Right to Information
Act,2005
The
Right to Information Act is aimed to promote openness, transparency and
accountability in Administration. The
details about NPPA are as follows :-
1. National Pharmaceutical Pricing Authority its functions
& Duties
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 Govt. of India Resolution
published in the Gazette of India No.159 dated 29.08.97. The functions of NPPA,
inter-alia, relates to fixation/revision of prices of scheduled bulk drugs/
formulations under DPCO’1995, monitoring and enforcement of the prices. Powers were delegated to the NPPA by the
Govt. of India vide Gazette Notification No. 637(E) dated 4th
September, 1997.
The
Resolution mentioned that the Government had been experiencing that the present
mechanism for the fixation and revision of prices of bulk drugs and
formulations was cumbersome, complicated and time consuming. Therefore, in order to streamline and
simplify the procedure and to bring about a greater degree of transparency as
well as objectivity, an expert body should be constituted with the powers,
inter alia, to fix prices and notify the changes therein, if any, of bulk drugs
and formulations from time to time, under the Drugs (Price Control) Order.
The
Government decided to establish an independent body of experts to be called as
the National Pharmaceutical Pricing Authority, consisting of a Chairperson in
the status of the Secretary to the Government of India, Members having
expertise in the field of pharmaceuticals, economics and cost accountancy and
Member Secretary in the status of Joint Secretary / Additional Secretary to the
Government of India. The Authority was
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 Authority is empowered to take final
decisions, which is subjected to review by the Central Government as and when
considered necessary. The Authority is
also required to monitor the prices of decontrolled drugs and formulations and
oversee the implementation of the provisions of the Drugs (Price Control)
Order. In addition to the above
mentioned functions, the Authority is entrusted with certain other functions
which are as follows :-
·
To
implement and enforce the provisions of the Drugs (Price Control) Order in
accordance with the powers delegated to it;
·
To
deal with all legal matters arising out of the decisions of the Authority;
·
To
monitor the availability of drugs, identify shortages, if any, and to take
remedial steps;
·
To
collect/ maintain data on production, exports and imports, market share of
individual companies, profitability of companies etc. for bulk drugs and
formulations;
·
To
undertake and / or sponsor relevant studies in respect of pricing of drugs /
pharmaceuticals;
·
To
recruit / appoint the officers and other staff members of the Authority, as per
rules and procedures laid down by the Government;
·
To
render advice to the Central Government on changes / revisions in the drug
policy;
·
To
render assistance to the Central Government in the parliamentary matters
relating to the drug pricing.
2. Powers and Duties of Officers &
Employees of NPPA
a) The general powers & duties of
officers are as follows :-
To
implement and enforce the provisions of Drug(Price Control) Order in accordance
with the powers delegated by Department of Chemicals & Petrochemicals.
To
collect, maintain data on production, exports, imports, market share of
individual companies, profitability of companies etc. for bulk drugs &
formulations.
To deal with
all legal matters arising out of the decisions of the Authority.
To monitor
the availability of drugs, identify shortages, if any, and to take remedial
steps.
To render
assistance to the Central Government in the parliamentary matters relating to the
drug pricing.
b) Specific division wise duties and
powers of officers are as follows :-
Bulk
Drugs Division : Bulk Drugs division handles the work relating
to collection and compilation of data relating to bulk drug and fixation /
revision of bulk drug prices.
Formulation
Division : Formulation
Division handles the work relating to collection and compilation of data
relating to formulation and fixation / revision of formulation prices.
Monitoring
& Enforcement Division (M&E) : M&E division handles the work relating to collection
and compilation of data relating to Monitoring of schedule and non schedule
formulations based on ORG IMS retail store audit report and based on price list
in form V. This division also examine
overcharging cases based on reference received from State Drug Controllers,
NGOs or complaint received from VIPs.
Legal
& Overcharging Division : Legal division handles the work relating to court cases, legal matters
arising out of decisions of NPPA. The
recovery of overcharged amount alongwith interest as per the provisions of Drug
Price Control Order 1995 and Essential Commodities Act 1955.
Administration
Division :
Administration division handles the work relating to Establishment,
Administrative and other matters like Sanctions of HBA, GPF Advance, GPF
Withdrawal, maintaining CR dossiers, court cases, promotions, increments,
monthly D.O. letter, Parliament Questions, Preparation of salary bills, work
related to Income Tax calculation, preparation of NPPA budget, and also look into
matter of R&I i.e. central registry, delivery of daks etc.
3. The Procedure followed in decision
making process
All the
decisions relating to fixation / revision of prices of Bulk Drugs and
Formulations are taken in the meeting of the Authority. The procedure followed are as follows :-
I) PROCEDURE
FOR PRICE FIXATION / REVISION OF BULK DRUGS
As per par 3 of DPCO, 1995 prices of scheduled bulk drugs
are fixed by the NPPA to make them available at a fair price from different manufacturers.
