Expert Committee recommends amendment of D&C act and include SCCPs as new drug
The expert committee submitted report to ministry of health and family welfare, Government of India on amendment of relevant rules in the Drugs and Cosmetics Act 1940 to include stem cells and other cell based products (SCCPs) as New Drugs.
Ministry had set up a committee in June 2013 under the Chairmanship of Prof. Lalji Singh, Vice Chancellor of Banaras Hindu University. They asked to suggest views and ideas on how the ministry of health and family welfare can guide and regulate the usage of stem cell and other cell based therapies in India. This decision of making committee was taken due to increasing use of stem cells and other cell based therapies in recent years by clinicians in India and internationally for treatment of human diseases. So, there is obvious need of creating perfect regulatory framework of such products.
After long and careful consideration or discussion, committee recommended few points out of which main is amendment of the relevant rules in the Drugs and Cosmetics Act of 1940 so as to include SCCPs as New Drugs.
Committee also suggests that there is need of set up a system which appointed technical evaluation committees and trained examiners for examining and licensing facilities where work related to SCCPs usage is being done or proposed to be done and also invite, evaluate and approve specific applications from companies, hospitals, research institutes and universities that propose to use SCCPs in clinical trials.
In accordance of above report government asked Drugs Controller General of India to take forward steps and to ensure that recommendations of the Committee are implemented at the earliest and instruments for starting the regulatory process is put in place.