India Mandates Fresh Safety Warnings For Two Commonly Used Drugs

Last Updated:February 19, 2026, 17:44 IST

India’s drug regulator has ordered updated safety warnings for doxycycline and carbimazole after reviews flagged new adverse effects, aiming to better inform doctors and patients.

India’s apex drug regulatory agency has directed manufacturers to update prescribing information on two commonly used drugs, after review flags new risks, News18 learnt. In a significant patient safety move, Central Drugs Standard Control Organisation (CDSCO) has ordered manufacturers of two widely used medicines — doxycycline and carbimazole — to update their prescribing information to include newly flagged adverse drug reactions.

In two separate letters addressed to all state and union territory licensing authorities, the Drugs Controller General of India (DCGI) has directed that specific side effects be incorporated into the Prescribing Information Leaflets (PILs) and promotional literature of these drugs.

The letters state that for doxycycline, manufacturers must incorporate “CNS Side Effects (Restlessness, Anxiety, Irritability, Nervousness, and Dizziness)" as adverse drug reactions in the caution section of the leaflet.

Similarly, for carbimazole, manufacturers have been asked to include “agranulocytosis" as an adverse drug reaction in the prescribing information.

Agranulocytosis means the body’s infection-fighting cells drop to dangerously low levels, making a person highly vulnerable to infections.

Doxycycline is a commonly prescribed antibiotic used for bacterial infections including respiratory, skin and sexually transmitted infections. Carbimazole is widely used to treat hyperthyroidism.

What does the move mean?

According to the letters written by DCGI Rajeev Singh Raghuvanshi on 17 February, the agency is strengthening safety warnings based on reported side effects.

The regulatory action follows assessment of Adverse Drug Reaction (ADR) reports under India’s Pharmacovigilance Programme.

According to the letter on doxycycline, seen by News18, “The National Coordination Centre for Pharmacovigilance Programme of India (NCC-PvPI), Indian Pharmacopoeia Commission (IPC), Ghaziabad, has forwarded recommendations arising from the assessment of Adverse Drug Reaction (ADR) reports pertaining to Doxycycline formulations…"

It further states that the PvPI “made recommendation to CDSCO to take necessary measures to incorporate ‘CNS Side Effects (Restlessness, Anxiety, Irritability, Nervousness, and Dizziness)’ as an adverse drug reaction in to the Prescribing information leaflet (PIL) of the Doxycycline based medical products marketed in the country."

After review by the Subject Expert Committee (SEC), the letter says the committee recommended that CDSCO should request State Drugs Controllers to direct manufacturers to incorporate the CNS side effects in the PIL.

The office then directed authorities, “Accordingly, you are requested to direct the manufacturers of Doxycycline formulations under your jurisdiction to mention ‘CNS Side Effects (Restlessness, Anxiety, Irritability, Nervousness, and Dizziness)’ as an adverse drug reaction in the caution section of Package insert/Promotional Literature of the drug."

A similar process was followed in the case of carbimazole. The letter, seen by News18, said that ADR reports were assessed and discussed in the 26th Signal Review Panel meeting.

It states that PvPI “made recommendation to CDSCO to take necessary measures to incorporate ‘agranulocytosis’ as an adverse drug reaction into the Prescribing information leaflet (PIL) of the Carbimazole based medical products marketed in the country."

Following review by the Subject Expert Committee on Endocrinology and Metabolism, the regulator directed authorities to ensure compliance. The letter reads: “Accordingly, you are requested to direct the manufacturers of Carbimazole formulations under your jurisdiction to mention ‘agranulocytosis’ as an adverse drug reaction in the Prescribing Information Leaflet (PIL) /Promotional Literature of the drug."

By mandating updates in official prescribing information, the regulator is formalising these risks in drug literature, ensuring doctors are alerted and patients are better informed.

The letters conclude by asking State authorities to intimate action taken, signalling that compliance will be monitored.

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