Emphasizing the fact that regulatory science is an evolving discipline and that there is a need to promote regulatory science research in the country, experts deliberated on harmonisation of regulations existing globally to make quality medicines available on the occasion of 4th Technical Seminar was held in Mumbai from September 9 to 10, 2014 by Indian Pharmaceutical Association (IPA) in association with the European Directorate for the Quality of Medicines and Healthcare (EDQM).
The theme of the conference was on ‘Quality of Pharmaceutical Ingredients: Applying Learnings to Practice'.
Advocating the need for training the pharma industry workforce in line with the global regulatory needs, experts said that this becomes more pertinent as there are diverse regulatory environment and constraints, different history and working principles, diverse source of material in pharma manufacturing and different decision making processes in different countries.
Speaking on the sidelines of the event, Dr G N Singh, Drug Controller General of India (DCGI) said that there is a need for upgrading the standards of Good Manufacturing Practices (GMP) along with harmonisation of laws. India is poised to gain the advantage in the process of harmonisation as it supplies generics to 205 countries globally."
Echoing similar views on India's delivery of quality medicines globally, Dr B Suresh, president, PCI, said, "Among other issues related to data integrity, Current Good Manufacturing Practices (cGMP), manufacturing deficiencies, electronic data controls, workforce training in the pharma industry need to be met on an urgent basis."
Talking about workforce training in the pharma industry Dr Susanne Keitel, director, EDQM said that a consortium of agencies in association with EDQM is planning to run a series of training programmes for all the stakeholders of the Indian pharma industry by the end of this year. Discussions on the same are currently going on.
Experts pinpointed that there is a regulatory vacuum and no clarity on regulations when it comes to talking about India besides the fact that regulatory system is mired by multiple controls. The Indian pharma is market driven and enforcement by regulatory agencies is lax. Workforce training is therefore the need of the hour in regulatory agencies and pharma industry.
S D Joag, secretary general, Indian Pharmaceutical Association (IPA) said that regulatory science in India should be incorporated in academics and should be industry driven. Research in regulatory science is the need of the hour. Adding to it Dr Suresh explained that pharma workforce should be upgraded in areas like biostatistics, decision theory and information technology, clinical trial design, clinical research and drug and device design and discovery. Courses like MSc in medical technology regulations and regulatory affairs should be introduced in the academics.
Other speakers on the event - Dr Aniruddh Vaidya from Analytical Solutions spoke on 'Pharmaceutical products –Extractables and Leachables concept', Dr Vinay Nayak, president, Alembic Pharmaceuticals on 'Pharmacopoeia Harmonization –Indian Perspectives and Challenges' and Dr Prashant Dixit, general manager, analytical research, Watson Pharma on 'Pharmaceutical Reference Standards'.