Category Archives: NEWS

Sildenafil (Viagra) May Cut Colorectal Cancer Risk

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


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 may hit India

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

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.

 “For Indian pharmaceutical companies, it is not going to be much different as imports of Indian drugs both generic and anti-cancer is possible only with the approval of China Food and Drug Administration (CFDA),” the official told news agency PTI on the condition of anonymity.

The announcement has not created any enthusiasm among the Indian firms as for both oral and injectable drugs a lengthy process of clearances is required in China which may take anywhere between two and half years to three years.

India has been lobbying actively with China to ensure quick clearances but it has not worked so far, he said. Any exports to China at this point of time is possible only if Beijing accepts certification by US Food and Drug Administration, which has approved a whole host of Indian drugs.

“As regards India benefiting because China has lifted import tariffs, I do not see it as a measure that is specifically favouring the Indian pharmaceutical products alone,” V Viswanath, a Beijing based senior consultant for Indian, Chinese as well as multi-national pharmaceutical firms told news agency PTI.

“This will benefit all imported products irrespective of which the country of origin is,” he said, highlighting the long drawn out struggle by Indian pharmaceutical firms to enter Chinese markets despite persistent campaign.

India has been asking China for long to open up its IT and pharmaceutical firms to reduce the trade deficit which has claimed to over $50 billion.

But ahead of Mr Luo’s announcement, China’s Cabinet or State Council on April 12 has approved a proposal that China will exempt import tariffs on all cancer drugs and encourage the import of more innovative drugs.

From May 1, import tariffs on all common drugs including cancer drugs, cancer alkaloid-based drugs, and imported traditional Chinese medicine will be exempted, state-run Xinhua news agency quoted an official statement as saying.


Beijing, May 13 (PTI) Chinas 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 here 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 Indias 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.

Luo?s announcement generated optimism that Indias 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.

“For Indian pharmaceutical companies, it is not going to be much different as imports of Indian drugs both generic and anti-cancer is possible only with the approval of China Food and Drug Administration (CFDA),” the official told PTI on the condition of anonymity.

The announcement has not created any enthusiasm among the Indian firms as for both oral and injectable drugs a lengthy process of clearances is required in China which may take anywhere between two and half years to three years.

India has been lobbying actively with China to ensure quick clearances but it has not worked so far, he said. Any exports to China at this point of time is possible only if Beijing accepts certification by US Food and Drug Administration, which has approved a whole host of Indian drugs.

“As regards India benefiting because China has lifted import tariffs, I do not see it as a measure that is specifically favouring the Indian pharmaceutical products alone,” V Viswanath, a Beijing based senior consultant for Indian, Chinese as well as multi-national pharmaceutical firms told PTI.

“This will benefit all imported products irrespective of which the country of origin is,” he said, highlighting the long drawn out struggle by Indian pharmaceutical firms to enter Chinese markets despite persistent campaign.

India has been asking China for long to open up its IT and pharmaceutical firms to reduce the trade deficit which has claimed to over USD 50 billion.

But ahead of Luo?s announcement, China?s Cabinet or State Council on April 12 has approved a proposal that China will exempt import tariffs on all cancer drugs and encourage the import of more innovative drugs.

From May 1, import tariffs on all common drugs including cancer drugs, cancer alkaloid-based drugs, and imported traditional Chinese medicine will be exempted, state-run Xinhua news agency quoted an official statement as saying.

Value Added Tax in the production and import of drugs will drop by a large margin, it said.

The authorities will reduce the prices of cancer drugs through centralised government procurement and eliminate premium prices for drugs by means of cross-border e-commerce, it said.

Imported innovative drugs, especially much-needed cancer drugs, will be incorporated into the catalogue of medical insurance reimbursement, the statement said.

So as of now there is nothing specific for Indian pharmaceutical industry as such, the Indian pharma firm, the Indian pharma firm official said.

The move is aimed at reducing exorbitant costs of medicines in general and cancer drugs in particular by the multinational firms in China, he said.

The tariff reduction is also not going to amount much as it accounts to only about three to four percent, which is negligible, he said.

In fact, the reimbursement for cancer drugs by the provincial and central governments is aimed at prevailing on the innovator multinational companies to reduce their prices, which they will considering the size of the Chinese market, he said.

With reimbursement on cards the multinational companies are going to bring down their prices to cash in on the scheme, he said adding that this may even stop the rampant smuggling of Indian cancer drugs to China as prices will come down.

“Pharma companies in general and Indian Pharma companies in particular have struggled to get their products approved by the China Food and Drug Administration (CFDA) which is the first step in commercialisation of products. Pharmaceuticals can only be imported and sold in China if they are registered with CFDA,” Viswanath said.

The announcement by China to import Indian drugs need to be “followed up with a more specific bilateral arrangement between China and India”, he said.

This is necessary as quality pharmaceutical products which are at very affordable prices are given fast-track approvals in CFDA.

India plans measures to facilitate drug exports to abroad

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

‘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