Category Archives: Pharma Policy

Draft Pharmaceutical Policy, 2017

The Department of Pharmaceuticals has circulated a Draft Pharmaceutical Policy, 2017 which can be accessed here.

The draft policy identifies the following key objectives:

a. Making essential drugs accessible at affordable prices to the common masses;

b. Providing a longer term stable policy environment for the pharmaceutical sector;

c. Making India sufficiently self-reliant in end to end indigenous drug manufacturing;

d. Ensuring world class quality of drugs for domestic consumption & exports;

e. Creating an environment for R&D to produce innovator drugs

It addresses a range of issues including indigenous production of API, quality control and regulatory approval, manufacturing arrangements, foreign direct investment, innovation and R&D and intellectual property. A major portion of the draft is devoted to pricing and makes various recommendations for the re-structuring of the NPPA and changes to the DPCO. 

A conference on the draft pharmaceutical policy is being organised by the Department of Pharmaceuticals on August 30 where various Ministries are expected to present relevant aspects of the policy to stakeholders for feedback. 

Pharma Price Control Policy: Unrealistic and Unfair

Economic & Political Weekly (EPW) August 23, 2014 Vol XlIX No 34

S Srinivasan, T Srikrishna, Malini Aisola

Despite the government’s and pharmaceutical lobby’s claims and counterclaims, the Drugs (Prices Control) Order, 2013, which covers only 18% of the total domestic market of Rs 71,246 crore, has had very little positive effect as a price control policy. This article points out that the Order leaves out much that should have been included, while including much that should have been left out. Its provisions have made the playing field more uneven, with multiple ceiling prices, which is very unfair to consumers already dealing with an irrationally priced market

LP_Commentary_23August2014.inddLP_Commentary_23August2014.indd  LP_Commentary_23August2014.indd

Why your medical bill is not coming down?

The price caps imposed by the Indian government on 348 drugs in 2013 have created only an illusion of control, keeping many medicines for conditions ranging from asthma to diabetes and heart disease beyond price regulations… reports The Telegraph. Read more

Moneylife reports that while market-based pricing can potentially reduce the price for two-thirds of essential medicines, there are far too many loopholes. Read more

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Infographic Source: The Telegraph

Compulsory Licensing in India: A historic move to make drugs affordable

The government’s decision to grant a compulsory licence for the manufacture of an important anti-cancer drug should be the first step towards making available essential drugs at little or no direct cost.

Read more: The Hindu, March 14, 2012

Global Week of Action: India- EU Free Trade Agreement (FTA)

GLOBAL WEEK OF ACTION: India- EU Free Trade Agreement (FTA)
6-10 February 2012

In 2001, India’s generics brought prices down from $15000 per person per year to $350 for first line AIDS medicines.

80% of people living with HIV in developing countries are on Indian generic ARVs

Over 90% of paediatric AIDS medicines are supplied by Indian generics.

BUT ALL THIS COULD CHANGE IF INDIA DOES NOT SAY NO TO INTELLECTUAL PROPERTY (IP) IN THE INDIA-EU FTA

In January 2012, another round of negotiations on intellectual property was held between Indian and EU negotiators as part of the India-EU Free Trade Agreement (FTA) talks. News reports in India quote the EU Ambassador as stating that discussions on Pharmaceuticals have progressed significantly.

On the 10th of February 2012, at the India-EU Summit to be held in Delhi, the EU & India will agree on and finalize the political framework for the FTA. Groups in India are worried – how have the IP negotiations progressed?

Are the EC and India progressing towards an agreement which includes provisions that will seriously hamper India’s ability to manufacture safe, effective and affordable generic medicines and export these to other developing countries?

WHY THE CALL FOR ACTION? 6th – 10th FEBRUARY 2012!!

Since 2007, people living with HIV in India and across the world have been resisting the pressure of the EC on India to sign an FTA with provisions on intellectual property that will endanger access to generic medicines from India. We must once more show the EC and the Indian government that our lives cannot be traded away!

