India – NEW DELHI: Popular and widely-used medicines like phenylpropanolamine or PPA (found in cough and cold remedies like Vicks Action-500, Solvin,
NEW DELHI: Popular and widely-used medicines like phenylpropanolamine or PPA (found in cough and cold remedies like Vicks Action-500, Solvin,
Wincold), gastrointestinal tegaserod (marketed as Ibsinorm, Tegod, Tegibs), antibacterial gatifloxacin (Gaity) and pain-killer nimesulide (Nice and Nimulid) are under government scanner on concerns raised about their adverse reactions. The drug technical advisory board (DTAB) will take a decision next month to ban or restrict the usage of these and other drugs whose combined market sales are pegged close to Rs 400-500 crore a year.
Other ‘‘controversial’’ drugs, letrozole (used for infertility treatment in women; letroz), emergency contraceptive drug levonorgestrel (I-pill and Unwanted 72), and human placenta extract (Placentrex lotion and gel sold by Albert David) will also be examined by the health ministry. Besides taking a decision on banning certain drugs or restricting the use of some, DTAB will examine next month whether emergency contraceptive pills should be available over-the-counter (OTC) as reports of their misuse are frequent. It will also take a decision on whether letrozole, approved for use in breast cancer, should be used for infertility treatment or not, a health ministry official told TOI.
Earlier this year, the DTAB banned anti-obesity drug, rimonabant, on account of its serious side effects.
The DTAB under the health ministry examines issues concerning the Drugs and Cosmetics Act, and can advise the government to ban or restrict use of certain medicines, and the drug regulator, Drugs Controller General, acts on the basis of its recommendations. Sources said that for medicines like PPA found in popular cough and cold remedies, a permissible limit may be fixed, and commonly used drug Analgin may also be reviewed.
Officials said that concerns have been raised by WHO, parliamentarians and industry experts on adverse reactions and side-effects of drugs like letrozole, which are banned in some parts of the world, but are widely used in the country. After receiving concerns of safety, efficacy and side-effects of drugs from regulatory bodies, health ministry decided that the expert body DTAB should examine the issues, the official added.
Nimesulide, which has been banned in several countries for use in children, is still sold in the country, says Dr C M Gulati, a medical expert. The medicine has been under scanner in the past but no regulatory decision was taken to ban its use in children here, he adds.
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