The Drug Controller General of India (DCGI) has issued advisory on rational use of antibiotics for limiting antimicrobial resistance and has asked the stakeholders for strict compliance of the requirements of the Drugs and Cosmetics Act and Rules and raising awareness in the public about the adverse effects of misuse of antibiotics.

Antibiotics resistance is the result of environmental and behavioural causes. Indiscriminate prescription of antibiotics and laxity in enforcement laws are the main causes of antimicrobial resistance. This may be due to injudicious use of antibiotics in hospitals as well as in private practice apart from easy availability of prescription drugs in the country. In this regard it is requested that you may kindly sensitise your members by raising awareness for rational use of antibiotics so as to curb antimicrobial resistance in the interest of patient safety. You may also take up the issue using other platforms of medical sciences to make this national issue of rational use of antibiotics a success, DCGI Dr GN Singh said in his advisory to presidents of Medical Council of India, Pharmacy Council of India, Nursing Council of India and Dental Council of India.  

The DCGI issued a separate advisory to Dr KK Agarwal, president, Indian Medical Association in which he asked him to sensitise the members of the Association to follow a Standard Treatment Guidelines while prescribing the antibiotics to the patients through the wide network of interactions with the members through the audio-visual programmes. He was also requested to take up the issue through other platforms of medical sciences.

As part of overall responsibility for ensuring the safety of public health and limiting development of antimicrobial resistance in the country, the DCGI has been continuously taking steps to curb and control indiscriminate use of antibiotics. In this direction, a separate Schedule H1 under the Drugs and Cosmetics Rules, 1945 was introduced by the CDSCO vide G.S.R 588(E) dated 30.08.2013 containing carbapenem class and III & IV generation of antibiotics along with certain habit forming and Anti-TB drugs for stricter control over these drugs.

Besides, the Drugs and Cosmetics Rules, 1945 were amended vide G.S.R 28(E) dated 17.01.2012 for making it mandatory to mention withdrawal period on the label of veterinary drugs used in food producing animals to ensure that the food stuffs produced from the animals do not exceed the residual limit specified for them. The Ministry of Agriculture also issued a circular to Directors/Commissioners of Animal Husbandry of all States and UT’s requesting the State Governments and Union Territories to advice State veterinarians, feed manufacturers and also the persons involved in the treatment of animals for judicious use of antibiotics and hormones for the treatment of ailing food producing animals.

The Pharmacovigillance Programme of India (PvPI) has been entrusted with the responsibility of collecting, collating and analysing the adverse drug reactions of the medicines manufactured and marketed in India through its 203 Adverse Drug Reaction Monitoring Centres across the country. Besides this the PvPI has vast network of information collecting system with public and private participation to help the drug regulators to take appropriate measures on the matters related to the patient safety. The PvPI through its 203 monitoring centres has been directed to carry out a surveillance programme at its centres in various hospitals to monitor the use of antibiotics, adverse reactions reported and cases of antibiotics resistance reported. They have also been asked to conduct awareness programme on monthly basis on misuse of antibiotics involving physicians, nurses, pharmacists, supply chain personnel as well as members of community.

Apart from all these measures, State Drugs Regulators have been advised vide Notice dated 16.01.2017 for strict compliance of the requirements of the Drugs and Cosmetics Act and Rules made and raising awareness in the public about the adverse effects of misuse of antibiotics. All India Organization of Chemists and Druggists has been directed to play an active role to 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 has also been asked to use their well developed marketing network to discourage the pharmacists in selling of such drugs without prescription.

All the stakeholders have been advised to join hands in optimal use of antibiotics to adhere to the mission of use of medicines appropriately to safeguard rights, safety and well being of the patients.