This is a Call for a week of Action across the globe from 6th – 10th February 2012 on the EU-INDIA FTA.

The week of action is a run up to the EU-India Summit that will be held in Delhi on 10th February 2012.

OUR DEMANDS

REMOVE:

§  Investment Rules, as they enable foreign companies to take the Indian government to private courts over domestic health policies like measures to reduce prices of medicines.

§  Border Measures, as they will deny medicines to patients in other developing countries with custom officials seizing generic medicines in transit.

§  Injunctions, as they undermine the independence of the Indian judiciary to protect right to health of patients over the profits of drug companies.

§  Other Intellectual Property Enforcement Measures, as they put third parties like treatment providers at risk of police actions and court cases.

DON’T BRING BACK:

§  Data Exclusivity, as it delays the registration of generic medicines and will not permit the placing of affordable versions of pediatric doses and combinations of “off-patent” medicines on the market. IT’S NOT REQUIRED UNDER THE TRIPS AGREEMENT!

§  Patent Term Extension, as it will extend patent life beyond 20 years.

The EC states that these two provisions are off the table. It must keep its word!

PLEASE JOIN US -YOUR FRIENDS- IN INDIA!

In the coming days, groups from around the world and in India will demonstrate against the EU-India FTA. We ask you to join us in sending a clear message to the European Commission: our lives cannot be traded away.

1.   Organise your own rally: You can organize rallies or demonstrations in front of European Commission offices in your countries to voice your opposition to their aggressive negotiations on intellectual property in FTAs. Don’t forget that the EU is also negotiating FTAs with many other developing countries and making the same demands.

2.    Raise awareness/media action: Even though you might not be able to support our rally financially or physically you can help us by spreading the word about our concerns. Write an editorial in your local paper. Hold a press conference. Issue a press release or press statement.

3.    Write to the Indian Government: You can also write to the Indian Government asking it to stay strong and not give in to the demands of the European Commission. India, as the pharmacy of the developing world, has an obligation to its citizens as well as patients across the world. Please try and meet the Indian ambassadors in your countries and convey to them how important it is that India reject ALL the demands of the EU. Millions of lives depend on this.

4.    Write to your own government: Public health programmes around the world depend on generic medicines from India. Ask your government to tell the EU and the Indian government to keep IP out of the FTA negotiations.

5.    Share your actions: PLEASE send us photos, articles, videos of all your actions immediately and FOLLOW the actions of other groups on Facebook or at Don’t Trade Away our Lives

6.    Donate: In order to organize these protests, we rely on funding. Any financial support is welcome. No amount is too small – or too big! If you know organizations, which are interested in funding, if you want donate to our protest, please contact us.

We plan to meet the aggressiveness of the European Commission with our peaceful protests. There is too much at stake. Join us NOW!

In Solidarity

Delhi Network of Positive People & Lawyers Collective HIV/AIDS Unit

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For information on the India-EU FTA see:

Medicine prices shouldn’t rise: Supreme Court on Medicine Prices – AIDAN PIL, Nov 17, 2011

To read/ download detailed media coverage on the Supreme Court’s hearing of the prices of medicines Public Interest Litigation case filed by AIDAN, Locost, JSS and others… Click here

EXCERPTS

1) IBNLIVE.com
Medicine prices shouldn’t rise: Supreme Court
New Delhi: The Supreme Court on Thursday told the central government that the prices of medicines should not rise further. “Bring it down, don’t escalate it in the name of policy,” the court said……………. The observation during the hearing on a public interest litigation (PIL) by the All India Drug Action Network (AIDAN), supported by NGOs, which had moved the court in 2003 seeking intervention to ensure that the prices of essential drugs remained within the reach of common man……………… Read full report here

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2) The Pioneer
Keep prices of medicines under check: Centre told
The Supreme Court on Thursday lent voice to the common man’s refrain against rising cost of medical treatment. ….. Wondering how the cost of medicines and treatment had escalated over the years, the bench of Justices GS Singhvi and SJ Mukhopadhyay remarked, “If hospitals like Ram Manohar Lohia, Safdarjung and AIIMS were not there, 10 per cent patients would have finished.” The court made the comment on a PIL filed by the All India Drug Action Network that has demanded essential drugs to be accessible to common man at low prices……………… Read full report here

