|
The Drugs Technical Advisory Board (DTAB) of the Union health ministry has recommended amendment of the New Drugs and Clinical Trials (NDCT) Rules, 2019 to mandate submission of periodic safety update reports (PSURs) for modified or sustained release and new drug delivery system, and certain advanced biological and specialised drugs, in regular intervals till the drug product is marketed.
The Board recommended the amendment after considering and agreeing with the recommendations of a sub-committee it has formed in 2024 to examine a proposal for submission of PSUR annually for the subsequent years till the drug product is marketed.
The current provisions mandate the submission of PSUR every six months for the first two years after approval of the drug and annually for the subsequent two years.
In the 93rd DTAB meeting held in February, the DTAB deliberated the recommendations of the sub-committee with regards to the amendment of the rules to extend the PSUR submission annually till the drug product is marketed.
The sub-committee recommended that the PSUR submission frequency for categories of new drugs under (iv) of Rule 2(w) of the NDCT Rules, 2019, shall be "the periodic safety update reports shall be submitted every six months for the first two years after approval of the drug is granted to the applicant. For subsequent two years - the periodic safety update reports need to be submitted annually and then once every three years till the drug product is marketed."
The sub clause (iv) of Rule 2(w) defines a modified or sustained release form of a drug or novel drug delivery system of any drug approved by the Central Licencing Authority, as a new drug.
The sub-committee recommends that the PSUR submission frequency for categories of new drugs as detailed under (v) of Rule 2(w) of the New Drugs and Clinical Trial Rules, 2019, shall be "the periodic safety update reports shall be submitted every six months for the first two years after approval of the drug is granted to the applicant. For subsequent years - the periodic safety update reports need to be submitted annually till the drug product is marketed."
The sub clause (v) of Rule 2(w) defines a vaccine, recombinant deoxyribonucleic acid (r-DNA) derived product, living modified organism, monoclonal antibody, 4 [cell or stem cell derived product], gene therapeutic product or xenografts, intended to be used as drug, as new drugs.
However, the PSUR submission frequency for categories of new drugs as detailed under (i), (ii), and (iii) of Rule 2(w) of the New Drugs and Clinical Trial Rules, 2019, shall remain unchanged. The periodic safety update reports of these drugs shall be submitted every six months for the first two years after approval of the drug is granted to the applicant. For subsequent two years - the periodic safety update reports need to be submitted annually.
The sub clause (I) refers to drugs including active pharmaceutical ingredient or phytopharmaceutical drugs which has not been used in the country to any significant extend, except in accordance with the provisions of the Act and the rules made thereunder, as per conditions specified in the labelling thereof and has not been approved as safe and efficacious by the Central Licencing Authority with respect to its claims.
Sub clause (ii) refers to drugs approved by the Central Licencing Authority for certain claims and proposed to be marketed with modified or new claims including indication, route of administration, dosage and dosage form.
Sub clause (iii) refers to fixed dose combinations of two or more drugs, approved separately for certain claims and proposed to be combined for the first time in a fixed ratio, or where the ratio of ingredients in an approved combination is proposed to be changed with certain claims including indication, route of administration, dosage and dosage form.
The Board, in a meeting last year, deliberated on a proposal for certain amendments to the PSUR under the Fifth Schedule, including substitution of the provisions for submission of PSURs for subsequent two years after the first two years of approval with provisions for annual submission of PSUR till the drug product is marketed.
The post marketing surveillance through PSUR under the fifth schedule of the NDCG Rules, mandates that the marketing company need to file the PSURs as part of post marketing surveillance of new drug.
Currently, the rules also add that the Central Licencing Authority may extend the total duration of submission of periodic safety update reports if it is considered necessary in the interest of public health. PSURs due for a period must be submitted within thirty calendar days of the last day of the reporting period. However, all cases involving serious unexpected adverse reactions must be reported to the licensing authority within fifteen days of initial receipt of the information by the applicant.
If marketing of the new drug is delayed by the applicant after obtaining approval to market, such data will have to be provided on the deferred basis beginning from the time the new drug is marketed.
|