NHRC notice to Centre, DCGI over study on antibiotics sale

The NHRC has issued notice to the Centre and the drug-control authority over a study, which claimed that millions of unapproved antibiotics were being sold in India each year, posing a threat to the global fight against the spread of drug-resistant microbes.
According to the study published in the British Journal of Clinical Pharmacology, multi-national pharmaceutical companies continue to manufacture drugs using dozens of unapproved formulations, despite the global health crisis of rising antimicrobial resistance.
The National Human Rights Commission (NHRC) today said it had taken suo motu cognisance of the findings of the study, published by the media.
The NHRC has issued notices to the Secretary, Union Ministry of Health and Family Welfare, and the Drugs Controller General of India (DCGI) and sought detailed reports in this regard in 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 the status of their implementation," the right panels said in a statement.
According to the researchers, India has one of the highest rates globally of antimicrobial resistance and antibiotic consumption and parliamentary investigations have highlighted the failures of the country's drug regulatory system in this regard.

"The total antibiotics sales increased by 26 per cent, from 2,056 million-units (2007-08) to 2,583 million-units (2011-12)," according to the study.
"Selling unapproved, unscrutinised antibiotics undermine the measures in India to control antimicrobial resistance," the lead author of the study, Patricia McGettigan of the Queen Mary University in London, said.

The NHRC has observed that if the content of the news reports and the UK-based researchers are to be believed, "the figures mentioned in the study are alarming".
To examine the availability of antibiotics and their approval status in India, the researchers analysed the regulatory records of antibiotics as well as sales data from 2007 to 2012.
The analysis included information on fixed-dose combination (FDC) antibiotics and single-drug formulation (SDF) antibiotics in the Indian markets.
According to the study, 118 different formulations of FDCs were sold in India between 2007 and 2012, compared to five in the UK and the US.

Of these 118 formulations, 64 per cent 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, according to the study.
In contrast to the FDCs, 93 per cent of the 86 SDF antibiotics in the Indian market had regulatory approval.
The 118 FDC formulations gave rise to 3,307 branded medicines made by 476 pharmaceutical manufacturers, including a dozen multi-national companies. The multi-national companies manufactured drugs using 53 of the 118 FDC formulations.