The facility in Puducherry, India manufactures a number of active pharmaceutical ingredients (APIs) and finished formulations for the pharmaceutical industry including ibuprofen, yet since Sunday operations at the site have stopped due to a strike by workers which has been deemed “illegal” by the company in an announcement to the Bombay Stock Exchange (BSE).
“Shasun Pharmaceuticals Ltd has informed BSE that an illegal strike was resorted by the workers at the Company's Pondicherry facility (API and Formulation) on June 15, 2013,” said the filing. “The Company is doing needful to resume the operations at the earliest.”
No one from Shasun was available from comment when approached by Outsourcing-Pharma.com.
The halting of operations can be a huge cost to a drug manufacturer as Shasun are aware. The company was affected by a 15-day industrial action over a wage settlement issue In May 2011, once again at the Puducherry site.
Speaking with India’s Financial Chronicle at the time, S Abhaya Kumar, Director of Operations at Shasun, said the strike cost the company INR 50m ($853,000) though added that the production loss would be made up within two months.
Furthermore, both Puducherry and Shasun’s multi-product facility in Cuddalore, India were affected by cyclonic storm thane in December 2011. In this case, suspension in operations cost the company an estimated INR15m ($281,000) per day, according to Kumar.
Contracting Issues
According to the company's website, the Puducherry facility manufactures the pain relief drug ibuprofen for chemist and OTC drug company Boots Co, UK – part of Allianceboots. The company also claims it is the only supplier of ibuprofen derivatives such as S+ ibuprofen, lysinate and sodium salts.
Furthermore, with new EU API import regulations approaching, in a list of manufacturers that have been issued “written confirmations” of quality by the Central Drugs Standards Control Council (CDSCO), and thus able to import APIs to Europe as of July 2nd, Shasun was not listed.
Outsourcing-Pharma.com contacted Boots UK asking whether supply of ibuprofen will be affected by either the strike or impending regulations. A spokesperson from the company said:
“Boots UK has full business continuity plans, including increased stockholding for long lead-time products. We work with a number of generic suppliers to ensure these potential issues have minimal effect on the supply of our products. We are fully supportive of the globalisation of the Falsified Medicines Directive and have communicated with all suppliers on this requirement.”
Since the publication of this article, the statement regarding Shasun supplying Boots has been removed from the company's website. In-Pharmatechnologist.com has also been contacted by BASF who has informed us that Shasun's claim that they are the only manufacturer of S+ ibuprofen and lysinate is not correct, as in fact BASF offers these products as well.