India-UK FTA may tighten screws on Generic drugs. Britain doing Big Pharma Bidding?

Several international organisations working to improve people’s access to medicines have written to the UK government protesting against provisions in a proposed India-UK FTA after the chapter on intellectual property was leaked. The provisions related to pharmaceutical IP could prevent India from making affordable generics on which the National Health Service (NHS) of the UK and several other countries depend. India’s ability to produce generics is crucial not only to the Global South but to the UK too.

Four out of five drugs used in the NHS are generics and a third of these are produced in India. So about 25% of the drugs in the NHS come from India. Between 2011 and 2016, the NHS started to experience a crisis in the amount of money it was spending on new, very expensive drugs. The amount the NHS spent rose in those years by £3.8 billion. That is more than twice the total NHS deficit at that time – £1.85 billion. The crisis was so severe that the NHS began to look for ways to save money, including importing more generics. It worked.

International non-profit calls upon calls upon India to stay vigilant and asks the U.K. to withdraw intellectual property proposals.

The proposals on intellectual property (IP) rights in the draft India-United Kingdom Free Trade Agreement (FTA) will hurt the global supply of generic medicines, Doctors Without Borders (Médecins Sans Frontières or MSF) warned on Wednesday. In a press note, the international organisation said low medicine prices help save lives in vulnerable communities across the world but the intellectual property chapter of the India-U.K. FTA contains “harmful IP provisions”. The IP-related chapter, leaked on October 31, showed that the controversial provisions tabled by the U.K. to “tighten the screws on producing, supplying and exporting affordable generic medicines from India”.

“Given the disastrous consequences, this leaked IP chapter could have on the global supply of generic medicines, the U.K. government should withdraw it completely. India should stay vigilant and not allow barriers to affordable medicines to be written into FTA negotiations,” Leena Menghaney, South Asia head of MSF’s Access Campaign, said.

U.K.-India trade talks continuing

In a “Fact Sheet”, MSF has argued that the demand for “harmonisation” of Indian patent law with the U.K.’s laws will lead to dilution of important provisions in the Indian patent system that are necessary for manufacturing generic medicines and vaccines.

“Article E.10 of the leaked IP chapter stipulates that both parties “shall not” make patent opposition proceedings available BEFORE the grant of a patent. In effect, this provision applies only to India as the U.K. does not have a pre-grant opposition system – this goes directly against the current Indian patent law, which allows patent opposition proceedings both before and after the grant of a patent,” the MSF said in its observations on the IP provisions.

MSF pointed out that under the proposals from the U.K., even treatment providers could be subjected to legal actions for prescribing generic medicines for which India is one of the largest manufacturing hubs. MSF said that the IP provisions brought up by the U.K. opened up possibilities for “excessive enforcement” that are likely to create difficulties for both Indian pharmaceutical companies as well as the legal set-up.

MSF highlighted that another problematic provision is Article J.11 of the leaked IP chapter. Under this provision, Customs officials could block legitimate medicines from leaving India for other developing countries if a multinational pharmaceutical corporation was to claim that their patents were being infringed upon by the Indian product. “Furthermore, Article J.5 and J.7 prescribe how courts should adjudicate IP disputes, which could impact [Indian] judicial discretion,” MSF said.

A British government spokesperson said they would not comment on the “alleged leaks” and will only sign “a deal that is fair, reciprocal, and ultimately in the best interests of the British people and the economy”.

“The U.K. and India are negotiating an ambitious Free Trade Agreement that will boost our current trading relationship, already worth more than ₤24 billion last year,” the spokesperson told The Hindu.

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November 11, 2022 0

Time to Regulate Health Administrators & Pharmaceuticals like Doctors #CBI- arrests-Joint-Drugs-Controller

CBI has arrested Joint Drugs Controller for allegedly taking a ₹4 lakh bribe to clear injections made by Biocon Biologics .The CBI has arrested Joint Drugs Controller S Eswara Reddy for allegedly receiving a Rs 4 lakh bribe from a conduit to waive the Phase 3 clinical trial of the ‘Insulin Aspart’ injection, an under development Biocon Biologics product to manage Type 1 and Type 2 diabetes, officials said on Tuesday.

The incident may be just a tip of the iceberg, to indicate collusion between administrators and various industries. It is the time to regulate all important components of health industry including health administrators as doctors are regulated – to achieve real cost effective health care.

