Last Updated on March 10, 2025 by The Health Master
Drug Approval
The Indian pharmaceutical landscape is undergoing a crucial shift regarding drug approval, with the Drugs Controller General (India) (DCGI) issuing a firm directive to all state and Union Territory (UT) drug regulators.
The message? Ensure absolute uniformity in implementing the New Drugs and Clinical Trial (NDCT) Rules, 2019, specifically regarding gastro-resistant and delayed-release dosage forms.
The Drugs Consultative Committee (DCC) has taken this action for standardization of the classification and drug approval process.
Focus on Delayed-Release Drugs?
The issue lies in the definition of “New Drug” as defined in the NDCT Rules, 2019.
Simply put, any modified or sustained-release form of an approved drug, including gastro-resistant tablets and capsules, is legally considered a “new drug.”
This designation mandates rigorous scrutiny and drug approval by the Central Drugs Standard Control Organization (CDSCO).
The DCGI’s Directive: A Call for Uniformity
Dr. Rajeev Singh Raghuvanshi, the DCGI, in a recent circular, explicitly emphasized the need for consistent application of Rule 2(1)(w) of the NDCT Rules.
It is mentioned in this rule that modified-release formulations, like enteric-coated tablets, are “new drugs.”
The clarity must be there to avoid discrepancies and other issues while drug approval has been granted across different states and UTs.
The Role of DCC:
The 64th DCC meeting, held on June 19, 2024, highlighted a crucial issue, i.e., a lack of uniform implementation across the country.
However, the rules clearly mention these drugs as “new drugs,” and the practical application varied state to state.
This inconsistency raised concerns about patient safety and drug efficacy, prompting the DCC to recommend a nationwide directive.
What Are “New Drugs” Under the NDCT Rules?
Let’s understand the definition of “new drugs.”.
Modified Release Forms:
The following drugs are always considered new drugs:
- Gastro-resistant,
- Delayed-release,
- Sustained-release,
- Extended-release,
- Prolonged-release, and
- Controlled-release products.
Biologicals and Advanced Therapies:
Vaccines, recombinant DNA products, monoclonal antibodies, cell and gene therapies, and xenografts are also always classified as new drugs.
Other Novel Drugs:
New chemical entities and other drugs that are not falling into the above categories are to be considered new drugs for four years from their initial drug approval.
Q: What are gastro-resistant dosage forms?
A: These are drugs designed to resist dissolution in the stomach due to the acidic environment and release the drug in the intestines.
Q: Why are delayed-release drugs are to be considered as “new drugs”?
A: Because they modify the mechanism of drug release, requiring separate evaluation for safety and efficacy of the drug.
Q: Who is the approving authority of the “new drugs” in India?
A: The Central Drugs Standard Control Organisation (CDSCO).
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
Disclaimer: The information we have provided is for general knowledge and for informational purpose only and it cannot be treated as medical advice. Always consult your doctor for any health issues and / or for the treatment of the same. The Health Master does not claim responsibility for this information.
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