Strides Pharma Science Ltd shares fell more than 8% on Wednesday after the US Food and Drug Administration (US FDA) red flagged significant violations of current good manufacturing practice (CGMP) at its drug manufacturing facility in Puducherry.
The US drug regulator said the company was involved in destruction of CGMP documents. Raising its doubt on the quality of products produced at the facility, the US FDA, in a warning letter to the company on July 1, said, “Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated."
The Bengaluru-based drugmaker was caught trying to dispose quality-control records, the FDA said. According to the US regulator, which had inspected Strides Pharma’s drug manufacturing facility in Puducherry from January 28 to February 5, 2019, said the company was caught trying to dispose quality-control records seven days before the inspection by US FDA.
“Our investigator observed discarded CGMP documents and evidence of uncontrolled shredding of documents. For example multiple bags of uncontrolled CGMP documents with color coding indicating that were from drug production and laboratory operations were awaiting shredding," it said.
A warning letter was henceforth issued to the company for violating CGMP. On the BSE, Strides Pharma Science share price declined as much as 8.15% to Rs. 347.00 apiece.
The destruction of quality-control paperwork and a lack of adequate documentation that its medicines are safe “raise questions about the effectiveness" of Strides’ quality unit “and the integrity and accuracy" of its data, the FDA’s Office of Manufacturing Quality said in the letter.
The FDA further said till the time violations at the company’s Puducherry plant are addressed and confirmed by the regulator, no new applications or supplements will be allowed into the US market. “Until you correct all violations completely and we confirm your compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug manufacturer. Failure to correct these violations may also result in FDA refusing admission of articles manufactured at Strides Pharma Puducherry," said the letter by Carla Norris, compliance Officer, US, FDA. Mint has reviewed a copy of the letter.
The regulator has asked Strides Pharma to respond within 15 working days. In a filing to the National Stock Exchange on 2 July, Strides said, “Puducherry site currently produces 6 ANDAs (abbreviated new drug application) which will not get impacted by the current development. However, the 10 ANDAs pending approval from the site will get deferred till the site is reclassified".
An email sent to the pharma company did not elicit any response as yet.
The warning letter, highlighting data integrity violations, exhibits a rising trend of such violations. An annual report of 2018 by the centre of drug evaluation and research office of compliance under the US FDA showed that out of the total 84 drug-related CGMP warning letters, 30 were feature data integrity violations. In June, Aurobindo Pharma Ltd was also warned by the FDA for ignoring impurities in an active ingredient it produced.