The Prof Ranjit Roy Chaudhury expert committee has recommended that the Central Drugs Standard Control Organisation (CDSCO) should be upgraded to a separate organisation/authority, with the DCGI at par with heads of similar organisations of the government of India as this will overcome the current malady of lack of functional and financial autonomy.
In its recent recommendations to the government, the committee said that reorganisation of the CDSCO is necessary as the lack of functional and financial autonomy “is the biggest bottleneck for decision-making and is causing enormous delays in day-to-day functioning”. The qualification and experience of the DCGI should be similar to that of a secretary or director general of other councils as this will overcome the current discrepancy that a Deputy Drugs Controller is expected to be more qualified and experienced than the DCGI, the panel in its report said.
In yet another significant recommendation, the committee said that all drug approvals, whether new or existing or generic, should lie only with the CDSCO, but some of the functions related to inspections, monitoring clinical trials and pharmacovigilance can be shared with the state authorities. Reporting of adverse events (AEs) and SAEs can be made to both agencies for better coordination and early intervention for weeding out unsafe, ineffective or sub effective drugs. There should be a regular dialogue in this regard between the Central and state regulatory agencies.
Regulatory science is not well developed in various curricula for medicine, pharmaceutical science or other biological and related sciences. As such, there is a severe lacuna in expertise related to regulatory issues. In-house staff as well as experts need constant updating of their skills. Till in-house expertise is developed as in other regulatory agencies such as the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), expertise of subject specialists may be utilized on a contractual basis with appropriate confidentiality and conflict of interest agreements, the committee recommended.
In its report, the committee further recommended that the current pharmacovigilance programme needs expansion and strengthening to cover the whole country. It should be reviewed and reorganized to detect unsafe drugs at the earliest. In addition, a participative system should be put in place involving the medical community, pharmacists, industry and patients.
It also recommended that a continuing education programme for all officers and technical staff in the CDSCO and state DCAs to upgrade their knowledge by suitable in-service training programmes within and outside the country should be put In place, so that the domestic knowledge base is at par with international standards.
The Prof Ranjit Roy Chaudhury expert committee was constituted by the union health ministry in February this year to formulate policy, guidelines and SOPs for approval of new drugs including biologicals, clinical trials and banning of drugs.