Requirements for drug approval with new claims

In case a drug already approved by the Central Licencing Authority for certain claims, which is now proposed to be clinically tried or marketed with modified or new claims, namely, indications, dosage, dosage form (including sustained release dosage form) and route of administration or novel drug delivery system (NDDS), the requirements of data and information for permission to import or manufacture of such new drug for sale or to undertake clinical trial shall depend on nature and regulatory status of the drug for the new claim in other country. Application for approval of manufacture or import of such new drug or to undertake Clinical trial may differ from application for a new drug molecule in that they allow the applicant and regulatory authority to rely at least in part, on the safety or efficacy data of drug formulation already approved. However, additional non-clinical or clinical data may be necessary to substantiate the new claims considering the following:—

1. Chemical and pharmaceutical information will be same as prescribed in this Schedule. However, the data requirements may be omitted depending on whether the drug formulation is already approved and marketed in the country by the applicant in the same dosage form for certain indication. If it is approved and marketed, no further chemical and pharmaceutical data is required to be submitted.
2. The animal pharmacological and toxicological data and clinical data needed in such cases will usually be determined on case-by-case basis depending on the type of new claims being made by the applicant as well as the mechanism of action, patho-physiology of the disease or condition, safety and efficacy profile in the respective conditions or population and clinical data already generated with the drug in the approved claim. The requirements may be abbreviated or relaxed or omitted as considered appropriate by the Central Licencing Authority under following conditions:
   • the drug is already approved and marketed in other country for the proposed new claim
   • clinical data supporting the benefit-risk ratio in favour of the drug in the proposed new claim is available;
   • the clinical trial doesn’t involve a route of administration, dose, patient population that significantly increases the risk associated with the use of the drug.
3. In case of an application for permission to undertake clinical trial of a new drug formulation, which is already approved in the country, no chemical and pharmaceutical data and non-clinical and clinical data is required to be submitted provided the clinical trial is proposed to be conducted with a new drug manufactured or imported by a firm under necessary new drug permission or import registration and licence, as the case may be, granted by the Central Licencing Authority