Drug Information Bulletin

Drug Information Centre (DIC) India

Indian Pharmaceutical Association approved
Bengal Branch manufacturing
Tele fax: 033 24612776, E-mail: ipabengal.dic@gmail.com & marketing of
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Contact: 09830136291 Remdesivir
&
Regulatory
from West Bengal Affairs Division (RAD), IPA
Volume: 14 Number: 05 30th May 2020

Content
 Editorial
 A group of scientists unable to confirm benefit of Hydroxychloroquine or Chloroquine in COVID-19 treatment:
Lancet
 Benefits of HCQ out weight risks, if any: Govt. of India
 Health Ministry Issues Guidelines on Reuse, Disinfection of Eye Protection Goggles
 Industry, Research Bodies Warn Of Reckless Use of Disinfectants against Covid-19
 NDMA Impurity Findings in Certain Metformin Extended-Release Products


Editorial
Entire scientific world are trying to have a weapon to fight the COVID-19 global pandemic and trying
to develop vaccine to prevent the disease and to develop a drug for treatment of the infected
patients.
It is known from reliable sources that globally about 200 projects and 30 projects in India are going on
to develop vaccine against COVID-19. Different groups are trying to develop different types of
vaccines which ranges from age old technique to the most modern RNA vaccine. Several companies
like- J & J, Sanofi, GSK, Merk etc. in the international level and Indian companies like- Zydus Cadila,
Bharat Biotech, Aurobindo etc. are working for development of COVID vaccines. Some of them are in
Phase I trial and some of them are moving to Phase II trial. In spite of huge initiative experts are
sceptical to develop and marketing a vaccine against COVID-19 very fast.

Dr. Subhash C. Mandal


Editor
E mail: subhash.mandaldr@gmail.com
Mob. 9830136291
A group of scientists unable to confirm benefit of (PPE) kit by a healthcare worker, according to the
Hydroxychloroquine or Chloroquine in COVID-19 latest guidelines issued by the Union Ministry of
treatment: Lancet Health & Family Welfare (MoH&FW) on the
rational use of the special glasses while attending
“We are unable to confirm a benefit of to coronavirus disease (Covid-19) patients or
Hydroxychloroquine or Chloroquine, when used related swab samples
alone or without a macrolide, on in-hospital “Goggles may be issued to each healthcare
outcomes for COVID-19. Each of these drug worker, who will decontaminate them after every
regimens was associated with decreased in- use. Goggles to be disinfected by users and
hospital survival and an increased frequency of reused at least five times each, whereby one pair
ventricular arrhythmias when used for treatment of goggles will suffice for six days. They may use
of COVID-19.”-stated by authors of a review them rationally till their transparency decreases,
article published in Lancet on 22nd May 2020. or they get damaged. The ratio of issue of goggles
For details: www.thelancet.com/journal to coverall is recommended at 1:6,” the advisory
Benefits of HCQ outweigh risks, if any: Govt. of said.
India Goggles are key to a PPE kit, whose components
on 28th May reiterated that use after their use are discarded as bio-medical waste
of Hydroxychloroquine (HCQ) will continue as per the standard operating procedure (SOP).
as prophylactic treatment against Covid-19 in However, the goggles that conform to the
high-risk categories and that this decision has prescribed quality specifications of the Bureau of
been taken with “responsibility”. Niti Aayog Indian Standards (BIS) can be reused after proper
member (health) and head of Covid-19 medical disinfection, the ministry said.
management empowered group, V K Paul said the “The purpose of this document is to enable
findings of studies conducted in India show individuals to reuse goggles used by them and
“benefits of the drug outweigh risks if any” and allowing an extended use without running the risk
therefore, the guidelines issued by the ICMR for of contracting infection,” the advisory said.
use of HCQ are “appropriate”. The ministry has been issuing advisories at regular
intervals to guide healthcare workers on how to
“We are doing what we are doing with rationally use their protective gear after the
responsibility,” Paul said, underlining country faced an acute shortage of PPE kits
that Chloroquine is an old medicine with known during the initial stages of the viral outbreak,
efficacy and HCQ is even advanced and safer. “We leading to widespread panic and a public outcry.
will use it in treatment as per the clinical protocol.
We will also revise the guidelines as we keep “We don’t face any shortage anymore but a
getting relevant data.” The comments come in rational use of the protective gear is still
the wake of many countries including France, Italy advisable. One must not waste the resources just
and Belgium stopping use of HCQ, after the WHO because the requirement is being met. The
suspended its use in clinical trials. ministry has been consulting experts and issuing
Paul said WHO was not the only platform where appropriate guidelines on a regular basis, as it is
the drug was being tried. Trials on HCQ are going an evolving situation,” said a senior government
on in many countries. Its effect in tissue culture is official, requesting anonymity.
well known. The Centre has provided 1.14 and 9 million N-95
Ref.: masks and PPE kits, respectively, to the states and
https://health.economictimes.indiatimes.com/news/d other central institutions to date.
iagnostics/benefits-of-hcq-outweigh-risks-if-any-
govt/76084650 “We’ve identified over 100 domestic
Health Ministry Issues Guidelines on Reuse, manufacturers and in about two months have
Disinfection of Eye Protection Goggles developed a robust industry indigenously, which
has a capacity of manufacturing close to 3 lakh
A single goggle can be worn at least six times as a masks and PPE kits each daily. It’s a remarkable
component of a personal protective equipment feat. Besides, the country is not dependent on the
import of these items anymore,” the official “The Bureau of Indian Standards has classified
added. sodium hypochlorite of 4-6 per cent
The Union Ministry of Textiles has identified eight concentration for household use. This
laboratories to run a quality control test of the concentration available commercially must be
PPE kits manufactured indigenously. diluted with water by a skilled person to make the
Industry, Research Bodies Warn Of Reckless Use solution for disinfection,” said Professor A B
of Disinfectants against Covid-19 Pandit, Vice-Chancellor ICT.

