Is the Indian Pharma Industry Ready to Take the Leap?

The Indian pharmaceutical industry is poised to change course. With the US-China trade war escalating, pharmaceuticals are also being drawn into the fold. The US is dependant on China for its bulk drugs, and China is in turn dependant on US for its drug formulations. The Indian industry could step in and become a partner to both. It certainly has the competence.

The Indian pharmaceutical sector is estimated at USD 40.4 billion in 2018, expected to grow at a CAGR of 22.4 percent over the next five years. While the domestic industry constitutes 48.7 percent, exports contribute the balance USD 20.7 billion. India is among the leading global producers of cost-effective generic medicines and vaccines, supplying 20 percent of the total global demand by volume. The country accounts for 30 percent by volume and 10 percent by value in the USD 75-billion US generics market. India is the only country in the world that has the highest number of USFDA-approved plants for generic drug manufacturing outside the US. Some of the leading Indian pharma companies derive about 50 percent of their turnover from exporting generic medicines to developed markets like the US and Europe.

Bulk drugs account for roughly one-fifth of the Indian industry output while formulations account for the rest. Whereas India is one of the major countries to export drug formulations to the US, its contribution to China is a minuscule 0.1 percent. However, US has been the second-biggest supplier to China at 15 percent of its total drug-formulation imports.

Of course the Indian industry has many mountains to climb first. While Indian companies are moving toward difficult-to-manufacture differentiated drugs like complex generics, specialty drugs, and biosimilars, they will have to ensure that Form 483 from USFDA is a thing of the past, be as cost competitive as China, and ensure that manufacturing is sterile – the biggest concern of US authorities. The gradual opening of the Chinese market for Indian generics seems to be a timely opportunity for pharma companies. Proactive companies are planning setting up plants in China, Cipla for respiratory products, and DRL, another facility, adjacent to its current one at Kunshan. Are other companies ready to take the plunge too?