Sunday, April 7, 2019

IIT-Delhi startup Sanfe falsely claim FDA approval and AYUSH ministry certificate for a pain relief roll-on - Alt News

IIT-Delhi startup Sanfe falsely claim FDA approval and AYUSH ministry certificate for a pain relief roll-on - Alt News


IIT-Delhi startup Sanfe falsely claim FDA approval and AYUSH ministry certificate for a pain relief roll-on - Alt News

Posted: 07 Apr 2019 09:23 AM PDT

On 8th of March 2019, four IIT-Delhi entrepreneurs launched a product 'Sanfe Period Pain Relief Roll-On' that claimed to help women with menstrual pain. The start-up group who launched the product consists of two textile engineering students (Archit Agarwal & Harry Sehrawat ), a faculty of economics (Dr Seema Sharma), and a professor in the department of design (Prof Srinivasan Venkataraman) at IIT-Delhi.

As reported by the Times of India on the 11th of March, the Tech student Archit Agarwal stated that 24-hour long research for almost seven months was required to finalise a composition that helped them acquire the FDA approval.

Several news outlets such as Indian Express, NDTV, Times of India, The Economic Times, India Today, DNA India, reported as per the Official IIT Delhi website release.

Claims:

As per the archived version of the Sanfe article, reportage by major news outlets as listed above, and during a phone conversation with Sanfe co-founder Archit Agarwal, it was collectively claimed that:

  1. It has received 'FDA approval claiming no side-effects'
  2. It has received an 'AYUSH ministry certificate of safety' instead
  3. It is developed, medically tested in collaboration with AIIMS Delhi

Fact Check:

The claim of FDA approval

The Food and Drug Administration (FDA), USA, examines and approves a broad range of treatments for medical use including drugs and medical equipment. Although, FDA can approve drugs from international manufacturers, it is to ensure the safety of such products for Americans.

FDA approval of treatments is public information. After checking with two online databases here, (Drugs@FDA and Orange Book), it was found that Sanfe was not approved by the FDA.

A cross-check via email to the Division of Drug Information in the FDA's Center for Drug Evaluation and Research (druginfo@fda.hhs.gov). The FDA CDER confirmed that 'Sanfe Period Pain Relief Roll-On' is not a U.S. FDA approved drug product (see screenshot of email response below).

When we established our 1st phone contact with Archit Agarwal, the co-founder of Sanfe, he confirmed that Sanfe doesn't have the American FDA approval, but actually acquired the approval from FDA, Haryana.

During our 2nd phone contact, also with Archit Agarwal, he suggested they hadn't acquired any FDA approval but instead had a safety certificate from the AYUSH ministry, Haryana by the manufacturers called Space Organics, Haryana.

Upon confronting the reason behind their misleading adverts of FDA approval, he elaborated that the AYUSH certificate was 'FDA like' and hence was advertised that way.

2. The claim of AYUSH ministry safety certificate

During our 2nd phone contact with Archit Agarwal, he claimed that an AYUSH ministry certificate was acquired by the manufacturer Space Organics, Haryana, to determine the safety of the Sanfe roll-on.

Thereafter, we contacted the owner of Space Organics Mr Bhupender Nagpal. He stated that his company manufactured Ayurvedic treatments in collaboration with a sister company called Space Life Sciences, led by his son. Mr. Nagpal clarified that neither the FDA approval nor the AYUSH ministry approval exists for the 'Sanfe roll-on'.

3. The claim of clinically tested in collaboration with AIIMS Delhi

The previous version (archived here) of the Sanfe website, also claimed that it was tested in 79 people in conjunction with AIIMS, Delhi. The owner of Space Organics Mr Bhupender Nagpal who manufactured Sanfe roll-on clarified that no 'clinical' or 'medical' testing was conducted as a part of safety and toxicity tests. The reason given was that it wasn't cost-effective for a business to test a product in the market that has a lower purchase value per product in comparison to the cost of the clinical testing.

Research databases such as PUBMED also provided no studies referring to the specific Sanfe product.

Conclusions

All the claims listed above, i.e. FDA approval, AYUSH ministry safety certificate as well as clinical testing in collaboration with AIIMS, Delhi were not substantiated by the Sanfe founders.

Fact-checks from FDA and the Sanfe manufacturers called Space organics also confirmed that the treatment had no official approvals or any ongoing clinical testing.

After our phone calls to Sanfe, the information about FDA approval and clinical testing in AIIMS promptly deleted at official IIT-Delhi website but can be compared with the archived version available here.

However, major media outlets had reported that Sanfe was released after an FDA approval and none of those articles had been retracted. Archit Agarwal, the Sanfe founder also stated that the FDA claim was a 'mistake' and they have published a corrigendum in major newspapers but no such corrigendum have been published so far.

The infographics on Sanfe have also been changed to remove the 'mistakenly' added FDA approval.

These claims collectively made by members of leading government institutions such as IIT-Delhi is grossly misleading to include tags such as FDA, AYUSH and AIIMS to market the product as a private company.

