The rise in “falsified and substandard medicines” has become a “public health emergency”. A surge in counterfeit and poor quality medicines means that thousands of patient a year are thought to die after receiving shoddy or outright fake drugs intended to treat ailments. Most of the deaths are in countries where a high demand for drugs combines with poor surveillance, quality control and regulations to make it easy for criminal gangs and cartels to infiltrate the market.
There is an urgent need for effort to combat a “pandemic of bad drugs” that is thought to kill hundreds of thousands of people globally every year.
More are thought to die from poor or counterfeit vaccines and antibiotics used to treat or prevent acute infections and diseases. Beyond the fakes that are made and sold by criminal gangs are poor-quality medicines that lack sufficient active ingredients to work properly, or fail to dissolve correctly when taken. Sloppy manufacturing is often to blame, but others are sold past their shelf life or have degraded in poor storage conditions.
Governments and pharmaceutical companies had to improve the security of the drug supply chain in all countries from the point of manufacture to the patient. Regarding online pharmacies, there is poor public understanding of how to differentiate between a legitimate online pharmacy and an illegal one. Illegal online pharmacies and the sale of medicines via social media platforms pose the greatest risk to the public.
To make big money, Pradhan got his cousin Shubham Manna and Ram Kumar involved in his plan and started making spurious cancer drugs. “He had been providing spurious medicines at a discounted 50% of market prices. He was manufacturing and supplying more than 21 spurious cancer medicines of various companies of different countries,” special commissioner (crime) Ravindra Yadav said. The syndicate comprised highly-qualified and well-earning individuals. Manna had completed his BTech and served in MNCs before joining hands with Pradhan. Police said his job was to generate barcodes, emboss batch numbers and expiry dates on medicines. He also looked after overall packaging of the spurious medicines. International syndicate used to procure capsules and manufactured fake medicines by filling them with starch.
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.
Take example for cough syrup related 66 deaths at Gambia or Injection Propofol related deaths at PGI Chandigarh. If deep investigations are not done, poor quality medicines will continue to be marketed and doctors would be held responsible for the adverse reactions and deaths. Strict regulations for quality of pharmaceutical agents is need of the hour.
Usually every problem related to health is called medical malaise, but that is a misnomer. In fact health care comprises tens of different industries. 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 largely unregulated. Collective malaise of all these is conveniently projected as medical problems as blame is conveniently passed on to doctors, as they are only visible component of mammoth health business. Rest all remain invisible, earn money and doctors are blamed for the poor outcome of the patient, as doctor is the only universal link that is visible with patient. By an average application of wisdom, it is easier to blame doctors for everything that goes wrong with patient.
Cough syrup related deaths at Gambia or Injection Propofol related deaths at PGI Chandigarh – two examples are only a tip of the iceberg. In routine, if patient gets fake or low quality medicines and does not get well, gets side effects, doctor will face harassment. Whereas people involved and industry will be sitting pretty and make money.
Therefore strict administration and quality check is required to correct Pharma malaise. It may be a complex issue because of complexity involved in implementation and execution of policies. But recognition and beginning to think of the problem is also an important step.
The WHO has issued an alert over four cough and cold syrups made by Maiden Pharmaceuticals in India, warning they could be linked to the deaths of 66 children in The Gambia
The World Health Organization (WHO) on Wednesday issued a warning over four cough and cold syrups made by an Indian company, saying that they could be linked to the deaths of 66 children in The Gambia. The WHO said that the cough and cold syrups, made by Maiden Pharmaceuticals in Haryana, could be the reason for serious kidney injuries. “Please do not use them,” the WHO said in its advisory.
The four cough and cold syrups that have been linked to the deaths of 66 children in The Gambia are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup. In a release, the WHO has said that the Indian company has not yet provided guarantees on the safety and quality of these products.
“Laboratory analysis of samples of each of the four products confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants,” the WHO said in a medical product alert. The WHO also warned that while the products had so far been found in The Gambia, they could have been distributed to other countries.
According to the WHO, diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal. Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death, the WHO said.
New Delhi-based Maiden Pharmaceuticals declined to comment on the matter.
The World Health Organization also said that it was conducting further investigation with the company and regulatory authorities in India regarding the cough syrup linked to deaths of 66 children.
