With a view to enhance patient safety and provide effective regulatory services in the country, the Central Drug Standards Control Organization (CDSCO) is all set to embark on a mission aimed at transforming and revamping the present regulatory system. Through this mission, CDSCO plans to change the entire legal and regulatory framework in such a way that it will be able to address the issues faced by the patients as well as the industry at large.

The decision to undergo massive structural change was unanimously agreed upon after analysing the issues that was highlighted in the 118 pages report submitted at the Rajya Sabha by the Parliamentary Standing Committee on health and family welfare in May. The report gives a detailed background of the present state of drug regulation in India and the manner in which it severely compromises the safety of Indian patients.

Report which is exhaustive and researched thoroughly raises very serious issues of overturning of Indian drug regulatory laws. With an aim to address these issues and put a rest to all the speculations, the CDSCO will be initiating the process of revamping the whole regulatory body during the first DCC meeting under the present DCGI, Dr G N Singh which is going to be held in Delhi on July 13.

Dr G N Singh informed that the changes will be undertaken as per the suggestions enlisted by the committee along with consultation from experts from the field so that main focus in given on needs and safety of the patent. He pointed out, “We are in the process of identifying the core problems that is affecting the regulation of the Indian drug industry, so that we can change it accordingly to ensure patents safety and health. We would like to reinstate that our main agenda and mission is to safeguard and enhance the public health by assuring safety, efficacy and quality of the drugs, cosmetics and medical devices that are used across the country and we will take all possible measures to ensure strong implementation of the same.”

It is understood that the CDSCO is at present working on the minutes of the meeting which will be clearly focused on the necessary changes required in the Indian regulatory system. Discussion will also be focused on increasing the work force with qualified man power and forming a more stronger group that is dedicated to work for public safety.

He informed that one of the main agenda during the DCC meeting would be to sensitise and inform all the drug controllers on present condition of the drug regulatory system and deliberate on ways to build a strong regulatory system in the states and at the centre. Special focus will also be given on establishing the Indian drug industry as an innovation based industry so that they get a universal recognition for their work. Dr Singh assured that their renewed vision is streamlined to support and recognise the efforts of the industry so that this will encourage them to take a innovative route.

“We have acknowledged the fact that our present system does not support innovation as it is expected. Thus we have decided to change our system accordingly so that it is more patient and innovation friendly,” Dr Singh stressed.