A sub-committee of the Drugs Technical Advisory Board (DTAB), constituted as per the Supreme Court order to analyze the prohibition on 300-plus fixed-dose combination (FDC) drugs, has asked All India Drug Action Network (Aidan), an applicant for the case, and the industry stakeholders to submit relevant information to substantiate their claims.
The panel headed by Dr. Nilima Kshirsagar, the chair in clinical pharmacology at ICMR Mumbai, has guided both the parties to submit data in regards to the FDCs being referred to in the prescribed format on or before April 7.
The decision to request stakeholders to submit data was taken at a meeting of the panel on March 1. The sub-committee has been requested to submit the report in three months for consideration of the DTAB.
The Union health ministry had last year restricted 344 FDCs, estimated to v around 6,000 brands after a specialist committee group declared them unsafe. Drug manufactures challenged the ban in high courts the country over seeking interim on their specific brands.
In January this year, the ministry moved the apex court challenging a Delhi high court order that suppressed the prohibition because that the DTAB was not consulted by the government. Aidan, a network of non-governmental organizations in the health sector, had also filed a special leave petition in the top court against the Delhi High Court order.
The government’s technical committee has now requested that Aidan give FDC composition details and the group’s opinion on the therapeutic justification for each ingredient. They can also state whether the FDC drug should be regulated or restricted. The opinions and arguments should be based on scientific evidence and backed by expert articles published on the subject.
The drug makers or appellants are required to furnish particulars of the FDC, its therapeutic value such as increased efficacy or reduced cost, pharmacokinetic rationality with half-life details of individual ingredients and published information on its safety and efficacy.
The regulatory status of the drug in different countries also should be provided. According to the top court’s order, the sub-committee should consider the perspectives of Aidan as well as the drug manufacturers before sending its report to the government for further action.
The panel should also consider the parameters set out in Section 26A – the power to prohibit the manufacture of drugs and cosmetics in public interest – of the Drugs and Cosmetics Act for each case.