Dusty roads like this one are typical in India.
But this road goes somewhere unexpected. It leads to a manufacturing center for Cipla,
one of India’s largest generic drugmakers. India supplies over 30% of the generic drugs
in the world. And Cipla itself produces one third of the
AIDS medications used in Africa. Plants like Cipla’s must comply with stringent
standards called current Good Manufacturing Practices.
Cipla is eager to show that its advanced pharmaceutical ingredient plant is in line with those standards.
But it takes some doing to get a camera inside. Everyone who enters must wear a lab coat.
They must cover their shoes, and their hair. They must also be mindful of safety.
Electronics could ignite volatile solvents. So Cipla uses this device, which measures
levels of solvents in the air. If levels are too high, cameras must be turned
off. Everything in the plant flows in a certain
way. That goes for the chemicals in the reaction
vessels, the water used in manufacturing, and even the employees.
They must enter and exit through specific doors.
They must record every change they make to big reactors like this one.
If someone opens a vessel, or changes a temperature, it gets written down. The plant that turns those compounds into
pills has additional regulations. A quarantine section holds materials that
the quality control team has yet to approve. Inside, Cipla keeps active ingredients in
blue barrels. They’re ready to be made into pills.
The coatings and inactive ingredients for finished doses are all stored separately.
Everything here is carefully tracked, down to the cardboard boxes.
If everything checks out, this plant combines the ingredients, packages the pills, and puts
them into boxes. These contain Atorlip, a generic for the cholesterol drug Lipitor.
These pills will be going out the door– and now, so will the camera.
But not before this gadget sucks away those shoe covers. There will be bumps in India’s road to becoming
the world’s drugstore. Other Indian drugmakers have had products
recalled or banned because of plant problems. India is also under pressure to make its patent
system more like those in Western countries. But India has found a market for low-cost
drugs. And no matter what happens in India, that
market’s not going away soon. Senior Correspondent Jean-François Tremblay
filmed and reported this story. For C&EN in Washington, I’m Carmen Drahl.