Last month, Gambia’s government said that it has also been investigating the deaths. The government statement came as a spike in cases of acute kidney injury among children under the age of five was detected in late July.
“While the contaminated products have so far only been detected in the Gambia they may have been distributed to other countries,” WHO Director General Tedros Adhanom Ghebreyesus said at a press conference on Wednesday.
The WHO Director General added that WHO recommends all countries detect and remove these products from circulation to prevent further harm to patients.
Meanwhile, the DSCO has already taken up an urgent investigation into the matter with the regulatory authorities in Haryana.
CHANDIGARH: Five patients had died after they were sedated before surgeries on a single day last week at PGI, prompting doctors to sound a red alert to Central Drugs Standard Control Organisation (CDSCO)on Propofol injection – an anesthetic given before any major surgery. In this case, the drug was taken from the chemist shop in the hospital emergency. “Following a complaint from PGI doctors, we came with a CDSCO team to collect samples. The samples have been sent to Central Drugs Laboratory, Kolkata,” said Sunil Chaudhary, senior drug control officer, UT. He said, “The suspected batch of drugs has been stopped for supply till reports are received.” Sources said test analysis will take around two-three weeks and final report will be submitted by the CDSCO team. The five patients had to undergo orthopaedic and neurosurgeries. On deliberating the cause of deaths, doctors found Propofol injection as the common thread.
The potential penalty by India’s fair trade regulator could be steep. The CCI (The Competition Commission of India) investigation is the first such action against exorbitant prices of medicines and services fixed by hospitals, which have operated free of regulation so far.
A four-year investigation by India’s fair-trade regulator has concluded that some of India’s largest hospital chains abused their dominance through exorbitant pricing of medical services and products in contravention of competition laws.
The Competition Commission of India (CCI) will soon meet to weigh in on the responses by Apollo Hospitals, Max Healthcare, Fortis Healthcare, Sir Ganga Ram Hospital, Batra Hospital & Medical Research and St. Stephen’s Hospital. It will then decide whether to impose penalties, said people familiar with the matter.
The CCI can impose a penalty of up to 10 percent of the average turnover for the past three preceding financial years of an enterprise that has violated competition laws. The penalties could be steep. Apollo Hospitals posted an average turnover of Rs 12,206 crore and Fortis Rs 4,834 crore in the past three financial years.
The CCI’s director-general found that 12 super-speciality hospitals of these chains that operate in the National Capital Region abused their positions of dominance by charging “unfair and excessive prices” for renting rooms, medicines, medical tests, medical devices, and consumables, according to a copy of the summary report that Moneycontrol reviewed.
Some hospital room rents exceeded those charged by 3-star and 4-star hotels, according to the findings by the DG, who examines anti-competitive practices.
Significance of the investigation
The CCI investigation is the first such action against exorbitant prices of medicines and services fixed by hospitals, which have operated unencumbered by regulation so far. The watchdog’s action could potentially rein in the prices of medicines and healthcare equipment, or at the very least, bring transparency in the way hospitals sell these items, according to competition lawyers.
Of the 12 hospitals that faced CCI scrutiny, six belonged to Max and two to Fortis.
The CCI and the hospital chains had no comment for this article.
Overcharging without checks
Exorbitant pricing is a common thread running through the CCI investigation report. The hospitals were found to charge more for certain medical tests as well as for X-rays, MRI and ultrasound scans than rates offered by other diagnostic centres. For consumables such as syringes and surgical blades, hospitals charged rates that were higher than those of other consumable makers, according to the CCI report.
The only exception was medicines, which hospitals sold at the maximum retail price, although they earned significant profits by procuring them at lower prices.
The CCI selected the hospitals for investigation on the basis of the number of doctors, paramedics, beds, and turnover for the period 2015-2018. The investigation found that these hospitals do not allow the use of purchase of consumables, medical devices, medicines and medical test results from outside, adding that patients use the service of in-house pharmacy and laboratories for ease of convenience.
Investigative reports pertaining to each of the hospital chains were submitted by the DG to the CCI on December 24, 2021. The CCI forwarded a copy of these reports to the hospitals on July 12, 2022, and sought their responses, according to the people, who did not want to be identified.