Finally, major leading news outlets reproduced the press release without any cross-verification and added significantly to spreading the misleading, deceitful marketing for the Sanfe brand.

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Will The Enrollment Scandal At U.S. Colleges Impact International Student Applications? - Forbes

Posted: 07 Apr 2019 11:20 AM PDT

This combination photo shows actress Felicity Huffman, from left, actress Lori Loughlin and her husband, clothing designer Mossimo Giannulli, outside federal court in Boston on Wednesday, April 3, 2019, where they faced charges in a nationwide college admissions bribery scandal. Could the scandal increase international student apprehensions about eligibility and the value of U.S. studies?(AP Photos/Charles Krupa, Steven Senne) photocredit: ASSOCIATED PRESS

The recent scandal involving U.S. college admissions may include implications for international students as well. In the scandal, parents of college students admitted to some of the most prestigious colleges in America are alleged to have bribed college officials to gain enrollments for their children. The implication for foreign students is that American colleges and universities are not free from corruption in terms of gaining admissions. This is unwelcome news for the U.S. academic world in its efforts to stem the decline in foreign enrollments observed recently.

For many years, the United States has been the largest recruiter of international students in the world. In fact, the United States is home to over one million of the 4.6 million international students worldwide.  They come from every continent, representing over 230 countries. Of course, this comes as no surprise since the U.S. is home to some of the world's most prestigious educational institutions. Nonetheless, not enough attention is being paid to the fact that international students bring immeasurable academic, cultural, and economic value to U.S. campuses and communities.  Indeed, too few people realize that education is a vital part of the American economy, especially because of the income America earns from international students. This "service export" contributed almost  $40 billion to the U.S. economy in the 2017-2018 academic year alone and created over 455,000 jobs .  Not only is the revenue from international student enrollments used to create jobs, but it also backs the growth and development of U.S. educational institutions and subsidizes the cost of domestic student enrollment.

Unfortunately, however, international student enrollment in American colleges is declining.  According to a Council of Graduate Schools survey of more than 240 institutions, international graduate student applications fell by four percent between the fall of 2017 and the fall of 2018.  While the total number of international students in the U.S. grew last year to a total of over 1 million, new student enrollment declined by over six percent over the same period. Corruption at U.S. educational institutions may factor into future foreign student choices about coming here.

While some people believe international students crowd-out classes and campuses, reducing the opportunity for others, the reality is quite the opposite. They increase overall domestic enrollment, ultimately creating more opportunity. When it comes to science and engineering, where America falls short due to a lack of domestic students enrolling, international students step in and fill the available seats. With an expected continuous increase of only 0.2% over the next nine years in the American college-aged population, international students are essential to keeping class sizes and revenue up. Failure to promote international student enrollment may result in budget cuts that could eliminate programs or downsize overall student enrollment, including domestic enrollment.

Young hispanic woman wearing graduation uniform holding flag of United States exhibits a serious face thinking about question of possible corruption in enrollments on U.S. campuses and how that will affect international student enrollments.

Getty

American universities and colleges have not halted their international recruitment efforts, so why exactly are they having a hard time attracting students from overseas? Multiple factors have contributed to these recent declines. The Institute of International Education cites visa delays and denials, the cost of attending a U.S. school, and the Trump administration's hard-right immigration policies as the primary reasons for enrollment decreases. Being granted a student visa is hard enough, but international students are taking a long term view of the situation and the scene isn't pretty. The current green card approval process has a massive backlog of applicants from India and China, two of the biggest exporters of international students to the U.S. The proposed bill H.R. 1044, also known as the Fairness for High-Skilled Immigrants Act, would seek to alleviate this backlog by removing the per-country limit on green cards. However, while this may easy the pressure on Indian and Chinese students somewhat, the proposed new system would only end up subjecting applicants from all the other countries to long, strenuous wait times, thereby causing foreign talent from a wider array of countries to look elsewhere.

When you consider just how many of the most successful American companies were founded by foreign-born entrepreneurs, losing out on so much talent now will hurt American innovation in the long run.  AT&T, Capital One, Google and Tesla are just some of the world's largest and most successful Fortune 500 companies founded by foreign-born entrepreneurs. Despite 216 of Fortune 500 companies being founded by immigrants, America seems to have forgotten its rich history of foreign-born entrepreneurs. First-generation immigrants who once relocated to the U.S. in search of opportunity, have given life to companies like Google and Facebook. Others like Apple and Amazon are founded by second-generation immigrants. These four companies have a combined market valuation of roughly three trillion dollars. In fact, a large percentage of U.S. startup companies first came to America to pursue a quality education. This begs the question - why not pave the way for more international students rather than turn them away? Especially since studies show immigrants are more likely to start their own businesses in the U.S. than native-born people.

The statistics indicate there is a direct correlation between international student enrollments and start up companies in the USA.

