The Drugs Controller General of India (DCGI) has approved the importation and marketing of the Cervidil vaginal insert in India. The product is manufactured by Controlled Therapeutics Ltd, Scotland (CTS) in Glasgow and will be imported by PAC Med Biotech Pvt Ltd, Kolkata, which has assigned all marketing and distribution rights throughout India to Trigenesis Lifesciences, Bangalore. The new product is expected to become available in Indian market very soon.
Cervidil is a novel hydrogel matrix that has become highly acclaimed because it provides a non-interventionist method of delivering dinoprostone to ripen the cervix prior to labour induction. The active drug is delivered gradually in a controlled-release manner over a period of up to 24 hours and in the event of an adverse reaction, may be easily withdrawn via a retrieval tape. As such, this unique technology represents a breakthrough in obstetric management.
Dinoprostone is widely used for cervical ripening and is currently available in India only in gel and tablet formats. However, one drawback to these traditional immediate-release formulations is that once administered, it is difficult to remove the drug in the event of adverse outcomes, such as uterine hyperstimulation and fetal distress. Cervidil, which has US FDA approval, has become the leading product in this segment in many countries because it provides an effective format for controlled-release of dinoprostone over a 24-hour period. As such, it offers significant advantages to both patients and clinicians, such as reduced adverse effects and easy withdrawal if a reaction should occur.
Trigenesis LifeSciences has 37 products in its portfolio, spanning the areas of osteoporosis, diabetes, anti-infectives, pain management, and women's health. The acquisition of distribution rights for Cervidil represents a key addition to its flagship line that currently includes Bescal (osteoporosis) and TriFenac-S (pain killer). All products are marketed in southern states. Plans for 2006-07 include entry into Chattisgarh, Orissa, Madhya Pradesh and Rajasthan.
PAC Med Biotech is an innovative new company that develops strategic business alliances with foreign pharma and biotech companies who wish to distribute their products in India. The company specialises only in introducing cutting-edge pharma and diagnostic products into the Indian marketplace in collaboration with its partners throughout India.