The CCI has been examining the pharmaceutical sector in India for years, scrutinising the pricing of medicines by healthcare companies. On April 19, 2020, it cautioned businesses, including healthcare companies, against taking advantage of Covid-19 to contravene competition laws.
Commercial sale of mother’s milk under Ayush licence has thrown up ethical questions. You can buy literally anything these days, even human breast milk. India is home to the only company in Asia that sells mother’s milk for profit, Bengaluru-based Neolacta Lifesciences Pvt Ltd. After activists objected to the commercialization of mother’s milk, the Food Safety and Standards Authority of India (FSSAI) cancelled the company’s licence stating that sale of mother’s milk was not permitted under its regulations. However, an FSSAI inspection revealed that the company continues to sell mother’s milk by obtaining an Ayush licence in November 2021 for its product dubbed ‘Naariksheera’ (breast milk). Neolacta, which was established in 2016, had originally obtained a licence from the Karnataka office of the FSSAI in the category of dairy products. “It is absolutely shocking that a company is being allowed to collect breast milk from young mothers and sell it like a dairy product with a huge price tag claiming to have added value to it,” said Nupur Bidla of the Breastfeeding Promotion Network of India (BPNI), which had alerted the government to this in 2020.
Saurabh Aggarwal, MD of Neolacta, told TOI that the company has significant experience in the human milk space supplying technology to set up the first milk bank in Australia. He said that NeoLacta had, over the past five years, “benefited over 51,000 plus premature babies across 450 hospitals.” Donated breast milk is mainly used to feed premature or sick babies when mothers are unable to nurse them for a variety of reasons. Usually, the milk is sourced through milk banks set up as non-profits. Milk collected from donors (healthy lactating mothers) is pasteurised, analysed for nutrient content and checked for contamination of any kind and is then frozen and stored. In most milk banks, especially those attached to government hospitals, the donated milk is given free of cost. However, in many others it might be free for a few poor patients but those who can afford it are usually charged a few hundred rupees for 50 ml of donated breast milk. There are over 80 non-profit human milk banks in India. Neolacta charges Rs 4,500 for 300 ml of frozen breast milk. A pre-term baby could require about 30 ml per day while a baby on full feed could need as much as 150 ml per day. It also sells human milk-derived powder that is readily available on ecommerce sites as well as its own. President of the National Neonatology Forum (NNF).
Dr Siddarth Ramji told TOI that “as a principle we do not support commercialisation of breast milk” but pointed out that NNF was not a regulatory body. Dr Satish Tiwari, national convenor of the Human Milk Banking Association of India, described it as a shame. “Does the company pay the mothers who are donors? Do they take it free and sell it at such a high cost? No one knows. The government should look into this.” In a research article published in December 2020 titled, ‘Nurture commodified? An investigation into commercial human milk supply chains’, social scientist Dr Michal Nahman and economist Prof Susan Newman from the UK examined the way Neolacta functioned. Speaking to TOI, Prof Newman said their research consultants had found evidence that women, mainly in rural areas, were actively being pursued by NGOs and associated ‘health workers’ and paid either with cash or with food packets. She pointed out that in the initial news reports on Neolacta, they freely admitted to collecting milk from women across four states but have since become more cagey about how they source the milk. The article adding that in 2016, an attempt by NeoLacta to collect breast milk from the largest government hospital for women and children in Bengaluru, Vani Vilas, was abandoned after serious concerns over the “commercial exploitation of breast milk”. “It was evident from our interviews with NeoLacta donors, intermediaries such as NGOs and community health workers and NeoLacta employees, donor milk is not framed as a commodity in spite of the marketisation of NeoLacta product. Rather, the way in which donor milk is operationalised as a ‘gift’ (or ‘daan’ in the Indian context) is built in to how it is commodified,” stated the article. Remuneration would depend upon the volume that women provide and 80% of the revenue would be paid to the mother with the NGO worker taking a 20% cut, it added.
