The Mashelkar Committee for reforms in Indian drug regulation will hold its last meeting on October 21, 2003. The SSI sector has gone an opportunity to present their views before the committee, it is learnt. The committee is to work on the final report that has to be submitted a week later.
The committee was set up early this year under the chairmanship of Dr. R.A. Mashelkar to examine all the aspects regarding the regulatory infrastructure and the extent and problem of spurious/substandard drugs in the country. The Committee was asked to make recommendations and suggest a roadmap for implementation of the recommended measures so that this problem could be solved in its entirety.
The Mashelkar Panel is known to have asked representatives of the small-scale drug-manufacturing sector to present their views before the final meeting of the committee. The views of the SSI sector is of atmost importance as the sector would be the most affected group if the stringent rules and regulations that are in the making are agreed upon by the committee and later pursued by the central government.
The Madhya Pradesh Small Scale Pharmaceutical Manufacturers Association will be presenting the case of SSI drug sector, sources said.
The interim report of the committee submitted three months back had concluded that the existing infrastructure at the Center and States was not probably adequate to perform the assigned functions efficiently and speedily. The Committee felt that creating another authority would not solve the problem at hand. It was essential to strengthen the existing organisations to enable them to undertake all the functions envisaged for NDA. A strong well equipped and professionally managed CDSO, which could be given the status of Central Drug Administration (CDA) was the most appropriate solution.
It had also noted that a strong CDA would require significant and highly qualified human capital. "It would, of course, need the creation of significant additional posts at the headquarters and at the field offices. It would also involve the commitment of the Government for additional funds. If the CDA has to perform the licensing of all manufacturing units in the country, it would need to set up offices in many States, where there is a concentration of drug manufacturers, and on a regional basis in States, where the drug manufacturing activity is less significant. This means enhanced deployment of technical manpower in the proposed CDA."
The final report is to come out with a proper structure and functions of the CDA suggested in the interm report.