The National Pharmaceutical Pricing Authority (NPPA) has made a number of changes to its Integrated Public Database Management System 2.0 (IPDMS), a cloud-based application to support the industry in statutory filings with the Authority. One of these changes includes a provision to add specific details of the bulk drug in the online product verification form based on suggestions from the stakeholders. Numerous recommendations are made in reference to irregularities in the current forms, and the Authority has said that these issues would be resolved once the forms are changed.
The Authority reported that the IPDMS 2.0 has received multiple requests for the addition of new bulk drugs/formulations & strengths. The issue has been investigated, and it has been discovered that the formulas are most often already available. However, the corporations desired that more precise information be included in the composition and that the Form-V reflect the same. When an SKU is selected by the user, the system will automatically fill in the composition information for SKUs with more than 80,000 SKUs. The user can also change these automatically provided data.
The Authority clarified the situation by saying, “It may be noted that the features provided in the “bulk medicine” may occasionally be a broad category. “For instance: The user expects the composition to be “Diclofenac Sodium” while the bulk drug displayed is “Diclofenac.” In such a situation, customers can enter the composition specifics in “Detailed composition (if any)” to add more particular information relevant to their product. The system has since been improved, and Form-V will now also represent the “Detailed composition (if any)”.
The authority said, “In the event that your SKU is not present in the system, the company may select the most pertinent category in ‘Bulk Drug’.” The Federation of Indian Chambers of Commerce and Industry (FICCI), the Associated Chambers of Commerce and Industry of India (Assocham), and Bharat Serums and Vaccines Ltd. provided input and ideas, which were considered and implemented. But according to the Authority, none of the problems mentioned in the representations stop the enterprises from submitting different forms in the IPDMS version 2.0.
In response to a request to return the form’s Price to Retailer (PTR) to its original format, which is consistent with the Drugs (Prices Control) Order (DPCO) and excludes Goods and Services Tax (GST), the NPPA stated that the form has been digitised in accordance with the notified Form II and that changes in this regard are in the works. In contrast, during the pre-GST era, enterprises had to submit “Inclusive of ED but exclusive of Value Added Tax (VAT)”; today, however, companies are registering with pricing exclusive of GST. The businesses may carry on in this manner. Once the modification is implemented, the forms must be modified, it continued.
According to the notified Form II, the batch number is a required field and cannot be changed, notwithstanding requests from the organisations, unless the forms are changed and it is a matter of policy. As the form is a time-bound submission to NPPA, the industry sought to make the field optional because at the time of submission, companies would not have clarity on batch numbers at an early stage. The NPPA recommended that the user enter “not determined” or “not available” if the batch numbers are not known or not available.
The industry asked the Authority to remove the “plant name” box from Form II since it will be difficult to collect data by plant name and because the exercise entails updating data by product. Additionally, it is occasionally unknown whether a product will be produced in a single plant or several plants. Additionally, it stated, the Form V will provide the plant name for a specific product. According to the NPPA, the web page’s plant name filter allows users to fill out the Form II plant-by-plant. Based on earlier recommendations from the industry, a facility for filing Form II plant-by-plant is now available. However, as requested, all plants’ data would also be made available for download in addition to those from individual plants, it was stated.
In response to a complaint that the forms do not include the ceiling pricing for some of the scheduled pharmaceuticals, it was said that 417 prices have been updated and the other ones are in the process of being updated. The functional flow is not, however, being obstructed by this. The Authority stated that even if the ceiling price is not displayed, the form must still be completed. It also stated that the system had been tested and that users could now submit, view, and amend forms that had been stored as draughts. Users could also download records for forms that had been saved as draughts or final submissions and print them out.
It continued that the elimination of the PTS column from the Form itself is being looked at, along with the revision of forms to include Price to Stockist without GST rather than PTS including GST in Form V. The industry also requested that while a category of “New Drug” existed in earlier iterations of the IPDMS, separate from scheduled and non-scheduled medicines, it not be shown in Version 2.0 when items are reviewed for updating of Form V. The Authority acknowledged that this was a fresh concern, but noted that the system now reflects the required adjustments to remedy the problem.
The medical device sector claimed that since medical equipment do not have batch numbers but rather random serial numbers, batch numbers should not be required in the Form VI. According to the NPPA, the batch number is a required field on the notified Form VI and cannot be modified unless the Forms are amended. However, if the batch number is not available or determined, the user may enter “not determined” or “not available.” The ability to alter Forms, which was previously limited to Form III, has now been made available for all forms. The forms do not include the brand MRP, and without changing the forms themselves, it is not possible to add them to the web forms.
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