PIL questions unchecked antibiotics saleDecember 13, 2018
A public interest litigation (PIL) has been registered in Bombay High Court demanding action to address unchecked sales of high potency antibiotics without prescriptions. It was filed by a city-based lawyer against the Union of India, Government of Maharashtra, Central Drugs Standard Control and the Drug Controller.
The PIL outlined mainly four aspects, including the unchecked sale and consumption of antibiotics as an OTC product, drug resistance and the impact on disease-control measures, increased cost of healthcare, insurance and research, and the unchecked sale and access to H and H1 category antibiotics.
The petition, filed by Bharat Kothari, a Mumbai-based lawyer, followed findings of a survey conducted across 500 pharmacies in Maharashtra.
In the survey, Bharat Sarge, an activist, discovered that antibiotics belonging to H and H1 categories were freely available across pharmacies. Listing the critical issues that surfaced due to unchecked consumption of high-potency antibiotics, such as serious drug resistance among infectious diseases and unauthorised sale, the lawyer felt there was great merit in a PIL.
According to Kothari, over 118 different antibiotic formulations are sold in India. Out of such a large number of antibiotic formulations — as against just five in the United Kingdom and the US — 64% are apparently not approved by the national drug regulator, the Central Drugs Standard Control Organisation. Presently, India is the largest consumer of antibiotics in the world, he added.
“Temporary suspension of licenses of local pharmacies have failed to control rising concerns and medicines continue to be dispensed irresponsibly by shop owners. It’s about time there is a system in place to control these irregularities effectively, and severe punishment should be levied against such defaulters,” says Bharat Serge of Venkateshwar Seva Sanstha, which conducted the survey.
The petition has outlined citizens’ rights to health, stated to have been compromised due to the indiscriminate OTC sale and unchecked use of prescription medication. It draws attention to the duty of the state to assess and monitor any dependency or addiction to antibiotics and other high-potency drugs and ensure that there is no damage to the consumers’ health by uncontrolled, unchecked self-medication.
Since it has been a strategic goal of WHO and many countries to limit antimicrobial resistance, most countries are taking brisk measures to prevent production and sale of illegal and unapproved medication.