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CCRAS herbal oral contraceptive drug enters phase II clinical trials
Joe C Mathew, New Delhi | Monday, June 28, 2004, 08:00 Hrs  [IST]

The Central Council for Research in Ayurveda & Siddha (CCRAS), an autonomous organization under the department of AYUSH has developed Pippalyadi Yog, world's first herbo-mineral female oral contraceptive drug. The drug is undergoing phase II clinical trials, it is learnt.

The multi-centric phase II trial is being carried out at All India Institute of Medical Sciences (AIIMS), New Delhi, PGI, Chandigarh, KEM Hospital, Mumbai and JIPMER, Pondichery. After the formulation proved in intra mural research of the Council, the project has been taken up by the Department of Family Welfare, Government of India to further access the efficacy. The phase-I clinical trials were successfully conducted in the same centres after due approval from the Drug Controller General of India.

According to sources, the phase-II trials are also showing promising results. As next step, the government is to ask National Institute of Pharmaceutical Education and Research (NIPER), Mohali to supply the capsules after ensuring quality and to simultaneously carry out the shelf-life studies and estrogen assay. The government would also ensure patent protection for the drug, it is learnt.

It was about four years ago that the Central Government decided to take up the study on Pippalyadi Yog for eventually including it in National ant-fertility programme. The clinical and pharmacological research carried out at CCRAS has also resulted in the development of Neem oil as a spermicidal agent.

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