CDSCO committee recommends exemption of chemical contraceptive FDC from Schedule H; Details
The said FDC of centchroman and ethinyloestradiol is a regular oral contraceptive pill sold under various brand names of contraceptive like Mala N, Mala D, Apsara, Choice, Ecroz, Khushi, Sunheri etc.
New Delhi: The Drugs Technical Advisory Board (DTAB) has recently recommended the Union Health Ministry to exempt the widely used chemical contraceptive sold in Fixed-Dose Combination (FDC) of Centchroman and Ethinyloestradiol from Schedule H of the Drugs and Cosmetics Rules.
DTAB was apprised that, “Schedule K” of the Drugs and Cosmetics Rules, under the entry no. 15 provides an exemption from taking a sale license for chemical contraceptive having the following composition per tablet:
(1) DL-Norgestrel-0.30 mg,
(2) Levonorgestrel-0.15 mg,
(3) Centchroman-30 mg
(4) Desogestrel-0.150 mg,
(5) Levonorgestrel-0.1 mg,
However, drugs centchroman and ethinyloestradiol are specified in the Schedule H of Drugs and Cosmetics Rules, at the entry no. 101 and 186 respectively.
A representation has been received from HLL Lifecare Limited mentioning that the company is manufacturing and supplying regular oral contraceptive pills to the Ministry of Health and Family Welfare under National Family welfare Programme since 1993 under various brand names of contraceptive like Mala N, Mala D, Apsara, Choice, Ecroz, Khushi, Sunheri etc. containing drug composition Levonorgestrol I.P. 0.15 mg, Ethinyloestradiol I.P. 0.03 mg, combo packed with Ferrous Fumarate I.P. 60 mg.
The firm has submitted that labelling of the above-said products was initially done by mentioning “Schedule K” on all the packing material as these products are covered under the “Schedule K” of Drugs and Cosmetics Rules, 1945.
However, objections have been raised by one of the State Drugs Controller Office on the labelling of these products with the following remarks:
- “Labelling part of above products shall be in line with Schedule H requirements: viz., printing of Rx, red box and Schedule H warning in the primary and secondary packages of the products.
- The labelling shall not include “Schedule K” as this is not a labelling requirement.”
Accordingly, the company has implemented the labelling requirements as per “Schedule H” in its packing artwork.
However, the company is facing difficulties to sell and supply these products under various schemes of MoHFW due to the following constraints:
a. “Schedule H drug cannot be advertised, which is very essential for Social Marketing to educate the people about the proper use of the product.
b. Schedule H drug can only be sold with a prescription of a registered medical practitioner whereas Social marketing products are meant for providing affordable contraceptive in the remotest area of the country where availability of registered medical practitioners is a constraint.
c. The selling of Schedule H drug requires the proper retail license for selling medicines which are not possible for Social marketing Organization, as their products are sold under Govt. schemes through Over the Counter (OTC) and not through prescription.”
In this regard, the HLL Lifecare Limited requested to make necessary amendment in the Drugs and Cosmetics Rules, 1945 to remove “Schedule H” labelling requirements on products containing;
(i) Levonorgestrol I.P. 0.15 mg, Ethinylestradiol I.P. 0.03 mg
(ii) Centchroman 30 mg
Therefore, it is proposed to make the following amendments in respect of item no.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 Levonorgestrol I.P. 0.15 mg in Tablet)”
DCC in its 56th meeting deliberated and agreed to amend „Schedule H‟ of the Drugs and Cosmetics Rules, 1945 to exempt Centchroman 30mg tablets and Ethinyloestradiol I.P. 0.03 mg in combination with Levonorgestrol I.P. 0.15 mg in Tablet from schedule H.
DTAB deliberated the proposal and recommended for amendment of the Drugs and Cosmetics Rules, 1945 to exempt Centchroman 30mg tablets and Ethinyloestradiol I.P. 0.03 mg in combination with Levonorgestrol I.P. 0.15 mg in Tablet from Schedule H.