The Central Drug Research Institute (CDRI), Lucknow the premier government sponsored drug research agency in the country, has successfully developed an herbal vaginal contraceptive cream.
The CDRI developed the herbal contraceptive vaginal cream 'Consap' from the plant Sapindus Mukorossi commonly known as Reetha. The technology has been transferred to the public sector Hindusthan Latex Limited (HLL), Thiruvananthapuram for manufacturing and marketing the product. Consap will be soon launched in the market and an MoU in this regard has been signed with HLL. Necessary inputs in the form of package insert, instructions for users and other relevant matter has been given to HLL recently, according to the annual performance report of CDRI for 2003-'04.
Meanwhile, it is learnt that the product will hit the market within the next six to eight months, and it has been tested among 400 volunteer women in Chennai, besides more tests planned at Bangalore, Hyderabad, and Kochi among 1000 volunteers. HLL is likely to offer India's first of its kind spermicidal contraceptive cream, also claimed as a side effects free product at a very cheap price in comparison to the available contraceptives for women.
The annual report of CDRI also said that clinical trials of the anti-malarial drug Arteether have been planned in 600 children suffering from P.falciparum malaria at the medical centres in Baroda, Guwahati, Rourkhela, Jodhpur and Jabalpur. The DCGI has given permission for conducting clinical trials for E-Mal (Arteether) ampoules (2000) and Themis Medicare Ltd, Mumbai, is manufacturing the drug. In association with Themis, efforts are also on to register the drug in Kenya, Uganda and other African countries for the treatment of multi-drug resistant Plasmodium falciparum malaria.
A detailed presentation among expert doctors and CME programmes on the drug was conducted at four centres in Kenya. Pharmacokinetic studies in 13 healthy human volunteers have been completed, besides the animal studies, said the report.
On the hepato protective drug - Picroliv being developed by CDRI, the report said controlled clinical trials are being done on 21 patients of tuberculosis receiving MDT and in six patients suffering from alcoholic cirrhosis, at two centres in Mumbai under expert supervision.
Further, double blind clinical trials are progressing for CT-1, an anti- hyperglycemic at KGMC, Lucknow and the study has been completed in 45 patients. Codes will be opened for the study after analyzing 50 samples.
Further, Phase I protocol and CRF along with preclinical data has been submitted to the DCGI for permission to conduct clinical trials for CDR-134 D 0123 - the antidiabetic and antidiarohheal drug. Research is also in various stages of progress to develop anti-filarial, hypolipidemic (fish oil), anti-stroke (herbal medicament) and anti-osteoporotic drugs, said the report.
CDRI developed a memory-enhancing capsule Promind from Bacopa extract and the manufacturing and marketing license was given to Lumen Marketing Company, Chennai. Encouraged by the success of Promind, the company launched two more brands named Memory Power and Memory Perfect, said the report.
About the other ongoing projects, the report said a license cum research collaborative agreement with Novo Nordisk, Denmark has been further extended to six months, and the Dabur Research Foundation has entered into a sponsored research agreement for generating the chemical libraries on their molecules using CDRI Multiple Organic Synthesizer and High Throughput Screening Facilities. The International Centre for Genetic Engineering and Biotechnology, New Delhi, has signed an MoU with CDRI to explore new lead molecules in the area of anti-malarials using HRP-II assay.
Further, the Central Institute of Fisheries Education, Mumbai and CDRI has entered into an MoU to undertake collaborative research, development and training programmes towards aquatic science, bio-active compounds from aquatic organisms, their application for human and fish health management related to biotechnological aspects on aquatic biodiversity and conservation programme, said the report, while reviewing the new projects of CDRI during year 2003-'04.