The Ahmedabad-based company, part of the Rs 14,000-crore Torrent Group, is the only domestic pharma company that has invested nearly $1 billion in local acquisition over the last three years.

Torrent Pharmaceuticals rose 1.09% to Rs 1,919.05 after the company said its board will meet on Monday, 27 January 2020, to consider fund raising.

A meeting of the board of directors will be held on 27 January 2020 to consider raising funds by issuing equity shares including convertible bonds/debentures through qualified institutional placement (QIP) and/or depository receipts or any other modes.

In 2017, the company acquired the India business of Unichem for Rs 3,600 crore, and before that it had bought distressed Elder Pharma for Rs 2,000 crore, consolidating its position as the No. 8 player in the Indian pharma market. But it is done with large acquisitions for now.

“Our key geographies of India, Brazil and Germany are where we expect future growth avenues to come from. We are seeing from other companies, too, a lot more focus back on the Indian market,” said Aman  Mehta, chief marketing officer of Torrent Pharma.

Aman is the son of Samir Mehta, founder and CEO of Torrent Pharma. He will be expected to take over the reins of the pharma business from his father in the coming years. The 28-year-old, a graduate of Columbia Business School, however, says that as a professionally run organisation, his succession will also be a step-by-step process.

“For us it is about diving deep into one role first and then moving to other roles, rather than the other way round. This is the same thing for others. I am in pharma business, my cousins Jinal and Varun are in power. All of us are hands on. So it is about taking it step-by-step”, Mehta told ET in an exclusive interview.

For now, he said, the focus of the company will be on launching new products in categories such as cardiology and diabetes, which is also the fastest growing therapy segment in India.

Torrent is betting on its new launches like cardiac drug Ticagrelor and anti-diabetic drug Vildagliptin and Remogliflozin for its future quarter growth.

In 2019, Torrent reported 13% growth in sales to Rs 4,328 crore, when the overall market grew at 9%.

The Indian pharma market, once the darling of investors, has come under pressure in the last five years. Regulatory actions in the US markets and policy changes at home, including price cuts and the implementation of GST, have chipped away the double-digit growth of companies that had churned out billionaires from the sector.

Torrent, too, has come under US drug regulator USFDA’s scrutiny for quality issues. Last year, the FDA issued a warning letter for the company’s manufacturing facility in Gujarat, which subsequently halted supplies to the US.

Source

Pharma companies seek hike in drug rates under price control

Chinese API imports turn 200% costlier, making production costlier in India. Over 70% of the country’s total bulk drug requirement comes from China. These bulk drugs or active pharmaceutical ingredient/Web Link / Source

With a 50-200% rise in the cost of raw materials imported from China, pharmaceutical lobby groups have urged the government to invoke extraordinary powers to hike prices of drugs under price control, according to sources.

Over 70% of the country’s total bulk drug requirement comes from China. These bulk drugs or active pharmaceutical ingredients (API) are used in producing medicines, including essential items like antibiotics, vitamins and folic acid.

At a meeting on Wednesday, industry lobby groups like Federation of Pharmaceutical Entrepreneurs (FOPE), Indian Pharmaceutical Alliance and Indian Drugs Manufacturers’ Association (IDMA) submitted recommendations to the department of pharmaceuticals (DoP), health ministry, department of biotechnology and the drug controller general of India (DCGI), seeking to invoke Para 19 of the Drugs (Prices Control) Order for raising prices of all scheduled drugs. Para 19 deals with increase or decrease of d ..

As of now, Para 19 has been used only to reduce the prices of stents and knee implants.

“If the prices become unviable, the government can invoke extraordinary powers and provide escalation in prices,” said an expert on condition of anonymity.

“API price escalation has impacted the economic viability for manufacturing such formulations,” said FOPE president BR Sikri.

APIs are the active raw materials used in a drug that give it the therapeutic effect.

In case of scheduled drugs, the prices can only be revised once in a year based on the Wholesale Price Index (WPI).

Prices of most of the commonly used APIs have increased in the range of 50% to 200%.

“Such increases are making the costing of formulations unviable for the manufacturer,” said another expert.

Over the past one year, nearly 150 API manufacturers in China have shut shop because of stricter environmental standards, leading to the price hike.

