New Delhi: A new report submitted by the think tank Vidhi Centre for Legal Policy , has asked the Union Health Ministry to strengthen the system to protect data from academic clinical trials and clearly define rare diseases in India, while providing public comments for the draft Drugs and Cosmetics Rules.
The report has submitted clause by clause comments to the health ministry, which is finally trying to update the Drugs and Cosmetics Rules from the 1940 Act still applicable in the country.
The Rules contain “insufficient provisions to prevent the misuse of the data generated from these trials for commercial or regulatory purpose”, said the report.
Academic trials are those conducted on already approved drugs, and are geared towards collecting data on new dosage, new form of the medicine, etc. - that is not to be used for commercial purposes.
The Rules have a clause mandating that data generated from academic clinical trials is not to be used to seek approval from the regulatory authority of any other country. But the report says there is no clear system as to how the data will be monitored. Without such a system, there’s a possibility of sponsors or investigators of clinical trials in India submitting data for regulatory approval in another country.
“Especially due to data exclusivity and data protection laws in several countries, this may not be detected,” adds the report.
The report asked the ministry to make the difference between the academic clinical trials and clinical trials where the data can be used to seek regulatory approvals and for commercial purposes.
The Rules talk about orphan drugs that are used to treat conditions affecting less than two lakh people in the country. However, the report points out that this is not a “sound scientific estimate”, and could “and could end up excluding people suffering from rare diseases who are in need of orphan drugs but where the prevalence exceeds this 2 lakh threshold”.
The report also asked the risk to volunteers in both forms of trials be clearly defined, trials should include a risk management protocol and also be categorised in terms of these risks. While the Rules define a “serious adverse event” where the trial subject could die, be permanently disabled or be hospitalised, the report asks that these risks are made uniform across all official documents and there be more clarity on what is “persistent or significant disability”.
The ministry’s National Policy for Treatment of Rare Diseases, added the report, does not define rare diseases such as, in terms of number of patients as there is insufficient epidemiological data to do so. Before defining an orphan drug, the ministry must define what a rare disease is.
In this context, said the report, it is useful to refer to the definition of ‘orphan drug’ used by the US Food and Drug Administration. This definition states simply that an orphan drug is "a drug intended for use in a rare disease or condition."
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