A study published recently says that 64% of fixed dose combination antibiotics sold in India are unapproved by drug regulators.

More microbes drug resistant thanks to unapproved medicine sales in IndiaImage for representation
Health Medicine Tuesday, February 06, 2018 - 16:23

Did you know that a vast majority of the antibiotics and drugs you are taking when sick were actually not certified by authorities?

A recent study published in the British Journal of Clinical Pharmacology has some troubling news about India’s drug quality control.

The study was conducted by researchers from Queen Mary University in London, Newcastle University and Lakshya Society for Public Health Education and Research in Pune. It found that extensive use unapproved of fixed dose combination (FDC) antibiotics is contributing to the rising rate of antimicrobial resistance (AMR) in India, which is already one of the highest in the world.

Why we should worry about AMR

The study defines FDCs as “formulations comprised of two or more drugs combined in a fixed ratio of doses and available in a single dosage form.”

AMR, which is an acknowledged global crisis, is defined by the World Health Organisation as “the ability of a microorganism (like bacteria, viruses, and some parasites) to stop an antimicrobial (such as antibiotics, antivirals and antimalarials) from working against it. As a result, standard treatments become ineffective, infections persist and may spread to others.”

AMR can affect everyone, because it creates organisms which are resistant to drugs, making the disease they cause harder to treat. Drug resistance is a natural evolutionary phenomenon, the WHO says, and the resistant microorganisms can pass on the resistance to their progeny. Inappropriate use – whether underuse, misuse or overuse - of antibiotics aids drug resistance.

A majority of FDCs sold in India are unapproved

The researchers used data from regulatory records in India, the UK and the US from 2007 to 2012 to ascertain “the approval status in each country of systemic antibiotic FDC and single drug formulations (SDFs) marketed in India.”

The records from India were taken from PharmaTrac, a commercial database recording pharmaceutical sales. The audits by PharmaTrac captured 35% of total sales in the country and were projected to estimate the national sales.

The findings painted a troubling picture.

Out of the 118 FDC formulations of antibiotics being sold in India, only 43 (36%) were approved by Central Drugs Standard Control Organisation (CDSCO), the national body for regulating drugs.

A shocking 75 formulations (64%) had no certification of regulatory approval. Five of these formulations were approved in the UK and/or the US.

“Almost half of formulations (58/118,49%) comprised dual antimicrobials, most unapproved in India (43/58,74%), and many pharmacologically problematic. In contrast, 80/86(93%) SDFs were approved in India and over two-thirds in the UK and/or US,” the study adds.

Multinationals selling drugs without approval

The 118 FDC formulations were being sold by 3307 brand names and manufactured by 476 entities. Of these, 464 were Indian manufactures, and 12 were MNCs.

These 12 MNCs were found to be making 53 (45%) FDC formulations in 148 brand names - Abbott, Astra Zeneca, Baxter, Bayer, Eli Lilly, GlaxoSmithKline (GSK), Merck/MSD, Novartis, Pfizer, Sanofi-Aventis, and Wyeth.

However, only 33 (62%) of these were CDSCO-approved. While most MNCs were found to be making between one and three unapproved formulations, Abott was found to be making 18 formulations that didn’t have CDSCO approval.

“In contrast to FDCs, most MNC-manufactured SDF formulations were CDSCO-approved and over 70% had UK/US regulatory approval,” researchers found.


Marketing drugs that are not centrally approved is illegal in India. Even so, “Unapproved FDC formulations comprised more than one-third of the FDC sales annually in India”, the study found.

Researchers recommended that the government ban the manufacture and sale of unapproved antibiotic formulations, starting with dual antimicrobial FDCs (those which have two antibiotic components). They contend that this way, patients won’t be deprived of the medication they need because CDSCO-approved SDFs are available.

As for MNCs, a justification for selling unapproved drugs should be required of them.

It also recommends work on understanding why unapproved formulations are being prescribed by medical professionals.