Punjab FDA cancels Jackson Laboratories manufacturing licence following 58 critical lapses in Amritsar unit

Image for Punjab FDA cancels Jackson Laboratories manufacturing licence following 58 critical lapses in Amritsar unit

Five women walked into a hospital in Kota to give birth.

They never walked out.

The suspected killer? A tiny vial of oxytocin — the hormone that's supposed to save mothers during labour.

Except investigators say some of those vials were allegedly filled with… water.


🚨 Then the inspectors walked in

A joint team from CDSCO and Punjab's FDA arrived at Jackson Laboratories' Amritsar plant.

What they found wasn't a factory.

It was a horror show in a lab coat.

  • 🧪 58 critical regulatory violations
  • 📋 451 major observations
  • 💧 Tap water used instead of RO water for injectables
  • 🏭 Tablet section opening directly to the outside
  • 🗑️ Reject bottles, loose labels, blister rolls scattered across the floor
  • 📦 Batches manufactured with no identification, no records, no documentation

Let that sink in. Drugs going into pregnant women's veins — made in a room with no paperwork and tap water.


⚡ The damning verdict

The inspection report didn't mince words.

👉 "The firm is not following principles of GMP at any stage."

The certificate of analysis the company submitted? Officials called it "not reliable."

No method validation. No process validation. No stability data.

Just vials. And trust. And dead mothers.


🔨 The hammer drops

Punjab FDA cancelled the Amritsar manufacturing licence and shut the plant.

Himachal Pradesh followed — that licence is gone too.

The Centre has demanded a full report from Rajasthan.

And now the story has crossed borders.


🌍 The WHO is asking questions

Here's where it gets bigger.

The World Health Organization has formally written to the Indian government.

One chilling question on top of the list:

Was this same oxytocin exported?

Because if those vials left India… this isn't a Kota tragedy anymore.

It's a global one.


🧠 The uncomfortable truth

India makes 60% of the world's vaccines and a huge chunk of its generics.

"Pharmacy of the world" — that's the proud tagline.

But every few months, the same script repeats:

  • Cough syrup deaths in Gambia.
  • Eye drops blinding people in the US.
  • And now oxytocin allegedly filled with water in Rajasthan.

The problem isn't capability.

It's enforcement.


🎯 The real takeaway

509 violations in one factory.

Five mothers gone.

A WHO inquiry on the desk.

The Jackson Laboratories shutdown isn't the end of a scandal.

It's the beginning of a reckoning India can no longer postpone.

That's all for now!