Regulator directs drug manufacturers to incorporate new recorded adverse effects in leaflets

The Drug Controller General of India (DCGI) has written to all state drug regulators to direct manufacturers of certain antibiotics and anti-psychiatric drugs to include their new recorded adverse effects in the leaflets inside the package to promote patients' safety.

The aim is to make the patients and doctors aware of the new adverse reactions of certain drugs which are prescribed frequently for certain conditions and also to stop indiscriminate use of such medicines, a senior health ministry official said.

The move comes following a report of by the Indian Pharmacopoeia Commission (IPC) which collected and analysed reports of adverse events associated with the use of certain drugs and then based on scientific findings sent recommendation to the Central Drugs Standard Control Organization for regulatory intervention.

"The National Co-ordination Centre or Pharmacovigilance Programme of India, functioning at IPC Ghaziabad, has forwarded their recommendations based on adverse drug reaction (ADR) reports on certain medicinal products with an objective to prescribe information leaflet change from Indian database and promote patient safety," the official said.

The recommendations were then deliberated in the subject expert committee's meeting at CDSCO headquarters which reached a decision that safety warnings mentioning the new side effects of certain drugs should be included in the packages.

According to the letters sent by DCGI, commonly used antibiotic like Cefotaxime, was found to be causing angioedema -- rapid edema, or swelling, of the area beneath the skin or mucosa -- while use of Cefixime leads to rapid development of sterile pustular lesions, fever and leucocytosis.

Ofloxacin, another antibiotic which useful for the treatment of a number of bacterial infections, was found be developing Stevens-Johnson Syndrome, a rare and life-threatening skin reaction.

Quetiapine, an antipsychotic drug used for the treatment of schizophrenia, bipolar disorder, and major depressive disorder was stated to cause urinary incontinence while Sodium valproate primarily used to treat epilepsy, bipolar disorder and to prevent migraine headaches was found to be causing gum hyperplasia -- swelling and bleeding in the gums.

The drug packages already have leaflets mentioning their side effect. But in the letter, the DCGI has asked the drug regulators in the states and Union Territories to direct the manufacturers of these drug formulations under their jurisdiction to incorporate the new recorded adverse drug reactions in the leaflets inside the package, the officials said.