Drug Information Center (DIC) of IPA started functioning with the release of its 1st Publication of Drug Information Bulletin (DIB) on 15th April 2007. Every week the center has successfully published this biweekly e-bulletin jointly with RAD without any interruption till the end of 8th year. Thereafter it is published bi-weekly without any interruption till date.

Our DIC and DIB have earned much reputation throughout the country and it has spread its wings to reach several other countries like- USA, UK Switzerland,  Sri Lanka, Bangladesh, Thailand etc. Every day we are receiving the request to send this bulletin to some more people including Doctors, Pharmacists, Nurses, Reporters, general people etc.

Several medical colleges and Pharmacy colleges are forwarding this amongst their faculty members and students. Some of them are taking print out of this and archiving in their library to make it available for their readers.

It is also being archived in the IPA Head Quarter website www.ipacentre.org, you can read this bulletin from this website under heading publication.

Drug Information Bulletin

Drug Information Centre (DIC)

Indian Pharmaceutical Association

Bengal Branch

Tele fax: 033 24612776, E-mail: ipabengal.dic@gmail.com

Web Site: http://www.ipabengal.org

Contact: 09830136291


Regulatory Affairs Division (RAD), IPA


• Editorial

• New Drug: Silodosin for benign prostatic hypertrophy

• Lamivudine Risk of hearing loss

• Amarasate extract Anaphylaxis

• Obeticholic acid Risk of serious liver injury

• Over 40 Techs in Pharma up for grabs for Gujarat companies



Oxytocin-an essential drug is used widely for inducing labour. But unfortunately it is being misused in several means. Medical experts point out

that sustained use of the drug can cause hormone imbalance in humans and harms the reproductive system of animals, reducing their life

span. Similarly, it was reported that minor girls were given repeated and unregulated shots of oxytocin injection to speed up their sexual

maturation. Moreover, consuming this hormone unknowingly through Milk, vegetables, which causes several dysfunctions in human body. It is

very harmful for humans who unwittingly are made to consume this hormone. Humans face all the harmful effects of this drug. Children are

most susceptible to its effects and it is known to have caused imbalanced hearing and weak eyesight. Common symptoms are exhaustion and

loss of energy. Govt. of India has taken several steps to curb this menace, through a notification vide no. 29 E dated 17.01.2014 and a recent

circular dated 22.10.2014. They has adopted further restrictions on movement of Oxytocin vide G.S.R.411(E) dtd. 27.04.2018, which are-

The manufacture of Oxytocin formulations for domestic use shall be by public sector undertakings or companies only and the label of the

product shall bear barcodes.

(i) The manufacture of Oxytocin formulations for export purposes shall be open to both public and private sector companies and the

packs of such manufacture for exports shall bear barcodes.

(ii) The manufacturers of active pharmaceutical ingredient of Oxytocin shall supply the active pharmaceutical ingredient only to the

public sector manufacturers licensed under the Drugs and Cosmetics Rules, 1945 for manufacture of formulations of the said drug

for domestic use.

(iii) The manufacturers of active pharmaceutical ingredient of Oxytocin shall supply the said active pharmaceutical ingredient to the

manufacturers in public and private sector licensed under the Drugs and Cosmetics Rules, 1945 for manufacture of formulations

of the said drug for export purpose.

(iv) The Oxytocin formulations manufactured by the public sector companies or undertakings licensed under the Drugs and Cosmetics

Rules, 1945 for domestic use shall supply the formulations meant for human and veterinary use only,- (a) to the registered

hospitals and clinics in public and private sector directly; or (b) to the Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP)

and Affordable Medicines and Reliable Implants for Treatment (AMRIT) outlets or any other Government entity which may be

specified by the Central Government for this purpose in the country which shall further supply the drug to the registered

hospitals and clinics in public and private sector.

(v) The Oxytocin in any form or name shall not be allowed to be sold through retail Chemist.

Subsequently it was further amended to make Oxytocin available from retail outlets and for further regulation Oxytocin was included in the

Schedule H1vide G.S.R. 795(E) dtd.21.08.2018.

Dr. Subhash C. Mandal


E mail: subhash.mandaldr@gmail.com

Mob. 9830136291

New Drug: Silodosin for benign prostatic


Approved indication: benign prostatic



4 mg and 8 mg capsules

Benign prostatic hyperplasia can cause lower

urinary tract symptoms such as slow urine flow,

nocturia and incomplete emptying of the bladder.

If these symptoms are sufficiently bothersome as

to require treatment, selective alpha-blockers

such as alfuzosin and tamsulosin are one option.

These drugs block alpha1 adrenoreceptors in the

smooth muscle of the prostate and bladder to

reduce resistance and so improve urinary flow.

Silodosin is another selective alpha-blocker. It has

much greater affinity for the alpha1A receptor

than the alpha1B receptor found in vascular

smooth muscle.

