The pharmaceutical industry in the country is enraged over Union Health Minister Dr Anbumani Ramadoss' recent statement in Chennai that the CDA will be formed in the next three years on the lines of US FDA. The minister's statement came the same day the Parliamentary Standing Committee on Health and Family Welfare began a nationwide study visit on January 7 to get first-hand information from the stake holders on formation of CDA (Central Drug Authority).
"What is the purpose of the visit of the Parliamentary Committee, if the minister has already decided everything on the formation of the CDA", a senior industry association leader asks. The minister should not have made such a definite statement in the midst of the visit of the Parliamentary Standing Committee. In his speech in the CII meeting in Chennai on January 7, the minister said that the CDA will be formed in the next three years on the lines of US FDA.
Meanwhile, the industry associations have made it an issue with the visiting Parliamentary Committee. The associations, which made presentations to the Parliamentary Committee during its recent visit to four southern states, raised the issue with the Parliamentary Committee chairman Amar Singh. "Amar Singh will raise the issue in Parliament, questioning the propriety of making such a statement amid the visit of the Parliamentary Committee", association leaders who interacted with Parliamentary Committee said.
After inviting suggestions from pharma associations and other stake holders on formation of CDA, the Amar Singh-led Parliamentary Committee undertook a study visit from January 7 to get first-hand information from the stake holders on formation of CDA. The committee visited Bangalore on January 7 & 8, followed by Thiruvananthapuram on January 9 & 10, Chennai on January 11 & 12 and Hyderabad on January 13 & 14. The roadmap for the visit of other cities is yet to be finalised.
During its study visit to these cities, the committee interacted on Drugs and Cosmetics (Amendment) Bill, 2007 with representatives of small and large drug manufacturers associations, experts, organisations, NGOs, consumer forums, etc.
The committee's visit to different cities is significant as the formation of CDA has attracted flak from different quarters. Almost all the pharma associations in the country, with the exception of OPPI, have already expressed their reservation on CDA formation. Though these associations and other stake holders have sent their suggestions to the committee in writing, the visit of the committee provided them a good opportunity to present their case in a better way.
The Drugs and Cosmetics (Amendment) Bill 2007 was presented in Rajya Sabha on August 21, 2007 and was later referred to the Parliamentary standing committee to examine and put forth its suggestions.
The Bill proposes to make amendments in the Drugs and Cosmetics Act, 1940, in order to facilitate the creation of CDA and introduce centralized licensing for manufacture of drugs in pursuance of the recommendations made by the Mashelkar Committee. The central government is planning to get the bill passed in the coming budget session of the Parliament, thus to set up the CDA and begin the process of issuing licences to the manufacturers at the national level.