Murky Drug Trial on Mentally ill and infants

Immediate action against the doctors conducting illegal drug trials

Greetings,

To

Drugs Controller General of India

Sub-Murky Drug Trial on Mentally ill and infants

Respected Sir,

A dozen government doctors were fined Rs.5,000 for conducting drug trials on children and mentally challenged persons. The doctors had expressed their inability to provide details of drug or vaccine trial, citing a provision of the Drug and Cosmetics Rules, 1945, The trials were done on 1,883 poor and unsuspecting hospital inmates, many of whom suffered from side effects and some even lost their lives.

Between 2006 and 2010, the paediatrics department of MGM Medical College, Chacha Nehru Bal Chikitsalay Avum Anusandhan Kendra, and the department of medicines and neurology of M. Y. Hospital - all Indore- based - allegedly conducted thousands of clinical trials on children, men and women. What was worse, the accused appeared to have covered their tracks by not furnishing the details of the drugs or vaccines used in the experiments as also the names and particulars of the victims. In these circumstances, assessing the precise extent of damage in terms of side effects and fatalities was an onerous task.

Instead of looking at the criminal conduct of errant doctors belonging to government hospitals of Indore, the probe conducted by the city's chief medical and health officer (CMHO), Dr Sharad Pandit, merely invoked the Madhya Pradesh Nursing Homes and Clinical Establishment (registration and licence) Amendment Act, 2003, to impose the paltry penalty. The Madhya Pradesh government's disdain for the victims was further laid bare by the untouched provision of the same law that provides for a maximum fine of Rs.50,000.

Every medicine has some side effects or risks associated with its use. It is very difficult to say what kind of side effects the patients on whom the drugs were tested may have suffered. The most shocking part of the entire Indore drug trial fiasco is that the doctors conducted investigational vaccination trials on illiterate persons without telling them about the implications involved.

I demand

1.DCGI office to act urgently by instituting a time bound inquiry into the Indore trials and the violations for which there was ample prima facie evidence and the inquiry must include the Ethics Committee members who acquiesced in the violations.

2.The pharmaceutical companies sponsoring the trials should be blacklisted and thei licenses should be cancelled and they shoudl be blacklisted .

3. There have been gross violations of the Drugs and Cosmetics Act are concerned and the violations of the Indian Council for Medical Research or Medical Council of India guidelines, there should be further investigations by the DCGI and the ICMR

4. Stringent punishment and legal action to be taken against the erring doctors

Sincerely

[Your name]