In a major development, the US Foods and Drugs Administration has decided to shift anti-histamine allergy drug, Claritin (Loratadine) from prescription to over the counter (OTC) segment. Morepen Laboratories Limited is the only Indian company to have got the US FDA approval to manufacture loratadine.

The drug currently has a market size of around $3.2 billion with volumes of around 15 tonnes. The volume is expected to increase to around 20 tonnes after it goes OTC. The drug is going off patent in the US market from December 19, 2002, which will open new opportunities for Morepen for export in the regulated US market.

Commenting on the occasion, Mr. Sushil Suri, chairman and managing director, Morepen Laboratories said, "As a result of the drug being shifted to over the counter mode, the volumes are expected to pick up substantially. The move is expected to make the drug being made available more easily without a prescription. Although the price of Loratadine is expected to fall, but it will be offset by the expected pick-up in volumes. We are fully committed and are ready to take up the challenge and have ample capacities meet any demand. The hard work of over seven years has now started yielding results and we expect substantial earnings in foreign exchange, especially in the US," added an elated Mr. Suri.

"Being the only USFDA approved plant in India, We expect to garner a market share of close to 35-40 per cent over the next few months. It is a long-term gain for us as the drug will now become a common product and will become a sustainable growth driver for us. Loratadine will no longer be a six-month bonanza for us," Mr. Suri added.

The company already has orders worth Rs 45-50 crore of Loratadine for the US market pending shipment, which will be dispatched in due course. USFDA on Wednesday had approved Claritin as an OTC allergy product, which was previously available only as a prescription drug. Claritin is approved for seasonal allergic rhinitis- a condition that causes runny nose, nasal congestion, sneezing and itchy nose, throat, eyes and ears.

"By making it easier to get this widely-used drug, today's action will enable many people to get less-sedating, effective relief for their allergy symptoms more quickly and at low cost," Mark B McClellan, MD, PhD, Commissioner of Food and Drugs has been quoted as saying on the FDA website.

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