Thalidomide, the controversial morning sickness drug banned in the 1960s, is back in the Indian market with the government allowing free marketing of the drug after restrictive use of the same for quite some time.

Dabur India Limited had launched its thalidomide brand, Thalix last month in capsules of 50 mg and 100 mg and this prescription-based drug was to initially be available in selective cancer hospitals, institutions and nursing homes only. This restricted availability of thalidomide also follows guidelines by the DCGI wherein post marketing surveillance study needs to be conducted for every new drug for an initial period of two years.

The side-effects associated with the use of thalidomide is well known. In fact it is one of the reasons why WHO started its international drug monitoring programme. In the late 1950's, use of thalidomide by expectant mothers raised concerns worldwide when several deformities were reported in newborn babies as a result of its use by mothers during pregnancy. The drug was later banned and withdrawn from most markets. However, thalidomide has recently been found to be effective in curing ENL and multiple myeloma worldwide. The drug is known to have a widespread use in the western countries as well as in developing countries.

Dabur is the first company in India to get approval from the Drug Controller General of India (DCGI) for manufacturing and marketing this drug and with this launch it also becomes the first company to launch this formulation in India. The new drug formulation is indicated for treating multiple myeloma, a type of blood cancer, and Erythma Nodosum Leprosum (ENL), a painful skin condition associated with leprosy.

Thalidomide seems to work by stabilising blood flow around tumours, thereby allowing better supply of the chemotherapy agents to the cancerous cells. It then goes on to prevent the growth of further blood vessels, halting tumour growth. The drug has been shown to be a highly effective treatment for multiple myeloma and Kaposi's sarcoma, as well as for rheumatoid arthritis and is an unlicensed indication for leprosy patients who are corticosteroid resistant.

Today thalidomide is approved in Brazil and Mexico. Developed countries including UK and USA have given restricted approval for marketing thalidomide for various indications. The drug is also approved in the US to treat painful, disfiguring skin sores associated with leprosy.