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Healthy Skepticism Library item: 9735

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: Journal Article

Ghosh A, Hazra A, Mandal SC.
New drugs in India over the past 15 years: analysis of trends.
Natl Med J India 2004 Jan-Feb; 17:(1):10-6


Abstract:

Background. New drugs are appearing in the Indian pharmaceutical market every day. To study the trends we analysed the pattern of new drug approvals and introductions in India over the past 15 years (1988-2002). Methods. Lists of new drugs approved by the Drugs Controller General of India, released half-yearly, were obtained and entered into a computer database. Additional Information, such as anatomical therapeutic chemical coding, availability status till 31 December 2002 and source were added to this database before analysing overall time trends and the situation in individual therapeutic categories. Result. Excluding unrecognized and compound formulations and 28 veterinary products, 396 drugs were approved for clinical use during this period. Of these, 315 have also been launched in the market and 5 were subsequently withdrawn. Nervous system-related drugs accounted for the largest number of approvals (82), followed by antimicrobials (73) and cardiovascular drugs (57). Five new antimalarials have emerged but other tropical diseases have been mostly ignored. Eleven vaccines have been added. Conclusion. There has been a sharp spurt in the annual number of approvals and introductions. The proliferation of brands and fixed-dose combinations has kept pace with the introduction of new molecules. Unfortunately, most new drugs are not major therapeutic advances. In the context of this rapid proliferation, meeting the information needs of prescribers, establishing an effective nationwide pharmacovigilance system and reorienting the focus of pharmacology education – from information provision to development of self-learning and critical judgement skills – are some issues for concern.

Keywords:
Databases Drug Approval/legislation & jurisprudence Drug Approval/statistics & numerical data* Drug Industry/statistics & numerical data Drug Industry/trends* Drug Information Services Humans India Pharmacology/education

 

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Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909