A sub-committee of the Drugs Technical Advisory Board (DTAB), constituted in accordance with the Supreme Court order to examine the ban on 300-plus fixed dose combination (FDC) drugs, has asked All India Drug Action Network (Aidan), a petitioner in the case, and the industry stakeholders to submit relevant data to substantiate their claims.

The panel headed by Dr Nilima Kshirsagar, the chair in clinical pharmacology at ICMR Mumbai, has directed both the parties to submit information regarding the FDCs in question in the prescribed format on or before April 7. The decision to ask stakeholders to furnish data was taken at a meeting of the panel on March 1.

Dr Rao V S V Vadlamudi, president, Indian Pharmaceutical Association, Telangana; O S Sadhwani, Joint Commissioner, FDA, Maharashtra; one representative from Indian Medical Association, New Delhi; one representative from Indian Medical Association, Mumbai; and one Clinical Pharmacologist are the members of the sub-committee.  Sanjeev Kumar Gupta, DDC (I) CDSCO (HQ) is the convener of the committee which  can co-opt subject experts as and when required. The sub-committee has been asked to submit the report in three months for consideration of the DTAB.

The Union health ministry had last year banned 344 FDCs, estimated to affect around 6,000 brands, after an expert committee declared them unsafe. Drug makers challenged the ban in high courts across the country seeking interim relief on their specific brands. In January this year, the ministry moved the apex court challenging a Delhi high court order that quashed the ban on the grounds that the DTAB was not consulted by the government. Aidan, a network of non-governmental organisations 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 asked Aidan to provide FDC composition details and the group’s opinion on the therapeutic justification for each ingredient. They can also state whether the FDC drug needs to be regulated or prohibited. The arguments and opinions should be based on scientific evidence and backed by expert articles published on the subject.  

The drug makers or appellants are expected 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 data on its safety and efficacy. The regulatory status of the drug in other countries also should be provided.

As per the top court’s order, the sub-committee should take into account the views of Aidan as well as the drug manufacturers before forwarding its report to the government for further action. The panel should also deliberate on the parameters set out in Section 26A -- power to prohibit manufacture of drugs and cosmetics in public interest -- of the Drugs and Cosmetics Act in each case.

Healthcare professionals and advocacy groups have cheered the apex court intervention as numerous studies show that thousands of medicines go on sale in Indian market without approval. A recent report in the British Journal of Clinical Pharmacology stated that of 118 FDC antibiotic formulations sold in India between 2007 and 2012, 64 per cent were not approved by the Central Drugs Standard Control Organisation. Only 4 per cent of the FDCs were cleared in the US or Britain.