The Drug Controller General of India (DCGI) has rejected the demand of an Aurangabad-based non-governmental organization (NGO) to impose an immediate ban on a wide range of neuroleptic drugs, used for treatment of schizophrenia and related disorders.
The NGO, Manav Mann Satya Shodhak Pariwar, had appealed to the DCGI in October 2002, blaming the neuroleptic drugs including thioridazine, chlorpromazine, haloperidol, and risperidone, for a number of debilitating and irreversible side effects in a growing number of patients.
In a letter to the NGO sent last week, the DCGI wrote that, "Various studies all over the world have shown that anti-psychotic drugs have cost effective benefits. The psychotic disorders are at times disabling and appropriate use of these drugs cuts down the disability."
The letter addressed to Dr Sanjay Helale, the spokesperson of the NGO, also mentioned that an expert group was set up under Dr R N Salhan (Officer on Special Duty), which met on November 22 and decided that there was no need to ban the drugs.
If the DCGI's office had agreed, it would have impacted the sales of several products with sales running into several hundred crore of rupees and possibly forced a number of pharmaceutical companies to sustain huge losses. Among these are pharmaceutical giants like Torrent, Sun Pharma, and Ajanta Pharmaceuticals (which manufacture haloperidol), Rhone-Poulenc and Sun Pharma (chlorpromazine), Novartis, Mano Pharma and Sun Pharma (thioridazine).
Dr Helale and his colleagues in their letter stated, "We have come to believe that millions of people all over the India are falling prey to the dangerous, toxic, adverse effects of the antipsychotic drugs. Moreover, these drugs are often prescribed without giving adequate information to the patient concerned. In many cases, the medicines are administered without the patient's consent."
"Neuroleptic drugs are known to be responsible for irreversible brain damage, neuroleptic malignant syndrome, and even death, while impotence or permanent blindness," said Dr Sanjay Helale, a practicing ENT surgeon himself.
In his letter, Dr Helale had quoted studies conducted in the United States by Dr Peter Breggin, who is one of the world's fiercest campaigners against the availability of neuroleptic drugs. Dr Breggin has asserts that antipsychotics drugs are responsible for the worst epidemic of long term brain damage in history.
Similarly, Elemer Szabadi, professor of psychiatry Queen's Medical Center, Nottingham, has described the Neuroleptic Malignant Syndrome, which all antipsychotic drugs can provoke and which proves fatal in upto 50 per cent of cases!
In the Standard Textbook of Psychiatry by Kaplan and Saddock, there are frightening descriptions of how neuroleptics can cause permanent blindness, tardive dyskinesia, and even impotence, apart from gynecomastia and galactorrhoea.
Dr Helale also questioned the logic of testing psychiatric drugs in animal models, since animals are not able to communicate with human beings. "What exactly do researchers study on animals? The answer is undoubtedly their physical activities only. At no cost, under any circumstances, can the interpretation of these studies can be applicable to human mind. Thus the purpose of these studies is totally defeated," he adds.