As per the rules under the Drugs and Cosmetics Act, “the Drug Controller General of India (DCGI) has an absolute authority to recommend a ban after a notification by the Union health ministry,” said Dr CM Gulhati, Editor of the monthly Index of Medical Specialties.

The drugs were banned after the recommendations of a sub-committee of the Drug regulator – Drug Technical Advisory Board (DTAB). Chaired by the Directorate General of health Services (DGHS), the DTAB has been a part of Drugs and Cosmetics Act since its inception. The standing committee of the DTAB consists of producers of the drug and experts from medical fraternity.

The drugs banned recently were picked after reviewing studies and data which showed their ill effects. There were no indigenous studies.

The Drug Controller General of India (DCGI), Dr Surinder Singh said this will improve in the years to come. “It is true that we don’t have any data as of now and are dependent on data from outside, but things are likely to improve in the next two years,” he said. “We will be in a better position to ban the drugs based on our own pharmacovigilance programme.”

Once the Union health ministry notifies ban of the drug, the drug goes off the shelves. “In India it has not happened that after the drug is banned, the manufacturers are still manufacturing it,” said Gulhati. But it is the responsibility of the state drug inspectors to keep a strict vigil on the market.

Even so, according to experts, many drugs banned internationally are still available in India.

“Painkiller Analgin (sold as Novalgin, Baralgon, Nimesulide for adults), Thioridazine (an anti-psychotic),Ccarisoprodol (muscle relaxant), Quiniodochlor (for diarrhoea), are some that are still available in India,” said Gulhati. “Because they are globally banned, they should be banned here as well. In fact, we are the only country where certain drugs which are not approved anywhere in the world are sold freely.”

Dr Randeep Guleria, Professor of Medicine, All India Institute of Medical Sciences (AIIMS) said: “There should be faster action. If the drugs are banned internationally, India should also take a faster call on it without delay.”

NIMESULIDE

Among the drugs recently banned here is the analgesic Nimesulide suspension, meant for paediatric use. Having been satisfied that the use of drug “is likely to involve risks to human beings” the Union health ministry prohibited its manufacture, sale and distribution in public interest. On February 10, the ministry notified the ban, the existing batches of which now has to be pulled off the market shelves.

“It is necessary to give advertisements to this effect,” Singh said. “Even though the state drug controllers have been alerted, it is necessary that people should know that these drugs are unsafe.” According to officials, the advertisements to this effect are likely to start soon.

Status

The analgesic Nimesulide is already banned in developed nations like the US, Canada and European Union countries. Worldwide, paedriatric Nimesulide was approved in few places including India, Russia, Columbia and Mexico. In the US and other developed nations, no one ever applied for marketing permission of this drug. In Switzerland — where the medicine was discovered – it was never used. Bangladesh, too, recently banned its use for children and disallowed its import.

The drug

Nimesulide is a non-steroidal anti-inflammatory drug with pain killing and fever-reducing properties. The drug is manufactured by Panacea Biotec — the paediatric brand being Nimulid – and Dr Reddy’s Lab – the brand Nise. It is available in a number of forms, mostly as 100 mg pills. The trade names include Namosid, Nicip, Nise, Nimulid and Nimutab.

Side effects

The adverse effects of this drug includes liver toxicity, which could further lead to liver damage. The other side effects are diarrhoea, vomiting, skin rash and dizziness.

SIBUTRAMINE

In November, the DCGI also recommended the ban of the anti–obesity drug Sibutramine. It is marketed in India by a dozen companies under brand names like Reductil, Meridia and Sibutrex.

Status

Prescribed worldwide for three decades, recent research has linked the drug to an increased incidence of cardiac arrests and strokes. The pharma giant Abbott Laboratories has withdrawn its products containing Sibutramine from the US, Australian, Canadian and other markets.

Moreover, a scout trial that began in 2003 involving about 9,000 people across 16 countries made the decision of India’s drug regulatory watchdog easy.

The drug

Around 90 per cent people use the drug for burning fat. In India, experts say Sibutramine was prescribed for obese diabetics. Using it for six months can result in a loss of 6-10 kgs. Dr Anoop Misra of Fortis Healthcare said Sibutramine was frequently prescribed for obese diabetics in India. Though the drug has been banned, he said it was good for those under 40 years in age.

Side effects

Sibutramine was associated with more deaths in people who had hypertension or had suffered a heart attack or stroke.

ROSIGLITAZONE

The well-known anti-diabetic drug Rosiglitazone, too, faced a ban in the Indian market from October, after the US Food and Drug Administration (FDA) restricted its use in response to data suggesting it could increase the risk of cardiovascular problems.

Status

Soon after the FDA warning, the DCGI suspended the manufacture and import of Rosiglitazone. He even asked state drug controllers to suspend the licenses of manufacturers for the sale and distribution of this drug and its fixed dose combinations. But flooded with complaints about the drug being still available in the market, the DCGI approached the health ministry to ban it completely.

The drug

Rosiglitazone was widely used in India for correcting blood sugar levels. In view of the FDA recommendations, an expert committee in India had observed that the Indian population is at a relatively higher risk of cardiovascular diseases because of factors like “genetic predisposition, higher incidence of dyslipidemia and metabolic syndrome”. All these factors, according to experts, could lead to increased cardiovascular problems with the continued use of the drug.

Side effects

Rosiglitazone was found to be posing a high risk of heart attacks to those taking it.

CISAPRIDE

In February, Cisapride, a “pro-kinetic agent” – substances that increase the movement of the gut and suppress acidity – which is also prescribed for alleviating constipation, has been banned after it was found out to be causing heart movement abnormalities.

Status

The drug was banned across the world in early 2000 after a study found that it caused abnormal heart movement in 341 people in the US of whom 80 died. The sale of Cisapride was severely restricted in the US and subsequently in Britain.

The drug

In India, action was taken last year after a standing parliamentary committee on health and family welfare sent a detailed questionnaire asking the Drug Controller about the lack of action on globally banned drugs including Cisapride. A committee was formed and based on western data, it was decided to ban the drug here too. “In fact most of these drugs have been banned due to that pull up,” said Gulhati.

Side effects

Cisapride was found to be causing abnormal heart movements.

PHENYLEPROPANOLAMINE

Phenylepropanolamine (PPA), used in cough syrups, has also been banned now in India.

Status

This drug was banned 10 years ago in the West after a large study by experts of Yale University found that it posed an increased risk of stroke in both adults and children. In November 2000, the results of a five-year study by the FDA of 702 patients that included Indians, corroborated the findings of the researchers from Yale.

The drug

PPA is one of the several ingredients used in cold and cough remedies. There were about 20 drugs in the market that contained PPA, but the manufacturers removed it and replaced it with safer alternatives.

Human Placenta Extract

This is used for to heal wounds, arthritis and other tropical applications.

Status

All products containing extract of human placenta have been banned by the US Food and Drug Administration since they can transmit diseases and pose serious health hazard. Placenta extract was never permitted for use as medicine in the countries like Canada, Britain, Australia, and European Union states due to lack of efficacy and safety data.

In February, it was banned in India too.

STILL UNDER SCANNER

Withdrawn earlier from the US the widely used antibiotic Gatifloxacin has recently been banned in India.