“The rates of scheduled products were fixed in 2013 and, in the last many years, the MRP has moved with the WPI. This time, the cost of many raw materials has increased. Due to increase in dollar rate and other facts, there is a significant increase and hence the industry is appealing for the base rates to be reviewed,” said Sunil Attavar, president of Karnataka Drugs and Pharmaceuticals Manufacturers’ Association (KDPMA).

GSK to recall Ranitidine from India

GlaxoSmithKline plc is a British multinational pharmaceutical company headquartered in Brentford, London.  Also GSK has filials in India.

NEW DELHI: British drugmaker GlaxoSmithKlineNSE -1.06 % on Wednesday said it is recalling heartburn drug Ranitidine from India, a day after the country’s drug regulator asked pharma companies to check their products for carcinogen.

“As a precautionary action, GSK has made the decision to initiate a voluntary recall (pharmacy/retail level recall) of Zinetac Tablets 150 mg and 300 mg products manufactured in India using API sourced from Saraca Laboratories Ltd,” a GSK spokesperson said in ..

Stem cells and Viagra

Using a combination of two well-known medications from the bone marrow of the experimental mice, stem cells were lured.

Medical scientists have proposed a new method for increasing the number of blood stem cells by expelling them from the red bone marrow with two drugs.

Both of them are currently widely used in medicine; the first one is AMD3100, which prevents the cells from returning to the bone marrow, and the second is sildenafil, which is the main active ingredient in all drugs for the treatment of erectile dysfunction.

Researchers have already tested this combination on laboratory mice. With its help, it is possible to get not much less cells than standard methods, and side effects from this procedure should be much milder.

Viagra, best known as a treatment for erectile dysfunction, is a safe and well-studied drug that promotes the widening of blood vessels (vasodilation), which increases blood flow to tissues. Initially developed as a treatment for high blood pressure, it is now used to treat a variety of vascular disorders, including pulmonary hypertension, altitude sickness, and preeclampsia.

Forsberg’s lab decided to test Viagra’s ability to help mobilize hematopoietic stem cells from the bone marrow after observing that vascular changes in a strain of mice they were studying led to increased stem cell mobilization. The mice lack the gene for a cell surface protein, Robo4, which the lab’s previous research had shown regulates blood vessel integrity to keep the stem cells in the bone marrow.

Plerixafor, the other drug in the combination, is an inhibitor of Cxcr4, which is a receptor on the surface of hematopoietic stem cells that helps them stick to their niche in the bone marrow. Plerixafor mobilizes the stem cells, but is not very effective on its own.

“When you dilate the blood vessels with Viagra, the cells mobilized by Plerixafor are better able to get out into the blood stream,” Smith-Berdan said.

Viagra by itself did not lead to detectable increases in hematopoietic stem cells in the blood, so patients using it for other reasons need not worry about inadvertent stem cell mobilization, the authors noted.

The Indian pharmaceutical industry

The Indian pharmaceutical industry has emerged as a significant contributor to the global pharmaceutical industry. As per the report by the Federation of Indian Chamber of Commerce and Industries (FICCI), “India is the largest provider of generic drugs globally. Indian pharmaceutical sector industry supplies over 50 per cent of global demand for various vaccines, 40 per cent of generic demand in the US and 25 per cent of all the medicine in the UK. Presently over 80 per cent of the antiretroviral drugs used globally to combat AIDS (Acquired Immune Deficiency Syndrome) is supplied by Indian pharmaceutical firms.”

One-of-its kind roadshow hosted more than 500 customers, partners and prospects under one roof in Ahmedabad, Bengaluru, Chandigarh, Hyderabad and Mumbai

Other partners included global industry leaders such as Ace Technologies, Aptar Pharma, Datwyler, Kaisha Lifesciences, Nemera, Packwell Industries, Shakai Packaging, Smart Skin Technologies, Snowbell Machines, Sovereign Pharma and Vanrx Pharmasystems Inc.

Jayant Joshi, Managing Partner, Shreedhar Group, distributors for Vanrx in India, shared, “We appreciate this association as it is the first time that so many players – representing foreign brands and local players have come together on a common platform. We use Schott Kaisha products and in fact, design our machines accordingly. Such events through the company are instrumental for us to get closer to our customers, gather new learnings and, in turn evolve our solutions.”

Today, India is undoubtedly a huge pharmaceutical market for the world, exerting unmatched strength in manufacturing of generic drugs for US and other global markets. With the Indian pharmaceutical packaging market estimated at Rs 147.8 billion in 2017 and expected to reach Rs 245.5 billion by the end of 2023, there is huge demand for an increased supply of high quality primary packaging material.

