85% of the World's HIV/AIDS Antiretroviral Drugs Made in India

[syedali73]

Sir,excellent post.
However,I have a question in my mind.What if we prepare vaccines by using viruses which simply alters cell's genetic code in such a way so that it becomes non permissive ie changing up recpetor sites which cannot be recognized by viral protein?

Regards

A very good question. Unfortunately, CD4, CCR5, and CXCR4 receptors (called chemokine receptors) are not only used by HIV but by other cells belonging to immune cascade too. An alteration in these molecules, especially CD4 that is primary receptor, by means of gene therapy have shown severe side effects. Therefore the idea of rendering cells non-receptive to HIV by targeting chemokine receptors has been dropped some years ago.

 

[VCheng]

"This placed communities at the centre of the response through the engagement of non-state actors and centrally managed policy and donor coordination," it said.

HIV treatment coverage for people living with HIV and TB has also increased and in terms of numbers of patients, the largest increases in antiretroviral therapy among people living with both HIV and TB have occurred in India, South Africa, Tanzania and Zambia.

This is the key thing to note: Prevention is better than treatment. Combating HIV not only requires easy access to affordable treatments, it also needs community based programs to reduce infections in the first place.

 

[anant_s]

How medicine attacks a virus? in layman's language...

I will talk how it works against HIV, for this is my area of expertise.

Target 1. In order to infect cells, HIV has to interact with the cells first. Only certain types of cells can be infected by HIV and it is because these cells contain protein molecules on their surface that are recognized by HIV. These molecules are called ‘receptors’. HIV also has certain proteins on its surface that interact with the ‘receptors’ on the cells it is going to infect. If HIV can be stopped from interacting with host cells, infection will not take place. In this particular scenario, we can either mask HIV molecules (gp120 and gp41) or molecules (CD4, CCR5, CXCR4) on the surface of host cells. Drugs called ‘Entry inhibitors’ (or fusion inhibitors) target these steps.

Target 2. Once an HIV manages to interact with the host cell via receptors, it will get itself attached with the host cell and inject a body called ‘capsid’ that contains HIV genome and various helping proteins. Once the ‘capsid’ is inside the cell, it disassembles in a coordinated fashion to release viral genome, which later gets integrated into host cell DNA. If we could stop the ‘capsid’ from disassembling or accelerate its assembly, the viral genome will not be released and not get integrated into the host DNA. Thus drugs can be designed to target these steps. At present no FDA approved drugs available to target capsid.

Target 3. Once the capsid is disassembled in a coordinated fashion, the viral genome that is in the form of a single stranded RNA is released into cytoplasm. This RNA is made into a double stranded DNA by the help of a viral enzyme called reverse transcriptase (RT). This step is crucial because viral genome can only get integrated into host DNA if it is in the form of a double stranded DNA. Thus drugs can be designed to target viral RT so that RNA genome does not get made into DNA. Drugs called ‘reverse transcriptase inhibitors’ target these steps.

Target 4. Once the RNA genome is converted into DNA, it gets inserted into host genome by the help of a viral enzyme called integrase (IN). If we could target this enzyme, we can stop the integration of viral DNA into the host genome and therefore new viruses will not be made. Drugs called ‘Integrase inhibitors’ target these steps.

Target 5. Once the viral DNA gets integrated into host DNA, it starts making viral proteins. These proteins are generally made as poly proteins i.e. a large protein that can be broken down into smaller functional proteins. There are three such poly proteins called Gag, Pol, and Env. In order to break them into smaller functional proteins, a viral enzyme called ‘protease’ is made by viral genome. If HIV protease could be stopped from breaking down poly proteins, the new viral particles will not be assembled. Hence drugs called ‘Protease inhibitors’ are designed to target these steps.

So as you see, HIV can be attacked at several steps of its lifecycle. HART (highly active retroviral therapy) regimen is therefore composed of at-least three drugs targeting different steps of HIV life cycle as described above.

@anant_s @Slav Defence

Thank you sir
one more thing the 5 steps you described, while treating how does a medic know which of the 5 lines of attack is to be followed and at what stage?

This is the key thing to note: Prevention is better than treatment. Combating HIV not only requires easy access to affordable treatments, it also needs community based programs to reduce infections in the first place.

Absolutely.
Infact in developing societies spreading awareness on prevention is the most cost effective method. Even if generic medicines do make way, it still is costly for a lot of patients to afford.
resources therefore will be much better utilised in creating awareness much in same manner as universal immunisation has worked in eradicating diseases such as polio.

