Letters to the editor
Not a lost opportunity
The article “Clinical trials, a lost opportunity for India” (FE, November 3) by Barbara Bierer and Mark Barnes is not only biased and misconceived but also full of factual errors. First, the concern in India is not on clinical trials per se but on phase II and III trials of experimental, new chemical and biological entities (NCEs/NBEs) not approved as drugs anywhere. These specific trials constitute just one-third of all clinical trials and are invariably conducted by or on behalf of foreign drug companies. Based on past experience, just one out of 100 such chemical and biological entities are finally approved as usable drugs. Second, the rules for domestically discovered and patented NCEs/NBEs are not only entirely different but quite liberal.
The two petitioners in the PIL in the Supreme Court are aware that every death that occurs during a trial need not be due to experimental molecule. However, leaving determination of the cause to investigators on the payroll of MNCs, with obvious conflict of interest, is totally unacceptable. Besides, a humiliating compensation of anywhere between $800 to $5,000 per death paid by MNCs, that too under media pressure, is an insult to India. The same companies have paid millions of dollars in the western countries. Even in Nigeria, the sum of $140,000 was paid per death in a vaccine trial. It is worth noting that not a single penny has been paid to those who were injured on account of clinical trials.
To say that regulating trials on NCEs/NMEs strictly will deprive Indian patients of new drugs is false. Apparently, the authors are not aware that rules for pre-approval clinical trials of new drugs approved in western countries are not only entirely different but liberal and even perfunctory. In fact, the multi-party Parliamentary Standing Committee on Health has suggested increased numbers and ethnic diversity of subjects for such trials.
Dr Chandra M Gulhati
Editor, MIMS (Monthly Index of Medical Specialities)
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