Govt Panel Approves Inclusion of Emergency Contraceptive Levonorgestrel Under Schedule K
New Delhi: In a move aimed at streamlining regulatory clarity and improving access to essential reproductive health products, the Drugs Consultative Committee (DCC) has agreed to include an additional strength of the emergency contraceptive levonorgestrel under Schedule K of the Drugs Rules, 1945.
The decision came after the committee examined the report of the expert subcommittee constituted to look into issues related to contraceptives.
Schedule K of the Drugs and Cosmetics Rules, 1945, lists drugs that are exempt from certain provisions of the Drugs and Cosmetics Act, 1940, including regulations on their manufacture, sale, and distribution. This exemption is granted to specific classes of drugs, such as certain analgesics, antacids, and household remedies like paracetamol tablets, with conditions and limitations defined in the schedule itself. For example, drugs listed in Schedule K can be sold over-the-counter (OTC) or by non-pharmacists under the specified conditions.
Schedule H is a list of medicines that cannot be sold without the prescription of a registered medical practitioner (doctor). It is essentially the list of “prescription-only drugs” in India.
As per the 62nd DCC recommendation, the reports of the subcommittee were presented in the matter. DCC was apprised about the various recommendations of the DCC sub-committee.
DCC noted that, based on the 91st DTAB meeting dated 14.08.2024, a draft notification has already been issued to avoid contradiction between provisions under Schedule K and Schedule H by providing a footnote under Schedule H that
“Class of drugs mentioned at serial no. 15 of Schedule K shall not be covered under this Schedule”.
Hence, the recommendation of the DCC sub-committee for amendment in Schedule H with respect to chemical contraceptives mentioned under entry no. 15 of Schedule K of the Drugs Rules, 1945, is already addressed.
Further, with regard to the subcommittee recommendation for inclusion of Ulipristal in Schedule H, DCC noted that DTAB in its 92nd meeting held on 24.04.2025 has already recommended updating the Schedule H list, which also includes Ulipristal.
DCC didn’t agree with the sub-committee recommendation with respect to the amendment under entry no. 31, 142, 186, and 304 of Schedule H, as the proposed amendment may not serve the purpose, as it will exclude certain categories of drugs from Schedule H i.e., androgenic anabolic.
However, based on other recommendations of the sub-committee, DCC agreed that:
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 and carton label and in the package insert:a. Does not offer any protection against HIV or any sexually transmitted infections.b. Do not take this medicine more than twice a month.c. Use of alternative methods of contraception is encouraged in consultation with a Registered Medical Practitioner.3. The package insert shall include the details as recommended in the subcommittee report.
