Emergency Contraceptive Pills May Soon Carry Stricter Warnings, Usage Restrictions Likely
New Delhi: The Drugs Technical Advisory Board (DTAB), in its 93rd meeting, has recommended key regulatory changes concerning emergency contraceptive pills, including their inclusion under Schedule K of the Drugs Rules, 1945 along with mandatory safety warnings.
The meeting was chaired by Dr Sunita Sharma, with Dr. Rajeev Singh Raghuvanshi serving as Member-Secretary. The board deliberated on recommendations forwarded from the 67th meeting of the Drugs Consultative Committee (DCC) held on November 17, 2025, regarding emergency contraceptives.
Under the Drugs Rules, 1945, Schedule K specifies a list of drugs and categories that are exempted from certain provisions of the Act and Rules, particularly regarding manufacture, sale, and distribution, subject to specific conditions.
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The DCC, while reviewing the subcommittee report, noted that certain recommendations had already been addressed. These include a draft notification issued following the 91st DTAB meeting to resolve overlap between Schedule K and Schedule H by clarifying that drugs listed under Entry No. 15 of Schedule K would not fall under Schedule H. It also noted that inclusion of Ulipristal under Schedule H had already been recommended by DTAB in its 92nd meeting.
Under the Drugs Rules, 1945, Schedule K specifies a list of drugs and categories that are exempted from certain provisions of the Act and Rules, particularly regarding manufacture, sale, and distribution, subject to specific conditions.
The DCC did not agree with proposed amendments to specific entries of Schedule H, stating that such changes could inadvertently exclude certain categories like androgenic anabolic drugs from regulatory control.
Based on the accepted recommendations, both DCC and DTAB agreed that Levonorgestrel Tablets 0.75 mg and 1.5 mg, used as emergency contraceptives, should be added as Serial No. 06 under Entry No. 15 of Schedule K of the Drugs Rules, 1945.
The Board further recommended that these products must carry boxed warnings on labels and package inserts stating that they do not protect against HIV or other sexually transmitted infections, should not be used more than twice a month, and that alternative contraceptive methods should be considered in consultation with a registered medical practitioner.
The minutes of 93rd meeting of the Drugs Technical Advisory Board (DTAB) stated,
"1. Levonorgestrel Tablets 0.75mg/1.5mg that are emergency contraceptives shall be included/added as S.No.06 of entry No. 15 of Schedule K of Drugs Rules 19452. These should include the following boxed warnings on the primary & carton label and in package insert:a. Does not offer any protection against HIV or any sexually transmitted infections.b. Do not take this medicine for more than twice in a month.c. Use of alternative methods of contraception is encouraged in consultation with Registered Medical Practitioner.3. The package insert shall include the details as recommended in the DCC sub-committee report."
DTAB has recommended that the rules be amended accordingly to incorporate these changes.
To view the official notice, click the link below:
