Here's a summary of the provided policy text, following your specified structure:
**Executive Summary:**
This Public Notice announces the constitution of a group to review and suggest improvements to the Drug Price Control Order (DPCO) 2013, based on implementation experience. The group will focus on making the pricing policy more favorable to the poor, strengthening regulatory provisions, enhancing data collection, and improving NPPA processes. Stakeholders are requested to send comments/suggestions urgently, and no later than May 1, 2017.
**Key Points / Main Content:**
* **Group Constitution & Membership:**
* A group is formed to review and recommend improvements to the DPCO, 2013.
* The group consists of Joint Secretaries from various departments (Pharmaceuticals, NIPER PSU, Ministry of Health), a representative from NPPA, the Executive Director of the National Institute of Health and Family Welfare (NIHFW), a representative from the National Health System Resource Centre (NHSRC) and the Director (Policy) DoP who will be the convener of the group.
* **Terms of Reference:**
* **Pricing Policy:** To suggest measures to make pricing policy more favorable to the poor.
* **DPCO Review:** Review the DPCO 2013 and suggest ways to strengthen its regulatory provisions.
* **Data Management:** Suggest ways to make the existing mechanism robust for data collection and strengthen the pharmaceutical database management system.
* **NPPA Improvements:** Recommend procedural improvements and process reengineering in NPPA for better implementation, transparency, and reduced litigations.
* **Standard Operating Procedures:** Draft detailed Standard Operating Protocols for regulatory functions like pricing and enforcement.
* **Comprehensive DPCO:** Suggest ways to make DPCO more comprehensive based on past experience.
* **Consultation:**
* The Group may consult with other government agencies, officials, industry representatives, or civil society for an effective DPCO.
* **Timeline:**
* First meeting was held on April 6, 2017.
* Stakeholders are requested to send comments/suggestions by May 1, 2017.
**Impact Analysis:**
* **Pharmaceutical Companies:**
* *Impact:* May need to adapt to changes in pricing regulations and SOPs, potentially affecting profitability and compliance procedures.
* *Action Required:* Provide input/suggestions to the committee by the specified deadline and prepare for possible adjustments to pricing strategies and compliance protocols.
* **National Pharmaceutical Pricing Authority (NPPA):**
* *Impact:* Procedures and processes may be reengineered to improve efficiency, transparency, and reduce litigation.
* *Action Required:* Prepare to implement recommended changes in procedures and SOPs.
* **Government (Ministry of Chemicals and Fertilizers, Department of Pharmaceuticals):**
* *Impact:* Will receive recommendations for improving the DPCO and its implementation, potentially leading to better healthcare affordability and regulation.
* *Action Required:* Review and implement recommendations from the committee.
* **Citizens/Patients (especially the poor):**
* *Impact:* Could benefit from a more favorable pricing policy for essential medicines, leading to better access and affordability.
* *Action Required:* No direct action required but will benefit from the overall outcome of the recommendations.
* **Civil Societies/NGO's**
* *Impact:* To send suggestions/ comments for improvements to the Drug Price Control Order (DPCO) 2013, based on implementation experience.
* *Action Required:* Provide input/suggestions to the committee by the specified deadline of May 1, 2017.
Key Entities Referenced
Ministry of Chemicals Fertilizers: A ministry of the Government of India.
Department of Pharmaceuticals: A department under the Ministry of Chemicals and Fertilizers, Government of India, responsible for policy related to pharmaceuticals.
New Delhi: Capital of India, location of Shastri Bhawan where the Department of Pharmaceuticals is located.
Drug Price Control Order, 2013 (DPCO 2013): A Government order relating to drug price control. Referred to in the document as a basis for experience gained during its implementation and for proposed improvements.
NIPER PSU: National Institute of Pharmaceutical Education and Research Public Sector Undertaking. Mentioned in the context of Joint Secretary NIPER PSU in Do Pharmaceuticals.
Pharmaceutical Pricing Authority (NPPA): National Pharmaceutical Pricing Authority. Mentioned as an entity for procedural improvements and process reengineering.
National Health System Resource Centre (NHSRC): Mentioned in the context of Director General of NHSRC.
Standard Operating Protocol (SOPs): Mentioned in the context of drafting SOPs for identified regulatory functions.
