The Union health ministry plans to modify the New Drugs and Clinical Trials (NDCT) rules 2019 for E compassionate utilization of novel unapproved drugs depending on the Drugs Technical Advisory Board (DTAB) recommendations. DTAB measured the draft notification about the same dated June 5, 2020, after proper consideration is recommended to alter the rules, including some of the provisions for compassionate utilization of novel drugs that have not obtained approval.
After a discussion with DTAB, the central government had released draft guidelines on June 5, 2020, about making some alterations in NDCT rules, 2019, for compassionate utilization of novel but unapproved drugs. It has also asked for suggestions on the draft guidelines from the industry.
DTAB explained that the depiction of the Cure SMA foundation of India had been received to make the rules and guidelines for the compassionate use of novel but unapproved drugs in India.
The whole illustration clearly mentioned that the medical treatment of the patients having chronic and life-threatening or seriously inactivating rare diseases can be really disappointing for both the suffering parents and their families. Sometimes physicians are also disappointed in cases where they cannot treat the patients with satisfaction. In India, market authorization of novel pharmaceuticals will take several years when there is a loss of valuable time.
Furthermore, it was mentioned that the best way to tackle market authorization is to permit those patients with some life-threatening problems to get new medicine under compassionate use. It was also recommended to create a framework for the compassionate use of new drugs that have not got approval.
According to the draft notification, it has been proposed that in chapter-XI after rule 96, 96A will be inserted, which is the application for importing drugs that have not been approved for treating patients by hospitals to any other medical. Then there are other rules like
● 96B that grants license for importing novel drugs for compassionate use.
● 96C Conditions of the license obtained.
● 96 C Suspension of cancellation of the license for importing new drugs.
● 96D Application to permit the manufacture of a novel drug for compassionate use.
● 96E Application for grant of permission.
● 96F contains the conditions for getting permission.
● 96 G inspecting the site of manufacturing.
● 96H Suspension of the permission to manufacture the new drug.
All these will come into force after the release of the final update. Hence making some slight alterations to the new drugs and clinical trials rules in India.
This post first appeared on Amendments Made In Medical Device Rules For NABL Accreditation, please read the originial post: here
