Home > Articles, health, News > Off The Shelves! Belatedly, the govt bans risky medicines

Off The Shelves! Belatedly, the govt bans risky medicines

Danger List…

  • Gatifloxacin: An antibiotic used for treating respiratory tract infections. Can cause diabetes.
  • Tegaserod: Used for constipation and irritable bowel syndrome. Increase risk of heart attack and stroke.
  • Cisapride: Used to increase motility in the upper gastrointestinal tract. Can cause serious cardiac problems.
  • Phenylpropanolamine: Decongestant that can also increase the risk of stroke
  • Human Placental Extract: Used for cosmetic skin treatments and female infertility. It can transmit diseases.
  • Sibutramine: Constituent of weight-loss pills. Said to cause heart problems.
  • lR-Sibutramine: Also a weight-loss medicine. Increases the chances of stroke and heart problems.
  • Nimesulide: Painkiller and antipyretic. Harmful to the liver.

***

In the last six months, the Union health ministry has suddenly adopted a proactive tack to banning drugs. After facing quite a lot of criticism internationally for the easy availability in India of suspect medicines—including drugs that have been banned abroad for many years—the ministry has come down heavily on the Drug Controller General of India (DCGI) to enforce bans and ensure that chemists do not stock or sell dangerous drugs.

In February, the ministry banned the manufacture, sale and distribution of gatifloxacin and tegaserod. The decision was taken on the Drug Technical Advisory Committee’s (DTAC) recommendation. Gatifloxacin is an antibiotic used for respiratory infections and is said to cause diabetes. Tegaserod is used for constipation and irritable bowel syndrome, but is said to increase the risk of heart disease and stroke.

In November last year, the drug controller announced a ban on weight-loss medication containing sibutramine and R-sibutramine, which are known to cause strokes. Several medical products containing the two drugs have been under the scanner but no action was taken until recently. One major problem with such products was that they were available without prescription.

India has been rather slow in banning drugs that have gone off the shelves abroad after research showed they were harmful. Nimesulide (paediatric), for instance, has been banned internationally, but health officials in India maintained that its use had shown no adverse effects in Indian children. It’s only after 10 years of safety assessment studies that it was finally banned this year. In all likelihood, the ministry has managed to fight off pressure mounted by pharmaceutical lobbies. “It is our responsibility to ensure that safe medicines are sold in the country,” says a senior health ministry official. “Even if it has taken a long time to come into effect, it’s never too late to take corrective steps.”

But not everyone is satisfied with the ministry’s actions. “The ban on several drugs has come under generic names but often the brand names are very different. Sometimes they are a combination or formulation of drugs, and this makes it difficult for doctors and consumers to know if they are banned,” says Dr Mira Shiva, a public health activist. “The ministry needs to make the names of these brands public and create more awareness. Otherwise the entire purpose is defeated.”

Earlier this week, the DCGI announced it has temporarily stopped giving marketing approval to new drugs in key therapeutic segments. The approvals will resume once a new approval system, in which the opinion of a 10-member panel of independent experts is taken into account, is streamlined. New drug advisory committees (NDACS) will be constituted for each therapeutic category, such as gastroenterology, oncology, urology etc. The committees will advise DCGI on both new drugs and on clinical trials of categories of medicines like antibiotics. India had approved 223 new drugs (including new combinations of already approved drugs) in 2010. There were 32 new drug approvals in January-March this year.

The new NDACS and the refusal of the ministry to approve drugs banned internationally may not go down well with pharmaceutical companies. But doctors and health ministry officials say it will be in the larger interest of the people. Patients can rest a bit more assured about their medication.

Source: The Outlook

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