Emergency contraceptive pills (ECPs), also known as morning-after pills (MAPs), have the capability to significantly reduce the risk of unwanted pregnancy. However, ECPs have their limitations and side effects. Given the prevalent use of ECPs, one would expect ECPs to be widely advertised to the public in India. However, it is rare to come across an advertisement that freely advertises an ECP. Even, the label of ECPs in itself does not indicate that it is intended to be used for the prevention of pregnancy in women after unprotected sex.
In this article, we have analysed the legal framework for the advertisement of ECPs in India and concluded that while there is a legal bar on the advertisement of ECPs, certain compositions and strengths of ECPs may be advertised.
Legal Framework for Advertisement of ECPs
There are two laws that regulate the advertisement of ECPs –the Drug Rules, 1945 (“Drugs Rules”) which bar the advertisement of prescription drugs, and the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 (“DMRA”) which bar advertisement of a drug in terms which may suggest that it may be used for prevention of conception in women. However, both Drugs Rules and DMRA have certain exceptions, which we will discuss in the following paragraphs.
Exceptions under Drugs Rules for ECPs
There are certain compositions of ECPs that have been exempted from the requirement of being sold under a drug license, with the underlying intent there being that such compositions ought not be sold under a prescription of a registered medical practitioner (“Doctor”). We have reproduced the composition of these ECPs in the table below.
| 1. DL-Norgestrel-0.30 mg. |
| Ethinyloestradiol-0.03 mg. |
| 2. Levonorgestrel-0.15 mg. |
| Ethinyloestradiol-0.03 mg. |
| 3. Centchroman-30mg. |
| 4. Desogestrel -0.150mg. |
| Ethinyloestradiol 0.030mg. |
| 5. Levonorgestrel 0.1mg |
| Ethinyloestradiol 0.02mg |
The above ECPs are clearly not prescription drugs, and therefore the bar on advertisement of prescription drugs would not apply to those ECPs.
Exception under the Drugs and Magic Remedies Act
The DMRA contains an enabling provisions through which the Central Government can restrict the scope of DMRA. In 1992, the Central Government notified a list of compositions of ECPs to which the restriction on advertisement under DMRA will not apply. We have reproduced the composition per tablet of these ECPs in the table below.
| a. DL-Norgestrel- 0.30 mg. |
| Ethinyl Estradiol- 0.03 mg; |
| b. Levo-norgestrel- 0.15 mg. |
| Ethinyl Estradiol- 0.03 mg; |
| c. Centchroman- 30 mg. |
Therefore, in so far as ECPs are concerned, only the below compositions of ECPs which are exempted under both Drug Rules and DMRA may be advertised in India, subject to certain basic compliance conditions and other informal guidance issued by Regulators from time to time.
| 1. DL-Norgestrel- 0.30 mg. |
| Ethinyl Estradiol- 0.03 mg; |
| 2. Levo-norgestrel- 0.15 mg. |
| Ethinyl Estradiol- 0.03 mg; |
| 3. Centchroman- 30 mg. |
Past controversies
In 2008, a criminal complaint was filed against Cipla Ltd. and its Directors, a major pharmaceutical company, for the advertisement of an ECP sold under the brand name ‘Ipill’, having a composition of Levonorgestrel IP-1.5 mg. In 2015, another criminal complaint was filed against Cipla Ltd. and its Directors, for the advertisement of another ECP having the same composition but bearing the brand name ‘EK Pill’. The grounds in both the complaints were the same, that Cipla Ltd. had violated DMRA by advertising an ECP to indicate that it can prevent conception in women. Cipla filed a petition against the criminal complaints and prevailed in both the cases on grounds that it had been explicitly permitted by the Central Drugs Standards Control Organization (CDSCO) to advertise the drugs. It relied on a 1961 notification under DMRA, which allowed companies to advertise ECPs, provided they were approved by the Central Government (CDSCO).
Therefore, it appears that the challenge to advertise ECPs is not strictly legal. From news reports, it appears that the challenge to advertise ECPs is driven by ethical and moral considerations. For instance, in 2009, a State Drug Controller in India reportedly stated that “The advertising of this drug will mean that women will think, ‘I can do anything and there is an easy way not to get pregnant’. We can’t allow such an attitude to grow.” Similarly, Doctors had reportedly voiced concern against the advertisement of ECPs when certain manufacturers were permitted to manufacture, on grounds that it may cause confusion with abortion pills, and health concerns surrounding the over-use of a drug that is meant for emergencies and has known side-effects.
Going forward
As indicated above, certain compositions of ECPs may be advertised. However, before advertising, it should be ensured that the advertisement meets the requirements of law and also guidelines that have been proposed by various authorities. For example, the advertisement should not be misleading. The ECPs should be promoted as emergency contraceptives only and not as regular means of contraception. A violation of the law can result in criminal prosecution as well as cancellation of a manufacturing license.