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Home / Companies / News /  Ban on fixed dose combination drugs in public interest: govt tells Delhi high court

New Delhi: The government on Monday urged the Delhi high court to lift its stay on a ban imposed on some fixed dose combination (FDC) drugs, saying the ban was in public interest.

“Where the combination of FDCs were found irrational even after second examination including replies from the manufacturers/applicants, the government had no option but to prohibit them to safeguard public interest," the government said in an affidavit.

The government’s response, reviewed by Mint, was on a plea by Pfizer Ltd and other drug makers challenging the ban imposed by the health ministry on 344 FDC drugs.

An FDC is a cocktail of two or more active drug ingredients in a fixed ratio of doses.

Justice Rajiv Sahai Endlaw on Monday said that the existing interim stay on the ban imposed on various drugs would continue till the next date of hearing. The case will be heard next on 28 March.

The government banned FDC drugs, extending to about 6,000 brands, on 10 March, citing health risks, based on a report by a six-member committee headed by Chandrakant Kokate.

The Kokate panel, which submitted its report on 20 January 2015, termed 963 FDCs “irrational", posing health threats.

Pharma companies soon moved the high court. Pfizer was the first to be granted a stay on the ban of its cough syrup Corex. The high court said the government action appeared hasty and arbitrary.

However, the government, in its affidavit, said that it had given the pharma companies enough chances to respond to its show-cause notices. These show-cause notices were sent to the drug makers who had applied for FDCs to the Central Drugs Standards Control Organization. Pharma companies were to respond within 30 days, a time period which was extended further.

“The government has made elaborate attempts to ensure that all facets of the matter get duly examined and no injustice is done to anybody and more importantly, the safety of the patient is not compromised," the government said.

Among the companies that won interim relief were Wockhardt Ltd, Laborate Pharmaceuticals, Abbott India, Macleods Pharmaceuticals Ltd, Pfizer India, Procter and Gamble Hygiene and Health Care (P&G), Glenmark Pharmaceuticals Ltd, Reckitt Benckiser of India Ltd, Piramal Enterprises Ltd and Alembic Pharma Ltd.

“While we agree that proven irrational formulations need to be weeded out, we are rather surprised and shocked that 344 drug combinations were banned by the ministry in one go. As these FDCs have been in wide use for long, sudden stoppage of supplies thereof will cause tremendous vacuum to take care of health problems of lakhs of suffering patients," said S.V. Veeramani, president of lobby group Indian Drug Manufacturers’ Association, in a statement to the media.

According to industry estimates, the current ban is expected to impact the 98,000 crore pharmaceutical industry in India by about 3,800 crore a year. The major brands included in the ban are P&G’s cold and cough drug Vicks Action 500 Extra, Pfizer India’s Corex, Piramal’s Saridon, Reckitt’s D Cold Total and Glenmark’s Ascoril-C.

Grania Brigden of the Medecins Sans Frontieres, an international non-government organization, welcomed the ban on the FDCs.

“MSF welcomes the Indian ministry of health’s 10 March notification on the prohibition of manufacture, sale and distribution of certain fixed dose combination drugs that put public health and lives of people at risk," she said, adding that there were certain anti-tuberculosis drugs available in the Indian private market which increased the prevalence of drug resistant tuberculosis.

“This year, India has a double challenge: to phase out irrational antibiotic FDCs in the private sector that are contributing to resistance generation, and to phase in the WHO-recommended daily FDC regimen for drug-sensitive TB (DS-TB)2 to the national TB programme, which has been shown to increase adherence and reduce pill burden," she said.

Jyotsna Singh contributed to this story.

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