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3) The Economic Times
Medicine prices should’nt rise: Supreme Court
NEW DELHI: The Supreme Court on Thursday told the central government that the prices of medicines should not rise further. “It should go down, not go up,” said an apex court bench of Justice G S Singhvi and Justice S J Mukhopadhaya. The observation came while hearing a public suit by the All India Drug Action Network of several NGOs which challenged the government’s proposed policy on drug pricing. ……………… Read full report here

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4)  The Economic Times
Medicines’ prices should not escalate, Supreme Court tells Centre
NEW DELHI: Amid fears that drug prices may shoot owing to the proposed drug pricing policy, the Supreme Court today asked the Union government to ensure that rates do not “escalate” causing a burden on the common man………………………… The matter came up for hearing during a PIL filed in 2003 by the All India Drugs Action Network and others which had complained that currently only around 78 drugs are placed under the Drugs (Prices Control) Order, 1995 (DPCO) making rest of the medicines beyond the reach of the common man. ……………… Read full report here

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5) BioScholar news: the latest research news
Medicine prices shouldn’t rise: Supreme Court
The Supreme Court Thursday told the central government that the prices of medicines should not rise further. “It should go down, not go up,” said an apex court bench of Justice G.S. Singhvi and Justice S.J. Mukhopadhaya…………….. The observation came while hearing a public suit by the All India Drug Action Network of several NGOs which challenged the government’s proposed policy on drug pricing.……………… Read full report here

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6) Hindustan Times
‘Drug policy should aim at lowering medicine cost’
The Supreme Court on Thursday told the Centre that its policy on controlling prices of essential drugs should be aimed at lowering the cost of medicines and not raising it…….. The court expressed its concern after the petitioner, All India Drug Action Network (AIDAN), pointed to several loopholes in the government’s fresh policy. The Ministry of Chemicals and Fertilisers has posted its new policy on its website and invited comments on it. The last date for submitting its comments is November 30. AIDAN has criticised the decision to delink the ceiling prices of formulations from the price of bulk drugs. According to the petitioner, if formulation ceiling price are not based on the bulk drug prices, the government would end up legitimising overpricing. ……………… Read full report here

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7) The Telegraph, Calcutta, India
Rein in drug prices, SC tells govt
New Delhi, Nov. 17: The Supreme Court today asked the Centre to ensure that drug prices go down, not up, if and when a new price control policy comes into force. “Prices may go down but should not go up because of policy,” Justice S.J. Mukhopadhyay, sitting alongside senior judge G.S. Singhvi, said. “Bring it down, don’t escalate it in the name of policy,” the bench told additional solicitor-general Parag Tripathi, who was speaking for the government. The bench was hearing a PIL, filed in 2003 by the All India Drug Action Network, seeking court intervention to ensure that essential medicines are made accessible to all. The NGO has since drawn the court’s attention to the government’s draft national pharmaceutical pricing policy, 2011, which it claims will see a further escalation in essential drug prices. ……………… Read full report here

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8 ) Deccan Herald
Ensure drug prices do not rise, SC tells Centre
The Supreme Court on Thursday asked the Central government to ensure that its new pharma policy would not lead to rise in prices of medicines. …………… The court was hearing a public interest litigation filed by All India Drug Action Network of NGOs challenging the government’s proposed policy on drug pricing. The court asked the government to file an affidavit on the new policy and posted the matter for further hearing on January 17. ……………… Read full report here

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9) The Times of India
Prices of 348 essential drugs to be controlled
NEW DELHI: The Centre on Thursday responded to the Supreme Court’s concern over spiralling prices of essential medicines and promised to make all-out efforts to put under strict price control regime all the 348 drugs included in the National List of Essential Medicines (NLEM), 2011……. The bench agreed to give three months time to the government to fulfill its promise and posted the PIL filed by All India Drug Action Network for further hearing in January. ……………… Read full report here