Pharmaceutical packaging company Schott Kaisha successfully concluded its five-city roadshow recently, bringing together industry experts, R&D specialists, business and sales leaders for discussions on latest technological advancements and best practices that lead to drug safety.

“We believe this two-pronged focus will enable the BPPI to expand to over 10,000 stores by FY21. With each store achieving monthly sales of around Rs 5 lakh, the scheme is set to top Rs 6,000 crore by FY21,” the report said.

It added that as unbranded generics and Jan Aushadhi gain steam, there will be further pressure on volume, leading to lower revenue growth for branded market.

It further said that branded revenue growth will become a challenge in the coming years as generics market share will keep on increasing.

Govt brings 42 non-scheduled cancer drugs under price control

In a move that could benefit over 1.5 million cancer patients by reducing their out-of-pocket expenses, the Union government on February 27 capped trade margins of 42 cancer drugs.

The government invoked paragraph 19 of DPCO, 2013, to fix trade margins at 30 percent and directed manufacturers to fix their retail price based on the price at first point of sale of product or Price to Stockist.

A trade margin is a difference between the price at which the manufacturers sell the drugs to stockist or distributors and the final price to patients (or maximum retail price)

The government notification shall be valid for one year from the date of notification.

“..considering the high trade margin in the sale of drugs leading to high out of pocket expenses on healthcare, the Government hereby, seeks to undertake the matter of price control through a ‘Trade Margin Rationalisation Approach’,” the National Pharmaceutical Pricing Authority (NPPA) notification said.

“And therefore, in order to bring in the regulation of drugs in the ‘non-scheduled’ segment the Government hereby seeks to undertake a Pilot for Proof of Concept by capping prices of select Anti-Cancer drugs, identified by the MoHFW as being essential for the treatment of this disease,” the notification added.

As per the WHO estimate, there are approximately 18 million cases globally and 1.5 million in India alone. There were eight lakh cancer deaths in India in 2018. The number of new cases is estimated to rise to double in India in 2040.

The financial burden associated with cancer can force patients and households to acute misery and even insolvency. It is also noted that out of pocket (OOP) expenditure on cancer hospitalization is about 2.5 times of overall average hospitalization expenditure. While catastrophic expenditure on cancer inpatient treatment is highest among all NCDs, poor health financing mechanisms and heavy reliance on out-of-pocket healthcare payments compel several cancer patients to resort to distressed means for treatment financing.

“It is estimated that almost more than 50% cancer patients avail the private sector facilities and out of pocket expenses in the Health care including cancer care is about around 65 percent,” NPPA said.

The All India Drug Action Network (AIDAN) that represents a network of healthcare NGOs and activists said the retail prices are not likely to be significantly affected through this move.

“However, by imposing mandatory margin caps, patients will benefit in hospitals which were undoubtedly indulging in profiteering by taking massive cuts,” AIDAN said.

The government said Wednesday it has brought 42 non-scheduled anti-cancer drugs under price control, capping trade margin at 30 per cent, which would reduce their retail prices by up to 85 per cent. The National Pharmaceutical Pricing Authority (NPPA) has invoked extraordinary powers in public interest, under Para 19 of the Drugs (Prices Control) Order, 2013 to bring 42 non-scheduled anti-cancer drugs under price control through trade margin rationalisation, an official release said.

“Invoking paragraph 19 of DPCO, 2013, the government hereby puts a cap on trade margin of 30 per cent and directs manufacturers to fix their retail price based on price at first point of sale of product… of the non-scheduled formulations containing any of the 42 drugs,” the Department of Pharmaceuticals (DOP) said in a notification. As per data available with NPPA, the MRP for 105 brands will be reduced up to 85 per cent entailing minimum saving of Rs 105 crore to consumers, it added.

Currently, 57 anti-cancer drugs are under price control as scheduled formulations. Now 42 non-scheduled anti-cancer medicines have been selected for price regulation by restricting trade margin on the selling price (MRP) up to 30 per cent, the notification said. “These would cover 72 formulations and 355 brands as per data available with NPPA. More data is being collected from hospitals and manufacturers to finalise the list,” it added.

