Mumbai based lawyer files PIL against drug regulators, draws attention to unchecked sale without prescription

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Mumbai, October 22, 2018: A PIL has been registered in Mumbai High Court by a city-based lawyer against the Union of India, Government of Maharashtra, Central Drugs Standard Control, the Drug Controller. The PIL demands action to address unchecked sales of high potency antibiotics without prescriptions as OTC products.
The PIL outlines
1)      Unchecked sale, consumption of antibiotics as an OTC product
2)      Drug resistance and impact on disease control measures
3)      Increased pressure on cost of healthcare, insurance and research
4)      Unchecked sale and access of H and H1 category of antibiotics
A writ petition has been filed by Bharat Kothari, a Mumbai based lawyer, to seek control on the over-the-counter (OTC) medicines in categories H and H1, sold without prescriptions. Citing the harmful effects of such freely available antibiotics, Kothari found it was a matter of concern.
The petition was a result of a survey conducted across 500 pharmacies. Bharat Sarge, an activist discovered that antibiotics in the range of H and H1 were freely available among other OTC products across pharmacies. Listing the critical issues that surfaced due to unchecked consumption of high potency antibiotics such as serious drug resistances among infectious deceases and unauthorised sale, the lawyer believed there was great merit in a PIL.
Kothari cites, “over 118 different formulations of FDCs were being sold in India, with just 5 in the United Kingdom and the United States. Of these 118 formulations, 64 percent were not approved by the national drugs regulator, the Central Drugs Standard Control Organisation, even though the sale of unapproved new drugs is illegal in India. In contrast to FDCs, 93% of 86 SDF antibiotics on the market in India had regulatory approval. Presently, India is the largest consumer of antibiotics in world.”
“Temporary suspension of licenses of local pharmacies have failed to control the rising concerns and medicines are continued to be dispensed irresponsibly by shop owners. It’s about time there is a system in place not only to control these irregularities effectively but severe punishment should levied against such defaulters”, said Mr. Bharat Serge of Venkateshwar Seva Sanstha.
The petition has outlined citizens’ rights to health, stated to have been compromised due to 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 addicted to the antibiotics and other high potency drugs and ensure that there is no damage to the consumer’s health by use of uncontrolled, unchecked self-medication.
It has been a strategic goal of WHO and many countries to limit antimicrobial resistance. Most countries are taking brisk measures to prevent the production and sale of illegal and unapproved medication, which is critical in case of OTC pharmacies. Clearly this petition is an effort to draw both attention and action against misuse of high potency drugs.