Ban imposed on import of Rabies vaccine from tainted Chinese company


The drug controller general of India on Tuesday banned the import of the rabies vaccine from Chinese vaccine manufacturer Changchun Changsheng Life Sciences, which was found to have faked records and ordered to stop production earlier this month by China’s drug controller.

Rabies kills an estimated 20,000 people in India each year, according to the National Rabies Control Programme.
The drug controller general of India on Tuesday banned the import of the rabies vaccine from Chinese vaccine manufacturer Changchun Changsheng Life Sciences, which was found to have faked records and ordered to stop production earlier this month by China’s drug controller.
Officials familiar with the matter said the vaccine is imported by India and procured by both private and government centres that administer it for protection from rabies, which is 100% fatal but can be prevented by vaccination. Rabies kills an estimated 20,000 people in the country each year, according to the National Rabies Control Programme.
“We’re in the process of issuing a show cause notice to the procurer who gets the vaccine for the government .

“The vaccine is being used in India, but we don’t have the exact details of the total number of units imported or where they have been distributed. I have asked my staff to prepare a detailed information report on its import and distribution,” Reddy added. “Once we get the information, we will ask for a recall of the vaccine from market. But till then, there is a blanket ban on its import.”
Rabies is endemic throughout the country, with the exception of Andaman & Nicobar and Lakshadweep. Dogs are responsible for about 97% of human rabies, followed by cats (2%) and monkeys, mongoose and others (1%). According to the city’s civic agencies, each week about 8,000 shots are given to prevent rabies in all government hospitals.
“We get 500 to 700 cases each day, which also includes people there for booster doses. Dog and rat bites are very common. A combination of anti-rabies vaccine, serum and tetanus is injected, depending on the severity of the bite,” said a staff member at Safdarjung Hospital who asked not to be named.
“We usually get products from procurers, who get it from importers. Both Indian- and foreign-made drugs and vaccines, including those from China, are used in the public sector.
On July 24, Chinese president Xi Jinping has ordered a “thorough investigation” into widespread concerns that hundreds of thousands of infants might have been administered fake vaccines produced by one of the country’s largest pharmaceutical firms.
According to official news agency Xinhua, Xi had termed “the illegal production of vaccines by Changchun Changsheng Life Sciences Limited as hideous and appalling”. Reports suggested the company may have supplied ineffective DPT (diphtheria, whooping cough and tetanus) vaccines that were given to babies as young as three months old, and forging data for anti-rabies vaccines.
As outrage among people in China grew over the past week, the company’s leaders apologised in a statement on Sunday, saying they felt “deeply ashamed”, according to the New York Times.

Viagra & anaesthetic drug sold as herbal alternative medicines


This news in Times of India  is just an tip of the iceberg, the reality  of alternative medicine  industry. Toxic substances being sold at exorbitant prices  labelled as herbal substances can be unmasked only if checked  and controlled strictly.  Gullible masses consume these substances without knowing the right dose or right drugs thinking them as herbal products . Assumptions that they are free from side effects is another myth, that goes unsaid.

MUMBAI: The Aurangabad division of FDA has found sildenafil citrate, commonly known as Viagra, and a short-acting anaesthetic drug in two alternative  medicines meant to increase sexual desire and potency that were randomly tested for quality recently. The worrying finding has prompted the drug regulatory body to issue a statewide circular asking its officials to seize any available stock of these drugs- Power up capsules and Tiger king cream. The containers of both the alternative medicines didn’t mention the allopathic components sildenafil and anaesthetic drug (lignocaine hydrochloride), giving rise to fear of serious health consequences in people who might consume them unknowingly. Viagra, in particular, which is given for erectile dysfunction, is supposed to be taken only when prescribed by a specialist as it can react with other ongoing medications and give rise to life-threatening complications. In July, FDA officials raided the office of Srishti Unani Medicine Agency in Aurangabad and found stocks worth Rs 16,000 that had arrived from Saharanpur district of Uttar Pradesh. Tests revealed each Power up capsule contained 49.45mg of Viagra, while Tiger king cream had a significant amount of lignocaine hydrochloride, though only the herbal components were mentioned in the packing material.

