Adverse drug reactions due to ophthalmic drugs: Reporting system in India.

Abstract

Sir, All new drugs including those for ophthalmic use are approved by Drugs Controller General (India) of Central Drugs Standard Control Organization (CDSCO) as per the schedule Y of Drugs and Cosmetics (D and C) Act 1940 and Rules 1945 thereunder after reviewing its efficacy and safety in Indian population. Even after the approval of new drug, as per schedule Y of the D and C rules, Periodic Safety Update Reports are required to be submitted to CDSCO every 6 months for the first 2 years and for the subsequent 2 years to be submitted annually.[1] Once the drug is introduced in the market, the responsibility to monitor the adverse drug reactions (ADRs) in larger population becomes the obligation of all prescribers as well as the concerned organization. Only a scant amount of ADRs information is available when a drug is introduced in the clinical practice because the investigational drug is exposed in limited subjects and duration. Therefore, there are possibilities of ADRs to occur when the drug has been used in larger population for prolonged periods. Therefore, pharmacovigilance, known as the science and activity relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem, came into existence to monitor ADRs till the life period of a drug.[2] In India, Ministry of Health and Family Welfare (MoHFW), Government of India launched a nationwide Pharmacovigilance Programme of India (PvPI) in the year 2010 to monitor the safety of drugs including for the ophthalmic use. Indian Pharmacopoeia Commission under the MoHFW functions as National Coordination Centre (NCC) for PvPI. NCC identified 150 ADRs monitoring centres (AMCs) across the country to report ADRs to NCC.[3,4] An ADR is response to a drug which is noxious and unintended and which occurs at doses normally used in human for the prophylaxis, diagnosis or treatment of disease, or for the modification of physiological function can be reported to AMC-PvPI. A trained team at AMC collects manages and assesses the report before submitting to NCC. A ADRs reporter (healthcare professionals) who is not a part of AMC can report ADRs with all ophthalmic products whether known or unknown, serious or nonserious, and frequent or rare by filling the suspected ADR reporting form [Fig. 1] and submitted in nearby AMC (available in www.ipc.gov.in). A helpline (1800 180 3024) also is available to provide assistance in ADRs reporting.[3] The obtained information is entered in the database, analyzed, and assessed to identify new signals. This is also used as main source for identifying and reducing the risks associated with the ophthalmic drugs. Figure 1 Suspected adverse drug reaction reporting form; for voluntary reporting of adverse drug reactions by healthcare professionals Submission of ADRs report does not have any legal implication on the reporter and reporter details are maintained confidentially.[5] The provided information used to take regulatory decisions, benefit-risk assessment, updating prescribing information leaflet, and promote rational use of medicines. Therefore, healthcare providers are encouraged to report ADRs if any due to the use of ophthalmic drugs for better understanding their risk and to safeguard the health of Indian population.