The drug manufacturers have been given seven days to recalculate the prices and inform the NPPA, state drug controllers, stockists and retailers, it said. The revised prices shall come into effect from March, 8, it added. The NPPA currently fixes prices of drugs placed in the National List of Essential Medicines (NLEM) under Schedule-I of the DPCO. So far, around 1000 drugs have been brought under price control under the initiative. Non-scheduled drugs are allowed an increase of up to 10 per cent in prices every year, which is monitored by the NPPA.

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India’s first draft guidelines on nano-medicines

The department of biotechnology (DBT) has put out India’s first draft guidelines on evaluation of nanopharmaceuticals for public consultation till March 10.

Nanopharmaceuticals are drug preparations that use nanoparticles the size of 1 to 100 nm as carriers for targetted delivery of an active pharmaceutical ingredient. As the drugs can be targeted to the site of the disease using the nanocarriers, it improves the safety and efficacy of certain drugs by lowering its dose and, thereby, reducing toxicity.

“This is a guideline document that will help the drug controller in evaluating nanopharmaceuticals and approving them for use in the Indian market. This document will also guide researchers on how to get their product approved. Currently, there are no nanopharmaceuticals in India but this is a proactive step as research on nanomedicine is on-going,” said Renu Swarup, secretary, DBT.

As part of India’s nano mission, the DBT and the Indian Council of Medical Research (ICMR) have been funding studies for formulation of drugs with nanoparticles for cancer, epilepsy, Alzheimer’s disease, pain management and to combat antimicrobial resistance.

“There are uses in diagnostics etc, which are not covered by these guidelines. The department will work on separate guidelines for diagnostics and applications in agriculture etc,” said Swarup.

“When the drug is in the nanoform, there are changes in pharmacokinetics or how it gets absorbed, distributed in the body, metabolised or excreted. The pharmacodynamics also change, meaning the way it binds with receptors. This may result in change in dosage, unexpected side effects etc.

Hence, there is a need for additional tests apart from the ones mentioned in Schedule Y of the Drugs and Cosmetics Act,” said Dr YK Gupta, the chairperson of the committee that drafted the guidelines.

source

USFDA supports generics made in India

The Indian drug makers are finally seeing a recovery with most of their factories being cleared by the US watchdog.

Mumbai: Indian drug companies have got a shot in the arm with the US Food and Drug Administration (USFDA) chief coming out in support of generics manufactured in India and the US to dispel fears over such medicines.

Generics account for 90% of the US drug market — up from 33% three decades ago. FDA commissioner Scott Gottlieb’s statement boosted the S&P BSE Healthcare index, which gained 0.7% on Monday.

For Indian drug makers, whose major part of business comes from the sale of generics in the US, Gottlieb’s statement has given a respite from the poor perception of generics as well as Indian-made drugs.

“Generic drugs are just as safe and effective as their branded drug counterparts… Generic medicines use the same active ingredients as brand-name medicines and work the same way, so they have the same risks and benefits,” Gottlieb wrote in a newsletter.

The FDA chief said the regulator’s rigorous standards and inspections apply equally to both generic and branded drugs — whether the medicines are being manufactured in Shandong, India, or in Indiana, USA.

In FY2017-18, the FDA tested 323 products from around the world — including more than 100 from India – to determine if foreign manufacturers had a higher incidence of product failure. All 323 samples met the US market quality standards using testing standards set by the United States Pharmacopeia (USP) or submitted in marketing applications, the regulator said. Though the inspections by the USFDA declined slightly in China from 2017-18, inspections in India have increased substantially, according to Gottlieb.

Getting a high testosterone reading offers bragging rights for some men of a certain age — and may explain in part the lure of testosterone supplements. But once you are within a normal range, does your level of testosterone, the male hormone touted to build energy, libido and confidence, really tell you that much?

Probably not, experts say.

Normal testosterone levels in men range from about 300 to 1,000 nanograms per deciliter of blood. Going from one number within the normal zone to another one may not pack much of a punch.

“You don’t see the big improvement once men are within the normal range,” said Dr. Shalender Bhasin, an endocrinologist and professor of medicine at Harvard Medical School. The largest differences in terms of energy and sex drive are when men go from below-normal to normal levels.

A 2015 study in JAMA found that sex drive improved among men who went from about 230, considered low, to 500, around the middle of what’s considered normal. There was no difference among men who moved within the normal range from 300 to 500.

11 Warning Signs of Low Testosterone

Treating diarrhea in Crohn’s disease

Diarrhea is a common symptom of Crohn’s disease. There are several anti-diarrheal medications that a person with Crohn’s can use to treat acute bouts of diarrhea.
Crohn’s disease causes long-term inflammation of the digestive tract and typically affects the end of the small intestine or the beginning of the colon.