In last few decades, as doctor-patient relationship has been getting more complex and medical industry has controlled the financial interaction, the medical costs have become expensive. Hence the health insurance industry is gradually becoming indispensable. As doctors are at the front and remain the visible component, they are blamed for the expensive medical treatments. The tremendous rise in health care expenses is usually borne by the government, taxpayer, insurance or patient himself. Therefore there has been an increasing dependence on investors in health care, along the lines of an industry to ensure its financial viability. 25 factors- why health care is expensive

Complex interplay of various industries like pharmaceutical, consumable industry and other businesses associated with health care remain invisible to patients. Various important components for example pharma industry, suppliers, biomedical, equipment, consumables remain unregulated. There is large number of administrators involved in such processes. Although doctors are strictly regulated and kind of over-regulated but such administrators and financial controllers who play important part in medicine, cost, sale and purchase, remain largely unregulated. Because of such undeserved criticism, doctors have actually been alienated from financial aspect but still they are often perceived as culprits for cost escalation.

CBI has arrested Joint Drugs Controller for allegedly taking a ₹4 lakh bribe to clear injections

The CBI has arrested Joint Drugs Controller S Eswara Reddy for allegedly receiving a ₹4 lakh bribe to waive the phase three clinical trial of the Insulin Aspart injection, a product of Biocon Biologics under development to manage Type 1 and Type 2 diabetes, officials said on Tuesday.

CBI has arrested Joint Drugs Controller for allegedly taking a ₹4 lakh bribe to clear injections made by Biocon Biologics

Biocon Biologics is a subsidiary of the Biocon. The company has denied allegations.The agency has also arrested director at Synergy Network India Private Limited, who was allegedly giving Reddy a bribe, they said.

After completing the necessary paperwork, the CBI has arrested Reddy and Dua, nabbed during a trap operation on Monday while the alleged bribe exchange was going on, the officials said.

The CBI has also booked Associate Vice President and Head-National Regulatory Affairs (NRA), Biocon Biologics Limited, Bangalore, L Praveen Kumar, as well as Director, Bioinnovat Research Services Private Limited, Delhi, Guljit Sethi in the case under IPC sections of criminal conspiracy and corruption.

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June 21, 2022 0

Price fixing by broad generic drug makers in collusion : allege 45 US states

The states said the drug makers and executives divided customers for their drugs among themselves, agreeing that each company would have a certain percentage of the market.

How large companies create a web of corrupt practices, and earn huge profits, is a common prevalent sentiment. Tip of the Iceberg has been revealed indicating a collusion among generic drug makers, to jack up prices. If these allegations are proved correct, it may expose one reason of exorbitant prices of pharmaceutical industry. Whereas doctors are blamed for healthcare being expensive, the real health industry remains hidden and earning huge profits by dubious means.

Soaring drug prices from both branded and generic drug manufacturers have sparked outrage and investigations in the United States. President Donald Trump this year accused pharmaceutical companies of “getting away with murder” with their drug pricing.

It might be the biggest price-fixing scheme in U.S. history. On Friday, Connecticut and a coalition of more than 40 states filed a 500-page lawsuit accusing the biggest generic drug makers of a massive, systematic conspiracy to bilk consumers out of billions of dollars. It’s a more sweeping version of a similar lawsuit the states filed in 2016 that’s still being litigated. The generic industry vehemently denies the allegations.

Congress established the current generic industry in 1984 to push prices down. The idea was that once patents on brand name drugs expired, generic makers would compete to make drugs more affordable. But 1,215 generics, many of them the most prescribed drugs, jumped on average more than 400 percent in a single year.

A large group of US states accused key players in the generic drug industry of a broad price-fixing conspiracy, moving on Tuesday to widen an earlier lawsuit to add many more drug makers and medicines in an action that sent some company shares tumbling.

The lawsuit, brought by the attorneys general of 45 states and the District of Columbia, accused 18 companies and subsidiaries and named 15 medicines. It also targeted two individual executives: Rajiv Malik, president and executive director of Mylan NV, and Satish Mehta, CEO and managing director of India’s Emcure Pharmaceuticals.

Shares of Pennsylvania-based Mylan, also named as a defendant, closed down 6.6%.

The states said the drug makers and executives divided customers for their drugs among themselves, agreeing that each company would have a certain percentage of the market. The companies sometimes agreed on price increases companies sometimes agreed on price increases in advance, the states added.

The states said Malik and Mehta spoke directly to one another to agree on their companies’ shares of the market for a delayed-release version of a common antibiotic, doxycycline hyclate.

“It is our belief that price-fixing is systematic, it is pervasive, and that a culture of collusion exists in the industry,” Connecticut Attorney General George Jepsen, who is leading the case, told a news conference in Hartford.

Mylan said in a statement it had found no evidence of price-fixing by the company or any of its employees, and vowed to defend itself vigorously. Malik, the company’s second-ranking official, has received more than $50 million in compensation over the past three years, last year making more than CEO Heather Bresch.

Emcure, also a defendant in the case, did not immediately respond to a request for comment.

