Published By LIBRARY & INFORMATION CENTRE INDIAN … · 2018-12-06 · 40 According to CDL...
Transcript of Published By LIBRARY & INFORMATION CENTRE INDIAN … · 2018-12-06 · 40 According to CDL...
Vol. 4, Issue 8, October 2018
Published By
LIBRARY & INFORMATION CENTRE
INDIAN PHARMACOPOEIA COMMISSION Ministry of Health & F. W., Govt. of India
Ghaziabad (U. P.)
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Index Contents Page No.
Vol. 4, Issue 8, October 2018
India tops in under-5 deaths due to toxic air, 60,000 killed in2016: WHO
The Times of India 1
One lakh children death due to Poison Polluted air
Dainik Jagran 2
Desi Pharma cos top in biosimilars globally
The Times of India 3
Ban on quack health minister set up enquiry
Nav Bharat Times 4
AIIMS studying 7000 to detect strock, dementia
The Times of India 5
Banned ingradients in diet pills putting Indians at risk
The Times of India 6
Antibiotics may cause infection in Intestine
Dainik Jagran 7
Zydus-Heinz India deal raises questions over Cadila’s role
The Economic Times 8
Pricing strategies of 50 cos under NAA Lence
The Economic Times 9
No oxytocin seized in 2016-18: CDSCO informs Delhi HC
The Indian Express 10
Pharma cos unreasonably high trade margins reason for costlier drug: CCI
The Economic Times 11
High drug prices due to unreasonable margin of cos: CCI
The Economic Times 12
CCI high trade margins pushing up drug prices -E Pharmacies can bring transparency
The Times of India 13
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Zydus to buy Kraft’s India biz for 4.6 crore
The Times of India 14
Game changer? New TB drug claim to cure 8 of 10 patients
The Times of India 15
Microplastic have found their way into your gut
The Times of India 16
Bio-Med founder garg gets bail, inspectors Apologise, Polio vaccine contamination case
The Economic Times 17
E-comm sites under scanner for selling spurious cosmetics
The Times of India 18
Pil filed in HC seeking curbs on Antibiotics sale without prescription
The Economic Times 19
Ayurvedic Medicine meets all standards
Nav Bharat Times 20
Heart patients need a rest break at every 20 minutes
Dainik Jagran 20
Immunotherapy may increase age of breast cancer patients
Dainik Jagran 21
Walking in has more benefits than sitting at park
Dainik Jagran 22
DM wrote letter to Govt. for action against generic store
Nav Bharat Times 23
Are cos bribing docs to push vaccine combos?
The Times of India 24
Our breast cancer solution addresses cultural issues
The Times of India 25
A blue pill is stopping HIV like never before
The Times of India 26
There is no safe level of alcohol consumption
The Indian Express 27
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Test imported pulses to check for toxins: FSSAI
The Times of India 28
Meditation helps patients of glaucoma: AIIMS Study
The Times of India 29
In Rajsthan No. of Zika hit touches 100
The Times of India 30
Pregnancy, Zika, microcephaly: 3 countries, same concerns
The Indian Express 31
Diet supplement found containing dangerous drug
The Times of India 32
12 new Zika cases in Jaipur No rises to 72
The Times of India 32
Big Pharma plan cheaper 2nd
brand for Modicare
The Times of India 33
Oct alone 350 cases of Dengue
The Times of India 34
Dr Reddy’s sells Hyderabad API Unit to Therapiva
The Economic Times 35
J&J patients Unhappy with Govt Panel over compensation process
The Economic Times 36
Piramal weighs $1bn contract pharma sale
The Times of India 37
Fears of mystery polio strain now haunt India
Mint 38
Abnormal eye sight in childhood damages brain
Dainik Jagran 41
Dr Dassan’s could cure Paralysis patients
Nav Bharat Times 42
Hepatitis B hit senior Surgeon
Amar Ujala 43
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Diabetes, Cancer, Obesity, Cholesterol, Indigestion is caused by these daily diets
Nav Bharat Times 44
Arteritis is curable if treatment starts within time –World Arteritis Day
Nav Bharat Times 44
3 in one Vaccine to cure Diarrhoea
Dainik Jagran 45
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Fears of mystery polio strain in vaccine now haunt India
About 150,000 contaminated vials of OPV made by Bio-Med are likely to have entered the govtrun vaccination
programme The testing standards are set by IPC. All the samples are tested for their potency as per the label claim... We
are following protocol ARUN BHARDWAJ Director, Central Drugs Laboratory, Kasauli From the day news of the P2 strain
in the polio vaccine surfaced until 4 October, a total of 16 batches had been tested at CDL Kasauli
From page 01 virus in sewage and stool samples in a development that threatens to rob India of its polio-free status.
