PARADIGM SHIFT IN PHARMA REGULATORY VIGILANCE

New Delhi
We agree that medicine is a double edged sword either saves life or kills life. Strong regulatory norms and regulatory vigilance can save more valuable life.
Building strong quality culture, adapting quality metrics, and demystifying data reliability issues were some of the broad issues discussed at the Indian Pharmaceutical Forum, organised by leading Indian pharma companies including Sun Pharmaceuticals, Lupin, Torrent, Cadila and Cipla.
The forum provided a platform to discuss ways to fix quality of drugs produced by leading drug regulators in the world including USFDA, UK’s Medicine and Healthcare Products Regulatory Agency and India’s Drug Controller, Drug Controller General of India,(DGCI).

“Quality is not an Indian problem, but a global problem. India has not done very differently than US or Europe,” Mathew Thomas, country director of the US Food and Drug Administration (USFDA), stated.

Qualification of staff at the ground level in pharma companies and issues about data integrity were some of the concern areas raised by Gerald Heddell, Director of Inspection, Enforcement and Standards at MHRA. Brenden Cuddy, head of the EMA’s manufacturing and quality compliance service, commented that the idea of inspections was to broaden coverage and maximise resources by focussing on sites of highest risk.

Some of the other issues related to data integrity were pointed out by Thomas Cosgrove, Director Office of Compliance at the FDA including lack of controlled access to computer systems, deletion of data and back-dating. Pharma company representatives stated that continuous engagement with the regulators will help raise the quality bar of the Indian drug industry and there was a need for senior management to be involved in manufacturing.
If medicine saves life then why there are so many different norms for quality medicine production and marketing.US FDA has their own set of norms and CDSCO has another set of norms and both require different documents for registeration.What are the quality parameters are following by Schedule M, GMP, WHO unit and  USFDA approved unit in India. If all medicine is safe then there should be one CTD guideline for global pharma industry and one set of rule to be followed by global pharma industry.
Email – medicarechief@gmail.com

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