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DCGI asks human vaccine manufacturers to submit details of pharmacovigilance system
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Our Bureau, New Delhi
December 31 , 2022
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The Central drug regulator has sought the manufacturers and importers of human vaccines to submit the documents related to compliance with the pharmacovigilance system as per the requirements of the Schedule 5 of the New Drugs and Clinical Trial (NDCT) Rules, 2019.
Drug Controller General of India (DCGI) Dr V G Somani, in a notice issued to all the manufactures and importers of human vaccines, requested to furnish the summary of established pharmacovigilance system, details of the pharmacovigilance officer-in-charge (PvOI) and the premises where the pharmacovigilance system is established and a self inspection report, if it is available.
The drug regulator said that as per the 5th Schedule of the NCDT Rules, 2019, the importer or manufacturer or any new drug for sale and distribution shall have a pharmacovigilance system in place for collecting, processing and forwarding the Adverse Drug Reaction reports to the Central Licensing Authority emerging from the use of the new drug imported or manufactured or marketed by the applicant in the country.
The pharmacovigilance system shall be managed by qualified and trained personnel and the officer-in-charge of collection and processing of data shall be a trained pharmacist or medical officer in collection and analysis of ADR reports.
"Accordingly, you are required to maintain qualified trained personnel and Officer-In-Charge of collection, processing of data and furnishing of PSUR (Periodic Safety Update Reports) as per fifth schedule of NDCT Rules, 2019 as the same may be subject to inspection at any time for verification of compliance," added the DCGI.
The fifth Schedule of the NCDT Rules deals with the post market assessment of new drugs. The Schedule explains that when a new drug is approved for marketing, assessment of safety and efficacy of the drug are generally based on data from a limited number of patients, many studied under the controlled conditions of randomized trials. Often, high risk patients and patients with concomitant illnesses that require use of other drugs are excluded from clinical trials, and long-term treatment data are limited. Moreover, patients in trials are closely monitored for evidence of adverse events.
However, in actual clinical practice, monitoring is less intensive, a broader range of patients are treated (age, co-morbidities, drugs, genetic abnormalities), and events too rare to occur in clinical trials may be observed.
"Therefore, subsequent to approval of a new drug, the drug shall be closely monitored and post marketing assessment of its benefit-risk profile shall be carried out once it is marketed," states the Schedule.
"A person intending to import or manufacture any new drug for sale or distribution shall have a pharmacovigilance system in place for collecting, processing and forwarding the adverse drug reaction report to the Central Licencing Authority emerging from the use of the drug imported or manufactured or marketed by the applicant in the country. The pharmacovigilance system shall be managed by qualified and trained personnel and the officer in-charge of collection and processing of data shall be a medical officer or a pharmacist trained in collection and analysis of adverse drug reaction reports," it says.
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