Common symptoms of Crohn’s include:

» Diarrhea «
» Stomach pain «
» Rectal bleeding «
» Unintended weight loss «
» Fatigue «
» Fever «

People with Crohn’s disease can find diarrhea a particularly troubling symptom. It can come on unexpectedly and interfere with daily activities significantly. If left untreated, diarrhea can also lead to serious health complications, such as severe dehydration.In this article, we look at different anti-diarrheal drug treatments for people with Crohn’s disease along with some general tips for managing diarrhea.

Prescription med’s for diarrhea

Colesevelam

Woman taking a pill which is an anti-diarrheal treatment for crohn’s
A doctor may prescribe anti-diarrheal treatment when a person has Crohn’s disease and diarrhea.

Colesevelam is a type of drug known as a bile acid sequestrant. Colesevelam is used along with diet, weight loss, and exercise to reduce the amount of cholesterol and certain fatty substances in the blood.These drugs treat diarrhea by regulating the amount of bile acid in the digestive system.

Bile acids help the body to digest food. However, in some people with Crohn’s disease, particularly those who have had part of the small bowel removed, bile acids can build up in the bowel and cause diarrhea.

Colesevelam is a prescription medication that comes in tablet form.

Diphenoxylate

Diphenoxylate is a synthetic opioid that treats diarrhea by slowing down the passage of stool through the intestines. Diphenoxylate is a centrally active opioid drug of the phenylpiperidine series that is used in a combination drug with atropine for the treatment of diarrhea. Diphenoxylate is an opioid and acts by slowing intestinal contractions; the atropine is present to prevent drug abuse and overdose.

Doctors usually prescribe diphenoxylate in combination with fluid and electrolyte replacement measures to treat people with severe diarrhea.

Because diphenoxylate can become addictive, manufacturers combine it with atropine to cause unpleasant side effects if a person takes too much of the medication. It is, therefore, essential to carefully follow the doctor’s instructions when taking diphenoxylate.

How Can I Feel Better?

Your rectal area may become sore because of all the bowel movements diarrhea brings. And you may have itching, burning, or pain when you go to the bathroom.

For relief, take a warm bath. Afterwards, pat the area dry (do not rub) with a clean, soft towel. You may also want to use a hemorrhoid cream or white petroleum jelly on the affected area.

Sources: Webmd.com, Medical News

Pharma companies & US generics

The volume share of Indian pharma companies in the US generic market has grown to nearly 40% in August despite regulatory woes and pricing pressures. A steady increase in drug approvals and portfolio rationalisation by MNCs resulted in India’s volume share rising by 5% over the last few months, though value is still impacted due to price erosion.

AT Kearney partner (healthcare and pharma) Abhishek Malhotra says, “The first stage of growth was based on leveraging India’s high-quality and low-cost manufacturing base, and primarily focused on generic drugs. Given the pressure on pricing, increased competition and higher regulatory scrutiny, many leading Indian companies have embarked on the second leg of the growth journey. This includes moving up the value chain and developing more complex and specialty drugs and acquiring US companies to have manufacturing and R&D assets in the US.”

PwC India leader (pharmaceutical & life sciences) Sujay Shetty says complex generics and speciality products, which are difficult to manufacture, and niche drugs could add value for domestic companies in the near to mid-term as they are more resilient to pricing pressure.

Viagra is set to get cheaper, thanks to Indian pharma companies

Pfizer’s Viagra patent is up for grabs and Indian pharmaceutical companies are on the prowl.

Viagra — equal parts erectile dysfunction treatment and dubious subject line starter in your spam folder — is set to get a lot less expensive. That is if Indian pharmaceutical corporations have their way. Pfizer, the American Pharma giant that manufactures the drug, is set to lose its patent.  Although sildenafil, the drug sold under the Viagra brand name, was originally intended to help people with hypertension and cardiovascular disease, it was discovered that the drug could induce strong penile erections. To treat erectile dysfunction, Pfizer filed a patent for the drug that was later marketed as Viagra in 1994.

