CDSCO Inspectors, Legal Authority, and Risk-Based Drug Inspections
The whole thing hinges on that drug regulator, the CDSCO . They’re the ones running these "risk-based inspections"—those surprise factory checks launched after some contaminated cough syrups ended up causing deaths in Gambia and Uzbekistan. It’s really brought the whole drug system in India under a huge spotlight.
For the last couple of years, these inspections have been CDSCO’s main way to enforce rules. They’ve been sweeping across manufacturing plants. Flagging bad practices, suspending licenses, ordering recalls. It’s been heavy-handed.
But now, things got legal.
The Himachal Pradesh High Court stepped in and asked a big question: Do these centrally appointed CDSCO inspectors actually have the legal muscle to do all that enforcement under the Drugs and Cosmetics Act ?
This came out of the Salus Pharmaceuticals case. Remember that? It was about a drug inspector collecting samples from a military hospital, and then prosecuting the company after the testing failed. The court decided to quash the criminal proceedings.
The core issue wasn’t just the inspection itself. It was the authority.
The case involved Salus, based in Himachal Pradesh. They collected samples of those Medrofex-180 tablets from a military hospital in Jalandhar back in August 2019. Later, a government lab declared the sample “not of standard quality.” That report kicked off the prosecution against the company and its partners.
Then Salus went to the High Court. They wanted the case dropped.
What the court ultimately said was kind of a punch to the system. It questioned whether the CDSCO inspectors, appointed by the central government, really have the legal authority to enforce things under Chapter IV of the Drugs and Cosmetics Act—the part dealing with making and selling medicines.
This matters because the entire basis of those nationwide inspection drives rests on this exact power.
The court basically said powers over manufacturing and sales mostly belong with the state governments and their own drug inspectors.
One of the key takeaways was pretty stark. The court noted that neither the Constitution nor any law Parliament passed—not even the Drugs Act or the Rules—gives the central government’s authorities the power to exercise executive functions related to Chapter IV. That includes the drug inspectors appointed by the center.
It was a really specific split. The court observed that while these central inspectors can handle stuff related to importing drugs and cosmetics (Chapter III), they can’t touch the manufacturing enforcement inside the states.
In simple terms? They can deal with imported stuff. They can’t necessarily enforce rules about how things are made within state borders.
And there was the testing delay. That was another piece. Under Rule 45 of the Drugs and Cosmetics Rules, samples needed testing within 60 days. In this case, the sample hit the lab on September 2nd, 2019. The bad report didn't come back until December 5th. Three months.
The company argued that the law required the test to happen within a specific timeframe, and that this delay weakened the whole prosecution. The court aGreed on the principle. It said that mandate had been violated, and that happened without proper consequence.
But there’s more. The court also looked at the partners. They argued that partners couldn’t be automatically prosecuted just because they were directors. It’s not enough. You need clear proof they were running the day-to-day operations. The complaint didn’t clearly map out what the partners were actually doing.
This judgment feels like it’s going to cause ripples. If other courts start looking at this, pharmaceutical companies might start challenging not just the findings of an inspection. They could start challenging the very legal right behind the inspection. That could really complicate the government’s push to build up this nationwide quality monitoring system through these coordinated checks. It opens up a lot of complications.
Written by Gree News Team — Senior Editorial Board
Gree News Team covers international news and global affairs at Gree News. Our collective of senior editors is dedicated to providing independent, accurate, and responsible journalism for a global audience.
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