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Pharma Medicine USFDA Drugs Image Credit: Outlook Business
Pharma Medicine USFDA Drugs Image Credit: Outlook Business

What Next For Pharma

The domestic pharma industry, which is already battling the US FDA, has now to contend with regulatory challenges at home.

Krishna Gopalan

Mitesh Shah has made a quiet fortune over the last decade. As a chemist in Thane’s sprawling Hiranandani Estate, he has a steady clientele of patients and doctors that keep his cash registers ringing. Three years ago, he spent a steep ₹2 crore in buying a large apartment in the township. Even with new chemists entering the area over time, his business has remained largely unaffected.

On a good day, Shah gets about 500 prescriptions from doctors and based on these, he dispenses medicines to his patients. With his experience and his D.Pharma degree, it is a job he has mastered —from the intricacies of each drug to being able to substitute one for another when the stocks run out.

In the third week of April, 30-year-old Mitesh was slightly surprised to see a prescription from a doctor without a brand name. Instead, it made a mention of just the generic name (or the chemical name of the drug) with the suggested brand in brackets. “It was the first time this had ever happened and it was for a diabetes drug. Since then, we have had about ten such prescriptions each day,” he says. This happened just about a week after Prime Minister Narendra Modi said that doctors will not be allowed to prescribe a brand, but only a generic drug.

This could possibly be a huge concern since the brands that pharma companies have built for many years could potentially count for nothing. At a tidy ₹100,000 crore, of the branded generics market with handsome profits, was a great place to be in for the biggies. Suddenly, that equation has changed.

Shah is not too thrilled either. “We cannot replace the doctor in any form. While m


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