Superbug death spurs drug regulator warning

New Delhi: 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.

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.