Last Updated on August 9, 2024 by The Health Master
Toxicity Data
The Central Drugs Standard Control Organisation (CDSCO), India’s drug regulator, has announced a significant change in its drug approval process.
In a recent circular, the CDSCO has stated its willingness to accept preclinical toxicity data generated and approved by regulatory authorities in other countries for the evaluation of new drugs, subsequent new drugs (SNDs), and fixed dose combinations (FDCs).
Relaxing Toxicity Data Requirements
This move is aimed at streamlining the drug approval process in India and reducing the burden on pharmaceutical companies.
Under the New Drugs and Clinical Trials Rules, 2019, repeated dose toxicity data were mandatory in most cases.
However, the CDSCO has now clarified that these studies may not be required if:
- Data Availability: Sufficient animal toxicity data has already been submitted and approved by a foreign regulatory authority.
- Data Quality: The quality of the data and the credibility of the laboratory that generated it meet the CDSCO’s standards.
Case-by-Case Evaluation
It’s important to note that the acceptance of foreign toxicity data will be evaluated on a case-by-case basis.
The CDSCO will consider factors such as:
- Nature of New Claims: If a drug is being approved for new indications, dosages, or formulations, additional toxicity data might be necessary.
- Mechanism of Action: The drug’s mechanism of action will also be considered when determining the need for further toxicity studies.
- Unapproved Excipients: If the drug formulation contains unapproved excipients, safety data related to these components will be required.
Exceptions to the Rule
While the CDSCO is relaxing toxicity study requirements in many cases, certain drugs will still necessitate traditional toxicity testing.
This includes:
- Intravenous Injections and Infusions: Sub-acute animal toxicity studies remain mandatory for these drug formulations as per the NDCT Rules, 2019.
Implications for the Pharmaceutical Industry
This decision by the CDSCO is expected to expedite the drug approval process in India, reducing time-to-market for new and innovative medicines.
It could also encourage foreign pharmaceutical companies to invest in the Indian market.
However, drug manufacturers will need to carefully evaluate the specific requirements for each drug to ensure compliance with CDSCO regulations.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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