The Pfizer patent which allows the formulation of Viagra, a drug used to treat erectile dysfunction (ED) among men, ends by 2020. Since America is India’s largest market for medicines, this move will open new avenues for Indian pharma companies. They will look to target the almost five crore American men who suffer from ED. Seven Indian companies have already secured permission and are a part of the 15 company group that has been granted approval by US health authority, Food and Drug Administration (FDA), to produce sildenafil citrate — the primary drug of Viagra.

The Indian companies currently in the fray to sell the Blue Pill are Rubicon Research, Hetero Drugs, Macleods Pharma, Dr Reddy’s, Aurobindo Pharma, Torrent Pharmaceuticals and Ajanta Pharma. The Indian companies are also working on plans to lower the price of Viagra by almost 99 per cent. According to a report in The Hindustan Times, The pill that cost around $65 (a little over 4,400 ruppes) currently in the US will see a huge drop in the prices once the Indian companies are allowed. The Mumbai-based Macleods Pharmaceuticals, which started exporting its products to the US in 2012, sells their version of Viagra in India called the Macsutra for just ruppes 58 per tablet. Even Ajanta Pharma, a publicly-listed form sells its version in India for just ruppes 32 per tablet.

The Indian company’s entry to the American markets will definitely leave a dent on Pfizer’s profits. The company earned over $1.68 billion (ruppes 11,535 crore) thanks to Viagra sales in 2014. In a research conducted by Transparency Market Research, the global erectile dysfunction drug market itself was valued at $4.35 billion (ruppes 29,876 crore) in 2016. But the Indian firms entering the US markets will have to contend with the rising FDA license fees. The FDA had earlier increased the fee by over 65 ruppes lakh from ruppes 45 lakh to 1.1 ruppes crore for the 2018 fiscal year.

original sourse

Could a daily dose of Viagra prevent cancer? New study says it’s possible

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The little blue pill that has famously changed the sex lives of countless men around the globe may have an even more powerful effect that could save people’s lives, new research reveals. Viagra may help in reducing the risk of colorectal cancer, which is the third leading cause of cancer-related deaths among both men and women in the United States, according to the American Cancer Society. A study published in February 2018 in the Journal Cancer Prevention Research found that when researchers gave a small, daily dose of sildenafil, also known as Viagra, to male and female mice that had been genetically modified to develop a large number of intestinal polyps, their risk of developing colorectal cancer dropped by 50 percent. (source)

Taking Viagra with the flu vaccine could prevent cancer and stop it spreading, according to new research.The uncoventional combination works by boosting the immune system – helping it mop up tumour cells left behind after surgery.
Experiments found they reduced spread of the disease by more than 90 percent in mice.

The results were so successful two dozen stomach cancer patients are to be given the unconventional therapy.Cancer kills because it migrates to other organs. And surgery makes this process easier, by weakening the immune system.

Viagra may help repair it.

Dr Rebecca Auer, surgical oncologist and head of cancer research at The Ottawa Hospital, Ontario , said: “Surgery is very effective in removing solid tumours.”However we’re now realising that, tragically, surgery can also suppress the immune system in a way that makes it easier for any remaining cancer cells to persist and spread to other organs.

“Our research suggests combining erectile dysfunction drugs with the flu vaccine may be able to block this phenomenon and help prevent cancer from coming back after surgery.”Viagra is widely used to treat impotence. It relaxes muscle cells around vessels so they can fill with blood much more easily.This is how it helps men with erectile dysfunction. But evidence is growing it can be used to treat a host of other disorders.

These include diabetes, lung problems, stroke, infertility, heart failure – and even premature births. Earlier this year US scientists found a daily dose dramatically reduced the risk of bowel cancer in mice genetically engineered to develop the disease. It prevented the formation of polyps – clumps of cells on the intestines which may become cancerous.

The latest study published in OncoImmunology analysed the effect of Viagra, another erectile disfunction drug Cialis and the flu vaccine Agriflu in mice with lung cancer. After surgery cases of tumour spread soared almost fourfold in the lab rodents. But this was more than five times less likely after treatment with Viagra or Cialis. And it was about 12 times less likely when the animals were given the flu vaccine as well as one of the impotence drugs.

Dr Auer is now leading the world’s first clinical trial of an impotence drug and the flu vaccine in cancer patients. It will involve 24 patients at The Ottawa Hospital undergoing surgery for abdominal tumours. Afterwards they will be given Cialis , with Agriflu.

