US Food and Drug Administration (USFDA) approvals to Indian companies in the past seem to have grown leaps and bounds with every passing year.The speedy approvals have led to the export of Generic drugs witnessing an 84% up in one year.
Smaller and medium pharmaceuticals like Shasun Pharma, Granules India, Ajanta Pharma,Gland Pharma and MSN Lab have been jumping into the largest and the most competitive industry of pharmaceuticals. These relatively smaller groups emerged as strong contenders in the pharmaceutical market as the likes of Dr. Reddy & Sun Pharma had taken a back seat, due to compliance issues with the USFDA.
USFDA has started taking a very stringent stand on Indian pharma groups. Primarily, because investigations in the past by the regulatory body, have more often than not found Indian drug companies on an erring foot. Faced with warnings regarding violations in their manufacturing plants, some of the big names have even begun to feel that they are being singled out to settle scores by the USFDA. All this saw escalation after Ranbaxy ( now part of Sun Pharma) came into rough seas with the drug regulator.
Indian drug companies which have the USFDA approval for their plants begin applying for launching of their generic drugs soon after. The approval figure of 109 for the year 2014-15, has witnessed a colossal jump to a figure of 201 FY 2016( April-March). An elevation of 84%, according to a USFDA analysis.
The regulator scrutiny reflects Aurobindo, Lupin and Glenmark leading with 50, 27 and 18 approvals, respectively for the year 2015-16. This being a comparative against the previous year’s performance of Sun Pharma at 14, Lupin-10 and Jubilant, Hetero Labs and Macleods at 8 each. The list of approvals shows some drug companies as first time entrants, while many belong to the category of specialised treatments.
India earns major revenue from the US generic market. It holds the US generic reins in the form of 30% by way of volume and 10% in terms of value. This, in a $70-80 billion US generic market.
India, in the present day generic drug scenario has emerged as a key player in the US market. It happens to enjoy greater plant strength and wider scale of operation. Besides this crucial drugs and injectables are being exported too from the country.Thus making it a dominant player in the US generic drug market. With USFDA inspections and rising generic drug export, the number of Indian companies supplying to the US market has increased three fold. Five years ago this number was minuscule.
Describing the Indian generic business as having gained grounds in the US , the Glenmark Pharmaceuticals, CMD, Glen Saldanha said that his company had 24 approvals including tentative consents for year 2016; the highest ever for the company.
“The increase in number of approvals is partly due to GDUFA (Generic Drug User Fee Act) under which the FDA had agreed to expedite the processing of ANDAs, and partly due to the importance of drugs and inadequate competition,” said D G Shah, Secretary General of Indian Pharmaceutical Alliance.
The GDUFA assist to the USFDA helped it clear 90% of the approvals backlog.
Some of the high-value approvals for generic versions received by Indian firms include: Anti-cancer drug Gleevec (imatinib) made by Novartis, Otsuka’s Abilify (aripiprazole) used for treating schizophrenia, Zetia (ezetimibe), a drug prescribed for treating hypertension made by MSD and Vigamox (moxifloxacin), a conjunctivitis drug made by Novartis company Alcon.