Two former executives of Emcure’s subsidiary Heritage Pharmaceuticals pleaded guilty in January to federal charges of conspiring to fix prices and divide up the market for doxycycline and the diabetes drug glyburide.

The two men, former Heritage president Jason Malek and former chairman and chief executive Jeffrey Glazer, reached a deal with 41 states and territories in which they each agreed to pay $25,000 and cooperate with the state probe.

Executives like Mylan’s Bresch and former Turing Pharmaceuticals CEO Martin Shkreli

have been called in front of Congress to defend the cost of their products.

MORE COMPANIES TARGETED

The original complaint, filed in December, targeted Mylan, Heritage, Aurobindo Pharma USA Inc, Citron Pharma LLC, Mayne Pharma USA Inc and Teva Pharmaceuticals USA Inc.

The states are pressing a new complaint that would add Novartis AG’s unit Sandoz, India-based Sun Pharmaceutical Industries Ltd, Endo International PLC’s unit Par Pharmaceutical, Dr

Reddy’s Laboratories, Apotex Corp, Glenmark Generics Ltd, Lannett Company Inc, Alkem Laboratories Ltd’s unit Ascend Laboratories and Cadila Healthcare Ltd’s unit Zydus Pharmaceuticals Inc.

Jepsen said the investigation is continuing, and that claims would likely be brought against more companies, and possibly executives, in the future.

The news hurt shares of companies named in the expanded suit that are traded in the United States. In addition to Mylan’s drop, Lannett lost 13.7 percent. Shares of Endo were up 7 percent, but down from their 12 percent peak before the news of the amended lawsuit.

Teva spokeswoman Denise Bradley said the company denied the allegations. Endo spokeswoman Heather Lubeski said the company would vigorously defend itself against the claims. Other companies did not immediately respond to requests for comment

The expansion of the suit requires the court’s permission.

The original lawsuit centred on just two medicines, delayed-release doxycycline and glyburide.

The price of doxycycline rose from $20 for 500 tablets to $1,849 between October 2013 and May 2014, according to US Senator Amy Klobuchar, a Minnesota Democrat who had been pressing for action on high drug prices.

The amended complaint would expand the number of drugs to include glipizide-metformin and glyburide-metformin, which are among the most commonly used diabetes treatments.

Others include: acetazolamide, which is used to treat glaucoma and epilepsy; the antibiotic doxycycline monohydrate; the blood pressure medicine fosinopril; the anti-anxiety medicine meprobamate; and the calcium channel blocking agent nimodipine.

The US Justice Department is conducting a parallel criminal investigation. On Friday, the department asked the Pennsylvania court presiding over the lawsuit to put the lawsuit’s discovery process on hold, saying it could interfere with the criminal probe.

Connecticut Assistant Attorney General Joseph Nielsen said on Tuesday the states would likely oppose that request, which could slow the lawsuit.

source

May 14, 2019 0

Leopard tortoise designed pill to administer insulin in diabetes

The discovery has a potential to transform lives of millions of patients with diabetics. It can counter the availability and cost of insulin in future. If successful , the new technology can even change the delivery of other drugs as well.

Scientists have developed a “needle pill” that could allow diabetics to take insulin without the need for daily injections.

The pea-sized capsule contains a small needle made of solid, compressed insulin, which is injected into the stomach wall after the capsule has been swallowed.

When tested in pigs, the device worked consistently and was able to deliver equivalent doses of insulin to those required by someone with diabetes.

Giovanni Traverso, an assistant professor at Harvard Medical School affiliated Brigham and Women’s hospital and a co-author of the study, said: “Our motivation is to make it easier for patients to take medication, particularly medications that require an injection. The classic one is insulin, but there are many others.”

Injections can be painful, cause injuries and be a barrier to people taking medication, he added.

The shape of the capsule is inspired by the leopard tortoise, found in Africa, which has a steep, domed shell that allows it to right itself if it rolls onto its back. In the case of the capsule, the domed shape ensures that the needle is continually reoriented towards the stomach wall. The needle is attached to a compressed spring that is restrained by a disk made from sugar. When the capsule is swallowed, water in the stomach dissolves the disk, releasing the spring and injecting the needle into the stomach wall.

The stomach wall does not have pain receptors, so it is unlikely that this would cause any discomfort. The insulin needle takes about an hour to dissolve into the bloodstream. In tests in pigs, the researchers said they were able to deliver five milligrams of insulin – comparable to the amount that a patient with type 2 diabetes would need to inject.

The metal spring and rest of the capsule passed through the digestive system, without seeming to cause any problems.

The team are now carrying out further tests in pigs and dogs and hope to start the first human trials within three years.

