The Central Drugs Standard Control Organisation(CDSCO) on 23rd December 2019 has issued a notification advising the Stakeholders to take steps in rational use of antibiotics to adhere to the mission of use of medicines appropriately to safe guard the rights, safety and well-being of the patients.
Earlier, the Ministry of health and family welfare in consultation with various stakeholders developed and released National Action Plan on AMR (“NAP- AMR) which outlines the priorities and interventions planned which address the use of and resistance to antimicrobial agents in human health, agriculture, food products and the environment.
Details of the Regulatory steps are as follows:
- The Antibiotics which are included in Schedule H and H1 of the Drug and Cosmetics Rules, 1945 are required to be sold by retail only under prescription of a Registered Medical Practitioner.
- Mentioning the withdrawal period on the label of veterinary drugs used in food producing animals.
- Prohibition on manufacturing, selling and distributing Colistin and its formulations for food producing animals, poultry, aqua farming and animal feed supplements.
- Various notices and advisories issued to state drug regulators for strict compliance of the Drug and Cosmetic Act and Rules.
Further CDSCO advises the stakeholders to take the following steps:
All State & UT Drugs Controllers should sensitize their enforcement officials to keep strong vigil to ensure that such drugs are not sold without prescription and All India Organisation of Chemists and Druggists should educate their members to follow the conditions of licence for sale of drugs strictly and co-operate with regulatory authorities to prevent such sale of drugs.
The Pharma Industry should use their well-developed marketing network to discourage the pharmacists in selling of such drugs without prescription.
Click here to read the Notification.
