The newly-revived Pharmaceutical Discussion Group (PDG) has urged Parliamentary Standing Committee scrutinising the Drugs and Cosmetic (Amendment) Bill, 2007, to carefully examine the bill which has misquoted Mashelkar Committee report and left obscure norms on the qualifications for the Central Drugs Authority chairman and members.

In a letter to the committee headed by Amar Singh, which has been examining the bill aimed at constituting the CDA, the group of veterans appreciated the initiative in this regard but strongly felt for some corrections in the proposed system. The meeting of PDG on March 23, meant to revive the forum, decided also to deliberate further on the CDA bill. The founder members of the PDG including veterans like Prafull D Sheth, Dr Prem K Gupta, Dr P R Pabrai and Dr S N Sharma met again recently to finalise their suggestions on the Bill.

``Attention is invited to para 2, of Statement of Objects and Reasons, wherein, it is stated that the Mashelkar Committee constituted in 2003 had recommended setting up of a Central Drugs Authority reporting directly to the Ministry of Health and Family Welfare. This statement is factually incorrect. It is not clear as to how the term of Central Drug Authority got introduced in the Bill while the Mashelkar Committee had specifically recommended setting up of a Central Drug Administration (CDA),'' the PDG letter said while quoting from para 5.6.4 and 5.7.3 of the Mashelkar Committee.

``We also wish to draw the attention of the panel to Section 5A of Chapter 1 A of the Bill, describing qualifications of Chairpersons and Members of the of the proposed amendment, wherein it is stated that these will be persons who have special knowledge of, and at least fifteen years professional experience in pharmaceutical industry, research or teaching, or public administration, finance or law. But strangely, the proviso given under this para specifies that a person who has held the post of Secretary or Additional Secretary to the Government is competent to be appointed Chairperson or a Member of the Authority thus nullifying the above mentioned technical qualifications,'' the letter said.

The veterans also felt that Section 5 (3) about the membership of the authority was deliberately left vague and capable of being misinterpreted. They suggested that at least two persons should be those having technical/professional qualifications. ``It is strongly felt that the chairperson of the Authority should be only a technical person with high academic and professional qualifications having knowledge and experience in manufacture and quality control of medicines, cosmetics, medical devices, etc. as well as in the enforcement of drug laws, rules and regulations,'' the letter added.