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10) Coverage in Hindi media (Excerpts)

नहींबढ़नीचाहिएदवाकीकीमतें: सुप्रीमकोर्ट

याहू! जागरण

नई दिल्ली। प्रस्तावित औषधि नीति के चलते दवा की कीमतें कहीं आसमान न छूने लगें, इसके मद्देनजर सुप्रीम कोर्ट ने सरकार से सतर्क रहने को कहा है। शीर्ष न्यायालय ने गुरुवार को सरकार से यह सुनिश्चित करने को कहा कि दवा की कीमतें नहीं बढ़नी चाहिए, क्योंकि इससे आम आदमी को परेशानी का सामना करना पड़ सकता है। न्यायमूर्ति जीएस सिंघवी और न्यायमूर्ति एसडी मुखोपाध्याय की पीठ ने कहा, ‘कीमतें नहीं बढ़नी चाहिए। यह आशंका जताई जा रही है कि दवा

http://in.jagran.yahoo.com/news/national/general/medicine-price-shoould-not-hike_5_1_8505848.html

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दवाइयोंकीकीमतेंबढ़नीनहींचाहिए: सुप्रीमकोर्ट

star.newsbullet

नई दिल्ली: सुप्रीम कोर्ट ने गुरुवार को केंद्र सरकार से कहा कि नई दवा नीति तैयार करते समय इस बात का पूरा ख्याल रखें कि दवाइयों की कीमतें नहीं बढ़े. अदालत ने सरकार को नई दवा नीति में जनता के हितों का ध्यान रखने की नसीहत दी. सुप्रीम कोर्ट ने सरकार को चेताया है कि नई दवा नीति के बाद ‘स्वास्थ्य सेवाएं और दवाइयां सस्ती होनी चाहिए, न की ये और बढ़ जाएं.’ सुप्रीम कोर्ट ने लगातार महंगे होते जा रहे इलाज पर गहरी चिंता जताई.

http://star.newsbullet.in/india/34-more/18835-2011-11-17-10-42-54

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नहींबढ़नेचाहिएदवाओंकेदाम : सुप्रीमकोर्ट

अमर उजाला

सुप्रीम कोर्ट ने गुरुवार को केंद्र सरकार से कहा कि दवाओं के दाम और नहीं बढ़ने चाहिए। न्यायमूर्ति जी.एस. सिंघवी और न्यायमूर्ति एस.जे. मुखोपाध्याय की पीठ ने कहा, ‘कीमत कम होनी चाहिए, बढ़नी नहीं चाहिए। पीठ ने कहा कि दवाओं की कीमत और साधारण लैब टेस्ट की कीमत पहले ही काफी अधिक है। पीठ ने सरकार से यह सुनिश्चित करने के लिए कहा कि ये दाम और न बढ़ें। पीठ ने यह बात एक याचिका की सुनवाई करते हुए कही। याचिका विभिन्न गैर सरकारी संगठनों के

http://www.amarujala.com/National/Medicine-prices-shouldnt-rise-Supreme-Court-18726.html

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‘दवा कीमतें अब नहीं बढ़े’

प्रातःकाल

नई दिल्ली। उच्चतम न्यायालय ने देश में दवाओं की आसमान छूती कीमतों को ध्यान में रखते हुए केंद्र सरकार को इनकी कीमतों में और अधिक वृद्धि नहीं करने की आज सलाह दी। न्यायमूॢत जी एस ङ्क्षसघवी और न्यायमूॢत एस जे मुखोपाध्याय की खंडपीठ ने सरकार की प्रस्तावित औषधि मूल्यनिर्धारण नीति को चुनौती देने वाली याचिका की सुनवाई के दौरान यह सलाह दी। खंडपीठ ने कहा कि दवाओं के मूल्य और सामान्य स्वास्थ्य जांच की दरें पहले से ही बहुत अधिक है ।

http://pratahkal.com/hindi-news/national/8336-2011-11-18-02-09-46.html

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कीमतें कम होनी चाहिए, नहीं चाहिए बढ़नी

