The National Pharmaceutical Pricing Authority (NPPA) plans to have a fully automated ecosystem for timely attending to, disposing of and monitoring of applications filed under various provisions of DPCO, 2013.
As per an issued office memorandum of NPPA, it mentioned that while the development and implementation of an ecosystem for timely disposal and monitoring of various applications filed with NPPA is under process, it has decided to switch to an online time-bound system for addressing applications, which are received under various provisions of DPCO, 2013 from pharma companies.
This includes:
Submission of Form-I (Application for the Pricing of New Drug): The applicant companies need to submit the application with all requisite documents on email ID: pricing-nppa@gov.in.
Submission of Form-l (Revised-Prices for Scheduled Formulations); Form-II (Quarterly Return in Respect of Production/Import and Sale of NLEM Drugs) and Form-V (Price List): Pharma companies should submit these forms on lPDMS within the prescribed timelines.
Submission of Form-IV (Discontinuation of Scheduled Formulation): The application for the discontinuation of the production of scheduled formulation with all requisite documents should be sent to email ID: monitoringnppa@gov.in.
Applications for special price for packaging under paragraph 11(3) of DPCO 2013: Application can be submitted on email ID: pricing-nppa@gov.in.
Holding of authority meeting: It would be preferably held every month. If due to certain circumstances the same could not be held in a particular month, the authority meeting would be held in subsequent months as per requirement
Meeting of the Multidisciplinary Committee of Experts: If required, it would be held prior to the authority meeting
Uniform Code of Pharmaceutical Marketing Practices (UCPMP): All Indian pharma manufacturer associations should upload the UCPMP on their website including the detailed procedure mentioned in paragraph 10 of the UCPMP regarding lodging of complaints. A quarterly report mentioning details of the complaint received and the decision taken thereon should be submitted by the concerned association to NPPA within 30 days of the end of the quarter via email to monitoring-nppa@gov.in.
The issued office memorandum also mentioned the timelines for disposal of applications in different categories:
- Form I is related to new drug prices and the given timeline is within 60 days.
- Form II is used for the revised prices of scheduled formulations, the set timeline to file is within 15 days from the date of notification.
- Form III is applied for the purpose of quarterly returns in respect of production/ import and sale of NLEM drugs, the set timeline for the manufacturer is within 15 days from the date of the end of quarter.
- Form IV and Form V are applied for the discontinuation of production of scheduled formulations and price list. Manufacturers need to file within 60 and 15 days from the date of notification respectively.
For further assistance, the NPPA has also created a helpdesk to deal with problems related to any documentary or technical issue while applicants are submitting their applications. It has also created email ids and phone numbers for each category. Queries related to Form I can be addressed to email id pricing-nppa@gov.in (011-23345175), and Form I1, Form II, Form IV and Form V to be at monitoring-nppa@gov.in (011-23345177) and for technical IT/IPDMS related issues applicants can be reached at nppa@nicin and 011-23360265.
Commenting on these directives, Dr Amit Rangnekar, Chairman, Pricing Committee, IDMA commented, “The ecosystem for timely disposal and monitoring of applications filed is an apt move by the NPPA, in the current situation. The ecosystem not only provides guidelines for submission and disposal of Form I, II, III, IV and V electronically but also has a clear pathway of communication regarding receipt, rejection and acknowledgement of the applications, as well as the timelines, and updation of the status of the applications. For any queries, a helpdesk has been provided to ensure faster approvals and lower rejections. Besides, the guidelines for the authority meetings have also been outlined. The IDMA has been proposing online submission and status, for various applications, and we welcome the move. The ecosystem should ensure timely and transparent dissemination of information, which will be mutually beneficial to all stakeholders.”
Vivek Padgaonkar, Independent Healthcare Consultant Ex-Director OPPI, Ex GSK expressed, “The online time-bound system for addressing applications is certainly a good step on the part of the government and will help the pharma industry. Stable pricing policies is a requisite in moving towards ease of doing business.”
He added, “The NPPA may also wish to look at the following:
1. To offer clarity on para 19. Para 19 of DPCO 2013 provides for plenary powers of the government to carry out price fixation or revision in certain emergency situations. Para 19 has been invoked in very few situations by NPPA in the past.
2. To make a proper guidance document for overcharging covered under para 20
3. For the submission of Form-I (Application for the pricing of New Drug), NPPA, the confirmation of the receipt of application along with acknowledgement number would be provided via return e-mail, within three days of receipt.
b) Incomplete application without the requisite documents would be returned and the same shall be informed to the applicant via email within 15 days after the receipt.
4. Many companies have issues with the IPDMS, need to take feedback in next 15 days and make the system robust.
5. Confirmation of the receipt of Form-IV along with acknowledgement number would be provided via return e-mail within 15 days