These prices are fixed from time to time by notification in official gazette. Following steps are involved in
fixation/revision of bulk drug prices :-
Step 1 : Identification of bulk drugs :
Bulk Drugs are taken up for study on following basis :-
Step 2 : Collection of data :
Data is collected by issuing questionnaire/Form I of DPCO,
1995/cost-audit report etc. and verification by plant visits, if required.
Step 3 : Preparation of actual cost statement :
Actual cost for the year for which data is submitted is
prepared based on data submitted / collected & verified during plant visit.
Step 4 : Preparation of Technical Parameters :
Technical parameters are prepared based on data submitted,
collected and verified during plant visits. Plant capacity is assessed
considering 330 working days for normal operation of plant leaving 35 days for
scheduled maintenance of plant. The achievable production level is considered
at 90% utilisation of assessed capacity allowing 10% production loss on account
of unforseen break down and non-scheduled maintenance.
Step 5 : Preparation of Estimated Cost :
The estimated cost for the pricing period are then prepared
based on actual cost & the technical parameters. While projecting the
future cost, an increment is recognised at 5% per annum in respect of salaries
& wages. Wage agreement, if any, which has been finalised and signed is
also recognised while preparing the estimates. In respect of other overheads of
fixed/semi variable nature, increase at 2.5% per annum is made to cover the
normal incremental effects. The customs duty and other taxes as per the current
budget are considered.
Step 6 : Calculation of Fair price of bulk
drug :
Fair price is calculated by providing returns as specified
in sub para (2), para 3 of DPCO, 1995.
While fixing the maximum sale price of the bulk drug, a post tax return
of 14% on networth or a return of 22% of capital employed or in respect of a
new plant an internal rate of return of 12% based on long term marginal costing
is considered depending upon the option exercised by the manufacturer of the
bulk drug. In case, the production is from basic stage, additional 4% return is
considered on net worth/capital employed.
Step 7 : Fixation of maximum sale price of the
drug :
When the number of manufacturers of the said drug is more
than one, the maximum sale price is fixed at 2/3rd cut off level or weighted
average price, depending upon the situation.
Step 8 : Notification of bulk drug price in official
Gazette.
Note : The
fair price may be further revised, if asked for by the manufacturers, based on
escalation formula for change in major raw materials and utilities rates.
II) PROCEDURE
FOR PRICING OF FORMULATIONS
Prices of formulations based on scheduled bulk drugs are
fixed in two ways viz.
(i) based
on applications of the manufacturers and
(ii) on suo-motu basis.
As per para 8 (2) of Drug (Prices Control) Order (DPCO),
1995, a manufacturer using scheduled bulk drug in his formulation is required
to apply for fixation of price of formulation within 30 days of fixation of
price of such bulk drug (s). Applications
received in NPPA from manufacturers in Form III and importers in Form IV of
DPCO are considered for price fixation. As per para 8(4), the time frame for
granting price approval on formulation is 2 months from the date of receipt of
the complete information from the company.
Procedure :
A.(a) Examination of Technical Parameters : Checking
the Quantity of Bulk Drug as per label claim. The overage claim is allowed as
per batch production record or norms fixed by Govt.
(b) Examination of Prices of Bulk Drug : When
notified price of bulk drug exists, the notified price or actual price is
considered. In the case of imported bulk drug used in the formulation, weighted
average import price is considered vis-à-vis the price submitted by the
applicant. For non-scheduled bulk drug used, the available information on
prices are applied.
(c) Examination of Excipient claims : Excipient
claims given in the application are examined and allowed after referring to
information available in NPPA.
(d) Examination of PL, CC, PC and PM cost : The
process loss (PL), conversion cost (CC) and packing charges (PC) are considered
as per the norms notified in the Gazette vide S.O. 578(E) dated 13.07.99. The packaging
material cost (PM) cost is allowed as per the actual claim supported by
invoices and after referring to information available with NPPA.
(e) Application of MAPE : Maximum
allowable post manufacturing expenses (MAPE) is given at 100% on the ex-factory
cost for indigenous formulation, while MAPE upto 50% of the landed cost is
allowed for imported formulation.
(f) Working out the retail price : The
retail price of formulations are worked out as per the formula given in para 7
of DPCO, 1995 viz.
"R.P. = [M.C. +C.C.+P.M.+P.C.] x [1+MAPE/100]
+E.D.",
where -
R.P., M.C., E.D. respectively denote retail price, material cost, excise duty
and the other symbols as denoted earlier.
