Category Archives: Pharma Industry

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

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Generic Dava – Isse Behtar Kuchch Nahi…

DainikBhaskar

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

Open letter to DG, WHO – Pentavalent vaccine related deaths in India

To

Dr. Margaret Chan The Director General, World Health Organisation, Geneva

Dear Dr Margaret Chan,

All India Drug Action Network (AIDAN) is a network of not-for-profit civil society organisations that has been campaigning and working for rational use of medicines, largely in the Indian context. We have written to you in the past. We would like to bring your attention to the deaths Pentavalent (DPT + Hib + Hepatitis B) vaccine related deaths in India.

According to the Brighton classification of ‘adverse events following immunization’ (AEFI), re-challenge and recurrence of symptoms in the individual is needed for classification of AEFI as ‘certainly related to vaccine’. Such re-challenge is impossible if in the first instance, AEFI results in death. In the absence of proof from a re-challenge experiment, deaths caused by vaccines can only be classified as ‘probably related to vaccine or possibly related’ to the immunization.

As you would know, there have been several Pentavalent vaccine related deaths in Sri Lanka, Bhutan and Pakistan. Using the WHO approved classification of AEFI many of these deaths are ‘probably related to the immunization’ because no alternate cause for the adverse events has been found. However an expert panel looking at the deaths in Sri Lanka deleted ‘probably related’ and ‘possibly related’ from the classification of Brighton for purposes of their evaluation report, and then certified that the vaccines were ‘unlikely to be due to the vaccines’. This report (Expert Panel Report 23 December 2008 Sri Lanka) is available on the World Wide Web.

One by one the WHO has delisted a number of brands of prequalified Pentavalent vaccine, but the problem has refused to go away. Pentavalent vaccine was introduced in two states in India on 14th December and 17th December 2011, to evaluate the safety of the vaccine in India. According to an affidavit filed in the Kerala High Court by the Government of Kerala India, there have been four deaths in less than two months since it was introduced in the public health system. For your information the full text of the submission by Kerala government can be accessed here.

The reactions in India suggest that the cause of the problem is unrelated to the brand or manufacturer or lot of the vaccine. It appears to be a form of ‘hypersensitivity reaction’ as described in the post mortem report on one of the children in Kerala. The vaccine can be administered to many patients without problems and there is no available method at present to predict which infant will react adversely. The US FDA has pointed out that vaccines are aimed mostly at healthy individuals for prevention of diseases to which an individual may never be exposed. Unlike conventional drug treatments meant for the management of existing disease, in prophylaxis with vaccines, safety is of paramount importance. Vaccines that frequently and unpredictably cause death of healthy children cannot be recommended.

Pentavalent vaccine is at present recommended by WHO and its introduction is supported by GAVI funds. Given these circumstances the WHO needs to re-evaluate the recommendations. We propose to copy this letter to countries supporting the GAVI initiative so that they may be able to initiate action in a responsible manner.

Looking forward to your early action in the regard.

1. Dr Jacob Puliyel, Drug Action Forum – Karnataka (DAF-K), New Delhi

2. Dr Mira Shiva, Medico Friend Circle, New Delhi

3. Dr Gopal Dabade, DAF-K, Dharwad

4. Mr Srinivasan. S, LOCOST, Vadodara

5. Mr Naveen Thomas, Headstreams, Bangalore

6. Mr Prasanna Saligram, AID India, Bangalore

7. Dr Anurag Bhargava, JSS, Chattisagarh

ALSO READ: Vaccine woes continue, Down To Earth, March 12, 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:

A victory for Novartis could spell death for millions

A reminder that Novartis is still challenging Section 3(d) in the Indian Supreme Court against the sane advice of people from all walks of life from across the world…

Many of you will remember that in 2005, the Indian parliament had to change India’s patent law to comply with the international trade rules. The Indian Parliament knew that AIDS treatment costs dropped from $10,000 to $60 thanks to generic competition from India.

So they inserted Section 3(d) a health safeguard in the Indian patent law that does not let companies get patents on new forms of old medicines or what is know as evergreening.

Evergreening is the practice of pharma companies to extend their patent protection (i.e. a monopoly of 20 years) on old or existing medicines by making minor changes in them.

Since 2005, people living with HIV have been in the patent office using Section 3(d) and other provisions to make sure key HIV medicines are not patented in India. As a direct result of these efforts, generic production of lamivudine/zidovudine, tenofovir, neverapine hemihydrate and other HIV medicines has continued.

Today over 80% of people living with HIV in the developing world are alive thanks to Indian generic ARVs.All this is at risk now with Swiss MNC Novartis challenging Section 3(d) in the Supreme Court – Novartis has sued the Government of India, cancer patients and several generic companies. The case hearing is TOMORROW. Although the case is about a cancer medicine, Novartis wants the Supreme Court to weaken Section 3(d) and its application – something that will have an impact on all medicines including HIV medicines. While health groups like the Cancer Patients Aid Association represented by the Lawyers Collective are part of this case, there is no indication that the government has appointed its top lawyer in this crucial case.The Supreme Court hearings start tomorrow and it is VITAL that the government immediately appoint the Attorney General in this matter of life and death. Unfortunately the current Solicitor General of India has actually appeared for Novartis in this case and so cannot be appointed in this matter.

It would also interest you to know that the current lawyer arguing for Novartis in the Supreme Court is Mr. Gopal Subramanium who till just a few months ago was the Solicitor General of India.

Millions of lives not only in India but across the developing world depend on the whether the government of India puts up a strong defence for this case.The government of India has to fulfill its responsibility of ensuring generic production not just for the people of India but for the people of all developing countries. As a first step, they should appoint the Attorney General on an urgent basis for this case.

You can read news article related to the case like this one:

http://www.thehindu.com/news/national/article2427529.ece

Since 2007 various groups have been asking Novartis to drop its various cases against India’s patent law. You can read more about this at these various sites:

Lawyers Collective: http://www.lawyerscollective.org/news/126-novartis-case-background-and-update-supreme-court-of-india-to-recommence-hearing.html

Cancer Patients Aid Association: http://www.cpaaindia.org/aboutus/theglivecstory.htm

Berne Declaration: http://www.evb.ch/en/p19070.html

Novartis Boycott: http://novartisboycott.org/
For any queries or information, write to: k0b0@yahoo.com