Morning-after pills: DTAB pushes for boxed warnings, stricter norms

CDSCO's DTAB panel proposes boxed warnings on emergency contraceptive pills and inclusion under Schedule K to ensure safer usage while retaining over-the-counter availability

In a bid to highlight side effects, the Drugs Technical Advisory Board (DTAB) has sought to mandate that manufacturers of emergency contraceptives, or morning-after pills such as i-pill and Unwanted-72, include boxed warnings on their packaging.

 

DTAB comes under the Central Drugs Standard Control Organisation (CDSCO) and is the highest statutory body on technical matters related to drugs, cosmetics, and medical devices in India.

 

According to the minutes of DTAB’s 93rd meeting held on February 16 this year, boxed warnings on primary and carton labels, as well as in package inserts, should state that these pills do not offer protection against HIV or other sexually transmitted infections.

   

The labelling will also advise women not to take these medicines more than twice a month and to use alternative methods of contraception in consultation with registered medical practitioners.

 

DTAB has also directed that higher dosage levels (0.75 milligrams (mg) and 1.5 mg) of levonorgestrel tablets — the active ingredient in several morning-after pills — be formally added as a specific entry under Schedule K of the Drugs and Cosmetics Rules, 1945.

 

The move comes nearly three years after the central drug regulator’s Drugs Consultative Committee (DCC) formed an expert subcommittee amid concerns over the irrational use of emergency contraceptive pills.

 

While these pills were sold over the counter (OTC) without prescriptions, they were not included in Schedule K of the Drugs and Cosmetics Rules, 1945, which exempts certain drugs from stringent manufacturing, distribution, and sales regulations.

 

“Levonorgestrel tablets 0.75 mg/1.5 mg, which are emergency contraceptives, shall be included as S. No. 6 under Entry No. 15 of Schedule K of the Drugs and Cosmetics Rules, 1945,” the minutes of the DTAB meeting said.

 

So far, combined oral contraceptives (CoCs), which contain lower levels of levonorgestrel, have been included in Schedule K.

 

CoCs are taken over several days and prevent pregnancy by suppressing ovulation over time, whereas morning-after pills are recommended for emergency use and work within 24 to 72 hours.

 

“With this move, morning-after pills will remain available OTC without a prescription to ensure easier access,” a Delhi-based gynaecologist told Business Standard.

 

These drugs are also included in the list of pills recommended by the World Health Organization for emergency birth control.