State Ministry Of Health Research Articles

Regulatory milieu in India.

The regulatory agency under the control of the Food and Drug Administration operating at both central and state levels in India is described. The Central Drug Controller operates under the Ministry of Health. Together with a panel of experts in an advisory capacity, a Drug Technical Advisory Board and its own staff of pharmacologists, chemists, and pharmacists, the Central Drug Controller, administers the introduction of new drugs, marketing and quality control, and drugs and cosmetics regulations. The State Drug Control Administration [unctions under the state Ministry of Health, working in close liaison with and under the supervisory control of the Central Drug Control Administration. The State Drug Controller enforces quality control during pharmaceutical manufacture, checks on quality control of marketed drugs, and enforces compliance witn Food and Drug regulations in the state. Prior to initiation of clinical trials, the sponsor is required to submit preclinical data and obtain permission for Phase I, II, and III trials, submitting data at each stage. Complete teratogenic data are to be submitted prior to receiving marketing permission. If clinical trials have been carried out in other countries, the available data of these trials should be submitted. The regulations for the introduction of new drugs in general follow the recommendations by WHO. Even if a drug has been marketed outside the country, the drug control authorities require limited clinical trials, particularly to determine the dosage and safety in the Indian population, because of lower body weight, nutritional status, and lower plasma protein values, the last being important as binding sites. Also unexpected toxicities may be revealed because of genetics and racial differences not noted in the country of the drug' sarigin. Monitoring of efficacy and of adverse reactions for at least 3 yr after marketing would be desirable, but is not done at present. The mechanics of collecting such data in India at present are not defined and are difficult.