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The Department of Pharmaceuticals (DoP) has amended various forms including the Form V for price list to be submitted by the pharmaceutical manufacturers and importers under the Drugs (Prices Control) Order, 2013 to add more details including the prices excluding Goods and Services Taxes (GST) and other taxes.
The amendment comes as an effort to update the forms after the introduction of GST. There was confusion among the manufacturers regarding submission of details online in the Integrated Public Database Management System 2.0 (IPDMS), the cloud-based application to support the industry in statutory filings with the Authority. The NPPA has recently said that the confusion would be addressed with the amendment of the forms in the DPCO, 2013.
The Drugs (Prices Control) Second Amendment Order, 2023, substitutes the item number 10 in Form I, which is the proforma for application for price fixation or revision of new drug formulation related to National List of Essential Medicines (NLEM) formulation, to the effect that it should include retail price claimed for approval - in rupees per unit, excluding taxes. The previous proforma only mentioned the retail price claimed for approval.
At least some of the manufacturers or importers by accident of by ignorance, included taxes with the retail price claim, which resulted in confusion and dispute after the prices were fixed.
The Form II for the proforma for submission of revised-prices for scheduled formulations has been amended to add columns to submit the GST rate in percentage, price to retailer per pack excluding taxes and the maximum retail price inclusive of all taxes. Earlier the form had a column to add the price to retailers inclusive of excise duty and the MRP inclusive of Excise duty and taxes.
In the Form IV, the proforma for submission of the details in respect of discontinuation of the production and/or import of scheduled formulation, also the details were amended to seek the applicable GST rate in percentage and existing MRP of pack including all taxes and its effective date, among others.
The Table A of the Form V has also been amended to include the details of GST rate in percentage, price to distributor excluding taxes, pre-revised MRP, if any, inclusive of all taxes. In deviation with the previous form, this has also added a column to submit production capacity.
Similar amendments were brought in to the Table B of the Form V, including the addition of columns for production capacity.
In April, this year, the NPPA had implemented various changes in the IPDM 2.0 version, including a provision to add specific details of the bulk drug in the online product verification form based on the suggestions by the stakeholders. Many of the suggestions are related to the anomalies in the then existing forms and the Authority has said that they would be addressed once the forms are amended.
The Authority said that several requests were received for the addition of the new bulk drug/formulation & strengths in the IPDMS 2.0. The matter has been examined and it is found that in most of the cases, the formulations are already available. However, the companies wanted to add more specific details in the composition and also wanted the same to be reflected in the Form-V.
In case of more than 80,000 SKUs, the composition details are available in the system and the same will be auto filled once the SKU is selected by the user. Also, the user can modify such auto filled details.
“It may be noted that the details mentioned in the “bulk drug” may sometimes be a broad category,” said the Authority while clarifying the matter.
“For example: the bulk drug shown is “Diclofenac” and the user wants the composition to be “Diclofenac Sodium”. In such a case, for adding more specific details pertaining to their product, the users can enter the composition details in “Detailed composition (if any)”. The system has now been upgraded and the “Detailed composition (if any)” will also be reflected in Form-V,” it added.
“In case your SKU is not available in the system, the company can choose the most relevant category in ‘Bulk Drug’,” added NPPA in a clarification to the industry earlier.
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