Adulterated Drugs On Decline Amid Crackdown

Rise in raids on illicit drug manufacturing units, alongside arrests for the production, sale, or distribution of spurious or adulterated drugs.

Photograph: Yves Herman/Reuters

The percentage of non-standard quality (NSQ) drugs in tested samples has been steadily declining, pointing to improvements in quality assurance.

Simultaneously, efforts to crack down on spurious medicines are intensifying, with a rise in raids on illicit drug manufacturing units, alongside arrests for the production, sale, or distribution of spurious or adulterated drugs.

Data reveals that the share of NSQ drugs in tested samples has nearly halved -- dropping from around 5 per cent in 2014-2015 to 2.8 per cent in 2021-2022, according to an answer given in the Lok Sabha by Bharti Pravin Pawar, then minister of state for health and family welfare, in February last year.

Meanwhile, the number of spurious drugs flagged in random sample tests surged from 83 in 2014-2015 to 379 in 2021-2022.

The overall number of samples tested also increased from 74,199 in 2014-2015 to 88,844 in 2021-2022.

Alongside this, prosecutions and arrests have seen a sharp uptick, with cases of prosecution rising from 152 in 2014-2015 to 592 in 2021-2022, and arrests climbing from 85 to 450 during the same period, shows data in Lok Sabha answers.

A senior official from a state food and drug administration told Business Standard that a decade ago, NSQ drugs accounted for about 10 per cent of all samples tested.

"Over the years, this figure has been consistently coming down. In 2023-2024, the national average for NSQ drugs was around 3 per cent, reflecting significant improvements," the official stated.

Quality assurance, audits, and the crackdown on spurious medicines are a continuous process and a list of medicines found to be sub-standard or adulterated is released every month, said a senior official at the Central Drugs Standard Control Organisation (CDSCO).

In 2023 alone, 646 drugs were flagged as NSQ, including painkillers, antibiotics, anti-diabetics, and antihypertensives.

The majority of these substandard drugs came from manufacturers based in Roorkee and Haridwar in Uttarakhand, Baddi and Sirmour in Himachal Pradesh, and Ahmedabad in Gujarat.

State FDAs on recruitment drive for drug inspectors

The Maharashtra state FDA is already taking proactive measures, training its drug inspectors and recruiting more officers via the MPSC (Maharashtra Public Service Commission).

State Drug Controller D R Gahane revealed that workshops have been held to prepare inspectors for audits of smaller manufacturing units for Schedule M compliance (good manufacturing practices).

The state, which has 200 posts for drug inspectors, is working to fill the 120 vacancies quickly to boost audit capacity.

Following the cough syrup scandal involving exporters in north India, Maharashtra has already audited liquid medicine manufacturers and found no major issues.

Similarly in Gujarat, H G Koshia, commissioner of the Food and Drug Control Administration, noted that the state is hiring more inspectors, with plans to add 40 more to its current force of 140-150.

Koshia also emphasised that Gujarat's NSQ rate, at 0.79 per cent, is lower than the national average, thanks to regular audits and sample testing.

"We have been regularly conducting audits of manufacturing sites, apart from sample testing at labs," he added.

On a national level, the CDSCO has been conducting risk-based audits since December 2022.

In June, the drugs controller general of India, Rajeev Raghuvanshi, had said that around 400 units had been inspected, with 36 per cent forced to shut down for failing to meet standards.

Of these, about 10 per cent permanently closed after failing to submit corrective action plans.

India has roughly 10,000 pharma manufacturing units, 80 per cent of which are micro, small, or medium enterprises.

Raghuvanshi pointed out that many units are struggling with issues like documentation, validation processes, and inadequate quality control labs, contributing to a broader failure in their quality management systems.

With inputs from Sanket Koul in New Delhi

Feature Presentation: Aslam Hunani/Rediff.com