By Special Messenger
F.No.21(63)/2010-Div.III/NPPA
Government of India
Ministry of Chemicals & Fertilizers
Department of Pharmaceutical
National Pharmaceutical Pricing Authority
Ph: 23345116, 23345118 & 23345122,
Fax : 23345119
Website: www.nppaindia.nic.in
5th / 3rd Floor,
YMCA Cultural Centre Building,
1, Jai Singh Road, New Delhi – 110 001.
Date: 11.04.12
To
Sh. Roshan Lal,
Under Secretary (PI.I),
Ministry of Chemicals and Fertilizers,
Department of Pharmaceutical,
Shastri Bhawan, New Delhi – 110 001
Fax: 23383392
Sub: Submission of RFD for the year 2012-13
Sir,
The undersigned is directed to refer to Deptt of Pharmaceutical’s letter dated 29.3.2012 on the above-mentioned subject and to enclose the RFD for the year 2012-13 of NPPA for further necessary action at your end.
Yours faithfully,
(Anshuman Mohanty)
Director
Ministry of Chemicals & Fertilizers
Department of Pharmaceuticals
National Pharmaceutical Pricing Authority
Result Framework Document (RFD)
Section 1
Vision
Ensuring abundant availability of medicines at reasonable prices in the country
Mission:
Ensure a fine balance between the conflicting interest of industry and consumers by: (i) fixation / revision of prices of scheduled bulk drugs/ medicines, (ii) effective enforcement of the provisions of the DPCO, 1995, and (iii) close monitoring of the prices of non-scheduled medicines in the country.
Objectives of the NPPA
- To effectively implement and enforce various provisions of the DPCO, 1995.
- To ensure reasonable prices of medicines in the Country.
- To review availability of drugs and ensure adequate availability of the required medicines in various parts of the country.
- To keep an effective check on the drug manufacturers to ensure that they do not over charge the consumers / patients.
- Advise the Government on modifications / revision in the Drug Policy.
Functions of the NPPA:
i) Price fixation and revision of scheduled drugs / medicines;
ii) Price fixation and revision of non-scheduled formulation packs in public interest as per para 10(b) of the DPCO, 1995;
iii) Updating the list of drugs under price control by inclusion / exclusion on the basis of established criteria / guidelines;
iv) Implementation and enforcement of the provisions of the DPCO 1995 in accordance with the powers delegated by the Government;
v) Monitoring of prices of decontrolled drugs and formulations;
vi) To deal with Legal matters arising out of the decisions of the NPPA;
vii) Monitoring of availability of Drugs, identify shortages and taking remedial steps;
viii) Collection and maintenance of data on production, exports and imports, market share and profitability of companies for bulk drugs and formulations;
ix) Undertaking and / or sponsoring relevant studies in respect of pricing of drugs / pharmaceuticals;
x) Rendering advice to the Central Government on modifications / revisions in the Drug Policy;
xi) Rendering advice to the Central Government in Parliamentary matters relating to Drug Pricing;
Section 2
Inter Se Priorities Among Key Objectives, Success Indicators And Targets
| I | Objectives | Weight | Actions | Success Indicators | Weight | Target/Criteria Value | ||||
|---|---|---|---|---|---|---|---|---|---|---|
-- |
-- |
-- |
-- |
-- |
(% of col 2) | Excellent | Very good 90% | Good 80% | Fair 70% | Poor 60% |
-- |
1 | 2 | 3 | 4a | 5 | 6a | 6b | 6c | 6d | 6e |
-- |
To fix / revise the prices of 74 scheduled bulk drugs listed in the 1stscheduled of DPCO’95 | 30 |
Fixation / Revision of Scheduled Bulk Drugs.
|
Study to be completed in 10 months from the date of complete data received. # | 50% | Study completed within 10 months | Study completed within 11months | Study completed within 12 months | Study completed within 13 months | Study completed after 13 months |
-- |
To fix / revise the prices of scheduled formulations under DPCO’95. |
Fixation / Revision of Formulations based on applications and suo moto.
