The Central Drugs Standard Control Organisation(“CDSCO”) has, through an Advisory dated 23rd December 2019, advised 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.
As we know that Antimicrobial Resistance (“AMR”) is a serious threat to public health and the spread of multi-drug resistant bacteria along with the lack of new antibiotics to treat infections caused by these organisms pose a rapidly increasing threat to human health which urgently needs to be tackled.
Earlier, the Ministry of Health and Family Welfare (“Ministry”) has, in consultation with various stakeholders developed and released National Action Plan on AMR (“NAP- AMR) which outlines the priorities and interventions planned to address the use of and resistance to antimicrobial agents in human health, agriculture, food products and the environment.
The Ministry along with CDSCO has been continuously taking certain regulatory steps in rational use of antibiotics to adhere to the mission of use of medicines appropriately. Some of the steps are:
- Inclusion of Antibiotics in Schedule H and H1 of the Drug and Cosmetics Rules, 1945 and 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 Colistin and its formulations from manufacturing, selling, distributing for food producing animals, poultry, aqua farming and animal feed supplements.
- Strict compliance of the Drug and Cosmetic Act and Rules.
Now, to curb and control the indiscriminate use of antibiotics and to safe guard the rights, safety and well-being of the patients, the 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.
- 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.
Source: Central Drugs Standard Control Organisation
