In the run up to the setting up of the Central Drug Authority (CDA) in the country on the lines of US FDA, the Union health ministry is learnt to be preparing to send a high level delegation to the US to study the working of FDA with a view to facilitate the establishment of CDA, for which a Bill has already been introduced in Parliament.
According to sources, as per the talks between union health minister Dr Ambumani Ramadoss and the US secretary of health and human services Michael O Leavitt along with US FDA commissioner Andrew C Von Eschenbach recently, a delegation would go to the US to study the FDA patterns in detail. The US, on its part had assured all guidance and assistance to set up the CDA in India. Health ministry sources said the committee was yet to be finalized for the purpose.
While the industry, especially the small scale sector, is apprehensive of India toeing the typical US FDA line by setting up the controversial CDA, both the countries are planning a number of measures to strengthen the mutual ties in streamlining the domestic drug industry.
Apart from the cooperation on CDA, the US FDA has begun scouting for a person as its representative to strengthen the presence in the country, though not inclined to open a full-fledged office at present. The US drug authorities are trying to lure in the former DCGI, Dr M Venkateshwarulu to intensify its operations in the country, it is learnt. However, Dr Venkateshwarulu, who just stepped down from the office, has a few other offers too at hand and is not yet decided on the US FDA post.
Though a full-fledged office at this stage is ruled out, the US FDA is so keen to have a representative in the country as part of its new strategy to build safety into every product and develop commonly shared standards. The US is in talks with different countries to work out common safety norms, as the current import protection system was not adequate. The US receives goods worth two trillion dollars from eight lakh manufacturers across the globe every year.
As the head of a working group to examine the importing practices, Leavitt made an extensive visit to India recently to study the functions of ports like Kochi and manufacturing facilities like that of Dr Reddy's, besides holding talks with the officials and ministers.