At the time of going to press, the Ayush ministry had not responded to this reporter’s queries. BPNI wrote to the health ministry in February 2020 that “Neolacta has been involved in commercializing human milk” even though the guiding principles for using donor human milk in India in the health ministry’s ‘National Guidelines on Lactation Management Centers in Public Health Facilities’ clearly states, “DHM (donated human milk) cannot be used for any commercial purpose”. With the ministry not responding, BPNI wrote to FSSAI asking how the licence was issued. Neolacta was established in 2016, a year after Cambodia banned selling of breastmilk after a public outcry about an American for-profit company Ambrosia sourcing breast milk from poor women in Cambodia and selling it in the US. A letter from the Cambodian government was quoted as stating: “Although Cambodia is poor and (life is) difficult, it is not at the level that it will sell breast milk from mothers.” In the context of Cambodia, UNICEF had said in a statement that the trade in breastmilk was “exploiting vulnerable and poor women for profit and commercial purposes”. Most countries do not allow the commercial sale of breastmilk.
Dr Arun Gupta of BPNI alleges that Neolacta aggressively markets its products on social media. “It is using the tactics of the infant formula industry in the way it is targeting healthcare providers to gain legitimacy. Infant formula companies harp on mothers not having enough milk and Neolacta goes on about mothers producing ‘excess breastmilk’ which they can donate. It claims that its products do not come under the IMS Act, which regulates the marketing of infant milk substitutes, but it does,” said. BPNI complained to the National Neonatology Forum (NNF) in February 2021. The NNF responded in April 2021 to state that the NNF had already taken a decision in its executive board meeting to abstain from providing any form of encouragement to Neolacta Lifesciences and that a letter communicating this decision had been sent to all the members of the forum. Officials from the Bengaluru branch of FSSAI inspected the Neolacta unit on April 22 and found stocks of packing materials bearing the suspended FSSAI License, which they seized. The local FSSAI office has also asked the company to recall from the market all its products which have used the FSSAI licence and to disable online selling of such products. The company was also issued a notice for carrying out food business without a valid FSSAI license. A commercial company selling breast milk would court healthcare providers including doctors and hospitals to become their suppliers, which would increase the cost to the healthcare system and create ethical dilemmas, warned public health researcher Sarah Steele of the University of Cambridge in a piece she wrote about commercial human milk banks in October 2021. She added that if mothers moved from donating to non-profit milk banks to such companies, healthcare providers would be forced to enter into contracts with such companies and this could result in the privatization of a previously public service. Dr Sushma Nangia, professor and head of the neonatology department in Lady Hardinge Medical college who established a human milk bank, explained that donated breast milk might be better than infant formula but was inferior to mother’s own milk. “Even for pre-term babies their own mother’s milk is best for them to thrive. Donated human milk is inferior to mother’s milk as milk from different sources is pooled and vital nutrients are lost when it is pasteurized. Obviously, there are cases where donated breast milk is needed and that is why we started a bank but we do not prescribe it for all pre-term or sick babies. Neonatologists and the increase in the business of neonatal ICUs in the private sector are behind the push for donated breastmilk. It has become a lucrative business. This menace (push for commercial donor milk) can be curbed if neonatologists invest time and resources in ensuring mother’s own milk for her baby rather than going for commercial donor milk and also providing unambiguous information to families that donor milk is not the same as their own mother’s milk. The government needs to step in and enquire where the milk is being sourced from,” said Dr Nangia.
After several countries reported cases of salmonellosis following the consumption of Kinder brand of chocolates, the company has decided to recall its products. Contamination with salmonella was found following the consumption of the Belgium-based Kinder brand of chocolate, the World Health Organization (WHO) informed that the brand has decided to recall its candy.
The incident has brought forth the need for attention and strict regulation, which is required to regulate hundreds and thousands of ready to eat products, fast foods, especially chocolates. They may carry deadly infections, if procedure to manufacture them is not up to mark and if the authorities are lax to check them periodically.
The major development came after 150 suspected cases of salmonellosis were found in Belgium (26), France (25), Germany (10), Ireland (15), Luxembourg (1), the Netherlands (2), Norway (1), Spain (1), Sweden (4), the United Kingdom (65) and the United States of America (1). According to the statement released by WHO on Wednesday, children under the age of 10 years have been most affected. Although nine children are still in hospital, no fatalities were reported until now.
