keen to make closer ties with Indian regulatory authority
MHRA is keen to
strengthen its relationship with Indian regulatory authorities, with
potential collaborations in the areas of inspections and information
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 and biotech production
plants in the country.
A team from the UK MHRA, the US equivalent of US FDA, who were in India
recently, met up the drug controller general of India at Central and
state level to have a mutual understanding of the respective regulatory
systems, and discuss areas of potential collaboration.
Set up in 2003, the UK MHRA is the government agency responsible for
the safety, quality and effectiveness of medicines, and medical devices
has been carrying out more than 50 inspections every year on Indian
plants exporting to the UK.
“This is the beginning of a new collaboration and the way
forward. Indian drugs are critical to UK healthcare and is the major
source of generic products. Around 26 percent of current UK marketing
authorizations name manufacturing sites in India, and 24 percent of all
UK Mas name an API manufacture in India,” said Prof. 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 to set up an office in India. But
we are committed to making closer ties with the India regulatory
authority,” he adds.
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, we
have initiated valuable discussion on how the industry and the
regulatory body can work together. We want to move to a position where
we can share independently the outcome of the joint
inspection,” said Prof. 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
“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 already has 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 and Standards, MHRA.
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
Ruling out the possibility of any collaboration of MHRA with DCGI,
Gallagher said, “There is no recognition for such agreements.
We will conduct inspections with independent