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DCGI directs states to ensure uniform implementation of NDCT Rules on new drugs approval
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Gireesh Babu, New Delhi
February 27 , 2025
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The Drugs Controller General (India) has directed all state and Union Territory (UT) drug regulators to ensure uniform implementation of relevant provisions under the New Drugs and Clinical Trial (NDCT) Rules, 2019 to treat gastro-resistant dosage forms or delayed-release dosage forms as new drugs.
The circular has been issued in line with a recommendation by the Drugs Consultative Committee (DCC) in a meeting held last year.
As per the definition of "New Drug" specified in Rule 2(1)(w) of the NDCT Rules, 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.
Dr Rajeev Singh Raghuvanshi, Drugs Controller General (India), in a circular on February 24, said, "...all the state/UT Drug Controllers are requested to ensure uniform implementation of the Rule 2(1)(w) of the New Drugs and Clinical Trials Rules, 2019 that modified or sustained release form of a drug including gastro-resistant tablets/capsules/delayed release tablets/capsules (enteric coated tablets/capsules) or novel drug delivery system shall always be deemed to be new drug as per the provisions of New Drugs and Clinical Trials Rules, 2019 under the Drugs and Cosmetics Act, 1940."
As reported earlier, the 64th Drugs Consultative Committee (DCC) meeting held on June 19, 2024, observed that while these drugs are considered as new drugs, there is lack of uniform implementation of the provisions across the country when it comes to issuing approvals.
The manufacturing licences and product approvals of the gastro-resistant dosage forms or delayed-release dosage forms (enteric coated tablets and capsules) are considered as ‘New Drugs’ and shall always be deemed to be new drugs, along with sustained-release, extended-release, prolonged-release, and controlled-release products.
Approval of these products, as new drugs, are issued by the Central Drugs Standard Control Organisation (CDSCO) in accordance with the NDCT Rules, 2019.
"The committee observed that there is a lack of uniform implementation of this rule regarding gastro-resistant dosage forms/delayed-release dosage forms (enteric coated tablets/capsules) among the state/UTs," said the Committee.
After detailed deliberation, it recommended the drug regulator to issue a circular to all the States and UTs regarding the interpretation of these products as New Drugs, as per Rule 2 clause (w) of the NDCT Rules, 2019, for uniform implementation of the provisions across the country.
The sub clause (iv) of Rule 2 clause (w) of the Rules states that a modified or sustained release form of a drug or novel drug delivery system of any drug approved by the Central Licencing Authority is considered as a new drug. The sub-clause (v) of the same clause defines a vaccine, recombinant deoxyribonucleic acid (r-DNA) derived product, living modified organism, monoclonal antibody, [cell or stem cell derived product], gene therapeutic product or xenografts, intended to be used as drug, is considered as new drugs.
While the other new drugs defined under the Rule 2 clause (w) shall continue to be new drugs for a period of four years from the date of their permission granted by the Central Licensing Authority, the drugs referred to in sub-clauses (iv) and (v) shall always be deemed to be new drugs, says the Rules.
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