Last Updated on December 31, 2023 by The Health Master
DPCO 2013: Amendment in Form 2, 4 & 5
Download notification no. S.O. 2324(E) dt 25-05-2023, the link is given below: The Department of Pharmaceuticals (DoP) has recently made amendments to various forms, including Form V, to streamline the submission of price lists by pharmaceutical manufacturers and importers under the Drugs (Prices Control) Order, 2013.
These amendments have been done vide notification No. S.O. 2324(E) dt 25-05-2023.
These changes aim to provide additional details, such as prices excluding Goods and Services Taxes (GST) and other taxes.
The update comes in response to confusion among manufacturers regarding online submissions in the Integrated Public Database Management System 2.0 (IPDMS), a cloud-based application supporting statutory filings.
The National Pharmaceutical Pricing Authority (NPPA) has acknowledged the confusion and confirmed that the amended forms in the DPCO, 2013 will address this issue.
Form I Amendments:
Under the Drugs (Prices Control) Second Amendment Order, 2023, the amendment replaces item number 10 in Form I.
This proforma, used for application of price fixation or revision of new drug formulation related to the National List of Essential Medicines (NLEM) formulation, now requires the inclusion of the claimed retail price for approval, in rupees per unit, excluding taxes.
The previous proforma only mentioned the retail price claimed for approval.
The amendment aims to eliminate disputes that arose when manufacturers or importers unintentionally included taxes in the retail price claim.
Form II Amendments:
Form II, used for the submission of revised prices for scheduled formulations, has been modified to include additional columns.
These columns allow for the inclusion of the GST rate in percentage, the price to the retailer per pack (excluding taxes), and the maximum retail price (inclusive of all taxes).
The previous version of the form included a column for the price to retailers inclusive of excise duty and the maximum retail price inclusive of excise duty and taxes.
Form IV Amendments:
The details in Form IV, which is used for the submission of information regarding the discontinuation of production and/or import of scheduled formulations, have also been amended.
The amended form now requests the applicable GST rate in percentage, the existing MRP of the pack (including all taxes), and its effective date, among other changes.
Form V Amendments:
Table A and Table B of Form V have both been amended to reflect the new requirements.
Table A now includes columns for the GST rate in percentage, the price to the distributor (excluding taxes), any pre-revised MRP (inclusive of all taxes), and the production capacity.
Similarly, Table B has been updated to include columns for the production capacity as well.
IPDMS 2.0 Changes:
In April of this year, the NPPA implemented several changes in the IPDMS 2.0 version, addressing stakeholder suggestions.
These changes included the provision to add specific details of bulk drugs in the online product verification form.
These updates aim to rectify anomalies in the existing forms. Manufacturers requested the addition of new bulk drugs/formulations and strengths in the IPDMS 2.0.
While most of the requested formulations were already available, companies sought to provide more specific details in the composition, which would be reflected in Form V.
Composition Details and System Upgrade:
For over 80,000 SKUs, composition details are available in the system and will be automatically filled once the SKU is selected by the user.
Users also have the option to modify the auto-filled details. The NPPA clarified that the “bulk drug” mentioned may sometimes be a broad category, such as “Diclofenac.”
In cases where users want to add more specific details, they can enter the composition details in the “Detailed composition (if any)” field.
The system has been upgraded to reflect this information in Form V.
If a SKU is not available in the system, the company can choose the most relevant category in the “Bulk Drug” field.
Conclusion:
The recent amendments to the forms for price list submission by pharmaceutical manufacturers and importers under the Drugs (Prices Control) Order, 2013, demonstrate the Department of Pharmaceuticals‘ commitment to addressing industry concerns.
By providing more detailed information, such as prices excluding taxes, the revised forms aim to streamline the submission process and reduce confusion among manufacturers.
The amendments also align with the introduction of GST and improve the accuracy of pricing data. These changes will ultimately benefit both the industry and consumers alike.
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