Dated: 5 November 2024

 

To 

Dr. Rajeev Singh Raghuvanshi

Drug Controller General (India), Central Drugs Standard Control Organisation (CDSCO)

Ministry of Health and Family Welfare, Directorate General of Health Services, 

FDA Bhavan, ITO, Kotla Road, New Delhi -110002

Email : dci@nic.in

 

Dear Dr. Raghuvanshi,

SUBJECT : Seeking clarity on the status of Emergency Contraceptive Pills Levonorgestrel LNG 0.75/1.5 mg following CDSCO’s press note dated 11.10.2024 to 

  1. Enable safe, un-stigmatising, sustained access for all those who need it
  2. Erase any space that exists to backtrack on bodily autonomy or circle back on controlling citizens’ choice of contraception 
  3. Ensure compliance by all stakeholders on stocking and sales

 

The Contraception Action Network (CAN) is a nationwide, rights-based partnership of individuals committed to safeguarding equitable access to contraceptive choices and ensuring last mile availability of reproductive and sexual health services and supplies.

This representation seeks clarity on Emergency Contraceptive Pills (ECPs) following the press note put out by CDSCO on 11 October 2024 in response to “various published media reports suggesting proposed change in the Rules by CDSCO regarding over the counter sale of emergency contraceptive pills (ECPs). One news report noted that Expert panel proposes prescription requirement for morning-after pill.”

A 20-year-old issue that will finally be resolved by rewriting 2 lines, is a reason to rejoice.

​​​​CAN welcomes the facts put out as points 1-5 in the CDSCO press note. As an issue that first made its appearance nearly twenty years ago and has been returning again and again as an agenda point including the  91st DTAB - Drug Technical Advisory Board meeting of 14-8-2024, we are pleased that the regulatory contradiction of the same daily oral contraceptive drugs appearing in both Schedule H and Schedule K of the Drugs Rules, 1945 is finally going to be corrected.

As per our understanding, the following amendments will be made in items 101 & 186 in Schedule H of the Drugs and Cosmetics Rules, 1945: 

“101. Centchroman (except for strength 30 mg in Tablet) 

 186. Ethinyloestradiol (except for strength Ethinyloestradiol I.P. 0.03 mg in combination with Levonorgestrel I.P. 0.15  mg in Tablet)” 

Or, as the press note proposes

“A clarifying statement “Class of drugs mentioned at entry no. 15 of Schedule K shall not be covered by this Schedule” will be added in Schedule H of the Rule”

Therefore, these drugs in certain strengths and combinations (DL-Norgestrel 0.30 mg + Ethinyloestradiol 0.30 mg, Levonorgestrel 0.15 mg + Ethinyloestradiol 0.03mg, Centchroman 30 mg, Desogestrel 0.15 mg + Ethinyloestradiol 0.03 mg, Levonorgestrel 0.10 mg + Ethinyloestradiol 0.02 mg), already listed as item 15 in Schedule K of the Drugs and Cosmetics Rules, 1945 can be prescribed, socially marketed and distributed without sales licence as per the exemptions granted by Schedule K of the Drugs and Cosmetics Rules, 1945. 

To quote from CDSCO’s press note,

“The strengths as defined in Schedule K, will be available without prescription, as it is available today. And all other remaining strengths will need a prescription, as it is required today.”

“This [proposed amendment] will remove the ambiguity and simplify the process for sale of such drugs (of selected strengths).”

What this means is that after the amendment, daily and weekly oral contraceptives including brands like Mala N, Mala D, Apsara, Choice, Ecroz, Khushi, Sunheri etc., can be distributed by community health workers in remote parts of the country in line with the law (finally to be amended) without worries about their labelling, prescription or sale licence. 

When this happens, it will be worth celebrating.

  • Recommendation (1): As Goa’s proposition urged as far back as 2004, this Schedule H amendment of the Drugs Rules 1945 must include not only the hormonal daily contraceptives listed at Entry No. 15 of Schedule K, but any other such conflicting entries or ambiguities by clarifying exceptions by way of combinations, drug strength and use category. 
  • Recommendation (2): In the case of the daily Combined Oral Contraceptive, there is no tactile indicator for blind people to ascertain the order in which the tablets should be taken, nor an indicator of which pills are ferrous fumarate. Ensuring accessibility of packaging information of the daily contraceptive pill could be easily achieved by providing a notched corner on the strip indicating the starting point of the 21 hormonal pills and a raised dot subsequently before the ferrous fumarate row (to warn those with transfusion-dependent thalassemia or other iron overload conditions) to ensure blind people can consume this independently even without knowledge of Braille.

