The Union health ministry will soon constitute an expert committee, consisting of at least three gynaecologists and three endocrinologists, to examine the essentiality of conducting the clinical trial of an injectable contraceptive Cyclofem and NET-EN by Indian Council of Medical Research (ICMR). The NET-EN is norethisterone enanthate 200 mg as a two monthly injectable hormonal contraceptive.
The issue of granting permission for this controversial clinical trial came up for discussion during the Drugs Technical Advisory Board (DTAB)'s meeting on November 25, 2013. In the meeting, the DCGI Dr GN Singh, who is the member-secretary of the Board, informed the members that the office of DCGI had received an application from an ICMR scientist Dr Malabika Roy for conducting study entitled “Pre-programme introduction of injectable contraceptive Cyclofem and NET-EN through district hospitals and NGO clinics- An ICMR Task Force study.”
They informed that the FDC of Oestrogen and Progestin (other than oral contraceptive) containing per tablet estrogen content of more than 50 mcg (equivalent to norethisterone acetate) and FDC injectable preparations containing synthetic Oestrogen and Progesterone was prohibited by the health ministry under section 26A of the Drugs and Cosmetics Rules, 1945 under entry number 27 of the list of banned drugs vide Gazette Notification G.S.R. 743(E) dated 10.08.1989.
Earlier a proposal of ICMR to conduct clinical trial in the country with the injectable preparations containing medroxyprogesterone acetate and estradiol cypionate (Cyclofem) as monthly contraceptive was recommended by the DTAB in its 48th meeting held on 08th July, 1999 for the reason that the clinical trial could continue without disturbing the present prohibitory status and the drugs would be imported for limited purpose of clinical trial only.
The proposal was deliberated in 61st meeting of DTAB held on July 24, 2012 also. The Board after deliberation recommended that an expert committee consisting of gynaecologists, pharmacologists may be constituted by the DCG(I) to examine the safety and efficacy of Cyclofem especially in the light of the fact that such contraceptive injections are prone to cause reduction in bone mineral density (BMD). The proposal of was deliberated in New Drug Advisory Committee (NDAC) (Reproductive and Urology) of the CDSCO on 17.09.2013.
The Committee recommended for the grant of permission of conducting clinical trial with Cyclofem and NET-EN subject to the following condition: The study should be titled as extended phase III clinical trial; the study should be conducted at multi speciality hospitals having emergency facilities and Institutional Ethics Committee registered with CDSCO; details of such sites along with Undertaking by Investigators as per Appendix VII of Schedule Y should be submitted; informed Consent Documents as per appendix V of schedule Y should be submitted; undertaking as per Rule 122DAB for compensation and providing medical management as per the rule in case of injury/death in clinical trial; denotification of the banning of Cyclofem i.e. Fixed Dose Combination Injectable preparations containing synthetic Oestrofen and Progesterone; and the recommendation may be placed before DTAB for further consideration.
After deliberations, the DTAB in its recent meeting recommended that an Expert Committee consisting of at least three gynaecologists, three endocrinologists, Dr Anoop Mishra and Dr Y K Gupta, HOD, Department of Pharmacology, AIIMS, New Delhi under the chairmanship of DGHS may be constituted to examine the essentiality of the clinical trial as well as the requirement, if any, of the amendment of entry number 27 in respect of the FDC of injectable preprations containing synthetic oestrogen and progesterone, in the context of present day knowledge.