Indian pharma gets US FDA booster dose

Sees 45% jump in approvals for new drugs compared to Jan-July period of last year

With Cadila Healthcare, Unichem Laboratories and Glenmark Pharmaceuticals getting the US drug regulator’s nod this week to launch one generic drug each, the tally of abbreviated new drug application (ANDA) approvals for Indian firms went up to 129 this year — a 45 per cent jump from 89 in the JanuaryJuly period of last year.

An ANDA contains data which, when submitted to the US Food and Drug Administration (FDA), provide for the review and ultimate approval of a generic drug product.

The FDA raised regulatory concerns several times over the last three years, leading to import bans and the suspension of new drug approvals from certain facilities of Indian pharma companies. The regulator has now started granting approvals for new drugs from some of these units where concerns have been addressed.

Experts also attribute the surge in number of approvals to the Trump administration's focus on reducing health care costs.

This month, Divi’s Laboratories became the fourth company to claim that it had redressed the FDA’s concerns. In February, Cadila Healthcare got the regulator’s clearance for its Moraiya plant in Gujarat after an inspection. The company plans to double its sales over the next three years to reach the $1-billion mark in the US from the current $553 million.

Also, in March, the FDA lifted its ban on India’s largest drug maker Sun Pharmaceutical's Mohali plant, paving the way for resumption of exports to the US. Hyderabad-based Dr Reddy’s Laboratories addressed the issues for its API (active pharmaceutical ingredient) plant at Miryalguda (Telangana) this year.

“While on the one hand the US FDA is putting pressure on companies to upgrade their facilities to its standard, on the other hand it has now become more efficient by providing faster approvals to new drugs,” said Jagdish Dore, managing director at Sidvim Lifesciences, a firm specialising in preparing Indian companies for FDA inspections.

There are still a large number of companies grappling with FDA concerns. While some of the facilities of Wockhardt, Ipca Laboratories, and Sun Pharmaceutical are still under import alert, some plants of Divi's Laboratories, Dr Reddy’s and Sun have received warning letters. The FDA does not give new drug approvals from facilities that receive a warning letter.

Though the new generic drug user fee amendments (GDUFA) that the FDA introduced in 2012 had promised to clear the backlog, applications were being cleared at a slower pace earlier.

“We have seen an increase in pace of drug approvals since last year after we complained to the FDA about delays,” said D G Shah, secretary general of the Indian Pharmaceutical Alliance.

“The FDA's recent move to expedite approval of generic drugs with limited competition will give further impetus to the process,” said Shah.

The higher number of approval for generic drugs is also coming at a time when the US government is working to bring down drug costs. May and June 2017 have seen the most generic drug approvals since the FDA began tallying its monthly approvals. It has also lent credence to FDA Commissioner Scott Gottlieb's pledge to speed approvals and lower drug costs.

“Higher number of new drugs approvals has increased earnings visibility for Indian pharma companies,” said

Amey Chalke, analyst at HDFC Securities.