According to this recent amendment fixed dose combination of haemoglobin in natural or synthetic form and fixed dose combination of pancreatin or pancrelipase combining amylase, protease and lipase with any other enzyme can now be manufactured for sale.

Earlier in August, 1999, the government had banned the manufacture and sale of these two combinations as it was likely to involve risk to human beings and that in the public interest it was found necessary and expedient to prohibit the manufacture, sale and distribution of these drugs under the provisions of section 6A of the Drugs and Cosmetics Act, 1940.

While imposing the ban the government stated that haemoglobin obtained from animal blood could be unhygenic and such preparations are needed to be taken in extraordinary high volumes to deliver the recommended level of iron in enaemic cases and thus lacks therapeutic rationale.