PROACTIVE DISCLOSURE UNDER RTI

1. ORGANISATION AND FUNCTION

The National Pharmaceutical Pricing Authority (NPPA), an independent body of experts in the Ministry of Chemicals and Fertilizers, was formed by the Govt. of India vide Resolution published in the Gazette of India No.159 dated 29.08.1997.

FUNCTIONS & DUTIES OF NPPA

NPPA is a five Member body as detailed below:

1. Chairman (in the rank of Secretary or Additional Secretary of Govt. of India).
2. Member Secretary (in the rank of Joint Secretary to the Govt. of India)
3. Three ex-officio Members, one each from:
   1. Adviser, Department of Economic Affairs.
   2. Adviser, O/o Chief Adviser Cost, Department of Expenditure.
   3. Drug Controller General of India, M/o H&FW.

The Authority is entrusted with the task of price fixation revision and other related matters such as updating the list of drugs under price control by inclusion and exclusion on the basis of the established criteria / guidelines. The National Pharmaceutical Pricing Authority shall be empowered to take final decisions, which shall be subject to review by the Central Government as and when considered necessary. The Authority shall also monitor the prices of decontrolled drugs and formulations and oversee the implementation of the provisions of the Drugs (Prices Control) Order. In addition to the above-mentioned functions, the Authority is entrusted with certain other functions as detailed in the Schedule annexed to the Resolution.

The Authority shall have power to regulate its own procedure for performing the functions entrusted to it. It shall be to call for notes, memorandum, results of studies, data and other material relevant to its work, from official and non-official bodies / organizations, and hold discussions with them. The Authority shall be empowered to maintain close touch with the Ministries of the Central Government, State Governments, Industry, consumers and other related organizations.

Other functions of the National Pharmaceutical Pricing Authority are as follows:

1. To implement and enforce the provisions of the Drugs (Price Control) Order DPCO in accordance with powers delegated to it.
2. To undertake and/or sponsor relevant studies in respect of pricing of drugs/formulations.
3. To monitor the availability of drugs, identify shortages, if any, and to take remedial steps.
4. To collect/maintain data on production, exports and imports, market share of individual companies, profitability of companies etc. for bulk drugs and formulations.
5. To deal with all legal matters arising out of the decisions of the Authority.
6. To render advice to the Central Government on changes/revisions in the drug policy.
7. To render assistance to the Central Government in parliamentary matters related to drug pricing.

POWERS AND DUTIES OF OFFICERS & EMPLOYEES OF NPPA

In exercise of the powers conferred by sections 3 and 5 of the Essential Commodities Act, 1955 (10 of 1955), the Central Government has directed that National Pharmaceutical Pricing Authority shall also exercise the functions of the Central Government. A copy of the delegation orders is available on the website of NPPA.

The general powers & duties of officers and other employees are as follows:

1. To implement and enforce the provisions of Drugs (Prices Control) Order in accordance with the powers delegated by Department of Pharmaceuticals
2. To deal with all legal matters arising out of the decisions of the Authority.
3. To monitor the availability of drugs, identify shortages, if any, and to take remedial steps
4. To render assistance to the Central Government in the parliamentary matters relating to the drug pricing.

PROCEDURE FOLLOWED IN DECISION MAKING PROCESS

The key decision-making points for the Authority are identified as follows:

1. Fixation/ Refixation of Ceiling Prices
2. Fixation/ Refixation of Retail Prices
3. Processing of Discontinuation intimations
4. Identification and processing of Overcharging cases
5. Monitoring and Enforcement activities

The detailed process has been provided in DPCO, 2013 and is further detailed in various decisions of the Authority and minutes of the same are available on the website of NPPA.

The final decision-making authority is the Authority except in certain cases where the powers have been specifically delegated to NPPA officials.

Related provisions, acts, rules etc.

NPPA, mainly, functions as per DPCO, 2013 which is an Order issued under Section 3 of EC Act, 1955.

Time limit for taking decisions, if any

The time limit for various activities is provided in OM dated 26-08-2020 which is available on the website of NPPA. Further, for certain activities like fixation of Ceiling Prices, the time limits are provided in DPCO, 2013.

Channel of supervision and accountability

The Channel of supervision and accountability is the same hierarchy as provided in the organization structure.

