Looking to further consolidate its presence beyond the borders of the country, Central Drug Research Institute (CDRI) is generating required data for the registration of its one of the premium drugs Ormeloxifene (Centchroman) and also for its inclusion in the WHO medicines list.
The premier research institute has entered into a sponsored project with HLL Lifecare for generating various data for registration of Ormeloxifene (Centchroman) in Brazil as per ANVISA guidelines and inclusion in WHO medicine list. CDRI also licensed the improved patented process of synthesis of Ormeloxifene for developing and marketing the drug as an oral contraceptive, according to sources.
Centchroman, a non-steroidal oral contraceptive, is the first nonsteroidal oral contraceptive to have been developed anywhere in the world. It is a weak estrogen and a potent antiestrogen with a high therapeutic index. It is marketed by Hindustan Latex Ltd under the trade name, Saheli and as Centron by Torrent Pharmaceuticals, Ahmedabad. The first non-steroidal once a week pill, centchroman was developed by CDRI and reached the general public by the end of the 1980's. This is the only anti-implantation agent approved for clinical use in the world.
Centchroman has also been found effective as an anti-breast cancer agent. Multicentric trials in stage III/IV breast cancer patients, who were not responsive to other modalities of therapy, were found to respond to Centchroman with an overall responsive rate of about 56 per cent. The data is being compiled for seeking marketing permission from DCGI, sources said.
Making its presence outside the country earlier, the institute had developed a plant-based natural memory enhancer formulation BESEB (Bacosides Enriched Standardized Extract of Bacopa) from the herb Bacopa monniera. BESEB has been licensed to Lumen Marketing Co., Chennai for manufacturing and marketing. Lumen is selling the product under different brand names with its business associates mainly as Memo Plus Gold in Malaysia, Philippines & Singapore, Keenmind & Membac in Australia & New Zealand and Memory Perfect in France & Germany. Lumen and Zaar Distributors Pvt. Ltd., New Delhi joined hands for extensive marketing of the product in India as Memory Sure. It will soon to be available in Thailand, Indonesia, SAARC countries, the UAE also soon.