Clinical trials and testing rules in India: 10 yr jail term for violating rules on testing new drugs in humans

India would punish clinical research firms, if they are found breaching the standard practices and rules for testing new drugs in humans, with severe penalties including 10 years of imprisonment and cancellation of licence.

The health ministry under the government of India is planning to make certain policy changes such as amending some sections of the Drugs & Cosmetics Act — which stipulates the rules for the country’s drugs sector –to bring in the new provisions.

“The new set of guidelines would ensure that those who do not follow the norms approved by the Drug Controller General of India (DCGI) for conducting clinical trials on humans are brought to book and punished,” Dr Vishwa Mohan Katoch, secretary in the department of health research and director general of the Indian Council of Medical Research (ICMR), stated in a media report.

Currently, India is emerging a favourable destination for drug testing in humans. Almost all the leading drug makers in the world have clinical research operations in the country. Besides, a large number of Indian and global clinical reserach organizations (CROs) are conducting human trail services for pharma companies across the world.

According to ClinicalTrials.org, a clinical trails registry maintained by the National Institute of Health, USA, there are 925 clinical studies are currently happening in India.

A vast diverse gene pool, drug naive patients -people who are not exposed to other medications, availability of large number of patient in almost all disease categories, increasing number of hospitals and doctors are the major attractions for foreign pharma companies.

Those pharma companies who prefer to conduct clinical studies in India also see a lot of cost savings as the patient recruitment time for trials are considerably, short compared to the western countries. 

Reduced time means substantial cuts in the overall cost of the highly expensive and time consuming clinical research.

At present, clinical research market is estimated at $389 million, which is forecast to touch $1 billion by 2010.

However, with the multiplying number of trials, there is also a growing concern among NGOs and various human rights groups that the Indian 

population is being exploited as guinea pigs by multinationals drug companies.

They also fear that certain important practices and guidelines for recruiting and conducting drug studies in humans are not followed in India. For example, informed consent, wherein the patients needs to be told about the benefits and possible risks of the new medication which is being tested in him or her.

Similarly, human rights activists also allege widespread unethical trials practiced throught the country by some physicians in cohort with drug companies. 

In India there is also no proper auditing of CROs to find out if there are any lapses in the conducting of human trials.

So, the new guidelines for conducting clinical trials of experimental drugs in India, are framed by ICMR, have been approved by the ministries of law and health, would go in a long way to address these concerns, it is hoped.

The move is intended to improve the country’s image in this area, which has been sullied by some cases of alleged unethical and sub-standard practices.

Generally, human studies using experimental drugs are done in three phases –Phase I, Phase 2 & phase 3.India does not allow Phase 1 trials, or initial experimentation on human subjects after a drug is found effective on laboratory animals, for molecules developed abroad.

In October last year, an infant’s death was reported during the trial Wyeth’s advanced pneumonia vaccine. It was found, later, that the child had been administered not the experimental vaccine but an already licensed, widely distributed vaccine in the double-blind study. But the child should not have been enrolled in the study at all on account of a cardiac condition it suffered from, the drug regulator’s audit had found. However, no action has been initiated against Wyeth in this case as there is no legal provisions in India.

In another incident last year, 49 children died during clinical trials at the country’s premier medical institution All India Institute of Medical Sciences. Later, a high-level committee found that none of the drugs had been tested on healthy children and rather they were suffering from high-risk illnesses and were also in a serious condition.

It is not yet mandatory in India to register clinical trials. There are only voluntary guidelines for testing experimental drugs on humans. Drug makers as well as companies which do such experiments for a fee may choose to register themselves with the ICMR or with the World Health Organisation (WHO).