Schedules To The Drugs And Cosmetics Rules 1945

 SCHEDULE

1) SCHEDULE-A:

                             Proforma for application for grant or renewal of licences, forms of various licences, forms of variuos memoranda,  certificates, receipts, reports etc.

2) SCHEDULE-B:

                             Fees for Test or Analysis by Central Drugs Laboratory or State Drugs Laboratory.

3) SCHEDULE-C:

                             List of "Biological and special products", Whose import, sale, distribution and manufacture are governed by special provisions. e.g.

         (a)  Sera 

         (b) Insulin

         (c) Ophthalmic  Preparation

         (d) Toxins

         (e) Antitoxins

4) SCHEDULE-C-1:

                                 List of "Others Special Products", Whose import, sale, distribution and manufacture are governed by special provisions. e.g.

         (a) Non-parenteral vaccines.

         (b) In-vitro Blood grouping sera.

         (c) Fish liver oil and its preparation.

         (d) In-vitro diagnostic devices for HIV, HbsAg and HCV.

   

5) SCHEDULE-D:

                              Classes of drug exempted from provisions of Act and rules, for import, the extent of exemptions.

6) SCHEDULE-E-1:

                                 List of "Poisonous Substance" under Ayurvedic, Siddha and Unani System of medicines:

        (a) Drug of vegetable origin:

             e.g. -  (1) Papaver somniferum 

                       (2) Abrus precatorius 

                       (3) Cannabis sativa

                       (4) Aconitum 

                       (5) Datura etc.

        (b) Drugs of Animal Origin:

              e.g. - Snake venom

        (c) Drugs of mineral origin:

              e.g. - Arsenic, Mercury, Lead oxide etc. 

 

7) SCHEDULE-F:

                               Requirements for the functioning and operation of a Blood bank and or for preparation of blood Components.

                     Requirements for manufacture of blood products.         

   :Schedule-f(1) :   Provision applicable to the production                               Bacterial Vaccines, Viral Vaccines, Antisera    and         Diagnosis Antigens.

   :Schedule-f(2) :- standards for "Surgical Dressing ".

 

   :Schedule-f(3) :- Standard for :"Umbilical  Tapes". 

             

   :Schedule-f f   :-  Standard for Ophthalmic preparation.

  

8)SCHEDULE-G:

                               List of drugs that are required to be used only under medical supervision and Which are to be labeled accordingly- e.g.

        

              (1) Aminopterin 

              (2) carbutamide 

              (3) chorthiazide

              (4) chlorpropamide 

              (5) Glibenclamide 

              (6) Insulin

 NOTE:- Excluding external or topical use preparation, all other preparation containing above mentioned substance are covered by this schedule.

9) SCHEDULE-H:

                           List of Drug which are required to be sold by retail on the prescription of a Registered Medical Practitioner only and are to be labeled accordingly.

Symbol RX :- Conspicuously displayed on the left top corner of the label.

              e.g. (1) Analgin 

                     (2) Atenolol

                     (3) Antibiotics

                     (4) Levodopa 

                     (5) Diazepam 

                     (6) Dopamine 

                     (7) Ibuprofen 

                     (8) Heparin 

 

10) SCHEDULE-J:

                             Disease and aliments (by Whatever name describe) Which a drug may not purports or Claims to prevent or cure. e.g.

                    (1) AIDS

                    (2) Baldness 

                    (3) Cataract 

                    (4) Blindness 

                    (5) Deafness 

                    (6) Diabetes 

                    (7) Goiter 

                    (8) Insanity

                    (9) Obesity

                    (10) Paralysis

    

11) SCHEDULE-M:

                                  Good manufacturing Practices And Requirements of Premises, Plant and equipment for Pharmaceutical Products.

 

12) SCHEDULE-N: 

                                 List of minimum equipment for the efficient running of pharmacy:

13) SCHEDULE-O:

                                 Standard for "Disinfectant Fluid"

14) SCHEDULE-P: 

                                 Life Period Drugs and their Storage Condition.

      (a) Cool place means place having temperature between 10 c to 25 c

      (b) cold place means a place having temperature less than 8 c

      (c) In a well closed container, protected from light, in a cool place.

      (d) At temperature between 2 c to 8 c and must not be allowed to freeze.

      (e) Capsules be stored in well closed container below 30 c

      (f) Stored at room temperature, if storage condition are not specified.

       Schedule-p-1:- Pack sizes of drug.

15) SCHEDULE-Q: (1) List of dyes, Colors and Pigment permitted to be used in Cosmetics and Soaps.

                                   

                                   (2) List of Colors permitted to be used in soaps only.

16) SCHEDULE-R: 

                                 Standard for Rubber Condoms and other Mechanical contraceptives.

17) SCHEDULE-S:

                                 Standard For Cosmetics.

  

18) SCHEDULE-T:

                                 Good Manufacturing Practice for Ayurvedic,  Siddha and Unani Medicines.

19) SCHEDULE-U:

                                 Particulars to be shown in Manufacturing Records.

 

20) SCHEDULE-V:

                                Standard for Patent and Proprietary Medicines.

21) SCHEDULE-X:

                                 List of Drugs import, manufacture, sale and distribution of which is regulated by special provisions.

                      (1) Amobarbital

                      (2) Amphetamine

                      (3) barbital 

                      (4) Pentobarbital

                      (5) Secobarbital 

22) SCHEDULE-Y:

                                 Requirements and guidelines for permission to import / manufacture of new drugs for sale or for clinical trials.