US FDA, DCG(I) explore more ways to work together

By: |
April 05, 2015 8:30 AM

Willing to collaborate with Indian regulators, other stakeholders: US FDA

Willing to collaborate with Indian regulators, other stakeholders: US FDA

20150415ep02Sklamberg, Deputy Commissioner for Global Regulatory Operations & Policy, US FDA and Cynthia Schnedar, Director, Office of Compliance at CDER, meet with Dr GN Singh, Drugs Controller General (India)

US FDA officials recently on a working visit to India seek to take forward the work started by the then Commissioner Margaret Hamburg, when she visited last year. In a recent blog post on FDA Voice, Howard Sklamberg, FDA’s Deputy Commissioner for Global Regulatory Operations and Policy and Michael Taylor, FDA’s Deputy Commissioner for Foods and Veterinary Medicine say that their top goal on this trip is to listen and learn, understand the challenges the Indian government is facing with regard to drug and food safety and discuss with their Indian counterparts a number of significant changes in the American regulatory system that affect the relationship.

Sklamberg, accompanied by Cynthia Schnedar, Director, Office of Compliance at CDER, and other members of the visiting team, have already met with Dr GN Singh, Drugs Controller General (India) and other top officials from the Indian regulatory side. The team also met both American companies operating in India, as well as Indian manufacturers.

The blog post acknowledges that the relationship between the two regulatory bodies has been challenged in the recent past by lapses of quality at a handful of pharmaceutical firms. And while the US regulator’s first regulatory responsibility is to protect the American patient and consumer, they are also very willing to collaborate with Indian regulators and other stakeholders to ensure the achievement of highest standards of safety and quality, something they feel only benefits both nations.

More recently, in November of 2014, as a continuation of FDA’s efforts to strengthen the quality, safety and integrity of imported drugs, the FDA India Office, in collaboration with our Center for Drug Evaluation and Research’s Office of Compliance and the Office of Regulatory Affairs, held four workshops in India. The workshops were held in partnership with European Directorate for the Quality of Medicines and Drug Information Association and involved the Indian Drug Manufacturers Association, Parenteral Drug Association and Organization of Pharmaceutical Producers of India.

Over 560 participants from the pharma industry in India attended four two-day workshops conducted in November last year, which were conducted by FDA India Office, in collaboration with the US Center for Drug Evaluation and Research’s Office of Compliance and the Office of Regulatory Affairs.

The meetings were also partnered by the European Directorate for the Quality of Medicines and Drug Information Association and involved the Indian associations like Indian Drug Manufacturers Association, Parenteral Drug Association and Organization of Pharmaceutical Producers of India.

The blog post concludes with the hope that this trip will yield more examples of such fruitful collaboration, moving the regulatory relationship between two of the world’s largest democracies to the next stage, from the intention to work together, to the ability of  working together for solving the complex globalisation issues facing both nations.

EP News BureauMumbai

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