Health Ministry will soon issue the final notification on adding Schedule H1 to the Drugs and Cosmetics (D&C) Act to curb the indiscriminate use of antibiotics, but may tone down the sterner provisions and limit the number of antibiotics in the list.
Thought it is not yet disclosed how many antibiotics will finally be included in the new Schedule H1, it is learnt that the government may notify only 40 drugs, mainly third and fourth generation antibiotics. These will be sold only with stringent conditions like retaining a copy of the prescription by the chemists.
“In order to have more focused provisions for regulating the use of antibiotics, a draft notification has been published for incorporation of the new Schedule H1 containing certain antibiotics, certain habit forming drugs and anti-TB drugs in the said Rules. The drugs included in the Schedule H1 would be required to be labelled with the warning in a box with a red border,” an official said, without going further into the issue.
The box will have the warning: ‘It is dangerous to take this preparation except in accordance with the medical advice. Not to be sold by retail without the prescription of a Registered Medical Practitioner’, the official added.
The government had initially planned to put 91 drugs under the Schedule H1, but it raised strong objections from different sections especially the trading community who expressed apprehensions on losing out business.
The final list may include third and fourth generation antibiotics like imipenem, meropenem, cefaclor, tigecycline and some pain-killers like tramadol. After the notification, the Central Drugs Standard Control Organisation (CDSCO) will take steps to monitor the order and hold surprise inspections in the pharmacies.
The DCGI had already issued a detailed note on the antibiotics and antibiotic resistance for the guidance of the industry, in line with the efforts to rationalise the use of antibiotics.