|
Number of applications disposed off within 60 days from the date of receipt of the application. | 50% | Applications disposed off within 60 days | Applications disposed off within 70 days | Applications disposed off within 80 days | Applications disposed off within 90 days | Applications disposed off beyond 90 days | |
-- |
Effective Monitoring Mechanism of the prices of scheduled drugs and formulations/ non-scheduled formulations | 15 | Examination of price list (Form V) | Examination to be completed within 30 days | 35% | Examination completed within 30 days | Examination completed within 35 days | Examination completed within 40 days | Examination completed within 45 days | Examination completed beyond 45 days |
| Examination of Monthly Report of IMS Health. | Examination to be completed within 30 days | 35% | Examination completed within 30 days | Examination completed within 35 days | Examination completed within 40 days | Examination completed within 45 days | Examination completed beyond 45 days | |||
| Issue of show cause notice to companies on the basis of references received from SDCs in case of price violations and those exceeding 10% in a year. | Notice to be issued within 30 days from the date of examination the reference from SDCs and those exceeding 10% in a year | 30% | Notice issued within 30 days | Notice issued within 35 days | Notice issued within 40 days | Notice issued within 45 days | Notice issued after 45 days | |||
-- |
Monitoring and Enforcing prices within the provisions of the DPCO,1995 |
10 | Number of test purchases/samples of Drugs (Scheduled and non Scheduled) made by NPPA | Sample to be purchased within the Financial Year | 30% | 600(and above) samples purchased | 500(and above) samples purchased | 450(and above) samples purchased | 350(and above) samples purchased | Below 350 samples purchased |
-- |
Examination of the samples purchased from the market.
|
Sample to be analysed within 45 days from the date of receipt/purchased of samples
|
50% |
Sample analysed within 45 days |
Sample analysed within 50 days |
Sample analysed within 55 days |
Sample analysed within 60 days |
Sample analysed beyond 60 days |
||
-- |
||||||||||
-- |
Examination of the complaints or references received from SDCs
|
Complaint to be attended within 45 days from the date of receipt of reference alongwith samples | 20% | Complaint attended within 45 days | Complaint attended within 50 days | Complaint attended within 55 days | Complaint attended within 60 days | Complaint attended beyond 60 days | ||
-- |
To deal with Legal matters arising out of decisions of NPPA | 40 |
Overcharging
Issue of show cause notice to companies in respect of overcharging cases.
|
Show cause notice to be issued within 45 days. |
20% |
Show cause notice issued within 45 days |
Show cause notice issued within 50 days |
Show cause notice issued within 55 days |
Show cause notice issued within 60 days |
Show cause notice issued beyond 60 days |
| Issue of demand notice to companies in respect of overcharging cases. | Issue of demand notice within 60 days depending upon availability of data | 20% | Issue of demand notice within 60 days | Issue of demand notice within 65 days | Issue of demand notice within 70 days | Issue of demand notice within 75 days | Issue of demand notice beyond 75 days | |||
| To make a reference to the District Collector for recovery of the overcharged amount. | Reference to be made to the District Collector within 60 days after issuance of demand notice. | 20% | Reference made to the District Collector within 60 days | Reference made to the District Collector within 65 days | Reference made to the District Collector within 70 days | Reference made to the District Collector within 75 days | Reference made to the District Collector beyond 75 days | |||
-- |
To defend the demand contested by the parties in the court of law. | To file counter affidavit / applications as the case may be in terms of notice / order. | To file counter affidavit / applications as the case may be in terms of notice / order within 120 days. | 40% | To file counter affidavit / applications as the case may be in terms of notice / order within 120 days. | To file counter affidavit / applications as the case may be in terms of notice / order within 150 days. | To file counter affidavit / applications as the case may be in terms of notice / order within 210 days. | To file counter affidavit / applications as the case may be in terms of notice / order within 260 days. | To file counter affidavit / applications as the case may be in terms of notice / order beyond 260 days. | |
-- |
Handling of RTI applications | 5 | Reply to RTI applications to be furnished. | Reply to be furnished within 30 days | 100% | Reply furnished within 30 days | -- |
-- |
-- |
-- |
-- |
-- |
100 | -- |
-- |
-- |
-- |
-- |
-- |
-- |
|
# (a) The fixation/revision of price depends upon the complete data submitted by the manufacturing units and
(b) The number of authority meeting held during the financial year
Section 3
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 values of the success indicators would be determined with reference to the success in terms of completion of activities within the stipulated time framework.
