A SEMINAR CUM WORKSHOP

On

  1. VAT Chargeable and Payable as per the Drugs Price Control Order
  2. Clarification and Changes in the Druges & Cosmetics Act & Rules and Drugs Price Control Order
  3. National Pharmaceutical Pricing Authority Policy 2011 - Draft
  4. Monitoring and Enforcement Authority on NPPA and Drugs Price Control Order
  5. E-SUGAM

The President, Office Bearers and the Managing Committee of the The Bangalore District Chemists & Druggists Association Cordially invites you for the function

Click here to watch Live!!!

01:30 PM → Registration & Lunch

02:45 PM → Inauguration

03:00 PM → Seminar cum Workshop

05:30 PM → High Tea

06:00 PM → Issue of Delegate Gifts

08:00 PM → New Year Royal Dinner

Bunts Sangha Convention Hall

No.324, Bunts' Sangha Complex

Chord Road, Vijayanagar

Bangalore - 560 040

Invitation

Subjects in Seminar

vat chargeable and payable as per the drugs price control order

Clarification and Changes in the Drugs & Cosmetics Act & Rules and Drugs Price Control Order

  • Rule 64 of Drugs and Cosmetic Act

    • Where ever [or renewed] to be DELETED
    • Regards on 64(2) has to be taken in to consideration before granting the licenses
    • Automatic renewal has to be renewed with prescribed fees Challan
    • Request to clarify and guide the procedure to obtain licenses [20,20B, 21,21B] in case of change of constitution, change of premises or both & change of name
    • To define geographical area of 10 Sq meters, and 15 Sq.meters
    • Request not to consider a licensee area in case of government acquisition
  • Rule 65 of Drugs and Cosmetic Act

    • To define cash/credit memo
    • To adhere to the conditions as per the license granted
  • Rule 66 of Drugs and Cosmetic Act

    • In case of suspension/cancellation of the licenses the order must be ineffective allowing him the privilege of 3 months of the date of the order to prefer appeal against the order as per rule 66(2)
    • In case of order of suspension /cancellation the licensee must be allowed to sell other products which are not in the ambit of licensees granted
    • In case of a license’s license suspended in effective: The licensing authority has to endorse the goods as per licenses granted in the premises before and after suspension
    • In case of a license’s license cancelled in effective: The licensing authority has to endorse the goods as per licenses granted in the premises before cancellation and disposal
  • Additional information sheet supplied with the application in Form 19, 19a, 19b

    • To clarify and guide storage facilities and working hours
    • Entire additional information sheet to be omitted
  • DPCO Para 7

    • As per DPCO definition for drug must be brought under the ambit of PARA 7
    • To insert - Allow distributor margin (ADM) 10%
    • Allow retailers margin (ARM) 20%
    • These words must be inserted after MAPE and before ED
    • Only distributor has to be defined stockiest must be deleted
    • Distributor and retailers to be regulated
  • DPCO Para 8

    • To insert - Allow distributor margin (ADM) 10%
    • Allow retailers margin (ARM) 20%
    • These words must be inserted after ceiling price and before ED
  • DPCO Para 9

    • To insert - ALL in place of Scheduled
  • DPCO Para 15

    • Amend the manufacturer to print
      Retail price - 100.00
      Excise Duty - 6.00
      VAT - 5.30
      MRP - 111.30 Inclusive of all taxes
    • In case of exemption of VAT and excise duty NIL has to be shown on the column specified
    • The name of manufacturer website has to be printed on the pack for clarification of prices printed on the pack
    • Retailer and dealer to be exempted from display of price list
  • DPCO Para 18

    • To clarify and define 18(A) & (B)
  • DPCO Para 19

    • 19(1) to be modified
    • A manufacturer sell any formulation to a retailer minus 20% on retail price excluding excise duty, VAT and other taxes and minus 10% on retailer price arrived
  • Commitee formed for State Amendments

    • To dissolve the existing committee formed and fresh committee to be appointed with chairman from the existing officials of the department
  • Conditions to be manitained for supply of Medicines to the Retailers from Wholesale Licensee

    • Request to clarify and guide the procedure and acknowledgement of supplies made by the wholesaler to retailers
  • Form V Pricelist

    • As requested in PARA 9 of the DPCO
    • Inspection on excise duty and VAT
    • Actual excise duty and VAT shown by the manufacturer in FORM V has to be paid by him before effecting a sale
    • The definition PARA 2 (KK) “local taxes” to be deleted
  • Your Office Letter dated 27.04.2005 signed by Chairman and Member Secretary of Committee to recommend guidelines for grant of Licenses for New Medical Stores

    • Guidelines to be implemented immediately
  • Clarificatory Circular on MRP issued by the Department of Chemicals & Petro-Chemicals dated 04.09.2006 vide No.5/42/05-PI.I Govt. of India, Ministry of Chemicals & Fertilizers

