 "We're working with India to ensure quality of pharma products: UK drug regulator")
With India supplying over a quarter of its medicine supplies, Britain has stepped up regulatory oversight of manufacturing units in India. Gerald Heddell, Director of Inspection, Enforcement and Standards, Medicines & Healthcare products Regulatory Agency (MHRA) tells Aneesh Phadnis that the agency is working closely with Indian government on drug safety.
UK MHRA signed an MOU with Indian government last year to ensure safety of pharma products sold in Britain. What has been the progress so far?
India is a very important supplier of medicines to Britain. Last October, we signed an MOU with India, which covers a wide range of areas, but essentially it is about sharing of information, collaboration and working together to ensure that medicines are safe.
What are the key regulatory concerns regarding India?
There have been small number of specific areas in which we have found problems. I have to say that this is not the case in majority of the companies but only in a small number.
But nonetheless it is important. What I am referring to is reliability of data and potential of cross contamination of products which are of key concern. Companies have responded to concerns we have raised and there are instances where action is complete and relationship is restored.
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Are you increasing inspections in India? Is there a plan to set up office in India?
We conducted about 50 inspections in India. It is a key area outside UK where we are conducting inspections. Within Europe, there is a mutual recognition. Other EU authorities are inspecting in India and we take their inspections into account. At the moment there are no plans to set up an office in India. India is just eight to nine hours away for us and almost every week we have people on ground in India.
It takes long time for companies under regulatory scrutiny to get clearance from authorities. Can it not be quickened?
We should understand that most companies do not experience that sort of regulatory action which results in disruption to supplies. But in those exceptional cases especially if there is certificate of non-compliance it typically would take a long time for restoration of approvals. But it is not the regulatory agency which is taking long time. It is the companies which take time in correcting the issues.
Once the issues are corrected there will have to be another inspection to see whether actions are satisfactory. Reduction of timelines would be related to efforts and investment companies put in correcting the issues.