The study is designed to evaluate safety and look for changes in the immune system. If successful, larger trials could look at possible benefits to patients. Dr Auer said: “We are really excited about this research because it suggests that two safe and relatively inexpensive therapies may be able to solve a big problem in cancer. “If confirmed in clinical trials, this could become the first therapy to address the immune problems caused by cancer surgery.”

Using a variety of mouse and human models, Dr Auer’s team has also made progress in understanding how impotence drugs and the flu vaccine affect cancer after surgery. Normally, immune cells called natural killer (NK) cells play a major role in killing cancer cells that have spread to other organs. But surgery causes another kind of immune cell called MDSC (myeloid derived suppressor cell) to block the NK cells. Dr Auer and colleagues found impotence drugs block these MDSCs, which allows the NK cells to do their job fighting cancer. The flu vaccine further stimulates the NK cells.(source)

US President Donald Trump’s new drug plan may hit India

WASHINGTON: US President Donald Trump on Saturday denounced foreign countries for “extorting unreasonably low prices from US drugmakers” to enable their citizens to pay much less than American consumers for the same drugs. Trump made the comments while unveiling his drug price policy which he said would “end the global freeloading” on US drug-making expertise “once and for all”.

The US President directed his top trade negotiator, Bob Lighthizer, to strongly take up with all countries the fixing of prices of American pharmaceuticals and medical devices, extending his ‘America First’ policy to put ‘American Patients First’ and vowing to “bring soaring drug prices down to earth”.

Trump’s new policy action could have an impact on India-US bilateral trade relations given that the American industry has been fighting with the recent move by the Indian government to fix prices of certain highly expensive pharmaceuticals and medical devices – like stents, for example.

Just last month, the US in its annual report card on the protection of intellectual property rights around the world had criticised the drug pricing and reimbursement policies of India and several other countries like Canada, South Korea, Japan, New Zealand and a number of European nations, saying that they did not adequately recognise the value of innovative medicines.

“America will not be cheated any longer, and especially will not be cheated by foreign countries,” Trump said at the White House Rose Gardens on Saturday. “As we demand fairness for American patients at home, we will also demand fairness overseas. When foreign governments extort unreasonably low prices from US drugmakers, Americans have to pay more to subsidise the enormous cost of research and development,” he said.

China’s Plan To Import Indian Medicines Receives Cold Response From Pharma Firms

On May 4, China, the second largest market for pharmaceuticals after the US, said it has removed import duties on as many as 28 medicines, including all cancer drugs, from May 1, a move which would help India to export these pharmaceuticals to the neighbouring country.

BEIJING:  China’s much-publicised announcement to slash tariffs on 28 medicines, including cancer drugs from India, has failed to create any buzz among the Indian pharmaceutical firms as exports to China are possible only after lengthy field trials and approvals, which could take years, an official at an Indian firm has said.

On May 4, China, the second largest market for pharmaceuticals after the US, said it has removed import duties on as many as 28 medicines, including all cancer drugs, from May 1, a move which would help India to export these pharmaceuticals to the neighbouring country.

“China has exempted import tariffs (duties) for 28 drugs, including all cancer drugs, from May 1. Good news for India’s pharmaceutical industry and medicine export to China. I believe this will help reduce trade imbalance between China and India in the future,” Chinese Ambassador to India Luo Zhaohui said in a tweet.

Mr Luo’s announcement generated optimism that India’s persistent demand from China to provide opening for Indian pharmaceutical firms to market their economically priced drugs compared to the multinational firms may be realised.

However, the official with the Indian pharmaceutical company said it is surprising to see the reports from the Indian media that the move to reduce tariffs will pave the way for exports of Indian pharmaceutical firms.

India plans measures to facilitate drug exports

The Central Drugs Standard Control Organisation (CDSCO), the apex regulatory authority that oversees the manufacture and sale of medicines in the country, has proposed a self declaration mechanism for pharmaceutical manufacturers for updation of information about the products they manufacture from their registered production centres. This information will then be verified by the State Licensing Authority.

The move is part of a series of industry friendly measures being planned by the apex regulator.

According to the proposal, the drug manufacturers licensed to manufacture in the country will be asked to upload the details of their manufacturing licences along with the list of the products permitted under such licences on an online data base developed by the government. The comprehensive database, termed “SUGAM”, will have the details of all the licenses issued by various state food and drug authorities (FDA) including the details of manufacturing sites, and approved products.

The CDSCO has created accounts on SUGAM for each state and is in the process of getting such accounts activated to facilitate the updation of the information.

