US pharmaceutical body says India needs strong drug standards

Indian pharma manufacturers have scripted a success story in the US market. However, there are many companies that still do not comply with the US standards.

The government’s efforts in further strengthening the Drugs Controller General of India (DCGI) and the industry’s focus on improving infrastructure would help raise the share of the Indian companies in the US pharma market.

“There are about 20,000 drug manufacturers in India of which only 20 firms have strong market in the US. However, there are many others that comply with the standards in unregulated markets. If we can help them advance to modern standards, it would improve the situation significantly,” Roger L Williams, chief executive officer, United States Pharmacopeia (USP), told DNA Money.

According to him, India needs to invest on infrastructure for strong regulatory authority which would eventually help the manufacturers meet the quality standards.

“To market a drug, you probably have to comply with thousands of standards. And Indian pharma makers have been successful in meeting the standards of markets such as the US, Europe and Japan,” he said.

William believes that, in India, the standards are not very strong. Hence, there are many manufacturers shipping medicines all over the globe and also into India, where they are not conforming to the modern standards.

“In India, USP is helping good pharma manufacturers understand the US market requirements and about exports to unregulated markets. We want to make big investments in India and will make reference and monograph standards available,” he said.
He feels that India has been focusing more on access than innovation.

According to William, the US market is driven by generics where Indian pharma companies have been playing a key role.
About 75% drugs prescribed in the US are generics which is cost effective for patients.

Since there is no drug price control mechanism in the US, generics tend to impact the drug pricing. India has been successful in penetrating the US generics market and about 10-30% of the generics sold in the US are made in India.