NORMS FOR DISCHARGE OF FUNCTIONS

National Pharmaceuticals Pricing Policy (NPPP,2012) was notified by the Government of India on 7th December, 2012. The key principles for regulation of prices of medicines as outlined in the NPPP,2012 are (i) essentiality of drugs, (ii) control of formulation prices only and (iii) market-based pricing. The NPPP, 2012 in accordance with the principles of essentiality of medicines has adopted the National List of Essential Medicines 2011, which was declared by the Ministry of Health and Family Welfare for the purpose of price fixation. A total of 348 ‘active pharmaceutical ingredients’ (excluding repetitions) were listed in the NLEM 2011.

Pursuant to the announcement of National Pharmaceutical Pricing Policy, 2012, Government notified Drugs (Prices Control) Order, 2013 (DPCO, 2013) on 15th May, 2013. All the medicines specified in the National List of Essential Medicines 2011 (NLEM) have been included in the First Schedule of DPCO, 2013 and brought under price control. Under DPCO, 2013, prices of drugs are fixed on ‘Market based pricing’ methodology in accordance with the principles outlined in the NPPP, 2012.

The NLEM Core-Committee through a series of meetings and consultations across the country deliberated and revised the National List of Essential Medicines (NLEM) 2015 as National List of Essential Medicines NLEM 2022 dated 13.11.2022 and now there are 384 medicines in NLEM 2022.

Under the DPCO, 2013, ceiling price of scheduled medicines is fixed based on the market-based data, inter alia, by taking simple average prices of all those manufacturers who have market share more than or equal to 1% of total market turnover on the basis of Moving Annual Turnover (MAT) of a specified medicine. The ceiling price is derived by adding 16% margin on the simple average price to the retailer (PTR) for the specified medicine. As provided for under the Order, the local taxes if actually paid, wherever applicable on actual basis, will be added to the ceiling price to arrive at the Maximum Retail Price to the consumers.

NPPA has fixed the ceiling prices in respect of 691 medicines under NLEM 2022 (as on 30.06.2023) (including medicines for diabetes, cancer, cardiovascular diseases, Asthma, HIV, analgesics and antipyretics and TB etc). Upward revision in the prices of scheduled formulations is permissible to the extent of increase in the Wholesale Price Index (WPI) for the particular year.

NPPA is also empowered, in case of extra-ordinary circumstances, if it considers necessary to do so in public interest, to fix the ceiling price or retail price of any drug for such period, as it may deem fit and where the ceiling price or retail price of the drug is already fixed and notified, the NPPA may allow an increase or decrease in the ceiling price or the retail price, as the case may be, irrespective of annual wholesale price index for that year.

NPPA has also fixed the retail price of 2450 ‘new drugs’ (As on 30.06.2023) which fall within the purview of Para 2(u) of DPCO.2013) under Para 5 of DPCO, 2013, since operationalization of DPCO, 2013.

The prices are notified through Gazette Notifications which are also uploaded on NPPA’s website at www.nppaindia.nic.in.

NPPA is entrusted with the job of monitoring the availability of drugs and to identify shortages, if any, and to take remedial steps to make the drugs available. NPPA is carrying out this responsibility mainly through the State Drugs Controllers. NPPA also give permission for discontinuation of scheduled medicines and also processes price exemption request received under Para 32 of DPCO, 2013.

Integrated Pharmaceutical Database Management System (IPDMS)

Integrated Pharmaceutical Database Management System (IPDMS) is an integrated responsive cloud-based application. It is a system for online information collection, processing and communication portal to monitor and regulate the prices of medicines and medical devices, to ensure availability and affordability of drugs and medical devices in the country. It provides a single window for submissions of all Forms as mandated under Drug Price Control Order (DPCO), 2013 & facilitates the stakeholders (Manufacturers/ Marketers/ Importers/ Public) to communicate with the National Pharma Pricing Regulator from across the country. IPDMS 2.0 will also automate the workflow of different divisions of NPPA.

The Pharma Jan Samadhan (PJS) is an online facility to raise complaint for Overpricing, Sale without Price Approval, Refusal of sale and Non-Availability of Drugs. Pharma Sahi Daam (PSD) is an online search tool for checking MRP of all medicines and Ceiling Prices instantly. The IPDMS/ Pharma Sahi Daam and Pharma Jan Samadhan is available on the link https://nppaipdms.gov.in. The PSD and PJS portals are also available on both iOS and Android platform with the name “Pharma Sahi Daam”.

Complaints/ Grievance handling

Any individual or consumer organization or stockist / distributor / dealer / retailer or State Drug Controller can lodge complaints at “Pharma Jan Samadhan” (PJS) portal of NPPA, through the toll-free number 1800111255 & Email — monitoring-nppa@gov.in. PJS is an online complaint redress system for speedy and effective resolution of complaints with respect to availability of drugs, overpricing of drugs, sale of ‘new drugs’ without prior price approval (WPA) and refusal to supply or sell drugs.

