Violation of guidelines for OTC sale of antibiotics to draw regulatory action- Health Minister

New Delhi: Through a recent written reply, Health Minister Dr Harsh Vardhan has apprised the parliament about the power possessed by the State Licensing Authorities to take action against any violations of the conditions of license including OTC sale of antibiotics against guidelines.

The Minister mentioned the regulatory measures and guidelines to restrict the OTC availability of certain antibiotics adopted by the Government.

Dr Vardhan emphasised that antibiotics are included in Schedule H of the Drugs and Cosmetics Rules, 1945 and are required to be sold in retail only under the prescription of a Registered Medical Practitioner. To further regulate the human consumption and restrict over the counter availability of certain antibiotics, the Drugs & Cosmetics Rules, 1945 were amended in August 2013, incorporating a new Schedule H1 wherein 24 third/fourth generation antimicrobials are covered.

"The supply of these drugs needs to be recorded in a separate register giving name and address of prescriber, patient and name of drugs and quantity supplied. The records shall be maintained for 3 years and be open for inspection. Schedule H1 drugs also have specific labelling requirements," reads the response.

The response further added that the sale and distribution of drugs are regulated under the provisions of the Drugs and Cosmetics Act, 1940 & Rules,1945 made thereunder. License for sale and distribution of drugs are granted by State Licensing Authorities appointed by respective State Government. State Licensing Authorities are empowered to take action against any violations of the conditions of license including over the counter sale against guidelines.

Moreover, queries related to an increase in the resistance to antibiotics during the past three years were raised by Kirit Premjibhai Solanki in Lok Sabha, seeking to know whether the Government has identified the key factors responsible for such rising antibiotic and antimicrobial resistance.

Replying to the same, Dr Vardhan stated that as per a report available in public domain, the Drug Controller General of India has reported that in the year 2015, U.S.A, France and Italy were leading High Income Country (HIC) consumers of antibiotics while India, China and Pakistan were the leading Low and Middle Income Country (LMIC) consumers.

Increase in the resistance to antibiotics like third-generation cephalosporins, fluoroquinolones and carbapenems is observed in the AMR surveillance network of ICMR.

The key factors responsible for such rising antibiotic and antimicrobial resistance as recognised by the Government include high burden of bacterial infections leading to higher use of antibiotics; overuse and misuse of antibiotics in humans and animals; syndromic management of infectious diseases due to poor utilization/access to microbiology labs for culture and antimicrobial sensitivity testing; over the counter availability of antimicrobials; prescribing antimicrobials for viral infections, such as, colds and influenza; use of antimicrobials for animals and fish as growth promoters; inadequate management of pharmaceutical waste; inadequate infection control, sanitary conditions and inappropriate food-handling are the key factors for rising antimicrobial resistance.

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