NHRC notices to Secretary, Health, DGCI, over sale of unapproved antibiotics

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New Delhi : The National Human Rights Commission (NHRC) has taken suo motu cognizance of a media report that millions of unapproved antibiotics are being sold in India each year posing a threat to the global fight against the spread of drug resistant microbes. The Commission has issued notices to the Secretary, Union Ministry of Health and Family Welfare, and the Drugs Controller General of India (DCGI) for detailed reports in the matter within six weeks.

The authorities are expected to submit their response within the stipulated time along with all the documents including guidelines and circulars etc. issued on the subject and their status of implementation, according to an NHRC release.

According to the media report carried on February 6, 2018, a study published in the British Journal of Clinical Pharmacology reveals that multinational pharmaceutical companies continue to manufacture a large number of unapproved formulations despite the global health crisis of rising antimicrobial resistance. India has been mentioned as having the highest antimicrobial resistance and antibiotic consumption and the parliamentary investigations have highlighted failures of the country’s drug regulatory system.

The Commission has observed that if the contents of the news report and reports of UK based researchers are to be believed, the figures mentioned in the study are alarming and raises the issue of violation of human rights of the consumers/ patients.

The NHRC further observed that the right to medical care and proper diagnosis is a basic human right. The right to take required medicines, approved by the regulatory body, is also a part of human rights. The pharmaceutical companies cannot be allowed to play with the health of the general public. It is for the authorities concerned to verify, whether the irregularities mentioned in the report are still prevalent.  Keeping in view, the grave danger to the human lives, it is obligatory on the part of the Government of India to take immediate corrective measures, though its regulators/ state agencies, to analyze and regulate the mechanism of approval for drugs of all kinds across the country.

While considering the news report, the Commission examined the report of the researchers at Queen Mary University of London and Newcastle University, where it has been observed that the sale of unapproved, unscrutinised Fixed Dose Combination ( FDC) antibiotics undermine the measures to control antimicrobial resistance. A starting point would be a Government ban on the manufacture and sale of unapproved antibiotic formulations, commencing with dual antimicrobial FDC. Marketing of Centrally unapproved formulations of new drugs is illegal.

The Queen Mary University, London, which has conducted the study, has examined the availability of antibiotics and their status of approval in India. The researchers analyzed the regulatory records of the antibiotics as well as sales data from 2007 to 2012. It was found that there were 118 different formulations of FDCs being sold in India between 2007 to 2012 compared to five in the UK and US.