“The risk of spread in the WHO European region and globally is assessed as moderate until the information is available on the full recall of the products,” the UN agency said in a statement. According to WHO, salmonella bacteria matching the current human cases of infection were found last December and January in the buttermilk tanks at a factory run by chocolate makers Ferrero, in the Belgian city of Arlon.
In a chocolate-making plant in Belgium salmonella bacteria have been found. Chocolate plant after receiving the news of bacteria in the plant (ChocolatePlant) production has been stopped. The sale of products sent for sale from the plant has been banned. All dealers associated with the plant have been prohibited from selling the product. Belgium ( BelgiumThe plant in which bacteria have been found is the world’s largest chocolate-making plant. Even before this salmonella bacteria (salmonellabacteria) has been confirmed.
The company also supplies products to Nestle.
The plant of the world’s largest company, Barry Callebaut, is located in the city of Vieze, Belgium. This company makes liquid chocolate, which supplies its products to many big brands. Company Liquid Chocolate Nestle ( Nestlé), Unilever (Unilever), Harshi (hershey), supplies to large companies such as Mondelez. Even before this, information about the presence of Salmonella bacteria in the products of other companies has come to the fore. This was confirmed in the product of Ferrero company based in Arlon, South Belgium.
A company spokesperson said that the sale of products made after June 25 has been banned. However, the company’s spokesperson also said that most of the products in which it has been confirmed are present in the company itself. After getting the bacteria, the company has informed the Food Safety Agency of Belgium. On behalf of the company, it has been said that the Food Safety Agency is investigating the matter. It was said on behalf of the company that the investigation process may take time, due to which there is a possibility of a decrease of 2.6 percent in the company’s stock. After the completion of the investigation, all the production lines of the company can be started for production.
Salmonella bacteria give rise to deadly diseases like typhoid and salmonellosis. Apart from this, this bacteria affects the intestine of humans and animals. This bacteria is spread by eating contaminated food or food items. Salmonella bacteria are also spread in humans by eating dirt, eggs, raw meat. Young children and the elderly are at greater risk from this bacteria.
It has been said in a media report that the effect of salmonella infection starts showing in 6 to 36 hours. Due to this, the infected person may have problems like abdominal pain, vomiting, fever, diarrhea. A research report states that there are about 40,000 infected cases of Salmonella bacteria in the United States every year.
Until a few decades back, a family physician used to be the right answer for most healthcare situations, right from the toddler in the house to the octogenarians. Medical emergencies always have been an exception. The family physician could offer expert comprehensive medical care to people of all ages and genders, making them a preferred choice, a dear friend for the common needs of the entire family. He was a great support to all family members at almost all stages of their lives.
Unlike other medical specialists who focus on a specific medical condition, one part of the body or just an organ, a family physician has the expertise and knowledge to provide comprehensive healthcare as well as emotional support to patients of all ages. He was a health guide from infancy to late adulthood and in old age as well. That made him the go-to doctor at any point for the family.
A major role of the family physician was to educate the patients about disease prevention and health maintenance. It included focussing on both physical and emotional health, which may include stress relief, anger management, fertility counselling, weight management and nutritional counselling. For day-to-day common ailments like flu, ear infection, common allergy, draining small abscess, the family physician was the preferred go-to medical resource for the treatment.
The family doctor could help recognise potential red flags for any emerging conditions that may require prompt attention, such as diabetes, heart disease, or cancer – especially if there was a family history of the condition. If there was any need for specialist medical treatment, the family physician would refer to an appropriate specialist.
But now, with increasing medical commercialisation and consumerism, primary care is at the crossroads. The primary care delivery systems are becoming unsustainable and lack the resiliency to survive in new changing environments. In an era of specialisation, the primary care has to struggle to remain relevant and viable.
There has been an increasing inclination of patients to have opinions from specialist even for minor issues. In last few years, with greater smartphone ownership, internet connections – a bevy of apps, online medical service aggregators have started operating brazenly, advertised by superstars and celebrities, aggressively pushing for tests and surgeries – have made the ‘family doctor’ look like ‘Dr Minimalist’. There are a number of reasons why more doctors want to become specialists: competitive pressures, greater income potential, higher status among peers, greater prestige in society and patients’ demand. These factors drive the preference for specialisation. The final result is being lot of specialists, who treat an organ but too few “doctors” to treat the human body as a whole. The media insinuation against doctors has created an environment of mistrust against doctors in the community and rift in doctor-patient relationship.