 

[VCheng]

Absolutely.
Infact in developing societies spreading awareness on prevention is the most cost effective method. Even if generic medicines do make way, it still is costly for a lot of patients to afford.
resources therefore will be much better utilised in creating awareness much in same manner as universal immunisation has worked in eradicating diseases such as polio.

There are many centers working on a vaccine for HIV. May be their efforts will bear fruit, and then the real impact will be a combination of treating old patients and preventing new infection at the same time.

 

[rockstarIN]

Pharmaceutical can generate 30-40% profit annually for 4-5 years or more. I'm putting most of my funds in Pharma now.

even me too!!!

You invest in Indian share market or somewhere else ?
I've recently made good investments in the Banking sector, both nationalized and private banks.

Only time will tell..lol, which scrips?

 

[SarthakGanguly]

These drugs are only manufactured in India because of cheap labor.

Regardless, we will continue to steal all your drugs and save lives.

 

[anant_s]

There are many centers working on a vaccine for HIV. May be their efforts will bear fruit, and then the real impact will be a combination of treating old patients and preventing new infection at the same time.

Amen to that sir.

 

[nForce]

Only time will tell..lol, which scrips?

Bank of India and Axis Bank

 

[dray]

Instead of stealing other's years of research & development efforts, India (or any country for that matter) should develop her very own medicines and then sell them for reasonable price or for free as she deems fit.

Charity made on stolen money is not charity, it is only charity when made on one's own money. I don't think it should be very difficult to understand by educated people.

The concept of patents, copy right protection, and their renewal is of-course beyond understanding for those who have never got themselves involved into serious R&D rather relying on stealing other's years of hard work and investment.

Again, you want to do charity, do it using your own money and not of others. Ancient texts are claimed to be full of remedies and cures for all worldly and heavenly diseases; dig those out, manufacture elixirs and potions and start distributing for free, not only in India but rest of the world. I believe all of us will be thankful to India for her humanitarian assistance.

But until then, please do not question the authority and right of patent holders on what they should do with their life long effort and hard work.

Ever-greening is not only illegal in Indian law, it is illegal as per international laws also, it's just that the big MNCs with their huge money power and political clout always try to get fresh patent rights by ever-greening, and many a times succeed to get patent perpetually.

Compulsory licensing is within the law, so are generic drugs, and ever-greening practiced by MNC pharma companies is blatantly illegal & unethical.

"Glivec was already on the market, however, so Novartis decided to seek a patent on a slightly altered version, potentially giving it a longer period of market exclusivity. The supreme court has thrown out the application, saying the new drug is not significantly different from the old version, and ordered Novartis to pay costs."

"The case hinged on the interpretation of section 3(d) of the Indian Patents Act, which does not allow patents of new versions of known drug molecules, unless they make the medicine significantly more effective than before.

Novartis argued that better physicochemical qualities, such as shape of the molecule, stability, hygroscopicity and solubility, would satisfy the test of enhanced efficacy.

But the court decided that the changes were simply an attempt at "evergreening" – refreshing the drug so that a new patent would be granted – which is common practice in Europe and North America."

"By refusing patent monopolies on minor changes to known molecules, this judgment will facilitate early entry of generic medicines into the market for other medicines and diseases too. The impact will be felt not only in India, but also across the developing world."

Novartis denied cancer drug patent in landmark Indian case | World news | The Guardian


Section 3(d) of Indian patent law reads: "the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.
Explanation: For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy;"

Essentially, it says that you can't tweak something that already exists and then patent it, if it doesn't enhance the known efficacy of that thing, or result in a new product. Novartis tried to do the same thing with Glivec which is an old drug. In fact, there are rising voices in EU, Australia, Canada, and they may follow India's Patent Law, here are some points:

1. Australian government body, IP Australia, asked for changes in its patent laws relating to drugs suggesting that the indiscriminate grant of patents to incremental innovations should be checked and that an independent review should be set up to examine these proposals, as reported The Times of India.

2. Canadian lawyers and health industry officials are also reportedly discussing tighter standards.
A clause in Indian law introduced in 1995 forces the patent applicant to prove the medical or therapeutic efficacy of any incremental innovation for which it is seeking a patent. The Indian law and the Supreme Court ruling recently denied patent protection to Novartis Glivec.

3. What the Novartis decision does is give other countries an imprimatur from a highly respected court that restricting ever greening is an important public policy, said Brooke Baker, Northeastern School of Law professor, who advised the Uganda government in drafting its patent law.