RULES, REGULATIONS, INSTRUCTIONS MANUAL AND RECORDS FOR DISCHARGING FUNCTIONS, CATEGORIES OF DOCUMENTS HELD BY THE AUTHORITY UNDER ITS CONTROL

Title and nature of the record/ manual /instruction, List of Rules, regulations, instructions manuals and records, Acts/ Rules manuals etc.

1. DPCO, 2013
2. Essential Commodities Act, 1955
3. Documents related to Authority Meeting
4. Documents related to fixation of ceiling price, retail prices, MRP and Trade margins.
5. Documents related to overcharging cases
6. Documents related to discontinuation of scheduled medicines and invocation of Para 3 of DPCO, 2013
7. Various Guidelines like Discontinuation, internal guidelines on Overcharging cases.

Transfer policy and transfer orders

Not applicable as all the officers and other employees are posted in the NPPA Headquarters.

BOARDS, COUNCILS, COMMITTEES AND OTHER BODIES CONSTITUTED AS PART OF THE PUBLIC AUTHORITY

The details of Committee constituted:

1. Multidisciplinary Committee of Experts (MDC)
2. Standing Committee for examination of discontinuation cases

DIRECTORY OF OFFICERS & EMPLOYEES

The Directory of Officers & Employees is available on NPPA’s website.

MONTHLY REMUNERATION RECEIVED BY OFFICERS & EMPLOYEES INCLUDING SYSTEM OF COMPENSATION

The scale of pay in respect of various officers (as on 31.05.2023) are as follows:

NAME, DESIGNATION AND PARTICULARS OF PUBLIC INFORMATION OFFICER

Name: Shri Saurabh Bansal
Designation: Deputy Director and CPIO
Address: 3^rd Floor, YMCA Cultural Centre Building, 1, Jai Singh Road, New Delhi – 110001
Email: saurabh[dot]bansal50[at]gov.in

Name: Shri Sanjay Kumar
Designation: Advisor (Cost) and FAA
Address:5^th Floor, YMCA Cultural Centre Building, 1, Jai Singh Road, New Delhi – 110001
Email: sanjay[dot]kr72[at]nic[dot]in

1. OF EMPLOYEES AGAINST WHOM DISCIPLINARY ACTION HAS BEEN PROPOSED/ TAKEN

No. of employees against whom disciplinary action has been

(i) Pending for Minor penalty or major penalty proceedings – Nil

(ii) Finalised for Minor penalty or major penalty proceedings- Nil

PROGRAMMES TO ADVANCE UNDERSTANDING OF RTI

1. The CPIO and FAA are routinely encouraged to gain knowledge about RTI through available online resources.
2. The CPIO and FAA participated in the Annual convention of CIC and attended the training programs held therein

TRANSFER POLICY AND TRANSFER ORDERS

Not applicable as all the officers and other employees are posted in the NPPA Headquarters.

1. BUDGET AND PROGRAMME

BUDGET ALLOCATED TO EACH AGENCY INCLUDING ALL PLANS, PROPOSED EXPENDITURE AND REPORTS ON DISBURSEMENTS MADE ETC.

FOREIGN AND DOMESTIC TOURS

Information related to procurements

THE MANNER OF EXECUTION OF SUBSIDY PROGRAMMES.

There are no subsidy programmes being implemented by this office.

DISCRETIONARY AND NON-DISCRETIONARY GRANTS

The details of the grants given under CAPPM scheme are available on the website at the following address:

https://www.nppaindia.nic.in/en/schemes/cappms/pmru-guidelines-2/

PARTICULARS OF RECIPIENTS OF CONCESSIONS, PERMITS OF AUTHORIZATIONS GRANTED BY THE PUBLIC AUTHORITY

No concessions or permits are issued by NPPA.

CAG & PAC PARAS

NIL

III. PUBLICITY BAND PUBLIC INTERFACE

PARTICULARS FOR ANY ARRANGEMENT FOR CONSULTATION WITH OR REPRESENTATION BY THE MEMBERS OF THE PUBLIC IN RELATION TO THE FORMULATION OF POLICY OR IMPLEMENTATION THERE OF

Relevant Acts, Rules, Forms and other documents which are normally accessed by citizens

Essential Commodities Act, 1955 and DPCO, 2013

Arrangements for consultation with or representation by – (a) Members of the public in policy formulation/ policy implementation, (b) Day & time allotted for visitors, (c) Contact details of Information & Facilitation Counter (IFC) to provide publications frequently sought by RTI applicants

All the draft working sheets for price notifications are published on the website for a specified period of time before the matter is placed before the Authority for approval.

