Drugs/ Pharmaceuticals made by Indians

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(Trientine/ D-Pencillamine)
 
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“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.
 
“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.
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=Tuberculosis/  Pretomanid=
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==TB Alliance/ Macleods Pharmaceuticals: 2019==
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[https://epaper.timesgroup.com/Olive/ODN/TimesOfIndia/shared/ShowArticle.aspx?doc=TOIM%2F2019%2F10%2F28&entity=Ar00717&sk=5827C095&mode=text  Rupali Mukherjee, Mumbai pharma company gets licence for breakthrough TB drug, October 28, 2019: ''The Times of India'']
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''When Taken With Other Meds, It Can Minimise Duration Of Treatment''
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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.
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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.
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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.
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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.
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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”.
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“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.
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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.
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 +
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.
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The US company holds non-exclusive rights to market the drug in India.
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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.
  
 
=See also=  
 
=See also=  

Latest revision as of 07:46, 10 November 2019

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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] 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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