The spurious drugs were manufactured in violation of the Drugs and Cosmetics Act. “We will lodge an FIR against Naman India, the UP-based manufacturer, that has been selling these drugs in the name of herbal medicine to gullible consumers,”, joint commissioner, FDA, Aurangabad. He said the department is yet to establish where these drugs were supposed to be distributed, but there is demand from across the state. It was during a raid in the city sometime in 2015 when the department woke up to rampant adulteration of so-called alternative  medicines with allopathic drugs. An official said it was an “industry worth millions” that clandestinely ran out of Tier-2 and 3 cities or slums in metros. “Under the Act, manufacturing of alternative  drugs needs a licence, but there are no legal provisions for distribution and supply. So monitoring becomes a challenge,” said an FDA official. Medically, doctors say, such rackets are not just about making spurious drugs and making a quick buck but messing with people’s lives. “It’s a menace that has existed for years unchecked. Alternative  practitioners charge exorbitant sums for these  medicines that illegally contain sildenafil, which otherwise costs just Rs 30-40 when sold as an allopathy drug.

India expenditure on health 1 %, of GDP, Lower than Bhutan, Nepal, Sri Lanka


  •  India’s per capita public expenditure on health increased from Rs 621 in 2009-10 to Rs 1,112 (around $16 at current exchange rate) in 2015-16
  • According to National Health Profile (2018), around 43 crore individuals or 34% of the population were covered under any health insurance in 2016-17

It is not difficult to diagnose the ailments of health system. System that requires more input, is suffering  due to  decades of neglect.  It  reflects  a lower priority to health sector.

India’s public health expenditure — 1% of its gross domestic product (GDP) — may have witnessed a marginal improvement from 0.98% in 2014, but it is still way behind even the low-income countries that spend 1.4% on an average, shows National Health Profile 2018.

India is spending even less than some of its neighbors countries such as Bhutan (2.5%), Sri Lanka (1.6%) and Nepal (1.1%), according to the annual report released on Tuesday by the Central Bureau of Health Intelligence, the health intelligence wing of the directorate general of health services in the Union ministry of health and family welfare.

In World Health Organization’s South-East Asian Region, which includes 10 countries, India finishes second last, above only Bangladesh (0.4%), when their health expenditure is compared. Maldives spends 9.4% of its GDP to claim the top spot in the list, followed by Thailand (2.9%).

India’s National Health Policy 2017 proposes raising the public health expenditure to 2.5% of the GDP by 2025.

India currently spends a little over 1% of GDP on health, far below Singapore which has the lowest public spend on health at 2.2% of GDP among countries with significant universal health coverage (UHC) service, according latest National Health Profile (NHP) data.

India’s per capita public expenditure on health increased from Rs 621 in 2009-10 to Rs 1,112 (around $16 at current exchange rate) in 2015-16. However, it is still “nominal”, compared to other countries. Switzerland spends $6944 on health per capita, whereas the US spends $4802 and UK spends$3500.

Government  plans to launch its ambitious National Health Protection Scheme (NHPS)- Ayushman Bharat – to cover over 10 crore poor families with an annual health cover of Rs 5 lakh per family. A successful implementation may bring some positive change to the ailing system.

Real challenge is to provide basic health facilities to remote areas.  Even good preventive care and primary care to under privileged can also  bring a significant change.

 

New price index for pharmaceutical products likely


  • Govt plans to introduce a new price index for pharmaceutical products
  • Under the proposed mechanism, the Centre plans to link prices of all medicines with the new pharmaceutical index
  • However, it seems the government’s latest move may also not go well with drug makers

The drug pricing mechanism in the country is likely to be overhauled before the end of this month (India). Among the changes proposed by the government is the move to introduce a new price index for pharmaceutical products that will become the benchmark to determine prices of all medicines sold in the country — even those that are currently outside the drug price control order.

Even now, the government loosely regulates prices of all medicines in public interest. Prices of around 850 essential drugs are capped by the government. The drug price regulator National Pharmaceutical Pricing Authority (NPPA) revises these prices annually based on the wholesale price index (WPI). For all other medicines, companies are allowed to raise prices by no more than 10% in a year.

Under the proposed mechanism, the Centre plans to link prices of all medicines with the new pharmaceutical index. Drug makers will be allowed to revise prices annually only on the basis of movement in the index, sources said.

The proposal is in its final stages and is likely to be notified by the department of pharmaceuticals in June itself. The proposed index will not only replace the WPI for revising prices of scheduled or price-controlled drugs, it will be used to regulate prices of non-scheduled medicines.

The proposal is part of the recommendations made by the government think-tank Niti Aayog for making changes to the Drug Price Control Order, 2013.