Silodosin is taken once a day with food. The dose

is halved if the patient has moderate kidney

impairment (creatinine clearance 30–59 mL/min)

and silodosin is not recommended for those with

severe impairment (creatinine clearance <30

mL/min). Most of the dose is metabolised, but no

data are available on the effect of severe hepatic

impairment. The terminal half-life of silodosin is

about 11 hours. As the metabolism of silodosin

involves cytochrome P450 3A4, it should not be

used with strong inhibitors of this enzyme system,

such as ketoconazole and ritonavir. Silodosin is

also a substrate of P-glycoprotein so using it with

strong inhibitors (amiodarone, verapamil) of this

transporter is not recommended.

The Australian approval of silodosin is mainly

based on three randomised trials. Two of them

compared silodosin with placebo in a total of 923

men.1 These patients had an average baseline

score of 21.3 on the 35-point International-

Prostate Symptom Score (I-PSS). After 12 weeks

of treatment this had reduced by 6.4 points in the

466 men who took silodosin 8 mg daily and by 3.5

points in the 457 who took placebo. There was

also a significant difference in urine flow rate.

Patient satisfaction was higher with silodosin,

with 32% of the men who took it being ‘delighted,

pleased or mostly satisfied’ compared with 22.5%

of the placebo group.1

The third trial compared silodosin with

tamsulosin, as well as placebo.2 In this trial the

baseline I-PSS was 19.1. After 12 weeks of

treatment it had reduced by a mean of 7.0 points

in the 371 men taking silodosin 8 mg daily and by

6.7 points in the 376 taking tamsulosin 0.4 mg.

The average reduction for the 185 taking placebo

was 4.7 points. The proportions of patients who

had an improvement of at least 25% in the I-PSS

were 66.8% with silodosin and 65.4% with

tamsulosin. These results were significantly better

than the 50.8% response rate to placebo. While

44–45% of the men were ‘delighted, pleased or

mostly satisfied’ with the active treatments, only

34% of the placebo group agreed.2

Silodosin was generally well tolerated, but caused

more adverse effects than placebo. In the placebo

controlled trials, 6.4% of the silodosin group

withdrew because of adverse events compared

with 2.2% of the placebo group. Problems that

were more frequent with silodosin included

dizziness, orthostatic hypotension, diarrhoea and

headache. A major difference between silodosin

and placebo was the adverse effect of retrograde

ejaculation (28.1% vs 0.9%).1 This abnormal

ejaculation is thought to be a consequence of the

selective blockade of the alpha1A receptors. This

specificity should reduce cardiovascular adverse

effects, but in the comparative study silodosin did

not have significantly different effects from

tamsulosin on pulse and blood pressure.2 Alphablockers

may cause floppy iris syndrome so the

patient’s ophthalmologist should be informed

when cataract surgery is being planned.

There can be a high placebo response when

treating symptoms associated with benign

prostatic hyperplasia. The trials controlled for this

by only randomising patients who had not

responded during a placebo run-in phase. Despite

this the differences between silodosin and

placebo were small. Although it is statistically

significant, a difference of 2–3 points in the I-PSS

is only a slight advantage. The mean difference in

maximum urine flow rates was 1

mL/second.1 Such a small advantage over placebo

is of questionable value.3 The overall efficacy of

silodosin is non-inferior to tamsulosin, but

silodosin is more likely to cause retrograde

ejaculation (14.2% vs 2.1%).2


1. Marks LS, Gittelman MC, Hill LA, Volinn W,

Hoel G. Rapid efficacy of the highly selective

alpha1A-adrenoceptor antagonist silodosin in

men with signs and symptoms of benign

prostatic hyperplasia: pooled results of 2

phase 3 studies. J Urol 2009;181:2634-40.

2. Chapple CR, Montorsi F, Tammela TL, Wirth

M, Koldewijn E, Fernández Fernández E;

European Silodosin Study Group. Silodosin

therapy for lower urinary tract symptoms in

men with suspected benign prostatic

hyperplasia: results of an international,

randomized, double-blind, placebo and activecontrolled

clinical trial performed in Europe.

Eur Urol 2011;59:342-52.

3. Dawson A. The price of urine. Aust Prescr


Source: Australian Prescriber

Lamivudine Risk of hearing loss

NCC-PvPI, IPC has made a recommendation to

CDSCO requesting that the drug safety label for

lamivudine is revised to include hearing loss as an

adverse reaction. Lamivudine is used for the

treatment of HIV infection in combination of at

least two other antiretroviral drugs. Between July

2011 and March 2018, NCC-PvPI received eight

ICSRs that reported hearing loss with lamivudine

use. A review of cases by the Signal Review Panel

(SRP)-PvPI, IPC suggested a strong causal

relationship between lamivudine and hearing

loss. Reference: Based on the communication

from IPC, NCC-PvPI, India (http://ipc.nic.in)

Propofol Contraindication in pregnant women


MHLW and PMDA have announced that

precautions of propofol preparations (Diprivan®)

should be revised to remove the contraindication

of use during pregnancy. Propofol can be used by

pregnant women or women who may be

pregnant provided the potential benefits

outweigh the risks. Propofol is indicated for

induction and maintenance of general anesthesia.

