CDSCO’s New “New Drug” Label: What It Means for Delayed-Release Medications
The CDSCO has recently announced that it will now consider delayed-release medications, such as gastro-resistant tablets and capsules, to be “new drugs.” This decision, which was made in response to concerns about the uniform implementation of this rule across India, has significant implications for the pharmaceutical industry.
What are delayed-release medications?
Delayed-release medications are designed to release their active ingredients into the body at a specific time or location. This can be done for a variety of reasons, such as to improve patient compliance, reduce side effects, or target a specific area of the body. Gastro-resistant tablets and capsules are a type of delayed-release medication that is designed to protect the active ingredients from being broken down by stomach acid.
Why is the CDSCO making this change?
The CDSCO is making this change to ensure that all delayed-release medications are held to the same high standards of safety and efficacy. By classifying these medications as “new drugs,” the CDSCO will be able to more closely regulate their development and approval.
What are the implications of this change?
The CDSCO’s decision has a number of important implications for the pharmaceutical industry. First, it will require companies to conduct additional studies to demonstrate the safety and efficacy of their delayed-release medications. Second, it will likely lead to an increase in the cost of developing and manufacturing these medications. Finally, it may lead to some delays in the approval of new delayed-release medications.
What does this mean for patients?
This change is ultimately good news for patients. By ensuring that all delayed-release medications are safe and effective, the CDSCO is helping to protect patients from potential harm.