Once in place, the new system will change the price movement of all medicines. Under the present price mechanism, only 17% of the over Rs 1 lakh crore domestic pharmaceutical market is under direct government price control. Even by volumes, the government regulates 24% of all medicines sold.

The suggestion to create a new index came in the wake of objections from the pharmaceutical industry to linking of prices with WPI. However, it seems the government’s latest move may also not go well with drug makers.
Experts who believe that linking prices to an index will be better and less discretionary than the present mechanism and may actually result in increase in prices rather than a decrease.

 

Pharma- Malaise may get treatment: unique IDs of drugs soon to check fakes


Usually every problem related to health is called medical malaise, but that is a misnomer.  In fact health care comprises tens of different industries. Collective malaise of all these is conveniently projected as medical malaise, related to doctors. Rest remain invisible, earn money and  doctors are blamed. As doctor is a common universal link that is visible with patient. By an average application of wisdom, it is easy to blame doctors for everything,    that goes wrong with patient.

One such problem is presence of fake medicines.  If patient gets fake or low quality medicines and does not get well or gets side effects, doctor will face harassment. Whereas people involved and industry will be sitting pretty and  make money.

Therefore any such step  to correct Pharma –malaise should be a welcome step for  doctors. Although it will 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.

May be a time to treat Pharma- malaise.

India’s highest advisory body on drugs will discuss a mechanism to end the menace of counterfeit medicines at a meeting on 16 May.

According to the proposal to be discussed at the Drug Technical Advisory Board meeting, consumers will be able to check whether the medicines that they have purchased are genuine by texting a unique code to be printed on the medicine’s package to a number, said two people aware of the matter, both of whom requested anonymity.

The government plans to initially build a data bank of 300 medicine brands and their consumption pattern in various parts of the country.

Drug companies will then be asked to print a unique 14-digit alphanumeric code on the package of the drug. Consumers buying the medicine can then inquire via a text message whether the code—and therefore the medicine—is genuine or not.

Pharma firms may be asked to print a unique 14-digit code on drugs’ packaging; consumers can send a text message to find out if the code is genuine or not

A government survey conducted between 2014 and 2016 had found 3.16% of drug samples it tested to be sub-standard, while 0.02% were spurious

A WHO report in 2017 revealed approximately 10.5% of medicines in low- and middle-income countries including India are sub-standard or fake

 

The unique identification code will help consumers avoid buying fake products. The idea is that within seconds, the person should receive a reply indicating whether the drug is legitimate.

 

Fake medicines lead to drug resistance in humans and cause a significant number of deaths, according to public health experts. A government survey

conducted between 2014 and 2016 to check the proportion of substandard drugs in India had found 3.16% of the samples it tested to be substandard, while 0.02% were spurious.

Significantly, even samples from big drug makers were found to be not of standard quality during the survey carried out through the National Institute of Biologicals, according to regulator Central Drugs Standard Control Organization.

Glenmark Pharmaceuticals under regulatory scrutiny for alleged misconduct


Glenmark Pharmaceuticals Ltd is under regulatory scrutiny for alleged misconduct in carrying out clinical trials recently in Jaipur.

The Central Drugs Standard Control Organisation (CDSCO) has allegedly found that fake identities were used in clinical trials, as well as evidence of substantial departures from good clinical practice (GCP), in what could be the latest blow for India’s drug-testing industry, which has run into a series of problems with international regulators in recent years.

The alleged misconduct on the part of the company has triggered a tough response from India’s apex drug regulatory authority, which has sent a show cause notice to the company for failing to ensure that clinical trial was conducted in accordance with the Drug and Cosmetics Act, 1940 and Rules 1945, GCP guidelines. The regulatory body has sought an explanation about the alleged irregularities within 10 days. Glenmark has, however, denied any wrongdoing.

The company came under the scanner following reports that several people were deceived into participating in an ongoing trial for pain medication to treat osteoarthritis at a  Multispeciality Hospital in Jaipur. A total of 38 kits were supplied by the company, of which only three were issued to the enrolled patients on April 6. Glenmark has suspended the trials.

CDSCO, which had initiated the inquiry and sent a team from its head office on 22 April to the site, found inadequate and inconsistent patient identification. According to the investigations, the enrolment of subjects was “falsified” and “cannot be relied upon”.

