CDSCO to place 91 drugs under Schedule H1 to rationalise use of antibiotics

Joseph Alexander, New DelhiThursday, December 6, 2012, 08:00 Hrs  [IST]

With a view to encourage rational prescribing of antimicrobials and minimise the development of resistance to antimicrobials in India, the Central Drugs Standard Control Organisation (CDSCO) has issued a detailed note on the antibiotics and antibiotic resistance for the guidance of the industry.

The move is viewed as part of the efforts by the Health Ministry to rationalise use of antibiotics by bringing certain number of drugs under schedule H1 to ban the over-the-counter sales. The Government already had drafted the rules for amending the Drugs and Cosmetics Rules, 1945, for insertion of a new Schedule H1 containing 91 drugs.

“Antibiotics should be used only when they improve patient outcome. Not all infections need anti-biotic treatment. For instance, in patients with sore throat, benefit from antimicrobial therapy is small and is counterbalanced by the risk of adverse events like rash. Narrow spectrum agents should be used whenever possible. Broad spectrum agents should not be used as a cover for lack of diagnostic precision,” the write-up by the CDSCO said.

“Antibiotics should be prescribed in optimal doses, regimens, and should be stopped when the infection is treated. Restrict the use of last line antibiotics for serious infections and only when simpler agents are likely to be ineffective. Whenever used for prophylaxis, antibiotics should be used for short courses and at appropriate times (e.g. during surgical prophylaxis, antibiotics should be given within an hour prior to incision),” it said.

On the prevention of infection, the document said the use of antimicrobials can also be reduced if infections are prevented in the first place. This can be achieved by improved use of vaccines and improved hygiene and infection control practices like compliance with hand washing protocols and aseptic techniques for catheterisation. Catheters and drains should be removed when no longer needed.

“Clinicians should be familiar with local antibiotic sensitivity profiles and should comply with the local antibiotic guidelines. A hospital antibiotic policy should be formulated based on local antimicrobial resistance data. Prescribers should be educated about the use of antibiotics, when not to use them and also the infection control strategies. Hospitals should carry out surveillance of resistance patterns-- how much, where, in which organisms and to what antibiotics. Similarly antibiotic use pattern can be studied and these data can be used to devise targeted interventions to minimise antimicrobial use,” the document said.