Question : Antibiotic Resistance

Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:

(a) whether use of old injectable antibiotics with known toxicity to kidneys and indiscriminate use of antibiotics in India is making common infections like Urinary Tract Infections (UTI) deadly;

(b) if so, the details thereof;

(c) whether pharmaceutical companies are focusing less on research for newer broad spectrum antibiotics and also there is a major cause of slowness in drug discovery to fight antibiotic resistance, as it may become useless because bacteria develops resistance;

(d) if so, the measures taken/proposed to be taken by the Government to strengthen the Pharmaceutical R&D to develop new antibiotics; and

(e) the other steps taken by the Government to strictly monitor to regulate over the counter sale and purchase of antibiotics and also to ensure that doctors to prescribe antibiotics as and when necessary?

ANSWER
THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND
FAMILY WELFARE
(SHRI FAGGAN SINGH KULASTE)
(a) & (b): Yes. It is a fact that the indiscriminate use of antibiotics enhances the development of Antimicrobial resistance (AMR) and this makes the treatment difficult and sometimes ineffective and thus making common infections like Urinary Tract Infections (UTI) deadly.

(c): The research and development of new antibiotics was a part of efforts to address the problem of infections in 1960s and 70s. In the past decade, no new antibiotic has been developed globally. Pharmaceutical firms are focusing less on research for newer broad spectrum antibiotics as their shelf life is lesser compared to drugs meant for chronic illnesses like diabetes.

(d): Department of Science & Technology has launched a Biopharma mission for vaccines and biosimilars. However no pharmaceutical company has approached Indian Council of Medical Research for strengthening of R&D of any new molecule.


Further, the Drug (Prices Control) Order, 2013 which was notified on 15.05.2013 by the National Pharmaceuticals Pricing Authority (NPPA) provides price exemption to manufacturers producing certain categories of new drugs so as to incentivize indigenous Research and Development.

(e): Antibiotics are included in Schedule H and H1 to the Drugs & Cosmetics Rules, 1945, and, therefore, cannot be sold in retail except on and in accordance with the prescription of a Registered Medical Practitioner.