February 12, 2019 0

Modern medicine still primitive compared to “Superbugs”

Antibiotic resistant superbug gene discovered in remote Arctic area thought to be among ‘last pristine ecosystems’ on Earth, shocking study reveals

Antibiotic resistant gene first found in Delhi waters in 2010 now found in Arctic
Researchers say it likely spread through human activity and bird, animal waste
In recent years, antibiotic resistance has grown to be a global health crisis

More the medical science has evolved, more we realize the primitiveness in front of natural phenomenon, the environmental systems and life around us. The evolution and adaptation of microbes, which we have discovered for just last hundred years, are in existence for millions of years, much before humans. Discoveries like this, just make us realize about our primitiveness in front of a superpower, which is best known as “Nature”. Scientists have found a gene linked to antibiotic-resistant superbugs in an area said to be one of the last ‘pristine’ locations on Earth.

These antibiotic-resistant genes (ARGs) were first detected outside of the lab in 2010 in surface waters in Delhi, India.

But now, experts say the genes have traveled roughly 8,000 miles through human activity and the fecal matter of birds and other wildlife to reach a remote area in the Norweigian archipelago, Svalbard.

The discovery doesn’t bode well for the fight against antibiotic resistance, which has grown to be a global health crisis in recent years.

In a new study published to the journal Environmental International, researchers form Newcastle University report the discovery of the gene blaNDM-1 and other antibiotic-resistant genes in Kongsfjorden, Svalbard.”

This gene is carried in the gut of animals and people.

‘Polar regions are among the last presumed pristine ecosystems on Earth, providing a platform for characterizing pre-antibiotic era background resistance against which we could understand rates of progression of AR “pollution,”’ said David Graham, an environmental engineer at Newcastle University.

‘But less than three years after the first detection of the blaNDM-1 gene in the surface waters of urban India we are finding them thousands of miles away in an area where there has been minimal human impact.

‘Encroachment into areas like the Arctic reinforces how rapid and far-reaching the spread of antibiotic resistance has become, confirming solutions to AR must be viewed in global rather than just local terms.’

Strains carrying blaNDM-1 were first identified in the lab in 2008 before they were found in Indian waters just two years later.

In the few years since, it’s been detected in over 100 more countries.

‘What humans have done through excess use of antibiotics on global scales is accelerate the rate of evolution, creating a new world of resistant strains that never existed before,’ Graham said.

Through the overuse of antibiotics, fecal releases, and contamination of drinking water, we have consequentially speeded-up the rate at which superbugs might evolve.

‘For example, when a new drug is developed, natural bacteria can rapidly adapt and can become resistant; therefore very few new drugs are in the pipeline because it simply isn’t cost-effective to make them.’

For the new study, the researchers analyzed DNA from forty soil cores taken from eight locations across Kongsfjorden.

And, they found a total of 131 ARGs in the samples

The resistance genes detected were associated with nine major antibiotic classes, including aminoglycosides, macrolides and β-lactams, which are used to treat many infections,’ Graham said.

‘As an example, a gene that confers MDR in Tuberculosis was found in all cores, whereas blaNDM-1 was detected in more than 60% of the soil cores in the study.

‘Identifying an ARG ‘gradient’ across the study landscape, which varies as a function of human and wildlife impact, shows there are still isolated Polar locations where ARG levels are so low they might provide nature’s baseline of antimicrobial resistance.’

According to the team, improvements in waste management and water quality around the world will be keep in staying on top of the spread of ARGs.

The gradient of resistance genes closely reflects corresponding indicators of wastes in the geochemistry, which suggests a novel basis for identifying sites for further AMR research,’ said lead author Dr Clare McCann.

January 30, 2019 0

Pharma industry sale growth rate doubles: reason to rejoice or matter of concern?

While for pharma industry, news is a matter to rejoice, but for common man and doctors, there may be something to worry or concern. The advancements in medical science & knowledge should lead to prevention of diseases , the use of medicines need to decline. With more mechanisms for diseases are discovered, should lead to lesser occurrence of diseases (preventive). There can be good reasons for pharmaceutical growth like more people using the medical systems and thereby consumption of medicine has increased, that can be a simple argument to support the growth. There can be scientific and pharmaceutical advancements, leading to healthy growth.

But there can be complex and thought provoking counter arguments, like more number of people suffering from diseases. There can be system failures and inability to prevent diseases resulting in more people falling sick and forced to take more medicines. If diseases like cardiac , respiratory and cancer are on the rise , a common man should be worried about life style, stress and our environment. What if infections are on the rise leading to more consumption of antibiotics? There can be chances that antibiotics are overused and misused. There can be other uncomfortable thoughts in few minds, which worry all the patients and many among medical fraternity. These are like overuse of medicines by doctors or even unauthorized physicians. There can be possibility of people indulging in crosspathy or aggressive marketing by pharma companies.

