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Pharmaceutical companies must disclose to the drug regulator the terms of all financial arrangements with any clinical research organisation (CRO) or investigators to conduct clinical trials.
A recent notification by the Drugs Controller General of India (DCGI) said companies must furnish “information regarding financial support, fees, honorarium, payments in kind, etc, to be paid to the investigator as per contract entered into by the sponsor with the investigator or institution in clinical trials”.
The idea is to bring in transparency and ensure no unfair means are used by either companies or investigators in clinical trials to manipulate data or mishandle patients, an official said.
The guidelines for good clinical practice require drug makers to enter into a formal and legal agreement with an investigator or CRO before starting a clinical trial. This agreement is supposed to detail the terms of the trial. The regulator has now said companies must ensure this agreement includes financial details between the two parties, to be furnished to the regulator while seeking an approval for the trial.
“The agreement should also define the relationship between the investigator and the sponsor in matters such as financial support, fees, honorarium, payments in kind, etc,” the notification said.
The move comes in the wake of the Supreme Court asking the government to keep a stringent check on clinical trials conducted in the country.
Although companies are required to seek permission from the DCGI to conduct or outsource clinical trials in the country, keeping a check on unethical practices had become an issue. After the apex court’s strict directions in the matter, the regulator and the health ministry are putting several guidelines in place.