Alkali Manufacturers Association of India (AMAI), CSIR-NCL, ICT Mumbai, and AMAI are jointly
National Chemical Laboratory, Pune (CSIR-NCL) suggesting 0.05 per cent (500 ppm) of bleach as a
and the Mumbai-based Institute of Chemical safe concentration for localised direct spray on
Technology (ICT) have come together to spread abiotic surfaces, but excluding general misting
awareness on the safe use of disinfectants that is and indoor/ outdoor fogging or fumigation. WHO
at the center of the on-going fight against COVID- guidelines do not allow the use of any type of
19. mist tunnel, fogging, or fumigation of outdoor
There have been many instances of disinfection spaces.
chambers being erected in the country which “Spraying individuals with disinfectants (such as in
spray a mist of disinfectants on those passing a tunnel, cabinet, or chamber) is not
through the chamber which could do more harm recommended under any circumstances. This
than good, the organizations said in a joint could be physically and psychologically harmful
statement. and would not reduce an infected person’s ability
Quoting a World Health Organisation (WHO) to spread the virus through droplets or contact”,
advisory, they stated that the use of disinfectants WHO stated.
such as sodium hypochlorite is for disinfecting The three organisations are of the view that 0.1-
surfaces and not human beings. 0.5 per cent (1000 to 5000 ppm) of bleach should
be used for wiping/ cleaning surfaces with a cloth.
“We are privileged to get the support of two The lower concentration of 0.1 per cent (1000
leading organisations involved in scientific ppm) is suitable for general-purpose home/ office
research who have endorsed our views on safe disinfection and a higher concentration of 0.5 per
disinfection after conducting laboratory tests”, cent (5000 ppm) for hospitals and resistant
said Jayantibhai Patel, President AMAI, the pathogens settings.
representative body of the alkali industry that Source: The Hindu Businessline
produces sodium hypochlorite, chlorine, NDMA Impurity Findings in Certain Metformin
bleaching solution/powder, etc. the major Extended-Release Products
chemicals used for disinfection.
The U.S. Food and Drug Administration is
According to Ashwini Kumar Nangia, Director, announcing today that agency laboratory testing
CSIR-NCL, sodium hypochlorite (NaOCl) or bleach has revealed levels of the nitrosamine impurity N-
or hypo must be used with utmost precautions as Nitrosodimethylamine (NDMA) above the
a disinfectant so as to avoid skin contact as it may agency’s acceptable intake limit in several lots of
harm the skin and cause irritation. Eyes should the extended-release (ER) formulation of
also be protected by using proper goggles/face metformin, a prescription drug used to control
shields. high blood sugar in patients with type 2 diabetes.
He added, “High concentration of disinfectants The agency is in contact with five firms to
can increase chemical exposure to users and may recommend they voluntarily recall their products.
also damage surfaces. The diluted disinfectant Company recall notices will be posted on FDA’s
solution should be uniformly applied to surfaces website. There are additional manufacturers of
and allowed to remain wet and untouched for at the metformin ER formulation that supply a
least one minute for the chemical to inactivate significant portion of the U.S. market, and their
pathogens and kill any microorganisms.” products are not being recalled. The FDA is
continuing to work closely with manufacturers to
ensure appropriate testing. Assessments are risk of excessive NDMA in their product and to
underway to determine whether metformin ER test each batch before it is released into the U.S.
