Unregulated sale of prescription medicines: PIL in HC against drug regulators

New Delhi: A Public Interest Litigation (PIL) was filed in Bombay High court by Mumbai based lawyer Bharat Kothari against the Government of Maharastra, Union of India and its various organisations including the Central Drugs Standard Control Organisation (CDSCO) and the Drug Controller General of India (DCGI) over the unauthorised sale of medicines without the prescription.

The PIL particularly pointed out the authorized sale of antibiotics which can only be sold on prescription.

The PIL alleged that antibiotic H and H1 were freely available among other OTC product in the surveyed pharmacies.

According to the plea, the provisions of Drugs and Cosmetics Act 1940, and Drugs and Cosmetics Rules 1945, prohibit online sale of medicines that mandatorily require a doctor’s prescription.

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

Schedule H :

The drugs under schedule H can be sold only based on the prescription of a registered medical practitioner and only the amount specified in the prescription should be sold. It can be supplied only to licenced parties. These drugs should be labelled with the symbol ‘Rx’ and conspicuously displayed on the left top corner of the label

Schedule H1 :

Drugs in schedule H1 was included in 2013 to check the indiscriminate use of antibiotics, anti-TB and some other drugs in the country. These drugs cannot be sold without a valid prescription. The package of the drugs will have a mandatory warning printed in a box with red colour border. The chemist should maintain the list of the customer names and details of the doctor who prescribed it. The list should be maintained with 3 years of data.