In addition to basic medical services, the family physician used to act as health advisors, guiding anxious patients to the appropriate healthcare facility. In today times, one of the most effective healthcare interventions is to advise the person to “when to see a specialist doctor and when not to go”. But that friendly advice with in comfort of homely atmosphere is getting distant gradually.
The family doctor – a helping hand, a dear friend and an all-time support of is getting far away from patients in this era of medical consumerism.
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.
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.
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.
An overstressed hospital system unable to bear the rising patient load is an important factor for the frequent fire incidents. Overstressed ICUs, ACs, lot of oxygen flowing, other combustible chemicals, gases, and electrical equipment all around make hospitals a dangerous place for the incidents of fire.
Last year Hospitals increased beds, equipment and staff to admit more Covid patients, but it is not possible to immediately expand the electrical wiring system. Medical equipment or wires carrying current beyond their capacity can overheat. That is what is happening in many hospitals. Besides looking at fire
audit, an electrical audit is also needed.
Fire prevention and safety is a matter of vital importance concerning everyone in the hospital industry. After another incident in Delhi, have further raised the concerns about safety of patients in hospitals. Unawareness of safety measures especially among staff of hospital can increase death toll among patients as well as health care workers. Such incidents happening frequently have become an eye opener for government, health administrators as well as health care providers. NABH and Fire Safety For fire prevention and safety in hospital, certain modifications in building design are required to deal with various potential emergency situations to avoid further incident and damage. The main objective of fire safety design of buildings should be assurance of life safety, property protection and continuity of operations or functioning.
120 patients died due to hospital fires since April 2020 Even the roads inside big hospitals, which should be 6 metres wide, are blocked with parked vehicles. If a fire breaks out, the fire tenders cannot even enter. Therefore norms & codes for building design & fire safety should be followed not only for high rise hospital buildings but also for small set up or nursing homes properly. Fire Codes process is a complex process which integrates many skills, products and techniques into its system. Hospital engineering service provision for Fire Protection according to NABH:
1. Fire fighting installation approval must be obtained 2. Location of control room should be easily accessible. 3. Control panel & manned, PA equipment should be connected with detection system or fire alarm system. 4. Pumps and pump room 5. 2 separate pumps i. e .Electric and diesel pump should be available 6. Provision of Forced ventilation should be there. 7. Arrangement of filling Fire tenders 8. 4 way fire inlet must be present in case of emergency 9. Proper access for Fire tender to fire tanks 10. Fire Drill should be performed 11. Yard Hydrants should be available 12. Ring main and yard hydrants should be as per strategic locations. 13. 2 way fire heads to charge the ring main 14. Landing Hydrant & Hose reels 15. Wet riser system must be installed 16. First aid Fire fighting appliances must be in working conditions 17. First aid equipment cabinets 18. Provision of Escape routes – escape stairs 19. Sprinklers system – basement & bldg. above 15 M in height 20. Automatic Smoke detectors / heat detectors 21. Provision of Fire Alarm System & Fire extinguishers
1. All high-rise buildings need to get NOC as per the zoning regulations of their jurisdiction concerned. 2. A road which abuts a high rise should be more than 12 metres wide, to facilitate free movement of Fire Services vehicles, especially the Hydraulic Platform and Turn Table Ladder. 3.Entrance width and clearance should not be less than 6 metres or 5 metres, respectively. 4. At least 40 per cent of the occupants should be trained in conducting proper evacuation, operation of systems and equipment and other fire safety provisions in the building, apart from having a designated fire officer at the helm. 5. The buildings should have open spaces, as per the Zonal Regulations. 6. Minimum of two staircases with one of them on the external walls of the building. They should be enclosed with smoke-stop-swing-doors of two-hour fire resistance on the exit to the lobby.
