- Accelerated approval process may be allowed to a new drug for a disease or condition, taking into account its severity, rarity, or prevalence and the availability or lack of alternative treatments, provided that there is a prima facie case of the product being of meaningful therapeutic benefit over the existing treatment.
In such case, the approval of the new drug may be based on data generated in clinical trial where surrogate endpoint shall be considered rather than using standard outcome measures such as survival or disease progression, which are reasonably likely to predict clinical benefit, or a clinical endpoint. These should be measurable earlier than irreversible morbidity or mortality (IMM) and reasonably likely to predict clinical benefit.
After granting accelerated approval for such drug, the post marketing trials shall be required to validate the anticipated clinical benefit.
Accelerated approval may also be granted to a new drug if it is intended for the treatment of a serious or life-threatening condition or disease of special relevance to the country, and addresses unmet medical needs. This provision is intended to facilitate and expedite review of drugs so that an approved product can reach the therapeutic armamentarium expeditiously.
If the remarkable efficacy is observed with a defined dose in the Phase II clinical trial of investigational new drug for the unmet medical needs of serious and life threatening diseases in the country, it may be considered for grant of marketing approval by the Central Licencing Authority based on Phase II clinical trial data.
In such cases, additional post licensure studies may be required to be conducted after approval to generate the data on larger population to further verify and describe the clinical benefits, as per the protocol approved by the Central Licensing Authority.
The type of information needed to demonstrate the potential of a drug to address an unmet medical need will depend on the stage of drug development. Early in development, such potential should be sufficiently demonstrated based on non-clinical models, a mechanistic rationale and pharmacologic data. Later in development, prior to new drug approval such potential should be demonstrated through clinical data to address an unmet medical need.
Situations where quick or expeditious review process can be sought for approval of a new drug after clinical development
In situation where the evidence for clinical safety and efficacy have been established even if the drug has not completed the all or normal clinical trial phases, the sponsor or applicant may apply to the licencing authority for expedited review process wherein the licencing authority will examine and
satisfy the following conditions:—
- it is for a drug that is intended to treat a serious or life threatening or rare disease or condition;
- if approved, the drug would provide a significant advantage in terms of safety or efficacy
- there is substantial reduction of a treatment-limiting adverse reaction and enhancement of patient compliance that is expected to lead to an improvement in serious outcomes;
the sponsor or applicant may also apply to the licensing authority for expedited review process for new drugs developed for disaster or defence use in extraordinary situation, such as war time, the radiation exposure by accident or intention, sudden deployment of forces at areas with higher health risk, where specific preventive and treatment strategy is required, where new intervention in the form of new drug, route of delivery or formulation has been developed and where real life clinical trial may not be possible. The permission for manufacture of such new drug may be granted if following conditions are satisfied:—
- The preclinical data makes a case for claimed efficacy;
- there is no possibility of obtaining informed consent from the patient or his legally acceptable representative, as the case may be, adopting inclusion and exclusion criteria and strict protocol adherence by each subject;
- there is no established management or therapeutic strategy available as on date and proposed intervention has clear possible advantage;
- such approval can be used only for one time. The subsequent approval shall only be granted once detailed efficacy report of such intervention is generated.
the new drug is an orphan drug as defined in clause (x) of rule 2 of these
Rules.
