Mumbai-Based Lawyer Files PIL Against Drug Regulators For Unregulated Sale Of Prescription Medicines

Mumbai-Based Lawyer Files PIL Against Drug Regulators For Unregulated Sale Of Prescription Medicines

Mumbai, 23 Oct 2018: A city-based lawyer Bharat Kothari has filed a PIL in Bombay High Court against Union of India, Government of Maharashtra, Central Drugs Standard Control Organisation (CDSCO) and the Drug Controller General of India (DCGI) to address the issue of unchecked sales of high potency antibiotics without prescriptions. 


Citing the harmful effects of availability of antibiotics without prescription, the writ petition is meant to seek control the medicines in categories H and H1, sold without prescriptions.


The PIL outlines unchecked sale, consumption of antibiotics as an OTC product, drug resistance and impact on disease control measures, increased pressure on cost of healthcare, insurance research and unchecked access of H, H1 category of antibiotics.


The petition is a result of a survey conducted across 500 pharmacies. 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. 


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 CDSCO, even though the sale of unapproved new drugs is illegal in India. In contrast to FDCs, 93 per cent of 86 single drug formulation (SDF) antibiotics of 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 high time that there should be a system in place to not only control these irregularities effectively but severe punishment to be levied against such defaulters,” said an activist from 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 to the antibiotics and other high potency drugs and to 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. Pharmabiz