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AIDCOC wants govt to clarify facts on quality issue charges to boost confidence on regulators

Suja Nair Shirodkar
Monday, January 5, 2015, 08:00 Hrs  [IST]

Concerned by the growing incidence of mistrust among global market over the flared-up of quality issues of Indian generic drugs as scripted by vested interests, the All India Drugs Control Officers' Confederation (AIDCOC) wants the government to take cognizance of this matter immediately.  Not only does the association want the Centre to clear the doubts of the critics by clarifying the facts, they also have appealed to the industry and the government to work together on addressing the core issues.

One big dilemma that the Indian companies are facing at present is lack of proper knowledge on requirements on data integrity, in spite of its necessity.  AIDCOC points out that most of the quality issues raked up by the media over the quality of the Indian generic drugs is due to non compliance of the data integrity rather than the issues in the quality of the end product.

Ironically, lack of proper training and understanding of the concept among the stakeholders and even the regulators at some point is being a hurdle, giving rise to such untoward events, pointed out Ravi Uday Bhaskar, secretary general of the AIDCOC.

“This is where the association wants the government and the pharma companies to work together to bring in better clarity on data integrity. After analysing the current situation, there is an innate need to sensitise the employees on the importance of data integrity for reviewing and assuring the quality parameters. For which adequate training is essential right from the base-level to the top, while duly introspecting the role of the regulators as guiding force in this initiative,” he stated.

He further stressed that considering the huge risk to the reputation of the industry and business globally; steps should be taken to avoid any circumstance in the future, that may give rise to data integrity issues. AIDCOC stressed that such unfavorable market condition can further breed mistrust and confusion among stakeholder, thus making it utmost essential for the government to come clean on it.

It is with this in view that Bhaskar who is also the chairman of the 66th Indian Pharmaceutical Congress (IPC), which is going to be flagged off in Hyderabad from January 23 to 25 is going to have a designated drug regulators meet.

Drug regulators from across the globe along with their Indian counterparts are expected to have a brainstorming meeting on regulatory challenges and other issues. Bhaskar stressed that most importantly, this opportunity will be utilised to clarify Indian regulators stand on quality issues to the global media and the regulators. Experts point out that it is a much needed step especially since, such rumors not only affect the morale of the generic drug industry alone but also questions the ability and competence of Indian drug regulatory mechanism as well.


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