Superbug death spurs drug regulator warning (Kevin Shine/Getty Images)Superbug death spurs drug regulator warning (Kevin Shine/Getty Images)
In the wake of the recent death of an American woman after contracting an infection resistant to antibiotics, the drug regulator has directed the pharma supply chain, including retailers, chemists and drug makers, to strictly follow norms while selling antibiotics.

The Drugs Controller General of India (DCGI) has also asked companies to carry specified warnings to avoid antimicrobial resistance. “To contain anti-microbial resistance, the office has been advising the supply chain system in India to follow strict requirements of Schedule H and H1 for sale of medicines,” DCGI G N Singh said in a notice issued to all state regulators and other stakeholders.

The Centre has also asked state drug regulators to take “strong policy measures including stringent regulatory action on the over-the-counter (without prescription) sale of high-end antibiotics”.

An American woman, who contracted an infection while being treated for a thigh bone fracture in India two years ago, died recently. CDC Atlanta, which houses one of world’s most advanced laboratories, conducted tests on the wound specimen later and confirmed the presence of New Delhi Metallo-Beta-Lactamase (NDM) – a superbug that makes bacteria resistant to antibiotics. The incident has triggered a lot of concerns among health experts. Though antibiotic resistance is a global public health threat, misuse of antibiotics is rampant in India. According to a 2016 report in international journal PLOS, the infectious disease mortality rate in India is 416.75 per 100,000 persons and is twice the rate prevailing in the United States when antibiotics were introduced.

Experts blame poor public health systems, hospital infection, high rates of infectious disease, inexpensive antibiotics, and rising incomes for the increasing prevalence of resistant pathogens. Antimicrobial resistance has resulted in striking rise in the burden of untreatable neonatal sepsis and health-care-associated infections. To check irrational use of antibiotics, the government has already introduced a ‘red line’ differentiating high end antibiotics from other drugs. The move is aimed at discouraging unnecessary prescription and over-the-counter sale of antibiotics causing drug resistance for several critical diseases including TB, malaria, urinary tract infection and even HIV.

High-end antibiotics are used for critical diseases and in serious infection cases. These also include some new and innovative medicines used in cancer treatments. However, misuse of such antibiotics for common health conditions help bacteria develop resistance.

The government is running campaigns against irrational prescriptions and over the counter sale of antibiotics. The World Health Organisation has also created pressure on India seeking urgent and concrete measures to arrest the reducing effectiveness of antibiotics. It has cautioned the government and public health experts that if enough was not done now, common bacterial infections such as skin sores or diaorrhea would become untreatable and fatal