The domestic pharma retail market registered a robust growth rate of around 10% in 2018, nearly doubling year-on-year, buoyed by higher volumes and launch of new drugs. In 2017, the market was impacted by the introduction of GST, resulting in a meagre growth rate of 5.5% – the lowest in recent years. Anti-diabetics, cardio-vascular, respiratory and derma medicines ended the year with strong double-digit growth, while overall drivers of the Rs 1.29-lakh-crore market include higher volumes (4.8%), price increase (2.2%) and new launches (2.4%), data from market research firm AIOCD-Awacs said. For December alone, the market showed 9.8% growth, higher than in November. In fact, growth has been consistently above 9% over the last four quarters.Expansion was driven by top domestic companies mainly by Anti-diabetic therapy, Ayurvedic hepatic protector Liv 52, Anti-infectives , cardiac, gastro-intestinal.

Be it any reason for pharmaceutical growth, people need to know about reasons for rocket trajectory growth of pharma companies . It indirectly depicts the health of the people and unfortunately inversely proportional to it. So there may be more matter to worry than rejoice.

January 22, 2019 0

Global corrupt medical (#implant) market & unholy nexus: tip of iceberg revealed

With aberrant evolution of modern medicine and advancement of medical procedures, everything appears to be controlled by medical industry. The investors have gained control of the financial game. How large companies create a web of corrupt practices, and earn huge profits, is a common prevalent sentiment. Tip of the Iceberg has been revealed indicating inducements to some doctors and dubious deals with hospitals. If these are the hallmarks of the big unregulated medical bazaar in India and some others, a rare case involving a global major has put a figure to it.

In a filing two months ago, the top financial regulator in the USA, the Securities and Exchange Commission (SEC), ordered the world’s leading manufacturer of orthopaedic implant devices, Stryker, to pay $7.8 million (over Rs 55 crore) in settlement for violating its corruption norms in India, China and Kuwait, documents accessed by The Indian Express reveal.

The settlement, recorded by the SEC on September 28, came after the Commission’s “accounting and audit enforcement” proceedings noted a number of “violations” by the company’s Indian subsidiary and its dealers. These “violations” include questionable payments to doctors for “consulting fees, travel, and other benefits” and “inflated invoices” issued to “mostly large, corporate hospitals”.

And that’s not all. In 2012, the anti-monopoly regulator, Competition Commission of India (CCI), fined an authorised distributor of Stryker India and two other firms Rs 3 crore for allegedly rigging bids, manipulating tenders and forming a cartel to sell equipment to the All India Institute of Medical Sciences (AIIMS) and Safdarjung Hospital, two of the largest government hospitals. In its scrutiny of Stryker’s India operations, including the findings of internal audits between 2010 and 2015, the US SEC concluded: “Payments intended to benefit HCPs (Health Care Providers) also lacked sufficient documentation, such as consulting fees paid to doctors without adequate explanation of the doctors’ consulting services or hours billed, and payments for HCP travel with documentation that appeared falsified…

“Additionally, the forensic review found missing or inaccurate documentation for numerous other transactions flagged as high-risk, including expenses related to consulting fees, travel, and other benefits to health-care professionals in India.”

The US regulator’s severe indictment of Stryker’s India operations is one of the most startling findings to emerge from the Implant Files investigation by The Indian Express and the International Consortium of Investigative Journalists (ICIJ) on the medical bazaar, where pharma majors hard sell their products without any regulation via a dubious nexus with hospitals and doctors.

Stryker India has four offices in the country — Delhi NCR, Mumbai, Chennai and Kolkata — and an annual turnover of Rs 300 crore in FY 2017-18, mainly from selling hip and knee implants, and medical devices for spine and neuro surgeries. The US-based parent company has a market cap of $58.87 billion with operations spread across 100 countries covering Asia, Europe, Africa and Latin America.

Dubious deals with hospitals:

Private hospitals that “requested inflated invoices from dealers profited from their purchase of Stryker orthopaedic products by passing on the higher (invoiced) prices to their patients or their patients’ insurers, even as the hospitals paid the lower prices previously negotiated with Stryker India to Stryker India’s dealers”, the US SEC found.

In doing so, the SEC said, the dealers “allowed these private hospitals to gain a windfall from passing on the higher (invoiced) prices to their patients or their insurance companies”.

Linking Stryker to these deals, the regulator said: “Stryker India authorized these dealer transactions only after Stryker India’s management negotiated and approved the price that the hospitals would pay to the dealers. Thus, in determining the price charged to dealers, Stryker India’s management and the dealers specifically negotiated the profit margin such dealers would stand to earn based on the difference between what hospitals paid the dealers and what the dealers paid Stryker India.”

