25 mg             27.03
                         LAMOTRIGINE                            TABLET               50 mg             47.28
                         LAMOTRIGINE                            TABLET              100 mg             78.82
EOG 04–0223
                           PRINTED AT THE DEPARTMENT OF GOVERNMENT PRINTING, SRI LANKA.