The team also found that out of three patients mentioned in the informed consent form (ICF), two were related to each other and did not visit the hospital in the last six months.

 

Expensive Medical college education (NEET) & poor health system: systematic root rot


Imagine, an opportunity is available to a patient, to decide the doctor as based on his route or marks for entry into medical college. Whether patient will like to get treated by a doctor, who   secured 20% marks, 30 % marks or 60% marks or 80% marks for medical college.  Even   an illiterate person can answer that well. But strangely for selection of doctors, rules were framed so as to dilute the merit to the minimum possible. So that a candidate who scores 20 -25 % marks also becomes eligible to become a doctor. What is the need to dilute and shortlist around half a million for few thousand seats. Answer to that is simple.  To select and find only those students from millions, who can pay millions to become doctors.  

      Although the whole effort and huge expenditure to become doctors in this way may be really worthless in today’s scenario, considering the difficult times and vulnerability of medical profession. By allowing a intentional dilution of quality  can be advantageous only to  few and detrimental to others.

  • Beneficiaries are rich candidates, medical colleges who collecting fee and may be public who will get numbers of doctors. Surplus of doctors is thought to be an advantage to society. But here quality is least of the consideration.
  • Disadvantage to students, who are meritorious but can’t pay, and possibly society in long run, who is deprived of good quality doctors.

 

Dilution of Merit :

  • Before NEET was made mandatory in 2016, the cut-offs for admission were 50% marks for the general category, and 40% for the reserved categories. From the 2016 admission year, these were changed to 50th and 40th percentile, respectively, opening the doors to candidates with just 18-20% marks in the NEET aggregate. Thereby candidates securing 5% marks (physics) and 20% in  biology are also eligible to be doctors (times of India).
  • The student with the highest NEET marks among those admitted into the private university had lower marks than the last student admitted to the open category in each of the government colleges.
  • In the private university, the fees for the MBBS course are Rs 64 lakh compared to just Rs 4 lakh in the government colleges.
  • when NEET was introduced, many private colleges increased their tuition fees many fold.  This  ensured that meritorious students without money would never get admission. The tuition fee is fixed arbitrarily to cater to only rich or super rich students. (times of India)         System of medical business and  medical education is created based on willful dilution of merit.   Quite a few successful candidates may eventually feel that the money spent and the hard work may not be worth it especially those candidates who may have invested in heavy fees or bought a seat in medical colleges with hefty amount. Some of them, who invested millions for becoming doctors, will be even probably unable to recover their investments. The students with strong financial backgrounds may be more benefited as they can become health  investors or health managers. But for others, it could be a dream turning into a nightmare.

    If the society continues to accept such below par practices, it has to introspect, whether it actually deserves to get good doctors. Paying the irrational fee of medical colleges may be unwise idea for the candidates, who are not from strong financial backgrounds. But at the same time unfortunately, it may be a compulsion and entrapment for students, who have entered the profession and there is no way  forward.  So children have to be careful while choosing medical careers from the beginning.

    A famous axiom “as you sow so shall you reap” has an application to health system in this scenario, so people should not rue scarcity of good doctors.  

NEET: Buying an expensive medical college seat & want to be doctor.  Worthless and unfair


At a time when students, parents and even doctors are uncertain whether opting for medical college along with the vulnerability and risk associated with   becoming a doctor is worth it or not, some are naive enough to pay millions as fee for medical education and for securing a seat  in medical college. The noble intentions of NEET were to minimize wastage of seats due to multiple admission procedures running concurrently and to do away with the variable criteria for selection used for admissions. But  there has been unregulated steep increase in fees of private medical colleges. So in the end, seats remain unfilled and may be a kind of auction, whosoever can pay millions, takes the seat.

        Going by selection of candidates as doctors, If given a choice, by whom  a patient will like to get treated? A candidate who scored 30 % marks or a person getting 60% or 80%  marks.   NEET eligibility getting lower and  a  candidate getting around 30 % of marks  may be able to secure a degree to treat patients.  What will be the deciding factor? The criteria as to why a person with 60%  marks will  not be given a seat and with 30% marks will be able to secure. It will depend upon, whether  a student  is able to pay the exorbitant fee or not. Present system and mechanism of admission permit and accept such huge  variation! That strange equation is acceptable in lieu of money paid!

