Gastro-Resistant, Delayed-Release Drugs Now Under 'New Drug' Category

The decision was taken following discussions during the 64th meeting of the Drugs Consultative Committee (DCC) on June 19, 2024, where concerns regarding the inconsistent implementation of this rule across different states were raised.

The official circular emphasized the need for clarity and standardization in regulatory enforcement. "The issues relating to uniform implementation of this rule regarding Gastro-resistant Dosage forms / Delayed-release Dosage forms (Enteric Coated Tablets/Capsules) across the country were deliberated in the 64th meeting of the Drugs Consultative Committee (DCC) held on 19-06-2024," it stated.

As per Rule 2(1)(w) of the New Drugs and Clinical Trials Rules, 2019, any modified or sustained-release formulation of an already approved drug or a novel drug delivery system will always be classified as a "New Drug." This definition explicitly includes Enteric Coated Tablets/Capsules, Gastro-Resistant Dosage Forms, and Delayed-Release Dosage Forms. The directive further clarifies, "A modified or sustained-release form of a drug or novel drug delivery system of any drug approved by the Central Licensing Authority shall always be deemed to be a new drug."

CDSCO has now instructed all State and UT Drugs Controllers to strictly enforce this classification to prevent pharmaceutical companies from bypassing the mandatory approval process. Dr. Rajeev Raghuvanshi, Drugs Controller General of India (DCGI), highlighted the significance of the decision, stating, "The committee deliberated extensively on the interpretation of Rule 2(1)(w) and recommended issuing a circular to ensure its uniform implementation across the country."

With this directive, pharmaceutical companies seeking approval for Gastro-Resistant or Delayed-Release formulations will now have to comply with regulations applicable to ‘New Drugs.’ This may include conducting additional clinical trials, providing bioequivalence studies, and obtaining fresh approval from the Central Licensing Authority (CLA) before marketing these formulations. The move aims to strengthen safety and efficacy assessments of modified drug formulations while maintaining strict regulatory compliance.

CDSCO has also issued strict instructions to State/UT regulators to monitor compliance and enforce this classification uniformly. Dr. Raghuvanshi emphasized the importance of regulatory alignment, stating;

"All the State/UT Drugs Controllers are requested to ensure uniform implementation of Rule 2(1)(w) of the New Drugs and Clinical Trials Rules, 2019, that modified or sustained-release forms of a drug—including Gastro-resistant Tablets/Capsules, Delayed-release Tablets/Capsules (Enteric Coated Tablets/Capsules), or novel drug delivery systems—shall always be deemed to be a new drug."

To facilitate smooth implementation, CDSCO has also forwarded copies of the directive to all zonal and sub-zonal offices of CDSCO as well as the Clinical Research Unit (CRU) at CDSCO headquarters for further monitoring.