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DTAB recommends to form sub-committee to amend NDCT Rules to mandate marketing cos to submit PSURs annually
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Gireesh Babu, New Delhi
October 18 , 2024
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The Drugs Technical Advisory Board (DTAB) has recommended constitution of a sub-committee to look into amending the New Drugs and Clinical Trials (NDCT) Rules, 2019 to mandate that the marketing companies need to submit the periodic safety update reports (PSURs) annually till the drug product is marketed, instead of the current provisions which mandates the submission of reports annually for the third and fourth year of approval.
The Board agreed to another proposal to amend the Rules to include inclusion of Pharmacovigilance System Master File (PSMF) along with other copies of documents required as appendix for the PSUR.
The Board, in its recent meeting held on August 14, deliberated on a proposal for certain amendments to the PSUR under the Fifth Schedule. One of the proposals was to amend the particular provision in the Fifth Schedule, substituting the provisions for submission of PSURs for subsequent two years after the first two years of approval.
The proposal was to substitute the words “For subsequent two years – the periodic safety update reports need to be submitted annually”, to “For subsequent years – the periodic safety update reports need to be submitted annually 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.
At present, the provisions are that all relevant clinical and non-clinical safety data should cover only the period of the report (interval data). The PSURs 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 PSURs need to be submitted annually.
Currently, the sub-clause also adds 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.
The Board, however, agreed to another proposal for an amendment to the same Schedule, in the NDCT Rules, after deliberation.
It has agreed to the proposed amendment to add PSMF as a document under the appendix of the fifth schedule.
The recommendation was to amend the appendix as, "The appendix includes the copy of marketing authorisation in India, copy of prescribing information, line listings with narrative of Individual Case Safety Reports (ICSR), Pharmacovigilance System Master File (PSMF)."
The Pharmacovigilance System Master File (PSMF) provides a description of the pharmacovigilance system used by the marketing authorisation holder with respect to pharmaceutical products marketed by them. The PSMF is not a part of the marketing authorization (MA) dossier and is maintained independently from the MA, according to an earlier draft guidance document of Indian Pharmacopoeia Commission.
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