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International regulators keen to work with Indian regulators to bridge gaps & strengthen regulatory set-up

A Raju, Hyderabad
Wednesday, January 28, 2015, 08:00 Hrs  [IST]

International regulators at the 66th IPC expressed their willingness to work in collaboration with Indian regulators and participate in joint inspections and regular training programmes for better understand and bridge the gaps, if any.

At an international regulatory meet in Hyderabad, almost all regulators from across 10 countries expressed their keenness to collaborate with Indian regulators and work towards harmonising regulatory blockages and gaps in way of product registration and issuing of licences for the international markets.

According to Mark Birse, Group Manager Inspectorate of MHRA, from United Kingdom, while expressing his views on the topic ‘Indian Generic Medicines-Perception of International Drug Regulators’, said except for few issues relating to certain pharma units, majority of Indian pharma companies have greatly improved in quality management and are complying GMP, GxP regulations stipulated by international regulatory standards.

“To bridge the gaps, and for better understanding of regulatory systems in both India and abroad, there should be regular exchange of information and regulators must take part in joint training programmes and should also conduct joint inspections for better understanding of regulatory issues and at the same time help in harmonising regulatory hindrances if any,” opined Mark.

While giving her perception on the Indian pharma industry and regulatory standards, Dr Susanne Keitel, Director, European Directorate for the Quality of Medicines and Healthcare (EDQM) opined that there are regulatory challenges in every country, despite gaps and limited resources, the Indian regulatory system has remarkably improved over the years, but now as times are changing due to drugs going off patent, industry in almost all the western countries are looking for cost cutting and at the same time want to sustain their market share. Therefore obviously there will be certain regulatory stiffness. But this should not be a problem for companies as the changes in regulatory standards apply to everybody and it is not specifically directed towards one country.

Caroline Larsen Le Tarnec, head of Division for EDQM, says “we are looking forward for more collaborative work with Indian regulators and the Industry. India is blessed with highly knowledgeable entrepreneurs and availability of skilled resources at affordable prices. As the government is looking forward for more reforms in its policy, the future looks quite optimistic for the India to reap better success in the field of pharmaceuticals and biotechnology.”

On the flipside, almost all regulators agreed that Indian pharma companies still have to inculcate a culture of sustainable quality management and should work towards transparency and improved data integrity. “When we inspected a pharma unit in India a year ago, we found that certain equipment were installed just a few days before inspection. In another case when we came back for a re-inspection of a unit we were surprised to see a total contradiction of what we were shown earlier and what exists. Without taking any approval from local regulators or from the international regulators, the unit management had introduced a large number of products on the same capacity without any safety or risk management systems in place.  Such instances not only raise suspicion but also creates an impression of doubt and lack of confidence on the entire industry,” says Dr Susanne.


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