Chapter II of the The Patents Act, 1970 on 'Inventions not patentable' reads as:

3. What are not inventions. The following are not inventions within the meaning of this Act:

(a) an invention which is frivolous or which claims anything obviously contrary to well established natural laws;

(b) an invention the primary or intended use or commercial exploitation of which could be contrary public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment;

(c)the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non-living substance occurring in nature;

(d) the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.
Explanation. For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy;

(e) a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance;

(f) the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way;

(g) Omitted by the Patents (Amendment) Act, 2002

(h) a method of agriculture or horticulture;

(i) any process for the medicinal, surgical, curative, prophylactic diagnostic, therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products.

 

[Force-India]

Misleading title!

These drugs are only manufactured in India because of cheap labor. All research and development work is done abroad in States and European Universities. Moreover Indian pharmaceutical companies have been involved in patent infringements, literally stealing the years of effort in R&D made by countless scientists working aboard. Interestingly enough, both India government and the judiciary is supporting this theft.

Merck Sues Glenmark Pharmaceuticals Over India Patent Infringement

Merck & Co. are the latest drug company to resort to court action to try and save the intellectual property of two of their patents in India, signalling a tougher stance from an industry under increasing pressure from generic competition.

Coming hot on the heels of a disappointing patent slapdown for Novartis this week, Merck & Co (trading outside the U.S. as Merck Sharp and Dohme), have asked the Delhi High Court to stop Glenmark Pharmaceuticals from marketing generic versions of two of its popular anti-diabetic drugs - Januvia and Janumed. MSD holds patents for both drugs which supposedly last for 20 years. However, under the Drugs and Cosmetics Act of India, companies can apply for approval to market a patented medication just four years after its launch.

An MSD spokesperson confirmed that “we have filed a suit in the hon'ble Delhi High Court against Glenmark for patent violation of our drugs Januvia and Janumet. We are disappointed with Glenmark's decision to introduce products that directly infringe upon our intellectual property.” The spokesperson added that “we believe our patents for Januvia and Janumet are valid and enforceable and will vigorously defend them.”

Glenmark is marketing its generic copies of the drugs as Zita and Zita Met, and the company has said that it will price the drugs at a 20% discount in the hope of capturing some of the 3,000 core Indian anti-diabetic market. Glenmark is the third Indian firm to challenge one of Big Pharma’s patents in this way- Bristol Myers-Squibb successfully warded off a challenge from Natco Pharma over its drug Dasatinib, obtaining an injunction from the Delhi High Court. Bayer was less successful as generics firm Cipla was awarded the right to manufacture its kidney cancer drug Nexavar at a largely reduced price. Merck has also had a run-in with Cipla last year, when Cipla successfully challenged a patent for an asthma drug held by Schering Corp. The company, later bought by Merck, had its patent revoked based on its “lacking an inventive feature.” The same reason was given for the Supreme Court’s decision this week to deny Novartis protection for its cancer med Glivec, although Novartis described the medication as a “life-saving, breakthrough drug.”

Both Novartis and MSD have reacted angrily to what they perceive as laxity on the part of the Indian government over guaranteeing intellectual property rights. After a year of patent revocations and following India’s recent propensity to issue compulsory licenses where it thinks a drug is too expensive, some pharma companies are getting desperate. Pfizer recently petitioned the U.S government to use “all available policy tools” to influence the behaviour of the “protectionist” regime. Novartis’s India chairman Ranjit Shahani declared after the Indian Supreme Court’s decision on Glivec that “we strongly believe that original innovation should be recognised in patents to encourage investment in medical innovation, especially for unmet needs." MSD’s spokesperson backed this up, saying that “strong intellectual property protection is essential for growing India's innovative capacity and economic growth. As an innovative pharmaceutical company, protection of our intellectual property is vital to ensuring that we continue to assume the tremendous monetary risks associated with the discovery of innovative medicines.”

India’s Finance Minister Palaniap pan Chidambaram recently attempted to reassure foreign investors, stating that “we are governed by the rule of law. We are a democracy. We have free press...We have a system of law and courts. Any dispute will be resolved through legal suit...that is what makes India not only an attractive destination but a safe destination.” Nevertheless, Big Pharma companies operating in India will be feeling that their patents are anything but safe after this week’s two new developments.

Merck Sues Glenmark Pharmaceuticals Over India Patent Infringement | Thought leadership and innovation for the Pharmaceutical Industry - EyeforPharma

Reads something about 'made in India'
Searches google for keywords 'India','Patent',Infringement'
Posts anything comes on top in search result, even if not related
Feels pro
Rather looks dumb


Quit hatred towards India. It makes you look silly posting anti India stuff on every other thread. Use this energy to make your country look better rather.

 

[syedali73]

... how does a medic know which of the 5 lines of attack is to be followed and at what stage?

Answer to this question is neither simple nor short. I will try to put it in as layman's a language as possible. There are a number of things that we need to take into account.

