The Parliamentary Standing Committee on Health and Family Welfare will take the views of all interested pharmaceutical associations on the proposed creation of a Central Drug Authority, which has already drawn flaks from different State regulators and the industry bodies.
The committee is likely to hold its meeting early second week of December and has sent invitations to all the major pharma organizations to present their views on the formation of the CDA, aimed at streamlining the drug licencing and monitoring on a centralized pattern, sources said.
Some of the industry associations like SME Pharma Industries Confederation (SPIC) said they got the invitations and they would be presenting their views on the CDA which, they felt, would only increase the bureaucratic hassles for the industry. The industry bodies are expected to garner support from maximum MPs against the CDA formation.
The Drugs and Cosmetics (Amendment) Bill 2007 was presented in the Rajya Sabha on August 21 and was later referred to the Parliamentary panel to examine and put forth their suggestions. The meeting of the panel recently got the briefing by the officials on the details of the CDA.
Meanwhile, the much-hyped CDA formation has run into criticism from many regulators in the States and pharma organizations. The All India Drug Control Officers Confederation (AIDCOC), SPIC and associations representing the small scale units have already gone on record against the CDA. Some of the industry bodies also led delegations to the Central Ministers including Agriculture Minister Sharad Pawar, who is heading the Group of Ministers, on the pharma policy to convey their apprehensions.
According to a section of the industry, the move was intended to suffocate the small scale in particular as it would increase hardships for them. They also felt the move was unnecessary at this point of time.
Though the members of the Parliamentary panel by and large welcomed the centralization of the regulatory procedures, the committee headed by Amar Singh decided in favour hearing the views of the public and the associations before finalizing its comments on the subject.
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 Centre 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.
The Bill, inter alia provides for substitution of the "Drugs Technical Advisory Board" as well as the "Drugs Technical Advisory Board for Ayurvedic, Siddha and Unani Drugs" by the CDA. It also seeks to insert a new Chapter 1A in the Act with a view to providing for the constitution of the Central Drugs Authority and other connected or incidental matters.