General Recommendations:
1. Hospitals of high rise buildings are found to be utilising the cellars for generators and transformers, which is strictly prohibited. 2. Canteens, OP blocks, dormitories and pathological labs are not allowed in cellars. 3. Regular refresher training courses for the fire brigade personnel. 4. Recommendation for creating Rural Fire Services in areas which are not at present under any full time Fire Service cover. 5. Augmentation of Municipal Hydrant System. 6. Adoption of best practices from other city codes like Mumbai Delhi and Hyderabad by State Government for fire safety. 7. Clarifying position of CFO and Fire Protection Consultant in approval procedures. 8. Recommendation for establishment of Disaster Control Room for cities. 9. A passing reference to NBC rules like provision of fire doors, fire separating walls, fire exit & fire lifts should not be overlooked.
Fire safety Measures have 4 Parameters namely means of access through approach roads, open spaces, means of escapes like external Staircases & Fire fighting equipment. Thus provision of all these is necessary from safety point of view within hospital premises. An effective fire program calls for an understanding of the hospital fire plan & the active participation of every employee at all times. Also at least 1 well trained fire officer should be elected at every hospital. There is no better protection against fire than constant vigil to detect fire hazards, prompt action to eliminate in safe conditions & a high degree of preparedness to fight fire.
Everyone should remember that every big fire starts from small one therefore nothing should be considered insignificant within hospital premises. Some hospitals lack trained staff to handle such emergencies therefore frequent mock as well as evacuation drills must be taken. Panic & confusion are the greatest hazards of fire & they can be countered only by sufficient preparedness which should be avoided by means of hospital staff in case of fire emergency.
India features a mixed-market health system where chronically low investment in public health systems has led to the proliferation of private care providers. In last few years, a bevy of apps and service aggregators have starting operating brazenly in the country, pushing aggressively for tests and surgeries and delivering drugs, often advertised by Superstars and Celebrities. Patient often zigzags between health providers with unclear referral pathways, and ends up receiving questionable quality of care that may typically neither be safe nor affordable.
Online health aggregators are nothing more than sophisticated commission agents. The medical business model thrives on advertisement and commission. Government rules prevent doctors from advertising or soliciting for surgeries, but these companies live on advertising. Any doctor or hospital can get advertised through these companies. In lieu of some money, anyone can be declared as the best and hence misguidance to the patients cannot be ruled out. The flow of patients to a health care facility can be enhanced by financing the advertisements and not by actual quality work and results in increasing medical business manifold. They do not contribute to much needed medical infrastructure and merely redirect patients to existing facilities. They may at the best be able to become facilitators of the process that attract patients by advertisements and result in skyrocketing cost to patients. Any of the Hospitals and doctors can be projected as the best, who tie up with these online aggregators in lieu of some money. Therefore the misguidance as well as increased costs is the two main drawbacks of such a lucrative arrangement of this new medical business. They charge hospitals and doctors for advertisements ( sending more patients) and patients for channelizing them. In the resulting Zig-Zag path, patients are treated more on the basis of advertisements that are many times aired by our ‘Filmy Superstars’.
The health service aggregators have no skin in the game. Neither do they invest in hospitals nor do they have the responsibility of running a hospital, but they want the money which a patient will spend on their health in a hospital. They have conveniently created online apps and are ranked top on search websites. This whole process is against the values and ethics, which healthcare delivery is supposed to be.
The damage caused by the unchecked presence of health service aggregators online is snowballing into a major healthcare crisis which the Union and state governments can ill afford to ignore. Instead of becoming a part of the solution, they have added to the problem by pushing aggressively for tests, surgeries and healthcare services without any medical requirement or prescription.
There are plenty of such apps which advertise about doctor consultations, quick surgeries and direct-to-consumer laboratory tests.
This is where the trouble begins.
In one case, the healthcare aggregator suggested surgery for constipation. The mention of surgery scared the patient, who then approached a hospital where they advised him to improve his diet.
For a kidney stone issue, a healthcare aggregator suggested a laser surgery to a patient without consulting a urologist. The laser surgery was done and the stones got stuck in his pelvi-uretery junction of the kidney-uretery track. He became aware of it two weeks later when he had severe pain in his flank, because of which he walked in to a hospital after the app refused to acknowledge his concerns.
In all of these cases, the apps charged almost double the existing rates for surgeries. For a piles operation, in a general ward, a hospital charges between Rs 50,000-70,000, inclusive of medicines in a patient without co-morbidities. The apps charged between 1.25 lakh to 1.5 lakh, while the national public health insurance scheme Ayushman Bharat rates for such surgeries begin at Rs 10,000.
