India: Over the Counter Sale and Use of RU 486 Can Increase Maternal Deaths

By Parliamentary Network for Critical Issues

abortionpillresearch46reResearchers in India continue to warn that over the counter sale (OTC) and use of RU 486–WHO’s “gold standard” for medication induced abortion, so-called ‘medical abortion’ –can lead to increased maternal mortality and morbidity.

In the recent abstract, “How safe are over the counter abortion pills-differences between its intended and practical usage and its implications – a study conducted in a tertiary care centre in Shillong, Meghalaya, India” authors Manika Agarwal and Amrita Datta addressed the 2002 Medical Termination Act in India which in legalizing ‘medical abortion’ for the first trimester restricted the prescribing of ‘medical termination of pregnancy (MTP) pills’ to “medical practitioners.”


“the rampant usage of over the counter medical abortifacients leads to complications. This study was done to gather data regarding the over the counter purchase and usage of medical abortifacients and its effect on women.”

Their conclusion is addressed to legislators in India

“Over the counter purchase of medical abortifacients without proper knowledge causes unprecedented maternal morbidity and mortality. National bodies should impose strict legislations to stop this.”

Similarly, ”Is It Safe to Provide Abortion Pills over the Counter? A Study on Outcome Following Self-Medication with Abortion Pills,”  by K. Nivedita and Fatima Shanthini, also reported that in India

“self-administration of abortion pills is rampant throughout the country due to over the counter availability of these drugs and complications are not uncommon due to this practice.

This study finds:

“In spite of such clear guidelines and recommendations, self-administration of these drugs by pregnant women without any medical consultation or supervision has become highly prevalent due to availability of these drugs over the counter without any prescription. Many women depend on medical abortion and consider it as a method of spacing between pregnancies. Due to unrestricted availability of these drugs the society considers this to be an extremely safe option of termination of pregnancy. Life threatening complications like excessive hemorrhage, sepsis and deaths due to undiagnosed ectopic pregnancies are not uncommon in women administering these drugs by themselves.”

It reports on the high prevalence of anemia [low red blood cell count] in pregnant women– almost 87%–and states that the condition is estimated to cause 22,000 maternal deaths a year. Concern is expressed for the lives of pregnant women with anemia who self-induce with drugs that are known to cause heavy blood loss:

“Self-medication of abortion pills in women with severe anaemia could be fatal.”

Other studies from India that raise concern on self-use of RU 486 are mentioned and referenced including the following:

“Studies comparing intake of abortion pills with medical supervision and self-administration showed that serious complications like anaemia, sepsis, failure and incomplete abortion is higher in women who self-administered the drug.

“Studies comparing medical and surgical methods have shown that hemorrhage and incomplete abortion and rate of surgical evacuation was more after medical abortion. In our study 62.5% of patients had presented with incomplete abortion, 5% with incomplete abortion in shock, 7.5% with incomplete abortion with sepsis and 22.5% with failed abortions. Thirty two (80%) patients required surgical evacuation in our study.

“Similar study on consequences of self-administration showed that 70.2% had incomplete abortion and 10.8% had failed abortion. This study also reported ruptured ectopic pregnancy and also one maternal death following self-administration of abortion pills. Another study reported 41.54% of incomplete abortion, 6.54% of septicemia and 1.15% of failed abortion.”

The study also concludes with a call for legislation:

“Unsupervised medical abortion can lead to increased maternal morbidity and mortality. To curtail this harmful practice, strict legislations are required to monitor and also to restrict the sales of abortion pills over the counter and access to abortion pills for the public should be only through centers approved for MTP. Large scale prospective studies are required to assess the actual magnitude of this problem.”

Pro-abortion activists and NGOs who sell abortion pills on the internet, who teach pharmacists to sell mifepristone and/or misoprostol, who instruct women via hotlines to buy and use abortion pills, who illegally dispense abortion pills to women who are without access to medical care, or who deliver the pills via drone need to read the data from India and stop putting the lives and health of pregnant women around the world at risk by promoting self-use of abortion pills.