It is estimated that, in
India, nearly 3/4th conceptions occurring annually are unplanned and almost 1/4th
are unwanted or mis-timed. They result in nearly 11 million recorded abortions
annually and many more unrecorded and unreported abortions. These unsafe abortions
are associated with a high maternal mortality and morbidity. All this is due to
poor awareness and accessibility of contraceptive services. It is, therefore,
necessary to improve the access and awareness about different methods being offered
in the ‘cafetaria-contraceptive basket’. One of the methods which needs to be
added to this basket is ‘emergency contraception’ to take care of unplanned sexual
Several methods are available for
use as Emergency Contraception. A brief on their merits and demerits was provided
to the group as background material.
- a specially-packed EC Pill as per
- 4 tablets cut from a pack of
high dose combined oral contraceptive (COC)
- 8 tablets cut from a low dose COC pack
- 20 tablets of progesterone
- mifepristone as a single tablet
- copper containing intra-uterine contra-ceptive devices
Questions to be Answered
The Group needed to decide
a. Which is the best method for India?
b. How should it be packaged?
c. What should
be the cost of this method?
Factors which may
help in deciding about a specific method include :
- intrinsic character of method
- efficacy and
- the window period
- side-effects and safety profile
on a dedicated method of choice, the Group was requested to deliberate on the
following issues :
• Should we have a method
that is already available, though it may not be specified as EC?
• Do we need a new method to be introduced in India based
on research evidence about safety and efficacy?
Do we need a single method or a method-mix with two or more methods to take care
of the diverse needs of women?
of the Group
A. Which is the best method for India?
The Group divided the recommendations in two sections,
I. For immediate implementation -
drugs/ methods already available in India.
For future introduction – drugs/methods which are currently not available, but
are better in terms of efficacy and safety profile, thus need to be introduced
in India as soon as possible.
Yuzpe regimen – 2 tablets containing Ethinyl Estradiol 50µg and Levonorgestrel
0.25mg – 2 tablets to be taken within 72 hours and 2 tablets 12 hours later. These
tablets are already available as combined oral contraceptive pills (COC).
• Copper IUD – if delay is upto 5 days, after checking and
ruling out PID, ideal for parous women who need subsequent regular contraception.
• Method-mix – both Yuzpe method and IUD to be made available
be introduced in future
Levonorgestrel only 0.75 mg tablet, 1 tablet within 72 hours and repeat 1 tablet
after 12 hours
• Mifepristone – 10 mg single
• Single dose Levonorgestrel (1.5 mg),
if multicentre WHO trial results show efficacy equal to total dose being given
in two doses, 12 hours apart. This will take care of the problem of getting up
in the middle of the night to take the second dose.
B. How should it be packaged?
It was recommended that tablets
for Yuzpe regimen should not be cut from a 21/28 tablet packet. The Group felt
that it should be made available as a 4 tablet separate pack, or LNG as a two
tablet pack, with the following qualities:
Moisture-resistant blister pack
• Insert in
the pack conveying instructions for use, side-effects, additional dose requirement,
failure rate, instructions on what to do if period is missed, etc., in multilingual
• Brand name / shape of pack
(e.g. bottle) to maintain secrecy
What should be the cost of this method ?
Since it is something for women’s health and well-being,
the Group felt it should be available cheap or free as Government supply
A. Method of choice
• Most experts in the Group
felt that there should be a single dedicated method of choice. Repackaging the
COC, though already available is not the ideal method as research has undisputedly
shown that LNG alone has a higher efficacy and lesser side-effects compared to
Yuzpe regimen. Yuzpe method has been given up in many countries. Though there
may be some delay in introducing LNG in India, but since we are starting a new
programme, it is more appropriate to start with a better method. The Expert Group
felt that a small wait will do no harm, but we will be compromising the efficacy
by using COC, which can put the whole programme into disrepute. Based on the emerging
data that LNG only regimen is more effective and has fewer side-effects than the
combined regimen, the expert Group unanimously felt that the product of choice
should be LNG.
• As there is need for pre-introduction
IEC, training of providers and counselling of clients, it was felt that having
one dedicated method will give clear-cut focussed messages, rather than confusing
now with one method and later on introducing another method. The advantages of
having a single method rather than a method-mix will be :
- focussed campaigns
- IEC tailored to one product
- training accordingly
• The only concern expressed
was delay in making a dedicated product available, which the Secretary, Family
Welfare promised to look into, so that the waiting period can be made as short
as possible. The Expert Group thus decided to have Emergency Contraceptive pill
(ECP) with LNG (0.75mg per tablet), to be introduced in India as a pack containing
• To evaluate the efficacy of single
versus two doses of LNG, a double blind multicentre randomized WHO study (trial
no. 97902) has already been completed. The interim analysis reveals equal efficacy
of 10 mg Mifepristone, 0.75mg LNG in two doses 12 hours apart and 1.5mg LNG as
a single dose. After the final analysis based on the results, it may be possible
to give the total dose of LNG (2 tablets) as a single dose, if the trial does
not reveal any increase in side-effects by doing so. The LNG formulation need
not be changed in these circumstances; just the instructions need to be modified
to say that the two tablets provided in the pack can be taken simultaneously instead
of 12 hours apart. A probable name suggested was ‘Tatkal’
in Hindi meaning instant use. Once a dedicated
product is made available, all IEC awareness campaigns and training can be more
focussed and specific.