Getty

There are certainly real risks if the U.S. continues on its current path. A decline in international students may mean fewer outstanding new companies, less creative research, a drop in innovation, an erosion of prestige in education, and less employment. In short, going forward, policymakers need to prioritize marketing the U.S. as a welcoming study destination for international students, and removing the impediments in the way, or risk losing Americas hard-earned reputation as a world leader in education. Getting to the bottom of the corruption scandal is another element that needs to be addressed so as to reassure foreign students of their eligibility and the value of an American education. It's time to roll up our sleeves and get this house back in order.

16th Edition of Start up Master Class Organized by the IIT Kanpur Alumni Association in New Delhi - BW Businessworld

Posted: 07 Apr 2019 03:32 AM PDT

Through its 14 editions, organized across various cities in India - Bangalore, Pune, Delhi, Hyderabad, Patna, Kanpur, Mumbai, SMC has engaged more than 6000 start-up enthusiasts, 500+ delegates and 1000+ start-ups.

Startup Master Class ( SMC ), the flagship entrepreneur event of Alumni Association IIT Kanpur, was organized along-with IITK Incubation centre, E Cell and other participating IIT's and IIMs. Fostering and nurturing budding entrepreneurs, it brings together start-ups, mentors and investors to build interactions and strengthen the network within the entrepreneurial community.

The vision of the overall event was to showcase current opportunities and the future of the technology in an exciting mix of verticals that weave in the key areas and lay them on the background of deep-tech & innovation. To bring Central and State level Initiatives, areas where competencies are built and the area where delivery can be assured together.
 
 Through its 14 editions, organized across various cities in India - Bangalore, Pune, Delhi, Hyderabad, Patna, Kanpur, Mumbai, SMC has engaged more than 6000 start-up enthusiasts, 500+ delegates and 1000+ start-ups. This has created an ecosystem for start-ups to leverage the power of the Alumni - the expertise, mentoring, funding, government and corporate connects - to support their journey.

 SMC's 16th Edition traced the changing game with string leadership at Delhi, exciting entrepreneurs & the proximity of the central policy driving dignitaries. The focus areas for Delhi edition included:

1.     Healthcare

Healthcare Infrastructure, affordable care along with the innovations that are important for the right scaling up in India

2.     Mobility

Transport continues to evolve given the expanse of the country, its large population. Besides being affordable, renewable, efficient and non-polluting sources are the key

3.     Fintech

Currency, payments, security and the ease of transaction all are required in the near time . How Fintech will evolve in India and the changing role of the stake holders will be considered
 
 The program format included the following:

·       Plenary session

·       Entrepreneur speaker

·       Theme Panels with speakers with a mix of entrepreneur, investor domain

·       Workshops

·       SMC Select: Top 10 startups pitch to the investors and mentors

·       1 on 1 for the attendees to meet the speakers and the mentors


 Saurabh Srivastava, Founder NASSCOM, spoke about some of the major factors that any startups should look for, in terms of what Investors would want to know, in order to make an informed. It includes:

- Customer: Knowing the customer is an important thing for any startup, to understand the kind of people that the product or service may serve.

- Market Size: How big the market may be, for any startups is also a major factor that Mr. Srivastava included. After a startup may understand the size and potential of any market, it is important to see the market from an economic point of view and create a USP accordingly as per the competitors in the related domain. It is often not a big yes for any investor if there is no or little competition.

One of the interesting things that Srivastava mentioned was the importance of the brain behind any initiative, more than the data that may fancy any spreadsheet. It is important to understand the potential of any team and how well the team may execute the solution of any problem in hand. The potential of any team may decide whether or not; how well it may cover all the bases. Arrogance, on the other hand is a big no in an investor's eye. It is important for an investor to understand his exit options and the return that he may get for his investment. The entrepreneur in case should ask himself/herself whether he/she knows the different between cash flow and profit. In order to make sure a healthy relationship and the overall growth of a startup, an entrepreneur must choose the investor very carefully. In the end, Mr. Srivastava mentioned that it always good to be passionate but if something is not working, one must never be afraid to drop and idea or to fail, for that matter.

Amitabh Kant, CEO, NITI Aayog spoke about the different ways and schemes that the government has implemented, to ensure a better and helpful environment for the emerging startups in the country. He went forward praising the excellent efforts by the Startup Masterclass community in nurturing the entrepreneurial cultural in the country and extended the support in various aspects. NITI Aayog has been working in making the whole startup spirit to glow further in the country envisioning an overall productive and efficient ecosystem, where startups may nurture in the country.
 
 He mentioned that there is a difference in the startup culture and market of India and USA and further suggested some ways in which Indian startups may grow and the ways in which different government initiatives like Startup India may help the enthusiastic entrepreneurs of the country. It is good to observe the positive environment that is being envisioned by the CEO of NITI Aayog and his efforts in making the whole ecosystem to flourish and work efficiently. Mega events like SMC may help providing a helping hand in making sure that such efforts may benefit the members who are in this game of making money and taking the economy to a new high.  

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