The government of India has asked all the promoters of over-the-counter oral contraceptive pills to stop advertising it on mass media, like television.
Drug Controller General of India (DCGI) has issued an advisory to all the marketers of oral emergency contraceptive pills (ECP) asking them not to advertise the product.
Since drug advertising is not permitted under the existing rule, we have sent an advisory to all pharmaceutical companies making ECPs, asking them not to advertise their products through mass media, reports said quoting the Health Ministry sources.
Although around 15 companies are now producing ECPs in the country, Piramal Healthcare, Morepen, and Mankind together control over 80 per cent share in the segment.
A Public Interest Litigation (PIL) has been filed in the Andhra Pradesh High Court seeking to ban the sales of over-the-counter emergency contraceptive pills such as i-pill, Unwanted 72 and Option 72 in India as they can lead to widespread misuse and dangerous consequences to the public.
Emergency contraceptive pills also known as `morning after pills’, which are used to prevent soon after sexual intercourse to prevent pregnancy, are currently available in the Indian drug stores as OTC and they don’t require a prescription from the physician.
Emergency contraceptive pills including i-pill, Unwanted 72 and Option 72 contains levo norgestrel -a synthetic version of female sex hormone – may cause dangerous side-effects to the users, alleged the PIL.
Citing scientific evidence from studies published in international peer-reviewed journals, the PIL argues that the use of levo norgestrel will result in various side effects and seeks a ban on the sale of i-pill, Unwanted 72 and Option 72 over the counter (OTC) s could result in serious consequences on the public.
Levo norgestrel containing i-pill, Unwanted 72 and Option 72 are promoted through commercial advertisements in TVs and other mass media claiming that these emergency contraceptive pills if consumed within 72 hours after unprotected sexual intercourse can stop the occurrence of pregnancy.
There are, however, ample evidence supporting the fact that pregnancies happen within the first 24 hours after sexual intercourse. In such circumstances, the side effects of i-pill, Unwanted 72 and Option 72 will be more serious, the petitios argue with the backing of studies.
The massive publicity campaign created by the promotional ads on i-pill, Unwanted 72 and Option 72 and increased accessibility of these pills OTC in retail drug stores will lead to misuse of the products by public, the PIL alleges.
Acting on the petition the High Court has send notices to the Drug Controller General of India (DCGI) asking him to provide details about the marketing permission given to some of the pharma companies on the levo norgestrel products.
Earlier, the High Court ordered the Andhra Pradesh state drug controller to file technical data on the product, such as the safety of the medicine, reports said.
The promotional ads i-pill, Unwanted 72 and Option 72 are temporarily banned from airing by DCGI following public outcry and has been left to DTAB for technical advice in this regard.
DTAB, the highest authority under the Union health ministry on technical matters concerning medicines, is yet to submit its report. But the ads have already reappeared on screen, reports said.
Various organisations and gynaecologists in India have been expressing concern on the no-holds-barred ad campaign for the emergency contraceptives i-pill, Unwanted 72 and Option 72 through TV and the possible misuse of the pill by the young generation.
The easy availability of emergency contraceptives in a closed society like India would only encourage promiscuity among the millions of youngsters.
OTC sales of these pills could also promote unsafe sex among younger generation and may result in the increase of HIV/AIDS and other sexually transmitted diseases, civil society groups argued.
The emergency contraceptives i-pill, Unwanted 72 and Option 72 have already become highly popular in Indian cities and among the rural youngsters who seek sexual freedom, the barrack of ads.
Buying emergency contraceptives has become like buying candy bars. They sell fast and many drug stores often run out of stock in cities like Bangalore, reports said.
But most of the youn women show a carefree attitude toward contraception owing to the cheap availability of the pills.
Young girls are increasingly approach gynecologists with problems such as irregular menstruation and pelvic infections because of the wrong use of the emergency contraceptive pills i-pill, Unwanted 72 and Option 72 as a primary method of contraception.
Several young women use the emergency pill much after the ‘safe’ time and have had to abort fetuses, expert said.
Unwanted-72 is marketed by Mankind Pharma Ltd, ‘Option-72? is promoted by New Delhi-based Morepan Laboratories in India. I-Pill, which was earlier sold by Cipla Ltd, is now being promoted by Piramal Healthcare
The national health regulator Drug Controller General of India (DCGI) had earlier this year withdrawn the permission to advertise ECPs through print and electronic media as the ads did not convey the fact that the pills were to be consumed only in case of emergency.
But later, the Health Ministry had permitted it on condition that such ads should make the consumer aware of the side-effects. But recently the DCGI sent notices to three drug makers for showing the ads without addressing the concerns raised by the government.
“The three companies have been asked to respond to the notice within 14 days, failing which the DCGI would may take action against them,” the source said.
The technical advisory body for drugs had also decided to frame guidelines on ads of ECPs following reports of side-effects in some cases due to indiscriminate use.