The All India Drugs Controller Officers Confederation (AIDCOC) has suggested to the government to form the Central Drug Authority (CDA) on the lines of National Food and Standard Authority established under the Food Safety and Standards Act, 2006. Earlier, some pharma associations had made the same proposal to the government.

In its proposals and suggestions sent to the Parliamentary committee, constituted under Amar Singh, MP, to examine and seek suggestions on CDA formation, the AIDCOC said that the scheme under the Food Safety and Standards Act, 2006 is ideal in the context of our federal structure and in the context of division of legislative powers of the central and state governments.

"Therefore, if the Central Govt. considers it absolutely necessary to establish Central Drug Authority it should be like National Food and Standard Authority established under the Food Safety and Standards Act, 2006. The scheme under Food Safety and Standard Act, 2006 should also be followed by making provision for appointment of Commissioner of Drug Safety in each state", the AIDCOC suggested.

The AIDCOC in its letter suggested that the powers, functions and duties of the CDA should be laid down in elaborate manner. It should devote its energy and resources in legislation, policy making, monitoring of implementation at state level, continuous review of the products approved at state level, import and approval of new drugs including clinical trials. The CDA should have powers to issue directives to the State Drugs Control Organizations and to review the actions taken by the State Drugs Control Organizations. The implementation of the Act including licensing should remain with the State Drugs Control Organizations.

The CDA at national level should be established with powers and functions in such a manner so that the legislative scheme and the division of responsibilities between the central government and state governments are not tinkered with. The CDA should be in addition to the Drugs Technical Advisory Board and substitute to DTAB. It is necessary to ensure that out of five member of the CDA at least two members are technical experts in pharmaceutical field. The State Drugs Controller or the officers of the level of Joint Commissioners with outstanding record should also be considered eligible for appointment to the post of Chairperson or Member of the Central Drug Authority.

The priority should be given to strengthening of the Drugs Control Organization at state level. The statement and object and reasons should have specific clause to focus on strengthening of the Drugs Control Organizations at central and state level. The objectives of strengthening can be achieved by incorporating provisions under the bill for appointment of Commissioner of Drugs Safety in each state. He should be technically qualified person and should be head of the department and controlling authority. It is necessary to strengthen Drugs Control Organizations at state level in terms of uniform organizational structure, adequate infrastructure, adequate and competent manpower.

The central government should take immediate steps to ensure that the Drugs and Cosmetics (Amendment) Bill, 2005 is immediately passed so as to provide for stringent punishment to the offenders for speedy trials under the Act.

The CDA and the Commissioner of Drug Safety should be given statutory responsibility to take steps to eradicate menace of spurious drugs by implementing various recommendations made by Dr Mashelkar Committee. The CDA and Commissioner of Drug Safety should be legally obliged to take suitable measures including following suggested measures to tackle menace of spurious drugs, the AIDCOC suggested.