    • As per the clarification the manufacturer has to be pay Excise duty, VAT and other taxes to the government as amount shown by him in FORM 5 before sale without uniform MRP
    • In case the manufacturer opts to uniform MRP a formula is allowed
  • Batch records

    • Every manufacturer before effecting a sale in a State has to submit batch wise quantity to the respective state drug control department
    • We request the drug control department to provide an online system to submit the above records
  • License records

    • As already the license records are online in our State we request to provide information regarding cancellations, suspension and fresh license
  • Substitution

    • To clarify substitution
    • Substitutions can be considered only on Formulations not on Branded names
  • Minimum salable pack

    • To define minimum salable pack
    • Whether the retailer is empowered to cut the strip and break the price and sell in loose

National Pharmaceutical Pricing Authority Policy 2011 - Draft

  • Schedule K

    • To implement Scheduled K (5)(5A)
  • Transfer of Stocks

    • To clarify transfer of stocks as per act and rules
  • Free Goods

    • Whether Drugs and Cosmetics ACT and Drug Price Control Order allows
    • A Product to be given free with a print MRP inclusive of all taxes
  • Test Samples on Physician Samples

    • Request to provide details of test Samples conducted on free samples given by the manufactures to the Doctors as promotional materials and also test samples on veterinary drugs till date
    • Request for compulsory analyzation of Physician samples veterinary drugs
  • Supervision by Registered Pharmacist

    • Registered pharmacist is not required to supervise the sale of branded named prescriptions, only formulation based prescriptions has to be supervised
    • Existing retail licensees who are not registered pharmacist has to be recognized as competent person to supervise a sale in his existing shop with a authorization by licensing authority
  • Jurisdiction of Sale Licenses, recommendations, guidelines, Orders by other State Drug Controllers

    • Request to clarify the Jurisdiction of the trade licenses granted by the department and consideration of recommendations, guidelines, Orders by other state controllers
  • Jurisdiction of Orders by judiciary bodies of respective States of our country

    • Request to clarify Jurisdiction of orders by Judiciary bodies of respective state of our country for consideration
  • Letter dates 04.11.2004 by the Prinicipal Secretary, Health & Family Welfare on the report submitted by Inspector General of Police (COD) on complaint filed by Shri.V.Harikrishnan & Shri.V.L.Dorairaj on violations by NOVA INSULIN(M/s Knoll)

    • As per the report submitted by the COD the above company violated Drug price control order PARA 12A & PARA 19 where the company has not allowed a sum of Rs. 1,60,00,000.00 ( One Crore Sixty Lakhs only ) on products sold by them to the retailer in the state of Karnataka as the complaintent we request the department to issue necessary orders to the manufacturer/marketer in force to deposit the above amount in the account of The Bangalore district chemist and druggist association
    • We request the department to penalised the manufacturer for the contravention of Drugs price control order
  • Food & Drug Administration

    • As all the State Drug control department are independent departments assigning the implementation and enforcement of central act
    • To circumvent the price controls many leading brands of prescribed tablets, capsules, powders, syrups are now being sold as dietary supplements and does not come under purview of the DRUG CONTROL DEPARTMENT but are licensed through food department which comes under the local municipal authority, All dietary supplements which are sold needs to be regulated under one umbrella Food and Drug Administration for better compliances. We have different authorities in our country to supervise and enforce the drug distribution and dietary supplements. In many states there is FDA where as in some states it is Drug Control Department
    • For better enforcement and monitor the drug and dietary supplements FDA is ideal to safe guard the national health

Monitoring and Enforcement Authority on NPPA and Drugs Price Control Order


E-SUGAM

VAT

Issued under the Essential Commodity Act for Safe & Quality Medicines at reasonable Prices


The Drugs Price Control Order clearly notifies to fix or arrive at a Price as per their Order


To Fix or arrive Retail Price without Excise VAT and other Taxes


It allows actual amount of Excise Duty if paid any on the Retail Price. VAT has to be charged on the above Price to arrive Maximum Retail Price inclusive of all Taxes as per Form V



Sl.No  Name of the Formulation  Strength  Pack Size  Ceiling Price/Arrived Price  Rate  Amount  Rate  Amount  Rate  Amount


(1)            (2)                              (3)          (4)              (5)                           (6)    (7)        (8)      (9)      (10)    (11)




Excise Duty,    Sales taxes/VAT    Other Local taxes    Price to be retailed Inclusive of Excise Duty,    Minimum Retail Price
if any             if any                  if any                    Sales Taxes,VAT and Other Local Taxes        (inclusive of all Taxes)


_               _               _                    _                                               _





Calculation of Retail Price for formulation:


The retail price of a formulation shall be calculated by the Government in accordance with the following formula namely


