Drugs, pharmaceuticals, medical devices made by Indians

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“The devices will all be made in India, given that there are hardly any imported components. And our American partner will take the device to the US. Cytotron is already an approved medical device and is in use in the UAE, Mexico, Malaysia and Hong Kong, among others,” Kumar said.
 
“The devices will all be made in India, given that there are hardly any imported components. And our American partner will take the device to the US. Cytotron is already an approved medical device and is in use in the UAE, Mexico, Malaysia and Hong Kong, among others,” Kumar said.
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==Turmeric- based curcumin==
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[https://epaper.timesgroup.com/Olive/ODN/TimesOfIndia/shared/ShowArticle.aspx?doc=TOIDEL%2F2020%2F01%2F14&entity=Ar01224&sk=27A87E1F&mode=text  Rajiv G, Turmeric-based tech to kill cancer cells gets US patent, January 14, 2020: ''The Times of India'']
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[[File: Researchers said ‘curcumin’, a molecule extracted from turmeric, targets malignant cancer cells while sparing the healthy ones.jpg|Researchers said ‘curcumin’, a molecule extracted from turmeric, targets malignant cancer cells while sparing the healthy ones <br/> From: [https://epaper.timesgroup.com/Olive/ODN/TimesOfIndia/shared/ShowArticle.aspx?doc=TOIDEL%2F2020%2F01%2F14&entity=Ar01224&sk=27A87E1F&mode=text  Rajiv G, Turmeric-based tech to kill cancer cells gets US patent, January 14, 2020: ''The Times of India'']|frame|500px]]
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A potentially breakthrough cancer-fighting technology involving a molecule extracted from turmeric has won Thiruvananthapuram’s Sree Chitra Tirunal Institute for Medical Sciences a US patent.
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According to Lissy Krishnan, head of Sree Chitra’s research team, delivery of “curcumin” directly to the affected tissues rather than through conventional oral or intravenous methods enables it to target malignant cancer cells while sparing the healthy ones around them.
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Turmeric has proven anticancer properties and curcumin, a molecule extracted from it, is easily absorbed by the body and aids blood clotting, Krishnan said. At Sree Chitra, research funded by the Indian Council for Medical Research focused on processing curcumin to form a easy-to-use wafer configuration. When applied to body tissues, the curcumin present in the wafer is released into tissue fluids.
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Human albumin, or rich proteins present in the fibrin clot produced from heavy bleeding, binds albumin receptors to cancer cells, thereby permitting its entry into the cells. Simultaneously, the fibrin clot is removed by the body’s natural clot breakdown mechanism without any adverse effect.
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“The fibrin wafer is targeted for implantation into the affected site after surgical removal of cancer tissue for killing any remaining malignant cells that have the potential to cause recurrence of cancer or spread to other parts of the body. In addition to drug delivery, the fibrin wafer can promote blood clotting at the surgical site,” said Asha Kishore, director of Sree Chitra.
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The institute is ready to transfer the technology for future development of curcumin as an anti-cancer treatment through animal and clinical trials. “The US patent adds value to our efforts to transfer technology and boosts the industry’s confidence in exploring validation and trials with international markets in mind,’’ Kishore said.
  
 
=Heart-valve technology=
 
=Heart-valve technology=

Latest revision as of 10:13, 16 January 2020

This is a collection of articles archived for the excellence of their content.
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Contents

[edit] Cancer detection

[edit] 2019/ Test to detect spread or relapse

Umesh Isalkar, Cheap desi test kit detects cancer early, August 21, 2019: The Times of India


A simple blood test costing Rs 15,000 will soon help doctors detect the spread or relapse of cancer in patients, helping them to plan an efficient treatment module. The test, based on a liquid biopsy technology called OncoDiscover, will help pick up circulating cancer cells in a patient’s blood much before they have affected or spread to other body parts.

Developed by Pune-based scientist Jayant Khandare, the diagnostic tool may also be used to plan treatment or to assess how well the existing treatment regime is working.

“The test will be launched in a phased manner all over India from September,” Khandare told TOI.

‘Indian cancer test kit will be far cheaper than the US version’

The long-term plan is to release the test in key global markets within the next few years,” Khandare told TOI.