recalls will result in shortages and the agency will market. If testing shows NDMA above the
work closely with manufacturers to prevent or acceptable intake limit, the manufacturer should
reduce any impact of shortages. inform the agency and should not release the
batch to the U.S. market.
“The FDA has strict standards for safety,
effectiveness and quality, and the agency makes In late 2019, the FDA announced it had become
every effort based on science and data to help aware of NDMA in some metformin products in
keep the U.S. drug supply safe. We understand other countries. The agency immediately began
that patients may have concerns about possible testing to determine whether the metformin in
impurities in their medicines, and want to assure the U.S. supply was at risk, as part of the ongoing
the public that we have been looking closely at investigation into nitrosamine impurities across
this problem over many months in order to medication types. By February 2020, the agency
provide patients and health care professionals had identified very low levels of NDMA in some
with clear and accurate answers,” said Patrizia samples, but at that time, no FDA-tested sample
Cavazzoni, M.D., acting director of the FDA’s of metformin exceeded the acceptable intake
Center for Drug Evaluation and Research. “Now limit for NDMA. The FDA has maintained that it
that we have identified some metformin products would continue with ongoing testing of
that do not meet our standards, we’re taking metformin and other medications, and if any
action. As we have been doing since this impurity levels of NDMA or other impurities were
was first identified, we will communicate as new identified, swift action would be taken.
scientific information becomes available and will
take further action, if appropriate.” Recently, the FDA became aware of reports of
Patients should continue taking metformin higher levels of NDMA in certain ER formulations
tablets even after recalls occur, until they consult of metformin via a citizen petition filed by a
with their health care professional who can private laboratory. FDA laboratories tested the
prescribe a replacement. Patients with type 2 same metformin lots that the private laboratory
diabetes could face dangerous health risks if they found to contain NDMA above the acceptable
stop taking their prescribed metformin. The FDA intake limit. The agency confirmed unacceptable
recommends that health care professionals NDMA levels in some, but not all, of those lots. In
continue to prescribe metformin when clinically other instances, our laboratory detected NDMA in
appropriate; FDA testing has not shown NDMA in lots that the private laboratory did not. The
immediate release (IR) metformin products (the agency also found that the levels of NDMA, when
most commonly prescribed type of metformin). present, were generally lower than reported by
The agency is working with manufacturers of the the private laboratory. Given FDA scientists’ deep
recalled tablets to identify the source of the experience quantifying these impurities in drugs,
NDMA impurity. At this time, the elevated levels the agency is confident in the reliability of the
of NDMA have been found in some finished-dose FDA’s testing method and results and will
tablets of the ER formulation but have not been continue to take action based on the latest
detected NDMA in samples of the metformin scientific information. The results have also been
active pharmaceutical ingredient. consistent with the findings of other regulatory
The agency is also asking all manufacturers of agencies’ laboratories around the world.
metformin containing ER products to evaluate the Source: US FDA News Release

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