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The Central drugs control authority may direct drug regulators of all the States and Union Territories (UTs) for uniform implementation of norms for new drugs under the New Drugs and Clinical Trial (NDCT) Rules, 2019, related to issuance of manufacturing licences or product approvals for the gastro-resistant dosage forms or delayed-release dosage forms.
The 64th Drugs Consultative Committee (DCC) meeting held earlier this year, has 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, is 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.
The DCC, during the meeting, also considered a proposal to exclude products covered under Schedule-O from the provisions of new drugs and import registrations.
As per Section 3 (b) (ii) of the Drugs and Cosmetics Act, 1940, disinfectants are also covered under the definition of drug. Whenever any drug is imported in the country, the applicant has to obtain an Import license together with registration certificate as per Drugs Rules, 1945. If any drug attracts the definition of new drug, in that case new drug approval is also required to be obtained as per NDCT Rules, 2019.
The Committee, after detailed deliberation, recommended the central drug regulator to prepare and issue a guidance for specific requirements for obtaining import registration certificate and new drug permission (marketing authorisation) for disinfectants.
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