The National Pharmaceutical Pricing Authority (NPPA) has issued an Office Memo stipulating for an online-bound system for addressing applications received from pharmaceutical companies under the Drugs (Price Control) Orders, 2013 (DPCO, 2013). This Memo was issued on 26th August 2020.
For this purpose it notifies the following procedure:
Submission of Form – I (Application for pricing of New Drug)/ Applications for Special price for packaging under DPCO, 2013
The applicant can now submit this form with requisite documents to the email ID: pricing-nppa@gov.in
After the application is submitted, a confirmation of its receipt along with an acknowledgement number will be generated via a return email.
Incomplete applications and those without requisite documents will be returned and the applicant will be intimated in this regard via email.
The applicant can check the status of his application on the NPPA website which will be updated fortnightly.
Submission of Form-II (Revised prices for scheduled formulations) / Form –III (Quarterly returns in respect of Production/ Import and Sale of NLEM Drugs)/ Form-V (Price List)
The Memo states that existing procedures and timelines will be followed in respect of submissions of Form-II, Form-II and Form-V.
Under the existing procedure, pharmaceutical companies submit these forms on the Integrated Pharmaceutical Database Management System (IPDMS).
Submission of Form-IV (Discontinuation of scheduled formulation)
The applicant can now submit this form with requisite documents to the email ID: monitering-nppa@gov.in
After the application is submitted, a confirmation of its receipt along with an acknowledgement number will be generated via a return email.
The applicant can check the status of his application on the NPPA website which will be updated monthly.
Meetings
The Authority may meet monthly and meetings of Multidisciplinary Committee of Experts if necessary, may be held before the meetings of the Authority.
Uniform Code of Pharmaceutical Marketing Practices (UCPMP):
All Indian Pharmaceutical Manufacturer Associations must upload UCPMP on their websites including the detailed procedure for lodging of complaints. The associations are also required to display on their websites the nature of the complaint, details of the company against whom a complaint is made, action taken by the committee under the association on such complaints including the current status of the complaint.
All such details should be maintained for three years on their website. Furthermore, a quarterly report mentioning details of the complaint received and the decision taken thereon shall be submitted by the association to NPPA within 30 days of the end of the quarter. This report must be submitted to the email ID: monitoring-nppa@gov.in.
Additionally, Annexure-I of this memo provides a list of required documents to be submitted with Form-I and Annexure-II states the timelines for submission and disposal of all the above-stated applications/ reports. It also provides contact details for the helpdesk in case of any documentary/ technical issues.
