DCGI to meet zonal officials to re-examine regulatory requirement for vaccines

  • 26th November, 2012

The Drug Controller General of India (DCGI) has planned to meet senior officials from all the zonal offices across the country in the coming week to assess and examine the regulatory mechanism adopted for its vaccine manufacturing programme. The meeting will focus on strengthening and enhancing the current regulatory requirements as per the latest guidelines of World Health Organisation (WHO) to ensure safety and efficacy of the products that are manufactured and exported from India.

This initiative is intended towards reassessing the country’s regulatory system for vaccine in the wake of the much anticipated visit from the WHO’s National Regulatory Authorities (NRA) on December 12. During this visit the officials from the WHO are expected to do a thorough assessment of the whole regulatory system so as to ensure that they are in tune with the indicators developed by the WHO for the vaccines.

It is understood that CDSCO has been working hard towards evaluating the current regulatory practices over last six months with extensive work and restructuring of the whole set up. Dr G N Singh, DCGI informed that the centre has been painstakingly working towards not only maintaining the best manufacturing standards for vaccines but also have been striving hard for upgrading the same as per the changing global regulatory needs as well.

He remarked, “India is one of the largest manufacturers and exporters of vaccines world wide, reinstating our thrust on maintaining highest quality and efficacy of the products that are manufactured within our country. We have always given importance on adhering to all the required norms and regulations as mandated by the WHO and are sure that we will yet again be successful in creating a bench mark.”

CDSCO has been gearing up for the assessment from the NRA for almost last eight to ten months with lot of regulatory changes in the wake. The DCGI’s office brought about a lot of regulatory changes that were aimed at strengthening the current regulatory mechanism to ensure compliance with WHO recommendations and UN tender specifications.

Some of the notable changes adopted by the CDSCO have been with regard to getting marketing authorisation and activities licensing, regulatory inspection, authorisation and monitoring of clinical trials (CTs) etc. Dr Singh added that the upcoming meeting will basically focus on reviewing the impact and progress of these strategic decisions along with assessing the possibilities of addressing the gaps for better monitoring and implementation of the regulatory norms.