Propofol is used for therapy in pregnant women

in Europe and the United States. For this reason

the MHLW requested the PMDA to conduct an

investigation into the use of propofol during

pregnancy. As a result, PMDA concluded that the

above-mentioned revision to safety precautions

of propofol is acceptable. Reference: Revision of

Precautions, MHLW/PMDA, 27 March 2018


Amarasate extract Anaphylaxis

The Medicines and Medical Devices Safety

Authority (Medsafe) has issued a warning about

the risk of anaphylaxis with the use of amarasate

extract (Calocurb®). Amarasate extract is a dietary

supplement marketed to support weight loss and

appetite control. Medsafe continues to monitor

reports of adverse reactions for this product and

all other dietary supplements. Reference: Safety

Information, Medsafe, 9 May 2018


Obeticholic acid Risk of serious liver injury

The MHRA has issued advice to healthcare

professionals about the risk of serious liver injury

in patients with pre-existing moderate or severe

liver impairment, taking obeticholic acid

(Ocaliva®). Health-care professionals are

reminded to adjust dosing according to liver

function. Obeticholic acid is indicated in the

treatment of primary biliary cholangitis in

combination with ursodeoxycholic acid. An EU

review assessed reports of serious liver injuries

and deaths in patients with primary biliary

cholangitis with preexisting moderate or severe

liver impairment who were not adequately doseadjusted.

Liver-related adverse events have

occurred both early in exposure and after months

of treatment. The review concluded that no

changes to the product information are required

but suggested that health-care professionals

should be reminded of the dosing

recommendations. The MHRA has received two

Yellow Card reports of hepatobiliary disorders in

the UK associated with obeticholic acid. One case

was lifethreatening and required hospital

admission. Obeticholic acid is subject to

additional monitoring, allowing quick

identification of new safety information.

Reference: Drug Safety Update, MHRA, 24 April

2018 (www.gov.uk/mhra) (See WHO

Pharmaceuticals Newsletters No.5, 2017: Risk of

serious liver injury in USA)

Over 40 Techs in Pharma up for grabs for Gujarat


Over 40 technologies developed by the National

Research Development Corporation (NRDC) in

drugs and pharmaceuticals have huge potential to

be commercialised by Gujarat-based companies,

a senior NRDC official said on Tuesday. With a

share of about 20%, Gujarat is one of the largest

recipients of technologies developed by NRDC.

NRDC has over 80 technologies in

pharmaceuticals and drugs, for which it is seeking

partners, through Transfer of Technology (ToT)

for commercialisation. "Of these, over 40 licenses

have high potential to be used by Gujarat based

companies," said Amitabh Mishra, senior

manager of biotechnology in NRDC, while

interacting with media persons on the sidelines of

a seminar on NRDC Industry Meet on Technology

Transfer Opportunities in Pharma, Biotech and

Health in Ahmedabad on Tuesday.

"Non-invasive diagnostic technologies targeted

and new-borns, solutions for control of diseases

like Hepatitis-B, as well as herbal medicines need

to be adapted by private companies," said


Jaimin Vasa, president of Gujarat Chamber of

Commerce and Industry (GCCI), said that small

businesses do not have the financial or human

resource to conduct research, during the seminar.

"SMEs need hand-holding during

commercialisation of technologies and to

minimise risks. We need more interactions of

industries with research institutions," said Vasa.

Arvind Kukreti, Deputy Drug Controller of Central

Drug Standard Control Organization (CDSCO)

called for better coordination between

regulators, Research and Development (R&D)

institutions and industry to ensure that the

interests of the consumers are met. Anil Jain, MD

of Ascent Finechem Private Ltd said that R&D is

also needed to bring down the cost and improve

affordability. Experts feel that there is a strong

need to develop technologies to cater to the

future needs of the society. With Gujarat being a

hub of pharmaceuticals and chemicals, it has an

important role to play, said Mishra.

With Maharashtra and Gujarat being one of the

most industrialised states, they are also the

largest recipients of technologies developed by

NRDC. While Gujarat companies are seeking

licenses in drugs and pharmaceuticals,

Maharashtra-based companies are also major

recipients of technologies in agriculture and food


Source: DNA Money


The Newsletter intends to provide updated and reliable information on medicines and other related issues in an

attempt to equip healthcare professionals to take informed decision in recommending medicines to the patients.

However, they are encouraged to validate the contents. None of the people associated with the publication of the

Newsletter nor the organization shall be responsible for any liability for any damage incurred as a result of use of

contents of this publication. The brand names of medicines, if mentioned, are for illustration only and the Newsletter

does not endorse them.


Please write to :

The Co-ordinator DIC & Editor DIB

Drug Information Bulletin

Drug Information Centre

Indian Pharmaceutical Association, Bengal Branch


Tel /Fax: 91 33 2461 2776 (Monday to Saturday from 5.00 pm to 8.00 pm)

Email: ipabengal.dic@gmail.com

Mobile: +91-9830136291