Khandare is the chief scientific officer at Actorius Innovations and Research Pvt Ltd, a startup co-founded by him and Aravindan Vasudevan in 2013. The startup has been funded for high-risk innovation by the Biotechnology Industry Research Assistance Council, an industry support wing of the department of biotechnology, Union ministry of science and technology.

Khandare said the technology was among the few laboratory-to-clinic translational researches, a rarity in India. “OncoDiscover can allow regular monitoring of disease progression. It can also help in providing an early indication for cancer relapse. It is a blood test that detects circulating tumour cells even when their presence is extremely low or minuscule in a patient’s blood,” he said.

The Central Drugs Standard Control Organisation, the regulatory body for drugs and medical devices, has already granted a licence for the manufacture and sale of the test kit in India under the Medical Device Rules, 2017.

Khandare says it is the second such technology in the world, after the one already available in the US. The Indian version would be far cheaper and more specific than the US one, he said. “CellSearch, the US test for the detection of circulating tumour cells has been sold to Menarini Biotech by Johnson & Johnson. It has been available in the US since 2004 and has the approval of the US Food and Drug Administration. The test costs between Rs 84,000 and Rs 1 lakh and is not available in India,” Khandare said.

[edit] Cancer treatment

[edit] Cytotron/ 2019

Chethan Kumar, Indian anti-cancer kit a breakthrough: USFDA, November 12, 2019: The Times of India


The US Food and Drug Administration (FDA)’s Centre for Devices and Radiological Health has designated a medical invention by a Bengaluru-based scientist as a “breakthrough device” in liver, pancreatic and breast cancer treatment.

Cytotron, developed by Rajah Vijay Kumar, aids in tissue engineering of cancer cells, altering how specific proteins are regulated to stop these cells from multiplying and spreading.

“We are pleased to inform you that your device and proposed indication for use meet the criteria and have been granted designation as a breakthrough device,” states a communique from the FDA wing to Shreis Scalene Sciences, the company that had taken the device to the US.


‘Anti-cancer device to be manufactured in India’

Cytotron is intended to cause degeneration of uncontrolled growth of tissues. “It is indicated for treating protein-linked, abnormally regenerating disorders such as neoplastic disease, and allowing extended progression free survival, with pain relief, palliation, improved quality and dignity of life,” says the letter.

Rajah Vijay Kumar had developed Cytotron at the Centre for Advanced Research and Development, which is headquartered in Bhopal, after nearly 30 years of research into cellular pathways and interactions with specifically modulated fast radio bursts.

“It is a great feeling that after so many years of hard work, against all odds, an institution like the USFDA is designating our work as a breakthrough in the treatment of three types of cancers,” Kumar said.

New technologies in the battle against cancer have generally been hard to come by. It’s even rarer for an Indian device to get breakthrough status in the US. The Centre for Devices and Radiological Health is responsible for pre-market approval of all medical devices in the US, ensuring they are safe for use and effective.

“The devices will all be made in India, given that there are hardly any imported components. And our American partner will take the device to the US. Cytotron is already an approved medical device and is in use in the UAE, Mexico, Malaysia and Hong Kong, among others,” Kumar said.

[edit] Turmeric- based curcumin

Rajiv G, Turmeric-based tech to kill cancer cells gets US patent, January 14, 2020: The Times of India

Researchers said ‘curcumin’, a molecule extracted from turmeric, targets malignant cancer cells while sparing the healthy ones
From: Rajiv G, Turmeric-based tech to kill cancer cells gets US patent, January 14, 2020: The Times of India


A potentially breakthrough cancer-fighting technology involving a molecule extracted from turmeric has won Thiruvananthapuram’s Sree Chitra Tirunal Institute for Medical Sciences a US patent.

According to Lissy Krishnan, head of Sree Chitra’s research team, delivery of “curcumin” directly to the affected tissues rather than through conventional oral or intravenous methods enables it to target malignant cancer cells while sparing the healthy ones around them.

