UK and India sign agreement to help ensure drug quality

The agreement, signed today, is the first between India’s Central Drugs Standard Control Organisation (CDSCO) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and intends to increase collaboration and strengthen ties between the two countries by promoting each other’s regulatory framework, requirements and processes

But the MoU will also help to ensure the safety of drug products imported from India into the UK, according to MHRA Chairman Sir Michael Rawlins.

“It’s essential that the commitment to good quality manufacturing comes right down from the top levels of management to those on the factory floor, and throughout the entire industry,” ​he said in a statement.

“Indian firms already accept and understand this, and the MOU is part of a concerted effort to ensure the UK and wider global public continue to have access to quality and safe medicines.”​

A spokesman told this publication "the MoU won’t have a direct impact on the day to day running of the MHRA.  Rather it serves as a statement to cement our already existing working relationship with India and to provide a platform from which to further develop that partnership."​

Quality Concerns​

There have been a number of concerns surrounding the quality of Indian-made drugs and drug products.

A number of facilities have been hit with warning letters and import alerts due to cGMP violations, Wockhardt​ and Ranbaxy​ being two of the most high-profile over the past few years. But smaller API makers​ and contract services firms such as GVK BioSciences​ have also been accused of data integrity issues.

According to the India Brand Equity Foundation (IBEF), India supplies around 25% of all UK medicines.

Despite this, just 49 of the 675 inspections (about 7%) carried out by the UK agency in 2014 were in India. The MHRA told in-Pharmatechnologist the MoU would not directly impact the number of inspections undertaken.