No. 31011/ 3 /2017-Policy
Government of India
Ministry of Chemicals & Fertilizers
Department of Pharmaceuticals
(Policy Section)
dok RAK
Shastri Bhawan, New Delhi,
Dated, the 6" April, 2017
PUBLIC NOTICE
p p Ea r st i si c ee e nn s tt i. o a M f lTe d mh Cei e odc mii G c mn o i oe v n ds ee isrc t.o n i n m Ss eet i si n n t ct Au e ct h te 1a , a 9 s 7 m 10s 9a i 5j on 5o c n .r e w ap T1o r h9r d et 6 s i 2 o l t an hh s e tao svf e De t r oh ui re gs d h s sei u r eg s (dh Ph ro o a iu r cvt d ee e s o r bf s Ce op ef no no tc r rk i oe sc lt so ) une etx Odrp r o ue dl nn l edis rn ee -g r 2 o 0t tf 1h ha 3e e
was notified by the Government on 15" May, 2013.
x f Ar
s
so om
c
it ahT te ih N oe a
n
t siD o ae n np a da l r
o
t P tm hhe ea rn r t m sa tch aea kus et hir oce lac dle
e
i rPv sre id sc ui gv n ga g er A si u to t iu hs
n
o gr r iie mtq pu ye
r
(s ot N vs P e/ P mr Ae ep ) nr , te ss t e h in e nt a tPt hhi eao prn rs m o a vi in I sc n il d ou u nd s si t n r og y f
DPCO-2013 based on the experience gained during its implementation.
3 a i: f n f o tr hd ea b DI i en l i pt t ah y re t al mni edg nh t ta c o c of e fs t sh Pie b hs i ae l r i mr t ae y cp eor ue f ts d ie r cn aut la g st si , o fn o Ms r i na t ihn sed t d rt yoo m f oeu fsr tt Cih hce er p mi a itm cip aer n lo t ssv ,e & tt hh Fee e rGa tov ia v li iel zra eb n ri sml i e ht n ay t, s
decided to constitute a group consisting of the following members:-
(i) Joint Secretary (Policy). D/o Pharmaceuticals
Gi) Joint Secretary (NIPER & PSU). D/o Pharmaceuticals
( (i ii vi )) J Jo oi in nt t Se Sc er ce rt ea tr ay r, y Mi &n is Mt ery m bof e rHe a Sl et ch r e& ta rF ya ,m i Nl ay t iW oe nl af la re Pharmaceutical
Pricing Authority(NPPA)
( (y vi) ) _ D Exr eu cg us t iCo vn et ro Dl irl ee cr t G oe r,n er Na al t io of n aI lnd i Ha e( aD lC thG I) System Resource Centre
(NHSRC)
to recommend to the Government further steps in this regard.
’ Director (Policy), D/o Pharmaceuticals shall be the Convener of the group. The
Terms of Reference of the Committee is as under:-
i. Measures to be taken for making pricing policy more in favour of poor
si. p Ra et vie in et w's t a hf ef so crd oa pb el e o fM te hd ei c Da rr ue g sa (n Pd r iH ce ea l Cot nh t S re oc lu )r i Ot ry d; er, 2013 (DPCO, 2013).
and to suggest ways for strengthening the regulatory provisions of the
iii. oS mru adg reg kre e:s tt - baw sa ey ds daf to ar om na k pi rin cg e s t ohe f me ex di is cti in ng e sm me oc rh ean i ros bm us s t f aor n d co sl tl re ec at mi -o ln i neo df
and for strengthening the existing pharmaceutical database management
system.a
Procedural improvements and process re-engineering in NPPA to ensure
iv. better and quicker implementation of Government Policy (Drug Price
Control Order) and bring greater transparency so as to reduce litigations
and review petitions. Draft detailed Standard Operating Protocol (SOPs)
may be recommended for identified regulatory functions such as pricing of
medicines, monitoring and enforcement activities, action against
p Sh ua gr gm ea sc te u wt ai yc sa l t oc o mm ap ka eni e Ds P Cin O o ,v e 2r 0p 1r 3ic i mn og r c ea s ce os m pet rc e.; hensive in light of past
experience of implementing DPCO.
The Group may also consult other Government agencies, officials or
vi. representatives of industry or civil society in the interest of a more
effective DPCO.
fl decidedI n t ot he i nF vi ir ts et M ce oe mt mei nn tg s o /f s ut gh ge e C so tm iom ni st te fe ro h me l ad l lo n s t6 a" k eA hp or li dl e, r 2 0 i1 n7 c, l ui dt ih na gs Cb ie ve in l
Societies/NGOs etc.
You are requested to send your comments/suggestions urgently and latest
ba y 01/05/2017 (chaudhary.ak@nic.in)
eR aR OR OE