After labelling fiasco,Hindustan Antibiotics restarts saline bottle production at Pimpri

FDA joint commissioner B R Masal said they had asked the company to stop work after a problem of labelling of bottles. “We had sought explanation from them. After receiving their reply,we asked the company to restart production.”

However,Masal said they have now issued a show-cause notice to the company. “We need some more clarifications from them and hence have issued notice to them. We are awaiting their reply,” he said.

Das said FDA officials had inspected the company before giving its approval. “We have taken the necessary corrective measures and covered whatever deficiencies were pointed out. We have complied with all the directives issued by the FDA,” said Das.

After the “labelling” goof up came to light,the HA management had filed a chargesheet against three employees. “A court of inquiry has been instituted against the employees. We will follow the natural principles of justice,” Das said.

The HA management had withdrawn over 1 lakh saline bottles — primarily from Jaipur — after the ‘labelling’ goof-up. The FDA had then described it as “gross negligence” on the part of the company.

The HA management continues to maintain that it was a “minor mistake that probably happened due to oversight”. The management also did not rule out the possibility of a sabotage due to fierce competition in the market.

Last month,FDA told Newsline that the saline bottles contain 0.9 per cent sodium chloride. However,the label put up by HA stated ‘5 per cent extra dextrose’ in Hindi. “We inspected the company premises on July 11-12 and took samples from eight batches,” Masal had said.

HA management said the company produces 40,000 saline bottles daily. Each bottle is worth Rs 8.40. “We had stopped the production for 15 days following FDA directives,” Das said. FDA officials said they were awaiting the laboratory report of the samples.