SC seeks review of fixed dose combination medicines

The Supreme Court on Friday asked the Centre to make arrangement for experts to examine 349 fixed dose combination (FDC) medicines to find out if there is any "therapeutic justification" to make these FDCs in the first place.

The experts from the Drug Technical Advisory Board (DTAB) would also check if these medicines have the therapeutic value as claimed by the manufacturers and whether they are safe.

Irrational FDCs pose a big concern in the Indian pharmaceutical market. These are drugs that are cocktail of two or more active molecules.

There are many medicines that are being sold on the basis of manufacturing permits from the state governments but without regulatory approval from the Drugs Controller General of India.

Irrational FDCs worth Rs 40,000-Rs 50,000 crore are sold in India each year, as against Rs 10,000 crore worth of scientific combinations," said S Srinivasan, co-convenor of All India Drug Action Network, a non-governmental outfit that campaigns against irrational FDCs.

The Supreme Court judgement comes against a 2016 ruling by the Delhi High Court that quashed 344 official notifications banning the manufacture of these FDCs. The companies appealed against those notifications in the high court.

Another five medicines were brought under the purview of DTAB screening.

'Apply mind'

In their ruling, Justice R F Nariman and Sanjay Kishan Kaul, also asked the DTAB to apply its mind to decide whether it is necessary in the larger public interest to regulate, restrict or prohibit the manufacture, sale or distribution of such FDCs.

"The DTAB or a sub-committee under DTAB must also indicate in its report as to why, in case it prohibits a particular FDC, restriction or regulation is not sufficient to control the manufacture and use of the FDC," the judgement said.

The technical panel is to submit its report within six months. The central government must apply its mind and act on the basis of the DTAB report.

"The 344 FDCs account for only about 5% of the value of total FDCs in India, approximately half of which are considered to be irrational. The government should proactively take advantage of the space afforded by this order to weed out other irrational FDCs in the interest of patient safety," Srinivasan said.