Turmeric has proven anticancer properties and curcumin, a molecule extracted from it, is easily absorbed by the body and aids blood clotting, Krishnan said. At Sree Chitra, research funded by the Indian Council for Medical Research focused on processing curcumin to form a easy-to-use wafer configuration. When applied to body tissues, the curcumin present in the wafer is released into tissue fluids.

Human albumin, or rich proteins present in the fibrin clot produced from heavy bleeding, binds albumin receptors to cancer cells, thereby permitting its entry into the cells. Simultaneously, the fibrin clot is removed by the body’s natural clot breakdown mechanism without any adverse effect.

“The fibrin wafer is targeted for implantation into the affected site after surgical removal of cancer tissue for killing any remaining malignant cells that have the potential to cause recurrence of cancer or spread to other parts of the body. In addition to drug delivery, the fibrin wafer can promote blood clotting at the surgical site,” said Asha Kishore, director of Sree Chitra.

The institute is ready to transfer the technology for future development of curcumin as an anti-cancer treatment through animal and clinical trials. “The US patent adds value to our efforts to transfer technology and boosts the industry’s confidence in exploring validation and trials with international markets in mind,’’ Kishore said.

[edit] Heart-valve technology

[edit] Transcatheter Aortic Valve Replacement

January 7, 2020: The Times of India


Made in India heart valve technology can keep your heart beating strong!

Sarah*, a French woman was 83, when she had been advised that she had only a few hours to live. However, she decided to opt for a unique, cutting-edge procedure that could grant her a fresh lease of life. Within a year of the procedure, she traveled to America to achieve her dream of addressing a large gathering at a prestigious conference. Now, at age of 90, she continues to live an active and normal life. What threatened her life, and which procedure saved her?

Sarah had a medical condition called Aortic Valve Stenosis (AS). The valve in her heart, which ensures normal blood-flow from the heart to the body, had narrowed with advancing age. This made it extremely difficult for her to carry out simple daily activities. She often felt out of breath. There was a tightness in her chest, frequently accompanied by pain. She felt dizzy even with brief movements. In short, living had become a struggle.

Medication did not provide any significant relief. The other available treatment was an open heart surgery for valve replacement. But that was an extremely risky option due to her age, the complex nature of the surgery, the long hospital stay, and high chance of complications post-surgery, especially during the recovery period of 10-12 months. Given these risks, surgical teams in Paris had refused to perform a surgical valve replacement.

At this point, Sarah consulted Dr. Alain Cribier, Professor emeritus at the Department of Cardiology, University Hospital Charles Nicolle in Rouen (France). Dr. Cribier suggested that she consider the option of an innovative non-surgical procedure called Transcatheter Aortic Valve Replacement (TAVR).

The procedure entailed a small cut in the groin or chest area to pass a catheter tube to replace the diseased valve with a bioprosthetic valve. There would be no need to cut open the chest cavity nor any need for general anesthesia as is usually required for surgery. The TAVR procedure would be performed over 30-40 minutes, and her recovery would be swift, requiring hospital stay of only 3 to 5 days.

[edit] Trientine/ D-Pencillamine

[edit] MSN Laboratories/ 2019

Malathy Iyer, Desi drug brings cheer to patients of a rare disease, March 17, 2019: The Times of India


Over two years after patients of a rare genetic condition called Wilson’s Disease suffered due to acute shortage of a life-saving drug called D-Pencillamine across the country, there is finally a reason to cheer. An Indian company has begun manufacturing a drug called Trientine, which is considered superior to D-Pencillamine due to fewer side-effects, at a fraction of its international price.

What makes this new drug launch an emotional event is the behind-the-scenes lobbying by a group of parents, an NGO and a doctor from Mumbai who worked to convince Hyderabad-based MSN Laboratories to take up the manufacture of Trientine.

At a time when stories of the greed of pharmaceutical companies abound, this is a positive instance of pharmaceutical support. Dr Aabha Nagral, a hepatologist who set up NGO Children’s Liver Foundation, said a couple of children had to stop treatment when the drug shortage occurred in 2016.


‘Firm involved in social work; not driven by profits’

We organised a picnic for our patient group where two youngsters shared that they had no drugs at that time and were worried about the future,” said Dr Nagral, who has treated approximately 100 Wilson’s Disease patients in her care at any given time.

