After opening the day in red, share markets in India have continued to slide and are trading below the dotted line. Sectoral indices are trading on a mixed note with stocks in the metal sector and stocks in the metal sector leading the losses.

The BSE Sensex is trading down by 175 points (down 0.5%), and the NSE Nifty is trading down by 53 points (down 0.5%). Meanwhile, the BSE Mid Cap index is trading down by 0.5%, while the BSE Small Cap index is trading down by 0.8%. The rupee is trading at 64.94 to the US$.

Lupin share price was in focus today after it was reported that the company received a ANDA (abbreviated new drug application) approval from the United States Food & Drug Administration (USFDA) for Clobetasol Propionate Spray.

The drug is a generic version of Galderma Laboratories’ Clobex Spray.

According to IQVIATM sales data, the Clobex Spray had sales of around US$ 30.5 million in the US for the twelve months ended January 2018.

Indian pharma companies catering to the US markets are breathing a sigh of relief. After being adversely affected by import bans and the suspension of new drug approvals from manufacturing facilities in the past three years, there has been a sharp pick-up in new drug approvals in FY17.

Expediting Drug Approval Process to be a Positive for Industry

However, note that USFDA alerts on Indian pharma companies have increased over the past few years. Regulators used to visit the plants every two years. Now they come every eight months. Increasing inspections have led to a total of 41 import alerts in the past eight years – 33 of them (80%) in just the last four years (2013-16). This clearly signifies increased USFDA scrutiny on Indian pharma firms. If that wasn’t enough, increasing pricing pressure in the generics segment has dented realizations.

However, the recent development of USFDA expediting the drug approval process can bring some respite for Indian pharma companies. This comes as drug approvals for Indian companies have gone up 50% in the period from January to June 2017 compared to the same period last year.

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