Delhi High Court sets aside Centre's ban on 344 fixed dose combinations, terms it haphazard

NEW DELHI: The Delhi High Court on Thursday set aside a government notification banning hundreds of fixed dose combinations (FDCs), bringing in big relief to the country's pharmaceutical industry. But the government and health activists voiced concerns over its negative impact on patient health and safety. FDCs are medicines made by combining two drugs into a single dose.

Justice Rajiv Sahai Endlaw ruled in favour of the industry in an 82-page order. “To say the least, the central government, though acting in public interest, seems to have gone about it in a haphazard manner,” the order said. “All 344 notifications… purportedly in exercise of power under Section 26A of the Drugs Act were found to be issued without following the procedure statutorily prescribed to be followed prior to issuance thereof.”

According to the order, the expert committee constituted to consider applications for approval of these FDCs by the Centre went into the aspects of risk to consumers, therapeutic value and therapeutic justification instead. The government stands by its notification and the process followed to ban these FDCs. “Irrespective of the high court verdict, we are convinced that this is a public health concern,” a senior government official told ET on condition of anonymity.


According to the official, the government intends to continue with its petitions at the Supreme Court to transfer and hear afresh all the cases related to the FDC issue. The apex court is expected to hear this petition on Friday. The government banned 344 FDCs on March 10, the impact of which was estimated to affect around 6,000 medicine brands. It was also expected to shave over Rs 3,000 crore from the Indian market estimated to have grown to over Rs 1 lakh crore.

The government and industry were at loggerheads over the move, with the central drug regulator arguing it acted in public interest after an expert committee found those medicines "irrational" and “unsafe” for consumption. The industry claimed that marketing approvals were granted after following the procedures. The ban hit several popular brands like Corex, Saridon, D’Cold Total and Vicks Action 500 Extra.

Drug makers immediately challenged it in high courts across the country, with Delhi receiving over 450 petitions asking for interim relief on specific brands. Petitions by industry associations, including Indian Drug Manufacturers Association and Federation of Pharma Entrepreneurs, followed suit—this time asking the Delhi High Court to stay the ban on all 344 FDCs. “The judgement has upheld the fact that due process and procedure was not followed by the government in issuing these notifications, thus, all 344 have been set aside,” said Ashish Prasad, who represented some of these associations.

IPA, a lobby group for many of the large domestic drug makers involved in the proceedings, claims that several medicine brands in the government’s ban list were not irrational. “We fully support the health ministry’s initiative of banning irrational combinations as long as it is done scientifically and in due process of law,” IPA secretary general DG Shah said.

Health activists have vehemently opposed the judgement over patient safety issues. “This is a decision that will undermine public health and patient safety,” said Leena Menghaney, a lawyer on public health and access to medicines.