The expert panel, constituted by the planning commission under the chairmanship of K Chandramouli, then secretary, ministry of health and family welfare, has recommended to the government a complete overhauling of the drug regulatory mechanism at the Centre and in the states.

The planning commission had constituted the working group on Drug and Food Regulation for the formulation of the 12th Five year plan (2012-2017) headed by Chandramouli. One of the terms of reference was to review the drug and food regulatory mechanism in the country to ensure providing quality, safe drugs and wholesome food in the country.

After delving deep into the prevailing drug regulatory mechanism in the country, the panel has found that there is inadequate manpower at the state and central levels and inadequate or weak drug control infrastructure at the state and central levels. It also noted that there is inadequate testing facilities and inadequate IT services in the country. The panel further found that there is non-uniformity of enforcement of law and regulation and also lack of training to regulatory officials in the country. The panel took note of the lack of data base also.

Summarizing the issue, the panel said, “Strengthening of drugs regulatory mechanisms is one of the major public health interventions. This ensures that safe, efficacious and quality drugs are made available to the people. Keeping in view the recommendations of the Mashelkar Committee, it is important that the infrastructure, both physical and human resource, both at the Centre as well as in the States is substantially augmented. A more transparent and effective monitoring of clinical trials is required. Regulation and control of all medical devices needs to be tightened.

“The proposed financial outlay for these activities is Rs.6256 crore for the Centre and the States which includes manpower augmentation, creation and upgradation of labs, setting up of new offices of drugs regulatory control, strengthening pharmacovigillance and creating awareness among people (care givers and receivers) regarding safe drugs both at the Centre and in the states. For providing financial and human resources support to the state, a Centrally Sponsored Scheme is proposed.”

These problems have got further accentuated with the increasing growth of the pharma industry in the country while there was no parallel strengthening of the Drug Regulatory System. For strengthening of CDSCO, the panel recommended that the Central government should create additional posts for uniform and effective implementation of Drugs and Cosmetics Act and Rules made thereunder. CDSCO would require 1045 additional posts to regulate the pharmaceutical market in the country. For this, Rs.45 crore is required per annum.

While considering the question of strengthening of state drug regulatory system it was felt that major responsibilities of the states are to grant/renew the drug manufacturing licences and sale licences. They are also involved in enforcement of various provisions of drugs and cosmetics act and rules including drawing of samples for analysis, prosecutions etc. At present, states have grossly inadequate infrastructure and manpower. There is a crying need to strengthen state drugs control organizations.

Considering the sensitivity of the pharma sector and lack of resources available with state governments, it is important to have a centrally sponsored scheme to strengthen their infrastructure, both physical and human resources. The panel recommended for strengthening of state drugs regulatory control mechanisms, which require Rs.3200 crore.