MHRA Restricts GMP Certificate for Indian Pharma Company Over Data Integrity

Regulatory Agency of medicines and health products in the UK (MHRA) announced Friday that due to concerns about data integrity, Marksans Pharma Goa, India based installation will be a "certificate GMP restricted" allowing the company follow only the manufacture and marketing of products critical to the UK.
In March 2015, British regulators discovered "several major shortcomings in the operation of pharmaceutical quality system" on the site.

November reinspection two days evidence that the company had destroyed "several parts of data records options" and investigations into the disappearance and deleting data in the laboratory site were also found incomplete.

The new survey also showed "a lack of evidence to prove the effectiveness of CAPA result [CAPA] taken and the lack of provisional safeguards to ensure that ongoing operations are GMP."

However, the MHRA said there was "no evidence of defective product on the market. Product recall is not considered necessary." The site produces more than 40 products for the UK and Dutch markets, including Teva Pharmaceuticals generic version of Viagra (sildenafil) in the Netherlands and various forms of ibuprofen and paracetamol.

No longer marketing authorization (MA) must be approved naming the site as a manufacturer, MHRA added, noting that current applications of MA should be detained pending or rejected, while the declaration of default remains in effect.

Marksans said in a statement on its website that the state GMP Limited would continue until the next inspection of the MHRA, which will come once the qualified person certifies the site to be ready for inspection.

"The competent national authorities should evaluate the criticality of the products offered on this website and to take measures to ensure the continuous supply," MHRA said. the marketing authorization holders are requested to contact the national competent authority to check whether their products are considered medically critical.