Health ministry issues alert against widely used antibiotic tetracycline
The Indian Pharmacopoeia Commission (IPC), a division of the health ministry, has issued an alert about the potential adverse reactions of Tetracycline. This antibiotic is commonly used to treat various infections such as typhus, tick fever, respiratory infections, cholera and malaria. The IPC's warning highlights that Tetracycline can cause skin reactions which could become life-threatening if not promptly treated.
Tetracycline linked to adverse drug reactions
The IPC's alert is based on an analysis of Adverse Drug Reactions (ADRs) from the Pharmacovigilance Programme of India (PvPI) database. The analysis revealed that Tetracycline, used for treating various infections including Rocky Mountain spotted fever and respiratory tract infections, has been causing an adverse drug reaction known as Fixed Drug Eruption (FDE). The commission has urged both doctors and patients to closely monitor for any signs of this ADR associated with Tetracycline use.
India's antibiotic consumption and regulatory actions
India is currently the world's largest consumer of antibiotics, with the anti-infective segment's market size reaching approximately ₹25,130 crore for fiscal year 2024 as per CRISIL Market Intelligence and Analytics. The IPC plays a crucial role in monitoring adverse drug reactions among Indians and assisting the Central Drugs Standard Control Organization (CDSCO) in making regulatory decisions for safe medicine use.
DCGI's directive and proposed regulation on antibiotic usage
In May, the Drugs Controller General of India (DCGI) Rajeev Raghuvanshi directed state licensing authorities to monitor the availability of unapproved antibiotic combinations in the market. This directive was issued due to concerns about excessive and irrational use of antibiotics in India, which can lead to drug resistance. Additionally, a proposal is currently being considered by the Centre to regulate antibiotic usage under the Drugs and Cosmetic Act, 1940.
