The Drugs and Cosmetics (Amendment) Bill 2007, seeking to set up the Central Drug Authority to streamline the drug licencing and monitoring at the national level, has been referred to the Parliamentary Standing Committee on Health and Family Welfare.
The committee, headed by Amar Singh, met here on Tuesday and took the preliminary notes on the much-awaited CDA formation as the Government officials presented the concept and details of the Bill to the members.
The committee decided to invite the suggestions from the public and the concerned groups on the proposed CDA before finalizing its comments on it. The officials also clarified several points on the CDA and the idea was welcomed by the members, sources said.
The Bill was introduced in the Rajya Sabha on August 21 and the committee would now examine it and make its report, giving suggestions and recommendations to be brought in further. 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 session of the Parliament, thus to set up the CDA and begin the process of issuing licences to the manufacturers at the national level, on the lines of FDA regime in the United States.
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.
The bill also has a new chapter detailing grant of permission for clinical trials, punishment for conducting clinical trial without permission, trial of offences, etc.
``In order to have wider consultations, the Committee has decided to invite written memoranda containing suggestions/ views/ comments of individuals / institutions/ organizations interested in the subject matter of the Bill,'' sources said.
Those desirous of submitting memoranda to the Committee may send two copies thereof, either in English or Hindi, to T N Pandey, deputy director, Room No 222, Rajya Sabha Secretariat, Parliament House Annexe, New Delhi - 110001 [Tel: 23035429(O), 27614506(R) Fax: 23018708] within 30 days. The committee also invited oral evidence from the desiring groups and persons in this regard. They can write to the concerned official ( E-mail: rsc-chfw@sansad.nic.in, tn.pandey@sansad.nic.in), sources said.