Trend Values Of The Success Indicators
| Objectives | Actions | Success Indicators | Actual value for 2009-10 | Actual value for 2010-11 | Actual value for 2011-12 | Projected value 2012-13 | Projected value 2013-14 |
|---|---|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 |
| To fix / revise the prices of 74 scheduled bulk drugs list in the 1st scheduled of DPCO’95 |
Fixation / Revision of Scheduled Bulk Drugs –
|
# Study to be completed in months 10 from the date ofcomplete data received. | Prices of 28 Scheduled Bulk Drugs and their Derivatives were fixed / revised | Prices of 21 # Scheduled Bulk Drugs and their Derivatives were fixed / revised | Prices of 21 # Scheduled Bulk Drugs and their Derivatives were fixed / revised | Prices of 18#Scheduled Bulk Drugs and their Derivatives would be fixed / revised | Prices of 18#Scheduled Bulk Drugs and their Derivatives would be fixed / revised |
| To fix / revise the prices of 74 scheduled formulations under DPCO’95. |
Fixation / Revision of Formulations based on applications and suomoto
|
Number pf applications disposed off within 60 days from the date of receipt of the application. | Prices of 1824 formulations packs were fixed / revised * | Prices of 713 $ formulation packs fixed / revised | Prices of 607$ formulation Packs fixed / revised | Prices of 900 $ formulations would be fixed / revised | Prices of 950 $ formulations would be fixed / revised |
| Monitoring of the prices of scheduled drugs and formulations/ non-scheduled formulations | Issue of show cause notice to companies where prices of non-scheduled formulations exceed 10% in a year. | Notice to be issued within 30 days from the date of examination of IMS-Health data. | 56000 packs analyzed on a monthly basis. | 61000 packs were analyzed on a monthly basis. | 61000 packs were analyzed on a monthly basis. | 61000 packs to be analyzed on a monthly basis. | 61000 packs to be analyzed on a monthly basis. |
| Issue of show cause notice to companies on the basis of references received from SDCs in case of price violations. | Notice to be issued within 30 days from the date of examination the reference received from SDCs with complete information along with samples | -- |
-- |
||||
|
Enforcement of the provisions of the DPCO, 1995 |
Enforcement
Examination of the samples purchased from the market.
|
Sample to be analysedwithin 45 days from the date of receipt/ purchased of samples | 464 samples were collected | 553 samples were purchased/collected and analyzed. | 558 werepurchased/collected. | 620 Samples would be collected/purchased | 690Samples would be collected and analyzed |
| Examination of the complaints or references received from SDCs. | Complaint to be attended within 45 days | -- |
-- |
||||
| To deal with Legal matters arising out of decisions of NPPA |
Overcharging Issue of show cause notice to companies in respect of overcharging cases. |
Show cause notice to be issued within 45 days. | 89 cases of overcharging were noticed. Rs. 35.41 crorerecovered. | Rs 17.26 Crore were recovered and 42cases of over charging were noticed during the year | Rs 10.69 crore was recovered and 40 cases of overcharging were noticed during the year. | Targets cannot be fixed as it depends on the number of violation cases committed by the companies and noticed by NPPA. | Targets cannot be fixed as it depends on the number of violation cases committed by the companies and noticed by NPPA |
| Issue of demand notice to companies in respect of overcharging cases. | Issue of demand notice within 60 days depending upon availability of data | -- |
|||||
| To make a reference to the District Collector for recovery of the overcharged amount. | Reference to be made to the District Collector within 60 days. | -- |
|||||
| To defend the demand contested by the parties in the court of law depending on the notice | To file counter affidavit / applications as the case may be in terms of notice / order. | To file counter affidavit / applications as the case may be in terms of notice / order within 120 days. | -- |
-- |
-- |
This will be determined by the court cases filed by the affected companies. | |
#(a) The fixation/revision of price depends upon the complete data submitted by the manufacturing units and
(b) The number of authority meeting held during the financial year
Section 4
Description of definition of Success Indicators and proposed measurement methodology
The success indicators have been defined on the basis of appropriate measurable parameters such as for time limit for fixation/ revision of the prices of scheduled bulk drugs/ formulations, examination of samples purchased, issue of show cause notice/ demand notice for violation of the provisions of DPCO, 1995 and recovery notice sent to the District Collectors for recovery of overcharged amount etc.