SEC records do not identify the dealers involved. But documents maintained by CCI show that it had fined PES Installations, an authorised distributor, and two other firms, MDD Medical System and Medical Product Services (MPS), Rs 3 crore in April 2012 for a number of alleged irregularities in sale of equipment to AIIMS and Safdarjung Hospital, both in Delhi.

Responding to a questionnaire from The Indian Express on the SEC findings, Stryker said in a statement: “We are committed to working with our customers to make healthcare better while operating ethically and in compliance with all applicable laws and regulations.”

The US SEC, meanwhile, found a number of similar violations in Stryker’s operations in China and Kuwait, too. According to the SEC, it took into consideration “Stryker’s cooperation and remedial acts undertaken” while deciding to accept the company’s settlement offer to be paid “within 14 days”.

Unlike in India, the US has robust anti-corruption checks in place with the Foreign Corrupt Practices Act (FCPA), enacted in 1977, prohibiting the payment of bribes to foreign officials to assist in obtaining or retaining business, and mandating companies “to maintain accurate books and records”. In Stryker’s case, the SEC decided on a settlement after issuing a “cease-and-desist” offer to the company.

WHAT THE US REGULATOR FOUND

Inadequate oversight of dealers

* In 2012, in response to allegations of misconduct concerning Stryker India’s dealers, Stryker exercised its audit rights over three dealers in India. Those audits revealed insufficiencies in the financial record-keeping and internal accounting controls of all three dealers. Additionally, Stryker identified suspicious expenses by one dealer and instances of another dealer over-billing a hospital upon the hospital’s request. While Stryker took some corrective actions in response to these audits, including terminating one of the three dealers, the actions were limited to the three dealers audited.

* (The)deficiencies violated Stryker India’s agreements with its dealers. Specifically, the deficiencies in dealers’ financial record-keeping violated dealers’ obligation to “maintain complete and accurate records relating to [their] promotion, marketing, use and distribution of [Stryker] Products,” and the over-billing violated Stryker’s business conduct policy prohibiting participation in any improper payments. Despite the red flags raised during the 2012 audits, and numerous complaints reported to Stryker of dealer misconduct, Stryker did not act to determine the scope of dealer-inflated invoices until 2015.

* In 2015, Stryker performed audits of other dealers in India. The audits revealed that the practice of Stryker India’s dealers inflating invoices for the sale of Stryker orthopaedic products to certain private hospitals — an improper practice identified three years earlier in connection with the 2012 audits — had become more widespread.

Lack of accurate books, records

* From 2010 through 2015, Stryker India failed to make and keep complete and accurate books and records that reflected its transactions and disposition of assets. In particular, Stryker India recorded potentially problematic payments to its dealers and to HCPs, some of which lacked any supporting documentation reflecting a clear business purpose.

* A forensic review of Stryker India’s general ledger for the period 2010 through 2015 found a complete lack of documentation for 144 out of 533 transactions selected as a sample of Stryker India’s highest-risk and most compliance-sensitive accounts.

* During the period of 2010 through 2015, Stryker was unable to provide any documentation for 27% of sampled high-risk transactions on Stryker India’s general ledger.

The SEC ordered Stryker to appoint an independent consultant, review and evaluate the company’s internal controls, record-keeping and anti-corruption policies, and procedures relating to use of dealers, agents, distributors, sub- distributors, and other such third parties that sell on behalf of the company. The SEC noted in its official filing: “Stryker fortified its existing compliance program, which is designed to prevent, detect, and remediate potential misconduct. This program develops, maintains, and implements corporate policies and standard operating procedures setting forth specific due diligence and documentation requirements for relationships with foreign officials, health care professionals, consultants, and distributors.”

The company has also retained an independent consultant to “formulate a work plan: that will be evaluated by the agency and Stryker to address the SEC’s findings”.

WHAT INDIA’S REGULATOR FOUND

Dealers rigging bids, forming cartel

* In April 2012, the CCI fined PES Installations, MDD Medical System and Medical Product Services for “bid-rigging and forming a cartel” in tenders for procurement of a Modular Operation Theatre (MOT) and other medical equipment at AIIMS and Safdarjung Hospital.

* The CCI also examined a contentious question: did the dealership agreement between Stryker India and PES violate sections of the Competition Commission Act? According to the official website of the Ministry of Corporate Affairs, the Act, enacted in 2002, aims “to

prevent practices having adverse effect on competition, to promote and sustain competition in markets, to protect the interests of consumers and to ensure freedom of trade carried on by other participants…”

* In its final order issued on April 16, 2014, based on the documents placed before it, CCI ruled that “according to the agreement struck with the dealer (PES Installations), Stryker could appoint any other firm as its dealer”. “However, according to the agreement, in this case PES Installations, the dealer could not sell products of any other company without the permission of Stryker,” the order said.