It is ironical that the medical profession is regulated, but medical business or medical education is not.  Such business of producing doctors based on their paying capacity should be clearly trounced for the benefit of public. Foundations of healthcare should be on touchstone of merit, ethics and character and not based on business deals. Therefore meritorious students, especially from average backgrounds, who opt to become doctors feel cheated when they pay massive fee to buy a seat. It is an insult to the very virtue of merit which should have been the sole criteria for these admissions.

Quite a few successful candidates may eventually feel that the money spent and the hard work may not be worth it especially those candidates who may have invested in heavy fees or bought a seat in medical colleges with hefty amount. Some of them, who invested millions for becoming doctors, will be even probably unable to recover their investments. The students with strong financial backgrounds may be more benefited as they can become investors or health managers. But for others, it could be a dream turning into a nightmare.

   Buying a seat may be a compulsion for many as a  result of entrapment into a system. Once aspiring child  decides to be a doctor  and there may not be any other way forward.

A famous axiom “as you sow so shall you reap “  has an application to health system. As NEET has been implemented and there has been some effort to find out information about  admissions to medical colleges, at least tip of the  iceberg is getting visible.  More you know or read the news items about NEET, more one is convinced that industry  selling medical college seats has been quite powerful and practically, every technique to sell seats is prevalent to by pass the merit and deny seat to deserving candidates. These meritorious children, who are denied seats could have been   good doctors and   real custodian for the health of people.  But if for some reason, business prevails and government fails to prevent this cruel and corrupt selling of medical seats, an Einstein brain is not required to  guess the whole malaise prevalent in health system.  Foundation  of  medical system is suffused with sand rather than touch stone of merit.

Astronomical and unreasonable fee of medical colleges without proper facilities and medical education can be born only by investors and not good candidates.   It is the people and society, who will be the real sufferers in future. Therefore resentment to such system should come from the society.

If every one is happy by the arrangement, then one has to introspect, whether  society really deserve  kind of  doctors, they wish.

NMC Bill and bridge course, a suggestion: How to create doctors for area of need, if required?


Crosspathy is dangerous to human race and potential global catastrophe because of antibiotic resistence.  All  allopathic medicines are hazardous chemicals in inexperienced hands. Incorrect and massive use of antibiotics will  cause antibiotic resistance, which has global ramifications. From this angle, it is a retrograde step. When all over the world, need is being felt that there has to be better control of antibiotic prescription.  We are entering an era, where antibiotics are getting useless and more so because of rampant misuse of antibiotics.  Rather than exercising a better control, it will be a catastrophic to human race world over by causing antibiotic resistance.

Will  thousands of alternate medicine graduate will dispense all antibiotics,  anticancer , anti diabetic , cardiac medications? It is hard to think about hundreds of potentially dangerous medicines being given without structured training and  proper exams in this system of crosspathy.

Following steps should be taken before implementation:

 

Main Aim; to create doctors  for area of need. (AON doctor)

  1. To identify areas of need; most basic step is to identify the areas of need, where doctors are not available. Government should identify area of need and implement the scheme in selected areas, and with  selected simple drugs. Such areas should be such that which do not have medical facilities or lack doctors. Areas which already have doctors will not accept the diluted  or suboptimal care, for example urban population.
  2. Limited seats-To identify the number required; let us say start with pilot project of  selecting 500 to1000 such doctors. All the lakhs of alternate doctors  can not be allowed to prescribe allopathic medicines. It will put the community at risk.

 

  1. To identify the skills required for the area; for example emergency, for paediatrics or obstretics and gynaecology, trauma.
  2. Willingness to work in area of need- to identify the doctors: have a written competition from all candidates who apply for bridge course. To identify doctors who have given willingness to work in these areas of need. People who perform well should be taken for bridge course  only on limited seats. Bridge course should not ne free for all.
  3. To develop a structured bridge course, which should be around one year after comparing the course of MBBS and the course done by the candidate.
  4. Admission and exit in the bridge course should be through exam and limited seats.
  5. Bridge course and allopathic medicines should not be made free for all, that any body can dispense it. We can get benefit only if is specific to needs of people. If everyone is allowed to practice allopathy in all locality, it will be a global hazard besides our community as well.
  6. These trained doctors will have an undertaking to serve in area of need only. For a period at least 10 to 20 years.
  7. Number should be limited but training should be good.
  8. A special course needs to be designed separately for one year, so that people in area of need do not get substandard care

Without proper planning and implementation and identification of area of need, this bridge course will not benefit anyone, rather it can be disastrous.

 

 

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