After opening the day on a positive note, share markets in India pared early gains and are trading flat. Sectoral indices are trading on a mixed note with stocks in the realty sector and stocks in the oil and gas sector trading in green, while stocks in the pharma sector are leading the losses.

The BSE Sensex is trading up by 10 points (up 0.1%), and the NSE Nifty is trading up by 3 points (up 0.1%). Meanwhile, the BSE Mid Cap index is trading up by 0.1%, while the BSE Small Cap index is trading up by 0.2% The rupee is trading at 64.17 to the US$.

In news from stocks in the pharma sector. Lupin share price hit a fresh 52-week low in today’s trade as The US Food and Drug Administration (USFDA) issued a form 483 to Lupin Ltd’s Goa facility.

Form 483 relates to certain critical observations issued to a company at the end of an inspection if there were any violations of the Food Drug and Cosmetic Act and other related acts of the US Government.

Companies that receive its observations must respond in writing with a corrective action plan and implement it quickly. If the company does not meet the USFDA’s expectations, a warning letter may be issued.

The USFDA cited three observations related to violation of good manufacturing practices following an inspection of the site between 27 March and 7 April this year.

The US drug regulator observed that the company failed to review and investigate unexplained discrepancy and out of specification components of a product batch at the facility.

The regulator also observed that Lupin did not have written procedures for production and process controls to assure quality of the product is as it is supposed to be as well as any established control procedures to monitor output of those manufacturing processes that cause variability in the characteristics of the drug.

On the face of it the observations seem to be strictly procedural in nature, and the company shall be able to resolve them in a few quarters at the most.