Ads are being run by online health service aggregators in newspapers and all kind of media.
For removal of kidney stones, hospitals charge Rs 50,000, while the apps charge upwards of Rs 1 lakh, while on the government’s Ayushman Bharat scheme, it is Rs 33,000.
Circumcision is priced at Rs 60,000 by the healthcare aggregators, when hospitals charge Rs 10,000 for a surgery such as this and it is Rs 3,000 for those availing it using Ayushman Bharat.
Their modus operandi? The healthcare aggregators have tie-ups with certain departments in certain hospitals, where after the app does the diagnosis, a doctor on their payroll is sent to the hospital to perform the surgery. After the surgery, the doctor walks away without any care and the patient is left at the hospital until he gains consciousness. At which point, if there is any immediate post-operative care, the nurse concerned does it based on the instructions of the doctor who left. Then the patient checks out.
A fee is paid by these healthcare aggregators to these hospitals for use of the premises for the surgery. In most cases, they approach smaller hospitals where either the top administration turns a blind eye towards these activities. Sometimes, the doctor who performed the surgery may not be on their rolls, but that from a healthcare aggregator.
“The health service aggregators have no skin in the game. Neither do they invest in hospitals nor do they have the responsibility of running a hospital, but they want the money which a patient will spend on their health in a hospital. They have conveniently created online apps and are ranked top on search websites. This whole process is against what healthcare delivery is supposed to be,” said Dr Jagadish Hiremath, CEO of ACE Suhas Hospital in Bengaluru.
Government rules prevent hospitals from advertising or soliciting for surgeries, pointed out Hiremath, but these companies live on advertising.
Such health care aggregators are feeding off hospitals and they need to be regulated. “If you remove the advertisements, these companies don’t exist. They have no physical presence except for a few labs or clinics,” he added.
“The problem is getting compounded by these discounts and offers for unnecessary medically and unwarranted testing in the name of wellness/immunity packages. It is a price war to offer maximum number of tests at lowest prices which is totally meaningless,” highlighted Malini Aisola, co-convenor of All India Drug Action Network (AIDAN)
These online health service aggregators have added to issue of illegal pathology laboratories mushrooming all over, pointed out Dr Jagadish Keskar of the Maharashtra Association of Pathologists and Microbiologists
Almost all of them have roped in big names as brand ambassadors – actor Hrithik Roshan, Amitabh Bachchan, singer Guru Randhawa, Rahul Dravid, actor Sonu Sood, actor Rajat Kapoor, Neha Dhupia, Yuvraj Singh and Randeep Hooda to talk about specific health issues and MS Dhoni.
“They have all these famous names as brand ambassadors as if they will perform the surgeries or look at your blood in a lab. This confuses the public, who are already bombarded with too much information,” quipped Hiremath.
Consumer Drug Advocacy group All India Drug Action Network (AIDAN) argued that the direct-to-consumer advertising has to stop completely. “It is too dangerous in healthcare. Aggregators are inducing demand when people are at their most vulnerable due to the pandemic. They are pushing promotions and offers on tests and surgeries and healthcare services without medical assessment or prescription,” said Aisola.
There is a danger particularly with surgeries, contended Aisola, because this could lead to bypassing medical opinions and identifying alternative treatments. When doctors, hospitals and labs associate themselves with the aggregators, there are ethical issues too, she pointed out.
The practice of doctors associating themselves with these healthcare aggregators have alarmed several doctors’ associations. Association of Minimal Access Surgeons of India (AMASI) wrote to its members stating that any member who has made such a contract with healthcare aggregators should disengage immediately failing which a member found to be in contract thereafter may be liable for disciplinary action by regulatory authorities.
They warned that any litigation arising from such practices will not be defended by the association during legal process by way of expert opinion or otherwise.
“It jeopardizes adequate clinical judgment by a trained person regarding need for surgery and decision as to the type of surgery that would be optimum for the particular patient. The apps are made for the sole purpose of making money,” said the AMASI notification.
Evolution of Medical profession-Extinction of good doctors 