The Delhi High Court has asked the union health ministry to allow the use of human placental extracts for two indications in the country. The two indications include topical application for wound healing and injectibles for pelvic inflammatory diseases.
Accordingly, the ministry will soon amend its notification dated February 10 this year in which it had banned several controversial drugs including human placental extract following the Drugs Technical Advisory Board (DTAB)'s recommendation to the ministry. Other controversial drugs banned by the ministry on February 10 included non-steroid anti-inflammatory drug nimesulide suspension, gastroprokinetic agent cisapride and decongestant drug Phenylpropanolamine (PPA).
After examining the reports submitted by the 9-member expert committee, which went into the issue of efficacy and safety data of human placental extract, the court ordered that human placental extracts should be allowed for two indications. In India, human placenta extract sold as Placentrex lotion, gel and injection is being actively promoted as a remedy for a variety of unrelated disorders such as vitiligo, wound dressing, prevention of adverse effects due to radiotherapy, fallopian tube blockage, female infertility, scarring, post-phlebitic ulcers, scars due to acne, etc.
Earlier on April 6 this year, hearing a petition by the Kolkatta-based pharma company Albert David Ltd, which was a pioneer in human placental extract therapy in the country, the Delhi High Court had asked the union health ministry to constitute an expert panel to go into the issue.
As per the high court order, the government constituted a 9-member expert panel headed by renowned pharmacologist Dr YK Gupta of AIIMS. Other members of the committee included Dr Ajay Kumar of IMA, Dr Vijay Kumar of IDRI, Dr Sharma of ICMR, Dr Kotwal of AIIMS, Dr VK Tiwari, Dr VK Chakravorthy, Dr CM Sharma and Dr Lakhbir Dhaliwal of PGI, Chandigarh.
The committee was asked to submit a report on the matter by May 15 this year. After examining the drug in detail, the panel submitted its report to the court.
Human Placenta extract was never permitted for use as medicine in the western countries such as US, UK, Australia, Canada and European Union states due to lack of efficacy and safety data. However, some companies in US were importing products containing human placenta as dietary supplements. However, on April 14, 2008, all products containing human placenta extracts even for use as cosmetics have been banned by the US government.
Source:Pharmabiz
Accordingly, the ministry will soon amend its notification dated February 10 this year in which it had banned several controversial drugs including human placental extract following the Drugs Technical Advisory Board (DTAB)'s recommendation to the ministry. Other controversial drugs banned by the ministry on February 10 included non-steroid anti-inflammatory drug nimesulide suspension, gastroprokinetic agent cisapride and decongestant drug Phenylpropanolamine (PPA).
After examining the reports submitted by the 9-member expert committee, which went into the issue of efficacy and safety data of human placental extract, the court ordered that human placental extracts should be allowed for two indications. In India, human placenta extract sold as Placentrex lotion, gel and injection is being actively promoted as a remedy for a variety of unrelated disorders such as vitiligo, wound dressing, prevention of adverse effects due to radiotherapy, fallopian tube blockage, female infertility, scarring, post-phlebitic ulcers, scars due to acne, etc.
Earlier on April 6 this year, hearing a petition by the Kolkatta-based pharma company Albert David Ltd, which was a pioneer in human placental extract therapy in the country, the Delhi High Court had asked the union health ministry to constitute an expert panel to go into the issue.
As per the high court order, the government constituted a 9-member expert panel headed by renowned pharmacologist Dr YK Gupta of AIIMS. Other members of the committee included Dr Ajay Kumar of IMA, Dr Vijay Kumar of IDRI, Dr Sharma of ICMR, Dr Kotwal of AIIMS, Dr VK Tiwari, Dr VK Chakravorthy, Dr CM Sharma and Dr Lakhbir Dhaliwal of PGI, Chandigarh.
The committee was asked to submit a report on the matter by May 15 this year. After examining the drug in detail, the panel submitted its report to the court.
Human Placenta extract was never permitted for use as medicine in the western countries such as US, UK, Australia, Canada and European Union states due to lack of efficacy and safety data. However, some companies in US were importing products containing human placenta as dietary supplements. However, on April 14, 2008, all products containing human placenta extracts even for use as cosmetics have been banned by the US government.
Source:Pharmabiz
why U.S. govmnt. banned this useful drug..?
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