(g) Treatment of Taxes : For
bulk drugs used in formulation, all the statutory taxes are considered at the
actuals and net of MODVAT. Allowance upto 8% on the notified price of scheduled
bulk drugs is considered on this account. The excise duty element is worked out
in NPPA based on companies claim. Allowance is made for 16% margin on price to
retailer (as per DPCO, 1995) and 8% margin to wholesaler as per practice, both
on the ex-factory price, which is the assessable value. The prevailing excise
duty rate is applied to the said assessable value. For ceiling packs, notified
prices are exclusive of excise duty. Manufacturers are required to work out the
excise duty.
B. Suo - Motu Cases : If the
manufacturers or companies do not apply for revision of formulation prices as
required under Para 8(2) of DPCO, 1995 within a period of 30 days of price
reduction of bulk drug or fall in other statutory levies, steps are taken for
suo-motu revision. Broadly the procedure given above is followed.
C. Notification of ceiling prices in the Gazette of
India : Ceiling prices are fixed or revised under Para 9 of
DPCO, 1995 for commonly marketed standard pack sizes of price control
formulations. It is obligatory for all, including small scale units, to follow
the ceiling prices which are notified in the Gazette of India (Extraordinary).
The ceiling prices are usually notified as exclusive of excise duty, local tax
etc. but maximum retail price (MRP) printed includes excise duty.
D. Pro-rata price : NPPA has issued
notification no. S.O.83 (E) on 27.01.98.on pro-rata pricing. As per this
notification, the manufactures of all the scheduled formulation pack sizes
different from the notified pack sizes under sub-paragraph (1) and (2) of the
paragraph 9 of the DPCO, 1995, shall have to work out the price for such pack
sizes, in respect of tablets and capsules of the same strength or composition
packed in different strips or blisters, on pro-rata basis of the latest ceiling
price fixed for such formulations.
E. Non-ceiling
Price Order : Non-ceiling Prices are fixed under Para 8 (1), (2) and (4) and Para 11
of the DPCO, 1995. They are specific to particular pack size and dosage form of
scheduled formulation of a particular company. Hence they are pack specific and
company specific. The prices fixed for non-ceiling packs are communicated to
the respective firms by issuing office orders. In such order, usually excise
duty element is shown separately. However, local taxes are not included in
Non-ceiling price. These orders are
available on the web-site www.nppaindia.nic.in
to the public
4. The norms for the discharge of its functions
The NPPA is governed by the
provisions of Drug Policy, 1994 and DPCO, 1995. In order to bring transparency and avoid arbitratariness, norms
have been fixed in respect of conversion cost (CC), packing charges (PC),
packing material (PM), process loss (PL) and same have been notified in the
official gazette. These norms are
placed at the web site of NPPA and are used by NPPA while fixing / revising the
prices of formulations.
5. Constitution of the Authority
Chairman,
NPPA
Member Secretary, NPPA
Ex-officio Members
All
decisions relating to price fixation / price revision of bulk drugs and formulations
are taken in the meeting of Authority.
6. Directory of Officers & Employees
National Pharmaceutical
Pricing Authority ( As on
26.07.2006)
(EPBAX
: 23345116, 23345118, 23345122, 23360265, 23747741, 23747748)
|
1. |
Sh. Ashok Kumar, Chairman |
23746639 |
|
2. |
Sh. Arun Jha, Member Secretary |
23746649 |
|
3. |
Sh. A.K. Singhal, Adviser (Pricing) |
23746643 |
|
4. |
Sh. L.M. Kaushal, Director (Monitoring) / (Admn.)
|
23746643 |
|
5. |
Sh. B.K. Pandey, Director ( Formulations ) |
2335176 |
|
6. |
Sh. M.P. Singh, Director (Legal) |
23746642 |
|
7. |
Dr. P. V. Appaji, Director (Enforcement) |
23746642 |
|
8. |
Sh. K.K. Jain, Dy. Director |
EPBAX |
|
9. |
Sh. N. Sridhar, Dy. Director (Cost) |
EPBAX |
|
10. |
Sh. S.K. Bhatt, Dy. Director (Tech.) |
EPBAX |
|
11. |
