Special cell in CDSCO to coordinate with agencies like ICMR for monitoring studies

Posted on Updated on


The Union health ministry has constituted a special Cell in the Central Drugs Standard Control Organisation (CDSCO) to coordinate with research agencies like ICMR for monitoring several studies to enable CDSCO for continued evaluation of drugs marketed in India and to take regulatory actions.

Dr Ramkishan, deputy drugs controller of India (CDCSO HQ); Somnath Basu, assistant drugs controller of India (CDSCO HQ); and M Balakumar, drugs inspector (CDCSO HQ) are the members of the Cell which will coordinate with research agencies like ICMR for the conduct of various studies.

According to sources, the members of the Cell will coordinate with research agencies such as ICMR for the conduct of specific studies for the post-marketing surveillance of drugs, rational use of medicines, drug utilisation studies, adverse drug reaction monitoring, etc that would enable CDSCO for continued evaluation of drugs marketed in India and to take regulatory actions on continued use of such drugs in the country.

The health ministry’s decision to constitute a cell in this regard is based on the recommendations of the Prof Ranjit Roy Chaudhury committee which in its reports had said that the CDSCO may need information continuously on post-marketing surveillance of drugs,  rational use of medicines, drug utilisation studies and adverse drug reaction monitoring, etc.

It will be useful if a research unit is created within the CDSCO. This unit would initiate and sponsor studies in these areas to be able to get the needed information to help in decision making, the report had recommended.

The ministry had constituted an expert committee in February last year under the chairmanship of Prof Ranjit Roy Chaudhury to formulate policy and guidelines for approval of new drugs, clinical trials and banning of drugs. After much deliberations, the committee submitted its recommendations in September, 2013, recommending sweeping changes in all these sectors.

 Source: PharmaBiz

Advertisements

Let us know what you think!

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s