New Delhi: An expert panel constituted by India’s apex drug controller is deliberating making a doctor’s prescription mandatory to access hormonal contraceptive pills, including emergency contraceptive pills (ECP), popularly known as morning-after pills, given concerns over their harmful side effects, government sources have told ThePrint. Women’s rights activists have said the move will have an adverse impact on women’s reproductive rights.
The proposal has been under examination by a three-member committee, set up by the Central Drugs and Standard Control Organisation (CDSCO) in September last year, and is now being legally vetted before it is submitted to the Drugs Controller General of India (DCGI) for approval, sources said.
At present, hormonal contraceptive pills are under Schedule K of the Drugs and Cosmetics (D&C) Act and Rules, 1945, meaning they can be bought over-the-counter at pharmacies, without a doctor’s prescription.
“The expert panel, which has a senior gynaecologist, a reproductive health scientist from the Indian Council of Medical Research (ICMR), and a senior official from Tamil Nadu drug administration has suggested that these drugs be brought number Schedule H, in which case pharmacists will need doctor’s prescription before dispensing them,” a senior CDSCO official told ThePrint.
If the DCGI accepts the recommendation, it will be sent to the Union Ministry of Health and Family Welfare for an amendment in the D&C Act, the official added.
State licensing and controlling authority in the Department of Drugs Control in Tamil Nadu, M.N. Sridhar, a member of the panel, confirmed to ThePrint that legal approval in the matter is awaited before the committee submits its final recommendation.
He added that the panel had been formed at the behest of the southern state, which feels that the drugs—especially morning-after pills—have the potential to harm “young girls” due to safety issues.
When contacted for comment, DCGI Rajeev Singh Raghuvanshi told ThePrint that he is not aware of the status of the recommendations made by the panel. “Also, if this is a confidential matter, it will be difficult to share the details at this stage,” he said.
Activists fighting for women’s reproductive rights, meanwhile, called the move a major infringement on women’s bodily autonomy and reproductive rights.
“This is a retrograde move that will have far-reaching consequences and it is definitely not in the favor of women’s reproductive rights,” said gender rights activist Debanjana Choudhuri.
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Concerns around safety
Sridhar said that, over the last few years, there have been several cases of young girls reporting serious side effects, such as heavy menstrual bleeding, following the use of emergency contraceptive pills.
“Due to this reason, the state drug authority has been of the view that a doctor should be consulted before using these hormonal pills,” he told ThePrint. Sridhar however did not say whether there have been any studies to assess these side-effects in users.
In India, two kinds of oral contraceptive pills are available—hormonal and non-hormonal.
Approved in India since 1990, non-hormonal contraceptive pills contain centchroman or ormeloxifene, a non-steroid, and are meant to be taken once a week. They are available under brand names such as Chhaya and Saheli. These pills work by preventing sperm from reaching the egg and are considered safer than hormonal contraceptive options.
There are three kinds of pills under the hormonal contraceptives category—combined hormonal contraceptives (COC), which contain both estrogen (usually ethinyl estradiol) and progestogen; progestin-only (POP), a synthetic analogue of natural progesterone; and emergency contraceptive pills (ECP).
ECPs—considered about 85 percent effective in preventing unwanted pregnancies—contain levonorgestrel, which prevents the release of an egg from the ovary and may also prevent the egg from attaching to the uterine wall. They have been approved in India since 2003.
For contraception, while COCs and POPs have to be taken daily by sexually active women, ECPs, available under the brand names i-pill and Unwanted-72, among others, are recommended to be taken within 72 hours of unprotected sex.
Despite some side effects, such as breakthrough bleeding (bleeding outside the menstrual period), nausea, headache, breast tenderness, and abdominal cramping, among others, which have been associated with COCs and POPs, they remain a popular method of birth control.
These drugs are also distributed by community health workers such as ASHAs (Accredited Social Health Activists) as part of the national family planning programme.
Dr Tripti Raheja, lead consultant of obstetrics & gynaecology at the CK Birla Hospital in Delhi, said that ECPs can also cause temporary side effects, such as nausea, headache, fatigue, dizziness, and breast tenderness, and may also lead to changes in the menstrual cycle, including delayed, early, or irregular periods or spotting, but added that these changes are generally limited to one cycle.
“Though available over the counter, it’s advisable to consult a doctor before use, especially if you have existing health conditions or are on medication. It’s important to note that ECPs are not 100 percent effective, and pregnancy may still occur despite timely consumption,” she said.
‘Not in women’s interest’
Gender rights activists, meanwhile, said the proposal was against women’s interests given that it would make access to contraception much harder.
“Access to ECPs, though a powerful tool for young women to avoid unwanted pregnancy, has been a challenge in many parts of India due to various reasons. Making a doctor’s prescription necessary to access it will make it further inaccessible to those in need,” said V.S. Chandrashekhar, India director of global health and development non-profit Americares.
Chandrashekhar said that hormonal contraceptives have been around for decades and are largely safe. “If a certain section now suddenly thinks these drugs are unsafe, I think it is mainly to do with perception rather than scientific evidence,” he told ThePrint.
Chandrashekhar also stressed that multiple studies have shown that the awareness and use of ECPs is higher among younger age-groups and those who are sexually active and therefore the proposal, if implemented, could put young girls at the highest risk of unwanted pregnancies and unsafe abortions.
“Since these ECPs are to be taken within 72 hours of unprotected intercourse—adding a requirement to finding a doctor for prescribing the pill within the timeframe will complicate the matter,” he added.
A detailed analysis of the National Family Health Survey 5 found that in 2019–2021, more than half of Indian women were not aware of the morning-after pill, and only 0.49 percent had ever used an ECP, but this percentage has increased since 2005–2006, when it was less than 0.2 percent.
It further showed that the use of ECPs was higher among younger and unmarried women, but awareness of its potential side effects was lower when compared to middle-aged and married women.
The Guidelines for Administration of Emergency Contraceptive Pills by Health Care Providers issued by the Ministry of Health and Family Welfare in 2008 said that these pills can be provided safely and effectively by any well-informed health care providers such as doctors, nurses, midwives, pharmacists, paramedics, family welfare assistants, health assistants and community-based health workers.
“ECPs should not be denied to clients within the reproductive years irrespective of their age and marital status,” the guidelines also said.
(Edited by Sanya Mathur)
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