The following got published in The Hindu:
(By Staff Reporter Posted: Wed, Jun 08, 2011)
The ban imposed by the Centre on manufacture, sale and distribution of drugs from human placental extract has been relaxed after a Kolkata-based pharmaceutical company took the matter to the Delhi High Court, company executives said here on Tuesday.
The Union Health and Family Welfare Ministry had passed a gazette notification to ban human placental extract and its formulations, among other drugs, on February 10 citing concerns about the safety of the product.
A city-based company, Albert David Ltd., which has been manufacturing drugs based on human placental extract for over five decades, challenged the order and filed a case in the Delhi High Court.
“Placentrex, a product made from the human placental extract, is a prestigious product of the company. It is a product developed from original research in India,” K. P. Mundhra, executive director of the company told journalists here on Tuesday.
On May 30, based on the recommendations of the an expert committee constituted by the Centre at the direction of the Delhi High Court, a relaxation has been given by another gazette notification allowing the use of human placental extract for topical application for healing wounds and injections for pelvic inflammatory disease.
The first licence granted to the company for a drug based on human placental extract was in 1949 for an injectible drug used for treatment of pelvic inflammatory disease, one of the causes of infertility among women. Subsequently it also obtained a licence for a gel that helps in tissue regeneration when applied to a wound.
“We also manufacture a lotion from human placental extract that may be used for curing Vitiligo. But we have been asked to carry out further clinical trials for the product,” Mr. Mundhra said.
Safety of product
Mr. Mundhra said all care is taken to ensure safety of the product in the manufacturing process to ensure that there are no micro-organisms present. He said that in 1989, in the wake of the threat from HIV, a temporary ban had been imposed on all blood products, but the temporary suspension of the manufacture of Placentrex was lifted after experts were satisfied with the safety of the product.
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