 

The ECP, like India’s daughters, is expected to take up less space even on a press note meant to put ‘rumours’ about it to rest!

The CDSCO press note ends with the statement “there is no change in the sales and distribution of Emergency Contraceptive Pill (ECP) brands like i-Pill or Unwanted – 72.”

The only status quo maintained by this single reference to ECPs in the press note is the ambiguity around its sales and distribution, and the reasons for this are multifold:

  1. In all drug related communication within and from central and state agencies, ECPs (Levonorgestrel 1.5 mg dose or Ulipristal tablets) are almost always clubbed together with oral contraceptives (primarily combination drugs that include Levonorgestrel). While both are to be consumed orally, they are drastically different in their drug make up and regimen – this decides when and how often they should be ingested – and therefore they are two different means to the same end (effective contraception).

 

The ECP, also known as the ‘Morning After Pill’ is to be taken within 72 hours of sexual intercourse to prevent conception. Popular brand names include i-Pill, Unwanted – 72, Clr-72, No-will pill, Preventol, idoz-72, Ezy Pill among others. The drug make-up of these tablets is Levonorgestrel IP 1.5 mg.

Oral contraceptives (not emergency) are taken daily or weekly over an extended period to avoid pregnancy. These are not single dosage tablets but those that need the user to “complete the course”, often 21 days. Popular brand names include Ovral L, Mala N, Mala D, Apsara, Choice, Ecroz, Khushi, Sunheri among others. These can be made up of a combination of drugs that may or may not include Levonorgestrel.

Keeping Emergency Contraceptive pills clubbed together with Oral Contraceptives in all conversations allows for them to be read and understood as one and the same, which is not the case. 

  1. As per the Drugs Rules, 1945, any drug that is not listed under Schedules H, H1, X of the act can be sold OTC, or over-the-counter without prescription or warning labelling or record keeping requirements.
  2. Furthermore, in the list of exemptions detailed in Schedule K item number 15, the 4 oral contraceptives listed do not require a sale licence, allowing sales and distribution by ASHA workers and social marketing channels to remote rural areas. Levonorgestrel (LNG) IP  1.5 mg that makes up the LNG ECP does not fall into any of the Schedules as a solo drug and therefore automatically qualifies for over-the-counter sales without a prescription. There is this line in the press note:

 

“The strengths as defined in Schedule K, will be available without prescription, as it is available today. And all other remaining strengths will need a prescription, as it is required today.”

This does not put to rest the fears about the continued over-the-counter availability of ECPs because the only mention of Levonorgestrel occurs in item 15 of Schedule K of the Drugs Rules, 1945 and that too in reduced strength as part of Combined Oral Contraceptives – this allows ample opportunity for misinterpretation of how the ECP with 1.5 mg Levonorgestrel should be stocked and sold.

There exists no list of over-the-counter medicines; There is no mention of Levonorgestrel in the Drugs Rules, 1945 as a separate entry classified for its use as a stand-alone drug in emergency contraceptive pills - this further muddles the issue.

Retailers and practitioners who likely go by drug names rather than brands or see all oral contraceptives as the same (refer Point 1 above), report confusion over prescription requirement for a higher dosage of 1.5 mg as Levonorgestrel 0.10 mg exempted in Schedule K in a fixed dose combination (FDC) drug is only what is recalled.

This ambiguity has fuelled a shadow ban on ECPs at retail outlets and pharmacies in states such as Tamil Nadu and this is despite the Levonorgestrel 1.5 mg tablet repeatedly appearing in the National List of Essential Medicines for use at primary, secondary and tertiary levels.

  1. The media reports referenced in the CDSCO press note including the one titled Expert panel proposes prescription requirement for morning-after pill came after The New Indian Express (TNIE) broke the story on 03 October 2024 with the article Over-the-counter sale ban likely on morning-after pill.

 

The above mentioned media reports as well as others were based on the minutes of the 62nd DCC - Drug Consultative Committee meeting of 26-9-2023, Agenda No.13 from the state of Tamil Nadu to consider an amendment to Drugs Rules, 1945 “regarding the sale of hormonal contraceptives including emergency contraceptives” for which “after detailed deliberation [it was] recommended to constitute a sub-committee to examine the matter comprising of DC, Tamil Nadu, one from CDSCO, two to three gynaecologist and one pharmacologist. One expert from ICMR may also be included.” 

