Dr Mike James, ex UK Regulator (MHRA) & technical director at Camridge Regulatory Services Ltd, UK was in Bangalore recently to attend a one-day international regulatory workshop to provide the industry, first-hand information on how to handle the regulatory processes in the West. The event titled 'Your Passport to the World' was organized by PharmaLeaf, India and Camridge Regulatory Services . In an interview with Nandita Vijay, he provides a global perspective of the good manufacturing practices (GMP) and highlights ways to overcome barriers in international regulated market for generics. Excerpts:
How would you describe the regulatory scene in terms of compliance in both developed and developing countries?
Compliance with regulatory requirements by all sectors of the pharmaceutical industry is generally good but it must be recognized that there will always be some companies who do not want to comply with the requirements and will try to avoid them in order to cut costs.
Health authorities in the US and EU are now undertaking risk- based assessments for GMP compliance and are concentrating their resources on new companies, critical products (for instance injections) and companies with poor compliance records. However this does not mean that other companies will escape inspection. It means that the repeat inspection frequency may be lengthened and the time for an initial inspection may be longer from lodging the request.
Compliance with other international standards like GLP and GCP is also subject to inspection by the US and EU authorities. GCP inspection is now a routine occurrence for major (Phase III) clinical studies and is increasingly being seen for bioequivalence studies too. GCP compliance is critical to the success of an application because a non-complaint clinical study cannot be corrected, the application must be withdrawn in many cases and the study repeated with a greater emphasis on GCP compliance.
What are your views of the present status of GMP compliance in India?
GMP compliance in India from the perspective of the US and EU regulators vary. There are many companies who have invested heavily in modern facilities that are as good or even better than facilities in Europe and the US but equally there are many companies with old facilities that are not acceptable to these markets.
If companies wish to sell products in the US or EU, they must invest time and money in facilities that fully comply with the GMP requirements operated by FDA and EMEA.GMP requirements in these markets are not the same as those required by the Indian authorities and it must not be assumed that GMP approval from the home authority will automatically lead to approval from FDA or EMEA. Also a company must not assume that approval by Europe will automatically lead to approval by FDA and vice versa because Europe and America currently have different ideas of what is acceptable GMP standards.
Regulatory authorities are not consultants and they do not exist to advise companies on how to comply with international standards. An unacceptable site will be failed for GMP compliance without the health authority inspector saying in precise detail how corrections should be made. If this happens it is frustrating for all involved because of the need to re-inspect the facility. Such a re-inspection may not occur for many months because of the need to schedule a visit from the same inspector and he may not be available to visit again for over one year.
Thus it is not advisable to undergo for a formal GMP inspection from FDA or a European authority without having been through one or more mock inspections from a skilled GMP auditor who can identify any areas of concern and also train staff in what to expect during the real inspection.
What are the key challenges for regulatory authorities in the growing pharma and biotech space?
The biggest challenge for regulatory authorities is to do more work with fewer resources so that costs are controlled and at the same time not reduce the level of compliance necessary for patient safety. The large number of new sites that have appeared in the recent past have put a strain on the resources available for inspections. Especially GMP inspections and health authorities have struggled to keep up with the demand as well as increasing the number of qualified GMP inspectors
Europe and the US have adopted new inspection models based on risk to concentrate resources into areas that are likely to have most impact on patient safety. All facilities will continue to be inspected but those operating less risky processes or those with good compliance records may be re-inspected at longer intervals compared to the historical re-inspection process that occurred approximately every two years. On the other hand, facilities with risky processes or poor compliance records are likely to be re-inspected more frequently under this mode of operation.