By Swapan Das, Calcutta
For the supporters of Human Placental Extract & its Formulations in India, the wait is all but over!
For the supporters of Human Placental Extract & its Formulations in India, the wait is all but over!
Human Placental Extract and its Formulations is back vide the Gazette Notification No. G.S.R. 418(E) dated May 30, 2011 of the Ministry of Health & Family Welfare.
On Friday May 20, 2011, the Delhi High Court on its verdict has given clearance to the manufacturing, sale and distribution of Human Placental Extract and its formulations for human use in India on the basis of the report submitted by the 9-member expert committee on Human Placental Extract and its formulations.
Earlier hearing the petition on April 6 filed by the Kolkata-based pharma manufacturer Albert David Ltd, which is a pioneer in human placental extract therapy in India, the Delhi High court asked the Indian Union Health Ministry to constitute a 9-member expert committee to go into the issue of efficacy and safety data of human placental extract. The expert committee was asked to submit a report on the matter by May 15, 2011. The 9-member expert committee formed by the Union Health Ministry which gave its clearance verdict after doing a thorough review on the issue of efficacy and safety data of human placental extract was consisted of:
- Dr YK Gupta of AIIMS, who headed the panel
- Dr Ajay Kumar of IMA
- Dr Vijay Kumar of IDRI
- Dr Sharma of ICMR
- Dr Kotwal of AIIMS
- Dr VK Tiwari
- Dr B.N. Chakraborty
- Dr CM Sharma
- Dr Lakhbir Dhaliwal of PGI, Chandigarh
Albert David Ltd., India applied the petition against the notification of the Union Health Ministry (GSR 82 E) dated February 10, 2011 in which Union Health Ministry had banned six drugs viz. non-steroid anti-inflammatory drug nimesulide (below 12 years age), gastroprokinetic agent Cisapride, decongestant drug Phenylpropanolamine (PPA), human placental extract & its formulations, Sibutramine & its formulations and R-Sibutramine & its formulations.
And on 30th May 2011, the Central Government has released an amended version vide gazette notification no. G.S.R. 418(E) allowing the use of Human Placental Extract and its formulations.
And on 30th May 2011, the Central Government has released an amended version vide gazette notification no. G.S.R. 418(E) allowing the use of Human Placental Extract and its formulations.
The rational review of the issue by the 9-member expert committee and Delhi High Court's judgment will boost the ongoing research work on Human Placental Extract in India and the general awareness on this domain which is quite low is expected to increase after this decision.
SUMMARY: Delhi High Court ruling & Central Government (India)'s notification no. G.S.R. 418(E) dated 30th May 2011 means:
SUMMARY: Delhi High Court ruling & Central Government (India)'s notification no. G.S.R. 418(E) dated 30th May 2011 means:
- Manufacture, sale and distribution of Human Placental Extract and its formulations is once again allowed in India following the guidelines of the amended notification.
- The use of Indian brand "PLACENTREX" manufactured by Albert David Ltd. ,Calcutta will continue while complying with the guidelines of the notification.
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