RAJNISH KATYAL/MINT
According to Dr Sylvia Karpagam, a public health expert based in Karnataka, the oral polio vaccine batch containing the
P2 strain has reached Uttar Pradesh and Telangana, endangering many of “those who have not received inactivated
polio vaccine (IPV) and are exposed to strain 2 and are now at risk of getting vaccinederived polio.
The bigger problem is that the virus can mutate and no one knows into what form— mild or virulent”. For a long time,
polio vaccines carried three strains of viruses—type 1, type 2 and type 3, also called P1, P2 and P3, respectively—and
were hence called trivalent vaccines. Worldwide, the second strain was withdrawn from vaccines several years ago on
confirmation that it had been eradicated among humans.
India, which continued to use the trivalent vaccine for some more time, switched to bivalent vaccines in April 2016,
joining the rest of the world, confident that the type 2 strain had been eliminated. The move also ensured that chances
of vaccine-derived polio were minimized. With this, companies producing polio vaccines were supposed to destroy their
stocks of strain 2. Therefore, the reappearance of the P2 strain comes as a shock and threatens to change India’s status
as a polio-free nation.
As part of a larger investigation, Mint visited the Central Drugs Laboratory (CDL) located in Kasauli, a hill station in
Himachal Pradesh, which tests vaccines before they are sent across the country. Although the health ministry has said
there is no need to panic, questions remain over how the supposedly eradicated P2 strain entered some batches of the
oral polio vaccine. The contaminated batches were manufactured in March this year and sent to Kasauli for mandatory
testing. At CDL Kasauli, vaccines are tested only for the viruses mentioned on the label.
This means testing is done on the assumption that what the manufacturer has mentioned on the label is accurate, so
testing is limited to just the strains mentioned on the label. If, for instance, the label mentions P1 and P3 strains, tests
would be conducted only for those two strains, with none for P2.
According to CDL, this is the protocol, which it has duly followed. “The testing standards are set by Indian
Pharmacopoeia Commission (IPC), an autonomous institution of the ministry of health and family welfare,” said CDL
Kasauli director Arun Bhardwaj. “All the samples are tested for their potency as per the label claim, before they the
market for the consumers. We are following a due protocol.”
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According to CDL officials who did not want to be identified, if the Kasauli laboratory starts suspecting every batch and
tests vaccines for every strain, no vaccine would reach the market since it’s a timeconsuming process.
A visitor to Bhardwaj’s office has to pass by piles of empty boxes, bearing testimony to CDL’s huge workload. The
director insists work is on track and that CDL is not short-staffed; yet, a large whiteboard in his office displaying the
amount of work has not been updated since July. It says that a total of 4,105 vaccines were tested that month. These
include vaccines for MMR, rabies, hepatitis B, hepatitis A, yellow fever, influenza, Japanese encephalitis, varicella,
measles and rotavirus. Polio accounts for the maximum, with 748 doses of the oral polio vaccine (OPV) tested in July.