* The Director General appointed by CCI, under section 26 of the CCI Act, to conduct the investigation noted that the agreement that restricts PES to Stryker alone “impeded and restricts competition” and “constitutes violation of the law”.

* However, the CCI ruled in its final order that the agreement was “not violative of the law” on the grounds that “there are other competing products in the market” that are available to other “similarly placed” distributors.

The point to ponder here is that, with such unholy scenario and milieu developing, where business deals and investors decide the treatment with aberrant medical evolution taking place. Doctors involved with such big companies will be promoted, projected and survive. Will the honest doctors, who are not part of the game, be able to survive, sustain themselves or ultimately alienated to extinction?

source

November 28, 2018 0

Made in India coronary stents non inferior to international stents

In a major advancement, a study shows that made in India coronary stents are as good as those manufactured in other countries by multinational companies, according to a recent scientific trial.

The study’s findings were presented at the prestigious international conference on Non Surgical Cardiac interventions—TCT (Trans Catheter Interventions)—on September 22 in San Diego, USA.

The study, which involved around 1,500 patients, was conducted in various countries of Europe and monitored by an international reputed clinical research organisation (CRO), Cardialysis.

The scientific study had the acronym TALENT.

The study dispels the perception among many doctors and patients that stents made in India may not be as safe and efficacious as those manufactured in foreign countries.

The TALENT trial was conceived by Prof Upendra Kaul, a well known interventional cardiologist who is currently the chairman of Batra Heart Centre, New Delhi, and Prof Patrick Serruys, an internationally acclaimed researcher in this field from the Netherlands.

Coronary stents are devices made of metal, usually chromium cobalt and coated with polymers and drug to treat blocked coronary arteries and also with a good and safe long-term performance.

In the recently conducted randomised trial to compare an India-made stent Supraflex with the world leader Xience stent from Abbott Vascular, the Supraflex sirolimus-eluting coronary stent manufactured by SMT in Surat emerged to be as good as the Xience stent made in Europe and the USA.

The study was sufficiently powered to give the final answer regarding non-inferiority of the Supraflex sirolimus-eluting stent versus the best-in class Xience stent from Abbott. The study was done in all comers with no exclusions, Prof Kaul said.

“The aim of the study was to test the hypothesis that both stents are equal in performance and safety. To dispel the belief that imported coronary devices are better, it needed a scientific study without any bias,” he explained.

In February, last year, when the Indian government decided to cap the prices of coronary stents, there was a dramatic reduction in prices from an average of USD 1,800 for the drug-eluting stent (DES) to USD 480 irrespective of the country they were manufactured in.

This resulted in increase in the usage of domestic stents because they offered it at lower prices, Dr Kaul said.

“However, the users still had the belief that India made stents may not be as good (as the imported ones). This required an acceptable scientific trial to draw a comparison between the two stents,” he claimed.

“The study was done in Europe to remove any bias and it was monitored by an international clinical research organisation (CRO), Cardialysis, which is world reputed,” Dr Kaul added.

The study showed that the composite end points consisting of cardiac death, target-vessel MI and clinically indicated repeat procedures at 12 months were similar for both.

Thus proving that the India made stent Supraflex was as good as the market leader Xinence, Dr Kaul claimed.

The study has important economic implications in countries where cost of the stent is an important issue. The full paper of this trial will soon be published in the Lancet, he said.

Dr Kaul further called upon other Indian manufacturers to do similar clinical trials to prove that their devices are worthy competitors to those made abroad.

source

November 15, 2018 0

Food supplement or Concealed harmful drugs? Dangling false promise of miracle

One of the paradox of the era is about dangling a false promise of miracle about health may be bought easily and used with great confidence rather than a scientifically proved truth and fact. Same is particularly truth about the health supplements and many so called “natural products” that are sold with just publicity or mere endorsement. There are no safe guards and users are completely oblivious of the harm caused by uncounted number of such health supplements or substances.

Be careful while popping a pill for weight loss, muscle building or sexual enhancement. Several dietary supplements, most of which are widely available in India, have been found adulterated with unapproved and even banned pharmaceutical ingredients in the US with potential to cause serious health risks, a latest study published in ‘JAMA Open’ revealed.

At least 776 dietary supplements sold over the counter in the US over a period of 10 years from 2007 to 2016 were found containing unapproved pharmaceutical ingredients such as sildenafil, sibutramine and synthetic steroids — which have potential to cause side-effects ranging from stroke to kidney failure and even death, say researchers, who extracted and analyzed data from the US Food and Drug Administration’s (US FDA) Center for Drug Evaluation and Research.

