Drug Report Submissions by Marketing Firms: DTAB directs to constitute sub-committee to amend NDCT Rules
New Delhi: The Drugs Technical Advisory Board (DTAB) has recommended forming a sub-committee to look into the proposed amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019, to mandate that marketing companies submit Periodic Safety Update Reports (PSURs) annually until the drug product is marketed. This would replace the current provision, which mandates the submission of PSURs only for the third and fourth years after drug approval.
PSURs are submitted by marketing companies to monitor the safety of drugs after they are approved for use.
Under the current NDCT Rules, post-marketing surveillance requires marketing companies to submit Periodic Safety Update Reports (PSURs) as part of the safety monitoring of new drugs. Initially, these reports must be filed every six months for the first two years after drug approval. Afterward, they are submitted annually for two more years. However, if necessary for public health, the Central Licensing Authority can extend this duration. Additionally, serious unexpected adverse reactions must be reported within 15 days, and if drug marketing is delayed, the PSUR submission begins once marketing starts.
During its meeting held in August, the DTAB was deliberating a proposal for certain amendments to the PSUR under the Fifth Schedule of NDCT Rules, 2019.
The periodic safety update reports (PSURs), which are currently required annually for the third and fourth years, was proposed to be mandated annually until the drug is marketed. The proposal read;
"In the sub-clause (iii) of clause (c) of sub-rule (5) of rule 1 under Fifth Schedule of NDCT Rules, 2019 the words “For subsequent two years – the periodic safety update reports need to be submitted annually.” Shall be substituted by the words “For subsequent years – the periodic safety update reports need to be submitted annually till the drug product is marketed.”
The Board was also apprised that the NDCT Rules, 2019 under Fifth Schedule as well as Drugs Rules, 1945 under Schedule M prescribes that the applicant/ licensee shall have a `Pharmacovigilance system in place for collecting, processing and forwarding the report to the licensing authority for information on adverse drug reactions emerging from the use of the drug imported or manufactured or marketed by the applicant in the country.
The amendments proposed to the NDCT Rules, 2019 suggested the inclusion of the word 'Pharmacovigilance System Master File (PSMF)' in the Fifth Schedule's appendix. The proposed amendment read;
"The words “Pharmacovigilance System Master File (PSMF)” shall be inserted under the appendix of Fifth Schedule of NDCT Rules, 2019 which is as under:
Appendix: 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)."
DTAB deliberated the matter and agreed to the proposed amendment to add PSMF as a document under the appendix of the fifth schedule. However, with regard to PSURs, the DTAB agreed to form a sub-committee to further deliberate on the proposed amendment related to the submission of the PSURs for subsequent years.
