This Article is From Mar 21, 2016

Court Lifting Ban On FDC Drugs Against Patient Safety: Government

Court Lifting Ban On FDC Drugs Against Patient Safety: Government

New Delhi: Government on Monday sought vacation of Delhi High Court's interim order staying the ban on some fixed dose combinations (FDC) medicines, saying it would be "against public interest and patient safety" and alleging that the drug firms' sole objective was to make profits.

The submission was made by the government in an affidavit filed before Justice Rajiv Sahai Endlaw, who had last week stayed operation of the Centre's ban on some FDC drugs of around 30 pharma companies, including Pfizer, Glenmark, Procter and Gamble (P&G) and Cipla.

Initially, the interim relief was given on March 14 to Pfizer's cough syrup 'Corex'. Later, during the course of the week, it was granted to over 30 companies, which also included Glaxo Smithkline, Reckitt Benckiser, Abbott Healthcare, Lupin, Piramal, Mankind Pharma and Wockhardt.

The court while staying operation of the government's notification till March 21 had directed the Centre not to take coercive steps against these companies. Later in some matters where companies had obtained licence from state authorities, the court had allowed government to take action under any other law available to it.

The order had come on the companies' pleas alleging that the government's March 10 notification banning over 300 FDC drugs, including cough syrup compositions, was done without issuing them a show cause notice or hearing them.

Refuting the allegations, the government affidavit on Monday said that "the interim order granted to the Petitioner would be against the public interest and endanger patient safety and, should, therefore be vacated without any further delay as the intention of the manufacturer has been mala-fide and solely motivated by commercial considerations and is to the detriment of public health and safety.

"Their objective is only to gain profits and the petition has been filed only to gain time and obstruct the legitimate functions of the Government of India."

The government said it had "made elaborate attempts to ensure that all facets of the matter get duly examined and... in the process, sufficient notice and opportunity had been given to all concerned".

It also said that FDC medicines are "new drugs" and thus, require licence from Drugs Controller General of India (DCGI) for sale and manufacture.

All the petitions filed last week and those moved on Monday were adjourned to March 28 by the court, as it could not hear them today. The court room was jam-packed with lawyers, interns, company representatives as well as scribes.

The court briefly heard, in-chamber, some counsel representing the companies as well as the government and said "interim orders will continue till next date of hearing".

In its affidavit, the government has said that between 1988 to 2012, licences for sale and manufacture of FDCs were being obtained from state authorities without seeking DCGI approval.

Thereafter, the government had put up a list of approved FDCs on Central Drugs Standard Control Organization (CDSCO) website and it was the responsibility of permission holders to inform DCGI if their product was not on the list.

It also said that a Parliamentary Standing Committee on health had in a report said that unauthorised FDCs that posed a risk to people need to be withdrawn immediately.

Then an expert committee under Professor C K Kokate was set up to deal with applications received by CDSCO from manufacturers seeking to prove safety and efficacy of their FDCs. Show cause notices were issued in cases where this panel had declared an FDC to be irrational, the affidavit said.

The government has also stated that "even if approval was granted in 1995 to a FDC, it was done on basis of available literature and knowledge at that point of time which does not bar the government from re-examining the FDC".

Referring to some of the cough syrups like Pfizer's Corex, the government has said the syrup as available in India is not approved in foreign nations.

It has also said the Drugs Consultative Committee (DSC) recommended ban on manufacture and sale of Phensedyl and similar preparations alleging that they are "rampantly misused" and "illegally exported to neighbouring countries".

Pursuant to the court's interim order, some well-known medicines on which the ban on sale was lifted were Pfizer's Corex cough syrup, P&G's Vicks Action 500 extra, Glaxo's Piriton expectorant, Reckitt's D'Cold, Piramal's Saridon, Glenmark's Ascoril and Alex cough syrups, Abbott's Phensedyl cough syrup and Alembic's Glycodin cough syrup.

Government had banned over 300 FDC drugs on the ground that they involve "risk" to humans and safer alternatives were available.

As per the notification, "On the basis of recommendations of an expert committee, the central government is satisfied that it is necessary and expedient in public interest to regulate by way of prohibition of manufacture for sale, sale and distribution for human use of said drugs in the country."

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