Bitter pills

Indiscriminate sale of illegal medications in India has become a global concern. India is believed to be the ‘pharmacy of the world’ due to its large pharmaceutical industry. While it has among the highest per capita sales of antibiotics globally, it also has the high levels of antimicrobial resistance.

To give the slips to the monitoring agencies, the pharmaceutical companies have derived a hoodwinking way: They have started manufacturing single pills – combining huge volume of anti-microbial drugs. And, most of these fixed-dose combination (FDC) formulations are thriving in drug industry, despite not being approved by the drug regulatory authorities. It may be noted that antibiotic resistance is a global crisis, threatening to reverse the astonishing health benefits achieved with antibiotics.

As bacteria acclimatise to survive, effective treatments, even for common infections, are drastically fading away. However, the more unfortunate thing is that the new antibiotics in development have yet not offered any realistic prospects for treating the infections caused by resistant bacteria – right from common kidney and chest infections to sepsis and meningitis.

Alarmed with the encounter of the limited power of antibiotics we have – against the disease-causing bacteria, the World Health Organization (WHO) had adopted a major policy change for rational use of antibiotics. It has already revised its list of essential medicines, classifying antibiotics into three categories with recommendations on when each category should be used in common bacterial infections, like the chest or kidney infections, excluding tuberculosis and viral infections as HIV.

On the other hand, despite the sale of unapproved new medicines is illegal in India, the drug regulating authorities are yet to make their stand clear on those 75 formulations. Surprisingly, those 75 formulations belong to the ‘reserve group’ antibiotics’ list of WHO, which should only be used as a last resort when all alternatives have failed.

And, the WHO categorically cautioned that these drugs should be ‘protected and prioritized’ to preserve their effectiveness.

Though the Indian government has banned some unapproved FDCs, including antibiotic formulations, the bans have been challenged by the industry. Government has no option left than to formulate strict pharmaceutical norms – to tighten the noose against the law-breakers.

         

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