Indian regulators are accused of laxity in not banning drugs
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《英国医生杂志》
Doctors and health activists in India have said that they would welcome a government ban on the arthritis drug rofecoxib but warned that there are other drugs withdrawn elsewhere in the world but still sold and prescribed in India.
They pointed out last week that Indian drug regulatory authorities have refused to ban the sale of 11 other drugs and over 80 combinations of drugs that have been discarded or have never been approved in many countries.
After the drug company Merck抯 recent announcement of the worldwide withdrawal of rofecoxib (Vioxx) (BMJ 2004;329:816, 9 October) Indian drug officials said that they would examine Indian data on adverse reactions to decide whether to ban the drug. Earlier this week, the government consulted experts and indicated that it would ban rofecoxib, although local drug companies had said that it did not cause any harm in short term use.
Indian law does not grant drug companies patents on drug compounds but on the process used to produce such chemicals. So Indian drug companies strive to find new processes to produce the chemicals. This allows them to produce generic versions of the drugs and market them under their own brand names.
More than 20 Indian companies produce rofecoxib, the top five brands accounting for annual sales of 400 million rupees (?.9m; $8.8m, �7.0m). Ranbaxy Laboratories, the company with the largest market share, said last week that it would ask doctors to prescribe rofecoxib exclusively for short term use.
"Our short term clinical studies in India show that the drug is effective without significant cardiovascular side effects," a Ranbaxy spokesperson said. "But we抮e now collecting fresh data and will send recommendations to the government."
Doctors campaigning for the sensible use of drugs say that regulatory authorities in India have not addressed the issue of being slow to withdraw drugs. Eleven drugs—including cisapride, furazolidone, nimesulide and phenylpropanolamine—that have been banned, withdrawn, or marketed under restrictions in North America, Europe, and many Asian countries continue to be sold in India.
"The drug regulatory system in India has geared itself to protect industry interests," said Dr Chandra Gulhati, editor of the Monthly Index of Medical Specialties India, a drug information bulletin. In addition to single ingredient drugs, regulators have also approved over 80 unorthodox, fixed dose combinations of drugs. "Many of these combinations remain untested, potentially dangerous, or simply ludicrous," Dr Gulhati said.
For instance, drug regulators approved a combination of aceclofenac and paracetamol earlier this year. Dr Gulhati said it was approved without the mandatory clinical trials that are required under Indian law for any new drug that is combined the first time. "You won抰 find this anywhere else," he said. Other such combinations include ciprofloxacin and tinidazole, alprazolam and atenolol, and the nonsteroidal anti-inflammatory drugs diclofenac and nimesulide.
However, Mr Ashwini Kumar, the drug controller general, said all decisions to approve or ban a drug are based on rigorous scientific review. "Some drugs are used differently in India than they are in other countries. We conduct a thorough benefit-risk analysis," he said.
Health activists said that drug companies?promotional practices influenced the choice of drugs that doctors prescribe.
"Even highly qualified and well experienced doctors write irrational prescriptions," said Dr Mira Shiva, head of public policy at the Voluntary Health Association of India.(New Delhi Ganapati Mudur)
They pointed out last week that Indian drug regulatory authorities have refused to ban the sale of 11 other drugs and over 80 combinations of drugs that have been discarded or have never been approved in many countries.
After the drug company Merck抯 recent announcement of the worldwide withdrawal of rofecoxib (Vioxx) (BMJ 2004;329:816, 9 October) Indian drug officials said that they would examine Indian data on adverse reactions to decide whether to ban the drug. Earlier this week, the government consulted experts and indicated that it would ban rofecoxib, although local drug companies had said that it did not cause any harm in short term use.
Indian law does not grant drug companies patents on drug compounds but on the process used to produce such chemicals. So Indian drug companies strive to find new processes to produce the chemicals. This allows them to produce generic versions of the drugs and market them under their own brand names.
More than 20 Indian companies produce rofecoxib, the top five brands accounting for annual sales of 400 million rupees (?.9m; $8.8m, �7.0m). Ranbaxy Laboratories, the company with the largest market share, said last week that it would ask doctors to prescribe rofecoxib exclusively for short term use.
"Our short term clinical studies in India show that the drug is effective without significant cardiovascular side effects," a Ranbaxy spokesperson said. "But we抮e now collecting fresh data and will send recommendations to the government."
Doctors campaigning for the sensible use of drugs say that regulatory authorities in India have not addressed the issue of being slow to withdraw drugs. Eleven drugs—including cisapride, furazolidone, nimesulide and phenylpropanolamine—that have been banned, withdrawn, or marketed under restrictions in North America, Europe, and many Asian countries continue to be sold in India.
"The drug regulatory system in India has geared itself to protect industry interests," said Dr Chandra Gulhati, editor of the Monthly Index of Medical Specialties India, a drug information bulletin. In addition to single ingredient drugs, regulators have also approved over 80 unorthodox, fixed dose combinations of drugs. "Many of these combinations remain untested, potentially dangerous, or simply ludicrous," Dr Gulhati said.
For instance, drug regulators approved a combination of aceclofenac and paracetamol earlier this year. Dr Gulhati said it was approved without the mandatory clinical trials that are required under Indian law for any new drug that is combined the first time. "You won抰 find this anywhere else," he said. Other such combinations include ciprofloxacin and tinidazole, alprazolam and atenolol, and the nonsteroidal anti-inflammatory drugs diclofenac and nimesulide.
However, Mr Ashwini Kumar, the drug controller general, said all decisions to approve or ban a drug are based on rigorous scientific review. "Some drugs are used differently in India than they are in other countries. We conduct a thorough benefit-risk analysis," he said.
Health activists said that drug companies?promotional practices influenced the choice of drugs that doctors prescribe.
"Even highly qualified and well experienced doctors write irrational prescriptions," said Dr Mira Shiva, head of public policy at the Voluntary Health Association of India.(New Delhi Ganapati Mudur)