Pressnote.in

सुप्रीमकोर्ट ने प्रस्तावित औषधि नीति पर अमल से दवा कीमतों में भारी वृद्धि की आशंका के मद्देनजर केंद्र से कहा है कि नई नीति से कीमतें कम होनी चाहिए, बढ़नी नहीं चाहिए। अदालत ने कहा है कि ऐसा नहीं हुआ तो आम आदमी को परेशानी का सामना करना पड़ सकता है। न्यायमूर्ति जीएस सिंघवी और एसडी मुखोपाध्याय ने एक याचिका पर सुनवाई के दौरान कहा, यह आशंका जताई जा रही है कि नई औषधि नीति अपनाने के बाद दवा की कीमतें बढ़ जाएंगी।

http://www.pressnote.in/National-News_145122.html

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नहींबढ़ना चाहिए दवाओं के दाम

देशबन्धु

नई दिल्ली ! दवाओं की लगातार बढ़ रही कीमतों को लेकर सर्वोच्च न्यायालय ने सरकार को सलाह दी है, कि कीमतों में और वृध्दि नहींहोना चाहिए। अदालत में केन्द्र सरकार एक बार फिर से स्वास्थ्य नीति पेश नहीं कर सकी और उसने तीन माह का समय मांग लिया। उल्लेखनीय है, कि पहले दवाओं का नियंत्रण रसायन मंत्रालय करता था, पर बाद में सरकार ने इसके लिए दवा मंत्रालय बना दिया है। विभाग ने कुछ समय पहले औषधि मूल्य निर्धारण नीति जारी की है।

http://www.deshbandhu.co.in/newsdetail/137945/1/20

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दवाओं के दाम नहीं बढ़ने चाहिएं : न्यायालय

देशबन्धु

नई दिल्ली | सर्वोच्च न्यायालय ने गुरुवार को केंद्र सरकार से कहा कि दवाओं के दाम और नहीं बढ़ने चाहिएं। न्यायमूर्ति जी.एस. सिंघवी और न्यायमूर्ति एस.जे. मुखोपाध्याय की पीठ ने कहा, “कीमत कम होनी चाहिए, बढ़नी नहीं चाहिए।” पीठ ने कहा कि दवाओं की कीमत और साधारण लैब टेस्ट की कीमत पहले ही काफी अधिक है। पीठ ने सरकार से यह सुनिश्चित करने के लिए कहा कि ये दाम और न बढ़ें। पीठ ने यह बात एक याचिका की सुनवाई करते हुए कही। याचिका विभिन्न गैर

http://www.deshbandhu.co.in/newsdetail/137893/1/21

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दवाओं की कीमतें नहीं बढ़नी चाहिए: सुप्रीम कोर्ट

SamayLive

सुप्रीम कोर्ट ने कहा कि दवाओं की कीमतें नहीं बढ़नी चाहिए क्योंकि इससे आम आदमी को परेशानी का सामना करना पड़ सकता है. उच्चतम न्यायालय ने प्रस्तावित औषधि नीति को अपनाने से दवाओं की कीमतों में भारी बढ़ोत्तरी होने की आशंका के मद्देनजर गुरुवार को केंद्र सरकार से यह सुनिश्चित करने को कहा कि दवाओं की कीमतें नहीं बढ़नी चाहिए. अदालत ने कहा, ”कीमतें नहीं बढ़नी चाहिए. यह आशंका जताई जा रही है कि कीमतें बढ़ जाएंगी. नयी नीति के नाम पर

http://www.samaylive.com/nation-news-in-hindi/133851/supreme-court-medicines-rate-justice-gs-singhvi-justice-sd-mukho.html

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Supreme Court Order in the AIDAN Drug Pricing PIL – Oct 11, 2011

