...Asks for strict monitoring on sale of schedule H and H1 drugs sale without prescription, and also directs pharmacies, consumer bodies to adhere to laws related to medicine
In reaction to the reports of death of a 70-year-old woman from US, who allegedly contracted New Delhi metallo-beta-lactamase (NDM-1) strain infection — superbug from India — a drug control department has alerted the States to strictly keep a check on sale of antibiotics without prescription.
The Central Drugs Standards Control Organization (CDSCO) under Ministry of Health and Family Welfare has also directed pharmaceutical companies and consumer associations to strictly adhere to laws and regulations regarding sale of medicines in India and spread awareness about hazards of antibiotic abuse.
“To contain anti-microbial resistance, we have been advising the supply chain system in India to follow strict requirements of Schedule H and H1 for sale of medicines,” said Dr GN Singh, Drugs Controller General of India in his letter to all the Drugs Controllers of the State and Union Territories, Pharmaceutical companies and Consumer Associations.
“Stakeholders have been advised for strict compliance of the requirement of the Drugs & Cosmetics Act and Rules made thereunder by taking strong policy measures including stringent regulatory action on the over the counter (without prescription) sale of high end antibiotics included in the above Schedules,” said Dr Singh. “The law may also be complied by raising awareness through consumer associations about the side effects of taking antibiotics without prescription, so that the antibiotic microbial resistance could be avoided for patient safety, their well-being and protection of their health,” he said.
Antimicrobial resistance is closely linked to inappropriate antibiotic use. It is estimated that 50 per cent or more of hospital antimicrobial use is inappropriate in India. Published reports in India reveal an increasing trend of drug resistance in common diseases of public health importance. It has been reported that cholera is now showing high level of resistance to commonly used antimicrobials like Furazolidone (60-80 per cent), Cotriamoxazole (60-80per cent) and Nalidixic Acid (80-90per cent). Resistance is also seen in Meningococcal infections, malaria, leprosy, kala-azar, TB, Enteric fever, Meningococcal infections, Gonococcal infections and HIV.
In wake of increasing antibiotic resistance across the globe, the National Centre for Disease Control (NCDC) also set to formulate a National Action Plan to curb it. NCDC said it would soon submit the plan to Union Health Ministry for incorporating it into the national policy.
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