Court revoking ban on cough remedy worries health activists

They say continuing availability of the drug poses health risk

By Moyna
Published: Monday 26 September 2011

The Madras High Court has revoked the ban on the drug formulation phenylpropanolamine (PPA) and all its combination drugs available in the market. PPA is commonly used in cough and cold medications and is also used as a nasal decongestant; it was approved by the drug controller's office about 20 years ago. The ban was imposed by the Centre in February this year following a recommendation of an expert committee. The court revoked the ban on September 9 following a petition filed by pharmaceutical giant Cipla.

The government notification of February had banned six drugs—nimesulide for use for children below 12, cisapride, PPA and its combinations, human placenta extract, sibutramine and R-sibutramine (See box on the uses and ill-effects).

The banned drugs and their effects

Nimesulide: Used to relieve acute pain, fever, symptomatic treatment of osteoarthritis and primary dysmenorrhoea. Many countries have withdrawn it because of concerns about the risk of liver damage

Cisapride and its formulations: Used to treat constipation and to treat symptoms of night-time heartburn due to reflux disease. Serious or fatal heart problems have occurred when cisapride was used alone or with other drugs

Phenylpropanolamine: Commonly used in cough and cold preparations. It leads to increase in heart rate, blood pressure, dilation of pupils, increased energy, drying of mucous membranes and increased sweating

Human placenta extract: Placentas are a source of Human Chorionic Gonadotropin, a naturally produced substance which is used in the treatment of obesity, asthma, gastritis, neurosis, heart damage, hyperlipemias, hypercholesterolemia, eczemas, glaucoma, alcoholism, and more recently a cancer-like tumour appearing in AIDS patients—Kaposi sarcoma. They can transmit diseases and pose serious health hazards to consumers. In India, human placenta extract sold as Placentrex lotion, gel, and injection

Sibutramine: Sibutramine is an appetite suppressant and is used in combination with a reduced calorie diet and exercise to help people lose weight and maintain weight loss. Sibutramine is an appetite suppressant. It has been associated with increased cardiovascular events and strokes

Many pharma companies challenged the notification. Albert David Ltd challenged the ban on human placenta extract in the Delhi High Court. The court referred the matter to an expert committee, which recommended strict monitoring on the use of placenta extract. The ban notification was accordingly modified. The notification now has strict guidelines that are to be followed during the manufacture and use of the drug. Its use is highly restricted. Smaller companies, under the banner of Confederation of Indian Pharmaceutical Industries, challenged the ban of nimesulide, but withdrew it in July 2011.

Cipla filed a petition in the Madras High court, calling the notification unlawful and illegal. Claiming PPA has been in use in the international market for over 50 years, Cipla said the drug has no reported ill-effects. The company also stressed on the need for the government to give them enough time to phase out the medicine instead of imposing ban with immediate effect.

The Union health ministry countered Cipla's claim stating that if a drug is found to be harmful it ought to be removed from the market immediately. Public health activist Gopal Dabade who heads the non-profit Jagruti agrees. He says Cipla's argument made no sense. “It is the same as saying we will kill people in a phased manner.”

During the court proceedings, counsel for Cipla, submitted numerous reports citing the benefits of PPA. The company contended that the union government had no data or basis to show that this drug was harmful. The court expressed its inability assess the drug's benefits. The court ordered lifting of the ban on the technical ground that the ban was imposed without the mandatory recommendation of the Drugs Technical Advisory Board (DTAB). The court added that the bench was not sitting in judgement on the government decision but was trying to “maintain democratic values of rule of law”. In this regard it stated that only with regard to phenylpropanolamine, the ban was revoked.

Health ministry officials say the six drugs have been banned because an expert committee set up by an earlier DTAB had suggested in November 2010 that they be removed from the market. “The committee after reviewing the benefit versus ill-effects ratio of these drugs felt they had to be removed from the market with immediate effect,” says Arun Panda, joint secretary. Sources in the ministry said the matter will be taken up further as the ban is in greater public interest.

Why many countries banned PPA

Dabade says that India does not have the infrastructure or any other system in place to be able question or study drugs the way it is done abroad.” He explains that many drugs are banned on the basis of studies carried out outside the country. One of the most emphatic researches presented in the court was a study by Yale University.

The drug is banned in many countries because of its association with cardiac congestive failure and haemorrhagic stroke at higher doses
Health ministry says phenylpropanolamine and the other five drags were banned after an expert committee reviewed the benefit versus ill-effects ratio of these drugs and felt they had to be removed from the market with immediate effect
Cipla's argument that the drug should have been phased out made no sense because it is the same as saying “we will kill people in a phased manner”, says health activist Gopal Dabade

The same study findings were used in other countries to ban this drug. PPA was withdrawn from the US in November 2000 due to its association with cardiac congestive failure and haemorrhagic stroke at higher doses. Canada, Cuba, Singapore, Malaysia Brazil and Oman were among the first few countries to remove the drug from the market between 2000 and 2001.

“When drugs are introduced in a country, more often than not, even companies use studies conducted abroad to show the merits. And when the drug (PPA) has been proved harmful across the globe, how can it be a different case for Indian consumers?” asks Dabade.

Dabade says this order is disheartening as it leaves the scope of further damage to the public. “In this country we do not have a satisfactory mechanism to monitor adverse affects of drug side-effects and data collections or surveys are very sporadic. Therefore, when people are suffering adverse effects no-one even knows,” he says. Explaining further, he says that by revoking the ban on technical grounds the court has left a huge window open for further abuse because of the drug.

S Srinivasan, a generic drug manufacturer in Chennai, says, “nowhere does the Drugs and Cosmetics Act make it mandatory for the DTAB to be in place for the ban of drugs. The government can ban drugs on the basis of expert group findings, which was in place.” According to him the fact that court recognised its limitation as a legal body and not a technical expert was positive but the revocation of the ban is puzzling as there is enough data and material to substantiate the ban.

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