Sh. Jagdish Kumar, Dy. Director (Tech.) |
EPBAX |
|
12. |
Sh. Rajeev Wadhawan, Dy. Director (Cost) |
EPBAX |
|
13. |
Sh. N.I. Chaudhary, Dy. Director (Cost) |
EPBAX |
|
14. |
Sh. S. D. Maurya, Dy. Director (Cost) |
EPBAX |
|
15. |
Sh. A.K. Pal, Dy. Director (Cost) |
EPBAX |
|
16. |
Sh. G.S. Sahu, Dy. Director (Cost) |
EPBAX |
|
17. |
Sh. P.K. Saha, Dy. Director (Cost) |
EPBAX |
|
18. |
Sh. Manish Goswami, Dy. Director (Cost) |
EPBAX |
|
19. |
Sh. B.L.Meena, Under Secretary
(Administration) |
EPBAX |
|
20. |
Sh. J.P. Uniyal, Section Officer |
EPBAX |
|
21. |
Sh. S.K.. Taneja, Section Officer |
EPBAX |
|
22. |
Sh. M.R. Sankla, Section Officer |
EPBAX |
7. Monthly remuneration received of Officers & Employees
The scale of pay in respect of
various officers are as follows :-
|
S. |
Name
of |
Existing |
Scale
of pay |
|
No. |
Post |
Strength |
|
|
|
1 |
2 |
3 |
|
|
|
|
|
|
1 |
Chairman |
1 |
22400-525-24500 |
|
2 |
Member
Secretary |
1 |
18400-500-22400 |
|
3 |
Adviser
(Cost) |
1 |
18400-500-22400 |
|
4 |
Director |
2 |
14000-400-18300 |
|
5 |
Director (Enforcement) |
1 |
12000-375-16500 |
|
6 |
Director
(Admn.) |
1 |
14000-400-18300 |
|
7 |
Deputy
Director ( Cost ) |
9 |
10000-375-15200 |
|
8 |
Deputy
Director ( Tech.) |
2 |
10000-325-15200 |
|
9 |
Under
Secretary |
1 |
10000-325-15200 |
|
10 |
P.P.S |
1 |
10000-325-15200 |
|
11 |
Section Officer/Under
Secy. |
3 |
8000-275-13500 |
|
12 |
P.S. |
1 |
6500-200-10500 |
|
13 |
Senior
Investigator |
1 |
6500-200-10500 |
|
14 |
Assistant |
1 |
6500-200-10500 |
|
15 |
Technical
Assistant |
0 |
5500-175-9000 |
|
16 |
P.A. (Steno Grade C) |
2 |
6500-200-10500 |
|
17 |
Junior
Investigator |
0 |
5000-150-8000 |
|
18 |
Steno
Grade D |
3 |
4000-100-6000 |
|
19 |
Hindi
Translator |
1 |
5500-175-9000 |
|
20 |
UDC |
2 |
4000-100-6000 |
|
21 |
LDC/Typist/Hindi
Typist |
1 |
3050-75-4590 |
|
22 |
Staff Car
Drivers |
2 |
3050-75-4590 |
|
23 |
Daftry |
1 |
2650-65-4000 |
|
24 |
Peon /
Messenger |
4 |
2550-55-3200 |
|
25 |
Safaiwala |
-- |
2550-55-3200 |
|
|
Total |
42 |
|
Head
wise Break-up of NPPA
Head |
Amount (Rs. Lakhs) |
|
Salaries |
128.50 |
|
Wages |
7.00 |
|
O.T.A |
1.50 |
|
Medical
Treatment |
10.00 |
|
Domestic
Travel Expenses |
12.00 |
|
Foreign
Travel Expenses |
7.00 |
|
Office
Expenses |
274.00 |
|
Rent,
Rate & Taxes |
90.00 |
|
Other
Administrative Expenses |
5.00 |
|
Professional
Services |
56.00 |
Total |
591.00 |
NPPA do not administer any scheme
where grants, concessions, permit etc. are given.
NPPA have published a compendium
containing prices of Scheduled Bulk Drugs & Ceiling and Non-ceiling prices
of Scheduled Formulation Packs, under Drug (Price Control) Order, 1995, is now
available on Reception Counter of NPPA on payment of Rs.100/- per copy.
11 Facilities available to citizens for
obtaining information
All information relating to working
of NPPA are available on the web site www.nppaindia.nic.in
. The details of the information are as
follows :-
Message from Chairman
From the Member Secretary’s Desk
Resolution of NPPA
Functions of NPPA
Drug Policy 1986
Modifications in Drug Policy 1986
Drugs(Price Control) Order 1995
List of Controlled Bulk Drugs
Exemption Order
Norms for CC/PC/PL
Production Data
What’s New – Latest price fixation / revision or
other matter
Archive – notification issued by NPPA relating to
Price Fixation / revision
Frequently Asked Questions
List of Officers
Notified Prices
Pharmaceutical Policy – 2002
Procedure for Price Fixation
Study on Drugs Prices
Questionnaire / Proforma
Prorata Price – Notifications
Issues for your Comments
Feedback
12. Name, Designation and other particulars
of Public Information Officer
Name : A.K. Singhal
Designation : Adviser
(Pricing)
Address : 5th
Floor, YMCA Cultural Centre Building
1,
Jai Singh Road, New Delhi – 110 001
Tel
Nos. : 23746933
23345116/117/122
(EPBAX)
Assistant
Public Information Officer
Name : M.R. Sankla
Designation : Section
Officer
Address : 5th Floor,
YMCA Cultural Centre Building
1,
Jai Singh Road, New Delhi – 110 001
Tel Nos. : 23746643, 23345116/117/122 (EPBAX)