Government speaks up on FDC ban, tells Delhi HC banned drugs are ‘unsafe’

Clients and lawyers waiting in the Delhi High Court
Clients and lawyers waiting in the Delhi High Court

The Delhi High Court will continue hearing the petitions of pharma companies challenging the Health Ministry’s ban on 344 FDC drugs.

Today when the case came up for hearing at 2.15 pm in Court No 12, entry was restricted to Justice RS Endlaw’s court.

The government’s legal team was headed by ASG Sanjay Jain with Senior Advocate Kapil Sibal appearing for the lead petitioners.

Jain had argued that the drugs that were off market shelves were ‘unsafe’ and and not efficacious and were therefore, banned. He further argued that most licenses given to the companies for manufacturing the drugs were given by State Governments and when the State Govts did not take any action against the said ‘harmful’ drugs, the Parliamentary Committee had to intervene and conduct a proper drug trial.

Jain also submitted that it was incorrect to probe the issue of grant of licences here as even the requisite licenses had not been obtained by the drug companies.

Considering the submissions, the Bench has now asked the Govt to produce a list of all the companies that have been granted licences by the State & Central Govt and also those, who do not have the requisite licenses. The Bench has decided to give a day-to-day hearing to the cases and the interim stay granted to the companies, continues.

Meanwhile, in its short reply the Central Govt has said that a mere grant of license cannot be construed as a safety seal on the drug.

“The fact that a product which falls under the definition of a new drug but is wrongly licenced by any State Licencing Authority without any approval of the licensing authority as defined under Rule 21(b), that is Drugs Controller General (India) cannot be the basis to assume that the product is rational, safe and efficacious.”

It further goes on to say,

“Such permission from the office of DCG(I) is a pre-requisite before new drugs are licensed by the State Licensing Authorities (SLAs) for manufacture for sale in the country. However, it was observed that the manufacturers were obtaining the licences for manufacturing of such FDCs, which fall under the ambit of New Drugs, without due approval from the DCG(I) from September, 1988 till 01.10.2012.”

Defending its stance on the edifice of public safety the reply also states,

“The Government has made elaborate attempts to ensure that all facets of the matter get duly examined and no injustice is done to anyone and more importantly the safety of patients is not compromised. In the process sufficient notice and opportunity had been given to all concerned to present their case. In case, where the composition of the FDCs were found irrational even after second examination including the replies from the manufacturers/applicants, the Government had no option but to prohibit them to safeguard public interest and hence these were prohibited under section 26A in order to safeguard public health from such irrational FDCs irrespective of the manufacturer.”