Drugs Controller General of India (DCGI) has directed state drug controllers (DCs) to help manufacturers implement incorporation of Stevens-Johnson syndrome (SJS) as an adverse drug reaction (ADR) into the prescribing information leaflet (PIL) of the Chloroquine drug marketed in the country.
SJS is a rare and serious disorder of skin and mucous membranes. It’s usually a reaction to a medication or an infection. It begins with flu-like symptoms followed by a painful red or purplish rash that spreads and blisters. It is a medical emergency that usually requires hospitalization.
Recovery after SJS can take weeks to months depending on the severity of condition
Chloroquine phosphate is in a class of drugs called antimalarials and amebicides is used to prevent and treat malaria.
Indian Pharmacopoeia Commission (IPC) had earlier recommended Central Drugs Standard Control Organization (CDSCO) to notify SJS or Toxic Epidermal Necrolysis (TEN) in package insert as ADR to drug Chloroquine based on a CDSCO constituted Subject Expert Committee (SEC) review and findings.
Based on the findings, experts recommended SJS or TEN to be incorporated in package insert as ADR to drug Chloroquine with an objective to detect signal or PIL change from Indian database and promote patient safety.
After detailed review and recommendations, Pharmacovigilance Programme of India (PvPI) on the basis of Individual Case Study Reports (ICSR) had also recommended CDSCO to take necessary steps to incorporate SJS or TEN as an ADR in to the PIL of the Chloroquine marketed in the country.
PvPI was launched with an objective to safe guard the health of people of India. ADRs are reported from all over the country to NCC-PvPI, which also work in collaboration with the global ADR monitoring centre (WHO-UMC), Sweden to contribute in the global ADRs data base.
IPC under the union health ministry has been functioning as the National Coordination Centre (NCC) for PvPI since April 2011.
NCC-PvPI monitors the ADRs among Indian population and helps CDSCO in taking decision for safe use of medicines.
“Accordingly, you are requested to direct the manufacturers of Chloroquine formulations under your jurisdiction to mention Stevens-Johnson Syndrome (SJS) or Toxic Epidermal Necrolysis (TEN) as an adverse drug reaction in the Package insert or Promotional Literature of the drug. Action taken in this regard may be intimated to DCGI office,” as per the DCGI alert notice to the state DCs.
IPC Ghaziabad had forwarded their recommendation based on ADR reports on certain medicinal products including Chloroquine which were discussed in the 15th Signal Review Panel (SRP) under the programme meeting held on September 19, 2019.
Subsequently, the PvPI recommendations were deliberated in the (SEC-Antimicrobial and Antiviral) meet held on October 30, 2019 at CDSCO headquarters in New Delhi.