Bangalore District Chemists and Druggists Association (BDCDA) is seeking immediate clarification and changes in the Drugs & Cosmetics Act and Rules and Drugs Price Control Order (DPCO) as both have serious deficiencies.
A memorandum in this regard has been submitted to the Drugs Control General of India (DCGI) recently.
“The pricing policy of the government is faulty. There are two major areas which need to be addressed at the earliest. The first is the prices of branded drugs and the second is to bring down the cost of generic drugs by pricing them much lower than the branded ceiling prices,” stated V Harikrishnan, president, BDCDA.
There needs to be more clarity in the Rule 64 of the D&C Act. The rule 64(2) has to be taken into consideration before granting the licenses. Automatic renewal has to be done with a prescribed fees challan. There is need for clarity on the procedure to obtain licenses in case of change of constitution, premises and name. The Act should define geographical area of 10 Sq meters, and 15 sq. m.
The Rule 65 of Act should define cash/credit memo. It should also adhere to the conditions as per the licence granted.
The Rule 66 which refers to license suspension and cancellation, a privilege of 3 months from the date of the order to appeal should be extended. The licensee must be allowed to sell other products which are not in the ambit of licensees granted. The licensing authority needs to endorse the goods as per licenses granted in the premises before and after suspension.
The additional information sheet supplied with the application in Form 19, 19A, 19B should precisely guide storage facilities and working hours.
Coming to DPCO, the BDCDA insists that distributors and retailers margin have to be regulated. Under Para 7, the definition for drug must be brought under its ambit. The BDCDA has urged to place inserts stating Allow Distributor Margin (ADM) 10 per cent and Allow Retailers Margin (ARM) 20 per cent in the packs after MAPE (Maximum Allowable Post Manufacturing Expenses) and before Excise Duty.
Under DPCO Para 15, BDCDA wanted the manufacturer to print retail price, specify VAT(value added tax) and Excise Duty. In case of exemption of VAT and ED, ‘Nil’ has to be shown on the column specified. The name of manufacturer's website needs to be printed on the pack for clarification of prices. Retailers and dealers are to be exempted from display of price list.
BDCDA has also demanded clarification on DPCO Para 18 and called to modify Para 19 where manufacturers could sell any formulation to a retailer minus 20 per cent on retail price excluding excise duty, VAT and other taxes and minus 10 per cent on retailer price arrived.
Further, the Association has also called to dissolve the existing Committee formed for the State amendments and appoint a new one with a chairman from the existing officials of the department along with the members of the trade.
Referring to the Form 5 of the Price List, the Association has called to inspect the excise duty and VAT. In fact, it has called for actual excise duty and VAT shown by the manufacturer in Form 5 which has to be paid by him before effecting a sale in any state.