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An expert panel, that advises the central drug regulator on new drug approvals and clinical trials among others, has recommended to the Central Drugs Standard Control Organisation (CDSCO) to take steps to include occurrence of Fixed Drug Eruption (FDE) associated to two drugs - paracetamol and piroxicam - in the Prescription Information Leaflet (PIL).
The advice follows a recommendation from a panel under the Pharmacovigilance Programme of India (PvPI), of Indian Pharmacopoeia Commission (IPC).
The Subject Expert Committee (SEC) for Analgesic and Rheumatology related matters, in its recent meeting has looked into recommendations submitted by the Signal Review Panel (SRP), PvPI, related to the chances of FDE associated with Paracetamol, an analgesic that also helps to reduce fever.
The SEC, after considering the recommendation, suggested that "CDSCO should request the State Drugs Controllers to instruct the manufacturers of the drug to incorporate Paracetamol associated Fixed Drug Eruption (FDE) in the PIL (Prescribing Information Leaflet) of the drug marketed in the country."
A similar recommendation from the SRP has been considered on Piroxicam, a nonsteroidal anti-inflammatory drug to address the pain and swelling related to arthritis.
The Committee recommended that the CDSCO should request the state drug regulators to instruct the manufacturers of the drug to incorporate Piroxicam associated FDE in the PIL of the drug marketed in the country.
A FDE is an adverse drug reaction in which recurrent lesions occur in the same site of skin every time after a particular drug is consumed.
The 22nd SRP recommendations, issued by the panel after its meeting on November 22, 2022, advised inclusion of signal on FDE in the PIL for both paracetamol and piroxicam. The panel also recommended to include the adverse reaction of muscle spasm to the PIL of Losartan during the meeting.
Earlier, various SECs has recommended similar actions to the CDSCO regarding Cephalosporin (for the adverse drug reaction of FDE), Minoxidil (for folliculitis), Tigecycline (for Coagulopathy), Olanzapine (for hyponatremia), Haloperidol (for Cogwheel rigidity), and Remdesivier (for Sinus bradycardia) based on the recommendations of SRP following its meeting on March, 2022.
The SRP is the panel of experts from the medical and regulatory fields and institutions which assess the database of the occurrence of signals of possible importance for public health, drug regulation and science, based on the data available with the PvPI on the reported possible relationship between an adverse event and a drug and recommends the drug regulator regarding the action it should carry out.
According to IPC, the signal, which is based on more than one report of adverse event, is a hypothesis together with data and arguments and it is not only uncertain, but also preliminary in nature with the possibility of the signal changing substantially over time one way or another.
The identified signals are thus varying levels of suspicions derived from examination of data in the PvPI database. Signal contains different hypotheses, primarily intended to inform national regulatory authorities, which may in turn consider the needs for possible further action (for instance further evaluation of source data, or a study for the testing of a hypothesis), said IPC.
"Central Drugs Standard Control Organisation and Indian Pharmacopoeia Commission are responsible for deciding further action including communicating the information in signal to relevant health professionals, and to the responsible market authorization holders, within their jurisdictions," it said in a document earlier.
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