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DCGI issued circular to rationalizing the use of antibiotics for limiting antimicrobial resistance

 

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Antibiotic resistance is the result of environmental and behavioral causes. Indiscriminate antibiotic prescribing and lax enforcement laws are the main causes of antimicrobial resistance. This may be due to reckless use of antibiotics in hospitals as well as in private practice outside the easy availability of prescription drugs in the country.

The Drug Controller General of India (DCGI) issued an opinion on the rational use of antibiotics to limit antimicrobial resistance and called on stakeholders to strictly comply with the requirements of the Drugs and Cosmetics Act and Rules and educate the public about the undesirable effects of antibiotics abuse.

As part of the overall responsibility for ensuring public health safety and limiting the development of antimicrobial resistance in the country, the CDSCO has consistently taken steps to curb and control the indiscriminate use of antibiotics

In this regard, DCGI Dr. GN Singh said in his opinion to the Presidents of the Medical Council of India , Pharmacy Council of India, Nursing Council of India and Dental Council of India  that you all are  requested to educate your members by raising awareness of the rational use of antibiotics in order to reduce antimicrobial resistance in the interest of patient safety. You can also take the question using other medical science platforms to make this national problem of the rational use of antibiotics a success.

DCGI issued a separate notice to Dr K.K. Agarwal President of the Indian Medical Association was asked to educate its members to follow the standard treatment guidelines while prescribing antibiotics. He was also invited to sensitize its members through its extensive network of interactions through audiovisual programs. He was also invited to address the issue by other medical science platforms.

 

Different steps taken by CDSCO in this direction such as 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.

In addition,  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.

Beside this the Ministry of Agriculture also issued a notice 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.

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.

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.

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