“Samples from all over India from all the companies manufacturing vaccines come here for testing before going to the
market,” said Bhardwaj. CDL Kasauli was established to ensure that the vaccines and antisera produced, distributed and
imported into the country are safe, efficacious and potent. It is mandated to regulate the quality of vaccines produced
indigenously for the domestic market, the government’s immunization programme, for exports and those imported into
the country.
Every day, CDL Kasauli tests two batches of polio vaccines for potency. From the day news of the P2 strain surfaced until
4 October, a total of 16 batches had been tested. “We need to investigate and find out what actually happened and how
the contamination occurred,” said WHO deputy director general Dr Soumya Swaminathan. In India, there are four major
manufacturers of the bivalent vaccine—Bio-Med (currently under the scanner), Bharat Biotech International, Panacea
Biotec, governmentowned Bharat Immunological and Biologicals Corp. Ltd (Bibcol) and Mumbai-based Haffkine Bio
Pharmaceutical Corp. Ltd.
The contaminated doses were manufactured by the lesser known Bio-Med. About 150,000 contaminated vials are
expected to have entered the government-run vaccinaenter tion programme. The regulator is investigating how the
type 2 strain was retained by the company even after the drug regulator had ordered manufacturers to completely
destroy it by 25 April 2016.
“The first question is: Did the company stop and destroy P2 strain,” asked Dr M.K. Bhan, former secretary in the
department of biotechnology under the ministry of science and technology.
“The companies were also supposed to remove the virus from the cold chain and dispose of it,” said Dr S. Eswara Reddy,
drug controller general of India (DCGI). The managing director of Bio-Med was arrested on 29 September after a first
information report was filed by CDSCO and later released on bail last week.
Three drug inspectors have since been investigating BioMed’s plant and paperwork.
“It seems the company was not following good manufacturing practices (GMP) standards to the full extent. The
company was not following certain quality parameters,” said the official in the regulatory authority quoted earlier. This
is, however, not the first time Bio-Med has got into trouble with regulators. In March, CDL Kasauli found two batches of
its
Peda Typh typhoid vaccine to be substandard.
How then did Bio-Med continue supplying vaccines for the government? Experts say the problem lies with the bidding
system under which the lowest bidder (L1) gets to supply the government. In this case, BioMed proved to be the L1.
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In a recent tender floated to procure OPV vaccines after the virus debacle, there was a difference of a mere 14 paise per
dose between L1 (Bio-Med) and the second-lowest bidder. According to documents seen by Mint, while Bio-Med
quoted ₹4.73 for a dose, Bharat Biotech quoted ₹4.87, Bibcol ₹5.05 and Haffkine the most expensive at ₹121.80.
“This is a disaster. They can sell cheap because they don’t have quality assurance,” Bhan said. “Price that we give to
manufacturer must be reasonable without sacrificing the quality. We like to get cheap products, but it should not be
held true for vaccines. The balance between quality and price is much needed.” The tender process has even become a
bone of contention among companies. “Have we put lives of children in danger to save 14 paise,”asked a polio vaccine
manufacturer, who lost the bid because he quoted higher, on condition of anonymity.
A spokesperson for Sanofi Pasteur, the world’s largest manufacturer of IPV, said: “At Sanofi Pasteur, it takes between 6-
36 months to produce, package and deliver one single dose of vaccine. Seventy percent of the production time is
dedicated to quality controls and thousands of tests are performed to make sure that the vaccine is of the highest
quality.” “The amount of money that has been invested in the polio campaign will be of no use if the regulatory
mechanisms and quality control measures are not of the highest quality,” Karpagam said. “The regulatory body is
equally liable for failing to adequately monitor the goof-up.”
Some experts are hopeful, though. “With the current status that we have, children are adequately protected and hence
we do not see any current threat of polio outbreak. India has a robust polio surveillance programme, it needs to be
continued,” said Dr Raj Shankar Ghosh, deputy director, vaccine delivery and infectious disease, at Bill and Melinda
Gates Foundation.
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