The Ranes from Vile Parle, too, recall how their daughter Gauri was hospitalised a few times during the shortage. “Fluid would get accumulated in her abdomen, requiring hospitalisation. It was a traumatising time as her liver was failing quickly,” said Satish Rane. Luckily, she got a cadaveric liver donation and is doing well since the transplant a year ago.

Rajesh S (name changed), a 45-year-old research scientist, was diagnosed with Wilson’s Disease a year back. “We had heard of shortages and expensive medicines costing almost Rs 1 lakh for 100 tablets but we now pay Rs 16,000 for 100 tablets,” said his wife.

The turnaround took months of gathering information and planning. After the shortage was fixed by the Union government’s directive to pharmaceutical companies in August 2016, Dr Nagral and the patient group actively started to seek information about Trientine. They heard from pharmaceutical agents that the active ingredient for Trientine was manufactured in an Indian company and exported to multinational companies located overseas.

“We applied through RTI to the Union ministry of information on the manufacture of Trientine and D-Pencillamine, but got little,” said Dr Nagral. That is when they began to directly appeal to pharmaceutical companies for help. MSN Laboratories, which has been manufacturing active pharmaceutical ingredients for export purposes for years, decided to help out. Ajit Bhadauria of MSN Laboratories said the company didn’t take up the manufacture of Trientine for profits. “It is purely a part of our social work as a pharmaceutical company,” he said.

[edit] Tuberculosis/ Pretomanid

[edit] TB Alliance/ Macleods Pharmaceuticals: 2019

Rupali Mukherjee, Mumbai pharma company gets licence for breakthrough TB drug, October 28, 2019: The Times of India


When Taken With Other Meds, It Can Minimise Duration Of Treatment

In a move which will make treatment of tuberculosis (TB) simpler, accessible and affordable, global nonprofit drug developer TB Alliance has tied up with domestic company Macleods Pharmaceuticals to develop and commercialise its ‘breakthrough’ drug Pretomanid in high-burden countries, including India.

Pretomanid is an important drug for the treatment of highly drug-resistant TB (DRTB), if taken along with other TB medicines. It is also the third new anti-TB drug approved by USFDA in over 40 years. Significantly, Macleods has now become the second generic manufacturer for the drug, globally, after the TB Alliance earlier granted rights to US drug maker Mylan in August this year.

Drug resistance is a major public health crisis thwarting the effective treatment of tuberculosis and India has the highest number of TB and DR-TB patients in the world.

The licence granted to the Mumbai-based company puts to rest doubts about the access and affordability of the new drug which when used in combination (with other drugs), can cut the duration of the treatment for drug-resistant TB from 18-24 months to sixnine months. Details regarding the drug’s pricing are yet to be worked out.

When contacted, Mel Spigelman, president and CEO, TB Alliance told TOI, “The licensing agreement with Macleods will allow the company to market Pretomanid as part of the BPaL (regimen consisting of bedaquiline, pretomanid and linezolid) in approximately 140 countries, which represents the vast majority of the global TB burden”.

“This new addition to Macleods’ existing anti-TB products portfolio, will lead to more people getting access to this essential medicine in countries where it is needed the most,” Vijay Agarwal, business development director at Macleods, said.

There is a growing resistance to certain existing drugs (implying the disease is becoming deadlier and more difficult to treat). Multidrug resistant (MDR) and extensively drug resistant (XDR) TB are forms of the disease caused by bacteria that do not respond to first-line anti-TB drugs. Existing treatments, therefore, consist of combinations of many different drugs, which is required to be taken for two years (approximately). Patients may take as many as 20 pills a day, resulting in numerous side-effects and a huge economic burden.

Regarding the agreement with Mylan, Spigelman said the company has submitted a new drug application to the office of Drug Controller General of India (DCGI) and is an advanced stage of discussion to expedite the product.

The US company holds non-exclusive rights to market the drug in India.

According to World Health Organization, in 2018, there were an estimated 4,84,000 new cases of multidrug-resistant TB worldwide, with a smaller portion of cases of extensively drug-resistant TB.

[edit] See also

Drugs and Pharmaceuticals: India

Drugs/ Pharmaceuticals made by Indians

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