NPPA has done well with changes in IPDMS 2.0

The system has now been upgraded and the ‘Detailed composition (if any)’ will also be reflected in Form-V. In case the SKU is not available in the system, the company can choose the most relevant category in ‘bulk drug’

In what could be a big boost to online filing of data for the pharmaceutical industry, the National Pharmaceutical Pricing Authority (NPPA) has made several changes to its Integrated Public Database Management System 2.0 (IPDMS), including a provision to add specific details of bulk drugs in the online product verification form.

The Authority’s move comes in the wake of suggestions and feedback from different stakeholders, including the Federation of Indian Chambers of Commerce and Industry (FICCI), Associated Chambers of Commerce and Industry of India (ASSOCHAM) and Bharat Serums and Vaccines Ltd.

IPDMS is the cloud-based application to support the industry in statutory filings with the Authority. The NPPA, in collaboration with the National Informatics Centre (NIC), developed the IPDMS with the objective of creating an appropriate mechanism for obtaining market-based data related to drugs. After the launch of the IPDMS in 2014, the NPPA had asked all the pharmaceutical companies in the country to register themselves under IPDMS for online filing of returns in Form II, III and V under DPCO 2013.

However, the response from the industry was lukewarm, forcing NPPA to extend the last registration day several times. Eventually, IPDMS has proved to be a useful tool for collection of data and information and for monitoring and analysis of data for the industry, the consumer and the regulator, and from which data on production, import and pricing of scheduled and non-scheduled formulations can be accessed and analysed before reports are generated. Following the success of IPDMS, the IPDMS 2.0 was launched by the Union Minister for Chemicals and Fertilizers Dr. Mansukh Mandaviya last year.

But, there were many anomalies in the system forcing the stakeholders to approach NPPA to rectify the mistakes. Many of the suggestions were related to the anomalies in the existing forms. The Authority assured to address the issue once the forms were amended. It pointed out that several requests were received seeking addition of new bulk drug/formulation and strengths in IPDMS 2.0. On a thorough examination, it was found that in most of the cases, the formulations were already available. However, the companies wanted to add more specific details in the composition and also wanted the same to be reflected in Form-V. In case of more than 80,000 SKUs (stock-keeping units), 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. For example, the bulk drug shows ‘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. In case the SKU is not available in the system, the company can choose the most relevant category in ‘bulk drug’.

On a request regarding restoring the format of Price to Retailer (PTR) excluding of Goods and Services Tax (GST), which is in line with the Drugs (Prices Control) Order (DPCO), instead of the PTR inclusive of excise duty in the Form, the NPPA said that the form is digitised as per the notified Form II and amendments in this regard are underway.

However, the companies were required to enter ‘Inclusive of ED but exclusive of Value Added Tax (VAT)’ during the pre-GST period and now the companies are filing with prices exclusive of GST. The companies can continue to do so. The forms shall be changed once the amendment is carried out. Batch number is a compulsory field as per the notified Form II and it cannot be changed as requested by the organisations unless the forms are amended and it is a policy matter.

The industry wanted to make the field optional, as the form is a time-bound submission to NPPA, but the time of submitting companies would not have clarity on batch numbers at an early stage. The NPPA suggested that if the batch numbers are not available or not determined, the user can enter ‘not determined’ or ‘not available’.

The industry urged the Authority to remove the field of ‘plant name’ from Form II, as capturing data at plant name wise will be a challenge and its exercise involves updating data product-wise. Also, sometimes it is not known that it will get manufactured in one plant or in multiple locations. Moreover, the plant name will be provided in Form V for a given product.

The NPPA said that the plant name field is provided on the web page as a filter so that users can fill the Form II plant-wise. The facility for the plant-wise Form II filing is based on the earlier suggestions from the industry. However, along with separate plants, the download of data of all plants shall also be given.

Overall, the changes made by the NPPPA will help the country’s pharmaceutical industry.

(The author is freelance journalist with varied experience in different fields)