These products were commonly marketed for sexual enhancement, weight loss, or muscle building.

In India the problem may be bigger here as most of the dietary supplements are easily available and widely used in India without any regulation and guidelines. Even the US regulator said it has been able to test only a portion of products available on the market.

Dietary supplements in India are not tested or sampled by any authority and are easily available.

The dietary supplement segment which include nutraceuticals, foods for special dietary use and foods for special medical purpose poised to become a $10 billion industry by 2025. While rising income levels coupled with changing lifestyle have kindled demand for such products.

But lack of regulation and usage guidelines have made these products easily available over the counter and through online sales.

In the absence of wherewithal to do product sampling and testing, quality, efficacy and safety of such dietary supplements continue to be under question.

Another major grey area in this issue is the overlapping between food and drugs. While drugs or medicines are regulated by the Drugs Controller General of India (DCGI), food supplements come under the purview of FSSAI. Often to circumvent drug price regulation or stringent pharmaceutical norms, companies tweak their pharma formulations and launch their products as food supplements, bypassing regulatory approvals from the DCGI. The US FDA data shows, more than 20% of adulterated dietary supplements contained more than one unapproved pharmaceutical ingredients.

Effectiveness and safety of many ingredients in dietary supplements remains questionable.

Good nutrition and a balanced diet are extremely important for good health. However, there are many people who turn to dietary supplements for a boost to their routines.

Many don’t seem to work, and some might even be harmful.

Dietary Supplements for Weight Loss guides readers through the confusing set of options in the marketplace.

People may not know that many manufacturers of weight-loss supplements don’t conduct studies in humans to find out whether their product works and is safe.

October 27, 2018 0

Invisible medical harms of carpet-bomb treatments with FDC (fixed dose combination): @ Government prohibits 328 fixed dose combinations

Drug Technical Advisory Board said there is no therapeutic justification for the ingredients contained in the 328 fixed-dose combination or FDC drugs.

A fixed-dose combination or FDC drug contains two or more active ingredients in a fixed dosage ratio. It means it’s not the single drug but a combination of the two or more, which may be unnecessary for consumption.

Antibiotic resistance: Most harmful impact can be because of antibiotics in FDC.

– Logic is simple. If some one is not able to recognize, whether it is a rat, cat, dog or tiger causing trouble, carpet bomb with combination of three or four bombs. Is it overuse of weapons? Yes, it is. Similarly, abuse of multiple antibiotics has potential to cause massive antibiotic resistance, can have global harmful effect.

–Quacks or by self medication, antibiotics may be overused and abused . Quacks or alternative medicine doctors often prescribe FDCs as they are unable to pinpoint the exact cause of an illness and carpet-bomb patients with combination doses, in the hope that one of the drugs would work.

Overuse of drugs: where one drug for example a paracetamol is required, patient will take three medicines.
Increase in side effects: instead of one medication, patient will have side effects of all other medicines also.
inadequate doses: If many drugs are combined in one, doses may be inadequate or less. So patient takes more drugs , but in adequate doses.
Increase in cost: instead of one , the patient pays for three drugs, thereby increase in cost.

Government prohibits 328 fixed dose combinations

Painkiller Saridon and skin cream Panderm are among 328 fixed-dose combination or FDC drugs banned by the government to stop their “irrational use”. The health ministry says the ingredients in these medicines do not markedly add to the benefits that people can get from taking them. The order immediately bans the manufacture, marketing and sale of several common cough syrups, painkillers, and cold and flu drugs. The country’s drug advisory body, the Drug Technical Advisory Board or DTAB, has said there is no therapeutic justification for the ingredients in these drugs and they must be banned in public interest.

-The government has added restrictions to dosage and use of six more FDCs, not among the 328 banned ones, over their ingredients having no therapeutic value and posing a risk to consumers.

-The health ministry took the decision after the country’s top drug advisory body, the Drug Technical Advisory Board or DTAB, in a report said taking the 328 FDCs would be a health risk. India has some 2,000 FDCs as against a little over 500 in USA.

-It is a good move for public health. Individual drugs are approved by the centre, but some manufacturers make combinations of two drugs and get state licences.

-Mixing two drugs create a new medicine. For new medicine , pharma companies should approach the Drugs Controller General of India and apply for a fresh licence, conduct trials and prove safety.

-In March 2010, the government restricted sales of 344 FDCs, a move that was challenged by pharma firms in court. The Supreme Court last December told the DTAB to ascertain whether FDCs should be banned from the market.

Every one is calculative about the loss of millions. The invisible losses to human kind are still to be calculated.

September 13, 2018 0

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