The Hindu : Tamil Nadu News : Ban on use of placental extracts and formulations for human use goes

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Tuesday, Jun 21, 2011
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Tamil Nadu

Tamil Nadu

Ban on use of placental extracts and formulations for human use goes

Special Correspondent

CHENNAI: The Central Government has withdrawn its February 10 ban on the use of human placental extracts and their formulations for human use.

It has, with effect from May 30, re-allowed the manufacturing and marketing of the extracts for use in wound healing and treating pelvic inflammatory disease.

It was in February 2011 that the Centre banned HPE along with five other molecules. Albert David, a Kolkata-based company, challenged the ban notification in the Delhi High Court. The government then gave an undertaking that issues related to safety and efficacy of the HPE, the primary reasons for the ban, would be re-examined by a nine member committee of experts.

This committee, comprising four medical experts, after deliberations on exhaustive scientific and clinical data on safety and efficacy, recommended that HPE continued to be manufactured, and used as injections for PID, and gel for local application to aid would healing. It however, rejected the use of HPE lotion for vitiligo.

The court then gave the government 10 days to make this new notification and a fresh notification allowing the manufacture and use of the HPE was issued on May 30.

K.P. Mundhra, executive director, Albert David, said the company's formulations, Placentrex (gel and injection) is the only human placenta based product in the country developed through indigenous research.

He added that not a single negative adverse drug reaction or side effect had been noted in the 60 years of use of the injection and 11 years' use of the gel. The placentas are collected from multiple city hospitals in Kolkata, thanks to a special arrangement with the State's Health and Family Welfare Ministry. About 300 placenta are collected every single day, refrigerated, transported to the factory, where they are stored for seven days after which the process of extraction begins.

During the processing, the product is tested at three stages for harbouring viruses or bacteria. “At the temperature we use as part of our patented process, it is impossible for these organisms to survive,” he said.

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