The union health ministry will soon re-examine the issue of introduction of injectable contraceptives like cyclofem in the country, which at present is included in the entry number 27 of the list of banned drugs under Section 26A of the Drugs and Cosmetics Act (D&C Act).

According to sources, the drugs controller general of India (DCGI) Dr GN Singh will soon constitute an expert committee consisting of gynaecologists and pharmacologists in this regard which will examine the overall safety and efficacy profile of the drug including assessment of the bone mineral density, if any done by ICMR during the clinical trial.

The issue for amendment of entry number 27 of the list of banned drugs under notification GSR 578(E) dated 23.07.83, relating to fixed dose combinations of injectable preparations containing synthetic oestrogen and progesterone, came up for deliberations in the Drugs Technical Advisory Board (DTAB), the highest authority in the union health ministry on technical matters, in its meeting held on July 24 this year.

After detailed deliberations, the DTAB came to the conclusion that an expert committee should be constituted 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.

Earlier, the DCGI informed the DTAB that an application from ICMR to conduct a study on “Pre-programme introduction of injectable contraceptive Cyclofem and Net-EN through district hospitals and NGO clinics- An ICMR Task Force Study” is pending with the CDSCO.

The DTAB in its 48th meeting held on July 8, 1999 had earlier agreed to the clinical trials of cyclofem injection by ICMR. Accordingly, the ICMR had conducted the study and submitted the report. Further, ICMR has applied for another clinical trial of cyclofem injection and Net-EN injection. Sun Pharma has also applied for permission for manufacture for sale of cyclofem (an FDC as an injectable suspension containing Medroxyprogesterone acetate 25 mg ad estradiol cypionate 5 mg per 0.5ml as injectable contraceptive).

The DCGI informed the DTAB that his office has been informed that the injectable preparation containing Medroxyprogesterone acetate and estradiol cypionate (Clyclofem) are available in USA, Indonesia, Hongkong and Thailand. The preparation is also included in the WHO model list of Essential Medicines.

DTAB in its recent meeting also decided that the proposals of ICMR to conduct the clinical trial would be considered by DTAB as per the recommendations of the expert committee.