QUESTIONNAIRE ON COST-CUM TECHNO ECONOMIC STUDY OF BULK DRUG (S)

  1. INSTRUCTIONS/CLARIFICATIONS FOR FURNISHING THE DATA
    1. Reply should be furnished in triplicate. The data on floppy in Excel may also be furnished, if possible.
    2. The Proforma (I) to ( XIX ) given in Part II to be filled in and submitted to this Authority are illustrative and not exhaustive, wherever minor modifications are called for the company may do it. If there is any matter on which you wish to submit additional information not specifically called for in the questionnaire, you may do so in separate enclosure to your reply.
    3. Information on the various points asked in the questionnaire should be furnished in respect of each of the units separately (in case of company having more than one unit).
    4. This copy of the questionnaire has been carefully checked and numbered. However, in case any pages are found defective or missing, you are requested to immediately write for the replacement of the specific pages that require to be replaced.
    5. Proforma (b) to (d) relating to cost of respective utilities is optional in case the total utility cost is less than 5 % of the total raw material cost for the drug under study.
    6. The questionnaires along with the proforma are available on the internet. It can be downloaded from the website www.nppaindia.nic.in, if required.
    7. Any information supplied to NPPA will be kept strictly confidential and will not be divulged to any other agency.
  1. PARTICULARS OF PROFORMA E
    1. Statement showing the cost of Production/Sales.
      1. Statement showing the cost of Raw Material, Utilities.
      2. Break-up of total cost of utilities.
      3. Cost Statement for Generation of Steam.
      4. Cost Statement for Generation for Electricity.
    2. Statement showing analysis of expenses.
      1. Details of allocated expenses to individual products & Intermediates.
      2. Details of expenditure excluded.
      3. Details of allocation of Overhead Expenditure on the basis of Machine Hours.
    3. Details of latest purchase rates of raw material, Packing material and utilities.
    4. Details of latest cost of Imported Raw Material.
    5. Statement showing the amount of interest alongwith rate of interest (to be filled in, if return on net-worth is opted).
    6. Statement showing the allocation of Assets.
    7. Details of Capital Employed for the Drug under study.
    8. Details of Foreign Exchange repatriated during the last two years.
    9. Details of import of Bulk Drug during the last two years.
    10. Details of Raw Material imported duty free under advance licence/ any other scheme currently in vogue during the last two years.
    11. Details of R&D and ETP Expenditure for the drug under study for the last two years.
    12. Details of Production, Consumption and Sales of the bulk drug.
    13. Details in respect of man-days/Employees.
    14. Details of Actual & Estimated Production and Sale Figures.
    15. Details of Plant Capacity.
    16. Details of Annual Average Consumption of Raw Material and Utilities for the last three years.
    17. Details of Batch Production Data.
    18. Details of Capital Addition/Replacement towards Plant & Machinery.
    19. Details of Recovery of By-product(s) at ETP level.
  2. A. GENERAL INFORMATION TO BE FURNISHED
    1. (a) Name of the drug for which information is furnished : 
      (b) Name of the Manufacturer : 
      (c) Address of the Registered/Head Office of the Manufacturer, Telephone/ Telex/ Fax Nos., if any : 
      (d) Address of the Factories where the bulk drug is manufactured : 

    2. (a) The names of other drugs/products, if any, produced in addition to the above.

    B. COSTING INFORMATION

    1. (a) Copies of the audited balance sheet and profit and loss account along with all the Schedules for the latest three years may be furnished : if the company has activities other than bulk drugs, in addition, Sectional Profit and Loss A/c and Balance Sheet covering the unit where bulk drug is manufactured may also be given.
      (b) A copy of the Cost Audit report for financial year for which data is submitted may be furnished. In case the cost audit for the said year is not yet completed, the report for the previous year may please be furnished.
    2. A short note on cost accounting system followed by the company.
    3. The method of depreciation adopted by your company in financial Accounts and Cost Accounts i.e. Written down value or straight line method as per rates provided in schedule XIV of Companies Act. If assets had been revalued, impact on depreciation may be shown separately and excluded from cost.
    4. Please give the option regarding the return to be provided as per DPCO, 1995 para 3 Sub para 2 of the following : 
      1. post-tax return of 14% on net worth : 
      2. Return of 22% on capital employed : 
      3. In case of new plant, an internal rate of return of 12% based on long run marginal costing : 
    5. If the bulk drug is produced in multipurpose product, the basis of allocation of common expenses of the plant to the bulk drugs individually may be detailed. If the allocation is made on equipment hour basis, details of equipment hours etc. may be furnished in proforma II-C.


    C TECHNICAL INFORMATION

    1. Installed Capacity : 
      1. Industrial License /IEM/SSI Registration No. alongwith the date : 
      2. Date of Commissioning : 
      3. Date of Commencement of Commercial production : 
      4. No. of shifts (one/Two/Three per day) : 
      5. No. of operating days per week : 
      6. Installed capacity per annum : 
      7. Dedicated /multipurpose equipment plant : 

      Note : Reasons for operating at lower capacity, if any.

      Manufacturing Process

      1. Describe the manufacturing process adopted by you alongwith the flow chart. Also mention appropriate chemical equations at all stages of reaction with molecular weight and recovery levels of solvents and by product at each stage.
      2. Please indicate if you have made any changes in the process or the technology has been upgraded since the last study or in the recent past. A brief write up may be provided.
    2. Research & Development Activities
      1. A brief write up on the current R&D activities of the company. Please, also specify the benefits accruing from your R&D efforts made during the recent past in the production of this drug.
      2. Technology Transfer/foreign collaboration/licences obtained etc. (if any) done by the company. Please specify the details thereof with advantages of such arrangement in terms of cost effectiveness, Quality improvement, introduction of new process/product etc. in respect of bulk drug under study.
    3. ETP Facilities
      1. In case the existing facilities are not adequate and are to be augmented to meet the standards, the details of the proposal indicating the cost involved, phasing of expenditure, etc. may be provided.
      2. In case you are not having any arrangement for the treatment of effluent arising out of the manufacture of the product, please state whether there are any proposals for installing and operating effluent treatment plant in the near future. If yes, details may be furnished even if these are estimates only as the same will be considered for fixation of fair price.
      3. Quality Control specification of the Effluent before and after treatment alongwith the standards laid down by the State Pollution Control Board. Latest in-house tests reports may be enclosed.
    4. Information/data regarding production, plant capacity, consumption of raw-materials and utilities, recovery of solvents/by-products and capital expenditure on plant and machinery may please be provided in the proforma XV to XIX.

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