A novel drug makes a great contribution to the welfare of human beings, as it helps in treating a disease or by enhancing the lifestyle of a patient. It also helps in prolonging the life of a person who is suffering from diseases that are not curable. But with every novel drug is associated the risk of side effects. This risk is one of the important concerns in association with proper regulation in the pharmaceutical sector. Such risk can cause detrimental effects for which was accepted as one of the important points to undertake for better regulation.
A novel drug means novel molecular entities but in reality, it takes varied forms starting from reformulated generics to some fixed-dose combinations of the existing drugs. It has been provisioned now that all kinds of study that involves humans that are not drug trials will be under the regulation of national ethical guidelines for biomedical and health research. It is now compulsory that ethics committees should be registered with CDSCO before they approve any regulatory clinical trial. Hence, improving the process for drug product registration in India.
DCGI has made it mandatory to test all categories of novel drugs for obtaining approval under New Drugs and Clinical Trials, 2019. On March 19, 2019, the New Drugs and Clinical Trials rules, 2019 was released by CDSCO or Central Drugs Standard Control Organization with a sole purpose of promoting authentic clinical research in India.
Another reason behind the need for such lab tests of novel drugs is to know about those drugs which are pharmacopoeial products or which have more strengths when compared to that drug that is already approved. CDSCO offers permission for importing and manufacturing of such drugs for selling and distributing. It is required to test the drugs in any of the Central Government laboratories for their approval.
This has been done to streamline the whole process of approval and must be done as per the proposed timeline unless there are any other special issues about drug testing. The proposed timeline for those drugs that have got approval is 4 weeks and those drugs that are pharmacopoeial is 6 weeks. Those drugs that are novel, the timeline is 8 weeks. This movement has been made for the safety of the public for using novel drugs.