The regulator is also exploring the possibility of relaxing the need for a no-objection-certificate (NOC) from CDSCO to manufacture and export drugs that are otherwise not approved for domestic use. At the moment, India’s drug law – the Drugs and Cosmetics Rules, 1945 – does not allow states to give manufacturing licenses for export of medicines that are not allowed to be sold in the country, without an NOC from CDSCO. The industry has been complaining that the need for such limited, export specific permissions, for manufacture of such drugs cause delay in executing export orders.

An apex drug advisory committee called “the Drugs Consultative Committee”, which draws members from the Centre and all the State Governments, is currently looking at these proposals to bring in uniformity in the administration of India’s drug regulations.

The suggestions of CDSCO are expected to streamline the process and facilitate the ease of doing business in the pharmaceutical sector, one of the most promising sectors where India has immense export growth potential.

According to the Pharmaceuticals Export Promotion Council of India (PHARMEXCIL), India’s pharmaceutical exports stood at $16.8 billion in 2016-17 and are expected to grow by 30 per cent, over the next three years, to reach US$ 20 billion by 2020. During April 2017- January 2018, India exported pharmaceutical items worth $10.76 billion.

India Brand Equity Foundation estimates that India accounts for 3.1-3.6 per cent of the global pharmaceutical industry in value terms and 10 per cent in volume terms. It is expected to grow to $100 billion by 2025. The market is expected to grow to $55 billion by 2020, thereby emerging as the sixth largest pharmaceutical market globally by absolute size. Branded generics dominate the pharmaceuticals market, constituting nearly 80 per cent of the market share (in terms of revenues). (link)

‘ISIS drug’ Tramadol comes under narcotics law regulation

NEW DELHI: Tramadol, a painkiller pharma drug, has been declared a “psychotropic substance” by the Union government and its sale in the country will now be strictly monitored after the NCB said it was being internationally smuggled, and had possible supply links to the global terror group ISIS.

The Union Finance Ministry, as per data accessed by PTI, has brought the drug under the control of the Narcotic Drugs and Psychotropic Substances (NDPS) Act and a gazette notification to this effect was issued on April 26  2018.

The Finance Ministry regulates certain sections of the NDPS Act like categorisation of pharma drugs as narcotic substances.
The synthetic opiate is known to be abused on a wide scale by terrorists of the so-called ISIS to suppress pain and boost strength during injury and hence, is also known as the ‘fighter drug’ among international anti-narcotics authorities.

The Narcotics Control Bureau (NCB), a national agency to coordinate drug law enforcement action by involving various state agencies, police and central departments, had asked the government in July last year to bring this drug under its “regulation and control” so that it could only be used for medicinal purposes and its abuse be checked.

“Tramadol, after the notification issued by the Department of Revenue under the Union Finance Ministry, will no longer be available freely over the counter in India.

“It will be regulated under the NDPS Act, which will empower the NCB and other law enforcement agencies to raid and prosecute those who prepare it without permission,” a senior official in the anti-narcotics establishment said.

The latest notification will ensure that the availability of Tramadol is substantially reduced and regulated, and agencies like the NCB and police are able to keep a tab on its movement. PTI had first reported on March 26 that the NCB has sought bringing Tramadol under the NDPS Act after it detected that it was being “diverted” illegally.
“Tramadol is used like codeine (another pharma drug). It is not covered under the NDPS Act, 1985. It is a schedule ‘H’ drug under the Drugs and Cosmetics Act, 1940 and can only be dispensed under the prescription of a registered medical practitioner.

“lt is also not included in any of the schedules of the 1971 UN convention on psychotropic substances. Internationally, it is banned in many countries and hence is often smuggled through India,” the NCB had said in its latest report released in March.

The drug, the NCB had said, “is trafficked via courier and manual means to countries like the US and Canada among others.”
The NCB gave out these details on Tramadol while reporting on the ongoing and emerging trends of drug abuse in the country in the last year by “diversion” of pharma drugs and hence sought its regulation.
Official records state that huge quantities of Tramadol were seized in the country last year, including in July when over 30,000 tablets of Tramadol Hydrochloride were seized from the cargo terminal of the Indira Gandhi lnternational Airport (IGI) along with other pharma drugs.

In another instance, in October last year, the NCB seized 710 tablets of Tramadol from the house of a Lucknow-based medicine supplier. These were supposed to be illegally dispatched to the United States of America (USA).  source