CHENNAI: The ban imposed by the government of India on the sale of drugs made of human placental extract has been relaxed following a Delhi High Court order, announced K P Mundra, Executive Director, Albert David Ltd, here on Monday.
On May 30, based on the recommendations of an experts committee constituted by the Centre at the direction of the Delhi High Court, a relaxation was given by an amended gazette notification allowing the use of human placental extract for topical application for healing wounds and injections for pelvic inflammatory disease.
A Kolkata-based company, Albert David Ltd, which has been manufacturing drugs based on human placental extract for over five decades, filed a case in the Delhi High Court after a ban was imposed by the Union Health and Family Welfare Ministry on February 10, 2011. This followed the recommendation of Drug Technical Advisory Board (DTAB) sub-committee based on safety concerns over the company’s product.
“Placentrex, a product made from the human placental extract, is an original research product of Albert David. During its presence, not even a single case of side effects or cross infection has been reported. In fact, thousands of doctors across India have recommended the product to millions of patients which speaks about the safety and efficacy of the product, claimed Mundra.
The company was first issued a licence to manufacture a drug based on human placental extract in 1949. It was for an injectible drug used for the treatment of pelvic inflammatory disease, common in women. It also secured licence for a product in gel form that helps in tissue regeneration when applied to a wound.
“We also manufacture a lotion from the human placental extract that is used for curing vitiligo. But the ban on the product has not been lifted as we have been asked to carry out further clinical trials for the product,” said Mundra.
He added that the company adopts stringent control measures at every stage of manufacturing process to ensure that there are no micro-organisms present. The company has adhered to the guidelines prescribed by the regulatory authorities.