UK MHRA (Medicines and Healthcare Products Regulatory Agency) is open for joint and mutual inspections with Indian inspectors during the process of regulatory clearances of pharma-biotech production plants in the country.
A team from the UK MHRA who were in India recently met up the drug controller general of India at Central and state level to have mutual understanding of the respective regulatory systems and discuss areas of potential collaboration.
This is the beginning of a new collaboration and the way forward. Indian drugs are critical to UK healthcare. The UK MHRA which is the government agency responsible for the safety of medicines and medical devices has been carrying out around 50 inspections every year on Indian plants exporting to the UK, said professor Kent Woods, chief executive, MHRA.
"Serious unacceptable production practices can be devastating. MHRA is now committed to work with pharma industry in India. We are following our inspections with a request initiative. At the moment we do not have any plans in to set up an office in India like the US FDA. But we are committed to making closer ties. Currently, we are well represented in India through the British High Commission," said professor Woods during an interaction at a seminar on 'Regulatory awareness programme: UK MHRA in conversation' in Bangalore, organized by the UK Trade & Investment (UKTI) and the Science and Innovation Network (SIN) of the British High Commission.
Vigilance is a key aspect of regulation and MHRA is looking for collaboration and cooperation. "The way we have collaborated is different in each country. But the key issue is the ability to share the details of the information about the inspection. In this regard, it has initiated valuable discussion on how the industry and the regulatory body works together. We want to move to a position where we can share independently the outcome of the joint inspection," said professor Woods.
The standards of manufacturing required by pharma companies in the UK and India are the same. Most of the inspections have satisfactory outcome although there are areas of improvement identified, said Shaun Gallagher, director of policy, UK MHRA.
"In India we are looking at pharmacogenomics and targeted therapies opportunities. In this regard, we are working with the industry and have put together a forum of industry experts for the same. Another focus is to improve the regulation of medical devices both from a regulator and developer point of view. For this a relevant regulatory framework is being set up," he said.
Biotech drugs are more complex than chemical based drugs. With the need for low cost drugs, MHRA has already a regulatory framework for biosimilars in place. When biosimilars approved for physician use companies provide a lot of data supporting the medication and its efficacy in treating diseases. This gives the medical expert, the option of choosing a biosimilar over a branded drug, said Gerald W Heddell, director of Inspection, Enforcement & Standards, MHRA.
In the area of herbal medicine, there are no statutory regulations at the moment. But these are being proposed and once that they are approved they will come under the purview of MHRA. Since 2004, a directive has been issued for herbal drugs and in 2006 for homoeopathy. Indian companies seeking to export to UK need to apply for a fully open general license. The clearance to market will depend on the data presented by the manufacturers.
In the area of clinical trials, MHRA has undertaken four bioequivalence studies in India. Its approach is based on risk assessment and is currently looking at the study and not the facility carrying out the bioequivalence study.