First of all we need to know whether the person in question is only HIV positive or an AIDS patient. An HIV positive, as the term implies, is an individual who's blood has been found positive for the presence of anti-HIV antibodies but he/she has not yet progressed to AIDS that is characterized by the low count of specific cell types called CD4+ cells. Only if the number of these cells drop to less than 200 cells per microliter blood, an HIV positive individual is declared as AIDS patient.

Next, we divide HIV positive/AIDS patients into two groups i.e.

a. Treatment naïve.
b. Treatment experienced.

Treatment naïve individuals are those who have never used ARVs (anti retroviral) whereas treatment experienced are those who have previously been exposed to ARV therapy.

The two groups are then further divided into as:

i. paediatric (birth up to 18 years old (21 years in US)).
ii. adult (21 years and above).

We also take into account of whether the patient in question is infected with HIV-1 or HIV-2 and whether we are dealing with HIV/Hepatitis B/C Virus or HIV/TB co-infection.

Lastly we want to see if we are dealing with a patient with other morbidities/diseases such as diabetes, cardiac dieses etc. because in this case we need to see which ARVs to prescribe that are compatible with drugs patient is already using for the treatment of other ailments.

The main objectives of anti-HIV therapy are -

a. suppress viral load.
b. restore CD4+ cells counts.

Guidelines for the Use of Antiretroviral Agents are found here: HIV/AIDS Treatment Guidelines | AIDSinfo

@anant_s

BTW, I did my post-Doc at Emory University's Center for AIDS Research (HIV/AIDS Research at Emory | Woodruff Health Sciences Center | Emory University) and working with world's leading HIV reseachers, I can tell with condifence that we are anything but close to a vaccine. I attended a conference in San Diego in 2008 where Dr. Desrosiers from Harvard University gave a thought provoking speech and literally trashed all those who were involved in AIDS vaccine research (including my boss Dr. James Curran). I consider Dr. Desrosiers's speech as classical and even after 8 years as relevant as it was back in 2008. Those who are genuinely interested to know why not a vaccine for HIV, please listen to the speech.

@Slav Defence @Gufi

 

[VCheng]

2008 was seven years ago:

New AIDS Vaccine Comes in a Capsule - NBC News

"Wanted: Volunteers to test an experimental new AIDS vaccine that is needle-free. The catch? You have to be willing to stay locked up in your room for 12 days.

The new vaccine comes in a capsule and it's made using a common cold virus called an adenovirus, genetically engineered with a tiny piece of the AIDS virus.

It's only a very early stage experiment, meant to show the vaccine is safe. However, if it is, it could be a start not only towards a much-needed vaccine against the AIDS virus, but needle-free vaccines against many different infections.

Researchers at the University of Rochester Medical Center are testing it in their specially designed facility usually used to test live influenza vaccines. The trial, which started Tuesday, is being paid for by the Bill & Melinda Gates Foundation."



A Promising HIV Vaccine in South Africa - The Atlantic

"CAPE TOWN, SOUTH AFRICA—More than 30 years into the HIV/AIDS pandemic that has claimed an estimated 35 million lives, a preventive vaccine has remained elusive. The only HIV-vaccine clinical trial that has shown potential so far is the United States’ and Thai military’s vaccine, RV144, the results of which were announced in 2009. RV144 demonstrated a “modest” 31 percent efficacy at the end of the three-year study. The vaccine apparently peaked early—it was 60 percent effective at the one-year mark, reported the U.S. Military HIV Research Program. But the effect quickly declined.

The first in a series of trials designed to build on the success of RV144 has now passed a key test in South Africa. A safety trial using the same vaccine regimen from RV 144—but with an added booster shot 12 months afterward—has has shown to be safe for South Africans and demonstrated “robust” immune responses. A successful safety trial was necessary to move forward with extensive clinical research. The research was first presented in late October by South African scientists in Cape Town. Clinical trials of a modified vaccine tailored to Southern Africa will begin in early 2015."

 

[syedali73]

Both HIV pathogenesis and human immune system have not changed a bit in seven years. Before posting a googled newsclip at least bother to listen to the speech and then talk about merits and demerits (if any) of it. The person giving the speech is leading HIV researcher (http://micro.med.harvard.edu/faculty/desrosiers.html not) and not some ignorant fool suffering with chronic verbal diarrhea.

 

[VCheng]

Nonetheless, there are several vaccines entering Phase 1 trials in 2015. Let us see how they proceed.

UR Tests HIV Vaccine Pill - Newsroom - University of Rochester Medical Center

 

[Skull and Bones]

Bank of India and Axis Bank

Andhra Bank is retailing for cheap, look into its PE ratio.