New Delhi : Pharma firm Strides Shasun said its business will not be impacted by WHO strictures on drugs approved on the basis of studies by Bangalore-based Semler Research Center due to data integrity issues as its two TB medicines have already been discontinued.
In a notice of concern issued by the WHO to the Bangalore based Semler on April 12, two pre-qualified products of Strides Shasun were also mentioned, it said in a BSE filing.
“There will not be any impact on the company’s business as the two tuberculosis products mentioned in the notice of concern pertaining to our institutional business have been discontinued since mid-2014,” it added.
Strides Shasun’s isoniazid/rifampicin 75mg/150mg and ethambutol HCL/Isoniazid/pyrazinamide/rifampicin 275 mg were in the list of drugs over which the World Health Organisation (WHO) raised questions to the validity of studies performed by Semler.
WHO had issued the notice to Semler citing data integrity issues and pulled up the contract research firm stating there were at manipulation of at least five studies over an extended period of time indicating it is a common practice.
The global body had asked companies whose products are in its pre-qualified list to carry out risk assessments with proposed corrective and preventive and submit all the studies within 30 days.
Earlier last week, USFDA had told drug firms that their applications seeking approvals on the basis of studies done by Semler would not be accepted citing data integrity issues.
Strides Shasun stock was trading at Rs 1,123.20, up 2.09 per cent, in the afternoon of BSE.