Data to be submitted along with the application to conduct clinical trials or import or manufacture of new drugs for sale in the country
Stability testing of new drugs
Stability testing is to be performed to provide evidence on how the quality of a drug substance or formulation varies with time under the influence of various environmental factors such as temperature, humidity and light, and to establish shelf life for the formulation and recommended storage conditions. Stability studies should include testing of those attributes […]
Animal Toxicology studies as per the CDSCO Guidance
General Principles: Toxicity studies should comply with the norms of Good Laboratory Practices (GLP). Briefly, these studies should be performed by suitably trained and qualified staff employing properly calibrated and standardized equipment of adequate size and capacity. Studies should be done as per written protocols with modifications (if any) verifiable retrospectively. Standard operating procedures (SOPs) […]
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 […]
Accelerated approval process
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 […]
Requirements and guidelines for permission to import or manufacture of new drug
Application for permission to import or manufacture new drug for sale or to undertake clinical trials under these Rules shall be made to the Central Licencing Authority accompanied with following data in accordance with the Table 1 or Table 2 or Table 3 or Table 4 of the Second Schedule as the case may be, […]
Import of New drug/Investigational drug for clinical trials
Any person or institution or organisation who intends to import a new drug or any substance relating thereto for conducting clinical trial or Any person or institution or organisation who intends to import a new drug or any substance relating thereto for conducting clinical trial or The application under sub-rule (2) shall be accompanied by […]
Regulation on Medical Device in India (Medical devices rules, 2017)
Ministry of health and family welfare on 31st January 2017 published the guidance regarding Medical devices. Regulation of Medical Device Classification of Medical devices: Classification of medical devices.— (1) Medical devices other than in vitro diagnostic medical devices shall be classified on the basis of parameters specified in Part I of the First Schedule, in […]
Manufacture of Medical Devices for sale or for distribution
According to the guidance provided by the CDSCO on Medical device manufacturing and distribution: Application for manufacture for sale or for distribution of Class A or Class B medical device.— (1) Any person who intends to manufacture a Class A or Class B medical device including in vitro diagnostic medical device shall make an application […]