1
ITEM NO.101 COURT NO.7 SECTION PIL
S U P R E M E C O U R T O F I N D I A
RECORD OF PROCEEDINGS
WRIT PETITION (CIVIL) NO(s). 423 OF 2003
ALL INDIA DRUG ACTION NETWORK AND ORS. Petitioner(s)
VERSUS
UNION OF INDIA AND ORS. Respondent(s)

(With appln(s) for permission to submit additional
document(s),PERMISSION TO FILE ADDITIONAL AFFIDAVIT)
Date: 11/10/2011 This Petition was called on for hearing today.
CORAM :
HON’BLE MR. JUSTICE G.S. SINGHVI
HON’BLE MR. JUSTICE SUDHANSU JYOTI MUKHOPADHAYA
For Petitioner(s) Mr. Colin Gonsalves, Sr. Adv.
Mr. Anuj Castleino, Adv.
Ms.Jyoti Mendiratta,Adv.(Not present)
For Respondent(s) Mr. T.S.Doabia, Sr. Adv.
Mr. Ashok Bhan, Sr. Adv.
Ms. Rekha Pandey, Adv.
Ms. Sadhana Sandhu, Adv.
Mr. R.K.Rathore, Adv.
Ms. Asha G. Nair, Adv.
Mr. Shalinder Saini, Adv.
Mr. P. Parmeswaran ,Adv(Not present)
Mr. D.S. Mahra ,Adv(Not present)
UPON hearing counsel the Court made the following O R D E R

At the commencement of hearing Shri Colin Gonsalves,
learned senior counsel appearing for the petitioners read
out portions of 45th Report of the Parliamentary Standing
Committee on Health and Family Welfare and 7th Report of the
2
Standing Committee on Chemicals and Fertilizers.
Thereafter, Shri Doabia, learned senior counsel appearing
for the Union of India placed before the Court a photostat copy of the Office Memorandum dated 20.06.2011 sent by the
Ministry of Health & Family Welfare to the Secretary,
Department of Pharmaceuticals on the issue of revision of
National List of Essential Medicines. Paragraph 2 of that
memorandum reads thus:
“2. In the above connection, it may be
stated that the National List of Essential
List (NLEM), 2003 has been revised. The
revised list, the NLEM, 2011 contains 348
drugs. While approving the list, the
Minister of Health & Family Welfare has also
approved that if affordable healthcare has
to become a reality, all the medicines
included in the NLEM, 2011 should be brought
within the ambit of price control under the
DPCO, considering the fact that the cost of
medicines in the overall cost of healthcare
constitutes more than 60% and a large
percentage of our people do not have access
to affordable healthcare. If, at all, such
medicines cannot be included under DPCO with
the same trade margins, there could be
graded system of trade/profit margins for
different categories and 348 medicines in
NLEM, 2011 could be so categorized. This
will ensure that reasonable margins and
growth of Pharma industry also do not get
adversely affected. The Minister has,
therefore, approved taking up the matter
with the Department of Pharmaceuticals for
further appropriate action.”
Shri Ashok Bhan, learned senior counsel appearing
for the Department of Chemicals and Fertilizers also placed
before the Court a xerox copy of Office Memorandum dated
04/05.10.2011. In para 6 thereof, it is mentioned that the
3
Department of Pharmaceuticals is examining all the
possibilities of control and monitoring of prices of
medicines including those covered under the NLEM, 2011.
Having perused the two Office Memorandums placed by
the learned senior counsel for Union of India and Department
of Chemicals and Fertilizers, we deem it proper to direct
the Secretaries of two Ministries to file their affidavits within four weeks indicating therein as to within what time
the revised list of National List of Essential Medicines
(NLEM) will be added in Schedule-I of the Drugs (Price
Control) order, 1995.
A comprehensive revised list of National List of
Essential Medicines (NLEM) be also produced along with
affidavit to be filed on behalf of the Ministry of Family &
Welfare.
List the case on 17.11.2011 for further hearing.
(Parveen Kr. Chawla) (Phoolan Wati Arora)
Court Master                Court Master