Section 5
Specific Performance requirements from other Departments
NPPA is an independent office mandated to fix/revise/monitor the prices of scheduled/non scheduled drugs and formulation. The proposal for fixation/revision of prices is approved by the Authority so constituted for this purpose. Accordingly NPPA is fully competent to take appropriate decision in respect of its core functions with the approval of the Authority. The number of cases of prices fixed/revised in case of bulk drugs depends upon the timely submission of required information/documents by the manufactures/industry association and in case of formulations upon the number of price fixation applications filed by the manufacturers. Similarly the number of samples purchased and analyzed by the Monitoring and Enforcement Divisions depends upon the number of complaint cases received and availability of medicines locally. As regards recovery of overcharged amount from the defaulting companies depends upon the response of the companies to the demand notice issued by NPPA and outcome of court judgment in case the demand notice issued by NPPA is contested by the company.
********************************
Section 6: Outcome/Impact of activities of organization ministry.
| Sr. no | Outcome/impact of Organization/RCS | Jointly responsible for influencing the following organizations(s) Departments/Ministries( | Success Indicators | Actual value for 2009-10 | Actual value for 2010-11 | Actual value for 2011-12 | Projected value 2012-13 | Projected value 2013-14 |
| 1 | 2 | 3 | 4 | 5 | 6 | 7 | 9 | 9 |
| 1 | To fix / revise the prices of 74 scheduled bulk drugs list in the 1st scheduled of DPCO’95 | NA | # Study to be completed in months 10 from the date of complete data received. | Prices of 28 Scheduled Bulk Drugs and their Derivatives were fixed / revised | Prices of 21 # Scheduled Bulk Drugs and their Derivatives were fixed / revised | Prices of 21# Scheduled Bulk Drugs and their Derivatives were fixed / revised | Prices of 18#Scheduled Bulk Drugs and their Derivatives would be fixed / revised | Prices of 18#Scheduled Bulk Drugs and their Derivatives would be fixed / revised |
| 2 | To fix / revise the prices of 74 scheduled formulations under DPCO’95. | NA | Number of applications disposed off within 60 days from the date of receipt of the application. | Prices of 1824 formulations packs were fixed / revised * | Prices of 713 $ formulation packs fixed / revised | Prices of 607 $ formulation Packs were fixed / revised | Prices of 900 $ formulations would be fixed / revised | Prices of 950 $ formulations would be fixed / revised |
| 3 | Monitoring of the prices of scheduled drugs and formulations/ non-scheduled formulations | NA | Notice to be issued within 30 days from the date of examination of IMS-Health data. | 56000 packs analyzed on a monthly basis. | 61000 packs were analyzed on a monthly basis. | 61000 packs were analyzed on a monthly basis. | 61000 packs to be analyzed on a monthly basis. | 61000 packs to be analyzed on a monthly basis. |
| 4 | -- |
Notice to be issued within 30 days from the date of examination the reference received from SDCs with complete information along with samples. | -- |
-- |
||||
| 5 | Enforcement of the provisions of the DPCO,1995 | -- |
Sample to be analysedwithin 45 days from the date of receipt/ purchased of samples | 464 samples were collected | 553 samples were purchased/collected and analyzed. | 558 samples were collected/purchased | 620 Samples would be collected/purchased | 690Samples would be collected and analyzed |
-- |
-- |
Complaint to be attended within 45 days | -- |
-- |
||||
| 6 |
Overcharging Issue of show cause notice to companies in respect of overcharging cases. |
-- |
89 cases of overcharging were noticed. Rs. 35.41 crorerecovered. | Rs 17.25Crore were recovered and 46cases of over charging were noticed during the year | Rs.10.69 crore was recovered and 40 cases of over charging were noticed during the year | Targets cannot be fixed as it depends on the number of violation cases committed by the companies and noticed by NPPA. | ||
| Issue of demand notice to companies in respect of overcharging cases. | -- |
-- |
||||||
| To make a reference to the District Collector for recovery of the overcharged amount. | -- |
-- |
||||||
| 7 | To file counter affidavit / applications as the case may be in terms of notice / order. | -- |
-- |
-- |
-- |
This will be determined by the court cases filed by the affected companies. | ||
#(a) The fixation/revision of price depends upon the complete data submitted by the manufacturing units and
(b) The number of authority meeting held during the financial year
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