The Health Ministry is planning to make the post- marketing surveillance of drugs mandatory for six years, instead of the current practice of four years,under Schedule Y provisions of the Drugs and Cosmetic (D&C) Rules. The move comes in accordance with the recommendations by the Prof Ranjit Roy Chaudhury expert committee.
Among several recommendations to streamline the clinical trials sector, the panel had suggested creation of a detailed protocol to monitor and record the side- effects and efficacy of the drugs.The focus of a PMS study should be to monitor hitherto-identified risks, potential risks and missing information, the panel said.
The PMS should include spontaneous/voluntary reporting including reporting from scientific literature, publications or meetings,voluntary or required reporting from observational studies and randomized clinical trials, drug-induced injury, detection of events not seen in clinical trials such as new, previously unknown adverse events or new drug interactions, and any observed increase either in quantity or severity of a known adverse event, according to the panel.
The expert panel report had mentioned that observations on adverse effects, serious adverse effects and benefits seen by the clinician or health personnel during or after treatment with a new drug or biological after marketing of the drug and thereafter for a period of five or six years are carefully recorded as per protocol by the treating clinician. These observations can also be reported by the patient or community to the treating clinician, who would then record and report the same directly to the DCGI and pharmaceutical company in case of AEs and SAEs. The pharmaceutical company will be required to make detailed records of the patient and report to the DCGI as per the laid-down protocol. Special attention would be required to pay towards recording of expected SAEs and occurrence of unexpected SAEs not listed on the package insert such as death, disability or any events or signs and symptoms which could possibly lead to death or disability or hospitalisation for treatment. Such events should be immediately reported to the ethics committee, DCGI and the pharmaceutical company.