RP      =  (MC+CC+PM+PC) X (1+MAPE/100)+ED


RP      =  means - Retail Price


MC    =  means - Material Cost


CC     =  means - Conversion Cost


PM     =  means - Packing Materials


PC      =  means - Packing Charge


PM     =  means - Packing Materials


MAPE =  means - Maximum Allowable Post Manufacturing Expenses All costs incurred by a                        Manufacture from the stage of Ex-factory cost to retailing and include Trade                            Margin and Margin for the Manufacture and it shall not exceed one Hundred                             percent for indigenously manufactured Scheduled Formulations


ED     =  means - Excise Duty


Breakup of Maximum Retail Price:

a) Material Cost

b) Conversion Cost

c) Packing Material Cost

d) Packing Charges

e) Ex-factory cost (a to d)

f) MAPE (100% on (e))

g) Excise Duty


Example : EF Cost 100 + 100 MAPE is allowed

Price have been arrived                      200.00

Add Excise Duty Paid if any

Including Educational Cess

added on the Price                              30.00

                                                _________

                                                    230.00

VAT has to be charged on the Price           11.50

                                                _________

                                                     241.50

Other Local Taxes if any                           _

                                                _________

                                                    241.50

                                                _________

As per the Order Excise duty has to be charged on the Retail Price if any and added If no Excise is paid or Excise exempted it cannot be added to the Retail Price


After adding Excise Duty paid if any to the Retail Price VAT has to be charged on that Price


The Order also allows any other Local Levies on the Price arrived after adding Excise Duty & VAT to conclude Maximum Retail Price Inclusive of all Taxes


This clearly refers that the Excise Duty /VAT and other Local Levies are in built and is to be paid by the Manufacturers before making the Sale subject to the actual Excise Duty Paid if any and VAT and other Taxes Paid by the Manufacturers as shown by him in the Prescribed Form V


Our humble request to the Commissioner of Commercial Taxes that the VAT has to be collected from the Manufacturers before the Sale in our State as Medicines (Drugs) are defined as per the Drugs Price Control Order


We therefore request your goodself to exempt us from filing any Form of VAT Forms


PACKING COMMODITIES:

The Prices on the Packing Commodities are printed on the Pack with MRP inclusive of Taxes


Example of a Part is shown:

A Pack of Cigarette which bears MRP Rs.48/- inclusive of all Taxes


We request for a breakup of this Price


Original Sales Rate + VAT added to arrive MRP inclusive of all Taxes

Rate  VAT  MRP

-       -      Rs.48.00


Any packing commodity Manufacturer has to give a breakup of his rate and the amount of VAT added to his rate to conclude MRP of all Taxes


We hereby request the Commissioner to collect the VAT amount added to the rate by the Manufacturer before effecting a Sale, if the Print on the Pack is MRP inclusive of Taxes

Or

Allow the Manufacturer to Print MRP – Local Taxes Extra, where Local Taxes Extra where VAT Acts & Rules can be enforced


Composition Scheme is not permitted to claim any input packs in any purchase made by him as per Section 15 (4) , similarly he is not permitted to collect Tax on his Sale and has to pay composition amount of 1% on his total turnover


No option Composition Scheme can be allowed to a dealer who is effecting a Sale of a Commodity which bears MRP inclusive of all Taxes


Composition Scheme can be allowed to a dealer whose commodity has no Price Printed on the commodity or a commodity therein MRP Local Taxes extra


Maximum Retail Price inclusive of Taxes allows the dealer to sell at a price printed on the Pack which includes the input and output Tax defeats the purpose of composition Tax


Hence no composition scheme can be allowed to a dealer whose purchase and sales of a commodity bears MRP inclusive of all Taxes


If composition scheme has to be allowed to a dealer who purchases and sells a commodity bearing MRP inclusive of Taxes the rate of the composition Tax has to be raised on the basis of 1% plus input Tax and output Tax


We request your goodself to kindly notify to give a breakup of rates and VAT added by the Manufacturer of a commodity bearing MRP inclusive of Taxes and collect the VAT amount as shown by him in his breakups and exempt Registration to the subsequent dealer who are small traders and petty dealers to allow Tax evasion free Trade


Any Commodity bearing MRP inclusive of all Taxes which is sold at a lesser Price has to pay the VAT amount as shown in his breakup


The amount of lesser price/ discount has to be allowed in his rate and not in the VAT amount


MRP inclusive of all Taxes defeats the VAT Act and Rules, hence we request the commodities must bear maximum MRP Local Taxes extra or VAT Act & Rules has to be modified



BDCDA Convention 2012. They're making it official on Sunday, January 01, 2012 at 02:45 pm at Bunts Sangha Convention Hall, Vijayanagar, Bangalore - 560 040.