• Expert Group also supported
having availability of IUD for EC, but main focus of efforts is to be directed
to having an EC pill. There are no contra-indications to the use of pill and its
distribution is not dependent on a network of trained doctors. Besides, so far,
IUD training has been focussing on insertion in the post-menstrual phase to avoid
unsuspected pregnancy; changing this may confuse the peripheral healthcare providers.
Thus, it was decided that CuT should be available as an Emergency Contraception,
but should not be specifically popularized since it has a number of contra-indications
and is not suitable for a field- based programme.
Mention of IUD as an effective EC with its potential advantages and disadvantages
should be included in the IUD training manuals. A longer efficacy time-frame (coitus-intervention
interval) of up to one week is to be highlighted as well as the possibility of
continued contraception. Potential contra-indications and risks need to be explained.
All providers should be informed about the potential benefits of IUD as EC, and
they should be able to counsel the potential clients about it.
No other specific steps are recommended for promoting IUD as an EC, especially
since, in some emergency situations e.g. rape, coercion etc., IUD may not be a
suitable choice due to potential risk of STI/RTI.
A few in the Expert Group expressed the need for having Mifepristone (MFP) as
EC. As and when MFP is marketed and is available in India, it can also be included
in the armamentarium, as it has minimal side-effects. Dr von Hertzen from WHO
informed the Group that MFP may not be a better choice. In terms of efficacy,
it is the same as LNG. The only problem with Mifepristone is higher incidence
of delayed periods, which not all women may find very convenient as the anxiety
continues as long as periods do not come. Mifepristone if used early in the cycle
may result in break-through ovulation, resulting in failure if subsequent unprotected
intercourse takes place. Besides, it may be confused with an abortifacient tablet.
Advantages of MFP include a single dose and fewer side-effects. If single dose
LNG study reveals similar efficacy with no increase in side-effects, LNG can
be regarded as the near ideal Emergency Contraceptive. Thus without confusing
the issue further, it was decided to have a 2 year pilot introduction with LNG
• Availability of an approved dedicated
product will extend legitimacy to make the project commercially viable.
• Besides the points presented by the Group, the
forum also felt that package insert should include a clear message that it is
not a substitute for regular contraception.
There was some discussion about including anti-emetic in the packet, but consensus
was that it was not required. It is enough to inform that nausea and vomiting
may occur. Most other side-effects are self-limiting.
It was felt that a too attractive a packing might not be very suitable as it may
discourage use by shy women, who may find it embarrassing to ask for one.
• Quality of product and batch to batch variation need to
be controlled by scrupulous quality control at the production level.
• It may be difficult to decide the cost at this stage,
as LNG has not yet been introduced in India. A composite view on logistics and
other issues like type of community-setting (urban / rural / semi-urban) will
need to be kept in view before deciding on the cost. In fact, women’s health is
the primary concern, and cost cannot be linked with it. It may be useful to have
both, free supply as well as moderately-priced, EC Pills.
time-frame by when ECP is going to be available and its cost.
2.1.1 Women have the right to control or manage their own sexuality
2.1.2 There is a felt need for
Emergency Contraception in India to prevent a large number of unplanned pregnancies
and, hopefully, the incidence of abortions and unwanted pregnancies will come
down with the availability of EC as a "back-up” method.
2.1.3 Emergency Contraception is indicated as ‘back-up’ in the following situations
(a) Problem during contraceptive usage e.g.
ruptured or slipped condom, misplaced intra-uterine device, displaced diaphragm
or forgotten pill.
(b) Unprotected intercourse
due to failure to use a contraceptive, miscalculation of safe period or inappropriate
(c) Incorrect or inconsistent
use of regular contraceptive.
intercourse due to rape, assault or sexual coercion.
2.1.4 ECP availability as a ‘back-up’ will increase confidence of users of spacing
contraception and increase their acceptability.
2.1.5 COC is already available in India but it is not recommended as an ideal
ECP. Levonorgestrel needs to be introduced as a dedicated method of choice.
2.1.6 Safety is an important issue even when the method is only for occasional
use. Thus it is better to start a programme with a better method, and even if
some wait is required in making LNG available, it is worthwhile in the interest
of women’s health.
2.1.7 ECP should be made
available as soon as possible as a two-pill pack, each tablet containing 0.75mg
(a) The packing should include
instructions on one-time use, method of use, side-effects, efficacy, action to
be taken in case of failure, need for regular contraception and no protection
(b) Packaging should be made
as non-embarrassing as possible, so that people do not shy away from use.
(c) Anti-emetic is not required in the packet; the woman just needs to be counselled
about the potential side-effects.
should be kept as low as possible, to make it accessible to all.
2.1.8 Training manuals for IUD and COC should mention their potential use as Emergency
Contraception including details of counselling in such situations.
2.1.9 Mifepristone should be introduced only at a later date when more research
has been done on its potential as Emergency Contraception and safety profile.