Published By LIBRARY & INFORMATION CENTRE INDIAN … · 2018-12-06 · 40 According to CDL officials who did not want to be identified, if the Kasauli laboratory starts suspecting

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


Ban on quack health minister set up enquiry

Nav Bharat Times 4

AIIMS studying 7000 to detect strock, dementia


Banned ingradients in diet pills putting Indians at risk


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


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


High drug prices due to unreasonable margin of cos: CCI


CCI high trade margins pushing up drug prices -E Pharmacies can bring transparency


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Zydus to buy Kraft’s India biz for 4.6 crore


Game changer? New TB drug claim to cure 8 of 10 patients


Microplastic have found their way into your gut


Bio-Med founder garg gets bail, inspectors Apologise, Polio vaccine contamination case


E-comm sites under scanner for selling spurious cosmetics


Pil filed in HC seeking curbs on Antibiotics sale without prescription


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?


Our breast cancer solution addresses cultural issues


A blue pill is stopping HIV like never before


There is no safe level of alcohol consumption


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Test imported pulses to check for toxins: FSSAI


Meditation helps patients of glaucoma: AIIMS Study


In Rajsthan No. of Zika hit touches 100


Pregnancy, Zika, microcephaly: 3 countries, same concerns


Diet supplement found containing dangerous drug


12 new Zika cases in Jaipur No rises to 72


Big Pharma plan cheaper 2nd

brand for Modicare


Oct alone 350 cases of Dengue


Dr Reddy’s sells Hyderabad API Unit to Therapiva


J&J patients Unhappy with Govt Panel over compensation process


Piramal weighs $1bn contract pharma sale


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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Documents

Published By LIBRARY & INFORMATION CENTRE INDIAN … · 2018-12-06 · 40 According to CDL officials who did not want to be identified, if the Kasauli laboratory starts suspecting