The TNIE article states:

“Interestingly, the six-member expert sub-committee was formed after the Tamil Nadu government proposed a ban on the OTC sale of hormonal contraceptives citing "its irrational usage" at the 62nd Drugs Consultative Committee meeting held in September 2023.”

“A highly-placed source privy to the deliberations of the panel told TNIE that although the committee is yet to submit the final report, it is overwhelmingly in favour of making prescriptions from a physician mandatory for the purchase of contraceptives, including ECPs.”

This discussion that took place just a year ago indicates two worrisome things:

  1. If it is not explicitly stated that the ECP is an over-the-counter drug, this will be a never ending debate and the easy availability of the ECP will constantly be under threat.
  2. Unless the issue is laid to rest backed by scientific evidence (which already exists) or through official communication that leaves no space for speculation, ‘morality’ and misconception about its usage will be used as excuses to rake up a discussion about ECPs at every chance that is presented. 

 

Sir, The ECP with Levonorgestrel IP 1.5 mg is vital in preventing unplanned pregnancies and reducing unsafe abortions that cause nearly 80,000 maternal deaths annually. Making this pill difficult to access threatens the autonomy of thousands of women, adolescents, and non-binary, gender queer, transmasculine individuals. The ECP is a lifeline to sexual assault survivors and a crucial method of contraception in under-resourced settings and under-served areas, including urban areas where there may be financial and time-use barriers to access registered medical practitioners. 

The contradictions and confusions around ECPs keep thousands of people from accessing lifesaving services thereby placing them at risk – the opposite of what a robust healthcare system must aim to be. The ECP needs to unambiguously stay an over-the-counter pill, and all communication from the CDSCO should reiterate it being an essential over-the-counter tablet and with no loose ends that lead to misinterpretation of information. 

In keeping with the civil rights movement’s guiding principle on inclusion ‘Nothing About Us Without Us’, no decisions on reproductive health should be made without directly consulting representatives from the affected communities as well as sexual and reproductive health advocates and activists.

Additionally, compliance with India’s 2014 Pre-Legislative Consultation Policy (PLCP) requirements must be ensured, with any changes to reproductive health policies transparently communicated through public and media announcements to ensure widespread awareness and accountability and avoid confusion on an issue already marred by stigma and misinformation. 

The Contraceptive Action Network (CAN) demands that the government 

  1. Safeguard citizens’ agency with respect to sexual and reproductive rights
  2. Protect people’s right to bodily autonomy 
  3. Commit to offering an array of contraception choices through multiple channels
  4. Enable access to contraception that is safe, non-stigmatising, and sustained, with privacy respected
  5. Enhance health services and systems to benefit and reach the most marginalised
  6. Erase historical contradictions in the laws pertaining to oral contraceptives
  7. End confusion once and for all on sales/consumption of ECPs

 

To this effect, CAN recommends the following:

  1. Distinguish daily/weekly oral contraceptives from emergency contraceptives in all formal communication.
  2. Amend Schedule K of the Drugs Rules, 1945 to include an entry of Levonorgestrel IP 1.5 mg that exempts it from prescription and sale licence.
  3. Issue a nationwide circular with immediate effect 
    1. clarifying the over-the-counter status of ECPs containing Levonorgestrel IP 1.5 mg, reiterating that it should be easy to market, distribute, sell and access as it is listed as an essential medicine in NLEP for use in primary, secondary and tertiary settings. 
    2. assuring that social marketing for ECPs can be done so it can be distributed by ASHA workers and at all pharmacies without fear of backlash.
    3. guaranteeing that Jan Aushadhi Kendras and primary health centres MUST have stock of ECPs.
    4. implying severe action in the case of non-compliance with regard to stocking and distribution.
  4. Stipulate guidelines for the packaging and labelling of ECPs that prominently display (a) side effects of frequent use (b) warning that this is to be consumed in the case of an emergency when contraceptive failure has occurred and not as a substitute for long term daily/weekly oral contraceptives (c) the limitations of ECPs in preventing unintended pregnancies.
  5. Create guidelines for advertising and awareness about ECPs that offer research-based evidence and initiates conversations that are difficult, as this is the way forward to prevent misuse, overuse or un-consensual use and close the claims of ‘irrational’ use rooted in misplaced priorities of quality healthcare provision, ‘morality’, misconception, misinformation and misinterpretation.

 

Looking forward to your response,

Contraceptive Action Network (CAN)