ARE THE DETAILS OF POLICIES / DECISIONS, WHICH AFFECT PUBLIC, INFORMED TO THEM

Yes, all the decisions are taken in the meetings of the Authority and the minutes of meeting of the Authority are placed on the website.

DISSEMINATION OF INFORMATION WIDELY AND IN SUCH FORM AND MANNER WHICH IS EASILY ACCESSIBLE TO THE PUBLIC.

Dissemination of information is done through various social media portals/ applications. Further, Pharma Sahi Daam portal is available on our website and the same is also available in the form of a mobile application. NPPA also publishes bimonthly e-newsletter Aushadh Sandesh.

FORM OF ACCESSIBILITY OF INFORMATION MANUAL/ HANDBOOK

All the documents are placed on the website.

WHETHER INFORMATION MANUAL/ HANDBOOK AVAILABLE FREE OF COST OR NOT

  Yes. All the documents are placed on the website, which can be downloaded free of cost.

1. 
   E- GOVERNANCE

Language in which Information Manual/Handbook Available

English. However, all gazette notifications, E-newsletter, mobile application and other major documents are issued in both Hindi and English.

When was the information Manual/Handbook last updated?

2023.

Information available in electronic form

Yes.

Particulars of facilities available to citizen for obtaining information

All information relating to working of NPPA are available on the website www.nppaindia.nic.in. NPPA has also launched a facility for citizens named Pharma Jan Samadhan where consumers can lodge online complaints against availability of medicines, overpricing of medicines, sale of ‘new drugs’ without prior price approval (WPA) and refusal of supply or sale of medicines.

Such other information as may be prescribed

1    Grievance redressal mechanism

Complaints can be filed on CPGRAMS portal or Pharma Jan Samadhan Portal.

2  Details of applications received under RTI and information provided

During the F.Y. 2022-23, 186 number of applications were received and information were provided in all cases.

3    List of completed schemes/ projects/Programmes

CAPPM is currently being implemented by NPPA.

4    List of schemes/ projects/ program me underway

CAPPM is currently being implemented by NPPA. No other scheme is underway.

5    Details of all contracts entered into including name of the contractor, amount of contract and period of Completion of contract

6      Annual Report

The Annual Report of DoP, containing updated of NPPA also, is published on the website   https://www.pharmaceuticals.gov.in/

7  Frequently Asked Question (FAQs)

FAQs are published in our bimonthly e-newsletter in every edition.

RECEIPT & DISPOSAL OF RTI APPLICATIONS & APPEALS

During the F.Y. 2022-23, 186 number of applications were received. All the applications were disposed of.

During the F.Y. 2022-23, 11 number of RTI appeals were received. All the applications were disposed of.

REPLIES TO QUESTIONS ASKED IN THE PARLIAMENT

NPPA provides inputs for the replies to PQs to Deptt. Of Pharmaceuticals.

1. INFORMATION AS MAY BE PRESCRIBED

Name & details of – (a) Current CPIOs & FAAs, (b) Earlier CPIO & FAAs from 1.1.2015

Details of third party audit of voluntary disclosure -(a) Dates of audit carried out , (b) Report of the audit carried out

No such audit conducted.

Appointment of Nodal Officers not below the rank of Joint Secretary/ Additional HoD – (a) Date of appointment , (b) Name & Designation of the officers

No such nodal officer appointed.

Consultancy committee of key stake holders for advice on suo-motu disclosure – (a) Dates from which constituted, (b) Name & Designation of the officers

No such committee constituted.

Committee of PIOs/FAAs with rich experience in RTI to identify frequently sought information under RTI – (a) Dates from which constituted, (b) Name & Designation of the Officers

No such committee constituted.

1. INFORMATION DISCLOSED ON OWN INITIATIVE

Item / information disclosed so that public have minimum resort to use of RTI act to obtain information

All the major information and document is already placed on the website.

Guidelines for Indian Government Websites (GIGW) is followed (released in February 2009 and included in the Central Secretariat Manual of Office Procedures (CSMOP) by Department of Administrative Reforms and Public Grievances, Ministry of Personnel, Public Grievance and Pensions, Govt. Of India)

NPPA has not yet obtained STQC certification for its website.