The drug lag: new drug introductions in India in comparison to United States.
BACKGROUND
Important drugs become available late in India, some much later, than in the United States. The prevailing trends in new drug introduction in India as compared to USA have been looked into this study.


OBJECTIVE
To determine the trends in new drug introduction, both qualitative and quantitative, during the period, 1988 to 1999, in India.


METHODS
Data search, compilation and analysis.


METHODS
Various issues (1982-1997) of "Journal of the American Pharmaceutical Association" and "Indian Drug Manufacturers Association" Bulletin (1988-2000).


METHODS
Average drug lag, trends in drug lag over years (1988-1999), drug lag by therapeutic categories, drug lag by FDA classification of drugs.


RESULTS
Average drug lag in India during the years 1988 to 1999 was 4.02 +/- 2.77 years. It has shown a decreasing trend over the years. Gastrointestinal drugs have the least drug lag (1.2 +/- 2 years). Cardiovascular drugs suffer the highest drug lag among therapeutic categories (5.21 +/- 2.2 years). 1AA drugs and 1P drugs (FDA classification) are priority drugs in India also. 1A drugs, which are important new therapeutics agents have been unfortunately neglected by drug developers and regulatory authorities in India.


CONCLUSIONS
Important new drugs become available in India with a drug lag. This 'drug lag' has declined over the years. Qualitative analysis show that 1A class drugs, supposedly the most important category, has been the worst affected.
Karan
R S
RS
Department of Pharmacology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
Malhotra
S
S
Pandhi
Promila
P
D017277:Drug Approval / Q000706:statistics & numerical data*; D006801:Humans; D007194:India; D013997:Time Factors; D014481:United States