The apex court in December referred the issue of 329 FDC drugs to the DTAB for a fresh review before recommending any action.
The Supreme Court on Friday restrained the Centre from taking any decision with regard to 15 banned fixed dose combination (FDC) drugs that were manufactured prior to September 1988.
The order was passed after a Bench led by justice RF Nariman was informed that the sub-committee of the Drugs Technical Advisory Board (DTAB) last week submitted its report on 349 FDC drugs to the central government. “…the government will act on the said report except for 15 drugs,” the Bench ordered.
The panel constituted by the government pursuant the apex court’s December 15, 2017 judgment reviewed the safety, efficacy and therapeutic justification of these FDC drugs, which were banned in 2015, along with those that had been banned before 1988.
The apex court had in December referred the issue of 329 FDC drugs to the DTAB for a fresh review before recommending any action. The court, however, kept out of the purview of its order the 15 FDCs that were licensed prior to 1988.
Two pharma majors Abbott Healthcare and Laboratoires Griffon had moved the SC, saying the 15 FDCs manufactured prior to September 21, 1988 were never meant to be referred to the DTAB/sub-committee which was constituted to re-look at the other 334 FDCs prohibited by the government by its two notifications in 2016.
The two pharma majors had asked the apex court to restrain the government from acting upon or implementing in any manner any recommendation of the DTAB/sub-committee which without any authority examined the 15 pre-1988 FDCs whose notifications were quashed by the top court.
“The sub-committee under the chairmanship of Nilima Kshirsagar did not even discuss or notice that pre-1988 FDCs were to be kept outside the purview of the re-examination. Although, the 2016 notifications on 15 pre-1988 FDCs had been quashed, the DTAB referred to all FDCs as ‘banned’ showing its complete ignorance of the SC judgment,” Abbott said in its application.
The review was ordered after the Centre had challenged the Delhi High Court ruling that quashed its March 10, 2016 notification banning 344 FDC drugs citing health risks and lack of therapeutic justification.
The ban on FDC drugs was enforced following a report by a six-member committee headed by Chandrakant Kokate, which in January 2015 had termed 963 FDCs “irrational”, posing health threats.
The Union health ministry’s ban on FDCs included painkillers, anti-diabetic, respiratory and gastro-intestinal medicines and covered about 6,000 brands from major pharma houses including Pfizer, Wockhardt, Alkem Labs, Cipla, Sanofi India, and Sun Pharma.
An FDC drug contains two or more active ingredients in a fixed dosage ratio.